Droplet delivery device using push discharge

Abstract

The droplet delivery device includes a housing with a mouthpiece port or outlet from the nasal device for ejecting droplets of fluid, a fluid reservoir, and an ejector bracket having a membrane disposed between a mesh with a plurality of openings and a vibrating member coupled to an electronic transducer, such as an ultrasonic transducer, The transducer vibrates the vibrating member, which causes fluid provided by the reservoir to be pushed by the membrane through the mesh, thereby generating droplets in an ejection stream that is ejected through the outlet.

Description

Technical Field

[0001] Cross - reference to related applications

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 280,643, filed on November 18, 2021; U.S. Provisional Patent Application No. 63 / 256,546, filed on October 16, 2021; U.S. Provisional Patent Application No. 63 / 256,245, filed on October 15, 2021; and U.S. Provisional Patent Application No. 63 / 213,634, filed on June 22, 2021, all of which are hereby incorporated by reference in their entirety.

[0002]

[0002] This disclosure relates to a droplet delivery device comprising an ejector mechanism, and more particularly to a droplet delivery device for the delivery of a fluid to be inhaled into the mouth, throat, nose, and / or lungs.

Background Art

[0003]

[0003] The use of droplet - generating devices for the delivery of substances to the respiratory system is a very prominent field. The main challenge is to provide a device that delivers an accurate, consistent, and verifiable amount of substance having a droplet size suitable for successfully delivering the substance to the target area of the respiratory system.

[0004]

[0004] Most current inhaler - type systems, such as metered dose inhalers (MDIs), pressurized metered dose inhalers (p - MDIs), or pneumatic / ultrasonic - driven devices, generally create high - velocity droplets having a wide range of droplet sizes, including large droplets having a large momentum and kinetic energy. A droplet plume having a larger size distribution and large momentum does not reach the target area within the respiratory system; rather, it deposits throughout the lung passages, mouth, and throat. Such off - target deposition can be undesirable for many reasons, including inappropriate dosing and unwanted side effects.

[0005]

[0005] The droplet plumes generated from current droplet delivery systems can also lead to localized cooling and subsequent condensation, deposition, and crystallization of the material on the device surface as a result of high-speed ejection and rapid expansion of the material-carrying propellant. The device surface can also be obstructed by deposited material residue, which is a problem.

[0006]

[0006] Furthermore, conventional droplet delivery devices for nicotine delivery, including vape pens, typically require the inhaled fluid to be heated to a temperature that adversely affects the aerosolized liquid. Specifically, such heating levels can produce undesirable toxic byproducts, as demonstrated in reports and literature. [Overview of the project] [Problems that the invention aims to solve]

[0007]

[0007] Therefore, there is a need for an improved droplet delivery device that delivers droplets of an appropriate size range, avoids surface fluid deposition and opening blockage, avoids the generation of undesirable chemical byproducts via heating, and delivers a constant and reproducible quantity. [Means for solving the problem]

[0008]

[0008] In one embodiment of the push mode, the “push mode” droplet delivery device does not involve heating requirements which may result in undesirable byproducts and comprises a container assembly having a mouthpiece port; a reservoir disposed within or in fluid communication with the container assembly to supply a constant volume of fluid; an ejector bracket in fluid communication with the reservoir, the ejector bracket comprising a mesh having a membrane operably coupled to an electronic transducer, the membrane being between the transducer and the mesh, the mesh comprising a plurality of openings formed to pass through the thickness of the mesh, the transducer being coupled to a power source and operable to vibrate the membrane and generate a discharge stream of droplets through the mesh; and a discharge channel within the container assembly configured to guide the droplet discharge stream from the mesh to the outlet. The vibrating membrane that “pushes” the liquid through the mesh is referred to herein as “push mode” discharge, and the device in the embodiment of the push mode of the present invention may be referred to as a push mode device.

[0009]

[0009] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes an ultrasonic transducer as an electronic transducer, preferably an ultrasonic transducer containing a piezoelectric material.

[0010]

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

[0011]

[0011] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes an ejector bracket configured to be releasably connected to a container assembly, the ejector bracket further configured to be releasably connected to an enclosure system including an electronic transducer and a power supply.

[0012]

[0012] In another embodiment of the invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a magnet configured to releasably connect an ejector bracket and an enclosure system.

[0013]

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

[0014]

[0014] In another embodiment of the invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a fluid reservoir having a self-sealing pairing mechanism configured to be coupled to a fluid discharge pairing mechanism of an ejector bracket.

[0015]

[0015] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a fluid discharge pairing mechanism having a fluid conduit configured to be inserted into a self-sealing pairing mechanism. In a preferred embodiment, the fluid discharge pairing mechanism includes a spike-shaped structure having a hollow interior configured to enable fluid communication between the reservoir and the membrane.

[0016]

[0016] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane cooperating with a mesh is configured such that the membrane does not come into contact with the mesh and pushes the fluid from the droplet delivery device through an opening in the mesh, which will be discharged as droplets.

[0017]

[0017] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a membrane having an inclined upward surface configured to contact a fluid supplied from a reservoir.

[0018] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a vibrating member having an inclined tip that contacts an opposing lower surface of the inclined upper surface of the membrane.

[0019] In a further embodiment of the present invention in push mode, an electronic transducer includes a piezoelectric material coupled to a vibrating member having a ring-shaped tapered tip, a rod-shaped tapered tip, a rod-shaped tip, or a ring-shaped non-tapered tip.

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

[0021] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a mesh having a bottom surface that is non-parallel to the upper surface of the membrane, i.e., an inclined configuration at a certain angle.

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

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

[0024] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a fluid in a reservoir that includes a therapeutic agent for treating or preventing a medical condition or injury state.

[0025]

[0025] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a laminar flow element disposed within the discharge channel of the container assembly in front of the mouthpiece port of the delivery device. In a preferred embodiment, the laminar flow element includes a plurality of porous openings. In some embodiments, the laminar flow element includes a blade-shaped wall that defines a plurality of porous openings. In another embodiment, one or more of the plurality of porous openings have a triangular prism shape, a square prism shape, a pentagonal prism shape, a hexagonal prism shape, a heptagonal prism shape, or an octagonal prism shape.

[0026]

[0026] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a breath-actuated sensor, such as a pressure sensor, operably connected to a power source, the breath-actuated sensor being configured to activate an electronic transducer when sensing a predetermined pressure change within the discharge channel or within a passage of the droplet delivery device in fluid communication with the discharge channel.

[0027]

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

[0028]

[0028] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane that cooperates with a mesh further includes a mesh made of at least one material of polyether ketone, polyether imide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, Ni, NiCo, Pd, Pt, Nipd, and metal alloys.

[0029]

[0029] In other embodiments, the mesh may be made of a single-crystal or polycrystalline material such as silicon, silicon carbide, aluminum nitride, or germanium, having a hole structure formed using semiconductor processes such as photolithography and isotropic / anisotropic etching. When photolithography and isotropic and / or anisotropic etching are used, a variety of hole shapes can be formed within the single-crystal wafer with very high precision. When sputtering is used, a film can be deposited on the surface at a variety of contact angles. In certain embodiments, the thin layer formed on or deposited on the surface will have significantly better adhesion than a film deposited on a metal mesh formed by electrolytic deposition or a polymer mesh formed by laser cutting. This better adhesion is because the surface on the single-crystal wafer "slice" is planar at the atomic level and can be etched to produce a precise surface roughness to facilitate mechanical adhesion using adhesives or other materials. Silicon carbide is a suitable material due to its high strength and toughness. In the mesh of the push-mode embodiment of the present invention, a key advantage of using a semiconductor process to fabricate the hole structure from a single-crystal wafer "slice" is that the contact angles between the holes and the surface are precise, without the variability seen in conventional ejector plates that use meshes made from electrolytic deposition or laser cutting.

[0030]

[0030] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a membrane made of at least one material selected from polyethylene naphthalate, polyethyleneimine, and polyetherketone.

[0031]

[0031] In another embodiment of the present invention in push mode, a droplet delivery device having a film cooperating with a mesh further includes a film made of at least one of the following materials: metal film, metallized polymer, threaded polymer, threaded nylon, threaded polymer coated with polymer or metal, threaded nylon coated with polymer or metal, threaded metal, threaded SiC, threaded graphite composite, metallized graphite composite, polymer coated graphite composite, carbon fiber-filled polymer sheet, carbon fiber-filled polyether ketone, SiC fiber-filled polymer sheet, ceramic fiber or metal fiber-filled polymer sheet, ULPA filter medium, Nitto Denko Temic Grade filter medium, Nitto Denko polymer sheet, threaded polymer bonded to a polymer sheet, nylon fabric bonded to polyether ketone or polyimide, graphite composite bonded to a polymer sheet, polymer fiber fabric with a metallized coating, and nylon sputtered on Al or vapor-deposited aluminum.

[0032]

[0032] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a PZT-based ultrasonic transducer coupled to a vibrating member having a tip portion made of at least one of Grade 5 titanium alloy, Grade 23 titanium alloy, and titanium of about 99% purity or higher. In certain embodiments, the tip portion of the vibrating member comprises titanium of about 99% purity or higher sputtered on an outer layer, providing a smooth tip surface configured to contact the lower bottom surface of the membrane opposite the outer top surface of the membrane located closest to the mesh, thereby helping to reduce membrane wear and improve the lifespan and operational consistency of the membrane (and possibly the tip portion of the vibrating member).

[0033]

[0033] In another embodiment of the invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes an outer surface of the membrane having a hydrophobic coating, opposite to a surface in the lower layer of the membrane that contacts the vibrating member. This helps to reduce wear of the membrane and improve the lifespan and operational consistency of the membrane (and possibly the tip portion of the vibrating member).

[0034]

[0034] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes an outer surface of the membrane having a hydrophilic coating, facing a surface in the lower layer of the membrane that contacts the vibrating member.

