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WO2022219591A2 - Dispositif d'administration d'aérosol intra-oral - Google Patents

Dispositif d'administration d'aérosol intra-oral Download PDF

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Publication number
WO2022219591A2
WO2022219591A2 PCT/IB2022/053547 IB2022053547W WO2022219591A2 WO 2022219591 A2 WO2022219591 A2 WO 2022219591A2 IB 2022053547 W IB2022053547 W IB 2022053547W WO 2022219591 A2 WO2022219591 A2 WO 2022219591A2
Authority
WO
WIPO (PCT)
Prior art keywords
liquid
inhalation
distal
previous
mesh membrane
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.)
Ceased
Application number
PCT/IB2022/053547
Other languages
English (en)
Other versions
WO2022219591A3 (fr
Inventor
Oron Zachar
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.)
Individual
Original Assignee
Individual
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
Priority claimed from PCT/IB2021/053088 external-priority patent/WO2021209928A1/fr
Priority claimed from PCT/IB2021/000724 external-priority patent/WO2023067365A1/fr
Application filed by Individual filed Critical Individual
Publication of WO2022219591A2 publication Critical patent/WO2022219591A2/fr
Publication of WO2022219591A3 publication Critical patent/WO2022219591A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • 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
    • A61M15/00—Inhalators
    • A61M15/0085—Inhalators using ultrasonics
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0015—Details of inhalators; Constructional features thereof with inhalation check valves located upstream of the dispenser, i.e. not traversed by the product
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0018—Details of inhalators; Constructional features thereof with exhalation check valves
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • 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
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
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    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
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    • A61M2202/00—Special media to be introduced, removed or treated
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
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    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/588—Means for facilitating use, e.g. by people with impaired vision by olfactory feedback, i.e. smell
    • 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
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7527—General characteristics of the apparatus with filters liquophilic, hydrophilic
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment
    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth
    • A61M2210/0637—Teeth
    • A—HUMAN NECESSITIES
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    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/437—Composition of exhalation the anaesthetic agent concentration

Definitions

  • the present application hereby includes by reference International Application No. PCT/IB2021/053088 also referred to as Publication Number WO/2021/209928 having International Filing Date 14- April-2021, the disclosure of which is incorporated herein by reference; and to International Application No. PCT/IB2021/000724, having International Filing Date 20-0ctober-2021, the disclosure of which is incorporated herein by reference; and US patent application 63159283 having a USA filing date of lO-March-2021, the disclosure of which is incorporated herein by reference; and International Application No.
  • PCT/IB2020/058342 also referred to as Publication Number WO/2021/044393 Publication Date 11 -March-2021, the disclosure of which is incorporated herein by reference, US provisional 63305009 filed on 2022-01-31, the disclosure of which is incorporated herein by reference, US provisional 63297818 filed on 2022-01-10, the disclosure of which is incorporated herein by reference.
  • the present invention relates to mist-delivery devices and refillable and/or replaceable containers for use therein, and to methods for using such devices.
  • the present invention relates to devices for intraoral use for delivering an aerosol to a user’s oropharynx.
  • the liquid-inlet can be configured to receive liquid from a container, the liquid-inlet and the container having respective mating arrangements for mating with each other.
  • the mating can be reversible.
  • the container can be detachably attachable to the proximal portion.
  • the inhalation device can additionally comprise the container.
  • the proximal portion can comprise a compartment for storing the liquid.
  • the inhalation device can additionally comprise a portable power source.
  • the inhalation device can additionally comprise an inhalation sensor for monitoring a flow in an inhalation flow-path.
  • the inhalation sensor can be effective to detect an air pressure in the inhalation-flow path.
  • the inhalation sensor can be effective to detect a difference between an air pressure in the inhalation flow-path and an ambient air pressure outside the inhalation device.
  • the inhalation device can comprise control circuitry configured to initiate and/or cease activation of the mesh membrane in response to a result of the monitoring of the flow in the inhalation-path.
  • the inhalation device can additionally comprise an exhalation sensor for monitoring a flow in an exhalation-flow path.
  • the exhalation sensor can be configured to detect a concentration of a chemical compound in the exhalation-flow path.
  • the chemical compound can be a component of the liquid.
  • the inhalation device can comprise control circuitry configured to cease or delay activation of the mesh membrane in response to a result of the monitoring of the flow in the exhalation flow path.
  • the mesh membrane can be effective to eject at least 5 times, or at least 10 times, or at least 20 times, or at least 50 times more liquid in the mist during user inhalation than during user exhalation.
  • the inhalation device can comprise an inhalation flow- path and an exhalation flow-path, each of the flow-paths including a respective one way fluid valve.
  • At least a portion of the distal portion can comprise a coating for generating a taste and/or odor sensation. In some embodiments, at least a portion of the intermediate portion can comprise a coating for generating a taste and/or odor sensation.
  • the inhalation device comprises control circuitry programable to cause the mesh membrane to eject, in the mist, a liquid quantity that is either predetermined or received in an input from a user.
  • at least a portion of the container can be above a plane longitudinally bisecting the intermediate portion when the device is rotated such that the plane is horizontal. In some embodiments, all of the container can be above a plane longitudinally bisecting the intermediate portion when the device is rotated such that the plane is horizontal.
  • the distal portion can comprise a liquid-retaining compartment in fluid communication with the liquid inlet via a conduit, and the liquid- retaining compartment can be shaped to receive a quantity of the liquid via the conduit by force of gravity when the inhalation device is in a first orientation, and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation.
  • the retaining can be by a wall of the liquid- retaining compartment, and wall can be effective to partially block an egress of the retained at least a part of the quantity.
  • the second orientation can be such that substantially all of the mesh membrane is in liquid communication with the retained at least a part of the quantity. In some embodiments, the second orientation can be such that a surface liquid level in the liquid-retaining compartment is higher than a surface liquid level in the container.
  • a maximum retainable fluid capacity of the liquid- retaining compartment is at least 0.5 cc and not more than 4 cc, or at least 1 cc and not more 3 cc, or at least 1.5 cc and not more 2.5 cc.
  • a ratio of (i) a combined fluid capacity of the container and the conduit to (ii) a maximum retainable fluid capacity of the liquid-retaining compartment can be at least 1 and not more than 4, or at least 1.5 and not more than 3, or at least 1.75 and not more than 2.5.
  • the inhalation device can additionally comprise a capillary pathway for conveying a portion of the liquid by capillary action from the liquid-inlet to the mesh membrane or to within 1 mm of the mesh membrane.
  • the mist-generating location can be at least 20% deep or at least 30% deep or at least 40% deep or at least 50% deep or at least 60% deep or at least 70% deep or at least 80% deep into an oral-cavity volume beneath the user’s hard palate.
  • the inhalation device can additionally comprise a display device configured to display information about at least one of: (i) a currently- remaining quantity of the liquid or of a component thereof, (ii) an already-misted quantity of the liquid or of a component thereof, and/or (iii) the identity of a component of the liquid.
  • the inhalation device can additionally comprising a display device configured to display information about at least one of: (i) a currently-remaining quantity of the liquid or of a component thereof, (ii) an already-misted quantity of the liquid or of a component thereof, (iii) the identity of a component of the liquid, and (iv) the detected concentration of the chemical compound in the exhalation-flow path.
  • the inhalation device can additionally comprise a portable power source. In some embodiments, the inhalation device can additionally comprise an inhalation sensor for monitoring a flow in an inhalation flow-path. In some embodiments, the inhalation sensor can be effective to detect an air pressure in the inhalation-flow path. In some embodiments, the inhalation sensor can be effective to detect a difference between an air pressure in the inhalation flow-path and an ambient air pressure outside the inhalation device. In some embodiments, the inhalation device can comprise control circuitry configured to initiate and/or cease activation of the mesh membrane in response to a result of the monitoring of the flow in the inhalation-path.
  • the inhalation device can additionally comprise an exhalation sensor for monitoring a flow in an exhalation-flow path.
  • the exhalation sensor can be configured to detect a concentration of a chemical compound in the exhalation-flow path.
  • the chemical compound can be a component of the liquid.
  • the inhalation device can comprise control circuitry configured to cease or delay activation of the mesh membrane in response to a result of the monitoring of the flow in the exhalation flow path.
  • the mesh membrane can be effective to eject at least 5 times, or at least 10 times, or at least 20 times, or at least 50 times more liquid in the mist during user inhalation than during user exhalation.
  • the inhalation device can comprise an inhalation flow-path and an exhalation flow-path, each of the flow-paths including a respective one-way fluid valve.
  • the distal portion can comprise a coating for generating a taste and/or odor sensation.
  • at least a portion of the intermediate portion can comprise a coating for generating a taste and/or odor sensation.
  • the inhalation device comprises control circuitry programable to cause the mesh membrane to eject, in the mist, a liquid quantity that is either predetermined or received in an input from a user.
  • a maximum retainable fluid capacity of the liquid- retaining compartment is at least 0.5 cc and not more than 4 cc, or at least 1 cc and not more 3 cc, or at least 1.5 cc and not more 2.5 cc.
  • a ratio of (i) a combined fluid capacity of the container and the conduit to (ii) a maximum retainable fluid capacity of the liquid-retaining compartment can be at least 1 and not more than 4, or at least 1.5 and not more than 3, or at least 1.75 and not more than 2.5.
  • the inhalation device can additionally comprise a capillary pathway for conveying a portion of the liquid by capillary action from the liquid-inlet to the mesh membrane or to within 1 mm of the mesh membrane.
  • the inhalation device can additionally comprise a capillary pathway for conveying a portion of the liquid by capillary action from within the liquid-storing volume to the mesh membrane
  • the mist-generating location can be at least 20% deep or at least 30% deep or at least 40% deep or at least 50% deep or at least 60% deep or at least 70% deep or at least 80% deep into an oral-cavity volume beneath the user’s hard palate.
  • the inhalation device can additionally comprise a display device configured to display information about at least one of: (i) a currently- remaining quantity of the liquid or of a component thereof, (ii) an already-misted quantity of the liquid or of a component thereof, and/or (iii) the identity of a component of the liquid.
  • the inhalation device can additionally comprise a display device configured to display information about at least one of: (i) a currently-remaining quantity of the liquid or of a component thereof, (ii) an already-misted quantity of the liquid or of a component thereof, (iii) the identity of a component of the liquid, and (iv) the detected concentration of the chemical compound in the exhalation-flow path.
  • the distal portion can comprise a distal casing encompassing the mesh membrane at least circumferentially.
  • the at least a part of the narrow section can be displaced proximally from the mesh membrane by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm.
  • the narrow section can be characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.
  • the minimum cross-sectional dimension of the narrow section and the minimum cross-sectional dimension of the distal portion can define vectors that are coplanar, or within ⁇ 15° of being coplanar, or within ⁇ 30° of being coplanar, or within ⁇ 45° of being coplanar.
