U.S. patent application number 10/208146 was filed with the patent office on 2002-12-26 for peripheral nerve stimulation apparatus.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Weiner, Richard L..
Application Number | 20020198572 10/208146 |
Document ID | / |
Family ID | 26834551 |
Filed Date | 2002-12-26 |
United States Patent
Application |
20020198572 |
Kind Code |
A1 |
Weiner, Richard L. |
December 26, 2002 |
Peripheral nerve stimulation apparatus
Abstract
A method for treating pain by subcutaneous electrical
stimulation of a peripheral nerve is disclosed. A lead is placed
subcutaneously over a peripheral nerve that is causing pain. The
peripheral nerve is electrically stimulated to cause paresthesia.
The method encompasses subcutaneous placement of an electrical lead
near any peripheral nerve causing pain and subsequent electrical
stimulation of the nerve to cause paresthesia. In particular, a
method for treating intractable occipital neuralgia using
percutaneous peripheral nerve electrostimulation techniques is
disclosed.
Inventors: |
Weiner, Richard L.; (Dallas,
TX) |
Correspondence
Address: |
BANNER & WITCOFF, LTD.
TEN SOUTH WACKER DRIVE
SUITE 3000
CHICAGO
IL
60606
US
|
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Family ID: |
26834551 |
Appl. No.: |
10/208146 |
Filed: |
July 30, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10208146 |
Jul 30, 2002 |
|
|
|
09577258 |
May 22, 2000 |
|
|
|
60136690 |
May 29, 1999 |
|
|
|
Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/0504 20130101;
A61N 1/36071 20130101; A61N 1/40 20130101; A61N 1/0551 20130101;
A61N 1/0526 20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 001/18 |
Claims
What is claimed is:
1. An apparatus for treating neuralgia emanating from a peripheral
nerve of a patient comprising in combination: (a) an implantable
signal generator for providing electrical stimulation; (b) an
implantable lead having a proximal end coupled to the signal
generator and a stimulation portion adapted to be implanted in a
fascia superior to and near the peripheral nerve to cause
paresthesia of a neuralgia emanating area, whereby the implantable
signal generator is capable of providing electrical stimulation to
the peripheral nerve via the stimulation portion of the implantable
lead to cause parasthesia of the neuralgia emanating area.
2. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the neuralgia is selected from the group
consisting of post herpetic neuralgia, chronic deafferentation
pain, chronic peripheral nerve pain, post crainiotomy pain,
incisional pain, clunial pain, post herniorrhapy pain, localized
low back or other spine pain, incisional neuroma pain, stump
neuroma pain, incisional scar pain, deafferention pain, chronic
peripheral nerve pain, sciatic neuralgia, medical neuralgia and
ulnar neuralgia.
3. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, further comprising an introducer needle capable
of being placed in the fascia superior to the peripheral nerve and
capable of passing the implantable lead so that the stimulation
portion is in position above the peripheral nerve.
4. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 3, wherein the introducer needle is curved so as to
conform to a contour of the patient's body superior to the
peripheral nerve.
5. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the implantable lead is a dual lead.
6. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near a supraorbital
nerve.
7. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near a clunial
nerve.
8. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near a iliolinguinal
nerve.
9. The apparatus for treating neuralgia emanating from a peripheral
nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near a median
nerve.
10. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near an ulnar
nerve.
11. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 1, wherein the stimulation portion of the
implantable lead is adapted to be implanted near a sciatic
nerve.
12. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 1, further comprising a screening device
capable of being coupled to the implantable lead for performing
test electrical stimulation with the implantable lead.
13. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 12, wherein the screening device is
capable of delivering electrical stimulation having an amplitude
between about 0.5 to about 4.0 volts.
14. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 12, wherein the screening device is
capable of delivering electrical stimulation having a rate between
about 50 Hz to about 400 Hz.
15. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 12, wherein the screening device is
capable of delivering electrical stimulation having a pulse width
between about 90 .mu.sec to about 200 .mu.sec.
16. An apparatus for treating neuralgia emanating from a peripheral
nerve of a patient comprising in combination: (a) an RF system
transmitter for generating RF signals; (b) an implantable RF system
receiver for providing electrical stimulation in response to the RF
signals; (c) an implantable lead having a proximal end coupled to
the implantable RF system receiver and a stimulation portion
adapted to be implanted in a fascia superior to and near the
peripheral nerve to cause paresthesia of a neuralgia emanating
area, whereby the implantable RF system receiver is capable of
providing electrical stimulation to the peripheral nerve via the
stimulation portion of the implantable lead to cause parasthesia of
the neuralgia emanating area.
17. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the neuralgia is selected
from the group consisting of post herpetic neuralgia, chronic
deafferentation pain, chronic peripheral nerve pain, post
crainiotomy pain, incisional pain, clunial pain, post herniorrhapy
pain, localized low back or other spine pain, incisional neuroma
pain, stump neuroma pain, incisional scar pain, deafferention pain,
chronic peripheral nerve pain, sciatic neuralgia, medical neuralgia
and ulnar neuralgia.
18. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, further comprising an introducer
needle capable of being placed in the fascia superior to the
peripheral nerve and capable of passing the implantable lead so
that the stimulation portion is in position above the peripheral
nerve.
19. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 18, wherein the introducer needle is
curved so as to conform to a contour of the patient's body superior
to the peripheral nerve.
20. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the implantable lead is a
dual lead.
21. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near a supraorbital
nerve.
22. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near a clunial
nerve.
23. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near a
iliolinguinal nerve.
24. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near a median
nerve.
25. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near an ulnar
nerve.
26. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, wherein the stimulation portion of
the implantable lead is adapted to be implanted near a sciatic
nerve.
27. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 16, further comprising a screening device
capable of being coupled to the implantable lead for performing
test electrical stimulation with the implantable lead.
28. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 27, wherein the screening device is
capable of delivering electrical stimulation having an amplitude
between about 0.5 to about 4.0 volts.
29. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 27, wherein the screening device is
capable of delivering electrical stimulation having a rate between
about 50 Hz to about 400 Hz.
30. The apparatus for treating neuralgia emanating from a
peripheral nerve of claim 27, wherein the screening device is
capable of delivering electrical stimulation having a pulse width
between about 90 .mu.sec to about 200 .mu.sec.
31. An apparatus for treating neuralgia emanating from an occipital
nerve of a patient comprising in combination: (a) an implantable
signal generator for providing electrical stimulation; (b) an
implantable lead having a proximal end coupled to the signal
generator and a stimulation portion adapted to be implanted in a
fascia superior to and near the occipital nerve to cause
paresthesia of a neuralgia emanating area, whereby the implantable
signal generator is capable of providing electrical stimulation to
the occipital nerve via the stimulation portion of the implantable
lead to cause parasthesia of the neuralgia emanating area.
32. The apparatus for treating neuralgia emanating from an
occipital nerve of claim 31, wherein the implantable lead is
capable of being placed at a level of C1 transversely across a base
of an occipital nerve trunk and wherein the implantable signal
generator is capable of providing electrical stimulation to the
occipital nerve trunk.
33. An apparatus for treating neuralgia emanating from an occipital
nerve of a patient comprising in combination: (a) an RF system
transmitter for generating RF signals; (b) an implantable RF system
receiver for providing electrical stimulation in response to the RF
signals; (c) an implantable lead having a proximal end coupled to
the implantable RF system receiver and a stimulation portion
adapted to be implanted in a fascia superior to and near the
occipital nerve to cause paresthesia of a neuralgia emanating area,
whereby the implantable RF system receiver is capable of providing
electrical stimulation to the occipital nerve via the stimulation
portion of the implantable lead to cause parasthesia of the
neuralgia emanating area.
34. The apparatus for treating neuralgia emanating from an
occipital nerve of claim 33, wherein the implantable lead is
capable of being placed at a level of C1 transversely across a base
of an occipital nerve trunk and wherein the implantable RF system
receiver is capable of providing electrical stimulation to the
occipital nerve trunk.
Description
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 09/577,258, filed May 22, 2000, for which
priority is claimed. This parent application is incorporated herein
by reference in its entirety.
FIELD OF THE INVENTION
[0002] This invention relates to a method for subcutaneously
electrically stimulating peripheral nerves and in a particular
embodiment relates to a method for subcutaneously electrically
stimulating one or more occipital peripheral nerve to treat
occipital neuralgia.
DESCRIPTION OF RELATED ART
[0003] Peripheral nerves are nerves in the body other than the
nerves of the brain or spinal cord. Peripheral nerve injury may
result in the development of chronic intractable pain. Some
patients prove unresponsive to conservative pain management
techniques. Peripheral Nerve Stimulation (PNS) has developed as a
successful therapy for pain management when the pain is known to
result from a specific nerve. PNS is based in part on the
Melzack-Wall gate control theory of pain. Sweet and Wespic first
used electrical stimulation of peripheral nerves in the 1960s to
mask the sensation of pain with a tingling sensation (paresthesia)
caused by the electrical stimulation. Subsequent refinements in the
technology, surgical technique and patient selection have led to
improved long term results.
