U.S. patent application number 17/446703 was filed with the patent office on 2022-05-12 for wearable light stimulation systems and methods.
This patent application is currently assigned to Kemeny Healthcare Inc.. The applicant listed for this patent is Kemeny Healthcare Inc.. Invention is credited to John H. SHADDUCK, Akos TOTH, Csaba TRUCKAI.
Application Number | 20220143420 17/446703 |
Document ID | / |
Family ID | 1000006104589 |
Filed Date | 2022-05-12 |
United States Patent
Application |
20220143420 |
Kind Code |
A1 |
TRUCKAI; Csaba ; et
al. |
May 12, 2022 |
WEARABLE LIGHT STIMULATION SYSTEMS AND METHODS
Abstract
Light stimulation systems and methods for elevating testosterone
levels in male patients.
Inventors: |
TRUCKAI; Csaba; (Saratoga,
CA) ; SHADDUCK; John H.; (Menlo Park, CA) ;
TOTH; Akos; (Cupertino, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kemeny Healthcare Inc. |
San Jose |
CA |
US |
|
|
Assignee: |
Kemeny Healthcare Inc.
San Jose
CA
|
Family ID: |
1000006104589 |
Appl. No.: |
17/446703 |
Filed: |
September 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16863664 |
Apr 30, 2020 |
11110295 |
|
|
17446703 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2005/0659 20130101;
A61N 2005/0632 20130101; A61N 2005/0662 20130101; A61N 2005/0628
20130101; A61N 2005/0652 20130101; A61N 5/0616 20130101 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. (canceled)
2. A light stimulation system for providing irradiance therapy to
an individual, the light stimulation system comprising: a structure
carrying a plurality of light emitters configured to emit at least
one selected wavelength between 400 nm and 850 nm, wherein the
structure is configured to be positioned in a wearable undergarment
of the individual to irradiate a groin of the individual; and a
controller configured to activate the plurality of light emitters
to provide a selected irradiance in a duty cycle consisting of an
ON and OFF sequence, wherein ON intervals total at least 5 minutes
over at least a 30 minute period and where the plurality of light
emitters provides an irradiance in the range of 20 mW/cm.sup.2 to
200 mW/cm.sup.2.
3. The light stimulation system of claim 2, wherein the ON
intervals total at least 5 minutes per hour over at least a 2 hour
period.
4. The light stimulation system of claim 2, wherein the ON
intervals total 10 minutes per hour over at least a 1 hour
period.
5. The light stimulation system of claim 2, wherein the irradiance
is from 20 mW/cm.sup.2 to 200 mW/cm.sup.2.
6. The light stimulation system of claim 2, wherein the irradiance
is from 50 mW/cm.sup.2 to 150 mW/cm.sup.2.
7. The light stimulation system of claim 2, wherein the irradiance
is from 80 mW/cm.sup.2 to 120 mW/cm.sup.2.
8. The light stimulation system of claim 2, wherein the plurality
of light emitters comprise an array of 2 to 200 LEDs.
9. The light stimulation system of claim 8 wherein the array is
carried by a flexible substrate.
10. The light stimulation system of claim 2, wherein the plurality
of light emitters comprise side-emitting optical fibers.
11. The light stimulation system of claim 10, wherein the optical
fibers are carried in a fabric.
12. The light stimulation system of claim 11, wherein the fabric is
separate from the wearable garment.
13. The light stimulation system of claim 11, wherein the fabric is
integrated in the wearable garment.
14. The light stimulation system of claim 2, wherein the controller
is configured to modulate operating parameters of the plurality of
light emitters, consisting of (i) at least one selected wavelength,
(ii) irradiance, and (iii) duty cycle.
15. The light stimulation system of claim 2, wherein the controller
is configured to activate the ON and OFF sequence with an ON
interval ranging from 1 millisecond to 30 minutes and an OFF
interval ranging from 1 millisecond to 10 minutes.
