U.S. patent application number 12/041494 was filed with the patent office on 2008-06-19 for treatment of obesity by sub-diaphragmatic nerve stimulation.
This patent application is currently assigned to CYBERONICS, INC.. Invention is credited to Burke T. Barrett, Mitchell S. Roslin.
Application Number | 20080147139 12/041494 |
Document ID | / |
Family ID | 25032031 |
Filed Date | 2008-06-19 |
United States Patent
Application |
20080147139 |
Kind Code |
A1 |
Barrett; Burke T. ; et
al. |
June 19, 2008 |
TREATMENT OF OBESITY BY SUB-DIAPHRAGMATIC NERVE STIMULATION
Abstract
A method and apparatus for treating obese or other patients with
compulsive overeating disorder includes unilaterally or bilaterally
stimulating one or both of the left and right branches of a
patient's vagus nerve directly or indirectly with an electrical
pulse signal generated by an implantable neurostimulator with at
least one operatively coupled nerve electrode to apply the pulse
signal to the selected nerve branch at a location below the
patient's diaphragm. The implantable neurostimulator is
programmable to enable physician programming of electrical and
timing parameters of the pulse signal, to induce weight loss of the
patient.
Inventors: |
Barrett; Burke T.; (Houston,
TX) ; Roslin; Mitchell S.; (Rockaway Park,
NY) |
Correspondence
Address: |
CYBERONICS, INC.
LEGAL DEPARTMENT, 6TH FLOOR, 100 CYBERONICS BOULEVARD
HOUSTON
TX
77058
US
|
Assignee: |
CYBERONICS, INC.
Houston
TX
|
Family ID: |
25032031 |
Appl. No.: |
12/041494 |
Filed: |
March 3, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10642135 |
Aug 18, 2003 |
7340306 |
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12041494 |
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09753758 |
Jan 2, 2001 |
6609025 |
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10642135 |
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Current U.S.
Class: |
607/40 |
Current CPC
Class: |
A61N 1/36007 20130101;
A61N 1/36085 20130101; A61N 1/36053 20130101; A61N 1/0551
20130101 |
Class at
Publication: |
607/40 |
International
Class: |
A61N 1/05 20060101
A61N001/05 |
Claims
1. A method of treating an obese patient, comprising: surgically
implanting in the abdomen of the patient an electrical signal
generator and at least one electrode operatively coupled thereto;
coupling said at least one electrode directly to a selected one of
the left vagus nerve and the right vagus nerve of the patient;
generating an electrical signal with said electrical signal
generator; applying said electrical signal, using said at least one
electrode, directly and unilaterally to said selected one of the
left vagus nerve and the right vagus nerve internally in the
abdomen at a location below the patient's diaphragm; and,
programming electrical and timing parameters of said electrical
signal, to induce weight loss of the patient.
2-5. (canceled)
6. The method of claim 1, wherein said stimulating electrical
signal comprises a sequence of electrical pulses.
7. The method of claim 1, wherein the step of stimulating comprises
applying said electrical signal to the vagus nerve at a location in
a range of from about two to about three inches below the patient's
diaphragm.
8. The method of claim 1, wherein the step of stimulating includes
applying said electrical signal intermittently, in alternating on
and off intervals according to a predetermined duty cycle.
9. The method of claim 1, wherein the step of stimulating includes
applying said electrical signal continuously.
10-28. (canceled)
29. A method of treating an obese patient, comprising: surgically
implanting in the abdomen of the patient an electrical signal
generator and at least a first and a second electrode operatively
coupled thereto; coupling said first electrode directly to a left
vagus nerve of the patient and said second electrode directly to a
right vagus nerve of the patient; generating an electrical signal
with said electrical signal generator; applying said electrical
signal, using said first and second electrodes, directly and
bilaterally to said left vagus nerve and said right vagus nerve
internally in the abdomen at a location below the patient's
diaphragm; and programming electrical and timing parameters of said
electrical signal, to induce weight loss of the patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/642,135 filed Aug. 18, 2003, which is a
continuation of U.S. patent application Ser. No. 09/753,758, filed
Jan. 2, 2001, the disclosures of which are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to methods and
apparatus for treating eating disorders by application of
modulating electrical signals to a selected cranial nerve, nerve
branch or nerve bundle, and more particularly to techniques for
treating patients with overeating disorders, especially obese
patients, by application of such signals unilaterally or
bilaterally to the patient's vagus nerve with one or more
neurostimulating devices.
