U.S. patent application number 14/522918 was filed with the patent office on 2015-04-16 for systems and methods to place one or more leads in tissue for providing functional and/or therapeutic stimulation.
The applicant listed for this patent is SPR Therapeutics, LLC. Invention is credited to Joseph W. Boggs, II.
Application Number | 20150105840 14/522918 |
Document ID | / |
Family ID | 52810309 |
Filed Date | 2015-04-16 |
United States Patent
Application |
20150105840 |
Kind Code |
A1 |
Boggs, II; Joseph W. |
April 16, 2015 |
SYSTEMS AND METHODS TO PLACE ONE OR MORE LEADS IN TISSUE FOR
PROVIDING FUNCTIONAL AND/OR THERAPEUTIC STIMULATION
Abstract
Systems and methods make possible the placement of one or more
electrode leads in a tissue region for providing functional and/or
therapeutic stimulation to tissue. The systems and methods are
adapted to provide the relief of pain.
Inventors: |
Boggs, II; Joseph W.;
(Chapel Hill, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SPR Therapeutics, LLC |
Cleveland |
OH |
US |
|
|
Family ID: |
52810309 |
Appl. No.: |
14/522918 |
Filed: |
October 24, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12653029 |
Dec 7, 2009 |
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14522918 |
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12653023 |
Dec 7, 2009 |
8954153 |
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12653029 |
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61201030 |
Dec 5, 2008 |
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61201030 |
Dec 5, 2008 |
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Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/0558 20130101;
A61N 1/36071 20130101; A61N 1/36017 20130101; A61N 1/36021
20130101; A61N 1/0551 20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/05 20060101 A61N001/05 |
Claims
1. A method comprising: percutaneously inserting and placing an
electrode at a targeted tissue region, the electrode includes a
coiled lead having an anchoring member generally preventing
migration of the electrode, wherein the targeted tissue region is
in proximity to a peripheral nerve innervating a painful region and
the targeted tissue region is spaced from the painful region,
providing percutaneous neurostimulation to the electrode,
activating the peripheral nerve via the neurostimulation, and as a
result of the neurostimulation, reducing post-amputation pain in
the painful region.
2. The method according to claim 1, wherein the targeted tissue
region comprises a brachial plexus.
3. The method according to claim 2, wherein the targeted tissue
region further comprises a region of adipose tissue on, in, or near
the brachial plexus.
4. The method according to claim 1, wherein the peripheral nerve
comprises at least one nerve group consisting of: a brachial
plexus, a sciatic nerve, and a femoral nerve.
5. The method according to claim 1, wherein the peripheral nerve
comprises at least one nerve in the group consist of: a sciatic
nerve and a femoral nerve.
6. The method according to claim 1, wherein the post-amputation
pain comprises residual limb pain.
7. The method according to claim 1, wherein the post-amputation
pain comprises phantom limb pain.
8. The method according to claim 7, wherein the post-amputation
pain further comprises residual limb pain.
9. A system comprising: a single percuanteous lead having at least
one electrode placed in vivo on, in, or near a brachial plexus, the
lead being a coiled wire and having an anchoring member generally
preventing migration of the lead, wherein the electrode is outside
of a region of post-amputation pain, and an ex vivo stimulator
percutaneously delivering neurostimulation through the lead and
electrode to stimulate a peripheral nerve effecting a reduction of
the post-amputation pain.
Description
RELATED APPLICATIONS
[0001] This application is a continuation in part of U.S. patent
application Ser. No. 12/653,029, filed Dec. 7, 2009, and entitled
"Systems and Methods to Place One or More Leads in Tissue for
Providing Functional and/or Therapeutic Stimulation," which claims
the benefit of U.S. Provisional Patent Application Ser. No.
61/201,030, filed 5 Dec. 2008, and entitled "Systems and Methods to
Place One or More Leads in Tissue for Providing Functional and/or
Therapeutic Stimulation," which are both incorporated herein by
reference. This application is also a continuation in part of U.S.
patent application Ser. No. 12/653,023, filed Dec. 7, 2009, and
entitled "Systems and Methods to Place One or More Leads in Tissue
for Providing Functional and/or Therapeutic Stimulation," which
claims the benefit of U.S. Provisional Patent Application Ser. No.
61/201,030, filed 5 Dec. 2008, and entitled "Systems and Methods to
Place One or More Leads in Tissue for Providing Functional and/or
Therapeutic Stimulation," which are both incorporated herein by
reference.
FIELD OF INVENTION
[0002] This invention relates to systems and methods for placing
one or more electrode leads in tissue for providing electrical
stimulation to tissue.
BACKGROUND OF THE INVENTION
[0003] Neurostimulation, i.e., neuromuscular stimulation (the
electrical excitation of nerves and/or muscle to directly elicit
the contraction of muscles) and neuromodulation stimulation (the
electrical excitation of nerves, often afferent nerves, to
indirectly affect the stability or performance of a physiological
system) and brain stimulation (the stimulation of cerebral or other
central nervous system tissue) can provide functional and/or
therapeutic outcomes. While existing systems and methods can
provide remarkable benefits to individuals requiring
neurostimulation, many quality of life issues still remain. For
example, existing systems include complicated procedures to place
electrodes and pulse generators, and issues remain with the
migration of electrodes which eventually reduce the effectiveness
of the neurostimulation. Furthermore, these systems are, by today's
standards, relatively large and awkward to manipulate, transport,
and adhere to the patient.
[0004] There exist both external and implantable devices for
providing neurostimulation in diverse therapeutic and functional
restoration indications. These neuro-stimulators are able to
provide treatment and/or therapy to individual portions of the
body. The operation of these devices typically includes the use of
an electrode placed either on the external surface of the skin
and/or a surgically implanted electrode. In the case of external
neurostimulators, surface electrode(s) and/or percutaneous lead(s)
having one or more electrodes may be used to deliver electrical
stimulation to the select portion of the patient's body.
[0005] One example of an indication where therapeutic treatment may
be provided is for the treatment of pain, such as to provide a
therapy to reduce pain in individuals with amputated limbs.
Amputation leads to chronic pain in almost all (95%) patients,
regardless of how much time had passed since the amputation
(Ephraim et al. 2005). The pain can be extremely bothersome to
amputees, significantly decrease their quality of life, correlate
with increased risk of depression, and negatively affect their
inter-personal relationships and their ability to return to work
(Kashani et al 1983; Blazer et al. 1994; Cansever et al. 2003). The
present methods of treatment, which are primarily medications, are
unsatisfactory in reducing amputation-related pain, have unwanted
side effects, offer a low success rate, and often lead to
addiction.
[0006] Most amputees have two types of pain: residual limb (stump)
pain and phantom pain. Approximately 72-85% of amputees have
phantom pain and 68-76% of amputees have residual limb (stump) pain
(Sherman and Sherman 1983; Sherman et al. 1984; Ehde et al. 2000;
Ephraim et al. 2005). Both stump pain and phantom limb pain are
chronic pains experienced after an amputation, and they are easily
distinguished by the perceived location of the pain. Stump pain is
sensed in the portion of the limb that remains after amputation,
and phantom limb pain is perceived in the portion of the limb that
has been removed. Typically, amputee patients with severe stump
pain also have severe phantom limb pain, but it is recommended that
their responses to treatment be measured independently (Jensen et
al. 1985; Kooijman et al. 2000). Stump and phantom pain can be
severe and debilitating to a large proportion of persons with
amputations, who will unfortunately often progress through a
battery of management techniques and procedures without finding
relief from their pain (Bonica 1953; Sherman et al. 1980; Ehde et
al. 2000; Loeser 2001a; Ephraim et al. 2005).
[0007] An estimated 80-95% of 1.7 millions persons who currently
live with amputations plus the additional 185,000 persons expected
to undergo amputation each year in the United States will suffer
from stump and/or phantom pain at an annual direct cost of $1.4-2.7
billion and overall associated costs of $13 billion (Sherman and
Sherman 1983; Sherman et al. 1984; Ehde et al. 2000; Mekhail et al.
2004; Ephraim et al. 2005). Severe post-amputation pain often leads
to further disability, reduced quality of life, and frequently
interferes with the simple activities of daily life more than the
amputation itself (Millstein et al. 1985; Schoppen et al. 2001;
Marshall et al. 2002; Whyte and Carroll 2002; Rudy et al. 2003),
and no available therapy is sufficient to manage it (Sherman et al.
1980; Jahangiri et al. 1994; Rosenquist and Haider 2008).
[0008] Many techniques have been developed to treat post-amputation
pain, but all of them are ultimately insufficient (Jahangiri et al.
1994). A review in 1980 found that none of the 68 treatments
available for post-amputation pain were uniformly successful
(Sherman et al. 1980), and more recent reviews have found that
little has changed and there remains a large need for an effective
method of treating stump and phantom pain (Davis 1993: Wall et al.
1994; Loeser 2001a; Halbert et al. 2002; Rosenquist and Haider
2008). Some studies report that as few as 1% of amputees with
severe phantom and stump pain receive lasting benefit from any of
the available treatments (Sherman and Sherman 1983; Sherman et al.
1984). Presently, most patients are managed with medications, but
approximately a third of amputees still report severe (intensity of
7-10 on a scale of 0-10) phantom and stump pain.
[0009] Non-narcotic analgesics, such as acetaminophen or
non-steroidal anti-inflammatory drugs (NSAIDS), have relatively
minor side effects and are commonly used for several types of pain.
However, they are not specific to stump or phantom pain and are
rarely sufficient in managing moderate to severe chronic
post-amputation pain (Sherman et al. 1980; Loeser 2001a; Rosenquist
and Haider 2008).
[0010] The use of narcotic analgesics, such as N-methyl-D-aspartate
(NDMA) antagonists, has shown only minor success with inconsistent
results. Narcotics carry the risk of addiction and side effects,
such as nausea, confusion, vomiting, hallucinations, drowsiness,
dizziness, headache, agitation, and insomnia. Several trials of
multiple narcotic agents have failed to show statistically
significant improvement in phantom pain (Stangl and Loeser 1997;
Nikolajsen et al. 2000; Loeser 2001a; Maier et al. 2003; Hayes et
al. 2004; Wiech et al. 2004; Rosenquist and Haider 2008).
[0011] Physical methods such as adjusting the prosthesis may be
helpful, but only if the pain is due to poor prosthetic fit. Other
physical treatments, including acupuncture, massage, and percussion
or heating/cooling of the stump, have few complications but also
have limited data to support their use and have not been well
accepted clinically (Russell and Spalding 1950; Gillis 1964; Monga
and Jaksic 1981; Loeser 2001a).
[0012] Psychological strategies, such as biofeedback and
psychotherapy, may be used as an adjunct to other therapies but are
seldom sufficient, and there are few studies demonstrating efficacy
and these approaches are not specific to stump or phantom pain
(Dougherty 1980; Sherman 1980). Mirror-box therapy has demonstrated
mixed results and is not widely used in clinical practice
(Ramachandran and Rogers-Ramachandran 1996; Brodie et al. 2007;
Chan et al. 2007; Rosenquist and Haider 2008).
[0013] Many surgical procedures have been attempted, but few are
successful and most are contraindicated for the majority of the
amputee patients (Loeser 2001a). Because neuromas are implicated
with stump and phantom pain, there have been many attempts to
remove them surgically, but ultimately a new neuroma will develop
each time a nerve is cut and the pain relief only lasts for the 3
weeks that it takes for a new neuroma to form (Sturm 1975;
Sunderland 1978; Sherman 1980). Furthermore, neuroablative
procedures carry the risk of producing deafferentation pain, and
any surgical procedure has a greater chance of failure than success
(Loser 2001a; Rosenquist and Haider 2008). Thus, present medical
treatments of stump and phantom pain are inadequate, and most
sufferers resort to living with pain that is poorly controlled with
medications.
[0014] Electrical stimulation systems hold promise for relief of
post-amputation pain, but widespread use of available systems is
limited.
[0015] Transcutaneous electrical nerve stimulation (TENS) has been
cleared by the FDA for treatment of pain and may be successful in
reducing post-amputation pain. TENS systems are external
neurostimulation devices that use electrodes placed on the skin
surface to activate target nerves below the skin surface. TENS has
a low rate of serious complications, but it also has a relatively
low (i.e., less than 25%) long-term rate of success.
[0016] Application of transcutaneous electrical nerve stimulation
(TENS) has been used to treat stump and phantom pain successfully,
but it has low long-term patient compliance, because it may cause
additional discomfort by generating cutaneous pain signals due to
the electrical stimulation being applied through the skin, and the
overall system is bulky, cumbersome, and not suited for long-term
use (Nashold and Goldner 1975; Sherman 1980; Finsen et al.
1988).
[0017] Spinal cord stimulation (SCS) systems are FDA approved as
implantable neurostimulation devices marketed in the United States
for treatment of pain. Similar to TENS, when SCS evokes
paresthesias that cover the region of pain, it confirms that the
location of the electrode and the stimulus intensity should be
sufficient to provide pain relief and pain relief can be excellent
initially, but maintaining sufficient paresthesia coverage is often
a problem as the lead migrates along the spinal canal (Krainick et
al. 1980; Sharan et al. 2002; Buchser and Thomson 2003).
[0018] Lead migration is the most common complication for spinal
cord stimulators occurring in up to 45-88% of the cases (North et
al. 1991; Andersen 1997; Spincemaille et al. 2000; Sharan et al.
2002). When the lead migrates, the active contact moves farther
from the target fibers and loses the ability to generate
paresthesias in the target area. SCS systems attempt to address
this problem by using leads with multiple contacts so that as the
lead travels, the next contact in line can be selected to be the
active contact.
[0019] Spinal cord stimulation is limited by the invasive procedure
and the decrease in efficacy as the lead migrates. When it can
produce paresthesias in the region of pain, spinal cord stimulation
is typically successful initially in reducing stump and phantom
pain, but over time the paresthesia coverage and pain reduction is
often lost as the lead migrates away from its target (North et al.
1991; Andersen 1997; Loeser 2001a).
[0020] Brain stimulation systems are limited by the lack of patient
selection criteria and the lack of studies demonstrating long-term
efficacy.
[0021] Peripheral nerve stimulation may be effective in reducing
post-amputation pain, but it previously required specialized
surgeons to place cuff- or paddle-style leads around the nerves in
a time consuming procedure.
[0022] Immediately following amputation, all patients experience
short-term (postoperative) pain, but it usually resolves within a
month as the wound heals. In contrast, a long-term pain often
develops and persists in the stump and phantom limb after the
amputated limb has healed into a healthy stump. Stump and phantom
pain are thought to have a peripheral and central component, and
both components may be mediated by stimulating the peripheral
nerves that were transected during amputation.
[0023] Neuromas develop when a peripheral nerve is cut and the
proximal portion produces new axon growth that forms a tangled mass
as it fails to connect with the missing distal portion of the
nerve. All amputations produce neuromas and not all neuromas are
painful, but neuromas are thought to be a major source of pain
after amputation (Burchiel and Russell 1987; Loeser 2001a;
Rosenquist and Haider 2008). Neuromas may generate spontaneous
activity (Wall and Gutnick 1974), and the level of activity in
afferent fibers innervating the region of pain has been linked to
the level of post-amputation pain (Nystrom and Hagbarth 1981).
