U.S. patent application number 13/180009 was filed with the patent office on 2011-11-03 for method of neurostimulation of distinct neural structures using single paddle lead to treat multiple pain locations and multi-column, multi-row paddle lead for such neurostimulation.
Invention is credited to John H. Erickson, Claudio A. Feler.
Application Number | 20110270350 13/180009 |
Document ID | / |
Family ID | 38309958 |
Filed Date | 2011-11-03 |
United States Patent
Application |
20110270350 |
Kind Code |
A1 |
Feler; Claudio A. ; et
al. |
November 3, 2011 |
METHOD OF NEUROSTIMULATION OF DISTINCT NEURAL STRUCTURES USING
SINGLE PADDLE LEAD TO TREAT MULTIPLE PAIN LOCATIONS AND
MULTI-COLUMN, MULTI-ROW PADDLE LEAD FOR SUCH NEUROSTIMULATION
Abstract
In some embodiments, a paddle lead is implanted within a patient
such that the electrodes are positioned within the cervical or
thoracic spinal levels. An electrode combination on a first row of
electrodes can be determined that is effective for a first pain
location with minimal effects on other regions of the body. The
first pain location can be addressed by stimulating a first dorsal
column fiber due to the relatively fine electrical field resolution
achievable by the multiple columns. Then, another electrode
combination on a second row of electrodes can be determined for a
second pain location with minimal effects on other regions. The
second pain location could be addressed by stimulating a second
dorsal column fiber. After the determination of the appropriate
electrodes for stimulation, the patient's IPG can be programmed to
deliver pulses using the first and second rows according to the
determined electrode combinations.
Inventors: |
Feler; Claudio A.; (Memphis,
TN) ; Erickson; John H.; (Plano, TX) |
Family ID: |
38309958 |
Appl. No.: |
13/180009 |
Filed: |
July 11, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11627699 |
Jan 26, 2007 |
7979131 |
|
|
13180009 |
|
|
|
|
60762616 |
Jan 26, 2006 |
|
|
|
Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/36071 20130101;
A61N 1/0553 20130101; A61N 1/36185 20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/34 20060101
A61N001/34 |
Claims
1. A system for treating pain in a patient using spinal cord
stimulation, wherein (i) the pain includes a first pain component
within a first bodily sub-region of a trunk of the patient, (ii)
the pain includes a second pain component within a second bodily
sub-region of lower extremities of the patient separated from the
first bodily sub-region by intervening bodily sub-regions, the
system comprising: a paddle structure adapted to be implanted
within epidural space of the patient with the paddle structure
having electrodes disposed in at least four mutually adjacent
columns and at least two adjacent rows on the paddle structure; a
pulse generator that is electrically coupled to the paddle
structure and that is programmable to deliver pulses to a spinal
cord of the patient using the electrodes of the paddle structure a
non-transient computer-readable medium with instructions stored
thereon that, when executed, cause the pulse generator to: (i)
generate a first electrical field, created by stimulation pulses
having a first set of stimulation parameters including one or more
first active electrode to treat pain in the first bodily
sub-region, the first set of stimulation parameters applied through
the first active electrode, has restricted spatial resolution to
stimulate a first set of one or more dorsal column fibers; and (ii)
generate a second electrical field, created by the stimulation
pulses having a second set of stimulation parameters including one
or more second active electrode to treat the pain in the second
bodily sub-region, the second set of stimulation parameters applied
through the second active electrode, has the restricted spatial
resolution to stimulate a second set of one or more dorsal column
fibers; wherein, in response to the program, the patient
experiences paresthesia in the first and second bodily sub-regions
and the patient experiences minimal sensory effects from applied
electrical pulses in the intervening bodily sub-regions.
2. The system of claim 1 further comprising a programmer device
capable of programming the pulse generator.
3. The system of claim 1 wherein the first set of one or more
dorsal column fibers are associated with a first fasciculus of a
dorsal column of the patient and the electrical field created by
the stimulation pulses restricts the stimulation to the first set
of dorsal column fibers associated with the first fasciculus while
minimizing the stimulation to adjacent dorsal column fibers in the
first fasciculus or adjacent dorsal column fibers in another
immediately adjacent fasciculus.
4. The system of claim 1 wherein the second set of one or more
dorsal column fibers are associated with a second fasciculus of a
dorsal column of the patient and the electrical field created by
the stimulation pulses restricts the stimulation to the second set
of dorsal column fibers associated with the second fasciculus while
minimizing the stimulation to the adjacent to the dorsal column
fibers in the second fasciculus or adjacent dorsal column fibers in
another immediately adjacent fasciculus.
5. The system of claim 1 wherein the paddle structure is configured
to spans a physiological midline of the patient.
6. A method of treating pain in a patient with spinal cord
stimulation, wherein i) the pain includes at least two bodily
sub-regions of the patient and the bodily sub-region of the patient
comprises upper extremities, lower extremities or a trunk of the
patient, ii) a paddle lead implanted within epidural space of the
patient, the method comprising selecting a set of stimulation
parameters including at least one active electrode combination to
treat the pain in the bodily sub-region, wherein the paddle lead
comprises a plurality of electrodes disposed in at least four
mutually adjacent columns and at least two adjacent rows on the
paddle structure; and controlling a pulse generator to generate
electrical pulses and to apply electrical pulses to the patient
through the paddle lead according to the stimulation parameters,
wherein: an electric field, created by stimulation pulses applied
through the active electrode combination, has a restricted spatial
resolution to stimulate one or more dorsal column fibers associated
with the bodily sub-region without causing the stimulation of the
dorsal column fibers associated with other bodily regions, wherein,
in response to applied electrical pulses, the patient experiences
paresthesia in the bodily sub-region with minimal sensory effects
from the applied electrical pulses in other the bodily regions.