16. The light stimulation system of claim 2, further comprising a
temperature sensor coupled to the structure.
17. The light stimulation system of claim 16, wherein the
controller is adapted to modulate operating parameters of the
plurality of light emitters in response to signals from the
temperature sensor.
18. The light stimulation system of claim 2, further comprising a
portable module carrying the controller and a power source, wherein
the plurality of light emitters are operatively connected to the
module.
19. The light stimulation system of claim 2, further comprising a
cooling mechanism configured to be carried by the wearable garment
and comprising at least one of a Peltier element, a flat flexible
polymer heat pipe and a heat sink element.
20. The light stimulation system of claim 2, further comprising a
sensing mechanism configured to be carried by the wearable garment,
wherein the sensing mechanism is selected from the group of: pulse
oximeters, impedance sensors and capacitance sensors.
21. The light stimulation system of claim 2, wherein the plurality
of light emitters are spaced apart from a perimeter of the
structure by at least 5 mm.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/863,664 filed Apr. 30, 2020, now U.S. Pat.
No. 11,110,295, the content of which is incorporated herein by
reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to light stimulation systems
and methods for elevating testosterone levels in male patients.
BACKGROUND OF THE INVENTION
[0003] Light stimulation therapy, also known as photobiomodulation
(PBM), has been known for many years. As early as 1939, Dr. Myerson
measured circulating testosterone in men and exposed their various
body parts to UV light. After five days, testosterone levels
increased by 120 percent when the light was focused on the
patient's chest. Testosterone levels increased by 200% after eight
days of light exposure to the patient's genitals, which reportedly
was due to a boost in the production of the cells that produce
testosterone (Leydig cells). Myerson, A. "Influence of ultraviolet
radiation on excretion of sex hormones in the male." Endocrinology
1939; 25:7-12.
[0004] In recent years, many researchers have investigated
photobiomodulation therapies, including studies using red and
near-infrared light wavelengths, such as: Wunsch, A. et al. "A
Controlled Trial to Determine the Efficacy of Red and Near-Infrared
Light Treatment in Patient Satisfaction, Reduction of Fine Lines,
Wrinkles, Skin Roughness, and Intradermal Collagen Density
Increase" Photomed Laser Surg. 2014 Feb. 1; 32(2): 93-100.
[0005] Red light wavelengths are reported to stimulate the creation
of ATP (adenosine triphosphate), which is involved with energy
production and also boosts the activity of the Leydig cells in the
testes. Such an effect may occur since red light wavelengths
penetrate deeper into the skin than other visible light colors.
When skin cells absorb such red light wavelengths, cell growth can
greatly accelerate, which can result in collagen and elastin
generation at an accelerated rate. For this major reason, therapies
with red light wavelengths are frequently used to treat eczema,
acne, psoriasis, and other skin disorders.
[0006] In 2016 meeting of the European College of
Neuropsychopharmacology, a researcher reported on the results of a
pilot trial in which 38 men with low libido were placed into one of
two groups: one received bright light therapy from a light box and
the other was exposed to a light box that had less bright light.
The light boxes were of the type used to treat Seasonal Affective
Disorder (SAD), a form of depression that responds well to such a
light therapy. After two weeks of daily exposure for 30 minutes,
the authors found that the testosterone levels of men who were
exposed to bright light increased by 300 percent, and their libido
increased by the same percentage. Fagiolini, A. "Lack of interest
in sex successfully treated by exposure to bright light" European
College of Neuropsychopharmacology (ECNP); Sep. 18, 2016.
SUMMARY OF THE INVENTION
[0007] The present disclosure includes methods and devices for
light stimulation to a region of the body. For example, such light
stimulation can enhance testosterone levels in a patient when the
stimulation is applied to the patient's testes.