[0035]

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

[0036]

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

[0037]

[0037] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating 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]

[0038] In another embodiment of the present invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a membrane having an operational life of 55,000 or more aerosol generation activations by a transducer.

[0039]

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

[0040]

[0040] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating with a mesh further includes a removable aluminum-treated polymer tab connected to the outer surface of the membrane adjacent to the mesh during storage.

[0041]

[0041] In another embodiment of the invention in push mode, a droplet delivery device having a membrane cooperating with a mesh includes a pre-assembly step of removing a sealed packaging including aluminum and / or an aluminum coating that incorporates a reservoir having fluid, preferably the reservoir being contained within a container assembly which is similarly packaged for storage within the sealed packaging. In some embodiments, the sealed packaging may contain dry nitrogen, argon, or other gas that does not contain oxygen.

[0042]

[0042] In another embodiment of the push mode of the present invention, a droplet delivery device having a membrane cooperating with a mesh may be used for oral or nasal inhalation. The mouthpiece port may be sized and molded to suit such a particular use and purpose of oral or nasal inhalation and may contain a material that is well suitable.

[0043]

[0043] The present invention of the push mode will be more clearly understood from the following description given as an example. [Brief explanation of the drawing]

[0044] [Figure 1A]

[0044] This is an exploded view showing the main components of a droplet delivery device according to an embodiment of the present disclosure. [Figure 1B]

[0045] This is a cross-sectional view showing the main components of a droplet delivery device according to an embodiment of the present disclosure. [Figure 2]

[0046] This is a schematic diagram showing a mesh bonded to a stainless steel ring supporting an elastic sealing ring of a droplet delivery device according to an embodiment of the present disclosure, referred to as Push Mode II. [Figure 3]

[0047] This is a schematic diagram showing the mesh supported by the inner tablet ring, the outer tablet ring, and the elastic sealing ring of a droplet delivery device according to an embodiment of the present disclosure, referred to as Push Mode I. [Figure 4]

[0048] This is a cross-sectional view showing specific dimensions of the discharge port and mouthpiece port of a droplet delivery device according to an embodiment of the disclosure. [Figure 5]

[0049] This is a cross-sectional view showing the fluid flow path of a droplet delivery device comprising a two-part cartridge according to an embodiment of the present disclosure. [Figure 6]

[0050] Figures 6A and 6B show the airflow of a droplet delivery device comprising a two-part cartridge according to an embodiment of the present disclosure. [Figure 7]

[0051] Figures 7A and 7B are exploded perspective views showing the main components of a push-mode I droplet delivery device (utilizing the mesh support shown in Figure 3) according to an embodiment of the present disclosure. [Figure 8]

[0052] This is an exploded view showing a droplet delivery device in push mode I according to an embodiment of the present disclosure (utilizing the mesh support shown in Figure 3). [Figure 9]

[0053] Figures 9A to 9E are separated perspective views showing a COC (cyclic olefin copolymer) ring, including the mesh (22), of a push-mode I droplet delivery device (utilizing the mesh support shown in Figure 3) according to an embodiment of the present disclosure. [Figure 10]

[0054] This is a schematic diagram showing a push-mode I droplet delivery device mesh suspension system (not necessary in Figure 3) within an embodiment of the present disclosure. [Figure 11]

[0055] This is a perspective view showing the lower ejector bracket, which includes vents located on each narrow side of the bracket of a droplet delivery device in push mode I (utilizing the mesh support shown in Figure 3) in an embodiment of the present disclosure. [Figure 12]

[0056] Figures 12A and 12B are perspective views showing the main components of a push-mode II droplet delivery device (utilizing the mesh support shown in Figure 2) according to an embodiment of the present disclosure. [Figure 13]

[0057] This is an exploded view showing a push-mode II droplet delivery device (utilizing the mesh support shown in Figure 2) according to an embodiment of the disclosure. [Figure 14]

[0058] This is a schematic diagram showing a push-mode II droplet delivery device mesh suspension system (also shown in Figure 2) within an embodiment of the present disclosure. [Figure 15]

[0059] This is a perspective view showing a lower ejector bracket including vents located on each of the wider sides of the bracket of a push-mode II droplet delivery device (utilizing the mesh support shown in Figure 2) in an embodiment of the present disclosure. [Figure 16]

[0060] This figure shows the lower container of a push-mode II droplet delivery device (utilizing the mesh support shown in Figure 2) in an embodiment of the present disclosure. [Figure 17]

[0061] This figure shows the lower container of a droplet delivery device in push mode I according to an embodiment of the present disclosure (utilizing a mesh support as shown in Figure 3). [Figure 18]

[0062] A perspective view showing a rod tip design for a vibrating member of a droplet delivery device according to one embodiment of the present disclosure. [Figure 19]

[0063] A perspective view showing a ring tip design for a vibrating member of a droplet delivery device according to one embodiment of the present disclosure. [Figure 20]

[0064] This is a cross-sectional view showing a single-part cartridge design comprising a long vibrating member within a droplet delivery device according to one embodiment of the present disclosure. [Figure 21]

[0065] Figures 21A and 21B are cross-sectional views showing a single-part cartridge design comprising a short vibrating member within a droplet delivery device according to one embodiment of the present disclosure. [Figure 22]

[0066] Figures 22A and 22B are cross-sectional views showing an alternative design for a single-piece cartridge with a long vibrating member in a droplet delivery device according to one embodiment of the present disclosure. [Figure 23]

[0067] Figures 23A and 23B are cross-sectional views showing an alternative design for a single-piece cartridge with a short vibrating member in a droplet delivery device according to one embodiment of the present disclosure. [Figure 24]

[0068] This is a separated cross-sectional view showing a cartridge design consisting of two parts within a droplet delivery device according to one embodiment of the present disclosure. [Figure 25]

[0069] This is a perspective view showing a droplet delivery device adapted for pharmaceutical use (but other uses may exist in other embodiments) according to one embodiment of the present disclosure, which utilizes membrane-driven aerosolization (i.e., “push-mode functionality”). [Figure 26]

[0070] This is an exploded view showing a droplet delivery device adapted for pharmaceutical use (but other uses may exist in other embodiments) according to one embodiment of the present disclosure, which utilizes membrane-driven aerosolization (i.e., “push-mode functionality”). [Figure 27]

[0071] Figures 27A to 27D show the main components of a droplet delivery device that utilizes membrane-driven aerosolization (i.e., "push-mode functionality") and is adapted for pharmaceutical use (but may be other uses in other embodiments) according to one embodiment of the present disclosure. [Figure 28]

[0072] Figure 28 is an assembly diagram showing the main components of a droplet delivery device adapted for pharmaceutical use (but other uses may exist in other embodiments) and utilizing membrane-driven aerosolization (i.e., “push-mode functionality”) according to one embodiment of the present disclosure. [Figure 29]

[0073] This is an exploded view showing the cap of a droplet delivery device adapted for pharmaceutical use (but other uses may exist in other embodiments) according to one embodiment of the present disclosure, which utilizes membrane-driven aerosolization (i.e., “push-mode functionality”). [Figure 30]

[0074] Figures 30A and 30B are side cross-sectional views showing a fluid cartridge of a droplet delivery device that utilizes membrane-driven aerosolization (i.e., “push-mode functionality”), adapted for pharmaceutical use (but other uses may be in other embodiments) according to one embodiment of the present disclosure. [Figure 31]

[0075] This is a cross-sectional view showing a vibrating member enclosure of a droplet delivery device adapted for pharmaceutical use (but other uses may be in other embodiments) and utilizing membrane-driven aerosolization (i.e., “push-mode function”), according to one embodiment of the present disclosure. [Figure 32]

[0076] This is a cross-sectional view showing an ejector bracket that utilizes a mesh suspension system adapted for pharmaceutical use (but other uses in other embodiments) according to one embodiment of the present disclosure, and which conforms to the structure and function of the mesh support shown in Figure 14. [Figure 33]

[0077] This is a cross-sectional view showing an ejector bracket that utilizes a mesh suspension system adapted for pharmaceutical use (but other uses in other embodiments) according to one embodiment of the present disclosure, and which conforms to the structure and function of the mesh support shown in Figure 10. [Figure 34]

[0078] Figures 34A and 34B are a side and front cross-sectional view showing a droplet delivery device adapted for pharmaceutical use (but which may also be other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push-mode function"), having two heating elements positioned beneath a vibrating member on either side of the ejector bracket, according to one embodiment of the present disclosure. [Figure 35]

[0079] Figures 35A to 35C are cross-sectional views showing airflow paths for a droplet delivery device having a bottom heating element and a single-part cartridge design, according to one embodiment of the present disclosure. [Figure 36]

[0080] This is a cross-sectional view showing a droplet delivery device having a bottom heating element and a speaker, having a single-part cartridge design, according to one embodiment of the present disclosure. [Figure 37]

[0081] This is a cross-sectional view showing an airflow path for a droplet delivery device having an internal heating element, having a cartridge design consisting of two parts, according to one embodiment of the present disclosure. [Figure 38]

[0082] This is a cross-sectional view showing an airflow path for a droplet delivery device having an internal heating element, having a single-part cartridge design, according to one embodiment of the present disclosure. [Figure 39]

[0083] This is a cross-sectional view showing an airflow path for a droplet delivery device having an external heating element, having a single-part cartridge design, according to one embodiment of the present disclosure. [Figure 40]

[0084] This cross-sectional view shows a droplet delivery device having a heated airstream, according to one embodiment of the present disclosure, which includes a temperature sensor used in conjunction with a closed-loop system to maintain a constant temperature in the airstream and further prevent overheating and injury to the user. [Figure 41]

[0085] Figures 41A and 41B show a droplet delivery device having adjustable air resistance through a sliding sleeve and associated vents, according to one embodiment of the present disclosure. [Figure 42]

[0086] This figure shows an elongated nasal inhalation port of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 43]

[0087] This figure shows an inhalation port of a shorter version of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e., “push mode function”), according to one embodiment of the present disclosure. [Figure 44]