7. The method of claim 6 wherein the active electrode combination
is moved laterally such that the electric field migrates across a
dorsal column of the patient providing perceived stimulation of the
bodily sub-region of the patient, wherein the sub-region is
associated with lateral segmentation of one or more fasciculus of
the dorsal column of the patient.
8. The method of claim 6 wherein the bodily sub-regions of the
patient are the trunk and the lower extremities.
9. The method of claim 6 wherein the bodily sub-regions of the
patient are the trunk and the upper extremities.
10. The method of claim 6 wherein the paddle structure is
positioned such that it spans one vertebral segment
11. The method of claim 6 wherein the paddle structure is
positioned epidurally in a lower thoracic vertebral level of the
patient.
12. The method of claim 6 wherein the paddle structure is
positioned epidurally in an upper cervical vertebral level of the
patient.
13. A method of treating pain in a patient using spinal cord
stimulation, the method comprising: operating a programming device
to control stimulation settings of a pulse generator, wherein (i)
the pulse generator is electrically coupled to a stimulation paddle
lead, (ii) the stimulation paddle lead is capable of being
implanted within epidural space of the patient, the stimulation
paddle lead comprises a structure having a plurality of electrodes
disposed in at least four mutually adjacent columns and at least
two adjacent rows on the structure; and selecting at least one
active electrode combination to define a stimulation therapy for
the patient, wherein application of electrical stimulation using
the selected one active electrode combination applies paresthesia
to at least two sub-regions of a bodily region of the patient and
does not cause paresthesia outside of the sub-regions or in
intervening sub-regions.
14. The method of claim 13 wherein the structure spans
physiological midline of the patient.
15. The method of claim 13 wherein the selected active electrode
combination is selected from electrode combinations that is
associated with any one of fasciculi of a dorsal column of the
patient.
Description
RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 11/627,699, filed Jan. 26, 2007, now U.S. Pat. No. 7,979,131,
which claims the benefit of U.S. Provisional Application No.
60/762,616, filed Jan. 26, 2006, the disclosures of which are
incorporated herein by reference.
TECHNICAL FIELD
[0002] The present application is generally related to providing an
effective neuromodulation therapy for multiple pain locations using
a multi-column, multi-row paddle lead.
BACKGROUND
[0003] Application of electrical fields to spinal nerve roots,
spinal cord, and other nerve bundles for the purpose of chronic
pain control has been actively practiced for some time. While a
precise understanding of the interaction between the applied
electrical energy and the nervous tissue is not fully appreciated,
it is known that application of an electrical field to spinal
nervous tissue (i.e., spinal nerve roots and spinal cord bundles)
can effectively mask certain types of pain transmitted from regions
of the body associated with the stimulated nerve tissue.
Specifically, applying electrical energy to the spinal cord
associated with regions of the body afflicted with chronic pain can
induce "paresthesia" (a subjective sensation of numbness or
tingling) in the afflicted bodily regions. Thereby, paresthesia can
effectively mask the transmission of non-acute pain sensations to
the brain.
[0004] Each exterior region, or each dermatome, of the human body
is associated with a particular spinal nerve root at a particular
longitudinal spinal position. The head and neck regions are
associated with C2-C8, the back regions extends from C2-S3, the
central diaphragm is associated with spinal nerve roots between C3
and C5, the upper extremities correspond to C5 and T1, the thoracic
wall extends from T1 to T11, the peripheral diaphragm is between T6
and T11, the abdominal wall is associated with T6-L1, lower
extremities are located from L2 to S2, and the perineum from L4 to
S4. In conventional neurostimulation, when a patient experiences
pain in one of these regions, a neurostimulation lead is implanted
adjacent to the spinal cord at the corresponding spinal position.
By example, to address chronic pain sensations that commonly focus
on the lower back and lower extremities using conventional
techniques, a specific energy field is typically applied to a
region between vertebrae levels T8 and T12. The specific energy
field often stimulates a number of nerve fibers and structures of
the spinal cord. By applying energy in this manner, the patient
commonly experiences paresthesia over a relatively wide region of
the patient's body from the lower back to the lower
extremities.
[0005] Positioning of an applied electrical field relative to a
physiological midline is also important. Nerve fibers extend
between the brain and a nerve root along the same side of the
dorsal column as the peripheral areas the fibers represent. Pain
that is concentrated on only one side of the body is "unilateral"
in nature. To address unilateral pain, electrical energy is applied
to neural structures on the side of a dorsal column that directly
corresponds to a side of the body subject to pain. Pain that is
present on both sides of a patient is "bilateral." Accordingly,
bilateral pain is addressed through application of electrical
energy along both sides of the column and/or along a patient's
physiological midline.
[0006] Percutaneous leads and laminotomy leads are the two most
common types of lead designs that provide conductors to deliver
stimulation pulses from an implantable pulse generator (IPG) to
distal electrodes adjacent to the pertinent nerve tissue. As shown
in FIG. 1A, conventional percutaneous lead 100 includes electrodes
101 that substantially conform to the body of the body portion of
the lead. Due to the relatively small profile of percutaneous
leads, percutaneous leads are typically positioned above the dura
layer through the use of a Touhy-like needle. Specifically, the
Touhy-like needle is passed through the skin, between desired
vertebrae to open above the dura layer for the insertion of the
percutaneous lead.
