U.S. patent application number 10/836924 was filed with the patent office on 2006-08-24 for method, system and device for treating disorders of the pelvic floor by electrical stimulation of the left and the right sacral nerves.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Martin T. Gerber.
Application Number | 20060190046 10/836924 |
Document ID | / |
Family ID | 46302018 |
Filed Date | 2006-08-24 |
United States Patent
Application |
20060190046 |
Kind Code |
A9 |
Gerber; Martin T. |
August 24, 2006 |
Method, system and device for treating disorders of the pelvic
floor by electrical stimulation of the left and the right sacral
nerves
Abstract
Described are implantable devices and methods for treating
various disorders of the pelvic floor by means of electrical
stimulation of the left and right sacral nerves, or portions
thereof. Two or more electrical stimulation regimes are applied on
a continuous, alternating, intermittent or other basis to the left
and right sacral nerves or nerve portions in an amount and manner
effective to treat a number of disorders, including, but not
limited to, urinary and/or fecal voiding dysfunctions such as
constipation, incontinence disorders such as urge frequency and
urinary retention disorders, sexual dysfunctions such as orgasmic
and erectile dysfunction, pelvic pain, prostatitis, prostatalgia
and prostatodynia.
Inventors: |
Gerber; Martin T.; (Maple
Grove, MN) |
Correspondence
Address: |
SHUMAKER & SIEFFERT, P. A.
8425 SEASONS PARKWAY
SUITE 105
ST. PAUL
MN
55125
US
|
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Prior
Publication: |
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Document Identifier |
Publication Date |
|
US 20050033372 A1 |
February 10, 2005 |
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Family ID: |
46302018 |
Appl. No.: |
10/836924 |
Filed: |
April 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10236578 |
Sep 6, 2002 |
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10836924 |
Apr 30, 2004 |
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10723316 |
Nov 26, 2003 |
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10836924 |
Apr 30, 2004 |
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10723903 |
Nov 26, 2003 |
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10836924 |
Apr 30, 2004 |
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10745757 |
Dec 23, 2003 |
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10836924 |
Apr 30, 2004 |
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60459077 |
Mar 31, 2003 |
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Current U.S.
Class: |
607/39 ; 607/40;
607/41 |
Current CPC
Class: |
A61N 1/0521 20130101;
A61N 1/0507 20130101; A61N 1/36071 20130101; A61N 1/0551 20130101;
A61N 1/36107 20130101; A61N 1/36007 20130101 |
Class at
Publication: |
607/039 ;
607/040; 607/041 |
International
Class: |
A61N 1/18 20060101
A61N001/18 |
Claims
1. A method of treating at least one diagnosed pelvic floor
disorder in a patient, the at least one disorder being selected
from the group consisting of urinary voiding dysfunction, fecal
voiding dysfunction, constipation, stress incontinence, urge
incontinence, urinary retention disorder, sexual dysfunction,
orgasmic dysfunction, erectile dysfunction, pelvic pain,
prostatitis, prostatalgia and prostatodynia, the method comprising:
providing an hermetically sealed implantable electrical pulse
generator configured to provide at least first and second
electrical stimulation pulse regimes via at least first and second
implantable medical electrical leads; providing the first
implantable medical electrical lead, the first lead being
configured for implantation adjacent a right sacral nerve or
branches or portions thereof, the first lead comprising proximal
and distal ends and at least a first electrode; providing the
second implantable medical electrical lead, the second lead being
configured for implantation adjacent a left sacral nerve or
branches or portions thereof, the second lead comprising proximal
and distal ends and at least a second electrode; implanting the
first lead in or near a first tissue volume of the patient
adjacent, around or in one of the left sacral nerve or branches or
portions thereof; implanting the second lead in or near a second
tissue volume of the patient adjacent, around or in one of the
right sacral nerve or branches or portions thereof; operably
connecting the proximal end of the first lead to the implantable
pulse generator; operably connecting the proximal end of the second
lead to the implantable pulse generator; implanting the implantable
pulse generator within the patient; and delivering, from the
implantable pulse generator, first electrical stimulation pulses to
or near at least portions of the first tissue volume through the
first lead and at least the first electrode, the first pulses being
provided in accordance with the first electrical stimulation pulse
regime; delivering, from the implantable pulse generator, second
electrical stimulation pulses to or near at least portions of the
second tissue volume through the second lead and at least the
second electrode, the second pulses being provided in accordance
with the second electrical stimulation pulse regime; wherein the
combination of the first and the second electrical pulse regimes
delivered through the first and second leads to or near at least
portions of the first and second tissue volumes provides to the
patient at least partial relief from the pelvic floor disorder.
2. The method of claim 1, wherein at least one of the first lead
and the second lead is selected from the group consisting of a
unipolar lead, a bipolar lead, a tri-polar lead, a quadrapolar
lead, and a multi-polar lead.
3. The method of claim 1, wherein at least one of the first lead
and the second lead is selected from the group consisting of a beam
steering lead comprising multiple electrodes and a lead comprising
multiple electrodes disposed in an areal pattern on a planar or
curved surface.
4. The method of claim 1, wherein at least one of the first lead
and the second lead is selected from the group consisting of a cuff
lead, a paddle lead, a tined lead, a lead having an active fixation
device or member disposed thereon, attached thereto or forming a
portion thereof.
5. The method of claim 1, wherein at least one of the first lead
and the second lead comprises a fixation mechanism selected from
the group consisting of a suture sleeve, a barb, a helical screw, a
hook and a tissue in-growth mechanism.
6. The method of claim 1, wherein at least one of the first lead
and the second lead further comprises one or more electrodes
configured to operate in conjunction with an electrically
conductive portion of the implantable pulse generator acting as an
indifferent electrode.
7. The method of claim 1, further comprising delivering electrical
pulses through a third tissue volume disposed near or between the
electrodes located on the first and second leads.
8. The method of claim 1, wherein the electrical stimulation pulses
that are delivered to the first and second tissue volumes cause
paresthesia, or the masking or blocking pain signals originating in
or carried by a desired or target nerve or nerve portion.
9. The method of claim 1, further comprising providing a lead
extension, operably connecting same between one of the proximal end
of the at least first lead and the proximal end of the at least
first lead, and the implantable pulse generator, and delivering the
electrical stimulation pulses through the lead extension.
10. The method of claim 1, wherein at least one of the first lead
and the second lead is selected from the group consisting of a lead
comprising a lead body less than about 5 mm in diameter, a lead
comprising a lead body less than about 1.5 mm in diameter, a lead
having a lead body comprising polyurethane or silicone, a lead
comprising electrical conductors disposed within the body thereof
and extending between the proximal and distal ends of the lead
wherein the conductors are formed of coiled, braided or stranded
wires, and a lead comprising at least one ring electrode, at least
one coiled electrode, at least one button electrode, at least one
electrode formed from a portion of wire, a cuff, a barb or a hook,
a spherically-shaped electrode, and a helically-shaped
electrode.
11. The method of claim 1, wherein an inter-electrode distance of
at least one of the first lead and the second lead is selected from
the group consisting of about 1 mm, about 2 mm, about 3 mm, about 4
mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,
about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm,
about 20 mm, about 25 mm, and about 30 mm.
12. The method of claim 1, wherein the at least one electrode of at
least one of the first lead and the second lead has an electrode
surface area ranging between about 1.0 sq. mm and about 100 sq. mm,
between about 2.0 sq. mm and about 50 sq. mm, or between about 4.0
sq. mm and about 25 sq. mm.
13. The method of claim 1, wherein the distance between the
proximal and distal ends of at least one of the first lead and the
second lead is selected from the group consisting of less than
about 4 inches, about 4 inches, about 6 inches, about 8 inches,
about 10 inches, about 12 inches, about 14 inches, about 16 inches
about 18 inches, about 20 inches and more than about 20 inches.
14. The method of claim 1, wherein the implantable pulse generator
comprises an electronic circuitry architecture selected from the
group consisting of a microprocessor-based architecture, a logic
architecture and a state machine architecture.
15. The method of claim 1, further comprising providing an external
programming unit and effecting telemetric communication between the
programming unit and the implantable pulse generator.
16. The method of claim 1, wherein the implantable pulse generator
further comprises at least one of a primary battery power source
and a secondary battery power source.
17. The method of claim 1, wherein the implantable pulse generator
is configurable so as to permit at least one of the frequency,
rate, amplitude, phase, width and morphology of the pulses
generated and delivered by the implantable pulse generator to be
varied programmably by a user.
18. The method of claim 1, wherein at least one of the first lead
and the second lead is configured for percutaneous introduction and
implantation within the patient.
19. The method of claim 1, wherein the implantable pulse generator
and at least one of the first lead and the second lead are capable
of generating and delivering electrical pulses having frequencies
ranging between about 50 Hz and about 100 Hz, between about 10 Hz
and about 250 Hz, and between about 0.5 Hz and about 500 Hz.
20. The method of claim 1, wherein the implantable pulse generator
and at least one of the first lead and the second lead are capable
of generating and delivering electrical pulses having amplitudes
ranging between about 1 Volt and about 10 Volts, between about 0.5
Volts and about 20 Volts, and between about 0.1 Volts and about 50
Volts.
21. The method of claim 1, wherein the implantable pulse generator
and at least one of the first lead and the second lead are capable
of generating and delivering electrical pulses having pulse widths
ranging between about 180 microseconds and about 450 microseconds,
between about 100 microseconds and about 1000 microseconds, and
between about 10 microseconds and about 5000 microseconds.
22. The method of claim 1, wherein the implantable pulse generator
and at least one of the first lead and the second lead are capable
of generating and delivering electrical pulses having varying
spatial or temporal phases.
23. The method of claim 1, further comprising delivering a drug to
the patient.
24. The method of claim 23, further comprising providing,
implanting and activating an implantable drug pump for providing
the drug to the patient.
25. The method of claim 1, wherein at least one of activation,
modification and termination of at least one of the first pulse
regime and the second pulse regime is carried out by the patient or
a health care giver.
26. The method of claim 25, wherein the at least one of activation,
modification and termination of at least one of the first pulse
regime and the second pulse regime is carried out in response to
patient symptoms appearing or disappearing, or the patient feeling
or not feeling symptoms
27. The method of claim 25, wherein patient or health care giver
activation, modification and/or termination of the first or second
pulse regime is accomplished through infra-red, telemetric, radio,
magnetic, or ultrasonic means.
28. The method of claim 1, wherein the first pulse regime is
delivered while delivery of the second pulse regime is initiated
later in response to a sensed physical parameter or symptom.
29. The method of claim 1, wherein the first and second pulse
regimes are initially delivered, and delivery of at least one of
the first and second pulse regimes is subsequently terminated or
modified.
30. The method of claim 1, wherein at least one of the first pulse
regime and the second pulse regime is one of activated, modified
and terminated in response to a physical parameter or symptom being
sensed.
31. The method of claim 30, wherein the physical parameter is
sensed using a sensor selected from the group consisting of a
bladder pressure sensor, a leak sensor, a volume sensor, a urinary
volume or pressure sensor, a urinary impedance sensor, a nerve
electrical signal sensor, and an electromyographic sensor.
31. The method of claim 1, further comprising delivering a drug to
the patient.
32. The method of claim 32, further comprising providing,
implanting and activating an implantable drug pump for providing
the drug to the patient.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of each of the
following U.S. patent applications, and claims priority and other
benefits from each such Application: (1) U.S. patent application
Ser. No. 10/236,578 to Gerber et al. entitled "Electrical and/or
Magnetic Stimulation Therapy for the Treatment of Prostatitis and
Prostatodynia" filed Sep. 6, 2002 and having Attorney Docket No.