[0008] A method under the present disclosure includes positioning a
wearable structure carrying light emitters proximate to testes of a
patient, where the wearable structure carrying light emitters emits
at least one selected wavelength between 400 nm and 850 nm;
actuating the light emitters in a duty cycle consisting of an
ON/OFF sequence wherein the ON interval totals at least 5 minutes
in at least a 30 minute period; and providing an irradiance in the
range of 20 mW/cm2 to 200 mW/cm2 to the patient's testes where such
irradiance enhances testosterone levels in the patient.
[0009] The present disclosure also includes light stimulation
systems comprising a structure carrying at least one light emitter
configured to emit at least one selected wavelength between 400 nm
and 850 nm, wherein the at least one light emitter is adapted for
carrying in a wearable garment configured to position the at least
one light emitter proximate to testes of a patient; and a
controller configured to activate the at least one light emitter to
provide a selected irradiance in a duty cycle consisting of an
ON/OFF sequence wherein the ON interval totals at least 5 minutes
per hour over at least a 2 hour period.
[0010] The light stimulation described herein can include
irradiance ranges from 50 mW/cm2 to 150 mW/cm2 or from 80 mW/cm2 to
120 mW/cm2.
[0011] Variations of the method and systems described herein can
employ light emitters that comprise LEDs carried in a substrate.
Alternatively, or in combination, other light sources can be used.
In additional variations, the light emitters comprise side-emitting
optical fibers carried in a fabric. For example, side-emitting
optical fibers can be detachably coupled to at least one LED. Any
combination of light emitting devices can be combined in a device
under the present disclosure.
[0012] In variations of the device, the fabric can be separate from
the wearable structure. Alternatively, the fabric can be integrated
in the wearable structure.
[0013] The methods and devices described herein can include a
controller to modulate operating parameters of the light emitters.
For example, actuating the light emitters includes using the
controller to control the irradiance in a duty cycle consisting of
an ON/OFF sequence wherein the ON intervals total at least 5
minutes over at least a 30 minute period.
[0014] In another variation, the methods and/or devices can include
an ON/OFF sequence having an ON interval ranging from 1 millisecond
to 30 minutes and an OFF interval ranging from 1 millisecond to 10
minutes.
[0015] Additional variations include a temperature sensor coupled
to the structure. The controller can modulate operating parameters
of the light emitters in response to signals from a temperature
sensor. Such operating parameters can include (i) at least one
selected wavelength, (ii) irradiance, and (iii) duty cycle.
[0016] In an additional variation, the methods and systems can
further include connecting the light emitters to a wearable module
carrying a controller and a power source.
[0017] The systems and methods described herein can include light
emitters comprising an array of 2 to 200 LEDs. The array can be
carried by a flexible substrate.
[0018] The methods and systems can further include a cooling
mechanism configured to be carried by the wearable garment and
comprising at least one of a Peltier element, a flat flexible
polymer heat pipe and a heat sink element. In additional
variations, the systems and methods include a sensing mechanism
configured to be carried by the wearable garment and selected from
the group of pulse oximeters, impedance sensors and capacitance
sensors.
[0019] In yet an additional variation, the light emitters are
spaced apart from a perimeter of the device by at least 5 mm.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0020] The present invention will be more fully appreciated and
understood from the following detailed description of the present
invention when viewed in conjunction with the accompanying
figures.
[0021] FIG. 1 is an illustration of a light stimulation device
comprising a flexible substrate carrying a plurality of LEDs having
a selected wavelength for light stimulation of a patient's testes,
wherein the substrate is shaped and configured for positioning and
wearing in an underwear-type garment and the device is operatively
connected to a wearable module carrying a controller and power
source.
[0022] FIG. 2 is a schematic view of a substrate of FIG. 1 carried
in a garment.
[0023] FIG. 3 is an illustration of another variation of a light
stimulation device comprising a fabric with side-emitting optical
fibers integrated into the fabric, wherein the fabric is shaped and
configured for positioning and wearing in the underwear-type
garment as in FIG. 2, and where the fabric device is operatively
connected to a wearable module carrying a controller and power
source.
