Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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NON-INVASIVE BRAIN TEMPERATURE REGULATING DEVICES FOR
ENHANCING SLEEP
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. provisional patent no.
61/727,054, filed on
11/15/2012, and titled "NON-INVASIVE BRAIN COOLING DEVICES FOR ENHANCING
SLEEP". This application also claims priority to U.S. provisional patent
application no.
61/859,161, filed on 7/26/2013, and titled "APPARATUS AND METHOD FOR
MODULATING SLEEP". All of these provisional applications are herein
incorporated by
reference in their entirety.
[0002] This application may be related to the following patents and
pending applications,
each of which is herein incorporated by reference in its entirety: U.S. patent
8,236,038, filed
11/788,694 (titled "METHOD AND APPARATUS OF NONINVASIVE, REGIONAL BRAIN
THERMAL STIMULI FOR THE TREATMENT OF NEUROLOGICAL DISORDERS"); U.S.
patent application no. 13/019,477, filed 2/2/2011 (titled "METHODS, DEVICES
AND
SYSTEMS FOR TREATING INSOMNIA BY INDUCING FRONTAL CEREBRAL
HYPOTHERMIA"); and U.S. patent application no. 12/288,417, filed 10/20/2008
(titled
"METHOD AND APPARATUS OF NONINVASIVE, REGIONAL BRAIN THERMAL
STIMULI FOR THE TREATMENT OF NERUOLOGICAL DISORDERS").
INCORPORATION BY REFERENCE
[0003] 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
[0004] Described herein are apparatuses (e.g., device and systems) and
methods for
enhancing sleep, including in particular enhancing the quality of sleep,
reducing sleep onset
time, increasing total sleep time, treating insomnia and treating other
neurological disorders by
non-invasively regulating the temperature of the frontal cortex prior to
and/or during sleep.
BACKGROUND
[0005] Sleep is essential for a person's health and wellbeing, yet
millions of people do not
get enough sleep and many suffer from lack of sleep. Surveys conducted by the
U.S. National
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Science Foundation between 1999 and 2004 found that at least 40 million
Americans suffer from
over 70 different sleep disorders, and 60 percent of adults report having
sleep problems a few
nights a week or more. Most of those with these problems go undiagnosed and
untreated. In
addition, more than 40 percent of adults experience daytime sleepiness severe
enough to interfere
with their daily activities at least a few days each month, with 20 percent
reporting problem
sleepiness a few days a week or more. Furthermore, 69 percent of children
experience one or
more sleep problems a few nights or more during a week.
[0006] Insomnia is the most common sleep complaint across all stages of
adulthood, and for
millions of people, the problem is chronic. Many health and lifestyle factors
can contribute to
insomnia including stress, depression, medical illnesses, pain, medications,
or specific sleeping
disorders. There is great need for additional research to better define the
nature of chronic
insomnia.
[0007] Existing treatments of neurological and/or sleeping disorders,
including insomnia,
include the use of over the counter or prescription drugs and/or behavioral
treatments.
Prescription drugs are known to aid patients suffering from sleeping
disorders, however, these
drugs can be quite expensive and potentially addicting. Some medications even
become less
effective as use continues. Additionally, the prescriptions can have unwanted
and harmful side
effects.
[0008] Other techniques to treat sleeping disorders include a variety of
behavioral measures
including stimulus control therapy, sleep restriction therapy, relaxation
training, cognitive
therapy, and sleep hygiene education. While these measures have moderate
effectiveness, they
are costly, require significant time to implement and require highly trained
clinicians to
implement.
[0009] One treatment technique previously described addresses these
issues by using non-
invasive and localized or regional thermal stimuli to the brain that helps
treat sleep disorders,
including insomnia. Specifically, this method may help restore or mimic normal
function in the
cerebral cortex. The restoration of function in the cerebral cortex plays a
significant role in
sleep. At the molecular and neuronal levels, hypothesized functions of sleep
include the
restoration of brain energy metabolism through the replenishment of brain
glycogen stores that
are depleted during wakefulness and the downscaling of synapses that have been
potentiated
during waking brain function. A homeostatic sleep drive, or pressure for
sleep, is known to build
throughout the waking hours and then is discharged during sleep. At the
electroencephalographic
(EEG) level, this is measured by EEG spectral power in the delta (0.5-4 Hz)
frequency band.
[00010] These sleep-related processes have some regional specificity for the
prefrontal cortex.
Slow wave sleep rhythms have both thalamic and cortical components. An
anterior dominance of
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EEG spectral power in the delta EEG spectral power range has been reported. A
frontal
predominance for the increase in delta power following sleep loss has been
also reported. This
region of the cortex also plays a prominent role in waking executive functions
which are
preferentially impaired following sleep deprivation. These sleep deprivation
induced cognitive
impairments have been related to declines in frontal metabolism after sleep
loss. While cerebral
metabolism declines globally from waking to NREM sleep, these declines are
most pronounced
in heteromodal association cortex, including the prefrontal cortex.
