Droplet delivery device with push ejection

Abstract

A droplet delivery device includes a housing with a mouthpiece port or outlet from a nasal device for releasing fluid droplets, a fluid reservoir, and an ejector bracket having a membrane positioned between a mesh with a plurality of openings and a vibrating member that is coupled to an electronic transducer, such as an ultrasonic transducer. The transducer vibrates the vibrating member which causes the membrane to push fluid supplied by the reservoir through the mesh to generate droplets in an ejected stream released through the outlet.

Description

(19) *EP004659870A2* (11) EP 4 659 870 A2 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: 10.12.2025 Bulletin 2025 / 50 (21) Application number: 25191082.4 (22) Date of filing: 22.06.2022 (51) International Patent Classification (IPC): B05B 17 / 00 (2006.01) (52) Cooperative Patent Classification (CPC): A61M 11 / 005; A61M 15 / 0085; A61M 15 / 06; B05B 17 / 0638; A61M 15 / 0021; A61M 2205 / 8206; A61M 2206 / 11 (84) Designated Contracting States: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR (30) Priority: 22.06.2021 US 202163213634 P 15.10.2021 US 202163256245 P 16.10.2021 US 202163256546 P 18.11.2021 US 202163280643 P (62) Document number(s) of the earlier application(s) in accordance with Art. 76 EPC: 22744049.2 / 4 359 046 (71) Applicant: Pneuma Respiratory, Inc. Boone, NC 28607 (US) (72) Inventors: • Hunter, Charles Eric Boone, 28607 (US) • Scoggin, Michael Boone, 28607 (US) • Miller, Jeffrey Boone, 28607 (US) • Salazar, Jose Boone, 28607 (US) • Beach, Brian Boone, 28607 (US) • Modlin, Caley Boone, 28607 (US) • Culpepper, Matthew Boone, 28607 (US) • Li, Jianqiang Boone, 28607 (US) • Li, Chengjie Boone, 28607 (US) • Wang, Shi Bo Boone, 28607 (US) • Lee, Chao-Ping Boone, 28607 (US) • Rapp, Gregory Boone, 28607 (US) • Clements, Judson Sidney Boone, 28607 (US) (74) Representative: Greaves Brewster LLP Copa House Station Road Cheddar, Somerset BS27 3AH (GB) Remarks: •A request for correction of the description has been filed pursuant to Rule 139 EPC. A decision on the request will be taken during the proceedings before the Examining Division (Guidelines for Examination in the EPO, A-V, 3.). •This application was filed on 22.07.2025 as a divisional application to the application mentioned under INID code 62. •Claims filed after the date of filing of the application / after the date of receipt of the divisional application (Rule 68(4) EPC). (54) DROPLET DELIVERY DEVICE WITH PUSH EJECTION (57) Adroplet delivery device includesahousingwith a mouthpiece port or outlet from a nasal device for releasing fluid droplets, a fluid reservoir, and an ejector bracket having a membrane positioned between a mesh with a plurality of openings and a vibratingmember that is coupled toanelectronic transducer, suchasanultrasonic transducer. The transducer vibrates the vibrating mem- berwhich causes themembrane to push fluid supplied by the reservoir through themesh to generate droplets in an ejected stream released through the outlet. EP 4 65 9 87 0 A 2 Processed by Luminess, 75001 PARIS (FR) Description CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 280,643 filed November 18, 2021, U.S. Provisional Patent Application No. 63 / 256,546 filed October 16, 2021, Provisional Patent ApplicationNo. 63 / 256,245filedOctober 15, 2021, andProvisionalPatentApplicationNo. 63 / 213,634filed June22, 2021, all of which are incorporated herein by reference in their entirety. FIELD OF THE PUSH MODE INVENTION

[0002] This disclosure relates to droplet delivery devices with ejector mechanisms and more specifically to droplet delivery devices for the delivery of fluids that are inhaled into mouth, throat nose, and / or lungs. BACKGROUND OF THE PUSH MODE INVENTION

[0003] The use of droplet generating devices for the delivery of substances to the respiratory system is an area of large interest. Amajor challenge is providing a device that delivers an accurate, consistent, and verifiable amount of substance, with a droplet size that is suitable for successful delivery of substance to the targeted area of the respiratory system.

[0004] Currently most inhaler type systems, such as metered dose inhalers (MDI), pressurized metered dose inhalers (p-MDI), or pneumatic and ultrasonic-driven devices, generally produce droplets with high velocities and a wide range of droplet sizes including large droplets that have high momentum and kinetic energy. Droplet plumes with large size distributions and high momentum do not reach a targeted area in the respiratory system, but rather are deposited throughout the pulmonary passageways, mouth, and throat. Such non-targeted deposition may be undesirable for many reasons, including improper dosing and unwanted side effects.

[0005] Droplet plumes generated from current droplet delivery systems, as a result of their high ejection velocities and the rapid expansion of the substance carrying propellant, may also lead to localized cooling and subsequent condensa- tion, deposition and crystallization of substance onto device surfaces. Blockage of device surfaces by deposited substance residue is also problematic.

[0006] Further, conventional droplet delivery devices for delivery of nicotine, including vape pens and the like, typically require fluids that are inhaled to be heated to temperatures that negatively affect the liquid being aerosolized. Specifically, such levels of heating can produce undesirable and toxic byproducts as has been documented in the news and literature.

[0007] Accordingly, there is aneed for an improved droplet delivery device that delivers droplets of a suitable size range, avoids surface fluid deposition and blockage of apertures, avoids producing undesired chemical byproducts through heating, and in an amount that is consistent and reproducible. SUMMARY OF THE PUSH MODE INVENTION

[0008] In oneembodiment of the pushmode invention, a "pushmode" droplet delivery device doesnot includeaheating requirement that could result in undesirable byproducts and comprises: a container assembly with an mouthpiece port; a reservoir disposed within or in fluid communication with the container assembly to supply a volume of fluid, an ejector bracket in fluid communicationwith the reservoir, the ejector bracket including ameshwith amembrane operably coupled to an electronic transducer with the membrane between the transducer and the mesh, wherein the mesh includes a plurality of openings formed through themesh’s thickness, andwherein the transducer is coupled to a power source and is operable to oscillate themembraneandgenerateanejected streamof droplets through themesh, andanejection channel within the container assembly configured to direct the ejected streamof droplets from themesh to the outlet. The vibrating membrane "pushing" liquid through themesh is referred to herein as "pushmode" ejection anddevices in embodiments of the push mode invention may be referred to as push mode devices.

[0009] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperateswith amesh further includes an ultrasonic transducer as an electronic transducer, and preferably an ultrasonic transducer that includes piezoelectric material.

[0010] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes the container assembly having a fluid reservoir.

[0011] Inanotherembodimentof thepushmode invention, adroplet deliverydevicehavingamembrane that cooperates with a mesh further includes an ejector bracket configured for releasably coupling to the container assembly and the ejector bracket further configured for releasable coupling to an enclosure system including an electronic transducer and a power source.

[0012] In another embodiment of the push mode invention, a droplet delivery device having a membrane that 2 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 cooperates with a mesh further includes magnets configured to releasably couple the ejector bracket and enclosure system.

[0013] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a snap mechanism and / or magnets configured to releasably couple the ejector bracket and the container assembly.

[0014] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a fluid reservoir with a self-sealing mating mechanism configured to couple to a fluid release mating mechanism of the ejector bracket.

[0015] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with amesh further includes a fluid releasematingmechanism that has a fluid conduit configured for insertion into the self-sealing mating mechanism. In a preferred embodiment, a fluid release mating mechanism includes a spike- shaped structure with a hollow interior configured to provide fluid communication between the reservoir and the membrane.

[0016] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh is configured so that the membrane does not contact the mesh and pushes fluid to be ejected as droplets from the droplet delivery device through openings in the mesh.

[0017] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes the membrane having a slanted upper surface configured to contact fluid supplied from the reservoir.

[0018] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a vibrating member having a slanted tip contacting an opposite underlying surface of a slanted upper surface of the membrane.

[0019] In further embodiments of the pushmode invention, an electronic transducer includes piezoelectricmaterial that is coupled to a vibratingmember with a ring-shaped beveled tip, rod-shaped beveled tip, rod-shaped tip, or a ring-shaped non-beveled tip.

[0020] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a mesh with a bottom surface in a parallel configuration with an upper surface of the membrane.

[0021] In another embodiment of the pushmode invention, a droplet delivery device havingmembrane that cooperates with amesh further includes the mesh including a bottom surface in a non-parallel, i.e., slanted at an angle, configuration with an upper surface of the membrane.

[0022] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with amesh further includes a central axis of the droplet delivery device passing through the ejection channel and the membrane, and wherein the transducer is coupled to a vibrating member that is coupled to the membrane at a position offset from the central axis.

[0023] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a fluid in the reservoir including at least one of a non-therapeutic substance, nicotine, or cannabinoid.

[0024] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a fluid in the reservoir including a therapeutic substance that treats or prevents a disease or injury condition.

[0025] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with amesh further includes a laminar flow element positioned in an ejection channel of a container assembly beforeamouthpieceport of thedelivery device. Inpreferable embodiments, the laminar flowelement includesaplurality of cellular apertures. In some embodiments, a laminar flow element includes blade-shaped walls defining the plurality of cellular apertures. In further embodiments, one or more of the plurality of cellular apertures include a triangular prismatic shape, quadrangular prismatic shape, pentagonal prismatic shape, hexagonal prismatic shape, heptagonal prismatic shape, or octagonal prismatic shape.

[0026] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a breath-actuated sensor, such as a pressure sensor, operatively coupled to the power source, wherein the breath-actuated senor is configured to activate the electronic transducer upon sensing a predetermined pressure change within the ejection channel or within a passageway of the droplet delivery device in fluid communication with the ejection channel.

[0027] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes the mesh made of a material of at least one of palladium nickel, polytetra- fluoroethylene, and polyimide.

[0028] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with amesh further includes themeshmade of amaterial of at least one of poly ether ketone, polyetherimide, 3 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 polyvinylidine fluoride, ultra-high molecular weight polyethylene, Ni, NiCo, Pd, Pt, NiPd, and metal alloys.

[0029] In other embodiments a mesh may be made of single crystalline or poly crystalline materials such as silicon, silicon carbide, aluminumnitride or germaniumwith hole structures formedusing semiconductor processes suchasphoto lithography and isotropic and anisotropic etching. With photolithography and isotropic and / or anisotropic etches different hole shapescanbe formed inasingle crystallinewaferwith veryhighprecision.Usingsputtering, filmscanbedepositedon the surfacewith different contact angles. Thin layers formedor depositedon the surfacewill have, in certain embodiments, muchbetter adherence thanfilmdepositedonmetalmesh formedbygalvanic depositionor polymermesh formedby laser ablation. This better adherence is because the surfaces on the single crystallinewafers "slices" are atomically smooth and can be etched to produce exact surface roughness to facilitate mechanical bonding with glue or other materials. Silicon carbide would be a preferable material because of its high strength and toughness. An important advantage of using semiconductor processes to fabricate hole structures fromasingle crystallinewafer "slice" in ameshof embodiment of the pushmode invention is that the holes and surface contact angleswill be exact without the variationwe see in conventional ejector plates using mesh made from galvanic deposition or laser ablation.

[0030] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes the membrane made a of material of at least one of polyethylene naphthalate, polyethylenimine and poly ether ketone.

[0031] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with amesh further includes themembranemade a ofmaterial of at least one ofmetal membranes, metalized polymers, threaded polymers, threaded nylon, threaded polymers that are coatedwith polymers ormetal, threaded nylon coated with polymers or metal. threaded metals, threaded SiC, threaded graphite composites, metalized graphite composites, graphite composites coated with polymers, polymer sheets filled with carbon fibers, poly ether ketone filled with carbon fibers, polymer sheets filled with SiC fibers, polymer sheets filled with ceramic or metal fibers, ULPA filter media, Nitto Denko TemicGrade filtermedia, Nitto Denko polymer sheets, threaded polymers bonded to a polymer sheet, nylon weave bonded to poly ether ketone or polyimide, graphite composites bonded to polymer sheets, polymer fiber weave with metalized coating, and nylon with sputtered on A1 or vapor deposited A1.

[0032] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a PZT-based ultrasonic transducer coupled to a vibrating member having a tipportionmadeof at least oneofGrade5 titaniumalloy,Grade23 titaniumalloy, andabout99%orhigher purity titanium. In certain embodiments, the vibrating member’s tip includes a sputtered on outer layer of and about 99% or higher purity titanium providing a smooth tip surface configured to contact an underlying bottom surface of the membrane that is opposite an exterior top surfaceof themembrane positioned nearest themesh so as to help reducewear of themembrane and increase the longevity and operation consistency of themembrane (and also possibly vibratingmember’s tip portion).

[0033] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes an exterior surface of the membrane, opposite an underlying surface of the membrane contacting the vibrating member, having a hydrophobic coating.

[0034] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes an exterior surface of the membrane, opposite an underlying surface of the membrane contacting the vibrating member, having a hydrophilic coating.

[0035] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a hydrophilic coating on one or more surfaces of the mesh.

[0036] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a mesh including a hydrophobic coating on one or more surfaces of the mesh.

[0037] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a hydrophobic coating on a first surface of the mesh and a hydrophilic coating on a second surface of the mesh.

[0038] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes the membrane having an operable lifespan of over 55,000 aerosol-creating activations by the transducer.

[0039] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes at least one superhydrophobic vent in fluid communication with the reservoir that is covered with a removable aluminized polymer tab during storage.

[0040] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh further includes a removable aluminized polymer tab coupled to an exterior surface of the membrane adjacent the mesh during storage.

[0041] In another embodiment of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh includes a pre-assembly step of removing a sealed packaging including aluminum and / or aluminum coating that contains the reservoir with a fluid, preferably wherein the reservoir is included in the container assembly that is alsopackaged for storage in the sealedpackaging. In someembodiments, sealedpackagingmay include 4 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 dry nitrogen, argon or other gas that does not contain oxygen.