[0024] As previously described, electrical stimulation has been
used and shown to be effective in treating amputee pain, but
present methods of implementation have practical limitations that
prevent widespread use. External systems are too cumbersome, and
implanted spinal cord stimulation systems often have problems of
lead migration along the spinal canal, resulting in either the need
for frequent reprogramming or clinical failure.
[0025] It is time that systems and methods for providing
neurostimulation address not only specific prosthetic or
therapeutic objections, but also address the quality of life of the
individual requiring neurostimulation, including a need to treat
amputee pain with minimally-invasive systems and methods that may
not require reprogramming, and include lead(s) that can be inserted
percutaneously near target peripheral nerve(s) and resist(s)
migration.
[0026] The electrical stimulation of nerves, often afferent nerves,
to indirectly affect the stability or performance of a
physiological system can provide functional and/or therapeutic
outcomes, and has been used for activating target nerves to provide
therapeutic relief of pain.
[0027] While existing systems and methods can provide remarkable
benefits to individuals requiring therapeutic relief, many issues
and the need for improvements still remain.
[0028] Many techniques have been developed to treat pain, but all
of them are ultimately insufficient.
[0029] Non-narcotic analgesics, such as acetaminophen or
non-steroidal anti-inflammatory drugs (NSAIDS), have relatively
minor side effects and are commonly used for several types of pain.
However, they are rarely sufficient in managing moderate to severe
chronic pain (Sherman et al. 1980; Loeser 2001a; Rosenquist and
Haider 2008).
[0030] The use of narcotic analgesics, such as N-methyl-D-aspartate
(NDMA) antagonists, has shown only minor success with inconsistent
results. Narcotics carry the risk of addiction and side effects,
such as nausea, confusion, vomiting, hallucinations, drowsiness,
dizziness, headache, agitation, and insomnia.
[0031] Psychological strategies, such as biofeedback and
psychotherapy, may be used as an adjunct to other therapies but are
seldom sufficient, and there are few studies demonstrating
efficacy.
[0032] Electrical stimulation systems have been used for the relief
of pain, but widespread use of available systems is limited.
[0033] There exist both external and implantable devices for
providing electrical stimulation to activate nerves and/or muscles
to provide therapeutic relief of pain. These "neurostimulators" are
able to provide treatment and/or therapy to individual portions of
the body. The operation of these devices typically includes the use
of an electrode placed either on the external surface of the skin
and/or a surgically implanted electrode. In most cases, surface
electrode(s), cuff-style electrode(s), paddle-style electrode(s),
spinal column electrodes, and/or percutaneous lead(s) having one or
more electrodes may be used to deliver electrical stimulation to
the select portion of the patient's body.
[0034] Transcutaneous electrical nerve stimulation (TENS) has been
cleared by the FDA for treatment of pain. TENS systems are external
neurostimulation devices that use electrodes placed on the skin
surface to activate target nerves below the skin surface. TENS has
a low rate of serious complications, but it also has a relatively
low (i.e., less than 25%) long-term rate of success.
[0035] Application of TENS has been used to treat pain
successfully, but it has low long-term patient compliance, because
it may cause additional discomfort by generating cutaneous pain
signals due to the electrical stimulation being applied through the
skin, and the overall system is bulky, cumbersome, and not suited
for long-term use (Nashold and Goldner 1975; Sherman 1980; Finsen
et al. 1988).
[0036] In addition, several clinical and technical issues
associated with surface electrical stimulation have prevented it
from becoming a widely accepted treatment method. First,
stimulation of cutaneous pain receptors cannot be avoided resulting
in stimulation-induced pain that limits patient tolerance and
compliance. Second, electrical stimulation is delivered at a
relatively high frequency to prevent stimulation-induced pain,
which leads to early onset of muscle fatigue in turn preventing
patients from properly using their arm. Third, it is difficult to
stimulate deep nerves and/or muscles with surface electrodes
without stimulating overlying, more superficial nerves and/or
muscles resulting in unwanted stimulation. Finally, clinical skill
and intensive patient training is required to place surface
electrodes reliably on a daily basis and adjust stimulation
parameters to provide optimal treatment. The required daily
maintenance and adjustment of a surface electrical stimulation
system is a major burden on both patient and caregiver.
[0037] Spinal cord stimulation (SCS) systems are FDA approved as
implantable neurostimulation devices marketed in the United States
for treatment of pain. Similar to TENS, when SCS evokes
paresthesias that cover the region of pain, it confirms that the
location of the electrode and the stimulus intensity should be
sufficient to provide pain relief and pain relief can be excellent
initially, but maintaining sufficient paresthesia coverage is often
a problem as the lead migrates along the spinal canal (Krainick et
al. 1980; Sharan et al. 2002; Buchser and Thomson 2003).
[0038] Spinal cord stimulation is limited by the invasive procedure
and the decrease in efficacy as the lead migrates. When it can
produce paresthesias in the region of pain, spinal cord stimulation
is typically successful initially in reducing pain, but over time
the paresthesia coverage and pain reduction is often lost as the
lead migrates away from its target (North et al. 1991; Andersen
1997; Loeser 2001a).
[0039] Lead migration is the most common complication for spinal
cord stimulators occurring in up to 45-88% of the cases (North et
al. 1991; Andersen 1997; Spincemaille et al. 2000; Sharan et al.
2002). When the lead migrates, the active contact moves farther
from the target fibers and loses the ability to generate
paresthesias in the target area. SCS systems attempt to address
this problem by using leads with multiple contacts so that as the
lead travels, the next contact in line can be selected to be the
active contact.
[0040] Peripheral nerve stimulation may be effective in reducing
pain, but it previously required specialized surgeons to place
cuff- or paddle-style leads around the nerves in a time consuming
procedure.
[0041] These methods of implementation have practical limitations
that prevent widespread use. External systems are too cumbersome,
and implanted spinal cord stimulation systems often have problems
of lead migration along the spinal canal, resulting in either the
need for frequent reprogramming or clinical failure.
[0042] Percutaneous, intramuscular electrical stimulation for the
treatment of post-stroke shoulder pain has been studied as an
alternative to surface electrical stimulation. A feasibility study
(Chae, Yu, and Walker, 2001) and a pilot study (Chae, Yu, and
Walker, 2005) showed significant reduction in pain and no
significant adverse events when using percutaneous, intramuscular
electrical stimulation in shoulder muscles.
[0043] This form of percutaneous, intramuscular electrical
stimulation can be characterized as "motor point" stimulation of
muscle. To relieve pain in the target muscle, the percutaneous lead
is placed in the muscle that is experiencing the pain near the
point where a motor nerve enters the muscle (i.e., the motor
point). In "motor point" stimulation of muscle, the muscle
experiencing pain is the same muscle in which the lead is placed.
In "motor point" stimulation of muscle, the pain is felt and
relieved in the area where the lead is located.
SUMMARY OF THE INVENTION
[0044] The invention provides improved systems and methods for
placing one or more electrode leads in tissue for providing
electrical stimulation to tissue to reduce pain.
[0045] One aspect of the invention provides lead placement
procedures that may be used for placing a single electrode lead to
activate a target nerve and/or nerves and/or nerve bundles (e.g.,
the brachial plexus, sciatic nerve, and/or femoral nerve, and/or
their roots or branches) that carry the pain signal(s) in a system
for the relief of neuropathic pain, such as post-amputation pain,
but is not exclusive to this application. For example, if the pinky
finger hurts, the systems and methods are well adapted to stimulate
the ulnar nerve (which innervates the pinky finger). The procedures
optimally allow using only a single lead, although it is to be
appreciated that more than one lead(s) may be used, to activate a
greater range of target nerves and/or nerve bundles.
[0046] Other features and advantages of the inventions are set
forth in the following specification and attached drawings.
[0047] The invention provides systems and methods for placing one
or more leads in tissue for providing electrical stimulation to
tissue to treat pain in a manner unlike prior systems and
methods.
[0048] The invention provides systems and methods incorporate a
discovery that pain felt in a given region of the body can be
treated, not by motor point stimulation of muscle in the local
region where pain is felt, but by stimulating muscle close to a
"nerve of passage" in a region that is superior (i.e., cranial or
upstream toward the spinal column) to the region where pain is
felt. Neural impulses comprising pain felt in a given muscle or
cutaneous region of the body pass through spinal nerves that arise
from one or more nerve plexuses. The spinal nerves in a nerve
plexus, which comprise trunks that divide by divisions and/or cords
into branches, comprise "nerves of passage." It has been discovered
that applying stimulation in a muscle near a targeted nerve of
passage relieves pain that manifests itself in a region that is
inferior (i.e., caudal or downstream from the spinal column) from
where stimulation is actually applied.
[0049] Phantom (or amputee) pain is one example of the
effectiveness of "nerves of passage" stimulation, because the area
in which phantom pain is felt does not physically exist. A lead
cannot be physically placed in the muscles that hurt, because those
muscles were amputated. Still, by applying stimulation in a muscle
that has not been amputated near a targeted nerve of passage that,
before amputation, natively innervated the amputated muscles,
phantom pain can be treated.
[0050] Chronic or acute pain in existing, non-amputated muscles can
also be treated by "nerves of passage" stimulation. By applying
stimulation in an existing muscle near a targeted nerve of passage
that caudally innervates the region where chronic or acute pain is
manifested, the pain can be treated.
[0051] In "nerves of passage" stimulation, a lead can be placed in
a muscle that is conveniently located near a nerve trunk that
passes by the lead on the way to the painful area. On "nerves of
passage" stimulation, the lead is placed in a muscle that is not
the target (painful) muscle, but rather a muscle that is upstream
from the painful region, because the proximal muscle presents a
convenient and useful location to place the lead.
[0052] The systems and methods make possible the treatment of
chronic or acute pain in which muscle contraction cannot be evoked
(e.g. in the case of amputation pain in which the target area has
been amputated is no longer physically present), or other cases of
nerve damage either due to a degenerative diseases or condition
such as diabetes of impaired vascular function (in which the nerves
are slowly degenerating, progressing from the periphery), or due to
trauma. The systems and methods make possible the placement
stimulation leads in regions distant from the motor point or region
of pain, e.g., where easier access or more reliable access or a
clinician-preferred access be accomplished; or in situations where
the motor nerve point is not available, damaged, traumatized, or
otherwise not desirable; or in situations where it is desirable to
stimulate more than one motor point with a single lead; or for
cosmetic reasons; or to shorten the distance between the lead and
its connection with a pulse generator; or to avoid tunneling over a
large area.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] FIG. 1 is an anatomical view of a patient utilizing one
embodiment of the present invention, including a percutaneous
electrode lead coupled to an external pulse generator.
[0054] FIG. 2 is an anatomical view of a patient utilizing another
embodiment of the present invention, including an implanted
electrode lead coupled to an implanted pulse generator.
[0055] FIGS. 3A and 3B are anatomical views of a patient's shoulder
showing the anatomical landmarks useful to guide the placement of a
needle electrode as a component and/or step of the present
invention.
[0056] FIG. 4 is an anatomical view of the shoulder as shown in
FIG. 3B, showing infraclavicular and subcoracoid neuroanatomy with
a needle introducer depicting a direction of lead insertion toward
the brachial plexus.
[0057] FIG. 5 is an anatomical view similar to FIG. 4, except
showing greater detail of the brachial plexus and the lead
insertion, and showing an anticipated region of activation.
[0058] FIG. 6 is an anatomical cross-sectional view (perpendicular
to the axis of the lead insertion) of the brachial plexus and
surrounding tissue.
[0059] FIG. 7 is an anatomical view of the shoulder as shown in
FIG. 3B, showing the percutaneous lead inserted through the skin in
the target area in the shoulder via an introducer needle.
[0060] FIG. 8 is an anatomical view of the shoulder as shown in
FIG. 7, showing the percutaneous lead coupled to the external pulse
generator and the return electrode.
[0061] FIG. 9 is a view of a possible electrode lead for use with
the systems and methods of the present invention.
[0062] FIGS. 10 and 11 are perspective views of another possible
electrode lead for use with the systems and methods of the present
invention, the lead including anchoring members.
[0063] FIG. 12 is a plan view of a kit packaging the systems and
methods components for use, along with instructions for use.
[0064] FIG. 13 is a plan view of an additional kit packaging the
systems and methods components for use, along with instructions for
use.
[0065] FIGS. 14A and 14B are schematic anatomic views, respectively
anterior and lateral, of a human peripheral nervous system.
[0066] FIG. 15A is a schematic anatomic view of a human spine,
showing the various regions and the vertebrae comprising the
regions.
[0067] FIGS. 15B and 15C are schematic anatomic views of the
dermatome boundaries of a human.
[0068] FIGS. 16A, 16B, and 16C are anatomic views of the
intercostal spinal nerves of a human.
[0069] FIGS. 17A and 17B are anatomic views of the spinal nerves of
the brachial plexus.
[0070] FIG. 18 is an anatomic views of the spinal nerves of the
lumbar plexus.
[0071] FIG. 19 is an anatomic view of the spinal nerves of the
sacral plexus.
[0072] FIG. 20 is an anatomic view of the spinal nerves of the
cervical plexus.
[0073] FIG. 21 is an anatomic view of the spinal nerves of the
solar plexus.
[0074] FIG. 22 is an idealized, diagrammatic view showing a motor
point stimulation system.
[0075] FIG. 23 is an idealized, diagrammatic view showing a nerve
of passage stimulation system.
[0076] FIGS. 24A to 24D are views showing a percutaneous lead that
can form a part of a nerve of passage stimulation system.
[0077] FIG. 25 is a view of a package containing a nerve of passage
stimulation system.
[0078] FIGS. 26A/B and 27A/B are representative leads that can form
a part of a nerve of passage stimulation system.
[0079] FIGS. 28A and 28B are schematic anatomic views of a system
for applying nerve of passage stimulation to spinal nerves in the
brachial plexus.
[0080] FIGS. 29A, 29B, and 29C are schematic anatomic views of a
system for applying nerve of passage stimulation to a femoral
nerve.
[0081] FIGS. 30A, 30B, and 30C are schematic anatomic views of a
system for applying nerve of passage stimulation to a
sciatic/tibial nerve.
[0082] FIGS. 31A and 31B are schematic sectional anatomic views of
systems for applying nerve of passage stimulation to a femoral
nerve and a sciatic/tibial nerve.
[0083] FIGS. 32A, 32B, and 32C are schematic sectional anatomic
views of a system for applying nerve of passage stimulation along a
sciatic/tibial nerve.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0084] Although the disclosure hereof is detailed and exact to
enable those skilled in the art to practice the invention, the
physical embodiments herein disclosed merely exemplify the
invention which may be embodied in other specific structures. While
the desired embodiment has been described, the details may be
changed without departing from the invention.
[0085] Any elements described herein as singular can be pluralized
(i.e., anything described as "one" can be more than one). Any
species element of a genus element can have the characteristics or
elements of any other species element of that genus. The described
configurations, elements or complete assemblies and methods and
their elements for carrying out the invention, and variations of
aspects of the invention can be combined and modified with, each
other in any combination.
[0086] The various aspects of the invention will be described in
connection with the placement of one or more leads 12 having one or
more electrodes 14, in tissue, e.g., on, in, or near nerves and/or
muscles, for improved recruitment of targeted nerves or muscles for
prosthetic or therapeutic purposes, such as for the treatment of
post-amputation pain. That is because the features and advantages
that arise due to the invention are well suited to this purpose.