P-1 0974; (2) U.S. patent application Ser. No. 10/723,316 to Gerber
et al. entitled "Method, System and Device for Treating Disorders
of the Pelvic Floor by Electrical Stimulation of the Pudendal
Nerves and Associated Nerves, and the Optional Delivery of Drugs in
Association Therewith" to Spinelli et al. filed Nov. 26, 2003 and
having Attorney Docket No. P-11358.00; (3) U.S. patent application
Ser. No. 10/723,903 to Gerber entitled "Method, System and Device
for Treating Various Disorders of the Pelvic Floor by Electrical
Stimulation of the Pudendal Nerves and the Sacral Nerves at
Different Sites" filed Nov. 26, 2003 and having Attorney Docket No.
P-11358.01; (4) U.S. patent application Ser. No. 10/745,757 to
Gerber et al. entitled "Method, System and Device for Treating
Various Disorders of the Pelvic Floor by Electrical Stimulation of
the Pudendal Nerves and the Sacral Nerves at Different Sites" to
Gerber filed Dec. 23, 2003 and having Attorney Docket No.
P-11358.02. This application hereby incorporates by reference
herein the foregoing '578, '316, '903 and '757 patent applications,
each in its respective entirety.
FIELD OF THE INVENTION
[0002] This invention relates to methods, systems and devices for
treating various disorders of the pelvic floor by delivering
electrical stimuli to the sacral nerves.
BACKGROUND
[0003] The medical device industry produces a wide variety of
electronic and mechanical devices for treating patient medical
conditions. Depending upon the medical condition, medical devices
may be surgically implanted or connected externally to a patient
receiving treatment. Clinicians use medical devices alone or in
combination with drug therapies and surgery to treat patient
medical conditions. For some medical conditions, medical devices
provide the best (and sometimes the only) therapy to restore an
individual to a more healthful condition and a fuller life.
Conditions that medical devices may effectively treat include
pelvic floor disorders.
[0004] Pelvic floor disorders adversely affect the health and
quality of life of millions of people. Pelvic floor disorders
include urinary control disorders such as urge incontinency, urge
frequency, voiding efficiency, fecal control disorders, sexual
dysfunction, and pelvic pain. Individuals with urinary control
disorders often face debilitating challenges in their everyday
lives. These individuals may be preoccupied with trips to the
bathroom, fears of embarrassment and sleepless nights. Some suffers
become so anxious that they become isolated and depressed. Pelvic
floor disorders may be treated with a variety of therapeutic
options such as behavior modification including biofeedback,
pharmacological treatment, mechanical intervention such as
self-catheterization, physical appliances such as diapers, and
surgical intervention. Surgical treatments are the most invasive
and are often considered after other therapies have proven
ineffective.
[0005] Urinary incontinence, or the inability to control the
passage of urine, is a relatively common problem. Although there
are a variety of different types of urinary incontinence, stress
incontinence, urge incontinence and urinary retention are the most
common.
[0006] Stress incontinence is the unacceptable passage of urine
under the stress of increased abdominal pressure. This increased
pressure typically results from coughing, sneezing, and Valsalva.
Stress incontinence is manifested urologically by normal
cystometry, obtuse urethral vesicular angle, abnormally low
urethral pressures and a physiologically short urethral length.
This disorder is most common in multiparous, post-menopausal
females. Physiologically, stress incontinence is a disorder of the
volitional muscular control of the urethral resistance to the flow
of urine. Laxity and partial denervation of the pelvic musculature
is the chief abnormality.
[0007] Urge incontinence is the involuntary passage of urine with a
concomitant sense of urgency. Systometry indicates detrusor
(bladder wall muscle) contractions with low bladder filling
pressures and volumes. These bladder contractions may not be
inhibited in the presence of voluntary EMG signals from the
sphincter, indicating reduction or loss of the
pudendal-parasympathetic inhibitory reflex. Unsolicited, premature
bladder contraction may result from mucosal irritation of varied
etiology. These premature contractions of the bladder may also be
the result of an abnormally high gain in the detrusor contractile
reflex due to the loss of inhibitory control with an
upper-motor-neuron lesion.
[0008] Urinary retention is characterized by the inability of a
patient to spontaneously and controllably urinate or void.
Catheterization of the urethra is provided to many patients
suffering from urinary retention, which is often a painful and
somewhat lengthy procedure having the added risk of causing
infection.
[0009] Constipation is a life-disturbing problem that afflicts
millions of Americans, from the very young to the elderly. Although
relatively rare among the young, it is a very common problem in
middle age, and is a nearly ubiquitous problem in the elderly.
Chronic constipation is a major problem for many individuals, and
frequently causes extreme discomfort to the afflicted. Such
discomfort may be a major obstacle to leading a normal life, and
may consume an enormous amount of the afflicted person's energy and
time.
[0010] Besides causing severe discomfort, chronic constipation may
also be harmful to the patient. For example, chronic constipation
may result in an intestinal obstruction that may cause the patient
great pain; or that may even cause the patient's death, unless
surgically corrected. Chronic constipation may also prevent the
patient from receiving the benefit of certain needed prescription
medications, because the medications may have undesirable side
effects on an already constipated gut.
[0011] Conventional therapies for chronic constipation are often
distasteful and unpleasant at best, since they may involve
treatments such as repeated consumption of large quantities of
laxatives, repetitive use of enemas, or both. Repeatedly consuming
large quantities of laxatives may be harmful to the patient, since
they may result in dehydration or even renal failure. The
repetitive use of enemas may be harmful since they may irritate or
physically harm the treated portion of the patient's gut.
[0012] Chronic constipation is usually thought of in association
with problems of the large intestine. Other parts of the patient's
gut, however, may also exhibit chronic constipation-like problems,
such as the esophagus, the stomach, and less frequently, the small
intestine. Problems associated with chronic constipation may
include depressed motility of the esophagus, stomach or small
intestine. For simplicity, chronic constipation, or chronic
constipation-like problems, of any portion of the patient's gut
from the esophagus to the anus will be referred to hereafter as
simply "constipation".
[0013] The prostate is a glandular and fibromuscular organ in the
male, which lies immediately below the bladder and surrounds the
urethra. Prostatitis, the third leading disease of the prostate, is
a common urologic condition that many clinicians find difficult to
treat effectively.
[0014] The main symptom of chronic prostatitis (category III) is
pain, followed by variable voiding (urgency/frequency) and erectile
or sexual dysfunction. Patients have symptoms such as painful
ejaculation or pain in the penis, testicles, or scrotum; low back,
rectal or perineal pain; pain along the inner aspects of the
thighs; irritative or obstructive urinary symptoms; and decreased
libido or impotence. As a rule, chronic non-bacterial prostatitis
patients do not have recurrent urinary tract infections.
[0015] Chronic prostatitis is a major male health issue. The
average urologist in the U.S. sees 173 prostatitis patients per
year, of which one-third are newly diagnosed. The prevalence of
prostatitis in the general male population is estimated to be
5-8.8%, and it has been estimated that about 2 million office
visits per year are related to prostatitis. Self-reported histories
of prostatitis are as prevalent as 16% of all reported cases.
Patients with chronic prostatitis experience a negative impact on
quality of life comparable to patients with unstable angina, recent
myocardial infarction or active Crohn's disease. The average age of
the prostatitis population is estimated at 50 years. Prostatitis is
the most common urologic diagnosis in men under 50 years old and
the third most common in men over 50 years old. The most common
classification of prostatitis is chronic prostatitis/chronic pelvic
pain syndrome (category ll), which may include as many as 90% of
all patients who meet the criteria of the condition.
[0016] Despite the widespread prevalence of prostatitis, the
diagnosis of chronic prostatitis represents a particular challenge
since its diagnosis is often based on exclusion. Prostatitis
remains poorly understood despite its prevalence because it
encompasses multiple diverse disorders that cause symptoms related
to the prostate gland. The etiology of acute and chronic bacterial
prostatitis is clearly defined, and is a result of pathogenic
bacteria that may cause systemic symptoms or urinary tract
infections. On the other hand, chronic prostatitis/chronic pelvic
pain syndrome does not have a clearly defined etiology, and there
are many theories about the cause of this disease.
[0017] Perhaps the most comprehensive or encompassing theory of
chronic non-bacterial prostatitis is one which advocates a
multifactorial mechanism initiated by a stimulus such as infection
or trauma. An interrelated cascade of events may follow, including
physical, chemical, immunologic or neurogenic components, resulting
in a local response of inflammation and/or neurogenic injury.
[0018] In the absence of consistent or clear etiologies for chronic
prostatitis/chronic pelvic pain syndrome, improvement in quality of
life and a reduction in symptoms are the usual goals of therapy.
The most common treatment for chronic prostatitis involves
pharmacologic treatments such as antibiotics, anti-inflammatory
agents, alpha blockers, anti-spasmodics, analgesics, allopurinol,
and muscle relaxants. Alpha blockers have successfully treated
symptoms of prostatitis, although adverse event rates have been
high. Muscle relaxants have shown significant improvement in small
studies for category IIIB patients with sphincter dyssynergia or
muscle spasm. Anti-inflammatory agents, such as pentosan
polysulfate, have proven successful for approximately 40% of
patients with category IIIA prostatitis.
[0019] Phytotherapeutic agents have demonstrated improvements in
small studies for pain and irritative voiding. Other treatments
include physiotherapy (such as biofeedback and pelvic muscle
exercises) and various modalities of invasive and minimally
invasive procedures (e.g., transurethral microwave therapy,
transurethral incision of the bladder neck, hydrodistensions,
acupuncture, electroneuromodulation, balloon dilation, YAG laser
therapy and heat therapy). Repetitive prostatic massage is a
popular treatment method due to the failure of consistent standard
medical therapy to treat the condition. Lifestyle changes, such as
meditation, discontinuation of bike riding, sitz-baths, dietary
changes and chiropractic therapy, are often prescribed.
[0020] As a result of unknown etiology, unsure diagnosis and
treatment options that are often myriad and ineffective, chronic
prostatitis is a "diagnosis of exclusion" and has a poor record of
treatment success. Accordingly, the present invention is intended
to provide solutions to the foregoing problems through improved and
more effective methods of treating pain and other symptoms
associated with chronic prostatitis, prostatalgia and
prostatodynia.
[0021] Sexual dysfunction comprises a broad range of maladies,
including erectile dysfunction, orgasmic dysfunction, premature
ejaculation and lack of lubrication. Sexual dysfunctions plague
both women and men, and may be life-long or acquired. To treat
impotence (also called erectile dysfunction), electrical conductors
may be implanted near the surface of the pelvic splanchnic nerve.
Stimulation of this nerve with low voltage electrical pulses is
believed to cause arterioles dilation and initiate erection. Also,
it is known that implantation of an electrode on the cavernous
nerves of a male, adjacent to his prostate gland, may also cause
penile erection. Further, other electrical impulse devices exist
that are not implanted but instead apply electrical stimuli
topically to the coccyx region to promote sexual excitation.
Impotence, however, should not be confused with orgasmic
dysfunction, where satisfactory erection may be obtained but there
is an absence of orgasm.
[0022] Current treatment of orgasmic dysfunction concentrates on
the psychological components of the disorder rather than the
physiological components. Orgasmic dysfunction is a physical malady
that results in marked distress and interpersonal difficulty. The
physical disorder causes psychological performance anxiety and
pressure. Sexual desire and frequency usually decline. The
patient's intimate relationships usually suffer from resentment and
conflict. There is anecdotal evidence of patients who have
experienced mild sensations in the genitalia while undergoing
spinal cord stimulation for pain relief.
[0023] Spinal cord stimulation, on the other hand, has been used as
a treatment for chronic painful conditions for approximately thirty
years. Commonly, spinal cord stimulation is used to alleviate pain
after failed surgery, pain due to neuropathies, or pain due to
inadequate blood flow. Neurostimulation systems have been found to
relieve chronic, intractable pain in the limbs or trunk.