[0042] In various embodiments of the push mode invention, a droplet delivery device having a membrane that cooperates with a mesh may be used for mouth inhalation or nasal inhalation. The mouthpiece port may be sized, shaped and include materials that are better suited for that particular mouth or nasal inhalation use and purpose. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Thepushmode inventionwill bemore clearly understood from the followingdescriptiongivenbywayof example, in which: FIG.1A is anexplodedviewofmajor componentsofadroplet deliverydevice inaccordancewithanembodimentof the disclosure. FIG. 1B is a cross-sectional viewofmajor components of a droplet delivery device in accordancewith an embodiment of the disclosure. FIG. 2 is a schematic view of a mesh bonded to a stainless-steel ring that supports an elastic sealing ring of a droplet delivery device in an accordance with an embodiment of the disclosure referred to as push mode II. FIG. 3 is a schematic view of a mesh supported by inner and outer tablet rings and an elastic sealing ring of a droplet delivery device in an accordance with an embodiment of the disclosure referred to as push mode I. FIG. 4 illustrates a cross-sectional view of certain dimensions of ejection and mouthpiece ports of a droplet delivery device in accordance with one embodiment of the disclosure. FIG. 5 illustrates a cross-sectional view of fluid flow path of a droplet delivery device with a two-part cartridge in accordance with one embodiment of the disclosure. FIGS. 6A and 6B illustrate airflow of a droplet delivery device with a two-part cartridge in accordance with an embodiment of the disclosure. FIGS. 7A and 7B illustrate perspective views of the disassembly of major components of a push mode I droplet delivery device (utilizing mesh support shown in FIG. 3) in an embodiment of the disclosure. FIG. 8 illustrates an exploded view of a pushmode I droplet delivery device (utilizingmesh support shown in FIG. 3) in an embodiment of the disclosure. FIG 9 illustrates isolated perspective views of COC (cyclic olefin copolymer) rings, including mesh (22), of a push mode I droplet delivery device (utilizing mesh support shown in FIG. 3) in an embodiment of the disclosure. FIG. 10 illustrates a schematic view of a pushmode I droplet delivery device mesh suspension system (redundant to FIG. 3) in an embodiment of the disclosure. FIG. 11 illustrates a perspective view of lower ejector bracket including vents located on each narrow side of the bracket of a push mode I droplet delivery device (utilizing mesh support shown in FIG. 3) in an embodiment of the disclosure. FIGS. 12A and 12B illustrate perspective views of the disassembly of major components of a push mode II droplet delivery device (utilizing mesh support shown in FIG. 2) in an embodiment of the disclosure. FIG. 13 illustrates an exploded view of a pushmode II droplet delivery device (utilizingmesh support shown in FIG. 2) in an embodiment of the disclosure. FIG. 14 illustrates aschematic viewof apushmode II droplet delivery devicemeshsuspension system (asalso shown in FIG. 2) in an embodiment of the disclosure. FIG. 15 illustrates a perspective view of lower ejector bracket including vents located on eachwide side of the bracket of a pushmode II droplet delivery device (utilizingmesh support shown in FIG. 2) in an embodiment of the disclosure. FIG.16 illustratesa lower containerof apushmode II droplet deliverydevice (utilizingmeshsupport shown inFIG.2) in an embodiment of the disclosure. FIG. 17 illustratesa lower container of a pushmode I droplet delivery device (utilizingmeshsupport shown inFIG. 3) in an embodiment of the disclosure. FIG. 18 illustrates a perspective view of a rod tip design for a vibrating member of a droplet delivery device in accordance with one embodiment of the disclosure. FIG. 19 illustrates a perspective view of a ring tip design for a vibrating member of a droplet delivery device in accordance with one embodiment of the disclosure. FIG. 20 illustrates a cross-sectional view of single part cartridge design with a long vibrating member in a droplet delivery device in accordance with one embodiment of the disclosure. FIGS. 21A and 21B illustrate cross-sectional views of single part cartridge design with a short vibrating member in a droplet delivery device in accordance with one embodiment of the disclosure. FIGS. 22A and 22B illustrate cross-sectional views of single part cartridge alternative designs with a long vibrating member in a droplet delivery device in accordance with one embodiment of the disclosure. FIGS. 23A and 23B illustrate cross-sectional views of single part cartridge alternative designs with a short vibrating 5 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 member in a droplet delivery device in accordance with one embodiment of the disclosure. FIG. 24 illustrates a cross-sectional and separated view of a two-part cartridge design in a droplet delivery device in accordance with one embodiment of the disclosure. FIG. 25 illustrates a perspective view of a droplet delivery device adapted for pharmaceutical use (but may be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 26 illustrates an exploded view of a droplet delivery device adapted for pharmaceutical use (but may be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 27A‑27D illustrate views ofmajor components of a droplet delivery device adapted for pharmaceutical use (but may be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e. "push mode function- ality") in accordance with one embodiment of the disclosure. FIGS. 28A‑28D illustrate an assembly view of major components of a droplet delivery device adapted for pharma- ceutical use (but may be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 29 illustrates an exploded view of a cap of a droplet delivery device adapted for pharmaceutical use (but may be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 30A and 30B illustrate respective front and side cross-sectional views of a fluid cartridge of a droplet delivery device adapted for pharmaceutical use (butmay be other uses in other embodiments) and utilizingmembrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 31 illustrates a cross-sectional view of a vibrating member enclosure of a droplet delivery device adapted for pharmaceutical use (butmay be other uses in other embodiments) and utilizingmembrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 32 illustrates a cross-sectional view of an ejector bracket adapted for pharmaceutical use (butmaybe other uses in other embodiments) andutilizingameshsuspension system that follows structureand function of themesh support shown in FIG. 14 in accordance with one embodiment of the disclosure. FIG. 33 illustrates a cross-sectional view of an ejector bracket adapted for pharmaceutical use (butmaybe other uses in other embodiments) and utilizing a mesh suspension system that follows the structure and function of the mesh support shown in FIG. 10 in accordance with one embodiment of the disclosure. FIGS. 34A and 34B illustrate respective side and front cross-sectional views of a droplet delivery device adapted for pharmaceutical use (butmay be other uses in other embodiments) and utilizingmembrane-driven aerosolization (i.e. "push mode functionality") having two heating elements positioned beneath a vibrating member on either side of the ejector bracket in accordance with one embodiment of the disclosure. FIG. 35A‑35C illustrate cross-sectional views of an airflow path for a droplet delivery device having a bottom heating element with a single part cartridge design in accordance with one embodiment of the disclosure. FIG. 36 illustrates cross-sectional view of a droplet delivery device having a bottomheating element and speakerwith a single part cartridge design in accordance with one embodiment of the disclosure. FIG. 37 illustrates a cross-sectional view of an airflow path for a droplet delivery device having an inside heating element with a two-part cartridge design in accordance with one embodiment of the disclosure. FIG. 38 illustrates a cross-sectional view of an airflow path for a droplet delivery device having an inside heating element with a single part cartridge design in accordance with one embodiment of the disclosure. FIG. 39 illustrates a cross-sectional view of an airflow path for a droplet delivery device having an external heating element with a single part cartridge design in accordance with one embodiment of the disclosure. FIG. 40 illustrates a cross-sectional view of droplet delivery device with a heated airstream including a temperature sensor that is used in conjunction with a closed loop system to keep the temperature of the airstream constant, and also avoid overheating and user injury, in accordance with one embodiment of the disclosure. FIGS. 41A and 41B illustrate views of a droplet delivery device with adjustable air resistance via sliding sleeve and associated vent in accordance with one embodiment of the disclosure. FIG.42 illustratesanelongatedandnarrow inhalationport of adroplet delivery deviceadapted for nasal inhalationand utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 43 illustrates a shorter-version inhalation port of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 44A and 44B illustrate a removal cap of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the dis- closure. 6 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 FIG. 45 illustrates ameshwith an attached plate havingmultiple openings for liquid to enter used in a droplet delivery device utilizingmembrane-driven aerosolization (i.e. "pushmode functionality") in accordance with one embodiment of the disclosure. FIG. 46 illustrates a cross-sectional view of a capacitance cartridge having two parallel plates placed across the liquid next to the mesh-membrane area in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 47A‑47C illustrate a perspective view (FIG.47A), front plan view (FIG. 47B) and side plan view (FIG. 47C) of a rectangular vibrating member tip in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 48A‑48C illustrate a perspective view (FIG. 48A), a perspective vibration amplitudemap view (FIG. 48B) and a top vibration amplitude plan view (FIG. 48C) of an eigenmode vibrating member tip without slots or tuning and the resulting vibration amplitude maps in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 49A‑49C illustrate a perspective view (FIG. 49A), a perspective vibration amplitudemap view (FIG. 49B) and a top vibration amplitude plan view (FIG. 49C) of an eigenmode vibrating member tip with slots and the resulting vibration amplitude maps in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 50 illustrates a contoured vibratingmember in a droplet delivery device utilizingmembrane-drivenaerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 51 illustrates a plunger vibrating member in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIG. 52 illustrates a sensor carrier vibrating member in a droplet delivery device utilizing membrane-driven aero- solization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 53A and 53B illustrate a spool vibratingmember and the resulting vibration amplitudemap in a droplet delivery device utilizingmembrane-driven aerosolization (i.e. "pushmode functionality") in accordance with one embodiment of the disclosure. FIGS. 54Aand54B illustrate an optimized cylindrical vibratingmember and the resulting vibration amplitudemap in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 55A and 55B illustrate an unoptimized slotted cylindrical vibrating member and the resulting vibration amplitude map in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 56Aand56B illustrateanoptimizedbar vibratingmemberand the resulting vibrationamplitudemap inadroplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 57A and 57B illustrate an unoptimized bar vibrating member and the resulting vibration amplitude map in a droplet delivery device utilizing membrane-driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 58A and 58B illustrate a perspective view (FIG. 58A) and cross-sectional vibration amplitude view (58B) of a booster vibrating member and the resulting vibration amplitude map in a droplet delivery device utilizing membrane- driven aerosolization (i.e. "push mode functionality") in accordance with one embodiment of the disclosure. FIGS. 59A‑59C illustrate a perspective view (FIG. 59A), top plan view (FIG. 59B) and front plan view (FIG. 59C) of an alternative vibrating member that couplee to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 60A‑60C illustrate a perspective view (FIG. 60A), top plan view (FIG. 60B) and front plan view (FIG. 60C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 61A‑61C illustrate a perspective view (FIG. 61A), top plan view (FIG. 61B) and front plan view (FIG. 61C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 62A‑62C illustrate a perspective view (FIG. 62A), top plan view (FIG. 62B) and front plan view (FIG. 62C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 63A‑63C illustrate a perspective view (FIG. 63A), top plan view (FIG. 63B) and front plan view (FIG. 63C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 64A‑64C illustrate a perspective view (FIG. 64A), top plan view (FIG. 64B) and front plan view (FIG. 64C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an 7 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 embodiment of the disclosure. FIGS.65A‑65D illustrateaperspectiveview (FIG.65A), topplanview (FIG.65B), front planview (FIG.65C)andcross- sectional view along A-A of FIG. 65B (FIG. 65D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 66A‑66C illustrate a perspective view (FIG. 66A), top plan view (FIG. 66B) and front plan view (FIG. 66C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 67A‑67C illustrate a perspective view (FIG. 67A), top plan view (FIG. 67B) and front plan view (FIG. 67C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 68A‑68D illustrate a perspective view (FIG. 68A), top plan view (FIG. 66B), front plan view (FIG. 66C) and side plan view (66D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 69A and 69B illustrate a perspective view (FIG. 69A) and side plan view (FIG. 69B) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordancewith an embodiment of the disclosure. FIGS. 70A‑70C illustrate a perspective view (FIG. 70A), top plan view (FIG. 70B) and front plan view (FIG. 70C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 71A‑71C illustrate a perspective view (FIG. 71A), top plan view (FIG. 71B) and front plan view (FIG. 71C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 72A‑72C illustrate a perspective view (FIG. 72A), top plan view (FIG. 72B) and front plan view (FIG. 72C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 73A‑73C illustrate a perspective view (FIG. 73A), top plan view (FIG. 73B) and front plan view (FIG. 73C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 74A‑74C illustrate a perspective view (FIG. 74A), top plan view (FIG. 74B) and front plan view (FIG. 74C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 75A‑75C illustrate a perspective view (FIG. 75A), top plan view (FIG. 75B) and front plan view (FIG. 75C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 76A‑76C illustrate a perspective view (FIG. 76A), top plan view (FIG. 76B) and front plan view (FIG. 76C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 77A‑77C illustrate a perspective view (FIG. 77A), top plan view (FIG. 77B), front plan view (FIG. 77C) and side plan view (FIG. 77D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 78A‑78C illustrate a perspective view (FIG. 78A), top plan view (FIG. 78B) and front plan view (FIG. 78C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 79A‑79C illustrate a perspective view (FIG. 79A), top plan view (FIG. 79B) and front plan view (FIG. 79C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 80A‑80D illustrate a perspective view (FIG. 80A), top plan view (FIG. 80B), front plan view (FIG. 80C) and side plan view (FIG. 80D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 81A‑81D illustrate a perspective view (FIG. 81A), top plan view (FIG. 81B), front plan view (FIG. 81C) and side plan view (FIG. 81D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 82A‑82D illustrate a perspective view (FIG. 82A), top plan view (FIG. 82B), front plan view (FIG. 82C) and side plan view (FIG. 82D) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 83A‑83C illustrate a perspective view (FIG. 83A), top plan view (FIG. 83B) and front plan view (FIG. 83C) of an alternative vibrating member that couples to a transducer of droplet delivery devices in accordance with an embodiment of the disclosure. FIGS. 84A‑84Q illustrate alternative structures of laminar flow elements of a container assembly of a droplet delivery 8 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 device in accordance with embodiments of the disclosure. FIG. 85A illustrates an ultrasonic transducer, including a vibrating member tip portion, in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 85B is a partial cross-sectional top view of the ultrasonic transducer of FIG. 85A coupling to a membrane in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 85C and 85D are schematic views of the ultrasonic transducer and membrane of FIG. 85B in droplet delivery devices in accordance with alterative embodiments of the disclosure wherein a mesh includes first securing mechanism in FIG. 85C and second securing mechanism in FIG. 85D. FIG. 86A is a partial cross-sectional top view of an ultrasonic transducer coupled to amembrane in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 86B and 86C are schematic views of the ultrasonic transducer and membrane of FIG. 86A in droplet delivery devices in accordance with alterative embodiments of the disclosure wherein a mesh includes first securing mechanism in FIG. 86B and second securing mechanism in FIG. 86C. FIG. 87 is partial cross-sectional top view of a droplet delivery device including an ultrasonic transducer with vibrating member tip portion offset from a central axis of the droplet delivery device passing through a slanted membrane and mesh in accordance with an embodiment of the disclosure. FIG. 88A is a partial cross-sectional top view of an ultrasonic transducer with a non-beveled ring-shaped vibrating member tip portion coupled to a tilted mesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 88B is a schematic view of the ultrasonic transducer and membrane of FIG. 88A in droplet delivery devices in accordance with an embodiment of the disclosure. FIG. 89A is a partial cross-sectional top viewof anultrasonic transducerwith a beveled ring-shapedvibratingmember tip portion coupled to a slanted membrane in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 89B illustrates a slanted membrane that cooperates with an ultrasonic transducer and mesh illustrated in FIG. 89A. FIGS. 89C and 89D are schematic views of the ultrasonic transducer and membrane of FIG. 89A in droplet delivery devices in accordance with alterative embodiments of the disclosure wherein a mesh includes first securing mechanism in FIG. 89C and second securing mechanism in FIG. 89D. FIG. 89E illustrates an ultrasonic transducer with a beveled ring-shaped vibrating member tip portion of FIG. 89A. FIG. 90A is a partial cross-sectional top view of an ultrasonic transducer with a non-beveled ring-shaped vibrating member tip portion coupled to amembrane and touching themesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 90B is a schematic view of the ultrasonic transducer and membrane of FIG. 90A in droplet delivery devices in accordance with an embodiment of the disclosure. This embodiment can be used with a mesh carrier either of push mode I or II. FIG. 91A is a partial cross-sectional top viewof anultrasonic transducerwith a beveled ring-shapedvibratingmember tip portion coupled to a slantedmembranewith a space between themesh andmembrane in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 91B is a schematic view of the ultrasonic transducer and membrane of FIG. 91A in droplet delivery devices in accordance with an embodiment of the disclosure. This embodiment can be used with a mesh carrier of either push mode I or II. FIG. 92 is schematic view of an ultrasonic transducer with a non-beveled ring-shaped vibrating member tip portion coupled to amembranewitha spacebetween themeshandmembrane inadroplet delivery device in accordancewith an embodiment of the disclosure. This embodiment can be used with a mesh carrier of either push mode I or II. FIGS. 93Aand93B are schematic views of an ultrasonic transducer of a droplet delivery devicewith an isolation view (FIG. 93A) anda cross-sectional view along lineA-A of FIG. 93A (FIG. 93B) of the ultrasonic transducer having awide and flat vibrating member tip portion together with membrane and mesh in accordance with an embodiment of the disclosure. FIGS. 94A‑94D are schematic views of a droplet delivery device (FIG. 94)with a cross-sectional isolation views of the ultrasonic transducer along line B-B of FIG. 94A (FIG. 94B), an isolation view (FIG. 94C) and a cross-section view along line A-A of FIG. 94C (FIG. 94D) of the ultrasonic transducer having a wide and ring-shaped tip portion together with membrane and mesh in accordance with an embodiment of the disclosure. FIG. 95 is a schematic block illustration of an aluminized polymer tab in an embodiment of the disclosure. FIGS. 96A‑96D are perspective views of amembrane of a droplet delivery device in accordancewith an embodiment of the disclosure. FIGS. 97A and 97B illustrate a cross-sectional view (FIG. 97A) and a zoomed view (FIG. 97B) of a polymer mesh supported in a raised position by a stainless-steel annulus with respect to a membrane and transducer coupled to a 9 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 vibratingmember having a tip portion in a droplet delivery device in accordancewith an embodiment of the disclosure. FIGS. 98A and 98B illustrate a cross-sectional view (FIG. 98A) and a zoomed view (FIG. 98B) of a polymer mesh supported in a lowered position by a stainless-steel annulus with respect to amembrane and transducer coupled to a vibratingmember having a tip portion in a droplet delivery device in accordancewith an embodiment of the disclosure. FIGS. 99A and 99B illustrate a cross-sectional view (FIG. 99A) and a zoomed view (FIG. 99B) of a polymer mesh supported in a raised position by a first stainless-steel annulus and having a second stainless steel annulus as a reinforcement coupled, such as by bonding with glue or adhesive, on top of the first annulus with respect to a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 100Aand100B illustrate across-sectional view (FIG. 100A)andazoomedview (FIG.100B) of apolymermesh supported in a lowered position by a first stainless-steel annulus and having a second stainless steel annulus as a reinforcement coupled, such as by bondingwith glue or adhesive, below the first annuluswith respect to amembrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 101A‑101C illustrate cross-sectional views of a polymer mesh supported in a raised position (FIG. 101A), lowered position (FIG. 101B) and via jagged support (FIG. 101C) with plastic elements of a ring-like support (and without ametal annulus) with respect tomembranes and transducer coupled to a vibratingmember in droplet delivery devices in accordance with embodiments of the disclosure. FIGS. 102A-C illustrate zoomed views of FIG. 101A (FIG. 102A), FIG. 101B (FIG. 102B) and FIG. 101C (FIG. 102C). FIG. 103A and 103B illustrate a cross-sectional view (FIG. 103A) and a zoomed view (FIG. 103B) of a polymermesh and stainless-steel capillary plate having openings in the plate and the plate underlying the polymermesh between a membrane covering a vibrating member tip portion and the mesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 103C is a schematic top plan view of a polymer mesh illustrated in FIGS. 103A and 103B. FIG. 103D is a schematic top plan view of a stainless-steel capillary plate illustrated in FIGS. 103A and 103B. FIG. 104 illustrates a schematic view of a polymermesh and capillary platewherein the capillary plate ismade of PEN material like themembrane covering the vibratingmember (alsomadeofPENmaterial) and further including a spacer (such as metal, ceramics or plastic) between the capillary plate and the mesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 105A and 105B illustrate a cross-sectional view (FIG. 105A) and zoomed view (FIG. 105B) of a polymermesh with a plastic or silicone ring-shaped type bracket (d) coupled to a stainless steel annulus shaped downward and then up toward a center portion of the annulus that couples to a polymermeshwith respect to amembrane and transducer coupled toavibratingmemberhavinga tipportion inadroplet deliverydevice inaccordancewithanembodiment of the disclosure. FIGS. 106A and 106B illustrats a cross-sectional view (FIG. 106A) and zoomed view (FIG. 106B) of a polymer mesh with a plastic or silicone ring-shaped type bracket center portion of the annulus that couples to a polymer mesh with respect to amembrane and transducer coupled to a vibratingmember having a tip portion in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 107A‑107B illustrate cross-sectional views of a polymer mesh with a plastic or silicone ring-shaped type bracket coupled to double-reinforced stainless-steel annuluses (similar to FIGS. 99 and 100) wherein the polymer mesh is raised with further extending top reinforcement (FIG. 107A), the polymer mesh is raised with extending top reinforcement (FIG. 107B), the polymer mesh is lowered with extending underlying reinforcement (FIG. 107C), the polymermesh is loweredwith further extending underlying reinforcement (FIG. 107D) with respect tomembrane and transducer coupled to a vibrating member having a tip portion in droplet delivery devices in accordance with embodiments of the disclosure. FIGS. 108A‑108D illustrats zoomed views of FIG. 107A (FIG. 108A), FIG. 107B (FIG. 108B), FIG. 107C (FIG. 108C) and FIG. 107D (FIG. 108D). FIGS. 109A‑109D illustrate a cross-sectional view (FIG. 109A), a perspective view (FIG. 109B), a top plan view (FIG. 109C) and a cross-sectional zoomed view along line C-C of FIG. 109C (FIG. 109D) of a crystalline silicon or silicon carbide "wafer"-type mesh between ring-structured supports and processed with semiconductor technology to provide exact fabrication of smooth openings, such as pseudo spherical, (zoomed cross-sectional view of FIG. 109D intended to show openings fully through mesh), in the mesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIG. 110 illustrates a cross-sectional and zoomedviewof a crystalline siliconor silicon carbide "wafer"-typemeshwith well-type openings that begin larger though the thickness of themesh and then terminate or are finished with smaller apertures in the openings (andwhich alsomaybe angledwith semiconductor technology processing) in themesh in a droplet delivery device in accordance with an embodiment of the disclosure. FIGS. 111A‑111C illustrate a perspective view of a first end of absorber and bafflewith fins (FIG. 111A), a perspective 10 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 view of a second opposite end of a baffle with fins (FIG. 111B) and a cross-sectional, partial schematic view a droplet delivery deviceairwayandejector platewithmesh includingabafflewith fins in accordancewith anembodiment of the disclosure. FIG. 112 is a streamline velocity field graphical map of an airflow path of a droplet delivery device including airflow directors without a baffle in accordance with an embodiment of the disclosure. FIG. 113 is a streamline velocity field graphicalmapof anairflowpathof a droplet delivery device includingabafflewith wicking material and no airflow directors in accordance with an embodiment of the disclosure. FIG. 114 is a streamline velocity field graphicalmapof anairflowpathof a droplet delivery device includingabafflewith wicking material and also including airflow directors in accordance with an embodiment of the disclosure. DETAILED DESCRIPTION Push Mode Overview