Still, it should be appreciated that the various aspects of the
invention can be applied to achieve other objectives as well.
I. REDUCTION OF POST-AMPUTATION PAIN
[0087] The present novel invention provides systems and methods for
the reduction of pain. Most amputees have two types of pain:
residual limb (stump) pain and phantom pain. The systems and
methods of the present invention are adapted to reduce either
and/or both types of pain by stimulating target nerves, generally
on the same side of the body as the amputation, i.e., the nerves
that innervate the regions of pain. It is to be appreciated that
amputation can include any or all portions of a limb, including
arms and legs in both humans and animals.
[0088] The present novel invention provides systems and methods
that place percutaneous electrode lead(s) 12 appropriately in
patients with amputations to electrically activate a target nerve
and/or nerves and/or nerve bundles (e.g., the brachial plexus,
sciatic nerve, and/or femoral nerve, and/or their roots or
branches) that carry the pain signal(s). For example, if the pinky
finger hurts, the systems and methods are well adapted to stimulate
the ulnar nerve (which innervates the pinky finger). If electrical
stimulation activates the target nerve sufficiently at the correct
intensity, then the patient will feel a comfortable tingling
sensation called a paresthesia in the same region as their pain. It
is to be appreciated that the sensation could be described with
other words such as buzzing, thumping, etc. Just as the patient can
have pain in the stump and/or the phantom limb, electrical
stimulation can evoke paresthesias that the patient also feels in
the stump and/or phantom limb. Evoking paresthesias in the regions
of pain confirms correct lead placement and indicates stimulus
intensity is sufficient to reduce pain.
[0089] The ability to insert the lead 12 percutaneously near a
target peripheral nerve simplifies the approach to a quick (e.g.,
5, or 10, or 20 minute) procedure, such as an out-patient procedure
that can be performed in a standard community-based clinic,
allowing widespread use and providing a minimally-invasive
screening test to determine if patients will benefit from the
systems and methods of the present invention, including a
percutaneous system 10 and/or a fully implanted system 11 (see
FIGS. 1 and 2).
[0090] The systems and methods of the present invention are well
suited to place a percutaneous lead 12 on, in, or near the brachial
plexus with a quick procedure to generate electrically a
comfortable (tingling) sensation of paresthesia in the regions of
stump and phantom pain and reduce the patients' pain.
[0091] In a percutaneous system 10, the lead 12 may be
percutaneously placed near the brachial plexus and exit at the skin
puncture site 16 and coupled to an external pulse generator 26. The
percutaneously placed lead 12 and external pulse generator 26 may
provide a screening test function to confirm paresthesia coverage
and/or pain relief of the painful areas. If the screening test is
successful, the patient may proceed to a home-trial (e.g., a day,
week, month, year) to determine if pain relief can be sustained in
the home environment. If either the screening test or home trial is
unsuccessful, the lead 12 may be quickly and easily removed. It is
to be appreciated that a home-trial is not a requirement for either
the percutaneous system or a fully implanted system.
[0092] However, if the screening test and/or home-trial are
successful, the patient's percutaneous system may be converted into
a fully implanted system 11 by replacing the external pulse
generator 26 with an implantable pulse generator 28 that is
implanted in a convenient area (e.g., the subclavicular area), and
coupling a new sterile lead 12, or a sterile lead extension, to the
implantable pule generator 28.
[0093] Inserting the lead 12 percutaneously allows the lead 12 to
be placed quickly and easily, and placing the lead 12 in a
peripheral location, where it is less likely to be dislodged,
addresses the lead migration problems of spinal cord stimulation
that result in decreased paresthesia coverage, decreased pain
relief, and the need for frequent patient visits for
reprogramming.
[0094] In the exemplary embodiment of the present invention,
placing the percutaneous lead 12 in adipose tissue of the
infraclavicular and subcoracoid space near the brachial plexus (to
be described in greater detail below), may minimize complications
related to lead movement. Perineural catheters connected to
infusion pumps have been placed in similar locations for use by
ambulatory patients in their home environment and have a low rate
of catheter dislocations and complications (Wilson et al 1998;
Ekatodramis and Borgeat 2000; Ilfeld et al. 2002).
[0095] In the percutaneous system 10, an electrode lead 12, such as
a coiled fine wire electrode lead may be used because it is
minimally-invasive and previous studies suggest it will perform
well in this location and tissue type during use.
[0096] In the fully implanted system 11, the same or different
electrode lead 12 may be used, such as a slightly larger electrode
lead that may be sized and configured to withstand greater
mechanical forces and resist migration during long-term use. A
larger electrode lead 12 may be sized and configured to withstand
forces in excess of those anticipated near the brachial plexus, and
other similarly flexible regions of the body.
II. IMPLANTING THE ELECTRODE LEAD
A. The Anatomic Landmarks
[0097] As already described, certain components of the systems and
methods of the present invention are well adapted to be implanted
in a particular location near the patient's shoulder, where it has
been discovered that effective stimulation of the nerves of the
brachial plexus can be achieved with a single electrode lead 12 to
reduce pain. As can be seen in FIGS. 3A and 3B, the main anatomic
landmarks guiding the unique placement of these components are the
clavicle and the coracoid process.
[0098] FIG. 4 shows the clavicle as a doubly curved short bone that
connects the arm (upper limb) to the body (trunk), located directly
above the first rib. It acts as a shunt to keep the scapula in
position so the arm can hang freely. The coracoid process is a
small finger-like structure on the upper lateral corner of the
scapula. Pointing laterally forward, it, together with the
acromion, serves to stabilize the shoulder joint. It is palpable in
the deltopectoral groove between the deltoid and pectoralis major
muscles.
[0099] Guided by these landmarks, the brachial plexus can be
identified. Referring to FIGS. 4 and 5, the brachial plexus
comprises an arrangement of nerve fibers, running from the spine,
formed by the ventral rami of the lower cervical and upper thoracic
nerve roots, specifically from above the fifth cervical vertebra to
underneath the first thoracic vertebra (C5-T1). It proceeds through
the neck, under the clavicle and generally anterior to the scapula,
through the armpit region and into the arm. The brachial plexus is
generally responsible for cutaneous and muscular innervation of the
entire upper limb, with only two exceptions; the trapezius muscle
is innervated by the spinal accessory nerve and an area of skin
near the armpit is innervated by the intercostobrachialis
nerve.
[0100] FIG. 6 is a cross-sectional view (perpendicular to the axis
of the lead insertion) of the brachial plexus and surrounding
tissue (Moayeri et al. 2008). As can be seen in FIG. 6, the
brachial plexus is surrounded by a large amount of adipose tissue
54 in the infraclavicular and subcoracoid regions, where the
electrode lead 12 will be placed, and is well suited for use in
adipose tissue. In the infraclavicular and subcoracoid sections of
cadavers studied, the brachial plexus was surrounded by about
6.90.+-.1.82 cm.sup.2 to about 7.06.-+.1.48 cm.sup.2, which is
ample area to place the electrode lead 12.
B. Implantation Methodology
[0101] Representative lead insertion techniques will now be
described to place an electrode lead 12 in a desired location in
adipose tissue 54 at or near the brachial plexus. It is this
desired placement that makes possible the stimulation of the
brachial plexus with a single lead 12 to provide pain relief.
[0102] FIGS. 7 and 8 show representative embodiments of the steps
that representative instructions for use 58 can incorporate or
direct for the placement of an electrode lead 12 in a targeted
tissue region for the relief of pain, such as post-amputation pain.
The instructions may include a series of steps that can be followed
to carry out portion or portions of the procedure. These steps may
include, but are not limited to:
1) Place the patient in a supine position with head turned away
from the lead insertion site 16 and forearm laid to rest in a
neutral position beside the body. 2) Prepare the lead insertion
site with antiseptic and local subcutaneous anesthetic (e.g., 2%
lidocaine). 3) Locate the site of skin puncture 16 with landmarks
as necessary, such as those previously described, e.g.,
approximately 2 cm medial and caudal to the coracoid process. 4)
Insert a sterile percutaneous electrode lead 12 at a predetermined
angle based on landmarks used, e.g., approximately 45 degrees
towards the top of the axillary fossa in relation to the axillary
artery. The lead 12 may be preloaded in the introducer needle 30
(see FIG. 7). 5) Place a surface stimulation return electrode 24 in
proximity of the area in which the percutaneous lead 12 has been
placed. Test stimulation will be applied to the lead 12, with the
surface electrode 24 providing a return path. The surface electrode
24 may be placed adjacent to the lead. Its position is not critical
to the therapy and it can be moved throughout the therapy to reduce
the risk of skin irritation. 6) Couple the lead 12 to the external
pulse generator 26 and to the return electrode 24 (see FIG. 8). Set
the desired stimulation parameters. Test stimulation may be
delivered using a current-regulated pulse generator, for example.
The external pulse generator 26 may be programmed to 4 mA. 100
.mu.s, 100 Hz, and an on-off duty cycle of 0.25 sec., as a
non-limiting example. 7) Advance the introducer slowly until the
subject reports the first evoked sensation in the stump or phantom
upper limb (e.g., hand). Progressively reduce the stimulus
amplitude and advance the introducer more slowly until the
sensation can be evoked in the phantom upper limb at a
predetermined stimulus amplitude (e.g., 1 mA). Stop the advancement
of the introducer, and increase the stimulus amplitude in small
increments (e.g., 0.1 mA) until the stimulation-evoked tingling
sensation (paresthesia) expands to overlay the entire region of
pain in the subject's stump and phantom limb.
[0103] It is expected to locate the brachial plexus after inserting
the introducer approximately 4 cm from the site of skin puncture
16. At this depth, it is expected that a low stimulus intensity may
evoke comfortable sensations (paresthesia) without generating
muscle contraction (Nashold and Goldner 1975; Picaza et al. 1975;
Nashold et al. 1982).
8) Withdraw the introducer 30, leaving the percutaneous lead 12 in
proximity to the brachial plexus. 9) Cover the percutaneous exit
site and lead 12 with a bandage 32. A bandage 34 may also be used
to secure the external portion of the lead 12 (or an extension
cable used to couple the lead 12 to the external pulse generator)
to the skin (see FIG. 1). It is expected the length of time to
place the lead 12 to be less than 10 minutes, although the process
may be shorter or longer. 10) Vary the stimulus amplitude in small
steps (e.g., 0.1-0.5 mA) to determine the thresholds at which
stimulation evokes first sensation (T.sub.SEN), sensation
(paresthesia) superimposed on the region of pain (T.sub.SUP),
muscle twitch (T.sub.MUS) of the triceps brachii (innervated by the
radial nerve branch of the brachial plexus), and maximum
comfortable sensation (T.sub.MAX). Query the subject at each
stimulus amplitude to determine sensation level, and visually
monitor muscle response. Record the results. 11) It is possible
that stimulation intensity may need to be increased slightly during
the process due to causes such as habituation or the subject
becoming accustomed to sensation, but the need for increased
intensity is unlikely and usually only occurs after several days to
weeks to months as the tissue encapsulates and the subject
accommodates to stimulation (Nashold 1975; Krainick and Thoden
1981; Goldman et al. 2008). It is to be appreciated that the need
for increased intensity could happen at any time, even years out,
which would likely be due to either lead migration or habituation,
but may also be due reasons ranging from nerve damage to
plasticity/reorganization in the central nervous system. 12) If
paresthesias cannot be evoked with the initial lead placement,
redirect the introducer 30 either caudal or cephalad, but avoid the
lung by never directing the needle introducer 30 medially. 13) If
sensations still cannot be evoked in a given subject, then the
muscle twitch response of the triceps brachii may be used to guide
lead placement and then increase stimulus intensity until
sufficient paresthesias are elicited in the stump and phantom limb.
Minimal muscle contraction may be acceptable if it is well
tolerated by the amputee patient in exchange for significant pain
relief and if it does not lead to additional discomfort or fatigue
(Long 1973). 14) If stimulation evokes muscle contraction at a
lower stimulus threshold than paresthesia (e.g. if
T.sub.MUS.ltoreq.T.sub.SUP) and contraction leads to discomfort,
then a lower stimulus frequency (e.g., 12 Hz) may be used because
low frequencies (e.g., 4-20 Hz) have been shown to minimize
discomfort due to muscle contraction and provide >50% relief of
shoulder pain in stroke patients while still inhibiting
transmission of pain signals in the central nervous system in
animals (Chung et al. 1984; Yu et al. 2001, 2004; Chae et al.
2005). If continued muscle contraction leads to pain due to
fatigue, change the duty cycle, using parameters shown to reduce
muscle fatigue and related discomfort in the upper extremity (e.g.
5 s ramp up, 10 s on, 5 s ramp down, 10 s off) (Yu et al. 2004;
Chae et al. 2005). 15) If stimulation fails to elicit paresthesia
in all areas of pain, then a second percutaneous lead 12' (not
shown) may need to be placed to stimulate the nerves that are not
activated by the first lead 12. If paresthesia coverage is
incomplete, it may likely be due to insufficient activation of the
musculocutaneous nerve because it has the most proximal branch
point relative to the other nerves and is the most likely to be
missed during single-injection nerve blocks of the brachial plexus.
To place a lead near the musculocutaneous nerve, use the modified
coracoid approach (a double-stimulation technique) that targets the
musculocutaneous nerve in addition to the main trunk of the
brachial plexus, as described above (Desroches 2003; Minville et
al. 2005). 16) If stimulation is successful, i.e., if the screening
test and/or home-trial are successful, the patient's percutaneous
system 10 (see FIG. 1) may be converted into a fully implanted
system 11 by replacing the external pulse generator 26 with an
implantable pulse generator 28 that is implanted in a convenient
area (e.g., the subclavicular area). In one embodiment, the
electrode lead 12 used in the screening test and/or home-trial may
be totally removed and discarded, and a new completely implantable
lead may be tunneled subcutaneously and coupled to the implantable
pulse generator. In an alternative embodiment, a two part lead may
be incorporated in the screening test and/or home-trial where the
implantable part is completely under the skin and connected to a
percutaneous connector (i.e., extension) that can be discarded
after removal. The implantable part may then be tunneled and
coupled to the implantable pulse generator, or a new sterile
extension may be used to couple the lead to the implantable pulse
generator.
III. ELECTRODE LEAD CONFIGURATIONS
[0104] It is to be appreciated that the configuration of one or
more leads 12 and electrodes 14, and the manner in which they are
implanted can vary. Stimulation may be applied through an electrode
lead 12, such as a fine wire electrode, paddle electrode,
intramuscular electrode, or general-purpose electrode, inserted via
a needle introducer or surgically implanted in proximity of the
target site. Once proper placement is confirmed, the needle may be
withdrawn, leaving the electrode in place. Stimulation may also be
applied through a penetrating electrode, such as an electrode array
comprised of any number (i.e., one or more) of needle-like
electrodes that are inserted into the target site. In both cases,
the lead may placed using a needle-like introducer, allowing the
lead/electrode placement to be minimally invasive.
[0105] The electrode 14 may be electrically insulated everywhere
except at one (monopolar), or two (bipolar), or three (tripolar),
for example, conduction locations near its distal tip. Each of the
conduction locations may be connected to one or more conductors
that run the length of the electrode and lead 12, proving
electrical continuity from the conduction location through the lead
12 to the stimulator 26 or 28.