[0003] Increasing prevalence of obesity is one of the most serious
and widespread health problems facing the world community. It is
estimated that, currently, about 6% of the total population of the
United States is morbidly obese and a much larger percentage is
either obese or significantly overweight. Morbid obesity is defined
as having a body mass index of more than forty, or, as is more
commonly understood, being more than one hundred pounds overweight
for a person of average height. Aside from what may be an epidemic
of obesity, it is believed by many health experts that obesity is
one of the first two leading causes of preventable deaths in the
United States, either ahead of or just behind cigarette smoking or
not that is an accurate assessment, studies have indicated that
morbid obesity dramatically increases health care costs. It is a
major cause of adult onset diabetes in the United States, up to
approximately eighty percent of the cases. It may be a leading
factor in as many as ninety percent of sleep apnea cases. Obesity
is also a substantial risk factor for coronary artery disease,
stroke, chronic venous abnormalities, numerous orthopedic problems
and esophageal reflux disease. Researchers have documented a link
between obesity, infertility and miscarriages, as well as post
menopausal breast cancer.
[0004] The classical treatment option for obese people combines
nutritional counseling with exercise and education, but has
demonstrated relatively little long term success. Liquid diets and
pharmaceutical agents can bring about acute, but not lasting weight
loss. Surgical procedures for either gastric restriction or
malabsorption in cases of severe obesity have shown the greatest
success long-term, but are major surgery that can lead to emotional
problems, and have their share of failures (e.g., Kriwanek,
"Therapeutic failures after gastric bypass operations for morbid
obesity," Langenbecks Archiv. Fur Chirurgie, 38(2): 70-74,
1995).
[0005] U.S. Pat. No. 5,263,480 to J. Wemicke et al., assigned to
the same assignee as the present application, discloses treatment
for eating disorders including obesity and compulsive overeating
disorder by selectively applying modulating electrical signals to
the patient's vagus nerve, preferably using an implanted
neurostimulator. Modulating signals may be used to stimulate vagal
activity to increase the flow of neural impulses up the nerve, or
to inhibit vagal activity to block neural impulses from moving up
the nerve, toward the brain, for producing excitatory or inhibitory
neurotransmitter release.
[0006] Both of these cases of modulating the electrical activity of
the vagus nerve have been termed vagus nerve stimulation, or VNS.
The '480 patent theorized that VNS could be used for appetite
suppression by causing the patient to experience satiety, a
sensation of "fullness" of the stomach which would result in
decreased food consumption and consequent weight reduction. For
example, the stimulus generator of the neurostimulator is implanted
in a convenient location in the patient's body, attached to an
electrical lead having a nerve electrode implanted on the vagus
nerve or branch thereof in the esophageal region slightly above the
stomach. If the patient's food consumption over a given period
exceeded a predetermined threshold level, detected and measured for
example by sensing electrodes implanted at or near the esophagus,
the stimulus generator is triggered to apply VNS and thereby induce
satiety. Alternatively, VNS is applied periodically during the
patient's normal waking hours except in periods of prescribed
mealtimes, or is applied as a result of patient intervention by
manual activation of the stimulus generator using external magnet
control. Patient intervention assumes a patient with an earnest
desire to control his or her eating behavior, but normally lacking
will power to control the compulsive behavior without the support
of VNS.
[0007] Like most of the pairs of cranial nerves, the tenth cranial
nerve, the vagus, originates from the brain stem. It passes through
foramina of the skull to parts of the head, neck and trunk. The
vagus is a mixed nerve, with both sensory and motor fibers, the
sensory fibers being primary and attached to neuron cell bodies
located outside the brain in ganglia groups, and the motor fibers
attached to neuron cell bodies located within the gray matter of
the brain. The vagus, as a cranial nerve, is part of the peripheral
nervous system or PNS whose nerves branch out from the central
nervous system (CNS) to connect the CNS to other body parts.
Somatic fibers of the cranial nerves are involved in conscious
activities and connect the CNS to the skin and skeletal muscles,
while autonomic fibers of these nerves are involved in unconscious
activities and connect the CNS to the visceral organs such as the
heart, lungs, stomach, liver, pancreas, spleen, and intestines.
[0008] The motor fibers of the vagus nerve transmit impulses to the
muscles associated with speech and swallowing, the heart, and
smooth muscles of the visceral organs of the thorax and abdomen. In
contrast, its sensory fibers transmit impulses from the pharynx,
larynx, esophagus and visceral organs of the thorax and abdomen.
