Aerosol delivery device

Abstract

An inhalation device for delivery of an aerosol to the oropharynx of a human user comprises a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; a distal aerosol delivery module, comprising a distally-open central plenum; and a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

Description

[0001] AEROSOL DELIVERY DEVICE

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] U.S. Provisional Patent Application No. 63 / 604,198, filed on November 30, 2023, is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 63 / 552,995, filed on February 13, 2024, is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 63 / 725,785, filed on November 27, 2024, is incorporated herein by reference in its entirety.

[0004] FIELD OF THE INVENTION

[0005] The present invention relates to mist-delivery devices and refillable and / or replaceable and / or pre-filled reservoir containers for use therein, and to methods for using such devices. In particular, the present invention relates to devices for intraoral use for delivering an aerosol to a user’s oropharynx.

[0006] BACKGROUND

[0007] Existing oral inhalers suffer from the problem that any mist produced must traverse the tongue and other parts of the oral cavity, causing part of any dosed substance to fail to reach the oropharynx. Therefore, a need exists for an intraoral inhaler capable of delivering a precise dosage of a substance to a user’s oropharynx, preferably configured to place a mist-generating location and / or mist-exiting location of the inhaler far enough into the oral cavity to overcome the aforementioned shortcoming. There is also a need for such an inhalation device to be compact and comfortable to use.

[0008] SUMMARY

[0009] According to embodiments, an inhalation device for delivery of an aerosol to the oropharynx of a human user comprises: (a) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; (b) a distal aerosol delivery module, comprising a distally-open central plenum; and (c) a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

[0010] According to embodiments, an inhalation device for delivery of an aerosol to the oropharynx of a human user comprises: (a) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; and (b) a distal aerosol delivery module comprising a distally-open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

[0011] A method is disclosed, according to embodiments, for delivering an aerosol to the oropharynx of a human user. The method comprises: (a) providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, (ii) a distal aerosol delivery module, comprising a distally-open central plenum, and (iii) a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; (b) placing the inhalation device in the user’s mouth; and (c) producing a user inhalation.

[0012] A method is disclosed, according to embodiments, for of delivering an aerosol to the oropharynx of a human user. The method comprises: (a) providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, and (ii) a distal aerosol delivery module, comprising a distally-open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; (b) placing the inhalation device in the user’s mouth; and producing a user inhalation.

[0013] BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Fig. 1 is a schematic elevation drawing of an inhalation device having a compact design, according to embodiments of the present invention.

[0015] Fig. 2 shows the inhalation device of Fig. 1, in situ, in an activated state producing a mist in a user’s oral cavity, according to embodiments of the present invention.

[0016] Figs 3A and 3B 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.

[0017] Figs. 4A 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.

[0018] Fig. 5 is an annotated schematic cross-sectional illustration of the inhalation device of Figs. 4A-15B.

[0019] Figs. 6A and 6B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention.

[0020] Figs. 7A and 7B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention.

[0021] Figs. 8 illustrates a placement of the device in use by a human user, according to embodiments of the invention.

[0022] Figs. 9 A and 9B are schematic illustrations of section cuts through the device to show some of the inside components and build elements.

[0023] Figs. 10A and 10B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention, including an assembly of a fluids compartment.

[0024] Figs. 11 A, 11B, 11C and 11D are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention, including an assembly of a fluids compartment.

[0025] Figs. 12A and 12B are schematic illustrations of kits including inhalation devices, according to embodiments of the present invention, including a safety element. Figs. 13A and 13B illustrate an embodiment of the system with a distal protection cover, according to embodiments of the invention.

[0026] Figs. 14A and 14B are schematic illustrations of an inhalation device, respectively in unassembled and assembles states, according to embodiments of the invention.

[0027] Figs. 15A and 15B are schematic illustrations of an inhalation device comprising a distal cap cover according to embodiments of the invention.

[0028] Fig. 16 is schematic illustrations of an inhalation device comprising a distal elastic band wrapping around a section of the delivery module according to embodiments of the invention.

[0029] Figs. 17 A and 17B are schematic illustrations of an inhalation device comprising an air channel according to embodiments of the invention.

[0030] Figs. 18A and 18B are schematic illustrations of an inhalation device comprising an air channel according to embodiments of the invention.

[0031] Fig 18C illustrates a removable liquids compartment according to embodiments of the invention.

[0032] Figs. 19 A and 19B are schematic illustrations of an inhalation device comprising a pump according to embodiments of the invention.

[0033] Figs. 20 A and 20B are schematic illustrations of pumps illustrations of an inhalation device comprising a pump according.

[0034] Fig. 21A schematically illustrates an inhalation device comprising a manual pump with surface access for thumb operation according to embodiments of the invention.

[0035] Figs. 21B,21C are schematic illustrations of manual pumps structures.

[0036] Figs. 22A and 22B show schematic illustrations of an inhalation device according to embodiments of the invention.

[0037] Figs. 23A and 23B show schematic illustrations of visual cuts through an inhalation device according to embodiments of the invention.

[0038] Figs. 24 A, 24B, 24C show schematic illustrations of kits of an inhalation device according to embodiments of the invention.

[0039] Figs. 25 A, 26B, 26C, 26D show schematic illustrations of kits of an inhalation device according to embodiments of the invention comprising a removable liquids compartment.

[0040] Figs. 26A and 26B show schematic illustrations of an inhalation device according to embodiments of the invention.

[0041] Figs. 27 A and 27B show schematic illustrations of visual cuts through an inhalation device according to embodiments of the invention.

[0042] Figs. 28A, 28B, 28C, 29 and 30 show schematic illustrations of inhalation devices according to embodiments of the invention.

[0043] Fig. 31 shows a schematic drawing of an inhalation device in situ, in an activated state producing a mist in a user’s oral cavity, according to embodiments of the present invention. Figs. 32A, 32B and 32C show respective schematic drawings of an inhalation device comprising a cartridge module comprising a reservoir, according to embodiments of the invention. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0044] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are generally used to designate like elements.

[0045] Note: Throughout this disclosure, subscripted reference numbers (e.g., 1 Or or 10A) may be used to designate multiple separate appearances of elements of a single species, whether in a drawing or not; for example: 1 Or 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 1 Or) when not referring to a specific one of the multiple separate appearances, i.e., to the species in general.

[0046] Following is a list of reference numbers used in the figures for physiological features: 10 - oral cavity; 15 - lips; 20 - teeth; 25 - tongue; 30 - hard palate; 40 - nasal cavity; 50 - oropharynx; 60 - velo-pharyngeal port; 70 - pharyngeal cavity

[0047] For convenience, in the context of the description herein, various terms are presented here. To the extent that definitions are provided, explicitly or implicitly, here or elsewhere in this application, such definitions are understood to be consistent with the usage of the defined terms by those of skill in the pertinent art(s). Furthermore, such definitions are to be construed in the broadest possible sense consistent with such usage. Physiological terms as used herein are to be understood according to their generally accepted meanings.

[0048] The terms ‘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.

[0049] The 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”.

[0050] An inhalation device is disclosed herein 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 ultrasonically vibrable assembly and includes a mesh membrane to generate the aerosol, and so the inhalation device has an aerosol outlet that in intended use will release the aerosol where desired. The terms ‘inhalation device’ and ‘inhalation device’ are used interchangeable regardless of the state of assembly, as are the terms ‘device’ and ‘system’.

[0051] Fig. 1 illustrates a more compact design for an inhalation device 100 according to embodiments, and Fig. 2 shows the in-situ placement of the device 100. Inhaler 100 of Figs. 1 and 2 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 2110 (which is optionally detachable / attachable). Compartment 110 has a opening for filling and refilling; the compartment 110 has an openable closing element 132. The inhalation device 100 of Fig. 1 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. As can be seen in Fig. 2, the air inlet 122 is positioned so as to remain outside the lips 15 when the device 100 is positioned for operation in situ. Referring again to Fig. 1, an ‘inhalation sensor’, i.e., flowmeter or airflow sensor 126IN is provided for activating the piezo assembly 180 upon detection of inhalation. In embodiments, 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. In some embodiments, the inhalation sensor 126IN is configured to detect an air pressure. In some embodiments, 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

[0052] Referring now to Figs. 3 A and 3B: an inhalation device 100 comprises a fluids compartment 105 is in fluid communication with the ultrasonic membrane 185. In an embodiment as shown in Fig. 3A and 3B, the fluids compartment 105 is fillable through filling port 103. In the design of Figs. 3A and 3B, 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 fluids compartment 105 is in contact with the mesh membrane. The fluids compartment 105 is designed such that for a range of angles 0 (horizontal, e.g., as in Fig. 3A) to 0 (e.g., as in Fig. 3B), the mesh 185 is kept in contact with liquid 120 retained in the fluids compartment 105. Setting the value of 0 is a design choice which reflects a desired range of angles at which the inhalation device 100 can work effectively.

[0053] It can be desirable to add a display screen (or, equivalently, any display device) to an inhalation device for visually communicating information to a user. 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.

[0054] Referring now to Figs. 4A and 4B, an inhalation device according to embodiments is schematically illustrated, respectively assembled and unassembled.

[0055] As shown in Fig. 4B, 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. 6B as 630) 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 liquidholding volume (not shown) and can be used as a replaceable reservoir 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 630. In some embodiments, 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. In some embodiments, at least an upper surface of 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.

[0056] 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- In embodiments, 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. Thus, when a user holds the inhalation device in his mouth, and the user’s lips 15 close around the neck portion 220 of the inhalation device 100, 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. Similarly, the sensor 126 can register the cessation of an inhalation and cease the operation of the piezo assembly and the generation of the mist.

[0057] In embodiments, 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 630. In embodiments the attachment is reversible, so as to enable a attachable / detachable link. For example, 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. Additionally or alternatively, other features can be added for making and stabilizing the connection of the second proximal module 210B and the inhalation-device section 630, as well as the connection of the first proximal portion 210A and the inhalation-device section 630.

[0058] Fig. 5 shows a schematic cross-section of the inhalation device 100 of Figs. 4A-4B. As can be seen, the inhalation device 100 of Figs. 4A-4B 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.

[0059] Referring to Figs. 6A and 6B, the modular components of the inhalation device 100 of Figs. 4A, 4B and 5 can be provided in a kit, packaged in a envelop 500. A first example of a kit is shown in Fig. 6A, 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- In some embodiments, the kit of Fig. 6A can include, as shown, at least one additional first proximal portion 210A. A second example of a kit is shown in Fig. 6B, comprising an inhalationsensor section that includes the distal portion 230 and the neck portion 220, and, unattached, the first and proximal modules 210A, 210B-

[0060] Referring to Figs 7A and 7B, illustrated is an embodiment of an inhalation device 100 for delivery of an aerosol to the oropharynx of a human user. 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 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 mesh plane 900 passing through the mesh membrane, the mesh plane 900 being perpendicular to the geometrical axis 910 perpendicular to and passing through the center of the mesh membrane 185.

[0061] The narrowness condition may be satisfied at more than one location along the aerosol delivery module 630. For example, as illustrated in Fig. 9A, proximally to the distal portion 230 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 mesh 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.

[0062] In embodiments, 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. In some embodiments, 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.

[0063] As illustrated in Fig. 7A the inhalation device 100 comprises a proximal device portion 210, which is proximal to the neck portion 220.

[0064] In the embodiment of Fig. 7A, at least part of 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.

[0065] Fig. 7A illustrates an embodiment wherein the fluids compartment 105 is in fluid communication with a filling port 103. In some embodiments, the filling port 103 comprises a checkvalve, or any other type of one-way valve. In other embodiments the fluids compartment may comprise an openable and re-closeable portion of its shell wall so as to enable insertion of liquids. In some embodiments the openable portion of the shall-wall may be detachable. In some other embodiments 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.

[0066] Fig. 7B illustrates an embodiment wherein the inhalation device has a control module 210B which is attachable and detachable from the aerosol delivery module 630. In the connected configuration state, a full system device 100 is formed. Thus, in an embodiment, 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 fluids compartment 105 in fluid communication with the mesh membrane 185. Correspondingly, in embodiments, 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.

[0067] As illustrated in Fig. 7B, in some embodiments, in addition to the filling port 103 into the liquids chamber, there is a secondary port 113 of smaller cross section than the filling port 103. Port 113 is serving as an air outlet simultaneously with liquids filling via the filling port 103. In some embodiments, the cross section area of the filling port 103 is smaller than 1 cm2and bigger than 0.1 cm2, or smaller than 0.5 cm2. In some embodiments, the cross-section area of the secondary filling port 113 is smaller than 0.3 cm2and bigger than 0.001 cm2, or smaller than 0.1 cm2.

[0068] 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 device 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 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- In terms of cost, the 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.

[0069] 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.

[0070] As illustrated, e.g., in Figs. 7B, 9A, and 9B, in the assembled configuration state, 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.

[0071] In embodiments, 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

[0072] (i) there is fluid communication between the distal port 222 to the pressure sensor 126 via a lumen 221;

[0073] (ii) 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;

[0074] (iii) 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.

[0075] In any of the embodiments disclosed herein, the inhalation device / inhalation device can be provided in an assembled state. Additionally or alternatively, any disclosed inhalation device / inhalation device 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 reservoir containers. In some embodiments, 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. For example, this can be useful when some liquid substances are used at small volume, such as less than 0.5ml (e.g., more expensive drugs), while other applications use liquid substances at higher volumes such as more than 1ml. These different use scenarios are better served by dedicated aerosol delivery module 630 comprising a liquids compartment 105 of different size or structural form.

[0076] As illustrated in Fig. 7A, an air channel 229 facilitates the flow of ambient air in proximity of the port 222. In particular, during use, when the user lips are wrapped around the device mid-portion neck, 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.

[0077] In embodiments, the system further comprises an electronic external indicator module 655 in electronic communication with the electronic control circuitry 135. For example, in some embodiments the indicator module 655 comprises an LED light. In some other embodiments, the indicator module 655 comprises a display screen 155. The indicator module 655 may serve to indicate various operational states of the system. For example, 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. For example, during system activation by inhalation sensing, the electronic control circuitry 135 is configured to change the indicator module 655 display state when the piezo assembly 180 is activated.

[0078] As an intra-oral device, the compactness of the aerosol delivery module 630 is important. In some embodiments the minimum width WD dimension of a more distal cross-section, at a mesh plane 900 passing through the mesh membrane, is less than 20mm, or less than 15mm, or less than 12mm, or less than 10mm.

[0079] Fig. 7B also illustrates an 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. In some embodiments, the cross section area of the filling port 103 is smaller than 1 cm2and bigger than 0.1 cm2, or smaller than 0.5 cm2. In some embodiments, the cross-section area of the secondary filling port 113 is smaller than 0.3 cm2 and bigger than 0.001 cm2, or smaller than 0.1 cm2.

[0080] As illustrated in Fig. 8, the inhalation device 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.

[0081] In embodiments, as illustrated in Fig. 8, 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.

[0082] The location of the port 222 is preferably deeper into the oral cavity than the external edge 15L or 15U of the lips. For example, in Fig. 8 the port 222 is shown situated roughly between the teeth.

[0083] As illustrated in Fig. 9A, in an embodiment, the inhalation device 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.

[0084] In some embodiments, 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. For example, 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.

[0085] Fig. 9A 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 185.

[0086] As illustrated in Fig. 9B, the inhalation device 100 additionally comprises an inhalation sensor 126. In embodiments, 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.

[0087] The inhalation device 100 additionally comprises control circuitry 135. In embodiments, 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. In embodiments the threshold limit is a pressure between 2 cm H2O and 20 cm H2O. In other embodiments the threshold limit is a pressure between 2 cm H2O and 15 cm H2O. In some other embodiments, the threshold limit is a pressure between 5 cm H2O and 15 cm H2O. As illustrated in Fig. 9A, in an embodiment, the inhalation device comprises a 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.

[0088] In some embodiments, 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.

[0089] In embodiments, 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.

[0090] As illustrated in Fig. 9B, in some embodiments, the distal port 222 is located distally from the inhalation sensor 126. In embodiments the inhalation sensor 126 is a pressure sensor. In embodiments the sensor 126 is located in the proximal section 210. When the inhalation device 100 is in the assembled configuration state, there is fluid communication between the distal port 222 to the inhalation sensor 126 via a lumen 221, and wherein in the unassembled state a distal portion 223 of the lumen 221 is within the mid-section of the device, and a portion 225 of the lumen 221 is within the device proximal section 210.

[0091] In embodiments, advantages comprise increased use versatility and better economic cost advantages by enabling different level of disposability of various parts. Previously we noted the advantage of the potential cheap disposability of the whole aerosol delivery module 630 with respect to the control module 210B. In embodiments, 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.

[0092] Figs. 10A and 10B illustrate embodiments further comprising a secondary fluids compartment in fluid communication with the fluids compartment 105. The secondary fluids compartment is an independent cartridge module 612, comprising reservoir container 110, detachably attachable to the fluids compartment 105. The cartridge may be prefilled with a liquid 120. In embodiments, the volume of reservoir container 110 is larger than the volume of the fluids compartment 105.

[0093] Fig. 10B illustrates an embodiment wherein the cartridge comprising reservoir container 110 comprises an outlet port 616, such that in the assembled state the reservoir container 110 is in fluid communication with the fluids compartment 105 via outlet port 616.

[0094] In the embodiment illustrated in Fig. 10B, the cartridge comprising reservoir container 110 comprises a hard shell, preferably fitting smoothly with the contours of the surface of the inserted location within the aerosol delivery module 630. To enable better transfer of liquids from the secondary cartridge comprising reservoir container 110 to the proximal volume of the fluids compartment 105, the aperture of outlet port 616 across the center of the aperture is preferably larger than 2 mm and less than 5mm. The cartridge comprising reservoir container 110 is side-mounted in some embodiments of the assembly process into the aerosol delivery module 630, as illustrated for example in Fig. 10B. 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. For example, Fig 5B 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 into the aerosol delivery module 630.

[0095] When the quantity of liquid intended for use is small, such as less than 1 ml, or less than 0.5 ml, less than 0.3ml, there may be preference to have the bulk of the fluids chamber itself constructed as a replaceable cartridge comprising reservoir container 110. An example of such an embodiment is illustrated in Figs. 11 A,11B,11C, and 1 ID. In this embodiment, a portion of the fluids compartment 105 comprises an independent fluids cartridge module 805 which is detachably attachable from the full aerosol delivery module 630 comprising the piezo assembly 180.

[0096] Fig 1 IB illustrates an embodiment wherein the fluids cartridge module 805 is prefilled with a liquid 120. The fluids cartridge module 805 comprises an orifice 806 such that, when in the assembled state attached to the piezo assembly 180, the liquid 120 inside the cartridge module 805 is in fluid communication with the piezo assembly 180 via the orifice 806. In the unassembled state the fluids cartridge module 805 comprises a removable liquid tight seal 807 on the orifice 806.

[0097] In the process of assembly for use, the fluids cartridge module 805 is commonly taken out in a sealed configuration state (as illustrated in Fig. 11 C) out of a kit package comprising multiple cartridges. The seal 807 is then removed (as illustrated in Fig. 1 IB). The unsealed fluids cartridge module 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.

[0098] In most practical uses, the cartridge module 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.

[0099] Figs. 12A and 12B illustrate an embodiment of the system comprising a sliding safety feature, which is meant to prevent excessive distal sliding of the device into the oral cavity of the human user. Such a safety feature comprises one or more lateral protrusions 681. For better effectiveness, the height of a protrusion 681 is more than 3mm and the thickness of the protrusion is less than 5mm. In embodiments, for better user comfort and to maintain the compactness of the device, 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. In some embodiments a protrusion 681 is located at the device mid-section neck portion 220.

[0100] Figs. 13A and 13B illustrate an embodiment of the system with a distal protection cover. In some embodiments of the system, at an initial state (i) 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. 13 A. Before use, at a second state (ii) the protection distal cover 663 is removed, such that the mesh membrane 185 is in unobstructed fluid communication with the ambient air. In some embodiments of a pre -filled aerosol delivery module, distal cover 663 may form an airtight seal preventing fluid communication between ambient air and the fluids compartment 105 through the mesh holes.

[0101] Figs. 14A and 14B illustrate, in unassembled and assembled states, an embodiment in which the aerosol delivery module 630 includes a sealed fluids compartment 105 that is prefilled with a liquid 120. In this embodiment, 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.

[0102] Figs. 14A and 14B further illustrate some 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. In embodiments where the liquids compartment is attachable and / or re-attachable (such as with a liquids compartment cassette, or attachable distal module 630 comprising the liquids compartment), 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. In the assembled state, resistance between the electrodes is measured in communication with 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.

[0103] In some embodiments, the system is geared for delivery of pre-set and pre-filled small dosages, typically less than 2mL. Moreover, in such embodiments, it may be preferred to have a single switch turn-ON and automatic turn-OFF functionality. In particular, for such applications an embodiment 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) a mesh membrane, (ii) a 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 portion aerosol delivery module 630 in fluid communication with the mesh membrane and the aerosol outlet, the distal end of the system being the distal end of the aerosol delivery module 630; b. a 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 IDLE-state to a subsequent ON-state; and c. a liquid comprising a drug formulation.

[0104] When the inhalation device is in an assembled state such that the aerosol delivery module is attached to the control module and the liquid is contained within the fluids compartment in fluid communication with the mesh membrane, the system is configured to have at least two activation states.

[0105] When the system is at an IDLE-state the control circuitry does not drain power from the battery.

[0106] 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 noninhalation state, and (B) an inhalation event state.

[0107] 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 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.

[0108] In some embodiments, the aerosol delivery module 630 is further comprising a distally extended aerosol delivery module 630 in fluid communication with the mesh membrane and the aerosol outlet, the distal end of the system being the distal end of the aerosol delivery module 630. Thereby, the aerosol delivery module 630 conducts fluid communication between the mesh membrane and the aerosol outlet.

[0109] In some embodiments, it is advantageous to both inform and alert the user to the state of the dose delivery. 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. In some embodiments, and external indicator, associated with an electronic indicator module, provides external signal of the state of dose delivery. In particular 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).

