U.S. patent application number 14/685278 was filed with the patent office on 2016-03-10 for method and apparatus for electrical stimulation therapy.
This patent application is currently assigned to EMKINETICS, INC.. The applicant listed for this patent is EMKinetics, Inc.. Invention is credited to James H. AHLMAN, Daniel R. BURNETT, Christopher HERMANSON, Bruno STRUL.
Application Number | 20160067515 14/685278 |
Document ID | / |
Family ID | 47881283 |
Filed Date | 2016-03-10 |
United States Patent
Application |
20160067515 |
Kind Code |
A1 |
BURNETT; Daniel R. ; et
al. |
March 10, 2016 |
METHOD AND APPARATUS FOR ELECTRICAL STIMULATION THERAPY
Abstract
Energy emitting systems are provided which include an adjustable
conductive coil configured to generate a magnetic or
electromagnetic field focused on a target nerve. The coil includes
a central aperture which may be adjustable between a first
configuration and a second configuration having a radius greater
than the radius of the first configuration. The adjustable or
movable nature of the coil allows the conductive coil to conform
to, accommodate, or be positioned on a particular anatomical
structure of a patient to position the coil in proximity to the
underlying target nerve. In certain embodiments, methods of
magnetic induction therapy are provided which include positioning a
conductive coil relative to a portion of a patient's body by
adjusting the central aperture of the coil such that the coil may
conform to, accommodate or be positioned on the portion of the
patient's body in proximity to the underlying target nerve.
Inventors: |
BURNETT; Daniel R.; (San
Francisco, CA) ; HERMANSON; Christopher; (Santa Cruz,
CA) ; AHLMAN; James H.; (Sunnyvale, CA) ;
STRUL; Bruno; (Portola Valley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EMKinetics, Inc. |
San Francisco |
CA |
US |
|
|
Assignee: |
EMKINETICS, INC.
San Francisco
CA
|
Family ID: |
47881283 |
Appl. No.: |
14/685278 |
Filed: |
April 13, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13457228 |
Apr 26, 2012 |
9005102 |
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14685278 |
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PCT/US2010/054353 |
Oct 27, 2010 |
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13457228 |
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12606941 |
Oct 27, 2009 |
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PCT/US2010/054353 |
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11866329 |
Oct 2, 2007 |
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12606941 |
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60848720 |
Oct 2, 2006 |
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Current U.S.
Class: |
600/14 |
Current CPC
Class: |
A61N 2/008 20130101;
A61B 5/4836 20130101; A61B 5/0488 20130101; A61N 2/002 20130101;
A61N 2/004 20130101; A61N 1/36031 20170801; A61N 2/006 20130101;
A61N 1/36007 20130101; A61N 2/02 20130101 |
International
Class: |
A61N 2/00 20060101
A61N002/00; A61B 5/0488 20060101 A61B005/0488; A61B 5/00 20060101
A61B005/00; A61N 2/02 20060101 A61N002/02 |
Claims
1. (canceled)
2. A headache treatment device, comprising: at least one power
source to store electrical energy; at least one coil to deliver a
magnetic pulse when electrical current from the at least one power
source is caused to flow through the at least one coil; at least
one switch sensor to control an activation state of the headache
treatment device; and a controller connected to the at least one
switch sensor, wherein the controller is adapted to initiate the
delivery of the magnetic pulse when the controller causes the
electrical current from the at least one power source to flow
through the at least one coil.
3. The device of claim 2, wherein the at least one switch sensor
controls the activation state of the device based on a positioning
of the at least one coil relative to a body part of a patient.
4. The device of claim 2, wherein the at least one switch sensor is
a mechanical switch.
5. The device of claim 2, wherein the at least one switch sensor is
an optical sensor.
6. The device of claim 2, wherein the switch sensor is positioned
next to or on the at least one coil.
7. The device of claim 2, wherein the at least one switch sensor
provides feedback indicating a correct positioning of the at least
one coil when the at least one switch sensor contacts or is
depressed by a body part of a patient.
8. The device of claim 2, further comprising at least one
conductive sensor configured to detect an electrical conduction in
a nerve of a patient or to detect a muscular response caused by the
electrical conduction in the nerve to indicate a positioning of the
at least one coil relative to a body part of a patient.
9. The device of claim 8, wherein the at least one conductive
sensor generates conductivity measurements or signals concerning
the electrical conduction or the muscular response caused by the
electrical conduction after the delivery of the magnetic pulse.
10. The device of claim 8, wherein the at least one conductive
sensor is an electromyography (EMG) sensor.
11. A headache treatment device, comprising: at least one coil
positioned in proximity to a head of a patient, wherein the at
least one coil is configured to generate a magnetic stimulus in
proximity to the head of the patient; at least one sensor
configured to provide feedback concerning a positioning of the at
least one coil relative to the head of the patient; and a
controller in communication with the at least one sensor and the at
least one coil, wherein the controller is configured to control the
generation of the magnetic stimulus by passing a current through
the at least one coil in response to the feedback concerning the
positioning of the at least one coil provided by the at least one
sensor.
12. The device of claim 11, wherein the at least one sensor is a
mechanical switch.
13. The device of claim 12, wherein the mechanical switch is
positioned next to or on the at least one coil.
14. The device of claim 12, wherein the mechanical switch provides
feedback indicating a correct positioning of the at least one coil
when the mechanical switch contacts or is depressed by a body part
of a patient.
15. The device of claim 11, wherein the at least one sensor is an
optical sensor.
16. The device of claim 11, wherein the at least one sensor is a
conductive sensor configured to detect an electrical conduction in
a nerve of a patient or to detect a muscular response caused by the
electrical conduction in the nerve indicating the positioning of
the at least one coil.
17. The device of claim 16, wherein the conductive sensor is an
electromyography (EMG) sensor.
18. An electromagnetic treatment device, comprising: at least one
coil positioned in proximity to a body part of a patient, wherein
the at least one coil is configured to generate a magnetic stimulus
in proximity to the body part of the patient; at least one sensor
configured to provide feedback concerning a positioning of the at
least one coil relative to the body part of the patient; and a
controller in communication with the at least one sensor and the at
least one coil, wherein the controller is configured to control the
generation of the magnetic stimulus by allowing a current to pass
through the at least one coil in response to the feedback
concerning the positioning of the at least one coil provided by the
at least one sensor.
19. A method of treating headaches with electromagnetic
stimulation, comprising: positioning at least one coil in proximity
to a head of a patient; providing feedback via at least one sensor
concerning the positioning of the at least one coil passing a
current through the at least one coil; generating a magnetic
stimulus in proximity to the head of the patient; and controlling
via a controller the generation of the magnetic stimulus by
adjusting the current passed through the at least one coil in
response to the feedback concerning the positioning of the at least
one coil provided by the at least one sensor.
20. The method of claim 19, wherein the at least one sensor is a
mechanical switch.
21. The method of claim 20, further comprising providing feedback
via the mechanical switch concerning the positioning of the at
least one coil before the generation of the magnetic stimulus.
22. The method of claim 20, wherein the mechanical switch is
positioned next to or on the at least one coil.
23. The method of claim 20, wherein the mechanical switch provides
feedback indicating a correct positioning of the at least one coil
when the mechanical switch contacts or is depressed by a body part
of a patient.
24. The method of claim 19, wherein the at least one sensor is an
optical sensor.
25. The method of claim 19, wherein the at least one sensor is a
conductive sensor configured to detect an electrical conduction in
a nerve of a patient or to detect a muscular response caused by the
electrical conduction in the nerve indicating the positioning of
the at least one coil.
26. The method of claim 25, wherein the conductive sensor is an
electromyography (EMG) sensor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/457,228 filed Apr. 26, 2012 (now U.S. Pat.
No. 9,005,102), which is a continuation of PCT International Patent
Application Number PCT/US2010/054353, filed Oct. 27, 2010, which is
a continuation in part of U.S. patent application Ser. No.
12/606,941, filed Oct. 27, 2009 (now abandoned), which is a
continuation in part of U.S. patent application Ser. No.
11/866,329, filed Oct. 2, 2007 (now abandoned), which claims the
benefit of priority to U.S. Provisional Application No. 60/848,720,
filed Oct. 2, 2006, the contents of which are incorporated herein
by reference in their entirety.
BACKGROUND
[0002] Overactive bladder ("OAB") and urinary incontinence ("UI")
affect over 16% of the American population each year, or
approximately 34 million men and women. Outside of the United
States, OAB and UI affects over 46 million Europeans. The economic
cost of OAB and UI is estimated to be in excess of $12 billion a
year in the United States alone.
[0003] Due to the social stigmas attached to OAB and UI and to
misunderstandings related to the symptoms associated with OAB and
UI, only 40% of the affected individuals in the United States seek
medical treatment. Of those 13.6 million Americans seeking medical
treatment, nearly 30% or 4 million individuals are reportedly
unsatisfied with their current therapy.
[0004] Known treatments for OAB and UI include exercise and
behavioral modifications, pharmacological therapies, surgical
intervention and neuromodulation, but each of these treatments
exhibits severe limitations.
[0005] Exercise and behavioral modifications often require patients
to adhere to stringent routines, including scheduled voiding,
maintenance of a bladder diary, and intense exercise regimens.
While this type of treatment may be a viable option for a small
group of highly dedicated individuals, its daily impact on a
person's life makes it unattractive for most patients.
[0006] Pharmacological intervention is the most widely prescribed
therapy for OAB and UI. Unfortunately, patients often suffer from
side effects related to their drug therapies. Such side effects are
sometimes serious and are particularly pronounced in elderly
patient populations that tend to use a plurality of medications. In
addition, approximately 30% of all patients subjected to
pharmacological therapies appear to be dissatisfied with the
efficacy of their prescribed treatments.
[0007] Surgical intervention IS extremely invasive and often
results in a long-term requirement for catheterization that may
become permanent in some instances. The negative impact of these
procedures on the patient's quality of life and their high expense
make surgical intervention a recommended option only when all other
treatment options have been exhausted.
[0008] Neuromodulation is another available therapy for OAB and UI.
In general, pulsed electromagnetic stimulation ("PES") has proven
to have beneficial effects in a variety of medical applications.
The related scientific principle is that an electric current
passing through a coil generates an electromagnetic field, which
induces a current within a conductive material placed inside the
electromagnetic field.
[0009] More particularly, PES has been shown to be an effective
method of stimulating a nerve positioned within the electromagnetic
field, thereby affecting a muscle controlled by that nerve. For
example, in the paper titled "Contactless Nerve Stimulation and
Signal Detection by Inductive Transducer" presented at the 1969
Symposium on Application of Magnetism in Bioengineering, Maass et
al. disclosed that a nerve threading the lumen of a toroid could be
stimulated by a magnetic field of 0.7 Volt peak amplitude and a 50
.mu.s duration in a monitor wire, and that such stimulation could
generate a contraction of major leg muscles in anesthetized
mammals.
[0010] Various attempts were made to use PES for treating a variety
of ailments. For example, U.S. Pat. No. 4,548,208 to Niemi
discloses an apparatus for inducing bone growth by generating an
electric current in the body through the external application of an
electromagnetic field. Such apparatus includes opposing clamps
disposed on a limb and may optionally include feedback coils and a
microprocessor for sensing the magnetic field, so to avoid an
overcurrent mode. Therefore, this apparatus optimizes the magnetic
field on the basis of measurements of the generated magnetic
field.
[0011] U.S. Pat. No. 4,940,453 to Cadwell discloses a method and
apparatus for magnetically stimulating the neural pathways of a
higher level organism. A sinusoidally fluctuating current flow is
created through a coil that overlies neurons to be stimulated, and
frequency of the current flow and frequency of the magnetic field
produced by the coil predetermined to correspond to the time
constant of the neurons to be stimulated. Sensors for sensing coil
conditions, such as coil temperature, may also be included.
[0012] U.S. Pat. No. 5,000,178 to Griffith discloses an electrical
to electromagnetic transducer for applying electromagnetic energy
to damaged parts of a living body by directing electromagnetic
radiation to a certain damaged body part. Electromagnetic radiation
is initially generated by a dipole consisting of a bar of high
permeability material wrapped with an electrically conductive coil.
Magnetic fields, which are generated away from the damaged body
part, intersect a conductive shield and establish eddy currents,
which in turn generate magnetic fields opposite and nearly equal to
the magnetic fields generated by the electromagnetic source. The
resultant electromagnetic fields reinforce the electromagnetic
field directed towards the damaged body part and diminish the
electromagnetic field directed away from the damaged body part.
[0013] U.S. Pat. No. 5,014,699 to Pollack et al. discloses a
non-invasive, portable electromagnetic therapeutic method and
apparatus for promoting the healing of damaged or diseased living
tissue, including fractured bone. These method and apparatus
involve generating a signal that has a series of substantially
symmetric voltage cycles of bursted pulses with narrow pulse widths
of 0.5 to 20 microseconds, and further involve converting the
signal into an electromagnetic field extending into an area that
contains tissue to be healed. It provides for no feedback on the
efficiency of the applied stimulation.