[0024] The basic concept of neurostimulation as it relates to pain
relief involves the substitution of sensations that reach the
thalamus of the brain. Rather than a pain message, the spinal cord
stimulation closes the gate in the spinal cord and replaces the
pain sensation with a tingling sensation. Electrodes are positioned
effectively to create paresthesia in the painful area. Paresthesia
refers to a change in sensation in an area of the body. Usually
paresthesia is used to show change in neurologic function caused by
damage to a nerve or nerves. Paresthesia is usually not an absence
of sensation, but a decrease or alteration of sensation. Patients
have described paresthesia as a "buzzing sensation."
[0025] Paresthesia is accomplished through the implantation of
stimulating electrodes within or near the spinal cord. The
electrodes are inserted between the vertebrae in parallel with the
spinal cord. Low-voltage electrical stimulation is precisely
applied to the spinal cord. Through direct stimulation of the
dorsal column or the targeted peripheral nerve, the sensation of
pain is replaced by a more pleasant "tingling" sensation. The
sensation may be adjusted in terms of amplitude to control
intensity and pulse width to control duration and frequency.
Usually such neurostimulation systems are implantable. Medtronic
Neurological, a division of Medtronic, Inc. of Minneapolis,
Minnesota, sells a neurostimulator system used for pain relief. The
device has been approved by the Federal Drug Administration for
implantation in the spinal cord to alleviate pain.
[0026] One surgical technique to treat urinary control disorders is
the implantable InterStim.RTM. therapy, available from Medtronic,
Inc., which applies mild electrical stimulation to the sacral
nerves in the lower region of the spine to influence the behavior
of structures such as the bladder, sphincter and pelvic floor
muscles. Generally, implantation of the InterStim system involves
surgically implanting a stimulation lead near the sacral nerves.
The stimulation lead is a very small, insulated, electrical
conductor with electrical stimulation contacts on the distal end
for implantation near the sacral nerves and an electrical connector
on the proximal end of the lead. The lead electrical connector is
typically connected to a small extension, and the extension is
connected to a small neurostimulator that operates in a fashion
broadly similar to that of a cardiac pacemaker by delivering
occasional small electrical pulses that sometimes create a tingling
sensation felt by the patient. The stimulation lead, lead extension
and neurostimulator are all implanted in the patient in a manner
that is typically not perceptible by others. InterStim therapy may
improve the condition of a pelvic floor disorder patient and allow
the patient to lead a full life. InterStim therapy is also
nondestructive and reversible.
[0027] Each year thousands of patients have sacral nerve
stimulation systems implanted within them for the treatment of
urinary incontinence and urinary retention. Therapy success is
determined through the evaluation of symptoms related to the
disorder. Clinical success for most therapies, including sacral
nerve stimulation, is defined as a 50% decrease in the following
symptoms:
[0028] Urge incontinence as measured by: [0029] Average number of
incontinent episodes per day, or [0030] Average severity ranking of
incontinent episodes, or [0031] Average number of absorbent pads or
diapers replaced due to incontinence.
[0032] Urinary frequency and urgency as measured by: [0033] Average
number of voids per day, or [0034] Average voided volume per void,
or [0035] Average degree of urgency prior to voiding.
[0036] Urinary retention as measured by: [0037] Decrease in
post-void urine residual, or [0038] Average number of
catheterizations consisting of .gtoreq.100 ml of urine, or [0039]
Average catheter volume per catheterisation (post-void
residual).
[0040] Today, electrical stimulation of the sacral nerve is fairly
common for the purpose of treating voiding dysfunction. Although
the majority of patients receiving sacral nerve stimulation obtain
satisfactory relief of their voiding dysfunction, some patients
(less than 50%) do not experience adequate relief from sacral nerve
stimulation techniques or desire to obtain better results from the
therapy.
[0041] Electrical stimulation delivered by an intravaginal or a
perineal surface electrode has been shown to inhibit premature and
inappropriate detrusor contractions. The mechanism for such effects
appears to derive from the electrical stimulation of pudendal nerve
afferents (sensory receptors or sensory nerve fibers). Input into
the pudendal afferent system inhibits a parasympathetic reflex loop
consisting of bladder wall afferents (sensory reflexes) and
efferents (motor reflexes). This parasympathetic loop normally
senses a distension of the bladder via the afferent limb and
responds by sending an efferent signal to contract the bladder.
Although such stimulation has shown therapeutic effects, electrode
placement and on-going stimulation do not lend themselves easily to
chronic stimulation.
[0042] Stimulation of the pudendal nerve as an alternative to
sacral nerve stimulation has been proposed in past. The
invasiveness of the surgical procedure for implanting electrical
stimulation leads and other reasons have made stimulation of the
pudendal nerve impractical, however. Since the pudendal nerve
directly innervates much of the pelvic floor, it is believed to be
a more optimal stimulation site with few undesired side effects.
Advancements in minimally invasive lead placement techniques along
with advancement in lead anchoring techniques have resulted in the
increased viability of chronic stimulation of the pudendal
nerve.
[0043] Some prior art publications relating to various embodiments
of the present invention are listed in Table 1 below.
TABLE-US-00001 TABLE 1 Prior Art Publications Juenemann et al.,
"Clinical Significance of Sacral and Pudendal Nerve Anatomy," The
Journal of Urology, Vol. 139, pp. 74-80 (January, 1988). Schmidt,
Richard A., "Technique of Pudendal Nerve Localization for Block or
Stimulation," The Journal of Urology, Vol. 142 (December, 1989).
U.S. Pat. No. Pat. No. 4,406,288 to Cash for "Bladder Control
Device and Method" U.S. Pat. No. Pat. No. 4,607,639 to Tanagho et
al. for "Method and System for Controlling Bladder Evacuation."
U.S. Pat. No. Pat. No. 4,771,779 to Tanagho et al. for "System for
Controlling Bladder Evacuation." U.S. Pat. No. Pat. No. 4,739,764
to Lue et al. for "Method for Stimulating Pelvic Floor Muscles for
Regulating Pelvic Viscera." U.S. Pat. No. Pat. No. 4,881,526 to
Johnson et al. for "Intravaginal Electrode and Stimulation System
for Controlling Female Urinary Incontinence" U.S. Pat. No. Pat. No.
5,425,751 to Baeten et al. for "Method and Apparatus for Optimum
Positioning of a Muscle Stimulating Implant" U.S. Pat. No. Pat. No.
5,540,730 to Terry, Jr. et al. for "Treatment of Motility Disorders
by Nerve Stimulation" U.S. Pat. No. Pat. No. 5,984,854 to Ishikawa
et al. for "Method for Treating Urinary Incontinence and Apparatus
Therefor" U.S. Pat. No. Pat. No. 6,055,456 to Gerber for "Single
and Multi- Polar Implantable Lead for Sacral Nerve Stimulation"
U.S. Pat. No. Pat. No. 6,366,814 to Boveja. for "Electrical
Stimulation Adjunct (Add-On) Therapy for Urinary Incontinence and
Urological Disorders Using an External Stimulator" U.S. Pat. No.
Pat. No. 6,449,512 to Boveja. for "Apparatus and Method for
Treatment of Urological Disorders Using Programmerless Implantable
Pulse Generator System" U.S. Pat. No. Pat. No. 6,587,719 to Barrett
et al. for "Treatment of Obesity by Bilateral Vagus Nerve
Stimulation" U.S. Pat. No. Pat. No. 6,609,025 to Barrett et al. for
"Treatment of Obesity by Bilateral Sub-Diaphragmatic Nerve
Stimulation" U.S. Pat. No. Patent Application Publication No.
2002/0055761 to Mann et al. for "Implantable Stimulator Systems and
Methods for Treatment of Incontinence and Pain" U.S. Pat. No.
Patent Application Publication No. 2002/0055779 to Andrews for
"Neural Prosthesis" PCT Patent Application WO 02/078592 to Grill et
al. for "Systems and Methods for Selectively Stimulating Components
In, On or Near the Pudendal Nerve or Its Branches to Achieve
Selective Physiologic Responses" European Patent Application No. 0
245 547 to Tanagho et al. for "Electronic Control System for
Controlling Pelvic Viscera via Neuro- Electrical Stimulation."
[0044] All patents and technical papers listed in Table 1
hereinabove are hereby incorporated by reference herein, each in
its respective entirety. As those of ordinary skill in the art will
appreciate readily upon reading the Summary of the Invention,
Detailed Description of the Preferred Embodiments and Claims set
forth below, at least some of the devices and methods disclosed in
the patents and publications of Table 1 may be modified
advantageously in accordance with the teachings of the present
invention. The foregoing and other objects, features and
advantages, which will now become more readily apparent by
referring to the following specification, drawings and claims, are
provided by the various embodiments of the present invention.
SUMMARY OF THE INVENTION
[0045] Simultaneous, concurrent or sequential electrical
stimulation of the left and right sacral nerves or nerve portions
has been discovered to provide a means of more directly or
effectively treating various pelvic floor disorders than has been
possible heretofore through means of employing conventional
therapeutic techniques. Various combinations and permutations of
sacral nerve or nerve portion electrical stimulation provide
particularly efficacious means of delivering therapies for a number
of different pelvic floor disorders.
[0046] It has been discovered that electrical stimulation of the
left and right sacral nerves, and/or portions thereof provides
beneficial effects and therapies for various disorders of the
pelvic floor over a wider anatomical region than merely
electrically stimulating the pudendal or sacral nerves or portions
thereof, or than may be attained through conventional sacral nerve
stimulation. Because the present invention provides for more
targeted electrical stimulation of the pelvic floor or portions
thereof, at least some of the undesirable side effects of sacral
nerve stimulation may be avoided or minimized.
[0047] Two or more electrical stimulation signals are applied to
appropriate portions of a patient's pelvic floor and the sacral
nerves or nerve portions in an amount and manner effective to treat
a number of disorders, including, but not limited to, urinary
and/or fecal voiding dysfunctions such as constipation,
incontinence disorders such as urge frequency and urinary retention
disorders, sexual dysfunctions such as orgasmic and erectile
dysfunction, pelvic pain, prostatitis, prostatalgia and
prostatodynia. Electrical stimulation parameters and drug type and
dosage are tailored to deliver the most efficacious therapy for a
given malady.
[0048] The two electrical stimulation signals are applied by one or
more IMDs that each have at least one medical electrical lead
positionable, secured or attached to or in a patient's pelvic floor
and in proximity to a sacral nerve or nerve portion. Each such lead
carries at least one electrode, and preferably at least two
electrodes, positionable or attachable for contact with or in
proximity to the patient's sacral nerves or nerve portions.
[0049] Various embodiments of the present invention are capable of
providing one or more solutions to one or more problems existing in
the prior art respecting conventional treatment for urinary and/or
fecal voiding dysfunctions such as constipation, incontinence
disorders such as urge frequency and urinary retention disorders,
sexual dysfunctions such as orgasmic and erectile dysfunction,
pelvic pain, prostatitis, prostatalgia and prostatodynia.
[0050] Such problems include, but are not limited to, one or more
of: (a) sequelae or side-effects resulting from the oral
administration of pharmaceutical products; (b) the requirement to
purchase expensive pharmaceutical products on an on-going basis;
(c) not having the ability to terminate or change instantaneously
administration of pharmaceutical therapy; (d) not having the
ability to target with a great deal of precision or specificity the
ailment in question using orally delivered pharmaceutical products;
(e) in the case of electrical stimulation, not having a
well-defined or reliable method of determining stimulation
electrode placement; (f) patients having chronic and essentially
untreatable pain having no effective pain relief therapy available
for use; (g) patients having to wear diapers, pads or other devices
for containing human waste, and/or (f) conventional sacral nerve
stimulation techniques being incapable of providing the desired
relief or therapy in many patients.