[0106] The electrode lead 12 is desirably provided in a sterile
package, and may be pre-loaded in the introducer needle 30. The
lead 12 desirably possess mechanical properties in terms of
flexibility and fatigue life that provide an operating life free of
mechanical and/or electrical failure, taking into account the
dynamics of the surrounding tissue (i.e., stretching, bending,
pushing, pulling, crushing, etc.). The material of the electrode
desirably discourages the in-growth of connective tissue along its
length, so as not to inhibit its withdrawal at the end of its use.
However, it may be desirable to encourage the in-growth of
connective tissue at the distal tip of the electrode, to enhance
its anchoring in tissue.
[0107] One embodiment of the lead 12 shown in FIG. 9 may comprise a
minimally invasive coiled fine wire lead 12 and electrode 14. The
electrode 14 may also include, at its distal tip, an anchoring
element 48. In the illustrated embodiment, the anchoring element 48
takes the form of a simple barb or bend. The anchoring element 48
is sized and configured so that, when in contact with tissue, it
takes purchase in tissue, to resist dislodgement or migration of
the electrode out of the correct location in the surrounding
tissue. Desirably, the anchoring element 48 is prevented from fully
engaging body tissue until after the electrode 14 has been
deployed. The electrode may not be deployed until after it has been
correctly located during the implantation (lead placement) process,
as previously described.
[0108] An alternative embodiment of an electrode lead 12 shown in
FIGS. 10 and 11, may also include, at or near its distal tip or
region, one or more anchoring element(s) 70. In the illustrated
embodiment, the anchoring element 70 takes the form of an array of
shovel-like paddles or scallops 76 proximal to the proximal-most
electrode 14 (although a paddle 76 or paddles could also be
proximal to the distal most electrode 14, or could also be distal
to the distal most electrode 14). The paddles 76 as shown are sized
and configured so they will not cut or score the surrounding
tissue. The anchoring element 70 is sized and configured so that,
when in contact with tissue, it takes purchase in tissue, to resist
dislodgement or migration of the electrode out of the correct
location in the surrounding tissue (e.g., soft adipose tissue 54).
Desirably, the anchoring element 70 is prevented from fully
engaging body tissue until after the electrode 14 has been
deployed. The electrode is not deployed until after it has been
correctly located during the implantation (lead placement) process,
as previously described. In addition, the lead 12 may include one
or more ink markings 74, 75 to aid the physician in its proper
placement.
[0109] Alternatively, or in combination, stimulation may be applied
through any type of nerve cuff (spiral, helical, cylindrical, book,
flat interface nerve electrode (FINE), slowly closing FINE, etc.)
that is surgically placed within muscle at the target site.
[0110] In all cases, the lead may exit through the skin and connect
with one or more external stimulators 26, or the lead(s) may be
routed subcutaneously to one or more implanted pulse generators 28,
or they may be connected as needed to internal and external coils
for RF (Radio Frequency) wireless telemetry communications or an
inductively coupled telemetry to control the implanted pulse
generator. The implanted pulse generator 28 may be located some
distance (remote) from the electrode 14, or an implanted pulse
generator may be integrated with an electrode(s), eliminating the
need to route the lead subcutaneously to the implanted pulse
generator.
[0111] Control of the stimulator and stimulation parameters may be
provided by one or more external controllers. In the case of an
external stimulator, the controller may be integrated with the
external stimulator. The implanted pulse generator external
controller (i.e., clinical programmer) may be a remote unit that
uses RF (Radio Frequency) wireless telemetry communications (rather
than an inductively coupled telemetry) to control the implanted
pulse generator. The external or implantable pulse generator may
use passive charge recovery to generate the stimulation waveform,
regulated voltage (e.g., 10 mV to 20 V), and/or regulated current
(e.g., about 10 .mu.A to about 50 mA). Passive charge recovery is
one method of generating a biphasic, charge-balanced pulse as
desired for tissue stimulation without severe side effects due to a
DC component of the current.
[0112] The neurostimulation pulse may by monophasic, biphasic,
and/or multi-phasic. In the case of the biphasic or multi-phasic
pulse, the pulse may be symmetrical or asymmetrical. Its shape may
be rectangular or exponential or a combination of rectangular and
exponential waveforms. The pulse width of each phase may range
between e.g., about 0.1 plsec. to about 1.0 sec., as non-limiting
examples.
[0113] Pulses may be applied in continuous or intermittent trains
(i.e., the stimulus frequency changes as a function of time). In
the case of intermittent pulses, the on/off duty cycle of pulses
may be symmetrical or asymmetrical, and the duty cycle may be
regular and repeatable from one intermittent burst to the next or
the duty cycle of each set of bursts may vary in a random (or
pseudo random) fashion. Varying the stimulus frequency and/or duty
cycle may assist in warding off habituation because of the stimulus
modulation.
[0114] The stimulating frequency may range from e.g., about 1 Hz to
about 300 Hz, and the frequency of stimulation may be constant or
varying. In the case of applying stimulation with varying
frequencies, the frequencies may vary in a consistent and
repeatable pattern or in a random (or pseudo random) fashion or a
combination of repeatable and random patterns.
IV. SYSTEM KITS
[0115] As FIGS. 12 and 13 show, the various devices and components
just described can be consolidated for use in one or more
functional kit(s) 60, 64. The kits can take various forms and the
arrangement and contents of the kits can vary. In the illustrated
embodiments, each kit 60, 64 comprise a sterile, wrapped assembly.
Each kit 60, 64 includes an interior tray 62 made, e.g., from die
cut cardboard, plastic sheet, or thermo-formed plastic material,
which hold the contents. Kits 60, 64 also desirably includes
instructions for use 58 for using the contents of the kit to carry
out the procedures described above, including the systems and
methods incorporating the percutaneous system 10 and/or the
implanted system 11.
[0116] The instructions 58 can, of course vary. The instructions 58
may be physically present in the kits, but can also be supplied
separately. The instructions 58 can be embodied in separate
instruction manuals, or in video or audio tapes, CD's, and DVD's.
The instructions 58 for use can also be available through an
internet web page.
V. THE PERIPHERAL NERVOUS SYSTEM
[0117] (Anatomic Overview)
[0118] As generally shown in FIGS. 14A and 14B, the peripheral
nervous system consists of nerve fibers and cell bodies outside the
central nervous system (the brain and the spinal column) that
conduct impulses to or away from the central nervous system. The
peripheral nervous system is made up of nerves (called spinal
nerves) that connect the central nervous system with peripheral
structures. The spinal nerves of the peripheral nervous system
arise from the spinal column and exit through intervertebral
foramina in the vertebral column (spine). The afferent, or sensory,
fibers of the peripheral nervous system convey neural impulses to
the central nervous system from the sense organs (e.g., the eyes)
and from sensory receptors in various parts of the body (e.g., the
skin, muscles, etc.). The efferent, or motor, fibers convey neural
impulses from the central nervous system to the effector organs
(muscles and glands).
[0119] The somatic nervous system (SNS) is the part of the
peripheral nervous system associated with the voluntary control of
body movements through the action of skeletal muscles, and with
reception of external stimuli, which helps keep the body in touch
with its surroundings (e.g., touch, hearing, and sight). The system
includes all the neurons connected with skeletal muscles, skin and
sense organs. The somatic nervous system consists of efferent
nerves responsible for sending central nervous signals for muscle
contraction. A somatic nerve is a nerve of the somatic nervous
system.
A. Spinal Nerves
[0120] A typical spinal nerve arises from the spinal cord by
rootlets which converge to form two nerve roots, the dorsal
(sensory) root and the ventral (motor) root. The dorsal and ventral
roots unite into a mixed nerve trunk that divides into a smaller
dorsal (posterior) primary ramus and a much larger ventral
(anterior) primary ramus. The posterior primary rami serve a column
of muscles on either side of the vertebral column, and a narrow
strip of overlying skin. All of the other muscle and skin is
supplied by the anterior primary rami.
[0121] The nerve roots that supply or turn into peripheral nerves
can be generally categorized by the location on the spine where the
roots exit the spinal cord, i.e., as generally shown in FIG. 15A,
cervical (generally in the head/neck, designated C1 to C8),
thoracic (generally in chest/upper back, designated T1 to T12),
lumbar (generally in lower back, designated L1 to L5); and sacral
(generally in the pelvis, designated S1 to S5). All peripheral
nerves can be traced back (distally toward the spinal column) to
one or more of the spinal nerve roots in either the cervical,
thoracic, lumbar, or sacral regions of the spine. The neural
impulses comprising pain felt in a given muscle or cutaneous region
of the body pass through spinal nerves and (usually) one or more
nerve plexuses. For this reason, the spinal nerves will sometimes
be called in shorthand for the purpose of description "nerves of
passage." The spinal nerves begin as roots at the spine, and can
form trunks that divide by divisions or cords into branches that
innervate skin and muscles.
[0122] Spinal nerves have motor fibers and sensory fibers. The
motor fibers innervate certain muscles, while the sensory fibers
innervate certain areas of skin. A skin area innervated by the
sensory fibers of a single nerve root is known as a dermatome. A
group of muscles primarily innervated by the motor fibers of a
single nerve root is known as a myotome. Although slight variations
do exist, dermatome and myotome patterns of distribution are
relatively consistent from person to person.
[0123] Each muscle in the body is supplied by a particular level or
segment of the spinal cord and by its corresponding spinal nerve.
The muscle, and its nerve make up a myotome. This is approximately
the same for every person and are as follows:
[0124] C3, 4 and 5 supply the diaphragm (the large muscle between
the chest and the belly that we use to breath).
[0125] C5 also supplies the shoulder muscles and the muscle that we
use to bend our elbow.
[0126] C6 is for bending the wrist back.
[0127] C7 is for straightening the elbow.
[0128] C8 bends the fingers.
[0129] T1 spreads the fingers.
[0130] T1-T12 supplies the chest wall & abdominal muscles.
[0131] L2 bends the hip.
[0132] L3 straightens the knee.
[0133] L4 pulls the foot up.
[0134] L5 wiggles the toes.
[0135] S1 pulls the foot down.
[0136] S3, 4 and 5 supply the bladder, bowel, and sex organs and
the anal and other pelvic muscles.
[0137] Dermatome is a Greek word which literally means "skin
cutting". A dermatome is an area of the skin supplied by nerve
fibers originating from a single dorsal nerve root. The dermatomes
are named according to the spinal nerve which supplies them. The
dermatomes form into bands around the trunk (see FIGS. 15B and
15C), but in the limbs their organization can be more complex as a
result of the dermatomes being "pulled out" as the limb buds form
and develop into the limbs during embryological development.
[0138] In the diagrams or maps shown in FIGS. 15B and 15C, the
boundaries of dermatomes are usually sharply defined. However, in
life there is considerable overlap of innervation between adjacent
dermatomes. Thus, if there is a loss of afferent nerve function by
one spinal nerve sensation from the region of skin which it
supplies is not usually completely lost as overlap from adjacent
spinal nerves occurs; however, there will be a reduction in
sensitivity.
B. Intercostal Nerves
[0139] The intercostal nerves (see FIGS. 16A, 16B, and 16C) are the
anterior divisions of the thoracic spinal nerves from the thoracic
vertebrae T1 to T11. The intercostal nerves are distributed chiefly
to the thoracic pleura and abdominal peritoneum and differ from the
anterior divisions of the other spinal nerves in that each pursues
an independent course without plexus formation.
[0140] The first two nerves supply fibers to the upper limb in
addition to their thoracic branches; the next four are limited in
their distribution to the parietes of the thorax; the lower five
supply the parietes of the thorax and abdomen. The 7th intercostal
nerve terminates at the xyphoid process, at the lower end of the
sternum. The 10th intercostal nerve terminates at the umbilicus.
The twelfth (subcostal) thoracic is distributed to the abdominal
wall and groin.
[0141] Branches of a typical intercostal nerve include the ventral
primary ramus; lateral cutaneous branches that pass beyond the
angles of the rubs and innervate the internal and external
intercostal muscles approximately halfway around the thorax; and
the anterior cutaneous branches that supply the skin on the
anterior aspect of the thorax and abdomen.
C. Spinal Nerve Plexuses
[0142] A nerve plexus is a network of intersecting anterior primary
rami. The sets of anterior primary rami form nerve trunks that
ultimately further divide through divisions and then into cords and
then into nerve branches serving the same area of the body. The
nerve branches are mixed, i.e., they carry both motor and sensory
fibers. The branches innervate the skin, muscle, or other
structures. One example of the entry of a terminal motor nerve
branch into muscle is called a motor point.
[0143] As shown in FIGS. 14A and 14B, there are several nerve
plexuses in the body, including (i) the brachial plexus, which
serves the chest, shoulders, arms and hands; (ii) the lumbar
plexus, which serves the back, abdomen, groin, thighs, knees, and
calves; (iii) the sacral plexus, which serves the buttocks, thighs,
calves, and feet; (iv) the cervical plexus, which serves the head,
neck and shoulders; and (vi) the solar plexus, which serves
internal organs. The following describes, from an anatomic
perspective, the spinal nerves of passage passing through the
various plexuses, and the muscle and/or skin regions they innervate
and where pain can be felt.
1. The Brachial Plexus
[0144] Most nerves in the upper limb arise from the brachial
plexus, as shown in FIGS. 17A and 17B. The brachial plexus begins
in the neck (vertebrae C5 through C7), forms trunks, and extends
through divisions and cords into the axilla (underarm), where
nearly all the nerve branches arise. Primary nerve branches of the
brachial plexus include the musculocutaneous nerve; the median
nerve; the ulnar nerve; the axillary nerve; and the radial
nerve.
a. The Musculocutaneous Nerve
[0145] The musculocutaneous nerve arises from the lateral cord of
the brachial plexus. Its fibers are derived from cervical vertebrae
C5, C6. The musculocutaneous nerve penetrates the coracobrachialis
muscle and passes obliquely between the biceps brachii and the
brachialis, to the lateral side of the arm. Just above the elbow,
the musculocutaneous nerve pierces the deep fascia lateral to the
tendon of the biceps brachii continues into the forearm as the
lateral antebrachial cutaneous nerve. In its course through the
arm, the musculocutaneous nerve innervates the coracobrachialis,
biceps brachii, and the greater part of the brachialis.
b. The Median Nerve
[0146] The median nerve is formed from parts of the medial and
lateral cords of the brachial plexus, and continues down the arm to
enter the forearm with the brachial artery. It originates from the
brachial plexus with roots from cervical vertebrae C5, C6, C7 and
thoracic vertebra T1. The median nerve innervates all of the
flexors in the forearm, except flexor carpi ulnaris and that part
of flexor digitorum profundus that supplies the medial two digits.
The latter two muscles are supplied by the ulnar nerve of the
brachial plexus. The median nerve is the only nerve that passes
through the carpal tunnel, where it may be compressed to cause
carpal tunnel syndrome.
[0147] The main portion of the median nerve supplies the following
muscles: (i) the superficial group comprising pronator teres
muscle; flexor carpi radialis muscle; palmaris longus muscle; and
(ii) the intermediate group comprising flexor digitorum
superficialis muscle.