[0110] The dose quantity itself can be defined and / or controlled in various ways. In an embodiment 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 difference 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. In another embodiment, to define and / or determine 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.

[0111] As illustrated in Figs. 15A and 15B, and as we noted previously, in some embodiments the system may further be comprising of a distal cap 663 or other forms of protective cover 663. For example, a protective cover over at least a portion of the distal tip, such as the tip of the aerosol delivery module 630, 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.

[0112] In some embodiments, usability may be simplified and / or streamlined, in constructions where the protective cap or cover also serve as an activation switch. Thereby, 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 IDLE-state. For example, in Fig. 15A 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 IDLE-state. The action step of removing of the cap (e.g., by a human user) both exposes the distal tip and simultaneously switches the system electronically to an ON-state. In some embodiments 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).

[0113] In some embodiments, an indicator is signaling externally the transition into an ON-state from a previous or packaged initial IDLE-state.

[0114] In some embodiments, such as when the system is intended for multiple time usage, the cap is reversibly attachable to the aerosol delivery module 630. Generally in such embodiments, 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 IDLE-state.

[0115] 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 IDLE-state to a subsequent ON-state, may be different, such as rotating movement or push / pull movement.

[0116] For switching, in some embodiments, the movement of the cap closes an electric contact or an electric circuit which is previously open.

[0117] As illustrated in Figs. 15A and 15B, in some embodiments 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. As illustrated in Fig. 16, 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. In some embodiments, the elastic band also covers over an inlet or a filling port 103 into the liquids chamber.

[0118] Figs. 17A and 17B illustrates an embodiment of the system wherein the aerosol delivery module 630 further comprising a tongue -depressing element 688 which extends more distally from the mesh membrane 185 by at least 5mm and preferably less than 30mm. The tongue-depressing element 688 extends at a level under the lowest perforated level of the mesh membrane, preferably at a level under the bottom edge of the mesh membrane, such that when the device 100 is in use inside the mouth of a human user the tongue-depressing element 688 keeps the tongue under it at a level below the level of the mesh membrane. Thereby, there is reduced possibility that the aerosol ejected 141 from the mesh membrane will collide with and settle onto the tongue tissue.

[0119] Figs. 17A and 17B also illustrates an embodiment of the system wherein the aerosol delivery module 630 further comprising a bottom-air-channel or air conduit element 121. The bottom- airchannel element 121 is comprising a proximal entry port 122, and a distal exit port 529 at a level below the center the mesh membrane. Thereby, an air passage for conduit of air around the mesh membrane at a level below the center the mesh membrane. When the device 100 is positioned in use inside the mouth of a human user, the proximal entry port 122 is situated outside of the mouth and enables ambient entering-air-flow 525 to enter into the bottom-air-channel element 121, and to distally channel an exiting-air-flow 526 via a distal exit port 529 at a level below the center the mesh membrane. The exiting-air-flow 526 provides an added buffering between the ejected aerosol stream 141 and the tongue under it at a level below the level of the mesh membrane. Thereby, there is reduced portion the aerosol ejected 141 from the mesh membrane that collide with and settle onto the tongue tissue, compared when no air flows in the bottom-air-channel element 121 (as can be tested experimentally by blocking of the bottom-air-channel element 121).

[0120] 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.

[0121] In some embodiments the system is intended for use as a disposable medication reservoir container. For example, the prefilled aerosol delivery module 630 is sealed such that external access to the respective fluids compartments 105, 110 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.

[0122] Most of the variability is in the aerosol delivery module 630. Therefore, embodiments of a kit 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 inhalation device comprises a packaging of the system 100 in a reservoir container such that the control module 210B that includes a power source 125 is detached from the aerosol delivery module 630.

[0123] The modularity and small size of the fluids cartridges comprising reservoir container 110 is conductive for the construction of both unfilled and pre -filled cartridges kits. In embodiments, 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 cartridge, 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 fluids compartment 105, e.g., via an outlet port 616.

[0124] In some embodiments, a kit comprising one or more cartridge module 805 prefilled with a liquid, is packaged in a reservoir container, the cartridge module 805 comprises a removable liquid tight seal 807 on an orifice 806, the cartridge module 805 is designed to fit to connect into a stable assembly in the inhalation device 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 module 805 is in fluid communication with the piezo assembly 180 via the orifice 806.

[0125] The inhalation device can be used for aerosol delivery of a variety of liquid 120 substances, primarily for medicinal purposes. Particular examples of such 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 corticosteroid medication, including but not limited to one of Fluticasone, Budesonide, Prednisolone, or a mixture thereof; d. a muscarinic medication, including but not limited to one of Revefenacin, Ipratropium bromide, Tiotropium bromide, or a mixture thereof; e. a Mucoactive medication, including but not limited to one of carbocysteine, erdosteine, N-acetylcysteine, or a mixture thereof; f. 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. Of particular interest and potential effective advantage is for 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. For the liquid to be suitable or optimized for use with the system, some properties are advantageous to pass the liquid through the mesh membrane. In particular where any one or a combination of these properties is satisfied for the liquid 120: a. 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.

[0126] In some embodiments, the ultrasonic mesh nebulizer of the present disclosure is implemented to emulate the use targets of a pressurized metered dose inhaler (pMDI). 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. For example, such pMDI are use for Asthma treatment with Ventolin.

[0127] In some embodiments, a method of emulating meter-dose-inhaler (MDI) dosage with an ultrasonic nebulizer is provided. Our ultrasonic mesh nebulizer, is characterized by a. an electronic circuit which is i. having a predetermined average rate of R1 milliliter per minute (ml / min) aerosol emission rate; ii. comprising a pressure sensor connected to an electronic circuit; b. activating the mesh ultrasonic vibration for a duration Di by the electronic circuit at each time Ti when the sensor detects a pressure difference below a pre-set thresh -hold limit LI, thereby a fractional dose F(Di,Ti)=Di*Rl milliliter; c. Indicating when the cumulated dose of the sum of at least a selection of previous F(Di,Ti) is greater than a pre-set target dose TD.

[0128] Thereby, the user knows that the target dose TD was reached. In common embodiments the target dose TD is greater than 0.05ml and smaller than 0.5ml. The target dose TD is often greater than 0.08ml and smaller than 0.3ml, or smaller than 0.2ml, or smaller than 0.12ml.

[0129] In some embodiments the average rate of R1 is greater than 0.2 ml / min and less than 3ml / min, or greater than 0.5 ml / min. Commonly R1 is less than 2 ml / min, or less than 1 ml / min.

[0130] In order to provide flexibility the electronic control circuit 135 is configured to controllably produce more than one emission-rate -modes, where each emission rate mode is characterized by an associated average rate per second of aerosol emission by the mesh membrane 185. In some implementations, during a period of one second there is an activation-duration portion of A% during which aerosol is produced, and a non-activation duration portion N% during which aerosol is not produced, where A% + N% = 100%, such that at least one emission-rate -mode has a higher activation-duration portion of A%=A1% than a second emission-rate -mode having an activationduration portion of A%=A2% , such that Al% is greater than A2%.

[0131] Figs 18A,18B,18C illustrate an embodiment of the inhalation device for delivery of an aerosol to the oropharynx of a human user. Similarly to other embodiment elaborated above, the inhalation device comprising: a. an aerosol delivery module 630 comprising: a mesh membrane 185 characterized by having small orifices, a fluids compartment 105 for containing a liquid 120 in the immediate proximity of and in fluid communication with the mesh membrane, and an aerosol outlet for a mist comprising droplets of the liquid generated by the mesh membrane, the mesh membrane defining a mist-generating location; and b. a piezo assembly 180 comprising an ultrasonic vibrable element; and c. a control module 210B.

[0132] In some embodiments, in principle as more explicitly illustrated in other figures, the various components of the system may be detachable and reassembled. In other some embodiments, some or all of the components may be permanently attached. When the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B.

[0133] In some embodiments, the fluids compartment 105 is fillable or pre-filled with a liquid 120.

[0134] As illustrated in Fig.18 A, in the assembled state the inhalation device is shaped to include a narrow section 226 characterized by a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller than a maximum vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane 185, preferably at least 30% smaller, or even 50% smaller. The mesh membrane is distal to the narrow section. The system geometry is horizontally elongated, and the majority of the weight of the control module is disposed proximally from the narrow section.

[0135] For the embodiment schematically illustrated in Fig.l8A, as with other embodiments noted above, when the inhalation device is in use, as illustrated in Fig.8, such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, the mesh membrane 185 resides within the user’s oral cavity, the mesh membrane is in direct fluid communication with the user’s oropharynx, the geometrical perpendicular axis 910 perpendicular to and passing through the center of the mesh membrane 185 is oriented preferably within less than 30 degrees parallel to the axis connecting the proximal most front teeth and the distal end of the oral cavity, and the majority of the weight of the control module resides outside of the user’s oral cavity.

[0136] As illustrated in Figs. 18A and 18B, the assembled state the inhalation device is further comprising an air-channel or air conduit element 121, the air channel is passing along a path that passes around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane, such that when the inhalation device is in use and the mesh membrane resides within the user’s oral cavity, a proximal portion of the air conduit element 121 comprising a proximal entry port 122 is outside of the oral cavity proximal to the teeth, and a distal portion of the air conduit element 121 comprising a distal exit port 529 is situated distally is inside of the oral cavity distal to the teeth. The air channel is preferably passing along a path that passes around a side of the mesh membrane at a level at least partially or predominantly below the center the mesh membrane.

[0137] Previous illustrations highlighted embodiments which, in the assembled state, the piezo assembly 180 is in mechanical communication to the mesh membrane 185, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the mesh membrane 185. Commonly in such embodiments, the vibrable portion of the piezo assembly 180 is situated distally to the mesh membrane 185 and attached thereto, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push of the mesh membrane 185 towards the liquid when is filled within the fluids compartment 105.

[0138] Fig.l8B highlights an embodiment wherein the vibrable portion of the piezo assembly 180 is situated proximally to the mesh membrane 185. The vibrable portion of the piezo assembly 180 is also situated proximally to a portion of the interior of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the intermediate liquid between the vibrable portion of the piezo assembly 180 the mesh membrane 185, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push of the liquid when is filled within the fluids compartment 105 towards the mesh membrane 185.

[0139] It is possible in some embodiments for the vibrable portion of the piezo assembly 180 to be in direct contact with the liquid 120. In other some embodiments, as further illustrated in Fig.l8B, the vibrable portion of the piezo assembly 180 is also situated proximally to a portion of and in contact with a proximal wall 104 of the fluids compartment 105, i.e., the proximal wall of the fluids compartment 105 is intermediate between the vibrable portion of the piezo assembly 180 and the liquid 120 within the fluids compartment 105. Thereby, vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on portion of and in contact with a compartment proximal wall 104 of the fluids compartment 105 which are then communicated to the the liquid 120 within the fluids compartment 105. Fig. 18C illustrates an embodiment wherein a portion of the fluids compartment 105 is a removable compartment which is detachably attachable to the rest of the aerosol delivery module 630. In some embodiments, the portion of the fluids compartment 105 is removed without the mesh membrane 185, similar to the embodiment previously illustrated in Fig. 1 ID. In other some embodiments, as illustrated in Fig.l8C, the fluids compartment 105 is detachably attachable together with the mesh membrane 185, thereby the fluids compartment 105 together with the mesh membrane 185, form a detachably attachable unit cartridge 805.

[0140] The fluids compartment 105 is a preferably a removable compartment which is detachably attachable in its entirety. In some embodiments wherein the inhalation device further comprises a reservoir container 110 of volume greater than the fluids compartment 105, wherein the reservoir container 110 is in fluid communication with the fluids compartment 105. In some embodiments, as illustrated in Fig.l8C, the detachably attachable unit cartridge 805 incorporates also the reservoir container 110.

[0141] Fig.l8C further illustrates an embodiment wherein the fluids compartment 105 is removable without including a vibrable portion of the piezo assembly 180.

[0142] For ergonomic fitting within the oral cavity of a human user, the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185. Preferably the ergonomic fitting of the system includes a rounded top. For better ergonomic fit, the top-most boundary of the reservoir container 110 is preferably situated less than 5mm above the top-most edge of the mesh membrane 185.

[0143] In some embodiments, when in use and filled with liquids, the majority of the volume of the reservoir container is situated above the level of the center of the mesh, such that liquids flow to enter through the top of the fluids compartment 105 from reservoir container 110.

[0144] As illustrated in Figs. 18B and 18C, the majority of the volume of the reservoir container 110 is situated sideways from the level of the fluids compartment 105. Thereby, when in use and filled with liquids, liquids flow to enter primarily through the sides of the fluids compartment 105 from reservoir container 110.

[0145] As illustrated in Figs. 18B and 18C, the width of the fluids compartment 105 is narrow enough in some embodiments such that the liquid flow through the sides of the fluids compartment 105 from reservoir container 110 comprises a capillary flow. For example, the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is preferably less than 0.5 mm. Preferably, the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is less than 0.3 mm.

[0146] In order to facilitate capillary flow through the sides of the fluids compartment 105 from reservoir container 110, there is a capillary wick element 109 in the intervening space between the compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185. Preferably, the fluids compartment 105 comprises a compartment proximal wall 104 facing across from the center of the mesh membrane, wherein the minimal distance between the compartment proximal wall 104 and the mesh membrane 185 is less than 5mm, or less than 2mm, or less than 1mm, or less than 0.5mm, or less than 0.2mm.

[0147] In order to facilitate flow from the sides into the center of the fluids compartment 105 the fluids compartment 105 may comprise a capillary wick 109. The capillary wick is preferably placed facing the orifices of the mesh 105. In some embodiments, the capillary wick 109 is in fluid communication with a reservoir container 110, the volume of the reservoir container 110 being larger than the volume enclosed by the capillary wick 109.

[0148] In order to produce a fine mist, the orifices are of average diameter greater than 1 micron and smaller than 100 micron. In some embodiments, in which ultrasonic frequencies higher than 1MHz are implemented in the vibrable element, the orifices may be of average diameter greater than 10 microns, to enable breaking of the surface of the water based liquid. For example, wherein the predominant ultrasonic frequency of the piezo assembly 180 is greater than 1 MHz and less than 3 MHz. More typically, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 1.5 MHz and less than 2.5 MHz. The liquid droplets produced are predominantly of diameter less than 10 microns.

[0149] In order to produce sufficiently small mist droplets at lower ultrasonic frequency of the piezo assembly 180, the mesh orifices are of average diameter greater than 1 micron and smaller than 10 micron. Preferably, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 80 kHz and less than 400 kHz. More typically, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 100 kHz and less than 300 kHz

[0150] As illustrated in Fig.l8B, the system is structurally elongated with the mesh membrane element at the distal end, and the majority of the control circuit 135 and battery 125 at the proximal portion. Thereby, a center of gravity of the inhalation device in the assembled state is being displaced proximally more than 3 cm from a mesh membrane 185 when the inhalation device is in a liquid-empty state. Preferably the center of gravity of the inhalation device in the assembled state is being displaced proximally more than 5 cm from the mesh membrane 185.

[0151] Ergonomic fit wherein the maximum of a width WD dimension is less than 20mm, in the top- to-bottom orientation, of a more distal cross-section at a mesh plane 900 passing through the mesh membrane, the mesh plane 900 being perpendicular to the geometrical axis 910 perpendicular to and passing through the center of the mesh membrane 185.

[0152] The previous claim wherein, at the cross-section plane 900 passing through the mesh membrane, the maximum of horizontal width HW of the system is greater than the maximum of vertical width WD dimension.

[0153] In some embodiments, with the fluids compartment inside the mouth, the volume of the fluids compartment 105 is less than 3ml and greater than 0.05ml. Preferably the volume of the fluids compartment 105 is less than 2ml, and most commonly less than 1ml, less than 0.5ml, or less than 0.2ml.

[0154] In order to provide larger dosages, in some embodiments the inhalation device is further comprising a reservoir container 110 of volume greater than the volume of fluids compartment 105, and less than 10ml, or less than 6ml, commonly less than 3ml, or less than 2ml, or less than 1ml.

[0155] In some embodiments, the inhalation device 100 is structured as a kit. The kit comprising: a. an aerosol delivery module 630; b. a fluids cartridge module 805 comprising a pre prefilled reservoir compartment 110; c. a power module 210B comprising (i) a power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135; wherein when the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B, and the fluids cartridge module 805 is attached to the delivery module 630 and in contact with the piezo assembly 180.

[0156] The kit may be such wherein the kit elements are configured to be attachable and detachable such that power module 210B electrical contacts 148 are engaged and disengaged with the distal electrical contacts 147, to establish an electrical communication between the piezo assembly 180 and the power source 125 and / or the electronic control circuit 135.

[0157] In some embodiment, as illustrated in Fig. 18C, the kit is such wherein a mesh membrane 185 is integrally attached to reservoir compartment 110. In other some embodiments, as illustrated in Fig. 11C, the reservoir compartment 110 is attachable and detachable from mesh membrane 185.

[0158] In some embodiment of the kit, the fluids cartridge module 805 which is detachably attachable from the piezo assembly 180. In other embodiments of the kit, the piezo assembly 180 is integral with the power module 210B, the piezo assembly is detachably attachable from the delivery module 630.

[0159] As illustrated in Figs. 19A,19B, in order to facilitate more precision and flexibility of dosing, some embodiments of the inhalation device further comprises a pump module 130, the pump module comprising a pump inlet port 131 and a pump outlet port 133 the pump outlet port being in fluid communication with the fluids compartment 105.

[0160] As illustrated in Figs. 19B, in some embodiments, where the reservoir container 110 is distanced from or not in immediate proximity of the fluids compartment 105, the pump inlet port 131 is in fluid communication with a reservoir container 110 of larger than the volume than the fluids compartment 105.

[0161] Advantageously, the pump outlet port 133 may be situated at and / or feeding a liquid into the fluids compartment 105 at a location leveled below the location of the center of the mesh membrane 185. Thereby, air bubbles are pushed up from the proximity of the mesh membrane 185. Preferably, there is provided an air escape hole in fluid communication with the top of the fluids compartment 105, such that air can escape out to avoid pressure buildup when the pump is pushing liquid into the fluids compartment 105.

[0162] Preferably, the pump module 130 comprises a piezoelectric component. Several types of piezo pumps are known in the art. Fig. 4A illustrates a type of pump wherein the piezoelectric electric mechanism component is changing the shape of a membrane plate. This type of pump module 130 commonly comprises at least one directional valve. Typically, the pump module 130 comprises at least one directional valve, a first valve in fluid communication with the pump outlet port 133, and a second valve in fluid communication with the pump inlet port 131.

[0163] Alternatively, as illustrated in Fig. 20B, the pump module 130 may be a peristaltic type pump.

[0164] As illustrated in Figs. 21A,21B,22C, in some other some embodiments, the pump module 130 is operated manually, comprising a deformable pump chamber, having at least one press- deformable wall portion 134, such as a wall membrane, which is pressed by application of external force and elastically returns to assume an equilibrium pump chamber shape and volume in the absence of external pressing force.

[0165] In some embodiments the system is provided in the form of a kit, either packaged together or packaged separately, the kit comprising: a. an aerosol delivery module 630; b. a fluids cartridge module 805 comprising a pre prefilled fluids compartment 105, attached to a mesh membrane 185; c. a power module base device portion 210B which is characterized by (i) comprising a power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135; wherein when the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B, and the fluids cartridge module 805 is attached to the delivery module 630 and in contact with the piezo assembly 180.

[0166] The kit in some embodiments is such wherein the power module base device portion 210B further comprise base electrical contacts 148.

[0167] In some embodiments the kit elements are configured to be attachable and detachable such that the base electrical contacts 148 are engaged and disengaged with the distal electrical contacts 147, to establish an electrical communication between the piezo assembly 180 and the power source 125 and / or the electronic control circuit 135.

[0168] As illustrated in Fig. 18C, in an exemplary kit setup the fluids cartridge module 805 which is detachably attachable from the piezo assembly 180. Preferably, the fluids cartridge module 805 further comprise a reservoir container 110 of volume greater than the fluids compartment 105. Commonly, the reservoir container 110 is in fluid communication with the fluids compartment 105. For improved ergonomic fit inside the mouth, the top-most boundary of the fluids compartment 105 is situated less than 10mm above the top-most edge of the mesh membrane 185. With the incorporation of reservoir container 110, it can be desirable that also the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185.

[0169] Figs 22A,22B and 23A,23B illustrate an embodiment inhalation device for delivery of an aerosol to the oropharynx of a human user. Similarly to other embodiment elaborated above, the inhalation device comprising: a. an aerosol delivery module 630 comprising: a mesh membrane 185 characterized by having small orifices, a fluids compartment 105 for containing a liquid 120 in the immediate proximity of and in fluid communication with the mesh membrane, and an aerosol outlet 186 for a mist comprising droplets of the liquid generated by the mesh membrane, the mesh membrane defining a mist-generating location; and b. a piezo assembly 180 comprising an ultrasonic vibrable element; and c. a control module 210B.

[0170] In some embodiments, in principle as more explicitly illustrated in other figures, the various components of the system may be detachable and reassembled. For example, the delivery module 630 may be detachable from the control module 210B. In other some embodiments, some or all of the components may be permanently attached. When the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B.

[0171] In some embodiments, the fluids compartment 105 is fillable or pre-filled with a liquid 120.

[0172] As indicated in Fig. 22B, the aerosol outlet 186 is preferably designated as the location of the distal most top edge of the device, distal to the mesh membrane 185.

[0173] In the assembled state the inhalation device is shaped to include a narrow section 226 characterized by a maximum vertical cross-sectional dimension WN of the narrow section that is at least 10% smaller than a distal maximum vertical cross-sectional dimension WD of the aerosol delivery module at the mesh membrane 185 or more distal then the mesh membrane 185, preferably at least 30% smaller, or even 50% smaller. The system geometry is horizontally elongated, and the majority of the weight of the control module is disposed proximally from the narrow section.

