U.S. patent application number 15/436538 was filed with the patent office on 2017-08-10 for cooling systems and methods for conductive coils.
The applicant listed for this patent is James H. AHLMAN, Daniel R. BURNETT, Christopher HERMANSON, Bruno STRUL. Invention is credited to James H. AHLMAN, Daniel R. BURNETT, Christopher HERMANSON, Bruno STRUL.
Application Number | 20170225005 15/436538 |
Document ID | / |
Family ID | 43497903 |
Filed Date | 2017-08-10 |
United States Patent
Application |
20170225005 |
Kind Code |
A1 |
BURNETT; Daniel R. ; et
al. |
August 10, 2017 |
COOLING SYSTEMS AND METHODS FOR CONDUCTIVE COILS
Abstract
An energy emitting apparatus for providing a medical therapy
includes one or more energy generators, a logic controller
connected to the one or more energy generators, and optionally one
or more sensors that are connected to the logic controller for
detecting muscle stimulation or electric conduction in a target
nerve. The energy generators produce energy focused on the target
nerve upon receiving a signal from the logic controller, and the
energy can be varied by the logic controller according to an input
provided by the one or more sensors. In certain embodiments, the
energy emitting apparatus includes one or more conductive coils
that produce a magnetic field focused on the target nerve upon
receiving an electric current. In certain embodiments, a variety of
cooling mechanisms or systems may be implemented for cooling the
coil.
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 |
BURNETT; Daniel R.
HERMANSON; Christopher
AHLMAN; James H.
STRUL; Bruno |
San Francisco
Santa Cruz
Sunnyvale
Portola Valley |
CA
CA
CA
CA |
US
US
US
US |
|
|
Family ID: |
43497903 |
Appl. No.: |
15/436538 |
Filed: |
February 17, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12509362 |
Jul 24, 2009 |
9610459 |
|
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15436538 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2/006 20130101;
A61N 2/02 20130101; A61N 2/008 20130101 |
International
Class: |
A61N 2/02 20060101
A61N002/02; A61N 2/00 20060101 A61N002/00 |
Claims
1. A system for providing a medical therapy, comprising: a
conductive coil configured to generate a magnetic field focused on
a target nerve, the conductive coil comprising a coil body and
further having a central aperture; a non-electrically conductive
material positioned at least partially on a surface of the coil
body such that remaining portions of the coil body are exposed,
wherein the non-electrically conductive material is configured to
maintain fluid flow gaps between adjacent turns of the coil body; a
cooling device; and a housing enclosing the cooling device and
conductive coil, wherein the cooling device is positioned within
the housing and in proximity to the conductive coil such that the
cooling device is positioned adjacent to the conductive coil
transverse to a plane defined by the conductive coil, and wherein
air is forced into a transverse direction relative to the plane of
the conductive coil and through the fluid flow gaps between
adjacent turns and through the central aperture such that airflow
passes through the turns to cool the conductive coil.
2. The system of claim 1 wherein the non-electrically conductive
material is selected from the group consisting of epoxy, plastic,
non-electrically conductive polymers, and silicone.
3. The system of claim wherein the non-electrically conductive
material comprises a tape wrapped around the coil body at a
non-zero angle, the tape configured to maintain fluid flow gaps
between adjacent turns of the coil body for cooling the conductive
coil.
4. The system of claim 1 wherein the cooling device comprises a fan
which provides an airflow rate of from about 1 liter per second to
2 liters per second.
5. The system of claim 1 wherein the conductive coil is
substantially, planar, and wherein the conductive coil has a spiral
configuration and a substantially flat surface.
6. The system of claim 1 wherein the conductive coil is
substantially conical,
7. The system of claim 1 wherein the conductive coil comprises 14
to 20 turns, and each turn is separated by a gap.
8. A method of magnetic induction therapy comprising: positioning a
first portion of a patient's body relative to an energy emitting
device such that a target nerve within the first portion of the
body is in proximity to a conductive coil having a plurality of
turns and a central aperture, wherein the conductive coil forms a
spiral configuration such that the plurality of turns and central
aperture are located within a single plane and a radius for each
successive turn increases from a center of the spiral coil; passing
a current through the conductive coil to generate a magnetic field
focused on the target nerve; concentrating a magnetic flux near the
target nerve; and drawing in air at a flow rate over the conductive
coil and in between first and second turns of the conductive coil
such that the air surrounds the first and second turns, and through
the central aperture of the conductive coil to cool the conductive
coil.
9. The method of claim 8 wherein the flow rate comprises a range of
flow rates selected from the group consisting of 1 liter per second
to about 5 liters per second or 2 liters per second to about 4
liters per second.
10. The method of claim 8 wherein the flow rate comprises a range
of flow rates selected from the group consisting of 20 CFM to about
100 CFM or from about 25 CFM to about 60 CFM.
11. The method of claim 8 wherein the flow produces a range of
pressure head selected from the group consisting of from about 0.5
inches of H20 to about 10 inches of H20 or from about 0.5 inches of
H20 to about 4 inches of H20.
12. The method of claim 8 further comprising venting warmed air
away from the first portion of a patient's body.
13. The method of claim 8 wherein the warmed air is vented in a
direction substantially opposite the first portion of the patient's
body.
14. The method of claim 8 further comprising detecting a
temperature of the warmed air.
15. The method of claim 14 wherein the energy emitting device
provides from about 36,000 to 45.000 pulses over about 20 to 40
minutes, while maintaining a patient interface plate of the device
at a temperature of no greater than 42 degrees C.
16. The method of claim 8 wherein the target nerve is the tibial
nerve.
17. The method of claim 8 further comprising treating a patient
exhibiting symptoms associated with urinary incontinence, fecal
incontinence, restless leg syndrome or premature ejaculation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
12/509,362 filed Jul. 24, 2009, which is incorporated herein by
reference in its 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 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 sonic 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 Dieing
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. In this invention, 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 pan 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 convening the signal
into an electromagnetic field extending into an area that contains
tissue to be healed. This invention 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. Nos. 5,181,902 Erickson et al, and 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 title: "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 at. 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
OAR 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 Kron berg discloses a method for
generating an electrical signal for use in biomedical applications
that includes two timing-interval generators. in this invention,
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. In this invention,
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, the Williams invention 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.
[0028] Also, therapies involving the use of traditional insertable
or implantable percutaneous needles require penetration into deeper
tissues and carry with them the added risk of infection, while
causing pain and discomfort to the patient. This often results in
ineffective treatment and/or reduced patient compliance.
[0029] Additionally, some existing techniques for cooling coils
include limitations and disadvantages. For example, some cooling,
techniques require air to first be cooled, e.g., refrigerated,
which involves the use of additional components and parts and could
increase cost. Some cooling devices utilize low flow rates and fail
to prevent rapid rises in temperature, such that coils must be
powered down frequently to prevent overheating damage. As a result,
large treatment gaps and low rep rates are often required during
therapy that utilizes such devices. Also, heated air is often
vented in the direction of the patient due to the configuration of
existing devices and necessary flow patterns Because the vented air
can reach high temperatures, this could pose a danger to patients.
These cooling deficiencies can limit the load, power and running
time at which coils may be operated.
SUMMARY
[0030] In certain embodiments, an energy emitting system for
providing a medical therapy is provided. The energy emitting system
may include one or more conductive coils configured to generate a
magnetic field focused on a target nerve. The conductive coil can
include a coil body having a central aperture, and a material may
be positioned on a surface of the coil body. Optionally, the
material is a non-electrically conductive material. The
non-electrically conductive material may be configured to maintain
air or fluid flow gaps between adjacent turns of the coil body for
cooling the conductive coil. The non-electrically conductive
material may also form air or fluid flow channels for cooling the
conductive coil.
[0031] In certain embodiments, an energy emitting system for
providing a medical therapy is provided. The energy emitting system
may include one or more conductive coils positioned within a
housing, where the conductive coil is configured to generate a
magnetic field or deliver an electrical stimulus to a patient. The
conductive coil can have a coil body having at least a first turn,
a second turn, and a central aperture. Optionally, a cooling device
may be provided, where the cooling device is configured to draw air
into the housing. The air may be drawn over the coil body, between
the first and second turns, and/or through the central aperture to
cool the coil.
[0032] In certain embodiments, an energy emitting system for
providing a medical therapy is provided. The energy emitting system
may include one or more conductive coils configured to generate a
magnetic field focused on a target nerve. The conductive coils
include at least a first turn and a second turn. The first turn can
include a first surface having at least one raised protrusion which
separates the first turn from the second turn, forming a gap that
allows for convection cooling of the coil.
[0033] In certain embodiments, an energy emitting system for
providing a medical therapy is provided. The energy emitting system
may include one or more conductive coils configured to generate a
magnetic field focused on a target nerve. The conductive coil can
include a first end and a second end, with a coil body positioned
between the first end and second end. The coil body may include a
lumen, which provides a passage extending from the first end to the
second end of the conductive coil. The lumen of the coil is
configured to permit the passage of fluid between the first end and
the second end for cooling the conductive coil.
