WO2015173752A1 - Pressure application device - Google Patents

Pressure application device Download PDF

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Publication number
WO2015173752A1
WO2015173752A1 PCT/IB2015/053532 IB2015053532W WO2015173752A1 WO 2015173752 A1 WO2015173752 A1 WO 2015173752A1 IB 2015053532 W IB2015053532 W IB 2015053532W WO 2015173752 A1 WO2015173752 A1 WO 2015173752A1
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WO
WIPO (PCT)
Prior art keywords
pressure
mpl
application members
pressure application
user
Prior art date
Application number
PCT/IB2015/053532
Other languages
French (fr)
Inventor
Michael G Tal
Yael KENAN
Original Assignee
Lacrima Medical Ltd.
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Filing date
Publication date
Application filed by Lacrima Medical Ltd. filed Critical Lacrima Medical Ltd.
Publication of WO2015173752A1 publication Critical patent/WO2015173752A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H7/00—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for
    • A61H7/001—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for without substantial movement between the skin and the device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0218—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement
    • A61H23/0236—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement using sonic waves, e.g. using loudspeakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0254—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor
    • A61H23/0263—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor using rotating unbalanced masses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/007—Stimulation by mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/04—Devices for pressing such points, e.g. Shiatsu or Acupressure
    • 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
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H2039/005—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture by means of electromagnetic waves, e.g. I.R., U.V. rays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0207—Characteristics of apparatus not provided for in the preceding codes heated or cooled heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0221—Mechanism for heating or cooling
    • A61H2201/0228—Mechanism for heating or cooling heated by an electric resistance element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1604—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1683—Surface of interface
    • A61H2201/169—Physical characteristics of the surface, e.g. material, relief, texture or indicia
    • A61H2201/1695—Enhanced pressure effect, e.g. substantially sharp projections, needles or pyramids
    • 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
    • A61M2021/0022—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 by the tactile sense, e.g. vibrations
    • 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
    • A61M2021/0027—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 by the hearing sense
    • 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
    • A61M2021/0055—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 electric or electro-magnetic fields
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0272—Electro-active or magneto-active materials
    • A61M2205/0294—Piezoelectric materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/002—Magnetotherapy in combination with another treatment

Definitions

  • the present invention relates generally to apparatus and a method for treating various disorders, such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, by pressure application in the area of the eyes.
  • various disorders such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, by pressure application in the area of the eyes.
  • Insomnia affects many people. Depending on the area, study, etc., between 10- 25% of the population are affected. Insomnia is twice as common in females. It increases with age; in the elderly population (aged 65 and older), insomnia symptoms were reported to be 33%-50%. In adolescents, insomnia incident is increasing recently, in the United States, 22.8 %, in Japan 25% and in China, 16.1%
  • the present invention seeks to provide apparatus for pressure application in the area of the eyes for treating various disorders, such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, as described more in detail hereinbelow.
  • various disorders such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, as described more in detail hereinbelow.
  • the invention may be applicable in treating other illnesses and disorders as a replacement or addition to vagus nerve stimulation, including but not limited to, Alzheimer's disease, migraines, fibromyalgia, obesity, tinnitus, alcohol addiction, atrial fibrillation, autism, bulimia nervosa, burn-induced organ dysfunction, chronic heart failure, chronic intractable hiccups, comorbid personality disorders, coronary artery disease, dravet syndrome, drop-attacks, heatstroke, intestinal epithelial barrier breakdown, Lennox- Gastaut syndrome, memory problems, mood disorders, myocarditis, multiple sclerosis, obsessive compulsive disorder, peripheral arterial occlusion disease, postoperative cognitive dysfunction, Rasmussen's encephalitis, mental diseases, and others.
  • vagus nerve stimulation including but not limited to, Alzheimer's disease, migraines, fibromyalgia, obesity, tinnitus, alcohol addiction, atrial fibrillation, autism, bulimia nervo
  • Fig. 1 is a simplified illustration of the medial palpebral ligament (MPL);
  • Fig. 2 is a simplified illustration of a nerve pathway from the eye to the Gasserian ganglion and finally to the vagus nerve;
  • MPL medial palpebral ligament
  • FIGs. 3 and 4 are simplified illustrations of a pressure device, in accordance with an embodiment of the invention.
  • Fig. 5 is a simplified illustration of a pressure device that applies pressure on the MPL and the opening in the nostrils, in accordance with a non-limiting embodiment of the invention
  • Fig. 6 is a simplified illustration of a holder which may be used for handling and applying the device
  • Figs. 7-11 are simplified illustrations of pressure devices, in accordance with other embodiments of the invention.
  • Fig. 12 is a simplified illustration of a pressure device, in accordance with an embodiment of the invention.
  • Fig. 13 is a simplified illustration of a pressure device, in accordance with another embodiment of the invention.
  • Fig. 14 is a simplified illustration of a pressure device with controller and feedback, possible for use with an app, in accordance with another embodiment of the invention.
  • the present invention provides novel pressure application devices on or near the area of the medial palpebral ligament (MPL). It is believed that such pressure can relieve many disorders. Although the invention is not bounds by any particular theory, explanations are provided herein for better understanding of the subject.
  • MPL medial palpebral ligament
  • Fig. 1 shows muscles of the face near the eye. Shown is the frontalis muscle, which is the major muscle of the forehead and is responsible for the expressions of the eyebrow.
  • the frontalis sits on the frontal bone of the skull and its muscle fibers interweave with the muscles of the eye, the orbicularis occuli, and the procerus at the bridge of the nose.
  • the orbicularis oculi is the muscle around the eye. It has two main parts: the orbital portion which is the larger, thicker, more outer part of the muscle that surrounds the eye socket, and the palpebral portion, better known as the eyelid; and the lacrimal portion.