[0007] As shown in FIG. 1B, conventional laminotomy or paddle lead
150 has a paddle configuration and typically possesses a plurality
of electrodes 151 (commonly, two, four, eight, or sixteen) arranged
in columns. Due to their dimensions and physical characteristics,
conventional laminotomy leads require a surgical procedure (a
partial laminectomy) for implantation. Multi-column laminotomy
leads enable more reliable positioning of a plurality of electrodes
as compared to percutaneous leads. Also, laminotomy leads offer a
more stable platform that tends to migrate less after implantation
and that is capable of being sutured in place. Laminotomy leads
also create a uni-directional electrical field and, hence, can be
used in a more electrically efficient manner than typical
percutaneous leads.
[0008] To supply suitable pain-managing electrical energy,
multi-programmable IPGs enable the pattern of electrical pulses to
be varied across the electrodes of a lead. Specifically, such
systems enable electrodes of a connected stimulation lead to be set
as an anode (+), as a cathode (-), or to a high-impedance state
(OFF). As is well known, negatively charged ions and free electrons
flow away from a cathode toward an anode. Consequently, using
laminotomy lead 150 of FIG. 1B as an example, a range of very
simple to very complex electrical fields can be created by defining
different electrodes in various combinations of (+), (-), and OFF.
Of course, in any instance, a functional combination must include
at least one anode and at least one cathode (although in some
cases, the "can" of the IPG can function as an anode).
SUMMARY
[0009] In some embodiments, a paddle lead is provided with multiple
columns and multiple rows. The paddle lead is preferably implanted
within a patient such that the electrodes are positioned within the
cervical or thoracic spinal levels. After implantation, an
electrode combination on a first row of electrodes can be
determined that is effective for a first pain location with minimal
effects on other regions of the body. The first pain location can
be addressed by stimulating a first dorsal column fiber due to the
relatively fine electrical field resolution achievable by the
multiple columns. Then, another electrode combination on a second
row of electrodes can be determined for a second pain location with
minimal effects on other regions of the body. The second pain
location could be addressed by stimulating a second dorsal column
fiber. After the determination of the appropriate electrodes for
stimulation, the patient's IPG can be programmed to deliver pulses
using the first and second rows according to the determined
electrode combinations. By employing such a stimulation
methodology, relatively complex pain patterns can be addressed
while only requiring a single implantation.
[0010] The foregoing has outlined rather broadly certain features
and/or technical advantages in order that the detailed description
that follows may be better understood. Additional features and/or
advantages will be described hereinafter which form the subject of
the claims. It should be appreciated by those skilled in the art
that the conception and specific embodiment disclosed may be
readily utilized as a basis for modifying or designing other
structures for carrying out the same purposes. It should also be
realized by those skilled in the art that such equivalent
constructions do not depart from the spirit and scope of the
appended claims. The novel features, both as to organization and
method of operation, together with further objects and advantages
will be better understood from the following description when
considered in connection with the accompanying figures. It is to be
expressly understood, however, that each of the figures is provided
for the purpose of illustration and description only and is not
intended as a definition of the limits of the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIGS. 1A and 1B respectively depict conventional
percutaneous and paddle leads.
[0012] FIG. 2 depicts the spinal cord and the nerve roots in
relation to the vertebral spinal canal.
[0013] FIG. 3 depicts the anatomical structures of the spinal cord
and
[0014] FIGS. 4A and 4B depict the dermatomes areas.
[0015] FIGS. 5A and 5B respectively depict a planar view and a
cross-sectional view of a multi-column, multi-row paddle lead
usable according to representative embodiments. FIGS. 5C and 5D
depict main electrodes with encircling and interstitial electrodes
designs that could be employed within the paddle of FIGS. 5A and
5B.
[0016] FIG. 6 depicts a system for implantable pulse generator with
a multi-column, multi-row paddle lead in communication with a
wireless programming device according to one representative
embodiment.
[0017] FIG. 7 depicts a stimulation paddle according to another
representative embodiment.
DETAILED DESCRIPTION
I. Definitions
[0018] Unless defined otherwise, technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. For
purposes of the present application, the following terms are
defined below.
[0019] As used herein, the use of the word "a" or "an" when used in
conjunction with the term "comprising" in the claims and/or the
specification may mean "one", but it is also consistent with the
meaning of "one or more," "at least one", and "one or more than
one". Still further, the terms "having", "including", "containing"
and "comprising" are interchangeable and one of skill in the art is
cognizant that these terms are open-ended terms. Some embodiments
of the invention may consist of or consist essentially of one or
more elements, method steps, and/or methods of the invention. It is
contemplated that any method or composition described herein can be
implemented with respect to any other method or composition
described herein.
[0020] As used herein, the use of the term "dorsal column" refers
to conducting pathways in the spinal cord that are located in the
dorsal portion of the spinal cord between the posterior horns, and
which comprises afferent somatosensory neurons. The dorsal column
is also known as the posterior funiculus.
[0021] As used herein, "spinal cord," "spinal nervous tissue
associated with a vertebral segment," "nervous tissue associated
with a vertebral segment" or "spinal cord associated with a
vertebral segment or level" includes any spinal nervous tissue
associated with a vertebral level or segment. Those of skill in the
art are aware that the spinal cord and tissue associated therewith
are associated with cervical, thoracic and lumbar vertebrae. As
used herein, C1 refers to cervical vertebral segment 1, C2 refers
to cervical vertebral segment 2, and so on. T1 refers to thoracic
vertebral segment 1, T2 refers to thoracic vertebral segment 2, and
so on. L1 refers to lumbar vertebral segment 1, L2 refers to lumbar
vertebral segment 2, and so on, unless otherwise specifically
noted. In certain cases, spinal cord nerve roots leave the bony
spine at a vertebral level different from the vertebral segment
with which the root is associated. For example, the T11 nerve root
leaves the spinal cord myelum at an area located behind vertebral
body T8-T9 but leaves the bony spine between T11 and T12.