[0034] In certain embodiments, a method of magnetic induction
therapy is provided. The method may include positioning a first
portion of a patient's body relative to an energy emitting device
such that a target nerve within the first portion of the body is in
proximity to a conductive coil disposed within or along the energy
emitting device. A current is passed through the conductive coil to
generate a magnetic field focused on the target nerve. The
patient's body is positioned in order to concentrate an
electromagnetic or magnetic flux near or over a target nerve. Also,
air may be drawn at a flow rate over the conductive coil body,
between the first and second turns of the conductive coil, and
through a central aperture of the conductive coil to cool the
conductive coil. The therapy may be used to treat or prevent a
variety of conditions, e.g., urinary incontinence, fecal
incontinence or restless leg syndrome.
[0035] 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
[0036] 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.
[0037] FIG. 1 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0038] FIG. 2 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0039] FIG. 3 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0040] FIG. 4 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0041] FIG. 5 is a schematic view of a variation of an apparatus
for magnetic induction therapy.
[0042] 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.
[0043] 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.
[0044] FIG. 8 is a schematic view of an embodiment that includes a
plurality of sensors.
[0045] FIGS. 9A-9D are schematic representations of different
garments adapted to operate as apparatus for magnetic induction
therapy.
[0046] FIG. 10 is a schematic view of an apparatus for providing
electrical stimulation.
[0047] FIG. 11 is a schematic view of another embodiment of an
apparatus for providing electrical stimulation.
[0048] FIG. 12 shows a schematic view of an energy emitting system
including a microneedle patch sensor.
[0049] FIG. 13-15 shows magnified bottom views of various
embodiments of microneedle patches.
[0050] FIGS. 16-17 shows magnified side views of various
embodiments of a microneedle patch.
[0051] FIG. 18 shows a magnified bottom perspective view of a
microneedle patch.
[0052] FIG. 19 shows a representative cross sectional view of the
skin composed of an outer stratum contemn covering the epidermal
and dermal layers of skin and the underlying subcutaneous tissue,
with a variation of a microneedle patch attached thereto.
[0053] FIGS. 20a-20d show various views of variations of
microneedle patches including multiple electrodes.
[0054] FIG. 21 shows a schematic view of an energy emitting system
including a microneedle patch sensor placed behind a subject's
knee.
[0055] FIGS. 22-23 show schematic views of energy emitting systems
including an electrode needle and sensor.
[0056] FIGS. 24-25 show schematic views of energy emitting systems
including an electrode needle without a sensor.
[0057] FIG. 26 shows a schematic view of an energy emitting system
including, a microneedle patch for providing stimulation.
[0058] FIGS. 27-28 show schematic views of energy emitting systems
including an electrode needle and microneedle patch for providing
stimulation.
[0059] FIGS. 29a-29d show prospective, side, top and rear views of
an energy emitting device M the form of a foot cradle.
[0060] FIGS. 30-31 show schematic views of an energy emitting
device in the form of a knee cradle.
[0061] FIG. 32 shows a front view of a variation of a conductive
coil.
[0062] FIG. 33 shows a prospective view of a variation of a
conductive coil.
[0063] FIG. 34 shows a side view of an energy emitting system
including the conductive coil of FIG. 32.
[0064] FIG. 35 shows a front view of a variation of a conductive
coil.
[0065] FIG. 36 shows a prospective view of a variation of a
conductive coil.
[0066] FIG. 37 shows a side view of an energy emitting system
including the conductive coil of FIG. 35.
[0067] FIG. 36 shows a side view of a variation of a conductive
coil.
[0068] FIG. 39 shows a cross sectional of the conductive coil of
FIG. 38 positioned over a malleolus.
[0069] FIG. 40 shows a cross sectional side view of an energy
emitting system including the conductive coil of FIG. 38.
[0070] FIG. 41 shows a top view of a portion of a coil turn.
[0071] FIG. 42 shows a cross section of the coil turn of FIG.
41.
[0072] FIG. 43 is a cross sectional view of a variation of a
conductive coil.
[0073] FIG. 44a is a front view of a variation of a conductive
coil.
[0074] FIG. 44b shows a top view of a portion of a coil turn of the
conductive coil of FIG. 44a.
[0075] FIG. 45 is a cross sectional view of a variation of a
conductive coil.
[0076] FIG. 46a shows a side view of an energy emitting system
including a variation of a conductive coil.
[0077] FIG. 46b shows a side view of an energy emitting system
including the conductive coil of FIG. 46a.
[0078] FIG. 47 is a cross sectional view of a variation of a
conductive coil positioned within a cooling system.
DETAILED DESCRIPTION
[0079] 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.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] 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.
[0084] 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.
[0085] 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.
[0086] 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 ma 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.
[0087] 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.
[0088] 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,
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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 sonic 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.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] 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. 101011 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.
[0101] 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.
[0102] 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.
[0103] 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.
[0104] 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 than 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.
[0105] 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.
[0106] 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.
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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)
[0111] 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.
[0112] 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] Ailments that may be treated through the use of the various
embodiments of the apparatus and methods described herein include
not only OAR 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.
[0124] 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.
[0125] 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.
[0126] 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.
[0127] 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.
[0128] 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.
[0129] An exemplary method of use of an apparatus according to the
embodiments described herein on a patient suffering from VI and/or
OAR includes the following steps:
[0130] 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.
[0131] 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.
[0132] 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.
[0133] 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
motors 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
[0134] 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.
[0135] 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.
[0136] 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.
[0137] 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.
[0138] 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.
[0139] In other embodiments, as shown in FIG. 12, 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, as
shown in FIG. 4, 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. 12) or over any other portion of the subject's body
suitable for detecting conduction of the target nerve.
[0140] Referring to FIGS. 13 and 16, the sensor may be in the form
of a microneedle patch 228, which can be removably attached to the
skin surface of a subject. The microneedle patch 228 may include a
housing 231, having one or more electrodes 232 and one or more
microneedles 235 deposited or arrayed on a surface of the electrode
232, forming one or more microneedle arrays 234. In FIG. 13,
microneedle patch 228 has the shape of a square, and the
microneedles 235 are arrayed on the bottom surface 236 of the
electrode 232 in a 16.times.16 configuration. However, as shown in
FIGS. 14-15, microneedle patches may be designed in a variety of
shapes, e.g., round, oval 229, rectangular 230, hexagonal, and a
variety of sizes. The microneedles may be arrayed in a variety of
arrangements and patterns (e.g., 14.times.14, 12.times.12, etc.)
depending on the particular use and needles.
[0141] Additionally, microneedles may be attached, deposited, or
arrayed on an electrode surface or patch in a variety of
configurations and arrangements, depending on where the particular
microneedle patch will be utilized and the treatment to be
delivered. The number of microneedles included in an array can
vary. For example, the number of microneedles may range from about
5 to 500 or 100 to 400 or about 200 to 300 or about 256. In certain
embodiments where microneedles are composed of strong, highly
conductive material, the number of microneedles necessary may be
less and may range from about 5 to 100 or 10 to 50 or 5 to 50.
However, where microneedles are composed of higher resistance
metal, a greater number of needles may be needed, e.g., about 100
to 500 or about 200 to 300 or greater than 500.
[0142] Referring to FIG. 18, a magnified view of a microneedle
array 234 composed of one or more microneedles 235 is shown.
Microneedles 235 may include a base portion 238 and an upper
portion 239. Microneedles 235 may have lengths in the range of
about 1 to 400 microns or 10 to 400 microns or preferably about 100
to 150 microns, and a diameter in the range of about 1 to 100
microns. A microneedle 235 may be tapered in diameter, going from a
larger to smaller diameter from the base portion 238 to the upper
portion 239 where the distal tip 240 of the microneedle is
preferably pointed or sharp. The upper portion 239 of the
microneedle 235 may have a diameter in the range of about 10-30
microns or about 15 to 25 microns. Optionally, for ease of
production, the base portion 238 of the microneedle 235 may be
thicker than the distal tip 240 or upper portion 239 of the
microneedle 235. In certain embodiments, as shown in FIG. 17, a
bulb 237 may be provided at the distal tip 240 of a microneedle 235
to provide for effective anchoring of the microneedle 235 in the
skin of a patient or subject. Microneedles 335 can include any
number of friction or grip increasing features. For example, they
may include projections, barbs, bulbs or a roughened surface or
tip. Microneedles 235 may take on various configurations, e.g.,
straight, bent, filtered, hollow or a combination of the above.
[0143] In other embodiments, microneedles may have lengths that
range from about 480 to 1450 microns, widths from about 160 to 470
microns, thicknesses from about 30 to 100 microns and tip angles
from about 20 to 90 degrees, and arrays can contain from 5 to 50
microneedles. For example, microneedles having these dimensions
have been shown to be less painful than hypodermic needles. Length
and number of microneedles can affect the level of pain
experienced. Decreasing microneedle length and/or the number of
microneedles may be beneficial and act to further reduce pain and
provide comfort.