  • the medial palpebral ligament MPL (also called tendo oculi), about 4 mm long and 2 mm wide, is attached to the frontal process of the maxilla in front of the lacrimal groove.
  • the MPL divides into two parts, upper and lower, each of which is attached to the medial end of the corresponding tarsus, upper and lower, resepctively (connecting tissue in the upper and lower eyelids).
  • MPL medial palpebral ligament
  • the involuntary eye closing activates processes related to sleep induction, sleepiness, relaxation and possibly stimulate the parasympathetic system.
  • the device acts to enhance sleep induction, relaxation and improved sleep quality.
  • the device creates a low pressure load on the MPL area, a process which facilitates closing the eyelids due to the connection between the MPL muscles and the upper and lower eyelids.
  • TCR Trigeminal Cardiac Reflex
  • TCR is a clinical phenomenon consisting of sudden onset of acute change in 10- 20% in mean arterial blood pressure and decease in heart rate. Pressing MPL by the designed device might cause minimal magnitude of the TCR (probably not reaching the threshold of 10%). Contemporary research has revealed the possibility of several subtype of the TCR, activated via the Gasserian ganglion.
  • the pathway is from the eye via ciliary nerves to the Gasserian ganglion (GG), to the trigeminal nerve (TN), to the sensory nucleus (SN) of the trigeminal nerve, to the short internuncial fibers (SIF), to the motor nucleus (MN) of the vagus nerve and finally to the vagus nerve (VN).
  • GG Gasserian ganglion
  • TN trigeminal nerve
  • SN sensory nucleus
  • SIF short internuncial fibers
  • MN motor nucleus of the vagus nerve
  • VN vagus nerve
  • Vagus stimulation may affect the neurohormone, oxytocin (OT) and increase its secretion in the brain.
  • OT has been shown to have anxiolytic and sedating effects in animal models and has been shown to attenuate neuroendocrine, neuroimmune, and autonomic stress responses in both human and animal models.
  • Figs. 3 and 4 illustrate a pressure device 10, in accordance with an embodiment of the invention.
  • the device 10 includes MPL pressure members 12 connected by a bridge member 14.
  • the pressure members 12 and the bridge member 14 may be made of a soft outer layer 16 with an inner stiffening member 18 (e.g., made of hard plastic).
  • the stiffening layer may be a unitary piece that extends from the bridge member 14 outwards to the pressure members 12.
  • the pressure members 12 may be cushions (e.g., an elastomer or resilient plastic) that apply a gently pressure to the MPL area; alternatively the pressure members 12 may by rigid, such as of a hard plastic.
  • Possible materials for the pressure members 12 include, without limitation, metal, foam, rubber, and silicone, hydrogels, PolyHEMA, poly(ethylene glycol)/poly(L-lactic acid-co- glycolic acid) (PEG/PLGA), acrylics, polyurethane, nylon, stainless steel and various plastics,
  • Pressing on or near the MPL is referred to as pressing on an anatomical site of a medial palpebral ligament of the subject.
  • rhythm dips and rises at different times of the day, wherein the drive to sleep is strongest at different times of the day and night.
  • Vibration may affect the circadian rhythm.
  • a vibration unit 20 (Fig. 4) may be positioned in or at pressure member(s) 12.
  • the vibration unit 20 may be, without limitation, a miniature motor with an eccentric weight, which when rotated causes vibration.
  • the vibration unit 20 may act softly but noticeably with or without non-audible indicators.
  • the pressure members 12 thus apply a controlled amount of pressure point with vibration.
  • the vibration unit may have any operating range, such as but not limited to, 2- 3.6V.
  • a small battery may be used as the power supply (other power sources are possible).
  • the pressure device of the invention may be useful in treating insomnia or symptoms related to insomnia.
  • the pressure applied on or near the MPL may help induce drowsiness in the patient.
  • the device may also additionally help treat sleep apnea, as is now described.
  • FIG. 5 illustrates a pressure device 100 that applies pressure on the MPL and the opening in the nostrils, in accordance with a non- limiting embodiment of the invention.
  • Anchoring to the nostrils will be done to facilitate opening the nostrils to help cases of sleep apnea or difficult breathing during the nighttime in case of nasal congestion.
  • the device 100 includes a solid or elastic bridge type anchored to the face in three locations: MPL, nostrils and above the MPL (upper nose bridge/forehead). This anchoring could be done by any type of method including adhesive tape or belt around the head.
  • device 100 may include a nose bridge portion (bridge member) 102 and two MPL pressure members 104 (e.g., pads or cushions) that are mounted at opposite ends of nose bridge portion 102.
  • MPL pressure members 104 e.g., pads or cushions
  • Two nostril arms 106 extend downward from nose bridge portion 102 and terminate in nostril cushions 108.
  • the nostril arms 106 are resilient and flexible and thus apply an outwards (lateral) force on the nostrils so as to increase the nostril openings.
  • the nostril arms 106 may be made of a shape memory alloy or other springy material.
  • an adjustment mechanism 110 may be provided for adjusting the outward expansion of nostril arms 106.
  • the nostrils' anchoring is accomplished by using a biasing device (nostril arms 106) connected to two MPL pressure members 104 (e.g., small soft cushions) which enter the nostrils.
  • the biasing device (nostril arms 106) may be preloaded. After applying by the user, the biasing device (nostril arms 106) causes lateral opening of the nostrils. Additional vertical nostrils opening may be done by anchoring the device to the upper bridge nose/forehead.
  • the pressure device may also include sonic (sound) transducers to add to the pressure, as is now described.
  • the added sound effects may be useful in some therapeutic applications,
  • the device may be combined with a sound unit (sonic transducer) 22 (Fig. 5), e.g., a miniature loudspeaker, to the cushion area of the pressure member(s) (12 or 104) or any other portion of the device. Sound is delivered to the bones as in headphones.