[0004] PNS is an accepted alternative for those patients who have
failed more conservative pain management therapies. Clinical
experience has shown that when applied to appropriate patients by
trained practitioners, PNS can reduce pain, reduce narcotic intake
to manage pain and improve the patient's activity levels and their
quality of life. PNS has been recognized to have the following
desirable characteristics:
[0005] The surgical procedure is relatively simple.
[0006] PNS is nondestructive. No known permanent surgical or
chemical interruption of nerve pathways occurs.
[0007] PNS is reversible. If the patient does not benefit, the
device can be turned off or removed. There are no known
long-lasting medical or surgical side effects.
[0008] Patients can be tested for response prior to implant of the
complete system.
[0009] Occipital nerves 2, 4 and 6 (FIG. 1) are peripheral nerves
that exit the spinal cord at the C2 level of the cervical vertebrae
and extend upward generally along the back and back-sides of the
head. The lesser occipital nerve 2 extends upward and toward the
sides of the head. The greater occipital nerve 4 extends upward
toward the top of the head. The third occipital nerve 6 extends
from near the neck around the back of the head toward the ear.
Because of the location where the occipital nerves leave the spinal
cord, the occipital nerves pass from the spinal column through
muscle and fascia to the scalp.
[0010] Occipital neuralgia is a condition characterized by
paroxysms of pain occurring within the distribution of the greater
and/or lesser occipital nerves. Occipital neuralgia has been
described as a "jabbing" pain in the area of the greater or lesser
occipital nerve. The pain may radiate from the back or sides of the
head toward the top or front of the head. Patients will vary in
their reporting of this pain. It has been characterized in the
medical literature as a unilateral or bilateral throbbing pain that
frequently radiates to the forehead and to the frontal region
(Stechison and Mullin, 1992) or as a lancinating pain extending
from the suboccipital region up to the top of the head. The pain is
less often described as including or consisting of a dull aching"
(Sulfaro and Gobetti, 1995). Occipital neuralgia is often
accompanied by diminished sensation and sometimes extreme localized
tenderness over the applicable nerve.
[0011] Though known causes of occipital neuralgia include closed
head injury, direct occipital nerve trauma, neuroma formation or
upper cervical root compression (spondylosis or ligamentous
hypertrophy), most patients have no demonstrable lesion. An
anesthetic block of the greater occipital nerve can be used to
confirm the diagnosis of occipital neuralgia (Khun, et al.,
1997).
[0012] Traditional treatment options for intractable occipital
nerve pain that has proven to be resistant to medications usually
involve chemical, thermal or surgical ablation procedures following
diagnostic local anesthetic blockade. Surgical approaches include
neurolysis or nerve sectioning of either the occipital nerve in the
occipital scalp or at the upper cervical dorsal root exit zone
(extradural). Forammal decompression of C2 roots as well as C2
ganglionectomy have also been effective in reported cases.
[0013] Many patients with occipital neuralgia do not favorably
respond to these medical treatments. Therefore, there is a need for
an additional effective treatment of occipital neuralgia.
BRIEF SUMMARY OF THE INVENTION
[0014] A method for treating pain by subcutaneous electrical
stimulation is disclosed. A lead is placed subcutaneously over
(superior to) a peripheral nerve that is causing pain. The nerve is
electrically stimulated to cause paresthesia. As a result, the pain
is masked. The method of the invention encompasses subcutaneous
placement of an electrical lead near any peripheral nerve causing
pain and subsequent electrical stimulation of the nerve to cause
paresthesia.
[0015] In particular, a method for treating intractable occipital
neuralgia using percutaneous peripheral nerve electrostimulation
techniques is disclosed. The method involves a subcutaneous
electrode placement at the level of C1 transversely across the base
of the occipital nerve trunk and subsequent electrical stimulation
of the occipital nerve trunk. This stimulation produces paresthesia
and pain relief covering the regions of occipital nerve pain.
[0016] It is therefore an object of the invention to provide a
method for subcutaneously electrically stimulating nerves causing
pain to create paresthesia.
[0017] It is another object of the invention to provide a method
for percutaneously placing leads subcutaneously to create
paresthesia.
[0018] These and other object of the invention will be clear from
the following detailed description of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a schematic view of the occipital nerves.
[0020] FIG. 2 is a schematic view of the hardware used to practice
the invention of the present invention.
[0021] FIG. 3 is a perspective view of a screener device and a
screening lead.
[0022] FIG. 4 is a top view of a permanent lead.
[0023] FIG. 5 is a perspective view of an implantable pulse
generator (IPG).
[0024] FIG. 6 is a perspective view of an RF system receiver and an
RF system transmitter.
