U.S. patent application number 15/674276 was filed with the patent office on 2018-05-24 for two-part pulsed electromagnetic field applicator for application of therapeutic energy.
This patent application is currently assigned to Endonovo Therapeutics, Inc.. The applicant listed for this patent is Endonovo Therapeutics, Inc.. Invention is credited to Andre' A. DIMINO, Matthew E. DRUMMER.
Application Number | 20180140861 15/674276 |
Document ID | / |
Family ID | 54321108 |
Filed Date | 2018-05-24 |
United States Patent
Application |
20180140861 |
Kind Code |
A1 |
DIMINO; Andre' A. ; et
al. |
May 24, 2018 |
TWO-PART PULSED ELECTROMAGNETIC FIELD APPLICATOR FOR APPLICATION OF
THERAPEUTIC ENERGY
Abstract
Pulsed electromagnetic field (PEMF) apparatuses and methods of
making and using them. In particular, described herein are two-part
PEMF apparatuses that include a self-contained, lightweight, small,
compact (e.g., in some variations, wearable) generator unit that is
adapted to releasably and replaceably mate with an applicator unit.
The generator unit typically includes a power source and a
controller that generated PEMF waveforms to be applied, including
the shape and timing of the PEMF waveforms. The applicator unit
typically includes a radio frequency (RF) power amplifier, a loop
antenna, and impedance matching circuitry for matching the
impedances for the connection between the antenna loop and the RF
power amplifier. Thus, the generator module may control the
application of PEMF signals without requiring impedance matching
between the separable generator unit and the applicator unit. The
applicator unit can include a plurality of variable capacitors that
can be used to tune the PEMF signals.
Inventors: |
DIMINO; Andre' A.;
(Woodcliff Lake, NJ) ; DRUMMER; Matthew E.; (Fort
Lee, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Endonovo Therapeutics, Inc. |
Woodland Hills |
CA |
US |
|
|
Assignee: |
Endonovo Therapeutics, Inc.
Woodland Hills
CA
|
Family ID: |
54321108 |
Appl. No.: |
15/674276 |
Filed: |
August 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15137737 |
Apr 25, 2016 |
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15674276 |
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14688602 |
Apr 16, 2015 |
9320913 |
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15137737 |
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62086987 |
Dec 3, 2014 |
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61980433 |
Apr 16, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2/02 20130101; A41D
13/1245 20130101; A47G 9/10 20130101; A61N 1/0484 20130101; A41D
2400/32 20130101; A61N 1/40 20130101; A47G 9/00 20130101; A42B
1/242 20130101 |
International
Class: |
A61N 2/02 20060101
A61N002/02; A61N 1/40 20060101 A61N001/40; A61N 1/04 20060101
A61N001/04; A47G 9/10 20060101 A47G009/10; A41D 13/12 20060101
A41D013/12; A42B 1/24 20060101 A42B001/24 |
Claims
1. A modular apparatus for applying pulsed electromagnetic field
(PEMF) energy to a subject, the apparatus comprising: a generator
unit including a signal generator configured to generate a PEMF
waveform and a first connector; and an applicator unit including a
second connector adapted to mate with the first connector, a radio
frequency (RF) power amplifier adapted to receive waveform
information from the generator unit though the second connector and
generate PEMF signals therefrom, a loop antenna connected to the RF
power amplifier and adapted to deliver the PEMF signals to the
subject wearing the applicator unit, impedance matching circuitry
configured to match the impedance between the RF power amplifier
and the loop antenna; wherein the generator unit is configured to
releasably connect to the applicator unit to drive transmission of
PEMF signals from the applicator unit based on the PEMF waveforms.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 15/137,737, filed Apr. 25, 2016, titled
"TWO-PART PULSED ELECTROMAGNETIC FIELD APPLICATOR FOR APPLICATION
OF THERAPEUTIC ENERGY", which is a continuation of U.S. patent
application Ser. No. 14/688,602, filed on Apr. 16, 2015 titled
"TWO-PART PULSED ELECTROMAGNETIC FIELD APPLICATOR FOR APPLICATION
OF THERAPEUTIC ENERGY," now U.S. Pat. No. 9,320,913, which claims
priority to U.S. Provisional Patent Application No. 61/980,433,
filed on Apr. 16, 2014, titled "TWO-PART PULSED ELECTROMAGNETIC
FIELD APPLICATOR FOR APPLICATION OF THERAPEUTIC ENERGY," and U.S.
Provisional Patent Application No. 62/086,987, filed on Dec. 3,
2014, titled "TWO-PART PULSED ELECTROMAGNETIC FIELD APPLICATOR FOR
APPLICATION OF THERAPEUTIC ENERGY," each of these applications is
herein incorporated by reference in its entirety.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference in their
entirety to the same extent as if each individual publication or
patent application was specifically and individually indicated to
be incorporated by reference.
FIELD
[0003] Described herein are pulsed electromagnetic field (PEMF)
treatment apparatuses including one or more integrated coils and
methods for making and for using PEMF apparatuses for the
therapeutic treatment of subjects. More particularly described
herein are non-invasive PEMF applicators having two parts: a PEMF
generator component, including a power supply and a signal
generator, that is adapted to removably couple with a wearable
applicator that includes a matched RF power amplifier and impedance
matched loop antenna.
BACKGROUND
[0004] Weak, non-thermal electromagnetic fields ("EMF") can result
in physiologically meaningful in vivo and in vitro bioeffects. See,
e.g., U.S. patents and pending applications: U.S. Pat. No.
5,370,680, U.S. Pat. No. 5,584,863, U.S. Pat. No. 5,723,001, U.S.
Pat. No. 7,740,574, U.S. Pat. No. 7,744,524, U.S. Pat. No.
7,758,490, U.S. Pat. No. 7,896,797, U.S. Pat. No. 8,343,027, U.S.
Pat. No. 8,415,123; U.S. 2010-0210893, U.S. 2010-0222631, U.S.
2013-0274540, U.S. 2014-0046115, U.S. 2014-0046117, U.S.
2011-0207989, U.S. 2012-0116149, and U.S. 2012-0089201, each of
which describes PEMF applicator and methods of using them. Each of
these publications is herein incorporated by reference in its
entirety.
[0005] Time-varying electromagnetic fields, comprising EMF, ranging
from several Hertz to about 100 GHz, have been found to be
clinically beneficial when used as a therapy for reducing pain
levels for patients undergoing surgical procedures, promoting
healing in patients with chronic wounds or bone fractures, and
reducing inflammation or edema in injuries (e.g. sprains).