[0051] Various embodiments of the present invention are capable of
providing one or more advantages, which may include, but are not
necessarily limited to: (a) targeting the delivery of therapies
with a high degree of specificity; (b) having the ability to change
the therapy delivered on-demand or instantaneously; (c) lowering
medical care costs in respect of pharmaceutical products; (d)
having the potential to delivery superior therapy; (e) permitting
stimulation lead implantation surgical procedures to be completed
more quickly; (f) reducing trauma or damage to a patient's pelvic
floor anatomy; and/or (g) improved physical and electrical coupling
of one or more stimulation electrodes to a pertinent sacral nerve
or nerve portion.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0052] These and other features and advantages of the present
invention will be more readily understood by referring to the
following detailed description of the preferred embodiments
thereof, when considered in conjunction with the drawings, in which
like reference numerals indicate identical structures throughout
the several views when appropriate. Note that the drawings are not
necessarily to scale.
[0053] FIG. 1 shows one embodiment of the present invention, where
INS 10 is a combination implantable pulse generator and drug pump
implanted in an upper buttock position in a patient, lead 18 is
implanted near or adjacent to pudendal nerve or nerve portion 26,
and drug delivery catheter 300 is implanted near or adjacent to
sacral nerve or nerve portion 25, to thereby effect therapeutic
relief;
[0054] FIG. 2 shows a block diagram illustrating some of the
constituent components of INS 10 in accordance with one embodiment
of the present invention illustrated in FIG. 1;
[0055] FIG. 3 shows a simplified anatomical view of portions of the
pelvic floor of a human patient, the locations of sacral and
associated nerves therein, and illustrative positionings of INS 10,
drug pump or delivery device 310, electrical stimulation lead 16
and corresponding electrodes 20-23, and drug delivery catheter
300;
[0056] FIG. 4 shows a simplified anatomical view of the pelvic
floor of a female human patient, the locations of the left and
right pudendal nerves 26 and 27 and associated nerves therein, the
positioning of drug pump or delivery device 310, and the
positioning of drug delivery catheters 300 and 301 such that the
distal portions thereof are located near left and right pudendal
nerves 26 and 27;
[0057] FIG. 5 shows a simplified male anatomical view of the pelvic
floor and the locations of the pudendal, sacral and associated
nerves therein;
[0058] FIG. 6 shows a simplified anatomical view of the pelvic
floor of a female human patient, the locations of the sacral nerves
25 and associated nerves therein, the positioning of drug pump or
delivery device 310, and the positioning of drug delivery catheter
300 such that the distal portion thereof is located near one or
more sacral nerves or nerve portions 25;
[0059] FIG. 7 shows a simplified anatomical view of portions of the
pelvic floor of a male human patient, the locations of pudendal and
associated nerves 26, the locations of sacral and associated nerves
25, and illustrative positionings of INS 10, electrical stimulation
lead 16 and corresponding electrodes 20-23, drug pump or delivery
device 310, and drug delivery catheter 300;
[0060] FIGS. 8A through 8E show various embodiments of the distal
end of leads 16 and 18 of the present invention;
[0061] FIG. 9 shows a flow diagram according to one embodiment of a
method of the present invention for electrically stimulating at
least one of the pudendal and sacral nerves, in combination with
delivering one or more drugs to at least one of a sacral nerve 25
and a pudendal nerve 26, associated nerves or portions thereof;
[0062] FIGS. 10A through 10F show various embodiments of first and
second electrical stimulation pulse regimes of the present
invention; and
[0063] FIGS. 11A through 11G show various embodiments of first and
second electrical stimulation pulse regimes and first and second
drug delivery regimes of the present invention.
DETAILED DESCRIPTIONS OF THE PREFERRED EMBODIMENTS
[0064] In the following description of the preferred embodiments,
reference is made to the accompanying drawings that form a part
hereof, and in which are shown by way of illustration several
specific embodiments of the invention. It is to be understood that
other embodiments of the present invention are contemplated and may
be made without departing from the scope or spirit of the present
invention. The following detailed description, therefore, is not to
be taken in a limiting sense. Instead, the scope of the present
invention is to be defined in accordance with the appended claims.
As employed herein, the term "sacral nerve 25" means any one of the
sacral nerves, portions of the sacral nerve(s), nerves
neurologically connected to any one of the sacral nerves and in
relatively close physical proximity thereto, and extensions or
branches of any one of the sacral nerves. As employed herein, the
term "pudendal nerve 26" means the pudendal nerve itself, portions
of the pudendal nerve, nerves neurologically connected to the
pudendal nerve and in relatively close physical proximity thereto,
and extensions or branches of the pudendal nerve. Additionally, the
term "INS 10" as employed herein is not necessarily limited to
meaning an "implantable neurological stimulator" only, but may also
mean, depending upon the context in which it is used, a combination
implantable neurological stimulator and drug pump or drug delivery
device.
[0065] Augmentation of sacral nerve stimulation with pudendal nerve
stimulation and/or targeted drug delivery to a target tissue volume
is capable of providing certain advantages and may help the patient
achieve better clinical outcomes. For example, the nerve integrity
of some patients may be compromised due to the progression of a
neurological disease such as multiple sclerosis or Parkinson's
disease. Other patients may have compromised nerves due to injury
caused by obstetrics or accidents. In the case of a compromised
neurological system in the pelvic floor, signal conduction may be a
major issue and a factor in their incontinence. Because the pelvic
floor is innervated by nerve fibers from each of the sacral nerves,
stimulation of a single sacral nerve does not always give adequate
or full relief of the patient's incontinence.
[0066] Stimulation of and/or drug delivery to both the sacral nerve
and the pudendal nerve provides broader electrical stimulation and
drug infusion patterns covering more of the pelvic floor and may
result in additional relief of the incontinence symptoms. In
addition to the sacral nerves, the pudendal and other nerves
described herein are good sites to stimulate and/or deliver drugs
to because they innervate much of the pelvic floor, including the
urinary sphincters.
[0067] The sacral nerves innervate the pelvic floor and the legs
and feet. Stimulation of the sacral nerve results in stimulation of
both the pelvic floor and the leg and foot. One issue that many
sacral nerve stimulation patients experience is an annoying
stimulation of the leg and/or foot, which at times may be mitigated
through reducing the stimulation level on the sacral nerve. An
advantage to stimulating both the sacral nerve and the pudendal
nerve is that lower stimulation levels may be used to achieve the
same or better therapeutic results which may eliminate the annoying
stimulation of the leg and/or foot. The lower stimulation levels
can result in less sensory stimulation and in the patient being
less aware of the presence of the stimulation. An additional
advantage is that lower electrical stimulation levels increase the
life of the battery powering the implanted pulse generator.
[0068] According to one embodiment of the present invention,
electrical innervation of and/or drug delivery to the sacral nerves
and/or the pudendal nerves is lateralized. That is, electrical
stimulation of and/or drug delivery to the sacral and/or pudendal
nerves occurs on opposite sides. For example, the sacral nerve may
be electrically stimulated on the left side while a drug is
delivered to the pudendal nerve on the right side. The amount and
degree of nerve laterilization is preferably determined by looking
to factors such as nerve EMG response, anatomical access, physician
preference and patient preference.
[0069] FIG. 1 shows one embodiment of the present invention, where
INS 10 is a combination implantable pulse generator and drug pump
implanted in an upper buttock position in a patient, lead 18 is
implanted near or adjacent to pudendal nerve or nerve portion 26,
and drug delivery catheter 300 is implanted near or adjacent to
sacral nerve or nerve portion 25, to thereby effect therapeutic
relief. Hermetically sealed enclosure 14 is preferably formed of a
biocompatible material such as an appropriate metal alloy
containing titanium. In addition to housing circuitry for effecting
electrical stimulation of the pelvic floor, INS 10 of FIG. 1 also
contains circuitry and mechanisms for holding one or more drugs in
a reservoir and delivering such drugs to a target tissue volume via
drug catheter 300.
[0070] FIG. 1 shows the distal end of lead 18 implanted near or
adjacent to pudendal nerve or nerve portion 26, and the distal end
of drug catheter 300 implanted near or adjacent to sacral nerve 25
or a sacral nerve portion, to thereby effect therapeutic relief.
Note, however, that INS 10 may be implanted in any appropriate
location in the patient, such as in the abdomen or side. Note
further that the positions of the distal ends of catheter 300 and
lead 18 may be exchanged such that a drug is delivered in close
proximity to pudendal nerve or nerve portion 26 while sacral nerve
25 is electrically stimulated.
[0071] Relief is effected by INS 10 and lead 18 as a result of
electrical stimulation signals being delivered to or near sacral
nerve 25 or nerve portion 8 by electrodes 40-43, and to or near
pudendal nerve 26 or nerve portion 8 by electrodes 40-43, as well
as by one or more drugs being delivered to the distal end of
catheter 300, the target tissue volume in proximity to the distal
end of drug catheter 300 being infused with such drugs through the
action of the drug pump component of INS 10/drug pump 314.
[0072] One, two, three, four or more electrodes 40, 41, 42 and 43
may be disposed at the distal end of lead 18. FIG. 1 shows four
electrodes located at the distal end of lead 18 near pudendal nerve
26. Other lead locations, electrode configurations and lead
configurations are possible and contemplated in the present
invention.
[0073] Drug catheter 300 may possess more than one port at or near
the distal end thereof for the infusion of drugs into a tissue
volume in proximity to such port. Indeed, such ports may be
disposed anywhere along the length of catheter 300 according to the
requirements at hand and the disease being treated. Drug catheter
300 may be formed from any of many different, well-known, suitable
biocompatible materials, such polyurethane, and may contain one,
two, three or more lumens disposed therewithin for carrying drugs
to the ports and catheter locations associated therewith.
[0074] In one embodiment of the present invention, lead 18 provides
electrical stimulation pulses to the desired nerve target site or
portion 26 and thereby stimulates the target nerve or nerve portion
located in the vicinity of the electrode(s) thereof. Lead 18 may
have unipolar electrodes disposed thereon (where enclosure 14 is
employed as an indifferent electrode) or may have bipolar
electrodes disposed thereon, where one or more electrodes disposed
on a lead are employed as the indifferent electrode. In one
embodiment of the present invention, Lead 18 extends from lead
connector 13, which in turn forms an integral portion of lead
extension 15 connected at its proximal end to connector header
module 12.
[0075] Typically, catheter 300 and lead 18 are tunneled
subcutaneously between the location of INS 10 and the location or
site of the nerve or nerve portion 26 that is to be stimulated. INS
10 is typically implanted in a subcutaneous pocket formed beneath
the patient's skin according to methods well known in the art.
Further details concerning various methods of implanting INS 10 and
lead and 18 are disclosed in the Medtronic Interstim Therapy
Reference Guide published in 1999, the entirety of which is hereby
incorporated by reference herein. Other known methods of implanting
and locating catheter 300 and lead 18 are of course contemplated in
the present invention.
[0076] Some representative examples of lead 18 include MEDTRONIC
nerve stimulation lead model numbers 3080, 3086, 3092, 3487, 3966
and 4350 as described in the MEDTRONIC Instruction for Use Manuals
thereof, all hereby incorporated by reference herein, each in its
respective entirety. Some representative examples of INS 10 include
MEDTRONIC implantable electrical stimulator model numbers 3023,
7424, 7425 and 7427 as described in the Instructions for Use
Manuals thereof, all hereby incorporated by reference herein, each
in its respective entirety. INS 10 may also be constructed or
operate in accordance with at least some portions of the
implantable stimulators disclosed in U.S. Pat. No. 5,199,428 to
Obel et al., U.S. Pat. No. 5,207,218 to Carpentier et al. or U.S.
Pat. No. 5,330,507 to Schwartz, all of which are hereby
incorporated by reference herein, each in its respective
entirety.