  • the inhalation device of can comprise a proximal portion that includes a power source for powering the piezo assembly.
  • the inhalation device can comprise a proximal portion that includes a liquid inlet.
  • the inhalation device can comprise a first proximal portion that includes a liquid inlet and a second proximal portion that includes a power source for powering the piezo assembly.
  • an outlet of the proximal portion that includes a liquid inlet is detachably attachable to the neck portion such that an interior volume of the proximal portion that includes a liquid inlet is arranged to be in fluid communication with an interior volume of the neck portion when a pressure-activated one-way valve is activated by pressure from the proximal portion that includes a liquid inlet.
  • a center of gravity of the inhalation device can be is displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state.
  • the inhalation device of any preceding claim additionally comprising an inhalation sensor for monitoring a flow in an inhalation flow-path.
  • the inhalation sensor can be effective to detect an air pressure in the inhalation-flow path.
  • the inhalation sensor can be effective to detect a difference between an air pressure in the inhalation flow- path and an ambient air pressure outside the inhalation device.
  • the inhalation device can comprise control circuitry configured to initiate and/or cease activation of the mesh membrane in response to a result of the monitoring of the flow in the inhalation flow path.
  • the distal portion can comprise a liquid-retaining compartment in fluid communication with the neck portion, the liquid-retaining compartment being shaped to receive a quantity of the liquid from the neck portion by force of gravity when the inhalation device is in a first orientation, and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation.
  • the retaining can be by a wall of the liquid-retaining compartment, the wall being effective to partially block an egress of the retained at least a part of the quantity.
  • the second orientation can be such that substantially all of the mesh membrane is in liquid communication with the retained at least a part of the quantity.
  • the second orientation can be such that a surface liquid level in the liquid-retaining compartment is higher than a surface liquid level in the container.
  • the inhalation device can be shaped such that when the user’s lips and/or teeth are transversely engaged with the intermediate portion, the mist- generating location is at least 20% deep, or at least 30% deep, or at least 40% deep, or at least 50% deep, or at least 60% deep, or at least 70% deep, or at least 80% deep, into an oral-cavity volume beneath the user’s hard palate.
  • kits can comprise the inhalation device according to any of the embodiments disclosed hereinabove, packaged in a container such that the proximal portion that includes a liquid inlet is detached from the neck portion.
  • the narrow section can be characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.
  • the minimum cross-sectional dimension of the narrow section and the minimum cross-sectional dimension of the distal portion can define vectors that are coplanar, or within ⁇ 15° of being coplanar, or within ⁇ 30° of being coplanar, or within ⁇ 45° of being coplanar.
  • the inhalation device can comprise a proximal portion that includes a power source for powering the piezo assembly.
  • the inhalation device can comprise a proximal portion that includes a liquid inlet.
  • the inhalation device can comprise a first proximal portion that includes a liquid inlet and a second proximal portion that includes a power source for powering the piezo assembly.
  • an outlet of the proximal portion that includes a liquid inlet is detachably attachable to the neck portion such that an interior volume of the proximal portion that includes a liquid inlet is arranged to be in fluid communication with an interior volume of the neck portion when a pressure-activated one-way valve is activated by pressure from the proximal portion that includes a liquid inlet.
  • At least a part of the narrow section can be displaced proximally from the mesh membrane by at least 0.5 cm and not more than 6 cm, or by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm.
  • the inhalation device can additionally comprise an inhalation sensor for monitoring a flow in an inhalation flow-path.
  • the inhalation sensor can be effective to detect an air pressure in the inhalation-flow path.
  • the inhalation sensor can be effective to detect a difference between an air pressure in the inhalation flow-path and an ambient air pressure outside the inhalation device.
  • the inhalation device can comprise control circuitry configured to initiate and/or cease activation of the mesh membrane in response to a result of the monitoring of the flow in the inhalation flow path.
  • the distal portion can comprise a liquid-retaining compartment in fluid communication with the neck portion, the liquid-retaining compartment being shaped to receive a quantity of the liquid from the neck portion by force of gravity when the inhalation device is in a first orientation, and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation.
  • the retaining can be by a wall of the liquid-retaining compartment, the wall being effective to partially block an egress of the retained at least a part of the quantity.
  • the second orientation can be such that substantially all of the mesh membrane is in liquid communication with the retained at least a part of the quantity.
  • the second orientation can be such that a surface liquid level in the liquid-retaining compartment is higher than a surface liquid level in the container.
  • the inhalation device can be shaped such that when the user’s lips and/or teeth are transversely engaged with the intermediate portion, the mist- generating location is at least 20% deep or at least 30% deep or at least 40% deep or at least 50% deep or at least 60% deep or at least 70% deep or at least 80% deep into an oral-cavity volume beneath the user’s hard palate.
  • a kit can comprise the inhalation device according to any of the embodiments disclosed hereinabove, packaged in a container such that the proximal portion that includes a liquid inlet is detached from the neck portion.
  • Fig. 1A is a schematic elevation drawing of an inhalation device, according to embodiments of the present invention.
  • Fig. IB shows the inhalation device of Fig. 1A together with optional wick and removable liquid container, according to embodiments of the present invention.
  • Fig. 1C shows the inhalation device of Fig. IB, with optional removal liquid container mated thereto, according to embodiments of the present invention.
  • Fig. 2A shows the inhalation device of Fig. 1C, in situ, in an activated state producing a mist in a user’s oral cavity, according to embodiments of the present invention.
  • Fig. 2B schematically illustrates percentages of deepness into the volume beneath the hard palate.
  • Fig. 3 is a schematic elevation drawing of an inhalation device having a compact design, according to embodiments of the present invention.
  • Fig. 4 shows the inhalation device of Fig. 3, in situ, in an activated state producing a mist in a user’s oral cavity, according to embodiments of the present invention.
  • Fig. 5 shows an inhalation device having inhalation and exhalation conveyances, in situ, in an activated state producing a mist in a user’s oral cavity, according to embodiments of the present invention.
  • Figs. 6A-6C show schematic views of an inhalation device according to embodiments of the present invention.
  • Figs. 7A-7B show schematic views of an inhalation device according to embodiments of the present invention.
  • Fig. 8 shows an inhalation device according to embodiments of the present invention.
  • Figs. 9A-D are schematic cross-sectional illustrations of the inhalation device of Fig. 8 and a liquid, according to embodiments of the present invention.
  • Figs. 10A and 10B are cross-sectional views of inhalation devices according to embodiments of the present invention, showing liquid conduits having, respectively, circular and oval cross-sections.
  • Fig. IOC is a partial cutaway view of the proximal end of an inhalation device according to embodiments of the present invention, showing inhalation and exhalation sensors.
  • Figs 11A and 11B are schematic cross-sectional illustrations of an inhalation device having a distal liquid-storage volume, according to embodiments of the present invention, at two respective orientations.
  • Figs 12A and 12B are, respectively, schematic top- and side-view illustrations of an inhalation device having a display screen affixed to an intermediate portion of the inhalation device, according to embodiments of the present invention.
  • Figs 13A and 13B are, respectively, schematic top- and side-view illustrations of an inhalation device having a display screen affixed to a proximal portion of the inhalation device, according to embodiments of the present invention.
  • Fig. 14 is an annotated schematic cross-sectional illustration of the inhalation device of Figs. 9A-D.
  • Figs. 15A and 15B show schematic views of an inhalation device according to embodiments of the present invention, respectively assembled and unassembled, according to embodiments of the present invention.
  • Fig. 16 is an annotated schematic cross-sectional illustration of the inhalation device of Figs. 15A-15B.
  • Figs. 17A and 17B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention.
  • Figs. 18A and 18B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention.
  • Figs. 19 illustrates a placement of the device in use by a human user, according to embodiments of the invention.
  • Figs. 20A and 20B are schematic illustrations of section cuts through the device to show some of the inside components and build elements.
  • Figs. 21A and 21B are schematic cross-sectional illustrations of an inhalation device having a distal liquid-storage volume, according to embodiments of the present invention, at two respective orientations.
  • Figs. 22A and 22B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention, including an assembly of a fluids compartment.
  • kits including inhalation devices according to embodiments of the present invention, including an assembly of a fluids compartment.
  • kits including inhalation devices according to embodiments of the present invention, including a safety element.
  • kits including inhalation devices according to embodiments of the present invention, including an assembly with a soft vial or ampule insert, according to embodiments of the invention.
  • Figs 26A and 26B illustrate an embodiment of the system with a prefilled liquid, according to embodiments of the invention.
  • Figs 27A and 27B illustrate an embodiment of the system with a distal protection cover, according to embodiments of the invention.
  • Figs. 28A and 28B are schematic illustrations of an inhalation system, respectively in unassembled and assembles states, according to embodiments of the invention.
  • Figs. 29A and 29B are schematic illustrations of an inhalation system comprising a distal cap cover according to embodiments of the invention.
  • Fig. 30 is schematic illustrations of an inhalation system comprising a distal elastic band wrapping around a section of the delivery module according to embodiments of the invention.
  • Fig. 31 is schematic illustrations of an inhalation system comprising a bubble deflection mechanism.
  • subscripted reference numbers may be used to designate multiple separate appearances of elements of a single species, whether in a drawing or not; for example: 10i is a single appearance (out of a plurality of appearances) of element 10.
  • 10i is a single appearance (out of a plurality of appearances) of element 10.
  • the same elements can alternatively be referred to without subscript (e.g., 10 and not lOi) when not referring to a specific one of the multiple separate appearances, i.e., to the species in general.
  • aerosol and ‘mist’ as used herein are synonymous and are used to describe a suspension of liquid droplets in air.
  • the terms ‘inhalation device’ and ‘inhaler’ as used herein are synonymous and are used to describe a device that delivers an aerosol to a user’s oral cavity.
  • colloquial expression “smaller than”, e.g., in the context of “10% smaller than,” “20% smaller than” should be understood “smaller than by 10%, ” smaller than by 20%, ” etc., meaning, respectively, “90% as large,” “80% as large,” etc. Similarly, “at least 20% smaller” means “no more than 80% as large”.
  • An inhalation device for delivering an aerosol of a liquid well inside the user’s oral cavity such that the device largely prevents the user’s tongue from interfering with the delivery of the aerosol to the user’s oropharynx.
  • the exemplary devices disclosed herein use a piezo assembly that includes an ultrasonically vibrable mesh membrane to generate the aerosol, and so the piezo assembly has an aerosol outlet that in intended use will release the aerosol where desired.
  • an inhalation device 100 according to embodiments is illustrated schematically.
  • an inhalation device 100 has a distal portion 175 which includes the distal end of the inhalation device 100.