[0044] Push mode has been developed as a reduced-risk product to deliver (i) nicotine, cannabinoids, and other non- therapeutic substances (devicesdescribedhereinas "BlueSky"arepreferable for usewith suchsubstances), aswell as (ii) therapeutic and prescriptive drug products (devices described herein as "Norway" are preferable for use with such products). The push mode device is designed to deliver the user a safe and controlled dose. The push mode droplet delivery device 10 is capable of delivering aqueous and nonaqueous solutions and suspensions at room temperature. Large molecule formulations, whether water soluble or not, can also be delivered with this technology. Harmful chemical by-products commonly foundwithheatednicotine, andother substances,areeliminated in thepushmodedevicemaking it a safer option for aerosol delivery.

[0045] Pushmodeutilizes a vibratingmember 1708and transducer 26 thatwork in conjunctionwith amembrane25and mesh 2 to aerosolize fluid 901, which is held in a reservoir 1200 and supplied to themesh 22 using variousmethods (e.g., wick material, hydrophilic coatings, capillary action, etc.). Preferably the vibrating member is coupled to the transducer, such as by bonding (e.g. adhesives and the like), welding, gluing, physical connections (e.g. brackets and other mechanical connectors), and the like. The transducer and vibrating member interact with the membrane to push fluid through the mesh. As illustrated and described in various embodiments, the membrane may in some cases contact the mesh while also "pushing" fluid through holes in the mesh, and may in other cases be separated without contacting the mesh to push liquid through holes in the mesh. The transducer may comprise one or more of a variety of materials (e.g., PZT, etc.). In certain embodiments the transducer is made of lead-free piezoelectric materials to avoid creation of unwantedor toxicmaterials inadroplet deliverydevice intended for human inhalation.Thevibratingmembermaybemade of one ormore of a variety of differentmaterials (e.g., titanium, etc.). Themeshmaybeoneormoreof a variety ofmaterials (e.g., palladium nickel, polyimide, etc.). After the fluid is pushed through the mesh, a droplet spray is formed and ejected through a mouthpiece port, carried by entrained air.

[0046] The device is tunable and precise. The device can be optimized for individual user preferences or needs. The aerosolmassejectionandmassmedianaerodynamic diameter (MMAD)canbe tuned todesired parameters via themesh hole size, mesh treatment, membrane design, vibratingmember design, airflow, manipulation of power to the transducer, etc. The design produces an aerosol comprised of droplets with a high respirable fraction, such that the lungs can absorb the aerosol most efficiently.

[0047] The vibrating member and transducer are both separate from the cartridge, isolated by the membrane. Not only does this create a safer product, but it eases manufacturability. The vibrating member and transducer are both typically expensive components. Keeping these components in the enclosure system rather than the cartridge reduces the cost of goods sold (COGS). Element Number Tables

[0048] Substance, feature, and part numbers are provided for convenient referencewith respect to the descriptions and figures provided herein in Table 1: Table 1: Element Numbers Substance Number Substance Name 100 Airflow 800 Air 900 Fluid flow 11 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 (continued) Substance Number Substance Name 901 Fluid Feature Number Feature Name 10 Droplet delivery device 12 Container assembly 15 Ejector bracket 17 Enclosure system 20 Airflow outlet 24 Airflow inlet 26 Heat exchange area 28 Spike 30 Air exchange outlet 40 Mouthpiece Port 41 Nasal Inhalation Port 42 Ejection Port 43 Nasal Inhalation Cap 45 Mesh plate with holes 47 Mesh and mesh plate spacer 170 Vibrating member tip 220 Central Axis 230 Vibrating member central axis 1200 Fluid reservoir 2200 Fluid reservoir 2250 Spiral Part Number Part Name Material Embodiment Push Mode I and / or II 22 Mesh Palladium nickel I and II 25 Membrane Various Material I and II 26 Transducer PZT, lead-free material I and II 1200’s BlueSky Container 1202 Mouthpiece COC I and II 1204 Vent material Sintered PTFE - PMA20 I and II 1206 Upper container COC I and II 1208 Middle container COC I and II 1210 Septum Butyl rubber I and II 1212 Lower container COC I 1213 Extended lower container COC II 1214 Container ring COC I and II 12 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 (continued) Part Number Part Name Material Embodiment Push Mode I and / or II 1500’s BlueSky Ejector Bracket 1502 Upper ejector bracket COC I and II 1504 Lower ejector bracket COC I and II 1506 Upper mesh carrier COC I 1508 Lower mesh carrier COC I 1510 Membrane holder COC I and II 1512 Suspension gasket Silicone I 1513 Carrier gasket Silicone II 1518 Stainless steel mesh carrier SUS316L II 1519 Wick I and II 1520 Magnet N54 Ni coating I and II 1522 Carrier O-Ring Silicone II 1524 Small O-Ring Silicone Simplified cartridge 1526 Large O-Ring Silicone Simplified cartridge 1528 Parallel plate capacitor 1600 Laminar flow element COC I and II 1700’s BlueSky Enclosure System 1702 Enclosure Aluminum 6063 alloy I and II 1704 Vibrating member front cover PC / ABS I and II 1706 Vibrating member rear cover PC / ABS I and II 1708 Vibrating member Titanium alloy I and II 1710 Transducer contact pin Brass 3604 alloy, gold-plated I and II 1712 Fingerprint / button / sealing bracket PC / ABS I and II 1714 Fingerprint / button cover PC / ABS I and II 1716 Enclosure rear cover PC / ABS I and II 1718 Enclosure sealing ring Silicone I and II 1720 Sensor director Silicone I and II 1722 Fingerprint / button PC / ABS I and II 1725 PCB Many materials All 1726 Spring electrode SUS304 All 1728 USB-C port PC / ABS All 1730 Battery / Power supply Li-Ion Heater-Beluga 1732 Airflow Sleeve PC / ABS Air resistance 1734 Speaker Speaker-Beluga 1760 Nodal-mounted sensing device 1762 Sensor control unit 1900’s Heating Components 1902 Heating element Nichrome 80 Heater 1904 Heat insulation Heater 13 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 (continued) Part Number Part Name Material Embodiment Push Mode I and / or II 1906 Airflow accelerator 1908 Electrode All 1910 Temperature Sensor Heater 2200’s Norway Ejector Bracket and Container 2201 Mouthpiece COC Norway D 2202 Faceplate SUS316L Norway D 2203 Ejector Bracket Bottom Cover COC Norway D 2204 Ejector Bracket ID Chip Many Materials Norway D 2205 Ejector Bracket COC Norway D 2206 O-Ring Silicon All 2207 Mesh Norway D 2208 Membrane Carrier COC Norway D 2209 Membrane Norway D 2210 Cartridge Spacer COC Norway D 2211 Septum Cap COC Norway D 2212 Septum Butyl Rubber Norway D 2213 Lower Container COC Norway D 2214 Vent Material Norway D 2215 Upper Container COC Norway D 2216 Vent Spacer Norway D 2217 Mesh Carrier 2218 Suspension gasket 2219 Carrier gasket 2220 Upper mesh carrier COC 2221 Lower mesh carrier COC 2222 Stainless steel mesh carrier SUS316L 2400’s Norway Face Seal 2401 Screw Norway D 2402 Cartridge Sealer Top Piece Norway D 2403 O-Ring Silicon Norway D 2404 Cartridge Sealer Middle Piece Norway D 2405 Screw Norway D 2406 Cartridge Sealer Bottom Piece Norway D 2407 Cap Spring Steel Alloy Norway D 2408 Screw Norway D 2409 Device Cap COC Norway D 2410 Screw Norway D 2411 Pin Screw COC Norway D 2412 Magnet All 14 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 (continued) Part Number Part Name Material Embodiment Push Mode I and / or II 2600’s Norway Vibrating Member Components 2601 Vibrating Member Enclosure Aluminum Alloy Norway D 2602 Vibrating Member Front Cover COC Norway D 2603 Vibrating Member and Transducer Assembly Titanium Alloy and PZT4 Norway D 2604 Vibrating Member Rear Cover COC Norway D 2605 Vibrating Member Cover Front Holder Silicon Norway D 2606 Vibrating member assembly Spring Steel Alloy Norway D 2607 Vibrating Member Device Bracket COC Norway D 2608 Vibrating Member Cover Rear Holder 2609 Screw 2800’s Norway Enclosure System 2801 Device Cap Release Axel Norway D 2802 Cartridge Release Button Cover Norway D 2803 Cartridge Release Button Actuator Norway D 2804 Spacer Norway D 2805 Cartridge Release Spring Norway D 2806 7-Seg Display Norway D 2807 Device Battery Cover Release Norway D 2808 Device Battery Cover Release Spring Norway D 2809 Device Battery Cover Axel Norway D 2810 Device Enclosure Gasket Norway D 2811 Device Bottom Enclosure Norway D 2812 AAA Batteries Norway D 2813 Device Battery Cover Gasket Norway D 2814 Device Battery Cover Norway D 2815 LED Display Cover Norway D 2816 Device Front Cover Buttons Norway D 2817 7-Seg Display Cover Norway D 2818 Device Top Enclosure Norway D 2819 Device Cap Release Norway D 3300 Aluminized polymer tab 4000 Baffle 4050 Baffle fin 4100 Absorbent Plug "BlueSky" Embodiments