[0174] When in use by a human subject, with the lips and / or teeth engaging the narrow section 226, the inhalation device 100 can be maintained in place hands-free, such that the tongue engages a bottom portion of the aerosol delivery module 630 and the oral cavity hard palate engages an opposite side upper portion of the aerosol delivery module 630.

[0175] For the embodiment schematically illustrated in Fig. 22A, as with other embodiments noted above, when the inhalation device is in use, such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, the mesh membrane 185 resides proximally to the exterior edge of the lips, the mesh membrane is in direct fluid communication with the user’s oropharynx, the geometrical perpendicular axis 910 perpendicular to and passing through the center of the mesh membrane 185 is oriented preferably within less than 30 degrees parallel to the axis connecting the proximal most front teeth and the distal end of the oral cavity, and the majority of the weight of the control module resides outside of the user’s oral cavity.

[0176] The assembled state the inhalation device is further comprising an air-channel or air conduit element 121, the air channel is passing along a path that passes around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane, such that when the inhalation device is in use and the mesh membrane resides within the user’s oral cavity, a proximal portion of the air conduit element 121 comprising a proximal entry port 122 is outside of the oral cavity proximal to the teeth, and a distal portion of the air conduit element 121 comprising a distal exit port 529 is situated distally is inside of the oral cavity distal to the teeth. The air channel is preferably passing along a path that passes around a side of the mesh membrane at a level at least partially or predominantly below the center of the mesh membrane.

[0177] Previous illustrations highlighted embodiments which, in the assembled state, the piezo assembly 180 is in mechanical communication to the mesh membrane 185, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the mesh membrane 185. Commonly in such embodiments, the vibrable portion of the piezo assembly 180 is situated distally to the mesh membrane 185 and attached thereto, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push of the mesh membrane 185 towards the liquid when is filled within the fluids compartment 105.

[0178] Fig.23B highlights an embodiment wherein the vibrable portion of the piezo assembly 180 is situated proximally to the mesh membrane 185. In some embodiments, as illustrated in Fig. 23B, the vibrable portion of the piezo assembly 180 is situated within the interior of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the intermediate liquid between the vibrable portion of the piezo assembly 180 the mesh membrane 185, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push on the liquid within the fluids compartment 105 towards the mesh membrane 185.

[0179] The control module 210B may comprise an light indicator and / or digital display 655. In some embodiments the control module 210B further comprises an activation button 659. The activation button 659 may switch the system ON / OFF and in some embodiments also switches between various modes of activation, such as Bluetooth connection, timer modes, aerosol intensity modes, and more.

[0180] It is possible in some embodiments for the vibrable portion of the piezo assembly 180 to be in direct contact with the liquid 120. In other some embodiments, the vibrable portion of the piezo assembly 180 is situated proximally to a portion of and in contact with a proximal wall 104 of the fluids compartment 105, i.e., the proximal wall of the fluids compartment 105 is intermediate between the vibrable portion of the piezo assembly 180 and the liquid 120 within the fluids compartment 105. Thereby, vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on portion of and in contact with a compartment proximal wall 104 of the fluids compartment 105 which are then communicated to the liquid 120 within the fluids compartment 105.

[0181] The fluids compartment 105 is a preferably a removable compartment which is detachably attachable in its entirety. In some embodiments wherein the inhalation device further comprises a reservoir container 110 of volume greater than the fluids compartment 105, wherein the reservoir container 110 is in fluid communication with the fluids compartment 105.

[0182] In the assembled state the inhalation device is shaped to include a narrow section 226 characterized by a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller than a vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane 185 or distal to the mesh membrane 185. The majority of the weight of the control module is disposed proximally from the narrow section. A maximum vertical cross-sectional dimension of the narrow section is at least 30% smaller than a vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane or distal to the mesh membrane 185. Preferably, a maximum vertical cross-sectional dimension of the narrow section is at least 50% smaller than a vertical cross- sectional dimension of the aerosol delivery module at the mesh membrane or distal to the mesh membrane 185. As illustrated in Figs. 23A,23B, the mesh membrane is preferably distal to the narrow section.

[0183] For ergonomic fitting within the oral cavity of a human user, the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185. Preferably the ergonomic fitting of the system includes a rounded top. For better ergonomic fit, the top-most boundary of the reservoir container 110 is preferably situated less than 5mm above the top-most edge of the mesh membrane 185.

[0184] As illustrated in Fig.23B, in some embodiments, when in use and filled with liquids, the majority of the volume of the reservoir container 110 is situated above the level of the center of the mesh.

[0185] In some embodiments, the fluids compartment 105 volume is defined to be geometrically bounded by (i) distally the mesh membrane 185, and (ii) cylindrical walls perpendicular a circle surrounding all the holes on the mesh membrane 185, with the cylinder having the diameter of the smallest circle surrounding all the holes in the mesh membrane 185.

[0186] As illustrated in Fig. 23A the majority of the volume of the reservoir container 110 is situated sideways from the level of the fluids compartment 105. Thereby, when in use and filled with liquids, liquids flow to enter through the sides of the fluids compartment 105 from reservoir container 110.

[0187] As illustrated in Figs. 23A,23B, preferably the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is larger than the total volume of proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185. Preferably the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 50% larger, or 100% larger, or 3 times larger, or 10 times larger than he total volume of proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185.

[0188] The previous claim wherein the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 100% larger than the total volume of fluids compartment 105 combined with the proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185. Thereby, in use, even when held tilted below horizontal (the proximal portion of the device below the distal portion of the device), liquid flows under gravity down from reservoir container 110 to the fluids compartment 105.

[0189] In some embodiments, the width of the fluids compartment 105 is narrow enough in some embodiments such that the liquid flow through the sides of the fluids compartment 105 from reservoir container 110 comprises a capillary flow. For example, the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is preferably less than 0.5 mm. Preferably, the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is less than 0.3 mm.

[0190] Intra-oral ergonomic fit is preferably such that the maximum of a vertical width WD dimension of the system 100 is less than 25mm or less than 20mm, in the top-to-bottom orientation, at any location more distal than the mesh membrane 185 and has a surface both above and below the level of the center of the mesh membrane.

[0191] Intra-oral ergonomic fit is preferably such that the maximum of a vertical width WD dimension of the system 100 is less than 25mm or less than 20mm, in the top-to-bottom orientation, at any location more distal than the mesh membrane 185.

[0192] Intra-oral ergonomic fit is preferably characterized in that the maximum of a vertical width WD dimension of the system 100 is less than 20mm or less than 15mm, or less than 10mm in the top-to-bottom orientation, at the location the mesh membrane 185.

[0193] In some embodiments, with the fluids compartment inside the mouth, the volume of the combined volume of fluids compartment 105 and reservoir compartment 110 which is within the oral cavity is less than 3ml and greater than 0.05ml, preferably less than 2ml, and most commonly less than 1ml, or less than 0.5ml, or less than 0.2ml.

[0194] In order to provide larger dosages, in some embodiments the inhalation device is further comprising a reservoir container 110 of volume greater than the volume of fluids compartment 105, and less than 10ml, or less than 6ml, commonly less than 3ml, or less than 2ml, or less than 1ml.

[0195] As illustrated Figs. 23A and 23B, preferably a longitudinal axis of the aerosol delivery module 630 is perpendicular to the plane tangential to the center of the mesh membrane 185. The longitudinal axis of the aerosol delivery module 630 defines the longitudinal axis of the device system in the assembled state. When the system is use by a human, the lips and / or the teeth of the user engage with the aerosol delivery module 630 such that the longitudinal axis of the aerosol delivery module 630 is oriented distally towards the inside of the mouth.

[0196] The mesh membrane 185 is located proximally to the middle of the aerosol delivery module 630. The mesh membrane 185 is connected to and housed within the aerosol delivery module 630.

[0197] In some embodiments as illustrated in Figs. 23A and 23B, the majority of the fluids compartment is housed within the aerosol delivery module 630. When the system is use by a human, the lips and / or the teeth of the user engage with the aerosol delivery module 630 such that the majority of the fluids compartment is within the oral cavity of the human user. In some embodiments, also the mesh membrane 185 is within the oral cavity of the human user.. The aerosol delivery module 630 further comprises a distal wide section, the distal wide section having a cross section width that is greater than minimal width of the narrow section.

[0198] As an integral part of the aerosol delivery module 630, in some embodiments the aerosol delivery module 630 comprises of a narrow section characterized by the following: (i) a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller than a maximum vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane 185. The narrow section may be characterized by the following: (ii) when the user’s lips and / or teeth are transversely engaged with the narrow section the aerosol outlet directs fluid communication with the user’s oropharynx.

[0199] Figs. 24A,24B,24C illustrate an exemplary kit of the inhalation device 100. The aerosol delivery module 630 is detachably attachable to the control module 210B. When the piezo assembly 180 is integral to the control module 210B, a guiding channel 181 directs the piezo assembly tip towards the proximity of the mesh membrane 185. In embodiments wherein the tip of the piezo assembly 185 penetrates into the fluids compartment 105, the piezo guiding channel 185 further comprise a liquid tight seal around a portion of the piezo assembly 180.

[0200] To elaborate more on the geometric aspects which facilitate the ergonomic fit properties of the system, the inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device is comprising: a. a distal aerosol delivery module 630 comprising a device distal portion 230 of the system distal module 630 including (i) mesh membrane 185 defining a mist-generating location, and (ii) a piezo assembly 180 including an ultrasonically vibrable element, which upon electrical activation produces a mist comprising droplets of the liquid emanating out of the mesh membrane 185 ; b. the distal module 630 further comprising a fluids compartment 105 in fluid communication with the mesh membrane 185; the compartment 105 comprising a compartment-proximal-wall 104, and c. 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 mesh plane 900 passing through the mesh membrane, the mesh plane 900 being perpendicular to the geometrical axis 910 perpendicular to and passing through the center of the mesh membrane 185; wherein the inhalation device 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.

[0201] Preferably, at least part of the neck portion 220 is within distal module 630 connected to the device distal portion 230.

[0202] Geometrically, the inhalation device having an elongated shape 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.

[0203] The inhalation device preferably has the narrow section is characterized by having a location of a narrow width cross-sectional dimension WN that is at least 10% 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.

[0204] For better ergonomic fit, 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.

[0205] As schematically illustrated in Figs.l8B, the inhalation device preferably has the fluids compartment 105 is 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.

[0206] Preferably, 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.

[0207] The system illustrated in Figs 25 A, 26A,26B and 27A,27B is similar to that illustrated in Figs 22A,22B, 23A,23B and 24A,24b,24C, illustrating an embodiment of the inhalation device for delivery of an aerosol to the oropharynx of a human user. Hence the written description and associated indicative number of various parts are similar, for example, the visual cuts in Figs 27A,27B to similarly oriented visual cuts in Figs 23A,23B. A certain highlighted difference is in the kit composition of the two embodiments. The kit decomposition of the system of Figs 25A,25B is illustrated in Figs 24A,24B,24C. But a variation of kit decomposition illustrated in Fig. 25B,26C,25D highlight an embodiment having a replaceable cartridge 805 comprising a fluids compartment 105 attached to a mesh membrane 185 and a reservoir 110. This bares similarities to the embodiment illustrated and described with respect to Fig. 18C, except that the reservoir container 110 majority of volume cavity is situated distal to and vertically above mesh membrane 185.

[0208] Thereby, under the force of gravity, liquids descend from reservoir container 110 to fluids compartment 105, and air bubbles rise up from the mesh membrane to collect at reservoir 185. This is enabled by the vertical extension of the reservoir contained 110 above the mesh membrane and the narrow section of the assembled device. Consequently, when in use such that the teeth of a human user engage with the narrow section, the reservoir container may come into contact with the hard palate or gums which enable to hold the system hands free when in use.

[0209] Some embodiments are implemented with a prefilled aerosol delivery module 630 comprising: a. a distal mesh membrane 185 in contact with a piezo assembly 180; b. electrical contacts 147 which are electrically connected to the piezo assembly 180; c. a distal fluid chamber 105 in fluid communication with the mesh membrane 185; d. a reservoir container portion defining an extension fluid chamber 610; and e. a sterile liquid 120 prefilled into the extension fluid chamber 610.

[0210] The liquid 120 is preferably in fluid communication with the mesh membrane 185.

[0211] For extended storage before use, the prefilled aerosol delivery module 630 of claim 313 wherein, (i) at a first configuration state the liquid is prefilled and sealed in an extension fluids reservoir container 110 such that a barrier 661 impedes flow of the liquid 120 between the fluids chamber 610 and the mesh membrane 185.

[0212] To enable the use of the system, at a second configuration state (ii), to enable active aerosol production use, the barrier 661 is removed or broken and fluid communication of the liquid 120 is established from fluids chamber 610 into the fluids compartment 105 and the mesh membrane 185.

[0213] To enable intermitted use or reuse at a later time, in some embodiments the barrier 661 is recoverable or resealable, such that to liquid flow between the extension fluids reservoir container 110 and chamber 105 is impeded or blocked.

[0214] In order to prevent accidental activation, the prefilled aerosol delivery module 630 at a first configuration state (i) a distal part of the distal device portion module 630 is covered with a protection distal cover 663, such that the mesh membrane 185 is protected before use. At a second configuration state (ii) the protection distal cover 663 is removed, such that the mesh membrane 185 is in unobstructed fluid communication with the ambient air.

[0215] When provided with a kit, it is of importance to consider also the method and conditions of proper assembly. A method of assembly of an inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising the steps of: a. providing a device distal portion 230 of the system distal module 630 including (i) a mesh membrane 185 defining a mist-generating location and (ii) a piezo assembly 180 including an ultrasonically vibrable element; b. providing a fluids compartment 105 in fluid communication with the mesh membrane 185; and c. providing a distal sub-assembly module 630 comprising of a device mid-section neck portion 220 connected to the device distal portion 230; the sub-assembly module 630 is further comprising (i) a distal port 222, (ii) an attachment element 265, and (iii) distal electrical contacts 147 electrically connected to the piezo assembly 180; d. providing a base device portion 210B that includes a power source 125, the proximal device portion 210 further comprising (i) a pressure sensor 126, (ii) an attachment element 260, and (iii) proximal electrical contacts 148; connecting the base device portion 210B to the distal sub-assembly module 630, such that in the assembled state

[0216] (i) there is fluid communication between the distal port 222 to the pressure sensor 126 via a lumen 221;

[0217] (ii) a proximal element 260 of the base device portion 210B is linked to a distal mechanical or magnetic attachment element 265 of the sub-assembly module 630 by a mechanical or magnetic attachment force;

[0218] (iii) 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.

[0219] The method of assembly of an inhalation device of claim 332 is also preferably such wherein the inhalation device 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.

[0220] The method of assembly of claim of an inhalation device wherein the distal sub-assembly module 630 is constructed such that a mid-section neck portion 220 is 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 mesh plane 900 passing through the mesh membrane, the mesh plane 900 being perpendicular to the geometrical axis 910 perpendicular to and passing through the center of the mesh membrane 185.

[0221] In order to improve user compliance, the liquid further comprises a coloring agent. Preferably the liquid is further comprising a sweetening flavoring agent, such as sugar, or salt flavoring agent, such as salt. In order to better comform to the natural lungs environment properties, the liquid includes a pH buffer stabilizing the liquid at a pH higher than pH=4 and lower than pH=8, preferably the pH is less than pH=7 and more than pH=6.

[0222] In order to improve predictable functionality of the aerosol properties, in some embodiments the liquid surface tension is between 70 mN / m to 75 mN / m at 25 degrees Celsius. In order to minimize error of use, in some embodiments, the system is configured to transition between a specific sequence of operation state. The inhalation delivery system wherein the control module 210B further comprises (i) a battery power source, (ii) a control circuitry for electrically powering the piezo assembly 180 comprising an ultrasonic vibrable element, (iii) an inhalation sensor, (iv) an activation switch configured for switching the control module between an initial IDLE-state to a subsequent ON-state; and wherein when the inhalation device is in an assembled state such that the aerosol delivery module 630 is attached to the control module 210B and a liquid 120 is contained within the fluids compartment 105 in fluid communication with the mesh membrane, the system is configured to have at least two activation states such that:

[0223] (i) when the system is at an IDLE-state aerosol mist is not emitted out from the mesh membrane;

[0224] (ii) when the activation switch is at an ON-state, the control circuitry is pre-set such that the piezo assembly is powered to vibrate ultrasonic vibrable element, thereby directly or indirectly generating a vibration pressing of the liquid through the mesh membrane and emit a mist of the liquid.

[0225] In some embodiments, 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. Preferably, the system switches from an IDLE-state to an ON-state after detecting an inhalation event conditioned on a sensor threshold limit.

[0226] In some embodiments the inhalation delivery system is further comprising a distally extended aerosol delivery module 630 in fluid communication with the mesh membrane and the aerosol outlet, the distal end of the system being the distal end of the aerosol delivery module 630. first dose quantity is more than 0.1 mL and less than 2 mL. In common medical applications, the liquid 120 comprises a drug formulation.

[0227] For information communication to the user, while the system is in operation, the system further comprises an indicator module 655 comprising an indicator switchable between an Indicator- OFF state and an Indicator-ON state. Preferably the system switches from an ON-state to an IDLE- state after detecting an inhalation event conditioned on a sensor threshold limit. The condition for switching from an IDLE-state to an ON-state is preferably that the sensor measured pressure difference from ambient pressure is above the threshold limit. In some embodiments, particularly during storage, the system is configured to further comprise an activation state of OFF-state characterized in that the control circuitry does not drain any power from the battery power source. Preferably, the condition is that the sensor measured pressure difference from ambient pressure is above the threshold limit.

[0228] The indicator is preferably a light indicator, such as an LED light indicator. When the indicator is in an Indicator-ON state, the indicator light is preferably switchable between two or more colors illumination states. The system may further comprises an indicator module 655 comprising an indicator switchable between an Indicator-IDLE state and an Indicator-ON state.

[0229] The system preferably switches from an ON-state to an IDLE-state after the detecting an inhalation event conditioned on a sensor threshold limit. The condition for switching from an IDLE- state to an ON-state may be that the sensor measured pressure difference from ambient pressure is above the threshold limit.

[0230] The condition for change of activation state is commonly that the sensor measured pressure difference from ambient pressure is above the threshold limit.

[0231] The system is preferably configured to further comprise an activation state of OFF-state characterized in that the control circuitry does not drain any power from the battery power source. For example, the system is at OFF-state during storage.

[0232] The indicator 655 is preferably a light indicator, such as an FED. The indicator may indicate an Indicator-ON state. For example, the indicator light is switchable between two or more colors illumination states. The indicator module may also emits a sound signal. So the indicator may also be switchable between two or more sound emitting states distinguished by sound pitch and / or sound rhythm or pulsation.

[0233] Preferable the indicator state is automatically switching such that the indicator state when the system is at an IDEE-state is different from the indicator state when the system is at an ON-state.

[0234] It can be desirable that there is a correspondence between the indicator state and the system state. To serve its purpose to the user, the indicator state is preferably externally visible and / or audible, thereby providing an externally communicated indication of the state of the system.

[0235] Generally, the system is switchable between at least two activation states selected from (A) an IDEE-state at which power is communicated from the battery to the control circuitry but the mesh membrane does not emit a mist, and (B) an ON-state at which the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid after the inhalation sensor detects an inhalation event. The switching between the at least two activation states is preferably conditioned on the control circuitry detection of an inhalation event.

[0236] In some embodiments, the activation duration is pre-set, such that when the system is at an ON-state, the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid for not more than 2 seconds after the inhalation sensor stops detecting an inhalation event. For example, the system is at an ON-state, the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid for not more than 1 second after the inhalation sensor stops detecting an inhalation event.

[0237] When the system is at an ON-state, the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid after and during the inhalation sensor detects an inhalation event. In an exemplary timer pre-set configuration, when the system is at an ON-state, the piezo assembly 180 is powered to vibrate the mesh membrane 185 and emit a mist of the liquid after the inhalation sensor detects an inhalation event and for a pre-set duration of more than 0.1 second and less than 5 seconds.

[0238] In the system configuration with the proximal wall 104 vibration mechanism, when the system is at an ON-state, the piezo assembly 180 is powered to vibrate a proximal wall 104 of the fluids compartment 105 and emit a mist of the liquid after the inhalation sensor detects an inhalation event and for a pre-set duration of more than 0.1 second and less than 5 seconds

[0239] The duration of activation can be different, for example, the piezo assembly is powered to vibrate after the inhalation sensor detects an inhalation event and for a pre-set duration of more than 0.5 second and less than 3 seconds, preferably more than 1 second.

[0240] The inhalation sensor may be associated with air flow, such that the inhalation sensor is a flow sensor configured to measure the air flow created by a human user one of at least inhaling and / or exhaling air. In particular, the inhalation event can be detected as a flow of air. In such a case, the sensor threshold limit is a minimal flow rate.

[0241] In some embodiments, the inhalation sensor is a pressure sensor. In such embodiments, the inhalation sensor is preferably in fluid communication with a port displaced distally therefrom, the inhalation sensor being effective to detect an air pressure difference between an air pressure at the port and an ambient air pressure proximal to the port. For example, the sensor threshold limit is a minimal pressure difference. In order to be associated with an inhalation event, when in use, the port is located more distal than the proximal most location of engagement of the lips of the user with the system casing. Thereby, the inhalation sensor is effective to detect a difference between an air pressure in the inhalation intra-oral flow-path and an ambient air pressure outside the inhalation device.

[0242] The control circuitry configured to initiate and / or cease activation of the piezo assembly in response to detection of an air pressure difference greater than a threshold limit, and / or cease activation of the piezo assembly in response to detection of an air pressure difference less than a pressure threshold limit. Preferably, the inhalation device is such wherein the threshold limit is a pressure more than 1 cm H2O and less than 10 cm H2O, or a pressure less than 5 cm H2O, or a pressure more than 2 cm H2O.

[0243] The sensor is preferably located in proximity to the electronic control module, which is proximally located way from the distal end of the system within the oral cavity. Therefore, the inhalation device is preferably comprising a lumen for establishing fluid communication between the port and the inhalation sensor, the lumen including a first lumen portion in the control module and a second lumen portion in the aerosol delivery module.