  • the term ‘distal end’ is used herein to mean the end of the inhaler 100 at which an aerosol exits the inhaler 100. During normal intended use, the distal end is farthest from a user’s hand, and/or is the first part of the device that enters a user’s oral cavity.
  • the term ‘distal’ may also used herein to indicate a direction towards the distal end.
  • Proximal refers to the end or direction which is opposite to the distal end or direction.
  • the device 100 also includes a proximal portion 165. It should be noted that in some contexts the terms proximal portion and distal portion may be understood more broadly than the specific respective portions demarcated in Fig. 1A, and can refer to any portion that includes the respective end of the device.
  • Figs. 1A-C show side elevation views, such that according to embodiments, the ‘top’ of the device 100 in each of the figures is the intended ‘top’ of the device 100 in actual use.
  • an upper surface 178 of the distal portion 175 is intended to be ‘on top’ during use
  • the lower surface 176 is intended to be ‘on the bottom’ during use.
  • the inhalation device 100 is usable in other positions, e.g., with top and bottom reversed.
  • the shape of the device 100 throughout the figures is shown as asymmetrical, i.e., the top of the device has a different contour than the bottom of the device. This can be beneficial for conforming to a user’s oral cavity.
  • the shape is symmetrical and does not have different contours on the top and the bottom of the device 100.
  • the ‘thickness’ (dimension from top to bottom) of the distal portion 175 is shown as substantially thicker than the thickness of some of, most of, or all of the proximal portion 165.
  • the distal portion 175 can have a thickness (e.g., maximum thickness, minimum thickness or average thickness) at least 30% or at least 50% or at least 100% greater than a corresponding thickness (respectively, maximum thickness, minimum thickness or average thickness) of the proximal portion 165.
  • the relative thickness of the distal portion 175 can be useful in encouraging the user to place the distal portion 175 on top of the tongue so as to allow a mist generated by the device to directly reach the oropharynx.
  • the distal portion 175 includes a piezo assembly 180 that includes an ultrasonically vibrable mesh membrane 185.
  • the mesh membrane 185 is the location at which an aerosol is generated/produced.
  • the distal portion can include an aerosol outlet displaced distally from the mesh membrane 185, where the the aerosol exits the device 100 via such an aerosol outlet. This can be useful, for example for bringing the aerosol closer to the user’s oropharynx or for directing the generated mist in a specific direction.
  • the ‘mist-generating’ location and the ‘mist-exiting’ location are the same location (for example, in Figs. 1 A- 1C) and in some embodiments these two locations are displaced from each other.
  • the proximal portion 165 can include a liquid inlet 160, through which a liquid 120 can be introduced into the device 100 for producing the mist.
  • the liquid inlet is preferably mateable with a source of the liquid 120.
  • the source of liquid is a replaceable/removable (i.e., attachable/detachable) container 110.
  • the term ‘mateable’ is used herein to indicate that a mating arrangement exists, e.g., corresponding threading, snap-closures or appropriately sized inlet-outlet diameters.
  • the container 110 has a liquid storage volume 115 and an outlet 117. The outlet 117 is mateable with the liquid-inlet 160 of the device 100.
  • Figure IB also shows a capillary pathway 140 for distally transporting liquid 120 in the direction of the mesh membrane 185.
  • the capillary pathway 140 is typically disposed, and optionally held, so that a distal portion thereof is in contact with the mesh membrane 185, or displaced no more than 2 mm or no more than 1 mm from the mesh membrane 185.
  • a proximal portion of the capillary pathway 140 is generally disposed within the liquid-storage volume 115 of the container 110 so as to establish a pathway for water transport from the liquid-storage volume 115 to the mesh membrane 85.
  • the container 110 is formed and/or provided as a component of the inhalation device 100.
  • a ‘capillary pathway’ 140 as the term is used herein is a material suitable for transport of a liquid) along a pathway by capillary action.
  • a material often includes fibers, such as plant-based fibers e.g., cellulose, polymer-based fibers e.g., polyester, glass fibers e.g., in a woven fabric or bundled or unbundled glass fibers, or carbon fibers.
  • the fibers can be very small, i.e., having diameters in the range of several or tens of microns. In other examples, the fibers can be larger.
  • the term “pathway” may appear to imply that a pathway for liquid transport to a mesh membrane may be a direct path, that is not necessarily the case.
  • the transport of a liquid through the capillary pathway may include progression in random directions or omnidirectional progression.
  • the capillary pathway 140 can include fibers arranged so as to form direct pathways from various parts of the liquid-storage volume 115 but this is not necessary for the capillary transport to be effective.
  • the capillary pathway can comprise a hydrophilic material that is effective to facilitate transport of an aqueous liquid.
  • an inhalation device 100 can include comfort element(s) 123 for ease of placement of teeth and/or lips. Whenever ‘teeth’ are referred to herein in the context of placement of distance therefrom, then ‘teeth’ can be understood as ‘front teeth’.
  • the two bumps shown in Fig. 1C are just one non-limiting example of such comfort elements; other non-limiting examples include depressions and single bumps. Such elements are not present in all designs within the scope of the present invention, but can be useful in some cases for optimal positioning of the device 100, and especially positioning of the distal portion 175, within the oral cavity. As shown in Fig. 1A.
  • an inhalation device 100 can include a power and electronics module 125, which can include, for example, a power source (e.g., a battery or connection for mains electricity), wireless communication arrangements, and/or control circuitry.
  • the control circuitry can include electronic hardware such as a printed circuit board, and firmware or software for operation of the device.
  • FIG. 2A the in-situ placement of an inhalation device 100 according to embodiments (and according to the example of Figs. 1A-C) is shown with respect to a user’s oral cavity 10 and mouth parts such as upper and lower teeth 20u, 20L, upper and lower lips 15u, 15L, tongue 25 and hard palate 30.
  • the inhalation device 150 is preferably dimensioned such that the distal portion 175 spans the oral cavity 10 from the tongue 25 to the hard palate 30.
  • Teeth 20 and/or lips 15 can close on the device 100 at teeth-engaging portions or lip-engaging portions that are distally displaced from the proximal portion 165, and thus help to maintain the position of the device 100 as illustrated.
  • Mist 141 is produced at the mesh membrane 185.
  • the terms ‘mist’ and ‘aerosol’ are used and understood interchangeably.
  • the generated aerosol is mixed into the inhaled air by the human user and carried into the bronchial tree and the lungs; as mentioned hereinabove, the mist- generating location and mist-exiting location (i.e., the aerosol exit from inhaler 100) are the same location in this exemplary design and are generally to be understood as one and the same as the aerosol generating location.
  • the mesh membrane 185 is also located in the distal portion 175.
  • both the mesh membrane and the aerosol exit are placed in fluid communication with the user’s oropharynx 50.
  • a proximal air inlet (not shown in Fig. 2A) can be added for ensuring that proper inhalation can still occur when lips 15 are closed around the device 100.
  • the distal portion 175 of the inhalation device 150 can comprise a coating for generating a taste and/or odor sensation for the user.
  • the coating can be applied, for example, on the tongue-contacting portion of the distal portion.
  • the inhaler 100 of Figs. 1-2 can be formed to be shorter, so that the container 110 is part of the proximal portion and the teeth-engaging and/or lip-engaging location is on a surface of the container 110.
  • the distal portion 175 of the inhalation device 150 includes the mist-generating location, i.e., the mesh membrane 185, and the device 150 is formed so that the mist-generating location is beneath the hard palate 30.
  • the volume of the oral cavity beneath the hard palate can be demarcated according to ‘hard-palate-deepness’ as illustrated schematically in Fig. 2B.
  • the mist- generating location can be in the deeper half of the volume beneath the hard palate 30 - or in the deepest 40% in the example of Fig. 2B, or in the deepest 20% (not shown).
  • the mist-generating location (and the mist-exiting location) can be at least 50% deep into the volume beneath the hard palate 30 or at least 60% deep or at least 70% deep or at least 80% deep.
  • the mist-generating location might not be quite as deep - for example, the mist-generating location can be at least 20% deep or at least 30% deep or at least 40% deep into the volume beneath the hard palate. Greater ‘deepness’ can be advantageous so as to shorten the path of fluid communication between the mist-exiting location and the oropharynx.
  • Fig. 3 illustrates a more compact design for an inhalation device 100 according to embodiments of the present invention
  • Fig. 4 shows the in-situ placement of the device 100.
  • the inhaler 100 of Figs. 3 and 4 has a distal portion 175 (comprising the piezo assembly 180 and the aerosol outlet which happens to be co-located with mesh membrane 185) and a proximal portion 165, power and electronics module 125, and optional comfort elements 123.
  • Liquid 120 for producing therefrom a mist is stored in compartment 131 (which is optionally detachable/attachable).
  • Compartment 131 has a opening for filling and refilling; the compartment 131 has an openable closing element 132.
  • the inhalation device 100 of Fig. 3 includes an airflow channel 121 having a proximal air inlet 122 for ensuring that proper inhalation can still occur when lips 15 are closed around the device 100.
  • the air inlet 122 is positioned so as to remain outside the lips 15 when the device 100 is positioned for operation in situ.
  • an ‘inhalation sensor’ i.e., flowmeter or airflow sensor 126IN is provided for activating the piezo assembly 180 upon detection of inhalation.
  • a piezo assembly 180 can be activated to produce a mist (in the presence of liquid) manually, e.g., by control circuitry in response to a user pressing a button or moving a switch, and/or automatically by control circuitry (e.g., in power and electronics module 125) monitoring the inhalation sensor 126IN for indication of an inhalation airflow.
  • control circuitry e.g., in power and electronics module 125
  • monitoring the inhalation sensor 126IN for indication of an inhalation airflow.
  • the inhalation sensor 126IN is configured to detect an air pressure.
  • the inhalation sensor 126IN is configured to detect a difference between an air pressure in the inhalation flow-path and an ambient air pressure outside the inhalation device
  • an inhalation device 100 is shown in-situ from a different angle than that of Figs. 2A-B and 4.
  • Two airflow channels 121, 129 are provided for conveyance of an inhalation airflow (indicated by arrow 150IN) and an exhalation airflow (indicated by arrow 150EX), respectively.
  • the inhalation airflow-channel 121 of Fig. 5 includes an air-inlet 122 positioned beyond user’s lips 15 outside of a potentially closed mouth.
  • the exhalation airflow- channel 129 includes an exhaust outlet 127 positioned beyond the user’s lips 15.
  • each of the airflow channels 121IN, 121EX can be equipped with respective one-way fluid valves 128IN, 128EX which by their presence define the directionality of airflow within each respective airflow-channel.
  • An inhalation sensor 126IN e.g., a flowmeter or air-pressure sensor, can be provided for monitoring and detecting the presence of an inhalation breath, so that control circuitry can activate or deactivate or otherwise modify the mist-generation of the mesh membrane 180.