[0144] In certain embodiments, the one or more microneedles may
include an electrically conductive material such that the
microneedles may transmit an electrical signal to an overlying
electrode or other surface. Microneedles may be constructed of an
electrically conductive material and/or coated with an electrically
conductive material. Optionally, microneedles may be coated with an
electrically conductive material and constructed of a
non-conductive material. Microneedles may be fabricated using a
variety of materials, e.g., metals, stainless steel, solid or coat
of gold over NI, Pd or Pd--Co. Pt, silicon, silicon dioxide,
polymers, glass, biocompatible polymers, titanium, silver, or
suture materials. Biodegradable polymers may also be used such that
if a tip of a microneedle were to snap or break off during
insertion, it would easily biodegrade.
[0145] A microneedle array 234 may be constructed or fabricated
using any variety of manufacturing methods known to persons of
ordinary skill in the art. Microneedles may be arrayed, attached,
etched or deposited onto a surface of an electrode. In another
embodiment, microneedles may be etched from or deposited onto a
silicon electrode, such that the microneedle patch, including
electrode and microneedles, are made from one material creating a
durable and stable microneedle patch.
[0146] As shown in FIG. 18, microneedles may be fabricated by
creating micron sized holes on a silicon substrate and by using a
KOH solution to create the needle shape. In other embodiments, the
microneedles may be made of non-conductive material but may still
be utilized to provide superior anchoring properties such that a
microneedle patch may effectively adhere or attach to a subject's
skin.
[0147] In certain embodiments, microneedle arrays are fabricated by
patterning SU-8 onto glass substrates and defining needle shapes by
lithography. The tips of the needles can be sharpened using
reactive ion etching. Optionally, holes may be drilled, e.g., by
laser, through the microneedles and base substrate. Holes may be
drilled off-center, but parallel to the microneedle axis,
terminating in side-opening holes along the needle shaft below the
needle tip. If desired, the holes can serve as micro fluidic needle
bores for injection or infusion of drugs, medicines, insulin,
proteins, nanoparticles that would encapsulate a drug or
demonstrate the ability to deliver a virus for vaccinations, etc.
to be used separately or in combination with electrical or magnetic
therapy. The microneedles may also be coated with nickel by
electroplating, which can increase their mechanical strength.
[0148] In certain embodiments, microneedle patches or microneedle
electrode arrays are made by fabricating master structures from
which replicates are molded and then made electrically active. For
example, SU-8 may be spun on a glass substrate bearing an array
mask pattern, baked, and then exposed from the backside to from a
tapered needle structure. Microneedles may be sharpened by RIE
etching. A PDMS (Polydimethylsiloxane) or similar material mold can
then be copied from the master. A PMMA (polymethylmethacrylate)
microneedle array is formed by solvent-casting and then released
from the mold.
[0149] To provide the arrays with electrical functionality, a Ti/Cu
seed layer may be deposited on the PMMA array and patterned by
excimer laser to electrically isolate adjacent rows. A Ni layer
(e.g., about 15 to 30 microns or 20 to 25 microns thick) may be
electroplated on the patterned seed layer to enhance structural
rigidity. A backside electrical connection to the array may be
formed by backside etching of a hole and forming an electrical
connection through the hole.
[0150] In another embodiment, the microneedle array is arranged in
a 16.times.16 array (i.e., 256 needles). Each needle has a height
of about 400 microns and the base diameter is about 100 microns.
The pitch between microneedles can be about 250 microns. The
microneedle arrays are then coated with metal and laser-etched to
provide electrical functionality. Optionally, rows of microneedles
can be electrically isolated from each other so that alternating
rows can provide alternating electrical polarity. The arrays are
also interfaced with a power source. Microneedles may be made of
polymer, coated with a metal, and etched to act as alternating
electrodes. In certain embodiments, the firing sequence of the
microneedles by rows or groups may be varied or configured to
alternate.
[0151] In certain embodiments, a microneedle array may include one
or more microneedles having multiple channels. For example, a
multichannel silicon microneedle may be constructed to deliver
bioactive compounds into neural or other tissue while
simultaneously monitoring and stimulating neurons and nerves.
[0152] FIG. 19 shows a cross sectional view of the skin 10 composed
of an outer stratum corneum 15 covering the epidermis 16 The skin
also includes the dermis 18, subcutaneous tissue/fat 12, and these
layers cover muscle tissue 14. As shown in FIG. 19, when a
microneedle patch 228 is attached to a subject's skin, the
microneedles 235 pierce the outer insulating stratum corneum layer
15. The microneedle patch 228 can detect current passing through a
stimulated nerve, and provide a superior signal as the current
detected is conducted through the microneedles 235, thereby
bypassing the poorly conductive stratum corneum layer 15 which
generally encompasses the outer 10 to 15 microns of skin. In other
embodiments, microneedles 215 may be fabricated to be long enough
to penetrate the stratum corneum 15, but short enough not to
puncture nerve endings, thus reducing the risk of pain, infection
or injury.
[0153] In certain embodiments, microneedles are filmed such that
they are in direct contact with their corresponding or overlying
electrodes. For example, a microneedle patch may include an
adhesive electrode pad and may utilize a conductive gel to help
hold the microneedles in place to prevent shear forces from
breaking or bending the microneedles.
[0154] In certain embodiment, as shown in FIGS. 20a-20d a
microneedle patch or applicator may include multiple electrodes on
a single patch or applicator, e.g., positive, negative, and/or
control or ground electrodes, where the microneedles will be
grouped in multiple arrays such that they conduct to the
appropriate electrode. For example. FIGS. 20a and 20b show a single
patch having positive, negative and control electrodes where a
separate array of electrodes is in contact with each respective
electrode. This arrangement can be created using a single patch.
Alternatively, as shown in FIG. 20c, two patches may be
implemented, one including the control electrode with corresponding
microneedle array and the other including the positive and negative
electrodes with corresponding microneedle arrays. The various
electrodes could be interchanged. Alternatively, as shown in FIG.
20d, three patches may be implemented, each having a separate
electrode (control, positive, or negative) with a corresponding
microneedle array. In use, in certain embodiments, the control may
be attached above or near bone, while the positive and/or negative
electrodes may be attached above nerve or muscle.
[0155] Referring again to FIG. 12, the energy emitting system 210
can be used to treat or prevent various conditions, e.g., urinary
incontinence, restless leg syndrome and fecal incontinence, among
others. Energy emitting system 210 includes one or more conductive
coils 212 disposed within or along a housing 214, one or more
sensors 216 configured to detect electrical conduction in the
target nerve or to detect muscle stimulation, and a controller 218
coupled 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, as shown in FIG. 4, however, the housing
could also be in the form of a flexible wrap, garment or other
design suitable for use with a subject.
[0156] Referring again to FIG. 12, energy emitting system 210 may
be used to treat prevent various conditions, e.g., urinary
incontinence, restless leg syndrome or fecal incontinence. In
certain embodiments, a method of using the energy emitting system
210 includes positioning a first portion of a patient's body, for
example a foot, ankle, or leg, relative to housing 214 such that a
posterior tibial nerve 220 within the first portion of the
patient's body is in proximity to one or more conductive coils 212
disposed within or along the housing. In this particular
embodiment, a patient's foot is positioned in a housing which is in
the form of a foot cradle 215. A sensor in the form of a
microneedle patch 228 may optionally be positioned along a second
portion of the patient's body in proximity to the posterior tibial
nerve 220. In this particular embodiment, microneedle patch 228 is
attached to the patient's foot over a muscle to detect muscle
stimulation. Alternatively, a patch could be placed elsewhere on
the patient, for example, on the leg in proximity to the posterior
tibial nerve 220, proximal to and up-stream from coils 212.
Microneedle patch 228 may be composed of one or more microneedle
arrays and one or more electrodes, as described supra.
[0157] Once the patient's foot is in position and the microneedle
patch 228 (e.g., conductive microneedle patch) is in place, a
current is passed from controller 218 through coils 212, and as a
result, the coils 212 generate a magnetic field which is focused on
the posterior tibial nerve 220. The magnetic field stimulates
tibial nerve 220, generating a current that will flow along the
tibial nerve 220 and spread along its length, to its sacral or
pudendal nerve roots. Microneedle patch 228 detects corresponding
muscle stimulation or twitching or electrical conduction through
the stimulated posterior tibial nerve. Upon detection, the
microneedle array may conduct and transmit an electrical signal to
the overlying electrode of microneedle patch 228. The signal may be
transmitted to controller 218, which can be integral or a separate
controller or device, or a separate controller coupled to
controller 218. The controller can then be varied or adjusted (to
adjust the current or magnetic field) based on the signal received
from microneedle patch 228 to ensure that adequate conduction of
the posterior tibial nerve 220 occurs and an adequate and accurate
dosage of treatment is being received. Although shown utilizing a
sensor, it is also contemplated that the system could be used
without a sensor.