[0077] U.S. patent application Ser. No. 10/004,732 entitled
"Implantable Medical Electrical Stimulation Lead Fixation Method
and Apparatus" and Ser. No. 09/713,598 entitled "Minimally Invasive
Apparatus for Implanting a Sacral Stimulation Lead " to Mamo et
al., the respective entireties of which are hereby incorporated by
reference herein, describe methods of percutaneously introducing
lead 18 to a desired nerve stimulation site in a patient.
[0078] Certain aspects of the subject matter described in U.S.
Provisional patent application Ser. No. 60/459,077 entitled
"Method, System and Device for Treating Disorders of the Pelvic
Floor by means of Electrical Stimulation of the Pudendal and
Associated Nerves, and the Optional Delivery of Drugs in
association", the entirety of which is hereby incorporated by
reference herein, where various methods of positioning and
implanting a medical electrical lead 18 so as to provide optimal
stimulation of the pudendal nerve 26 or a portion thereof, may be
adapted for use in conjunction with at least some embodiments of
the present invention.
[0079] FIG. 2 shows a block diagram illustrating some of the
constituent components of INS 10 in accordance with one embodiment
of the present invention, where INS 10 is a combined implantable
electrical stimulator and drug pump having a microprocessor- or
controller-based architecture. Other architectures of INS 10 are of
course contemplated in the present invention, such as the logic or
state machine architecture employed in the Medtronic Model Number
3023 INS. For the sake of convenience, INS 10 in FIG. 2 is shown
with one catheter 300 and one 18 connected thereto; similar
circuitry and connections not shown in FIG. 2 apply generally to
other possible additional leads and catheters not shown in the
drawings.
[0080] INS 10 may be an open-loop non-feedback-control system, or a
closed-loop feedback control system. In the case of a closed-loop
feedback control embodiment of the present invention, FIG. 2 shows
optional input amplifier 97 connected to sensing electrodes 45 and
46 through capacitor 99. Similarly, feedback sensors may be
employed to control the delivery of drugs to the patient from drug
pump portion 313.
[0081] In the embodiment of the present invention shown in FIG. 2,
drug pump portion 313 in FIG. 2 comprises drug reservoir 302,
safety valve 303 and pump 304. The proximal end of outlet catheter
300 is connected to drug pump 304. Outlet catheter 300 has a
discharge port located at the distal end thereof, which is located
in proximity to a tissue volume intended to be treated with the
drug disposed in reservoir 302. In accordance with well-known
methods and devices known in the art, needle 306 is employed to
refill reservoir 302 through an inlet port connected to reservoir
302. Note that drug pump portion 313 may contain multiple
reservoirs, safety valves, pumps, and outlet catheters. Digital
controller/timer circuit 74 and micro-computer circuit 58 control
the operation of drug pump portion 313, most preferably according
to particularized instructions programmed within micro-computer
circuit 58 by a health care provider. In some embodiments of the
present invention, one or more drugs are dispensed through catheter
300 upon receiving a patient-activated command. Micro-computer 58
is preferably programmed by a health care provider to lock out
patient-activated commands that occur during periods of time when
drugs should not be dispensed.
[0082] INS 10 in FIG. 2 is most preferably programmable by means of
external programming unit 11. One such programmer is the
commercially available Medtronic Model No. 7432 programmer, which
is microprocessor-based and provides a series of encoded signals to
INS 10, typically through a programming head which transmits or
telemeters radio-frequency (RF) encoded signals to INS 10. Another
suitable programmer is the commercially available Medtronic Model
No. 8840 programmer, which is also microprocessor-based but
features a touch control screen. Any of a number of suitable
programming and telemetry methodologies known in the art may be
employed so long as the desired information is transmitted to and
from the implantable electrical stimulator 10.
[0083] As shown in FIG. 2, lead 18 is coupled to a node in INS 10
through capacitor 98. Microcomputer circuit 58 preferably comprises
on-board circuit 60 and off-board circuit 62. By way of example,
circuit 58 may correspond to a microcomputer circuit disclosed in
U.S. Pat. No. 5,312,453 to Shelton et al., hereby incorporated by
reference herein in its entirety. On-board circuit 60 preferably
includes microprocessor 64, system clock circuit 66 and on-board
RAM 68 and ROM 70. Off-board circuit 62 preferably comprises a
RAM/ROM unit. On-board circuit 60 and off-board circuit 62 are each
coupled by data communication bus 72 to digital controller/timer
circuit 74. Microcomputer circuit 58 may comprise a custom
integrated circuit device augmented by standard RAM/ROM
components.
[0084] Electrical components shown in FIG. 2 are powered by an
appropriate implantable primary (i.e., non-rechargeable) battery
power source 76 or secondary (i.e., rechargeable) battery power
source 76. For the sake of clarity, the coupling of battery 76 to
the various components of INS 10 is not shown in FIG. 2. Antenna 56
is connected to microcomputer circuit 58 via digital
controller/timer circuit 74 and data communication bus 72 to permit
uplink/downlink telemetry through RF transmitter and receiver
telemetry unit 78. By way of example, telemetry unit 78 may
correspond to that disclosed in U.S. Pat. No. 4,566,063 issued to
Thompson et al. It is generally preferred that the particular
programming and telemetry scheme selected permit the entry and
storage of electrical stimulation parameters. The specific
embodiments of antenna 56 and other telemetry circuitry presented
herein are shown for illustrative purposes only, and are not
intended to limit the scope of the present invention.
[0085] Continuing to refer to FIG. 2, V.sub.REF and bias circuit 82
most preferably generate stable voltage reference and bias currents
for analog circuits included in output circuit 54. Operating
commands for controlling the timing of INS 10 are coupled by data
bus 72 to digital controller/timer circuit 74, where digital timers
and counters establish the specific stimulation parameters of INS
10 as well as various timing windows for controlling the operation
of peripheral components disposed within input/output circuit 54.
Output pulse generator 96 provides electrical stimuli to desired
nerve and/or nerve portion 25 or 26 through coupling capacitor 98
in response to a trigger signal provided by digital
controller/timer circuit 74, when an externally transmitted
stimulation command is received, or when a response to other stored
commands is received.
[0086] By way of example, output amplifier 96 may correspond
generally to an output amplifier disclosed in U.S. Pat. No.
4,476,868 to Thompson, hereby incorporated by reference herein in
its entirety. The specific embodiments of output amplifier 96
identified herein are presented for illustrative purposes only, and
are not intended to be limiting in respect of the scope of the
present invention. The specific embodiments of such circuits may
not be critical to practicing some embodiments of the present
invention so long as they provide means for generating an
appropriate train of stimulating pulses to desired nerve or nerve
portion 25 and/or 26.
[0087] In various embodiments of the present invention, INS 10 may
be programmably configured to operate so that it varies the rate at
which it delivers stimulating pulses to desired nerve or nerve
portion 25 and/or 26, and/or to vary the rate or manner at which
outlet catheter 300 delivers one or more drugs to a desired tissue
volume, in response to one or more selected outputs being
generated, or in response to one or more signals of interest being
detected by one or more sensors. INS 10 may further be programmably
configured to operate so that it may vary the morphology of the
stimulating electrical and/or drug output pulses it delivers.
Numerous implantable electrical stimulator features and functions
not explicitly mentioned herein may be incorporated into INS 10
while remaining within the scope of the present invention. Various
embodiments of the present invention may be practiced in
conjunction with one, two, three or more leads, in conjunction with
one, two, three, four or more electrodes disposed on each lead, or
in conjunction with one, two, three or more outlet catheters
connected thereto.
[0088] Leadless embodiments of the present invention are also
contemplated, where one or more electrical stimulation, drug pump
or other type of drug delivery device, and/or sensing electrode
capsules or modules are implanted at or near a desired nerve or
nerve portion 25 and/or 26, and the capsules or modules deliver
electrical stimuli or drugs directly to the selected site using a
preprogrammed stimulation or drug delivery regime, and/or the
capsules or modules sense electrical, chemical or other pertinent
signals for monitoring and feedback control purposes. Such capsules
or modules are preferably powered by rechargeable batteries that
may be recharged by an external battery charger using well-known
inductive coil or antenna recharging means, and preferably contain
electronic circuitry sufficient to permit telemetric communication
with a programmer, to deliver electrical stimuli and/or sense
electrical or other signals, and to store and execute instructions
or data received from the programmer. Alternatively, in one
embodiment of the present invention INS 10 is configured to
recharge such a remotely positioned capsule or module by RF means
on a periodic basis according to battery state of charge
requirements measured or exhibited by such remote capsule or
module.
[0089] Examples of methods and devices that may be adapted for use
in the wireless devices and methods of the present invention
include those described in U.S. Pat. No. 6,208,894 to Schulman et
al. entitled "System of implantable devices for monitoring and/or
affecting body parameters;" U.S. Pat. No. 5,876,425 to Schulman et
al. entitled "Power control loop for implantable tissue
stimulator;" U.S. Pat. No. 5,957,958 to Schulman et al. entitled
"Implantable electrode arrays;" U.S. patent application Ser. No.
09/030,106 filed Feb. 25, 1998 to Schulman et al. entitled
"Battery-Powered Patient Implantable Device," and U.S. Pat. No.
6,650,943 to Whitehurst et al. entitled "Fully Implantable
Neurostimulator for Cavernous Nerve Stimulation as a Therapy for
Erectile Dysfunction and Other Sexual Dysfunction."
[0090] FIG. 3 shows a simplified anatomical view of portions of the
pelvic floor of a human patient, the locations of sacral and
associated nerves therein, and illustrative positionings of INS 10,
drug pump or delivery device 310, electrical stimulation lead 16,
corresponding electrodes 20-23, and drug delivery catheter 300.
FIG. 3 shows INS 10 implanted in an appropriate location within the
patient, with lead 16 being implanted near or adjacent to one or
more of sacral nerves S1, S2, S3, and/or S4, and the distal end of
outlet catheter implanted near or adjacent to sacral nerve or nerve
portion 25 to thereby effect therapeutic relief. Such relief is
effected as a result of electrical stimulation signals and drugs
being delivered to or near to or near one or more of such nerves
S1, S2, S3 25, S4, and/or pudendal nerve or nerve portion 26, or a
nerve(s) in proximity thereto, by electrodes 20, 21, 22, and/or 23
and outlet catheter 300. One, two, three, four or more electrodes
20, 21, 22 and 23 may be disposed at the distal end of lead 16. A
second electrical stimulation lead 18, not shown in FIG. 2, having
one, two, three, four or more electrodes 40, 41, 42 and 43 may be
employed to electrically stimulate nerve or nerve portion 25 or 26,
according to the particular requirements at hand. Consistent with
the foregoing description, other lead locations, electrode
configurations and outlet catheter configurations are of course
possible and contemplated in the present invention.
[0091] FIG. 4 shows a simplified anatomical view of the pelvic
floor of a female human patient, the locations of the left and
right pudendal nerves 26 and 27 and associated nerves therein, the
positioning of drug pump or delivery device 310, and the
positioning of drug delivery catheters 300 and 301 such that the
distal portions thereof are located near left and right pudendal
nerves 26 and 27. Note that the distal ends of drug delivery or
outlet catheters 300 and 301 may also be located near sacral
nerve(s) or nerve portion(s) 25, and that various permutations and
combinations of locations near or at pudendal nerves or nerve
portions 26 and sacral nerve or nerve portions 25 are also
contemplated in the present invention.
[0092] As shown in FIG. 4, pudendal nerve or nerve portion 26
innervates the pelvic floor muscle and sphincters. FIG. 4 shows INS
10 implanted in an appropriate location within the patient, with
drug delivery catheters 300 and 301 being implanted near or
adjacent to one or more of left pudendal nerve or nerve portion 26
and right pudendal nerve or nerve portion 27, to thereby effect
therapeutic relief. Such relief is effected as a result of an
appropriate amount of drug being delivered to the desired tissue
volume(s) according to an appropriate schedule time regime, where
such tissue volumes are in proximity to the desired nerve or nerve
portion. Consistent with the foregoing description, other drug
delivery catheter locations and configurations are of course
possible and contemplated in the present invention.