[00011] Insomnia is associated with global cerebral hypermetabolism. Nofzinger
et al. (Am J
Psychiatry, 2004) assessed regional cerebral glucose metabolism during both
waking and NREM
sleep in insomnia patients and healthy subjects using [18F] fluoro-2-deoxy-D-
glucose positron
emission tomography (PET). Insomnia patients show increased global cerebral
glucose
metabolism during sleep and wakefulness; and a smaller decline in relative
metabolism from
wakefulness to sleep in wake-promoting regions of the brain. In a comparison
between insomnia
and depressed patients, insomnia patients demonstrated increased waking
relative metabolism in
the prefrontal cortex. Finally, recent research has shown that the amount of
wakefulness after
sleep onset, or WASO, in insomnia patients correlates with increasing
metabolism in the
prefrontal cortex during NREM sleep.
[00012] The relationship between body temperature and quality of sleep
generally has been
described in connection with prior research in the field of sleep medicine.
Heat loss, via selective
vasodilatation of distal skin regions (measured by the distal minus proximal
skin temperature
gradient (DPG), seems to be a crucial process for the circadian regulation of
core body
temperature (CBT) and sleepiness (Aschoff 1956; Krauchi and Wirz-Justice 1994,
2002; Krauchi
et al. 1998, 2000). Increased DPG before lights off has been noted to promote
a rapid onset of
sleep, suggesting a link between thermoregulatory and arousal (sleepiness)
systems (Krauchi et
al. 1999, 2000). Hot environments impair the sleep process including falling
asleep and
maintaining sleep as well as generating slow wave sleep as the increased
ambient temperature
interferes with the normal declines in core body temperature associated with
the sleep onset
process. Finally, rapid and intense temperature drops around the sleep onset
or sleeping periods
are expected to have an arousing effect (Horne and Reyner 1999; Hayashi et al.
2003). In
contrast, the apparatuses and methods described herein minimize such adverse
effects from
temperature changes through application of a controlled (including relatively
constant) thermal
regulation over a prolonged period of time to a localized surface of the
scalp. Thus, it has been
found that noninvasive, regional thermal stimulus to the scalp (e.g., between
10 degrees C and 40
degrees C) of the head may help adjust metabolism in the cerebral cortex
underlying the stimulus
and, thereby, provide treatment for neurological disorders.
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[00013] Previously described technologies for brain temperature regulation
(e.g., cooling)
may use a cooling apparatus configured to be placed over the scalp/head
immediately atop the
frontal cortex region, and cooling of the apparatus is typically applied by
circulating coolant,
although other cooling mechanisms are discussed. Described herein are
advancements and
further refinements of this early work, expanding the types of thermal
regulation apparatuses that
may be used, as well as ways for securing the apparatus to the proper region
of a patient's head.
SUMMARY OF THE DISCLOSURE
[00014] In general, described herein are non-invasive methods and apparatuses
(including
devices and systems) for applying thermal therapy to the skin over the
prefrontal cortex. In some
variations, the apparatuses and methods of using them to enhance sleep
accomplish sustained
thermal regulation (warming or cooling) in an appropriate therapeutic range
and time using one
or more phase change materials. Also described are devices and methods to
enhance sleep that
accomplish sustained thermal regulation (cooling) in an appropriate
therapeutic range and time
using sustained evaporative cooling to enhance sleep. Finally, also descried
herein is headgear
that is specifically adapted to hold a thermal applicator to provide sustained
thermal regulation in
the appropriate anatomical region of the head.
[00015] In many of the therapeutic methods described herein, the apparatuses
(devices or
systems) include and applicator having a thermal transfer region and a phase
change material that
is configured to contact or be placed in thermal contact, with the patient's
skin; specifically the
skin over the prefrontal cortex. The thermal transfer region may be further
temperature
controlled by any appropriate thermal regulator region, particularly passive
thermal regulator
regions, which do not require active heating/cooling (by an electrically
powered devices such as
a heater/chiller, Peltier, etc.). For example, a passive thermal regulator may
include a phase
change material, evaporative cooling, or some combination thereof. Phase
changing materials
and sustained evaporative cooling may be used specifically to provide
appropriate therapeutic
cooling in various embodiments a described herein. Although passive thermal
regulators are
described in particular detail here, any of the applicators and methods
described herein (unless
the context indicates otherwise) may include an active thermal regulator in
addition or in
alternative. An active thermal regulator may include a fluid cooled/warmed, a
solid state (e.g.,
Peltier device), or the like.
[00016] Also described herein are methods of enhancing the sleep, such as
enhancing the
quality of sleep, reducing sleep onset, sustaining sleep and/or treating
insomnia by non-
invasively applying thermal regulation to the subject's frontal cortex using
an applicator
including a phase-changing cooling region and/or evaporative cooling region.