  • a sound unit sonic transducer 22 (Fig. 5), e.g., a miniature loudspeaker, to the cushion area of the pressure member(s) (12 or 104) or any other portion of the device. Sound is delivered to the bones as in headphones.
  • a 3D camera or face picture may be used to design the device specifically for each user. Based on the broad variety of anatomy in the eye corner, nose bridge in the MPL area, the device may also be designed based on 3D scan of the user.
  • a holder 37 may be provided for holding device 10 (or any of the other pressure devices described herein).
  • the holder 37 has outer grasping portions 39 for grasping by fingers of the user.
  • the holder 37 has crevices 41 for receiving therein the pressure members 12 and has a protrusion 43 that protrudes towards (and may support) bridge member 14.
  • the device 50 includes MPL pressure members 52 connected by a bridge member 54.
  • MPL pressure members 52 may be pillows or cushions, made of a soft material, such as cloth, foam, elastomer and the like.
  • Bridge member 54 extends as a bow out to MPL pressure members 52.
  • Extremities 56 of bridge member 54 serve as holders for MPL pressure members 52.
  • the device 50 may include an adhesive mounting member 57 with an adhesive strip 58 for bonding the device on the face of the user. The adhesive is compatible with use on the skin and allows the device to be removed without harm to the patient.
  • the device placement is based on the human ability to place the fingers in the exact ligament location intuitively and in accurate position.
  • the device is packaged in a way such that the device is grasped with three fingers: thumb, index finger and middle finger.
  • thumb, index finger and middle finger the user pulls the device from the pack.
  • the device adheres to the three fingers by glue and thereafter the user brings the device to the desired location near the eye using the three fingers.
  • pressure device 50 may include a magnetic field transducer 60 near the MPL pressure member(s) 52 to enhance the sleepiness effect.
  • the magnetic parameters may be, without limitation, 1-20 ⁇ , 1-500 Hz magnetic field (e.g., elliptical or circular field).
  • the device may include a thermal element 62 in the MPL pressure member(s) to increase the potential effect on sleepiness.
  • thermal element 62 is an electric heater.
  • a temperature- up timer circuit may be used to raise the temperature of the electric heater by an amount in the range of 1-15° C.
  • the MPL pressure members combine a controlled amount of pressure with heat.
  • the heater may be mounted on other parts of the pressure device. The heating effect may help due to the circadian rhythm of the body. Heat treatments that enhance the peripheral gradient for heat loss have the potential to facilitate sleep onset and quality. Heat makes muscles relax and therefore causes tiredness and sleepiness.
  • thermal element 62 is a cooling element (for example, a thermoelectric element that can be used for heating or cooling). Cooling the MPL area may provide therapeutic benefits in some applications.
  • the device may include a plastic flexible lever and elastic cushions. Both function as springs and compensate for different users' anatomy and skin movement in response to device administration. Examples are now described with reference to Figs. 8-11.
  • Fig. 8 is a modified version of the embodiment of Fig. 7, with like elements being designated by like reference numerals.
  • a pressure pad 64 is provided on bridge member 54 and tightened or loosened by an adjustment fastener 66 (e.g., threaded shaft with knob).
  • the device 70 includes MPL pressure members 72 connected by a bridge member 74.
  • the bridge member 74 is a resilient member, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel. The springiness of bridge member 74 provides the pressure to MPL pressure members 72.
  • the device 80 includes MPL pressure members 82 connected by a bridge member 84.
  • the bridge member 84 is a resilient and bendable member, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel. The flexibility and bending of bridge member 84 provides the pressure to MPL pressure members 82 and provides enhanced capability of adapting the device to any anatomy.
  • the device 90 includes MPL pressure members 92 connected by a bridge member 94.
  • the bridge member 94 is made of resilient and bendable wires with a central hub 95, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel.
  • the flexibility and bending of bridge member 94 provides the pressure to MPL pressure members 92 and provides enhanced capability of adapting the device to any anatomy.
  • the pressure device may be anchored to the subject's face by adhesive. Additionally or alternatively, a ratchet or screw or any other adjustable mechanism may be used to adjust the device to the exact force the user needs.
  • the device may be applied using alternative anchoring methods, such as a belt around the head or ears instead of or in addition to adhesive.
  • the bridge member is adjustable in shape to permit adjusting a spatial relationship between the pressure application members.
  • the device may include a plastic or flexible aluminum (or other metal) body designed to facilitate the transition point for the desired maximum power threshold on the MPL. This device improves device adjustment to the needs of different users and allows tightening the device force after placing the device on the user.
  • the cushions may serve also as springs for better placement and pressure application, and do not irritate the user's face.
  • FIG. 12 illustrates a pressure device 200, in accordance with an embodiment of the invention.
  • Pressure device 200 includes pressure application members 202 (or pressure members, for short), such as cushions extending from a bridge portion 204.
  • bridge portion 204 is adapted and shaped for lying over a nose bridge of a user.
  • Pressure application members 202 are spaced from one another so that they are aligned with and arranged to apply pressure on or in the vicinity of medial palpebral ligaments (MPLs) of a particular user.
  • Bridge portion 204 has a central base member 206 from which extends a face member 208, such as an adhesive pad.
  • face member 208 is an adhesive pad, the pad may be provided with a removable backing sheet or foil to expose the adhesive backing for applying to the face.
  • a pressure adjustment device 210 such as a thumbscrew, is mounted (such as through a threaded hole) in central base member 206 and is operative to move the face member 208 and the pressure application members 202 so as to apply the face member 208 to the nose and to adjust the pressure the pressure application members 202 apply to the patient.
  • the pressure adjustment device 210 may have a shaft 212 which is threaded on a portion thereof, whereas another portion of the shaft 212 is not threaded. This allows moving the shaft 212 of the pressure adjustment device 210 a relatively long distance for coarse adjustment and threaded movement for fine adjustment.