[0025] FIG. 7 is a top view of an introducer needle curved to
facilitate placement of the permanent lead to treat occipital
neuralgia.
[0026] FIG. 8 is a schematic view of the entry site used to implant
a screening lead or a permanent lead for treating occipital
neuralgia.
[0027] FIG. 9 is a schematic view of the placement of the
introducer needle prior to placing the screening lead.
[0028] FIG. 10 is a schematic view of the placement of the
introducer needle with the screening lead being inserted into the
introducer needle.
[0029] FIG. 11 is a schematic view of dual leads placed to treat
bi-lateral pain.
[0030] FIG. 12 is a perspective view of a patient prior to being
implanted with a permanent lead.
[0031] FIG. 13 is a schematic view of the placement of the
introducer needle prior to placing the permanent lead.
[0032] FIG. 14 is a schematic view of the placement of the
introducer needle with the permanent lead being inserted into the
introducer needle.
[0033] FIG. 15 is a schematic view of the location of the
subcutaneous pocket for housing the loop of the permanent lead and
the lead anchor.
[0034] FIG. 16 is a perspective view of a human torso and arm
showing the location of the leads for two embodiments of the
invention.
[0035] FIG. 17 is a perspective view of a human torso and arm
showing the exit sites of the leads and preferred location for an
IPG for the method of FIG. 16.
[0036] FIG. 18 is a perspective view of a human leg showing the
location of a lead and IPG for an embodiment of the invention.
[0037] FIG. 19 is a perspective view of a human leg showing the
location of a lead and IPG for another embodiment of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0038] The present invention comprises a method of stimulating
peripheral nerves. The method is preferentially accomplished in two
stages: a test implantation and screening stage and a permanent
implantation of a lead and electrical stimulation system stage. The
invention contemplates using, as shown in FIG. 2, a screening lead
10 (shown in detail in FIG. 3), a screener device 12 (also shown in
detail in FIG. 3), a permanent lead 14 (shown in detail in FIG. 4)
and either an implanted pulse generator (IPG) 16 (shown in detail
in FIG. 5) or an implanted RF system receiver 18 and its
corresponding RF system transmitter 20 (shown in detail in FIG.
6).
[0039] The screening lead 10 and permanent lead 14 are preferably
percutaneous leads chosen from the Pisces-Quad.RTM. family of
quadripolar leads. Screener device 12 is preferably a Model 3625
Screener or a Model 3628 DualScreen.RTM. Screener. IPG 16 is
preferably an Itrel.RTM. IPG. RF system receiver 18 and RF system
transmitter 20 are both preferably part of an RF stimulation system
such as the X-trell.RTM. or Matrix.RTM. RF Stimulation Systems.
Screening lead 10, permanent lead 14, screener device 12, IPG 16,
RF system receiver 18 and RF transmitter 20 are all available from
Medtronic, Inc. of Minneapolis, Minn.
[0040] The method for treating pain due to peripheral nerves
involves subcutaneous placement of a permanent lead 14 transversely
across the peripheral nerve that is causing the pain. This
peripheral nerve is subsequently electrically stimulated to cause
paresthesia of the painful area. The method also preferably
involves placement of a screening lead 10 and subsequent test
electrical stimulation prior to placing the permanent lead 14.
Although the method preferably involves placing both a screening
lead 10 and then a permanent lead 14, the method also includes
implanting just the permanent lead 14 as will be described in
detail hereafter. For illustration purposes, the method for
treating pain due to peripheral nerves will be described with
reference to treating occipital neuralgia by electrically
stimulating the occipital nerves.
[0041] One key to the technical success of this invention is the
accurate placement of the permanent lead 14. Because of the
importance of accurate placement of the permanent lead 14, accurate
placement of permanent lead 14 is facilitated by the placement of
the screening lead 10 and the subsequent test electrical
stimulation. The steps in the invention to percutaneously place a
screening lead 10 to treat occipital neuralgia will now be
described in detail. These steps are given as the preferred method
of implementing the invention for most patients. It is recognized,
however, that the skilled physician will adapt the method described
herein using his or her professional skill and judgment to the
particular circumstances of a particular patient. Further, although
the method of treating pain described in detail herein is
specifically directed to treating occipital neuralgia, unless
otherwise specifically directed, any reference to the occipital
nerve or occipital neuralgia refers as well to any peripheral nerve
or neuralgias corresponding to a peripheral nerve,
respectively.