[0148] The anterior interosseus branch of the median nerve supplies
the deep group comprising flexor digitorum profundus muscle
(lateral half); flexor pollicis longus muscle; and pronator
quadratus.
[0149] In the hand, the median nerve supplies motor innervation to
the 1st and 2nd lumbrical muscles. It also supplies the muscles of
the thenar eminence by a recurrent thenar branch. The rest of the
intrinsic muscles of the hand are supplied by the ulnar nerve of
the brachial plexus.
[0150] The median nerve innervates the skin of the palmar side of
the thumb, the index and middle finger, half the ring finger, and
the nail bed of these fingers. The lateral part of the palm is
supplied by the palmar cutaneous branch of the median nerve, which
leaves the nerve proximal to the wrist creases. The palmar
cutaneous branch travels in a separate fascial groove adjacent to
the flexor carpi radialis and then superficial to the flexor
retinaculum. It is therefore spared in carpal tunnel syndrome.
c. The Ulnar Nerve
[0151] The ulnar nerve comes from the medial cord of the brachial
plexus, and descends on the posteromedial aspect of the humerus. It
goes behind the medial epicondyle, through the cubital tunnel at
the elbow (where it is vulnerable to injury for a few centimeters,
just above the joint). One method of injuring the nerve is to
strike the medial epicondyle of the humerus from posteriorly, or
inferiorly with the elbow flexed. The ulnar nerve is trapped
between the bone and the overlying skin at this point. This is
commonly referred, to as hitting one's "funny bone."
[0152] The ulnar nerve is the largest nerve not protected by muscle
or bone in the human body. The ulnar nerve is the only unprotected
nerve that does not serve a purely sensory function. The ulnar
nerve is directly connected to the little finger, and the adjacent
half of the ring finger, supplying the palmar side of these
fingers, including both front and back of the tips, as far back as
the fingernail beds.
[0153] The ulnar nerve and its branches innervate muscles in the
forearm and hand. In the forearm, the muscular branches of ulnar
nerve innervates the flexor carpi ulnaris and the flexor digitorum
profundus (medial half). In the hand, the deep branch of ulnar
nerve innervates hypothenar muscles; opponens digiti minimi;
abductor digiti minimi; flexor digiti minimi brevis; adductor
pollicis; flexor pollicis brevis (deep head); the third and fourth
lumbrical muscles; dorsal interossei; palmar interossei. In the
hand, the superficial branch of ulnar nerve innervates palmaris
brevis.
[0154] The ulnar nerve also provides sensory innervation to the
fifth digit and the medial half of the fourth digit, and the
corresponding part of the palm. The Palmar branch of ulnar nerve
supplies cutaneous innervation to the anterior skin and nails. The
dorsal branch of ulnar nerve supplies cutaneous innervation to the
posterior skin (except the nails).
d. The Axillary Nerve
[0155] The axillary nerve comes off the posterior cord of the
brachial plexus at the level of the axilla (armpit) and carries
nerve fibers from vertebrae C5 and C6. The axillary nerve travels
through the quadrangular space with the posterior circumflex
humeral artery and vein. It supplies two muscles: the deltoid (a
muscle of the shoulder), and the teres minor (one of the rotator
cuff muscles). The axillary nerve also carries sensory information
from the shoulder joint, as well as from the skin covering the
inferior region of the deltoid muscle, i.e., the "regimental badge"
area (which is innervated by the superior lateral cutaneous nerve
branch of the axillary nerve). When the axillary nerve splits off
from the posterior cord, the continuation of the cord is the radial
nerve.
e. The Radial Nerve
[0156] The radial nerve supplies the upper limb, supplying the
triceps brachii muscle of the arm, as well as all twelve muscles in
the posterior osteofascial compartment of the forearm, as well as
the associated joints and overlying skin. The radial nerve
originates from the posterior cord of the brachial plexus with
roots from cervical vertebrae C5, C6, C7, C8 and thoracic vertebra
T1.
[0157] Cutaneous innervation is provided by the following nerves:
(i) posterior cutaneous nerve of arm (originates in axilla); (ii)
inferior lateral cutaneous nerve of arm (originates in arm); and
(iii) posterior cutaneous nerve of forearm (originates in arm). The
superficial branch of the radial nerve provides sensory innervation
to much of the back of the hand, including the web of skin between
the thumb and index finger.
[0158] Muscular branches of the radial nerve innervate the triceps
brachii; anconeus brachioradialis; and the extensor carpi radialis
longus.
[0159] The deep branch of the radial nerve innervates the extensor
carpi radialis brevis; supinator; posterior interosseous nerve (a
continuation of the deep branch after the supinator): extensor
digitorum; extensor digiti minimi; extensor carpi ulnaris; abductor
pollicis longus; extensor pollicis brevis; extensor pollicis
longus; and extensor indicis.
[0160] The radial nerve (and its deep branch) provides motor
innervation to the muscles in the posterior compartment of the arm
and forearm, which are mostly extensors.
2. Sacral and Lumbar Plexuses
[0161] The lumbar plexus (see FIG. 18) is a nervous plexus in the
lumbar region of the body and forms part of the lumbosacral plexus.
It is formed by the ventral divisions of the first four lumbar
nerves (L1-L4) and from contributions of the subcostal thoracic
nerve (T12), which is the last (most inferior) thoracic nerve.
[0162] Additionally, the ventral rami of sacral vertebrae S2 and S3
nerves emerge between digitations of the piriformis and coccygeus
nuscles. The descending part of the lumbar vertebrae L4 nerve
unites with the ventral ramus of the lumbar vertebrae L5 nerve to
form a thick, cordlike lumbosacral trunk. The lumbosacral trunk
joins the sacral plexus (see FIG. 19). The main nerves of the lower
limbs arise from the lumbar and sacral plexuses.
a. Nerves of the Sacral Plexus the Sacral Plexus Provides Motor and
Sensory Nerves for the Posterior Thigh, Most of the Lower Leg, and
the Entire Foot. (1) the Sciatic Nerve
[0163] As shown in FIGS. 14A and 19, the sciatic nerve (also known
as the ischiatic nerve) arises from the sacral plexus. It is the
longest and widest single nerve in the human body. It begins in the
lower back and runs through the buttock and down the lower limb.
The sciatic nerve supplies nearly the whole of the skin of the leg,
the muscles of the back of the thigh, and those of the leg and
foot. It is derived from spinal nerves L4 through S3. It contains
fibers from both the anterior and posterior divisions of the
lumbosacral plexus.
[0164] The nerve gives off articular and muscular branches. The
articular branches (rami articulares) arise from the upper part of
the nerve and supply the hip-joint, perforating the posterior part
of its capsule; they are sometimes derived from the sacral plexus.
The muscular branches (rami musculares) innervate the following
muscles of the lower limb: biceps femoris, semitendinosus,
semimembranosus, and adductor magnus. The nerve to the short head
of the biceps femoris comes from the common peroneal part of the
sciatic, while the other muscular branches arise from the tibial
portion, as may be seen in those cases where there is a high
division of the sciatic nerve.
[0165] The muscular branch of the sciatic nerve eventually gives
off the tibial nerve (shown in FIG. 1A) and common peroneal nerve
(also shown in FIG. 14A), which innervates the muscles of the
(lower) leg. The tibial nerve goes on to innervate all muscles of
the foot except the extensor digitorum brevis (which is innervated
by the peroneal nerve).
b. Nerves of the Lumbar Plexus
[0166] The lumbar plexus (see FIG. 18) provides motor, sensory, and
autonomic fibres to gluteal and inguinal regions and to the lower
extremities. The gluteal muscles are the three muscles that make up
the buttocks: the gluteus maximus muscle, gluteus medius muscle and
gluteus minimus muscle. The inguinal region is situated in the
groin or in either of the lowest lateral regions of the
abdomen.
(1) The Iliohypogastric Nerve
[0167] The iliohypogastric nerve (see FIG. 18) runs anterior to the
psoas major on its proximal lateral border to run laterally and
obliquely on the anterior side of quadratus lumborum. Lateral to
this muscle, it pierces the transversus abdominis to run above the
iliac crest between that muscle and abdominal internal oblique. It
gives off several motor branches to these muscles and a sensory
branch to the skin of the lateral hip. Its terminal branch then
runs parallel to the inguinal ligament to exit the aponeurosis of
the abdominal external oblique above the external inguinal ring
where it supplies the skin above the inguinal ligament (i.e. the
hypogastric region) with the anterior cutaneous branch.
(2) The Ilioinguinal Nerve
[0168] The ilioinguinal nerve (see FIG. 18) closely follows the
iliohypogastric nerve on the quadratus lumborum, but then, passes
below it to run at the level of the iliac crest. It pierces the
lateral abdominal wall and runs medially at the level of the
inguinal ligament where it supplies motor branches to both
transversus abdominis and sensory branches through the external
inguinal ring to the skin over the pubic symphysis and the lateral
aspect of the labia majora or scrotum.
(3) The Genitofemoral Nerve
[0169] The genitofemoral nerve (see FIG. 18) pierces psoas major
anteriorly below the former two nerves to immediately split into
two branches that run downward on the anterior side of the muscle.
The lateral femoral branch is purely sensory. It pierces the
vascular lacuna near the saphenous hiatus and supplies the skin
below the inguinal ligament (i.e. proximal, lateral aspect of
femoral triangle). The genital branch differs in males and females.
In males it runs in the spermatic cord and in females in the
inguinal canal together with the teres uteri ligament. It then
sends sensory branches to the scrotal skin in males and the labia
majora in females. In males it supplies motor innervation to the
cremaster.
(4) The Lateral Cutaneous Femoral Nerve
[0170] The lateral cutaneous femoral nerve (see FIG. 18) pierces
psoas major on its lateral side and runs obliquely downward below
the iliac fascia. Medial to the anterior superior iliac spine it
leaves the pelvic area through the lateral muscular lacuna. In the
thigh it briefly passes under the fascia lata before it breaches
the fascia and supplies the skin of the anterior thigh.
(5) The Obturator Nerve
[0171] The obturator nerve (see FIG. 18) leaves the lumbar plexus
and descends behind psoas major on it medial side, then follows the
linea terminalis and exits through the obturator canal. In the
thigh, it sends motor branches to obturator externus before
dividing into an anterior and a posterior branch, both of which
continues distally. These branches are separated by adductor brevis
and supply all thigh adductors with motor innervation: pectineus,
adductor longus, adductor brevis, adductor magnus, adductor
minimus, and gracilis. The anterior branch contributes a terminal,
sensory branch which passes along the anterior border of gracilis
and supplies the skin on the medial, distal part of the thigh.
(6) The Femoral Nerve
[0172] The femoral nerve (see FIG. 18 and also FIG. 19A) is the
largest and longest nerve of the lumbar plexus. It gives motor
innervation to iliopsoas, pectineus, sartorius, and quadriceps
femoris; and sensory innervation to the anterior thigh, posterior
lower leg, and hindfoot. It runs in a groove between psoas major
and iliacus giving off branches to both muscles. In the thigh it
divides into numerous sensory and muscular branches and the
saphenous nerve, its long sensory terminal branch which continues
down to the foot.
3. The Cervical Plexus
[0173] The cervical plexus (see FIG. 20) is a plexus of the ventral
rami of the first four cervical spinal nerves which are located
from C1 to C4 cervical segment in the neck. They are located
laterally to the transverse processes between prevertebral muscles
from the medial side and vertebral (m. scalenus, m. levator
scapulae, m. splenius cervicis) from lateral side. Here there is
anastomosis with accessory nerve, hypoglossal nerve and sympathetic
trunk.
[0174] The cervical plexus is located in the neck, deep to
stemocleidomastoid. Nerves formed from the cervical plexus
innervate the back of the head, as well as some neck muscles. The
branches of the cervical plexus emerge from the posterior triangle
at the nerve point, a point which lies midway on the posterior
border of the Sternocleidomastoid.
[0175] The nerves formed by the cervical plexus supply the back of
the head, the neck and the shoulders. The face is supplied by a
cranial nerve, the trigeminal nerve. The upper four posterior
primary rami are larger than the anterior primary rami. The C1
posterior primary ramus does not usually supply the skin. The C2
posterior primary ramus forms the greater occipital nerve which
supplies the posterior scalp. The upper four anterior primary rami
form the cervical plexus. The cervical plexus supplies the skin
over the anterior and lateral neck to just below the clavicle. The
plexus also supplies the muscles of the neck including the
scalenes, the strap muscles, and the diaphragm.
[0176] The cervical plexus has two types of branches: cutaneous and
muscular.
[0177] The cutaneous branches include the lesser occipital nerve,
which innervates lateral part of occipital region (C2 nerve only);
the great auricular nerve, which innervates skin near concha
auricle and external acoustic meatus (C2 and C3 nerves); the
transverse cervical nerve, which innervates anterior region of neck
(C2 and C3 nerves); and the supraclavicular nerves, which innervate
region of suprascapularis, shoulder, and upper thoracic region
(C3,C4 Nerves)
[0178] The muscular branches include the ansa cervicalis (loop
formed from C1-C3), etc. (geniohyoid (C1 only), thyrohyoid (C1
only), sternothyroid, sternohyoid, omohyoid); phrenic (C3-05
(primarily C4)), which innervates the diaphragm; the segmental
branches (C1-C4), which innervate the anterior and middle
scalenes.
4. The Solar Plexus
[0179] The solar plexus (see FIG. 21) is a dense cluster of nerve
cells and supporting tissue, located behind the stomach in the
region of the celiac artery just below the diaphragm. It is also
known as the celiac plexus. Rich in ganglia and interconnected
neurons, the solar plexus is the largest autonomic nerve center in
the abdominal cavity. Through branches it controls many vital
functions such as adrenal secretion and intestinal contraction.
[0180] Derived from the solar plexus are the phrenic plexus
(producing contractions of the diaphragm, and providing sensory
innervation for many components of the mediastinum and pleura); the
renal plexuses (affecting renal function); the spermatic plexus
(affecting function of the testis); as well as the gastric plexus;
the hepatic plexus; the splenic plexus; the superior mesenteric
plexus; and the aortic plexus.
VI. THE SYSTEM
[0181] The various aspects of the invention will be described in
connection with the placement of one or more leads 12 having one or
more electrodes 14, in muscle, and in electrical proximity but away
from nerves, for improved recruitment of targeted nerves for
therapeutic purposes, such as for the treatment of pain. That is
because the features and advantages that arise due to the invention
are well suited to this purpose. It is to be appreciated that
regions of pain can include any or all portions of the body,
including arms and legs in both humans and animals.
A. Stimulation of Nerves of Passage
[0182] FIG. 22 shows a typical "motor point" system and method for
stimulating a nerve or muscle A by placing a lead 12(A) with its
electrode 14(A) close to motor point A. As previously described, a
motor point A is the location where the innervating spinal nerve
enters the muscle. At that location, the electrical stimulation
intensity required to elicit a full contraction is at the minimum.
Any other location in the muscle would require more stimulation
intensity to elicit the same muscle contraction.
[0183] FIG. 23 shows a "nerves of passage" system and method, that
is unlike the "motor point" system and method shown in FIG. 22, and
which incorporates the features of the invention. As shown in FIG.