Presently several EMF devices constitute the standard armamentarium
of orthopedic clinical practice for treatment of difficult to heal
fractures. The success rate for these devices has been very high.
The database for this indication is large enough to enable its
recommended use as a safe, non-surgical, non-invasive alternative
to a first bone graft. Additional clinical indications for these
technologies have been reported in double blind studies for
treatment of avascular necrosis, tendinitis, osteoarthritis, wound
repair, blood circulation and pain from arthritis as well as other
musculoskeletal injuries.
[0006] In addition, cellular studies have addressed effects of weak
electromagnetic fields on both signal transduction pathways and
growth factor synthesis. It has been shown that EMF stimulates
secretion of growth factors after a short, trigger-like duration.
Ion/ligand binding processes at intracellular buffers attached to
the cell membrane are an initial EMF target pathway structure. The
clinical relevance to treatments, for example, of bone repair, is
up-regulation such as modulation, of growth factor production as
part of normal molecular regulation of bone repair. Cellular level
studies have shown effects on calcium ion transport, cell
proliferation, Insulin Growth Factor ("IGF-II") release, and IGF-II
receptor expression in osteoblasts. Effects on Insulin Growth
Factor-I ("IGF-I") and IGF-II have also been demonstrated in rat
fracture callus. Pulsed electromagnetic fields ("PEMF") have also
been shown to have an effect on transforming growth factor beta
("TGF-.beta.") messenger RNA ("mRNA") in a bone induction model in
a rat. Studies have also demonstrated up-regulation of TGF-.beta.
mRNA by PEMF in human osteoblast-like cell line designated MG-63,
wherein there were increases in TGF-.beta.1, collagen, and
osteocalcin synthesis. PEMF stimulated an increase in TGF-.beta.1
in both hypertrophic and atrophic cells from human non-union
tissue.
[0007] Further studies demonstrated an increase in both TGF-.beta.1
mRNA and protein in osteoblast cultures resulting from a direct
effect of EMF on a calcium/calmodulin-dependent pathway. Cartilage
cell studies have shown similar increases in TGF-.beta.1 mRNA and
protein synthesis from EMF, demonstrating a therapeutic application
to joint repair. U.S. Pat. No. 4,315,503 (1982) to Ryaby, U.S. Pat.
No. 7,468,264 (2008) to Brighton and U.S. Pat. Nos. 5,723,001
(1998) and U.S. Pat. No. 7,744,524 (2010) to Pilla typify the
research conducted in this field.
[0008] There are currently two types of applicators adapted for
applying PEMF. For example, integrated applicators in which the
power supply and signal conditioner is integrated into the
applicator have been proposed, including those discussed above.
Such applicator may be lightweight and wearable, however the
operation of the device may be limited by the power supply.
Further, although fixedly coupling the signal generator and power
amplifier to the antenna delivering the PEMF to the body simplifies
the impedance matching between the applicator (antenna) and the
power source, the result is somewhat inflexible in operation.
[0009] Modular applicators have also been designed, in which the
power supply, including the power/signal amplification and
waveform/signal generator is separate from the applicator, and may
be connected by a cord or wire to one or more applicator. The
applicators may be disposable, and typically include only the
applicator (e.g., antenna) and connector. This arrangement, while
conceptually simple, has various drawbacks. For example, to achieve
maximum efficiencies, the impedance of all components of the radio
frequency (RF) power pathway must have the same impedance. Thus,
the transmission lines and RF connector must have fixed
characteristic impedance values. The RF power amplifier and
applicator antenna must be impedance matched (e.g., by impedance
adjusting circuits) to match the impedance of the cord/transmission
line. This arrangement has significant drawbacks for low-power
devices. In order to achieve sufficient field strength, the antenna
impedance matching circuit must have a high quality factor
("Q-factor") with a very narrow bandwidth. With the normal
component variability of high Q-factor components, carrier
frequency drift, and tuning variability due to mechanical
vibrations, the output field strength may be severely affected,
particularly between different applicators connected to the same
power supply. Thus, modular PEMF applicators that include separate
applicators and power supplies typically require a somewhat
complicated (and as a result, large and unwieldy or heavy) power
supply portion.
[0010] Accordingly, described herein are PEMF applicator systems
that may address the need for electromagnetic therapy devices
(e.g., PEMF devices) that are simple, lightweight (and wearable)
and include a removable/re-attachable signal generator that can
couple with one (or more) antenna applicators.
SUMMARY OF THE DISCLOSURE
[0011] Described herein are two-part (e.g., modular) PEMF
applicator apparatuses and methods of making and using them. In
particular, described herein are PEMF applicators that may include:
a generator module that includes a power supply (e.g., battery,
capacitive power supply, etc.) and signal conditioning (e.g., pulse
generator), including timing and control circuitry, but that does
not include power amplification or tuning (e.g. impedance
matching); and an applicator component that includes power
amplification and impedance matching between the amplifier(s) and
the delivery antenna(s). The generator and applicator components
maybe removably coupleable to each other and the combined generator
and applicator can be worn or supported on a subject's body as a
lightweight component or part of a delivery component such as a
garment (hat, clothing, etc.) or bandage (brace, cast, etc.).
[0012] In general, the generator component may include a power
supply such as a battery or set of batteries (E.g., AAA alkaline
batteries), and may include a processor for preparing the signals
(including waveform shaping and timing) to be delivered. The
generator component may include a housing that is adapted to mate
with an applicator housing that is attached or includes the
applicator. Thus, the generator may include a releasable coupling
that mates with a coupling on the applicator component to secure
the two together. The generator may also be adapted to receive
and/or transmit information (e.g., to a microprocessor for control,
and/or recording or storing information). The generator may also
include one or more indicators for indicating the status of the
apparatus (e.g., on/off, delivering PEMF, low power, etc.). The
applicator may also include a processor (microprocessor, CPU, etc.)
which be used to control operation of the device, including shaping
and/or timing of the PEMF waveforms delivered by the
applicator.
[0013] In general, the applicator unit may include a complimentary
coupler for attaching to the generator component. For example, the
applicator may include a plug (male, female or hybrid) that couples
with the generator. The applicator also includes one or more
antenna. In particular, the applicator may include a loop antenna
formed of a loop of wire (e.g., having a diameter of 5 inches, 6
inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12
inches, etc.). The wire antenna may be flexible/shapeable, and may
be positioned over or adjacent to the subject. In some variations
the antenna may be integrated into a holder such as a garment or
brace. For example, the applicator (including the antenna) may be
adapted to fit into a hat or cap to be worn on a subject's
head.