[0014] In a paper titled "Selective Stimulation and Blocking of
Sacral Nerves: Research Setup and Preliminary Results," published
in Annual International Conference of the IEEE Engineering in
Medicine and Biology Society, Vol. 13, No. 2, 1991, Wijkstrda et
al. used an external pulsed magnetic coil to stimulate a peripheral
nerve for the treatment of urinary incontinence. The authors used a
large magnetic field produced by a single coil to ensure that the
nerve was fired and the resulting nerve conduction was frequently
painful or intolerable. In addition, coil alignment was problematic
because an internally implanted coil was utilized, which had to be
aligned with the fully external magnetic field to stimulate the
nerve. Due to the difficulty in positioning the device, the
practical application of this therapy does not permit home
healthcare usage without a preset alignment and monitoring of the
nerve, and no provision was made to insure that the nerve was
actually being stimulated or to adjust the device in response to
commonly occurring physiologic and anatomic variations in nerve
locations.
[0015] U.S. Pat. No. 5,181,902 Erickson et al. and U.S. Pat. No.
5,314,401 to Tepper disclose pulsed electromagnetic field ("PEMF")
transducer systems usable to perform PEMF therapies (such as after
spinal fusion) by generating flux-aided electromagnetic fields. The
drive electronics includes a PEMF processor that executes a PEMF
program for controlling the activation of the electromagnetic
fields (field strength and cycle).
[0016] In a paper titled: "Magnetic Stimulation of the Bladder in
Dogs" presented at the 1993 AAEM Annual Meeting, the abstract of
which was published in the Muscle & Nerve issue of October
1993, Lin et al. disclosed that magnetic stimulation could be
employed to stimulate the cortex, spinal nerves and peripheral
nerves of dogs through direct trans-abdominal stimulation of the
detrusor muscles or through stimulation of the lumbosacral
roots.
[0017] As shown, however, there has been no provision made to
measure the efficacy of PES treatment, causing patients to be
treated improperly, either by an insufficient or excessive exposure
to PES. Other attempts to monitor PES dosage exhibit serious
drawbacks. For example, U.S. Pat. No. 5,518,495 to Kot discloses an
apparatus for the treatment of arthritis utilizing a magnetic field
therapy, which includes an adjustable voltage source that is
connected to a source of line voltage and a coil connected to the
adjustable voltage source. This apparatus has no feedback system to
advise a healthcare provider of the efficiency of the
treatment.
[0018] U.S. Pat. No. 5,984,854 to Ishikawa et al. discloses a
method for treating urinary incontinence based on delivering a
train of current pulses through one or more magnetic stimulation
coils so to induce a train of magnetic flux pulses, which then
induce an eddy current within the body and stimulates a group of
pelvic floor muscles, the pudendal nerve, the external urethral
sphincter, or the tibial nerve. While this method includes the use
of pulsed electromagnetic for treating urinary incontinence, no
specific components are envisioned to facilitate the placement of
the magnetic coils over a targeted region of the body or a system
for monitoring the efficiency of the therapy being applied.
[0019] U.S. Pat. No. 6,086,525 to Davey et al. discloses a magnetic
nerve stimulator that includes a core constructed from a material
having a high field saturation having a coil winding disposed
thereon. A thyrister capacitive discharge circuit pulses the
device, and a rapidly changing magnetic field is guided by the
core, preferably made from vanadium permendur.
[0020] U.S. Pat. No. 6,701,185 to Burnett et al. also discloses an
electromagnetic stimulation device that includes a plurality of
overlapping coils, which can be independently energized in a
predetermined sequence such that each coil will generate its own
independent electromagnetic field and significantly increase the
adjacent field. Unfortunately, none of these patents provides a
system for monitoring the efficiency of the therapy in progress,
either with respect to the proper positioning of the winding over
the area to be treated or of the intensity of the magnetic field to
be applied.
[0021] Other PES therapies require the implantation of devices into
the patient, with the consequent discomfort, risk and cost to the
patient. For example, U.S. Pat. No. 6,735,474 to Loeb et al.
discloses a method and system for treating UI and/or pelvic pain by
injecting or laparoscopically implanting one or more battery- or
radio frequency-powered microstimulators that include electrodes
placed beneath the skin of the perineum and/or adjacent the tibial
nerve.
[0022] U.S. Pat. No. 6,941,171 to Mann et al. describes a method
and a system for treating incontinence, urgency, frequency, and/or
pelvic pain that includes implantation of electrodes on a lead or a
discharge portion of a catheter adjacent the perineal nerve(s) or
tissue(s) to be stimulated. Stimulation pulses, either electrical
or drug infusion pulses, are supplied by a stimulator implanted
remotely through the lead or catheter, which is tunneled
subcutaneously between the stimulator and stimulation site.
[0023] Other PES therapies involve the use of electrodes placed on
or beneath the skin of a patient. Recent data on invasive,
needle-based PES of the posterior tibial nerve in individuals with
OAB and UI indicates that PES can modulate bladder dysfunction
through its action on the pudendal nerve and the sacral plexus,
which provide the major excitatory input to the bladder.
[0024] In a paper titled "Percutaneous Tibial Nerve Stimulation via
Urgent.RTM. PC Neuromodulation System--An Emerging Technology for
managing Overactive Bladder," which was published in Business
Briefing: Global Surgery 2004, CystoMedix, Inc. disclosed that
peripheral tibial nerve stimulation ("PTNS") had been found
effective in treating OAB. The disclosed procedure involved the use
of electrode and generator components, including a small 34-gauge
needle electrode, lead wires and a hand-held electrical generator.
However, the procedure requires the permanent implantation of an
electrical stimulation device in the patient. One estimate put the
cost of treatment at nearly $14,000 with additional routine care
costs of $593 per patient per year. Additionally, risks of battery
failure implant infection, and electrode migration led to a high
re-operation rate and made this procedure unattractive.
[0025] U.S. Pat. No. 7,117,034 to Kronberg discloses a method for
generating an electrical signal for use in biomedical applications
that includes two timing-interval generators. Skin-contact
electrodes may be placed over an area of interest and a
microprocessor may direct timing and sequencing functions, although
such timing and sequencing functions are not related to the actual
efficacy of the treatment while treatment is being performed.
[0026] U.S. Patent Application Publication No. 2005/0171576 to
Williams et al. discloses an electro-nerve stimulation apparatus
that includes a pulse generator, a first electrically conductive,
insulated lead wire, a second electrically conductive, insulated
lead wire, an electrically conductive transcutaneous electrode and
an electrically conductive percutaneous needle electrode. Connected
to one end of the first and second lead wires is a connector for
electrically coupling with the pulse generator. A percutaneous
needle electrode is inserted through the skin in proximity to the
desired internal stimulation site and electric stimulation is
employed, rather than pulsed electromagnetic stimulation. Moreover,
Williams does not contemplate mechanisms for facilitating use of
the device by an untrained user, nor a monitoring of the applied
therapy.
[0027] A neuromodulation alternative is a posterior tibial nerve
stimulator, often referred to as SANS, but as is the case with
other forms of neuromodulation, this procedure is invasive in
nature and requires the insertion of a needle five centimeters into
the patient's ankle region to stimulate the posterior tibial nerve.
This procedure also requires a minimum of twelve sessions for
initial treatment, possibly with additional sessions required for
maintenance.
SUMMARY
[0028] Energy emitting systems and methods for providing a medical
therapy are provided. In certain embodiments, the energy emitting
system may include a conductive coil configured to generate a
magnetic or electromagnetic field focused on a target nerve. The
conductive coil may be adjustable and include a first end, a second
end, and one or more turns positioned there between where the first
turn surrounds a central aperture. The central aperture may be
adjustable or movable between a first configuration and a second
configuration where the second configuration has a radius that is
greater than the radius of the first configuration. The adjustable
or movable nature of the coil allows the conductive coil or energy
emitting system to conform to, accommodate, surround or be
positioned or fit on a particular anatomical structure of a patient
and to thereby be positioned in proximity to the underlying target
nerve.
[0029] Optionally, the conductive coil can include a hinge or other
pivoting mechanism positioned along a central axis of the
conductive coil. The hinge could divide the coil into a first
portion and a second portion where either the first portion, second
portion or both are pivotable about the hinge such that dimensions
of the central aperture and the coil could be adjusted, altered, or
manipulated.
[0030] In certain embodiments, a method of magnetic induction
therapy includes positioning a conductive coil relative to a first
portion of a patient's body in proximity to an underlying target
nerve to concentrate an electromagnetic flux on the underlying
target nerve. The positioning of the coil may include adjusting or
manipulating the central aperture of the conductive coil, such that
the conductive coil accommodates, conforms to, surrounds or is
positioned or fit on or around the first portion of the patient's
body. Once the coil is in place, a current is passed through the
conductive coil to generate a magnetic field focused on the target
nerve.
[0031] In other embodiments, an energy emitting system for
providing a medical therapy can include a conductive coil
configured to generate a magnetic or electromagnetic field focused
on a target nerve. The conductive coil may have a first end, a
second end, and one or more turns there between. The first turn
surrounds a central aperture which is sized to receive a first
portion of a patient's body such that the conductive coil can be
positioned in proximity to the underlying target nerve.
[0032] Other features and advantages will appear hereinafter. The
features and elements described herein can be used separately or
together, or in various combinations of one or more of them.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] The drawings constitute a part of this specification and
include exemplary embodiments of the invention, which may be
embodied in various forms. It is to be understood that in some
instances various aspects of the embodiments may be shown
exaggerated or enlarged to facilitate an understanding of the
embodiments.
[0034] FIG. 1 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0035] FIG. 2 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0036] FIG. 3 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0037] FIG. 4 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0038] FIG. 5 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0039] FIGS. 6A-6D are schematic illustrations depicting a first
method of use of an apparatus for magnetic induction therapy. This
method is based on adjusting the position of the conductive coils
so to optimize a magnetic flow applied to a target nerve.
[0040] FIGS. 7A-7D are schematic illustrations of a second method
of use of an apparatus for magnetic induction therapy. This method
is based on locking the conductive coils in position once
electrical conduction in a target nerve has been detected.
[0041] FIG. 8 is a schematic view of an embodiment that includes a
plurality of sensors.
[0042] FIGS. 9A-9D are schematic representations of different
garments adapted to operate as apparatus for magnetic induction
therapy.
[0043] FIG. 10 is a schematic view of an apparatus for providing
electrical stimulation.
[0044] FIG. 11 is a schematic view of another embodiment of an
apparatus for providing electrical stimulation.
[0045] FIG. 12a shows a schematic view of an energy emitting system
including a sensor.
[0046] FIG. 12b shows a side view of a variation of a conductive
coil.
[0047] FIG. 12c shows a cross sectional view of the conductive coil
of FIG. 12b positioned on a patient.
[0048] FIG. 13a shows a side view of a variation of a conductive
coil.
[0049] FIG. 13b shows a side view of the conductive coil of FIG.
13a with the central aperture in an expanded configuration.
[0050] FIG. 13c shows an end view of the conductive coil of FIG.
13a.
[0051] FIG. 13d shows a cross sectional view of the conductive coil
of FIG. 13a positioned on a patient.
[0052] FIG. 14a shows a side view of a variation of a conductive
coil.
[0053] FIG. 14b shows a side view of the conductive coil of FIG.
14a with the central aperture in an expanded configuration.
[0054] FIG. 15a shows a side view of a variation of a conductive
coil.
[0055] FIG. 15b shows a side view of the conductive coil of FIG.
15a with the central aperture in an expanded configuration.
[0056] FIG. 16a shows an end view of a variation of conductive
coil.
[0057] FIG. 16b shows a cross sectional view of the conductive coil
of FIG. 16a positioned on a patient.
[0058] FIG. 17 shows a variation of a system including a sensor for
detecting the position of a body part.
DETAILED DESCRIPTION
[0059] Detailed descriptions of various embodiments are provided
herein. It is to be understood, however, that the embodiments may
be embodied in various forms. Therefore, the specific details
disclosed herein are not to be interpreted as limiting, but rather
as a representative basis for teaching one skilled in the art how
to employ the various embodiments in virtually any detailed system,
structure, or manner.
[0060] Various embodiments will now be described. The following
description provides specific details for a thorough understanding
and enabling description of these embodiments. One skilled in the
art will understand, however, that the embodiments may be practiced
without many of these details. Additionally, some well-known
structures or functions may not be shown or described in detail so
as to avoid unnecessarily obscuring the relevant description of the
various embodiments.
[0061] The terminology used in the description presented below is
intended to be interpreted in its broadest reasonable manner, even
though it is being used in conjunction with a detailed description
of certain specific embodiments. Certain terms may even be
emphasized below. Any terminology intended to be interpreted in any
restricted manner, however, will be overtly and specifically
defined as such in this detailed description section.
[0062] Where the context permits, singular or plural terms may also
include the plural or singular term, respectively. Moreover, unless
the word "or" is expressly limited to mean only a single item
exclusive from the other items in a list of two or more items, then
the use of "or" in such a list is to be interpreted as including
(a) any single item in the list, (b) all of the items in the list,
or (c) any combination of items in the list.
[0063] Referring first to FIG. 1, a first embodiment includes a
coil wrap 20, which is depicted as disposed over ankle 22
circumferentially to surround a portion of tibial nerve 24. Because
tibial nerve 24 is targeted, this embodiment is particularly suited
for the treatment of OAB and VI. In other embodiments, coil wrap 20
may be configured to surround other body parts that contain a
portion of tibial nerve 24 or of other nerves branching from or
connected to tibial nerve 24, still making these embodiments
suitable for treating OAB and VI. In still other embodiments, coil
wrap 20 may be configured for surrounding body parts that contain
other nerves when treatments of other ailments are intended.
