EP2919843A1 - Dispositifs non invasifs de régulation de la température du cerveau pour améliorer le sommeil - Google Patents

Dispositifs non invasifs de régulation de la température du cerveau pour améliorer le sommeil

Info

Publication number
EP2919843A1
EP2919843A1 EP13854814.4A EP13854814A EP2919843A1 EP 2919843 A1 EP2919843 A1 EP 2919843A1 EP 13854814 A EP13854814 A EP 13854814A EP 2919843 A1 EP2919843 A1 EP 2919843A1
Authority
EP
European Patent Office
Prior art keywords
applicator
subject
thermal
phase change
region
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13854814.4A
Other languages
German (de)
English (en)
Other versions
EP2919843A4 (fr
Inventor
Robert E. Tucker
Jeffrey J . SCHIRM
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ebb Therapeutics LLC
Original Assignee
Cereve Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cereve Inc filed Critical Cereve Inc
Publication of EP2919843A1 publication Critical patent/EP2919843A1/fr
Publication of EP2919843A4 publication Critical patent/EP2919843A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M21/02—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A61F2007/0007—Forehead, e.g. headbands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A61F2007/0063—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit for cooling
    • A61F2007/0064—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit for cooling of gas
    • A61F2007/0065—Causing evaporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0292—Compresses or poultices for effecting heating or cooling using latent heat produced or absorbed during phase change of materials, e.g. of super-cooled solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0066—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3646—General characteristics of the apparatus related to heating or cooling by heat accumulators, e.g. ice, sand