[0024] FIG. 4 is a greatly enlarged view of a portion of the fabric
device of FIG. 3 showing the side-emitting optical fibers
integrated with the woven fabric.
[0025] FIG. 5 is another variation of a light stimulation device
similar to that of FIGS. 1 to 4 that carries a cooling
mechanism.
[0026] FIG. 6 is another variation of a light stimulation device
similar to that of FIGS. 1 to 4 that has an edge or skirt around at
least portions of the device to substantially prevent light
emissions around the edge of the device.
DETAILED DESCRIPTION OF THE INVENTION
[0027] The following detailed description describes currently
contemplated modes of carrying out the invention. The description
is not limiting but is made for the purpose of illustrating the
general principles of the invention.
[0028] FIG. 1 illustrates a light stimulation system 100 for
providing a photobiomodulation (PBM) therapy to elevate
testosterone levels in a male patient. The system 100 includes a
device 105 comprising a substrate 108 carrying a plurality or array
of LED light emitters 110 that are adapted to irradiate a male
patient's genitals 111 and more particularly the patient's testes
112 (see FIG. 2). The substrate 108 can be designed to have varying
levels of flexibility. In additional variations, the substrate can
be rigid.
[0029] The testes are the body's main source of male hormones such
as testosterone, and light stimulation is adapted to increase
testosterone levels. Referring to FIG. 2, a flexible substrate 108
carries the LEDs 110 and is shaped and configured to be positioned
proximate to the patient's genitals 111 and testes 112 by being
carried within an underwear-type garment 114, which can take any
form, such as conventional briefs or a specially made undergarment.
Additional variations of the device can be positioned in any type
of garment. As can be seen in FIG. 1, the flexible substrate 108
and LEDs 110 are operatively coupled to a portable module 118 which
carries a power source 120 (e.g., a battery) for energizing the
LEDs 110 and a processor or controller 125 for controlling
operating parameters of the LEDs. The battery can be a rechargeable
lithium battery with low voltage that allows for USB charging or
the like.
[0030] As can be seen in FIGS. 1 and 2, the LEDs 110 are detachably
connected to the module 118 by an electrical cable 126 with a first
connector 128a that cooperates with a second connector 128b in the
module 118. The module 118 is adapted to be carried by, or worn by,
the patient and can be configured with belt loops, can be carried
by velcro attachment to a garment, can be carried within a pocket
in an undergarment, or carried in a pocket in an outer garment.
[0031] As can be understood from FIG. 1, light is emitted from the
LEDs in expanding light beams 132 that propagate generally
perpendicularly to the plane of the flexible substrate 108. The
array of light LED emitters 110 can comprise from 2 to 200 LEDs. In
one variation, the LEDs emit at least one selected wavelength that
ranges between 400 nm and 850 nm. The controller 125 is configured
to activate or actuate the LEDs 110 to provide a selected
irradiance described below in a duty cycle consisting of an ON/OFF
sequence wherein the ON interval totals at least 5 minutes over at
least a 30 minute period, and often 10 minutes per hour over at
least a 1 hour period. In a variation, the LEDs operate to provide
an irradiance that ranges from 20 mW/cm.sup.2 to 200 mW/cm.sup.2.
Often, the irradiance is from 50 mW/cm.sup.2 to 150 mW/cm.sup.2 or
from 80 mW/cm.sup.2 to 120 mW/cm.sup.2.
[0032] In a variation, the controller 125 carried by the system 100
includes algorithms for modulating operating parameters of the
system 100, where the parameters consist of (i) at least one
selected wavelength, (ii) irradiance, and (iii) duty cycle. The
device 105 can carry a plurality of LEDs wherein the various LEDs
have different wavelengths or alternatively the device can carry a
plurality of LEDs that provide varied different wavelengths. The
controller 125 further can selectively modulate the selected
wavelengths over a treatment interval to thus provide a
polychromatic photobiomodulation therapy. The controller 125 can
also modulate the irradiance over the time of a treatment interval,
wherein the varied irradiance can be within the range described
above, e.g., an irradiance range from 20 mW/cm.sup.2 to 200
mW/cm.sup.2. In a variation, the controller 125 also can modulate
the duty cycle, wherein the ON/OFF sequence includes an ON interval
ranging from 1 millisecond to 30 minutes and an OFF interval
ranging from 1 millisecond to 10 minutes.