23, the system and method identifies a region where there is a
local manifestation of pain. The region of pain can comprise, e.g.,
skin, bone, a joint, or muscle. The system and method identify one
or more spinal nerves that are located anatomically upstream or
cranial to the region where pain is manifested, through which
neural impulses comprising the pain pass. A given spinal nerve that
is identified can comprise a nerve trunk located in a nerve plexus,
or a divisions and/or a cord of a nerve trunk, or a nerve branch,
provided that it is upstream or cranial of where the nerve
innervates the region affected by the pain. The given spinal nerve
can be identified by medical professionals using textbooks of human
anatomy along with their knowledge of the site and the nature of
the pain or injury, as well as by physical manipulated and/or
imaging, e.g., by ultrasound, fluoroscopy, or X-ray examination, of
the region where pain is manifested. A desired criteria of the
selection includes identifying the location of muscle in electrical
proximity to but spaced away from the nerve or passage, which
muscle can be accessed by placement of one or more stimulation
electrodes, aided if necessary by ultrasonic or electro-location
techniques. The nerve identified comprises a targeted "nerve of
passage." The muscle identified comprises the "targeted muscle." In
a preferred embodiment, the electrodes are percutaneously inserted
using percutaneous leads.
[0184] The system and method place the one or more leads 12(B) with
its electrode 14(B) in the targeted muscle in electrical proximity
to but spaced away from the targeted nerve of passage. The system
and method apply electrical stimulation through the one or more
stimulation electrodes to electrically activate or recruit the
targeted nerve of passage that conveys the neural impulses
comprising the pain to the spinal column.
[0185] The system and method can apply electrical stimulation to
nerves of passage throughout the body. For example, the nerves of
passage can comprise one or more spinal nerves in the brachial
plexus, to treat pain in the chest, shoulders, arms and hands;
and/or one or more spinal nerves in the lumbar plexus, to treat
pain in the back, abdomen, groin, thighs, knees, and calves; and/or
one or more spinal nerves in the sacral plexus, to treat pain in
the buttocks, thighs, calves, and feet; and/or one or more spinal
nerves in the cervical plexus, to treat pain in the head, neck and
shoulders; and/or one or more spinal nerves in the solar plexus, to
treat pain or dysfunction in internal organs.
[0186] For example, if the pinky finger hurts, the system and
method can identify and stimulate the ulnar nerve at a location
that it is upstream or cranial of where the nerve innervates the
muscle or skin of the pinky finger, e.g., in the palm of the hand,
forearm, and/or upper arm. If electrical stimulation activates the
target nerve of passage sufficiently at the correct intensity, then
the patient will feel a comfortable tingling sensation called a
paresthesia in the same region as their pain, which overlap with
the region of pain and/or otherwise reduce pain.
[0187] It is to be appreciated that the sensation could be
described with other words such as buzzing, thumping, etc. Evoking
paresthesias in the region of pain confirms correct lead placement
and indicates stimulus intensity is sufficient to reduce pain.
Inserting a lead 12 percutaneously allows the lead 12 to be placed
quickly and easily, and placing the lead 12 in a peripheral
location, i.e., muscle, where it is less likely to be dislodged,
addresses the lead migration problems of spinal cord stimulation
that result in decreased paresthesia coverage, decreased pain
relief, and the need for frequent patient visits for
reprogramming.
[0188] Placing the lead 12 percutaneously in muscle in electrical
proximity to but spaced away from the targeted nerve of passage
minimize complications related to lead placement and movement. In a
percutaneous system, an electrode lead 12, such as a coiled fine
wire electrode lead may be used because it is minimally-invasive
and well suited for placement in proximity to a nerve of passage.
The lead can be sized and configured to withstand mechanical forces
and resist migration during long-term use, particularly in flexible
regions of the body, such as the shoulder, elbow, and knee.
B. The Lead
[0189] As FIG. 24A shows, the electrode lead can comprise, e.g., a
fine wire electrode 14, paddle electrode, intramuscular electrode,
or general-purpose electrode, inserted via a needle introducer 30
or surgically implanted in proximity of a targeted nerve of
passage. Once proper placement is confirmed, the needle introducer
30 may be withdrawn (as FIGS. 24B and 24C show), leaving the
electrode in place. Stimulation may also be applied through a
penetrating electrode, such as an electrode array comprised of any
number (i.e., one or more) of needle-like electrodes that are
inserted into the target site. In both cases, the lead may placed
using a needle-like introducer 30, allowing the lead/electrode
placement to be minimally invasive.
[0190] In a representative embodiment, the lead 12 comprises a
thin, flexible component made of a metal and/or polymer material.
By "thin," it is contemplated that the lead should not be greater
than about 0.75 mm (0.030 inch) in diameter.
[0191] The lead 12 can comprise, e.g., one or more coiled metal
wires with in an open or flexible elastomer core. The wire can be
insulated, e.g., with a biocompatible polymer film, such as
polyfluorocarbon, polyimide, or parylene. The lead is desirably
coated with a textured, bacteriostatic material, which helps to
stabilize the lead in a way that still permits easy removal at a
later date and increases tolerance.
[0192] The lead 12 may be electrically insulated everywhere except
at one (monopolar), or two (bipolar), or three (tripolar), for
example, conduction locations near its distal tip. Each of the
conduction locations may be connected to one or more conductors
that run the length of the lead and lead extension 16 (see FIG.
24C), proving electrical continuity from the conduction location
through the lead 12 to an external pulse generator or stimulator 28
(see FIG. 24C) or an implanted pulse generator or stimulator 28
(see FIG. 24D).
[0193] The conduction location or electrode 14 may comprise a
de-insulated area of an otherwise insulated conductor that runs the
length of an entirely insulated electrode. The de-insulated
conduction region of the conductor can be formed differently, e.g.,
it can be wound with a different pitch, or wound with a larger or
smaller diameter, or molded to a different dimension. The
conduction location or the electrode 14 may comprise a separate
material (e.g., metal or a conductive polymer) exposed to the body
tissue to which the conductor of the wire is bonded.
[0194] The lead 12 is desirably provided in a sterile package 62
(see FIG. 25), and may be pre-loaded in the introducer needle 30.
The package 62 can take various forms and the arrangement and
contents of the package 62. As shown in FIG. 12, the package 62
comprises a sterile, wrapped assembly. The package 62 includes an
interior tray made, e.g., from die cut cardboard, plastic sheet, or
thermo-formed plastic material, which hold the contents. The
package 62 also desirably includes instructions for use 58 for
using the contents of the package to carry out the lead location
and placement procedures, as will be described in greater detail
below.
[0195] The lead 12 desirably possess mechanical properties in terms
of flexibility and fatigue life that provide an operating life free
of mechanical and/or electrical failure, taking into account the
dynamics of the surrounding tissue (i.e., stretching, bending,
pushing, pulling, crushing, etc.). The material of the electrode 14
desirably discourages the in-growth of connective tissue along its
length, so as not to inhibit its withdrawal at the end of its use.
However, it may be desirable to encourage the in-growth of
connective tissue at the distal tip of the electrode, to enhance
its anchoring in tissue.
[0196] One embodiment of the lead 12 shown in FIG. 26A may comprise
a minimally invasive coiled fine wire lead 12 and electrode 14. The
electrode 14 may also include, at its distal tip, an anchoring
element 48. In the illustrated embodiment, the anchoring element 48
takes the form of a simple barb or bend (see also FIG. 24C). The
anchoring element 48 is sized and configured so that, when in
contact with tissue, it takes purchase in tissue, to resist
dislodgement or migration of the electrode out of the correct
location in the surrounding tissue. Desirably, the anchoring
element 48 is prevented from fully engaging body tissue until after
the electrode 14 has been correctly located and deployed.
[0197] An alternative embodiment of an electrode lead 12 shown in
FIGS. 27A and 27B, may also include, at or near its distal tip or
region, one or more anchoring element(s) 70. In the illustrated
embodiment, the anchoring element 70 takes the form of an array of
shovel-like paddles or scallops 76 proximal to the proximal-most
electrode 14 (although a paddle 76 or paddles could also be
proximal to the distal most electrode 14, or could also be distal
to the distal most electrode 14). The paddles 76 as shown are sized
and configured so they will not cut or score the surrounding
tissue. The anchoring element 70 is sized and configured so that,
when in contact with tissue, it takes purchase in tissue, to resist
dislodgement or migration of the electrode out of the correct
location in the surrounding tissue (e.g., muscle 54). Desirably,
the anchoring element 70 is prevented from fully engaging body
tissue until after the electrode 14 has been deployed. The
electrode is not deployed until after it has been correctly located
during the implantation (lead placement) process, as previously
described. In addition, the lead 12 may include one or more ink
markings 74, 75 (shown in FIG. 27A) to aid the physician in its
proper placement.
[0198] Alternatively, or in combination, stimulation may be applied
through any type of nerve cuff (spiral, helical, cylindrical, book,
flat interface nerve electrode (FINE), slowly closing FINE, etc.),
paddle (or paddle-style) electrode lead, cylindrical electrode
lead, and/or other lead that is surgically or percutaneously placed
within muscle at the target site.
[0199] In all cases, the lead may exit through the skin and connect
with one or more external stimulators 28 (shown in FIG. 24C), or
the lead(s) may be routed subcutaneously to one or more implanted
pulse generators 28 (shown in FIG. 24D), or they may be connected
as needed to internal and external coils for RF (Radio Frequency)
wireless telemetry communications or an inductively coupled
telemetry to control the implanted pulse generator. As shown in
FIG. 24D, the implanted pulse generator 28 may be located some
distance (remote) from the electrode 14, or an implanted pulse
generator may be integrated with an electrode(s) (not shown),
eliminating the need to route the lead subcutaneously to the
implanted pulse generator.
[0200] The introducer 30 (see FIG. 24A) may be insulated along the
length of the shaft, except for those areas that correspond with
the exposed conduction surfaces of the electrode 14 housed inside
the introducer 30. These surfaces on the outside of the introducer
30 are electrically isolated from each other and from the shaft of
the introducer 30. These surfaces may be electrically connected to
a connector 64 at the end of the introducer body (see FIG. 24A).
This allows connection to an external stimulator 28 (shown in FIG.
24A) during the implantation process. Applying stimulating current
through the outside surfaces of the introducer 30 provides a close
approximation to the response that the electrode 14 will provide
when it is deployed at the current location of the introducer
30.
[0201] The introducer 30 may be sized and configured to be bent by
hand prior to its insertion through the skin. This will allow the
physician to place lead 12 in a location that is not in an
unobstructed straight line with the insertion site. The
construction and materials of the introducer 30 allow bending
without interfering with the deployment of the lead 12 and
withdrawal of the introducer 30, leaving the lead 12 in the
tissue.
C. Insertion of the Lead
[0202] Representative lead insertion techniques will now be
described to place an electrode lead 12 in a desired location in
muscle in electrical proximity to but spaced away from a nerve of
passage. It is this lead placement that makes possible the
stimulation of the targeted nerve or nerves of passage with a
single lead 12 to provide pain relief.
[0203] Instructions for use 58 (see FIG. 25) can direct use of
system and method for the placement of a lead 12 in muscle in
electrical proximity to but spaced away from the nerve or nerves of
passage for improved recruitment of target nerves, e.g., with the
placement of one or more leads 12. The instructions for use may
include instructions for placing a lead 12 for the activation of
the targeted nerve of passage in a system for the relief of pain,
for example. The instructions for use may also include instructions
for recording stimulus parameters, including intensity associated
with a first sensation of stimulation, a first noticeable muscle
contraction, and a maximum tolerable contraction at multiple
locations, which can be used to aid in determining desired
stimulation parameters for optimal stimulation.
[0204] The instructions 58 can, of course vary. The instructions 58
may be physically present in a kits holding the lead 12 (as FIG. 25
shows), but can also be supplied separately. The instructions 58
can be embodied in separate instruction manuals, or in video or
audio tapes, CD's, and DVD's. The instructions 58 for use can also
be available through an internet web page.
[0205] To determine the optimal placement for the lead 12, test
stimulation may be delivered through needle electrodes, and muscle
responses may be observed. The motor point(s) of the target
muscle(s) may be located first in order to confirm that the muscles
are innervated. Needle electrodes may be used because they can be
easily repositioned until the optimal location to deliver
stimulation is determined.
[0206] At least one lead(s) may be placed in muscle tissue near a
targeted nerve of passage. The lead may be inserted via the
introducer 30 in conventional fashion, which may be similar in size
and shape to a hypodermic needle. The introducer 30 may be any
size. In a preferred embodiment, the introducer 30 may range in
size from 17 gauge to 26 gauge. Prior to inserting the introducer
30, the insertion site may be cleaned with a disinfectant (e.g.
Betadine, 2% Chlorhexidine/80% alcohol, 10% povidone-iodine, or
similar agent). A local anesthetic(s) may be administered topically
and/or subcutaneously to the area in which the electrode and/or
introducer will be inserted.
[0207] The position of the electrodes may be checked by imaging
techniques, such as ultrasound, fluoroscopy, or X-rays. Following
placement of the lead(s), the portion of the leads which exit the
skin may be secured to the skin using covering bandages and/or
adhesives.
[0208] Electrical stimulation may be applied to the targeted nerve
of passage during and after placement of the electrode to determine
whether stimulation of the targeted nerve of passage can generate
comfortable sensations or paresthesias that overlap with the region
of pain and/or reduce pain. The pain may be perceived to be
contained within a specific part(s) of the body and/or it may be
perceived to be located outside of the body, as may be the case in
persons with amputations who have phantom pain or pain in the
amputated (or phantom) limb(s).
[0209] In a percutaneous system 10 (as FIGS. 24A to 24D show, the
lead 12 may be percutaneously placed near the targeted nerve of
passage and exit at a skin puncture site 16. A trial or screening
test may be conducted in a clinical setting (e.g. an office of a
clinician, a laboratory, a procedure room, an operating room,
etc.). During the trial, the lead is coupled to an external pulse
generator 28 and temporary percutaneous and/or surface return
electrodes, to confirm paresthesia coverage and/or pain relief of
the painful areas.
[0210] If the clinical screening test is successful, the patient
may proceed to a home-trial coupled to an external pulse generator
28 (as shown in FIG. 24C) and temporary percutaneous and/or surface
return electrodes, to determine if pain relief can be sustained in
the home environment. The trial period may range from minutes to
hours to days to weeks to months. The preferred trial period may be
between 3 and 21 days.
[0211] If either the screening test or home trial is unsuccessful,
the lead 12 may be quickly and easily removed.
[0212] However, if the screening test and/or home-trial are
successful, the patient's percutaneous system may be converted into
a fully implanted system (as shown in FIG. 24D) by replacing the
external pulse generator with an implantable pulse generator 28
(the housing of which serves as a return electrode).
[0213] Alternatively, it may be preferred to use a percutaneous
system(s) as a therapy without proceeding to a fully implantable
system. It is also to be appreciated that a home-trial is not a
requirement for either the percutaneous system or a fully implanted
system.
[0214] The duration of therapy for a percutaneous system may range
from minutes to days to weeks to months to multiple years, but a
preferred embodiment includes a duration ranging from 1 to 12
weeks.