[0088] Figures 44A and 44B show a removable cap for a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e., “push-mode function”), according to one embodiment of the present disclosure. [Figure 45]

[0089] This figure shows a mesh comprising a mounted plate having multiple openings for liquid, within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 46]

[0090] This is a cross-sectional view showing a capacitance cartridge having two parallel plates positioned to traverse the liquid adjacent to a mesh-membrane region within a droplet delivery device utilizing membrane-driven aerosolization (i.e., “push-mode function”) according to one embodiment of the present disclosure. [Figure 47]

[0091] Figures 47A to 47C are perspective, front, and side views showing the tip of a rectangular vibrating member in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 48]

[0092] Figures 48A to 48C show a perspective view, a perspective view of the vibration amplitude map, and a top view of the vibration amplitude within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure, specifically the tip of an unadjusted, eigenmode vibrating member and the obtained vibration amplitude map. [Figure 49]

[0093] Figures 49A to 49C are perspective views, a perspective view of the vibration amplitude map, and a top view of the vibration amplitude, showing the tip of an intrinsic mode vibrating member with slots and the obtained vibration amplitude map, respectively, within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 50]

[0094] This figure shows a curved vibrating member within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 51]

[0095] This figure shows a plunger vibrating member in a droplet delivery device that utilizes membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 52]

[0096] This figure shows a sensor carrier vibrating member in a droplet delivery device that utilizes membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 53]

[0097] Figures 53A and 53B show a spool vibrating member and an obtained vibration amplitude map in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 54]

[0098] Figures 54A and 54B show an optimized cylindrical vibrating member and the resulting vibration amplitude map within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 55]

[0099] Figures 55A and 55B show an unoptimized cylindrical vibrating member having a slot in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure, and the resulting vibration amplitude map. [Figure 56]

[0100] Figures 56A and 56B show an optimized rod vibrator and the resulting vibration amplitude map within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 57]

[0101] Figures 57A and 57B show an unoptimized rod vibrating member and the resulting vibration amplitude map in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 58]

[0102] Figures 58A and 58B are vibration amplitude cross-sectional views showing a booster vibrating member and an obtained vibration amplitude map within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode function") according to one embodiment of the present disclosure. [Figure 59]

[0103] Figures 59A to 59C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 60]

[0104] Figures 60A to 60C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 61]

[0105] Figures 61A to 61C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 62]

[0106] Figures 62A to 62C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 63]

[0107] Figures 63A to 63C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 64]

[0108] Figures 64A to 64C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 65]

[0109] Figures 65A to 65D are perspective views, top views, front views, and cross-sectional views along AA in Figure 65B, showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 66]

[0110] Figures 66A to 66C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 67]

[0111] Figures 67A to 67C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 68]

[0112] Figures 68A to 68D are perspective views, top views, front views, and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 69]

[0113] Figures 69A and 69B are perspective and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 70]

[0114] Figures 70A to 70C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 71]

[0115] Figures 71A to 71C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 72]

[0116] Figures 72A to 72C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 73]

[0117] Figures 73A to 73C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 74]

[0118] Figures 74A to 74C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 75]

[0119] Figures 75A to 75C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 76]

[0120] Figures 76A to 76C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 77]

[0121] Figures 77A to 77D are perspective views, top views, front views, and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 78]

[0122] Figures 78A to 78C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 79]

[0123] Figures 79A to 79C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 80]

[0124] Figures 80A to 80D are perspective views, top views, front views, and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 81]

[0125] Figures 81A to 81D are perspective views, top views, front views, and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 82]

[0126] Figures 82A to 82D are perspective views, top views, front views, and side views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 83]

[0127] Figures 83A to 83C are perspective, top, and front views showing alternative vibrating members connected to the transducer of a droplet delivery device according to embodiments of the present disclosure. [Figure 84A]

[0128] Figure 84A shows an alternative structure for the laminar flow element in a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84B] Figure 84B shows an alternative structure for the laminar flow element in the container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84C] Figure 84C shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84D] Figure 84D shows an alternative structure for the laminar flow element in a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84E] Figure 84E shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84F] Figure 84F shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84G] Figure 84G shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84H] Figure 84H shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84I] Figure 84I shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84J] Figure 84J shows an alternative structure for the laminar flow element in a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84K] Figure 84K shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84L] Figure 84L shows an alternative structure for the laminar flow element in the container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84M] Figure 84M shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84N] Figure 84N shows an alternative structure for the laminar flow element in the container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84O] Figure 84O shows an alternative structure for the laminar flow element of a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84P] Figure 84P shows an alternative structure for the laminar flow element in a container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 84Q] Figure 84Q shows an alternative structure for the laminar flow element in the container assembly of a droplet delivery device according to an embodiment of the present disclosure. [Figure 85A]

[0129] This figure shows an ultrasonic transducer, including the tip portion of a vibrating member, within a droplet delivery device according to an embodiment of the present disclosure. [Figure 85B]

[0130] This is a partial cross-sectional view showing an ultrasonic transducer connected to a membrane in a droplet delivery device according to an embodiment of the present disclosure, as shown in Figure 85A. [Figure 85C]

[0131] Figure 85B is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a first fixing mechanism. [Figure 85D] Figure 85B is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a second fixing mechanism. [Figure 86A]

[0132] This is a partial cross-sectional top view showing an ultrasonic transducer connected to a membrane within a droplet delivery device according to an embodiment of the present disclosure. [Figure 86B]

[0133] Figure 86A is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a first fixing mechanism. [Figure 86C] Figure 86A is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a second fixing mechanism. [Figure 87]

[0134] This is a partial cross-sectional top view showing a droplet delivery device according to an embodiment of the present disclosure, which includes an ultrasonic transducer having a vibrating member tip portion offset from the central axis of the droplet delivery device that passes through a slanted membrane and a mesh. [Figure 88]

[0135] Figure 88A is a partial cross-sectional top view showing an ultrasonic transducer in a droplet delivery device according to an embodiment of the present disclosure, which includes a non-gradient ring-shaped vibrating member tip portion connected to an inclined mesh.

[0136] Figure 88B is a schematic diagram showing the ultrasonic transducer and membrane of Figure 88A within a droplet delivery device according to an embodiment of the present disclosure. [Figure 89A]

[0137] This is a partial cross-sectional top view showing an ultrasonic transducer within a droplet delivery device according to an embodiment of the present disclosure, which includes a tapered ring-shaped vibrating member tip portion connected to a sloping membrane. [Figure 89B]

[0138] Figure 89A shows a gradient membrane working in conjunction with the ultrasonic transducer and mesh. [Figure 89C]

[0139] Figure 89A is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a first fixing mechanism. [Figure 89D] Figure 89A is a schematic diagram showing an ultrasonic transducer and membrane in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh includes a second fixing mechanism. [Figure 89E]

[0140] Figure 89A shows an ultrasonic transducer equipped with a tapered ring-shaped vibrating member tip. [Figure 90]

[0141] Figure 90A is a partial cross-sectional top view showing an ultrasonic transducer in a droplet delivery device according to an embodiment of the present disclosure, which includes a non-gradient ring-shaped vibrating member tip portion connected to a membrane and in contact with a mesh.

[0142] Figure 90B is a schematic diagram showing the ultrasonic transducer and membrane of Figure 90A within a droplet delivery device according to an embodiment of the present disclosure. This embodiment may be used with a mesh carrier in either push mode I or II. [Figure 91]

[0143] Figure 91A is a partial cross-sectional top view showing an ultrasonic transducer in a droplet delivery device according to an embodiment of the present disclosure, which has a tapered ring-shaped vibrating member tip portion connected to a sloping membrane, with a space between the mesh and the membrane.

[0144] Figure 91B is a schematic diagram showing the ultrasonic transducer and membrane of Figure 91A within a droplet delivery device according to an embodiment of the present disclosure. This embodiment may be used with a mesh carrier in either push mode I or II. [Figure 92]

[0145] This is a schematic diagram showing an ultrasonic transducer in a droplet delivery device according to an embodiment of the present disclosure, comprising a membrane-connected, non-gradient, ring-shaped vibrating member tip portion having a space between the mesh and the membrane. This embodiment may be used with a mesh carrier in either push mode I or II. [Figure 93A]

[0146] Figure 93A is a schematic separation diagram showing the ultrasonic transducer of a droplet delivery device. [Figure 93B] Figure 93B is a cross-sectional view along line BB in Figure 93A, showing an ultrasonic transducer having a broad, flat vibrating member tip portion together with a membrane and mesh, according to an embodiment of the present disclosure. [Figure 93C] Figure 93C is a cross-sectional view along line AA in Figure 93B, showing an ultrasonic transducer having a broad, flat vibrating member tip portion together with a membrane and mesh, according to an embodiment of the present disclosure. [Figure 94A]

[0147] This is a schematic diagram of a droplet delivery vise showing an ultrasonic transducer having a wide ring-shaped tip portion along with a membrane and mesh, according to an embodiment of the present disclosure. [Figure 94B] This is a cross-sectional view along line BB of Figure 94A showing an ultrasonic transducer having a broad ring-shaped tip portion together with a membrane and mesh according to an embodiment of the present disclosure. [Figure 94C] This is a separate view showing an ultrasonic transducer having a wide ring-shaped tip portion along with a membrane and mesh, according to an embodiment of the present disclosure. [Figure 94D] This is a cross-sectional view along line AA in Figure 94C, showing an ultrasonic transducer having a broad ring-shaped tip portion together with a membrane and mesh, according to an embodiment of the present disclosure. [Figure 95]

[0148] This is a schematic block diagram showing an aluminum-treated polymer tab in an embodiment of the present disclosure. [Figure 96]

[0149] Figures 96A to 96D are perspective views showing the film of a droplet delivery device according to an embodiment of the present disclosure. [Figure 97]