[0042] The first step of the test implantation and screening stage
is the implantation of a screening lead 10. The method involves
subcutaneous placement of a screening lead 10 in the fascia 34
above (superior to) the occipital nerve causing pain and proximal
to the level of detected pain. The first step in locating the area
to implant the screening lead 10 is to palpate the area of pain to
identify the specific nerve that is causing the pain. If it is
confirmed that an occipital nerve is causing the pain and the
specific occipital nerve has been identified, an introducer needle
22 is used to place the screening lead 10.
[0043] The preferred embodiment for the introducer needle 22 is a
Touhy needle. As shown in FIG. 7, the introducer needle 22 has a
terminal end 24 that has a beveled edge 26 and a proximal end 28
that includes a hub 30. Beveled edge 26 is a sharp edge that allows
the terminal end 24 to be pushed through tissue. Hub 30 allows the
physician to manipulate the introducer needle 22. Hub 30 also has a
notch 32 that is aligned with the beveled edge 26 to indicate the
orientation of beveled edge 26 to the hub 30 by tactile
sensation.
[0044] The introducer needle 22 is then subcutaneously placed in
the fascia 34 above (superior to) the nerve 36 that is causing the
pain. In the case of treating occipital neuralgia, the introducer
needle 22 is placed in the fascia 34 above (superior to) the
occipital nerve that is causing the pain. Fascia 34 is a sheet of
fibrous tissue that envelops the body under the skin and also
encloses the muscles. In the described method, the introducer
needle 22 will be introduced into the fascia 34 so that the
introducer needle will be between the patient's skin and muscle.
The nerve causing the pain will be located within or under the
musculature. In the case of treating occipital neuralgia, the
introducer needle 22 will be introduced into the fascia 34 so that
the introducer needle will be between the patient's skin and the
occipital nerve.
[0045] The introducer needle 22 is preferably introduced through a
small stab wound "A" at the needle entry site (FIG. 8). Rapid
needle insertion is preferably used. This technique usually
obviates the need for even a short acting general anesthetic.
[0046] The introducer needle 22 is moved through the fascia 34 to a
position over the occipital nerve that is causing the pain (FIG.
9). When the introducer needle 22 is in position above the
occipital nerve, the screening lead 10 is passed through the
introducer needle 22 (FIG. 10) until the screening lead 10 is also
in position above the occipital nerve causing the pain. Then, the
introducer needle 22 is removed leaving the screening lead 10 in
place above the occipital nerve.
[0047] Single or dual quadripolar as well as single or dual
octapolar screening leads 10 may be used depending on whether the
pain is unilateral (on one side of the body only) or bilateral (on
both sides of the body). Where the pain is bilateral and two
screening leads 10 are used (FIG. 11), each screening lead 10 will
be placed as described above.
[0048] Following placement of the screening lead 10 by the
introducer needle 22, the screening lead 10 is connected to the
screening device 12, as is well understood in the art. With the
screening lead 10 in place as described above and the screening
lead 10 connected to the screening device 12, the patient is
electrically stimulated by the screening lead 10 and screener
device 12 to evaluate the screening lead 10 position and to develop
optimal stimulation parameters. Stimulation is applied using the
screener device 12 to select various electrode combinations,
enabling the patient to report stimulation location, intensity and
overall sensation. This allows the physician to test the
stimulation and determine optimum stimulation parameters prior to
permanently implanting the permanent lead 14 and the source of
electrical stimulation pulses, either the IPG 16 or the RF system
receiver 18. The effect of this stimulation is determined and the
parameters of stimulation adjusted for optimal pain relief. It is
preferred that the patient be awake and alert so that the patient
will provide verbal feedback regarding paresthesia coverage of the
painful area to assist in determining the optimum stimulation
parameter settings.
[0049] The following have been found to be typical ranges for
stimulation parameters for screening by the screener device 12 and
the screening lead 10 to optimize paresthesia levels for pain
coverage. These parameters can vary from patient to patient and may
be outside the ranges given here. Never-the-less, these
representative values are given for the purpose of illustrating the
invention and not for the purpose of limiting the invention. Values
for these parameters may be higher or lower than the values
shown.
1 Amplitude: 0.5-4.0 volts Pulse Width: 90-200 .mu.sec Rate: 50-400
Hz
[0050] If the patient reports muscle contractions (grabbing
sensation) or burning, this usually indicates that the screening
lead 10 is located too deep (anterior) in the subcutaneous tissue.
It may also indicate that the screening lead 10 is not positioned
correctly above (superior to) the nerve. It may be necessary to
remove and reposition the screening lead 10. If adjustment of
screening lead 10 is necessary, the screener device 12 is removed
from the screening lead 10. Then, the position of the screening
lead 10 is adjusted and stimulation is tested again for optimal
pain relief. Adjusting the position of the screening lead 10 may
mean removing the screening lead 10 and re-implanting the screening
lead 10 according to the technique described above.