[0014] The applicator component also typically includes a power
amplifier for amplification of signals received by the RF generator
of the generator module. The power amplifier may be tuned
(automatically or manually) and is integrated into the applicator
module/component with the antenna and an impedance match component
that matches the impedance of the antenna of the applicator with
the power amplifier.
[0015] Additional details are provided below including by reference
to the figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1A shows a front perspective view of a two-part
therapeutic PEMF apparatus including a generator unit that is
coupled to an antenna applicator unit.
[0017] FIG. 1B shows a back perspective view of the apparatus of
FIG. 1A.
[0018] FIG. 1C shows an enlarged view of the coupling between the
generator unit and the applicator unit of the PEMF apparatus shown
in FIGS. 1A and 1B.
[0019] FIG. 2A is a front perspective view of a generator unit of a
therapeutic PEMF apparatus.
[0020] FIG. 2B is a back perspective view of the generator unit of
FIG. 2A.
[0021] FIG. 2C is an exploded view of the generator unit shown in
FIGS. 6A-6D.
[0022] FIG. 3A is an exemplary front view of a generator unit of a
two-part therapeutic PEMF apparatus, including exemplary
dimensions.
[0023] FIG. 3B shows a back view of the generator unit shown in
FIG. 3A.
[0024] FIGS. 3C and 3D illustrate bottom and side views of the
generator unit shown in FIG. 3A.
[0025] FIG. 4A is a front perspective view of the applicator (or
antenna) unit.
[0026] FIG. 4B is a back perspective view of the applicator unit of
FIG. 4A.
[0027] FIG. 4C shows an exploded view of the applicator unit of
FIGS. 4A and 4B.
[0028] FIG. 5A shows a side view, including exemplary dimensions,
of a PEMF apparatus including a generator module and an applicator
module. The loop antenna is partially cut off in this figure.
[0029] FIG. 5B is a partial top view, including exemplary
dimensions, of the PEMF apparatus of FIG. 5A. The loop antenna is
partially cut off in this figure.
[0030] FIG. 5C is a partial front view, including exemplary
dimensions, of the PEMF apparatus of FIGS. 5A and 5B. The loop
antenna is partially cut off in this figure.
[0031] FIG. 6 illustrates one variation of a wearable two-part
therapeutic PEMF apparatus configured in a baseball cap, with the
applicator integrated into the cap and the generator unit
configured to be attached and removed from the cap as
necessary.
[0032] FIG. 7 schematically illustrates a modular PEMF apparatus
having an integrated amplification on the generator side (prior
art).
[0033] FIG. 8 schematically illustrates a two-part PEMF apparatus
in which the RF power amplifier and impedance matching/tuning is
present on the applicator unit but not on the generator unit.
[0034] FIG. 9 illustrates an embodiment of a wearable two-part
therapeutic PEMF apparatus configured in a baseball cap with the
generator not attached to the baseball cap.
[0035] FIG. 10 illustrates a plurality of loop antennas with
applicator units in accordance with some embodiments. The loop
antennas are illustrated as engaged with ring-shaped
structures.
[0036] FIGS. 11A-11E illustrates various aspects of a two-part
therapeutic PEMF apparatus.
[0037] FIGS. 12A-12C illustrate various aspects of a two-part
therapeutic PEMF apparatus.
[0038] FIGS. 13A-13C illustrate another variation of a two-part
therapeutic PEMF apparatus, configured as a pillow such as a
travel-type pillow (FIG. 13A) or standard bed pillow (FIGS.
13B-13C).
DETAILED DESCRIPTION
[0039] Described herein are pulsed electromagnetic field (PEMF)
apparatuses and methods of making and using them. In particular,
described herein are two-part PEMF apparatuses that include a
wearable (e.g., lightweight, small, compact form) generator unit
that is adapted to releasably and replaceably mate with an
applicator unit. The generator unit, which may also be referred to
as a generator module, or generator component, typically includes a
power source (e.g., battery, capacitor, etc.), and a controller
(e.g., microcontroller and/or microprocessor) and/or waveform
generator that generates the RF waveform to be applied as well as
controlling the timing. The generator unit may also include a
communication module (e.g., wireless module) for communicating with
a separate controller/processor for transmitting data (including
stimulation history) and/or receiving instructions (including
waveform parameters and timing control). The generator unit may
also include memory, for storing instructions and/or stimulation
history.
[0040] In general, the generator unit may be configured so that it
does not include any RF power amplification or minimal RF power
amplification. Thus, the generator may also be configured so that
it does not have impedance matching circuitry. The absence of power
amplification and impedance matching circuitry may be an advantage.
Surprisingly, the inventors have found that this allows the
applicator (e.g., applicator module) to be removable from the
generator without suffering radio frequency power losses due to
transmission line impedance mismatching.
[0041] The applicator unit may also be referred to as an applicator
module, antenna unit, antenna module, antenna component and/or
applicator component. In general, the applicator unit includes an
antenna (such as a wire loop antenna, for inductive or capacitive
coupling to the subject's tissues). The antenna may be flexible and
may be formed of a loop (e.g., a four inch diameter loop, a five
inch diameter loop, a six inch diameter loop, a seven inch diameter
loop, an eight inch diameter loop, a nine inch diameter loop, a ten
inch diameter loop, an eleven inch diameter loop, a twelve inch
diameter loop, etc.) of wire. The wire loop may be bendable and/or
configurable, for placement over or against the tissue. The antenna
is connected to an impedance matching circuit (including, e.g.,
tuning circuitry) and connection to an RF power amplifier, which
may also include tuning circuitry. Thus, the applicator unit may
include impedance matching circuitry for connecting a radio power
amplifier to an applicator by intrinsically pairing a high Q-factor
impedance matching circuit to the power amplifier and the antenna.
The applicator unit can include a plurality of tuning capacitors
that can be tuned to provide the desired electric field and
frequency. In some embodiments the applicator unit can include a
plurality of ports that each allow for access to tuning capacitors
in the applicator unit. The tuning capacitors can be tuned by
accessing them through the ports. The tuning capacitors can be
variable capacitors. A probe can be used to measure the induced
voltage of the antenna. The probe can be placed around the middle
of the antenna or coil. The tuning capacitors can be adjusted until
the induced voltage is at a desired level. In some cases tuning is
done such that the induced voltage is greater than about 120
mV.