[0150] Figures 97A and 97B show a cross-sectional and enlarged view of a polymer mesh supported at a high position by a stainless steel annular structure, relating to a membrane and transducer connected to a vibrating member having a tip portion, within a droplet delivery device according to an embodiment of the present disclosure. [Figure 98]

[0151] Figures 98A and 98B are a cross-sectional and enlarged view, respectively, of a polymer mesh supported at a low position by a stainless steel annular structure, relating to a membrane and transducer connected to a vibrating member having a tip portion, within a droplet delivery device according to an embodiment of the present disclosure. [Figure 99]

[0152] Figures 99A and 99B show a cross-sectional and enlarged view of a polymer mesh in a droplet delivery device according to an embodiment of the present disclosure, relating to a membrane and transducer connected to a vibrating member having a tip portion, the mesh being supported at a high position by a first stainless steel annular, and further having a second stainless steel annular as a reinforcing, which is connected to the first annular by bonding using an adhesive or other means. [Figure 100]

[0153] Figures 100A and 100B show a cross-sectional and enlarged view of a polymer mesh in a droplet delivery device according to an embodiment of the present disclosure, relating to a membrane and transducer connected to a vibrating member having a tip portion, the mesh being supported at a lower position by a first stainless steel annular, and further having a second stainless steel annular as a reinforcing, connected below the first stainless steel annular by bonding using an adhesive or other means. [Figure 101]

[0154] Figures 101A to 101C are cross-sectional views showing a polymer mesh supported at a high position (Figure 101A), a low position (Figure 101B), and via a corrugated support (Figure 101C) by a plastic element of a ring-shaped support (without a metal annular object) in relation to a membrane and transducer connected to a vibrating member within a droplet delivery device according to an embodiment of the present disclosure. [Figure 102]

[0155] Figures 102A to 102C are enlarged views of Figures 101A, 101B, and 101C, respectively. [Figure 103]

[0156] Figures 103A and 103B are cross-sectional and enlarged views, respectively, of a droplet delivery device according to an embodiment of the present disclosure, showing a polymer mesh and a stainless steel capillary plate having an opening in the plate, with the plate between the membrane covering the tip portion of the vibrating member and the mesh, and the mesh being located beneath the polymer mesh.

[0157] Figure 103C is a schematic top view showing the polymer mesh shown in Figures 103A and 103B.

[0158] Figure 103D is a schematic top view showing the stainless steel capillary plate shown in Figures 103A and 103B. [Figure 104]

[0159] This is a schematic diagram showing a polymer mesh and a capillary plate, where, in a droplet delivery device according to an embodiment of the present disclosure, the capillary plate is made of a PEN material, such as a membrane covering a vibrating member (also made of PEN material), and further has a spacer (such as metal, ceramic, or plastic) between the capillary plate and the mesh. [Figure 105]

[0160] Figures 105A and 105B are cross-sectional and enlarged views showing a polymer mesh connected to a stainless steel annular structure having a shape that slopes downward and upward toward the central portion of the annular structure, relating to a membrane and transducer connected to a vibrating member having a tip portion in an embodiment of the present disclosure, and a plastic or silicone ring-shaped bracket (d) connected to the polymer mesh, relating to the membrane and transducer connected to the tip portion of the vibrating member in an embodiment of the present disclosure. [Figure 106]

[0161] Figures 106A and 106B are cross-sectional and enlarged views, respectively, of a polymer mesh in a droplet delivery device according to an embodiment of the present disclosure, which includes a polymer mesh with a central ring-shaped bracket made of plastic or silicone, connected to a membrane and transducer connected to a vibrating member having a tip portion. [Figure 107]

[0162] Figures 107A to 107D are cross-sectional views showing a polymer mesh with a plastic or silicone ring-shaped bracket connected to a double-reinforced stainless steel annular structure (similar to Figures 99 and 100). In Figure 107A, the polymer mesh rises at a reinforcing bracket extending further above it, in relation to a membrane and transducer connected to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In Figure 107B, the polymer mesh rises at a reinforcing bracket extending further above it, in relation to a membrane and transducer connected to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In Figure 107C, the polymer mesh descends at a reinforcing bracket extending further below it, in relation to a membrane and transducer connected to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In Figure 107D, the polymer mesh descends at a reinforcing bracket extending further below it, in relation to a membrane and transducer connected to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. [Figure 108]

[0163] Figures 108A to 108D are enlarged views of Figures 107A to 107D. [Figure 109]

[0164] Figures 109A to 109D show cross-sectional, perspective, top, and enlarged cross-sectional views along line CC in Figure 109C of a crystalline silicon or silicon carbide "wafer" type mesh processed by semiconductor technology to achieve precise fabrication of smooth openings such as pseudospheres between ring-structured supports within the mesh of a droplet delivery device according to embodiments of the present disclosure (the enlarged cross-sectional view in Figure 109D is intended to show an opening that passes through the mesh completely). [Figure 110]

[0165] This is a cross-sectional enlargement view showing a wafer-type mesh of crystalline silicon or silicon carbide within a liquid droplet delivery device of the present disclosure, having well-type openings that start from a larger portion through the thickness of the mesh and terminate or are finished in such a way as to have smaller openings within the openings (which may be further angled by semiconductor technology processing). [Figure 111]

[0166] Figure 111A is a perspective view showing a first end of an absorber and a baffle with fins according to an embodiment of the present disclosure. Figure 111B is a perspective view showing a second end opposite the baffle with fins according to an embodiment of the present disclosure. Figure 111C is a partial schematic cross-sectional view showing a droplet delivery device airway and an ejector plate with a mesh including the baffle with fins according to an embodiment of the present disclosure. [Figure 112]

[0167] An embodiment of the present disclosure shows a streamline velocity field graphical map illustrating the airway path of a droplet delivery device including a baffle-less airway director. [Figure 113]

[0168] This is a streamlined velocity field graphical map showing the airway path of a droplet delivery device, which includes a baffle with a core material but does not include an airway director, according to an embodiment of the present disclosure. [Figure 114]

[0169] This is a streamlined velocity field graphical map showing the airway path of a droplet delivery device, which includes a baffle comprising a core material and further includes an airway director, according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0045]

[0170] Overview of Push Mode

[0171] Pushmode was developed as a risk-reducing product for delivering (i) nicotine, cannabinoids, and other non-therapeutic agents (devices described herein as “BlueSky” are suitable for use with these substances), and (ii) therapeutic and prescription drug products (devices described herein as “Norway” are suitable for use with these products). Pushmode devices are designed to deliver safe and controlled doses to the user. Pushmode droplet delivery devices 10 can deliver liquid and non-liquid formulations as well as suspensions at room temperature. Macromolecule formulations, whether water-soluble or not, can also be delivered using this technology. Harmful chemical byproducts and other substances commonly found with heated nicotine are eliminated in Pushmode devices, making this a safer option for aerosol delivery.

[0046]

[0172] The push mode utilizes a vibrating member 1708 and transducer 26 working with the membrane 25 and mesh 2 to aerosolize the fluid 901, which is held in a reservoir 1200 and supplied to the mesh 22 using various methods (e.g., core material, hydrophobic coating, capillary action, etc.). Preferably, the vibrating member is connected to the transducer by bonding (e.g., adhesive), welding, gluing, and physical connections (e.g., brackets and other mechanical connectors). The transducer and vibrating member interact with the membrane to push the fluid through the mesh. As shown and described in various embodiments, the membrane can, in some cases, be in contact with the mesh and simultaneously "push" the fluid through the holes in the mesh, and in other cases, be separated from the mesh without contact with the mesh to push the liquid through the holes in the mesh. The transducer can include one or more materials from a variety of materials (e.g., PZT, etc.). In certain embodiments, the transducer is made of a lead-free piezoelectric material to avoid the generation of undesirable or toxic substances within the droplet delivery device intended for human inhalation. The vibrating member may be made of one or more of a wide variety of materials (e.g., titanium). The mesh may be one or more of a wide variety of materials (e.g., palladium nickel, polyimide). After the fluid is pushed through the mesh, a droplet spray is formed and discharged through the mouthpiece port, carried by the mixed air.

[0047]

[0173] This device is adjustable and precise. It can be optimized for the individual user's preferences or requirements. Aerosol mass emission and mass median aerodynamic diameter (MMAD) can be adjusted to the desired parameters through the mesh pore size, mesh treatment, membrane design, vibrating member design, airflow, and manipulation of power to the transducer. This design produces an aerosol consisting of droplets with a high inhalability fraction, allowing the lungs to absorb the aerosol most efficiently.

[0048]

[0174] Both the vibrating element and the transducer are separated from the cartridge and isolated by a membrane. This not only results in a safer product but also simplifies manufacturability. Both the vibrating element and the transducer are typically expensive components. By keeping these components within the enclosure system rather than in a cartridge, the cost of goods sold (COGS) is reduced.

[0049]

[0175] Table of element signs

[0176] Table 1 (Tables 1 to 5) shows the reference numerals for objects, structures, and parts for convenient reference relating to the descriptions and figures provided herein.

[0177] [Table 1]

[0050]

[0178] [Table 2]

[0051]

[0179] [Table 3] [Table 4] [Table 5]

[0052]

[0180] "BlueSky" Implementation

[0181] Referring to Figures 1A and 1B, the BlueSky push mode device 10 includes main components which are a container assembly 12, an ejector bracket 15, and an enclosure system 17. Currently, two embodiments of the BlueSky push mode I and II are being manufactured and tested as prototypes. Referring to Figure 2, the inclusion of a mesh supported by a stainless steel ring and an elastic sealing ring within the droplet delivery device 10 is referred to herein as “push mode II”. Referring to Figure 3, the inclusion of an upper and lower mesh carrier and a mesh supported by an elastic sealing ring within the droplet delivery device 10 is referred to herein as “push mode I”.