The vagus is split into left and right branches, or left and right
vagi, which run respectively through the left and right sides of
the neck and trunk. It is the axial portion of the body, which
includes the head, neck and trunk with which we are primarily
concerned in respect of the present invention. The ventral cavity
of the axial portion contains visceral organs and includes the
thoracic cavity and the abdominopelvic cavity, which are separated
by the diaphragm, a broad thin muscle. Visceral organs in the
thoracic cavity include the right and left lungs, the heart, the
esophagus, the trachea and the thymus gland. Below the diaphragm,
in the abdominopelvic cavity and specifically the upper abdominal
portion or abdominal portion, the visceral organs therein include
the stomach, liver, spleen, gall bladder, and majority of the small
and large intestines.
[0009] The vagus nerve is the dominant nerve of the
gastrointestinal (GI) tract, the right and left branches or nerve
afferents of the vagus connecting the GI tract to the brain. After
leaving the spinal cord, the vagal afferents transport information
regarding that tract to the brain. In the lower part of the chest,
the left vagus rotates, becomes the anterior vagus, and innervates
the stomach. The right vagus rotates to become the posterior vagus,
which branches into the celiac division and innervates the duodenum
and proximal intestinal tract.
[0010] The exact mechanisms leading an individual to satiety are
not fully known, but a substantial amount of information has been
accumulated. Satiety signals include the stretch of
mechanoreceptors, and the stimulation of certain chemosensors
(e.g., "A Protective Role for Vagal Afferents: An Hypothesis,"
Neuroanatomy and Physiology of Abdominal Vagal Afferents, Chapter
12, CRC Press, 1992). These signals are transported to the brain by
the nervous system or endocrine factors such as gut peptides (e.g.,
"External Sensory Events and the Control of the Gastrointestinal
Tract An Introduction" id. at Chapter 5). It has been demonstrated
that direct infusion of maltose and oleic acid into the duodenum of
rats leads to a reduction in food intake, and that the response is
ablated by vagotomy or injection of capsaicin, which destroys vagal
afferents. Introduction of systemic cholecystokinin also reduces
intake in rats, and is ablated by destruction of vagal
afferents.
[0011] While the vagus is often considered to be a motor nerve
which also carries secretory signals, 80% of the nerve is sensory
consisting of afferent fibers (e.g., Grundy et al., "Sensory
afferents from the gastrointestinal tract," Handbook of Physiology,
Sec. 6, S. G., Ed., American Physiology Society, Bethesda, Md.,
1989, Chapter 10).
[0012] U.S. Pat. No. 6,587,719 discloses a method of treating
patients for obesity by bilateral stimulation of the patient's
vagus nerve (i.e., bilateral VNS) in which a stimulating electrical
signal is applied to one or both branches of the vagus. The
parameters of the signal are predetermined to induce weight loss of
the patient. The signal is preferably a pulse signal applied at a
set duty cycle (i.e., its on and off times) intermittently to both
vagi. In any event, VNS is applied at a supra-diaphragmatic
position (i.e., above the diaphragm) in the ventral cavity. The
electrical pulse stimuli are set at a current magnitude below the
retching level of the patient (e.g., not exceeding about 6
milliamperes (mA), to avoid patient nausea) in alternating periods
of continuous application and no application. Pulse width is set at
or below 500 microseconds (.mu.s), and pulse repetition frequency
at about 20-30 Hz. The on/off duty cycle (i.e., first period/second
period of the alternating periods) is programmed to a ratio of
about 1:1.8. The neurostimulator, which may be a single device or a
pair of devices, is implanted and electrically coupled to lead(s)
having nerve electrodes implanted on the right and left branches of
the vagus.
SUMMARY OF THE INVENTION
[0013] According to the present invention, a method of treating
patients for obesity comprises unilateral or bilateral stimulation
of the left and right vagi at a sub-diaphragmatic position (i.e.,
below the diaphragm) in the ventral cavity, rather than at a
supra-diaphragmatic position as taught by U.S. Pat. No. 6,587,719.
The stimulating electrical signal is preferably applied to the
vagus two to three inches below the diaphragm, and may be applied
either synchronously or asynchronously to both the right and left
branches, preferably in the form of a series of pulses applied
intermittently to both branches according to a predetermined on/off
duty cycle. The intermittent application is preferably chronic,
rather than acute. However, continuous application or acute
application by bilateral stimulation of the right and left vagi or
unilateral stimulation of either branch, at the sub-diaphragmatic
position, is also contemplated.