[0244] When and / or after an inhalation event is not detected the system preferably is in or switching into a non-inhalation state. A non-inhalation detection is when the inhalation sensor and / or the control module do not detect an inhalation event. A non-inhalation state is commonly a state at which and / or after the control circuitry and / or the inhalation sensor do not detect an inhalation event.

[0245] In some embodiments, the system further comprises a fill-level sensor comprising at least two electrodes exposed to interior of the liquid chamber and electronically connected to control circuitry, wherein the fill level sensor measures the resistance between the two electrodes. Commonly, a detection of a change in the liquid fill-level of the fluids compartment corresponds to a change in the sensor resistance measurement and / or to an increase of the resistance measurement above a limit value.

[0246] In association with a desired dosage control, a pre-determined fill-level sensing state or limit value by the sensor and control circuitry corresponds to an End-of-dose event detection. For example, a realization of the fill level sensor may include one or more of the electrodes of the fill level sensor is located near the bottom of the distal liquids chamber. Typically, an increase resistance corresponds to a low-fill state.

[0247] A cartridge module 855 may comprise one of the fluids compartment 105 or the reservoir container 110, or both. Preferably, the fluids cartridge module further comprises a fill-level sensor, in the form of at least one or more electrodes, the fluids cartridge module comprising externally exposed fill-sensor-contacts connected to the at least one electrode of the fill sensor. When in assembled state with the fluids cartridge module inserted, the fill-sensor contacts are in electronic communication with the electronic circuitry of the control module.

[0248] In embodiment comprising a fill detection module, preferably an End-of-dose state is further characterized by a low-fill detection.

[0249] In some embodiment the system, preferably a longitudinal axis of the aerosol delivery module 630 is perpendicular to the plane tangential to the center of the mesh membrane 185. The longitudinal axis of the aerosol delivery module 630 defines the longitudinal axis of the device system in the assembled state. When the system is use by a human, the lips and / or the teeth of the user engage with the aerosol delivery module 630 such that the longitudinal axis of the aerosol delivery module 630 is oriented distally towards the inside of the mouth.

[0250] The mesh membrane 185 is located proximally to the middle of the aerosol delivery module 630. The mesh membrane 185 is preferably located distally to the middle of the aerosol delivery module 630.

[0251] The mesh membrane 185 is connected to and housed within the distal 50% of the aerosol delivery module 630.

[0252] In embodiments wherein both (i) the piezo assembly and the mesh membrane 185, and (ii) the majority of the fluids compartment is housed within the aerosol delivery module 630. When the system is use by a human, the lips and / or the teeth of the user engage with the aerosol delivery module 630 such that both (i) the piezo assembly comprising the mesh membrane 185, and (ii) the majority of the fluids compartment is within the oral cavity of the human user. In some embodiments the aerosol delivery module 630 further comprises a proximal wide section, the proximal wide section having a cross section width that is greater than minimal width of the narrow section.

[0253] As an integral part of the aerosol delivery module 630, in some embodiments the aerosol delivery module 630 comprises of a narrow section characterized by the following: (i) a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller than a maximum vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane 185. The narrow section may be characterized by the following: (ii) when the user’s lips and / or teeth are transversely engaged with the narrow section, the mesh membrane 185 resides within the user’s oral cavity and the aerosol outlet is in direct fluid communication with the user’s oropharynx.

[0254] In common medical applications, the liquid 120 is a drug formulation containing Epinephrine at a concentration greater than 0.5 mg / mL and less than 8 mg / mL. For example, the liquid 120 is a drug formulation containing Epinephrine at a concentration greater than 1 mg / mL, or the liquid 120 is a drug formulation containing Epinephrine at a concentration greater than 2 mg / mL, or the liquid 120 is a drug formulation containing Epinephrine at a concentration less than 5 mg / mL, or The previous claim wherein the liquid 120 is a drug formulation containing Epinephrine at a concentration is about 4 mg / mL.

[0255] For proper dosing in common medical applications, the dose quantity of the liquid is configured for delivery such that the dose is more than 0.1 mL, or more than 0.2ml, or more than 0.4 mL, or more than 0.6 m, or more than 0.8 mL. Commonly the dose is less than 1.2 mL.

[0256] For Epinephrine containing liquids delivery, the dose quantity of the liquid is configured for delivery such that the total amount of Epinephrine contained in the first dose quantity is more than 0.3 mg and less than 8 mg, commonly the total amount of Epinephrine contained in the first dose quantity is more than 0.5 mg. When planned for stepped dose delivery, the total amount of Epinephrine contained in the first dose quantity is preferably more than 1 mg. Commonly the total amount of Epinephrine contained in the first dose quantity is less than 6 mg, or less than 4 mg, or about 2 mg.

[0257] For improving inhalation dosing precision, the dose quantity of the liquid is configured for delivery such that the dose quantity is predetermined by a corresponding dose-total-activation-period, the dose-total-activation-period being a combined activation time during which the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid. Preferably, the system and / or the control module automatically switch to the IDLE-state after the combined activation time during which the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid is equal or greater than a pre-set dose-total-activation-period.

[0258] In some embodiments, an End-of-dose state characterized and / or detected by one of (i) detecting that the dose quantity has been delivered, and (ii) the indicator is changing its activation state. Advantageously, detecting that the dose quantity has been delivered is determined by at least one of: (i) the quantity of liquid in the fluids compartment is reduce from a previous amount by an amount equal to about the predetermined dose quantity, (ii) a corresponding dose-total-activation- period has been completed, (iii) a pre -determined fill-level sensing state or limit value by the sensor and control circuitry.

[0259] For external indication to the user, an indicator is changing its activation state. Preferably, the indicator is a light indicator where light is switching from one color state to another color. In some embodiments, the indicator is switching from one sound emitting state to another.

[0260] Visual indication od the dosing progress can also be performed by the user in some embodiments wherein at least a portion of the fluids compartment 105 bounding walls is of sufficient transparency such that a level of the liquid fill level surface is visually discernable as a change of color or hue. For example, where at least a portion of the fluids compartment 105 bounding walls or a is of sufficient transparency such that a level of the liquid fill level surface is visually discernable as a change of color or hue.

[0261] In some embodiments multiple dosages are contained for delivery within a the system capabilities without the need for refill. For example, the fluids compartment, such as the reservoir container 110, is sized sufficiently to contain both a first dose quantity and a second dose quantity of the same size as the first dose quantity.

[0262] For medical safety, it can be desirable that the control circuitry is configured such that a switch needs to be engaged to enable the administration of a second or subsequent dose if needed by a user. Preferably, an indicator is pre-set to indicate the termination of the second dose quantity.

[0263] There are several preferred initial settings. The system and the control module are commonly configured to be is initially at an IDLE-state.

[0264] For application cases of fast use need, the drug inhalation delivery system is pre-assembled.

[0265] A preferred default pre-set is determined for the values of (i) the sensor threshold limit, (ii) the dose quantity.

[0266] For proper operation, at least a portion of the liquid is within the fluids compartment.

[0267] For fast and sterile medical applications pre -filling may be preferred, such that the liquid comprising a drug formulation is pre -filled within the fluids compartment. For example, the liquid comprising a drug formulation is pre -filled and sealed within the fluids compartment. In common medical formulations for inhalation the liquid is sterile.

[0268] For protection of the sensitive mesh and / or for accidental activation block the system is further comprising a distal cap 663. For example, wherein the distal cap is a protective cover. The distal cap may be connected to the aerosol delivery module 630. In some embodiments the cap is a portion of the aerosol delivery module 630. In some embodiments the cap is a removable portion of the aerosol delivery module 630.

[0269] For post-use protection, the cap may be reversibly attachable to the aerosol delivery module 630 or generally to the distal aerosol delivery module 630. For example, wherein the distal cap is at least partially covering over the aerosol outlet. The cap is typically removable. During storage and / or before use, the system is typically configured to be initially at an OFF- state.

[0270] The protective distal cap 663 is preferably also operating as a switch such that a movement of the cap enable switching the control module between an initial OFF-state to IDLE-state to a subsequent ON-state. For example, the cap is an activation switch such that a movement of the cap is switching the control module between an initial OFF-state to a subsequent IDLE-state. Preferably the cap is an activation switch such that a movement of the cap is switching the control module to a subsequent ON-state. For simplicity of use, in some embodiments a movement of the cap is a removal of the cap. For example, the mechanism of movement of the cap can be a turning of the cap. In order to enable re-storage for future re-use, in some embodiments the cap 663 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 IDLE-state. For example, the operation of the cap as a switch is configured such that the movement of the cap closes an electric contact or an electric circuit which is previously open.

[0271] In general, in some embodiments of the system, the activation switch is a reversible switch such that reversing the configuration of the switch enable switching the control module between an initial ON-state to a subsequent IDLE-state or to a subsequent OFF-state.

[0272] In other some embodiments, gear for securing single use, the activation switch is non- reversible such that the switching the control module between an initial ON-state to a subsequent OFF-state is blocked.

[0273] Realization of the switch may be wherein the switch element is selected from: a cap, a press button, a touch contact, a lever movement.

[0274] Typically, a first engagement with the switch is switching the system and / or the control module from an OFF-state to an ON-state or an IDLE-state. Optionally, a second engagement with the switch is switching the system and / or the control module from an ON-state to an OFF-state.

[0275] For protection of the system in more rugged storage, such as within bags or in a pocket of the user, the system is further comprising a rigid protective casing 695, the protective casing covers over the majority of the aerosol delivery module 630 and the control module.

[0276] In order to facilitate fast emergency use, the activation switch remains exposed for external user access without removal of the protective casing. Moreover, preferably in addition the distal end of the protective casing comprises a central aperture such that a mist can exit distally from the aerosol outlet without removal of the protective casing. In some embodiments, a distal cap can be removed from the protective casing and / or the aerosol delivery module 630 without removal of the protective casing. For example, when in use, the user lips and / or teeth engage with the protective casing covering over the aerosol delivery module 630.

[0277] For improved user sensation when in engagement with oral soft tissue, an elastic band is wrapped around at least a portion of the aerosol delivery module 630. Typically, the portion is a distal section of the aerosol delivery module 630. In order to enable flexible choice for users, the elastic band is reversibly removable.

[0278] In some embodiments, the elastic band also covers over an inlet or a filling port 103 into the liquids chamber. Thereby, it is functioning also as a removable seal on the inlet filling port 103.

[0279] For improvement of user intra-oral engagement, in some embodiments at least a portion of the aerosol delivery module 630 is further comprising a taste -producing and / or aroma producing surface section 224. For example, the taste -producing and / or aroma producing surface comprises a flavoring agent and / or a scented embedded agent and / or coating. Preferably the taste -producing and / or aroma producing surface is reversibly removable. For example, the taste -producing and / or aroma producing surface is in the form of an elastic band.

[0280] In some embodiments, the system is comprising, 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. For example, 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. In some embodiments, the cross section area of the filling port 103 is smaller than 1 cm2 and bigger than 0.1 cm2, or smaller than 0.5 cm2. In some embodiments, the cross-section area of the secondary filling port 113 is smaller than 0.3 cm2and bigger than 0.001 cm2, or smaller than 0.1 cm2.

[0281] It can be desirable to implement a consistent method for performing a drug dose inhalation using the inhalation device, wherein, the inhalation device is comprising: a. an aerosol delivery module comprising: a mesh membrane 185, a piezo assembly 180 comprising an ultrasonic vibrable element, a fluids compartment 105 in fluid communication with the mesh membrane, an aerosol outlet; and a distally extended aerosol delivery module 630 in fluid communication with the mesh membrane and the aerosol outlet; b. a 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 IDLE-state to a subsequent ON-state; and c. a liquid 120 contained within the fluids compartment 105; wherein 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; and wherein the method comprising: i. the system is initially at an OFF-state at which the control circuitry does not drain power from the battery; ii. engaging the activation switch thereby switching the system from an OFF-state to an IDLE-state at which power is communicated from the battery to the control module; iii. placing the distal tip of the system such that the lips engage an outer surface of the system and the mesh membrane is in fluid communication with the oral cavity; iv. detecting an inhalation event conditioned on a sensor threshold limit; v. powering the piezo assembly to vibrate the mesh membrane and emit a mist of the liquid after detecting an inhalation event; vi. automatically subsiding and / or stopping the powering of the piezo assembly to subside or stop the emission of a mist after either detecting a non-inhalation state or a pre-determined fixed activation period.

[0282] To improve user tracking and awareness of the process, the method may be further comprising a step (vii) indicating that a pre-determined first dose quantity of the liquid has been delivered, the first dose quantity is more than 0.1 mL and less than 2 mL.

[0283] For medical applications, the liquid is comprising a drug formulation.

[0284] To improve user tracking and user awareness of the process, the method may be further comprising the step of turning on an external visible and / or audible indicator in parallel with at least a portion of the time when powering the piezo assembly to vibrate. The method may be further comprising the step of detecting that a dose quantity has been delivered.

[0285] Preferably the methods is further comprising the step of detecting an End-of-dose state.

[0286] To improve user tracking and user awareness of the process, the method may be comprising the step changing the activation state of an of indicator after detecting that a dose quantity has been delivered.

[0287] To improve accuracy of delivery wherein the placing of the distal tip of the system is positioned such that both the mesh membrane 185 is within the oral cavity distally from the lips. For example, placing of the distal tip of the system is positioned such that also the majority of the fluids compartment 105 volume is within the oral cavity distally from the lips. Preferably, the placing the distal tip of the system is positioned such that the lips and / or the teeth engage in contact with the narrow section.

[0288] For prevention of unintended activation, the method may be comprising the switching the system from an IDEE-state to and ON-state comprise of moving a distal cap or protective cover. For example, the moving of the distal cap or protective cover comprises of removing the distal cap or protective cover.

[0289] For preferably enabling re-use, switching the system from an IDEE-state to an ON-state is simultaneously also setting the system into a default state of powering the piezo assembly to vibrate the mesh membrane and emit a mist of the liquid after detecting an inhalation event. Preferably, the switching the system from an IDEE-state to and ON-state is simultaneously also setting the system into a default state with a predetermine dose quantity. In some mode of operating, the switching the system from an IDEE-state to and ON-state is simultaneously also setting the a predetermine End-of- dose state.

[0290] For improved inhalation delivery, the aerosol delivery module is further comprising a bottom-air-channel or air conduit element 121, the bottom-air channel is passing along a path that is passing around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane, Preferably the bottom-air-channel element 121 is comprising a proximal entry port 122 situated proximally to the mesh membrane, and a distal exit port 529 situated distally to the mesh membrane at a level below the center the mesh membrane.

[0291] For lowering the undesired deposition of aerosol in the oral cavity, in an embodiment the distal exit port 529 is situated at a level at least partially or predominantly below the center of the mesh membrane 185. Preferably, when in the assembled state the aerosol delivery module is positioned in use inside the mouth of a human user, the proximal entry port 122 is situated outside of the mouth and enables ambient entering-air-flow 525 to enter into the bottom-air-channel element 121, and to a distal exiting-air-flow 526 via a distal exit port 529 at a level below the center the mesh membrane inside the mouth. Thereby, there is a reduced portion the aerosol ejected 141 from the mesh membrane that collide with and settle onto the tongue tissue, compared with when no air flows in the bottom- air-channel element 121.

[0292] For lowering the undesired deposition of aerosol in the oral cavity, in an embodiment the aerosol delivery module 630 further comprising a tongue -depressing element 688 which extends more distally from the mesh membrane 185 by at least 5mm, the tongue-depressing element 688 extends at a level under the lowest perforated level of the mesh membrane, preferably at a level under the bottom edge of the mesh membrane. Preferably, The previous claim wherein the tonguedepressing element 688 which extends more distally from the mesh membrane 185 by at less than 30mm. For example, the tongue -depressing element 688 extends at a level at least 3mm, or at least 5mm, below the center of mesh membrane. More optimally, the tongue -depressing element 688 extends at a level below the edge of mesh membrane. For example, at least a portion of the tonguedepressing element 688 extends at a at level below the bottom-air-channel element 121.

[0293] The inhalation delivery method is preferably implemented for medicinal application wherein the liquid is comprising a pharmaceutical active substance. Commonly the liquid is comprising an FDA approved drug.

[0294] Suitable pharmaceutical active substances in liquid form may be comprising 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.

[0295] Suitable pharmaceutical active substances in liquid form may be comprising a corticosteroid medication, including but not limited to one of Fluticasone, Budesonide, Prednisolone, or a mixture thereof.

[0296] Suitable pharmaceutical active substances in liquid form may be comprising a muscarinic medication, including but not limited to one of Revefenacin, Ipratropium bromide, Tiotropium bromide, or a mixture thereof. Suitable pharmaceutical active substances in liquid form may be comprising a Mucoactive medication, including but not limited to one of carbocysteine, erdosteine, N-acetylcysteine, or a mixture thereof.

[0297] Suitable pharmaceutical active substances in liquid form may be comprising a antiinflammatory medication, including but not limited to Methylxanthines.

[0298] Suitable pharmaceutical active substances in liquid form may be comprising nicotine.

[0299] Suitable pharmaceutical active substances in liquid form may be antimicrobial agent, including but not limited to one of Silver nanoparticles, PVP Iodine, tobramycin, colistin, and aztreonam lysine.

[0300] Suitable pharmaceutical active substances in liquid form may be comprising a vaccine. For example, the vaccine may be a vaccine for a respiratory infection caused by a virus selected from influenza or corona viruses.

[0301] Suitable pharmaceutical active substances in liquid form may be comprising a cannabinoid substance.

[0302] Suitable pharmaceutical active substances in liquid form may be comprises a B12 vitamin.

[0303] Suitable pharmaceutical active substances in liquid form may be comprising an aqueous emulsion of droplets encapsulating the drug or active substance.

[0304] Suitable pharmaceutical active substances in liquid form may be comprising encapsulating nanoparticles dispersed within an aqueous solution.

[0305] Suitable for aerosol characteristics are nanoparticles or droplets having a size distribution peak at droplets size larger than 5nm and smaller than lOOOnm. For example the nanoparticles or droplets diameter is having a size distribution peak at size larger than 600nm and smaller than 900nm, such as having a size distribution peak at size larger than 300nm and smaller than 600nm, or nanoparticles diameter is having a size distribution peak at size larger than lOOnm and smaller than 300nm, or a size distribution peak at size larger than 50nm and smaller than lOOnm, or a size distribution peak at size larger than lOnm and smaller than 50nm.

[0306] For improved performance consistency, 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. In some embodiments, the liquid is comprising an aqueous colloid of nanoparticles, wherein the nanoparticles have a zeta potential of size greater than 10 mV. Preferably, the nanoparticles diameter is having a size distribution peak at size larger than 2nm and smaller than lOOnm.

[0307] In some embodiment, the liquid further comprises a coloring agent.

[0308] For improved biocompatibility, the liquid includes a pH buffer stabilizing the liquid at a pH higher than pH=4 and lower than pH=8, preferably the pH is less than pH=7, and also preferably the pH is more than pH=6. To improve user sensation, the liquid is further comprising a sweetening flavoring agent. For example, the sweetening agent is sugar. Alternatively, or in supplement, the liquid is further comprising a salting flavoring agent, such as sodium chloride.

[0309] To improve consistency of performance, the liquid surface tension is between 70 mN / m to 75 mN / m at 25 degrees Celsius.

[0310] Typically the volume of the fluids compartment 105 is less than 3ml and greater than 0.01ml. Preferably, the volume of the fluids compartment 105 is less than 1ml, or less than 0.2ml, or less than 0.1ml.

[0311] Typically reservoir container 110 is of volume greater than the volume of fluids compartment 105, and less than 10ml, preferably less than 6ml, or less than 3ml, or less than 2ml, or less than 1ml.

[0312] For avoidance of any doubt, any reference to volumes of “reservoir container” or “fluids compartment” is meant to refer to the cavity space of these elements which can be filled by fluids. The physical structure of a “reservoir container” or “fluids compartment” is meant as comprising also at least some physical boundary walls enclosing and supporting the volume cavities.

[0313] **

[0314] It will be clear to the skilled artisan that any of the features described in connection with any of the figures can be combined with each other with the scope of the present invention even if not explicitly combined in this disclosure. For example, 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. As another non-limiting example, 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 reservoir container at least partly higher than the liquid-retaining compartment.

[0315] The system illustrated in Figs 28A,28B,28C and in Figs 29,30 has many similarity to the systems illustrated in Figs 25A,B,C,D and Figs 26A,B and Figs 27 A, B. We here highlight some additional features and differences. A plenum space 530 is situated distal to mesh membrane 185 and is distally-open. A portion of the plenum space 530, preferably the majority of plenum space 530, is situated between distal reservoir 110 from above and a tongue depressing element 688. In Figs 28A and 29, axis 920 indicate a vertical axis orientation going through the plane of mesh membrane 185. A vertical axis 920B parallel to vertical axis 920 and more distal along a horizontal axis 910 passing perpendicularly through any location of the mesh membrane, such that it passes from the bottom through tongue depressing element 688, then through plenum space 530, and then through distal reservoir 110. The majority of distal reservoir 110 is situated above the top level of the plenum space 530. Thereby, when aerosol is ejected, from mesh membrane 185, it passes through the planum space 530 under the distal reservoir 110. Specifically, a horizontal axis 910 should be understood as any representative axis passing perpendicularly through any location on the mesh membrane, such as through the center of the mesh membrane or any other location on the mesh membrane, preferably through majority of locations on the mesh membrane.

[0316] Fig. 28B illustrates the assembly of the inhalation device 110 with distal aerosol delivery module 630 moved to be attached to proximal control module 210, thereby constructing the assembled configuration illustrated in Fig.28A. As illustrated, in some embodiments that attachment movement is along longitudinal axis 910.

[0317] Fig. 28C illustrates the assembly of distal aerosol delivery module 630 with cartridge 805 comprising of distal reservoir 110 moved to be attached to a holding portion of distal aerosol delivery module 630 comprising a tongue depressing element 688, thereby constructing the assembled configuration of a full distal aerosol delivery module 630 as illustrated in Fig. 28B. As illustrated, in some embodiments that attachment movement is along a quasi-vertical axis approximately parallel to vertical 920.