[0051] After good paresthesia coverage is obtained by manipulating
the parameters of stimulation applied through screening lead 10,
percutaneous testing wires can be externalized for the test
stimulation period as is well understood in the art. This period is
used to evaluate the patient's response to stimulation before
complete implantation of all system components.
[0052] Alternately, once satisfactory paresthesia is confirmed, the
screener device 12 may be removed from the screening lead 10 and a
source of electrical stimulation pulses such as the IPG 16 or RF
system receiver 18 is immediately implanted and attached to the
screening lead 10. Hence, screening lead 10 in this embodiment
becomes permanent lead 14. However, it is preferred that the
patient use the implanted screening lead 10 and screener system 12
for several days prior to implanting a permanent stimulation
system.
[0053] Once the screening lead 10 has been appropriately positioned
and tested, if satisfactory results are obtained, the method should
proceed to the "permanent implantation of a lead and electrical
stimulation system" stage. The steps in the invention to
permanently implant a stimulation system will now be described in
detail in connection with the treatment of occipital neuralgia. As
mentioned above, it is possible to implant a source of electrical
stimulation pulses such as the IPG 16 or RF system receiver 18 and
attached it directly to the screening lead 10 so that screening
lead 10 becomes the permanent lead 14. However, the preferred
embodiment of the invention contemplates removing the screening
lead 10 and replacing it with a permanent lead 14.
[0054] After it has been determined that the patient is receptive
to pain relief from electrically stimulating the peripheral nerve
causing the pain and the paresthesia associated with the electrical
stimulation has been maximized, the screener device 12 is
disconnected from the stimulation lead 10 and the screening lead 10
is removed. The patient is then prepared for placement of the
permanent lead 14 and the implanted pulse generator (IPG) 16 or
implanted RF system receiver 18. The purpose of the "permanent
implantation of a lead and electrical stimulation system" stage is
to internalize (that is, implant) the permanent lead 14 and either
the IPG 16 or the RF system receiver 18. Therefore, this stage
includes implanting the permanent lead 14, neurostimulator (either
IPG 16 or RF system receiver 18) and any extension sometimes used
to connect permanent lead 14 and either IPG 16 or RF system
receiver 18 as is well understood in the art.
[0055] As stated above, one key to the technical success of this
invention is the accurate placement of the permanent lead 14. It is
therefore crucial to the success of the invention to have a lead
placement for the permanent lead 14 that results in paresthesia
that covers the patient's painful area. Therefore, lead placement
is preferably determined using patient feedback during
intraoperative testing of the efficacy of the permanent lead 14
placement and the stimulation parameters. Performing implantation
of the permanent lead 14 under local anesthetic allows for this
feedback.
[0056] A local anesthetic is preferably used in the area of the
introducer needle 22 entry site to ensure the patient is alert and
able to respond during the procedure. To help the patient relax,
sedatives are also preferably administered intravenously.
Prophylactic antibiotics can also be administered intravenously for
protection from postoperative infection. As a result, the patient
is preferably awake and alert during the placement of the permanent
lead 14 and the subsequent test stimulation.
[0057] Where treating occipital neuralgia, the patient is
preferably placed in a lateral position, or in a prone position
with the head to the side, on a radiolucent table (FIG. 12). The
patient is prepared and draped according to standard surgical
procedure. Fluoroscopy is used to identify the location of the C1
vertebra. The location and midline of the C1 vertebra is marked on
the patient's skin with a sterile marker.
[0058] A Touhy needle is preferably used as an introducer needle 22
to introduce permanent lead 14. The introducer needle 22 includes a
stylet 42. The introducer needle 22 is manually gently curved by
the physician to conform to the contour of the patient's body above
the peripheral nerve to facilitate placement of the permanent lead
14. Where the peripheral nerve is the occipital nerve, the
introducer needle 22 is manually gently curved by the physician to
conform to the contour of the patient's neck (FIG. 7) to facilitate
placement of the permanent lead 14.
[0059] A small stab wound "A" is made at the needle entry site
(FIG. 8) at the C1 level. Using local anesthesia, a 2 cm. vertical
skin incision is made in the patient's neck lateral to the midline
of the spine at the level of C1. The introducer needle 22 is
introduced into the subcutaneous tissue, superficial to the fascia
34 and muscle layer but below the skin, without further dissection
across the trunk of the occipital nerves. These nerves are located
within the cervical musculature and overlying fascia 34.