  • the device 200 is applied by first removing the removable backing sheet or foil to expose the adhesive backing of the face member 208.
  • the device is placed against the face with the pressure application members 202 on opposite sides of the bridge of the nose near the corners of the eye.
  • the face member 208 does not yet touch the nose.
  • the pressure adjustment device 210 is then pushed (coarse adjustment) to apply the face member against the nose.
  • the pressure adjustment device 210 may then be turned (fine threaded movement) to finely adjust the pressure of the cushions against the face. Pressure should be comfortable and excessive pressure should be avoided.
  • Fig. 13 illustrates a pressure device 220, in accordance with an embodiment of the invention.
  • Pressure device 220 includes pressure application members (e.g., cushions) 222 mounted on arms 224 that extend from a pressure adjustment mechanism 226 mounted above the nose bridge on a head band 228.
  • pressure application members 222 are spaced from one another so that they are aligned with and arranged to apply pressure on or in the vicinity of medial palpebral ligaments (MPLs) of a particular user.
  • MPLs medial palpebral ligaments
  • Another adjustment element 227 may be provided that adjusts the device to the user head size and enables increasing pressure on the sides of the user's nose.
  • the pressure adjustment mechanism 226 may be a wheel threadingly linked to arms 224. By turning adjustment mechanism 226, the arms 224 are either brought tighter against the MPLs or less against them. The tightness of the head band 228 can be adjusted behind the head, such as by pulling the head band strap tighter or loosening it.
  • the pressure adjustment device 210 or 216 may be used with any of the other devices described herein.
  • Device 220 is affixed to the user by means of the head band 228 and does not require any adhesive for fixation to the user's nose or face (although adhesive may optionally be used as well, but not necessarily in the vicinity of the nose - the adhesive could be applied to other areas on the face or head).
  • device 220 may include ear plugs 230 that serve a dual purpose: improved fixation to the user's head and diminished noise, which diminishes disturbance to the user to help fall asleep.
  • Device 220 may additionally include one or more sensors 232, such as motion sensors (e.g., accelerometers), which can be used to monitor the user before or/and during sleeping.
  • the sensors may be located at different places on the device. For example, the sensors can be used to monitor how long it took the person to fall asleep, how long the person remained asleep, how many times the person woke up from sleep over a certain period of time, etc.
  • the monitor can be used in a feedback system, in which based on the monitored sleep data, the system provides feedback to the user regarding specific device user instructions. For example, the feedback may determine how much pressure a specific user requires to achieve the optimal sleep induction for sleep maintenance, including information about device release during the sleeping period.
  • the monitoring system provides user sleeping patterns and habits related to the patient's environment, such as heat, cold, humidity, dryness, noise or air pollution effects on sleep.
  • the feedback can be sent to the person's smartphone, for example, such as to an app described below.
  • the feedback can be done in real time; for example, if the person falls asleep faster with classical music in the background, the system may turn on such music from a bedside MP4 player upon detecting the person waking up.
  • the pressure applied by the device may be adjusted during the sleep period or other period of application.
  • the pressure is modified with a constant change, which may be accomplished by means of a spring or ratchet or any other adjustable mechanism which lessens the pressure (or increases the pressure) at a constant or non-constant rate.
  • the pressure is modified with a variable change, such as by manually adjusting the pressure by adjusting a screw that applies the pressure (such as a ratchet or screw used to adjust the device to the exact force the user needs, as in Fig. 12 or 13).
  • the pressure is modified by means of a controller that works in a feedback control cycle from data received from pressure sensors (piezoelectric sensors, strain gauges, etc.) or other biological sensors.
  • the device may be wearable (such as a band) and/or may be connected to any sensor outside the device (e.g., a smartphone sensor or electrosensory sensors, for example. Sensors in the device monitor and record data indicative of sleep quality (e.g., heartbeat sensors, pulse sensors, C0 2 sensors, skin temperature sensors, sweat sensors, etc.).
  • the device may send the data wirelessly or by any other means to a dedicated app to provide patient feedback and/or optimize treatment.
  • the app analyzes the pulse or sleep data and compares the data with stored values to determine if the sleep is clam or disturbed.
  • the device may use identification protocols to uniquely identify the user or to provide security that the personal data is kept private.
  • the monitoring system and app do not have to be only for individual patients but can be used as a community tool.
  • the sensor(s) can be placed in or on other places external to the user, such as but not limited to, a bed, clothing, different places in the room, etc.

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Abstract

A device includes pressure application members (12) extending from a bridge member (14). The bridge member is adapted and shaped for lying over a nose bridge of a user. The pressure application members are spaced from one another so that they are aligned with and arranged to apply pressure on an anatomical site of medial palpebral ligaments (MPLs) of a particular user. The bridge member is adjustable by head band or band connected to the ears with a biofeedback mechanism to optimize and treat a patient, such as for sleep induction, sleep maintenance, calming effect or ability to concentrate for sleep disorders, insomnia, ADD, depression, anxiety, increased high blood pressure or ADHD patients. The device may comprise an adhesive mounting member for bonding the device on a face of the user. The device may further comprise a vibration unit, a sonic transducer, a magnetic field transducer and/or a thermal element positioned in or at one or more of said MPL pressure application members (12).

Description

PRESSURE APPLICATION DEVICE
FIELD OF THE INVENTION
The present invention relates generally to apparatus and a method for treating various disorders, such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, by pressure application in the area of the eyes.