[0093] FIG. 5 shows a simplified male anatomical view of the pelvic
floor and the locations of pudendal nerve 26 and nerves associated
therewith, where in accordance with some embodiments of the present
invention leads 16 and/or 18, electrodes 20-23 and/or 40-43, and
drug delivery catheters 300 and 301 may be attached, connected or
implanted in proximity thereto. Pudendal nerve 26 may be seen to
extend downwardly past sacrospinal ligament 43, greater sciatic
foramen 48, and lesser sciatic foramen 49, and thereafter to branch
into inferior rectal nerves 51, perineal nerves 52, scrotal nerves
53 and dorsal nerve 55 of penis 35.
[0094] FIG. 6 shows a simplified anatomical view of the pelvic
floor of a female human patient, the locations of the sacral nerves
and nerve portions 25 and associated nerves therein, the
positioning of drug pump or delivery device 310, and the
positioning of drug delivery catheter 300 such that the distal
portion thereof is located near one or more sacral nerves or nerve
portions 25. Other sites or tissue volumes to which one or more
drugs may be delivered by drug pump 300 and drug delivery catheter
301 are also illustrated in FIG. 6, such as the lesser splanchnic
nerve or nerve portion, the least splanchnic nerve or nerve
portion, the sympathetic trunk nerve or nerve portion, the lumbar
splanchnic nerve or nerve portion, the L1, L2, L3, L4, etc, spinal
nerve or nerve portion, the ovarian plexus, aorticorneal ganglia,
the superior mesenteric ganglion, the intermesenteric (aortic)
plexus, the superior hypogastric nerves or nerve portions, the
uterovaginal plexus, the inferior hypogastric plexus, one or more
of the pelvic splanchnic nerves or nerve portions.
[0095] FIG. 7 shows a simplified anatomical view of portions of the
pelvic floor of a male human patient, the locations of pudendal and
associated nerves 26, the locations of sacral and associated nerves
25, and illustrative positionings of INS 10, electrical stimulation
lead 18 and corresponding electrodes 40-43, drug pump or delivery
device 310, and drug delivery catheter 300. In FIG. 7, the distal
end of drug delivery catheter 300 is located near or at the
prostatic plexus. Other sites or tissue volumes to which one or
more drugs may be delivered by drug pump 300 and drug delivery
catheter 301 are also illustrated in FIG. 7, such as the prostate,
the bladder, the penis, and the superior hypogastric nerves or
nerve portions. Many locations within a patient's body may be
electrically stimulated or infused with one or more drugs in
accordance with various embodiments of the present invention,
including, but not limited to, a sacral nerve or branches or
portions thereof, a pudendal nerve or branches or portions thereof,
a hypogastric nerve or branches or portions thereof, a prostatic
plexus nerve or branches or portions thereof, a sacral splanchnic
nerve or branches or portions thereof, a pelvic splanchnic nerve or
branches or portions thereof, the prostate or branches or portions
thereof, the pelvic floor, the colon or branches or portions
thereof, the bladder or portions thereof, the vagina or portions
thereof, the anus or portions thereof, the external anal sphincter
or portions thereof, the urethra or portions thereof, the penile
dorsal nerve or portions thereof, inferior rectal nerves or
branches or portions thereof, perineal nerves or branches or
portions thereof, scrotal nerves or branches or portions thereof,
the scrotum or portions thereof, Alcock's Canal or branches or
portions thereof, sacro-tuberous ligament or branches or portions
thereof, ischial tuberosity or branches or portions thereof,
greater sciatic foramen or branches or portions thereof, or lesser
sciatic foramen or branches or portions thereof,
[0096] FIGS. 8A through 8E show various embodiments of a distal end
of medical electrical lead 16 and/or 18 of the present invention.
In FIG. 8A, lead 16/18 is a paddle lead having electrodes 20-23
arranged along an outwardly facing planar surface. Such a paddle
lead 16/18 is preferably employed to stimulate peripheral nerves.
In FIG. 8B, lead 16/18 is a conventional quadrapolar lead having no
pre-attached anchoring mechanism 19. Electrodes 20-23 are
cylindrical in shape and extend around the circumference of the
lead body.
[0097] In FIG. 8C, lead 16/18 is a quadrapolar lead having tined
lead anchors 19. Tines 19 may be formed from flexible or rigid
biocompatible materials in accordance with the desired application.
Representative examples of some tined and other types of leads
suitable, adaptable or modifiable for use in conjunction with the
systems, methods and devices of the present invention include those
disclosed in U.S. patent application Ser. No. 10/004,732 entitled
"Implantable Medical Electrical Stimulation Lead Fixation Method
and Apparatus" and Ser. No. 09/713,598 entitled "Minimally Invasive
Apparatus for Implanting a Sacral Stimulation Lead " to Mamo et
al., as well as those disclosed in U.S. Pat. No. 3,902,501 to
Citron entitled "Endocardial Lead," U.S. Pat No. 4,106,512 to
Bisping entitled "Transvenously Implantable Lead," U.S Pat No.
5,300,107 to Stokes entitled "Universal Tined Myocardial Pacing
Lead."
[0098] In FIG. 8D, lead 16/18 is a quadrapolar lead having
pre-attached suture anchor 19. In FIG. 8E, lead 16/18 is a
tri-polar cuff electrode, where cuff/anchor 19 is wrapped around
desired nerve or nerve portion 8 to thereby secure the distal end
of lead 16/18 to the nerve and position electrodes 20-22 against or
near nerve or nerve portion 25 or 26. The Medtronic Model No. 3995
cuff electrode lead is one example of a lead that may be adapted
for use in the present invention, the Instructions for Use manual
of which is hereby incorporated by reference herein in its
entirety.
[0099] Leads 16 and 18 are preferably less than about 5 mm in
diameter, and most preferably less than about 1.5 mm in diameter.
Polyurethane is a preferred material for forming the lead body of
leads 16 and 18, although other materials such as silicone may be
employed. Electrical conductors extending between the proximal and
distal ends of leads 16 and 18 for supplying electrical current to
the electrodes are preferably formed of coiled, braided or stranded
wires comprising an MP35N platinum-iridium alloy. Electrodes 20,
21, 22 and 23 and 40, 41, 42 and 43 may be ring electrodes, coiled
electrodes, electrodes formed from portions of wire, barbs, hooks,
spherically-shaped members, helically-shaped members, or may assume
any of a number of different structural configurations well known
in the art. Inter-electrode distances on leads 16 and 18 are
preferably about 3 mm, but other inter-electrode distances may be
employed such as about 1 mm, about 2 mm, about 4 mm, about 5 mm,
about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about
12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25
mm, about 30 mm.
[0100] Preferred surface areas of electrodes 20, 21, 22 and 23 and
40, 41, 42 and 43 range between about 1.0 sq. mm and about 100 sq.
mm, between about 2.0 sq. mm and about 50 sq. mm, and about 4.0 sq.
mm and about 25 asq. mm.
[0101] Preferred lengths of electrodes 20, 21, 22 and 23 and 40,
41, 42 and 43 range between about 0.25 mm and about 10 mm, between
about 0.50 mm and about 8 mm, and about 1 mm and about 6 mm.
[0102] Electrodes 20, 21, 22 and 23 and 40, 41, 42 and 43 are
preferably formed of platinum, although other metals and metal
alloys may be employed such as stainless steel or gold.
[0103] The distal portion of lead 16 extends to a target site or
position near a desired nerve or nerve portion 25 and/or 26, and is
preferably held in such position by lead anchor 19. Note that lead
anchor 19 may assume any of a number of different structural
configurations such one or more suture sleeves, cuffs, tines,
barbs, hooks, helical screws, tissue in-growth mechanisms,
adhesive, polycyanoacrylate, or glue.
[0104] One, two, three, four or more electrodes 20, 21, 22 and 23
or 40, 41, 42 and 43 may be disposed at the distal end of lead 16
and/or lead 18. Electrodes 20, 21, 22 and 23 and 40, 41, 42 and 43
are preferably arranged in an axial array, although other types of
arrays may be employed such as inter-lead arrays of electrodes
between the distal ends of leads 16 and 18 such that nerves or
nerve portions 8 disposed between leads 16 and 18 may be
stimulated.
[0105] Leads 16 and 18 preferably range between about 4 inches and
about 20 inches in length, and more particularly may be about 6
inches, about 8 inches, about 10 inches, about 12 inches, about 14
inches, about 16 inches or about 18 inches in length, depending on
the location of the site to be stimulated and the distance of INS
10 from such site. Other lead lengths such as less than about 4
inches and more than about 20 inches are also contemplated in the
present invention.
[0106] FIG. 9 shows a flow diagram according to one embodiment of a
method of the present invention for electrically stimulating one or
more sacral nerves or nerve portions 25, and infusing one or more
drugs to one or more pudendal nerves or nerve portions 26. Note
that the order in which the steps shown in FIG. 9 are carried out
may be changed, and that the resulting method will nevertheless
fall within the scope of the present invention. In FIG. 9, at step
110 one or more desired sacral nerve electrical stimulation
locations are located. Various techniques such as visualization
under fluoroscopy or the use of anatomical landmarks may be used to
locate the sacral nerve or nerve portion 25 to be stimulated. Step
120 is employed to test and verify proper sacral nerve or nerve
portion 25 response prior to implantation of the stimulation
electrode. An electrical signal delivered to the nerve through a
needle is typically employed to elicit such a nerve response. The
nerve response may be detected through a motor response that may be
visually detected, a sensory response as reported by the patient or
through an electrical response. Following verification of proper
nerve response, at step 130 the sacral nerve electrode is
implanted. In step 140, INS 10 having drug pump portion 314
disposed therewithin is implanted in an appropriate location within
the patient such that the proximal end of lead 16 or 18 may be
operably connected thereto, and such that INS 10 is placed in such
a location that discomfort and the risk of infection to the patient
are minimized.
[0107] Step 150 in FIG. 7 is employed to locate the pudendal nerve.
Location of pudendal nerve or nerve portion 26 is typically done
through the identification of anatomical landmarks. Palpation of
the patient as well as usage of fluoroscopy, x-ray and EMG may be
employed to assist in proper location of the pudendal nerve. Before
or after step 170, INS 10 is implanted in an appropriate location
within the patient such that drug delivery catheter 300 may be
operably connected thereto, and such that INS 10 is placed in such
a location that discomfort and the risk of infection to the patient
are minimized. Step 180 is used to operably connect INS 10 to one
or more drug delivery catheters 300, which may or may not require
the use of an optional lead or catheter extension and catheter
connector. In Step 190, INS 10 is activated and stimulation pulses
are delivered to electrodes 20, 21, . . . n or 40, 41, . . . n
through lead 16 or 18 to the desired nerve stimulation location 25
or 26 and one or more drugs are delivered via one or more drug
delivery catheters 300 to the desired tissue volume(s). In step
200, electrical pulse stimulation and drug delivery parameters are
adjusted to optimize the therapy delivered to the patient. Such
adjustment may entail one or more of adjusting the number or
configuration of electrodes, leads and/or drug delivery catheters
used to stimulate or infuse with drugs the selected location, pulse
amplitude, pulse frequency, pulse width, pulse morphology (e.g.,
square wave, triangle wave, sinusoid, biphasic pulse, tri-phasic
pulse, etc.), times of day or night when pulses or drugs are
delivered, pulse cycling times, the positioning of the lead or
leads and/or catheter or catheters, and/or the enablement or
disablement of "soft start" or ramp functions respecting the
stimulation regime or drug supply regime to be provided. Note that
methods of the present invention further contemplate the placement
and implantation of multiple electrical stimulation leads and
multiple drug delivery catheters.