In general, these
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methods may include: positioning an applicator having a phase change material
or evaporative
cooling region so that a thermal transfer region is in communication with the
subject's skin over
the prefrontal cortex, as shown in FIGS. 1 and 2; and regulating (holding) the
temperature at a
predetermined temperature (e.g., a temperature between 10 degree C and 40
degrees C) for a
predetermined time (e.g., 30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs,
7hrs, 8hrs) using a phase
changing material having a transition temperature at about the predetermined
temperature, and
maintaining the temperature within prescribed limits for the predetermined
time period of at least
minutes and up to 480 minutes or more.
[00017] For example, described herein are applicators to enhance sleep by
regulating the
10 temperature of a subject's frontal cortex when worn. An applicator may
include: a thermal
regulator region comprising a phase change material having a phase transition
between about 10
degrees C and about 40 degrees C; a thermal transfer region in thermal
communication with the
thermal regulator region, wherein the thermal transfer regions is configured
to conform to and to
contact a subject's forehead so that the thermal transfer region is positioned
against the subject's
15 head over the frontal cortex; and a strap configured to hold the
applicator against the subject's
head when the subject is sleeping.
[00018] Any appropriate phase change material may be used. For example, a
phase change
material may be a homogenous material (e.g., all a single material) or the
phase change material
may be made up of a plurality of different phase change materials, each having
a different phase
transition temperature. The phase transition temperature in the case of a
phase transition
material that comprises a mixture of different component phase transition
materials may be the
temperature (or temperatures) at which the temperature of the thermal
regulator sustains by the
passive release/absorption of energy during use (and following pre-chilling or
pre-warming
before use), for example, a temperature between about 10 degrees C and about
40 degrees C.
[00019] In some variations the thermal regulator includes a plurality of
smaller bodies
including the phase change material. These smaller bodies may be capsules, or
may otherwise
encapsulate the phase change material. For example the thermal regulator may
comprise a
plurality of capsules, wherein each capsule encapsulates the phase change
material. These
capsules may be connected by another material (e.g., the material of the
thermal transfer region
or a different material), or suspended in another material. The material in
which the capsules
are held typically has a relatively high thermal conductivity (e.g., greater
than about .1 watts per
meter kelvin (W/(m*K)), 0.2 W/m*K, 0.3 W/m*K, 0.4 W/m*K, 0.5 W/m*K, 0.5 W/m*K,
0.7
W/m*K, 0.8 W/m*K, 0.9 W/m*K, 1 W/m*K, 2 W/m*K, 5 W/m*K, etc.). In some
variations the
thermal regulator region comprises a plurality of capsules each encapsulating
the phase change
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material, wherein the capsules are arranged in a matrix of thermally
conductive and conformable
material.
[00020] In some variations the thermal regulator is formed of a single body.
For example, the
thermal regulator may comprise a single body comprising the phase change
material.
[00021] As mentioned, the phase change material may be any appropriate phase
change
material having a phase transition temperature at the appropriate temperature.
For example, the
phase transition material may be an organic phase change material, such as a
paraffin. As
mentioned, the phase change material may comprise a mixture of two or more
different phase
change materials.
[00022] In general, the thermal regulator may be configured so that the phase
change material
is sustained at the phase transition temperature for greater than a minimum
time (e.g., 15
minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6
hours, 7 hours, 8
hours, or 15 minute increments of any of these). The duration that the phase
change material is
held at its phase transition temperature may depend primarily on the nature of
the phase change
material, and is related to the rate at which the phase change material
releases or absorbs thermal
energy as it changes phase. Other factors, including the amount of phase
change material, and
the ambient (surrounding) temperature and pressure may also effect the
duration. However,
assuming that the phase change material begins with the material completely at
an initial phase
(e.g., solid or liquid), and assuming that the ambient temperature (e.g., air
temperature and the
skin temperature of the subject wearing the applicator) are generally the same
when comparing
different applicators, the material properties of the phase change material as
well as the amount
of phase change material may primarily determine the duration that the phase
change material is
held at its phase transition temperature. Thus, the thermal regulator may be
configured so that
the phase change material is maintained at about the phase transition
temperature for greater than
about 30 minutes when the applicator is worn by a subject. In some variations,
the thermal
regulator is configured so that the phase change material is maintained at
about the phase
transition temperature for greater than about 6 hour when the applicator is
worn by a subject.
[00023] In general, the thermal transfer region is configured to transfer
thermal energy
between the region of the subject's head over the frontal cortex and the
thermal regulator region.
Thus, the thermal transfer regions may be formed of a material having a
relatively high thermal
conductivity. The thermal transfer region may also be configured to be
flexible and/or form-
fitting over the patient's head, to optimize the contact and transfer of
thermal energy. For
example, the thermal transfer region may include a material having a thermal
conductivity of
greater than about 0.1 watts per meter kelvin (W/(m*K)) (e.g., greater than
about 0.2 W/m*K,
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0.3 W/m*K, 0.4 W/m*K, 0.5 W/m*K, 0.5 W/m*K, 0.7 W/m*K, 0.8 W/m*K, 0.9 W/m*K, 1
W/m*K, 2 W/m*K, 5 W/m*K, etc.).