BACKGROUND OF THE INVENTION
Insomnia affects many people. Depending on the area, study, etc., between 10- 25% of the population are affected. Insomnia is twice as common in females. It increases with age; in the elderly population (aged 65 and older), insomnia symptoms were reported to be 33%-50%. In adolescents, insomnia incident is increasing recently, in the United States, 22.8 %, in Japan 25% and in China, 16.1%
SUMMARY OF THE INVENTION
The present invention seeks to provide apparatus for pressure application in the area of the eyes for treating various disorders, such as but not limited to, insomnia, and symptoms related to insomnia, ADHD, ADD, lowering blood pressure, calming anxiety, jet lag, sleep apnea and other sleep disorders, as well as helping patients with various neurological disorders or diseases, as described more in detail hereinbelow.
The invention may be applicable in treating other illnesses and disorders as a replacement or addition to vagus nerve stimulation, including but not limited to, Alzheimer's disease, migraines, fibromyalgia, obesity, tinnitus, alcohol addiction, atrial fibrillation, autism, bulimia nervosa, burn-induced organ dysfunction, chronic heart failure, chronic intractable hiccups, comorbid personality disorders, coronary artery disease, dravet syndrome, drop-attacks, heatstroke, intestinal epithelial barrier breakdown, Lennox- Gastaut syndrome, memory problems, mood disorders, myocarditis, multiple sclerosis, obsessive compulsive disorder, peripheral arterial occlusion disease, postoperative cognitive dysfunction, Rasmussen's encephalitis, mental diseases, and others.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
Fig. 1 is a simplified illustration of the medial palpebral ligament (MPL); Fig. 2 is a simplified illustration of a nerve pathway from the eye to the Gasserian ganglion and finally to the vagus nerve;
Figs. 3 and 4 are simplified illustrations of a pressure device, in accordance with an embodiment of the invention;
Fig. 5 is a simplified illustration of a pressure device that applies pressure on the MPL and the opening in the nostrils, in accordance with a non-limiting embodiment of the invention;
Fig. 6 is a simplified illustration of a holder which may be used for handling and applying the device;
Figs. 7-11 are simplified illustrations of pressure devices, in accordance with other embodiments of the invention;
Fig. 12 is a simplified illustration of a pressure device, in accordance with an embodiment of the invention;
Fig. 13 is a simplified illustration of a pressure device, in accordance with another embodiment of the invention; and
Fig. 14 is a simplified illustration of a pressure device with controller and feedback, possible for use with an app, in accordance with another embodiment of the invention.
DETAILED DESCRIPTION OF EMBODIMENTS
The present invention provides novel pressure application devices on or near the area of the medial palpebral ligament (MPL). It is believed that such pressure can relieve many disorders. Although the invention is not bounds by any particular theory, explanations are provided herein for better understanding of the subject.
Reference is now made to Fig. 1, which shows muscles of the face near the eye. Shown is the frontalis muscle, which is the major muscle of the forehead and is responsible for the expressions of the eyebrow. The frontalis sits on the frontal bone of the skull and its muscle fibers interweave with the muscles of the eye, the orbicularis occuli, and the procerus at the bridge of the nose. The orbicularis oculi is the muscle around the eye. It has two main parts: the orbital portion which is the larger, thicker, more outer part of the muscle that surrounds the eye socket, and the palpebral portion, better known as the eyelid; and the lacrimal portion.
The medial palpebral ligament MPL (also called tendo oculi), about 4 mm long and 2 mm wide, is attached to the frontal process of the maxilla in front of the lacrimal groove. The MPL divides into two parts, upper and lower, each of which is attached to the medial end of the corresponding tarsus, upper and lower, resepctively (connecting tissue in the upper and lower eyelids).
Applying constant light pressure on the medial palpebral ligament (MPL) triggers sleep induction, desire to close the eyes and relaxation. This may be due to the MPL being responsible for eyelids closure.
The involuntary eye closing activates processes related to sleep induction, sleepiness, relaxation and possibly stimulate the parasympathetic system. The device acts to enhance sleep induction, relaxation and improved sleep quality.
The device creates a low pressure load on the MPL area, a process which facilitates closing the eyelids due to the connection between the MPL muscles and the upper and lower eyelids.
The exact mechanism of action is not known at this stage. It is possible that device pressure on the MPL area activates different processes related to sleep induction and relaxation. One hypothesis is stimulation of the vagus nerve via minor trigeminal cardiac reflex). Vagus nerve stimulation may lead to the release of oxytocin. Secretion of the hormone oxytocin in the brain may result in increased sleepiness, increased sleep rapid eye movement (REM) and relaxation.
This invention is not bound by any theory, and the following is presented merely to help understand certain concepts.
Trigeminal Cardiac Reflex (TCR)
TCR is a clinical phenomenon consisting of sudden onset of acute change in 10- 20% in mean arterial blood pressure and decease in heart rate. Pressing MPL by the designed device might cause minimal magnitude of the TCR (probably not reaching the threshold of 10%). Contemporary research has revealed the possibility of several subtype of the TCR, activated via the Gasserian ganglion.
The pathway, as seen in Fig. 2, is from the eye via ciliary nerves to the Gasserian ganglion (GG), to the trigeminal nerve (TN), to the sensory nucleus (SN) of the trigeminal nerve, to the short internuncial fibers (SIF), to the motor nucleus (MN) of the vagus nerve and finally to the vagus nerve (VN).
Role of Oxytocin
Vagus stimulation may affect the neurohormone, oxytocin (OT) and increase its secretion in the brain. OT has been shown to have anxiolytic and sedating effects in animal models and has been shown to attenuate neuroendocrine, neuroimmune, and autonomic stress responses in both human and animal models. Reference is now made to Figs. 3 and 4, which illustrate a pressure device 10, in accordance with an embodiment of the invention. The device 10 includes MPL pressure members 12 connected by a bridge member 14. The pressure members 12 and the bridge member 14 may be made of a soft outer layer 16 with an inner stiffening member 18 (e.g., made of hard plastic). The stiffening layer may be a unitary piece that extends from the bridge member 14 outwards to the pressure members 12. The pressure members 12 may be cushions (e.g., an elastomer or resilient plastic) that apply a gently pressure to the MPL area; alternatively the pressure members 12 may by rigid, such as of a hard plastic. Possible materials for the pressure members 12 include, without limitation, metal, foam, rubber, and silicone, hydrogels, PolyHEMA, poly(ethylene glycol)/poly(L-lactic acid-co- glycolic acid) (PEG/PLGA), acrylics, polyurethane, nylon, stainless steel and various plastics,
Pressing on or near the MPL is referred to as pressing on an anatomical site of a medial palpebral ligament of the subject.