[0022] As used herein the term "chronic pain" refers to a
persistent state of pain experienced for a substantial amount of
time (e.g., longer than three months).
[0023] As used herein the term "complex regional pain syndrome" or
"CRPS" refers to painful conditions that usually affect the distal
part of an upper or lower extremity and are associated with
characteristic clinical phenomena. CRPS is divided into two
subtypes CRPS Type I and CRPS Type II. Generally, the clinical
characteristics of Type I are the same as seen in Type II. The
central difference between Type I and Type II is that Type II
typically occurs following a sensory nerve injury whereas Type I
occurs in the absence of any known nerve injury.
II. Organization of the Nervous System
[0024] The nervous system comprises two general components, the
central nervous system, which is composed of the brain and the
spinal cord, and the peripheral nervous system, which is composed
of ganglia or dorsal root ganglia and the peripheral nerves that
lie outside the brain and the spinal cord. One of skill in the art
realizes that the nervous system may be linguistically separated
and categorized, but functionally they are interconnected and
interactive.
[0025] The central nervous system comprises the brain and spinal
cord, which together function as the principal integrator of
sensory input and motor output. In general terms, the brain
consists of the cerebrum (cerebral hemispheres and the
diencephalons), the brainstem (midbrain, pons, and medulla); and
the cerebellum. The spinal cord is organized into segments, for
example, there are 8 cervical (C1-C8), 12 thoracic (T1-T12), 5
lumbar (L1-L5), 5 sacral (S1-S5), and 1 cocygeal (Co1) spinal
segments. In adults, the spinal cord typically ends at the level of
the L1 or L2 vertebral bones. As shown in FIG. 2, the nerve roots
travel downward to reach their exit points at the appropriate
levels. Left and right sensory and motor nerve roots arise from
each segment of the spinal cord except for the C1 and Co1 segments,
which have no sensory roots. As shown in FIG. 3, the sensory nerve
root 301 and motor nerve root 302 fuse to form a single mixed
spinal nerve 303 for each segment. The mixed spinal nerves further
fuse and intermingle peripherally to form plexuses and nerve
branches.
[0026] The peripheral nervous system is divided into the autonomic
system (parasympathetic and sympathetic), the somatic system and
the enteric system. The term peripheral nerve is intended to
include both motor and sensory neurons and neuronal bundles of the
autonomic system, the somatic system, and the enteric system that
reside outside of the spinal cord and the brain. Peripheral nerve
ganglia and nerves located outside of the brain and spinal cord are
also described by the term peripheral nerve.
[0027] A. Organization of the Spinal Cord
[0028] The present application is drawn to specific stimulation of
fibers in the spinal cord, thus, a further description of the
spinal cord is discussed herein.
[0029] The spinal cord is known to contain a butterfly-shaped
central gray matter surrounded by ascending and descending white
matter columns or funiculi. Sensory neurons in the dorsal root
ganglia have axons that bifurcate. One branch relays sensory
information from the periphery and the other branch carries this
information through the dorsal nerve root filaments into the dorsal
aspect of the spinal cord. The peripheral region that is innervated
by sensory fibers from a single nerve root is known as a dermatome.
As shown in FIGS. 4A and 4B, dermatomes are divided into sacral
(S1-S5), lumbar (L1-L5), thoracic (T1-T12) and cervical
(C2-C8).
[0030] FIG. 3 shows that the central gray matter 10 of the spinal
cord can be divided into the dorsal (posterior) horn 11 that is
involved in sensory processing, an intermediate zone 12 that
contains interneurons and specialized nuclei and a ventral
(anterior) horn 13 that contains motor neurons. The white matter 20
of the spinal cord is divided into dorsal or posterior columns 30,
lateral columns 40 and ventral or anterior columns 50. Those of
skill in the art realize that the spinal cord does not appear the
same at all levels; for example, the white matter is thickest in
the cervical levels, where the most ascending fibers have already
entered the cord and the most descending fibers have not yet
terminated on their targets, while the sacral cords are mostly gray
matter. In addition the spinal cord has two enlargements, the
cervical enlargement and the lumosacral enlargement that give rise
to the nerve plexuses for the arms and legs. The spinal cord has
more gray matter at the cervical and lumbosacral levels than at the
thoracic levels particularly in the ventral horns where lower motor
neurons for the arms and legs reside.
[0031] B. Dorsal Column of the Spinal Cord
[0032] Furthermore, the present application is directed to
stimulation of fibers within the dorsal column of the spinal cord
and not the dorsal roots of the spinal cord according to some
representative embodiments. Based upon the below description, one
of skill in the art understands the fiber types that would need to
be stimulated to produce the desired effect.
[0033] The dorsal column of the spinal cord contains four different
fiber types that are classified according to axon diameter, for
example A-.alpha. or I has a diameter of 13-20 .mu.m, A-.beta. or
II has a diameter of 6-12 .mu.m, A-.delta. or III has a diameter of
1-5 .mu.m and C or IV has a diameter of 0.2-1.5 .mu.m. Fibers
A-.alpha. relay proprioception. Fibers A-.beta. relay
proprioception, touch (e.g., superficial touch, deep touch), and
vibration. Fibers A-.delta. relay pain and temperature (cool).
Fibers C relay temperature (warm) and itch.
[0034] The dorsal column or posterior column of the spinal cord is
associated with the somatosensory pathways that is divided into to
two pathways: the posterior column-medial lemniscal system that
conveys proprioception, vibration sense, and fine and
discriminative touch and the anterolateral systems that conveys
pain, temperature sense and crude touch.