[00024] The thermal transfer region may generally be configured to position
the thermal
regulator over just the subject's frontal cortex when the applicator is worn
by the subject, or
primarily over just the subject's frontal cortex (e.g., over just the frontal
cortex and immediately
adjacent regions). For example, the thermal transfer region may be configured
to contact the
subject's forehead but not to contact the subject's periorbital or cheek
regions of the subject's
face when the applicator is worn by the subject. The thermal transfer region
may be configured
to contact the subject's forehead but not to contact the back of the subject's
head when the
applicator is worn by the subject, and/or the back and sides of the subject's
head (generally
excluding the temples).
[00025] As mentioned, the thermal transfer region may include a layer of
thermally
conductive material configured to contact the subject's forehead when the
applicator is worn by
the subject. Examples of thermally conductive materials include fabrics
(and/or coated fabrics,
etc.) having a relatively high thermal conductivity (e.g., greater than 0.1,
0.2, 0.3, 0.4, 0.5, etc.
W/(m*K)). The thermal conductivity may be enhanced by include a high thermal
conductivity
coating (e.g., diamond-like coatings, metal oxides, nitrides, carbides, glass,
etc.)
[00026] Any of the applicators described herein may include an attachment to
secure the
applicator to the subject's head. For example, an applicator may include a
strap configured as a
headgear. The headgear may contact any portion of the subject's head,
including the face, eye
orbit, etc.) but typically does not provide thermal contact between the
thermal regulatory region
and the subject's head. Thus, the exchange of thermal energy between the
thermal regulatory
region and the subject's head may be relatively limited by the thermal
transfer region to the
region of the subject's head above the frontal cortex. For example, a headgear
may include a
headband, hat, cap, kerchief, or the like, for holding the thermal transfer
region in contact with
the appropriate region of the head (e.g., the forehead/scalp), but preventing
thermal contact
between the thermal regulatory region and the rest of the head/face.
[00027] Any of the applicators to enhance a subject's sleep by regulating
the temperature of
the frontal cortex when worn may include: a thermal regulator region
comprising a plurality of
bodies each enclosing a phase change material having a phase transition
between about 10
degrees C and about 40 degrees C; a thermal transfer region in thermal
communication with the
thermal regulator region, wherein the thermal transfer regions is configured
to conform to and to
contact a subject's head so that the thermal transfer region is positioned
against the subject's
head over the frontal cortex, further wherein the thermal transfer region is
configured to contact
and the subject's forehead but not to contact the subject's periorbital or
cheek regions of the
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subject's face to regulate temperature when the applicator is worn by the
subject; and a strap
configured to hold the thermal transfer region against the subject's head when
the subject is
sleeping.
[00028] Also described herein are methods of enhancing sleep. In general, a
method of
enhancing sleep may include a method of reducing the sleep onset time, and/or
prolonging the
duration of sleep (e.g., increasing total sleep time), and/or increasing the
quality of sleep, and/or,
treating insomnia, and/or treating other neurological disorders by non-
invasive temperature
regulation of the frontal cortex before or after sleep onset.
[00029] For example, described herein are methods of enhancing sleep in a
subject, the
method comprising: positioning an applicator having a thermal regulator region
comprising a
plurality of bodies each enclosing a phase change material having a phase
transition between
about 10 degrees C and about 40 degrees C and a thermal transfer region in
thermal
communication with the thermal regulator region so that the thermal transfer
region contacts the
subject's forehead but does not contact the periorbital or cheek regions of
the subject's face; and
maintaining the temperature of the thermal transfer region at the phase
transition temperature to
enhance the subject's sleep.
[00030] The step of positioning may comprise positioning the applicator so
that the thermal
transfer region does not contact the top or back of the subject's head. In any
of these variations,
the step of positioning comprises adjusting a headgear to hold the applicator
to the subject's
head.
[00031] Maintaining may mean maintaining the temperature of the thermal
regulator region at
the phase transition temperature for at least some minimum time (e.g., 30
minutes, 60 min, 2
hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, etc.). For
example, maintaining may
mean maintaining the temperature of the thermal regulator region at the phase
temperature for at
least 1 hr. In some variations, maintaining comprises maintaining the
temperature of the thermal
regulator region at the phase temperature for at least 6 hrs.
[00032] In general, positioning may mean adjusting the thermal transfer region
of the
applicator to conform to the subject's head.
[00033] A method of enhancing sleep in a subject may include: positioning an
applicator
having a thermal regulator region comprising a plurality of bodies each
enclosing a phase change
material having a phase transition between about 10 degrees C and about 40
degrees C and a
thermal transfer region in thermal communication with the thermal regulator
region so that the
thermal transfer region contacts the subject's forehead but does not contact
the periorbital, cheek,
top or back regions of the subject's head; and maintaining the temperature of
the thermal transfer
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region at the phase transition temperature for more than about 30 minutes to
enhance the
subject's sleep.
BRIEF DESCRIPTION OF THE DRAWINGS
[00034] FIG. 1 is a front view of one variations of a non-invasive brain
thermal regulation
applicator on the head of a subject.