[0033] In another variation, still referring to FIG. 1, the device
105 can carry at least one temperature sensor 140 carried in the
substrate 108 (e.g., a surface or within the surface), which is
adapted to send temperature signals to the controller 125. In this
variation, the controller 125 can further include algorithms
adapted to modulate the operating parameters of the LEDs, (i.e.,
(i) selected wavelength, (ii) irradiance, (iii) duty cycle) in a
feedback mode that is responsive to the temperature signals from
the sensor 140. The temperature sensor can comprise any form of
temperature sensing mechanism, such as a thermistor, a positive
temperature coefficient (PTC) resettable switch, a thermocouple,
negative temperature coefficient (NTC) or the like. In other
variations, the device 105 can carry one or more other sensing
mechanisms for sensing environmental or patient conditions at the
treatment site and sending signals to the controller 125 which then
allows for feedback control of the operating parameters of the
system. Such alternative a sensing mechanism can be carried by the
device 105 or the wearable garment 114 (FIG. 2) and include of
pulse oximeters, impedance sensors and capacitance sensors.
[0034] Referring to FIG. 1, the device 105 also may be configured
with a thin film reflective layer 135, such as mylar, on the back
side 142 of the substrate 108 that opposes the front side 144 of
the device which emits light to the patient. In general, the
reflective material is adapted to reflect light emitter by the LEDS
toward the targeted site in the patient.
[0035] Now turning to FIG. 3, in another variation, light
stimulation device 200 of the invention comprises a light-emitting
fabric member 205 that is adapted for positioning in the patient's
underwear-type garment 114 as shown in FIG. 2. In this variation,
the fabric member 205 can consist of any woven, knit, braided, or
entangled threads together with side-emitting optical fibers 210
integrated therein, as shown schematically in FIG. 4. The optical
fibers 210 are processed so that the surface cladding allows light
to be emitted or diffused in emissions indicated at 211 along the
full length of the fibers, hence the term "side-emitting" optical
fibers. The fabric member 205 is similar to any synthetic fabric as
it can be sewn and washed. In general, the optical fibers 210 are
arranged and distributed in the fabric member 205 to be parallel
with one another. The fibers have a small diameter, for example
from 100 .mu.m to 500 .mu.m. Typically, the optical fibers 210 are
distributed evenly across the width of the fabric member 205, but
such fibers 210 also may be integrated into the fabric member in
different densities or patterns to focus light emissions. The
proximal ends 212 of the optical fibers 210 are collected into a
fiber-optic bundle or cable 215 that can be detachably connected to
the LED light source 220 in a wearable module 222 (see FIG. 3)
similar to that described previously. In this variation, the module
222 carries a controller 225 and battery 230 that are similar to
the previous embodiment. In another variation, as illustrated in
FIG. 4, the fabric member 205 can also carry a thin-film reflective
layer 235 (e.g., mylar film) as described previously that is
configured to reflect light toward the patient. The reflective
layer 235 is useful since the side-emitting fibers 210 generally
emit light in all directions around each fiber.
[0036] In one variation shown in FIG. 3, the system 200 further
includes a communication unit 240 configured to function as a
wireless link that is adapted to send and receive data from the
cloud 245 or from an alternative memory unit for storing and
analyzing patient and user data. The communication unit 240 also is
adapted to communicate with a touchscreen 250 or other means for
monitoring, adjusting and controlling all operating parameters of
the system 200. The wireless link to the cloud 245, the tablet or
the phone 250 can be used for monitoring patient compliance, for
data collection, or for remote adjustment of operating parameters
of the system 200.