[0049] Referring toFIGS. 1Aand1B, aBlueSkypushmodedevice10 includesmain components of container assembly 12, ejector bracket 15 and enclosure system 17. Currently, two embodiments of BlueSky push mode, I and II, have been prototypedand tested.Referring toFIG.2, inclusionof ameshsupportedbyastainless-steel ringandelastic sealing ring in 15 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 a droplet delivery device 10 is referred to as "push mode II" herein. Referring to FIG. 3 inclusion of a mesh supported by upper and lower mesh carrier and an elastic sealing ring in a droplet delivery device 10 is referred to as "push mode I" herein.

[0050] Thepushmode I and II embodiments havea transducer consisting of a lead zirconate titanate (PZT) disc bonded to the bottomof a vibratingmembermade of titaniumalloy. The vibratingmember and transducer are encased by a plastic cover in an enclosure system 17. Amembranemade of polyethylene naphthalate (PEN) in the ejector bracket 15 isolates the transducer and vibrating member from the fluid that is supplied from a reservoir in the container assembly 12. The membranecanbe thermoformed to theshapeof thevibratingmember tip. Theembeddedsystemon thedevice consists of the transducer, pressure sensor, and lithium-ion battery all connected on a single board microcontroller. The aluminum enclosure that houses the embedded system contains a button that can double as a fingerprint sensor for use with controlled substances.Thedevice is charged throughaUSB-Cchargingport.Magnets areused tohold thecartridge in the enclosure.

[0051] Embodiments use a two-component cartridge system to keep the fluid from contacting themesh in storage. This design involves two spikes, one of which contains wicking material, on one part of the cartridge, the ejector bracket. The other part of the cartridge, the container, houses a fluid reservoir and two septa. The user pushes the ejector bracket and container together, and the spikes puncture the septa, creating a path for fluid to flow to themesh. The wickingmaterial in onespikeaids in the supplyof fluid to themesh.Theother spike,whichdoesnot includewickingmaterial, allowsair toenter the container for pressure equalization. Vents covered with vent material are located at the top of each side of the fluid reservoir and are connected to the open atmosphere via airflow outlets, allowing for equalization of pressure.

[0052] Referring to FIG. 4, there is an ejection port 42 with a length of 25mm and a mouthpiece port with a length of 10mm.Thepreferred length of the ejection port is 0mm‑50mm.Thepreferredmouthpiece port length isOmm‑50mm.FIG. 5 shows the fluid 900 and ventilation 100 flow paths through the spikes 28 in prototyped embodiments. FIGS. 6A and 6B show the entrained air path of prototyped embodiments. BlueSky I push mode

[0053] FIGS. 7A and 7B show a rendering and a CAD overview, respectively, of the push mode I embodiment. The overviews in FIGS. 7A and 7B show the container assembly 12, ejector bracket 15, and the enclosure system 17, from left to right.

[0054] FIG. 8 provides an exploded view of the components from the push mode I embodiment.

[0055] Referring toFIG.9, thepushmode I embodiment includesameshcarrier that includes twoCOCrings1506, 1508 that are ultrasonically welded holding the mesh 22 and suspension gasket 1512. The COC rings sandwich the mesh and suspension gasket as shown in FIG. 10. The gasket is placed between the upper and lower ejector brackets.

[0056] Referring toFIG. 11, two vents are locatedon thenarrowsidesof the lower ejector bracket 1504 in thepushmode I embodiment. The spikes are located on the upper ejector bracket 1502. The container, which houses the fluid reservoir 1200, includes three COC pieces. The two septa 1210 are held between the middle and lower container pieces. A container ring is bonded onto the upper 1206 andmiddle 1208 container pieces and themouthpiece 1202 snaps onto the upper container piece 1206.

[0057] BlueSky II push mode

[0058] FIGS. 12A and 12B show a rendering and a diagrammatic overview of the push mode II embodiment, respectively. The overviews in FIGS. 12A and 12B show the container assembly 12, ejector bracket 15, and the enclosure assembly 17, from left to right.

[0059] FIG. 13 illustrates an exploded view of the components of the push mode II embodiment.

[0060] In the pushmode II embodiment, a stainless-steel annulus carrier 1518 is bonded to themesh 22. A gasket 1513 isplacedabove themeshandmeshcarrierbetween theupper1502and lower1504ejectorbrackets.FIG.14 illustrates the push mode II embodiment mesh carrier 1518 and gasket 1513.

[0061] Two vents are located on the wide sides of the lower ejector bracket 1504 as shown in FIG. 15. The spikes are located on the upper ejector bracket 1502.

[0062] As in push mode I, the container, which houses the fluid reservoir, includes three COC pieces. The lower container for the pushmode II embodiment extends further than in pushmode I, with the tubular portion extending into the upper ejector bracket.

[0063] FIG. 16 (push mode II) and FIG. 17 (push mode I) illustrate a comparison of the lower containers of each embodiment. The extension is necessary because the mesh sits lower, compared to I, due to the stainless-steel mesh carrier being thinner than the COC carrier of I. The two septa are held between the middle and lower containers. A container ring is bonded onto the upper and middle container pieces and the mouthpiece snaps onto the upper container piece. 16 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 BlueSky Vibrating Member and Membranes

[0064] Push mode has multiple vibrating member and membrane designs. Table 2 and Table 3 contain descriptions of the vibrating member and membrane designs, respectively, that have been prototyped and tested. Referring to FIGS. 18 and 19, there are currently two different tips for the vibrating member rod tip and ring tip, respectively. Table 2: Description of vibrating members Vibrating Member Description H1 1.0mm diameter rod tip H2 1.5mm diameter rod tip H3 2.0mm diameter rod tip H4 3.5mm diameter rod tip H5 3.5mm diameter ring tip with a 2-degree tilt H6 3.5mm diameter ring tip with a 5-degree tilt H7 3.5mm diameter ring tip with an 8-degree tilt H8 3.5mm diameter ring tip with no tilt H9 3.5mm diameter rod tip with 3-degree tilt Table 3: Description of membranes Membrane Style Description M1 Thermoformed to a 1.0mm diameter circle with a round plateau, used with H1 M2 Thermoformed to a 1.0mm diameter circle with a 2-degree tilt, used with H1 M3 Thermoformed to a 1.0mm diameter circle with a 5-degree tilt, used with H1 M4 Thermoformed to a 1.0mm diameter circle with an 8-degree tilt, used with H1 M5 Thermoformed to a 1.5mm diameter circle with a 2-degree tilt, used with H2 M6 Thermoformed to a 1.5mm diameter circle with a 5-degree tilt, used with H2 M7 Thermoformed to a 1.5mm diameter circle with an 8-degree tilt, used with H2 M8 Thermoformed to a 2.0mm diameter circle with a 2-degree tilt, used with H3 M9 Thermoformed to a 2.0mm diameter circle with a 5-degree tilt, used with H3 M10 Thermoformed to a 2.0mm diameter circle with an 8-degree tilt, used with H3 M11 Thermoformed to a 3.5mm diameter circle with a round plateau, used with H4 M12 Thermoformed to a 3.5mm diameter circle with a 2-degree tilt, used with H5 M13 Thermoformed to a 3.5mm diameter circle with a 5-degree tilt, used with H6 M14 Thermoformed to a 3.5mm diameter circle with an 8-degree tilt, used with H7 M15 Thermoformed to a 3.5mm diameter circle with no tilt, used with H4 or H8

[0065] The transducer requires a large amount of power during the actuation of the device. As the power usage increases, the heat generated by the printed circuit board assembly (PCBA) increases. The effect from the heat is mitigated throughseveral design features in thePCBA.A four-layerPCBA increasesanti-interferenceandheatdissipation capabilities. The PCBAalso contains a large amount of copper foil, making it conducive to heat dissipation. TheMOSFET driving the transducer adopts a high-current package to avoid damage caused by heating in long-term continuous operation. The automatic transformer, to increase the voltage output, it is suspended to insulate it from the rest of PCBA. These features allow the device to operate for days without concern of overheating or being subjected to electrical noise. 17 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 BlueSky Life Testing

[0066] TheprototypeBlueSkypushmodeembodiments, I and II, havegone through life testing. The life test consistedof repeated three-second dosingwith one-second resting intervals over the course of several days.Mass ejection was done before and after the life test. Mass ejection is defined as the mass the device aerosolizes over one three-second dose. Mass ejection data before the life test is listed in Table 3 and the data for after life testing is listed in Table 4. The mass ejection of one embodiment remained consistent before and after 55,000 doses and can likely go beyond. This embodiment, II push mode with H4 and M11, has a stainless-steel mesh carrier. There is a second embodiment, I push mode,which has aCOCplasticmesh carrier.Due to heat from theextremedosing cycling, the plasticmesh carrierwarped during testing. This led to a decrease inmassejectionafter the life test.However, the stainless-steel carrier in II pushmode did not warp from the heat, which allowed it to remain consistent after testing. In both I and II, thermal management is improved througha four-layer PCBA, a larger than standard amount of copper foil, and ahigh currentMOSFETdriver. The conditions of the testing are not representative of normal consumer use. During normal daily use, where extreme heating doesnot occur, bothembodiments, I and II, showconsistentmassejection.Tables2and3providedetails of the referenced Vibrating Member and Membrane, respectively. Table 4. Mass ejection data for push mode devices before life testing Type Vibrating Member Membrane Ejector Average Scale Ejection (mg) Average Nicotine (µg) II H4 M11 R52 2.45 73.5 I H5 M12 W11 3.30 99 I H8 M15 W11 3.60 108 Table 5. Mass ejection data for push mode devices after life testing Type Vibrating Member Membrane Ejector Average Scale Ejection (mg) Average Nicotine (µg) II H4 M11 R52 3.26 97.8 I H5 M12 W11 1.16 34.8 I H8 M15 W11 1.54 46.2 Comparison of Push Mode and Prior Art Ring Mode

[0067] As set forth in Example 1 described subsequently, prototypes of BlueSky I and II push mode were tested and compared toprior technology, referred to asBlueSky ringmode (suchasdescribedand shownwith respective test data for that technology in WO 2020 / 264501), is provided as follows: Example 1

[0068] Ejectors with a hole size of 2.0 µm were tested in each device. Half of the ejectors tested had a hydrophilic entranceandhydrophobicexit (R).Theotherhalf hadahydrophobicentranceandexit (W).The testingwasperformedwith a TSI Mini-MOUDI Model 135 and a Thermo Fisher Vanquish UHPLC. Eight different design combinations (vibrating members, membranes, ejector treatments) were tested with BlueSky I and II. Based on the results of the testing, push mode I appears to be the preferred embodiment for pushmode. The pushmode I design resulted inmore consistentmass ejection andMMAD values versus II. Seven of the eight design combinations resulted in comparable mass ejections and MMADs. One outlier, H5 with M12 and R-treated ejector, had a significantly higher mass ejection than the others. Upon comparisonof I pushmode toBlueSky ringmode, I deliveredhigherandmoreconsistentmassejectionand lowerMMADs. Table 6, Table 7 and Table 8 provide the data obtained from ring mode, I push mode, and II push mode, respectively. The data in the tables include micrograms of nicotine ejected, MMAD, geometric standard deviation (GSD), and the percentage of ejected solution in stage 1 and stage 2 of the mini-MOUDI. All the vibrating member and membrane combinations testedwith I pushmode, found inTable7,performedwellwith bothejector treatments.Asseen inTable8, the best performing combinations with II push mode were H4 with M11 and H5 with M12, both using W-treated ejectors. 18 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 Table 6: Ring Mode Mini-MOUDI results: Treatment Nicotine (µg) MMAD (µm) GSD Stage 1 (%) Stage 2 (%) Stage 1 and 2 (%) R 47.040 1.38 1.76 0.299 1.322 1.62 R 59.367 1.61 1.68 0.406 4.340 4.75 R 23.830 1.12 1.76 0.340 1.073 1.41 W 38.057 1.50 1.77 0.288 4.159 4.45 W 69.387 1.77 1.69 1.057 10.316 11.37 W 39.653 1.22 1.86 0.207 1.443 1.65

[0069] The results obtained from Push Mode I device are shown in Table 7. Tables 2 and 3 provide details of the referenced Vibrating Member and Membrane, respectively. Table 7: Push Mode I Mini-MOUDI results: Treatment Vibrating member Style Membrane Stye Nicotine (µg) MMAD (µm) GSD Stage 1 (%) Stage 2 (%) Stage 1 and 2 (%) R H4 M11 85.880 1.40 1.95 6.20 3.07 9.27 R H4 M15 76.250 1.14 1.56 1.06 0.45 1.51 R H5 M12 141.957 1.30 1.81 2.00 1.66 3.66 R H8 M15 90.124 1.26 1.81 1.61 1.27 2.88 W H4 M11 99.705 1.40 1.78 0.72 2.78 3.50 W H4 M15 108.750 1.27 1.82 1.07 1.71 2.78 W H5 M12 102.493 1.37 1.79 0.87 2.41 3.28 W H8 M15 102.177 1.22 1.69 0.55 1.14 1.69

[0070] The results obtained from Push Mode II device are shown in Table 8. Tables 2 and 3 provide details of the referenced Vibrating Member and Membrane, respectively. Table 8: Push Mode II Mini-MOUDI results: Treatment Vibrating member Style Membrane Stye Nicotine (µg) MMAD (µm) GSD Stage 1 (%) Stage 2 (%) Stage 1 and 2 (%) R H3 M10 32.64 1.02 1.59 0.51 0.53 1.04 R H4 M11 96.29 1.85 1.59 0.84 9.37 10.21 R H5 M12 50.58 1.21 1.84 1.69 2.57 4.26 R H7 M14 45.22 1.17 1.66 0.69 1.32 2.01 W H3 M10 13.75 0.96 1.63 1.35 0.27 1.62 W H4 M11 75.77 1.4 1.73 0.64 1.47 2.11 W H5 M12 88.26 1.28 1.87 4.45 1.24 5.69 W H7 M14 229.53 1.45 4.37 20.5 7.84 28.34

[0071] Based on the results of the testing, I push mode is the preferred embodiment when compared to II. BlueSky Single Piece Cartridge and Low Cost of Goods Sold Designs

[0072] Another embodiment of push mode incorporates the two-part cartridge system into a singular component. 19 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 Having the cartridge in one piece simplifies setup for the user and increasesmanufacturability while reducing cost. FIGS. 20, 21A and 21B show two single piece cartridge embodiments. The embodiment shown in FIG. 20 includes a long vibrating member with the fluid reservoir residing under the mesh. In this design, the container is two pieces that are assembled during manufacturing.