[0108] FIGS. 10A through 10F shows various embodiments of the first
and second electrical stimulation pulse regimes of the present
invention. In FIG. 10A, electrical pulses delivered to a first
nerve or nerve portion are synchronized with the electrical pulses
delivered to a second nerve or nerve portion. In FIG. 10B,
electrical pulses delivered to a first nerve or nerve portion are
out of phase in respect of the electrical pulses delivered to a
second nerve or nerve portion. In FIG. 10B, the electrical pulses
delivered to the first nerve or nerve portion have a lower
frequency than the electrical pulses delivered to the second nerve
or nerve portion. In FIG. 10D, electrical pulses delivered to a
first nerve or nerve portion are characterized in having different
stimulation parameters than those of the electrical pulses
delivered to a second nerve or nerve portion. In FIG. 10E,
electrical pulses are delivered without interruption and on a
continuous basis to a first nerve or nerve portion, while the
delivery of electrical pulses to a second nerve or nerve portion is
suspended for a period of time. In FIG. 10F, electrical pulses are
delivered to a first nerve or nerve portion and a second nerve or
nerve portion, but at a certain point in time are suspended for a
predetermined period of time or until a sensed quantity changes in
a predetermined fashion.
[0109] Some examples of dual electrical stimulation techniques
falling within the scope of the present invention are as follows:
[0110] One pulse regime may be delivered continuously, while the
other pulse regime is turned on and off in accordance with the
patient's symptoms, as such symptoms may wax and wane; [0111] Both
pulse regimes may be delivered continuously, one intermittently and
the other continuously, or both intermittently; [0112] The two
pulse regimes may be different in respect of amplitude,
pulse-width, frequency, pulse morphology, and the like; [0113] One
or both pulse regimes may be delivered according to a scheduled or
detected activity, or according to a predetermined or detected
schedule, the activity or schedule having one or more pulse regimes
associated therewith, the activities or schedules comprising one or
more of circadian rhythms, daytime or nighttime activities or
schedules, meals, periods of exercise, periods of sleep, sexual
activity, and the like; [0114] One pulse regime may be delivered in
accordance with a preprogrammed regime, while the other pulse
regime may be delivered, activated, modified and/or terminated via
patient activation, modification or termination; [0115] One or both
pulse regimes may be delivered between different leads having one
or more electrodes each to obtain a spatially broad stimulation
pattern; [0116] One or both pulse regimes may be controlled,
activated and/or terminated by the patient to customize the
delivered therapy.
[0117] Some representative ranges of preferred electrical pulse
stimulation parameters capable of being delivered by INS 10 through
leads 16 and/or 18 include the following: TABLE-US-00002 Frequency:
Between about 50 Hz and about 100 Hz; Between about 10 Hz and about
250 Hz; and Between about 0.5 Hz and about 500 Hz. Amplitude:
Between about 1 Volt and about 10 Volts; Between about 0.5 Volts
and about 20 Volts; and Between about 0.1 Volts and about 50 Volts.
Pulse Width: Between about 180 microseconds and about 450
microseconds; Between about 100 microseconds and about 1000
microseconds; and Between about 10 microseconds and about 5000
microseconds.
[0118] In the event multiple signals are employed to stimulate a
desired site, the spatial and temporal phase between the signals
may be adjusted or varied to produce the desired stimulation
pattern or sequence. That is, in the present invention beam forming
and specific site targeting via electrode array adjustments are
specifically contemplated. Electrode configurations, arrays and
stimulation patterns and methods similar to those disclosed by
Holsheimer in U.S. Pat. No. 6,421,566 entitled "Selective Dorsal
Column Stimulation in SCS, Using Conditioning Pulses," U.S. Pat.
No. 5,643,330 entitled "Multichannel Apparatus for Epidural Spinal
Cord Stimulation" and U.S. Pat. No. 5,501,703 entitled
"Multichannel Apparatus for Epidural Spinal Cord Stimulator," the
respective entireties of which are hereby incorporated by reference
herein, may also be adapted or modified for use in the present
invention. Electrode configurations, arrays, leads, stimulation
patterns and methods similar to those disclosed by Thompson in U.S.
Pat. No. 5,800,465 entitled "System and Method for Multi-site
Steering of Cardiac Stimuli," the entirety of which is hereby
incorporated by reference herein, may also be adapted or modified
for use in the present invention to permit the steering of
electrical fields. Thus, although FIG. 1 shows four electrodes
located at the distal end of lead 16 near sacral nerve S3, other
lead locations and electrode configurations are possible and
contemplated in the present invention.
[0119] In various embodiments of the present invention it is
contemplated that drugs be delivered to specific sites within a
patient using fully implantable or external drug pump devices in
combination with providing electrical stimulation to the nerves or
nerve portions described above. According to such devices and
methods, and as discussed above, drug pump portion 314 may be
incorporated into the same housing as INS 10 or, if fully
implantable, be separate therefrom in its own hermetically sealed
housing. Drug delivery catheter 300 may be attached to drug pump
portion 314 of INS 10, or may be attached to a separate implantable
or external drug pump through which one or more drugs are delivered
to a specific desired target tissue volume. Drug delivery catheter
300 may also be incorporated into lead 16 or 18, or may be separate
therefrom. Drugs or therapeutic agents delivered in accordance with
this method include, by way of example, antibiotics, pain relief
agents such as demerol and morphine, radioactive or
radio-therapeutic substances or agents for killing or neutralizing
maycer cells, genetic growth factors for encouraging the growth of
healthy tissues, drugs for facilitating or encouraging penile or
clitoral engorgement, and so forth, more about which we say
below.
[0120] Drug pumps employed to treat various disease states in
accordance with some embodiments of the present invention may be of
the well known peristaltic type having reservoirs filled with a
liquid containing the drug(s) to be dispensed, or may constitute
any of a number of different types of implantable or external drug
pump or dispenser types, such as an implantable drug dispenser
adapted to deliver drug pellets in solid or semi-solid form to an
internal portion of a patient's body at pre-defined intervals. Drug
pumps of the present invention may be powered by primary or
rechargeable batteries, and may be communicated with or programmed
in accordance with telemetry protocols such as those employed in
pacemakers or currently marketed implantable drug pumps.
[0121] Moreover, in the present invention it is contemplated that
drugs be delivered to one or more target tissue volumes in the
vicinity of target nerves or branches or portions thereof, as well
as into other tissues or voids such as the bladder, one or more
smooth muscles, the spinal column, the kidneys, the prostate gland,
the testes or testicles, the uterus, the vagina, the penis, the
colon, one or more of the pelvic floor muscles, the vascular
system, the intestines, the digestive tract, the stomach, the
esophagus, or any of a number of different sphincters (e.g.,
urethral, anal, etc.) or other muscles or organs.
[0122] The following issued U.S. patents, all of which are
incorporated by reference herein, each in its respective entirety,
describe various aspects pertaining to different embodiments of the
of the drug pumps and communication systems of the present
invention: [0123] U.S. Pat. No. 4,692,147 to Duggan for "Drug
administration device;" [0124] U.S. Pat. No. 4,987,897 to Funke for
"Body bus medical device communication system;" [0125] U.S. Pat.
No. 5,083,908 to Gagnebin et al. for "Miniature peristaltic pump;"
[0126] U.S. Pat. No. 5,382,236 to Otto et al. for "Implantable
infusion pump;" [0127] U.S. Pat. No. 5,480,656 to Okada et al. for
"Prolonged release microcapsules;" [0128] U.S. Pat. No. 5,551,849
to Christensen for "Medication delivery device and method of
construction;" [0129] U.S. Pat. No. 5,609,575 to Larson et al. for
"Infusion pump and method with dose-rate calculation;" [0130] U.S.
Pat. No. 5,639,275 to Baetge for "Delivery of biologically active
molecules using cells contained in biocompatible immunoisolatory
capsules;" [0131] U.S. Pat. No. 5,683,432 to Goedeke for "Adaptive,
performance-optimizing communication system for communicating with
an implanted medical device;" [0132] U.S. Pat. No. 5,733,313 to
Barreras et al. for "RF coupled, implantable medical device with
rechargeable back-up power source;" [0133] U.S. Pat. No. 6,210,368
to Rogers for "Reservoir volume sensors;" [0134] U.S. Pat. No.
6,263,246 to Goedeke for "Method and apparatus for communications
with an implantable device;" [0135] U.S. Pat. No. 6,283,949 to
Roorda for "Refillable implantable drug delivery pump;" [0136] U.S.
Pat. No. 6,322,330 to Thomas for "Compact peristaltic metering
pump;" [0137] U.S. Pat. No. 6,358,202 to Arent for "Network for
implanted computer devices;" [0138] U.S. Pat. No. 6,458,118 to Lent
et al. for "Drug delivery through microencapsulation;" [0139] U.S.
Pat. No. 6,471,645 to Warkentin for "Communications system for an
implantable device and a drug dispenser;" [0140] U.S. Pat. No.
6,485,464 to Christenson et al. for Reduced height implantable drug
infusion device;" [0141] U.S. Pat. No. 6,551,290 to Elsberry et al.
for "Catheter for target specific drug delivery;" [0142] U.S. Pat.