[00035] FIG. 2 is a side view of the embodiment of the non-invasive brain
thermal regulation
applicator similar to the applicator shown in FIG. 1.
[00036] FIG. 3A is a front view of a variation of a non-invasive brain thermal
regulation
applicator on the head of a subject.
[00037] FIG. 3B is a side view of the non-invasive brain thermal regulation
applicator of
FIG. 3A on the head of a subject.
[00038] FIG. 4 is a cross-sectional view through one variation of a thermal
regulation
applicator.
[00039] FIG. 5 is a cross-sectional view through another variation of a
thermal regulation
applicator.
[00040] FIG. 6 is a cross-sectional view through another variation of a
thermal regulation
applicator.
[00041] FIG. 7 is a cross-sectional view through another variation of a
thermal regulation
applicator.
DETAILED DESCRIPTION
[00042] In general, described herein are thermal regulation applicators
that are specifically
configured to be comfortably worn on the subject's head, to thermally regulate
(e.g., hold to a
predetermined temperature) specific regions of the subject's brain (e.g., the
frontal cortex
region/prefrontal cortex) while remaining comfortable, and sustaining the
temperature of the
specific region of the head at a desired temperature for a specific one or
more periods of time. In
general, these devices may include a thermal transfer region to be worn
directly against the
subject's skin (in the head region above the frontal cortex) and a thermal
regulator region
passively holding the predetermined temperature (or predetermined temperature
range) which is
in thermal contact with the thermal transfer region. All of the apparatuses
(devices and systems)
herein described are intended to address the subjects comfort while the
applicator is maintained
in a position above the pre-frontal (or frontal) cortex.
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[00043] The thermal transfer region may be temperature regulated by any
appropriate
mechanism, particularly passive thermal regulator regions. In some variations,
the thermal
transfer region may be thermally regulated by a phase change material forming
the thermal
regulator region. There are many types of phase change materials that could be
utilized. A phase
change material (PCM) is a substance with a high heat of fusion which, melting
and solidifying
at a certain temperature, is capable of storing and releasing relatively large
amounts of energy.
Heat is absorbed or released when the material changes from solid to liquid
and vice versa; thus,
PCMs are classified as latent heat storage (LHS) units.
[00044] PCMs latent heat storage can be achieved through solid¨solid,
solid¨liquid, solid¨gas
and liquid¨gas phase change. However, the phase change used for PCMs is
typically the solid¨
liquid change, as liquid-gas phase changes are not typically practical for use
as thermal storage
due to the large volumes or high pressures required to store the materials
when in their gas
phase. Liquid-gas transitions do have a higher heat of transformation than
solid-liquid
transitions. Solid¨solid phase changes are typically very slow and have a
rather low heat of
transformation.
[00045]
Solid¨liquid PCMs typically behave like sensible heat storage (SHS) materials;
their
temperature rises as they absorb heat. Unlike conventional SHS, however, when
PCMs reach the
temperature at which they change phase (their melting temperature) they absorb
large amounts of
heat at an almost constant temperature. The PCM continues to absorb heat
without a significant
rise in temperature until all the material is transformed to the liquid phase.
When the ambient
temperature around a liquid material falls, the PCM solidifies, releasing its
stored latent heat. A
large number of PCMs are commercially available in any required temperature
range from ¨5 up
to 190 C. Within the human comfort range of 20 to 30 C (or within 10 degrees
C to 40 degrees
C, or within 14 degrees C to 40 degrees C, etc.), some PCMs are very
effective. They store 5 to
14 times more heat per unit volume than conventional storage materials such as
water, masonry
or rock.
[00046] The brain temperature-regulating applicator apparatuses described
herein (which may
be referred to as non-invasive frontal or pre-frontal cortical stimulation
regions) may use one or
more phase change materials to thermally regulate a region of the subject's
head, and therefore a
region of the subject's underlying cortex (pre-frontal/frontal cortex) within
the therapeutic range
to enhance sleep and/or sleep onset. However, such devices should also be
configured so that
they can be comfortably worn. For example, they must conform to the subject's
head over the
appropriate region, and must be sufficiently light and compact (and in some
variation flexible) so
that they do not disrupt or prevent sleep, and must prevent tangling and/or
disturbing the subject
wearing the device while sleeping, including moving while sleeping.
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[00047] Typically, phase change materials that change from a solid to either a
liquid or gas
exhibit limited conformability when in the solid state. This lack of
conformability impacts the
subjects overall comfort. Phase change materials are used in many applications
to include relief
from pain, swelling and stress reduction, however such materials have not
previously been
described as part of a device that is capable of enhancing sleep, including
reducing sleep onset.