[0073] In another embodiment, there is a short vibratingmemberwith the fluid reservoir above themesh (seeFIGS. 21A and21B). In thisdesign, thecontainer is comprisedof threepieces that areassembledduringmanufacturing.After thefluid reservoir is filled, the mouthpiece snaps onto the container with the container ring between.

[0074] The vibrating member and transducer work in conjunction with amembrane and mesh, as previously described embodiments of BlueSky pushmode. Themembrane also serves to isolate the vibratingmember and transducer from the fluid. A mesh carrier is used in both designs. Magnets on the bottom of the containers hold the cartridge in the enclosure.

[0075] Furtherembodiments, shown inFIGS.22Aand22B,of asinglepiececartridge includeasimplerdesign, reducing the COGS in manufacturing by decreasing the number of injection molded parts and bonds. FIG. 22A illustrates a simplifiedversionof thedesign inFIG.21Abutwitha longvibratingmember. Thedesign inFIG.22A reduces thenumberof ultrasonic welds and injection molded parts. FIG. 22B further simplifies the design from FIG. 21A with fewer ultrasonic welds and injection molded parts.

[0076] The low COGS designs shown in FIGS. 23A and 23B are a simplification of the design shown in FIG. 21B. This design is a single part cartridge that can be inserted into the enclosure. Air exchanges between the seal of themouthpiece and the upper container. The cartridges shown in FIGS. 22A‑22B and FIG. 24 have removed the ejection port leaving the 10mm mouthpiece port. The preferable ejection port and mouthpiece port lengths are the same as previously set forth, 0mm‑50mm. BlueSky Two-Piece Cartridge

[0077] FIG.24 illustratesa two-piececartridgedesign for a longvibratingmember.Thecontainer andejector bracket are swapped where the ejector bracket is connected to the mouthpiece and the container is below. The spikes on the ejector bracket face downward onto the septa on the container. Pharmacuetical / Therapeutic (Norway) Embodiments

[0078] Another embodiment of pushmode, Norway, is similar to its BlueSky counterpart in most aspects, except that is tailored for prescriptive andmedical use.Much likeBlueSky,Norway features a releasable cartridgewhich contains a fluid reservoir and ejector bracket. The device can also be used to assess lung health using spirometry. FIG. 25 shows one embodiment of Norway push mode.

[0079] Patients diagnosed with lung diseases can use the Norway device to track their medication dosages and take lung function tests so their treatment progression can be assessed. The patient can perform lung function tests and view dosage history via a phone app which pairs to the Norway device with Bluetooth. The device saves pressure sensor measurements fromeach dosage ofmedication. Inspiratory flowmeasurements can be derived from the pressure sensor measurements to ensure the user is inhaling theirmedication at a flow ratewhich delivers the solutionmost efficiently. The device can also perform lung function tests to measure a patient’s forced expiratory volume over 1 second, forced vital capacity, peakexpiratory flow,andother spirometrymeasurements. Thedata fromdosage trackingand lung function tests are uploaded to the cloud so that the patient and doctor may view the patient’s progression.

[0080] The ejector bracket has been designed to accept many different sizes of containers, where the fluid reservoir volume changes. This makes the device capable of being used with biologics, or one time use ejections. Possible fluid reservoir volumes range from 1µL to 20mL.

[0081] Themouthpiece for the Norway embodiment has a preferred length of 15mm. There are two slits on the sides of themouthpiecewith a dimension of 9mmby 3mm for an area of 27mm2. The length of themouthpiece could be anywhere from 5mm to 30mm. The area for the mouthpiece could be from 1mm2 to 100mm2. The mouthpiece opening has dimensionsof 14mmx24mm for anareaof 336mm2.Theareaof themouthpieceopening could beanywhere from10mm2 to 500mm2.

[0082] The cartridge can be inserted into the main body of the device. The front of the cartridge can be sealed by an O- Ring attached to the cap that presses around the mesh on a stainless-steel annulus when closed to prevent any evaporation through the mesh, this is the face seal. The device features voice coaching and LED lights to guide the user through the ejection inhalation. There is an LCD screen to display dose count, and other necessary information. FIG. 26 shows an exploded view of one embodiment of Norway push mode.

[0083] Referring to FIGS. 27A-D, the cartridge assembly (FIG. 27A) is composed of three parts: the container (FIG. 27B), cartridge spacer (FIG. 27C), and the ejector bracket (FIG. 27D). The cartridge spacer keeps the ejector bracket separated from thecontainer to prevent thefluid fromcontacting themeshduring storageprior to thepushmode Initial use.

[0084] Thecartridge spacer canbe removedso the container canbepusheddownonto theejector bracket such that the 20 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 spikes pierce the septamaking the cartridgeonepiece. Then, the cartridge canbepushed into themain body of the device to complete the device. This process is illustrated in FIG. 28.

[0085] The cap of the Norway embodiment is designed to create a firm seal around the cartridge after each use. An O- Ring is seated on a spring-loaded plastic piece which lightly compresses onto the cartridge assembly when the cap is closed, generating a seal between the cartridge and open atmosphere. The components of the cap are shown isolated in as illustrated in FIG. 29.

[0086] The critical components to generate precise aerosol of the ejector bracket include themesh, gasket,membrane, ventmaterial, andmouthpiece.Themembrane ispositionedsuch that themembrane face isheldparallel to themesh face, orat a small preciseangle.Theejectorbracket alsohas twospikesprotrudingoutof the top that pierce thecontainer.One is for fluid supply, and theother providesa ventilationpath for air generatedbyejection.On thesideof theejector bracketwith the air ventilation spike there is an opening covered by vent material to help relieve pressure and build-up of air. The mouthpiece is positioned following the face of the mesh.

[0087] The critical components of the container to maintain consistent aerosol are vent material, a spiral, septa, and septacaps.Theventmaterial ispositionedbetween thefluidand thespiral. Thespiral is createdby theuppercontainerand vent spacer which minimizes evaporation of the fluid through the vent material. The vent spacer is bonded onto the top of the upper container to create the sealed spiral with an opening to the push mode Inside of the container assembly and another opening to atmosphere.Theseptaareat thebottomof the container. Theseptaareplaced intoa cavity in the lower container and held in place with septa caps that are bonded onto the lower container. The critical components of both the ejector bracket and container can be seen in FIGS. 30A and 30B.

[0088] The main body of the Norway contains the vibrating member and transducer assembly. In one embodiment, as shown in FIG. 31, the vibrating member and transducer assembly is encased by a vibrating member front cover and vibratingmember rearcover.Thecoversareheld togetherbycircular capscalled the frontand rearvibratingmembercover holders. Theencased vibratingmember is then put into the vibratingmember enclosure, followed by the vibratingmember assembly spring, and finally seated into the vibratingmember device bracket. The vibratingmember enclosure allows the spring to press the vibrating member and transducer assembly to the membrane.

[0089] Additional embodiments of Norway push mode include different suspension systems to hold the mesh in the cartridge, similar to those in BlueSky push mode. With the suspension systems seen in FIGS. 32 and 33, the vibrating member and transducer assembly no longer has a spring; therefore, it no longer needs to be in the vibrating member enclosure, nor does it need the vibrating member device bracket.

[0090] An additional embodiment of the Norway push mode device includes a heating element that increases the push mode Inhaled air temperature to roughly 50°C to make the dose more comfortable. As with the BlueSky designs that include heating elements, the heated air temperature is kept below thermal degradation levels, so the pushmode Integrity of the formulation is maintained, and no harmful by-products are produced. This can be accomplished because, as with BlueSky, the device does not depend on heat to aerosolize. FIGS. 34A and 34B illustrate one design that includes two heating elements positioned beneath the vibratingmember on either side of the ejector bracket. As seen in FIGS. 34Aand 34B, air enters through openings in the bottom of the ejector bracket, passes through the heating elements, and exits into themouthpiece. Additionally, thewarmer air will causeminimal evaporation of the aerosolized fluid resulting in a decrease in MMAD. Biocompatibility

[0091] In the push mode design, the vibrating member and transducer are completely isolated from the push mode Inhaled solution by a membrane. The transducer, which typically contains heavy metals, is located behind a vibrating member, such that it is completely removed from the ejection area and fluid reservoir. The membrane separates the fluid reservoir from the vibratingmember, presenting a chemically inert barrier that permits little or nodiffusion, and subsequent evaporation. In one embodiment, a palladium nickel alloy mesh is used to atomize the fluid. A polyimide mesh has also been testedandwasshown tobeaviableoption.Usingapolymermeshwouldsignificantly reducemanufacturingcost and potentially improve the extractable / leachable profile of the device. The non-metallic components in prototyped embodi- ments are primarily comprised of cyclic olefin copolymer (COC) and silicone, both widely accepted materials used in the medical device industry. Heated Air Design

[0092] FIGS.35A‑35C throughFIG. 38showembodimentswhich includeaheatingelement to increase thepushmode I inhaled air temperature to roughly 50°C, making the dose more comfortable. Air passes perpendicularly through the heating element to be most efficiently heated. Since the heated air temperature is kept below thermal degradation levels, the pushmode Integrity of the formulation ismaintained, and no harmful by-products are produced. Also, the specific heat of the fluid is much greater than air; therefore, the temperature of the aerosolized fluid will heat minimally. This can be 21 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 accomplished because the device does not depend on heat to aerosolize. Here, the heat is only used to optimize the user experience. Additionally, the warmer air will cause minimal evaporation of the aerosolized fluid resulting in a decrease in MMAD. Finally, the heating element will be surrounded by insulation material to keep all the components of the device insulated from heat.

[0093] The heating element is breath actuated such that the element only heats air as the user inhales. This allows the battery to have amuch longer life. It also creates amuch safer device in that the heating element is not always on. This can be accomplished due to the push mode Incorporation of small gauge wire. This wire heats up very quickly, so the heating element responds as soon as the user inhales.

[0094] In theembodiment shown inFIGS.35A‑35C,after air enters thedevice, theair pathway isnarrowedby theairflow accelerator to increase velocity. Then, the air is passed through the heating element, which is positioned in the heat exchange area. Finally, the heated air flows into themouthpiece. FIGS. 35A‑35C features three views of this embodiment. This design allows for a larger battery to be installed in the device which supplements the heating element.

[0095] Referring to FIG. 36, a speaker can also be incorporated into any of the heated air BlueSky embodiments. This will allow for an additional sensory experience for the user (i.e., crackling / heating sound upon inhalation).

[0096] In the embodiments shown in FIG. 37 andFIG. 38, the heating element is positioned below the vibratingmember in a separate chamber inside theenclosure. Theair enters through theairflow inlet, is passed through theheating element, and exits above the ejector. This design can be used in the two-part cartridge design (FIG. 37) or the single piece cartridge design (FIG.98). Theseembodimentsoffer theadvantageofamorecompact device, compared to theembodiment shown in FIGS 35A‑35C, at the cost of battery life.

[0097] Another embodiment features external heating elements seated on the outside of the enclosure (FIG. 39). Air passes through the heating elements, enters the mouthpiece above the mesh, and exits through the end of the mouthpiece. This design may in some embodiments provide a removable heating element.

[0098] In another embodiment of a heated air push mode device, closed loop control is used to regulate the power delivered to the heating element. The power is adjusted to keep the airstream temperature constant and at safe levels. Referring to FIG. 40, the airstream temperature is measured by a temperature sensor such as an RTD. The power delivered to the heating element changes as a result of the temperature sensor readings.

[0099] In another embodiment of the heated air push mode device, open loop control is used to regulate the power delivered to the heating element. The power is adjusted to keep the airstream temperature constant. The pressure drop from inhalation is sensed. The amount of power needed to supply the heating element to keep the air stream temperature constant due to changes in pressure drop is known.A look-up table is created to determine the amount of power needed to supply the heating element to keep the air stream temperature constant based upon the pressure sensor value.

[0100] In another embodiment of the heated air push mode device, one or more of the push mode Internal device components that are in contact with heated air is preferablymade ofmetal (i.e., aluminum, Inconel, etc.). This will insulate the heating element and enhance biocompatibility of the device.

[0101] In another embodiment of the heated air push mode device, any component that could be compromised by the heated air is preferably made of metal (i.e., titanium, aluminum, Inconel, etc.). These components include, but are not limited to the mouthpiece, the heating chamber, and like components that heated air could negatively affect.

[0102] In one embodiment of the heatedair pushmodedevice, themetal components that are in contactwith the heated air are preferably made of a material with a low thermal conductivity, such as Inconel.

[0103] In one embodiment of the heated air push mode device, ceramic is used to insulate the heating element. Adjustable Air Resistance Design

[0104] Another embodiment of pushmode incorporates amechanism to adjust the size of the airflow inlets. The airflow inlets can be opened and closed using a sleeve or an adjustable aperture. In this way, the resistance experienced by the user can be adjusted to individual preferences. FIGS. 41A and 41B show a BlueSky device with a sliding sleeve 1732 around the enclosure. The sleeve can be adjusted to partially or completely cover the airflow inlets, increasing the resistance felt by the user. Additionally, the airflow in the mouthpiece will change as the position of the sleeve is changed. This will also change the MMAD of the dose due to changes in the airflow current. Nasal Device Embodiments

[0105] BlueSky push mode has also been adapted for nasal inhalation. FIGS. 42‑44 show several embodiments of a nasal BlueSky pushmode device. As seen in FIGS. 42‑44, there are multiple variations of the pushmode Inhalation port. However, preferable embodiments of the nasal device have longer and narrower inhalation ports (see FIG. 42) than in other designs with shorter inhalation ports (see FIG. 43) for optimal nostril use. As seen in FIG. 44, a capmay be added to protect the pushmode Inhalation port and keep it clean. The preferred droplet sizes are between 1‑110micron range, but 2‑23 microns is preferred. 22 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 Additional Features Hydrophilic / Hydrophobic tubes

[0106] Another embodiment of pushmode incorporates a tubewith a hydrophilic interior that supplies fluid from the fluid reservoir to the mesh. A hydrophilic tube eliminates the need for wicking material and allows for a wider variety of suspensions and solutions to be delivered from the device. An example of one of these tubes is the spike onBlueSky I and II.