It is known that the body has internal circadian biological clocks that regulate the timing of periods of sleepiness and wakefulness throughout the day. The circadian rhythm dips and rises at different times of the day, wherein the drive to sleep is strongest at different times of the day and night.
Vibration may affect the circadian rhythm. In accordance with an embodiment of the invention, a vibration unit 20 (Fig. 4) may be positioned in or at pressure member(s) 12. The vibration unit 20 may be, without limitation, a miniature motor with an eccentric weight, which when rotated causes vibration. The vibration unit 20 may act softly but noticeably with or without non-audible indicators. The pressure members 12 thus apply a controlled amount of pressure point with vibration.
The vibration unit may have any operating range, such as but not limited to, 2- 3.6V. A small battery may be used as the power supply (other power sources are possible).
The pressure device of the invention may be useful in treating insomnia or symptoms related to insomnia. The pressure applied on or near the MPL may help induce drowsiness in the patient. The device may also additionally help treat sleep apnea, as is now described.
Reference is now made to Fig. 5, which illustrates a pressure device 100 that applies pressure on the MPL and the opening in the nostrils, in accordance with a non- limiting embodiment of the invention. Anchoring to the nostrils will be done to facilitate opening the nostrils to help cases of sleep apnea or difficult breathing during the nighttime in case of nasal congestion.
The device 100 includes a solid or elastic bridge type anchored to the face in three locations: MPL, nostrils and above the MPL (upper nose bridge/forehead). This anchoring could be done by any type of method including adhesive tape or belt around the head. For example, device 100 may include a nose bridge portion (bridge member) 102 and two MPL pressure members 104 (e.g., pads or cushions) that are mounted at opposite ends of nose bridge portion 102. Two nostril arms 106 extend downward from nose bridge portion 102 and terminate in nostril cushions 108. The nostril arms 106 are resilient and flexible and thus apply an outwards (lateral) force on the nostrils so as to increase the nostril openings. The nostril arms 106 may be made of a shape memory alloy or other springy material. In addition, an adjustment mechanism 110 may be provided for adjusting the outward expansion of nostril arms 106.
Accordingly, the nostrils' anchoring is accomplished by using a biasing device (nostril arms 106) connected to two MPL pressure members 104 (e.g., small soft cushions) which enter the nostrils. The biasing device (nostril arms 106) may be preloaded. After applying by the user, the biasing device (nostril arms 106) causes lateral opening of the nostrils. Additional vertical nostrils opening may be done by anchoring the device to the upper bridge nose/forehead.
The pressure device may also include sonic (sound) transducers to add to the pressure, as is now described. The added sound effects may be useful in some therapeutic applications,
For example, environmental factors, such as increase of noise, may cause sleep disturbance of patients. Adding music will mask the environmental noises and calm the user. The device may be combined with a sound unit (sonic transducer) 22 (Fig. 5), e.g., a miniature loudspeaker, to the cushion area of the pressure member(s) (12 or 104) or any other portion of the device. Sound is delivered to the bones as in headphones.
It is well known that music therapy has benefits in various health conditions. Combining music therapy with the device increases its effectiveness.
A 3D camera or face picture may be used to design the device specifically for each user. Based on the broad variety of anatomy in the eye corner, nose bridge in the MPL area, the device may also be designed based on 3D scan of the user.
As seen in Fig. 6, a holder 37 may be provided for holding device 10 (or any of the other pressure devices described herein). The holder 37 has outer grasping portions 39 for grasping by fingers of the user. The holder 37 has crevices 41 for receiving therein the pressure members 12 and has a protrusion 43 that protrudes towards (and may support) bridge member 14.
Reference is now made to Fig. 7, which illustrates a pressure device 50, in accordance with an embodiment of the invention. The device 50 includes MPL pressure members 52 connected by a bridge member 54. MPL pressure members 52 may be pillows or cushions, made of a soft material, such as cloth, foam, elastomer and the like. Bridge member 54 extends as a bow out to MPL pressure members 52. Extremities 56 of bridge member 54 serve as holders for MPL pressure members 52. The device 50 may include an adhesive mounting member 57 with an adhesive strip 58 for bonding the device on the face of the user. The adhesive is compatible with use on the skin and allows the device to be removed without harm to the patient.
Accordingly, the device placement is based on the human ability to place the fingers in the exact ligament location intuitively and in accurate position.
In order to facilitate the application process, the device is packaged in a way such that the device is grasped with three fingers: thumb, index finger and middle finger. In the second stage the user pulls the device from the pack. The device adheres to the three fingers by glue and thereafter the user brings the device to the desired location near the eye using the three fingers. Lastly, the user releases the sticker's release liner and the device adheres to the face.
Research conducted by Pelka et al (Impulse magnetic -field therapy for insomnia: a double-blind, placebo-controlled study. Adv Ther 2001;18: 174-80) showed that a continuous 5 μΤ, 4 Hz magnetic field had significant improvements in self -reported sleep outcomes compared with placebo in a clinical study setting. Accordingly, pressure device 50 (or any of the other pressure devices described herein) may include a magnetic field transducer 60 near the MPL pressure member(s) 52 to enhance the sleepiness effect. The magnetic parameters may be, without limitation, 1-20 μΤ, 1-500 Hz magnetic field (e.g., elliptical or circular field).