[0064] Coil wrap 20 may be manufactured from a variety of materials
suitable for wearing over ankle 22. Preferably, coil wrap is
produced from a soft, body-compatible material, natural or
synthetic, for example, cotton, wool, polyester, rayon.
Gore-Tex.RTM., or other fibers or materials known to a person
skilled in the art as non-irritating and preferably breathable when
tailored into a garment. Coil wrap 22 may even be manufactured from
a molded or cast synthetic material, such as a urethane gel, to add
extra comfort to the patient by providing a soft and drapable feel.
Additionally, coil wrap 20 may be produced from a single layer of
material or from multiple material layers and may include padding
or other filling between the layers.
[0065] Coil wrap 20 contains one or more conductive coils 26
arranged to produce a pulsed magnetic field that will flow across
tibial nerve 24 and generate a current that will flow along tibial
nerve 24 and spread along the length of tibial nerve 24 all the way
to its sacral or pudendal nerve root origins. Coils 26 may be a
single coil shaped in a simple helical pattern or as a figure eight
coil, a four leaf clover coil, a Helmholtz coil, a modified
Helmholtz coil, or may be shaped as a combination of the
aforementioned coils patterns. Additionally, other coil designs
beyond those mentioned hereinabove might be utilized as long as a
magnetic field is developed that will encompass tibial nerve 24 or
any other target nerve. When a plurality of coils is utilized, such
coils may be disposed on a single side of ankle 22, or may be
disposed on more than one side, for example, on opposing sides,
strengthening and directionalizing the flow of the magnetic field
through tibial nerve 24 or other peripheral nerves of interest.
[0066] Coil wrap 20 is preferably configured as an ergonomic wrap,
for example, as an essentially cylindrical band that can be pulled
over ankle 22, or as an open band that can be wrapped around ankle
22 and have its ends connected with a buckle, a hoop and loop
system, or any other closing system known to a person skilled in
the art. By properly adjusting the position of coil wrap 20 over
ankle 22, a patient or a health care provider may optimize the flow
of the magnetic field through tibial nerve 24, based on system
feedback or on sensory perceptions of the patient, as described in
greater detail below.
[0067] The electric current that produces the magnetic field by
flowing through coils 26 is supplied by a programmable logic
controller 28, which is connected to coils 26, for example, with a
power cord 32. A sensor 30 that feeds information to logic
controller 28 is also provided, in order to tailor the strength of
the magnetic field and control activation of coils 26 based on
nerve conduction. The purpose of sensor 30 is to detect and record
the firing of the target nerve and to provide related information
to logic controller 28, so to render the intended therapy most
effective. For example, sensor input may cause logic controller 28
to alter the strength or pulse amplitude of the magnetic field
based on sensor input, or fire the coils in a certain sequence.
[0068] In this embodiment, as well as in the other embodiments
described hereinafter, sensor 30 may include one or more sensor
patches and may be placed at different distances from the region of
direct exposure to the magnetic field. For example, sensor 30 may
be configured as a voltage or current detector in the form of an
EKG patch and may be placed anywhere in the vicinity of the target
nerve to detect its activation. For ease of description, the term
"coils" will be used hereinafter to indicate "one or more coils"
and "sensor" to indicate "one or more sensors," unless specified
otherwise.
[0069] By virtue of the above described arrangement, coil wrap 20
provides a reproducibly correct level of stimulation during an
initial therapy session and during successive therapy sessions,
because the presence or absence of nerve conduction is detected
and, in some embodiments, measured when coil wrap 20 is first
fitted and fine-tuned on the patient. In addition to properly
modulating the applied magnetic field, the positioning of coils 26
over ankle 22 may also be tailored according to the input provided
by sensor 30, so to fine-tune the direction of the magnetic field.
Such an adjustment of the direction, amplitude, and level of the
stimulation provided to the target nerve through the above
described automated feedback loop, to ensure that peripheral nerve
conduction is being achieved can be an important feature when
implemented.
[0070] If the magnetic pulse does not substantially interfere with
sensor 30, sensor 30 may be placed directly within the field of
stimulation, so that power supplied to the system may be conserved.
This is particularly important for battery-powered systems.
Alternatively, sensor 30 may also be placed at a distance from the
magnetic field and still properly detect neural stimulation.
[0071] In a method of use of coil wrap 20, the amplitude and/or
firing sequence of coils 26 may be ramped up progressively, so that
the magnetic field is increased in strength and/or breadth until
nerve conduction is detected, after which the applied stimulus is
adjusted or maintained at its current level for the remainder of
the therapy. The level of stimulation may be also controlled
through a combination of feedback from sensor 30 and feedback based
on perceptions of the patient. For example, the patient may
activate a switch once she perceives an excessive stimulation, in
particular, an excessive level of muscular stimulation. In one
instance, the patient may be asked to push a button or turn a knob
when she feels her toe twitching or when she experiences
paresthesia over the sole of her foot. The patient will then
continue pressing the button or keep the knob in the rotated
position until she can no longer feel her toe twitching or
paresthesia in her foot, indicating that that level of applied
stimulation corresponds to an optimal therapy level. From that
point on, the patient may be instructed to simply retain her foot,
knee, or other limb within coil wrap 20 until therapy has been
terminated while the system is kept at the optimal level. Adding
patient input enables control of coil wrap 20 during outpatient
treatments, because the patient is now able to adjust the intensity
of the magnetic field herself beyond the signals provided to logic
controller 28 by sensor 30.
[0072] Detecting and, if the case, measuring conduction in one or
more nerves along the conduction pathways of the stimulated nerve
confirms that the target nerve has been stimulated, providing an
accurate assessment of the efficiency of the applied therapy on the
patient. A concomitant detection of muscle contraction may also
confirm that the target nerve is being stimulated and provide an
indication to the patient or to a healthcare provider as to whether
stimulation has been applied at an excessive level in view of the
anatomical and physiological characteristics of the patient.
[0073] Based on the foregoing, coil wrap 20 allows for a
consistent, user-friendly targeting and modulation of the
peripheral nerves via the posterior tibial nerve on an outpatient
basis, in particular, the targeting and modulation of the pudendal
nerve and of the sacral plexus. When multiple coils 26 are present,
coils 26 may be activated simultaneously or differentially to
generate the desired magnetic field. The direction and location of
each of coils 26 may be reversibly or irreversibly adjusted by the
healthcare provider or by the patient, customizing the location of
the applied stimulation to the anatomy and therapy needs of each
patient. After a healthcare provider has optimized position and
firing sequence for each of coils 26, the patient may be sent home
with coil wrap 20 adjusted to consistently target the desired
nerve. In one variant of the present embodiment, an automatic
feedback system adjusts one or more of firing sequence, firing
strength or position of coils 26 within coil wrap 20 during the
initial setup and also during successive therapy sessions.
[0074] In summary, certain embodiments include the creation of a
loop consisting of feeding information on nerve conduction to logic
controller 28 and on logic controller 28 tailoring the electrical
current sent to coil wrap 20 according to the information received
from sensor 26 based on whether or not the nerve is receiving the
desired stimulation and, in some embodiments, the desired amount of
stimulation. This arrangement offers an unparalleled level of
therapy control and flexibility within a home care setting, because
a consistent, repeatable stimulation of the target nerve can be
attained. Aside from adjusting the position of coils 26 in
accordance with the patient's anatomy and physiological variations,
controlling pulse amplitude is also of great importance even during
different therapy sessions with the same patient. For example, a
patient with leg edema will encounter difficulties in properly
adjusting coil wrap 20 based on whether her legs and ankles are
swollen or not swollen, and the power required to penetrate to
posterior tibial nerve 24 (in the case of a VI therapy) will vary
greatly due to the variable depth of the nerve. Thus, having
feedback provided by sensor 26 becomes a necessity for achieving an
accurate dosage of the treatment rather than an option. Benchtop
testing has demonstrated that a system constructed according
embodiments described herein is capable of non-invasively
generating electrical currents similar to those found in
therapeutic electro-stimulation and to do so in different
settings.
[0075] Referring now to FIG. 2, a second embodiment will be
described with reference to a coil wrap 34 disposed over ankle 36
for the purpose of treating VI by targeting tibial nerve 38. In
this second embodiment, one or more Helmholtz coils 40 are disposed
within coil wrap 34 to create a more narrowly directed magnetic
field over tibial nerve 38. Like in the all other embodiments
described herein, more than one coil (in the present embodiment,
more than one Helmholtz coil 40) may be placed within coil wrap 34
and be disposed in different positions within coil wrap 34, in
order to optimize magnetic flux over tibial nerve. For example, two
Helmholtz coils may be disposed one opposite to the other within
coil wrap 34.
[0076] Having coil windings arranged along a common longitudinal
axis, as required in a Helmholtz coil configuration, generates a
more focused magnetic field and a more accurate targeting of tibial
nerve 38 or of any other nerve. Like in the previous embodiment,
the operation of coils 40 is controlled by a logic controller 42,
which is in turn connected to sensor 44 that monitors conduction in
tibial nerve 44 and that generates a feedback to logic controller
42 about the efficiency of the therapy in progress. Therefore, like
in the previous embodiment, the coupling of sensor 44 with logic
controller 42 optimizes operation of coil wrap 34 according to
results measured at the level of tibial nerve 38. Also like in the
previous embodiment, manual adjustments to the parameters of
electric current provided by logic controller 42 to Helmholtz coil
40 may also be made manually by the patient or by a healthcare
provider, and coil wrap 34 may be structured so that the position
of Helmholtz coil 40 within coil wrap 34 is adjusted as desired
either manually by the patient or by a healthcare provider, or
automatically by logic controller 42.
[0077] Referring now to FIG. 3, a third embodiment includes a coil
wrap 46 configured for wrapping over the popliteal fossa of a
patient, in the region of the knee, to stimulate the posterior
tibial nerve (not shown). The configuration and structure of coil
wrap 46 reflect the body portion covered by coil wrap 46, but the
key system components of coil wrap 46, such as the type, number and
disposition of the coils (for example, the use of overlapping
coils); the connections of the coils with a logic controller; and
the use of one or more sensors (also not shown) to detect nerve
conduction are all comparable to those in the previously described
embodiments.
[0078] Referring now to FIG. 4, a fourth embodiment includes a
footrest or foot cradle 48, which is structured to contain at least
a portion of a foot 50. One or more coils 52 are enclosed within
cradle 48, and a sensor 54 is disposed along the pathway of tibial
nerve 55, sensing conduction in tibial nerve 55, and is also
connected to a logic controller 56. Coils 52, sensor 54 and logic
controller 56 may be arranged in different configurations, in the
same manner as in the preceding embodiments.
[0079] Cradle 48 may be made from a variety of materials and may be
monolithic, or have a hollow or semi-hollow structure to enable the
movement of coils 52 within cradle 48, as described in greater
detail below. Preferably, cradle 48 has an ergonomically design
allowing the ankle and heel of the patient to be retained within
cradle 48, in a position that matches the positions of stimulating
coils 52 to the area of stimulation. The design of cradle 48
provides for a particularly comfortable delivery of therapy to
patients that prefer to remain seated during their therapy, and
enables the patient to perform the required therapy within a health
care facility, or to take cradle 48 home, typically after an
initial session and appropriate training in a health care facility.
In that event, the patient will be trained to apply sensor 54
autonomously and to adjust stimulation to a comfortable level.
[0080] FIG. 4 shows coils 52 disposed as overlapping and the use of
a single sensor patch 54 positioned proximally to the stimulation
site. However, coil 52 may be configured as a single coil, a figure
eight coil, a four leaf clover coil, a Helmholtz coil, a modified
Helmholtz coil or a any combination of the aforementioned coils, or
as any other coil design providing an effective stimulation to the
target nerve. In addition, coils 52 may be fired individually,
sequentially or simultaneously according to the feedback provided
by sensor 54.
[0081] In one variant of this embodiment, sensor 54 may include a
conductive electrode patch that provides a feedback to logic
controller 56 for adjusting, if necessary, the stimulation
parameters of coils 52. Alternatively, sensor 54 may be a sensor
patch that is either applied to the skin of the patient or is
incorporated within the structure of cradle 48.
[0082] Referring now to FIG. 5, a fifth embodiment includes a knee
rest or knee cradle 58 that contains one or more conductive coils
60, one or more sensors 62 and a logic controller 64. The
components of this embodiment are similar to those described with
reference to the preceding embodiments, as regards the structure
and materials of cradle 58, the nature and disposition of coils 60,
the type and operation of sensor 62, and the function and operation
of logic controller 64. Cradle 58 is configured to target the
popliteal fossa of the patient, thus to target tibial nerve 66. In
that respect, the present embodiment is similar to the embodiment
illustrated in FIG. 3, but while the embodiment of FIG. 3 is
configured as a wrap that may be worn while the patient is
standing, the present embodiment is configured as a cradle that is
more suited for treatment while the patient is sitting or laying
down.