[0053]

[0182] Embodiments of push mode I and II have a transducer consisting of a lead zirconate titanate (PZT) disc bonded to the bottom of a vibrating member made of titanium alloy. The vibrating member and transducer are housed in an enclosure system 17 by a plastic cover. A membrane made of polyethylene naphthalate (PEN) inside the ejector bracket 15 isolates the transducer and vibrating member from the fluid supplied from the reservoir in the container assembly 12. The membrane can be thermoformed to the shape of the tip of the vibrating member. The embedded system on the device consists of a transducer, pressure sensor, and lithium-ion battery, all connected on a single-board microcontroller. The aluminum enclosure housing the embedded system also contains a button that can also serve as a fingerprint sensor for use with controlled substances. The device is charged via a USB-C charging port. Magnets are used to hold the cartridge in place within the enclosure.

[0054]

[0183] Multiple embodiments utilize a two-component cartridge system to prevent fluid from coming into contact with the mesh during storage. This design involves two spikes, one of which contains a core material in one part of the cartridge, which is an ejector bracket. The other part of the cartridge, which is a container, houses a fluid reservoir and two partitions. When the user pushes the ejector bracket and container together, the spikes puncture the partitions, thereby creating a path for the fluid to flow to the mesh. The core material in one of the spikes assists in supplying the fluid to the mesh. The other spike, which does not contain a core material, allows air to enter the container for pressure equalization. Ventilation holes, covered with a breathable material, are located at the top of each side of the fluid reservoir and are connected to the open atmosphere via air outlets, thereby allowing for pressure equalization.

[0055]

[0184] Referring to Figure 4, there is an exhaust port 42 with a length of 25 mm and a mouthpiece port with a length of 10 mm. The preferred length of the exhaust port is 0 mm to 50 mm. The preferred length of the mouthpiece port is 0 mm to 50 mm. Figure 5 shows the fluid 900 and ventilation 100 flow paths through the spike 28 in an embodiment manufactured as a prototype. Figures 6A and 6B show the mixed air paths in an embodiment manufactured as a prototype.

[0056]

[0185] BlueSky I-push mode

[0186] Figures 7A and 7B show renderings and CAD overviews of an embodiment of push mode I, respectively. The overviews in Figures 7A and 7B, from left to right, show the container assembly 12, the ejector bracket 15, and the enclosure system 17.

[0057]

[0187] Figure 8 provides an exploded view of the components from an embodiment of push mode I.

[0188] Referring to Figure 9, an embodiment of push mode I includes a mesh carrier comprising two ultrasonically welded COC rings 1506, 1508 that hold the mesh 22 and suspension gasket 1512. The COC rings sandwich the mesh and suspension gasket as shown in Figure 10. The gasket is positioned between the upper and lower ejector brackets.

[0058]

[0189] Referring to Figure 11, in the embodiment of push mode I, two vents are located on the narrow side of the lower ejector bracket 1504. The spike is located on the upper ejector bracket 1502. The container housing the fluid reservoir 1200 includes three COC (Call of Container) sections. Two partitions 1210 are held between the central container section and the lower container section. A container ring is bonded to the upper container section 1206 and the central container section 1208, and the mouthpiece 1202 snaps onto the upper container section 1206.

[0059]

[0190] BlueSkyII Push Mode

[0191] Figures 12A and 12B show renderings and schematic diagrams of an embodiment of push mode II, respectively. The overviews in Figures 12A and 12B, from left to right, show the container assembly 12, the ejector bracket 15, and the enclosure assembly 17.

[0060]

[0192] Figure 13 shows an exploded view of the components of the Push Mode II embodiment.

[0193] In the Push Mode II embodiment, a stainless steel annular carrier 1518 is bonded to the mesh 22. A gasket 1513 is positioned above the mesh and mesh carrier between the upper ejector bracket 1502 and the lower ejector bracket 1504. Figure 14 shows the mesh carrier 1518 and gasket 1513 in the Push Mode II embodiment.

[0061]

[0194] As shown in Figure 15, two ventilation holes are located on the wider side of the lower ejector bracket 1504. The spike is located on the upper ejector bracket 1502.

[0062]

[0195] Similar to push mode I, the container housing the fluid reservoir includes three COC sections. For the push mode II embodiment, the lower container extends further than in push mode I, with the tubular portion extending into the upper ejector bracket.

[0063]

[0196] Figures 16 (Push Mode II) and 17 (Push Mode I) show a comparison of the lower containers in each embodiment. This extension is necessary because the stainless steel mesh carrier is thinner than the COC carrier in I, causing the mesh to be positioned lower compared to I. Two partitions are held between the central container and the lower container. Container rings are bonded to the upper and lower container sections, and a mouthpiece snaps into the upper container section.

[0064]

[0197] BlueSky vibrating members and membranes

[0198] The push mode has multiple vibrating member and membrane designs. Tables 2 (Table 6) and 3 (Table 7) contain descriptions of vibrating member and membrane designs that were manufactured and tested as prototypes, respectively. Referring to Figures 18 and 19, there are currently two different tip designs for the vibrating member rod tip and ring tip, respectively.

[0065]

[0199] [Table 6]

[0066]

[0200] [Table 7]

[0067]

[0201] Transducers require a significant amount of power during device operation. Increased power usage leads to increased heat generation by the printed circuit board assembly (PCBA). The effects of heat are mitigated through several design features within the PCBA. A four-layer PCBA improves interference prevention and heat dissipation capabilities. The PCBA incorporates a large amount of copper foil, further contributing to heat dissipation. The MOSFETs driving the transducers employ high-current packages to avoid overheating damage during prolonged continuous operation. Automatic transformers for increasing voltage output are suspended to isolate them from the rest of the PCBA. These features allow the device to operate for several days without concerns about overheating or electrical noise.

[0068]

[0202] BlueSky Life Test

[0203] Life testing was performed on prototype BlueSky push mode embodiments I and II. The life testing consisted of repeated 3-second doses with 1-second rest intervals over several days. Mass evacuation was performed before and after the life testing. Mass evacuation is defined as the mass aerosolized by the device over a single 3-second dose. Mass evacuation data before the life testing is listed in Table 4 (Table 8), and data after the life testing is listed in Table 5 (Table 9). Mass evacuation for one embodiment remained constant before and after 55,000 doses and is likely to continue beyond that. This embodiment, push mode II with H4 and M11, has a stainless steel mesh carrier. A second embodiment exists, push mode I, which has a COC plastic mesh carrier. When subjected to heat from extreme dosing cycles, the plastic mesh carrier deformed during testing. This resulted in a decrease in mass evacuation after the life testing. However, the stainless steel carrier in push mode II did not deform due to heat, allowing it to remain constant after testing. In both embodiments I and II, thermal management is improved by four layers of PCBA and high-current MOSFET drivers, which is more than the standard amount of copper foil. The test conditions do not represent typical consumer use. Under normal daily use without extreme overheating, a certain mass discharge is shown in both embodiments I and II. Tables 2 and 3 provide details of the vibrating members and films referenced, respectively.

[0069]

[0204] [Table 8]

[0205] [Table 9]

[0206] Comparison of push mode and conventional ring mode

[0207] As described in Example 1, which will be explained later, prototypes of the BlueSky I and II push modes were tested and compared with a conventional technology referred to as the BlueSky ring mode (provided below, along with the respective test data for this technology, as described and shown in WO2020 / 264501, etc.).

[0070]

[0208] <Example 1>

[0209] Ejectors with a pore size of 2.0 μm were tested with each device. Half of the tested ejectors had a hydrophilic inlet and a hydrophobic outlet (R). The other half had a hydrophobic inlet and a hydrophobic outlet (W). Tests were performed using TSI Mini-MOUDI Model 135 and Thermo Fisher Vanquish UHPLC. Eight different design combinations (vibrating member, membrane, ejector treatment) were tested with BlueSky I and II. Based on the test results, Push Mode I is considered a suitable implement liquid for Push Mode. Push Mode I designs yielded more consistent mass discharge and MMAD values ​​compared to II. Seven of the eight design combinations yielded comparable mass discharge and MMAD. One outlier, H5 with M12 and R treated ejectors, showed significantly higher mass discharge than the others. Comparing Push Mode I to BlueSky Ring Mode, I delivers higher and more consistent mass discharge and lower MMAD. Tables 6 (Table 10), 7 (Table 11), and 8 (Table 12) provide data obtained from the 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 liquid ejected in stages 1 and 2 of the mini-MOUDI. All combinations of vibrating members and membranes tested using the I-push mode, as seen in Table 7, yielded good results in both ejector treatments. As can be seen in Table 8, the best-performing combinations using the II-push mode were H4 with M11 and H5 with M12, both of which used the W-treatment ejector.

[0071]

[0210] [Table 10]

[0072]

[0211] The results obtained from the device in push mode I are shown in Table 7 (Table 11). Tables 2 and 3 provide details of the referenced vibrating members and membranes, respectively.

[0073]

[0212] [Table 11]

[0074]

[0213] The results obtained from Push Mode II are shown in Table 8 (Table 12). Tables 2 and 3 provide details of the vibrating members and membranes used, respectively.

[0075]

[0214] [Table 12]

[0076]

[0215] Based on the test results, the I-push mode is a preferred embodiment compared to II.

[0077]

[0216] BlueSky single-piece cartridge and low cost of goods sold design

[0217] Another embodiment of the push mode incorporates a two-part cartridge system into a single component. Having a single-piece cartridge simplifies user setup and improves manufacturability while reducing costs. Figures 20, 21A, and 21B illustrate embodiments of a two-piece single-piece cartridge. The embodiment shown in Figure 20 includes a long vibrating member with a fluid reservoir located beneath a mesh. In this design, the container is a two-piece assembly that is put together during manufacturing.

[0078]

[0218] In another embodiment, a short vibrating member with a fluid reservoir on top of a mesh is present (see Figures 21A and 21B). In this design, the container consists of three parts that are assembled during manufacturing. After the fluid reservoir is filled, the mouthpiece is snap-fitted onto the container, with a container ring in between.