[0318] Fig. 29 illustrated a vertical cut thought the system. In an embodiment shown in Fig. 29, in the assembled configuration, a piezo assembly tip penetrates into chamber 105. Thereby, when liquid is filled into chamber 105, a piezo assembly tip and comes into in contact with the liquid.

[0319] Fig 30 illustrates longitudinal airflow channels 121 in fluid communication between a proximal inlet 122 proximal to the mesh membrane and the central plenum space 530 distal to the mesh membrane, thereby channel 121 is shaped to direct airflow of a user inhalation. In some embodiments, a distal port 124 communicates between airflow channel 121 and central plenum space 530 at a location proximal to the distal end of reservoir 110, thereby directing a flow of incoming air closer to the mesh membrane. Air-channel or air conduit element 121 is preferably traverse along a path that passes around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane, such that when the inhalation device is in use and the mesh membrane resides within the user’s oral cavity, a proximal portion of the air conduit element 121 comprising a proximal entry port 122 is outside of the oral cavity proximal to the teeth, and a distal portion of the air conduit element 121 comprising a distal exit port 529 is situated distally is inside of the oral cavity distal to the teeth. In some embodiments, air channel 121 is preferably passing along a path that passes around a side of the mesh membrane at a level at least partially or predominantly below the center of the mesh membrane. In some embodiments, during use, when the user lips are wrapped around the device mid-portion neck, the air channel 121, 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. As illustrated in Fig.30, during use in some embodiments, air stream entering the oral via air channel 121 is distally split into a portion streaming within central plenum space 530 and a portion streaming in parallel outside of central plenum space 530.

[0320] Fig. 31 illustrates a typical placement of the system 100, of an embodiment similar to one illustrated in Figs 28A,28B and 28C, with respect to an oral cavity when in use by a human. In some embodiments, when the inhalation device 100 is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, at least a portion of a reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips. Preferably, the majority of reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips. In some embodiments, as illustrated in Fig. 31, the majority of reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the teeth. In some embodiments, the distal surface of the teeth set the proximal boundary of the oral cavity, and at least a portion of proximal air inlet port 122 is proximal to the distal surface of the teeth, thereby ambient airflow communication into the oral cavity is facilitated through inlet port 122.

[0321] In some embodiments, the cartridge 805 comprising reservoir 110 is detachable and reattachable to the remaining distal aerosol delivery module 630 which comprises the mesh membrane and tongue depressor 688. Thereby, in such embodiments, the complete distal aerosol delivery module 630 is an assembly comprising, when joined, a detachable component cartridge 805 comprising reservoir 110.

[0322] In some instances herein, the portion of a distal aerosol delivery module 630 not comprising the cartridge 805 is called a ‘distal frame’. In other instances that portion is called a distal aerosol module, and the meaning is made clear from the context.

[0323] An example of an inhalation device comprising a cartridge which comprises the distal reservoir 110 (but not the mesh membrane 185 and / or the proximal chamber 105) is illustrated in Figs. 32A, 32B and 32C.

[0324] FIRST ADDITIONAL DISCUSSION OF EMBODIMENTS

[0325] According to embodiments, an inhalation device 100 for delivery of an aerosol to the oropharynx of a human user is disclosed. The inhalation device comprising: a. an aerosol delivery module 630 comprising: a mesh membrane 185 characterized by having small orifices defining a mist-generating location, a fluids compartment 105 for containing a liquid 120 proximal to and in fluid communication with the mesh membrane; and b. a piezo assembly 180 comprising an ultrasonic vibrable element; c. a control module 210B comprising a battery power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135; d. a reservoir container 110 of volume greater than fluids compartment 105;

[0326] When the inhalation device is in an assembled state, such that the aerosol delivery module 630 is attached and distally disposed to the control module 210B, the assembled inhalation device is shaped to include a narrow section 226. In some embodiments, a pre -filled cartridge module 805 comprises: a. a mesh membrane 185; b. a fluids compartment 105 proximal to and in fluid communication with the mesh membrane; c. a reservoir container 110 of volume greater than the fluids compartment 105; d. a liquid 120 prefilled in reservoir container 110 and sealed from ambient air.

[0327] Typically, reservoir container 110 of volume greater than the fluids compartment 105 by at least a factor 2 times, or at least a factor 5 times, or at least a factor 10 times.

[0328] According to embodiments, an inhalation device 100 comprising a. The prefilled cartridge module 805 of claim 3, in which mesh membrane 185 defines a mist-generating location; b. a control module 210B comprising battery power source 125, a piezo assembly 180, and an electronic control circuitry 135; c. an aerosol delivery module 630 connected or connectable to the control module 210B and connected or connectable to cartridge module 805, such that in the assembled state piezo assembly 180 is in contact with cartridge module 805;

[0329] Also with the prefilled cartridges, preferably when the inhalation device is in an assembled state, such that the aerosol delivery module is distally disposed and the control module is proximally attached thereto, the assembled inhalation device is shaped to include a narrow section 226.

[0330] The system is preferably of elongated shape wherein, (i) a geometrical axis 910 defines a longitudinal axis of the system perpendicular to and passing through the center of the mesh membrane, (ii) a vertical axis crossing the longitudinal axis 910 in a vertical orientation perpendicular to longitudinal axis 910; and the system 100 is of elongated shape in the sense that the extent of the inhalation device 100 along the longitudinal axis 910 is greater than extent of the inhalation device 100 along the vertical axis by a factor of at least 3 time, or at least 5 times.

[0331] According to embodiments, a cartridge element of the system may be either prefilled or refillable, wherein aerosol delivery module 630 comprise cartridge module 805, comprising: e. mesh membrane 185; f. fluids compartment 105 proximal to and in fluid communication with the mesh membrane; g. reservoir container 110 of volume greater than fluids compartment 105; and

[0332] A cartridge module 805 is attachable detachable to aerosol delivery module 630. A refillable cartridge module typically includes an inlet access to reservoir container 110 for refilling

[0333] When in use, reservoir container 110 is in fluid communication with fluids compartment 105. For clarity of distinction, the fluids compartment 105 cavity is defined to be geometrically bounded by (i) the mesh membrane 185, and (ii) cylindrical walls perpendicular to a circle of largest diameter that can be embedded within the mesh membrane 185. The mesh membrane forms the distal wall of fluids compartment 105, thereby, fluids compartment 105 is all proximal to the mesh membrane 185.

[0334] For extended storage need, before use, when cartridge module 805 is prefilled with a liquid 120, the liquid is sealed from ambient air within the aerosol delivery module. The seal is removable such that fluid communication is established between the 120 and ambient air via holes in the mesh membrane 185. In some embodiments, a sealing element may be an external cover over the mesh membrane, isolating the mesh holes from ambient air. In other embodiment, the sealing element may be an internal removable barrier between liquids stored within reservoir 110 and fluids compartment 105.

[0335] According to embodiments, the system is further comprising a tongue-depressing element 688 extends distally to the mesh membrane, at a level vertically below the lowest perforated level of the mesh membrane, or at a level below the bottom edge of the mesh membrane.

[0336] In the assembled state the inhalation device is further comprising an air-channel or air conduit element 121 comprising a proximal entry port 122 and a distal exit port, the distal exit port being more distal than the mesh membrane. Typically an air channel 121 comprises a lumen portion and / or a grove portion.

[0337] In some embodiments, the majority of reservoir container 110 cavity is distal to fluids compartment 105.

[0338] In some embodiments, reservoir container 110 is detachably attachable to the fluids compartment 105.

[0339] Typically, the inhalation device 100 is additionally characterized by (i) a narrow section having a maximum vertical axis cross-sectional dimension that is at least 10% smaller, or at least 30% smaller, than a vertical axis cross-sectional dimension of the aerosol delivery module distal to the narrow section; and (ii) when a user’s lips and / or teeth are transversely engaged in the vertical orientation with the narrow section, the mesh membrane resides within the user’s oral cavity.

[0340] Typically, a narrow section characterized by a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller, or at least 30% smaller, than a maximum vertical cross- sectional dimension of the aerosol delivery module at the mesh membrane 185.

[0341] In some embodiments, the inhalation device 100 is characterized by a maximum vertical axis cross-sectional dimension of the narrow section that is at least 10% smaller, or at least 30% smaller, than a vertical axis cross-sectional dimension of the aerosol delivery module 630 distal to the narrow section and more distal than the distal most edge of the mesh membrane and of the reservoir container 110 cavity.

[0342] In some embodiments, the majority of the weight of the control module 210B is disposed proximally from the narrow section, and the majority of the volume of the reservoir container 110 is distal to the narrow section 226. In some embodiments, a maximum vertical cross-sectional dimension of the narrow section is at least 50% smaller than a vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane or distal to the mesh membrane 185.

[0343] Typically, the narrow section is proximal to the mesh membrane 185, and wherein the narrow section is narrower, by at least 10% or at least 30%, in the vertical direction than any portion of the delivery module 630 distal to the mesh membrane having both a bottom surface and a top surface of an air channel 121. typically, when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, the mesh membrane 185 resides distally to the proximal edge of the lips towards and / or within the user’s oral cavity.

[0344] In some embodiments, the air channel extends along a path that passes around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane.

[0345] In some embodiments, when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, proximal entry port 122 is outside of the oral cavity and the distal exit port is inside of the oral cavity. Preferably, the air channel is passing along a path that passes around a side of the mesh membrane at a level at least partially or predominantly below the center the mesh membrane.

[0346] Typically, a portion of the air channel 121 passes below the cavity of reservoir container 110. In some embodiments, a portion of the air channel 121 passes below the majority of the cavity of reservoir container 110. Thereby, a wide low resistance air channel may be implemented, with reduced deposition of aerosol droplets on the wall of the channel. Preferably, the majority of air channel 121 distal to the mesh membrane 185 passes under the cavity of reservoir container 110.

[0347] Typically, a proximal port 122, of air channel 121, is proximal to the mesh membrane 185.

[0348] Preferably, to enable ergonomic fit within the oral cavity, the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185.

[0349] In some embodiments, when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, at least a portion of a reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips. Preferably, the majority of reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips.

[0350] In some embodiments, the majority of the volume reservoir container 110 volume is distal to the mesh membrane 185. For example, more than 60%, or more than 80% of the reservoir container 110 volume is distal to the mesh membrane 185.

[0351] In some embodiments, the majority of the volume of the reservoir container 110 volume is above the center of the mesh membrane 185. For example, more than 60%, or more than 80% , or more than 90% of the reservoir container 110 volume is above the center of the mesh membrane 185. In some embodiments, the majority of the volume of the reservoir container 110 volume is above the top-most hole of the mesh membrane 185. For example, more than 60%, or more than 80% , or more than 90% of the reservoir container 110 volume is above the top-most hole of the mesh membrane 185.

[0352] In some embodiments, the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is larger than the total volume of proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185. For example, the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 100% larger than the total volume of fluids compartment 105 combined with the proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185. Preferably, the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 3 times or at least 10 times larger than the total volume of fluids compartment 105 combined with the proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185.

[0353] Typically, the ergonomic fit is characterized in that reservoir container 110 dimensions are such the largest horizontal extension, in the proximal -distal axis, of the reservoir container 110 is greater than the vertical extension.

[0354] In some embodiments, the maximum of vertical width WD dimension, of a cross-section parallel mesh plane, is less than 20mm or less than 25mm at the mesh membrane or at any location more distal than the mesh membrane that also passes through the reservoir container 110 cavity.

[0355] The illustrated embodiments of the reservoir should not be considered as limiting to the illustration. In particular, the reservoir container 110 may be fillable or pre -filled with a liquid 120.

[0356] Typically, when in use and filled with liquids, the majority of the volume of the reservoir container is situated above the level of the center of the mesh membrane. Preferably, when in use and filled with liquids, the majority of the volume of the reservoir container is situated above the level of the top-most orifice of the mesh membrane.

[0357] In some embodiments, when device 100 is in use inside the mouth of a human user the tongue -depressing element 688 keeps the tongue under it. Typically, air channel 121 runs intermediate between the majority of the surface of the tongue-depressing element 688 below it, and the majority of the reservoir container 110 cavity portion distal to the mesh membrane above it.

[0358] In order to enable better flow of the aerosol-air mix, with reduced deposition on the walls of the system, the distal tip of the tongue-depressing element 688, along the middle line vertically below the longitudinal axis 910, is below the bottom most level of the narrow section.

[0359] Preferably, tongue-depressing element 688 extends under a reservoir container 110 portion distal to the mesh membrane 185 for a length of more than 5mm, or more than 10mm. Typically, tongue -depressing element 688 extends under the majority of reservoir container 110 portion distal to the mesh membrane 185. Commonly, the bottom of the tongue depressing element 688 is at a level below the mesh membrane 185.

[0360] In some embodiments, the liquid flow from reservoir container 110 into fluids compartment 105 comprises a capillary flow. For example, the previous claim wherein the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is less than 0.5 mm, or less than 0.3 mm. To enhance the capillary action, there may be a capillary wick element 109 in the intervening space between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185. fluids compartment 105 comprises a compartment proximal wall 104 facing across from the center of the mesh membrane, wherein the minimal distance between the compartment proximal wall 104 and the mesh membrane 185 is less than 5mm, or less than 2mm, or less than 1mm, or less than 0.5mm, or less than 0.2mm.

[0361] In some embodiments, fluids compartment 105 comprises a capillary wick 109. For example, the capillary wick 109 is in fluid communication with a reservoir container 110, the volume of the reservoir container 110 being larger than the volume enclosed by the capillary wick 109.

[0362] In some embodiments, in the assembled state, the piezo assembly 180 is in mechanical communication to the mesh membrane 185, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the mesh membrane 185. For example, the vibrable portion of the piezo assembly 180 may be situated distally to the mesh membrane 185 and attached thereto.

[0363] In alternative embodiments, in the assembled state, a vibrable portion of the piezo assembly 180 is situated proximally to the mesh membrane 185. For example, the vibrable portion of the piezo assembly 180 is also situated proximally to a portion of the interior of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the intermediate liquid between the vibrable portion of the piezo assembly 180 and the mesh membrane 185, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push of the liquid when is filled within the fluids compartment 105 towards the mesh membrane 185. Preferably, the vibrable portion of the piezo assembly 180 is also situated proximally to a portion of and in contact with a wall of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the portion of and in contact with a compartment proximal wall 104 of the fluids compartment 105.

[0364] For improved modularity, fluids compartment 105 may be removable without including a vibrable portion of the piezo assembly 180.

[0365] For effective delivery to the lungs, the majority of orifices of mesh membrane 185 are of average diameter greater than 1 micron and smaller than 10 micron.

[0366] Ultrasonic frequency of operation may be diverse. For example, the predominant ultrasonic frequency of the piezo assembly 180 may be greater than 1 MHz and less than 3 MHz. Alternatively, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 1.5 MHz and less than 2.5 MHz. Alternatively, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 80 kHz and less than 400 kHz. Alternatively, the predominant ultrasonic frequency of the piezo assembly 180 is greater than 100 kHz and less than 300 kHz

[0367] In some embodiments, the mesh membrane 185 is connected to and housed within the aerosol delivery module 630, such that the aerosol delivery module 630 is comprising a shell encasing.

[0368] In some embodiments, a portion of reservoir container 110 is housed outside of and proximal to the aerosol delivery module 630.

[0369] Typically, the air flowing in air-channel 121 is mixing with the liquid droplets emitted from the mesh membrane 185 throughout the majority of the air passage under reservoir container 110.

[0370] For improved modularity, when in inhalation operation, the fluids compartment 105 comprising the mesh membrane 185, is reversibly removable from and re-insertable into contact with the electronically activated piezo 180 element.

[0371] In some embodiments, intra-oral ergonomic fit is characterized in that the maximum of a vertical width WD dimension of the system 100 is less than 25mm or less than 20mm, in the top-to- bottom orientation, at any location more distal than the mesh membrane 185 that has a surface both above and below the level of the center of the mesh membrane.

[0372] In some embodiments, intra-oral ergonomic fit is characterized in that the maximum of a vertical width WD dimension of the system 100 is less than 20mm or less than 15mm, or less than 10mm in the top-to-bottom orientation, at the location the mesh membrane 185.

[0373] Typically, inhalation device 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. For controlling the system it comprises a 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. For example, the threshold limit is a pressure between 2 cm H2O and 20 cm H2O.

[0374] In alternative embodiments, the inhalation device is further comprising a pump module 130, the pump module comprising a pump inlet port 131 and a pump outlet port 133 the pump outlet port being in fluid communication with the fluids compartment 105. For example, a pump inlet port 131 is in fluid communication with a reservoir container 110 of larger than the volume than the fluids compartment 105. Preferably, pump outlet port 133 is situated at and / or feeding a liquid into the fluids compartment 105 at a location leveled below the location of the center of the mesh membrane 185. In some embodiments, the pump module 130 comprises a piezoelectric component. In some constructions, the piezoelectric electric component is changing the shape of a membrane plate. Alternatively, pump module 130 may be a peristaltic pump. For example, the pump module 130 comprises at least one directional valve.

[0375] In some embodiments, the pump module 130 comprises at least one directional valve, a first valve in fluid communication with the pump outlet port 133, and a second valve in fluid communication with the pump inlet port 131.

[0376] In some embodiments, pump module 130 is operated manually, comprising a deformable pump chamber which is pressed by application of external force and elastically returns to assume an equilibrium pump chamber shape and volume in the absence of external pressing force.

[0377] For secured placement, wherein the inhalation device further comprises one or more protrusions 681 extending vertically. For example, the height of a protrusion 681 is more than 3mm and the thickness of the protrusion is less than 5mm. Preferably, a protrusion 681 is located at the device mid-section neck portion, proximally from the lips engagement location of the narrow section 226.

[0378] The modularity of the system is manifested in a kit comprising: a. an aerosol delivery module 630; b. a fluids cartridge module 805 comprising a pre prefilled reservoir compartment 110; c. a power module 210B comprising (i) a power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135;

[0379] When the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B, and the fluids cartridge module 805 is attached to the delivery module 630 and in contact with the piezo assembly 180.

[0380] Typically, the kit elements are configured to be attachable and detachable such that power module 210B electrical contacts 148 are engaged and disengaged with the distal electrical contacts 147, to establish an electrical communication between the piezo assembly 180 and the power source 125 and / or the electronic control circuit 135.

[0381] In some embodiments, mesh membrane 185 is integrally attached to the reservoir compartment 110.

[0382] In some embodiments, reservoir compartment 110 is attachable and detachable from mesh membrane 185.

[0383] In some embodiments, a fluids cartridge module 805 is detachably attachable from the piezo assembly 180.

[0384] In some embodiments, piezo assembly 180 is integral with the power module 210B, the piezo assembly is detachably attachable from the delivery module 630.

[0385] Typically, the top-most boundary of the reservoir compartment 110 is situated less than 15mm or less than 10mm above the top-most edge of the mesh membrane 185. In some embodiments, fluids cartridge module 805 further comprise a reservoir container 110 of volume greater than the fluids compartment 105. When in operation, the reservoir container 110 is in fluid communication with the fluids compartment 105. Preferably, the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185.

[0386] For common medical use, the liquid 120 comprises an a pharmaceutically active substance.

[0387] According to embodiments disclosed herein, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) respective proximal and distal portions, the proximal portion including an inlet for a liquid, the distal portion including (i) a mesh membrane and (ii) a piezo assembly including an ultrasonically vibrable element for producing, upon electrical activation, a mist comprising droplets of the liquid emanating from the mesh membrane orifices, the mesh membrane defining a mist-generating location; and (b) an intermediate portion disposed distally from the proximal portion and proximally from the distal portion, wherein the inhalation device is shaped such that when the user’s lips and / or teeth are transversely engaged with the intermediate portion, the mist-generating location resides within the user’s oral cavity and the mist-exiting location is in direct fluid communication with the user’s oropharynx.

[0388] According to embodiments, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) respective proximal and distal portions, the proximal portion including an inlet for a liquid, the distal portion including (i) a mesh membrane defining a mist-generating location and (ii) a piezo assembly including an ultrasonically vibrable element, for producing, upon electrical activation, a mist comprising droplets of the liquid, the mesh membrane defining a mist-generating location; and (b) an intermediate portion disposed distally from the proximal portion and proximally from the distal portion, wherein the distal portion is dimensioned to vertically span the user’s oral cavity from tongue to hard-palate when the user’s lips and / or teeth are transversely engaged with the intermediate portion, so as to place the mist-exiting location in fluid communication with the user’s oropharynx.

[0389] In some embodiments, the liquid-inlet can be configured to receive liquid from a reservoir container, the liquid-inlet and the reservoir container having respective mating arrangements for mating with each other. The terms “reservoir container” and “container” are used interchangeably herein. In some embodiments, the mating can be reversible.

[0390] In some embodiments, the reservoir container can be detachably attachable to the proximal portion. In some embodiments, the inhalation device can additionally comprise the reservoir container. In some embodiments, the proximal portion can comprise a compartment for storing the liquid.

[0391] In some embodiments, 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.

[0392] In some embodiments, the inhalation device can additionally comprise an exhalation sensor for monitoring a flow in an exhalation-flow path. In some embodiments, the exhalation sensor can be configured to detect a concentration of a chemical compound in the exhalation-flow path. In some embodiments, the chemical compound can be a component of the liquid. In some embodiments, 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.

[0393] In some embodiments, 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.

[0394] In some embodiments, 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.

[0395] In some embodiments, 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.

[0396] In some embodiments, 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.

[0397] In some embodiments, at least a portion of the reservoir 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 reservoir container can be above a plane longitudinally bisecting the intermediate portion when the device is rotated such that the plane is horizontal.

[0398] In some embodiments, 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. In some embodiments, 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.

[0399] In some embodiments, 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 reservoir container. In some embodiments, 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.

[0400] In some embodiments, a ratio of (i) a combined fluid capacity of the reservoir 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.