[0158] Referring to FIG. 21, the method of using energy emitting
system 210 described above with respect to FIG. 12 may be varied
such that a conductive microneedle patch 228 is placed in proximity
to or proximally over the afferent posterior tibial nerve 220,
i.e., behind the patient's knee. In this position, a conductive
microneedle patch 228 detects electrical conduction through the
afferent posterior tibial nerve, i.e., it detects the electrical
signal traveling through the posterior tibial nerve back up to the
brain and spinal cord or it may detect corresponding muscle
stimulation. The microneedle patch 228 sends the signal to
controller 218 or to a separate controller coupled to controller
218. The controller can then be varied or adjusted based on the
signal received from microneedle patch 228 to ensure that adequate
conduction or stimulation of the posterior tibial nerve 220 occurs
and an adequate and accurate dosage of treatment is being
received.
[0159] A sensor utilized in the energy emitting system 210 may be a
microneedle patch 228 as described above or optionally the sensor
may be a sensor type known in the art (e.g., EKG sensor) or as
described in any of the embodiments described herein. It is also
contemplated that energy emitting system 250 can be utilized
without a sensor. Optionally, the sensor may be positioned within
or along, the housing, e.g., the foot cradle, along with the one or
more conductive coils, or positioned at a site distant from the
housing or conductive coils.
[0160] In certain embodiments, energy emitting system 210 my
optionally include one or more conductive microneedle patches which
can be positioned in proximity to the target nerve or muscle and
provide an additional or supplemental electrical or magnetic
stimulus to the target nerve or muscle.
[0161] Referring to FIG. 22, the energy emitting system 210
described above with respect to FIG. 12 may be varied to create
energy emitting system 260. Energy emitting system 260 further
includes one or more percutaneous electrode needles 262 or other
needles or other percutaneous electrodes coupled to a controller
218 and having an end insertable into a subject's body in proximity
to said target nerve or stimulation site. The percutaneous
electrode needle 262 is inductively coupled to one or more
conductive coils 212. In use, a first portion of a patient's body,
for example a foot, ankle, or leg, is positioned relative to
housing 214, e.g., foot cradle 215. such that a target nerve, e.g.,
posterior tibial nerve 220, located within the first portion of the
patient's body is in proximity to one or more conductive coils 212
disposed within or along the housing 214. Conductive coils 212 are
positioned proximate, optionally down-stream or distal to, a
selected stimulation site 261. The percutaneous electrode needle
262 is inserted through the skin at a location and to a depth that
brings the tip in close proximity to the stimulation site or target
nerve to be stimulated. The controller 218 is activated and a
current passes through conductive coils 212. The resulting magnetic
field generates a current that traverses the internal stimulation
site 261 by passing from conductive coils 212 to the internal
percutaneous electrode needle 262, as indicated by arrow i. Also,
the percutaneous electrode needle may be positioned within the
generated magnetic field, whereby the magnetic field generates a
current in the percutaneous electrode which stimulates a target
nerve or traverses an internal stimulation site. Optionally, a
current may be passed from the controller 218 through conductive
coils 212 and/or from the controller 218 through percutaneous
electrode needle 262, traversing the internal stimulation site as
the current passes between the coils and needle.
[0162] In energy emitting system 260, current density and
subsequent electric field intensity generated between conductive
coils 212 and percutaneous electrode needle 262 is greater than
that generated by traditional percutaneous stimulators. A greater
electric field intensity makes site location for conductive coils
212 and percutaneous electrode needle 262 easier. Furthermore, the
load impedance through the surface of the skin is much higher than
the internal impedance, and as such, the relatively high load
impedance lessens the likelihood of damage to tissue and nerves due
to high current pulses.
[0163] Referring again to FIG. 22, a percutaneous electrode needle
for use in any of the energy emitting systems described herein may
include a variety of designs. For example, percutaneous electrode
needle 262 may include a metal or plastic handle 263 to provide a
secure grip for the user, while minimizing the risk of shock to the
user. The needle tip can have a terminal portion 264 which may
extend between about 0.5 and 10 mm or about 2.0 mm from the needle
tip and may be constructed out of medical grade stainless steel or
other biocompatible metals. The diameter of the needle can be small
(less than about 0.25 mm) which minimizes trauma during insertion.
Optionally, needle 262 can be coated with Teflon or similar
insulative material 265 except for an exposed tip area 264. This
allows for a higher Field density at the tip for more precise
operation. The exposed needle tip area 264 should have a
sufficiently large surface area so as not to create too high a
local current field that may cause irritation or pain.
[0164] In another embodiment, as shown in FIG. 23, percutaneous
electrode needle 272 may be used in energy emitting system 260.
Percutaneous electrode needle 272 may be constructed out of medical
grade stainless steel or other biocompatible electrically
conductive metal. Percutaneous electrode needle 272 includes a
first end 276 for insertion into the patient's body in proximity to
the preselected internal stimulation site or target nerve to be
stimulated, and a second end 277. The size of the needle electrode
272 is preferably small, for example 34G needle electrode
(0.22.times.10 mm), to minimize trauma during insertion.
Percutaneous electrode needle 272 may also include an electrically
conductive adaptor, e.g., an electrically conductive tape member
273. The tape member 273 includes an electrically conductive
adhesive portion 274 and an electrically conductive non-adhesive
portion 275. Alternatively, the adaptor may include an electrically
conductive clip. The second end 277 of the needle electrode 272
preferably includes an enlarged portion to enable the electrically
conductive tape member 273 to be more easily adhered thereto. Once
it is determined that the percutaneous needle electrode 272 is
properly positioned, the needle is fixedly adhered to the
electrically conductive tape member 273 by folding the ends of the
adhesive portion 274 of the electrically conductive tape member 272
over the second end 277 of the needle electrode thereby forming an
electrical connection there between. The percutaneous needle
electrode 272 is electrically coupled to controller 218 via
electrically conductive tape member 273. Various other implantable
or insertable electrode needles known to persons of skill in the
art may also be utilized in the above described systems.
[0165] In certain embodiments of energy emitting system 260 as
described above and shown in FIGS. 22-23, a sensor 216, such as a
conductive microneedle patch 228, may be utilized to detect
electrical conduction through the stimulated posterior tibial nerve
220 or to detect muscle stimulation and transmit the signal to
controller 218. The signal may be transmitted to controller 218, a
separate controller or device, or a separate controller coupled to
controller 218. The controller can then be varied or adjusted based
on the signal from microneedle patch 228 to ensure that adequate
conduction of the posterior tibial nerve 220 occurs and an adequate
and accurate dosage of treatment is being received. It is also
contemplated that energy system 260 may be utilized without a
sensor 216, see for example FIGS. 24-25. Optionally, other types of
sensors may be used in place of a microneedle patch sensor, such as
other sensors described herein and sensors known to persons of
ordinary skill in the art. The sensor may be placed over a portion
of the subject's body suitable for detecting conduction of the
target nerve (e.g., on the leg as shown) or over a muscle to detect
muscle stimulation resulting from stimulating the target nerve.
[0166] In certain embodiments, as shown in FIG. 26, an energy
emitting system 250 for providing a medical therapy includes a
microneedle patch 252 (e.g., conductive microneedle patch) having
one or more microneedle arrays deposited on a surface of one or
more electrodes; one or more sensors 221 configured to detect
electrical conduction in the target nerve or to detect muscle
stimulation; and a controller 218 coupled to microneedle patch 252
and in communication with sensor 221. The microneedle patch 252 is
configured such that an electrical current generated by the
controller 218 is passed through the microneedle patch 252,
generating a magnetic field or delivering or generating an
electrical or magnetic stimulus to 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 microneedle patch 252.
[0167] Referring to FIG. 26, a method of using the energy emitting
system 250 may include placing a conductive microneedle patch 252
on a first portion of a patient's body, for example a foot, ankle,
or leg, in proximity to posterior tibial nerve 220 within the first
portion of the patient's body. Sensor 221 is positioned along a
second portion of the patient's body in proximity to the posterior
tibial nerve 220. In this particular embodiment, sensor 216 is
attached to the patient's leg in proximity to the posterior tibial
nerve 220, proximal to and up-stream from conductive microneedle
patch 252, Conductive microneedle patch 252 is composed of one or
more microneedle arrays and one or more electrodes, as described in
the embodiments above.