[0215] Electrical stimulation is applied between the lead and
return electrodes (uni-polar mode). Regulated current is the
preferred type of stimulation, but other type(s) of stimulation
(e.g. non-regulated current such as voltage-regulated) may also be
used. Multiple types of electrodes may be used, such as surface,
percutaneous, and/or implantable electrodes. The surface electrodes
may be a standard shape or they may be tailored if needed to fit
the contour of the skin.
[0216] In a preferred embodiment of a percutaneous system, the
surface electrode(s) may serve as the anode(s) (or return
electrode(s)), but the surface electrode(s) may be used as the
cathode(s) (active electrode(s)) if necessary. When serving as a
return electrode(s), the location of the electrode(s) is not
critical and may be positioned anywhere in the general vicinity,
provided that the current path does not cross the heart. If a
surface electrode(s) serves as an active electrode(s), it (they)
may be positioned near the target stimulation area(s) (e.g. on the
skin surface over the target nerve or passage).
[0217] The electrode lead may be placed via multiple types of
approaches. In one embodiment, the approach may be similar needle
placement for electromyography (EMG).
[0218] For example (as shown in FIG. 28A), if the targeted nerve of
passage includes nerves of the brachial plexus, the approach can
include:
[0219] Place the patient in a comfortable and/or appropriate
position with head turned away from the lead insertion site.
[0220] Prepare the lead insertion site with antiseptic and local
subcutaneous anesthetic (e.g., 2% lidocaine).
[0221] Locate the site of skin puncture with appropriate landmarks,
such as the clavical, coracoid process, and axilla, as
necessary.
[0222] Insert a sterile percutaneous electrode lead 12 preloaded in
the introducer needle 30 at a predetermined angle based on
landmarks used.
[0223] Place a surface stimulation return electrode in proximity of
the area in which the percutaneous lead 12 has been placed. Test
stimulation will be applied to the lead 12, with the surface
electrode providing a return path. The surface electrode may be
placed adjacent to the lead. Its position is not critical to the
therapy and it can be moved throughout the therapy to reduce the
risk of skin irritation.
[0224] Couple the lead 12 to the external pulse generator 28 and to
the return electrode. Set the desired stimulation parameters. Test
stimulation may be delivered using a current-regulated pulse
generator, for example. The external pulse generator 28 may be
programmed to 4 mA, 100 .mu.s, 100 Hz, and an on-off duty cycle of
0.25 sec., as a non-limiting example.
[0225] Advance the introducer slowly until the subject reports the
first evoked sensation in the region experiencing pain.
Progressively reduce the stimulus amplitude and advance the
introducer more slowly until the sensation can be evoked in the
painful region at a predetermined stimulus amplitude (e.g., 1 mA).
Stop the advancement of the introducer, and increase the stimulus
amplitude in small increments (e.g., 0.1 mA) until the
stimulation-evoked tingling sensation (paresthesia) expands to
overlay the entire region of pain.
[0226] Withdraw the introducer 30, leaving the percutaneous lead 12
in proximity but away from the target nerve (see FIG. 28B).
[0227] Cover the percutaneous exit site and lead 12 with a bandage.
A bandage may also be used to secure the external portion of the
lead 12 (or an extension cable used to couple the lead 12 to the
external pulse generator) to the skin. It is expected the length of
time to place the lead 12 to be less than 10 minutes, although the
process may be shorter or longer.
[0228] Vary the stimulus amplitude in small steps (e.g., 0.1-0.5
mA) to determine the thresholds at which stimulation evokes first
sensation (TSEN), sensation (paresthesia) superimposed on the
region of pain (TSUP), muscle twitch (TMUS) of the target muscle
(innervated or not innervated by the target nerve), and maximum
comfortable sensation (TMAX). Query the subject at each stimulus
amplitude to determine sensation level, and visually monitor muscle
response. Record the results.
[0229] It is possible that stimulation intensity may need to be
increased slightly during the process due to causes such as
habituation or the subject becoming accustomed to sensation, but
the need for increased intensity is unlikely and usually only
occurs after several days to weeks to months as the tissue
encapsulates and the subject accommodates to stimulation. It is to
be appreciated that the need for increased intensity could happen
at any time, even years out, which would likely be due to either
lead migration or habituation, but may also be due reasons ranging
from nerve damage to plasticity/reorganization in the central
nervous system.
[0230] If paresthesias cannot be evoked with the initial lead
placement, redirect the introducer 30.
[0231] If sensations still cannot be evoked in a given subject,
then the muscle twitch response of the muscle innervated or not
innervated by the target nerve may be used to guide lead placement
and then increase stimulus intensity until sufficient paresthesias
are elicited in the painful region. Minimal muscle contraction may
be acceptable if it is well tolerated by the patient in exchange
for significant pain relief and if it does not lead to additional
discomfort or fatigue.
[0232] If stimulation evokes muscle contraction at a lower stimulus
threshold than paresthesia (e.g. if TMUS.ltoreq.STSUP) and
contraction leads to discomfort, then a lower stimulus frequency
(e.g., 12 Hz) may be used because low frequencies (e.g., 4-20 Hz)
have been shown to minimize discomfort due to muscle contraction
and provide >50% relief of shoulder pain in stroke patients
while still inhibiting transmission of pain signals in the central
nervous system in animals. If continued muscle contraction leads to
pain due to fatigue, change the duty cycle, using parameters shown
to reduce muscle fatigue and related discomfort in the upper
extremity (e.g. 5 s ramp up, 10 s on, 5 s ramp down, 10 s off).
[0233] If stimulation fails to elicit paresthesia in all areas of
pain, then a second percutaneous lead (not shown) may need to be
placed to stimulate the nerves that are not activated by the first
lead 12.
[0234] If stimulation is successful, i.e., if the screening test
and/or home-trial are successful, the patient's percutaneous system
(see FIG. 14) may be converted into a fully implanted system by
replacing the external pulse generator 28 with an implantable pulse
generator that is implanted in a convenient area (see FIG. 24D)
(e.g., in a subcutaneous pocket over the hip or in the
subclavicular area). In one embodiment, the electrode lead 12 used
in the screening test and/or home-trial may be totally removed and
discarded, and a new completely implantable lead may be tunneled
subcutaneously and coupled to the implantable pulse generator. In
an alternative embodiment, a two part lead may be incorporated in
the screening test and/or home-trial where the implantable part is
completely under the skin and connected to a percutaneous connector
(i.e., extension) that can be discarded after removal. The
implantable part may then be tunneled and coupled to the
implantable pulse generator, or a new sterile extension may be used
to couple the lead to the implantable pulse generator.
[0235] Alternatively, when the targeted nerve of passage includes
one or more nerves of the lumbar plexus or sacral plexus, the
approach may be either a posterior (shown in FIG. 29A) or an
anterior approach (shown in FIG. 30A), similar to those used for
regional anesthesia of the same targeted nerve of passage, except
that the approach is used for placement through an introducer of
stimulation lead(s) in electrical proximity to but spaced away from
a nerve of passage, and not for regional anesthesia. Unlike
regional anesthesia, the approach to nerves of the lumbar plexus or
sacral plexus do not involve the application of anesthesia to the
nerve, and, when the introducer is withdrawn, the lead(s) may be
left behind to desired stimulation of the target nerve of
passage.
[0236] For example, when the targeted nerve of passage includes the
sciatic nerve (see FIG. 31A), the introducer(s) 30 and/or lead(s)
12 may be directed towards the sciatic nerve using a posterior
approach, such as the transgluteal approach or subgluteal approach,
which are both well described and commonly used in regional
anesthesiology (Dalens et al. 1990; Bruelle et al. 1994; di
Benedetto et al. 2001; Gaertner et al. 2007).
[0237] This approach allows lead placement near a targeted nerve of
passage with a simple, quick (e.g. less than 10 minutes) outpatient
procedure that may be performed in a standard community-based
clinic. This makes possible widespread use and provides a
minimally-invasive screening test to determine if patients will
benefit from the device before receiving a fully implanted
system.
[0238] The landmarks for the transgluteal approach may include the
greater trochanter and the posterior superior iliac spine. The
introducer 30 may be inserted distal (e.g. approximately 2 cm to 6
cm, preferably 4 cm, in a preferred embodiment) to the midpoint
between the greater trochanter and the posterior iliac spine. As a
non-limiting example of patient positioning, the patient may be in
a lateral decubitus position and tilted slightly forward in a
preferred embodiment. The landmarks for the subgluteal approach may
include the greater trochanter and the ischial tuberosity. The
introducer may be inserted distal (e.g. approximately 2 cm to 6 cm,
preferably 4 cm, in the preferred embodiment) to the midpoint
between the greater trochanter and the ischial tuberosity.
[0239] For example, when the targeted nerve of passage includes the
femoral nerve (see FIG. 31A), percutaneous leads 12 may be directed
towards the femoral nerve using an anterior approach. The landmarks
may include the inguinal ligament, inguinal crease, and femoral
artery. The subject may be in the supine position with ipsilateral
extremity slightly (approximately 10 to 20 degrees) abducted. The
introducer may be inserted near the femoral crease but below the
inguinal crease and approximately 1 cm lateral to the pulse of the
femoral artery.
[0240] The size and shape of tissues, such as the buttocks,
surrounding the target nerves may vary across subjects, and the
approach may be modified as needed to accommodate various body
sizes and shapes to access the target nerve.
[0241] In non-amputee patients, introducer placement can be often
guided by muscle response to electrical stimulation, but the muscle
response may not be available in amputees, or may not be available
and/or be unreliable in other situations (e.g., a degenerative
diseases or condition such as diabetes of impaired vascular
function in which the nerves are slowly degenerating, progressing
from the periphery, or due to trauma).
[0242] In these situations, placement may be guided by the
individual's report of stimulus-evoked sensations (paresthesias) as
the introducer is placed during test stimulation. Additionally, the
response of remaining muscles to stimulation may also be used to
guide placement of the introducer and electrode.
[0243] As shown in FIG. 31B, more than a single lead 12 may be
placed around a given nerve of passage, using either an anterior
approach (e.g., femoral nerve) or a posterior approach (e.g.,
sciatic nerve). As FIGS. 32A, B, and C show, one or more leads 12
can be placed at different superior-inferior positions along a
nerve of passage and/or along different nerves of passage.
[0244] As FIG. 29B (anterior approach, e.g., femoral nerve) and 17B
(posterior approach, e.g., sciatic nerve) show, the lead 12 can be
coupled to an external pulse generator 28 worn, e.g., on a belt 52,
for a trial or temporary stimulation regime. In this arrangement,
the lead 12 is covered with a bandage 50, and a surface electrode
54 serves as a return electrode. The external/percutaneous system
shown in FIGS. 29B and 30B may be replaced by an implanted system
using an implanted pulse generator 60 and intramuscular and
tunneled leads 62, as shown in FIGS. 29C and 30C, respectively. In
this arrangement, the case of the implanted pulse generator 60A
comprises the return electrode.
D. Stimulation Parameters
[0245] Control of the stimulator and stimulation parameters may be
provided by one or more external controllers. In the case of an
external stimulator, the controller may be integrated with the
external stimulator. The implanted pulse generator external
controller (i.e., clinical programmer) may be a remote unit that
uses RF (Radio Frequency) wireless telemetry communications (rather
than an inductively coupled telemetry) to control the implanted
pulse generator. The external or implantable pulse generator may
use passive charge recovery to generate the stimulation waveform,
regulated voltage (e.g., 10 mV to 20 V), and/or regulated current
(e.g., about 10 .mu.A to about 50 mA). Passive charge recovery is
one method of generating a biphasic, charge-balanced pulse as
desired for tissue stimulation without severe side effects due to a
DC component of the current.
[0246] The neurostimulation pulse may by monophasic, biphasic,
and/or multi-phasic. In the case of the biphasic or multi-phasic
pulse, the pulse may be symmetrical or asymmetrical. Its shape may
be rectangular or exponential or a combination of rectangular and
exponential waveforms. The pulse width of each phase may range
between e.g., about 0.1 .mu.sec. to about 1.0 sec., as non-limiting
examples. The preferred neurostimulation waveform is cathodic
stimulation (though anodic will work), biphasic, and
asymmetrical.
[0247] Pulses may be applied in continuous or intermittent trains
(i.e., the stimulus frequency changes as a function of time). In
the case of intermittent pulses, the on/off duty cycle of pulses
may be symmetrical or asymmetrical, and the duty cycle may be
regular and repeatable from one intermittent burst to the next or
the duty cycle of each set of bursts may vary in a random (or
pseudo random) fashion. Varying the stimulus frequency and/or duty
cycle may assist in warding off habituation because of the stimulus
modulation.
[0248] The stimulating frequency may range from e.g., about 1 Hz to
about 300 Hz, and the frequency of stimulation may be constant or
varying. In the case of applying stimulation with varying
frequencies, the frequencies may vary in a consistent and
repeatable pattern or in a random (or pseudo random) fashion or a
combination of repeatable and random patterns.
[0249] In a representative embodiment, the stimulator is set to an
intensity (e.g. 1-2 mA (or 0.1-40 mA, or 0.01-200 mA), 100-300 us
(or 40-1000 us, or 1-10,000 us)) sufficient to activate the
targeted nerve of passage at some distance (e.g. 1 mm) away (from
the targeted nerve of passage). If the stimulus intensity is too
great, it may generate muscle twitch(es) or contraction(s)
sufficient to disrupt correct placement of the lead. If stimulus
intensity is too low, the lead may be advanced too close to the
targeted nerve of passage (beyond the optimal position), possibly
leading to incorrect guidance, nerve damage, mechanically evoked
sensation (e.g. pain and/or paresthesia) and/or muscle contraction
(i.e. when the lead touches the nerve of passage), inability to
activate the target nerve fiber(s) without activating non-target
nerve fiber(s), improper placement, and/or improper anchoring of
the lead (e.g. the lead may be too close to the nerve and no longer
able to anchor appropriately in the muscle tissue).
[0250] In a representative embodiment, the stimulator is set to a
frequency (e.g. 0.5-12 Hz (or 0.1-20 Hz, or 0.05-40 Hz)) low enough
to evoke visible muscle twitches (i.e. non-fused muscle
contraction) and/or muscle contraction(s) of the targeted muscle(s)
innervated by the target nerve of passage, but high enough that
that the targeted nerve of passage will be activated before the
lead is advanced beyond the optimal position.
[0251] As an alternative to using muscle twitch(es) or
contraction(s) as indicator(s) of lead placement (distance from the
nerve of passage to electrode contact), patient sensation could
instead be used to indicate lead location relative to the targeted
nerve of passage. Any combination of stimulus parameters that evoke
sensation(s) may be used. Some stimulus parameters may evoke a more
desirable response (e.g. more comfortable sensation, or a sensation
that may be correlated with or specific to the specific target
nerve fiber(s) within the targeted nerve of passage. As an example,
higher frequencies (e.g. 12 Hz, or 4 Hz, or 0.1 Hz) may evoke
sensation(s) or comfortable paresthesia(s) in the region(s) of pain
or in alternate target region(s) (real or phantom) and though they
may (or may not) also evoke muscle contraction(s), the muscle
contraction(s) may not be noticeable (e.g. stimulus intensity may
not be sufficient to evoke a contraction or a twitch from the
present lead location or stimulus intensity may be sufficient to
evoke contraction but the muscle contraction is fused (and no
longer visually twitching), making it difficult to observe
visually, unless EMG is used). To take advantage of both potential
indicator responses (muscle twitch and patient sensation), higher
frequencies may be applied intermittently (at lower frequencies),
where the higher frequencies (e.g. 20-120 Hz, or 12-200 Hz) would
normally caused fused muscle contraction if they were applied
continuously but they are applied at an intermittent frequency
(e.g. 0.5-4 Hz, or 0.1-11 Hz) that is low enough to allow the
muscle to relax during the gaps between the bursts of stimulation,
making it easier to visualize while still generating patient
sensation at a higher frequency, allowing both muscle twitch and
patient sensation to be used simultaneously as indicators of lead
location relative to the targeted nerve of passage.