[0401] In some embodiments, 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.

[0402] In some embodiments, 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.

[0403] In some embodiments, 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.

[0404] In some embodiments in which the inhalation device includes an exhalation sensor, 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.

[0405] According to embodiments disclosed herein, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) respective proximal and distal portions, the distal portion including (i) a volume for storing a liquid, (ii) a mesh membrane defining a mist-generating location and (iii) a piezo assembly including an ultrasonically vibrable element, for producing, upon electrical activation, a mist comprising droplets of the liquid, the mesh membrane defining a mist-generating location; and (b) an intermediate portion disposed distally from the proximal portion and proximally from the distal portion, wherein the inhalation device is shaped such that when the user’s lips and / or teeth are transversely engaged with the intermediate portion, the mist-generating location resides within the user’s oral cavity and the mist-exiting location is in direct fluid communication with the user’s oropharynx.

[0406] According to embodiments, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) respective proximal and distal portions, the distal portion including (i) a volume for storing a liquid, (ii) a mesh membrane defining a mist-generating location and (iii) a piezo assembly including an ultrasonically vibrable element, for producing, upon electrical activation, a mist comprising droplets of the liquid, the mesh membrane defining a mist- generating location; and (b) an intermediate portion disposed distally from the proximal portion and proximally from the distal portion, wherein the distal portion is dimensioned to vertically span the user’s oral cavity from tongue to hard-palate when the user’s lips and / or teeth are transversely engaged with the intermediate portion, so as to place the mist-exiting location in fluid communication with the user’s oropharynx.

[0407] In some embodiments, 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.

[0408] In some embodiments, the inhalation device can additionally comprise an exhalation sensor for monitoring a flow in an exhalation-flow path. In some embodiments, the exhalation sensor can be configured to detect a concentration of a chemical compound in the exhalation-flow path. In some embodiments, the chemical compound can be a component of the liquid. In some embodiments, 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.

[0409] In some embodiments, 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. In some embodiments, 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.

[0410] In some embodiments, 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.

[0411] In some embodiments, 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.

[0412] In some embodiments, 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.

[0413] In some embodiments, a ratio of (i) a combined fluid capacity of the reservoir 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. In some embodiments, 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.

[0414] In some embodiments, 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.

[0415] In some embodiments, 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.

[0416] In some embodiments, 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.

[0417] In some embodiments in which the inhalation device includes an exhalation sensor, 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.

[0418] According to embodiments disclosed herein, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) a distal portion including (i) an aerosol outlet defining a mist-exiting location and (ii) a piezo assembly including an ultrasonically vibrable element, for producing, upon electrical activation, a mist comprising droplets of the liquid, the mesh membrane defining a mist-generating location; and (b) a neck portion including a narrow section, the narrow section being characterized by a maximum vertical cross-sectional dimension that is at least 10% smaller than a maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, at least a part of the narrow section being displaced proximally from the mesh membrane by at least 0.5 cm and not more than 6 cm, wherein the inhalation device is shaped such that when the user’s lips and / or teeth are transversely engaged with the narrow section, the mist-generating location resides distal to the user’s teeth within the user’s oral cavity and the mist-exiting location is in direct fluid communication with the user’s oropharynx.

[0419] In some embodiments, the distal portion can comprise a distal casing encompassing the mesh membrane at least circumferentially.

[0420] In some embodiments, 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.

[0421] In some embodiments, the narrow section can be characterized by a maximum vertical cross- sectional dimension that is at least 20% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.

[0422] In some embodiments, the maximum vertical cross-sectional dimension of the narrow section and the maximum vertical 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.

[0423] In some embodiments, the inhalation device of can comprise a proximal portion that includes a power source for powering the piezo assembly.

[0424] In some embodiments, the inhalation device can comprise a proximal portion that includes a liquid inlet.

[0425] In some embodiments, 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.

[0426] In some embodiments, it can be that 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.

[0427] In some embodiments, 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.

[0428] In some embodiments, the inhalation device of any preceding claim, additionally comprising an inhalation sensor for monitoring a flow in an inhalation flow-path. In some such 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 flow path. In some embodiments, 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. In some such embodiments, 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. In some embodiments, 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 reservoir container.

[0429] In some embodiments, 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.

[0430] In some embodiments, a kit can comprise the inhalation device according to any of the embodiments disclosed hereinabove, packaged in a reservoir container such that the proximal portion that includes a liquid inlet is detached from the neck portion.

[0431] According to embodiments disclosed herein, an electrically-powered inhalation device for delivery of an aerosol to the oropharynx of a user comprises: (a) a distal portion including (i) an aerosol outlet defining a mist-exiting location and (ii) a piezo assembly including an ultrasonically vibrable element, for producing, upon electrical activation, a mist comprising droplets of the liquid, the mesh membrane defining a mist-generating location; and (b) a neck portion including a narrow section, the narrow section being characterized by a maximum vertical cross-sectional dimension that is at least 10% smaller than a maximum vertical cross-sectional dimension passing through and parallel to the mesh membrane, a center of gravity of the inhalation device being displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state, wherein the inhalation device is shaped such that when the user’s lips and / or teeth are transversely engaged with the narrow section, the mist-generating location resides within the user’s oral cavity and the mist-exiting location is in direct fluid communication with the user’s oropharynx.

[0432] In some embodiments, the distal portion can comprise a distal casing encompassing the mesh membrane at least circumferentially.

[0433] In some embodiments, the narrow section can be characterized by a maximum vertical cross- sectional dimension that is at least 20% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the maximum vertical cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.

[0434] In some embodiments, the maximum vertical cross-sectional dimension of the narrow section and the maximum vertical 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.

[0435] In some embodiments, the inhalation device can comprise a proximal portion that includes a power source for powering the piezo assembly.

[0436] In some embodiments, the inhalation device can comprise a proximal portion that includes a liquid inlet.

[0437] In some embodiments, 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. In some embodiments, it can be that 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.

[0438] In some embodiments, 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.

[0439] In some embodiments, the inhalation device can additionally comprise an inhalation sensor for monitoring a flow in an inhalation flow-path. In some such embodiments, the inhalation sensor can be effective to detect an air pressure in the inhalation-flow path.

[0440] 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.

[0441] 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 flow path.

[0442] In some embodiments, 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. In some such embodiments, 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. In some embodiments, 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 reservoir container.

[0443] In some embodiments, 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.

[0444] In some embodiments, a kit can comprise the inhalation device according to any of the embodiments disclosed hereinabove, packaged in a reservoir container such that the proximal portion that includes a liquid inlet is detached from the neck portion.

[0445] SECOND ADDITIONAL DISCUSSION OF EMBODIMENTS

[0446] The following paragraphs summarize inventive concepts disclosed herein as numbered ‘additional embodiments’ for easier cross-reference.

[0447] Additional embodiment 1. An inhalation device 100 for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising: a. an aerosol delivery module 630 comprising: a mesh membrane 185 characterized by having small orifices defining a mist-generating location, a fluids compartment 105 for containing a liquid 120 proximal to and in fluid communication with the mesh membrane; and b. a piezo assembly 180 comprising an ultrasonic vibrable element; c. a control module 210B comprising a battery power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135; d. a reservoir container 110 of volume greater than fluids compartment 105; wherein when the inhalation device is in an assembled state, such that the aerosol delivery module 630 is attached and distally disposed to the control module 210B, the assembled inhalation device is shaped to include a narrow section 226.

[0448] Additional embodiment 2. A pre-filled cartridge module 805, comprising: a. a mesh membrane 185; b. a fluids compartment 105 proximal to and in fluid communication with the mesh membrane; c. a reservoir container 110 of volume greater than the fluids compartment 105; d. a liquid 120 prefilled in reservoir container 110 and sealed from ambient air.

[0449] Additional embodiment 3. Additional embodiment 1 or Additional embodiment 2 wherein reservoir container 110 of volume greater than the fluids compartment 105 by at least a factor 2 times, or at least a factor 5 times, or at least a factor 10 times.

[0450] Additional embodiment 4. An inhalation device 100 comprising a. The prefilled cartridge module 805 of Additional embodiment 3, in which mesh membrane 185 defines a mist-generating location; b. a control module 210B comprising battery power source 125, a piezo assembly 180, and an electronic control circuitry 135; c. an aerosol delivery module 630 connected or connectable to the control module 210B and connected or connectable to cartridge module 805, such that in the assembled state piezo assembly 180 is in contact with cartridge module 805; wherein when the inhalation device is in an assembled state, such that the aerosol delivery module is distally disposed and the control module is proximally attached thereto, the assembled inhalation device is shaped to include a narrow section 226.

[0451] Additional embodiment 5. Additional embodiment 1 or Additional embodiment 4 wherein, (i) a geometrical axis 910 defines a longitudinal axis of the system perpendicular to and passing through the center of the mesh membrane, (ii) a vertical axis crossing the longitudinal axis 910 in a vertical orientation perpendicular to longitudinal axis 910; and the system 100 is of elongated shape in the sense that the extent of the inhalation device 100 along the longitudinal axis 910 is greater than extent of the inhalation device 100 along the vertical axis by a factor of at least 3 time, or at least 5 times.

[0452] Additional embodiment 6. Additional embodiment 1 or Additional embodiment 4 wherein aerosol delivery module 630 comprise cartridge module 805, comprising: a. mesh membrane 185; b. fluids compartment 105 proximal to and in fluid communication with the mesh membrane; c. reservoir container 110 of volume greater than fluids compartment 105; and wherein cartridge module 805 is attachable detachable to aerosol delivery module 630.

[0453] Additional embodiment 7. Additional embodiment 1 or Additional embodiment 2 wherein the fluids compartment 105 cavity is defined to be geometrically bounded by (i) the mesh membrane 185, and (ii) cylindrical walls perpendicular to a circle of largest diameter that can be embedded within the mesh membrane 185.

[0454] Additional embodiment 8. Additional embodiment 4 or Additional embodiment 6 wherein cartridge module 805 is prefilled with a liquid 120 wherein the liquid is sealed from ambient air within the aerosol delivery module.

[0455] Additional embodiment 9. Additional embodiment 1 or Additional embodiment 4 wherein the system is further comprising a tongue -depressing element 688 extends distally to the mesh membrane, at a level vertically below the lowest perforated level of the mesh membrane, or at a level below the bottom edge of the mesh membrane.

[0456] Additional embodiment 10. Additional embodiment 1 or Additional embodiment 4 wherein in the assembled state the inhalation device is further comprising an air-channel or air conduit element 121 comprising a proximal entry port 122 and a distal exit port, the distal exit port being more distal than the mesh membrane.

[0457] Additional embodiment 11. The previous Additional embodiment wherein the air channel 121 comprises a lumen portion and / or a grove portion.

[0458] Additional embodiment 12. Additional embodiment 2 or Additional embodiment 8 wherein the seal is removable such that fluid communication is established between the 120 and ambient air via holes in the mesh membrane 185.

[0459] Additional embodiment 13. Additional embodiment 1 or Additional embodiment 3 wherein reservoir container 110 is in fluid transfer communication with fluids compartment 105.

[0460] Additional embodiment 14. The previous Additional embodiment wherein the fluid transfer communication comprises fluids flow.

[0461] Additional embodiment 15. Any one of the previous two Additional embodiments wherein the fluids transfer communication comprises a pump.

[0462] Additional embodiment 16. Additional embodiment 1 or Additional embodiment 3 wherein the majority of reservoir container 110 cavity is distal to fluids compartment 105.

[0463] Additional embodiment 17. Additional embodiment 1 or Additional embodiment 4 wherein reservoir container 110 is detachably attachable to the fluids compartment 105.

[0464] Additional embodiment 18. Additional embodiment 1 or Additional embodiment 4 wherein the inhalation device 100 is additionally characterized by (i) a narrow section having a maximum vertical axis cross-sectional dimension that is at least 10% smaller, or at least 30% smaller, than a vertical axis cross-sectional dimension of the aerosol delivery module distal to the narrow section; and (ii) when a user’s lips and / or teeth are transversely engaged in the vertical orientation with the narrow section, the mesh membrane resides within the user’s oral cavity.

[0465] Additional embodiment 19. Additional embodiment 1 or Additional embodiment 4 wherein a narrow section characterized by a maximum vertical cross-sectional dimension of the narrow section is at least 10% smaller, or at least 30% smaller, than a maximum vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane 185.

[0466] Additional embodiment 20. Additional embodiment 1 or Additional embodiment 4 wherein the inhalation device 100 is characterized by a maximum vertical axis cross-sectional dimension of the narrow section that is at least 10% smaller, or at least 30% smaller, than a vertical axis cross- sectional dimension of the aerosol delivery module 630 distal to the narrow section and more distal than the distal most edge of the mesh membrane and of the reservoir container 110 cavity.

[0467] Additional embodiment 21. Additional embodiment 1 or Additional embodiment 4 wherein the majority of the weight of the control module 210B is disposed proximally from the narrow section, and the majority of the volume of the reservoir container 110 is distal to the narrow section 226. Additional embodiment 22. Additional embodiment 1 or Additional embodiment 4 wherein a maximum vertical cross-sectional dimension of the narrow section is at least 50% smaller than a vertical cross-sectional dimension of the aerosol delivery module at the mesh membrane or distal to the mesh membrane 185.

[0468] Additional embodiment 23. Additional embodiment 10 wherein the narrow section is proximal to the mesh membrane 185, and wherein the narrow section is narrower, by at least 10% or at least 30%, in the vertical direction than any portion of the delivery module 630 distal to the mesh membrane having both a bottom surface and a top surface of an air channel 121.

[0469] Additional embodiment 24. Additional embodiment 1 or Additional embodiment 4 wherein, when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, the mesh membrane 185 resides distally to the proximal edge of the lips towards and / or within the user’s oral cavity.

[0470] Additional embodiment 25. Additional embodiment 1 or Additional embodiment 4 wherein the air channel extends along a path that passes around a side of the mesh membrane from a more proximal to a more distal side of the mesh membrane.

[0471] Additional embodiment 26. Additional embodiment 10 wherein when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, proximal entry port 122 is outside of the oral cavity and the distal exit port is inside of the oral cavity.

[0472] Additional embodiment 27. The previous Additional embodiment wherein the air channel is passing along a path that passes around a side of the mesh membrane at a level at least partially or predominantly below the center the mesh membrane.

[0473] Additional embodiment 28. Additional embodiment 10 wherein a portion of the air channel 121 passes below the cavity of reservoir container 110.

[0474] Additional embodiment 29. Additional embodiment 10 wherein a portion of the air channel 121 passes below the majority of the cavity of reservoir container 110.

[0475] Additional embodiment 30. Additional embodiment 10 wherein the majority of air channel 121 distal to the mesh membrane 185 passes under the cavity of reservoir container 110.

[0476] Additional embodiment 31. Additional embodiment 10 wherein a proximal port 122, of air channel 121, is proximal to the mesh membrane 185.

[0477] Additional embodiment 32. Additional embodiment 1 or Additional embodiment 4 wherein the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185.

[0478] Additional embodiment 33. Additional embodiment 1 or Additional embodiment 4 wherein, when the inhalation device is in use such that the user’s lips and / or teeth are transversely engaged with the narrow section 226, at least a portion of a reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips. Additional embodiment 34. The previous Additional embodiment wherein the majority of reservoir compartment 110 resides within the user’s oral cavity distally to the proximal edge of the lips.

[0479] Additional embodiment 35. Additional embodiment 1 or Additional embodiment 4 wherein the majority of the volume reservoir container 110 volume is distal to the mesh membrane 185.

[0480] Additional embodiment 36. The previous Additional embodiment wherein more than 60%, or more than 80% of the reservoir container 110 volume is distal to the mesh membrane 185.

[0481] Additional embodiment 37. Additional embodiment 1 or Additional embodiment 4 wherein the majority of the volume of the reservoir container 110 volume is above the center of the mesh membrane 185.

[0482] Additional embodiment 38. The previous Additional embodiment wherein more than 60%, or more than 80% , or more than 90% of the reservoir container 110 cavity volume is above the center of the mesh membrane 185.

[0483] Additional embodiment 39. Additional embodiment 1 or Additional embodiment 4 wherein the majority of the volume of the reservoir container 110 cavity volume is above the top-most hole of the mesh membrane 185.

[0484] Additional embodiment 40. Additional embodiment 1 or Additional embodiment 4 wherein more than 60%, or more than 80% , or more than 90% of the reservoir container 110 cavity volume is above the top-most hole of the mesh membrane 185.

[0485] Additional embodiment 41. Additional embodiment 1 or Additional embodiment 4 wherein the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is larger than the total volume of proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185.

[0486] Additional embodiment 42. The previous Additional embodiment wherein the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 100% larger than the total volume of fluids compartment 105 combined with the proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185.

[0487] Additional embodiment 43. The previous Additional embodiment wherein the distal portion volume of the reservoir container 110 which is more distal than the mesh membrane 185, is at least 3 times or at least 10 times larger than the total volume of fluids compartment 105 combined with the proximal portion volume of the reservoir container 110 which is more proximal than the mesh membrane 185.

[0488] Additional embodiment 44. Additional embodiment 1 or Additional embodiment 4 wherein the ergonomic fit is characterized in that reservoir container 110 dimensions are such the largest horizontal extension, in the proximal-distal axis, of the reservoir container 110 is greater than the vertical extension. Additional embodiment 45. Additional embodiment 1 or Additional embodiment 4 wherein the maximum of vertical width WD dimension, of a cross-section parallel mesh plane, is less than 20mm or less than 25mm at the mesh membrane or at any location more distal than the mesh membrane that also passes through the reservoir container 110 cavity.

[0489] Additional embodiment 46. Additional embodiment 1 or Additional embodiment 4 wherein the reservoir container 110 is fillable or pre -filled with a liquid 120.

[0490] Additional embodiment 47. Additional embodiment 1 or Additional embodiment 4 wherein, when in use and filled with liquids, the majority of the volume of the reservoir container is situated above the level of the center of the mesh membrane.

[0491] Additional embodiment 48. Additional embodiment 1 or Additional embodiment 4 wherein, when in use and filled with liquids, the majority of the volume of the reservoir container is situated above the level of the top-most orifice of the mesh membrane.

[0492] Additional embodiment 49. Additional embodiment 9 wherein when device 100 is in use inside the mouth of a human user the tongue-depressing element 688 keeps the tongue under it.

[0493] Additional embodiment 50. Additional embodiment 9 or Additional embodiment 10 wherein air channel 121 runs intermediate between the majority of the surface of the tongue-depressing element 688 below it, and the majority of the reservoir container 110 cavity portion distal to the mesh membrane above it.

[0494] Additional embodiment 51. Additional embodiment 9 wherein the distal tip of the tonguedepressing element 688, along the middle line vertically below the longitudinal axis 910, is below the bottom most level of the narrow section.

[0495] Additional embodiment 52. Additional embodiment 9 wherein tongue -depressing element 688 extends under a reservoir container 110 portion distal to the mesh membrane 185 for a length of more than 5mm, or more than 10mm.

[0496] Additional embodiment 53. Additional embodiment 9 wherein tongue -depressing element 688 extends under the majority of reservoir container 110 portion distal to the mesh membrane 185.

[0497] Additional embodiment 54. Additional embodiment 9 wherein the bottom of the tongue depressing element 688 is at a level below the mesh membrane 185.

[0498] Additional embodiment 55. Additional embodiment 1 or Additional embodiment 4 wherein the liquid flow from reservoir container 110 into fluids compartment 105 comprises a capillary flow.

[0499] Additional embodiment 56. The previous Additional embodiment wherein the distance between compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185 is less than 0.5 mm, or less than 0.3 mm.

[0500] Additional embodiment 57. Any of the previous 3 Additional embodiments wherein there is a capillary wick element 109 in the intervening space between the compartment proximal wall 104 of the fluids compartment 105 and the center of the mesh membrane 185. Additional embodiment 58. Additional embodiment 1 wherein the fluids compartment 105 comprises a compartment proximal wall 104 facing across from the center of the mesh membrane, wherein the minimal distance between the compartment proximal wall 104 and the mesh membrane 185 is less than 5mm, or less than 2mm, or less than 1mm, or less than 0.5mm, or less than 0.2mm.

[0501] Additional embodiment 59. Additional embodiment 1 wherein the fluids compartment 105 comprises a capillary wick 109.

[0502] Additional embodiment 60. The previous Additional embodiment wherein the capillary wick

[0503] 109 is in fluid communication with a reservoir container 110, the volume of the reservoir container

[0504] 110 being larger than the volume enclosed by the capillary wick 109.

[0505] Additional embodiment 61. Additional embodiment 1 or Additional embodiment 4 wherein, in the assembled state, the piezo assembly 180 is in mechanical communication to the mesh membrane 185, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the mesh membrane 185.

[0506] Additional embodiment 62. The previous Additional embodiment wherein the vibrable portion of the piezo assembly 180 is situated distally to the mesh membrane 185 and attached thereto.

[0507] Additional embodiment 63. Additional embodiment 1 or Additional embodiment 4 wherein, in the assembled state, a vibrable portion of the piezo assembly 180 is situated proximally to the mesh membrane 185.

[0508] Additional embodiment 64. The previous Additional embodiment wherein the vibrable portion of the piezo assembly 180 is also situated proximally to a portion of the interior of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the intermediate liquid between the vibrable portion of the piezo assembly 180 and the mesh membrane 185, thereby vibrations of the vibrable portion of the piezo assembly 180 communicates vibrational push of the liquid when is filled within the fluids compartment 105 towards the mesh membrane 185.

[0509] Additional embodiment 65. The previous Additional embodiment wherein the vibrable portion of the piezo assembly 180 is also situated proximally to a portion of and in contact with a wall of the fluids compartment 105, such that vibrations of the ultrasonic vibrable element of the piezo assembly 180 exert vibrations on the portion of and in contact with a compartment proximal wall 104 of the fluids compartment 105.

[0510] Additional embodiment 66. Additional embodiment 1 or Additional embodiment 4 wherein the fluids compartment 105 is removable without including a vibrable portion of the piezo assembly 180.