[0037] In general, a light stimulation method corresponding to the
invention comprises (i) providing a wearable structure carrying
light emitters that emit at least one selected wavelength between
400 nm and 850 nm, wherein the light emitters are positioned in the
wearable structure to be proximate to testes of a patient, (ii)
actuating the light emitters in a duty cycle consisting of an
ON/OFF sequence wherein the ON interval totals at least 5 minutes
per hour over at least a 2 hour period, and (iii) providing an
irradiance in the range of 20 mW/cm.sup.2 to 200 mW/cm.sup.2 to the
patient's testes to thereby enhance testosterone levels in the
patient. Often, the method provides an irradiance ranging from 50
mW/cm.sup.2 to 150 mW/cm.sup.2 or from 80 mW/cm.sup.2 to 120
mW/cm.sup.2
[0038] In another variation, the system allows for recording of a
patient's treatment in terms of operating parameters. In a typical
form of treatment, the system is adapted for personal use under a
physician's care wherein the stored data then can be reviewed by
the physician for patient compliance with the treatment program.
Typically, a patient will wear the garment and light stimulation
device for treatments period which may be from 1 weeks to 6 months.
In some variations, the light stimulation may be used indefinitely
as a maintenance therapy to maintain testosterone levels at a
selected level. As described above, the system can include a module
for uploading the treatment data to the cloud 245 which then can be
reviewed by the physician for compliance.
[0039] In another variation, the light stimulation systems 100 and
200 of FIGS. 1, 2 and 3 can further include a cooling mechanism
carried by the wearable device 105, 205 or the garment 114 (FIG. 2)
comprising at least one of flat flexible polymer heat pipes, heat
sink elements or flexible thermoelectric (Peltier) elements (see
FIG. 5). While the irradiance levels described above are configured
to generate little to no heat, or use temperature-responsive
feedback control, some system embodiments my benefit from a passive
or an active cooling mechanism. FIG. 5 is a schematic view of a
system with a passive cooling mechanism where the light emitter
device 280 that has a light-emitting LEDs or fibers in a first
portion 285A that is similar to the devices 105 and 205 of FIGS. 1
and 3 above. In addition, the device 280 can have a second portion
285B adapted for dissipating heat transferred from the
light-emitting portion 285A. In this embodiment, heat sink or heat
transfer elements 290 are shown in FIG. 5, which can be heat
conductors (e.g., copper elements, flat flexible polymer heat
pipes, or the like. In one variation, the second portion 285B can
be disposed in a region of the garment 114' spaced apart from the
treatment site.
[0040] Referring to FIG. 6, another variation of a device 305
similar to the light stimulation systems 100 and 200 of FIGS. 1 and
3 is configured with the LEDs or light emitting fibers 310 being
positioned inwardly a distance D of at least 5 mm and often at
least 10 mm from edges 312 of the device 305. In other words, the
substrate of material of the device 305 is configured with a skirt
portion 315 that is not light transmissible which is adapted to
prevent light from propagating outside the perimeter P of the
device. The skirt portion thus prevents any light being visible
during use through the user's clothing.
[0041] In another variation, a light emitting device 105 or 205 as
shown in FIGS. 1 and 3 can be adapted to provide a
self-disinfecting mode of operation, where LEDs emit UV radiation
that can reduce or eliminate biological contamination on the
device. In this variation, the controller would include an
algorithm for activating a selected cycle of UV radiation after am
interval of light stimulation. Such a UV light cycle could be
performed while the patient was wearing the garment. In another
variation, the UV light cycle could be performed with the light
stimulation device disposed within an enclosure (e.g., a bag,
pouch, box, container, etc.) after being worn by the patient. Such
an enclosure can include reflective interior surfaces to cause the
UV radiation to irradiate all surfaces of the device effectively.
In another variation, the light emitting device 105 or 205 of FIGS.