[00048] Any of the applicators described herein may be configured to applying
cooling to
enhance sleep, as demonstrated, for example, in U.S. patent 8,236,038, to the
frontal cortex to
enhance sleep. Thus, and of the applicators described herein may be configured
to cool the
subject's head over the pre-frontal/frontal cortex to a temperature that is
between about 0 degrees
C and about 35 degrees C (e.g.., a temperature between about 10 degrees C and
30 degrees C, a
temperature between about 14 degrees C and 30 degrees C, etc.) The temperature
may be
selected from within this range and held relatively constant at that
temperature for some
predetermined amount of time.
[00049] Any of the applicators described herein may also (or alternatively) be
configured to
apply generally "warming" (warming relative to the surface temperature of the
subject) to the
patient's head, e.g., between about 30 degrees C and about 40 degrees C, e.g.,
between about 32
degrees C and about 38 degrees C, etc. Warming has surprisingly been shown
recently to
enhance sleep in some patients; and particularly warming provide specifically
(and/or
exclusively) over the pre-frontal/frontal cortical region (e.g., forehead,
etc.), and sustained at a
relatively constant temperature for a predetermined period of time (e.g., 15
min, 30 min, 1 hour,
2 hours, 3 hours, 4 hours, 5 hours, etc.). As described in greater detail
below, for variations in
which the applicator includes a phase change material as part of the thermal
regulator, the phase
change material may be chosen so that appropriate warming/cooling temperature
is select.
Further, before operation of the applicator, the applicator (or at least the
thermal regulator
portion of the applicator including the phase change material) may be cooled
or heated beyond
the phase transition temperature so that the applicator will passively remove
or apply thermal
energy once applied to the subject.
[00050] In some variations of the apparatuses and systems described herein,
the phase change
material may be formulated to target a specific temperature for the phase
change to occur that
would be most beneficial for enhancing sleep, such as sleep quality, onset,
duration, and/or for
treating insomnia. The specific temperature may be a temperature that is not
perceived as
uncomfortably cold when cooling temperatures are applied (e.g., typically
greater than or about
10 C, e.g., about 14 C.). In warming variations, other specific temperatures
could be targeted
between about, for example, 36 C to about 44 C (e.g., 38 C, 40 C, etc.)
The thermal capacity
of the phase change material would be sufficient to maintain the targeted
temperature for a time
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period ranging from about 15 minutes to over 480 minutes (e.g., over about 15
min., over about
30 min., over about 45 min, over about 1 hr., over about 6 hrs., etc.)
[00051] The phase change material may be encapsulated in a bio-compatible
material suitable
for extended contact with the subject's skin, or for contact with a thermal
transfer region that
directly contacts the skin. The encapsulating material may be flexible and may
act as a thermal
conductor. Encapsulated phase change material could be used in conjunction
with a mold to
form the material into the shape of the forehead while being cooled below the
phase change
temperature/heated above the phase change temperature (e.g., if the applicator
is intended to
apply cooling). The shape of the mold could be generic based upon standard
anatomy
measurements, or could be custom shaped to the subjects head above the
prefrontal cortex.
[00052] In some variations, the phase change material may be encapsulated into
one
compartment within the applicator. For example, a phase change material may be
present in a
large compartment
[00053] In some variations, the phase change material is formulated to
maintain a high level
of flexibility to enhance conformability and comfort.
[00054] In some variations, the phase change material is encapsulated into
many
compartments within the applicator allowing the applicator to become form
fitting over the
prefrontal cortex. The size of the compartments may be the same or may vary by
location over
the pre frontal cortex. In some variations, the compartments could be
connected or independent
to each other.
[00055] In some variations, the phase change material may be encapsulated into
individual
capsules or containers within the applicator, as shown in FIGS. 4 and 5. The
capsules 401 may
have a uniform size and shape or the size and shape could be varied to achieve
enhanced
conformability. Additionally, the size and shape of the capsules could be
varied to develop
specific thermal characteristics across the applicator. In some variations,
different phase change
materials with different solidification temperatures may be used to provide a
matrix of regions or
capsules in order to provide a broader range of temperatures. In such an
application, one phase
change material solidification temperature could be used as the preferred
applicator temperature
with one or more other phase change materials used to maintain a second or
third temperature
sequentially. In FIG. 4, the applicator is shown in cross-section from a top
view. The applicator
may include a headgear, e.g., a strap 407, for holding the applicator to the
subject's head over the
appropriate region. The thermal regulation region 401 including the phase-
change material
maybe in thermal communication with a thermal transfer material 405 for
transferring thermal
energy between the thermal regulator bodies (capsules 401) and the surface of
the applicator that
contacts the subject and includes a thermal transfer region 403. In FIG. 4,
the thermal transfer
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region is configured as a pad. The applicator is generally configured so that
other region of the
applicator do not conduct the thermal energy to/from the thermal regulator
bodies and the
patient's head in regions that are not over the subject's frontal (prefrontal)
cortex. For example,
the subject's eyes, cheeks, back of the head, etc.