[0042] The antenna can be engaged with a ring-shaped structure to
hold the antenna while still allowing movement of the antenna
within the ring-shaped structure and movement axially relative to
the ring-shaped structure. The ring shaped structures can engage
with the hat or be held in place relative to the hat with a clip or
other fastener or attachment structure. The ring-shaped structure
can non-rigidly engage with the antenna while still allowing
movement of the antenna such that the antenna is more comfortable
to wear and makes the antenna less likely to deform or break. The
ring-shaped structure can be connected to a structure worn by the
user to position the antenna relative to a target treatment
location on the user. In some cases a plurality of ring-shaped
structures can be used to engage the antenna to the structure worn
by the user. The ring-shaped structures can be made out of
materials such as metal, plastic, polymers, etc. In some cases the
ring-shaped structure can be a flexible polymer material, such as a
shrink wrap or shrink tubing. In some embodiments the ring-shaped
structure can provide some friction to reduce movement between the
ring-shaped structure and the antenna while still allowing the
antenna to slide relative to the ring-shaped structure.
[0043] The generator module is typically adapted to releasably and
replaceably mate with the applicator module. Any appropriate
connector between the two units may be used, including prongs,
plugs, snaps, magnets, Velcro, fasteners, or the like. The
connector typically makes an electrical connection between the two
so that signals can be transmitted between the generator and the
applicator units. Multiple connectors may be used. The connector
may be a mechanical connector, an electrical connector, a magnetic
connector, or some combination thereof. The connector may also
provide physical stability between the two units, preventing
physical disruption of the connection. In some variations the
apparatus may be configured so that either or both the generator
module and the applicator module include a housing that engages
with the opposite module.
[0044] One variation of a PEMF applicator apparatus is shown in
FIG. 1A. In FIG. 1A the apparatus (referred to as "TheraCap" in
this example), includes a generator unit 101 that is shown coupled
to an applicator unit 103. The applicator unit includes a loop
antenna 105. The generator unit may include a power source (e.g.,
batteries), as well as the circuitry for controlling the operation
of the device. The controller (not visible in FIG. 1A) may be a
processor (e.g., microprocessor) that is adapted to create and
sequence (e.g., time) the RF waveforms to be delivered. The
processor or controller may also be adapted to record and/or
transmit information about the operation of the device and/or to
receive information (control commands) from one or more inputs,
including wireless control inputs.
[0045] Thus, the generator unit may user controls and outputs. For
example, the generator unit may include an output (such as a
display screen, LED, indicator light(s), speaker, etc.). The
generator unit may also include one or more inputs, including
buttons, dials, sliders, switches, etc. The outer portion of the
generator may include a housing. Examples of status indicators may
include power (power on, power level, charge level) stimulation
indicators (indicating when stimulation is being applied),
transmission indicators (indicating when data is being
received/transmitted by the apparatus), or the like. For example,
in FIG. 1A, the face of the generator includes an LED indicating
that PEMF is being applied 133, as well as a low battery indicator
143 and a power on/off indicator 153. FIG. 1B shows the back of the
apparatus shown in FIG. 1A. The applicator unit 103 is shown
connected to the generator unit 101. The applicator unit includes a
housing that holds the circuitry including the RF amplifier
circuitry, impedance matching circuitry and connects to the
antenna. FIG. 1C shows a slightly enlarged view of the coupled
applicator unit 103 coupled to the generator unit 101.
[0046] FIGS. 2A and 2B show front and back perspective views,
respectively, of one variation of a generator 201. The generator is
shown in FIG. 2A to include an outer housing having a front panel
including inputs and outputs (e.g., manual inputs and visual
outputs). The back of the housing shown in FIG. 2B includes a door
that can open to reveal a battery compartment 211. The back housing
also includes an opening for a connector 213. The connector in this
example is a female plug into which a male connector on the
applicator unit (described below) may attach. In some examples
additional attachment sites may be included to connect the
generator and the applicator.
[0047] FIG. 2C shows an exploded view of the generator shown in
FIGS. 2A and 2B. In this example, the generator includes a two-part
housing (top generator housing 219 and bottom generator housing
217) that may be used to enclose the controller and other generator
components. The housing may be fastened together in any appropriate
means, including snaps, screws 217, or the like. For example, the
housing may enclose the power supply (shown in FIG. 2C as two AAA
alkaline batteries 215) behind a removable door (battery flap 221).
The controller may be part of the internal circuitry. For example,
a printed circuit board (PCB) 221 may be housed within the housing
and may include the controller/processor as well as any
communications module. As mentioned above, the controller/processor
may include the signal generator for generating waveforms of the
desired frequency and timing. Examples of the desired waveforms are
described in U.S. Pat. No. 5,370,680, U.S. Pat. No. 5,584,863, U.S.
Pat. No. 5,723,001, U.S. Pat. No. 7,740,574, U.S. Pat. No.
7,744,524, U.S. Pat. No. 7,758,490, U.S. Pat. No. 7,896,797, U.S.
Pat. No. 8,343,027, U.S. Pat. No. 8,415,123; U.S. 2010-0210893,
U.S. 2010-0222631, U.S. 2013-0274540, U.S. 2014-0046115, U.S.
2014-0046117, U.S. 2011-0207989, U.S. 2012-0116149, and U.S.
2012-0089201, each of which is again herein incorporated by
reference in its entirety.
[0048] FIGS. 3A-3D show examples of front, back, bottom and side
views, respectively of a housing of a generator module, including
exemplary dimensions. For example, in FIG. 3A, the front of the
housing may include outputs such as an audio indicator 305, a low
battery indicator 307, an activity indicator 309. One or more
inputs (e.g., manual inputs) may also be included, such as a power
control 310 (e.g., for turning the device on/off). A start/stop
control may also be included. The applicator may also include a
couple/uncouple control for coupling the generator to the
applicator unit. A couple/uncouple control may prepare the units
for attaching and detaching, initiating calibration or matching
between the devices, and may engage or disengage the coupling
elements holding the two units together. In some variations a
coupling/uncoupling control may also trigger a self-check or
diagnostic testing, or a shutdown/startup sequence. In general the
generator unit may detect when it is connected or disconnected from
the applicator unit, and may trigger an error code if disconnected
(or if the connection degrades), including if disconnecting without
using a disconnection procedure (e.g., pushing a
coupling/uncoupling control).