As seen in Fig. 5, the device may include a thermal element 62 in the MPL pressure member(s) to increase the potential effect on sleepiness. In one embodiment, thermal element 62 is an electric heater. For example, without limitation, a temperature- up timer circuit may be used to raise the temperature of the electric heater by an amount in the range of 1-15° C. The MPL pressure members combine a controlled amount of pressure with heat. The heater may be mounted on other parts of the pressure device. The heating effect may help due to the circadian rhythm of the body. Heat treatments that enhance the peripheral gradient for heat loss have the potential to facilitate sleep onset and quality. Heat makes muscles relax and therefore causes tiredness and sleepiness.
In another embodiment, thermal element 62 is a cooling element (for example, a thermoelectric element that can be used for heating or cooling). Cooling the MPL area may provide therapeutic benefits in some applications.
In accordance with non-limiting embodiments of the invention, the device may include a plastic flexible lever and elastic cushions. Both function as springs and compensate for different users' anatomy and skin movement in response to device administration. Examples are now described with reference to Figs. 8-11.
Fig. 8 is a modified version of the embodiment of Fig. 7, with like elements being designated by like reference numerals. In the embodiment of Fig. 8, instead of adhesive mounting, a pressure pad 64 is provided on bridge member 54 and tightened or loosened by an adjustment fastener 66 (e.g., threaded shaft with knob).
Reference is now made to Fig. 9, which illustrates a pressure device 70, in accordance with an embodiment of the invention. The device 70 includes MPL pressure members 72 connected by a bridge member 74. The bridge member 74 is a resilient member, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel. The springiness of bridge member 74 provides the pressure to MPL pressure members 72.
Reference is now made to Fig. 10, which illustrates a pressure device 80, in accordance with an embodiment of the invention. The device 80 includes MPL pressure members 82 connected by a bridge member 84. The bridge member 84 is a resilient and bendable member, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel. The flexibility and bending of bridge member 84 provides the pressure to MPL pressure members 82 and provides enhanced capability of adapting the device to any anatomy.
Reference is now made to Fig. 11, which illustrates a pressure device 90, in accordance with an embodiment of the invention. The device 90 includes MPL pressure members 92 connected by a bridge member 94. The bridge member 94 is made of resilient and bendable wires with a central hub 95, which may be made, without limitation, of plastic, nylon, nitinol or other shape memory alloy or spring steel. The flexibility and bending of bridge member 94 provides the pressure to MPL pressure members 92 and provides enhanced capability of adapting the device to any anatomy. In summary, the pressure device may be anchored to the subject's face by adhesive. Additionally or alternatively, a ratchet or screw or any other adjustable mechanism may be used to adjust the device to the exact force the user needs. The device may be applied using alternative anchoring methods, such as a belt around the head or ears instead of or in addition to adhesive.
The bridge member is adjustable in shape to permit adjusting a spatial relationship between the pressure application members.
In one non-limiting embodiment, the device may include a plastic or flexible aluminum (or other metal) body designed to facilitate the transition point for the desired maximum power threshold on the MPL. This device improves device adjustment to the needs of different users and allows tightening the device force after placing the device on the user.
The cushions may serve also as springs for better placement and pressure application, and do not irritate the user's face.
Reference is now made to Fig. 12, which illustrates a pressure device 200, in accordance with an embodiment of the invention.
Pressure device 200 includes pressure application members 202 (or pressure members, for short), such as cushions extending from a bridge portion 204. As in the other embodiments, bridge portion 204 is adapted and shaped for lying over a nose bridge of a user. Pressure application members 202 are spaced from one another so that they are aligned with and arranged to apply pressure on or in the vicinity of medial palpebral ligaments (MPLs) of a particular user. Bridge portion 204 has a central base member 206 from which extends a face member 208, such as an adhesive pad. When face member 208 is an adhesive pad, the pad may be provided with a removable backing sheet or foil to expose the adhesive backing for applying to the face. A pressure adjustment device 210, such as a thumbscrew, is mounted (such as through a threaded hole) in central base member 206 and is operative to move the face member 208 and the pressure application members 202 so as to apply the face member 208 to the nose and to adjust the pressure the pressure application members 202 apply to the patient. The pressure adjustment device 210 may have a shaft 212 which is threaded on a portion thereof, whereas another portion of the shaft 212 is not threaded. This allows moving the shaft 212 of the pressure adjustment device 210 a relatively long distance for coarse adjustment and threaded movement for fine adjustment. In a typical application, the device 200 is applied by first removing the removable backing sheet or foil to expose the adhesive backing of the face member 208. The device is placed against the face with the pressure application members 202 on opposite sides of the bridge of the nose near the corners of the eye. The face member 208 does not yet touch the nose. The pressure adjustment device 210 is then pushed (coarse adjustment) to apply the face member against the nose. The pressure adjustment device 210 may then be turned (fine threaded movement) to finely adjust the pressure of the cushions against the face. Pressure should be comfortable and excessive pressure should be avoided.
Reference is now made to Fig. 13, which illustrates a pressure device 220, in accordance with an embodiment of the invention.
Pressure device 220 includes pressure application members (e.g., cushions) 222 mounted on arms 224 that extend from a pressure adjustment mechanism 226 mounted above the nose bridge on a head band 228. As in the other embodiments, pressure application members 222 are spaced from one another so that they are aligned with and arranged to apply pressure on or in the vicinity of medial palpebral ligaments (MPLs) of a particular user. Another adjustment element 227 may be provided that adjusts the device to the user head size and enables increasing pressure on the sides of the user's nose.
The pressure adjustment mechanism 226 may be a wheel threadingly linked to arms 224. By turning adjustment mechanism 226, the arms 224 are either brought tighter against the MPLs or less against them. The tightness of the head band 228 can be adjusted behind the head, such as by pulling the head band strap tighter or loosening it.