  • the mesh membrane can be effective to eject at least 5 times, or at least 10 times, or at least 20 times, or at least 50 times more liquid 120 in the mist 141 during user inhalation than during user exhalation. It will be apparent to those skilled in the art that it does not matter which of the airflow channels 121 is used for inhalation and which is used for exhalation, and the labeling in the figures is merely for convenience.
  • FIGs. 6A to 6C show various schematic views of an inhalation device 100 according to embodiments, including embodiments already described hereinabove. Respective distal and proximal directions are illustrated throughout by arrows 1200 or 1201, depending on direction - arrow 1200 is shown when distal is to the left, and arrow 1201 is shown when distal is to the right.
  • the inhalation device 100 includes a distal portion 230, a proximal portion 210 and an intermediate portion 220 that is displaced proximally from the distal portion 230 and distally from proximal portion 210.
  • the proportions of the respective portions 210, 220, 230 are entirely for illustration purposes only, and any of the respective portions 210, 220, 230 can be larger or smaller. In some examples, they can also be contiguous, i.e., without gaps between the various portions.
  • the intermediate portion 220 is contacted, i.e., transversely engaged, by a user’s lips 15 and or teeth 20, and the distal portion 230, which includes the mist-generating mesh 185, is disposed within the user’s oral cavity 10.
  • Fig. 6B where the outer envelope of the inhalation device 100 is made ‘transparent’, schematically illustrates typical internal components of the inhalation device of Fig. 6A: capillary pathway 140 leading from liquid inlet 160 (where a container or compartment, not shown, would hold a quantity of a liquid) to the mesh 185, and electrical wire(s) 146 leading from control circuitry and power supply 125 to the mesh 185.
  • the inhalation device 100 can include air-inlet holes 122 which are proximal of the intermediate portion 220 such that the air-inlet holes 122 are outside the mouth.
  • a taste-producing surface section 224 can be provided in the distal portion 230 and/or the intermediate portion 220.
  • the taste-producing surface section 224 is preferably on the ‘bottom’ of the inhalation device 100 during use so as to bring the taste-producing surface section 224 into contact with the user’s tongue 25.
  • Figs. 7A and 7B another inhalation device 100 according to embodiments is illustrated.
  • a plane 1150 is shown longitudinally bisecting the intermediate portion 220 (and/or the distal portion 230).
  • the horizontally- bisecting plane 1150 is held horizontal, e.g., parallel to a floor (not shown)
  • the container 110 is held higher than the plane 1150 and therefore higher than the mesh 185, so that liquid can be made by gravity to flow to the mesh 185.
  • Fig. 7B shows the entire container 110 as being higher than the plane, in some designs it can be that a portion of the container higher than the plane.
  • Fig. 8 illustrates another inhalation device 100 according to embodiments, wherein the container 110 does not extend across the entire proximal portion 210 of the inhalation device 100.
  • FIG. 9 A a quantity of liquid 120 is disposed in a container 110 which is engaged with liquid-inlet 160.
  • the distal portion 230 includes a distal liquid-retaining fluids compartment 105 in fluid communication with the ultrasonic membrane 185.
  • the liquid-retaining compartment 105 in fluid communication is with the proximal liquid inlet 160 vis a liquid conduit 108, illustrated in Figs 9A-D as a connecting tube or pipe.
  • the liquid- retaining compartment 105 is partially bounded on one side by a liquid-retaining wall 104.
  • the inhalation device 100 is turned upside-down as shown in Fig. 9B, the liquid 120 flows down with gravity (indicated by arrow 1300) to fill the liquid-retaining compartment 105, as well as at least a portion of the liquid conduit 108. While Fig.
  • FIG. 9B shows the entire liquid conduit 108 full of liquid, and a portion of the liquid remaining in the container 110, in other examples there can be more or less liquid 120 provided, and/or the relative capacities of the retaining compartment 105, the liquid conduit 108 and/or the container 110 can be larger or smaller than illustrated in Fig. 9B such that the liquid 120 fills the liquid-retaining compartment 105 but only some or none of the liquid conduit 108, such that the container 110 is emptied in such examples.
  • Fig. 9C illustrates the function of the liquid-retaining wall 104 that partially bounds the liquid-retaining compartment fluids 105.
  • the inhalation can be brought to a horizontal position for use as shown in Fig. 9C, which causes the liquid in the connected reservoirs of the liquid-retaining compartment 105 and the container 110 to tend to ‘seek its own level’.
  • the liquid-retaining wall 104 prevents a portion of the liquid 120 delivered to the liquid-retaining compartment 105 (during the reversing of the inhalation device 100) from leaving the liquid-retaining compartment 105 after the inhalation device 100 is turned horizontal, or, as illustrated in Fig. 9D, ‘below horizontal’.
  • the liquid 120 in the liquid-retaining fluids compartment 105 can thus be ‘cut off’ from the remainder of the liquid in the container 110 and conduit 108.
  • the height of the liquid-retaining wall 104 is preferably sufficient to ensure that for a range of angles 0 (horizontal, e.g., as in Fig. 9C) to Q (e.g., as in Fig. 9D), the mesh 185 is kept in contact with liquid 120 retained in the liquid-retaining compartment 105. Setting the value of Q is a design choice which reflects a desired range of angles at which the inhalation device 100 can work effectively.
  • the height of the liquid-retaining wall 104 should be sufficient to retain liquid 120 in the compartment 105 through the range of angles 0 to Q even though the surface level of the liquid 120 in the compartment 105 is higher than in the container 110, as illustrated in the example of Fig. 9D.
  • the user can simply upend the inhalation device (as in Fig. 9B) to ‘refill’ the liquid-retaining compartment 105 from the remaining liquid 120 in the container 110 and conduit 108. and then restore the comfortable use position of Fig. 9C or Fig. 9D.
  • a maximum retainable fluid capacity of the liquid-retaining compartment fluids 105 (i.e., the quantity of the liquid 120 retained by the liquid- retaining wall 104) is at least 0.2 cc and not more than 4 cc. In some embodiments, the maximum retainable fluid capacity of the liquid-retaining compartment 105 is at least 0.5 cc and not more 3 cc. In some embodiments, the maximum retainable fluid capacity of the liquid-retaining compartment 105 is at least 0.5 cc and not more 2.0 cc. A ratio of (i) a combined fluid capacity of the container 110 and the conduit 108 to (ii) the maximum retainable fluid capacity of the liquid-retaining compartment 105, is at least 1 and not more than 4.
  • this ratio is at least 1.5 and not more than 3. In some embodiments, this ratio is at least 1.75 and not more than 2.5.
  • Figs. 10A, 10B and IOC both of which show cross- sectional views corresponding to section A-A in Fig. 8 such that the liquid conduit 108 and respective airflow channels 121IN, 121EX can be seen.
  • the liquid conduit 108 of Fig. 10A has a circular cross-section.
  • the liquid conduit 108 of Fig. 10B has an oval cross-section, which, inter alia, can be effective to reduce turbulent flow within the liquid conduit 108.
  • Fig. IOC shows respective inhalation and exhalations sensors 126IN, 126EX.
  • each of the sensors 126 is in communication with a respective flow path 121. In some embodiments, only one of the sensors 126 is present.
  • the inhalation sensor 126IN is provided for monitoring a flow in an inhalation flow-path, e.g., inhalation flow path 121IN.
  • the inhalation sensor 126IN can be effective to detect an air pressure in the inhalation-flow path 121IN.
  • the inhalation sensor can be effective to detect a difference between an air pressure in the inhalation flow-path 121IN and an ambient air pressure outside the inhalation device 100.
  • the control circuitry 135 is configured to initiate and/or cease activation of the mesh membrane 185 in response to a result of the monitoring of the flow in the inhalation-path 121IN.
  • the exhalation sensor 126EX is for monitoring a flow in an exhalation-flow path, e.g., exhalation flow path 121EX.
  • the exhalation sensor 126EX is configured to detect a concentration of a chemical compound in the exhalation-flow path 121EX.
  • the chemical compound is a component of the liquid 120 which is misted by the inhalation device.
  • the chemical compound is a chemical compound of interest to a user. For example, a user may wish to know the concentration of an intoxicating chemical compound in an exhalation, such as, for example, and not exhaustively, alcohol or tetrahydrocannabinol.
  • the chemical compound can be an indicator of a disease or of a current health condition of the user.
  • the control circuitry 135 is configured to cease or delay activation of the mesh membrane 185 in response to a result of the monitoring of the flow in the exhalation flow path 121EX.
  • an inhalation device 100 comprises a distal fluids compartment 105 is in fluid communication with the ultrasonic membrane 185.
  • the fluids compartment 105 is fillable through filling port 103.
  • the inhalation device 100 does not include a proximal source of liquid 120, nor does it include a liquid conduit 108. Instead, the liquid in the distal fluids compartment 105 is in contact with the mesh membrane.
  • the distal fluids compartment 105 is designed such that for a range of angles 0 (horizontal, e.g., as in Fig.
  • the information to be communicated can include, for example, and not exhaustively: the quantity or percentage of liquid remaining; the quantity or percentage of a compound in the liquid that is remaining; the amount or percentage of liquid (or of the compound in the liquid) that has already been consumed by the delivery of the mist, with or without including prior any fills of the liquid; the identity of the compound; a power meter showing remaining battery life; a concentration of a compound detected in an exhalation airflow; whether a concentration of a substance in the exhalation airflow exceeds a preset limit for intoxication; and a health indicator such as the presence of a virus, bacteria, or any other health indicator that can be detected in an exhalation.
  • a display screen can be mounted to or installed on any convenient section of any of the inhalation devices 100 disclosed herein.
  • Figs. 12A and 12B top and ide views, respectively of an inhalation device 100 according to embodiments
  • Figs. 13A and 13B top and ide views, respectively of an inhalation device 100 according to embodiments
  • the liquid 120 can include a medicament.
  • the quantity of liquid 120 used to generate the mist 141 can be a based on a predetermined dosage. This can be accomplished by the control circuitry in accordance with previous programming or in response to a user input.
  • a capillary pathway 140 may be used to transport liquid to the mesh membrane.
  • the inhalation device 150 can be used ‘hands-free’, i.e., when the inhalation device 150 is disposed so that the user’s teeth are engaged with a front-teeth-engaging portion distally displaced from the proximal portion 165, and/or the user’s lips are engaged with a lip-engaging portion distally displaced from the proximal portion 165, the device 150 can be held in place by the user’s lips 15 and or teeth 20 during activation/operation and mist-generation without having to use a hand to keep it in place.
  • FIG. 14 An inhalation device 100, e.g., the inhalation device 100 of Figs. 9A-9D, is illustrated with annotations marking certain locations and dimensions according to embodiments.
  • a plane indicated by arrow 900 passes through the mesh membrane 185 and is parallel thereto.