No. 6,669,663 to Thompson for "Closed loop medicament pump;" [0143]
U.S. Pat. No. 6,669,663 to Thompson for "Closed loop medicament
pump;"
[0144] Tables 1 through 10 below lists drugs that may be employed
in various embodiments of the present invention according to the
general disease state they are intended to treat (e.g., bladder
over-activity or stress incontinence), the effects or actions such
drugs promote or cause, the applicable class(es) of drugs having
such effects or actions, the names of some of the specific drugs
falling within the scope of such drug class(es), and delivery sites
for such drugs. TABLE-US-00003 TABLE 1 Drugs for Treatment of
Bladder Over-Activity Action Drug Class Specific Drug Delivery Site
Depress Bladder Antimuscarinic Tolterodine, Digestive system,
central Contractions (Anticloinergic) Trospium, nervous system,
pudendal Propantheline, nerves, sacral nerves, vascular Atropine,
system Hyoscyamine, Darifenacin, Solifenacin Detrusor Muscle
Membrane Calcium Digestive system, central Inhibitor channel drugs
Antagonists and nervous system, pudendal Potassium nerve, sacral
nerves, vascular Channel Openers system Mixed Mode Antimuscarinic
and terodiline, Digestive system, central channel blockers
oxybuynin, nervous system, pudendal propiverine and nerves, sacral
nerves, vascular flaxoxate. system Detrusor Muscle Alpha Alfuzosin,
Digestive system, central Relaxant Adrenoceptor Doxazosin, nervous
system, pudendal Antagonists Prazosin, nerves, sacral nerves,
vascular Terazosin, system Tamsulosin. Detursor Inhibitor Beta
Adrenoceptor Terbutaline, Digestive system, central Agonists
Chenbuterol, nervous system, pudendal Salbutomol nerves, sacral
nerves, vascular system Detursor Inhibitor Antidepressants
Imipramine. Digestive system, central Blockade of Re- nervous
system, pudendal uptake of Serotonin nerves, sacral nerves,
vascular and Noradrenaline system Prostatglandin Prostatglandin
Indomethacin, Digestive system, central Synthesis Inhibitors
Synthesis Flurbiprofen. nervous system, pudendal Inhibitors nerves,
sacral nerves, vascular system Motor Neuron Motor Neuron Baclofen
Digestive system, central Suppression Supression nervous system,
pudendal nerves, sacral nerves, vascular system Sensory Sensory
Resiniferatoxin, Bladder desensitization Capsaicin Inflammation,
Pain, Inflammation, pain Dimethyl Sulfoxide Bladder Muscle or
bacillus Contractions Calmette-Guerin (BCG) Hormonal Hormone
estrogen Digestive system, central treatment nervous system,
pudendal nerves, sacral nerves, vascular system
[0145] TABLE-US-00004 TABLE 2 Drugs for Treatment of Stress
Incontinence Action Drug Class Specific Drug Delivery Site
sphincter and Alpha Ephedrine and Digestive system, central
urethral muscle Adrenoceptor Norephedrine nervous system, Alpha
Adrenoceptor Antagonists pudendal nerves, sacral Antagonists
nerves, vascular system Control of the Beta Adrenoceptor
Propranolol Digestive system, central Urethra Agonists nervous
system, pudendal nerves, sacral nerves, vascular system, urethra
Contractility of the adrenaline and Imipramine Digestive system,
central Urethra serotonin uptake nervous system, inhibitor pudendal
nerves, sacral nerves, vascular system, urethra External Urethral
Duloxetine Duloxetine Digestive system, central Sphincter Neural
nervous system, Activity Enhancer pudendal nerves, sacral nerves,
vascular system, urethra, urethral sphincter Hormonal Treatment
Hormone Estrogen Digestive system, central nervous system, pudendal
nerves, sacral nerves, vascular system, pelvic floor, urethra,
bladder
[0146] TABLE-US-00005 TABLE 3 Drugs for Treatment of Overflow
Incontinence Action Drug Class Specific Drug Delivery Site Increase
Bladder Alpha- Alfuzosin, Digestive system, central Sensitivity
Adrenoceptor Doxazosin, nervous system, Antagonists Prazosin,
pudendal nerves, sacral Terazosin, nerves, vascular system,
Tamsulosin and bladder Phenoxybenzamine Increase Bladder Muscarinic
Bethanechol, Digestive system, central Sensitivity Receptor
Agonists Carbahol nervous system, pudendal nerves, sacral nerves,
vascular system, bladder Increase Bladder Anticholinesterase
Distigmine Digestive system, central Sensitivity Inhibitors nervous
system, pudendal nerves, sacral nerves, vascular system, bladder
Hormonal Treatment Hormone Estrogen Digestive system, central
nervous system, pudendal nerves, sacral nerves, vascular system,
pelvic floor, urethra, bladder
[0147] TABLE-US-00006 TABLE 4 Interstitial Cystitis Action Drug
Class Specific Drug Delivery Site Bacterial antibiotic
Flouroquinolones, Digestive system, Elimination Trimethoprimsulfa
vascular system, methoxazole prostate Pain relief Analgesic
Aspirin, Central nervous acetaminophen, system, pudendal
phenazopyridine, nerve, sacral nerves opioid medications such as
meperidine, hydromorphone, methandone, levorphanol, morphine
[0148] TABLE-US-00007 TABLE 5 Interstitial Cystitis Action Drug
Class Specific Drug Delivery Site Bladder Lining Anti-inflammatory
Glucosamine, Bladder Healing chondroitin and quercetin combination,
hyaluronic acid, pentosan polysulfate sodium, heparin sodium Pain
Relief Analgesic Aspirin, Central nervous system, acetaminophen,
pudendal nerve, sacral phenazopyridine, nerves opioid medications
such as meperidine, hydromorphone, methandone, levorphanol,
morphine Bladder Tricyclic Amitriptyline, Bladder, sacral nerves,
Antispasmodic antidepressants deipramine, pudendal nerves
nortriptyline, doxepin, imipramine Bladder Muscle relaxant
Hyoscyamine, Bladder, pudendal Antispasmodic oxybutynin nerves,
sacral nerves, chloride, central nervous system cyclobenzprine,
hyoscyamine sulfate, baclofen Urinary Urgency Anticholinergic
Tolterodine tartrate Bladder, pudendal nerve, sacral nerves,
central nervous system Pain Sensory Resiniferatoxin Bladder
desensitization Inflammation, Pain, Inflammation, pain Dimethyl
Sulfoxide Bladder Muscle Contractions or bacillus Calmette-Guerin
(BCG) Aid in Repair of Bladder lining Pentosan Bladder Bladder
Lining Polysufate Sodium Hormonal Treatment Hormone estrogen
Central nervous system, pudendal nerves, sacral nerves, vascular
system, pelvic floor, urethra, bladder
[0149] TABLE-US-00008 TABLE 6 Fecal Incontinence/Irritable Bowel
Syndrome Action Drug Class Specific Drug Delivery Site Diarrhea
Anti-diarrheal Loperamide, Digestive tract alosetron Motility
Motility inhibition Diphenoxylate, Digestive tract difenoxin,
alosetron, cilansetron Motility Motility stimulation Tagaserod,
Digestive Tract cisapride, erythomycin, caffeine Incontinence
Tricyclic Amitriptyline Digestive Tract antidepressant
[0150] TABLE-US-00009 TABLE 7 Female Sexual Dysfunction Action Drug
Class Specific Drug Delivery Site Libido, Vaginal Sildenafil
Digestive system, Dryness, Sexual vascular system, Nervous Arousal
system Libido, Vaginal Hormone Estrogen, Digestive system, Dryness,
Sexual Replacement testosterone vascular system Arousal Smooth
Muscle Amino acid L-arginine Digestive system, Relaxant vascular
system Smooth Muscle Smooth Muscle Phentolamine Digestive system,
Relaxant, Increased Relaxant vascular system Vaginal Blood Flow
Dopamine Activation Orgasm, libido Amantadine Digestive system,
vascular system, central nervous system, deep brain Serotonin
Re-uptake Orgasm Bupropion Digestive system, Inhibitor vascular
system, central nervous system, deep brain Anti-anxiety Orgasm,
Libido Buspione Digestive system, vascular system, central nervous
system, deep brain Antiserotonergic Orgasm, Libido Cypropeptadine
Digestive system, vascular system, central nervous system, deep
brain Sympathomimetic Orgasm Dextroamphetamine Digestive system,
vascular system, central nervous system, deep brain Sympathomimetic
Orgasm Pemoline Digestive system, vascular system, central nervous
system, deep brain Adrenergic Receptor Orgasm, Libido Yohimbine
Digestive system, Antagonist vascular system, central nervous
system, deep brain
[0151] TABLE-US-00010 TABLE 8 Erectile Dysfunction Action Drug
Class Specific Drug Delivery Site Smooth Muscle Enzyme Inhibitor
Sildenafil, Vardenafil, Digestive system, Relaxant Tadalafil,
Yohimbine vascular system, penis Vascular Dilator, Vascular
Dilator, Prostagladin, Digestive system, Smooth Muscle Smooth
Muscle Phentolamine vascular system, penis Relaxant Relaxant
Libido, Sexual Arousal Hormone Estrogen, testosterone Digestive
system, Replacement vascular system, penis
[0152] TABLE-US-00011 TABLE 9 Premature Ejaculation Action Drug
Class Specific Drug Delivery Site Delayed Ejaculation Selective
Serotonin Sertraline, Paroxetine Digestive system, Reuptake
Inhibitor vascular system, central nervous system, penis Delayed
Ejaculation Tricyclic Clomipramine Digestive system,
Antidepressants vascular system, central nervous system, penis
[0153] TABLE-US-00012 TABLE 10 Prostatitis Action Drug Class
Specific Drug Delivery Site Bacterial Antibiotic Flouroquinolones,
Digestive system, Elimination Trimethoprimsulfamet vascular system,
hoxazole prostate Pain relief Analgesic Aspirin, Central nervous
acetaminophen, system, pudendal phenazopyridine, nerves, sacral
nerves opioid medications such as meperidine, hydromorphone,
methandone, levorphanol, morphine
[0154] FIGS. 11A through 11G show various embodiments of first and
second electrical stimulation pulse regimes and first and second
drug delivery regimes of the present invention. FIG. 11A
illustrates an electrical stimulation pulse regime being applied to
a first electrical stimulation site and a drug bolus being
delivered to a first target tissue volume. One example where such
an electrical pulse regime and drug delivery regime could be
employed is periodic electrical stimulation to treat incontinence
and the delivery of a patient-activated drug bolus for pain
relief.
[0155] FIG. 11B shows periodic electrical stimulation applied to a
first electrical stimulation site and periodic drug delivery to a
first target tissue volume. One example where such an electrical
pulse regime and drug delivery regime could be employed is periodic
electrical stimulation to treat incontinence and periodic drug
delivery to treat interstitial cystitis. FIG. 11C shows periodic
electrical stimulation applied to a first electrical stimulation
site, periodic drug delivery to a first target tissue volume, and
bolus drug delivery to a second target tissue volume. One example
where such an electrical pulse regime and drug delivery regime
could be employed is electrical stimulation for the treatment of
incontinence, drug delivery for the treatment of pain, and the
delivery of a patient-activated drug bolus to treat sexual
dysfunction.
[0156] FIG. 11D shows periodic drug delivery to a first target
tissue volume. One example where such a drug delivery regime could
be employed is the delivery of one or more drugs to a target tissue
volume for the treatment of prostatitis.
[0157] FIG. 11E shows continuous drug delivery to a target tissue
volume. One example where such a drug delivery regime could be
employed is the delivery of one or more drugs to the bladder for
the treatment of interstitial cystitis.
[0158] FIG. 11F shows periodic drug delivery to a first target
tissue volume and continuous drug delivery to a second tissue
volume. One example where such a drug delivery regime could be
employed is the periodic delivery of a first drug for the treatment
of pelvic pain and the continuous delivery of a second drug for the
treatment of interstitial cystitis.
[0159] FIG. 11G shows periodic electrical stimulation being applied
to a first electrical stimulation site, periodic electrical
stimulation being applied to a second electrical stimulation site,
and the delivery of a bolus of one or more drugs to a first target
tissue volume. One example where such an electrical stimulation and
drug delivery regime could be employed is periodic electrical
stimulation at a first stimulation site for the treatment of fecal
incontinence, periodic electrical stimulation at a second
electrical stimulation site for the treatment of urinary
incontinence, and the delivery of a patient-activated bolus of one
or more drugs for the treatment of erectile dysfunction.
[0160] The various embodiments of the present invention described
and shown thus far may be adapted and modified to permit the use of
a number of different communication schemes. Accordingly,
incorporated by reference herein, in its entirety, is U.S. patent
application Ser. No. 20020082665A1 to Haller et al. published Jun.
27, 2002 entitled "System and Method of Communicating between an
Implantable Medical Device and a Remote Computer System or Health
Care Provider," which patent application teaches methods and
devices that may be adapted for use in some embodiments of the
present invention. In the present invention it is contemplated that
the methods and devices described hereinabove be extended to
include the various communication systems of Haller et al. for, by
way of example, one or more of monitoring the performance of INS 10
and/or an implantable drug pump implanted within the body of a
patient, monitoring the health of the patient and remotely
delivering an electrical stimulation and/or drug therapy to the
patient through INS 10 and/or implantable or external drug pump
310, INS 10 and/or implantable or external drug pump 310 being
capable of bidirectional communication with a communication module
located external to the patient's body, the system comprising: (a)
INS 10 and/or implantable or external drug pump 310; (b) a
communication module; (c) a mobile telephone or similar device
operably connected to the communication module and capable of
receiving information therefrom or relaying information thereto;
(e) a remote computer system, and (f) a communication system
capable of bi-directional communication.
[0161] The preceding specific embodiments are illustrative of the
practice of the invention. It is to be understood, therefore, that
other expedients known to those skilled in the art or disclosed
herein may be employed without departing from the invention or the
scope of the appended claims.
[0162] In the claims, means plus function clauses are intended to
cover the structures described herein as performing the recited
function and their equivalents. Means plus function clauses in the
claims are not intended to be limited to structural equivalents
only, but are also intended to include structures which function
equivalently in the environment of the claimed combination. All
printed publications and patents referenced hereinabove are hereby
incorporated by referenced herein, each in its respective
entirety.
* * * * *