[0014] The sub-diaphragmatic application of VNS may have an
enhanced effect in inducing satiety in the patient, being in closer
proximity to the stomach itself. Certainly, in the case of
neurostimulator device implantation superficially in the abdominal
region of the patient, the sub-diaphragmatic application has an
advantage of enabling shorter leads for the nerve electrode(s).
Additionally, application of the neurostimulator may be more easily
accomplished with this approach as opposed to a supra-diaphragmatic
approach which requires accessing the vagi in the chest cavity.
[0015] Acute application of the stimulating electrical signal to
the right and left vagi during a customary mealtime, or from a
short time preceding and/or following the mealtime, according to
the patient's circadian cycle, may be effective in certain cases.
Automatic delivery of bilateral intermittent stimulation is
preferred, but it is alternatively possible to control application
of the stimulating electrical signal to the right and left vagi by
an external commencement signal produced by the patient's placement
of an external magnet, or by another patient-applied signal, in
proximity to the location of the implanted device.
[0016] Preferably, the same stimulating electrical signal is
applied to both the right and left vagi, but as an alternative, a
stimulating electrical signal might be applied to the right vagus
which is different from the stimulating electrical signal applied
to the left vagus. And although two separate nerve stimulator
generators may be implanted for stimulating the left and right
vagi, respectively, as an alternative a single nerve stimulator
generator may be implanted for bilateral stimulation if the same
signal is to be applied to both the left and right branches of the
vagus nerve, whether, delivered synchronously or asynchronously to
the vagi.
[0017] As with the method disclosed in U.S. Pat. No. 6,587,719, the
current magnitude of the stimulating signal is programmed to be
less than about 6 mA, and in any case is held below the retching
level of the patient as determined by the implanting physician at
the time the implant procedure is performed, or shortly thereafter.
This is important to avoid patient nausea during periods of vagus
nerve stimulation. Preferably, the pulse width is set to a value
not exceeding about 500 .mu.s, the pulse repetition frequency is
set at about 20-30 Hertz (Hz), the VNS regimen follows alternating
periods of stimulation and no stimulation, with the second period
about 1.8 times the length of the first period in the alternating
sequence (i.e., the on/off duty cycle is 1:1.8).
[0018] The apparatus of the present invention for treating obese
patients suffering from eating disorders includes an implanted
neurostimulator for simultaneously stimulating left and right
branches of the patient's vagus nerve via separate lead/electrodes
operatively coupled to the neurostimulator and implanted on the
right and left vagi in a sub-diaphragmatic position, the
stimulation being applied continuously during a first period,
alternating with no stimulation during a second period, throughout
the prescribed duration of the stimulation regimen.
[0019] Accordingly, it is a principal objective of the present
invention to provide methods and apparatus for treating and
controlling the overeating disorder, especially in obese patients,
by means of bilateral electrical stimulation of the patient's right
and left vagi at a sub-diaphragmatic location.
[0020] Another aim of the invention is to provide methods of
treating and controlling compulsive overeating and obesity by
bilateral intermittent electrical pulse stimulation of right and
left vagi at a sub-diaphragmatic position in the patient.
[0021] Alternative techniques include indirect stimulation of the
vagus, either bilaterally or unilaterally, at a location near one
or both branches of the nerve or elsewhere, which has the effect of
stimulating the vagus nerve as well. This may be accomplished
through afferents or efferents, for example.
[0022] It is also contemplated that direct or indirect unilateral
or bilateral stimulation applied at or by way of a
sub-diaphragmatic location of one or more of the other cranial
nerves of suitable sensory, motor or mixed fiber types may be
effective in treating compulsive overeating disorder, as an
alternative to vagus nerve stimulation.
[0023] Some differences may be observed from stimulator to
stimulator in magnitude of current in the pulses of the stimulation
signal, and may be attributable to things such as patient
impedance, variation of the vagus nerve from right to left or
between patients, and variation in contact between the vagus and
the electrode implanted thereon from implant to implant.