[0035] 1. Posterior Column-Medial Lemniscal Pathway
[0036] The large-diameter, myelinated axons of the posterior
column-medial lemniscal system conveys proprioception, vibration
sense, and fine and discriminative touch. These axons enter the
spinal cord via the medial portion of the dorsal root entry zone
and ascend to the posterior column nuclei in the medulla.
[0037] Somatotopic organization of the dorsal column reveals fibers
that are added laterally from higher levels as the dorsal columns
ascend. As shown in FIG. 3, the medial portion of the dorsal column
is the gracile fascilculus 31 and carries information from the legs
and lower trunk while the more lateral portion of the dorsal
column, cuneate fasciculus 32, carries information from the upper
trunk above about T6 and from the arms and neck. First-order
sensory neurons that have axons in the gracile and cuneate
fasciculi synapse onto second-order neurons in the nucleus gracilis
and nucleus cuneatus, respectively, which decussate as internal
arcuate fibers and then form the medial lemniscus on the other side
of the medulla. Next, the medial lemniscus axons terminate or
synapse in the ventral posterior lateral nucleus (VPL) of the
thalamus which project through the posterior limb of the internal
capsule in the thalamic somatosensory radiations to reach the
primary somatosensory cortex.
[0038] 2. Spinothalamic Tract and Other Anterolateral Pathways
[0039] This part of the somatosensory system contains
smaller-diameter and unmyelinated axons that carry or relay
information about pain and temperature sense. The axons also enter
the spinal cord via the dorsal root entry zone, however, they
synapse in the gray matter of the spinal cord, mainly the dorsal
horn marginal zone (lamina I) and/or lamina V. The second-order
sensory neurons in the central gray matter cross over in the spinal
cord anterior (ventral) commissure to ascend into the anterolateral
white matter. Somatotopic organization reveals that the feet are
most laterally represented fibers are added medially as the
anterolateral pathways ascend the spinal cord. Eventually, the
information is relayed in the thalamus which projects to the
somatosensory cortex.
III. Stimulation Leads and Systems
[0040] FIG. 5A depicts an example laminotomy lead 210 for treatment
of multi-location pain locations according to one representative
embodiment. Laminotomy lead 210 includes proximal end 212 and
distal end 214. Proximal end 212 includes a plurality of
electrically conductive terminals 218. Distal end 214 includes a
plurality of electrically conductive electrodes 220 (only
electrodes 220-1 through 220-10 are annotated for the sake of
clarity) arranged within a flat, thin paddle-like structure 216.
The electrodes 220 are mutually separated by insulative material of
the paddle. For a paddle structure adapted for implantation within
a cervical vertebral level, the electrodes are preferably spaced
apart 1.5 mm laterally and 2.5 mm longitudinally. For a paddle
adapted for implantation within a thoracic vertebral level, the
electrodes are preferably spaced apart by 1.0 mm laterally and 2 mm
or 3 mm longitudinally. Conductors 222 (which are embedded within
the insulative material of the lead body) electrically connect
electrodes 220 to terminals 218.
[0041] In the specific example shown in FIG. 5A, paddle 216
includes five columns and four rows of electrodes 220. Alternative
numbers of columns and rows may be employed. For example, in some
embodiments, thirty-two or more electrodes are distributed into
multiple rows and multiple columns. Also, every row need not
contain the same number of columns. For example, a number of rows
can include a "tri-pole" design having three columns of electrodes
while additional rows can include five or more columns of
electrodes to enable a greater amount of electrical field
resolution (see paddle 700 as shown in FIG. 7). The multiple
columns of electrodes enable lateral control of the applied
electrical field to stimulate the exact lateral position of the
pertinent nerve fiber(s). Specifically, it is desirable to
selectively stimulate a given dorsal column fiber that is
associated with an afflicted region of the patient's body without
affecting regions of the patient's body. The multiple columns of
paddles according to representative embodiments provide sufficient
resolution to relatively finely control the stimulation of one or
several specific fibers. Additionally, the multiple columns provide
a degree of positional tolerance during the surgical placement of
paddle 216 within the epidural space, because any one of the
columns can be used to stimulate the pertinent nerve fiber(s).
Also, if paddle 216 is displaced relative to the pertinent nerve
fibers subsequent to implantation (e.g., due to lead migration),
the stimulation pattern applied by the pulse generator can be
shifted between columns to compensate for the displacement.
[0042] The multiple rows of paddles according to representative
embodiments enable multiple pain locations to be treated with a
single implanted lead. Specifically, a first row can be used to
treat a first pain complaint (e.g., pain in the lower extremities)
and a second row can be used to treat a second pain location (e.g.,
post-laminectomy pain in the back). Furthermore, by separating the
first and second rows by one or several "buffer" rows of
high-impedance electrodes, the stimulation in first and second rows
may occur in a substantially independent basis. Specifically,
anodes on the second row will have relatively minimal effect on the
field distribution generated by cathodes on the first row.
[0043] In some embodiments, a paddle lead can be implanted within a
patient such that the electrodes are positioned within the cervical
or thoracic spinal levels. After implantation, an electrode
combination on a first row of electrodes can be determined that is
effective for a first pain location with minimal effects on other
regions of the body. The first pain location can be addressed by
stimulating a specific dorsal column fiber due to the relatively
fine electrical field resolution achievable by the multiple
columns. Then, another electrode combination on a second row of
electrodes can be determined for a second pain location with
minimal effects on other regions of the body. The second pain
location could be addressed by stimulating another dorsal column
fiber as an example. After the determination of the appropriate
electrodes for stimulation, the patient's IPG can be programmed to
deliver pulses using the first and second rows according to the
determined electrode combinations.