[0079]

[0219] The vibrating member and transducer work together with the membrane and mesh, as in the embodiment described above for the BlueSky push mode. The membrane also serves to isolate the vibrating member and transducer from the fluid. Mesh carriers are used in both designs. Magnets at the bottom of the container hold the cartridge in place within the enclosure.

[0080]

[0220] Further embodiments of a single-piece cartridge, shown in Figures 22A and 22B, have a simpler design that reduces COGS in manufacturing by reducing the number of injection-molded parts and bonded parts. Figure 22A shows a simplified version of the design in Figure 21A, but with a longer vibrating member. The design in Figure 22A reduces the number of ultrasonically welded and injection-molded parts. Figure 22B further simplifies the design in Figure 21A by reducing the number of ultrasonically welded and injection-molded parts.

[0081]

[0221] The low COGS designs shown in Figures 23A and 23B are simplified forms of the design shown in Figure 21B. This design is a single-part cartridge that can be inserted into an enclosure. Air is exchanged between the mouthpiece seal and the upper container. The cartridges shown in Figures 22A-22B and 24 have the exhaust port, which exits from the 10mm mouthpiece port, removed. The preferred lengths of the exhaust port and mouthpiece port are the same as described above, 0mm to 50mm.

[0082]

[0222] The BlueSky cartridge consists of two parts.

[0223] Figure 24 shows a cartridge design consisting of two parts for a long vibrating member. The container and ejector bracket are swapped, with the ejector bracket connected to the mouthpiece and the container below. The spike on top of the ejector bracket points downward towards the bulkhead on top of the container.

[0083]

[0224] Forms of dispensing / treatment (Norway)

[0225] The Norway Push Mode embodiment is in most respects similar to its counterpart in BlueSky, except that it is tailored for prescription and medical use. Similar to BlueSky, Norway features a retractable cartridge with an integrated fluid reservoir and ejector bracket. The device can also be used to assess lung health using vital capacity measurements. Figure 25 shows one embodiment of Norway's Push Mode.

[0084]

[0226] Patients diagnosed with lung disease can use the Norway device to track their medication dosage and perform lung function tests to assess their treatment progress. Patients can perform lung function tests and view their medication history via a phone app paired with the Norway device using Bluetooth. The device stores pressure sensor measurements from each medication dose. Inspiratory flow measurements can be calculated from the pressure sensor measurements, ensuring that the user inhales their medication at the flow rate that delivers the liquid most efficiently. The device can also perform lung function tests to measure the patient's forced expiratory capacity (EFF), forced vital capacity (FFF), maximum expiratory flow rate (PFF), and other vital capacity measurements. Data from medication tracking and lung function tests is uploaded to the cloud, allowing patients and doctors to monitor the patient's progress.

[0085]

[0227] The ejector bracket is designed to accept many different sized containers, where the fluid reservoir capacity varies. This results in a device that can be used with biologics or for single-use ejection. Possible fluid reservoir capacities range from 1 μL to 20 mL.

[0086]

[0228] For the Norwegian embodiment, the mouthpiece has a suitable length of 15 mm. There are two slits on the side of the mouthpiece, which have dimensions of 9 mm x 3 mm, and 27 mm 2 It has an area of ​​1 mm². The length of the mouthpiece can be between 5 mm and 3 mm. The area of ​​the mouthpiece is 1 mm². 2 From 100mm 2 It can be up to this point. The mouthpiece opening has dimensions of 14mm x 24mm, and 336mm 2 It has an area of ​​10 mm². The opening area of ​​the mouthpiece is 10 mm². 2 From 500mm 2 It could be any of the following.

[0087]

[0229] The cartridge can be inserted into the body of the device. The front of the cartridge can be sealed by an O-ring attached to the cap, which presses around the periphery of the mesh against a stainless steel annular when closed to prevent evaporation through the mesh. This is a face seal. The device features voice coaching and LED light to guide the user during ejection inhalation. An LCD screen is present to display the dosage count and other necessary information. Figure 26 shows an exploded view of one embodiment of the Norway push mode.

[0088]

[0230] Referring to Figures 27A-D, the cartridge assembly (Figure 27A) consists of three parts: a container (Figure 27B), a cartridge spacer (Figure 27C), and an ejector bracket (Figure 27D). The cartridge spacer keeps the ejector bracket separated from the container, thereby preventing the fluid from coming into contact with the mesh during storage before initial use in push mode.

[0089]

[0231] The cartridge spacer can be removed, which may cause the container to be pushed down onto the ejector bracket, causing the spike to penetrate the bulkhead and thereby break the cartridge into pieces. The cartridge can then be pushed into the device body, thereby completing the device. This process is shown in Figure 28.

[0090]

[0232] The cap of the Norwegian embodiment is designed to create a tight seal around the cartridge after each use. An O-ring sits atop a spring-loaded plastic piece that lightly presses against the cartridge assembly when the cap is closed, thereby forming a seal between the cartridge and the open air. The components of the cap are shown isolated as illustrated in Figure 29.

[0091]

[0233] The crucial components for generating precise aerosols in the ejector bracket include mesh, gaskets, membranes, ventilation material, and a mouthpiece. The membrane is positioned so that its surface is held parallel to the mesh surface or at a small, precise angle. The ejector bracket further has two spikes projecting outward from the top for penetrating the container. One spike is for fluid supply, and the other is for providing a ventilation path for the air generated by the ejection. On the side of the ejector bracket with the ventilation spikes, there is an opening covered with ventilation material to help relieve pressure and increase airflow. The mouthpiece is positioned to conform to the mesh surface.

[0092]

[0234] The most important components of the container for maintaining a constant aerosol are the ventilation material, the spiral structure, the bulkhead, and the bulkhead cap. The ventilation material is placed between the fluid and the spiral structure. The spiral structure is made up of the upper container and ventilation spacers that minimize the evaporation of the fluid through the ventilation material. The ventilation spacers are glued to the top of the upper container, thereby creating a sealed spiral structure with an opening to the inside of the container assembly in push mode and another opening to the atmosphere. The bulkhead is located at the bottom of the container. The bulkhead is placed in a cavity within the lower container and is held in place using bulkhead caps glued to the top of the lower container. The most important components of both the ejector bracket and the container can be seen in Figures 30A and 30B.

[0093]

[0235] The main body of the Norway device houses the vibrating member and transducer assembly. In one implementation, as shown in Figure 31, the vibrating member / transducer assembly is housed by a front vibrating member cover and a rear vibrating member cover. These covers are held together by circular caps called the front vibrating member cover holder and the rear vibrating member cover holder. The housed vibrating member is then placed into the vibrating member enclosure, followed by the vibrating member assembly spring, and finally the vibrating member is positioned within the vibrating member device bracket. The vibrating member enclosure allows the spring to press the vibrating member / transducer assembly against the membrane.

[0094]

[0236] Additional embodiments of Norway's push mode, similar to BlueSky's push mode system, include a different suspension system for holding the mesh within the cartridge. When using the suspension system, which can be seen in Figures 32 and 33, the vibrating member-transducer assembly does not have a spring and therefore does not need to be located within a vibrating member enclosure, nor does it require a vibrating member device bracket.

[0095]

[0237] An additional embodiment of the Push Mode device from Norway includes a heating element that raises the Push Mode inhalation air temperature to approximately 50°C to make administration more comfortable. Similar to the BlueSky design with a heating element, the heated air temperature is maintained below the thermal degradation level, resulting in the maintenance of the formulation integrity of the Push Mode and the absence of harmful byproducts. This can be achieved because, as with the BlueSky, the device is heat-independent in performing aerosolization. Figures 34A and 34B show one design including two heating elements positioned beneath the vibrating member on either side of the ejector bracket. As can be seen in Figures 34A and 34B, air enters through an opening located in the bottom of the ejector bracket, passes through the heating elements, and exits towards the mouthpiece. In addition, warmer air minimizes evaporation of the aerosolized fluid, thereby reducing MMAD.

[0096]

[0238] Biocompatibility

[0239] In the push mode design, the vibrating member and transducer are completely isolated from the inhaled fluid of the push mode by a membrane. Transducers, which typically contain heavy metals, are located behind the vibrating member, and as a result, the transducer is completely removed from the discharge area and fluid reservoir. The membrane separates the fluid reservoir from the vibrating member, thereby providing a chemically inert barrier that allows little to no diffusion and subsequent evaporation. In one embodiment, a palladium-nickel alloy mesh is used to atomize the fluid. Polyimide meshes have also been tested and shown to be a viable option. Using polymer meshes would significantly reduce manufacturing costs and potentially improve the extractable / leachable profile of the device. Non-metallic components in the embodiments fabricated as prototypes consist mainly of cyclic olefin copolymers (COCs) and silicones, both of which are widely accepted materials used in the medical device industry.

[0097]

[0240] Design of heated air

[0241] Figures 35A to 35C through 38 show embodiments that include a heating element to raise the inhaled air temperature to approximately 50°C in push mode I to make administration more comfortable. The air passes vertically through the heating element, thereby being heated most efficiently. Since the temperature of the heated air is maintained below the thermal degradation level, the formulation integrity of the push mode is maintained and no harmful by-products are produced. Furthermore, the specific heat of the fluid is significantly higher than that of the air, and therefore the temperature of the aerosolized fluid rises to a minimum. This can be achieved because the device does not rely on heat to perform aerosolization. Here, heat is used only to optimize the user experience. In addition, with warmer air, evaporation of the aerosolized fluid is minimized, thereby reducing MMAD. Finally, to isolate all components of the device from heat, the heating element will be surrounded by insulating material.

[0098]

[0242] Because the heating element is breath-activated, it only heats the air when the user inhales. This allows for a significantly longer battery life. Furthermore, since the heating element is not always on, a significantly safer device can be created. This can be achieved by incorporating a small-diameter wire in the push mode. Such a wire heats up very quickly, and therefore the heating element reacts immediately when the user inhales.