[0083] A method of use of the foot cradle depicted in FIG. 4 is
described with reference to FIGS. 6A-6D. During a first step
illustrated in FIG. 6A, foot 68 is disposed in cradle 70 that
contains one or more conductive coils 72, which are connected to a
logic controller (not shown) that manages the flow of electric
power to coils 72.
[0084] During a second step illustrated in FIG. 6B, a sensor 74 is
disposed on foot 68 or on ankle 76 or on another appropriate
portion of the patient's body, in order to detect conductivity in
tibial nerve 78 or in another target nerve.
[0085] During a third step illustrated in FIG. 6C, a healthcare
provider analyzes conductivity measurements provided by sensor 74
(for example, by reading gauge 77) and first adjusts the
positioning of coils 72 until conduction in nerve 78 is detected.
For example, the healthcare provider may rotate a knob 80, slide a
lever or actuate any other displacement system for coils 72 that is
known in the art, so that coils 72 are translated until a magnetic
field of the proper amplitude and intensity is applied to cause
conduction in nerve 78. The position of coils 72 is then fine-tuned
manually until an optimal level of conduction in nerve 78 is
attained, and the therapy is continued for a length of time as
prescribed by the attending healthcare provider.
[0086] During a fourth, optional step illustrated in FIG. 6D,
settings for successive therapy sessions are set, for example by
locking knob 80 (in one embodiment, with a pin 81) so that the
healthcare provider or the patient repeat the therapy using the
predetermined settings. Alternatively, the patient may be trained
to adjust the amplitude and/or strength of the applied magnetic
field, as each therapy session requires.
[0087] While the present method has been described with regard to
foot cradle 70, the same method steps may be envisioned for coil
wraps or cradles of different configurations, for example, for the
coil wraps and cradles described with reference to the previous
figures.
[0088] In an alternative embodiment, the logic controller (not
shown) may automatically adjust coil positioning to optimize
therapy during the initial and successive sessions. While this
set-up may be more difficult to implement, it also provides for an
accurate targeting of the target nerve during each therapy session,
regardless of alterations in patient positioning or changes to the
anatomy of the patient (for example, when a foot is swollen). In
this embodiment, the device simply varies the orientation of coils
84 until stimulation has been sensed.
[0089] Further, coils 84 may be translated along a single direction
(for example, horizontally) or along a plurality of directions, to
provide for the most accurate positioning of coils 84 with respect
to the target nerve.
[0090] A second method of use of the foot cradle depicted in FIG. 4
is described now with reference to FIG. 7. While this second method
is also described with reference to a foot cradle 82 employing one
or more coils 84 that have a reversibly lockable, adjustable
orientation, the present method may be equally implemented with a
body-worn coil wrap, such as those described with reference to the
previous figures, or to other embodiments. In this method, the
patient or the healthcare provider adjusts the positioning of coils
84 to detect conductivity in target nerve 89.
[0091] The position of coils 84 may be translated in different
directions (in the illustrated embodiment, may be translated
horizontally) and may be locked in an initial position once
conduction in nerve 89 is detected by a sensor (for example,
sensing patch 86)
[0092] More particularly, FIG. 7A illustrates the initial
positioning of foot 88 into cradle 82 and of sensor patch 86 on
ankle 90 or other appropriate body part of the patient. After
proper positioning of foot 88 is attained, a knob 92 (or other
equivalent device) may be employed to adjust the position of coils
84, based on the signals (for example, nerve conduction signals)
provided by sensor patch 86, as shown in FIG. 7B.
[0093] With reference to FIG. 7C, after neural conduction is
detected, coils 84 are locked in place, and, with further reference
to FIG. 7D, foot cradle 82 retains coils 84 locked in position for
further use in a home or healthcare office environment. Therefore,
in the present method, the patient or a healthcare provider simply
adjusts coil position by sliding coils 84 back and along one axis
until electric conduction in the target nerve is detected, although
adjustments along all three axes may be possible in different
variants of the present embodiment.
[0094] Referring now to FIG. 8, a sixth embodiment relates to the
use of multiple sensors. While FIG. 8 depicts an embodiment shaped
as a foot cradle 98, it should be understood that the following
description also relates to any other design, whether shaped as a
cradle or a wrap or otherwise. The plurality of sensors 94
described herein may detect a variety of physiologic changes,
including neural impulses, muscular contraction, twitching, etc.
that may occur with neural or muscular stimulation.
[0095] One or more of the illustrated sensors 94 may be employed
over body regions being stimulated (for example, back, leg, arm,
neck, head, torso, etc.) and may be either incorporated within an
actual cradle or wrap or, otherwise, be applied separately from the
cradle or the wrap.
[0096] Sensors 94 may be structured as disposable, single-use,
EKG-type patches that are attached to the body outside of cradle 98
along the nerve conduction pathway and are then connected to the
logic controller (not shown) before beginning therapy. This
arrangement provides for an intimate body contact of sensors 94
without the risk of infection or other detrimental side effects
that may be present with transcutaneous devices. Sensors 94 may be
employed both for beginning and for monitoring the stimulation
therapy; more specifically, sensors 94 may be employed during the
beginning of the therapy to optimize the strength of the magnetic
field and/or to adjust the positioning of coils 96 within the
cradle 98. Once therapy has begun, sensors 94 continue to monitor
nerve conduction to ensure that the correct level of stimulation is
being provided. In the event that for some reason nerve conduction
decays during therapy, the logic controller can automatically
adjust the magnetic field, ensuring that the appropriate therapy is
delivered for the appropriate amount of time.
[0097] One or more of sensors 94 in this embodiment, or any of the
embodiments described herein, may take the form of an inductive
coil designed to receive impulses from the underlying nerves, so
that inductive technologies may be used to both stimulate the nerve
or tissues as well as to record the effect of the stimulation on
nerves or tissues. Any of sensors 94 may be connected to the logic
controller through one or more connection modes, including, but not
limited to, wireless signals, wired signals, radio frequencies,
Bluetooth, infrared, ultrasound, direct switching of the current
circuit, etc., so long as communication between the sensor and the
device is effective.
[0098] During implementation of the present method, a healthcare
provider may simply elect to use sensors 94 to adjust the device,
for example, to lock coils 96 into position, during the first
therapy session and not require the use of sensors 94 during each
successive therapy session.
[0099] Referring now to FIGS. 9A-9D, there are shown different,
non-limiting embodiments shaped as body worn ergonomic applicator
garments. Each of these embodiments is shown with overlapping
coils, although coils of any configurations may be used. Each of
the wraps of FIGS. 9A-9D corresponds to a coil wrap, into which a
body part may be placed. These garments contain one or more sensors
(not shown) that provide feedback to a logic controller (also not
shown), or sensors may be applied separately from those garments.
Systems may also be included for reversibly or irreversibly locking
the coils within the applicator.
[0100] More particularly, FIG. 9A illustrates an embodiment, in
which coils 100 are embedded in a knee wrap 102 and are connected
to a logic controller (not shown) by a connector 104. FIG. 9B
instead illustrates an embodiment, in which coils 106 are disposed
within an abdominal garment, for example shorts 108 and in which
coils 106 are also connected to a logic controller (not shown) by a
connector 110. A marking 112 may be added on one side of shorts 108
to indicate wrap orientation. FIG. 9C illustrates a coil wrap
shaped like a band 114, in which coils 116 are connected to a logic
controller (not shown) by a connector 118. When this embodiment is
employed, band 114 may be wrapped around a body portion (for
example, an arm) and be retained in place by a system known in the
art, for example, a hook and loop system, a strap and buckle
system, or simply a hook disposed at one end of band 114 for
engaging fabric or other material in another portion of band 114.
FIG. 9D illustrates an embodiment shaped as a shoulder strap 120,
the length of which may be adjusted by a buckle 122 and which has
coils 124 disposed in one or more points, for example, at the joint
between an arm and a shoulder as shown. Each of these embodiments
includes one or ore sensors (not shown) that may be coupled to the
garment, or that may be applied separately from the garment.
[0101] Other embodiments that are not illustrated include, bur are
not limited to: a head worn garment, such as a cap; a neck worn
garment, such as a neck brace; and a lower-back garment. Each
garment and applicator may also utilize the locking, targeting coil
feature described previously, without requiring the use of the any
sensing components after a proper positioning of the coils in
relation to the target nerve or nerves has been established.
[0102] Still other embodiments are depicted in FIGS. 10 and 11. In
these embodiments, the source of energy for nerve stimulation is
electrical energy that is dispensed through a percutaneous
stimulator, such as a percutaneous needle 124, or a transcutaneous
stimulator, such as an electrode 126. As shown in FIG. 10, an
electrical pulse controller 128 is electrically connected both to
percutaneous needle 124 and to sensor 134, to provide the desired
feedback and modulate the power to percutaneous needle 134. In the
embodiment of FIG. 11, electrical pulse controller 130 is connected
both to electrode 126 and to sensor 136, and performs a function
similar to that of electrical pulse controller 128. With these
embodiments, nerve conduction may be detected at a site
sufficiently distant from the site of stimulation, so to enable
detection of nerve conduction despite the confounding interference
from the direct electrical stimuli. Further, direct electrical
stimulation of nerve and muscle may be tailored to provide optimal
therapy and, in the case of electrode migration or other electrode
malfunction, to report lack of stimulation of the bodily tissues.
Still further, these embodiments enable a reduction in power
requirement, because control of the signal is provided by the
sensor to the signal generator loop.
[0103] As shown, a device constructed according to the principles
described herein can provide a targeted and precise stimulation of
the posterior tibial nerve, or of other peripheral nerves, in a
non-invasive manner by employing an ergonomic wrap or cradle that
specifically targets the posterior tibial nerve in a consistent and
repeatable manner. For example, in patients with OAB or VI, the
novel, reversibly lockable movement of the coils and the use of a
logic controller-sensor loop enables the application of a magnetic
field that can be varied in location, amplitude and strength
according to the amount of stimulation actually induced in one or
more target nerves and of the response of the patient to the
therapy. An apparatus according to certain embodiments described
herein may deliver any frequency of stimulation, including low
frequencies, high frequencies, mid frequencies and ultrahigh
frequencies, and overlapping and non-overlapping coils may be used
to generate the desired field, although overlapping or Helmholtz
coils are preferred due to their ability to target a broader region
and achieve more thorough stimulation.
[0104] Ailments that may be treated through the use of the various
embodiments of the apparatus and methods described herein include
not only OAB and VI, but also obesity, depression, urinary
incontinence, fecal incontinence, hypertension, pain, back pain,
restless leg syndrome, Guillain Barre syndrome, quadriplegia,
paraplegia, diabetic polyneuropthy, dyskinesias, paresthesias,
dental procedure pain, knee osteoarthritis, anesthesia (pain relief
during surgery), Alzheimer's disease, angina (chest pain from heart
disease), ankylosing spondylitis, back pain, burn pain, cancer
pain, chronic pain, dysmenorrhea (painful menstruation), headache,
hemiplegia, hemiparesis (paralysis on one side of the body), labor
pain, local anesthesia during gallstone lithotripsy, facial pain,
trigeminal neuralgia, bruxism (tooth grinding) pain, myofascial
pain, pregnancy-related nausea or vomiting, neck and shoulder pain,
pain from broken bones, rib fracture or acute trauma, diabetic
peripheral neuropathy, phantom limb pain, post-herpetic neuralgia
(pain after shingles), postoperative ileus (bowel obstruction),
irritable bowel syndrome, postoperative nausea or vomiting,
postoperative pain, post-stroke rehabilitation, rheumatoid
arthritis, skin ulcers, spinal cord injury, temporomandibular joint
pain, detrusor instability, spinal muscular atrophy (in children),
pain during hysteroscopy, gastroparesis, chronic obstructive
pulmonary disease rehabilitation, carpal tunnel syndrome, soft
tissue injury, multiple sclerosis, intermittent claudication,
attention-deficit hyperactivity disorder (ADHD), cognitive
impairment, knee replacement pain, achalasia, atopic eczema,
bursitis, carpal tunnel syndrome, dementia, depression, dry mouth,
dystonia, enhanced blood flow in the brain, enhanced blood
perfusion of the uterus and placenta, esophageal spasm,
fibromyalgia, fracture pain, Guillain-Barre syndrome, hemophilia,
herpes, hip pain, interstitial cystitis, irritable bowel syndrome,
pruritis, joint pain, labor induction, local anesthesia, menstrual
cramps, muscle cramps, muscle spasticity, muscle strain or pain,
musculoskeletal trauma, myofascial pain dysfunction syndrome, nerve
damage, osteoarthritis, pain medication adjunct, pancreatitis,
Raynaud's phenomenon, repetitive strain injuries, sacral pain,
schizophrenia, shingles, shoulder subluxation, sickle cell anemia
pain, Skin flap ischemia (during plastic surgery), sphincter of
Oddi disorders, sports injuries, thrombophlebitis, tinnitus
(ringing in the ear), restless legs, tremor, whiplash and
neuralgias. In contrast to implantable nerve stimulators, this
therapy is completely non-invasive and does not require a major
surgery to implant a permanent nerve stimulation device. Moreover,
this therapy can be controlled to optimize the level of therapy
delivered according to power consumption and nerve stimulation
requirements and need not be delivered by a professional healthcare
provider.