[0044] When determining the appropriate electrode configurations,
the selection of electrodes to function as anodes can often
facilitate isolation of the applied electrical field to desired
fibers and other neural structures. Specifically, the selection of
an electrode to function as an anode at a position adjacent to
another electrode functioning as a cathode causes the resulting
electron/ion flow to be limited to tissues immediately surrounding
the two electrodes. By alternating through the possible
anode/cathode combinations, it is possible to gain greater
resolution in the stimulation of dorsal column fibers. Also, it is
possible to confine the applied electrical field to or away from
the periphery of the paddle structure.
[0045] The operation of anodes can also be used to hyperpolarize
neural tissue. Depending on the anode amplitude and the proximity
to the pertinent neural tissue, the hyperpolarization can be used
to prevent selected neural tissue from propagating action
potentials. The hyperpolarization can also be used to prevent an
adjacent cathode from initiating propagation of an action potential
beginning at the selected neural tissue.
[0046] The multiple columns of electrodes also enable lateral
"steering" of the electrical field using a single channel pulse
generator. A single channel pulse generator refers to a pulse
generator that provides an equal magnitude pulse to each active
electrode at a given time. Specifically, each electrode is either
"active" (i.e., it is coupled to the pulse generator output during
pulse generation by a suitable gate or switch) or "inactive" (i.e.,
the gate or switch does not couple the electrode to the pulse
generator output). Each "active" electrode experiences the same
amplitude; only the polarity varies depending upon whether the
electrodes are set as cathodes or anodes as defined by the
positions of the respective gates or switches.
[0047] The steering of the electrical field occurs by selecting
appropriate states for the electrodes. Depending upon the desired
neural tissue to be stimulated, it may be beneficial to confine the
electrical field along the periphery of paddle 216. Confinement of
the electrical field along the periphery can be accomplished by
setting electrode 220-1 to function as a cathode and setting
electrode 220-2 to function as an anode. Because the electrical
field will generally be confined between these two electrodes
during stimulation pulses, only nerve fibers within the adjacent
area will be stimulated. Generally speaking, nerve fibers past
electrode 220-2 would not be stimulated when a pulse is delivered
via electrode 220-1 due to the anodal blocking. If desired due to
paddle placement or otherwise, an initial "inward" adjustment in
the electrical field can be accomplished by setting electrode 220-1
as a cathode, setting electrode 220-2 as an anode, and setting
electrode 220-3 as an anode thereby steering the stimulation toward
the inward lateral direction. Another inward adjustment could be
made by setting electrode 220-1 to the cathode state, setting
electrode 220-2 to the high impedance state, and setting electrode
220-3 to the anode state.
[0048] The anodal blocking may be programmed to work in similar
manner to controllably steer the stimulation toward the outward
lateral direction and guard tissues at the periphery of the paddle
216. For example, electrode 220-3 can be set to function as a
cathode and electrodes 220-2 and/or 220-1 can be set to the anodal
state.
[0049] Other anode/cathode combinations and designs may be employed
according to some representative embodiments. For example, as shown
in FIG. 5C, each main electrode 220 of paddle structure 216 can be
associated with one or several smaller encircling electrodes 250.
The encircling electrodes 250 can be set as anodes to confine the
electrical field during pulse generation substantially within the
perimeter defined by the encircling electrodes 250. When employing
such a design, other adjacent main electrodes 220 could be
selectively set as anodes to stretch the field in a specific
direction beyond the perimeter of the respective encircling
electrodes 250, if desired. In some embodiments, since each
encircling electrode 250 is intended to function as an anode, each
encircling electrode 250 can be coupled to the same conductor 222
to minimize the number of conductors 222 within the lead 210. FIG.
5D depicts another design in which main electrodes 220 are
associated with interstitial electrodes 260 for anodal blocking. In
a similar manner, interstitial electrodes 250 could be coupled to a
common conductor.
[0050] Conductors 222 are carried in sheaths 224. In some
embodiments, each sheath 224 carries eight conductors 222. With
only two sheaths 224 with eight conductors each, there would only
be sixteen conductors 222. To accommodate the lower number of
conductors 222 than electrodes 220, multiple electrodes 220 are
coupled to the same conductor 222 (and, hence, to a common terminal
218). In one embodiment, electrodes 220-1 and 220-4 are coupled to
a common conductor 222, electrodes 220-5 and 220-6 are coupled to a
common conductor 222, electrodes 220-7 and 220-8 are coupled to a
common conductor, and electrodes 220-9 and 220-10 are coupled to a
common conductor.
[0051] In some embodiments, other electrode designs can be employed
to minimize the number of conductors 222 required to support the
various electrodes 220. For example, a relatively large number of
electrodes (e.g., thirty-two, sixty-four, and greater) could be
utilized on the paddle structure. The electrodes could be coupled
to one or several electrical gates (e.g., as deposited on a flex
circuit). The electrical gates can be controllably configured to
couple each electrode to a conductor 222 carrying cathode pulses,
to couple each electrode to an anode termination, or to maintain
each electrode at a high impedance state. The electrical gates
could be controlled using a main controller (a logic circuit) on
the paddle structure that is coupled to a data line conductor 222.
The data line conductor 222 is used to communicate signals from the
IPG that identify the desired electrode states. The main controller
responds to the signals by setting the states of the electrical
gates as appropriate.
[0052] In another embodiment, a cathode conductor line 222 and an
anode conductor line 222 are provided in one or several lead bodies
along with a plurality of optical fibers. The optical fibers are
used to carry optical control signals that control the electrode
states. Specifically, the paddle structure includes photodetectors
(e.g., photodiodes) that gate connections to the anode conductor
line and the cathode conductor line. The use of optical fibers to
carry optical control signals is advantageous, because the diameter
of optical fibers suitable for such functionality is smaller than
electrical conductors. Therefore, a larger number of electrodes (as
compared to using a separate electrical conductor for each
electrode) can be independently controlled while maintaining the
lead body diameters at an acceptable size.