1 and 3 can be configured with LEDs capable of increasing the
temperature of the device to disinfect surfaces of the device. Such
elevated temperatures can be controlled by the controller and used
in conjunction with, or independent of, UV irradiance as a
disinfecting mechanism. In these variations, the device 105 or 205
of FIGS. 1 and 3 also can include sensors in the device that
monitor the UV light emitted and/or the device temperature to
modulate energy delivery base on feedback from the sensors to
assure that the device has been treated sufficiently to disinfect
the surfaces of the device.
[0042] In another variation, the wearable device 105 or 205 of
FIGS. 1 and 3 can have a curved shape, a pouch shape or any
suitable shape for conforming to the patient's body. In a
variation, device can be shapeable to the user's anatomy, and can
carry a layer of uncured material (e.g., a resin, gel, etc.) that
can be exposed to oxygen and/or moisture from the air which can set
the material of the device into a permanent shape. In a variation,
the material can be set into a selected final shape by the light
wavelengths emitted by LEDs carried by the device, such as UV
irradiation. In another variation, a light emitting facemask can
use a similar material that can be shaped to a particular patient's
face and then cured to the custom selected shape.
[0043] Although particular embodiments of the present invention
have been described above in detail, it will be understood that
this description is merely for purposes of illustration and the
above description of the invention is not exhaustive. Specific
features of the invention are shown in some drawings and not in
others, and this is for convenience only and any feature may be
combined with another in accordance with the invention. A number of
variations and alternatives will be apparent to one having ordinary
skills in the art. Such alternatives and variations are intended to
be included within the scope of the claims. Particular features
that are presented in dependent claims can be combined and fall
within the scope of the invention. The invention also encompasses
embodiments as if dependent claims were alternatively written in a
multiple dependent claim format with reference to other independent
claims.
[0044] Other variations are within the spirit of the present
invention. Thus, while the invention is susceptible to various
modifications and alternative constructions, certain illustrated
embodiments thereof are shown in the drawings and have been
described above in detail. It should be understood, however, that
there is no intention to limit the invention to the specific form
or forms disclosed, but on the contrary, the intention is to cover
all modifications, alternative constructions, and equivalents
falling within the spirit and scope of the invention, as defined in
the appended claims.
[0045] The use of the terms "a" and "an" and "the" and similar
referents in the context of describing the invention (especially in
the context of the following claims) are to be construed to cover
both the singular and the plural, unless otherwise indicated herein
or clearly contradicted by context. The terms "comprising,"
"having," "including," and "containing" are to be construed as
open-ended terms (i.e., meaning "including, but not limited to,")
unless otherwise noted. The term "connected" is to be construed as
partly or wholly contained within, attached to, or joined together,
even if there is something intervening. Recitation of ranges of
values herein are merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range, unless otherwise indicated herein, and each separate value
is incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g., "such as") provided herein, is
intended merely to better illuminate embodiments of the invention
and does not pose a limitation on the scope of the invention unless
otherwise claimed. No language in the specification should be
construed as indicating any non-claimed element as essential to the
practice of the invention.
[0046] Preferred embodiments of this invention are described
herein, including the best mode known to the inventors for carrying
out the invention. Variations of those preferred embodiments may
become apparent to those of ordinary skill in the art upon reading
the foregoing description. The inventors expect skilled artisans to
employ such variations as appropriate, and the inventors intend for
the invention to be practiced otherwise than as specifically
described herein. Accordingly, this invention includes all
modifications and equivalents of the subject matter recited in the
claims appended hereto as permitted by applicable law. Moreover,
any combination of the above-described elements in all possible
variations thereof is encompassed by the invention unless otherwise
indicated herein or otherwise clearly contradicted by context.
[0047] All references, including publications, patent applications,
and patents, cited herein are hereby incorporated by reference to
the same extent as if each reference were individually and
specifically indicated to be incorporated by reference and were set
forth in its entirety herein.
* * * * *