[0168] Once conductive microneedle patch 252 and sensor 221 are in
position, a current is passed from controller 218 through
conductive microneedle patch 252, resulting in an electrical
stimulus of the posterior tibial nerve 220. Alternatively, the
microneedle array may be insulated or constructed of non conductive
material such that the microneedle patch 252 generates a magnetic
field that stimulates tibial nerve 220 in a manner similar to the
one or more coils described in the embodiments above, without an
electrical stimulus. Whether the stimulus is electrical or
magnetic, either stimulus will generate a current that will flow
along the tibial nerve 220 and spread along its length, to its
sacral or pudendal nerve roots. Sensor 221 detects electrical
conduction through the stimulated posterior tibial nerve 220, and
then transmits the signal to controller 218. In certain
embodiments, the sensor may be in the form of a microneedle patch
sensor. The signal may be transmitted to controller 218, a separate
controller or device, or a separate controller coupled to
controller 21.8. The controller can then be varied or adjusted
based on the signal from sensor 221 to ensure that adequate
conduction of the posterior tibial nerve 220 occurs and an adequate
and accurate dosage of treatment is being received.
[0169] The sensor utilized in the energy emitting system 250 may be
a sensor of the type described above, with respect to other
embodiments. Optionally, for example, the sensor may be a
microneedle patch. It is also contemplated that energy emitting
system 250 can be utilized without a sensor.
[0170] In certain embodiments, energy emitting system 250 my
optionally include one or more conductive coils disposed within or
along a housing which can be positioned in proximity to the target
nerve or muscle and provide an additional or supplemental
stimulation of the target nerve or muscle.
[0171] Referring to FIG. 27, the energy emitting system 250
described above with respect to FIG. 26 may be varied to create
energy emitting system 280. Energy emitting system 280 further
includes one or more percutaneous electrode needles 262 coupled to
a controller 218 and having an end insertable into a subject's body
in proximity to said target nerve. Optionally, the electrode needle
may be non-percutaneous, such that it is insertable in an orifice
or opening in the subject, such as a natural orifice. The
percutaneous electrode needle 262 may be inductively coupled to
conductive microneedle patch 252, in use, a microneedle patch 252
is placed on a first portion of a patient's body, for example a
foot, ankle, or leg, in proximity to posterior tibial nerve 220
within the first portion of the patient's body and down-stream or
distal to a selected stimulation site 261. The percutaneous
electrode needle 262 is inserted through the skin at a location and
to a depth that brings the tip in close proximity to the target
nerve to be stimulated.
[0172] The controller 218 is activated and a current passes through
microneedle patch 252 and traverses the internal stimulation site
261 by passing from microneedle patch 252 to the internal
percutaneous electrode needle 262, as indicated by arrow i. The
current passing through microneedle patch 252 may also generate a
magnetic field which can generate a current that traverses the
internal stimulation site 261 by passing from microneedle patch 252
to the internal percutaneous electrode needle 262. Also, the
percutaneous electrode needle may be positioned within the
generated magnetic field, whereby the magnetic field generates a
current in the percutaneous electrode which stimulates a target
nerve and traverses an internal stimulation site. Optionally, a
current may be passed from the controller 218 through microneedle
patch 252 and/or from the controller 218 through percutaneous
electrode needle 262, traversing the internal stimulation site as
the current passes between the patch and needle.
[0173] Referring to FIG. 28, energy emitting system 280 may be
modified by using percutaneous electrode needle 272 in place of
percutaneous electrode needle 262. Percutaneous electrode needle
272 would be constructed and function as described above with
respect to FIG. 23. Various other implantable or insertable
electrode needles known to persons of skill in the art may also be
utilized in the above described systems. Additionally, energy
emitting system 280 may utilize a sensor to detect electrical
conduction through the stimulated posterior tibial nerve 220 and
send a corresponding signal indicative of the detected conduction
to controller 218 or other device such that the electrical or
magnetic stimulus can be adjusted as necessary. The sensor may be a
sensor 221, or optionally the sensor may be a microneedle patch. It
is also contemplated that energy emitting system 280 can be
utilized without a sensor. The sensor may be placed over a portion
of the subject's body suitable for detecting conduction of the
target nerve (e.g., on the leg as shown) or over a muscle to detect
muscle stimulation resulting from stimulating the target nerve.
[0174] In any of the above systems, embodiments are contemplated
where the sensors are also coupled or connected to or otherwise in
communication with energy emitting devices, e.g., the conductive
coils or conductive microneedle patches.
[0175] In certain embodiments, the one or more microneedles of the
microneedle patch may include an electrically conductive material
such that the microneedles may transmit an electrical signal to an
overlying electrode or other surface. Microneedles may be
constructed of an electrically conductive material and/or coated
with an electrically conductive material. Optionally, microneedles
may be coated with an electrically conductive material and
constructed of a non-conductive material. Microneedles may be
fabricated using a variety of materials e.g., metals, stainless
steel, solid or coat of gold over NI, Pd or Pd--Co, Pt, silicon,
silicon dioxide, polymers, glass, biocompatible polymers, titanium,
silver, or suture materials. Biodegradable polymers may also be
used such that if a tip of a microneedle were to snap or break off
during insertion, it would easily biodegrade. Optionally, the
microneedle patch may be non-conductive.
[0176] In certain embodiments, an electrode patch for improved
conductance or conduction is provided. The patch can include at
least one electrode having a first surface and/or a second surface.
The electrode may optionally be attached to various other materials
or adhesive materials. An array of microneedles may be deposited on
a surface of the electrode, or attached to a patch or other
material and indirectly or directly connected to the electrode. The
array of microneedles may include a conductive material. Such
patches may be used as a sensor to detect muscle stimulation or
electrical conductance, or to provide or deliver an electrical
stimulus or magnetic field, e.g., to a target nerve, and may
optionally be used in any of the embodiments described herein or in
any application where improved conductance or conduction is
desired. Microneedles yield improved reduction in impedance
compared to simple abrasion and other techniques, and are less
painful and more comfortable for the patient.
[0177] In certain embodiments, typical voltage sensed at the skin
and detectable or conductable by a microneedle patch or microneedle
array may range from about 1 to 400 microvolts or about 10 to 300
microvolts.
[0178] 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 will 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.
[0179] 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.
[0180] 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.
[0181] 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.
[0182] 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.
[0183] 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 cods 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.
[0184] 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.
[0185] 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.
[0186] 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:
[0187] 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.
[0188] 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.
[0189] 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.
[0190] 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 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.
[0191] 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.
[0192] 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.
[0193] In certain embodiments, the amplitude, frequency, direction
of a generated magnetic field, electrical or magnetic stimulus, or
tiring 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.
[0194] 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.
[0195] 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.
[0196] 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.
[0197] 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.
[0198] 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.
[0199] 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 0.2.5 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.
[0200] In certain embodiments, as shown in FIG. 29a-29d, an energy
emitting device can include a controller 289 and a foot cradle 290.
Foot cradle 290 may include vertical foot plate 291, and horizontal
foot plate 292, where each plate can be adjusted using vertical
foot plate knob 293 and horizontal foot plate knob 294. One or more
EMG plugs 295 are provided. An air core coil 297 or other type of
coil is provided. A display screen 296 may also be provided along,
with power cord 298. The display screen 296 can display a variety
of information to the user and/or practitioner such as the level of
power or current applied, treatment time, temperature of the cradle
device, detected current levels and/or physiological parameters,
etc., to facilitate effective and efficient therapeutic treatment.
The information can be used to vary or adjust the controller to
ensure that adequate conduction of a target nerve, e.g., posterior
tibial nerve 220 or muscle stimulation, occurs and an adequate and
accurate dosage of treatment is being received. Controls may also
be included to affect the following: power, field strength,
frequency, pulse, start/pause and cancelation of therapy (as
shown), or other parameters one of skill in the art would find
necessary or useful to control or monitor. In certain embodiments,
a sensor may be connected, or in communication with the foot cradle
or other energy emitting apparatus, controller, housing, conductive
coils, or microneedle patch.
[0201] In certain embodiments, as shown in FIGS. 30-31, an energy
emitting device may include a controller and a knee cradle. The
cradle may be configured to provide the conductive coil in
proximity to the popliteal fossa or area directly behind the knee.
In certain embodiments, the knee cradle may configured to cradle or
surround at least a portion of the knee or substantially the entire
knee without placing direct pressure on the popliteal fossa,
thereby minimizing or avoiding venous thrombosis. In one
embodiment, the device may be utilized while the knee is in the
flexed position (FIG. 30). In another embodiment, the device may be
utilized while the knee is in a non-flexed position (FIG. 31).
[0202] 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.
[0203] 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.
[0204] 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 a 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.
[0205] Referring to FIG. 32, in certain embodiments, a conductive
coil 300 may be configured in the form of a spiral. The conductive
coil 300 may have a coil body 302. The coil body 302 includes a
first end portion 304 and a second end portion 306. The first end
portion 304 and the second end portion 306 may include electrical
contact points 305. In between the first and second end portions
304, 306 the coil body includes one or more turns 307 forming a
spiral configuration. Each turn 307 may be spaced apart from an
immediately adjacent turn such that a space or gap 308 is provided
between adjacent turns. The space or gap between a turn and an
immediately adjacent turn may vary. For example, the space or gap
may be from about 0.05 mm to about 0.5 mm or from about 0.15 mm to
about 0.25 mm or the gap may be about 0.15 mm. The radius of
curvature for each turn may increase from the inner turn 309,
positioned at the center of the coil body 302, to the outer turn
310, which forms the outer perimeter of the coil body 302. Thus,
the radius for each successive turn may increase from the center of
the spiral coil to the outer perimeter of the spiral coil.