[00056] FIG. 5 illustrates another example of an applicator including a phase
change material
forming a passive thermal regulator. The thermal regulator is generally
conformable, as the
phase change material 503 is encapsulated/held in bodies within the thermal
regulator, and the
body of the thermal regulator is conformable; the body 505 may be formed of a
material
including a fabric having a relatively high thermal conductivity. The
applicator may also include
a thermal transfer region 509 that transmits thermal energy to the subject's
head and is
conformable so that it can be comfortably worn. The thermal transfer region
may also be
disposable/replaceable. In any of these variations the thermal transfer region
may be breathable
or configured so that it will absorb sweat and/or allow some air exchange
(e.g., may include
pores, etc.) The applicator may also include a headgear (e.g., strap 507) to
hold the device to the
subject's head.
[00057] In some variations, the phase change material could be mixed with
other materials to
form a matrix of materials such that the phase change material in the solid
form would be
suspended within other materials. Such a matrix may produce a more flexible
and comfortable
applicator.
[00058] As mentioned, in some variations, the phase change material could be
attached to an
interface material. The interface material may provide a higher degree of
formability to the
subject's anatomy above the pre frontal cortex than could be achieved by the
phase change
material encapsulations previously discussed. The interface material is
typically a thermal
transfer region having a relatively high thermal conductivity. For example, a
thermal transfer
region could be a gel material with high thermal conductivity, water or other
formable materials
that would enhance subject comfort, as illustrated in FIG. 7. In FIG. 7, the
phase change
material is a conformable phase change material 705, which is in thermal
communication with a
thermal transfer region 703 that is also conformable. The applicator may
include a headgear
(such as a strap 707).
[00059] Examples of phase change material formulations that could be used for
sleep
enhancement include inorganic (e.g., salt hydrates), eutectics (Organic-
organic, organic-
inorganic, inorganic-inorganic compounds, including paraffins), and
Hygroscopic materials.
[00060] In use, any of the phase change material devices described herein may
be prepared by
cooling or warming prior to application. For applicators intended to cool the
subject's
frontal/prefrontal cortex, prior to placing the applicator in position on the
subject's forehead over
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the brain (e.g., frontal, prefrontal) region of interest, the applicator may
be cooled to, or in some
variations, below, the phase change temperature by any appropriate method. In
some variations
the applicator is cooled by placing in a refrigerator until the phase change
occurs. In other
variations, a bedside cooling device is used to achieve the required
temperature for phase change
to occur. This bedside cooling device could cool the applicator utilizing any
readily available
refrigeration techniques including, but not limited to: compressor driven
and/or Pelletier
refrigeration. In any of the system/device variations described, a cooling
mold could be used to
pre-shape the applicator to conform to the subject's forehead. This may
provide for additional
comfort and may enhance the thermal contact of the applicator. Once positioned
on the subject's
forehead the applicator would maintain the temperature in a narrow temperature
range due to the
heat absorbing characteristics of the phase change material. Similarly, in
variations in which the
applicator is intended to warm the subject by passively holding the thermal
regulator at a
warming temperature (above ambient skin temperature), the applicator or just
the thermal
regulator region could be heated above the transition temperature of the phase
change material in
the applicator. For example, a phase change material could be a Sodium Acetate
solution that
produces heat when it crystalizes. The crystallization of Sodium Acetate
occurs when
heterogeneous nucleation is initiated (e.g., a nucleation agent that is below
the phase transition
temperature).
[00061] FIG. 6 shows a variation of an applicator in which the phase change
material 605 his
generally conformable, and is encapsulate in a material 603 having a
sufficiently high thermal
conductivity (at least on the side of the applicator facing the subject) to
form a thermal transfer
region. In some variations an additional thermal transfer region (not shown)
may be used. The
applicator may also include a headgear 607 for holding the applicator against
the subject's head
in the appropriate position, so that the thermal transfer region is adjacent
to the forehead and
other regions above the frontal/prefrontal cortex.
[00062] FIGS. 1 and 2 illustrate one variation of an applicator being worn by
a subject 101.
In this variation the applicator includes an outer shell 103 over a thermal
regulator 11 that is
positioned above the frontal cortex. The shell may form a headgear holding the
device to the
subject's head. The applicator may also include a thermal transfer region (not
visible in FIG. 1)
on the inner surface just between the thermal regulator 11 portion within the
applicator and the
subject's forehead/scalp, over the frontal/prefrontal cortex.
[00063] Two variations of side views are shown in FIG. 2. In FIG. 2, the
applicator 201
housing the thermal regulator 11 includes a headgear comprising the outer
shell and a strap 205
that goes around the back of the subject's head. The strap 205 is configured
to be comfortably
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worn during sleep. The strap does not transfer thermal energy between the
thermal regulator 11
and the other portions of the subject's head.
[00064] FIG. 3A-3B illustrate another variation of an applicator that can be
used as described
herein. In this variation, the applicator includes an internal thermal
regulator 303 that is
surrounded on the outside surfaces by a headgear 305 including a region
covering the subject's
eyes. An internal thermal transfer region (not visible in FIG. 3A) is present
between the thermal
regulator and the region of the applicator that is worn over the subject's
prefrontal cortex. Other
regions of the applicator (e.g., the headgear), including the region over the
subject's eyes, is not a
thermal transfer region, and does not transfer thermal energy between the
thermal regulator and
that portion of the subject's head. FIG. 3B shows a side view of the
applicator of FIG. 3A worn
on a patient.