[0105] In other embodiments, neural stimulation may be applied as
electrical transcutaneous stimulation, for example, by inserting an
invasive electrical needle into a target body part and by
modulating stimulation is modulated on the basis of information
sent back to the logic controller from the one or more sensors that
are used to detect and/or maintain the correct level of
stimulation. The transcutaneous electrical stimulation sensor may
be placed in the body independently or be incorporated within the
wrap and may provide, among other things, feedback as to the
quality of the electrical connection to the skin, which is directly
related to the burn risk inherently associated with this type of
therapy. In fact, these methods of stimulation may not be optimal
due to the resulting skin irritation and risk of potential burns, a
very serious issue in the large percentage of patients that have
neuropathies. Even when patches are applied to monitor
transcutaneous stimulation very closely, the patches may still
become displaced and allow a burn to occur. Moreover, potentially
interfering electrical impulses may develop at the treatment site,
creating a noisy environment for the detection of nerve
conduction.
[0106] In still other embodiments, an external coil or coils may be
inductively connected to an implanted coil or coils may be
utilized. In these embodiments, an ergonomic applicator may be
adjusted by the user or by a healthcare provider such to optimize
inductive power transmission between the external and implanted
coils. One or more sensors may be utilized to provide a feedback
that the relative coil positions have been optimized, and the
external coil may then be reversibly locked into position within
the ergonomic applicator. Two applications of this embodiment
relate to the transfer of power to recharge an implantable device,
and to the transfer of power to activate an implantable device.
[0107] In the first application, when an implantable rechargeable
device is utilized, the external coils may be used for recharging
the implanted device by means of inductive fields generated by the
external coils. The external coils may include circuitry that
determines the amount of resistance encountered by the magnetic
field or other electrical properties related to the quality and
degree of the magnetic coupling that is being established. Based on
this feedback, the position of the external coils may be adjusted
manually or automatically to optimize the coupling achieved with
during each recharging session. Alternatively, a sensor may be
incorporated into the implantable device and may communicate the
degree and quality of the magnetic coupling to the external coils
and/or the connected circuitry via wireless communication,
providing a feedback for the automatic or manual adjustment of the
external recharging coils.
[0108] The coils within the ergonomic applicator may be reversibly
locked into place for the duration of the recharge session, and the
implantable device may also communicate to the external recharging
unit that the implantable device has been fully recharged,
terminating the recharging session has been completed. By providing
for an intermittent recharging of an implanted device, an apparatus
according to various embodiments described herein can enable the
implantable device to devote more power to performing its intended
function optimally and with a lesser concern about protecting or
extending battery life.
[0109] In the second application, the powering coils may contain
circuitry to determine the amount of resistance encountered by the
applied magnetic field, or other electrical properties that may
reflect the quality and degree of the magnetic coupling that is
being achieved. Based on this feedback, the powering coils in the
applicator may be adjusted manually or automatically to activate
and optimize the coil coupling at the beginning of each therapy
session. Alternatively, a sensor may be incorporated into the
implantable device and communicate the degree and quality of the
magnetic coupling externally via wireless communication, which may
in turn provide feedback for the automatic or manual adjustment of
the powering coil. In one variant of the present embodiment, the
inductive coils may be magnetically coupled to a needle targeting
the posterior tibial nerve.
[0110] An exemplary method of use of an apparatus according to the
embodiments described herein on a patient suffering from VI and/or
OAB includes the following steps:
[0111] The patient places a conductive wrap contained within a
flexible material over a region of the ankle (or alternatively over
the knee) to provide the required pulsed magnetic field.
Alternatively, the patient may use an ergonomic foot/leg rest or
cradle having embedded coils.
[0112] A sensor (for example, a sensor patch) is placed on the
patient's body along the path of the nerve, ideally proximal to the
stimulation site to ensure afferent nerve stimulation, and is
connected to a logic controller.
[0113] A physician or healthcare provider adjusts the coils in the
wrap or cradle until nerve conduction is achieved based on patient
and sensor feedback. An optimal position is sought, and the coils
may be reversibly locked into position within the conductive wrap
or ergonomic cradle and remain in this position during subsequent
use.
[0114] During the therapy session, the logic controller provides an
electric current to the coils, generating an inductive magnetic
field. In one embodiment, this field begins at low amplitude and
slowly ramps up until nerve conduction exceeds a threshold level,
as signaled by the sensor and possibly by the patient, who may feel
motory conduction. Alternatively, one or more coils may also be
activated to increase the covered area of stimulation in the event
that stimulation does not occur with the initial coil configuration
or is inadequate
[0115] The optimal stimulation may be determined in a variety of
manners, for example, by measuring exposure to electromagnetic
fields capable of generating a square wave electric signal at a
frequency of 10-30 Hz at the targeted tissue depth. The square wave
configuration of the signal may be generated via Fourier
transformation or may be a ramped current generated in any
manner.
[0116] The inductive magnetic pulses continue for an appropriate
duration of use, for example, for 15-30 minutes. The sensor may
remain in place during the entire therapy session to ensure that
stimulation occurs consistently and to provide for appropriate
corrections if nerve conduction deteriorated. The logic controller
may be powered either by a portable power source such as a battery,
or by or a fixed power source such as a traditional wall
outlet.
[0117] The conductive wrap and/or ergonomic cradle is removed from
the body when therapeutic stimulation is not being delivered,
typically at the end of the therapy session.
[0118] The conductive wrap and/or ergonomic cradle is reapplied
along with the sensor patch (ideally disposable) from time to time
as indicated, for example, on a daily basis, and steps 4-8 are
repeated.
[0119] The devices and methods described herein may be applied to
any body tissues, including nerve, muscle, skin, vasculature, or
any other organ or tissue within the human body. Further, the
devices and methods described herein may be used to treat any
conditions suited for neuromodulation regardless of whether the
stimulation source is an electromagnetic field, a direct electric
current, a RF field, infrared energy, visible light, ultraviolet
light, ultrasound, or other energy dispensing device.
[0120] In other embodiments, as shown in FIG. 12a, an energy
emitting system 210 for providing a medical therapy may include one
or more conductive coils 212 disposed within or along a housing
214, one or more sensors 216 configured to detect electrical
conduction in a target nerve or to detect muscle stimulation,
and/or a controller 218 coupled or connected to the conductive
coils 212 and optionally in communication with the sensor 216. The
coils 212 are configured such that an electrical current generated
by the controller 218 is passed through the coils 212 generating a
magnetic field which will stimulate a target nerve, e.g., the
tibial nerve 220, a muscle or other body part containing a portion
of a target nerve, or any nerves branching off of a target nerve,
located in proximity to the coils 212. In this particular
embodiment, the housing 214 is in the form of a foot cradle,
however, the housing could also be in the form of a flexible wrap,
garment or other design suitable for use with a subject. In various
embodiments described herein, sensors may detect voltage or current
and may be connected, coupled, wirelessly connected or coupled or
otherwise in communication with the housing and/or controller using
a variety of methods or techniques known in the art. The sensor may
be placed over a muscle to detect muscle stimulation as a result of
stimulating the target nerve (as shown in FIG. 12a) or over any
other portion of the subject's body suitable for detecting
conduction of the target nerve.
[0121] In certain embodiments, methods of treating a subject with
urinary incontinence or various pelvic floor disorders utilizing
the energy emitting systems described herein are contemplated.
Symptoms associated with urinary incontinence may be observed,
detected, or diagnosed. An energy emitting device having one or
more energy generators, e.g., one or more conductive coils or one
or more microneedle patches, may be positioned in proximity to a
target nerve, e.g., the tibial or posterior tibial nerve or
popliteal or sacral nerve or branches thereof of a subject or
patient along a first portion of a subject's or patient's body. The
subject may or may not be exhibiting symptoms associated with
urinary incontinence. In the case of the conductive coils, the
coils may be positioned within or along a housing, such as a foot
or knee cradle, and a foot or leg may be positioned therein. In the
case of a microneedle patch, the patch may be attached to a
subject's skin. Optionally, the method involves positioning a first
portion of a subject's body, the subject exhibiting symptoms
associated with urinary incontinence, relative to an energy
emitting device such that a target nerve within the first portion
of the body is in proximity to at least one energy generator
disposed within or along the energy emitting device.
[0122] A current is then passed through the energy generator to
produce, generate or deliver energy, e.g., a magnetic or
electromagnetic field or electrical or magnetic energy or stimulus,
focused on the tibial or posterior tibial nerve or branches
thereof. This in turn may cause the stimulation of a pudendal
nerve, sacral plexus, or other nerves in the pelvic floor. Various
nerves innervating the various muscles, sphincters, nerves, organs
and conduits of the urinary tract and bladder may be stimulated
directly or indirectly. In certain embodiments, a current is passed
through one more coils, which generates a magnetic or
electromagnetic field which stimulates the posterior tibial nerve.
In certain embodiments, the positioning of the coils relative to
the first portion of the subject's body may be adjusted to re-focus
the magnetic field on the posterior tibial nerve as needed. In
certain embodiments, a current is passed through a microneedle
patch generating or delivering an electrical or magnetic stimulus
or field. The positioning of the microneedle patch relative to the
first portion of the subject's body may be adjusted to re-focus the
electrical or magnetic stimulus or field on the posterior tibial
nerve as needed.
[0123] Optionally, electrical conduction through the target nerve,
e.g., the posterior tibial nerve, or muscle stimulation can be
detected via at least one sensor. A conductive sensor may be
positioned in proximity to the posterior tibial nerve along a
second portion of the subject's body. Optionally, a sensor may be
positioned over a corresponding muscle to detect muscle stimulation
or twitching resulting from nerve stimulation. Optionally, the
electrical conduction is detected along a second portion of the
subject's body which is different from the first portion of the
body. Optionally, the sensor in the form of a microneedle patch. In
certain embodiments, the sensor may be positioned behind a
subject's knee to detect the electrical conduction along the
afferent posterior tibial nerve or on another portion of a
patient's leg or foot. In other embodiments, the sensor may be
positioned within or along a housing along with the one or more
conductive coils.
[0124] Where a sensor is used, a signal is received from the
sensors and the signal is indicative of the electrical conduction
of the target nerve, e.g., posterior tibial nerve. The current may
be adjusted or varied using a controller which is in communication
with the energy generator. Adjustments may be made in response to
the nerve or muscle stimulation detected by the conductive sensor,
in order to optimize or ensure adequate treatment of urinary
incontinence by achieving the appropriate level of conductance and
appropriate level of nerve or muscle stimulation. Appropriate
levels for current, frequency, magnetic field, treatment duration,
etc., are levels that result in an observed or detected reduction
or prevention of symptoms associated with urinary incontinence.
Treatment could also be administered and the appropriate levels and
parameters achieved through observing or detecting reduction or
prevention of symptoms where a sensor is not used. Examples of
these symptoms include but are not limited to the inability to
control urinary function, urinary leakage, and loss of bladder
control.
[0125] In certain embodiments, the amplitude, frequency, direction
of a generated magnetic field, electrical or magnetic stimulus, or
firing sequence of the coils or microneedles making up the
microneedle array may be adjusted. Optionally, the current may be
varied according to a muscular response in the patient. Thus, to
treat urinary incontinence, the magnetic field or electrical
stimulus is applied to a subject or patient until the desired
effects (e.g., reduction of symptoms) are achieved.
[0126] In certain embodiments, methods of treating a subject with
fecal incontinence utilizing the energy emitting systems described
herein are contemplated. Symptoms associated with fecal
incontinence may be observed, detected, or diagnosed. An energy
emitting device having one or more energy generators, e.g., one or
more conductive coils or one or more microneedle patches, may be
positioned in proximity to a target nerve, e.g., the tibial or
posterior tibial nerve, or popliteal or sacral nerve or branches
thereof of a subject along a first portion of a subject's body. The
subject may or may not be exhibiting symptoms associated with fecal
incontinence. In the case of the conductive coils, the coils may be
positioned within or along a housing, such as a foot or knee
cradle, and a foot or leg may be positioned therein. In the case of
a microneedle patch, the patch may be attached to a subject's skin.
Optionally, the method involves positioning a first portion of a
subject's body, the subject exhibiting symptoms associated with
fecal incontinence, relative to an energy emitting device such that
a target nerve within the first portion of the body is in proximity
to at least one energy generator disposed within or along the
energy emitting device.
[0127] A current is then passed through the energy generator to
produce, generate or deliver energy, e.g., a magnetic or
electromagnetic field or electrical or magnetic energy or stimulus,
focused on the tibial or posterior tibial nerve or branches
thereof. This in turn causes the stimulation of a pudendal nerve,
sacral plexus, or nerves in the pelvic floor. Various nerves
innervating the various muscles, sphincters, rectum, nerves, organs
and conduits associated with bowel movements, fecal control, and
the intestines may be stimulated directly or indirectly.
Optionally, a current is passed through one more coils, which
generates a magnetic or electromagnetic field which stimulates the
posterior tibial nerve. In certain embodiments, the positioning of
the coils relative to the first portion of the subject's body may
be adjusted to re-focus the magnetic field on the posterior tibial
nerve as needed. In certain embodiments, a current is passed
through a microneedle patch generating or delivering an electrical
or magnetic stimulus or field. The positioning of the microneedle
patch relative to the first portion of the subject's body may be
adjusted to re-focus the electrical or magnetic stimulus or field
on the posterior tibial nerve as needed.