Definitions

  • 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.
  • apparatuses e.g., device and systems
  • 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.
  • 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.
  • Existing treatments of neurological and/or sleeping disorders 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.
  • 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.
  • 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.
  • 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.
  • EEG electroencephalographic
  • Insomnia is associated with global cerebral hypermetabolism.
  • Nofzinger et al. 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.
  • insomnia patients demonstrated increased waking relative metabolism in the prefrontal cortex.
  • WASO the amount of wakefulness after sleep onset, or WASO, in insomnia patients correlates with increasing metabolism in the prefrontal cortex during NREM sleep.
  • noninvasive, regional thermal stimulus to the scalp may help adjust metabolism in the cerebral cortex underlying the stimulus and, thereby, provide treatment for neurological disorders.
  • Previously described technologies for brain temperature regulation e.g., cooling
  • 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.
  • non-invasive methods and apparatuses for applying thermal therapy to the skin over the prefrontal cortex.
  • 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.
  • 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.
  • headgear that is specifically adapted to hold a thermal applicator to provide sustained thermal regulation in the appropriate anatomical region of the head.
  • the apparatuses 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.).
  • 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.
  • any of the applicators and methods described herein 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.
  • these 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.
  • regulating holding (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
  • a predetermined temperature e.g., a temperature between 10 degree C and 40 degrees C
  • a predetermined time e.g., 30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7hrs, 8hrs
  • 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 head over the frontal cortex; and a strap configured to hold the applicator against the subject's head when the subject is sleeping.
  • 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.
  • 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.
  • 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.).
  • the thermal regulator region comprises a plurality of capsules each encapsulating the phase change material, wherein the capsules are arranged in a matrix of thermally conductive and conformable material.
  • the thermal regulator is formed of a single body.
  • the thermal regulator may comprise a single body comprising the phase change material.
  • the phase change material may be any appropriate phase change material having a phase transition temperature at the appropriate temperature.
  • the phase transition material may be an organic phase change material, such as a paraffin.
  • the phase change material may comprise a mixture of two or more different phase change materials.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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, 0.3 W7m*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) e.g., greater than about 0.2 W/m*K, 0.3 W7m*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
  • 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).
  • 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).
  • 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.
  • 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.)
  • any of the applicators described herein may include an attachment to secure the applicator to the subject's head.
  • 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.
  • 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.
  • 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.
  • the appropriate region of the head e.g., the forehead/scalp
  • 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 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.
  • 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.
  • a method of enhancing sleep in a subject 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
  • 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.
  • 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.
  • the step of positioning comprises adjusting a headgear to hold the applicator to the subject's head.
  • 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.
  • positioning may mean adjusting the thermal transfer region of the applicator to conform to the subject's head.
  • 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 region at the phase transition temperature for more than about 30 minutes to enhance the subject's sleep.
  • FIG. 1 is a front view of one variations of a non-invasive brain thermal regulation applicator on the head of a subject.
  • 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.
  • FIG. 3A is a front view of a variation of a non-invasive brain thermal regulation applicator on the head of a subject.
  • FIG. 3B is a side view of the non-invasive brain thermal regulation applicator of FIG. 3 A on the head of a subject.
  • FIG. 4 is a cross-sectional view through one variation of a thermal regulation applicator.
  • FIG. 5 is a cross-sectional view through another variation of a thermal regulation applicator.
  • FIG. 6 is a cross-sectional view through another variation of a thermal regulation applicator.
  • FIG. 7 is a cross-sectional view through another variation of a thermal regulation applicator.
  • 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.
  • 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.
  • the thermal transfer region may be temperature regulated by any appropriate mechanism, particularly passive thermal regulator regions.
  • the thermal transfer region may be thermally regulated by a phase change material forming the thermal regulator region.
  • phase change material 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.
  • PCMs are classified as latent heat storage (LHS) units.
  • PCMs latent heat storage can be achieved through solid-solid, solid-liquid, solid-gas and liquid-gas phase change.
  • 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.
  • 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.
  • the brain temperature-regulating applicator apparatuses described herein 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.
  • 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.
  • 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.
  • pre-frontal/frontal cortex pre-frontal/frontal cortex
  • 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
  • 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.
  • 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.
  • 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.
  • 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.).
  • the phase change material may be chosen so that appropriate warming/cooling temperature is select.
  • 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.
  • 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).
  • phase change material 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 period ranging from about 15 minutes to over 480 minutes (e.g., over about 1 min., over about
  • 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.
  • the phase change material may be encapsulated into one compartment within the applicator.
  • a phase change material may be present in a large compartment
  • the phase change material is formulated to maintain a high level of flexibility to enhance conformability and comfort.
  • 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.
  • 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.
  • 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.
  • 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.
  • the thermal transfer 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.
  • 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.
  • 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.
  • 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.
  • a matrix may produce a more flexible and comfortable applicator.
  • 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.
  • 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.
  • 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).
  • 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.
  • inorganic e.g., salt hydrates
  • eutectics Organic-organic, organic- inorganic, inorganic-inorganic compounds, including paraffins
  • Hygroscopic materials include inorganic (e.g., salt hydrates), eutectics (Organic-organic, organic- inorganic, inorganic-inorganic compounds, including paraffins), and Hygroscopic materials.
  • any of the phase change material devices described herein may be prepared by cooling or warming prior to application.
  • the applicator may be cooled to, or in some variations, below, the phase change temperature by any appropriate method.
  • the applicator is cooled by placing in a refrigerator until the phase change occurs.
  • 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.
  • 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.
  • the applicator or just the thermal regulator region could be heated above the transition temperature of the phase change material in the applicator.
  • 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).
  • 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.
  • a sufficiently high thermal conductivity at least on the side of the applicator facing the subject
  • 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.
  • the applicator 201 housing the thermal regulator 1 1 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 worn during sleep. The strap does not transfer thermal energy between the thermal regulator 1 1 and the other portions of the subject's head.
  • FIG. 3A-3B illustrate another variation of an applicator that can be used as described herein.
  • 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
  • FIG. 3B shows a side view of the applicator of FIG. 3 A worn on a patient.
  • the apparatuses and systems could utilize evaporative cooling to maintain the temperature of the applicator at the desired therapeutic temperature to enhance sleep.
  • evaporative cooling 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.
  • the evaporative cooling device includes sodium polyacrylate crystals to enhance moisture retention.
  • the evaporative cooling applicator is manufactured from hydrophilic fibers specifically formulated and produced in a manner to enhance moisture retention.
  • 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.
  • 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.
  • An evaporative cooling device may be configured so that the applicator does not leak or spill water.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • the headgear is produced from an elastic material in fixed sizes without adjustability i.e. small, medium and large.
  • 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.
  • 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.
  • 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.
  • the headgear may include a pocket or clips to secure an applicator against the subject's head.
  • 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.
  • the headgear may be constructed of multiple pieces for better thermal contact and comfort of the patient.
  • the headgear may be constructed to allow adjustment to allow for better thermal contact and comfort of the patient.
  • a headgear may be for single use, or it may be reusable.
  • the headgear may be a singular use and replaced on each application.
  • 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.
  • 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.
  • 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.
  • inventive concept 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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  • Anesthesiology (AREA)
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Abstract