[0252] While stimulation is being applied, the lead (non-limiting
examples of the lead could include a single or multi-contact
electrode that is designed for temporary (percutaneous) or
long-term (implant) use or a needle electrode (used for in-office
testing only)) may be advanced (e.g. slowly advanced) towards the
targeted nerve of passage until the desired indicator response
(e.g. muscle twitch, muscle contraction, patient sensation, and/or
some combination) is obtained. The intensity may then be decreased
(e.g. gradually decreased) as the lead is advanced (e.g. advanced
slowly) closer to the targeted nerve of passage until the desired
indicator response(s) may be obtained at smaller intensity(ies)
within the target range (e.g. 0.1-1.0 mA (or 0.09-39 mA, or
0.009-199 mA), 100-300 us (or 40-1000 us, or 1-10,000 us)) at some
distance (e.g. X2 mm, where X2.gtoreq.X1, and (as a non-limiting
example) X1 may be multiple times larger than X2, such as
X1.gtoreq.2*X2, or X1.gtoreq.5*X2, or X1.gtoreq.20*X2) from the
target nerve. If specific response(s) (e.g. desired response(s)
and/or undesired response(s)) can be obtained at a range of
intensities that are too low, then the lead may be located in a
non-optimal location (e.g. too close to the target nerve(s)).
Non-limiting examples of ranges of intensities that may be
considered too low include those that are a fraction (e.g. <2/3,
or <1/5, or < 1/10) of the intensities that obtained the
desired response(s) at X1.
[0253] The preferred stimulus intensities are a function of many
variables, are meant to serve as non-limiting examples only, and
may need to be scaled accordingly. As an example, if electrode
shape, geometry, or surface area were to change, then the stimulus
intensities may need to change appropriately. For example, if the
intensities were calculated for a lead with an electrode surface
area of approximately 20 mm.sup.2, then they may need to be scaled
down accordingly to be used with a lead with an electrode surface
area of 0.2 mm.sup.2 because a decrease in stimulating surface area
may increase the current density, increasing the potential to
activate excitable tissue (e.g. target and non-target nerve(s)
and/or fiber(s)). Alternatively, if the intensities were calculated
for a lead with an electrode surface area of approximately 0.2
mm.sup.2, then the intensities may need to be scaled up accordingly
to be used with a lead with an electrode surface area of 20
mm.sup.2. Alternatively, stimulus intensities may need to be scaled
to account for variations in electrode shape or geometry (between
or among electrodes) to compensate for any resulting variations in
current density. In a non-limiting example, the electrode contact
surface area may be 0.1-20 mm.sup.2, 0.01-40 mm.sup.2, or 0.001-200
mm.sup.2. In a non-limiting example, the electrode contact
configuration may include one or more of the following
characteristics: cylindrical, conical, spherical, hemispherical,
circular, triangular, trapezoidal, raised (or elevated), depressed
(or recessed), flat, and/or borders and/or contours that are
continuous, intermittent (or interrupted), and/or undulating.
[0254] Stimulus intensities may need to be scaled to account for
biological factors, including but not limited to patient body size,
weight, mass, habitus, age, and/or neurological condition(s). As a
non-limiting example, patients that are older, have a higher
body-mass index (BMI), and/or neuropathy (e.g. due to diabetes) may
need to have stimulus intensities scaled higher (or lower)
accordingly (Bigeleisen et al 2009).
[0255] As mentioned above, if the lead is too far away from the
targeted nerve of passage, then stimulation may be unable to evoke
the desired response (e.g. muscle contraction(s), comfortable
sensation(s) (or paresthesia(s)), and/or pain relief) in the
desired region(s) at the desired stimulus intensity(ies). If the
lead is too close to the targeted nerve of passage, then
stimulation may be unable to evoke the desired response(s) (e.g.
muscle contraction(s), comfortable sensation(s) (or
paresthesia(s)), and/or pain relief) in the desired region(s) at
the desired stimulus intensity(ies) without evoking undesirable
response(s) (e.g. unwanted and/or painful muscle contraction(s),
sensation(s) (or paresthesia(s)), increase in pain, and/or
generation of additional pain in related or unrelated area(s)). In
some cases, it may difficult to locate the optimal lead placement
(or distance from the targeted nerve of passage and/or it may be
desirable to increase the range stimulus intensities that evoke the
desired response(s) without evoking the undesired response(s) so
alternative stimulus waveforms and/or combinations of leads and/or
electrode contacts may be used. A non-limiting example of
alternative stimulus waveforms may include the use of a pre-pulse
to increase the excitability of the target fiber(s) and/or decrease
the excitability of the non-target fiber(s).
[0256] Those skilled in the art will recognize that, for simplicity
and clarity, the full structure and operation of all devices and
processes suitable for use with the present invention is not being
depicted or described herein. Instead, only so much of an
implantable pulse generator and supporting hardware as is unique to
the present invention or necessary for an understanding of the
present invention is depicted and described. The remainder of the
construction and operation of the IPGs described herein may conform
to any of the various current implementations and practices known
in the art.
VII. REPRESENTATIVE INDICATIONS FOR CHRONIC OR TEMPORARY PAIN
THERAPY
[0257] Localized pain in any area of the body (e.g., the skin,
bone, joint, or muscle) can be treated with by applying electrical
stimulation to a muscle in electrical contact with but spaced from
a targeted nerve of passage. Electrical stimulation of nerves of
passage works by interfering with or blocking pain signals from
reaching the brain, as FIG. 10 schematically shows.
[0258] Many pain indications can be treated by nerves of passage
stimulation.
[0259] Pain in the leg may occur in areas such as the thigh, calf,
hip, shin, knee, foot, ankle, and toes. There may be multiple
causes of leg pain, including but not limited to injury (e.g.
traumatic) to a muscle, joint, tendon, ligament or bone; muscle or
ligament damage; ligament sprain, muscle or tendon strain; disease
or disorders; phlebitis, swelling, or inflammation; claudication;
insufficient blood flow into (arterial insufficiency) or away from
(venous insufficiency) a part of the leg or foot; ischemia;
peripheral artery disease; arthritis; tumor (malignant or benign);
peripheral neuropathy; diabetic peripheral neuropathy; and post
herpetic neuralgia.
[0260] For example, peripheral artery disease can cause pain
(especially during activity such as walking or running) because the
effective narrowing of the arteries leads to a decrease in the
supply of blood and therefore in the supply of nutrients such as
oxygen to the active muscles, leading to pain. This phenomenon can
occur in almost in area of the body but may be more common in the
leg, especially parts of the lower leg, such as the calf. Activity
is not always required to elicit pain and pain may occur even at
rest (without activity or exercise). Nerve entrapment, compression,
injury or other types of damage may cause pain in the areas
innervated by the damaged nerve, which can lead to referred pain in
an area distal to the injury.
[0261] The femoral nerve has anterior branches (intermediate
cutaneous nerve and medial cutaneous nerve) and posterior branches.
The saphenous nerve (branch of the femoral nerve) provides
cutaneous (skin) sensation in the medial leg. Other branches of the
femoral nerve innervate structures (such as muscles, joints, and
other tissues) in the thigh and around the hip and knee joints. As
an example, branches of the femoral nerve innervate the hip joint,
knee joint, and the four parts of the Quadriceps femoris (muscle):
Rectus femoris (in the middle of the thigh) originates on the ilium
and covers most of the other three quadriceps muscles. Under (or
deep to) the rectus femoris are the other 3 of the quadriceps
muscles, which originate from the body of the femur. Vastus
lateralis (on the outer side of the thigh) is on the lateral side
of the femur. Vastus medialis (on the inner part thigh) is on the
medial side of the femur. Vastus intermedius (on the top or front
of the thigh) lies between vastus lateralis and vastus medialis on
the front of the femur. Braches of the femoral nerve often
innervate the pectineus and Sartorius muscles arises.
[0262] The sciatic nerve has branches that innervate the biceps
femoris, semitendinosus, semimembranosus, and adductor magnus
muscles. 2 major branches of the sciatic nerve are the tibial and
common peroneal nerves that innervate much of the lower leg (around
and below the knee). For example, the tibial nerve innervates the
gastrocnemius, popliteus, soleus and plantaris muscles and the knee
joint. Most of the foot is innervated by the tibial and peroneal
nerve.
[0263] For example, claudication pain (occurring in the calf
muscle) could be treated by nerves of passage stimulation by
placing the lead in the gluteus muscle near the sciatic nerve,
which passes by the gluteus muscle on its way to innervate the calf
muscle.
[0264] In general pain due to poor blood flow to an area or damage
to an area can be relieved by stimulation of the nerve innervating
that area. Since diabetic neuropathy typically leads to pain in the
more distal areas (toes/foot), stimulation of the sciatic nerve can
relive that pain. Pain in the skin of the medial (inner) calf can
be relieved by stimulation of the femoral nerve. Pain in the front
of the thigh (quad's) can be relieved by stimulation of the femoral
nerve. If pain overlaps more than one area, stimulation of multiple
nerves (e.g., sciatic and femoral nerves) can be beneficial.
[0265] Stimulation of the intercostal nerves (originating from the
Thoracic nerve roots (T1-12)) can relieve pain in regions
innervated by the intercostal nerves such as pain from intercostal
neuralgia or post herpetic neuralgia. The pain may be confined to
the area (e.g. dermatomic area) innervated by 1 or 2 nerves and may
follow outbreak (and recovery) of herpes zoster. The pain may last
up to several months or years in some patients and may be caused by
nerve irritation or damage due to herpes zoster.
[0266] Amputation (phantom) pain can also be treated by nerves of
passage stimulation. For example, upper extremity stimulation of
spinal nerves passing through the brachial plexus can relive
phantom pain that results from amputation of an upper limb.
Likewise, lower extremity stimulation of spinal nerves passing
through the lumber plexus sacral plexus (e.g., the sciatic nerve or
the femoral nerve) can relive phantom pain that results from
amputation of a lower limb.
VIII. CONCLUSION
[0267] In "nerves of passage" stimulation, the lead is placed in a
muscle by which the targeted nerve passes, but stimulation actually
relieves pain that is felt distal (downstream) from where the lead
is placed. In "nerves of passage" stimulation, the lead can be
placed in a muscle that is conveniently located near a nerve trunk
that passes by the lead on the way to the painful area. The key is
that the lead is placed in a muscle that is not the target
(painful) muscle, but rather a muscle that is proximal (upstream)
from the painful region because the proximal muscle is a more
convenient and useful location to place the lead.
[0268] The advantages of nerves of passage stimulation can be
recognized by anesthesiologists who are used to placing needles
deeper in the muscle near nerves of passage Anesthesiologists are
accustomed to placing needles proximal (upstream) from the areas of
pain to numb the areas downstream. Anesthesiologists already use
ultrasound and the electro-location techniques that would be needed
to place leads to access nerves of passage.
[0269] Nerves of passage stimulation provides stimulation-generated
paresthesias (that ideally overlap with the area of pain) but does
not require evoking a muscle contraction to place the lead
correctly. The target regions in which pain is felt and which are
targeted for generation of paresthesia are not the same region in
which the lead is placed. This is an advantage because physicians
(e.g. anesthesiologists) who will typically be placing the lead are
accustomed to using paresthesias (sensory feedback description of
from the patient) to guide lead placement and tuning of stimulation
parameters.
[0270] Evoking muscle contraction with stimulation is not required
for pain relief or lead location. Evoking muscle contraction with
stimulation may help in relieving pain or placing the lead, but it
is not required. It is an advantage that muscle contraction is not
required because it allows this method to treat pains in which
muscle contraction cannot be evoked (e.g. in the case of amputation
pain in which the target area has been amputated and is no longer
physically present or other cases of nerve damage either due to a
degenerative diseases or conditions such as diabetes of impaired
vascular function, in which the nerves are slowly degenerating,
progressing from the periphery, or due to trauma.
[0271] In nerves of passage stimulation, the primary targeted pain
area is distal to the lead, meaning that the lead is in between the
major area in which pain (e.g. the worst, most troubling, or most
interfering pain) is felt and the center of the body (e.g. the
spinal cord)).
[0272] Imaging (e.g., ultrasound or an alternate imaging technique,
e.g. fluoroscopy) may be used to improve lead placement near nerves
of passage. Ultrasound may improve lead placement in the form of
increasing the total speed of the procedure (shortening the
procedure's duration, not necessarily increasing the speed at which
the lead is advanced in the form of locating the lead in a more
optimal location (to improve recruitment of the target fibers in
the target nerve and minimize recruitment of non-target fibers
(e.g. c fibers, other non-target sensory fibers, motor fibers,
etc.) in either the target nerve and/or in non-target nerve(s); in
the form of minimizing risk and/or damage to the patient during
placement of the lead (by avoiding blood vessels, organs, bones,
ligaments, tendons, lymphatic vessels, &/or other structures)
that may be damaged. One reason that imaging may be useful is that
some nerves of passage are (but do not have to be) located
relatively deeply. Fluoroscopy is not required to place the lead.
It may help, but it is not required. Imaging is not required.
[0273] The patient is not required to give verbal, written, or
other type of feedback or indication of what they feel as the lead
is being advanced towards the nerve of passage if muscle
contraction or imaging is used to guide lead placement, but patient
feedback during lead advancement may improve lead placement in some
patients, especially in cases where (distal) muscle contraction
cannot be used to confirm correct lead placement (e.g. amputees,
nerve injury, nerve degeneration (e.g. due to vascular dysfunction,
diabetes, etc), stimulation of a sensory nerve). The patient may
indicate sensations during tuning of stimulus intensity (but this
is a different step in the process and is performed after the lead
has been correctly positioned). As non-limiting examples, those
sensations reported by the patient may include first sensation
(minimum stimulus intensity that evokes a sensation), level of
comfort, maximum tolerable sensation, pain, qualities &/or
descriptions of the sensations.
[0274] The region in which the patient perceives
stimulation-induced sensations and/or paresthesias may be an
important indicator of the potential success of the therapy (e.g.
used in screening potential candidates), and the stimulation
parameters (including but not limited to lead location) may be
adjusted so that the region in which paresthesias are perceived
overlaps with the region of pain.
[0275] As an alternative to using perception of stimulation induced
sensations and/or paresthesia, the level of pain and/or change in
the intensity of pain during and/or due to stimulation may be used
to adjust stimulation parameters (including but not limited to lead
location).
[0276] The foregoing is considered as illustrative only of the
principles of the invention. Furthermore, since numerous
modifications and changes will readily occur to those skilled in
the art, it is not desired to limit the invention to the exact
construction and operation shown and described. While the desired
embodiment has been described, the details may be changed without
departing from the invention.
[0277] Various features of the invention are set forth in the
following Claims.
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