[0128] Optionally, electrical conduction through the target nerve,
e.g., the posterior tibial nerve, or muscle stimulation can be
detected via at least one sensor. A conductive sensor may be
positioned in proximity to the posterior tibial nerve along a
second portion of the subject's body. Optionally, a sensor may be
positioned over a corresponding muscle to detect muscle stimulation
or twitching resulting from nerve stimulation. Optionally, the
electrical conduction is detected along a second portion of the
subject's body which is different from the first portion of the
body. Optionally, the sensor is in the form a of a microneedle
patch. In certain embodiments, the sensor may be positioned behind
a subject's knee to detect the electrical conduction along the
afferent posterior tibial nerve or on another portion of a
patient's leg or foot. In other embodiments, the sensor may be
positioned within or along a housing along with the one or more
conductive coils.
[0129] Where a sensor is used, a signal is received from the
sensors and the signal is indicative of the electrical conduction
of the posterior tibial nerve. The current may be adjusted or
varied using a controller which is in communication with the energy
generator. Adjustments may be made in response to the nerve or
muscle stimulation detected by the conductive sensor, in order to
optimize or ensure adequate treatment of fecal incontinence by
achieving the appropriate level of conductance and appropriate
level of nerve or muscle stimulation. Appropriate levels for
current, frequency, magnetic field, treatment duration, etc., are
levels that result in an observed or detected reduction or
prevention of symptoms associated with fecal incontinence.
Treatment could also be administered and the appropriate levels and
parameters achieved through observing or detecting reduction or
prevention of symptoms where a sensor is not used. Examples of
these symptoms include but are not limited: the loss of voluntary
control to retain stool in the rectum; loss of fecal control;
inability to control bowel movements, and fecal leaking:
[0130] In certain embodiments, the amplitude, frequency, direction
of a generated magnetic field, electrical or magnetic stimulus, or
firing sequence of the coils or microneedles making up the
microneedle array may be adjusted. Optionally, the current may be
varied according to a muscular response in the patient. Thus, to
treat fecal incontinence, the magnetic field or electrical stimulus
is applied to a subject or patient until the desired effects (e.g.,
reduction of symptoms) are achieved.
[0131] In certain embodiments, methods of treating a subject with
restless leg syndrome utilizing the energy emitting systems
described herein are contemplated. Victims afflicted with Restless
Leg Syndrome (RLS or Ekbom's syndrome), are unable to remain seated
or to stand still. Activities that require maintaining motor rest
and limited cognitive stimulation, such as transportation, e.g., in
a car, plane, train, etc., or attending longer meetings, lectures,
movies or other performances, become difficult if not impossible.
These sensations become more severe at night and RLS patients find
sleep to be virtually impossible, adding to the diminishing quality
of their lives. The urge to move, which increases over periods of
rest, can be completely dissipated by movement, such as walking.
However, once movement ceases, symptoms return with increased
intensity. If an RLS patient is forced to lie still, symptoms will
continue to build like a loaded spring and, eventually, the legs
will involuntary move, relieving symptoms immediately.
[0132] Thus, symptoms associated with restless leg syndrome may be
observed, detected, or diagnosed. An energy emitting device having
one or more energy generators, e.g., one or more conductive coils
or one or more microneedle patches, may be positioned in proximity
to a target nerve, e.g., the tibial or posterior tibial nerve, or
popliteal or sacral nerve or branches thereof or other nerves
associated with restless leg syndrome, of a subject along a first
portion of a subject's body. The subject may or may not be
exhibiting symptoms associated with restless leg syndrome. In the
case of the conductive coils, the coils may be positioned within or
along a housing, such as a foot or knee cradle, and a foot or leg
may be positioned therein. In the case of a microneedle patch, the
patch may be attached to a subject's skin. Optionally, the method
involves positioning a first portion of a subject's body, the
subject exhibiting symptoms associated with restless leg syndrome,
relative to an energy emitting device such that a target nerve
within the first portion of the body is in proximity to at least
one energy generator disposed within or along the energy emitting
device.
[0133] A current is then passed through the energy generator to
produce, generate or deliver energy, e.g., a magnetic field or
electrical or magnetic energy or stimulus, focused on the tibial or
posterior tibial nerve or branches thereof or other nerves
associated with restless leg syndrome. This in turn causes the
stimulation of a pudendal nerve, sacral plexus or other nerves
innervating the various muscles, nerves, or organs associated with
restless leg syndrome. The various nerves may be stimulated
directly or indirectly. Optionally, a current is passed through one
more coils, which generates a magnetic or electromagnetic field
which stimulates the posterior tibial nerve. In certain
embodiments, the positioning of the coils relative to the first
portion of the subject's body may be adjusted to re-focus the
magnetic field on the posterior tibial nerve as needed. In certain
embodiments, a current is passed through a microneedle patch
generating or delivering an electrical or magnetic stimulus or
field. The positioning of the microneedle patch relative to the
first portion of the subject's body may be adjusted to re-focus the
electrical or magnetic stimulus or field on the posterior tibial
nerve as needed.
[0134] Optionally, electrical conduction through the target nerve,
e.g., the posterior tibial nerve, or muscle stimulation can be
detected via at least one sensor. A conductive sensor may be
positioned in proximity to the posterior tibial nerve along a
second portion of the subject's body. Optionally, a sensor may be
positioned over a corresponding muscle to detect muscle stimulation
or twitching resulting from nerve stimulation. Optionally, the
electrical conduction is detected along a second portion of the
subject's body which is different from the first portion of the
body. Optionally, the sensor in the form a of a microneedle patch.
In certain embodiments, the sensor may be positioned behind a
subject's knee to detect the electrical conduction along the
afferent posterior tibial nerve or on another portion of a
patient's leg or foot. In other embodiments, the sensor may be
positioned within or along a housing along with the one or more
conductive coils.
[0135] Where a sensor is used, a signal is received from the
sensors and the signal is indicative of the electrical conduction
of the target nerve, e.g., posterior tibial nerve. The current may
be adjusted or varied using a controller which is in communication
with the energy generator. Adjustments may be made in response to
the nerve or muscle stimulation detected by the conductive sensor,
in order to optimize or ensure adequate treatment of restless leg
syndrome by achieving the appropriate level of conductance and
appropriate level of nerve or muscle stimulation. Appropriate
levels for current, frequency, magnetic field, treatment duration,
etc., are levels that result in an observed or detected reduction
or prevention of symptoms associated with restless leg syndrome.
Treatment could also be administered and the appropriate levels and
parameters achieved through observing or detecting reduction or
prevention of symptoms where a sensor is not used. Examples of
these symptoms include but are not limited to: uncomfortable
sensations in the limbs, irresistible urges to move, usually the
legs; motor restlessness; when at rest, symptoms return or worsen;
and symptoms worsen in the evening and at night.
[0136] In certain embodiments, the amplitude, frequency, direction
of a generated magnetic field, electrical or magnetic stimulus, or
firing sequence of the coils or microneedles making up the
microneedle array may be adjusted. Optionally, the current may be
varied according to a muscular response in the patient. Thus, to
treat restless leg syndrome, the magnetic field or electrical
stimulus is applied to a subject or patient until the desired
effects (e.g., reduction of symptoms) are achieved.
[0137] In certain embodiments, methods of treating a subject
suffering from premature ejaculation or various pelvic floor
disorders utilizing the energy emitting systems described herein
are contemplated. Symptoms associated with premature ejaculation
may be observed, detected, or diagnosed. An energy emitting device
having one or more energy generators, e.g., one or more conductive
coils or one or more microneedle patches, may be positioned in
proximity to a target nerve, e.g., the tibial or posterior tibial
nerve or popliteal or sacral nerve or branches thereof of a subject
along a first portion of a subject's body. The subject may or may
not be exhibiting symptoms associated with premature ejaculation.
In the case of the conductive coils, the coils may be positioned
within or along a housing, such as a foot or knee cradle, and a
foot or leg may be positioned therein. In the case of a microneedle
patch, the patch may be attached to a subject's skin. Optionally,
the method involves positioning a first portion of a subject's
body, the subject exhibiting symptoms associated with premature
ejaculation, relative to an energy emitting device such that a
target nerve within the first portion of the body is in proximity
to at least one energy generator disposed within or along the
energy emitting device.
[0138] A current is then passed through the energy generator to
produce, generate or deliver energy, e.g., a magnetic or
electromagnetic field or electrical or magnetic energy or stimulus,
focused on the tibial or posterior tibial nerve or branches
thereof. This in turn may cause the stimulation of a pudendal
nerve, sacral plexus, or other nerves in the pelvic floor or nerves
associated with the control of ejaculation. Various nerves
innervating the various muscles, sphincters, nerves, organs and
conduits of the urinary tract, bladder or reproductive system, or
pelvic floor may be stimulated directly or indirectly. Optionally,
a current is passed through one more coils, which generates a
magnetic or electromagnetic field which stimulates the posterior
tibial nerve. In certain embodiments, the positioning of the coils
relative to the first portion of the subject's body may be adjusted
to re-focus the magnetic field on the posterior tibial nerve as
needed. In certain embodiments, a current is passed through a
microneedle patch generating or delivering an electrical or
magnetic stimulus or field. The positioning of the microneedle
patch relative to the first portion of the subject's body may be
adjusted to re-focus the electrical or magnetic stimulus or field
on the posterior tibial nerve as needed.
[0139] Optionally, electrical conduction through the target nerve,
e.g., the posterior tibial nerve, or muscle stimulation can be
detected via at least one sensor. A conductive sensor may be
positioned in proximity to the posterior tibial nerve along a
second portion of the subject's body. Optionally, a sensor may be
positioned over a corresponding muscle to detect muscle stimulation
or twitching resulting from nerve stimulation. Optionally, the
electrical conduction is detected along a second portion of the
subject's body which is different from the first portion of the
body. Optionally, the sensor in the form of a microneedle patch. In
certain embodiments, the sensor may be positioned behind a
subject's knee to detect the electrical conduction along the
afferent posterior tibial nerve or on another portion of a
patient's leg or foot. In other embodiments, the sensor may be
positioned within or along a housing along with the one or more
conductive coils.
[0140] Where a sensor is used, a signal is received from the
sensors and the signal is indicative of the electrical conduction
of the target nerve, e.g., posterior tibial nerve. The current may
be adjusted or varied using a controller which is in communication
with the energy generator. Adjustments may be made in response to
the nerve or muscle stimulation detected by the conductive sensor,
in order to optimize or ensure adequate treatment of premature
ejaculation by achieving the appropriate level of conductance and
appropriate level of nerve or muscle stimulation. Appropriate
levels for current, frequency, magnetic field, treatment duration,
etc., are levels that result in an observed or detected reduction
or prevention of symptoms associated with premature ejaculation.
Treatment could also be administered and the appropriate levels and
parameters achieved through observing or detecting reduction or
prevention of symptoms where a sensor is not used. Examples of
these symptoms include but are not limited to: ejaculation that
frequently occurs within one minute or less of penetration; the
inability to delay ejaculation on penetrations; or persistent or
recurrent ejaculation with minimal stimulation before, on or
shortly after penetration.
[0141] In certain embodiments, the amplitude, frequency, direction
of a generated magnetic field, electrical or magnetic stimulus, or
firing sequence of the coils or microneedles making up the
microneedle array may be adjusted. Optionally, the current may be
varied according to a muscular response in the patient. Thus, to
treat premature ejaculation, the magnetic field or electrical
stimulus is applied to a subject or patient until the desired
effects (e.g., reduction of symptoms) are achieved.
[0142] Exemplary treatment parameters for treating various
conditions, e.g., urinary incontinence, using the systems and
methods described herein may include the following. Operation of a
conductive coil at about 10 to 20 hertz generating a magnetic field
of about 0.25 to 1.5 tesla, where the coil is administered to a
patient for a duration of about 30 minutes/day or 30 minutes per
week, depending on the severity of the symptoms, until the symptoms
subside. The above treatment parameters or variations on the
parameters may be used for treatment of urinary incontinence, fecal
incontinence, restless leg syndrome, or premature ejaculation or
other conditions. For example, the coil may be operated at various
parameter ranges falling with the following ranges: about 5 to 100
hertz, about 1 to 10 tesla, for about 15 minutes to 2 hours per day
or week. In treating premature ejaculation, a patient may receive
treatment about 4 to 10 hours prior to intercourse. A maintenance
phase of treatment, after the initial treatment, may vary for
various conditions. For example, the maintenance phase may require
application of the systems and methods described herein at the
parameters described herein for 30 minutes/week or 30
minutes/month. Any treatment parameter may be varied or modified
based on the effect on the patient or sensor or patient feedback
regarding stimulation, until the desired result of treating or
preventing a condition is achieved.
[0143] In certain embodiments, the energy emitting device, e.g.,
foot cradle, knee cradle, etc., includes a conductive coil
positioned such that a target nerve is automatically targeted. The
conductive coil is configured, sized and positioned within the
device such that the generated electromagnetic or magnetic field
may encompass and stimulate the target nerve in any patient based
on the target nerve's anatomical location, thus providing automatic
targeting of the nerve in any patient once the patient positions a
particular body portion in the device.