Optionally, a central aperture 312 is provided at the center of the
coil body. The central aperture 312 is surrounded by inner turn
309.
[0206] The diameter of the central aperture 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 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.
[0207] 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.
[0208] In certain embodiments, referring to FIGS. 32 and 33, a
material 314, e.g., a non-electrically conductive, thermally
conductive, non-thermally conductive and/or insulator material
positioned on the surface of the coil body 302 or conductive coil
300. The material may be an epoxy or other material having similar
properties. Such materials can include but are not limited to,
e.g., plastic, non-electrically conductive polymers, silicone, etc.
The material, for example, a non-electrically conductive material
314, may be configured in a variety of shapes, sizes, designs,
etc., depending on the particular coil and may be applied over or
along portions of the surfaces of the conductive coil 300 or coil
body 302 to hold or maintain the coiled configuration as well as to
maintain separation between adjacent turns of the coil body 302,
maintaining air flow or fluid flow gaps 308 between the adjacent
turns. For example, in the embodiments shown in FIGS. 32 and 33,
the non-electrically conductive. material 314 can be configured in
the form of a wedge. The wedge may be positioned on the surface of
coil body 302. A wedge may be adhered to or otherwise attached or
affixed to One or more surfaces or faces of a coil body 302. The
wedge may extend from the central aperture or the inner turn 309 of
the coil body 302 over a front face or surface of the coil body,
around and over the outer surface of the outer turn or outer
perimeter of the conductive coil, and over a back surface or back
face of the coil body 302, thereby partially encasing or
surrounding the coil body. Optionally, the wedges or other
configuration of non-electrically conductive material may be
attached on a single surface or face of the coil body, or as
separate pieces or a single piece on the front and back faces and
outer perimeter or surface of the coil body, or on one or both of
the front and back faces of the coil body and the outer surface of
the outer turn or perimeter of the coil body. The total diameter of
the coil body with the non-electrically conductive material on its
surface, may vary. For example, the total diameter may range from
about 3 to about 7 inches or from about 4 to about 5 inches or the
total diameter may be about 5 inches. Although shown in a tapered
wedge configuration, other Shapes or configurations are utilizable;
for instance, a uniform strip of material may be applied along one
or more radii of the coil body 302. Any number of alternative
variations may be applied so long as the material maintains
separation between the turns of the coil body 302.
[0209] In certain embodiments, as shown in FIGS. 32 and 33, one or
more wedges of non-electrically conductive material 314 are
positioned on or around the coil body 302. The wedges maintain
separation between adjacent turns of the coil body 302, maintaining
gaps 308 between adjacent turns for air flow or fluid flow passage,
and further providing one or more air flow or fluid flow channels
315 in between each wedge. The gaps 308 between adjacent turns
provide a path or passage for air or other fluid to pass through
the coil body in between and over the coil turns, which assists in
cooling the coil. Also, the air or fluid flow channels 315 provide
a path for directing air or other fluid to pass over or around the
coil body, which assists in cooling the coil.
[0210] FIG. 34 shows a side view of an embodiment of the conductive
coil 300, positioned within a housing 316 (a cross section of the
housing is shown surrounding the conductive coil). The housing 316
includes a patient interface plate 318. The housing and/or patient
interface plate can be made from a variety of materials having
various properties, such as non-electrically conductive or
non-thermally conductive or insulating materials. Such materials
may include but are not limited to, e.g., ceramic, ceramic alloy,
plastic, epoxy, other materials made by Cool Polymers.RTM. or
materials having similar properties. The patient interface plate
318 may be substantially rigid, if desired. A rigid plate helps
prevent bending or flexing of the plate due to pressure applied
against the plate by a patient during use, thus avoiding contact
between the patient interface plate 318 and the non-electrically
conductive material 314, e.g., an epoxy.
[0211] In certain embodiments, a shield of insulating material or
an insulating shield or layer, e.g., an overlay of thin flexible
plastic or other non-electrically conductive or non-thermally
conductive material, may optionally be provided over or under the
patient interface plate. This material would serve as a backup
insulator providing an additional barrier between the patient and
the conductive coil. One or more insulating shields or layers may
be provided. The shield or layer provides additional insulation and
backup insulation should the patient interface plate crack or
break. The shield or layer may optionally be made from any of the
materials described herein for making the patient interface plate
or housing.
[0212] The conductive coil 300 may be positioned within the housing
such that a space or gap is provided between the conductive coil
300 and the patient interface plate 318, e.g., gap 320. The
distance between the patient interface plate 318 and the
non-electrically conductive material 314 may vary. For example, the
distance may range from about 0.2 mm to 0.5 mm or about 0.2 mm to
0.7 mm or about 0.3 mm to 0.5 mm or the distance may be about 0.5
mm. The distance between the patient interface plate 318 and the
front face 321 of the conductive coil may vary. For example, the
distance may range from about 0.5 mm to 3 mm or about 1 mm to 2 mm
or the distance may be about 1.5 mm. A space or gap 322 may also be
provided between the housing and the outer turn or outer perimeter
of the conductive coil. The distance making up gap 322 may vary.
For example, the distance of the gap may range from about 1.58 mm
to 6.35 mm (about 1/16 inch to about 1/4 inch) or the distance may
be about 3.17 mm (about 1/8 inch).
[0213] Still referring to FIG. 34, a cooling device, e.g., a blower
324, may be provided within or near the housing 316. In certain
embodiments, the conductive coil 300 is positioned between the
patient interface plate 318 and the blower 324. The blower 324 may
be a fan or other device for pulling, pushing, forcing or
circulating air. The air may be ambient, cooled, refrigerated, etc.
The blower 324 may be, e.g., configured to pull air over, around,
and/or through the conductive coil 300, thereby cooling and/or
insulating the conductive coil 300.
[0214] In operation in certain embodiments, as indicated by the
arrows in FIG. 34, blower 324 actively pulls or pushes air into the
housing 316 through one or more inlets 319. The air is pulled or
pushed through gaps 320 and 322, around and/or over the conductive
coil 300 and in between wedges 314 and through air flow channels
315. The air may be pulled or pushed through gaps 308, in between
turns 307, which make up coil body 302, and/or through the central
aperture 312 (shown in FIG. 32). Therefore, air is continuously or
periodically refreshed as it is circulated and flows over, around,
and/or through the conductive coil 300 and coil body 302, in
between the patient interface plate 318 and the remainder of the
housing, and the conductive coil 300, and is withdrawn from the
housing 316, thereby cooling or insulating the conductive coil and
keeping the patient interface plate 318 at an acceptable
temperature for patient use. For example, the patient interface
plate 318 may be kept a temperature less than about 50 degrees
Celsius or less than about 45 degrees Celsius or less than about 42
degrees Celsius or from about 37 to 42 degrees Celsius. In the
event that the blower 324 is used to push airflow through gaps 320,
one or more blowers may be positioned to force airflow through the
gaps 320 such that the heated air is pushed (rather than pulled)
over and through the coil 300 and vented from the housing 316. In
certain embodiments, various fluids, including air or other fluids,
may be actively or passively pulled or pushed over, around and/or
through the spaces and/or gaps of the coil to provide cooling.
[0215] Optionally, the warmed air or other fluid is withdrawn from
the housing by being vented out of the rear face of the housing or
a venting plate 325, opposite the patient interface plate. The rear
face of the housing may have one or more vents, outlets or openings
for venting the heated air. In certain embodiments, one or more
vents, outlets or openings for venting warmed air may be located at
various positions on the housing, e.g., the side, top, bottom,
etc.
[0216] In certain embodiments, the fluid flow or airflow may vary.
For example, the flow rate may be greater than about 100 CFM (cubic
feet per minute) or it may range from about 20 CFM to about 100 CFM
or from about 25 CFM to about 60 CFM. In other embodiments, the
cooling device may provide an air or fluid flow at a flow rate
ranging from about 0.5 liters per second to about 4 liters per
second or from about 1 liter per second to about 2 liters per
second. The pressure head parameters may vary. For example, the
pressure head may range from about 0.5 inches of H20 to about 0.10
inches of H20 or from about 0.5 inches of H20 to about 4 inches of
H20.
[0217] In certain embodiments, the conductive coil 300 may be
configured without a material, e.g., a non-electrically conductive
or thermally conductive material, on its surface. Air or other
fluid may still be pulled or pushed over, through, and/or around
the conductive coil to cool the coil.
[0218] In certain embodiments, a chilling or refrigerator device,
external or internal cooling supply, water or other fluid reservoir
or other device may optionally be used alone as the cooling device
or in combination with another cooling device, e.g., a blower, to
provide cool fluid over, through, and/or around the coil to cool
the conductive coil.