Evaporative Cooling
[00065] In some variations the apparatuses and systems could utilize
evaporative cooling to
maintain the temperature of the applicator at the desired therapeutic
temperature to enhance
sleep. There are many forms of evaporative cooling commercially available,
however, to date no
effective evaporative cooling systems or devices have been formulated or
configured specifically
for sleep enhancement or the treatment of insomnia. As described herein, any
appropriate
evaporative cooling systems, devices, or materials could be engineered to meet
the specific
requirements for sleep enhancement and the treatment of insomnia.
[00066] For example, in some variations, the evaporative cooling device
includes sodium
polyacrylate crystals to enhance moisture retention. In some variations the
evaporative
cooling applicator is manufactured from hydrophilic fibers specifically
formulated and
produced in a manner to enhance moisture retention. In such a variation the
applicator would be
produced from the hydrophilic textile material and would be shaped to conform
to cover the
subject's forehead or possibly the entire frontal cortex area by common
textile manufacturing
techniques. The hydrophilic textile material would be held in place by a
headgear or adjustable
strap. In use, the hydrophilic material would be saturated in water prior to
being placed in
position on the subject and cooling of the pre frontal cortex area would occur
from the
evaporation of the moisture contained within the applicator. Figures 1 &2
indicate the relative
shape and location of the evaporative material applicator on a subject. The
type and quantity of
the selected evaporative material used would ensure sufficient cooling for at
least 15 minutes. In
some variations, the evaporative cooling material is shaped to form an
applicator comprising a
thermal transfer region in communication with the subject's skin over the
prefrontal cortex.
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[00067] An evaporative cooling device may be configured so that the applicator
does not leak
or spill water. For example, the evaporative cooling device maybe sealed
around all but one or
more evaporative air ports; the air ports may be configured to provided fluid
locks that minimize
or prevent fluid leakage.
Headgear
[00068] As discussed above, any of the applicators described herein may be
used with a
headgear that is specifically configured to maintain the applicator in thermal
contact with the
subject's head in a snug but non-restrictive manner. Thus, in some variations
the applicator is
held in position with a headgear. The headgear maintains thermal contact of
the applicator to
provide regional cooling of the area in proximity to the frontal cortex. The
headgear may be
configured to allow the subject to adjust the amount of contact pressure
applied to the applicator
and to adjust for comfort, while maintaining the position of the thermal
transfer region of the
applicator over the frontal cortex. The headgear can be configured from a
variety of materials.
In some variations where the cooling is achieved by a phase change material
the headgear could
include an insulation material that covers the surface of the applicator
distal to the subject to
reduce parasitic heat from accelerating the phase change. The insulation
material may be an
elastic material or covered with an elastic material that would induce
increased contact pressure
of the applicator to the subject's forehead when stretched by adjustable
straps wrapping the
circumference of the subjects head. The adjustable straps can be produced from
any suitable
material either exhibiting an elastic characteristic or not and incorporate
any adjustable feature
readily available such as Velcro, snaps, buttons, hooks etc. In some
variations, the adjustment
features may allow for macro adjustment of the circumferential head size and
secondary
adjustment features to micro adjust specific areas of the applicator to ensure
optimal thermal
contact and comfort. In some variations, the headgear is produced from an
elastic material in
fixed sizes without adjustability i.e. small, medium and large.
[00069] The headgear utilized for an evaporative cooling applicator may be
configures so that
it does not cover the distal side of the evaporative cooling material with an
insulation layer as
this would inhibit the evaporative process.
[00070] The headgear may be reusable and/or separate from the applicator.
Alternatively the
headgear may be integral with the applicator. The headgear may be constructed
of a singular
piece to allow thermal contact for the regional cooling. For example, the
headgear may include a
thermal transfer region oriented so that it is positioned against the head
over the subject's frontal
(and/or prefrontal) cortex region. The other regions of the headgear may be
thermally insulated.
In general, the headgear may include a pocket or clips to secure an applicator
against the
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subject's head. In some variations the applicator is one or more standard
sizes, and the headgear
is provided in different sizes that may fit the standard size(s) of the
applicator. The headgear is
typically adjustable. In general the headgear may be cushioned, particularly
in the regions
surrounding the applicator.
[00071] In some variations, the headgear may be constructed of multiple pieces
for better
thermal contact and comfort of the patient.
[00072] As mentioned, in some variations, the headgear may be constructed to
allow
adjustment to allow for better thermal contact and comfort of the patient.
[00073] As mentioned, a headgear may be for single use, or it may be reusable.
For example,
in some variations, the headgear may be a singular use and replaced on each
application.
[00074] 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.
[00075] 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 "/".
[00076]
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
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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.
[00077] 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.
[00078] 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.
[00079] 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.
[00080] 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
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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.
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