  • a cross section of the distal portion 230 and through the mesh membrane 185 can be round, oval, or any other shape.
  • a minimum dimension of the cross-section, i.e., measured by an arc or line segment that passes through a center-point of the cross-section is a minimum cross-sectional dimension of the distal portion 230 passing through and parallel to the mesh membrane 185.
  • the mesh membrane in embodiments, is encompassed, at least circumferentially, by a distal casing 190.
  • a neck portion 220 of the inhalation device 100 analogous to the intermediate portion 220 shown, e.g., in Figs. 6A and 7A, is located proximal to the distal portion 230.
  • the neck portion 220 is contiguous with the distal portion 230 and in some designs there can be additional inhaler length in between that for purposes of this disclosure has the distinguishing features of neither the distal portion nor the neck portion, and can be arbitrarily assigned to either one.
  • the neck portion 220 includes at least one narrow section.
  • a narrow section can comprise a single point or a longer length of the neck portion 220.
  • a narrow section is characterized by having a cross-section with a minimum dimension that is smaller, by a given margin, than the minimum cross-sectional dimension of the distal portion 230 passing through and parallel to the mesh membrane 185.
  • All uses of the term ‘cross- sectional dimension’ herein refer to external cross-sectional dimensions unless explicitly stated otherwise.
  • a minimum cross-sectional dimension in a narrow section can be at least 10% smaller than the minimum cross-sectional dimension of the distal portion 230 passing through and parallel to the mesh membrane 185. Any given point in a narrow section need not be the narrowest point of the inhalation device/system.
  • the minimum cross-sectional dimension in a narrow section can be at least 20% smaller, or at least 30% smaller, or at least 40% smaller, or at least 50% smaller, or even smaller.
  • the minimum cross-sectional dimension of the narrow section and the minimum cross-sectional dimension of the distal portion 230 define vectors that are coplanar, or within ⁇ 15° of being coplanar, or within ⁇ 30° of being coplanar, or within ⁇ 45° of being coplanar.
  • the entire neck portion 220 can be considered as comprising one narrow section from one end of the neck portion 220 to the other, because in Fig. 14 the entire neck portion 220 clearly can be seen to be characterized by a minimum cross-sectional dimension that is at least 10% smaller than the minimum cross-sectional dimension at the plane 900 of the distal portion 230 passing through and parallel to the mesh membrane 185.
  • the first i.e., distal most point of the ‘narrow section’ meeting the 10%-smaller limitation can be is of interest, although in some embodiments all points of the narrow sections of the neck portion 220 can be of interest.
  • the first (distalmost) annotated point in the neck portion 220 is defined by a cross- section at plane 901.
  • the plane 901 is proximally displaced from the mesh membrane 185, i.e., from the plane 900 passing through and parallel to the mesh membrane 185, by a distance indicated by the arrow Di.
  • this distance Di is at least 0.5 cm and not more than 5.5 cm, or at least 0.5 cm and not more than 5 cm, or at least 0.5 cm and not more than 4.5 cm, or at least 0.5 cm and not more than 4 cm, or at least 1 cm and not more than 6 cm, or at least 1 cm and not more than 5.5 cm, or at least 1 cm and not more than 5 cm, or at least 1 cm and not more than 4.5 cm, or at least 1 cm and not more than 4 cm.
  • the corresponding distance from the mesh membrane 185 (and plane 900) D2 would be, in such a design, at least 0.5 cm and not more than 5.5 cm, or at least 0.5 cm and not more than 5 cm, or at least 0.5 cm and not more than 4.5 cm, or at least 0.5 cm and not more than 4 cm, or at least 1 cm and not more than 6 cm, or at least 1 cm and not more than 5.5 cm, or at least 1 cm and not more than 5 cm, or at least 1 cm and not more than 4.5 cm, or at least 1 cm and not more than 4 cm.
  • the corresponding distance from the mesh membrane 185 (and plane 900 ) D3 would be, in such a design, at least 0.5 cm and not more than 5.5 cm, or at least 0.5 cm and not more than 5 cm, or at least 0.5 cm and not more than 4.5 cm, or at least 0.5 cm and not more than 4 cm, or at least 1 cm and not more than 6 cm, or at least 1 cm and not more than 5.5 cm, or at least 1 cm and not more than 5 cm, or at least 1 cm and not more than 4.5 cm, or at least 1 cm and not more than 4 cm.
  • the first (distalmost) point in the narrow section i.e., the distal end of a narrow section, which meets the 10%- smaller limitation is at a distance from the mesh membrane 185 (and plane 900) that falls in one of the ranges above, i.e., at least 0.5 cm and not more than 5.5 cm, or at least 0.5 cm and not more than 5 cm, or at least 0.5 cm and not more than 4.5 cm, or at least 0.5 cm and not more than 4 cm, or at least 1 cm and not more than 6 cm, or at least 1 cm and not more than 5.5 cm, or at least 1 cm and not more than 5 cm, or at least 1 cm and not more than 4.5 cm, or at least 1 cm and not more than 4 cm.
  • the 10%-smaller limitation is used as a non-limiting example, and in some embodiments the minimum cross-sectional dimension in a narrow section can be at least 10% smaller than the minimum cross-sectional dimension of the distal portion 230 passing through and parallel to the mesh membrane 185.
  • the inhalation device 100 is designed so that a center of gravity of the inhalation device 100 is proximal to the first (distalmost) point in the narrow section i.e., the distal end of a narrow section, which meets the 10%-smaller limitation, when the inhalation device 100 contains no liquid.
  • FIGs. 15A and 15B an inhalation device according to embodiments is schematically illustrated, respectively assembled and unassembled.
  • this design can be supplied in a modular configuration, where two proximal modules 210A, 210B are detachably attachable to/from an inhalation-device section (shown in Fig. 17B as 450) comprising both the distal portion 230 of the inhalation device 100 and the neck portion 220 of the inhalation device 100.
  • a first proximal portion 210A includes an interior liquid-holding volume (not shown) and can be used as a replaceable container for the inhalation device 100.
  • the first proximal portion 210A includes, according to some embodiments at least one of a liquid inlet 170 and a pressurable surface 174, e.g., a flexible surface that can be manually depressed so as to cause a liquid to flow out of the first proximal portion 210A and into the neck portion 220 of the inhalation-device section 450.
  • the outlet 270 of the first proximal portion 210A includes a pressure-activated one-way valve such as, in a non-limiting example, a duckbill valve.
  • first proximal portion 210A is flexible and a separate pressurable surface 174 is unnecessary, and in some embodiments, the entire first proximal portion 210A is flexible and a separate pressurable surface 174 is unnecessary.
  • An electronic and/or electrical connection 146 inserts into a corresponding hole (not shown) in the second proximal module 210B for powering the piezo assembly 180 from a power source 125 located in the second proximal module 210B.
  • an inhalation sensor 126 for indication of an inhalation airflow is provided on the second proximal module 210B. In the assembled state, the inhalation sensor 126 is in fluid communication with the end 223 of an airflow channel 221 having a distal air inlet 222 located proximal to the distal portion 230.
  • an inhalation will draw air through the distal air inlet 222 and through the air channel 221, causing the inhalation sensor 126 to register a pressure drop and initialize the activation of the piezo assembly 180 and generate a mist.
  • the sensor 126 can register the cessation of an inhalation and cease the operation of the piezo assembly and the generation of the mist.
  • one or more stabilization attachments 260 may be provided for making and stabilizing the connection of the second proximal module 210B and the inhalation-device section 450.
  • the attachment is reversible, so as to enable a attachable/detachable link.
  • the stabilization attachments 260 may take the form of a mechanical pin (illustrated example) or a snap or a magnetic attachment as known in the art.
  • the one or more stabilization pins 260 are arranged for being inserted into corresponding hole(s) 265.
  • FIG. 16 shows a schematic cross-section of the inhalation device 100 of Figs. 15A-15B.
  • the inhalation device 100 of Figs. 15A-15B incorporates many of the features disclosed hereinabove for the various designs of inhalation devices 100, including, and not exhaustively: the liquid-retaining compartment 105 partially bounded on one side by a liquid-retaining wall 104; the definition of narrow sections as discussed with reference to Fig. 14; the distal casing 190 encompassing, at least circumferentially, the mesh membrane 185; and the internal power source 125 and electronic circuitry 135 connected by electric contact 146.
  • kits. 17A and 17B the modular components of the inhalation device 100 of Figs. 15 A, 15B and 16 can be provided in a kit, packaged in a container 500.
  • a first example of a kit is shown in Fig. 17A, comprising an inhalation-sensor section 460 that includes the distal portion 230, the neck portion 220, and the second proximal module 210B.
  • the kit also includes a first proximal portion 210A.
  • the kit of Fig. 17A can include, as shown, at least one additional first proximal portion 210A.
  • a second example of a kit is shown in Fig. 17B, comprising an inhalation- sensor section 450 that includes the distal portion 230 and the neck portion 220, and, unattached, the first and proximal modules 210A, 210B.
  • the system 100 comprises an aerosol delivery module 630 comprising a device distal portion 230 of the aerosol delivery module 630.
  • the distal portion 230 comprises (i) an aerosol outlet 186 defining a mist-exiting location and (ii) a piezo assembly 180 including an ultrasonically vibrable mesh membrane, which upon electrical activation produces a mist comprising droplets of the liquid, the mesh membrane 185 defining a mist- generating location.
  • the aerosol delivery module 630 further comprising a distal fluids compartment 105 in fluid communication with the mesh membrane 185; the compartment 105 comprising a compartment-proximal-wall 104, and a device mid section neck portion 220 including a narrow section, the narrow section being characterized by having a location of a narrow width cross-sectional dimension WN that is at least 10% smaller than a minimum width WD dimension of a more distal cross-section at a membrane plane 900 passing through the mesh membrane, the membrane plane 900 being perpendicular to the geometrical axis 910 perpendicular to and passing through the center of the mesh membrane 185.
  • the narrowness condition may be satisfied at more than one location along the aerosol delivery module 630. For example, as illustrated in Fig.
  • the thickness or width of the system 100 gets gradually narrower along the aerosol delivery module 630, as one progress through cross sections 901 to 902. It is already true that the width at cross section 901 is already less than 90% of the width WD dimension of a cross-section at a membrane plane 900 passing through the mesh membrane. But the width at the cross section 902 is even narrower by a significant amount, as much as 50% or more. There is user comfort and stability advantage to have a significantly narrow portion 220, since the system 100 is intended to be held in use with the distal section 230 being within the mouth and the narrow portion 220 may be engaged with the teeth and/or lips.
  • the narrow section is characterized by having a location of a narrow width cross-sectional dimension WN that is at least 20% smaller, or at least 30% smaller, or at least 50% smaller, or at least 70% smaller, than a minimum width WD dimension of a more distal cross-section at a plane 900 passing through and tangential to the center of the mesh membrane.