Cette invention concerne des méthodes, des systèmes et des dispositifs pour améliorer le sommeil, comprenant l'amélioration de la qualité du sommeil, la réduction du temps d'endormissement, l'augmentation du temps de sommeil total, le traitement de l'insomnie, et/ou le traitement d'autres troubles neurologiques par une régulation non invasive de la température du cortex frontal avant et/ou pendant le sommeil. Des applicateurs thermiques qui comprennent des matériaux à changement de phase et/ou un système de refroidissement par évaporation, ainsi qu'un casque pour maintenir les applicateurs confortablement contre la région appropriée de la tête de l'utilisateur sont décrits.
EP13854814.4A 2012-11-15 2013-11-15 Dispositifs non invasifs de régulation de la température du cerveau pour améliorer le sommeil Withdrawn EP2919843A4 (fr)

Applications Claiming Priority (3)

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US201261727054P 2012-11-15 2012-11-15
US201361859161P 2013-07-26 2013-07-26
PCT/US2013/070251 WO2014078630A1 (fr) 2012-11-15 2013-11-15 Dispositifs non invasifs de régulation de la température du cerveau pour améliorer le sommeil

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EP2919843A1 true EP2919843A1 (fr) 2015-09-23
EP2919843A4 EP2919843A4 (fr) 2016-08-03

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JP (1) JP2016501074A (fr)
AU (1) AU2013344545A1 (fr)
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WO2015013576A1 (fr) 2013-07-26 2015-01-29 Cereve, Inc. Appareil et procédé pour la modulation du sommeil
US10004632B2 (en) 2015-07-16 2018-06-26 Slumber Science LLC Devices, systems, and kits for regulating skin temperature for mammals
EP3810003A4 (fr) * 2018-06-19 2022-07-20 Thermaquil, Inc. Systèmes et méthodes pour le traitement thermique de nerfs
US10695530B1 (en) 2019-06-10 2020-06-30 Slumber Science LLC Methods, devices, systems, and kits for regulating skin temperature for mammals to induce and/or maintain sleep
KR102672546B1 (ko) * 2021-09-22 2024-06-04 안영환 펜형 주사장치의 커버형 온도유지시스템

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US4964402A (en) * 1988-08-17 1990-10-23 Royce Medical Company Orthopedic device having gel pad with phase change material
US5274865A (en) * 1992-11-25 1994-01-04 Sanwa Life Cela Kabushiki Kaisha Cooling device
US7744640B1 (en) * 1999-08-11 2010-06-29 Medical Products, Inc. Thermal treatment garment and method of thermally treating body portions
AU2350300A (en) * 1999-11-30 2001-06-12 Procter & Gamble Company, The Cooling pad
US6755852B2 (en) * 2001-12-08 2004-06-29 Charles A. Lachenbruch Cooling body wrap with phase change material
JP4308561B2 (ja) * 2002-10-15 2009-08-05 大阪瓦斯株式会社 冷却材
EP1727503A1 (fr) * 2004-02-23 2006-12-06 Aqueduct Medical, Inc. Dispositif a temperature reglable
US8425583B2 (en) * 2006-04-20 2013-04-23 University of Pittsburgh—of the Commonwealth System of Higher Education Methods, devices and systems for treating insomnia by inducing frontal cerebral hypothermia
WO2007124012A1 (fr) * 2006-04-20 2007-11-01 University Of Pittsburgh Procédé et appareil de stimulation thermique de région cérébrale non invasive pour le traitement des troubles neurologiques
US20100312317A1 (en) * 2009-06-06 2010-12-09 Carol Baltazar Hot/cold temperature treatment apparatus

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AU2013344545A1 (en) 2015-05-07
EP2919843A4 (fr) 2016-08-03
JP2016501074A (ja) 2016-01-18
WO2014078630A1 (fr) 2014-05-22
CA2890215A1 (fr) 2014-05-22

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