[0144] In various embodiments described herein, sensors may detect
voltage or current and may be connected, coupled, wirelessly
connected or coupled or otherwise in communication with housing,
conductive coils, microneedle patch, energy emitting apparatus or
device, energy generators, or electrode needles and/or controller
using a variety of methods or techniques known in the art. In
various embodiments described herein, housings, conductive coils,
microneedle patches, energy emitting apparatus, energy generators,
or electrode needles may be connected, coupled, wirelessly
connected or coupled or otherwise in communication with each other,
controllers or sensors, using a variety of methods or techniques
known in the art.
[0145] An energy emitting system for providing a medical therapy
according to any of the embodiments described herein may include an
energy emitting device and/or one or more energy generators for
generating an electromagnetic field or magnetic field and/or
delivering an electromagnetic stimulus. In certain embodiments, the
energy generator may be a conductive coil, which is configured to
generate an electromagnetic or magnetic field to be focused on a
target nerve. The one or more conductive coils are optionally
positioned within or along a housing, as described herein. Various
embodiments of conductive coils are contemplated. A conductive coil
utilized in any of the embodiments described herein may optionally
include a variety of configurations or features, e.g., cooling
features for conduction or convection cooling, which optimize the
conductive coil's effectiveness in generating a magnetic field and
stimulating a target nerve, while providing a safe and effective
medical therapy for a patient.
[0146] The conductive coils described herein may have a variety of
dimensions, shapes, and sizes. The diameter of the central aperture
of a coil may vary. For example, the diameter may range from about
0.5 inch to 2 inches or 1 inch to 1.5 inches or the aperture may
have a diameter of about 1 inch. The diameter of the coil body may
vary. For example, the diameter may range from about 3.0 to about 7
inches or from about 4 to about 5 inches or the diameter may be
about 4.5 inches. The coil body may include any suitable number of
turns. For example, the coil body may include from about 2 to about
25 turns or from about 10 to about 20 turns or 14 to 17 turns. A
turn may have various dimensions. For example, the turn or end or
cross section of the turn may have a height that is greater than
its width or thickness, e.g., 15 to 60 times or 25 to 50 times
greater in height relative to its width. In certain embodiments, a
turn or an end or cross section of a turn may have a height ranging
from about 1 to 5 cm or from about 10 mm to 51 mm (about 0.3 inches
to 2 inches) or about 25 mm to 40 mm (about 1 inch to 1.5 inches)
or about 12 mm to 40 mm (about 0.5 inch to 1.5 inch) or about 0.5
inch to 2 inch. The turn or end or cross section of the turn may
have a width ranging from about 0.5 mm to about 5 mm (about 0.019
inch to 0.19 inch) or from about 1 mm to about 2 mm (about 0.03
inch to 0.07 inch) or about 0.2 mm to about 1.6 mm (about 0.01 inch
to 0.06 inch). Optionally, the dimensions may allow the coil turns
to be tightly packed or rolled while still maintaining gaps or
spaces in between adjacent turns, allowing for conduction and/or
cooling. Optionally, the dimensions may allow the coil to be more
loosely packed or rolled, allowing for conduction and/or cooling.
The above are exemplary dimensions, where other dimensions are also
contemplated depending on the use and configuration of a
device.
[0147] In certain embodiments, a turn or end or cross section of a
turn may have a height ranging from about 1 to 5 cm or from about
10 mm to 51 mm (about 0.3 inches to 2 inches) or about 25 mm to 40
mm (about 1 inch to 1.5 inches) or about 12 mm to 40 mm (about 0.5
inch to 1.5 inch) or about 0.5 inch to 2 inch. The turn or end or
cross section of the turn may have a width ranging from about 0.5
mm to about 5 mm (about 0.019 inch to 0.19 inch) or from about 1 mm
to about 2 mm (about 0.03 inch to 0.07 inch) or about 0.2 mm to
about 1.6 mm (about 0.01 inch to 0.06 inch). The dimensions may
allow the coil turns to be tightly packed or rolled while still
maintaining gaps or spaces in between adjacent turns, allowing for
conduction and/or cooling. The conductive coil may have a diameter
ranging from about 4.5 inches to about 5 inches. In certain
embodiments, the number of turns of a conductive coil can vary,
e.g., a coil may include from about 14 to 20 turns, where a gap
separates all or many of the turns from an adjacent turn.
[0148] Any of the embodiments of coils described herein and
illustrated in the corresponding figures may have the above
dimensions and configurations or any other suitable dimension or
configuration depending on the coils intended use.
[0149] In any of the conductive coil embodiments described herein,
the first turn of a conductive coil may optionally surround a
central aperture which is sized to receive a first portion of a
patient's body such that the conductive coil is positioned in
proximity to the underlying target nerve. The central aperture also
aids in the cooling process as air or other fluid can pass through
the aperture, over and around the conductive coil surface.
Optionally, the central aperture may be sized to surround at least
a portion of a malleolus or other body portion, such that the
conductive coil is positioned in proximity to the tibial nerve. As
described supra, the conductive coils may be in the form of a
spiral that is substantially planar, substantially conical or other
configurations best suited for a particular device or patient.
[0150] Coils used in any of the embodiments described above and
illustrated in the corresponding figures may take on a variety of
shapes, sizes, and configurations. For example, a coil may be
shaped as a spiral (as shown) or have a simple helical pattern or
be a figure eight coil, a four leaf clover coil, a Helmholtz coil,
a modified Helmholtz coil, or may be shaped as a combination of the
aforementioned coil patterns. Additionally, other coil designs
beyond those mentioned hereinabove might be utilized as long as a
magnetic field is developed that will encompass a target nerve.
[0151] Optionally, any of the conductive coils described herein can
be coated or otherwise covered with a material, e.g., a
non-electrically conductive material, to ensure that the conductive
surface of the turns making up the coil do not come into contact
with each other.
[0152] In any of the above embodiments, the system may optionally
include a sensor, e.g., a laser Doppler or ultrasound Doppler. The
sensor may be used to detect (e.g., through the openings or spaces
in the coil) the positioning of the tibial artery which runs along
the tibial nerve, to help ensure proper placement of the patient's
body relative to the conductive coil in order to conduct magnetic
induction therapy.
[0153] It is also contemplated that any of the energy emitting
systems or devices described herein can be used with or without a
sensor for detecting conduction of a stimulated nerve or muscle
stimulation resulting from the magnetic field generated by the
conductive coil and delivered to a patient or an electrical
stimulus delivered to a patient. Also, in any of the above
embodiments, a controller may optionally be connected, coupled,
integral to or otherwise in communication with the conductive coils
and/or the sensor. Optionally, the sensor may be connected,
coupled, integral to or otherwise in communication with the
conductive coil.
[0154] Energy emitting systems described herein may include a
variety of conductive coils. In certain embodiments, a conductive
coil 310 (as shown in FIG. 12b) is provided which includes a first
end 312, a second end 314, and one or more turns 315 extending
there between. The ends of the coil include electrical contact
points 311, 313. A first turn 316 surrounds a central aperture 318
which is sized to receive a portion of a patient's body such that
the conductive coil can be positioned in proximity to an underlying
target nerve. One or more second turns 315 surrounding the first
turn 316 may have a radius or radius of curvature greater than the
radius or radius of curvature of the first turn.
[0155] FIG. 12c shows a cross section of coil 310 positioned on a
patient. The central aperture 318 may be sized or configured to
surround a portion of a patient's body, for example, at least a
portion of a malleolus A. The radius of the central aperture 318
has a length sufficient to allow the central aperture 318 to
surround at least a portion of malleolus A, such that the
conductive coil can be positioned in closer proximity to the
underlying tibial nerve B. As a result, the electromagnetic flux
generated by the conductive coil is concentrated or substantially
concentrated on the target nerve, e.g., the tibial nerve, thereby
maximizing conduction of the target nerve by the electromagnetic or
magnetic field generated by the coil. Examples of suitable radius
lengths include but are not limited to a radius having a length
from about 1 cm to 20 cm or from about 2 cm to about 10 cm or from
about 2 cm to about 5 cm. The radius length may vary and/or be
adjustable depending on the anatomy of a particular patient in
order to accommodate the patient's anatomy and provide efficient
conduction of a target nerve. The coil may be adjustable or in
certain embodiments it may be fixed or pre-sized or not
adjustable.
[0156] Referring to FIG. 13a, in certain embodiments, an energy
emitting system may include an adjustable, movable or manipulatable
conductive coil 330 configured to accommodate the anatomy of a
patient and to generate an electromagnetic or magnetic field
focused on a target nerve. The conductive coil 330 may have a first
end 332, a second end 34, and one or more turns 335 extending there
between. A first turn 336 surrounds a central aperture 338, wherein
the central aperture 338 is adjustable or movable between at least
a first configuration and a second configuration, the second
configuration having a radius that is greater than a radius of the
first configuration, such that the conductive coil can accommodate,
conform to, surround or be positioned or fit around or on an
anatomical structure of a patient and thereby be positioned in
proximity to the underlying target nerve.
[0157] In certain embodiments, the central aperture 338 is
adjustable and/or movable or can be manipulated from a first
configuration to a second configuration or between various
non-expanded, expanded and contracted configurations such that the
conductive coil 330 may be conformed, adjusted or fit onto or
around or positioned onto or around or accommodate an anatomical
structure of a patient, thereby allowing the conductive coil 330 to
be positioned in proximity to an underlying target nerve. The
adjustable conductive coil 330 may be expanded and/or contracted to
adjust or vary the dimensions of the coil or the central aperture
338, increasing and/or decreasing the diameter or radius of the
coil or central aperture 338 to accommodate the anatomy of a
patient or to be positioned or fit around or over an anatomical
structure of a patient.
[0158] In certain embodiments, as shown in FIGS. 13a-13c, the
adjustable conductive coil 30 may include a pivot or hinge 340
positioned along a central axis of the conductive coil 330. The
hinge 340 may be positioned on one or more turns 336 of the coil.
In certain embodiments, a hinge is positioned on each turn 335 of
the coil, along a central axis of the coil. The hinge 340 defines a
coil first portion 342 and a coil second portion 343 and the coil
first portion 342 and/or coil second portion 343 may be pivotable
about the hinge 340. By pivoting the coil first portion 342, the
coil second portion 343, or both, the radius or diameter of central
aperture 338 may be expanded, thereby expanding the conductive coil
330. The coil may be pivoted in a manner that reduces or contracts
the central aperture from an expanded configuration.
[0159] For example, as shown in FIGS. 13a and 13b, the diameter of
the central aperture may be adjusted such that it is increased from
diameter D1 to an expanded diameter D2 when the coil 330 is
expanded by pivoting or rotating coil first portion 342 and/or coil
second portion 343 about hinge 340. By pivoting or rotating coil
first portion 342 and/or coil second portion 343 about hinge 340,
the diameter D2 of central aperture 338 can be expanded relative to
the diameter D1 of central aperture 338 and/or contracted to return
the coil 330 to a closed configuration, e.g., after placement.
[0160] FIG. 13c shows a side view of the conductive coil 30, where
coil second portion 343 is rotatable or pivotable about a hinge 340
in order to adjust the diameter or radius of the coil and/or the
diameter or radius of the central aperture.
[0161] Any suitable mechanism known in the art for providing
pivoting or rotational movement such that the portions of the coil
or the coil turns may pivot or rotate relative to one another such
that the coil can be positioned or fit into place on a patient may
be utilized in the embodiments described herein.
[0162] As shown in FIG. 13d, which is a cross sectional view of
coil 330 positioned around a patient's leg, adjusting or
manipulating the central aperture 338, e.g., by expanding,
contracting, enlarging, or reducing the size of the central
aperture 338, allows the conductive coil 330 to be positioned or
advanced over a first portion of a patient's body, for example a
patient's foot, such that the coil can be placed around or in
proximity to a second portion of a patient's body, for example, an
ankle or leg, and therefore, positioned in close proximity to an
underlying target nerve, e.g., the tibial nerve B. Such placement
and positioning helps focus or concentrate the electromagnetic flux
delivered by the coil on the target nerve and maximize conductance
of the nerve and the effectiveness of the electromagnetic therapy.
The adjustable nature of the coil allows the coil to accommodated
differing anatomy and body portion sizes and shapes of different
patients.
[0163] As shown in FIGS. 14a and 14b, another embodiment of an
adjustable conductive coil 350 is provided. Conductive coil 350
includes a pivot or hinge 360 positioned on the outer most turn 357
of the conductive coil 350. Optionally, a non-conductive material
may be used to connect adjacent turns to one another to maintain
separation between adjacent turns as the coil and central aperture
358 are adjusted and coil first portion 352 and/or coil second
portion 353 are rotated relative to one another. For example, the
non-conductive material may be in the form of a wedge 361 (e.g., an
epoxy wedge) attached to the surfaces and/or around conductive coil
350. Additionally, each of the turns may include a break 362 or
separation along a central axis of the coil and in line with the
pivot or hinge 360, which separates the coil 350 into coil first
portion 352 and a coil second portion 353.
[0164] In use, coil first portion 352 and/or coil second portion
353 may be rotated or pivoted about hinge 360, thereby separating
the first and second portions 352, 353 from one another and
expanding the central aperture 358, as shown in FIG. 14b. Expansion
of the coil 350 allows the coil to be fit or positioned around a
portion of a patient's body, e.g., a leg or ankle, like a bracelet,
such that the coil can be placed in close proximity to the
underlying target nerve, and the electromagnetic or magnetic flux
generated by the coil can be concentrated on the target nerve.