  • the narrow width cross-sectional dimension WN is of size between 8mm and 10mm, or between 6mm and 8mm, or between 4mm and 6mm, or less than 4mm.
  • the inhalation system 100 comprises a proximal device portion 210, which is proximal to the neck portion 220.
  • the neck portion 220 is within the aerosol delivery module 630.
  • the proximal device portion 210 is a part of a control module 210B which may also comprise narrow parts which may or may not be included in the neck portion 220.
  • Fig. 18A illustrates an embodiment wherein the fluids compartment 105 is in fluid communication with a filling port 103.
  • the filling port 103 comprises a check-valve, or any other type of one-way valve.
  • the fluids compartment may comprise an openable and re-closeable portion of its shell wall so as to enable insertion of liquids.
  • the openable portion of the shall-wall may be detachable.
  • the openable portion of the shall- wall may be connected to the fluids compartment, for example on a hinge or by a string or strap.
  • Fig 18B illustrates an embodiment wherein the inhalation system has a control module 210B which is attachable and detachable from the aerosol delivery module 630.
  • system 100 is an assembly combining two main parts, the aerosol delivery module 630 and the control module 210B.
  • the aerosol delivery module 630 comprises the device distal portion 230 of the system distal section which includes (i) an aerosol outlet 186 defining a mist-exiting location and (ii) a piezo assembly 180 including an ultrasonically vibrable mesh membrane.
  • the aerosol delivery module 630 also includes a distal fluids compartment 105 in fluid communication with the mesh membrane 185.
  • a proximal control module 210B includes a power source 125, the control module 210B further comprising (i) a pressure sensor 126, (ii) an attachment element 260, and (iii) proximal electrical contacts 148.
  • the cross section area of the filling port 103 is smaller than 1 cm 2 and bigger than 0.1 cm 2 , or smaller than 0.5 cm 2 .
  • the cross-section area of the secondary filling port 113 is smaller than 0.3 cm 2 and bigger than 0.001 cm 2 , or smaller than 0.1 cm 2 .
  • the aerosol delivery module 630 When in use, the aerosol delivery module 630 resides at least in part within the mouth of the user. In some embodiments, a narrow section at a proximal end of the aerosol delivery module 630 can be outside the mouth, or can include the location where the user’s lips and/or teeth can close upon the inhalation system 100. Moreover, the mesh membrane 185 and the fluids compartment 105 are in contact with the liquids which are used. In embodiments, the control module 210B remains outside the mouth and does not come in contact with the liquids put into the distal fluids compartment 105. Therefore, from a cleanliness and maintenance perspective, it may be desirable to replace the aerosol delivery module 630 more often than control module 210B.
  • control module 210B may comprise elements more costly than the aerosol delivery module 630 such that a disposable aerosol delivery module 630 can be replaced at a lower cost while maintaining the same control module 210B for multiple uses.
  • the attachment mechanism in embodiments may be by a proximal mechanical or magnetic attachment element 260 of the control module 210B that is linked to a distal mechanical or magnetic attachment element 265 of the aerosol delivery module 630.
  • distal electrical contacts 147 are electrically connected to the piezo assembly 180, and where proximal electrical contacts 148 are connected to the power source 125, and wherein in the assembled state of the system the proximal electrical contacts 148 are engaged with the distal electrical contacts 147, establishing an electrical communication between the piezo assembly 180 and the power source 125.
  • assembling the system 100 by the user comprises the steps of: connecting the control module 210B to the aerosol delivery module 630, such that in the assembled state
  • a proximal element 260 of the control module 210B is linked to a distal mechanical or magnetic attachment element 265 of the aerosol delivery module 630 by a mechanical or a magnetic attachment force;
  • the inhalation device/inhalation system can be provided in an assembled state, as illustrated, e.g., in Figs. 1A. 1C, 2A, 2B, 3-5, 6A-C, 7A-B, 8, 9A-D, 11A-B, 12A-B. 13A-B, 14, 15A, 16, 18A, 19, 20A-B,
  • any disclosed inhalation device/inhalation system can be provided in an unassembled state as separate parts or in a kit optionally including multiple components and/or modules, and optionally including one or more containers, as illustrated, e.g., in Figs. IB, 15B, 17A-B, 18B, 22B, 23A-D, 24B, 25B-C, and 28A.
  • a versatile kit is formed by having available more than one construction of the aerosol delivery module 630 which are connectable and operable with the same proximal device portion 210B that includes a power source 125.
  • dedicated aerosol delivery module 630 comprising a liquids compartment 105 of different size or structural form.
  • an air channel 229 facilitates the flow of ambient air in proximity of the port 222.
  • the air channel 229 along at least part of the side of the device mid-portion neck, creates an unblocked air fluid communication path for inhalation even when the mouth and lips is closed around the system device. This feature prevents the need for the human user to be conscious of actively letting air pass by the device sides when the lips are more naturally closed.
  • the system further comprises an electronic external indicator module 655 in electronic communication with the electronic control circuitry 135.
  • the indicator module 655 comprises an LED light.
  • the indicator module 655 comprises a display screen 155.
  • the indicator module 655 may serve to indicate various operational states of the system.
  • the indicator module is configured to indicated at least one or more of the states of (i) power on, (ii) Bluetooth connection to an external device, (iii) activation of the piezo assembly 180, (iv) battery charging level, (v) battery being charged on, or more.
  • the electronic control circuitry 135 is configured to change the indicator module 655 display state when the piezo assembly 180 is activated.
  • the compactness of the aerosol delivery module 630 is important.
  • the minimum width WD dimension of a more distal cross-section, at a membrane plane 900 passing through the mesh membrane is less than 20mm, or less than 15mm, or less than 12mm, or less than 10mm.
  • Fig. 18B also illustrates a preferred embodiment wherein in addition to the filling port 103 into the fluids chamber 105, also a secondary port 113 of smaller cross section than the filling port 103.
  • the port 113 is serving as an air outlet, for release of air from the fluids chamber, simultaneously with liquids filling via the filling port 103.
  • the cross section area of the filling port 103 is smaller than 1 cm 2 and bigger than 0.1 cm 2 , or smaller than 0.5 cm 2 .
  • the cross- section area of the secondary filling port 113 is smaller than 0.3 cm2 and bigger than 0.001 cm 2 , or smaller than 0.1 cm 2 .
  • the inhalation system 100 is shaped such that when the user’s lips and/or teeth are transversely engaged with the narrow section, the mist- generating location 185 resides within the user’s oral cavity and the mist-exiting location is in direct fluid communication with the user’s oropharynx.
  • the aerosol delivery module 630 is shaped such that when the user’s lips and/or teeth are transversely engaged with a a location of a narrow section, the depth DM of mist-generating location 185 beyond the teeth into the oral cavity is at least 1cm deep, or at least 2cm deep, or at least 3cm deep.
  • the location of the port 222 is preferably deeper into the oral cavity than the external edge 15L or 15U of the lips.
  • the port 222 is shown situated roughly between the teeth.
  • the inhalation system 100 has an elongated shape such the geometrical axis 910, perpendicular to and passing through the center of the mesh membrane 185, defines a longitudinal axis of the system in the sense that the dimensional extension of the system along the longitudinal axis 910 is larger than the dimensional extension of the system along any axis perpendicular to the axis 910.
  • the elongated shape is such that the geometrical axis 910, perpendicular to and passing through the center of the mesh membrane 185, defines a longitudinal axis of the system in the sense that the dimensional extension of the system along the longitudinal a longitudinal-axis oriented similar to the axis 910 is larger than the dimensional extension of the system along any axis perpendicular to the axis said longitudinal axis, wherein said longitudinal-axis is passing through the center of the mesh membrane 185 and is at an angle deviating less than 30 degrees from the axis 910.
  • a longitudinal axis 911 passes through the center of the mesh membrane 185 and is at an angle deviating less than 30 degrees from the axis 910.
  • Fig. 20A shows a schematic cross section of the system 100 in a vertical orientation, illustrating that it includes a power source 125 for electrically powering the piezo assembly 180, the proximal portion is proximal to the distal portion 230, such that more than 50% of the mass of the power source is proximal to the mesh membrane
  • the inhalation system 100 additionally comprises an inhalation sensor 126.
  • the inhalation sensor 126 is in fluid communication with a distal port 222.
  • the inhalation sensor 126 is effective to detect an air pressure difference between an air pressure at the distal port 222 and an ambient air pressure more proximal than the distal port 222.
  • the inhalation system 100 additionally comprises control circuitry 135.
  • the control circuitry 135 configured to initiate and/or cease activation of the piezo assembly 180 in response to detection of an air pressure difference greater than a threshold limit, and/or cease activation of the piezo assembly 180 in response to detection of an air pressure difference less than a pressure threshold limit.
  • the threshold limit is a pressure between 2 cm H20 and 20 cm H20. In other embodiments the threshold limit is a pressure between 2 cm H20 and 15 cm H20. In some other embodiments, the threshold limit is a pressure between 5 cm H20 and 15 cm H20.
  • the inhalation system comprises a distal fluids compartment 105 bounded by a compartment-proximal-wall 104 which is proximal to the mesh membrane 185, such that the compartment-proximal-wall 104 is extended above and below a height of the line 900 perpendicular to the middle of the of the mesh membrane 185.
  • the fluids compartment 105 has a volume of more than 0.1 ml and less than 5ml, or less than 4ml, or less than 3ml, or less than 2ml, or less than 1ml.
  • a center of gravity of the inhalation device is being displaced proximally more than 3 cm from a mesh membrane 185 when the inhalation device is in a liquid-empty state.
  • the distal port 222 is located distally from the inhalation sensor 126.
  • the inhalation sensor 126 is a pressure sensor.
  • the sensor 126 is located in the proximal section 210.
  • the present invention advantages comprise increased use versatility and better economic cost advantages by enabling different level of disposability of various parts.
  • further versability and disposability is implemented with respect to the fluids chamber 105 component of the system 100 in general and the aerosol delivery module 630 in particular.
  • Figs.21 A and 2 IB illustrate some aspects of embodiments with a liquid residing within the fluids compartment 105.
  • compartment 105 is filled with an amount of liquid 120 less than 0.5ml and the aerosol delivery module 630 is oriented horizontally, such that the axis 910 is perpendicular to the force of gravity, the average surface of the liquid 120 is at a level higher than the middle of the mesh 185.
  • compartment 105 when compartment 105 is filled with an amount of liquid 120 less than 0.2ml and the system 100 is oriented horizontally, such that the axis 910 is perpendicular to the force of gravity, the average surface of the liquid 120 is at a level higher than the middle of the mesh 185.
  • the system can be functional in a wide range of holding angles with respect to gravity.