[0511] Additional embodiment 67. Additional embodiment 1 or Additional embodiment 4 wherein the majority of orifices of mesh membrane 185 are of average diameter greater than 1 micron and smaller than 10 micron. Additional embodiment 68. Additional embodiment 1 wherein the predominant ultrasonic frequency of the piezo assembly 180 is greater than 1 MHz and less than 3 MHz.

[0512] Additional embodiment 69. Additional embodiment 1 wherein the predominant ultrasonic frequency of the piezo assembly 180 is greater than 80 kHz and less than 400 kHz.

[0513] Additional embodiment 70. Additional embodiment 1 or Additional embodiment 4 wherein the mesh membrane 185 is connected to and housed within the aerosol delivery module 630, such that the aerosol delivery module 630 is comprising a shell encasing.

[0514] Additional embodiment 71. Additional embodiment 1 or Additional embodiment 4 wherein a portion of reservoir container 110 is housed outside of and proximal to the aerosol delivery module 630.

[0515] Additional embodiment 72. Additional embodiment 10 wherein the air flowing in air-channel 121 is mixing with the liquid droplets emitted from the mesh membrane 185 throughout the majority of the air passage under reservoir container 110.

[0516] Additional embodiment 73. Additional embodiment 1 or Additional embodiment 4 wherein, when in inhalation operation, the fluids compartment 105 comprising the mesh membrane 185, is reversibly removable from and re -insertable into contact with the electronically activated piezo 180 element.

[0517] Additional embodiment 74. Additional embodiment 1 or Additional embodiment 4 wherein intra-oral ergonomic fit is characterized in that the maximum of a vertical width WD dimension of the system 100 is less than 25mm or less than 20mm, in the top-to-bottom orientation, at any location more distal than the mesh membrane 185 that has a surface both above and below the level of the center of the mesh membrane.

[0518] Additional embodiment 75. Additional embodiment 1 or Additional embodiment 4 intra-oral ergonomic fit is characterized in that the maximum of a vertical width WD dimension of the system 100 is less than 20mm or less than 15mm, or less than 10mm in the top-to-bottom orientation, at the location the mesh membrane 185.

[0519] Additional embodiment 76. Additional embodiment 1 or Additional embodiment 4 wherein inhalation device 100 additionally comprise an inhalation sensor 126.

[0520] Additional embodiment 77. The previous Additional embodiment, wherein 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.

[0521] Additional embodiment 78. The previous Additional embodiment, comprising 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. Additional embodiment 79. The previous Additional embodiment wherein the threshold limit is a pressure between 2 cm H20 and 20 cm H2O.

[0522] Additional embodiment 80. Additional embodiment 1 or Additional embodiment 4 wherein the inhalation device is further comprising a pump module 130, the pump module comprising a pump inlet port 131 and a pump outlet port 133 the pump outlet port being in fluid communication with the fluids compartment 105.

[0523] Additional embodiment 81. Additional embodiment 80 wherein the pump inlet port 131 is in fluid communication with a reservoir container 110 of larger than the volume than the fluids compartment 105.

[0524] Additional embodiment 82. Additional embodiment 80 wherein the pump outlet port 133 is situated at and / or feeding a liquid into the fluids compartment 105 at a location leveled below the location of the center of the mesh membrane 185.

[0525] Additional embodiment 83. Additional embodiment 80 wherein the pump module 130 comprises a piezoelectric component.

[0526] Additional embodiment 84. The previous Additional embodiment wherein the piezoelectric electric component is changing the shape of a membrane plate.

[0527] Additional embodiment 85. Additional embodiment 80 wherein the pump module 130 is a peristaltic pump.

[0528] Additional embodiment 86. Additional embodiment 80 wherein the pump module 130 comprises at least one directional valve.

[0529] Additional embodiment 87. The previous Additional embodiment wherein the pump module 130 comprises at least one directional valve, a first valve in fluid communication with the pump outlet port 133, and a second valve in fluid communication with the pump inlet port 131.

[0530] Additional embodiment 88. Additional embodiment 80 wherein the pump module 130 is operated manually, comprising a deformable pump chamber which is pressed by application of external force and elastically returns to assume an equilibrium pump chamber shape and volume in the absence of external pressing force.

[0531] Additional embodiment 89. Additional embodiment 1 or Additional embodiment 4 wherein, wherein the inhalation device further comprising one or more protrusions 681 extending vertically.

[0532] Additional embodiment 90. The previous Additional embodiment wherein the height of a protrusion 681 is more than 3mm and the thickness of the protrusion is less than 5mm.

[0533] Additional embodiment 91. The previous Additional embodiment wherein a protrusion 681 is located at the device mid-section neck portion, proximally from the lips engagement location of the narrow section 226.

[0534] Additional embodiment 92. A kit comprising: a. an aerosol delivery module 630; b. a fluids cartridge module 805 comprising a pre prefilled reservoir compartment 110; c. a power module 210B comprising (i) a power source 125 for electrically powering a piezo assembly 180, (ii) an electronic control circuitry 135; wherein when the inhalation device is in an assembled state the aerosol delivery module 630 is attached to the control module 210B, and the fluids cartridge module 805 is attached to the delivery module 630 and in contact with the piezo assembly 180.

[0535] Additional embodiment 93. The kit of Additional embodiment 100 wherein the kit elements are configured to be attachable and detachable such that power module 210B electrical contacts 148 are engaged and disengaged with the distal electrical contacts 147, to establish an electrical communication between the piezo assembly 180 and the power source 125 and / or the electronic control circuit 135.

[0536] Additional embodiment 94. Additional embodiment 100 wherein mesh membrane 185 is integrally attached to the reservoir compartment 110.

[0537] Additional embodiment 95. Additional embodiment 100 wherein reservoir compartment 110 is attachable and detachable from mesh membrane 185.

[0538] Additional embodiment 96. Additional embodiment 100 wherein the fluids cartridge module 805 is detachably attachable from the piezo assembly 180.

[0539] Additional embodiment 97. Additional embodiment 100 wherein the piezo assembly 180 is integral with the power module 210B, the piezo assembly is detachably attachable from the delivery module 630.

[0540] Additional embodiment 98. Additional embodiment 100 wherein the top-most boundary of the reservoir compartment 110 is situated less than 15mm or less than 10mm above the top-most edge of the mesh membrane 185.

[0541] Additional embodiment 99. Additional embodiment 100 wherein the fluids cartridge module 805 further comprise a reservoir container 110 of volume greater than the fluids compartment 105.

[0542] Additional embodiment 100. The previous Additional embodiment wherein the reservoir container 110 is in fluid communication with the fluids compartment 105.

[0543] Additional embodiment 101. The previous Additional embodiment wherein the top-most boundary of the reservoir container 110 is situated less than 10mm above the top-most edge of the mesh membrane 185.

[0544] Additional embodiment 102. Additional embodiment 1 or Additional embodiment 4 wherein the liquid 120 comprises an a pharmaceutically active substance.

[0545] Additional embodiment 103. Additional embodiment 110 wherein the liquid 120 is a drug formulation containing Epinephrine at a concentration greater than 0.5 mg / mL and less than 8 mg / mL.

[0546] Additional embodiment 104. The previous Additional embodiment wherein the liquid 120 is a drug formulation containing Epinephrine at a concentration greater than 2 mg / mL. Additional embodiment 105. The previous Additional embodiment wherein the liquid 120 is a drug formulation containing Epinephrine at a concentration less than 5 mg / mL.

[0547] Additional embodiment 106. Additional embodiment 110 wherein the dose quantity of the liquid is configured for delivery such that the dose is more than 0.2 mL.

[0548] Additional embodiment 107. The previous Additional embodiment wherein the dose is more than 0.6 mL.

[0549] Additional embodiment 108. The previous Additional embodiment wherein the dose is more than 0.8 mL.

[0550] Additional embodiment 109. The previous Additional embodiment wherein the dose is less than 1.2 mL.

[0551] Additional embodiment 110. Additional embodiment 111 wherein, the dose quantity of the liquid is configured for delivery such that the total amount of Epinephrine contained in the first dose quantity is more than 0.3 mg and less than 8 mg.

[0552] Additional embodiment 111. The previous Additional embodiment wherein the total amount of Epinephrine contained in the first dose quantity is more than 1 mg.

[0553] Additional embodiment 112. The previous Additional embodiment wherein the total amount of Epinephrine contained in the first dose quantity is less than 6 mg.

[0554] Additional embodiment 113. The previous Additional embodiment wherein the total amount of Epinephrine contained in the first dose quantity is less than 4 mg.

[0555] Additional embodiment 114. The previous Additional embodiment wherein the total amount of Epinephrine contained in the first dose quantity is about 2 mg.

[0556] Additional embodiment 115. Additional embodiment 111 wherein, the dose quantity of the liquid is configured for delivery such that the dose quantity is predetermined by a corresponding dose-total-activation-period, the dose-total-activation-period being a combined activation time during which the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid.

[0557] Additional embodiment 116. The previous Additional embodiment wherein the system and / or the control module automatically switch to the IDLE-state after the combined activation time during which the piezo assembly is powered to vibrate the mesh membrane and emit a mist of the liquid is equal or greater than a pre-set dose-total-activation-period.

[0558] Additional embodiment 117. Additional embodiment 111 further comprising an End-of-dose state characterized and / or detected by one of (i) detecting that the dose quantity has been delivered, and (ii) the indicator is changing its activation state.

[0559] Additional embodiment 118. The previous Additional embodiment wherein detecting that the dose quantity has been delivered is determined by at least one of: (i) the quantity of liquid in the fluids compartment is reduce from a previous amount by an amount equal to about the predetermined dose quantity, (ii) a corresponding dose-total-activation-period has been completed, (iii) a predetermined fill-level sensing state or limit value by the sensor and control circuitry. Additional embodiment 119. Any of the previous 4 Additional embodiments wherein an indicator is changing its activation state.

[0560] Additional embodiment 120. The previous Additional embodiment wherein the indicator light is switching from one color state to another color.

[0561] Additional embodiment 121. Any of the previous two Additional embodiments wherein the indicator is switching from one sound emitting state to another.

[0562] Additional embodiment 122. Additional embodiment 1 or Additional embodiment 4 wherein at least a portion of the fluids compartment 105 bounding walls is of sufficient transparency such that a level of the liquid fill level surface is visually discernable as a change of color or hue.

[0563] Additional embodiment 123. Additional embodiment 1 or Additional embodiment 4 wherein at least a portion of the fluids compartment 105 bounding walls or a is of sufficient transparency such that a level of the liquid fill level surface is visually discernable as a change of color or hue.

[0564] Additional embodiment 124. Additional embodiment 1 or Additional embodiment 4 wherein the fluids compartment is sized sufficiently to contain both a first dose quantity and a second dose quantity of the same size as the first dose quantity.

[0565] Additional embodiment 125. The previous Additional embodiment wherein the control circuitry is configured such that a switch needs to be engaged to enable the administration of a second or subsequent dose if needed by a user.

[0566] Additional embodiment 126. Any of the previous two Additional embodiments wherein an indicator is pre-set to indicate the termination of the second dose quantity.

[0567] Additional embodiment 127. Additional embodiment 1 or Additional embodiment 4 wherein the fluids compartment is sized sufficiently to contain both a first dose quantity and a second dose quantity of the same size as the first dose quantity.

[0568] Additional embodiment 128. The previous Additional embodiment wherein the control circuitry is configured such that a switch needs to be engaged to enable the administration of a second or subsequent dose if needed by a user.

[0569] Additional embodiment 129. Any of the previous two Additional embodiments wherein an indicator is pre-set to indicate the termination of the second dose quantity.

[0570] Additional embodiment 130. Additional embodiment 1 or Additional embodiment 4 wherein the system and the control module configured to be is initially at an IDLE-state.

[0571] Additional embodiment 131. Additional embodiment 1 or Additional embodiment 4 inhalation device is pre-assembled.

[0572] Additional embodiment 132. Additional embodiment 1 or Additional embodiment 4 wherein a default pre-set is determined for the values of (i) the sensor threshold limit, (ii) the dose quantity.

[0573] Additional embodiment 133. The previous Additional embodiment wherein the distal cap is a protective cover. Additional embodiment 134. The previous two Additional embodiments wherein the distal cap is connected to the aerosol delivery module 630.

[0574] Additional embodiment 135. Any of the previous 2 Additional embodiments wherein the cap is a portion of the aerosol delivery module 630.

[0575] Additional embodiment 136. The previous Additional embodiment wherein the cap is a removable portion of the aerosol delivery module 630.

[0576] Additional embodiment 137. The previous Additional embodiment wherein the cap is reversibly attachable to the aerosol delivery module 630.

[0577] Additional embodiment 138. Any of the previous 5 Additional embodiments wherein the distal cap is at least partially covering over the aerosol outlet.

[0578] Additional embodiment 139. Any of the previous 6 Additional embodiments wherein the cap is removable.

[0579] Additional embodiment 140. Additional embodiment 111 wherein the system is configured to be initially at an OFF-state.

[0580] Additional embodiment 141. Any of the previous 9 Additional embodiments wherein the cap is a switch such that a movement of the cap enable switching the control module between an initial OFF-state to IDLE-state to a subsequent ON-state.

[0581] Additional embodiment 142. The previous Additional embodiment wherein the cap is an activation switch such that a movement of the cap is switching the control module between an initial OFF-state to a subsequent IDLE-state.

[0582] Additional embodiment 143. Any of the previous 2 Additional embodiments wherein the cap is an activation switch such that a movement of the cap is switching the control module to a subsequent ON-state.

[0583] Additional embodiment 144. Any of the previous 3 Additional embodiments wherein a movement of the cap is a removal of the cap.

[0584] Additional embodiment 145. Any of the previous 4 Additional embodiments wherein a movement of the cap is a turning of the cap.

[0585] Additional embodiment 146. Any of the previous 5 Additional embodiments wherein 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 IDLE-state.

[0586] Additional embodiment 147. Any of the previous 6 Additional embodiments wherein the movement of the cap closes an electric contact or an electric circuit which is previously open.

[0587] Additional embodiment 148. Additional embodiment 111 wherein the activation switch is a reversible switch such that reversing the configuration of the switch enable switching the control module between an initial ON-state to a subsequent IDLE-state or to a subsequent OFF-state. Additional embodiment 149. Additional embodiment 111 wherein the activation switch is non-reversible such that the switching the control module between an initial ON-state to a subsequent OFF-state is blocked.

[0588] Additional embodiment 150. Any of the previous 3 Additional embodiments wherein the switch element is selected from: a cap, a press button, a touch contact, a lever movement.

[0589] Additional embodiment 151. Any of the previous 4 Additional embodiments wherein a first engagement with the switch is switching the system and / or the control module from an OFF-state to an ON-state.

[0590] Additional embodiment 152. The previous Additional embodiment wherein a second engagement with the switch is switching the system and / or the control module from an ON-state to an OFF-state.

[0591] Additional embodiment 153. Additional embodiment 111 further comprising a rigid protective casing, the protective casing covers over the majority of the aerosol delivery module 630 and the control module.

[0592] Additional embodiment 154. The previous Additional embodiment wherein the activation switch remains exposed for external user access without removal of the protective casing.

[0593] Additional embodiment 155. The previous Additional embodiment wherein in addition the distal end of the protective casing comprises a central aperture such that a mist can exit distally from the aerosol outlet without removal of the protective casing.

[0594] Additional embodiment 156. The previous Additional embodiment wherein a distal cap can be removed from the protective casing and / or the aerosol delivery module 630 without removal of the protective casing.

[0595] Additional embodiment 157. Any of the previous Additional embodiments wherein, when in use, the user lips and / or teeth engage with the protective casing covering over the aerosol delivery module 630.

[0596] THIRD ADDITIONAL DISCUSSION OF EMBODIMENTS

[0597] The following paragraphs summarize inventive concepts disclosed herein as numbered ‘inventive concepts’ for easier cross-reference.

[0598] Inventive concept 1. An inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising: a. a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; and b. a distal aerosol delivery module comprising a distally -open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

[0599] Inventive concept 2. The inhalation device of Inventive concept 1, wherein the electronic control circuitry comprises a sensor circuit configured to detect a user inhalation. Inventive concept 3. The inhalation device of either one of Inventive concepts 1 or 2, wherein the electronic control circuitry comprises a breath-activation circuit.

[0600] Inventive concept 4. The inhalation device of any one of Inventive concepts 1 to 3, wherein the electronic control circuitry comprises at least one of an airflow sensor and a pressure sensor.

[0601] Inventive concept 5. The inhalation device of any one of the preceding Inventive concepts, wherein the distal aerosol delivery module includes a distal frame and a cartridge module comprising the distal reservoir.

[0602] Inventive concept 6. The inhalation device of Inventive concept 5, wherein the cartridge module comprises the proximal chamber and the mesh membrane.

[0603] Inventive concept 7. The inhalation device of Inventive concept 6, wherein when the cartridge module is joined together with the distal frame, the mesh membrane is in fluid communication with the central plenum.

[0604] Inventive concept 8. The inhalation device of any one of the preceding Inventive concepts, wherein a liquid-holding capacity of the distal reservoir has a volume at least twice the volume of a liquidholding capacity of the proximal chamber.

[0605] Inventive concept 9. The inhalation device of any one of the preceding Inventive concepts, wherein a majority of the liquid-holding capacity of the distal reservoir is distally displaced from the mesh membrane.

[0606] Inventive concept 10. The inhalation device of any one of Inventive concepts 5 to 9, in a fully assembled state in which the cartridge module is joined to the distal frame to form an assembled aerosol delivery module, and the assembled distal aerosol delivery module is joined to the proximal control module.

[0607] Inventive concept 11. The inhalation device of Inventive concept 10, wherein the cartridge module is fixedly and / or irreversibly joined to the distal frame to fixedly and / or irreversibly form the assembled aerosol delivery module, and the assembled distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

[0608] Inventive concept 12. The inhalation device of Inventive concept 11, wherein the cartridge module is reversibly joined to the distal frame to reversibly form the distal aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

[0609] Inventive concept 13. The inhalation device of any one of Inventive concepts 1 to 9, provided in a kit comprising a subassembly comprising the distal frame and the proximal control module fixedly and / or irreversibly joined to each other to fixedly and / or irreversibly, and a cartridge module.

[0610] Inventive concept 14. The inhalation device of any one of Inventive concepts 1 to 9, provided in a kit comprising a subassembly comprising the distal aerosol delivery module and the proximal control module fixedly and / or irreversibly joined to each other, and one or more cartridge modules each having a liquid held therewithin. Inventive concept 15. The inhalation device of any one of the preceding Inventive concepts, oriented such that a central longitudinal axis of the inhalation device is horizontal or inclined downward by up to 45° from a distal end thereof.

[0611] Inventive concept 16. The inhalation device of any one of the preceding Inventive concepts, oriented such that a plane defined by the mesh membrane is within ± 10° of vertical.

[0612] Inventive concept 17. The inhalation device of any one of the preceding Inventive concepts, oriented such that a plane defined by the mesh membrane is within ± 5° of vertical.

[0613] Inventive concept 18. The inhalation device of any one of the preceding Inventive concepts, oriented such that a plane defined by the mesh membrane is vertical.

[0614] Inventive concept 19. The inhalation device of any one of Inventive concepts 15 to 18, wherein a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume.

[0615] Inventive concept 20. The inhalation device of any one of Inventive concepts 15 to 19, wherein a majority of the liquid-holding capacity is higher than a top edge of the mesh membrane.

[0616] Inventive concept 21. The inhalation device of any one of Inventive concepts 15 to 20, wherein a majority of the liquid-holding capacity of the distal reservoir is disposed above the central plenum.

[0617] Inventive concept 22. The inhalation device of any one of the preceding Inventive concepts, wherein when the piezo assembly is activated by the control circuit, a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane.

[0618] Inventive concept 23. The inhalation device of either one of Inventive concepts 19 or 20, wherein when the piezo assembly is activated by the control circuit, a liquid held in or introduced into the distal reservoir flows into the proximal chamber by force of gravity to replace liquid aerosolized therefrom.

[0619] Inventive concept 24. The inhalation device of any one Inventive concepts 21 to 23, wherein when the piezo assembly is activated by the control circuit in response to a user inhalation, an aerosol generated at the mesh membrane is at least partly entrained by an airflow of the user inhalation and passes under the distal reservoir.

[0620] Inventive concept 25. The inhalation device of any one of the preceding Inventive concepts, wherein the distal frame comprises a tongue -depressing element.

[0621] Inventive concept 26. The inhalation device of any one of Inventive concepts 15 to 25, wherein the aerosol delivery module comprises a tongue-depressing element extending distally under the distal reservoir.

[0622] Inventive concept 27. The inhalation device of any one of Inventive concepts 15 to 25, wherein the central plenum is bounded from above by the distal reservoir and from below by a tonguedepressing element.

[0623] Inventive concept 28. The inhalation device of any one of Inventive concepts 25 to 27, wherein the tongue-depressing element is integrally formed with the aerosol delivery module. Inventive concept 29. The inhalation device of any one of the preceding Inventive concepts, wherein the distal frame comprises a neck portion proximal to the central plenum.

[0624] Inventive concept 30. The inhalation device of any one of the preceding Inventive concepts, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum.

[0625] Inventive concept 31. The inhalation device of any one of Inventive concepts 15 to 30, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum, the neck portion characterized by having therein a thinnest portion of the inhalation device in a vertical direction.

[0626] Inventive concept 32. The inhalation device of Inventive concept 31, wherein a majority of the liquid-holding capacity of the distal reservoir is disposed higher than a top surface of the neck portion.

[0627] Inventive concept 33. The inhalation device of any one of the preceding Inventive concepts, wherein the distal frame is shaped to direct a flow of a user inhalation.

[0628] Inventive concept 34. The inhalation device of any one of the preceding Inventive concepts, wherein the distal frame comprises a plurality of longitudinal airflow channels.

[0629] Inventive concept 35. The inhalation device of any one of the preceding Inventive concepts, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels.