[0053] Terminals 218 and electrodes 220 are preferably formed of a
non-corrosive, highly conductive material. Examples of such
material include stainless steel, MP35N, platinum, and platinum
alloys. In a preferred embodiment, terminals 218 and electrodes 220
are formed of a platinum-iridium alloy. Each conductor 222 is
formed of a conductive material that exhibits desired mechanical
properties of low resistance, corrosion resistance, flexibility,
and strength. While conventional stranded bundles of stainless
steel, MP35N, platinum, platinum-iridium alloy, drawn-brazed silver
(DBS) or the like can be used, a preferred embodiment uses
conductors 222 formed of multi-strands of drawn-filled tubes (DFT).
Each strand is formed of a low resistance material and is encased
in a high strength material (preferably, metal). A selected number
of "sub-strands" are wound and coated with an insulative material.
With regard to the operating environment of representative
embodiments, such insulative material protects the individual
conductors 222 if its respective sheath 224 was breached during
use.
[0054] In addition to providing the requisite strength,
flexibility, and resistance to fatigue, conductors 222 formed of
multi-strands of drawn-filled tubes, in accordance with the above
description, provide a low resistance alternative to other
materials. Specifically, a stranded wire, or even a coiled wire, of
approximately 60 cm and formed of MP35N or stainless steel or the
like would have a measured resistance in excess of 30 ohms. In
contrast, for the same length, a wire formed of multi-strands of
drawn-filled tubes could have a resistance less than 4 ohms.
[0055] Sheaths 224 and paddle structure 216 are preferably formed
from a medical grade, substantially inert material, for example,
polyurethane, silicone, or the like. Importantly, such material
should be non-reactive to the environment of the human body,
provide a flexible and durable (i.e., fatigue resistant) exterior
structure for the components of lead 210, and insulate adjacent
terminals 218 and/or electrodes 220. Additional structure (e.g., a
nylon mesh, a fiberglass substrate) (not shown) can be internalized
within the paddle structure 216 to increase its overall rigidity
and/or to cause the paddle structure 216 to assume a prescribed
cross-sectional form.
[0056] The paddle structure may be fabricated to possess a
substantially flat profile. As one alternative, the paddle
structure may be fabricated to possess a prescribed arc along a
transverse or lateral direction of the paddle structure 216 as
shown in the cross-sectional view of FIG. 5B. On each longitudinal
side of paddle structure 216, "wing" structures 232 may be formed
for the purpose of retaining paddle structure 216 within the
central portion of the epidural space. In some embodiments, one or
several electrodes 220 could be disposed on the wing structures
232.
[0057] While a number of material and construction options have
been discussed above, it should be noted that neither the materials
selected nor a construction methodology is critical to the present
invention.
[0058] FIG. 6 depicts paddle lead 210 coupled to IPG 310 which is
in wireless communication with programmer device 320. An example of
a commercially available IPG is the Eon.TM. Rechargeable IPG
manufactured by Advanced Neuromodulation Systems, Inc, although any
suitable IPG, such as RF powered devices, could be alternatively
employed. As shown in FIG. 6, paddle lead 210 is coupled to the
headers ports 311 of IPG 310. Each header port 311 electrically
couples the respective terminals 218 (shown previously in FIG. 5A)
to a switch matrix (not shown) within IPG 310.
[0059] The switch matrix selectively connects the pulse generating
circuitry (not shown) of IPG 310 to the various terminals 218, and,
hence to the electrodes 220. The sealed portion 312 of IPG 310
contains the pulse generating circuitry, communication circuitry,
control circuitry, and battery (not shown) within an enclosure to
protect the components after implantation within a patient. The
control circuitry may comprise a microprocessor, one or more ASICs,
and/or any suitable circuitry for controlling the pulse generating
circuitry. The control circuitry controls the pulse generating
circuitry to apply electrical pulses to the patient via electrodes
220 of paddle 210 according to multiple pulse parameters (e.g.,
pulse amplitude, pulse width, pulse frequency, etc.). The
electrodes 220 are set to function as cathodes or anodes or set to
a high-impedance state for a given pulse according to the couplings
provided by the switch matrix. The electrode states may be changed
between pulses.
[0060] When paddle lead 210 is initially implanted within the
patient, a determination of the set(s) of pulse parameters and the
electrode configuration(s) that effectively treat the patient's
condition is made. The determination or programming typically
occurs through a physician's interaction with configuration
software 321 executed on the programmer device 320. Configuration
software 321 steps the physician through a number of parameters and
electrode configurations. In preferred embodiments, the electrode
configurations are stepped through by laterally "steering" the
electrical field by moving the anodes and/or cathodes along a row
of the paddle as discussed above. The patient provides feedback to
the physician regarding the perceived stimulation that occurs in
response the pulse parameters and electrode configuration(s). The
physician effects changes to the parameters and electrode
configuration(s) until optimal pulse parameters and electrode
configuration(s) are determined. The final pulse parameters and
configurations are stored within IPG 310 for subsequent use. The
pulse parameters and configurations are used by IPG 310 to control
the electrical stimulation provided to the patient via paddle lead
310.
[0061] Although single channel IPGs have been described according
to some embodiments, multiple current or voltage source IPGs could
alternatively be employed. For example, a design similar to the
stimulator disclosed in U.S. Pat. No. 5,501,703, which is
incorporated herein by reference in its entirety, could be employed
when coupled to a suitable paddle lead. The stimulation amplitudes
associated with the various channels can be varied and delivered to
adjacent electrodes to "steer" the stimulation. The steering of the
stimulation field may be used to facilitate stimulation of the
particular dorsal column fiber to address pain in a particular
region of the patient's body while avoiding affecting other
regions.