[0060] The physician then advances the introducer needle 22
transversely from the lateral incision point to and across the
midline of the spine under fluoroscopic observation to the
appropriate location above the trunk of the occipital nerve (FIG.
13). The beveled edge 26 of the introducer needle 22 should face
toward the front of the body (anterior). The orientation of the
beveled edge 26 can be verified by referring to the notch 32 on the
needle hub 30 of the introducer needle 22.
[0061] The curve of the introducer needle 22 may be checked, if
desired, by the physician by removing and re-inserting the needle
stylet 42. A useful, curved introducer needle 22 is ensured if it
is easy to remove and reinsert the stylet 42 within the introducer
needle 22. If desired, an additional check can be made by removing
the stylet 42, then carefully inserting the permanent lead 14
through the introducer needle 22 to just beyond the beveled edge 26
of the introducer needle 22. If the curvature of the introducer
needle 22 is correct, the permanent lead 14 should pass easily to
just beyond the beveled edge 26 of the introducer needle 22. The
permanent lead 14 is then removed and the stylet 42 re-inserted
into the introducer needle 22.
[0062] Once the desired position has been reached, the stylet 42 is
removed from the introducer needle 22. The permanent lead 14 is
slowly inserted through the introducer needle 22 until the distal
tip 36 of the permanent lead 14 just exits the introducer needle 22
(FIG. 14). Then, the introducer needle 22 is carefully removed over
the permanent lead 14. The permanent lead 14's placement is
verified with fluoroscopy. Alternately, the introducer needle 22
can be partially removed. This allows the electrode contacts on the
permanent lead 14 to be exposed while facilitating introducer
needle 22 reinsertion if repositioning of the permanent lead 14 is
needed. Fluoroscopy is used to ensure that all electrodes of the
permanent lead 14 are exposed. If necessary, the introducer needle
22 may be adjusted to move the permanent lead 14 to a location
where the permanent lead 14 will optimally stimulate the targeted
occipital nerve(s).
[0063] If more than one permanent lead 14 is to be implanted, for
example, on each side of the midline to treat bilateral pain, the
procedure described above is repeated for each such permanent lead
14.
[0064] Following placement of the permanent lead 14 by the
introducer needle 22, the permanent lead 14 is again connected to
the screening device 12, as is well understood in the art. This
allows the physician to test the stimulation and confirm that
paresthesia is obtained with the placement of the permanent lead 14
prior to permanently implanting the IPG 16 or the RF system
receiver 18. Since the patient is preferably awake and alert, the
patient will provide verbal feedback regarding paresthesia coverage
of the painful area to assess the placement of the permanent lead
14.
[0065] If the patient reports muscle contractions (grabbing
sensation) or burning, this usually indicates that the electrodes
on the permanent lead 14 are too deep (anterior) in the
subcutaneous tissue. It may also indicate that the electrodes are
significantly above or below the C1 landmark. It may be necessary
to remove and reposition the permanent lead 14. If adjustment of
permanent lead 14 is necessary, the screener device 12 is removed
from the permanent lead 14. Then, the position of the permanent
lead 14 is adjusted and stimulation is tested again.
[0066] After good paresthesia coverage is obtained, the screener
device 12 is removed from the permanent lead 14. It is now possible
to implant the source of electrical stimulation pulses such as the
IPG 16 or RF system receiver 18 and any extension sometimes used to
connect permanent lead 14 and either IPG 16 or RF system receiver
18 as is well understood in the art. Internalization of the
neurostimulation system for occipital nerve stimulation preferably
follows the protocol used for other Peripheral Nerve Stimulation
(PNS) indications as is well understood in the art. Basically, the
procedure involves creating a subcutaneous pocket 24 in tissue
(FIG. 15), anchoring the permanent lead 14, implanting the IPG 16
or RF system 18, tunneling the permanent lead 14 and connecting the
permanent lead 14 to the IPG 16 or RF system 18 as is well
understood in the art.
[0067] The following have been found to be typical ranges for
stimulation parameters applied to the permanent lead 14 to obtain
optimum paresthesia levels for pain coverage to treat occipital
neuralgia. These values can vary from patient to patient and may be
outside the ranges given here. Never-the-less, these representative
values are given for the purpose of illustrating the invention and
not for the purpose of limiting the invention. Again, values for
these parameters may be higher or lower than the values shown.
2 Amplitude: 0.5-4.0 volts Pulse Width: 90-200 .mu.sec Rate: 50-400
Hz
[0068] These steps are given as the preferred method of
implementing the invention for most patients. It is recognized,
however, that the skilled physician will adapt the method described
herein using his or her professional skill and judgment to the
particular circumstances of a particular patient.