[0630] Inventive concept 36. The inhalation device of either one of Inventive concepts 34 or 35, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

[0631] Inventive concept 37. The inhalation device of any one of Inventive concepts 34 to 36, wherein the longitudinal airflow channels are in fluid communication with the central plenum.

[0632] Inventive concept 38. The inhalation device of any one of the preceding Inventive concepts, wherein the central plenum comprises a plurality of open passageways through respective walls.

[0633] Inventive concept 39. The inhalation device of any one of Inventive concepts 34 to 38, wherein the longitudinal airflow channels are in fluid communication with the central plenum

[0634] Inventive concept 40. The inhalation device of any one of Inventive concepts 34 to 39, wherein the distal aerosol module in fluid communication with the central plenum through respective open passageways formed in an inward-facing wall of each of the channels.

[0635] Inventive concept 41. The inhalation device of any one of Inventive concepts 15 to 40, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels formed on respective lateral surfaces of the aerosol delivery module

[0636] Inventive concept 42. The inhalation device of any one of Inventive concepts 15 to 41, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels laterally displaced from each other across a vertical plane bisecting the distal aerosol delivery module .

[0637] Inventive concept 43. The inhalation device of any one of Inventive concepts 38 to 42, wherein when the piezo assembly is activated by the control circuit in response to a user inhalation, a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane, and a portion of an airflow caused by the user inhalation is diverted from the longitudinal airflow channels into the central plenum through the respective open passageways and is effective to entrain at least a portion of an aerosol generated at the mesh membrane.

[0638] Inventive concept 44. The inhalation device of any one of Inventive concepts 34 to 43, wherein the longitudinal airflow channels comprise a distal port located distal to the mesh membrane and a proximal port located proximal to the mesh membrane.

[0639] Inventive concept 45. The inhalation device of any one of the preceding Inventive concepts, wherein a distal wall of the proximal chamber comprises a portion that is elastic and / or movable and / or pivotable.

[0640] Inventive concept 46. The inhalation device of any one of the preceding Inventive concepts, wherein a distal wall of the proximal chamber is effective to facilitate a movement of the mesh membrane or a portion thereof in a direction perpendicular to plane defined by the mesh membrane, in response to a pressure of the liquid within the proximal chamber.

[0641] Inventive concept 47. A method of delivering of an aerosol to the oropharynx of a human user, the method comprising: a. Providing the inhalation device of any one of the preceding Inventive concepts, in the fully assembled state; b. Placing the inhalation device in a user mouth such that a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume and the central plenum is in fluid communication with the oropharynx; c. producing a user inhalation to activate the piezo assembly and create an aerosol at the mesh membrane.

[0642] Inventive concept 48. A method of delivering an aerosol to the oropharynx of a human user, the method comprising, a. providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, and (ii) a distal aerosol delivery module, comprising a distally-open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; b. placing the inhalation device in the user’s mouth; and c. producing a user inhalation.

[0643] Inventive concept 49. The method of Inventive concept 48, wherein the electronic control circuitry comprises a sensor circuit configured to detect a user inhalation.

[0644] Inventive concept 50. The method of either one of Inventive concepts 48 or 49, wherein the electronic control circuitry comprises a breath-activation circuit. Inventive concept 51. The method of any one of Inventive concepts 48 to 50, wherein the electronic control circuitry comprises at least one of an airflow sensor and a pressure sensor.

[0645] Inventive concept 52. The method of any one of Inventive concepts 48 to 51, additionally comprising, before the placing: reversibly joining the distal aerosol delivery module and the proximal control module to each other.

[0646] Inventive concept 53. The method of any one of Inventive concepts 48 to 52, wherein the distal aerosol delivery module includes a distal frame and a cartridge module comprising the distal reservoir.

[0647] Inventive concept 54. The method of Inventive concept 53, wherein the cartridge module comprises the proximal chamber and the mesh membrane.

[0648] Inventive concept 55. The method of Inventive concept 54, wherein when the cartridge module is joined together with the distal frame, the mesh membrane is in fluid communication with the central plenum.

[0649] Inventive concept 56. The method of any one of Inventive concepts 53 to 55, additionally comprising, before the placing: reversibly joining the cartridge module to the distal frame to form the aerosol delivery module.

[0650] Inventive concept 57. The method of any one of Inventive concepts 53 to 55, additionally comprising, before the placing: reversibly joining the cartridge module to the distal frame to reversibly form the distal aerosol module, and reversibly joining the distal aerosol delivery module to the proximal control module.

[0651] Inventive concept 58. The method of any one of Inventive concepts 53 to 55, wherein the provided inhalation device is in an assembled state in which the cartridge module is joined to the distal frame to form the aerosol delivery module, and the distal aerosol delivery module is joined to the proximal control module.

[0652] Inventive concept 59. The method of Inventive concept 58, wherein the cartridge module is fixedly and / or irreversibly joined to the distal frame to fixedly and / or irreversibly form the aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

[0653] Inventive concept 60. The method of Inventive concept 58, wherein the cartridge module is reversibly joined to the distal frame to reversibly form the distal aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

[0654] Inventive concept 61. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a central longitudinal axis of the inhalation device is horizontal or inclined downward by up to 45° from a distal end thereof. Inventive concept 62. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is within ± 10° of vertical.

[0655] Inventive concept 63. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is within ± 5° of vertical.

[0656] Inventive concept 64. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is vertical.

[0657] Inventive concept 65. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume.

[0658] Inventive concept 66. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity is higher than a top edge of the mesh membrane.

[0659] Inventive concept 67. The method of any one of Inventive concepts 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is disposed above the central plenum.

[0660] Inventive concept 68. The method of any one of Inventive concepts 48 to 67, wherein the delivery frame comprises a neck portion proximal to the central plenum.

[0661] Inventive concept 69. The method of any one of Inventive concepts 48 to 67, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum.

[0662] Inventive concept 70. The method of any one of Inventive concepts 48 to 67, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum, the neck portion characterized by having therein a thinnest portion of the inhalation device in a vertical direction.

[0663] Inventive concept 71. The method of any one of Inventive concepts 61 to 70, placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is disposed higher than a top surface of the neck portion.

[0664] Inventive concept 72. The method of any one of Inventive concepts 68 to 71, wherein placing the inhalation device in the user’s mouth includes contacting the neck with at least one of a lip and a tooth.

[0665] Inventive concept 73. The method of any one of Inventive concepts 48 to 72, wherein the user inhalation is effective to activate the piezo assembly.

[0666] Inventive concept 74. The method of any one of Inventive concepts 48 to 72, wherein the user inhalation is effective to cause a breath-activation circuit to activate the piezo assembly so to generate an aerosol. Inventive concept 75. The method of Inventive concept 63, wherein the aerosol is generated at a proximal end of the central plenum.

[0667] Inventive concept 76. The method of any one of Inventive concepts 48 to 75, wherein the distal frame comprises a plurality of longitudinal airflow channels.

[0668] Inventive concept 77. The method of any one of Inventive concepts 48 to 75, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels.

[0669] Inventive concept 78. The method of any one of Inventive concepts 76 to 78, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

[0670] Inventive concept 79. The method any one of Inventive concepts 76 to 78, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

[0671] Inventive concept 80. The method of any one of Inventive concepts 76 to 79, wherein the longitudinal airflow channels are in fluid communication with the central plenum.

[0672] Inventive concept 81. The method of any one of Inventive concepts 48 to 80, wherein the central plenum comprises a plurality of open passageways through respective walls.

[0673] Inventive concept 82. The method of any one of Inventive concepts 76 to 81, wherein the longitudinal airflow channels are in fluid communication with the central plenum

[0674] Inventive concept 83. The method of any one of Inventive concepts 48 to 82, wherein the distal aerosol module in fluid communication with the central plenum through respective open passageways formed in an inward-facing wall of each of the channels.

[0675] Inventive concept 84. The method of any one of Inventive concepts 61 to 83, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels formed on respective lateral surfaces of the aerosol delivery module

[0676] Inventive concept 85. The method of any one of Inventive concepts 61 to 84, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels laterally displaced from each other across a vertical plane bisecting the distal aerosol delivery module.

[0677] Inventive concept 86. The method of any one of Inventive concepts 61 to 85, wherein a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane, and a portion of an airflow caused by the user inhalation is diverted from the longitudinal airflow channels into the central plenum through the respective open passageways and is effective to entrain at least a portion of an aerosol generated at the mesh membrane.

[0678] Inventive concept 87. An inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising: a. a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; b. a distal aerosol delivery module, comprising a distally-open central plenum; and c. a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

[0679] Any or all of the Inventive concepts referring to Inventive concepts 1-47 can be combined, in any combination, with Inventive Concept 87 replacing Inventive concept 1.

[0680] Inventive concept 88. A method of delivering an aerosol to the oropharynx of a human user, the method comprising, a. providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, (ii) a distal aerosol delivery module, comprising a distally-open central plenum, and (iii) a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; b. placing the inhalation device in the user’s mouth; and c. producing a user inhalation.

[0681] Any or all of the Inventive concepts referring to Inventive concepts 48-86 can be combined, in any combination, with Inventive Concept 88 replacing Inventive concept 48.

[0682] The following patent applications and / or patent publications are incorporated herein by reference in their entirety: US 2024 / 0215639 which published on July 4, 2024; US 2023 / 0141645 which published on May 11, 2023; PCT / IB2022 / 053547 which was filed on April 14, 2022, and which published as WO2022219591A2; PCT / IB2021 / 000724 which was filed on October 20, 2021, and which published as WO2023067365A1.

[0683] The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons skilled in the art to which the invention pertains.

Claims

CLAIMS1. An inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising: a. a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; and b. a distal aerosol delivery module comprising a distally-open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

2. The inhalation device of claim 1, wherein the electronic control circuitry comprises a sensor circuit configured to detect a user inhalation.

3. The inhalation device of either one of claims 1 or 2, wherein the electronic control circuitry comprises a breath-activation circuit.

4. The inhalation device of any one of claims 1 to 3, wherein the electronic control circuitry comprises at least one of an airflow sensor and a pressure sensor.

5. The inhalation device of any one of the preceding claims, wherein the distal aerosol delivery module includes a distal frame and a cartridge module comprising the distal reservoir.

6. The inhalation device of claim 5, wherein the cartridge module comprises the proximal chamber and the mesh membrane.

7. The inhalation device of claim 6, wherein when the cartridge module is joined together with the distal frame, the mesh membrane is in fluid communication with the central plenum.

8. The inhalation device of any one of the preceding claims, wherein a liquid-holding capacity of the distal reservoir has a volume at least twice the volume of a liquid-holding capacity of the proximal chamber.

9. The inhalation device of any one of the preceding claims, wherein a majority of the liquidholding capacity of the distal reservoir is distally displaced from the mesh membrane.

10. The inhalation device of any one of claims 5 to 9, in a fully assembled state in which the cartridge module is joined to the distal frame to form an assembled aerosol delivery module, and the assembled distal aerosol delivery module is joined to the proximal control module.

11. The inhalation device of claim 10, wherein the cartridge module is fixedly and / or irreversibly joined to the distal frame to fixedly and / or irreversibly form the assembled aerosol delivery module, and the assembled distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

12. The inhalation device of claim 11, wherein the cartridge module is reversibly joined to the distal frame to reversibly form the distal aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

13. The inhalation device of any one of claims 1 to 9, provided in a kit comprising a subassembly comprising the distal frame and the proximal control module fixedly and / or irreversibly joined to each other to fixedly and / or irreversibly, and a cartridge module.

14. The inhalation device of any one of claims 1 to 9, provided in a kit comprising a subassembly comprising the distal aerosol delivery module and the proximal control module fixedly and / or irreversibly joined to each other, and one or more cartridge modules each having a liquid held there within.

15. The inhalation device of any one of the preceding claims, oriented such that a central longitudinal axis of the inhalation device is horizontal or inclined downward by up to 45° from a distal end thereof.

16. The inhalation device of any one of the preceding claims, oriented such that a plane defined by the mesh membrane is within ± 10° of vertical.

17. The inhalation device of any one of the preceding claims, oriented such that a plane defined by the mesh membrane is within ± 5° of vertical.

18. The inhalation device of any one of the preceding claims, oriented such that a plane defined by the mesh membrane is vertical.

19. The inhalation device of any one of claims 15 to 18, wherein a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume.

20. The inhalation device of any one of claims 15 to 19, wherein a majority of the liquid-holding capacity is higher than a top edge of the mesh membrane.

21. The inhalation device of any one of claims 15 to 20, wherein a majority of the liquid-holding capacity of the distal reservoir is disposed above the central plenum.

22. The inhalation device of any one of the preceding claims, wherein when the piezo assembly is activated by the control circuit, a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane.

23. The inhalation device of either one of claims 19 or 20, wherein when the piezo assembly is activated by the control circuit, a liquid held in or introduced into the distal reservoir flows into the proximal chamber by force of gravity to replace liquid aerosolized therefrom.

24. The inhalation device of any one claims 21 to 23, wherein when the piezo assembly is activated by the control circuit in response to a user inhalation, an aerosol generated at the mesh membrane is at least partly entrained by an airflow of the user inhalation and passes under the distal reservoir.

25. The inhalation device of any one of the preceding claims, wherein the distal frame comprises a tongue-depressing element.

26. The inhalation device of any one of claims 15 to 25, wherein the aerosol delivery module comprises a tongue-depressing element extending distally under the distal reservoir.

27. The inhalation device of any one of claims 15 to 25, wherein the central plenum is bounded from above by the distal reservoir and from below by a tongue-depressing element.

28. The inhalation device of any one of claims 25 to 27, wherein the tongue-depressing element is integrally formed with the aerosol delivery module.

29. The inhalation device of any one of the preceding claims, wherein the distal frame comprises a neck portion proximal to the central plenum.

30. The inhalation device of any one of the preceding claims, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum.

31. The inhalation device of any one of claims 15 to 30, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum, the neck portion characterized by having therein a thinnest portion of the inhalation device in a vertical direction.

32. The inhalation device of claim 31, wherein a majority of the liquid-holding capacity of the distal reservoir is disposed higher than a top surface of the neck portion.

33. The inhalation device of any one of the preceding claims, wherein the distal frame is shaped to direct a flow of a user inhalation.

34. The inhalation device of any one of the preceding claims, wherein the distal frame comprises a plurality of longitudinal airflow channels.

35. The inhalation device of any one of the preceding claims, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels.

36. The inhalation device of either one of claims 34 or 35, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

37. The inhalation device of any one of claims 34 to 36, wherein the longitudinal airflow channels are in fluid communication with the central plenum.

38. The inhalation device of any one of the preceding claims, wherein the central plenum comprises a plurality of open passageways through respective walls.

39. The inhalation device of any one of claims 34 to 38, wherein the longitudinal airflow channels are in fluid communication with the central plenum40. The inhalation device of any one of claims 34 to 39, wherein the distal aerosol module in fluid communication with the central plenum through respective open passageways formed in an inward-facing wall of each of the channels.

41. The inhalation device of any one of claims 15 to 40, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels formed on respective lateral surfaces of the aerosol delivery module42. The inhalation device of any one of claims 15 to 41, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels laterally displaced from each other across a vertical plane bisecting the distal aerosol delivery module .

43. The inhalation device of any one of claims 38 to 42, wherein when the piezo assembly is activated by the control circuit in response to a user inhalation, a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane, and a portion of an airflow caused by the user inhalation is diverted from the longitudinal airflow channels into the central plenum through the respective open passageways and is effective to entrain at least a portion of an aerosol generated at the mesh membrane.

44. The inhalation device of any one of claims 34 to 43, wherein the longitudinal airflow channels comprise a distal port located distal to the mesh membrane and a proximal port located proximal to the mesh membrane.

45. The inhalation device of any one of the preceding claims, wherein a distal wall of the proximal chamber comprises a portion that is elastic and / or movable and / or pivotable.

46. The inhalation device of any one of the preceding claims, wherein a distal wall of the proximal chamber is effective to facilitate a movement of the mesh membrane or a portion thereof in a direction perpendicular to plane defined by the mesh membrane, in response to a pressure of the liquid within the proximal chamber.

47. A method of delivering of an aerosol to the oropharynx of a human user, the method comprising: a. Providing the inhalation device of any one of the preceding claims, in the fully assembled state; b. Placing the inhalation device in a user mouth such that a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume and the central plenum is in fluid communication with the oropharynx; c. producing a user inhalation to activate the piezo assembly and create an aerosol at the mesh membrane.

48. A method of delivering an aerosol to the oropharynx of a human user, the method comprising, a. providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, and (ii) a distal aerosol delivery module, comprising a distally-open central plenum, a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; b. placing the inhalation device in the user’s mouth; and c. producing a user inhalation.

49. The method of claim 48, wherein the electronic control circuitry comprises a sensor circuit configured to detect a user inhalation.

50. The method of either one of claims 48 or 49, wherein the electronic control circuitry comprises a breath-activation circuit.

51. The method of any one of claims 48 to 50, wherein the electronic control circuitry comprises at least one of an airflow sensor and a pressure sensor.

52. The method of any one of claims 48 to 51, additionally comprising, before the placing: reversibly joining the distal aerosol delivery module and the proximal control module to each other.

53. The method of any one of claims 48 to 52, wherein the distal aerosol delivery module includes a distal frame and a cartridge module comprising the distal reservoir.

54. The method of claim 53, wherein the cartridge module comprises the proximal chamber and the mesh membrane.

55. The method of claim 54, wherein when the cartridge module is joined together with the distal frame, the mesh membrane is in fluid communication with the central plenum.

56. The method of any one of claims 53 to 55, additionally comprising, before the placing: reversibly joining the cartridge module to the distal frame to form the aerosol delivery module.

57. The method of any one of claims 53 to 55, additionally comprising, before the placing: reversibly joining the cartridge module to the distal frame to reversibly form the distal aerosol module, and reversibly joining the distal aerosol delivery module to the proximal control module.

58. The method of any one of claims 53 to 55, wherein the provided inhalation device is in an assembled state in which the cartridge module is joined to the distal frame to form the aerosol delivery module, and the distal aerosol delivery module is joined to the proximal control module.

59. The method of claim 58, wherein the cartridge module is fixedly and / or irreversibly joined to the distal frame to fixedly and / or irreversibly form the aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

60. The method of claim 58, wherein the cartridge module is reversibly joined to the distal frame to reversibly form the distal aerosol delivery module, and the distal aerosol delivery module is fixedly and / or irreversibly joined to the proximal control module.

61. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a central longitudinal axis of the inhalation device is horizontal or inclined downward by up to 45° from a distal end thereof.

62. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is within ± 10° of vertical.

63. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is within ± 5° of vertical.

64. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a plane defined by the mesh membrane is vertical.

65. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is higher than the proximal volume.

66. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity is higher than a top edge of the mesh membrane.

67. The method of any one of claims 48 to 60, wherein placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is disposed above the central plenum.

68. The method of any one of claims 48 to 67, wherein the delivery frame comprises a neck portion proximal to the central plenum.

69. The method of any one of claims 48 to 67, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum.

70. The method of any one of claims 48 to 67, wherein the aerosol delivery module comprises a neck portion proximal to the central plenum, the neck portion characterized by having therein a thinnest portion of the inhalation device in a vertical direction.

71. The method of any one of claims 61 to 70, placing the inhalation device in the user’s mouth is in an orientation in which a majority of the liquid-holding capacity of the distal reservoir is disposed higher than a top surface of the neck portion.

72. The method of any one of claims 68 to 71, wherein placing the inhalation device in the user’s mouth includes contacting the neck with at least one of a lip and a tooth.

73. The method of any one of claims 48 to 72, wherein the user inhalation is effective to activate the piezo assembly.

74. The method of any one of claims 48 to 72, wherein the user inhalation is effective to cause a breath-activation circuit to activate the piezo assembly so to generate an aerosol.

75. The method of claim 63, wherein the aerosol is generated at a proximal end of the central plenum.

76. The method of any one of claims 48 to 75, wherein the distal frame comprises a plurality of longitudinal airflow channels.

77. The method of any one of claims 48 to 75, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels.

78. The method of any one of claims 76 to 78, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

79. The method any one of claims 76 to 78, wherein the longitudinal airflow channels are formed on respective outer surfaces of the aerosol delivery module.

80. The method of any one of claims 76 to 79, wherein the longitudinal airflow channels are in fluid communication with the central plenum.

81. The method of any one of claims 48 to 80, wherein the central plenum comprises a plurality of open passageways through respective walls.

82. The method of any one of claims 76 to 81, wherein the longitudinal airflow channels are in fluid communication with the central plenum83. The method of any one of claims 48 to 82, wherein the distal aerosol module in fluid communication with the central plenum through respective open passageways formed in an inward-facing wall of each of the channels.

84. The method of any one of claims 61 to 83, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels formed on respective lateral surfaces of the aerosol delivery module85. The method of any one of claims 61 to 84, wherein the distal aerosol delivery module comprises a plurality of longitudinal airflow channels laterally displaced from each other across a vertical plane bisecting the distal aerosol delivery module.

86. The method of any one of claims 61 to 85, wherein a portion of a liquid held in the proximal chamber is aerosolized at the mesh membrane, and a portion of an airflow caused by the user inhalation is diverted from the longitudinal airflow channels into the central plenum through the respective open passageways and is effective to entrain at least a portion of an aerosol generated at the mesh membrane.

87. An inhalation device for delivery of an aerosol to the oropharynx of a human user, the inhalation device comprising: a. a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry; b. a distal aerosol delivery module, comprising a distally-open central plenum; and c. a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber.

88. A method of delivering an aerosol to the oropharynx of a human user, the method comprising, a. providing inhalation device comprising (i) a proximal control module comprising a piezo assembly, a battery, and electronic control circuitry, (ii) a distal aerosol delivery module, comprising a distally-open central plenum, and (iii) a cartridge module comprising a mesh membrane, a proximal chamber comprising a distal wall at least partly open to the mesh membrane, and a distal reservoir in fluid communication with the proximal chamber; b. placing the inhalation device in the user’s mouth; and c. producing a user inhalation.

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