[0219] The patient interface plate 318 may optionally include a
reflective surface, to provide an additional cooling mechanism. A
reflective surface positioned on or next to the patient interface
plate 318 may be used in addition to or in place of the blower 324.
A reflective surface may reflect light and radiant heat, thereby
cooling the patient interface plate 318 and helping to maintain the
patient interface plate 318 at an acceptable temperature for
patient use.
[0220] Referring to FIGS. 35-37, in certain embodiments, a material
in the form of a tape, wrap or strip, may be positioned along
portions of the surfaces of the conductive coil 330. For example, a
non-electrically conductive tape 331 may be wrapped around the coil
body 333 such that when the coil is wrapped about itself, at least
one surface of apposed adjacent surfaces of turns 337 of the coil
body 333 are maintained at a distance from one another by the tape
331 to provide air flow or fluid flow gaps 338. The tape 331 also
creates a series of air flow or fluid flow channels 332 on the
surface of the coil body 333 directing fluid over the coil.
Optionally, the tape 331 is wrapped about the coil body 333 at a
non-zero angle, e.g., at about a 45 degree angle to prevent or
minimize denting or bending of the turns 337. In some embodiments,
a zero angle wrap may be suitable. The tape 331 may be made from a
variety of materials. For example, the tape may be made from
silicone or other materials having similar properties. Such
materials may include but are not limited to, e.g., plastic,
non-electrically conductive polymers, epoxy, etc.
[0221] In operation, as indicated by the arrows in FIG. 37, blower
324 can pull or push air into the housing 316 through one or more
inlets 319. The air is pulled or pushed through gaps 320 and 322
and around or over the conductive coil 330 and in between the
strips of non-electrically conductive tape 331 and through air or
fluid flow channels 332. The air may also be pulled or pushed
through air or fluid flow gaps 338, in between turns 337 which make
up coil body 333, and/or through the central aperture 312 (shown in
FIG. 35). Therefore, air is continuously or periodically refreshed
as it is circulated and flows over, around, and/or through the
conductive coil 330 or coil body 333, in between the patient
interface plate 318 and the remainder of the housing and the
conductive coil 330, and is withdrawn from the housing 316. This
allows for cooling or insulating of the conductive coil and keeping
the patient interface plate 318 at an acceptable temperature for
patient use. For example, the patient interface plate 318 may be
kept a temperature less than about 50 degrees Celsius or less than
about 45 degrees Celsius or less than about 42 degrees Celsius or
from about 37 to 42 degrees Celsius.
[0222] Referring again to FIGS. 34 and 37, in certain embodiments,
an energy emitting device includes a conductive coil positioned
within a housing, the conductive coil has a coil body which has one
or more turns and a central aperture. A material may be positioned
on a surface of the coil body to provide a fluid flow channel for
cooling the conductive coil and to maintain separation between
adjacent coil turns. Also, a cooling device may be provided. The
cooling device may be a blower 324 or other device configured to
cool the conductive coil by drawing air into the housing, over the
coil body, through the gap in between the turns, and/or through the
central aperture.
[0223] Optionally, the housing can include a patient interface
plate 318, which can come into contact with the patient and
separates the patient from the conductive coil 300 or 330. The
housing may also include a venting plate 325. The venting plate 325
may be positioned substantially opposite the patient interface
plate 318, facing generally away from the patient and enclosing the
cooling device, e.g., blower 324 or other device for cooling the
conductive coil.
[0224] In certain embodiments, (e.g., as shown in FIG. 34) a
sensor, e.g., sensor 326, may optionally be provided, positioned
near to or in dose proximity to the venting plate 325 or in the
path of the vented air. The sensor may be attached to the housing,
conductive coil, or cooling device, or may be separate from the
energy emitting device, but located in close proximity to the
energy emitting device. The sensor may be a temperature sensor used
to monitor the temperature of warmed air vented from the venting
plate 325 to ensure that the temperature does not reach dangerous
levels that could be harmful to the patient, physician or other
user, even when the conductive coil is operating continuously at
heavy loads. Optionally, the desired temperature may be maintained
by providing automatic or manual feedback loop, where the load at
which the conductive coil is being run may be adjusted according to
the temperature data provided by the sensor.
[0225] Optionally, a temperature sensor may be provided to monitor
the temperature of the patient interface plate 318. The sensor may
be attached to the housing, conductive coil, or patient interface
plate, or may be separate from the energy emitting device, but
located in close proximity to the patient interface plate 318. The
sensor may be a temperature sensor used to monitor the temperature
of the patient interface plate to ensure that the temperature does
not reach dangerous levels that could be harmful to the patient as
the conductive coil is operating continuously at heavy loads. In
certain embodiments, a temperature sensor for monitoring
temperature of the patient interface plate ensures that the plate
remains at a temperature of no greater than about 42 degrees C.
Optionally, the desired temperature may be maintained by providing
an automatic or manual feedback loop, where the load at which the
conductive coil is being run may be adjusted according to the
temperature data provided by the sensor.
[0226] In certain embodiments, the conductive coil may be
configured to run continuously or periodically at various loads,
including very high loads, while a patient interface plate
positioned on the housing remains at an acceptable and patient safe
temperature, e.g., a temperature of no greater than about 42
degrees C. For example, the number of pulses provided by the energy
emitting system and the time intervals for doing so can vary. For
example, the energy emitting system may be configured such that the
conductive coil provides from about 34,000 to about 47,000 pulses
or 36,000 to about 45,000 pulses over about 20 to 40 minutes or up
to about 44,400 pulses over about 30 minutes, while the patient
interface plate, positioned on the housing is maintained at a
temperature of no greater than about 42 degrees C. The various
features of the energy emitting system described herein, including
the conductive coil, housing and cooling, device, allow the
conductive coil to operate at high power rates and heavy loads. For
example, the coils may operate at the following parameters: about
10 to 30 hertz or about 15 to 25 hertz or about 20 hertz and at
about 700 to 1100 volts or about 800 to 1000 volts or about 900
volts, for over about 25 to 40 minutes or 27 to 35 minutes or about
30 minutes. In certain embodiments, the features of the energy
emitting system allow the conductive coil to be operated
continuously, substantially continuously, periodically, or at a
high rep rate, with no shutdown of the conductive coil necessary to
prevent overheating or to prevent a risk to the patient.
[0227] In certain embodiments, a method of magnetic induction
therapy is provided. The method includes positioning a first
portion of a patient's body relative to an energy emitting device
such that a target nerve within the first portion of the patient's
body is in proximity to the conductive coil disposed within or
along the energy emitting device. A current is then passed through
the conductive coil to generate a magnetic field focused on the
target nerve. The first portion of the patient's body, e.g., the
patient's leg or ankle, is positioned relative to the energy
emitting device and conductive coil, or optionally, the conductive
coil is situated relative to the first portion of the patient's
body, such that the electromagnetic or magnetic flux generated by
the conductive coil is concentrated on, near or over the target
nerve or in close proximity to the target nerve.
[0228] The conductive coil can be cooled during, after or before
operation. Cooling may be performed by drawing air or other fluid
at a flow rate over the conductive coil body, between the various
turns making up the conductive coil, and optionally through a
central aperture of the conductive coil. The fluid flow or airflow
may vary. For example, the flow rate may be greater than about 100
CFM or it may range from about 20 CFM to about 100 CFM or from
about 25 CFM to about 60 CFM. In other embodiments, the cooling
device may provide air or fluid flow at a flow rate ranging from
about 0.5 liters per second to about 4 liters per second or from
about 1 liter per second to about 2 liters per second. The pressure
head parameters may vary. For example, the pressure head may range
from about 0.5 inches of H20 to about 10 inches of H20 or from
about 0.5 inches of H20 to about 4 inches of H20.
[0229] As the conductive coil is cooled, warm air or other warm
fluid that has passed, over, around and/or through the conductive
coil to cool the coil may be vented out of the energy emitting
device away from the first portion of a patient's body. The energy
emitting device or housing may have a venting plate or other outlet
whereby the warmed air is vented such that it exits the device in a
direction substantially opposite the first portion of the patient's
body to prevent or minimize the patient's contact with warmed or
heated air.
[0230] Optionally, the temperature of the warmed air exiting the
device is monitored such that the temperature can be regulated to
maintain temperatures at a relatively safe level. In certain
embodiments, the temperature of the patient interface plate or a
portion of the energy emitting device that can come into contact
with the patient may also be monitored or detected. This monitoring
allows the temperature to be regulated to maintain temperatures at
a relatively safe level, e.g., no greater than about 42 degrees
C.
[0231] In certain embodiments, the conductive coil may be
configured to run continuously or periodically at various loads
including very high loads, while a patient interface plate
positioned on the housing remains at an acceptable and patient safe
temperature, e.g., a temperature of no greater than about 42
degrees C. For example, the number of pulses provided by the energy
emitting system and the time intervals for doing so can vary. For
example, the energy emitting system may be configured such that the
conductive coil provides from about 34,000 to about 47,000 pulses
or 36,000 to about 45,000 pulses over about 20 to 40 minutes or up
to about 44,400 pulses over about 30 minutes, while the patient
interface plate positioned on the housing is maintained at a
temperature of no greater than about 42 degrees C.