[0049] In FIG. 3C, the bottom of the device is shown, and an
in-circuit programming access slit 325 is included, allowing access
to the controller/processor. This access may allow in circuit
programming without the need to dismantle the enclosure or replace
hardware (e.g., IC chips). As mentioned above the
controller/processor (e.g., CPU) may include flash memory, enabling
parameters to be stored for the use and operation of the device.
Information on the operation of the device may be stored and/or
transmitted, including the stimulation parameters, run times, error
codes related to failure or behavior of the apparatus, the number
of treatments applied, etc. Control information, including the
waveform configurations, timing (e.g., frequency of application,
duration of application, burst frequency within an application,
etc.) may be stored within the device and modified by modification
of the controller.
[0050] FIG. 3D shows a side view of the generator, including a
proposed thickness 330 (e.g., 0.675 inches). Other dimensions are
indicated in FIG. 3A (e.g., height 315 of 1.1745 inches, and width
317 of 2.609 inches). In general, these dimensions are intended as
exemplary only. Generally the dimensions may be larger or smaller
than those indicated. For example, the overall thickness may be
much thinner (e.g., less than 0.5 inches, etc.). The smaller
dimensions may allow a lighter, and more readily wearable device.
As shown in FIG. 3D, one or more edges of the device may be rounded
or radiused. As the device is to be worn, this may be
beneficial.
[0051] An example of an applicator unit is shown in FIGS. 4A-4C.
For example in FIG. 4A, a side perspective view of an applicator
module 401 is shown. The applicator unit 401 may include an antenna
(in this example, a wire loop antenna 405 is shown. The wire loop
antenna shown may be flexible, and bendable, so as to form against
the body, or be shaped to permit it to conform to the body. An
applicator unit housing 403 is also shown, from which the flexible
wire loop antenna 405 extends. One or more coupling elements that
are complimentary to connectors or couplers on the generator may be
included on the applicator unit. For example in FIG. 4A, and male
connector 407 extends from the applicator unit housing 403. The
applicator unit may also include one or more sensors (e.g., touch
sensors) as mentioned above, which may detect when the unit is
being worn on or against a subject. For example, a touch sensor
(capacitive touch sensor) on the applicator unit housing 403 may
detect when the applicator is being worn against a subject's skin.
Because the energy may be delivered from the antenna though the
skin, and even though clothing or bandages, a sensor may be adapted
to sense the presence of the subject though one or more intervening
layers.
[0052] The connector 407 may be any appropriate connector, and
typically electrically couples the generator to the applicator
unit. Thus electrical signals may be transmitted to the applicator
unit from the generator (e.g., the waveform to be applied). In some
variations, as well the applicator unit has a touch sensor, data
may be transmitted from the applicator unit to the generator unit.
FIG. 4B shows an alternative view of the applicator unit of FIG.
4A, showing the back of the applicator unit housing 40.
[0053] FIG. 4C shows an exploded view of the applicator unit
housing of FIGS. 4A and 4B. In this example, the applicator unit
housing includes a front housing 421 and a back housing 423 than
enclose a circuitry (e.g., on printed circuit board, PCB 427) that
typically includes RF amplification circuitry (e.g., class E
amplified) and impedance matching circuitry and connections to the
loop antenna 405. The housing may include one or more openings
(e.g. holes 431) for access to and/or controls for tuning the
impedance matching. In FIG. 4C a label or cover 429 ("calibration
label") may cover these openings. One or more contact sensors (not
visible in the example of FIG. 4C) maybe included, e.g., off or on
the back housing 423.
[0054] The tuning of the device can be changed by adjusting the
capacitance of one or more capacitors in the applicator unit. The
one or more holes 431 can provide access to the tuning capacitors
within the applicator unit. The tuning capacitors can be variable
capacitors. In some embodiments there are two variable capacitors
with a first variable capacitor connected to a first end of the
loop antenna 405 and a second variable capacitor connected to a
second end of the loop antenna 405. The variable capacitors can be
adjusted such that the loop antenna 405 produces a PEFM signal or
waveform with desired characteristics. The use of a plurality of
tuning capacitors allows for the operator or user to quickly adjust
the capacitance of the device to allow for more control over the
treatment conditions. For example, tuning the capacitors allows for
the user to adjust the device properties by balancing between the
generator unit and applicator unit.
[0055] In some embodiments the tuning can be performed by placing a
probe on the coil. In some cases the probe is placed on the middle
of the coil. The probe can be placed on the desired area of the
coil that will be closest to the target treatment area of the user.
In one example the coil can be tuned such that the applied field
results in an induced voltage on the probe that is greater than
about 120 mV. In some embodiments the tuning capacitors allow for
individual tuning of the applicator to the proper frequency by
adjusting the capacitors.
[0056] The generator unit may be combined with applicator unit, as
illustrated in FIGS. 5A-5C, to form the apparatus. In FIG. 5A, the
generator unit 501 is attached/coupled to the applicator unit 503
though an article of clothing (such as a cap, bandage, garment,
etc.). FIG. 6 shows one example of this. In FIG. 5A, the overall
thickens of the applicator unit, intervening garment (not shown)
and the generator unit 511 is shown as approximately 1.029 inches
(assuming a gap/thickness of the intervening garment 509 of 0.059
inches). Thus, the connectors described herein may be adapted to
couple the generator unit and the applicator unit in a manner that
permits the two to be coupled together through a bandage, garment,
cap, helmet, or the like.
[0057] FIGS. 5B and 5C show top and front views, respectively, of
the partial apparatus shown in FIG. 5A (the applicator antenna is
only partially shown in FIGS. 5A-5C). FIGS. 5B and 5C show
exemplary dimensions. As mentioned, FIG. 6 shows one example of an
applicator attached to a garment (a cap, referred to herein as a
"TheraCap"). The cap (hat) includes the applicator on an inner
surface (closest to the region worn against the head (not show),
e.g., around the brim of the hat. The cap may be adapted for
connecting the generator unit with the applicator unit through the
cap. For example, a window, opening or the like may be included in
the cap where the generator unit and applicator unit may couple to
each other. In some variations the cap may include a holder (e.g.,
frame, pocket, pouch, etc.) to hold the generator.
[0058] In operation, the functions of the PEMF delivery apparatus
may be divided between a generator unit and an applicator unit.