[0024] According to other aspects of treatment by stimulation of
the vagus or other suitable cranial nerve in the vicinity of the
patient's diaphragm, beneficial weight reduction is aided by
increased activity attributable to release of norepinephrine,
serotonin or other mechanisms, increased metabolism and change in
gastric motility. This therapy may also have beneficial effect in
treatment of other disorders such as type II diabetes, high blood
pressure and orthopedic problems which typically co-exist with
compulsive overeating disorder and obesity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The above and still further aims, objectives, aspects,
features and attendant advantages of the present invention will be
better understood from a consideration of the following detailed
description of a presently contemplated best mode of practicing the
invention, by reference to a preferred exemplary method and
embodiment thereof, taken in conjunction with the accompanying
Figures of drawing, in which:
[0026] FIG. 1 is a simplified partial front view of a patient (in
phantom) having an implanted neurostimulator for generating the
desired signal stimuli which are applied directly and bilaterally
at sub-diaphragmatic location to the right and left branches of the
patient's vagus via an implanted lead/nerve electrode system
electrically connected to the neurostimulator;
[0027] FIG. 2 is a simplified partial front view of a patient
similar to that of FIG. 1, but in which a pair of implanted
neurostimulators is used for generating the desired signal
stimuli;
[0028] FIG. 3 is a simplified partial front view of a patient in
which an implanted neurostimulator and associated electrode is used
for unilateral stimulation of only one branch of the vagus
nerve;
[0029] FIG. 4 is a simplified partial front view of a patient in
which the signal stimuli are applied at a portion of the nervous
system remote from the vagus nerve such as at or near the stomach
wall, for indirect stimulation of the vagus nerve; and
[0030] FIG. 5 is a simplified partial front view of a patient in
which the signal stimuli are applied remotely from electrical
stimulating device placed by an endoscope from an area composing
the GI tract.
DESCRIPTION OF THE PRESENTLY CONTEMPLATED BEST MODE
[0031] A generally suitable form of neurostimulator for use in the
apparatus and method of the present invention is disclosed, for
example, in U.S. Pat. No. 5,154,172, assigned to the same assignee
as the instant application (the device also referred to from time
to time herein as a NeuroCybernetic Prosthesis or NCP device (NCP
is a trademark of Cyberonics, Inc. of Houston, Tex., the
assignee)). Certain parameters of the electrical stimuli generated
by the neurostimulator are programmable, preferably by means of an
external programmer (not shown) in a conventional manner for
implantable electrical medical devices.
[0032] Referring to FIG. 1, the neurostimulator, identified in the
drawing by reference number 10 is implanted in a patient 12,
preferably in the abdominal region, for example, via a left
laparotomy incision. For the preferred implementation and method of
direct bilateral stimulation, lead-electrode pair 15, 16 is also
implanted during the procedure, and the proximal end(s) of the
lead(s) electrically connected to the neurostimulator. The
lead-electrode may be of a standard bipolar lead nerve electrode
type available from Cyberonics, Inc.
[0033] According to the preferred method of the invention, the
nerve electrodes 17, 18 are implanted on the right and left
branches 19, 20, respectively, of the patient's vagus nerve at a
sub-diaphragmatic location. The nerve electrodes are equipped with
tethers for maintaining each electrode in place without undue
stress on the coupling of the electrode onto the nerve itself.
Preferably, the sub-diaphragmatic location of this coupling is
approximately two to three inches below the patient's diaphragm 22
for each branch 19, 20.
[0034] Neurostimulator 10 generates electrical stimuli in the form
of electrical impulses according to a programmed regimen for
bilateral stimulation of the right and left branches of the vagus.
During the implant procedure, the physician checks the current
level of the pulsed signal to ascertain that the current is
adjusted to a magnitude at least slightly below the retching
threshold of the patient. Typically, if this level is programmed to
a value less than approximately 6 mA, the patient does not
experience retching attributable to VNS although variations may be
observed from patient to patient. In any event, the maximum
amplitude of the current should be adjusted accordingly until an
absence of retching is observed, with a suitable safety margin. The
retching threshold may change noticeably with time over a course of
days after implantation, so the level should be checked especially
in the first few days after implantation to determine whether any
adjustment is necessary to maintain an effective regimen.
[0035] The bilateral stimulation regimen of the VNS preferably
employs an intermittent pattern of a period in which a repeating
series of pulses is generated for stimulating the nerve, followed
by a period in which no pulses are generated. The on/off duty cycle
of these alternating periods of stimulation and no stimulation
preferably has a ratio in which the off time is approximately 1.8
times the length of the on time. Preferably also, the width of each
pulse is set to a value not greater than about 500 .mu.s, and the
pulse repetition frequency is programmed to be in a range of about
20 to 30 Hz. The electrical and timing parameters of the
stimulating signal used for VNS as described herein for the
preferred embodiment will be understood to be merely exemplary and
not as constituting limitations on the scope of the invention.