[0107] Another embodiment of pushmode incorporates a tubewith a hydrophilic interior that supplies fluid from the fluid reservoir to themeshwithout awickmaterial, allowing for awider variety of suspensions and solutions to bedelivered from the device; and an opposite hydrophobic tube that encourages gas migration from the fluid supply area between the membrane and mesh. Polymer mesh holes

[0108] In another embodiment, as shown in FIG. 45, a polymermesh 22 is usedwith a plate 45 attached to it. It has been found that a 2mm hole on a plate works best for ejection. Therefore, another embodiment is where the plate has multiple 2mm openings for the liquid to enter. The holes on the plate can range from 0.1mm‑20mm. Tidal Breathing

[0109] Another embodiment of pushmodeusesa tidal breathingsystem that canbeused for pediatric therapy.Thepush mode technology supplies aerosol a mask similar to the Aero Chamber Plus Z-Stat Pediatric Mask (MonaghanMedical). This allows for long use therapy. When a user inhales, the device will start ejection and when the user exhales the device will stop ejection. Due to the robustness of push mode, this can be a very effective device for extended therapies. Capacitance Cartridge

[0110] In another embodiment, two parallel plates 1528 surround the fluid next to themesh andmembrane area. These two parallel plates will measure the capacitance of the fluid. The capacitance of the supplied fluid is known. If the capacitancemeasured is different than the known capacitance, the device will not work. This will prevent tampering of the cartridge, and it will prevent unauthorized fluids to be inserted into the cartridge. One of the parallel plates is shown in FIG. 46. Microfluidic Pump

[0111] Another embodiment of push mode utilizes vibrating member and membrane geometries at their coupled interface toact asbothanatomizer andmicrofluidic pump inapplicationswherewickingmaterials arenot incorporated into the preferred embodiment for certain suspensions, solutions, and othermedical, therapeutic, and consumer applications. The tip of the vibrating member is coupled to a membranematching the desired geometry allowing fluid to enter between themeshandmembranewhile also encouraging any gas to exit freely. Thesemembranesmaybe treated by technologies mentioned previously to be hydrophilic or hydrophobic.

[0112] Another embodiment utilizes a separate microfluidic pump to direct the proper amount of fluid and pressure between the mesh and membrane when powered on, at breath actuation, at set intervals, etc. to ensure proper dosing. Vibrating member geometry optimization

[0113] Vibrating members of the embodiments are to bemade of materials featuring proper acoustical andmechanical properties. Thin film sputtering of various nonreactive metals such as titanium, palladium, gold, silver, etc. can be performed on the vibratingmember tip section to further enhance biocompatibility. According to industry leaders, titanium has the best acoustical properties of the high strength alloys, has a high fatigue strength enabling it to withstand high cycle rates at high amplitudes, and has a higher hardness than aluminum, making it more robust. Correct material must be selected, vibratingmembersmust be balanced, designed for the required amplitude, and be accurately tuned to a specific frequency. One aspect of tuning is making the vibrating member have the correct elongated length. Another aspect of tuning ismatching the vibratingmember to themeshandhaving the correct gain ratio. Incorrectly tunedvibratingmembers may cause damage to the power supply and won’t be resonating at the device’s optimized frequency, decreasing mass ejection and longevity. (see alsoUltrasonic Vibrating member catalog - Emerson. Catalog - Ultrasonic Vibrating member (2014). Available at: www.emerson.com / documents / automation / catalog-ultrasonic-vibrating member-branson-en- 23 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 us‑160126.pdf. (Accessed: 2nd November 2021) - incorporated herein by reference.)

[0114] For example, Titanium 7‑4material has farmore uniformwave propagation in one direction (axial) than Titanium 6‑4.

[0115] Embodiments must have vibrating members with proper moduli of elasticity, acoustical properties, sound speeds, mechanical properties, molecular structure, etc. such as Ti Grade 23, Ti Grade 5, Ti Pure >99.9%, TIMETAL ® 7‑4, 302 Stainless Steel, 303 Stainless Steel, 304 Stainless Steel, 304L Stainless Steel, 316 Stainless Steel, 347 Stainless Steel, A1 6061, A1 6063, A1 3003, etc.

[0116] Other embodiments have crystalline vibrating members with proper moduli of elasticity, acoustic properties, sound speeds,mechanical properties,molecular structure, etc. suchas:Sapphire (Al2O3Aluminumoxide),monocrystal- line silicon, etc.

[0117] In one embodiment, vibratingmember design is based on industrial ultrasonic vibratingmember design such as disclosed by the pushmode Indicated reference subsequently noted, but optimized to be used for the purposes of aerosol generation in the delivery of fluids to the lungs, nose, ear, eye, etc.

[0118] Referring toFIG. 47, the vibratingmember is rectangular at themembrane interface. This rectangular tip features three periodic slots along theXdirections and two periodic slots along theYdirections of themember tip based on a quasi- periodic phononic crystal structure.

[0119] Referring to FIGS. 48 and 49, the rectangular vibrating member tip combined with a conical section and a cylindrical section can effectively improve the output amplitude gain and utilizes the band gap property of the structure to effectively suppress lateral vibration of the vibrating member tip, improving the amplitude distribution uniformity at the membrane interface (seealsoLin, J. &Lin,S.Studyona large-scale three-dimensional ultrasonic plasticwelding vibration system based on a quasi-periodic phononic crystal structure. MDPI (2020). Available at: www.mdpi.com / 2073‑4352 / 10 / 1 / 21 / htm. (Accessed: 2nd November 2021) - incorporated herein by reference).

[0120] In other embodiments, shown in FIGS. 50‑58, the vibrating member 1708 is tuned and machined similarly to industrial ultrasonic vibrating member designs (such drawings being disclosed in the noted reference) but optimized for aerosol generation in the delivery of fluids to the lungs, nose, ear, eye, etc. such as contoured vibratingmember (FIG. 50), plunger vibratingmember (FIG.51), product authenticity sensor vibratingmember (FIG.52), spool vibratingmember (FIG. 53), slotted cylindrical vibratingmember (FIGS. 54and55), bar vibratingmember (FIGS. 56and57), andbooster vibrating member (FIG. 58). See also Industrial resonators Available at: www.krell-engineering.com / fea / industr / industrial_reso- nators.htm. (Accessed: 2nd November 2021) - incorporated herein by reference.

[0121] Referring toFIG.50, vibratingmemberscanbecontoured tomake intimatecontactwith themembranegeometry.

[0122] Referring to FIG. 51, plunger members have nodally-mounted plungers that can be used to exert pressure on a given surface of the membrane contacted by the vibrating member.

[0123] Referring to FIG. 52, sensor carrier vibratingmembers feature an internal cavity partially or fully encapsulating a nodal-mounted sensing device. The sensing device is coupled with a sensor control unit which outputs a signal to the PCBA. This signal can be used to disable aerosol generation when non-compliant, incorrect, unlicensed, etc. cartridges are attempted to be used.

[0124] Referring toFIG. 53, spool vibratingmembersareunslotted cylindricalmembers featuring undercut sidesbehind the face to form a spool shape. This spool shape improves the face amplitude uniformity. Because a spool vibrating member does not have slots, its stresses are much lower than comparable slotted cylindrical vibrating members making machining costsmuch lower. Using cavities, slots, and back extension to optimize axial resonance creates a very uniform amplitude across the members face. The member is one half-wavelength long at axial resonance, as indicated by the single node that is generally transverse to the principal direction of vibration. Spool vibrating members generally have about 1:1 gain, although somewhat higher gain is possible.

[0125] Referring to FIGS. 54 (optimized) and 55 (unoptimized), slotted cylindrical vibrating members feature long- itudinal slots used to reduce the transverse couplingdue to thePoissoneffect. Such slots are usually radial, althoughother configurations are sometimes useful. Without such slots, the vibrating member will either have very uneven amplitude across the face or may even resonate in a nonaxial manner. They also have a face cavity that extends deep within the member to increase its gain. The vibrating member is one half-wavelength long at axial resonance, as indicated by the single node that is generally transverse to the principal direction of vibration. Slotted cylindrical vibrating members generally have low-to-moderate gain (1:1 to 2:1).

[0126] Referring to FIGS. 56 (optimized) and 57 (unoptimized), bar vibrating members are rectangular and either unslotted or slotted only through the thickness. Special design techniques give optimum face amplitude uniformity. The vibrating member’s thickness has been reduced in the blade section in order to provide reasonable gain. The vibrating member is one half-wavelength long at the axial resonance, as indicated by the single node that is generally transverse to the principal direction of vibration. Bar vibrating members generally have low-to-moderate gain (1:1 to 4:1).

[0127] Referring toFIG. 58, A booster is a coupling resonator that is placedbetween a transducer and vibratingmember inorder to change themember’samplitudeandor asameansof supporting the resonator stack. Thebooster body is rigidly supported by a collar that is bonded to the booster’s node. Because the rigid booster is constructed only of metal (no 24 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 compliant elastomers), it has excellent axial and lateral stiffness. For additional stiffness a second collar can be incorporated into a full-wave design. The collar is tuned to isolate the motion of the booster body from the support structure. This is shown is the following image of a displaced booster, where the coolest colors indicate the lowest amplitudes.Eachboosterhasafixedgain (ratioof output amplitude to input amplitude), generally between0.5:1and3.0:1.

[0128] With further reference to FIGS. 59‑83, further alternative embodiments of vibratingmembers 1708with vibrating member tip170 that couple to transducers26of droplet deliverydevices10 inaccordancewith variousembodimentsof the disclosure are shown. Other Vibrating Member and Membrane Alignments and Designs

[0129] In other embodiments, the vibrating member 1708 may include other shapes and the membrane 25 may also include alternative shapes. For example, FIG. 85A illustrates an ultrasonic transducer coupled to a rod-shaped vibrating member tip portion 170. FIG. 85 shows the vibrating member of FIG. 85A coupled to a centrally peaked or pointed membrane25 in adroplet delivery device 10. FIGS. 85Cand85Dshowultrasonic transducer 26 andmembrane25of FIG. 85B in alterative embodiments wherein a mesh 22 includes first securing mechanism in FIG. 85C (see FIG. 2 and accompanying description) and second securing mechanism in FIG. 85D (see FIG. 3 and accompanying description).

[0130] FIG. 86A further illustrates in another embodiment an ultrasonic transducer 26 with a rod-shaped tip portion 170 coupled to a membrane 25 with a wide or dome / rounded exterior surface in a droplet delivery device 10. FIGS. 86B and 86C show ultrasonic transducer 26 andmembrane 25 of FIG. 86A in alterative embodiments wherein amesh 22 includes first securingmechanism inFIG. 86B (seeFIG. 2 andaccompanying description) and second securingmechanism inFIG. 86C (see FIG. 3 and accompanying description).

[0131] FIG. 87 shows an alternative embodiment of a droplet delivery service including an ultrasonic transducer 26with rod-shaped vibrating member tip portion 170 offset from a central axis 220 of the droplet delivery device passing through the ejection channel 23, a slanted / slopedmembrane 25 andmesh22andwherein the central axis of the vibratingmember 230 is not aligned with central axis 220 of the device 10.

[0132] In another embodiment, FIGS. 88A and 88B illustrate an ultrasonic transducer 26 with a non-beveled ring- shaped vibratingmember tip portion 170 coupled to a tiltedmesh 22 in contact with amembrane 25 having a generally flat exterior top surface (nearest the mesh 22) in a droplet delivery device 10.

[0133] In further embodiment shown in FIG. 89A an ultrasonic transducer 26 with a beveled ring-shaped vibrating member tip portion 170 may be coupled to a slanted / sloped membrane 25 in contact with a membrane 25 in a droplet delivery device 10. FIG. 89B illustrates the slanted membrane 25 of FIG. 89A and FIG. 89E illustrate an ultrasonic transducerwith a beveled ring-shaped vibratingmember tip portion 170also shown in FIG. 89A. FIGS. 89Cand89Dshow the ultrasonic transducer 26 and membrane 25 of FIG. 89A in droplet delivery devices in accordance with alterative embodiments of the disclosure wherein a mesh 22 includes first securing mechanism in FIG. 89C (see FIG. 2 and accompanying description) and second securing mechanism in FIG. 89D (see FIG. 3 and accompanying description).

[0134] FIGS. 90A and 90B show an ultrasound transducer 26 with a non-beveled ring-shaped vibrating member tip portion 170 coupled to amembranewith agenerally flat exterior surface in contact and in a parallel plane to theplaneof the fluid-entry underlying surface of mesh 22.

[0135] FIG. 91A and 91B show ultrasonic transducer 26 with a beveled ring-shaped vibrating member tip portion 170 coupled to a slanted / sloped membrane 25 with a space between the membrane 25 and the mesh 22.

[0136] FIGS. 90A and 92B illustrate an ultrasonic transducer 26 with a non-beveled ring-shaped vibrating member tip portion170coupled toamembrane25havingagenerally flat andparallel exterior surface relative toandnot in contactwith the underlying fluid-facing flat surface of the mesh 22 in a further embodiment.

[0137] FIGS. 93A‑93D showan alternative embodiment of a droplet delivery device 10with an ultrasonic transducer 26 having a wide and flat vibrating member tip portion 170 together with membrane 25 having a generally flat surface and mesh 22 being generally flat. A preferable suspension system for mesh 22 is further illustrated by FIGS. 30C and 30D.

[0138] FIGS. 94A‑94D shown another embodiment with an ultrasonic transducer 26 having a wide and ring-shaped tip portion 170 together with membrane 25 having a generally flat surface and mesh 22 being generally flat. A preferable suspension system for mesh 22 is further illustrated by FIGS. 94C and 94D. Membranes

[0139] The membranes 25 of the embodiments are made of materials featuring robust and proper acoustical and mechanical properties such as polyethylene naphthalate, polyethylenimine, poly ether ketone, polyamide, poly-methyl methacrylate, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, and the like.

[0140] Themembranesof theembodimentsmayhaveahydrophobic coating, hydrophobic etching, hydrophilic etching, hydrophilic coating, roughening etch, etc.

[0141] In some embodiments, such as shown in FIGS. 96A‑96D, membranesmay include various shapes and surface 25 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 textures, including "bumps" in one embodiment. Meshes

[0142] Meshes 22 of the embodiments are to be made of materials featuring robust and proper acoustical and mechanical properties such as poly-methyl methacrylate, poly ether ketone, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, polytetrafluoroethylene (PTFE), Ni, NiCo, Pd, Pt, NiPd, and metal alloys.