[0099]

[0243] In the embodiment shown in Figures 35A to 35C, after air enters the device, the air path is narrowed by an airflow accelerator to increase its velocity. The air then passes through a heating element located within a heat exchange region. Finally, the heated air flows into the mouthpiece. Figures 35A to 35C feature three different views of this embodiment. This design allows for the inclusion of a larger battery within the device to complement the heating element.

[0100]

[0244] Referring to Figure 36, a speaker can also be incorporated into any embodiment of the heated air BlueSky. This allows for the addition of sensory experience for the user (i.e., abnormal sounds / heating sounds in the lungs during inhalation).

[0101]

[0245] In the embodiments shown in Figures 37 and 38, the heating element is positioned below the vibrating member in a separate chamber inside the enclosure. Air enters through an air inlet, passes through the heating element, and exits from above the ejector. This design can be used for a two-part cartridge design (Figure 37) or a single-piece cartridge design (Figure 98). These embodiments offer the advantage of a more compact device compared to the embodiments shown in Figures 35A–35C, at the expense of battery life.

[0102]

[0246] Another embodiment features an external heating element located outside the enclosure (Figure 39). Air passes through the heating element, enters a mouthpiece above the mesh, and exits through the end of the mouthpiece. In some embodiments, this design can provide a removable heating element.

[0103]

[0247] In another embodiment of a heated air push mode device, closed-loop control is used to manage the power supplied to the heating element. The power is adjusted to maintain the air stream temperature at a safe level. Referring to Figure 40, the air stream temperature is measured by a temperature sensor such as an RTD. The power supplied to the heating element changes in response to the temperature sensor reading.

[0104]

[0248] In another embodiment of a heated air push mode device, open-loop control is used to manage the power supplied to the heating element. The power is adjusted to maintain a constant air stream temperature. A pressure drop from the intake is sensed. Due to the change in pressure drop, the amount of power that needs to be supplied to the heating element to maintain a constant air stream temperature is known. A reference table is created to determine the amount of power that needs to be supplied to the heating element to maintain a constant air stream temperature based on the pressure sensor values.

[0105]

[0249] In another embodiment of a heated air push mode device, one or more of the internal device components that come into contact with the heated air in the push mode are preferably made of metal (i.e., aluminum, Inconel, etc.). This isolates the heating element and improves the biocompatibility of the device.

[0106]

[0250] In another embodiment of the heated air push mode device, any components that may degrade due to heated air are preferably made of metal (i.e., titanium, aluminum, Inconel, etc.). These components include, but are not limited to, a mouthpiece, a heating chamber, and similar components that may be adversely affected by heated air.

[0107]

[0251] In one embodiment of a heated air push mode device, the metal components that come into contact with the heated air are preferably made of a material having low thermal conductivity, such as Inconel.

[0108]

[0252] In one embodiment of a heated air push mode device, a ceramic is used to isolate the heating element.

[0109]

[0253] Adjustable air resistance design

[0254] Another embodiment of the push mode incorporates a mechanism for adjusting the size of the air inlet. The air inlet can be opened or closed using a sleeve or an adjustable opening. This allows the resistance experienced by the user to be adjusted to individual preferences. Figures 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 air inlet, thereby increasing the resistance felt by the user. In addition, the airflow within the mouthpiece changes as the position of the sleeve changes. This further changes the MMAD of the dose due to the changes in airflow.

[0110]

[0255] Embodiment of a nasal device

[0256] The BlueSky push mode is also adapted for nasal suction. Figures 42–44 show several embodiments of the nasal BlueSky push mode device. As can be seen in Figures 42–44, there are several variations of the push mode inhalation port. However, a preferred embodiment of the nasal device has a longer and narrower inhalation port (see Figure 42) than other designs with shorter inhalation ports (see Figure 43) for optimal use in the nostrils. As can be seen in Figure 44, a cap may be added to protect the push mode inhalation port and keep it clean. A preferred droplet size is in the range of 1 micron to 110 microns, but 2 microns to 23 microns is preferred.

[0111]

[0257] Additional features

[0258] Hydrophilic / Hydrophobic Tubes

[0259] Another embodiment of the push node incorporates a tube with a hydrophilic interior that supplies fluid from a fluid reservoir to a mesh. The hydrophilic tube eliminates the need for a core material and allows for a wider range of suspensions and fluids to be delivered from the device. One example of these tubes is the spike in BlueSky I and II.

[0112]

[0260] Another embodiment of the push mode incorporates a coreless tube having a hydrophilic interior that supplies fluid from a fluid reservoir to a mesh, thereby enabling a wider variety of suspensions and liquids to be delivered from the device, and a hydrophobic tube on the opposite side that facilitates gas transfer from the fluid supply area between the membrane and the mesh.

[0113]

[0261] Polymer mesh pores

[0262] In another embodiment, as shown in Figure 45, the polymer mash 22 is used with a plate 45 attached to the polymer mesh 22. It has been found that 2 mm holes in the plate work best for discharge. Therefore, in another embodiment, the plate has multiple 2 mm openings for holding liquid. The holes in the plate can range from 0.1 mm to 20 mm.

[0114]

[0263] Tidal Breathing

[0264] Another embodiment of the push mode utilizes a periodic breathing system that can be used for pediatric treatment. This push mode technology delivers aerosols to the mask, similar to the Aero Chamber Plus Z-Stat Pediatric Mask (Monaghan Medical). This enables long-term treatment. When the user inhales, the device begins to expel, and when the user exhales, the device stops expelling. Due to the robustness of the push mode, this can be a very effective device for long-term treatment.

[0115]

[0265] Capacitance cartridge

[0266] In another embodiment, two parallel plates 1528 surround the fluid adjacent to the mesh and membrane regions. These two parallel plates measure the capacitance of the fluid. The capacitance of the supplied fluid is known. If the measured capacitance is different from the known capacitance, the device will not work. This will prevent tampering with the cartridge and prevent unauthorized fluid from being inserted into the cartridge. One of the parallel plates is shown in FIG. 46.

[0116]

[0267] Microfluidic pump

[0268] Another embodiment of the push mode utilizes the geometry of the vibrating member and the membrane that functions as both a nebulizer and a microfluidic pump at its connection interface in applications where the core material is not incorporated for certain suspensions, formulations, as well as in other medical, therapeutic, and consumer applications. The tip of the vibrating member is connected to the membrane while conforming to the desired geometry that allows fluid to enter between the mesh and the membrane while facilitating the free exit of any gas. These membranes can be treated by the techniques mentioned above to be hydrophilic or hydrophobic.

[0117]

[0269] Another embodiment utilizes a separate microfluidic pump to induce an appropriate amount of fluid and an appropriate pressure magnitude between the mesh and the membrane when the power is turned on, at intervals set to ensure proper dosing, for example, when actuated by inhalation.

[0118]

[0270] Optimization of the geometry of the vibrating member

[0271] The vibrating members of these embodiments will be made of materials characterized by appropriate acoustic and mechanical properties. To further improve biocompatibility, thin film sputtering of various non-reactive metals such as titanium, palladium, gold, silver, etc. can be performed on the tip section of the vibrating member. According to industry leaders, titanium has the best acoustic properties of high-strength alloys, and further has a high fatigue strength that enables it to withstand high cycle speeds at high amplitudes, and further has a higher hardness than aluminum, thereby improving its robustness. The appropriate material must be selected, the vibrating member must be designed with its balance adjusted for the required amplitude, and must be precisely adjusted to match a specific vibration frequency. One aspect of the adjustment is to make the vibrating member have an appropriate length in the elongated direction. Another aspect of the adjustment is to make the vibrating member conform to the mesh and have an appropriate gain ratio. An inappropriately adjusted vibrating member may damage the power supply device, fail to resonate at the optimal vibration frequency of the device, thereby reducing mass discharge and shortening the lifespan. (Available at https: / / www.emerson.com / documents / automation / catalog-ultrasonic-vibrating member-branson-en-us-160126.pdf. (Accessed on November 2, 2021), incorporated herein by reference, see also Ultrasonic Vibrating member catalog-Emerson. Catalog-Ultrasonic Vibrating member(2014).)

[0119]

[0272] For example, the titanium 7-4 material has more uniform wave propagation in one direction (axial direction) compared to titanium 6-4.

[0120]

[0273] Multiple embodiments must include a vibrating member having appropriate elastic modulus, acoustic properties, acoustic velocity, mechanical properties, molecular structure, etc., such as Ti grade 23, Ti grade 5, Ti with a purity of over 99.9%, TIMETAL® 7-4, 302 stainless steel, 303 stainless steel, 304 stainless steel, 304L stainless steel, 316 stainless steel, 347 stainless steel, Al6061, Al6063, Al3003, etc.

[0121]

[0274] Other embodiments include crystalline vibrating members having appropriate elastic modulus, acoustic properties, acoustic velocity, mechanical properties, molecular structure, etc., such as sapphire (Al2O3 aluminum oxide) and single-crystal silicon.

[0122]

[0275] In one embodiment, the design of the vibrating member is based on the design of an industrial ultrasonic vibrating member, such as the design disclosed by the reference example of the push mode cited later, but is optimized for use in aerosol generation for delivering fluid to the lungs, nose, ears, eyes, etc.

[0123]

[0276] Referring to Figure 47, the vibrating member has a rectangular shape at the membrane interface. This rectangular tip is characterized by three periodic slots along the X direction and two periodic slots along the Y direction, based on a quasi-periodic phononic crystal structure.

[0124]

[0277] Referring to Figures 48 and 49, the rectangular vibrating member tip combined with conical and cylindrical sections can effectively improve the output amplitude gain, and the bandgap characteristics of the structure are utilized to effectively suppress lateral vibration of the vibrating member tip, thereby improving the uniformity of the amplitude distribution at the membrane interface. (See also 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 (2020), which is incorporated herein by reference and is available at https: / / www.mdpi.com / 2073-4352 / 10 / 1 / 21 / htm. (accessed November 2, 2021).)