  • the chamber 105 proximal wall 104 has sufficient extent such that in a second orientation, such that the axis 910 is more than 30 degrees below horizontal, the liquid 120 is in contact with the mesh membrane 185, and the average surface of the liquid 120 at a level higher than 2mm below the center of the mesh 185.
  • Figs 22A and 22B illustrate embodiments further comprising a secondary fluids compartment in fluid communication with the distal fluids compartment 105.
  • the secondary fluids compartment is an independent cartridge device 612 detachably attachable to the distal fluids compartment 105.
  • the cartridge 611 may be prefilled with a liquid 120. In embodiments, the volume of cartridge 611 is larger than the volume of the distal fluids compartment 105.
  • Fig. 22B illustrates an embodiment wherein the cartridge 611 comprises an outlet port 616, such that in the assembled state the interior of the cartridge 611 is in fluid communication with the distal fluids compartment 105 via outlet port 616.
  • the cartridge 611 comprises a hard shell, preferably fitting smoothly with the contours of the surface of the inserted location within the aerosol delivery module 630.
  • the aperture of outlet port 616 across the center of the aperture is preferably larger than 2 mm and less than 5mm.
  • the cartridge 611 is side-mounted in some embodiments of the assembly process into the aerosol delivery module 630, as illustrated for example in Fig. 22B.
  • Side-mounting is in the sense of inserting motion directed primarily in a direction perpendicular to the longitudinal axis 910.
  • Such side mounting embodiment is not meant to be limiting.
  • a parallel sliding mounting can also be realized in some other embodiments.
  • Fig 17B illustrates an embodiment of parallel axis mounting of a proximal module 210A.
  • a similar method of mounting can be realized also for the mounting of the cartridge 611 into the aerosol delivery module 630.
  • the secondary fluids compartment comprises a vial 855
  • the vial 855 is characterized by comprising a soft wall.
  • the vial 855 commonly comprises a narrow outlet port 616.
  • the vial 855 is prefilled with a liquid.
  • a prefilled vial comprises a detachable liquid tight seal 857 which seals the outlet port 616.
  • the prefilled vial 855 is commonly taken out in a sealed configuration state (as illustrated in Fig. 25B) out of a kit package comprising multiple vials.
  • the seal 857 is then removed (as illustrated in Fig. 25C).
  • the open vial 855 is then inserted into attachment with fluids chamber 105 of the main body of the aerosol delivery module 630.
  • a liquid tight connection is formed between the vial 855 outlet port 616 and an inlet orifice 858 of the fluids chamber 105, as illustrated for example in Fig. 25D.
  • a portion of the distal fluids compartment 105 comprises an independent fluids cartridge device 805 which is detachably attachable from the full aerosol delivery module 630 comprising the piezo assembly 180.
  • Fig 23B illustrates an embodiment wherein the fluids cartridge device 805 is prefilled with a liquid 120.
  • the fluids cartridge device 805 comprises an orifice 806 such that, when in the assembled state attached to the piezo assembly 180, the liquid 120 inside the cartridge device 805 is in fluid communication with the piezo assembly 180 via the orifice 806.
  • the fluids cartridge device 805 In the unassembled state the fluids cartridge device 805 comprises a removable liquid tight seal 807 on the orifice 806.
  • the fluids cartridge device 805 is commonly taken out in a sealed configuration state (as illustrated in Fig. 23C) out of a kit package comprising multiple cartridges.
  • the seal 807 is then removed (as illustrated in Fig. 23B).
  • the unsealed fluids cartridge device 805 is then inserted into the main body of the aerosol delivery module 630, thereby forming a complete attachment with fluids chamber 105 in fluid communication with the mesh membrane 185.
  • the cartridge device 805 comprise a compartment of volume greater than 0.1 ml and less than 4ml, or less than 3ml, or less than 2ml, or less than 1ml, or less than 0.5ml.
  • Figs. 24A and 24B illustrate an embodiment of the system of the present invention comprising a sliding safety feature, which is meant to prevent excessive distal sliding of the device into the oral cavity of the human user.
  • a safety feature comprises one or more lateral protrusions 681.
  • the height of a protrusion 681 is more than 3mm and the thickness of the protrusion is less than 5mm.
  • the lateral extension of a protrusion is less than 20mm.
  • the illustrated embodiment shows dual sided protrusions 681. But some embodiments may function well with only one-sided protrusion 861.
  • a protrusion 681 is located at the device mid-section neck portion 220.
  • Figs 26A and 26B illustrate an embodiment of the system with a prefilled liquid in the secondary fluids compartment 611.
  • a part of the aerosol delivery module 630 is prefilled with a liquid 120.
  • a part of the aerosol delivery module 630 is prefilled with a liquid 120 such that the liquid is in contact with the liquid 120 is at least partially filled into the distal fluids compartment 105, thereby also in contact or in fluid communication with the mesh membrane 185.
  • a barrier 661 prevents liquid flow between the secondary fluids compartment 611 and the distal fluids compartment 105 in a non-operative state, i.e., a state in which the inhalation system 100 is not operating, and, in some embodiments, cannot operate.
  • barrier 661 impedes flow of the liquid 120 between the secondary fluids compartment 611 and the mesh membrane 185.
  • the barrier 661 is at least partly removed or broken or rendered ineffective (e.g., perforated) so as to enable flowing of the liquid from the secondary fluids compartment 611 into the distal fluids compartment 105, thereby enabling contact of the liquid 120 with the mesh membrane 185.
  • the barrier 661 is recoverable or resealed, such that to prevents liquid flow between the secondary fluids compartment 611 and the distal fluids compartment 105
  • Figs 27A and 27B illustrate an embodiment of the system with a distal protection cover.
  • a distal part of the aerosol delivery module 630 is covered with a protection distal cover 663, such that the mesh membrane 185 is protected before use, e.g., during storage, for example as illustrated in Fig. 27 A.
  • the protection distal cover 663 is removed, such that the mesh membrane 185 is in unobstructed fluid communication with the ambient air.
  • Figs. 28A and 28B illustrate, in unassembled and assembled states, an embodiment in which the aerosol delivery module 630 includes a sealed distal fluids compartment 105 that is prefilled with a liquid 120.
  • the aerosol delivery module includes no narrow section (i.e., part of a neck section 220), and the neck portion 220 and substantially all narrow locations are part of the proximal control module 210B.
  • Figs. 28A and 28B further illustrate preferred embodiments comprising a fill- level sensor.
  • the fill-level sensor inclusion can be made to be comprised in any of the previously discuss embodiments. Hence, the non-marking of a fill-level sensor in any drawing should not be understood as an indication of absence.
  • the fill-level sensor comprises one or more electrodes 691.
  • connection contacts 692 may be extending from the internal electrode 691 to the external contact 692. Then when in an assembled state, electronic connection is established between the electronic contact 692 and the control module.
  • the electrodes are embedded in the liquids compartment(s) such that when liquid is filled in the compartment it covers a portion of the electrode.
  • resistance between the electrodes is measured in communication with the control module circuitry.
  • the control module circuitry When the liquid fill level in the compartment gets low enough, the reduces covering by liquid of the electrode leads to increased associated resistance measurement. The increased resistance is then interpreted as a detection of low fill level in the compartment.
  • the system is geared for delivery of pre-set and pre-filled small dosages, typically less than 2mL.
  • it may be preferred to have a single switch turn-ON and automatic turn-OFF functionality.
  • a preferred embodiment of the invention is an inhalation delivery system for carrying out a drug inhalation procedure by a human user comprising: a.
  • an aerosol delivery module comprising a piezo assembly including: (i) an ultrasonically vibrable mesh membrane, (ii) a distal fluids compartment proximal to the mesh membrane in fluid communication with the mesh membrane, and (iii) an aerosol outlet for a mist comprising droplets of the liquid and generated by the mesh membrane; (iv) a distally extended mouthpiece in fluid communication with the mesh membrane and the aerosol outlet, the distal end of the system being the distal end of the mouthpiece; b.
  • control module comprising (i) a battery power source, (ii) a control circuitry for electrically powering the piezo assembly, (iii) an inhalation sensor, (iv) an activation switch configured for switching the control module between an initial OFF- state to a subsequent ON-state; and c. a liquid comprising a drug formulation.
  • the system When the inhalation system is in an assembled state such that the aerosol delivery module is attached to the control module and the liquid is contained within the distal fluids compartment in fluid communication with the mesh membrane, the system is configured to have at least two activation states.
  • control circuitry When the system is at an OFF-state the control circuitry does not drain power from the battery.
  • control circuitry When the system is turned on, for facilitating hands-free dynamic activation, the control circuitry is configured to detect and/or distinguish between at least two inhalation states, (A) a non-inhalation state, and (B) an inhalation event state.
  • the control circuitry When the activation switch is at an ON-state, the control circuitry is pre-set such that (i) the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid only after the detecting an inhalation event conditioned on a sensor threshold limit (ii) a pre-determined first dose quantity of the liquid is configured for delivery, the first dose quantity is more than 0.1 mL and less than 2 mL.
  • the system is preferably pre-set for a specific default dose.
  • the liquids compartment is preferably comprising at least a portion of the distal liquids compartment bounding walls being of sufficient transparency such that a level of the liquid fill level surface is visually discernable as a change of color or hue. Yet such visual information of the fill level by the user may not be sufficiently precise and/or requires active engagement and attention by the user.
  • and external indicator associated with an electronic indicator module, provides external signal of the state of dose delivery.
  • the End-of-dose status is associated with a corresponding indicator state, which may be visual (such as by an LED light) or audible (such as by an associated alarm sound).
  • the dose quantity itself can be defined and/or controlled in various ways.
  • to define and/or determine the dose quantity is by the target quantity of emitted liquid.
  • the quantity emitted can be assessed and/or defined by a fill-level sensor.
  • the fill level sensor may detect the different between two fill levels of the liquids compartment.
  • a pre-determined fill-level sensing may correspond to a detection that a dose has been reached, or a corresponding End-of-dose event.
  • the dose quantity is by a total period or duration of mesh ON-state activation.
  • the logic is that there is an estimated average emission rate of the mist when the mesh membrane vibration is active. Therefore, there is a corresponding liquids emission rate quantity which is estimated to have been delivered during the period.
  • the system may further be comprising of a distal cap 663 or other forms of protective cover 663.
  • a protective cover over at least a portion of the distal tip, such as the tip of the mouthpiece, which also serve to protect the delicate mesh membrane from external damage.
  • Such a cover may also serve as a visual indicator that the system has not been used or tempered with. This is particularly important with medical drug delivery application which are supposed to be single use.
  • usability may be simplified and/or streamlined, in constructions where the protective cap or cover also serve as an activation switch.
  • the natural act of removing a cover before use also serve as the step for turning on the system to an ON-state from a previous or packaged initial OFF-state.