[0232] The methods described above can be use to treat or prevent
various conditions and/or reduce or minimize their associated
symptoms. Examples of such conditions include urinary incontinence,
fecal incontinence and/or restless leg syndrome.
[0233] The conductive coil as described in any of the embodiments
herein ma take on a variety of shapes or configurations. For
example, the conductive coil may be substantially planar. The
spiral conductive coil 300 shown in FIGS. 32-34 is substantially
planar. Optionally, referring to FIGS. 38-39, the conductive coil
340 may be substantially conical in configuration or shape. In a
conical configuration, as shown in FIG. 38, the center of the
conductive coil, starting with inner turn 348, is positioned a
distance Y from the outer turn 349, along the longitudinal axis of
the coil (shown as dashed line). Each successive turn may extend
beyond the perimeter or circumference of the adjacent larger turn
along the longitudinal axis. The conical coil may optionally also
have a material, e.g., non-electrically conductive material
attached to its surface or wrapped around the coil as described
above.
[0234] FIG. 39 shows a cross sectional side view of an embodiment
of a conductive coil 340, having a conical configuration. In use,
the conductive coil 340 may be positioned against a patient's leg,
over at least a portion of a patient's malleolus or ankle, in
proximity to the underlying target nerve, e.g., tibial nerve.
Optionally, as shown in FIG. 40, the conical coil 340 may be
positioned within a housing 342, and incorporate any of the cooling
mechanisms described above, for example, using cooling device 324
to pull or push air or other fluid around, over, and/or through the
conductive cod 340.
[0235] In any of the embodiments described herein, the coil may
take on a variety of configurations. For example, a cross-sectional
area of the coil may be substantially rectangular, square, or
circular in shape. In certain embodiments, as shown in FIGS. 41 and
42, the coil may take on a ribbon-like configuration, FIG. 41 shows
a top view of a section of a coil turn. The surface of the coil
turn is substantially flat. FIG. 42 shows a cross section of the
coil turn, where the height of the cross section is greater than
its width, e.g., 25 to 60 times greater in height relative to its
width. An end of the coil turn could have similar dimensions. This
allows the coil to be tightly rolled or packed into a spiral
configuration, suitable for conducting electrical current and
generating an electromagnetic or magnetic field and/or cooling. The
coil can be made from a variety of conductive materials, e.g.,
copper or other materials having similar properties.
[0236] In another embodiment, an energy emitting system for
providing a medical therapy can include a conductive coil 350 (a
cross section of which is shown in FIG. 43) configured to generate
a magnetic field focused on a target nerve. The conductive coil 350
can have a first end 351 and a second end 352 with a coil body 353
positioned between the first end and second end. A lumen 354 can
extend through the coil body 353, from a first end to a second end.
The lumen 354 provides a passage extending from the first end 351
to the second end 352 of the coil, which permits the passage of
fluid between the first end and the second end for cooling the
conductive coil 350. For example, air or a non-electrically
conductive cooling liquid (indicated by the arrows) could be passed
through the lumen 354 of the coil, thereby cooling the coil as it
passes from one end to the other. The fluid can be cooled and
recycled or a continuous stream of fresh fluid can be passed
through the coil. Optionally, the conductive coil can be partially
or completely coated with a material, e.g., a non-electrically
conductive material (not shown) to ensure that the conductive
surface of the coil turns making up the coil do not come into
contact with each other.
[0237] In another embodiment, an energy emitting system for
providing a medical therapy can include a conductive coil 360
configured to generate a magnetic field focused on a target nerve.
(FIG. 44a and 44b) shows a top view of a portion of a coil turn
making up the conductive coil 360). The conductive coil may have at
least a first turn 307 and a second turn 307 or a series of turns.
The second turn may have a radius of curvature that is greater than
the radius of curvature of the first turn, such that the radius of
each successive turn from the center of the coil to its outer
perimeter increases. Each turn 307 has a top surface 361 and a
bottom surface 362 and the top and/or bottom surface of the turns
307 may have one or more raised protrusions 363 extending
therefrom. The protrusions 363 separate successive turns 367 from
one another, forming a gap that allows for the passage of air or
other fluid for cooling, e.g. by convection. Additionally, the
protrusions 363 help ensure that the conductive surfaces 361, 362
of the turns 367 making up the coil do not conic into contact with
each other. The raised protrusion 363 may be made from various
materials, e.g., ceramic or other materials having similar
properties, and may be configured in a variety of shapes, e.g.,
circular, oval, rectangular, spherical, etc. The protrusions may be
adhered, attached or otherwise affixed the surface of the coil by
any suitable manner known in the art.
[0238] In another embodiment, (a cross section of which is shown in
FIG. 45), at least a portion of a conductive coil 370, e.g., a
surface of a turn 377 or the entire turn, may be coated or
otherwise covered with a material 371, e.g., a non-electrically
conductive or phase changing material. Material 371 can separate
the turns 377 from one another and allow for cooling by conduction.
The heat from the coil can be absorbed by the material 371 which
acts as a heat sink. Various non-electrically conductive or phase
changing materials may be used, e.g. wax or other materials having
similar properties.
[0239] In use, the wax or other material absorbs the heat generated
from the conductive coil. The wax may melt and change phases as it
provides a heat sink. A cooling device (not shown), e.g., a fan,
blower, etc., may also be implemented in the system where the
cooling device is configured to cool and thereby harden the melted
wax after or during the cooling process. Optionally, the coated
conductive coil turns 377 can be surrounded by a casing (not shown)
that holds the wax or other material in place such that it may be
resolidified on the conductive coil 370 when cooled.
[0240] The non-electrically conductive or phase changing material
can by applied or coated on the coil surface by a variety of
techniques known to persons of skill in the art, by spraying,
vapor, or dip. The coating can be reused or a fresh coating can be
.reapplied after each use. For example, wax can be melted and
removed. Or the conductive coil can be replaced after use, once the
wax or other coating is melted. The coating of the material may be
applied such that it has a thickness on the coil's surface suitable
to adequately cool a particular coil depending, on the coils size,
configuration, load, and/or power. The thickness may vary. For
example, the material may have a thickness from about 25 inch to 1
inch or about 0.5 inch to 0.75 inch.
[0241] Optionally, in various embodiments, each turn of a
conductive coil can be individually encased or coated within a
material, e.g. a non-electrically conductive or phase changing
material, such that the conductive coil turns are separated from
one another or the entire coil body is insulated or covered. In
other embodiments, one or more surfaces of the coil may be coated
and not every coil turn may be coated.
[0242] FIG. 46a shows a side view of an embodiment of a conductive
coil 380 which may be potted, covered or encased in a material 381,
e.g., a non-electrically conductive or non-thermally conductive or
thermally conductive material, e.g., a thermally conductive
plastic, epoxy, or materials made by Cool Polymers g or other
materials having similar properties or a combination of such
properties. A cross section of the material 381 surrounding the
conductive coil is shown in FIG. 46. The potting or casing material
381 may include a patient interface plate 382, separating the
patient from the conductive coil as described above which is
non-electrically conductive and/or non-thermally conductive or
otherwise thermally or electrically insulated to protect the
patient. A fluid may be passed over the back face 383 of the
potting or casing, thereby cooling the conductive coil 380.
[0243] Optionally, as shown in FIG. 46b, one or more heat fins 384
can extend from the back face 383 of the potting or casing,
providing channels for passing fluid over the conductive coil 380,
thereby cooling the coil. The heat fins 384 may be attached to the
casing or potting or be an extension thereof The fluid may be
supplied with a cooling device, e.g., fan, blower, refrigerator
device. A pump or other system could be used for supplying the
fluid over the potting or casing. The fluid could optionally be
recycled for reuse, or cooled using a cooling device before initial
or recycled use. Ambient air, or water or other fluid may
optionally be used.
[0244] In another embodiment, (a cross section of which is shown in
FIG. 47), a conductive coil 390 may be encased or covered in a
material, e.g., a non-electrically conductive material 391 such as
a ceramic. The conductive coil 390 can then be placed in an
additional casing or housing 392 which may hold fluid to be passed
over and around the coil to cool the coil creating a cooling
system. A pump 393 or other system could be implemented for moving
the fluid over or around the coil and in between the coil turns. A
cooling device 394 for cooling warmed or heated fluid that has
passed through the system or for cooling fluid about to pass
through the system may also be implemented. In certain embodiments,
water may be the fluid used to cool the conductive coil.
[0245] 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, 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.
[0246] 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.
[0247] 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.
[0248] The conductive coils described herein may have a variety of
dimensions, shapes, and sizes. For example, 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.
[0249] 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.
[0250] 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,
[0251] 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.
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