III. Stimulation of Nerve Fibers to Treat Pain
[0062] The stimulation system according to representative
embodiments is utilized to preferentially stimulate nerve fibers in
the dorsal column of the spinal cord. One technique that offers the
ability to affect neuronal function is the delivery of electrical
stimulation to target tissues via an implanted device having a
probe. The probe is, for example, a stimulation lead or electrode
assembly. An electrode assembly may be one electrode, multiple
electrodes, or an array of electrodes in or around the target area.
The proximal end of the probe is coupled to the system to operate
the device to stimulate the target site. Thus, the probe is coupled
to an electrical signal source, which, in turn, is operated to
stimulate the predetermined treatment site of the dorsal column.
Stimulation of the predetermined site is performed to modulate
neuronal fibers of the dorsal column. Modulation of this neuronal
tissue may result in efficacious treatment of a neurological
disorder, for example, pain, in a subject. While optimal results
from the treatment may result in the complete cessation of pain in
a subject, any lessening of the amplitude of a subject's pain may
be considered successful according to the representative
embodiments.
[0063] Electrical energy can be delivered through electrodes
positioned external to the dura layer surrounding the spinal cord.
Stimulation on the surface of the cord (subdurally) is also
contemplated; for example, stimulation may be applied to the dorsal
columns as well as to the dorsal root entry zone or the dorsal root
ganglia and/or nerve root. In preferred embodiments, the dorsal
column of the spinal cord is stimulated; more particularly, any
neuronal tissue of the dorsal column associated with any of the
cervical vertebral segments (C1, C2, C3, C4, C5, C6, C7) and/or any
tissue associated with any of the thoracic vertebral segments (T1,
T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, 12) and/or any tissue
associated with any of the lumbar vertebral segments (L1, L2, L3,
L4, L5, L6) and/or any tissue associated with the sacral vertebral
segments (S1, S2, S3, S4, S5). Such electrical energy is provided
by the laminotomy leads discussed above.
[0064] In certain embodiments, the stimulation device is used to
stimulate fiber types of the dorsal column, more specifically in
the area of the mid-thoracic and low-thoracic vertebral levels
(T8-T11) or the high cervical levels (C1-C2). The advantage of high
cervical stimulation of the dorsal column is that the white matter
of the dorsal column is thickest in the cervical levels because
this is where most of the ascending fibers have already entered the
cord and most descending fibers have not yet terminated. Thus,
stimulation of these fibers may result in a greater effect than
stimulating the thoracic areas. Also, stimulation in this cervical
area of the dorsal column may also elicit a sympathetic response in
the peripheral nervous system.
[0065] The laminotomy lead of representative embodiments is
implanted such that it stimulates the dorsal column of the spinal
cord, more specifically, it stimulates a predetermined fiber type
of the dorsal column. For example, the pain modulation may be
altered by stimulating non-pain fibers, such as A-.beta. fibers.
More specifically, the periaqueductal gray receives inputs from the
hypothalamus, amygdala, and cortex, and inhibits pain transmission
in the dorsal horn via a relay in the rostral ventral medulla.
[0066] Representative embodiments are particularly useful in the
treatment of pain in humans. Pain can include chronic pain, for
example CRSII or CRSI. However, one skilled in the art appreciates
that representative embodiments are applicable to other animals
which experience pain. This may include, for example, primates,
canines, felines, horses, elephants, dolphins, etc. Utilizing the
various embodiments of the present invention, one skilled in the
art may be able to modulate the pain via dorsal column stimulation
to achieve a desirable result.
[0067] Thus, using the therapeutic stimulation system of the
representative embodiments, the predetermined site is stimulated in
an effective amount or effective treatment regimen to decrease,
reduce, modulate or abrogate the pain. Thus, a subject is
administered a therapeutically effective stimulation so that the
subject has an improvement in the parameters relating to pain. The
improvement is any observable or measurable improvement. Thus, one
of skill in the art realizes that a treatment may improve the
patient condition, but may not be a complete cure of the
disease.
[0068] Treatment regimens may vary as well, and often depend on the
health and age of the patient. Obviously, certain types of disease
will require more aggressive treatment, while at the same time,
certain patients cannot tolerate more taxing regimens. The
clinician will be best suited to make such decisions based on the
known subject's history.
[0069] For purposes of this invention, beneficial or desired
clinical results include, but are not limited to, alleviation of
symptoms, improvement of symptoms, diminishment of extent of
disease, stabilized (i.e., not worsening) state of disease, delay
or slowing of disease progression, amelioration or palliation of
the disease state, and remission (whether partial or total),
whether objective or subjective. The improvement is any observable
or measurable improvement. Thus, one of skill in the art realizes
that a treatment may improve the patient condition, but may not be
a complete cure of the disease.
[0070] Although representative embodiments and advantages have been
described in detail, it should be understood that various changes,
substitutions and alterations can be made herein without departing
from the spirit and scope of the appended claims. Moreover, the
scope of the present application is not intended to be limited to
the particular embodiments of the process, machine, manufacture,
composition of matter, means, methods and steps described in the
specification. As one of ordinary skill in the art will readily
appreciate from the disclosure that processes, machines,
manufacture, compositions of matter, means, methods, or steps,
presently existing or later to be developed that perform
substantially the same function or achieve substantially the same
result as the corresponding embodiments described herein may be
utilized. Accordingly, the appended claims are intended to include
within their scope such processes, machines, manufacture,
compositions of matter, means, methods, or steps.
* * * * *