FIG. 7 shows a schematic of a prior art apparatus in which an
amplifier (RF power amplifier) was directly connected/integrated
with the signal generator. In FIG. 7, the portion of the device
including the signal generator 705 ("device" 701) is directly
connected to an RF power amplifier 707 (in this example, the RF
power amplifier is a 50 ohm power amplifier that includes tuning
circuitry 708 for impedance matching). The device is connected or
connectable via an appropriate RF connector 709 (e.g., shown as a
50 ohm connector in FIG. 7), which connects via a transmission line
711 that is also impedance matched (e.g., 50 ohm) to a tunable 714
impedance matching circuit 713 coupled to the applicator antenna
715. In this arrangement, the radio frequency power amplified and
applicator antenna impedance matching circuits are separated. To
achieve maximum efficiency, the impedance of all components of the
RF power pathway must have the same impedance. The transmission
line and RF connector have fixed characteristic impedance values
(shown in this example as 50 ohms). The RF power amplified and
applicator antenna contain impedance-adjustable circuits to match
the impedance of the transmission line.
[0059] FIG. 8 shows a schematic of the apparatuses described
herein, in which the separable generator unit 801 includes the
signal generator, but not any RF amplification. The RF amplifier is
instead included in just the applicator unit 803. As described
above, the power amplifier in this example is incorporated into the
applicator and intrinsically paired to the high Q-factor impedance
matching circuit. This may allow the applicator to be removable
without suffering RF power losses due to transmission line
impedance miss-matching (e.g., due to poor connection, drift, and
noise). In FIG. 8, the processor (controller/processor 805)
generates the stimulation waveform having the shape and timing
characteristics. The signal transmitted to the amplifier may be
unamplified and may be encoded with the amplification information
(e.g., including the desired amplification/frequency components)
that may be acted on at the applicator by the on-board RF power
amplifier 807. The connection 809 between the generator unit 801
and the applicator 803) may be adapted specifically to pass both
the signal waveform information (e.g., shape, timing, frequency,
etc.) used by the amplifier to apply to the antenna, as well as the
power (DC, AC, offset AC, etc.) to drive the applicator unit. As
mentioned above, the connector may also pass signals from the
applicator to the generator unit (e.g., feedback, sensor
information, error codes, etc.). In addition to the RF power
amplifier 807, the circuitry in the applicator may include
impedance matching/tuning 808/814 circuitry 808, 814, 813 for
either or both the RF power amplifier and the applicator antenna
815.
[0060] In general, any of the apparatuses described herein may be
adapted to operate in a power-saving mode, for example, the
applicator and/or generator unit may include a sensor (e.g.,
capacitive touch sensor) to determine when the unit is in contact
with a subject's body. This optional touch sensor may be integrated
into the applicator to allow automatic regulation of operation
depending on when the apparatus is being worn or not. In general,
the generator unit may include a standby mode that consumes little
power (e.g., 1 to 19 uA). Standby mode may be entered when the
device is not being worn and/or between stimulation periods.
[0061] In use, the applicator unit may be attached to a subject's
body on, over and/or around the target tissue. Thus, an applicator
unit, including the antenna, may be coupled to the patient so that
the applicator can be worn. For example, in some variations the
target tissue includes the subject's head, for delivery of PEMF to
the brain and neural tissue. If the target is the head, for
example, the applicator may be worn as part of a cap, hat, helmet,
or bandage (see, e.g., FIG. 6). The flexible antenna loop may be
placed or present within the brim of the cap, hat, etc. Prior to a
desired start of therapy, the apparatus may prepared by connecting
a generator unit to the applicator unit. For example a generator
unit which is sufficiently charged (e.g., having on-board battery
power) may be coupled to the applicator unit worn by the subject.
In the example in FIG. 6, a generator unit may be snapped onto the
applicator unit worn in the cap. The generator unit may connect by
one or more connectors. Connecting may trigger to the generator
(controller) that the device is connected and can be used to apply
PEMF energy. The apparatus may then run one or more checks to
determine and/or confirm the status of the connection. For example,
the apparatus may trigger the connection is active and ready for
operation. The apparatus may also confirm that the device is ready
for operation based on a contact sensor on the device (e.g.,
indicating that the apparatus is in contact with the subject to be
treated. Application of a treatment regime may then begin. The
controller in the generator may control the treatment regime (e.g.,
pulse length, pulse width, pulse duration, repetition rate, etc.).
During the process of connecting, activating and treating, one or
more indicators may be active or activated. Any appropriate
indicators may be used, including visual, audible, thermal and
tactile. In particular, a subject may receive tactile feedback that
the apparatus is operating when signal/energy (PEMF) is being
applied.
[0062] FIG. 9 illustrates an embodiment of a wearable two-part
therapeutic PEMF apparatus configured in a baseball cap 900 with
the generator 902 not attached to the baseball cap 900. The
baseball cap 900 includes an opening 904 configured to allow a
connector on the generator unit 902 to connect to the applicator
unit (not shown). The generator unit 902 includes a magnet that can
be used to hold the generator unit to the applicator unit. In some
embodiments powerful magnets, such as rare-earth or static magnets
are used to hold the generator unit and applicator unit
together.
[0063] The generator unit with the power supply is held on the
outside of the cap. In some cases the generator unit can also be
held via a mechanical attachment to the cap, such as using Velcro
or other fasteners. The magnetic connection can be used in addition
to or instead of a mechanical connection between the generator
unit/power supply and the cap. The magnetic connection can securely
hold the generator connected to the applicator unit and coil. The
magnetic connection allows the generator unit and applicator to be
easily and quickly connected.
[0064] In the embodiments illustrated in FIG. 9, the loop coil is
held in a floating configuration within the inside near the brim of
the hat (e.g., edge of the cap). The loop coil is positioned in
this location because the target for the effect of the PEMF signal
is a region near the midpoint of the frontal lobe. Thus placing the
coil in this plane passes the signal through the target treatment
location. The coil is held just above the hat band in the
embodiments illustrated in FIG. 9. The coil can be positioned
anywhere in the cap to deliver the PEMF signal to the target
treatment location on the user.
[0065] The power supply/generator may be easily swapped out or
removed by the user. The generator is held on the right front side
of the cap 900 illustrated in FIG. 9. In some embodiments the
generator unit may be held anywhere on the cap. In the embodiments
illustrated in FIG. 9 the generator location is mostly for
aesthetic reasons. In some embodiments the generator unit can be
located anywhere along the plane of the coil.