[0036] The patient's eating behavior should be allowed to stabilize
at approximately the preoperative level before the VNS regimen is
actually administered. Treatment applied in the form of chronic
intermittent bilateral nerve stimulation over each twenty-four hour
period may be observed initially to result in no change in eating
behavior of the patient. But after a period of several days of this
VNS regimen, a discernible loss of interest in heavy consumption of
food should occur. A typical result would be that mealtime
consumption tends to stretch over a considerably longer period of
time than that observed for the patient's preoperative behavior,
with smaller quantities of food intake separated by longer
intervals of no consumption in the course of a single meal. The VNS
treatment should not affect normal behavior in other aspects of the
patient's life. A complete suspension of the VNS regimen would
result in a relatively rapid return to the previous overeating
behavior, ending after resumption of the VNS regimen. Observations
appear to indicate that treatment by bilateral stimulation may be
safe and effective in changing eating patterns and behavior in
obese human patients, and more generally in human patients
suffering from compulsive overeating disorder.
[0037] Animal testing using bilateral VNS has tended to demonstrate
that slowed eating and apparent lack of enthusiasm in food
consumption is centrally mediated and the result of a positive
response of inducing a sensation of satiety mimicking that which
would occur after consumption of a full meal, rather than of a
negative response of nausea or sick stomach.
[0038] The intermittent aspect of the bilateral stimulation resides
in applying the stimuli according to a prescribed duty cycle. The
pulse signal is programmed to have a predetermined on-time in which
a train or series of electrical pulses of preset parameters is
applied to the vagus branches, followed by a predetermined
off-time. Nevertheless, continuous application of the electrical
pulse signal may also be effective in treating compulsive
overeating disorder.
[0039] Also, as shown in FIG. 2, dual implanted NCP devices 10a and
10b maybe used as the pulse generators, one supplying the right
vagus and the other the left vagus to provide the bilateral
stimulation. At least slightly different stimulation for each
branch may be effective as well. Use of implanted stimulators for
performing the method of the invention is preferred, but treatment
may conceivably be administered using external stimulation
equipment on an outpatient basis, albeit only somewhat less
confining than complete hospitalization. Implantation of one or
more neurostimulators, of course, allows the patient to be
completely ambulatory, so that normal daily routine activities
including on the job performance is unaffected.
[0040] The desired stimulation of the patient's vagus nerve may
also be achieved by performing unilateral sub-diaphragmatic
stimulation of either the left branch or the right branch of the
vagus nerve, as shown in FIG. 3. A single neurostimulator 10 is
implanted together with a lead 15 and associated nerve electrode
17. The nerve electrode 17 is implanted on either the right branch
19 or the left branch 20 of the nerve, preferably in a location in
a range of from about two to about three inches below the patient's
diaphragm 22. The electrical signal stimuli are the same as
described above.
[0041] In a technique illustrated in FIG. 4, the signal stimuli are
applied at a portion of the nervous system remote from the vagus
nerve such as at or near the stomach wall 25, for indirect
stimulation of the vagus nerve in the vicinity of the
sub-diaphragmatic location. Here, at least one signal generator 10
is implanted together with one or more electrodes 17 subsequently
operatively coupled to the generator via lead 15 for generating and
applying the electrical signal internally to a portion of the
patient's nervous system other than the vagus nerve, to provide
indirect stimulation of the vagus nerve in the vicinity of the
desired location. Alternatively, the electrical signal stimulus may
be applied non-invasively to a portion of the patient's nervous
system for indirect stimulation of the vagus nerve at a
sub-diaphragmatic location.
[0042] In an arrangement shown in FIG. 5, the signal stimuli are
applied remotely from electrical stimulating device 10 placed by an
endoscope 27 from an area composing the GI tract 30.
[0043] It is again noted that the principles of the invention may
be applicable to selected cranial nerves other than the vagus, to
achieve the desired results. It will thus be seen that a variety of
different techniques and arrangements may be employed to practice
the invention. Accordingly, although a presently contemplated best
mode and certain other modes of treating and controlling overeating
disorders to induce weight loss in the patient through a regimen of
cranial nerve, and more specifically vagus nerve, stimulation
either directly or indirectly at a sub-diaphragmatic location has
been described herein, variations and modifications may be made
within the scope of the present invention. It is therefore desired
that the invention be limited only as required by the following
claims and by the rules and principles of the applicable law.
* * * * *