[0165] In certain embodiments, in order to maintain electrical
current flow through the coil turns and portions of an expandable
coil and to minimize energy loss, a variety of contacts, couplers
or connecting features may be implemented on portions of a
conductive coil. For example, in certain embodiments, the interface
between a coil first portion and coil second portion may include an
electrically conductive material forming a contact or coupler. The
contacts may be positioned on the first and/or second coil portions
or on the interface between the first and/or second portions, such
that when the first and second coil portions are reconnected after
being positioned on a patient, the electrical current conducted
through the coil is uninterrupted and flows through the conductive
coil without substantial current or energy loss, in order to
generate an electromagnetic or magnetic field.
[0166] In certain embodiments, female and male interconnecting
members may be provided on the first and/or second coil portions
along a central axis of the adjustable conductive coil in order to
connect or hold the first and second coil portions together. For
example, a coil first portion may include a female member for
receiving a male member positioned on the coil second portion,
thereby providing a secure coupling or electrical connection
between the first and second coil portions to maintain electrical
current flow through and between the first and second conductive
coil portions and to prevent interruption of electrical current
flow between the first and second coil portions.
[0167] In certain embodiments, as shown in FIGS. 15a & 15b, an
adjustable conductive coil 370 may be expanded by unraveling or
loosening the conductive coil 370 such that the diameter or radius
of the central aperture 378 of the conductive coil 370 is increased
from diameter D1 (shown in FIG. 15a) to an expanded diameter D2
(shown in FIG. 15b). The conductive coil may include a variety of
materials which provide flexibility, are bendable, or have shape
memory properties. Examples of such materials include but are not
limited to, nitinol, copper, and other conductive materials. The
conductive coil 370 may be unraveled to expand the central aperture
378 and/or contracted or tightened to reduce the size of the
central aperture in order to accommodate, surround, be positioned
on, or conform to the anatomy of a patient, thereby permitting
positioning of the conductive coil in close proximity to the
underlying target nerve.
[0168] In another embodiment of a conductive coil, referring to
FIGS. 16a-16b, the conductive coil 380 may have a substantially
conical configuration or shape. In a conically configured coil, as
shown in FIG. 16a, the center of the conductive coil 380, starting
with inner turn 386, is positioned a distance Y from outer turn
387, along the longitudinal axis (shown as dashed line) of the
coil. Each successive turn 385 may extend beyond the perimeter or
circumference of the adjacent larger turn 385 along the
longitudinal axis of the coil.
[0169] FIG. 16b shows a cross sectional side view of the conductive
coil 380, having a conical configuration. In use, the conductive
coil 380 may be positioned against, over or around a portion of a
patient's body, for example, a leg, over at least a portion of a
patient's malleolus A or ankle and thereby in close proximity to
the underlying target nerve B, e.g., a tibial nerve.
[0170] In certain embodiments, the conductive coil 380 may be
adjusted by either increasing or decreasing the distance Y between
the inner and outer turns 386, 387. Depending on the anatomy of a
patient, the inner turn 386 may be pushed or advanced a distance Y
away from the outer turn 387, such that the conductive coil 380
expands into a cone shape, which can be placed over and/or around a
portion of a patient's body, for example, a malleolus A. Thus, the
varying diameters of the successive turns 385 from the inner to the
outer turns 386, 387 allow the coil to accommodate, surround, be
positioned on, or conform to varying sizes of portions of a
patient's body, allowing the coil 380 to be positioned in close
proximity to an underlying target nerve. The conductive coil 380
may include a variety of materials which provide flexibility, are
bendable, or have shape memory properties. Examples of such
materials include but are not limited to, nitinol, copper, and
other conductive materials. Additionally, the conductive coil 380
may include any of the pivoting or rotational mechanism discussed
herein to provide for expansion or contraction of the conductive
coil, any of the turns of the coil, or the central aperture of the
coil.
[0171] In certain embodiments, methods of electromagnetic or
magnetic induction therapy utilizing the various adjustable
conductive coil configurations described herein, which accommodate
varying anatomy of patients and allow for improved positioning of a
conductive coil in close proximity to a target nerve are provided.
The methods may include positioning a conductive coil relative to a
first portion of a patient's body in proximity to an underlying
target nerve such that the electromagnetic flux generated by the
conductive coil can be concentrated or focused on the underlying
target nerve. The conductive coil or a central aperture of the
conductive coil may be adjusted, such that the conductive coil is
expanded or contracted in order to surround, be positioned on,
conform to, accommodate, approximate or receive the first portion
of the patient's body. Once in position or during positioning of
the coil, an electrical current can be passed or conducted through
the conductive coil to generate an electromagnetic or magnetic
field focused on the target nerve for stimulating the target
nerve.
[0172] In certain embodiments, adjusting a conductive coil may
involve expanding a central aperture of the conductive coil to
surround a first portion of a patient's body to position the
conductive coil in close proximity to the underlying nerve. In
certain embodiments, adjusting a conductive coil may involve
contracting a central aperture of the conductive coil to surround a
first portion of a patient's body to position the conductive coil
in close proximity to the underlying nerve. Expansion or
contraction of an adjustable conductive coil may be performed by a
variety of mechanisms as described herein. Examples include but are
not limited to pivoting a first and or second portion of a
conductive coil about a hinge, unraveling or tightening the
conductive coil to increase or decrease the radius or diameter of
the central aperture and/or one or more turns making up the
conductive coil.
[0173] An adjustable coil may include an expandable central
aperture that can be advanced over a second portion of the
patient's body to position the conductive coil in proximity to a
first portion of the patient's body. For example, the adjustable
features of a coil may allow the coil to expand to a sufficient
size or diameter to fit over or around a patient's foot such that
the coil may be advanced and positioned around the patient's leg or
ankle. Once in position, the coil can be contracted or further
adjusted, as necessary, to snuggly or closely fit around a
patient's leg and in close proximity to the underlying target
nerve, e.g., the tibial nerve.
[0174] Optionally, a sensor configured to detect electrical
conduction of the target nerve may be utilized and a controller may
be coupled to or in communication with the coil and/or the sensor
(not shown), as described in various embodiments herein.
[0175] A coil can take on a variety of configurations depending on
the materials used to construct the coil and the particular use of
a coil. For example, a coil may be substantially planar in certain
embodiments. In other embodiments, a coil may be substantially
conical or the coil may be in the shape of solenoid.
[0176] In certain embodiments, an energy emitting system for
providing a medical therapy comprises a conductive coil configured
to generate an electromagnetic or magnetic field focused on a
target nerve, the conductive coil having a first end, a second end,
and a first turn there between, the first turn surrounding a
central aperture; wherein the central aperture can be manipulated
or is movable between a first configuration and a second
configuration, the second configuration having a radius that is
greater than a radius of the first configuration, such that the
conductive coil can accommodate an anatomical structure of a
patient and/or be positioned in proximity to the underlying target
nerve.
[0177] The conductive coil further may comprise a hinge positioned
along a central axis of the conductive coil, the hinge defining a
coil first portion and a coil second portion, wherein the coil
first portion or coil second portion are pivotable about the hinge
such that dimensions of the central aperture can be manipulated or
altered or enlarged or reduced. The central aperture may be
expandable from non-expanded configuration to an expanded
configuration such that the conductive coil can conform to an
anatomical structure of a patient and/or be positioned in proximity
to the underlying target nerve.
[0178] The central aperture may have a radius with a length from
about 1 cm to 10 cm or from about 2 cm to about 5 cm in length. The
interface between the coil first portion and coil second portion
may comprise an electrical coupling contact. The coil first portion
may have a male member and a coil second portion may have a female
member for receiving the male member, such that the coil first and
second portions connect to maintain electrical coupling.
[0179] The central aperture may be movable or can be manipulated
such that the conductive coil can be positioned around a patient's
leg in proximity to the underlying target nerve. The central
aperture may be movable or can be manipulated such that the
conductive coil can be positioned around a patient's ankle in
proximity to the underlying target nerve. The central aperture may
be movable or can be manipulated such that the conductive coil can
be positioned around at least a portion of a patient's malleolus in
proximity to the underlying tibial nerve.
[0180] In certain variations, an energy emitting system may include
a sensor configured to detect muscle stimulation or electrical
conduction of a target nerve or to detect stimulation of a nerve,
muscle or other body tissue. A controller may be provided which is
coupled to the coil and in communication with the sensor.
[0181] In certain embodiments, a method of magnetic induction
therapy comprises: positioning a conductive coil relative to a
first portion of a patient's body in proximity to an underlying
target nerve to concentrate an electromagnetic flux on the
underlying target nerve, wherein positioning comprises altering,
moving, enlarging, reducing, adjusting or manipulating a central
aperture of the conductive coil or the coil, such that the
conductive coil can accommodate, approximate or receive the first
portion of the patient's body; and passing a current through the
conductive coil to generate an electromagnetic or magnetic field
focused on the target nerve.
[0182] The central aperture of the conductive coil may be expanded
to surround a first portion of a patient's body such that the
conductive coil can be positioned in proximity to the underlying
nerve. The central aperture of the conductive coil may be
contracted to surround a first portion of a patient's body such
that the conductive coil can be positioned in proximity to the
underlying nerve. The altering, moving, enlarging, reducing,
adjusting or manipulating of the central aperture may comprise
pivoting a first portion of a conductive coil about a hinge or it
may comprises unraveling the conductive coil or it may comprise
tightening the conductive coil. The central aperture of the
conductive coil may be advanced over a second portion of the
patient's body to position the conductive coil in proximity to the
first portion of the patient's body.
[0183] In any of the embodiments described herein, the central
aperture or coil, e.g., the shape, dimensions, size, orientation,
or configuration of the coil, or any portion of the coil, e.g., the
central aperture or other turns of the coil, may be altered,
adjusted, manipulated, moved, expanded, enlarged, reduced, or
contracted temporarily, permanently or interchangeably in order to
position or maneuver the coil or energy emitting system and/or
position the coil relative to a body or body part.
[0184] The variations of conductive coils described herein are
configured or designed in a manner that allows for positioning of a
coil in close proximity to a target nerve, muscle or other body
tissue to be stimulated. The ability to position the coil in close
proximity to the target stimulation site allows the energy emitting
systems or devices for performing electromagnetic therapy to
operate at lower power levels, which may result in a reduction of
energy requirements, noise and costs associated with the systems or
devices described herein.
[0185] In certain variations, an energy emitting system may include
a sensor for detecting the position of patient's body part relative
to a conductive coil or vice versa, to determine whether or ensure
that a patient's body or body part is properly positioned or
correctly located in proximity to a conductive coil or to determine
whether or ensure that the conductive coil is properly positioned
or correctly located in proximity to a patient's body or body part
for effective electromagnetic stimulation or therapy. The
positioning of the patient's body part or the positioning of the
conductive coil may be adjusted based on feedback provided by the
sensor regarding the relative position of the system or coil and
the patient's body part. The sensor may be positioned anywhere on
an applicator, housing, or coil of the system. Various sensors may
be utilized, including, for example, mechanical switches, optical
detection sensors, and any other sensor known in the art which
would be suitable for detecting the position of a body part and/or
a conductive coil relative to one another. The system may also
include sensors, e.g., EMG sensors, for detecting stimulation of a
target nerve, muscle, or other body tissue. The above sensors,
together or alone, may ensure effective application of
electromagnetic therapy via the various systems, devices and/or
methods described herein.
[0186] FIG. 17 shows an example of a system including a sensor 320
in the form of a mechanical switch. The mechanical switch is
positioned next to or on the conductive coil 310. The mechanical
switch may be thrown, moved or altered when it comes into contact
with or into the proximity of a body part positioned in proximity
to the coil or touching a region of the coil. In FIG. 17, the
mechanical switch is shown depressed when a foot or ankle region
(e.g., a malleolus) is properly positioned relative to or in
proximity to the conductive coil 310. The mechanical switch or
sensor may provide feedback to the system, patient, or operator
regarding the positioning of the body part relative to the coil or
the positioning of the coil relative to the body part prior to or
during stimulation or therapy, to ensure proper positioning of the
body part and/or coil such that the body part may receive effective
electromagnetic stimulation. The sensor 320 may be used in any of
the systems, devices or with any of the coils described or
illustrated herein.
[0187] In certain variations, an energy emitting system may include
a sensor 320 for detecting positioning and/or an EMG or other
sensor for detecting nerve, muscle or tissue stimulation to ensure
accurate or proper body part positioning in proximity to the
conductive coil, and to ensure that proper stimulation is occurring
in the target nerve, muscle or other body tissue.
[0188] It is also noted that in certain of the figures, various
components of the system, e.g., the coil turns or central aperture,
may be magnified or reduced in scale, individually or relative to
one another, for illustration purposes.
[0189] While the invention has been described in connection with
the above described embodiments, it is not intended to limit the
scope of the invention to the particular forms set forth, but on
the contrary, it is intended to cover such alternatives,
modifications, and equivalents as may be included within the scope
of the invention. Further, the scope of the present invention fully
encompasses other embodiments that may become obvious to those
skilled in the art and the scope of the present invention is
limited only by the appended claims.
* * * * *