[0066] As described herein the generator unit can have a
lightweight and small profile. The illustrated generator unit 902
weighs less than about 3 ounces and has a height of less than about
2 inches, a width of less than about 3 inches, and a thickness of
less than about 0.5 inches. The generator unit 902 includes a power
supply that can include one or more replaceable batteries to power
the device. In some embodiments AAA batteries are used. In some
embodiments the generator unit can be made smaller and lighter
depending on the size of the batteries used for the power supply.
The battery can be replaced by removing the generator unit from the
hat.
[0067] FIG. 10 illustrates a plurality of loop antennas 1000 with
applicator units 1004 in accordance with some embodiments. The loop
antennas 1000 are illustrated as engaged with a plurality of
ring-shaped structures 1002. Each of the loop antennas are
illustrated with four ring-shaped structures 1002. The ring-shaped
structures 1002 can be attached to the hat via a clip or other
attachment mechanism. The ring-shaped structures 1002 include an
open channel that holds the loop antenna 1000. The ring-shaped
structures 1002 can engage with the hat to hold the loop antenna to
the hat in a non-rigid manner. The loop antenna 1000 can slide
relative to the ring-shaped structure 1002 axially through the
interior volume of the ring-shaped structure and within a plane
formed by the interior volume of the ring-shaped structure. The
ring-shaped structure 1002 can hold the loop antenna 1000 in
approximately the same plane within the hat such that the coil
treats the targeted area of the user. The ring-shaped structure
1002 allows the loop antenna 1000 to move within the hat, making
the loop antenna 1000 more comfortable to wear and also making it
less likely for the loop antenna 1000 to break and/or deform during
use. In some embodiments the ring-shaped structure can produce some
friction between the loop antenna and the ring-shaped structure.
For example the ring shaped structure can be made out of a rubber,
shrink wrap material, shrink tubing and/or could have a roughened
surface, or other surface that can cause friction against the loop
antenna.
[0068] FIGS. 11A-11E illustrate various aspects of a two-part
therapeutic PEMF apparatus. FIGS. 11A and 11B illustrate a front
view and a back view of a first part 1100 of a two-part PEMF
apparatus including an applicator unit 1102 and loop antenna 1104.
The back of the applicator unit 1102 includes a connector 1106 and
two magnets 1108. The front of the applicator unit 1102 includes a
first tuning capacitor 1110 and a second tuning capacitor 1112. The
tuning capacitors 1110, 1112 are configured to be tuned by turning
a screw head within the housing of the applicator unit 1102. FIG.
11C illustrates the applicator unit 1102 and loop antenna 1104
within a cap 1114. The loop antenna 1104 is engaged with a
ring-shaped structure 1116. FIG. 11D illustrates an applicator unit
1102 and loop antenna 1104 engaged with a plurality of ring-shaped
structures 1116. FIG. 11E illustrates the loop antenna 1104 secured
to the cap 1114 by securing the ring-shaped structure 1116 to the
cap 1114. The ring-shaped structure 1116 can be clipped or fastened
to the cap 1114 to non-rigidly secure the loop antenna 1104 within
the cap 1114. The loop antenna 1104 can slide through the interior
volume of the ring-shaped structures 1116.
[0069] FIGS. 12A-12C illustrate various aspects of a two-part
therapeutic PEMF apparatus that can be used with the embodiments
illustrated in FIGS. 11A-11E. FIG. 12A illustrates the cap engaged
with the applicator unit 1102 such that the connector 1106 and two
magnets 1108 protrude through an opening in the cap 1114. FIG. 12B
illustrates a generator unit 1118 with a connector 1120 and magnets
1122. The illustrated connector 1120 has a female receptacle that
is configured to complementarily engage with the connector 1106 on
the applicator unit 1102. The magnets 1122 of the generator unit
1118 are configured to engage with the magnets 1108 of the
applicator unit. FIG. 12C illustrates the cap 1118 with the
generator unit 1118 engaged with the applicator unit.
[0070] Although many of the variations and examples described above
are specific to hat or wearable devices, any of these apparatuses
may be non-wearable. For example, in some variations the
apparatuses are integrated into furniture (e.g., bedding, chairs,
etc.) or sleeping devices (e.g., pillows, bedding, mattresses,
cushions, etc.), and particularly those configured so that the user
places his or her head on the device.
[0071] For example, in some variations, the apparatus is configured
as a pillow or mattress (e.g., bedding). In FIG. 13A, for example,
the apparatus is configured as a travel pillow 1301 that includes
an applicator 1304 loop that is incorporated near an outer portion
(though internal to the pillow and/or pillow cover) . FIG. 13A
shows a travel pillow that is engaged with the applicator loop 1304
such that an applicator unit 1302 (similar to the applicator units
described above, including one or more connectors, e.g., magnets),
that is present on an outer surface of the pillow. The applicator
loop 1304 is positioned on a region of the pillow where the user
will position her or his head when wearing the pillow, as shown in
FIG. 13A.
[0072] Any of these apparatuses may also be two-part therapeutic
PEMF apparatuses. For example, in FIGS. 13A to 13B, the pillows are
configured as two-part PEMF apparatuses and configured so that a
first part of a two-part PEMF apparatus including an applicator
unit 1302 and loop antenna 1304 is integrated into the pillow. As
mentioned, the applicator unit 1302 includes a connector 1306 which
may include one or more (e.g., two) magnets. As discussed above,
the applicator unit 1302 may also include a first tuning capacitor
and a second tuning capacitor (not shown) configured to be tuned by
turning a screw head within the housing of the applicator unit
1302.
[0073] Any of these pillows may also be marked to indicate "top" or
"bottom" or specifically indicate where the applicator is, so that
the user can position their head close to the loop. As mentioned,
the applicator may be held within the pillow near an outer surface,
or in or between a cover (e.g., pillow case) over a cushion of the
pillow. In FIG. 13A, the applicator unit 1302 is shown on an upper
surface of the pillow, away from the region where the user's head
will rest; in general the applicator unit may be located anywhere
on (or in some variations, in) the pillow, so that the generator
unit 1318 may be connected unobtrusively, but may be easily swapped
out. For example, the applicator unit may be located in a pocket
that may also hold the generator unit; this pocket may be on an
outer surface (not shown) on an inner surface, away from where the
head will rest (e.g., on the back portion of the pillow), for
comfort. In this example, the pillow or cushion shown is a
travel-type pillow configured with a curved/U-shape so that it can
fit around a user's neck. In general, the pillow may have any
appropriate shape, including traditional rectangular/square shapes,
as illustrated in FIGS. 13B (back) and 13C (front).