[0143] In one embodiment, themesh is made from single crystalline or poly crystalline materials such as silicon, silicon carbide, aluminumnitride, boron nitride, silicon nitride, or aluminumoxide. Different hole shapes can be formed in a single crystalline wafer via high precision photolithography with and without using greyscale masks, and isotropic and / or anisotropic etches. Sputtered films can be deposited on the mesh to modify the wettability of the surface. Thin layers formed or deposited on the surface will have, in certain embodiments, much better adherence than films deposited on metalmesh formedbygalvanic depositionor polymermesh formedby laserablation. Thesurfaceson thesingle crystalline wafers "slices" are atomically smooth and can be etched to produce exact surface roughnesses. Exact surface rough- nesses can be used for better adherence of mechanical bonding with glue or other materials. Silicon carbide would be a preferable material because of its high strength and toughness. An important advantage of using semiconductor processes to fabricate hole structures from a single crystalline wafer "slice" in a mesh of embodiment of the push mode invention is that the holes and surface contact angleswill be exactwithout the variation seen in conventional ejector plates using mesh made from galvanic deposition or laser ablation. This mesh, as noted in Table 9 may be fixed as in II, or suspended as in I, and the membrane is coupled with an optimized vibrating member with a thin film sputtering of nonreactive metals such as palladium or gold member tip section to further enhance biocompatibility.

[0144] Thehole structures of other embodiments are formedusing semiconductor processes such asphoto lithography and isotropic and anisotropic etching, laser ablation, femtosecond laser ablation, electron beam drilling, EDM (Electrical discharge machining) drilling, diamond slurry grinding, etc. See also FIGS. 109 and 110. Table 9 Mesh Design Embodiment Brief Description Single Crystalline Wafer II Fixed mesh coupled to optimized vibrating member Single Crystalline Wafer I Suspended mesh coupled to optimized vibrating member

[0145] The meshes of the embodiments may have a hydrophobic coating, hydrophobic etching, hydrophilic etching, hydrophilic coating, roughening etch, etc. or a combination thereof.

[0146] In other embodiments, FIGS. 97‑108 illustrate various implementationsof polymermeshesutilized in pushmode I and II devices. Laminar Flow Element

[0147] In embodimentsof thepushmode invention, a laminar flowelement1600, suchasshown inFIG. 1B, is preferably secured in the ejection port before the mouthpiece port of a droplet delivery device. In preferable embodiments, laminar flowelement includesaplurality of cellularapertures. In someembodimentsa laminar flowelement includesblade-shaped walls defining the plurality of cellular apertures. In further embodiments, one or more of the plurality of cellular apertures include a triangular prismatic shape, quadrangular prismatic shape, pentagonal prismatic shape, hexagonal prismatic shape, heptagonal prismatic shapeor octagonal prismatic shape.FIGS.84A‑84Qshowvariousembodimentsof a laminar flow element. Preventing Oxygen Diffusion

[0148] Referring to FIG. 95, a droplet delivery device in an embodiment where an ejector bracket and container assemblyare integratedasasingle assembly includesamembranecooperatingwithamesh further preferably includesat least one superhydrophobic vent in such single assembly in fluid communication with the reservoir and is covered in storagewith a removable aluminizedpolymer tab3300 to help prevent oxygendiffusion into the fluid in the reservoir during such storage. In another embodiment of the push mode invention, a droplet delivery device in an embodiment where an ejector bracket and container assembly are integrated as single assembly that includes a membrane cooperating with a mesh further preferably further includes a removable aluminized polymer tab 3300 coupled to an exterior surface of the membrane adjacent the mesh during storage to help prevent oxygen diffusion into the fluid in the reservoir during such storage. 26 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55

[0149] In another embodiment of the push mode invention, a droplet delivery device 10 having a membrane 25 that cooperates with a mesh 22 includes a pre-assembly step of removing a sealed packaging including aluminum and / or aluminum coating that contains the reservoir with a fluid, preferably wherein the reservoir is included in the container assembly that is also packaged for storage in the sealed packaging. Decreasing Large Droplets in Aerosol

[0150] In embodiments of the push mode invention, it is desirable to decrease large droplet formation and encourage smaller droplet sizes to be delivered out of the droplet delivery device and in the aerosol stream.

[0151] In one embodiment, a hydrophilic wickingmaterial may be provided to line themouthpiece of the droplet delivery device. Droplets formed on the outer perimeter of a mesh exit are absorbed by the hydrophilic wicking material and decrease the likelihood of large droplets propelling off the surface of the mesh exit. This wicking material absorption of large droplets increases MMAD repeatability and prevents pooling.

[0152] In another embodiment, a one-dimensional hydrophilic lattice (see laminar flowelement 1600 but taking such as a cross section), or a series of one dimensional hydrophilic lattices, may be used to absorb large droplets that might "pop" off the mesh due to pooling.

[0153] It has been noticed in tests of push mode droplet production that a fog of aerosol may remain within the mouthpiece tube after inhalation. This fog could lead to pulling on the mesh and along the outer perimeter. This pulling happens due to no entrained air pulling the tail end of the aerosol ejection out. Via electronic programming andmonitoring through a microcontroller or microchip integrated or coupled in the droplet delivery device, the droplet device can be progammably controlled to start spraying when the air flow rate reaches a threshold and then the droplet delivery device detection controller records your maximum air intake every 2 ms. The droplet delivery device is programmed to stop spraying when the flow rate recedes to a percentage of the maximum flow rate achieved during inhalation. In embodi- ments, a parameter labeled "pressure cutoff" can be added to a graphical user interface (GUI) for control / programming of the droplet delivery device so that a manufacturer or other device operator and alter the stop condition parameter for the spray.

[0154] Referring to FIGS. 111A‑111C, in another embodiment a baffle 4000 is inserted into the aerosol path. The baffle 4000 may comprise a plastic piece with fins 4050 to hold it in place in the aerosol tube of the droplet delivery device. The plastic piece has a cylindrical cavity which holds an absorbent plug 4100 (e.g., porous polyester or other wicking materials). The plug 4100 is inserted into the baffle cavity and is long enough to extend beyond the opening of the cavity. The absorbent plug faces the ejectormesh 22.On the side of the baffle opposite themesh 22, the plastic baffle 4000 has a teardrop shape to direct airflow and prevent eddies from forming. The baffle 4000 is designed to inertially filter the aerosol by capturing large droplets in the absorbent plug 4100 upon ejection. Initial data using 3 ejectors is shown in the table below. As seen in Table 10, the baffle 4000 decreased the MMAD by approximately 0.1 - 0.2 um for each ejector. This inertial filtering creates a smoother inhalation experience with less irritation. The plastic piece of the baffle 4000 and the absorbent plug 4100 may be various lengths and / or diameters. Table 10: Baffle Inertial Filtering Sample MMAD (um) without baffle MMAD (um) with baffle 1 0.83 0.69 2 0.86 0.67 3 0.82 0.75

[0155] As described, it is important to get all the small droplets out of the mouthpiece. The small droplets have a very small stopping distance; therefore, the airflow must be close enough to the ejector plate to carry the small droplets. One design was tested wherein airflow directors were used to point the airflow towards the end of the mouthpiece and away from themesh.Asshown inFIG.112, theairflowpathwith theairflowdirectors causedbackwardseddies causing the small droplets to stay down by the ejector plate. Taking the airflow directors out helped the airflow catch some of the small droplets; however, the airflow was still leaving behind some of the small droplets. The holder for the ejector plate was sloped tohelp guide theairflow to theejector plate. This encourages theair to catchmost of the small droplets and send the droplets down the middle of the mouthpiece tube, but the ejector still produces larger unwanted droplets.

[0156] FIG. 113 illustrates the results when an insertable baffle 4000 was placed in the middle of the mouthpiece tube. Thisbaffleholdsawickingmaterial.As theairflow ispulleddown themiddleof themouthpiece tube, theair flowsaround the baffle. The droplets follow the airflow; however, the larger droplets carry toomuchmomentumand cannotmake the turn to flowaround thebaffle.The larger droplets smash into thewickingmaterial. Thewickingmaterial holds the liquid to keep the liquid from falling back onto the ejector plate. The liquid can then evaporate from the wicking material. 27 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55

[0157] FIG.114 illustratesadditional resultswhenan insertablebaffle4000wasalsousedwithairflowdirectors.This test resulted inairflowcoming fromtheairflowdirectorsandshootingdown thesidesof thebaffle.Eddieswerestill formed in the middle of themouthpiece tube and pushed small droplets back onto the ejector plate. These eddies also caused the large droplets to flow around the baffle and resulted in no inertial filtering.