  • Fig. 29A the system is illustrated in an initial assembled state with the protective cap 663 covering over the distal tip of the system, the system is further initially at an OFF-state.
  • the action step of removing of the cap e.g., by a human user
  • the system switching into an ON-state is also having an external indicator module manifestation in a changing state of the indicator 655 (e.g., LED light illumination change).
  • an indicator is signaling externally the transition into an ON-state from a previous or packaged initial OFF-state.
  • the cap is reversibly attachable to the mouthpiece.
  • the cap is a reversible switch such that reversing a movement of the cap enable switching the control module between an initial ON-state to a subsequent OFF- state.
  • the above discussion of the manipulation of the cap or protective cover by removal should not be considered as limiting.
  • the cap or protective cover manipulation is an activation switch, such that a movement of the cap is switching the control module between an initial OFF-state to a subsequent ON-state, may be different, such as rotating movement or push/pull movement.
  • the movement of the cap closes an electric contact or an electric circuit which is previously open.
  • the system is further comprising of an optional protective casing or shell 695.
  • the protective casing 695 preferably leaves exposed the switching element (e.g., a cover cap) and an indicator, thereby operation of the system can be performed without removal of the protective casing.
  • the protective casing is preferably rigid.
  • a taste-producing surface section 224 can be provided in the distal portion 230 in the form of an elastic band.
  • the taste-producing surface can be implemented in the form of a flavoring agent or a scented embedded agent or coating.
  • the elastic band can be reversibly removable, such that the user can place or change between different elastic band.
  • the elastic band also covers over an inlet or a filling port 103 into the liquids chamber.
  • the aerosol delivery module 630 further comprising a deflecting protrusion or protrusion 696 within the distal fluids compartment 105, wherein the deflecting protrusion 696 extends from a protrusion-distal-end located in proximity to the mesh membrane 185 to a protrusion-proximal-end located at least 2 mm more proximal from the mesh membrane than the protrusion-distal-end.
  • the purpose of the deflecting protrusion is effective to deflect air bubbles 697 preferentially upwards and/or sideways away from the mesh membrane for air bubbles coming into the distal liquids chamber through the mesh membrane when the mesh membrane is powered to vibrate and eject a droplets liquid mist 141 out in the distal direction.
  • the deflecting protrusion 696 is a ridge raised from the floor of the distal fluids compartment 105 by more than 1mm and less than 10 mm. But this is not meant to be limiting.
  • the deflecting protrusion 696 can also be extended from a side or roof portion of the fluids compartment 105.
  • the modular construction of the system enables economical packaging of the system into various sets of kits, each with its own advantages and potential use scenarios.
  • the system is intended for use as a disposable medication container.
  • the prefilled aerosol delivery module 630 is sealed such that external access to the respective fluids compartments 105, 611 is permanently blocked, in order to prevent additional liquid from being refilled in.
  • Such embodiments are useful for sterile medication delivery and to prevent refill of medication by unprofessional end-user patients.
  • kits may comprise more than one construction of the aerosol delivery module 630 which are connectable and operable with the same control module 210B that includes a power source 125, and preferably also the sensor 126.
  • An embodiment of a fully functional starter kit of the invention inhalation system comprises a packaging of the system 100 in a container such that the control module 210B that includes a power source 125 is detached from the aerosol delivery module 630.
  • the modularity and small size of the fluids cartridges is conductive for the construction of both unfilled and pre-filled cartridges kits.
  • a kit of cartridges comprising one or more secondary fluids compartment(s) such as cartridges 612 and/or vials 855, prefilled with a liquid, may be packaged in a container, wherein a cartridge 612 or vial 855 is designed to fit to connect into a stable assembly in the aerosol delivery modules 630, such that in the assembled state the interior of the cartridge 612 or vial 855 is in fluid communication with the distal fluids compartment 105, e.g., via an outlet port 616.
  • a kit comprising one or more cartridge device 805 prefilled with a liquid, is packaged in a container, the cartridge device 805 comprises a removable liquid tight seal 807 on an orifice 806, the cartridge device 805 is designed to fit to connect into a stable assembly in the inhalation system 100 of an aerosol delivery module 630, such that when in the assembled state attached to the piezo assembly 180, the liquid 120 inside the cartridge device 805 is in fluid communication with the piezo assembly 180 via the orifice 806.
  • the inhalation system of the present invention can be used for aerosol delivery of a variety of liquid 120 substances, primarily for medicinal purposes.
  • liquids include: a. an FDA approved drug; b. a bronchodilator medication, including but not limited to one of albuterol, levalbuterol, ipratropium, aclidinium, arformoterol, formoterol, glycopyrrolate, indacaterol, olodaterol, revefenacin, salmeterol, tiotropium, umeclidinium, Terbutaline, or a mixture thereof; c.
  • a bronchodilator medication including but not limited to one of albuterol, levalbuterol, ipratropium, aclidinium, arformoterol, formoterol, glycopyrrolate, indacaterol, olodaterol, revefenacin, salmeterol, tiotropium, umeclidinium, Terbuta
  • a corticosteroid medication including but not limited to one of Fluticasone, Budesonide, Prednisolone, or a mixture thereof
  • a muscarinic medication including but not limited to one of Revefenacin, Ipratropium bromide, Tiotropium bromide, or a mixture thereof
  • a Mucoactive medication including but not limited to one of carbocysteine, erdosteine, N-acetylcysteine, or a mixture thereof
  • a anti-inflammatory medication including but not limited to Methylxanthines; g. nicotine; h.
  • an antimicrobial agent including but not limited to one of Silver nanoparticles, PVP Iodine, tobramycin, colistin, and aztreonam lysine; i. a vaccine.
  • a vaccine for a respiratory infection caused by a virus selected from influenza or corona viruses; j. a cannabinoid substance; k. vitamin B 12 l. a liposomes-encapsulated, pharmaceutically-active substance.
  • the liquid 120 comprises an aqueous in the sense that more than 50% of the liquid composition is water; b. the liquid 120 comprises an aqueous emulsion; c. the emulsion comprises droplets having a size distribution peak at droplets size larger than 5nm and smaller than lOOnm; d. the emulsion comprises droplets having a size distribution peak at droplets size larger than lOnm and smaller than 90nm; e.
  • the emulsion comprises droplets having a size distribution peak at droplets size larger than 20nm and smaller than 80nm; f. the emulsion liquid has surface tension such that the contact angle of a 3mm diameter droplet of the liquid with mesh membrane is less than 90 degrees; g. the liquid 120 comprises an aqueous colloid of nanoparticles, wherein the nanoparticles have a zeta potential of size greater than 10 mV; h. the nanoparticles diameter is having a size distribution peak at size larger than 2nm and smaller than lOOnm.
  • the ultrasonic mesh nebulizer of the present invention is implemented to emulate the use targets of a pressurized metered dose inhaler (pMDI).
  • pMDI pressurized metered dose inhaler
  • a typical pMDI implements a pressurized propellant gas to spray a short burst of dose of liquid droplets, typically of total liquid droplets spray volume, total dose or interchangeably target dose (TD) between 0.05ml and 0.2ml. Most commonly, TD is around 0.12ml, such as between 0.08ml to 0.12ml.
  • TD interchangeably target dose
  • such pMDI are use for Asthma treatment with Ventolin.
  • a method of emulating meter- dose-inhaler (MDI) dosage with an ultrasonic nebulizer is provided.
  • a design for which an airflow sensor was not explicitly shown may include an airflow sensor to trigger activation/initiation (or deactivation/cessation) of the piezo assembly and generation of mist by the mesh membrane, or a design for which a capillary pathway was not explicitly shown may include a capillary path for transport of liquid to the mesh membrane.
  • any of the designs illustrated can incorporate a liquid-retaining compartment effective to be filled using gravity and to retain liquid using a liquid-retaining wall, such that the mesh remains in contact with liquid, after the inhalation device is turned horizontal or ‘below horizontal’, i.e., with the container at least partly higher than the liquid-retaining compartment.
  • each of the verbs, “comprise”, “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.
  • the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise.
  • the term “a marking” or “at least one marking” may include a plurality of markings.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'inhalation alimenté électriquement d'administration d'un aérosol à l'oropharynx d'un utilisateur, comprenant une partie distale logeant un ensemble piézoélectrique comprenant une membrane en treillis vibratile par ultrasons, et une partie de col comprenant une section étroite caractérisée par une dimension de section transversale minimale qui est d'au moins 10 % inférieure à une dimension de section transversale minimale de la partie distale traversant la membrane en treillis et parallèle à cette dernière. Au moins une partie de la section étroite est déplacée de manière proximale de la membrane en treillis d'une distance supérieure ou égale à 0,5 cm et inférieure ou égale à 6 cm. Le dispositif d'inhalation est façonné de sorte que, lorsque les lèvres et/ou les dents de l'utilisateur contactent transversalement la section étroite, l'emplacement de génération de brouillard soit distal par rapport aux dents de l'utilisateur à l'intérieur de la cavité buccale de l'utilisateur et que l'emplacement de sortie de brouillard soit en communication fluidique directe avec l'oropharynx de l'utilisateur.
PCT/IB2022/053547 2021-04-14 2022-04-14 Dispositif d'administration d'aérosol intra-oral Ceased WO2022219591A2 (fr)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
PCT/IB2021/053088 WO2021209928A1 (fr) 2020-04-14 2021-04-14 Dispositif d'administration d'aérosol intra-oral
IBPCT/IB2021/053088 2021-04-14
PCT/IB2021/000724 WO2023067365A1 (fr) 2021-10-20 2021-10-20 Dispositif d'administration d'aérosol intra-oral
IBPCT/IB2021/000724 2021-10-20
US202263297818P 2022-01-10 2022-01-10
US63/297,818 2022-01-10
US202263305009P 2022-01-31 2022-01-31
US63/305,009 2022-01-31
US202263318826P 2022-03-11 2022-03-11
US63/318,826 2022-03-11

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WO2022219591A3 WO2022219591A3 (fr) 2023-04-06

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025114978A1 (fr) * 2023-11-30 2025-06-05 Inhalimed Ltd Dispositif de distribution d'aérosol

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8875697B2 (en) * 2007-07-24 2014-11-04 Ric Investments, Llc Drug delivery apparatus and method
CN102264421B (zh) * 2008-12-23 2014-02-12 皇家飞利浦电子股份有限公司 用于气雾剂药物输送的方法和包括台阶式吹口的装置
PT2846859T (pt) * 2012-03-09 2017-03-23 Vectura Gmbh Canal de mistura para um aparelho de inalação e aparelho de inalação
WO2021209928A1 (fr) * 2020-04-14 2021-10-21 Van Dyke, Marc Dispositif d'administration d'aérosol intra-oral

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025114978A1 (fr) * 2023-11-30 2025-06-05 Inhalimed Ltd Dispositif de distribution d'aérosol

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