The pressure adjustment device 210 or 216 may be used with any of the other devices described herein.
Device 220 is affixed to the user by means of the head band 228 and does not require any adhesive for fixation to the user's nose or face (although adhesive may optionally be used as well, but not necessarily in the vicinity of the nose - the adhesive could be applied to other areas on the face or head).
Alternatively or additionally, as shown in broken lines, device 220 may include ear plugs 230 that serve a dual purpose: improved fixation to the user's head and diminished noise, which diminishes disturbance to the user to help fall asleep.
Device 220 may additionally include one or more sensors 232, such as motion sensors (e.g., accelerometers), which can be used to monitor the user before or/and during sleeping. The sensors may be located at different places on the device. For example, the sensors can be used to monitor how long it took the person to fall asleep, how long the person remained asleep, how many times the person woke up from sleep over a certain period of time, etc. The monitor can be used in a feedback system, in which based on the monitored sleep data, the system provides feedback to the user regarding specific device user instructions. For example, the feedback may determine how much pressure a specific user requires to achieve the optimal sleep induction for sleep maintenance, including information about device release during the sleeping period. In addition, the monitoring system provides user sleeping patterns and habits related to the patient's environment, such as heat, cold, humidity, dryness, noise or air pollution effects on sleep. The feedback can be sent to the person's smartphone, for example, such as to an app described below. The feedback can be done in real time; for example, if the person falls asleep faster with classical music in the background, the system may turn on such music from a bedside MP4 player upon detecting the person waking up.
In accordance with an embodiment of the invention, the pressure applied by the device may be adjusted during the sleep period or other period of application. In one embodiment, the pressure is modified with a constant change, which may be accomplished by means of a spring or ratchet or any other adjustable mechanism which lessens the pressure (or increases the pressure) at a constant or non-constant rate. In another embodiment, the pressure is modified with a variable change, such as by manually adjusting the pressure by adjusting a screw that applies the pressure (such as a ratchet or screw used to adjust the device to the exact force the user needs, as in Fig. 12 or 13). In another embodiment, the pressure is modified by means of a controller that works in a feedback control cycle from data received from pressure sensors (piezoelectric sensors, strain gauges, etc.) or other biological sensors.
Reference is now made to Fig. 14. The device may be wearable (such as a band) and/or may be connected to any sensor outside the device (e.g., a smartphone sensor or electrosensory sensors, for example. Sensors in the device monitor and record data indicative of sleep quality (e.g., heartbeat sensors, pulse sensors, C02 sensors, skin temperature sensors, sweat sensors, etc.). The device may send the data wirelessly or by any other means to a dedicated app to provide patient feedback and/or optimize treatment. For example, the app analyzes the pulse or sleep data and compares the data with stored values to determine if the sleep is clam or disturbed. The device may use identification protocols to uniquely identify the user or to provide security that the personal data is kept private. Alternatively, the monitoring system and app do not have to be only for individual patients but can be used as a community tool. Additionally or alternatively, the sensor(s) can be placed in or on other places external to the user, such as but not limited to, a bed, clothing, different places in the room, etc.

Claims

CLAIMS What is claimed is:
1. A device comprising:
medial palpebral ligament (MPL) pressure application members (12) extending from a bridge member (14), said bridge member (14) being adapted and shaped for lying over a nose bridge of a user and said MPL pressure application members (12) being spaced from one another so that said MPL pressure application members (12) are aligned with and arranged to apply pressure on an anatomical site of a medial palpebral ligament of the user; and
a pressure adjustment device (210, 216) operative to adjust pressure of the pressure application members (12).
2. The device according to claim 1, wherein said bridge member (74, 84, 94) is adjustable in shape to permit adjusting a spatial relationship between said pressure application members.
3. The device according to claim 1, further comprising a vibration unit (20) positioned in or at one or more of said MPL pressure application members (12).
4. The device according to claim 1, further comprising a biasing device (106) that extends from said bridge member (102) and which terminates in nostril cushions (108).
5. The device according to claim 1, further comprising a sonic transducer (22) positioned in or at one or more of said MPL pressure application members (12).
6. The device according to claim 1, further comprising an adhesive mounting member (57) for bonding the device on a face of the user.
7. The device according to claim 1, further comprising a magnetic field transducer (60) positioned in or at one or more of said MPL pressure application members (12).
8. The device according to claim 1, further comprising a thermal element (62) positioned in or at one or more of said MPL pressure application members (12).
9. The device according to claim 1, wherein said pressure adjustment device comprises a pressure pad (64) which is tightened or loosened by an adjustment fastener (66).
10. The device according to claim 1, wherein said pressure adjustment device comprises a face member (208) and a thumbscrew operative to move the face member (208).
11. The device according to claim 1, further comprising a head band (228).
12. The device according to claim 1, further comprising ear plugs (230).
13. The device according to claim 1, further comprising one or more motion sensors (232) or sleep quality sensors.
14. The device according to claim 13, wherein the device is operative to sense data from the sensors to a dedicated app to provide patient feedback or optimize treatment.
15. A method comprising:
applying pressure on an anatomical site of a medial palpebral ligament of a user with medial palpebral ligament (MPL) pressure application members (12) extending from a bridge member (14), said bridge member (14) lying over a nose bridge of the user, wherein said MPL pressure application members (12) are spaced from one another so that said MPL pressure application members (12) are aligned with and arranged to apply pressure on said anatomical site.
PCT/IB2015/053532 2014-05-14 2015-05-13 Pressure application device WO2015173752A1 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201461992991P 2014-05-14 2014-05-14
US61/992,991 2014-05-14
US201462051984P 2014-09-18 2014-09-18
US62/051,984 2014-09-18
US201562113464P 2015-02-08 2015-02-08
US62/113,464 2015-02-08

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