[0158] While the push mode invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changesmay bemade and equivalentsmay be substituted for elements thereof without departing from the scope of the push mode invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings without departing from the essential scope thereof. Therefore, it is intended that the push mode invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the push mode invention will include all embodiments falling within the scope of the appended claims. The following clauses define particular aspects and embodiments of the invention. Clause 1. A droplet delivery device comprising: a container assembly with a mouthpiece port; a reservoir disposed within or in fluid communication with the container assembly and configured to supply a volume of fluid; anejector bracket in fluidcommunicationwith the reservoir, theejectorbracket includingameshwithamembrane operably coupled to a vibrating member that is coupled to an electronic transducer with the membrane between the vibratingmemberand themesh,wherein themesh includesaplurality of openings formed through themesh’s thickness and wherein the transducer is coupled to a power source and is operable to oscillate the vibrating member and the membrane and generate an ejected stream of droplets through the mesh; and an ejection channel within the container assembly configured to direct the ejected stream of droplets from the mesh to the outlet. Clause2.Thedroplet delivery deviceof anyof clause1,wherein thecontainerassembly is releasablydetachable from the ejector bracket or releasably detachable togetherwith the ejector bracket relative to one ormore other detachable parts of the delivery device. Clause 3. The droplet delivery device of clause 1, wherein the reservoir includes a self-sealing mating mechanism configured to couple to a fluid release mating mechanism of the ejector bracket. Clause 4. The droplet delivery device of clause 1, wherein the membrane is configured not to contact the mesh. Clause 5. The droplet delivery device of clause 1,wherein themembrane includes a slanted upper surface configured to contact fluid supplied from the reservoir. Clause 6. The droplet delivery device of clause 1, wherein the vibrating member includes a ring-shaped beveled tip. Clause 7. The droplet delivery device of clause 1, wherein the vibratingmember includes a ring-shaped non-beveled tip. Clause 8. The droplet delivery device of clause 1, wherein themesh has a top surface in a parallel configurationwith a flat surface of a tip of the vibrating member. Clause 9. The droplet delivery device of clause 1, wherein the vibrating member includes a rod-shaped tip. Clause 10. The droplet delivery device of clause 1, wherein the mesh has a bottom surface in a non-parallel configuration with an upper surface of the membrane. Clause 11. The droplet delivery device of clause 1, further comprising a central axis of the droplet delivery device passing through the ejection channel and themembrane, andwherein the vibratingmember includes a tip coupling to the membrane at a position offset from the central axis. Clause12. Thedroplet delivery deviceof clause1, further comprisinga laminar flowelement positioned in theejection port of the container assembly before the mouthpiece port of the delivery device. 28 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 Clause 13. The droplet delivery device of clause 12, wherein the laminar flow element includes a plurality of cellular apertures. Clause 14. The droplet device of clause 1, wherein themesh comprises amaterial of at least one of palladium nickel, polytetrafluoroethylene, and polyimide. Clause 15. The droplet delivery device of clause 1,wherein themesh comprises amaterial of at least one of poly ether ketone, polyetherimide, polyvinylidene fluoride, ultra-highmolecular weight polyethylene, Ni, NiCo, Pd, Pt, NiPd, and metal alloy. Clause 16. The droplet delivery device of clause 1, wherein the membrane comprises a material of at least one of polyethylene naphthalate, polyethylenimine and poly ether ketone. Clause17.Thedroplet deliverydeviceof clause1,wherein themembranecomprisesamaterial of at least oneofmetal membranes, metalized polymers, threaded polymers, threaded nylon, threaded polymers that are coated with polymers or metal, threaded nylon coated with polymers or metal, threadedmetals, threaded SiC, threaded graphite composites, metalized graphite composites, graphite composites coated with polymers, polymer sheets filled with carbonfibers, polyether ketonefilledwith carbonfibers, polymersheetsfilledwithSiCfibers, polymersheets filledwith ceramic or metal fibers, ULPA filter media, Nitto Denko Temic Grade filter media, Nitto Denko polymer sheets, threaded polymers bonded to a polymer sheet, nylon weave bonded to poly ether ketone or polyimide, graphite composites bonded to polymer sheets, polymer fiber weave with metalized coating, and nylon with sputtered on Al or vapor deposited Al. Clause 18. Thedroplet delivery device of clause 1,wherein theelectronic transducer is coupled to a vibratingmember including a tip portion comprised of at least one of Grade 5 titanium alloy, Grade 23 titanium alloy, and about 99% or higher purity titanium. Clause 19. Thedroplet delivery device of clause 1,wherein theelectronic transducer is coupled to a vibratingmember includinga tipportionof a sputteredonouter layer of about 99%orhigher purity titaniumprovidingasmooth tip surface configured to contact an underlying bottom surface of the membrane that is opposite an exterior top surface of the membrane positioned nearest the mesh. Clause 20. The droplet delivery device of clause 1, wherein an exterior surface of the membrane, opposite an underlying surface of the membrane contacting the vibrating member, includes a hydrophobic coating. Clause 21. The droplet delivery device of clause 1, wherein an exterior surface of the membrane, opposite an underlying surface of the membrane contacting the vibrating member, includes a hydrophilic coating. Clause 22. The droplet delivery device of clause 1, wherein themesh includes a hydrophobic coating on one or more surfaces of the mesh. Clause 23. The droplet delivery device of clause 1, wherein the mesh includes a hydrophilic coating on one or more surfaces of the mesh. Clause 24. Thedroplet delivery device of clause 1,wherein themesh includes ahydrophobic coating on a first surface of the mesh and a hydrophilic coating on a second surface of the mesh. Clause 25. The droplet delivery device of clause 1, wherein the membrane has an operable lifespan of over 55,000 aerosol-creating activations by the transducer. Clause 26. The droplet delivery device of clause 1, further comprising at least one superhydrophobic vent in fluid communication with the reservoir that is covered with a removable aluminized polymer tab. Clause 27. The droplet delivery device of clause 1, further comprising a removable aluminized polymer tab coupled to an exterior surface of the membrane adjacent the mesh. Clause 28. A method for assembling a droplet delivery device of clause 1, comprising removing a sealed packaging including aluminum and / or aluminum coating that contains the reservoir with a fluid stored in the reservoir and 29 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 coupling the container assembly to an enclosure system including the power source. Clause 29. A droplet delivery device comprising: a membrane supported in the device and coupled via a vibrating member to an electronic transducer; and a mesh supported in the device between the membrane and a port in a mouthpiece or nostril insertion element, wherein the membrane, mesh and port are all in fluid communication with one another. Clause 30. A method of producing a droplet stream from a fluid comprising delivering a fluid volume between a membrane and mesh, electronically activating an ultrasonic transducer coupled to the membrane via a vibrating member and producing a droplet stream by pushing the fluid volume through openings in the mesh. Claims 1. A droplet delivery device comprising: an inhalation port of either a mouthpiece port (40) or nasal inhalation port (41); an ejector bracket (15) including a mesh (22) with a plurality of openings formed in the mesh (22), wherein the mesh (22) is operably coupled to a vibratingmember (1708) coupled to an electronic transducer (26) and an exit side of the mesh (22) is positioned in or adjacent an ejection channel that exits at themouthpiece port (40) or the nasal inhalation port (41); and a fluid reservoir (1200) in fluid communication with the ejection bracket (15), characterized in that a membrane (25) is operably coupled to the vibrating member between the vibrating member (1708) and the mesh (22),wherein themembrane (25)providesachemically inert barrier that separates thefluid reservoir (1200) from the vibrating member (1708). 2. A droplet delivery device comprising: a container assemblywith a port, the port being sized, shaped and includingmaterials that are suited formouth or nasal inhalation; a reservoir disposed within or in fluid communication with the container assembly and configured to supply a volume of fluid; anejector bracket in fluidcommunicationwith the reservoir, theejectorbracket includingameshwithamembrane operably coupled to a vibrating member that is coupled to an electronic transducer with the membrane between the vibratingmemberand themesh,wherein themesh includesaplurality of openings formed through themesh’s thickness and wherein the transducer is coupled to a power source and is operable to oscillate the vibrating member and the membrane and generate an ejected stream of droplets through the mesh; an ejection channel within the container assembly configured to direct the ejected stream of droplets from the mesh to the outlet; and wherein the membrane (25) provides a chemically inert barrier that separates the fluid reservoir (1200) from the vibrating member (1708) 3. The droplet delivery device of claim 1, wherein the inhalation port is releasably detachable from the ejector bracket or releasably detachable together with the ejector bracket relative to one or more other detachable parts of the delivery device. 4. The droplet delivery device of claim 1 or 2, wherein the fluid reservoir includes a septum configured to puncture upon connection of the ejector bracket. 5. The droplet delivery device of one of claims 1‑3, wherein the membrane is configured not to contact the mesh. 6. Thedroplet deliverydeviceofoneof claims1‑4,wherein themembrane includesaslantedupper surfaceconfigured to contact fluid supplied from the fluid reservoir. 7. The droplet delivery device of one of claims 1‑4, wherein the mesh has a top surface in a parallel configuration with a flat surface of a tip of the vibrating member. 30 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 8. The droplet delivery device one of claims 1‑4, wherein the vibrating member includes a rod-shaped tip. 9. Thedroplet delivery deviceof oneof claims1‑4,wherein themeshhasabottomsurface in anon-parallel configuration with an upper surface of the membrane. 10. Thedroplet delivery deviceof oneof claims1‑8, further comprisinga central axis of thedroplet delivery device passing through the ejection channel and the membrane, and wherein the vibrating member includes a tip coupling to the membrane at a position offset from the central axis. 11. The droplet delivery device of one of claims 1‑9, wherein the mesh comprises a material of at least one of palladium nickel, polytetrafluoroethylene, polyimide, poly ether ketone, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, Ni, NiCo, Pd, Pt and metal alloy. 12. The droplet delivery device of one of claims 1‑10, wherein the membrane comprises a material of at least one of polyethylene naphthalate, polyethylenimine and poly ether ketone. 13. The droplet delivery device of one of claims 1‑10, wherein themembrane comprises amaterial of at least one ofmetal membranes, metalized polymers, threaded polymers, threaded nylon, threaded polymers that are coated with polymers or metal, threaded nylon coated with polymers or metal, threadedmetals, threaded SiC, threaded graphite composites, metalized graphite composites, graphite composites coated with polymers, polymer sheets filled with carbonfibers, polyether ketonefilledwith carbonfibers, polymersheetsfilledwithSiCfibers, polymersheets filledwith ceramic or metal fibers, ULPA filter media, Nitto Denko Temic Grade filter media, Nitto Denko polymer sheets, threaded polymers bonded to a polymer sheet, nylon weave bonded to poly ether ketone or polyimide, graphite composites bonded to polymer sheets, polymer fiber weave with metalized coating, and nylon with sputtered on Al or vapor deposited Al. 14. Thedroplet delivery device of one of claims 1‑12,wherein anexterior surface of themembrane in fluid communication with the reservoir includes a hydrophobic coating or . a hydrophilic coating. 15. Thedroplet deliverydeviceof oneof claims1‑14,wherein themesh includesoneormoreof ahydrophobic coatingand hydrophilic coating. 31 EP 4 659 870 A2 5 10 15 20 25 30 35 40 45 50 55 32 EP 4 659 870 A2 33 EP 4 659 870 A2 34 EP 4 659 870 A2 35 EP 4 659 870 A2 36 EP 4 659 870 A2 37 EP 4 659 870 A2 38 EP 4 659 870 A2 39 EP 4 659 870 A2 40 EP 4 659 870 A2 41 EP 4 659 870 A2 42 EP 4 659 870 A2 43 EP 4 659 870 A2 44 EP 4 659 870 A2 45 EP 4 659 870 A2 46 EP 4 659 870 A2 47 EP 4 659 870 A2 48 EP 4 659 870 A2 49 EP 4 659 870 A2 50 EP 4 659 870 A2 51 EP 4 659 870 A2 52 EP 4 659 870 A2 53 EP 4 659 870 A2 54 EP 4 659 870 A2 55 EP 4 659 870 A2 56 EP 4 659 870 A2 57 EP 4 659 870 A2 58 EP 4 659 870 A2 59 EP 4 659 870 A2 60 EP 4 659 870 A2 61 EP 4 659 870 A2 62 EP 4 659 870 A2 63 EP 4 659 870 A2 64 EP 4 659 870 A2 65 EP 4 659 870 A2 66 EP 4 659 870 A2 67 EP 4 659 870 A2 68 EP 4 659 870 A2 69 EP 4 659 870 A2 70 EP 4 659 870 A2 71 EP 4 659 870 A2 72 EP 4 659 870 A2 73 EP 4 659 870 A2 74 EP 4 659 870 A2 75 EP 4 659 870 A2 76 EP 4 659 870 A2 77 EP 4 659 870 A2 78 EP 4 659 870 A2 79 EP 4 659 870 A2 80 EP 4 659 870 A2 81 EP 4 659 870 A2 82 EP 4 659 870 A2 83 EP 4 659 870 A2 84 EP 4 659 870 A2 85 EP 4 659 870 A2 86 EP 4 659 870 A2 87 EP 4 659 870 A2 88 EP 4 659 870 A2 89 EP 4 659 870 A2 90 EP 4 659 870 A2 91 EP 4 659 870 A2 92 EP 4 659 870 A2 93 EP 4 659 870 A2 94 EP 4 659 870 A2 95 EP 4 659 870 A2 96 EP 4 659 870 A2 97 EP 4 659 870 A2 98 EP 4 659 870 A2 99 EP 4 659 870 A2 100 EP 4 659 870 A2 101 EP 4 659 870 A2 102 EP 4 659 870 A2 103 EP 4 659 870 A2 104 EP 4 659 870 A2 105 EP 4 659 870 A2 106 EP 4 659 870 A2 107 EP 4 659 870 A2 108 EP 4 659 870 A2 109 EP 4 659 870 A2 110 EP 4 659 870 A2 111 EP 4 659 870 A2 112 EP 4 659 870 A2 113 EP 4 659 870 A2 114 EP 4 659 870 A2 115 EP 4 659 870 A2 116 EP 4 659 870 A2 117 EP 4 659 870 A2 118 EP 4 659 870 A2 119 EP 4 659 870 A2 120 EP 4 659 870 A2 121 EP 4 659 870 A2 122 EP 4 659 870 A2 123 EP 4 659 870 A2 124 EP 4 659 870 A2 125 EP 4 659 870 A2 126 EP 4 659 870 A2 127 EP 4 659 870 A2 128 EP 4 659 870 A2 129 EP 4 659 870 A2 130 EP 4 659 870 A2 131 EP 4 659 870 A2 132 EP 4 659 870 A2 133 EP 4 659 870 A2 134 EP 4 659 870 A2 135 EP 4 659 870 A2 136 EP 4 659 870 A2 137 EP 4 659 870 A2 138 EP 4 659 870 A2 139 EP 4 659 870 A2 140 EP 4 659 870 A2 141 EP 4 659 870 A2 142 EP 4 659 870 A2 143 EP 4 659 870 A2 144 EP 4 659 870 A2 145 EP 4 659 870 A2 146 EP 4 659 870 A2 147 EP 4 659 870 A2 148 EP 4 659 870 A2 149 EP 4 659 870 A2 150 EP 4 659 870 A2 151 EP 4 659 870 A2 152 EP 4 659 870 A2 153 EP 4 659 870 A2 154 EP 4 659 870 A2 155 EP 4 659 870 A2 156 EP 4 659 870 A2 157 EP 4 659 870 A2 REFERENCES CITED IN THE DESCRIPTION This list of references cited by the applicant is for the reader’s convenience only. 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[0001] • US 63213634

[0001] • WO 2020264501 A

[0067] Non-patent literature cited in the description • EMERSON. Ultrasonic Vibrating member catalog. Catalog - Ultrasonic Vibrating member, 2014, www. emerson.com / documents / automation / catalog-ultra- sonic-vibrating member-branson-en-us-160126.pdf

[0113] • LIN, J. ; LIN, S. Study on a large-scale three- dimensional ultrasonic plastic welding vibration system based on a quasi-periodic phononic crystal structure. MDPI, November 2021, www.mdpi. com / 2073-4352 / 10 / 1 / 21 / htm

[0119] • Industrial resonators, November 2021, www.krell- engineering.com / fea / industr / industrial_resonators. htm

[0120] Abstract DROPLET DELIVERY DEVICE WITH PUSH EJECTION A droplet delivery device includes a housing with a mouthpiece port or outlet from a nasal device for releasing fluid droplets, a fluid reservoir, and an ejector bracket having a membrane positioned between a mesh with a plurality of openings and a vibrating member that is coupled to an electronic transducer, such as an ultrasonic transducer. The transducer vibrates the vibrating member which causes the membrane to push fluid supplied by the reservoir through the mesh to generate droplets in an ejected stream released through the outlet. 摘要 帶推射功能的微滴輸送裝置 一種液滴輸送裝置包括一個殼體，該殼體設有用於釋放液滴的鼻用裝置的嘴部端 口或出口；一個液體儲液器；以及一個噴射支架，該噴射支架具有一個膜片，該 膜片位於一個具有多個開口的網狀結構與一個振動部件之間，且該振動部件與一 個電子換能器（例如一個超聲波換能器）相連。該換能器驅動振動部件振動，從 而促使膜片將儲液罐供應的流體推過網狀結構，形成通過出口釋放的噴射液流 中的液滴。 摘要

Claims

1. A droplet delivery device comprising: an inhalation port of either a mouthpiece port (40) or nasal inhalation port (41); an ejector bracket (15) including a mesh (22) with a plurality of openings formed in the mesh (22), wherein the mesh (22) is operably coupled to a vibrating member (1708) coupled to an electronic transducer (26) and an exit side of the mesh (22) is positioned in or adjacent an ejection channel that exits at the mouthpiece port (40) or the nasal inhalation port (41); and a fluid reservoir (1200) in fluid communication with the ejection bracket (15), characterized in that a membrane (25) is operably coupled to the vibrating member between the vibrating member (1708) and the mesh (22), wherein the membrane (25) provides a chemically inert barrier that separates the fluid reservoir (1200) from the vibrating member (1708).

2. A droplet delivery device comprising: a container assembly with a port, the port being sized, shaped and including materials that are suited for mouth or nasal inhalation; a reservoir disposed within or in fluid communication with the container assembly and configured to supply a volume of fluid; an ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh with a membrane operably coupled to a vibrating member that is coupled to an electronic transducer with the membrane between the vibrating member and the mesh, wherein the mesh includes a plurality of openings formed through the mesh's thickness and wherein the transducer is coupled to a power source and is operable to oscillate the vibrating member and the membrane and generate an ejected stream of droplets through the mesh; an ejection channel within the container assembly configured to direct the ejected stream of droplets from the mesh to the outlet; and wherein the membrane (25) provides a chemically inert barrier that separates the fluid reservoir (1200) from the vibrating member (1708)3. The droplet delivery device of claim 1, wherein the inhalation port is releasably detachable from the ejector bracket or releasably detachable together with the ejector bracket relative to one or more other detachable parts of the delivery device.

4. The droplet delivery device of claim 1 or 2, wherein the fluid reservoir includes a septum configured to puncture upon connection of the ejector bracket.

5. The droplet delivery device of one of claims 1-3, wherein the membrane is configured not to contact the mesh.

6. The droplet delivery device of one of claims 1-4, wherein the membrane includes a slanted upper surface configured to contact fluid supplied from the fluid reservoir.

7. The droplet delivery device of one of claims 1-4, wherein the mesh has a top surface in a parallel configuration with a flat surface of a tip of the vibrating member.

8. The droplet delivery device one of claims 1-4, wherein the vibrating member includes a rod-shaped tip.

9. The droplet delivery device of one of claims 1-4, wherein the mesh has a bottom surface in a non-parallel configuration with an upper surface of the membrane.

10. The droplet delivery device of one of claims 1-8, further comprising a central axis of the droplet delivery device passing through the ejection channel and the membrane, and wherein the vibrating member includes a tip coupling to the membrane at a position offset from the central axis.

11. The droplet delivery device of one of claims 1-9, wherein the mesh comprises a material of at least one of palladium nickel, polytetrafluoroethylene, polyimide, poly ether ketone, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, Ni, NiCo, Pd, Pt and metal alloy.

12. The droplet delivery device of one of claims 1-10, wherein the membrane comprises a material of at least one of polyethylene naphthalate, polyethylenimine and poly ether ketone.

13. The droplet delivery device of one of claims 1-10, wherein the membrane comprises a material of at least one of metal membranes, metalized polymers, threaded polymers, threaded nylon, threaded polymers that are coated with polymers or metal, threaded nylon coated with polymers or metal, threaded metals, threaded SiC, threaded graphite composites, metalized graphite composites, graphite composites coated with polymers, polymer sheets filled with carbon fibers, poly ether ketone filled with carbon fibers, polymer sheets filled with SiC fibers, polymer sheets filled with ceramic or metal fibers, ULPA filter media, Nitto Denko Temic Grade filter media, Nitto Denko polymer sheets, threaded polymers bonded to a polymer sheet, nylon weave bonded to poly ether ketone or polyimide, graphite composites bonded to polymer sheets, polymer fiber weave with metalized coating, and nylon with sputtered on Al or vapor deposited Al.

14. The droplet delivery device of one of claims 1-12, wherein an exterior surface of the membrane in fluid communication with the reservoir includes a hydrophobic coating or . a hydrophilic coating.

15. The droplet delivery device of one of claims 1-14, wherein the mesh includes one or more of a hydrophobic coating and hydrophilic coating.

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