[0074] For example, in FIG. 13B, the back of a pillow 1311 is
shown, with the connector 1306 of the applicator unit 1302 located
in one corner. In this example, the first part of the two-part
apparatus (including the applicator coil) may be integrated into
the pillow or into a pillow holder/case in which the pillow fits. A
generator unit 1318 that is adapted to connect to the connector of
the applicator unit (e.g., by one or more fasteners such as snaps,
magnets, etc.) is also shown in FIG. 13B. The connector region of
the shown in this example includes a female receptacle that is
configured to complementarily engage with the connector 1106 on the
applicator unit 1102. The magnets 1122 of the generator unit 1118
are configured to engage with the magnets 1108 of the applicator
unit. FIG. 12C illustrates the cap 1118 with the generator unit
1118 engaged with the applicator unit.
[0075] FIG. 13C shows a front view (or top view) of the pillow
apparatus of FIG. 13B; the applicator loop 1304 is shown in the
dashed lines, as it may be located (and connected to the applicator
unit by one or more wires, not shown) within the pillow or pillow
covering, or between the pillow and pillow covering, as mentioned
above.
[0076] In use, any of the two part-devices described herein may be
configured so that a first part that is attached to the hat,
garment, furniture, pillow, etc., and the second part may be
removably attached to the first part to provide power and/or
signals to the applicator of the first part. The same second part
may be used interchangeably with multiple first parts.
[0077] When a feature or element is herein referred to as being
"on" another feature or element, it can be directly on the other
feature or element or intervening features and/or elements may also
be present. In contrast, when a feature or element is referred to
as being "directly on" another feature or element, there are no
intervening features or elements present. It will also be
understood that, when a feature or element is referred to as being
"connected", "attached" or "coupled" to another feature or element,
it can be directly connected, attached or coupled to the other
feature or element or intervening features or elements may be
present. In contrast, when a feature or element is referred to as
being "directly connected", "directly attached" or "directly
coupled" to another feature or element, there are no intervening
features or elements present. Although described or shown with
respect to one embodiment, the features and elements so described
or shown can apply to other embodiments. It will also be
appreciated by those of skill in the art that references to a
structure or feature that is disposed "adjacent" another feature
may have portions that overlap or underlie the adjacent
feature.
[0078] Terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the invention. For example, as used herein, the singular forms "a",
"an" and "the" are intended to include the plural forms as well,
unless the context clearly indicates otherwise. It will be further
understood that the terms "comprises" and/or "comprising," when
used in this specification, specify the presence of stated
features, steps, operations, elements, and/or components, but do
not preclude the presence or addition of one or more other
features, steps, operations, elements, components, and/or groups
thereof. As used herein, the term "and/or" includes any and all
combinations of one or more of the associated listed items and may
be abbreviated as "/".
[0079] Spatially relative terms, such as "under", "below", "lower",
"over", "upper" and the like, may be used herein for ease of
description to describe one element or feature's relationship to
another element(s) or feature(s) as illustrated in the figures. It
will be understood that the spatially relative terms are intended
to encompass different orientations of the device in use or
operation in addition to the orientation depicted in the figures.
For example, if a device in the figures is inverted, elements
described as "under" or "beneath" other elements or features would
then be oriented "over" the other elements or features. Thus, the
exemplary term "under" can encompass both an orientation of over
and under. The device may be otherwise oriented (rotated 90 degrees
or at other orientations) and the spatially relative descriptors
used herein interpreted accordingly. Similarly, the terms
"upwardly", "downwardly", "vertical", "horizontal" and the like are
used herein for the purpose of explanation only unless specifically
indicated otherwise.
[0080] Although the terms "first" and "second" may be used herein
to describe various features/elements, these features/elements
should not be limited by these terms, unless the context indicates
otherwise. These terms may be used to distinguish one
feature/element from another feature/element. Thus, a first
feature/element discussed below could be termed a second
feature/element, and similarly, a second feature/element discussed
below could be termed a first feature/element without departing
from the teachings of the present invention.
[0081] As used herein in the specification and claims, including as
used in the examples and unless otherwise expressly specified, all
numbers may be read as if prefaced by the word "about" or
"approximately," even if the term does not expressly appear. The
phrase "about" or "approximately" may be used when describing
magnitude and/or position to indicate that the value and/or
position described is within a reasonable expected range of values
and/or positions. For example, a numeric value may have a value
that is+/-0.1% of the stated value (or range of values), +/-1% of
the stated value (or range of values), +/-2% of the stated value
(or range of values), +/-5% of the stated value (or range of
values), +/-10% of the stated value (or range of values), etc. Any
numerical range recited herein is intended to include all
sub-ranges subsumed therein.
[0082] Although various illustrative embodiments are described
above, any of a number of changes may be made to various
embodiments without departing from the scope of the invention as
described by the claims. For example, the order in which various
described method steps are performed may often be changed in
alternative embodiments, and in other alternative embodiments one
or more method steps may be skipped altogether. Optional features
of various device and system embodiments may be included in some
embodiments and not in others. Therefore, the foregoing description
is provided primarily for exemplary purposes and should not be
interpreted to limit the scope of the invention as it is set forth
in the claims.
[0083] Throughout this specification and the claims which follow,
unless the context requires otherwise, the word "comprise", and
variations such as "comprises" and "comprising" means various
components can be co-jointly employed in the methods and articles
(e.g., compositions and apparatuses including device and methods).
For example, the term "comprising" will be understood to imply the
inclusion of any stated elements or steps but not the exclusion of
any other elements or steps.
[0084] The examples and illustrations included herein show, by way
of illustration and not of limitation, specific embodiments in
which the subject matter may be practiced. As mentioned, other
embodiments may be utilized and derived there from, such that
structural and logical substitutions and changes may be made
without departing from the scope of this disclosure. Such
embodiments of the inventive subject matter may be referred to
herein individually or collectively by the term "invention" merely
for convenience and without intending to voluntarily limit the
scope of this application to any single invention or inventive
concept, if more than one is, in fact, disclosed. Thus, although
specific embodiments have been illustrated and described herein,
any arrangement calculated to achieve the same purpose may be
substituted for the specific embodiments shown. This disclosure is
intended to cover any and all adaptations or variations of various
embodiments. Combinations of the above embodiments, and other
embodiments not specifically described herein, will be apparent to
those of skill in the art upon reviewing the above description.
* * * * *