[0069] A specific example of percutaneous nerve stimulation has
been given for treating occipital neuralgia. Although the method of
treating occipital neuralgia has been described in detail, the
steps described can be adapted to treating other peripheral nerve
applications as medical judgment and necessity require. Examples of
other applications for the described subcutaneous PNS technique
include peripheral nerves in the head and neck, trunk and limbs.
Examples of neuralgias in the head and neck that can be treated by
stimulating peripheral nerves include, but are not limited to, post
herpetic neuralgia, chronic deafferentation pain, chronic
peripheral nerve pain, post craniotomy pain and incisional pain.
For post herpetic neuralgia, the permanent lead 14 should
preferably be placed in the vicinity of the supraorbital nerve in
the forehead area. For chronic deafferentation pain, the permanent
lead 14 should preferably be placed subcutaneously in the vicinity
of the deafferentation pain. For chronic peripheral nerve pain, the
permanent lead 14 should preferably be placed proximal to any
peripheral nerve throughout the body. For chronic post craniotomy
pain, the permanent lead 14 should preferably be placed in the
region of the craniotomy incision.
[0070] Examples of neuralgias in the trunk that can be treated by
stimulating peripheral nerves include, but are not limited to,
clunial nerve pain, post herniorrhapy pain, localized low back or
other spine pain and incisional neuroma pain. For clunial nerve
pain, the permanent lead 14 should preferably be placed over the
clunial nerve in the buttock area. For post herniorrhapy pain, the
permanent lead 14 should preferably be placed subcutaneously in the
region of the iliolinguinal nerve. For localized low back or other
spine pain, the permanent lead 14 should preferably be placed in
the vicinity of the localized area of pain. For incisional neuroma
pain, the permanent lead 14 should preferably be subcutaneously
placed in the region of the incisional neuroma.
[0071] Examples of neuralgias in the limbs that can be treated by
stimulating peripheral nerves include, but are not limited to,
stump neuroma pain, incisional scar pain, deafferention pain and
chronic peripheral nerve pain as for example with the median nerve
or ulnar nerve. For stump neuroma pain, the permanent lead 14
should preferably be subcutaneously placed in the region of the
neuroma. For incisional scar pain, the permanent lead 14 should
preferably be subcutaneously placed in the region of the incision.
For chronic peripheral nerve pain of the medial nerve or ulnar
nerve, the permanent lead 14 should preferably be placed over the
medial nerve 38 or ulnar nerve 40, respectively, as shown in FIG.
16. Here, the technique described above is applied to the placement
of screening lead 10 and permanent lead 14 with the leads 10, 14
located above (superior to) the desired peripheral nerve through
medial nerve incision site 42 and ulnar nerve incision site 44,
respectively. Once the permanent lead 14 is in place, the IPG 16 or
RF system receiver 18 is implanted as is well understood in the art
(FIG. 17) and connected to the permanent lead 14.
[0072] FIGS. 18 shows the placement of a permanent lead 14 next to
the sciatic nerve 46 in the leg. Permanent lead 14 is implanted as
described above through the sciatic nerve incision site 48.
Placement of permanent lead 14 and the subsequent electrical
stimulation of the sciatic nerve 46 could treat neuromas or chronic
pain emanating from this peripheral nerve.
[0073] Further, FIG. 19 shows the placement of a permanent lead 14
next to a peripheral nerve 48 in the ankle, foot or other localized
are of pain. Permanent lead 14 is implanted as described above
through a peripheral nerve incision site 50. Placement of permanent
lead 14 and the subsequent electrical stimulation of the affected
peripheral nerve 44 could also treat neuromas in or around this
peripheral nerve and also chronic pain arising from this nerve.
[0074] The examples of the method of the invention shown in FIGS.
16-19 have been given to illustrate examples of peripheral nerves
to which the present method could apply. The application of the
present invention to other peripheral nerves with their
corresponding maladies and neuromas will occur to those skilled in
the art. Conversely, once neurological maladies or neuromas and
their corresponding peripheral nerves have been identified, as will
also occur to those skilled in the art, the present invention may
be used to treat such maladies or neuromas. It is clear that those
skilled in the art will be able to practice the invention described
above as applied to any peripheral nerve or to treat any particular
neuroma by applying the disclosed method to its corresponding
peripheral nerve.
[0075] The description contained herein is intended to be
illustrative and not exhaustive. Many variations and alternatives
will occur to one of ordinary skill in this art. All these
alternatives and variations are intended to be included within the
scope of the attached claims. Those familiar with the art may
recognize other equivalents to the specific embodiments described
herein which equivalents are also intended to be encompassed by the
claims attached hereto.
* * * * *