[0125]

[0278] In other embodiments, as shown in Figures 50–58, the vibrating members 1708 are tuned and machined in a manner similar to the design of industrial ultrasonic vibrating members (such figures are also disclosed in the references cited), but are optimized for the purpose of aerosol generation in delivering fluids to the lungs, nose, ears, eyes, etc., such as curved vibrating members (Figure 50), plunger vibrating members (Figure 51), product authenticity sensor vibrating members (Figure 52), spool vibrating members (Figure 53), cylindrical vibrating members with slots (Figures 54 and 55), rod vibrating members (Figures 56 and 57), and booster vibrating members (Figure 58). See also Industrial resonators, incorporated herein by reference, available at http: / / www.krell-engineering.com / fea / industr / industrial_resonators.htm (accessed November 2, 2021).

[0126]

[0279] Referring to Figure 50, the vibrating member can be curved in shape so as to be in close contact with the geometry of the membrane.

[0127]

[0280] Referring to Figure 51, the plunger member has a plunger that is nodally mounted on a nodal base which can be used to apply pressure to a given surface of a member that is in contact with the vibrating member.

[0128]

[0281] Referring to Figure 52, the sensor carrier vibrating member features an internal cavity that partially or completely encloses a sensing device mounted on a nodal base. This sensing device is connected to a sensor control unit, which outputs a signal to the PCBA. This signal can be used to disable aerosol generation in cases of attempting to use an incompatible, unsuitable, or unlicensed cartridge, etc.

[0129]

[0282] Referring to Figure 53, the spool vibrator is a slotless cylindrical member characterized by an undercut side behind the face that forms the spool shape. This spool shape improves the uniformity of the face amplitude. Because the spool vibrator is slotless, its stress is significantly reduced compared to an equivalent circular vibrator with slots, thereby significantly reducing machining costs. By using cavities, slots, and back extensions to optimize axial resonance, a very uniform amplitude can be obtained across the entire face of the member. The member is half the wavelength of the axial resonance, as indicated by a single node that is generally perpendicular to the principal direction of vibration. Spool vibrators generally have a gain of about 1:1, but somewhat larger gains are also possible.

[0130]

[0283] Referring to Figures 54 (optimized) and 55 (unoptimized), a cylindrical vibrating member with slots features longitudinal slots used to reduce lateral coupling due to the Poisson effect. Such slots are usually radial, but other configurations may be useful in some cases. Without such slots, the vibrating member would have a highly non-uniform amplitude across the entire surface or may resonate in directions other than the axial direction. This vibrating member further has a surface cavity that extends deep into the member to improve its gain. The vibrating member is half the wavelength of the axial resonance, as indicated by a single node that is generally oriented transversely to the principal direction of vibration. Cylindrical vibrating members with slots generally have low to moderate gains (1:1 to 2:1).

[0131]

[0284] Referring to Figures 56 (optimized) and 57 (unoptimized), the rod vibrator is rectangular and has no slots or slots only in the thickness direction. Optimal surface amplitude uniformity is given by special design techniques. The thickness of the vibrator is reduced at the blade section to provide a moderate gain. The vibrator is half the wavelength of the axial resonance, as indicated by a single node that is generally perpendicular to the principal direction of vibration. The rod vibrator generally has low to moderate gain (1:1 to 4:1).

[0132]

[0285] Referring to Figure 58, the booster is a coupling resonant device positioned between the transducer and the vibrating member, serving as a means for varying the amplitude of the member and / or supporting the resonant stack. The booster body is rigidly supported by collars bonded to the booster's nodes. Because this rigid booster is constructed solely of metal (without flexible elastomers), it has excellent axial and lateral rigidity. To further improve rigidity, a second collar may be incorporated into the full-wave design. The collar is adjusted to isolate the motion of the booster body from the support structure. This is shown in the later diagram of the displaced booster, where the coolest color indicates the smallest amplitude. Each booster has a fixed gain (ratio of output amplitude to input amplitude), generally between 0.5:1 and 3.0:1.

[0133]

[0286] Furthermore, referring to Figures 59-83, another alternative embodiment of the vibrating member 1708, comprising a vibrating member tip 170 connected to the transducer 26 of the droplet delivery device 10 according to various embodiments of the present disclosure, is shown.

[0134]

[0287] Alignment and design of other vibrating members and membranes

[0288] In other embodiments, the vibrating member 1708 may have a different shape, and the membrane 25 may also have an alternative shape. For example, Figure 85A shows an ultrasonic transducer connected to the tip portion 170 of a rod-shaped vibrating member. Figure 85 shows the vibrating member of Figure 85A connected to a membrane 25 that is raised or protruding in the center, within a droplet delivery device 10. Figures 85C and 85D show the ultrasonic transducer 26 and membrane 25 of Figure 85B in an alternative embodiment, where the mesh 22 includes a first fixing mechanism in Figure 85C (see Figure 2 and accompanying description) and a second fixing mechanism in Figure 85D (see Figure 3 and accompanying description).

[0135]

[0289] Figure 86A further illustrates an ultrasonic transducer 26 in another embodiment, comprising a rod-shaped tip portion 170 connected to a membrane 25 having a broad or dome-shaped / circular outer surface within a droplet delivery device 10. Figures 86B and 86C show the ultrasonic transducer 26 and membrane 25 of Figure 86A in an alternative embodiment, where the mesh 22 includes a first fixing mechanism in Figure 86B (see Figure 2 and accompanying description) and a second fixing mechanism in Figure 86C (see Figure 3 and accompanying description).

[0136]

[0290] Figure 87 shows an alternative embodiment of a droplet delivery service including an ultrasonic transducer 26 with a discharge channel 23, a sloping / sloping membrane 25, and a rod-shaped vibrating member tip portion 170 offset from the central axis 220 of the droplet delivery device, passing through a mesh 22, where the central axis of the vibrating member 230 is not aligned with the central axis 220 of the device 10.

[0137]

[0291] In another embodiment, Figures 88A and 88B show an ultrasonic transducer 26 in a droplet delivery device 10, comprising a non-gradient ring-shaped vibrating member tip portion 170 connected to an inclined mesh 22 that contacts a membrane 25 having a substantially flat outer top surface (closest to the mesh 22).

[0138]

[0292] In another embodiment shown in Figure 89A, an ultrasonic transducer 26 having a tapered ring-shaped vibrating member tip portion 170 may be coupled to a sloping membrane 25 that contacts the membrane 25 in the droplet delivery device 10. Figure 89B shows the sloping membrane 25 of Figure 89A, and Figure 89E shows the ultrasonic transducer having the tapered ring-shaped vibrating member tip portion 170 similarly shown in Figure 89A. Figures 89C and 89D show the ultrasonic transducer 26 and membrane 25 of Figure 89A in a droplet delivery device according to an alternative embodiment of the present disclosure, where the mesh 22 includes a first fixing mechanism in Figure 89C (see Figure 2 and accompanying description) and a second fixing mechanism in Figure 89D (see Figure 3 and accompanying description).

[0139]

[0293] Figures 90A and 90B show an ultrasonic transducer 26 having a non-gradient ring-shaped vibration member tip portion 170 connected to a membrane having a substantially flat outer surface that contacts a plane parallel to the plane of the fluid inlet surface in the lower layer of the mesh 22.

[0140]

[0294] Figures 91A and 91B show an ultrasonic transducer 26 having a gradient ring-shaped vibration member tip portion 170 connected to an inclined / sloped membrane 25 having a space between the membrane 25 and the mesh 22.

[0141]

[0295] Figures 90A and 92B show an ultrasonic transducer 26 having a non-gradient ring-shaped vibration tip portion 170 connected to a membrane 25 having a substantially flat outer surface that does not contact and is substantially parallel to the fluid-facing flat surface in the lower layer of the mesh 22 in another embodiment.

[0142]

[0296] Figures 93A - 93D show an alternative embodiment of a droplet delivery device 10 comprising an ultrasonic transducer 26 having a wide and flat vibration member tip portion 170 that is integral with a membrane 25 having a substantially flat surface and a substantially flat mesh 22. A suitable suspension system for the mesh 22 is further shown in Figures 30C and 30D.

[0143]

[0297] Figures 94A - 94D show another embodiment having an ultrasonic transducer 26 having a wide ring-shaped tip portion 170 that is integral with a membrane 25 having a substantially flat surface and a substantially flat mesh 22. A suitable suspension system for the mesh 22 is further shown in Figures 94C and 94D.

[0144]

[0298] membrane

[0299] The films 25 in these embodiments are made from materials that are robust and possess suitable acoustic and mechanical properties, such as polyethylene naphthalate, polyethyleneimine, polyetherketone, polyamide, polymethyl methacrylate, polyetherimide, polyvinylidene fluoride, and ultra-high molecular weight polyethylene.

[0145]

[0300] The films of these embodiments may have hydrophobic coatings, hydrophobic etching, hydrophilic etching, hydrophilic coatings, or roughening etching.

[0146]

[0301] In some embodiments, such as those shown in Figures 96A to 96D, the film may have various shapes and various surface textures, including "protrusions" in one embodiment.

[0147]

[0302] mesh

[0303] The mesh 22 in these embodiments is made of a material characterized by robustness and suitable acoustic and mechanical properties, such as polymethyl methacrylate, polyether ketone, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, polytetrafluoroethylene (PTFE), Ni, NiCo, Pd, Pt, NiPd, and metal alloys.

[0148]

[0304] In one embodiment, the mesh is made from a single-crystal or polycrystalline material such as silicon, silicon carbide, aluminum nitride, boron nitride, silicon nitride, or aluminum oxide. A variety of hole shapes can be formed within the single-crystal wafer via high-precision photolithography with or without a grayscale mask, as well as isotropic and / or anisotropic etching. A sputtered film may be deposited on the mesh to correct surface wetting. In certain embodiments, the thin layer formed or deposited on the surface will have significantly better adhesion than a film deposited on a metal mesh formed by electrolytic deposition or a polymer mesh formed by laser cutting. The surface on a single-crystal wafer "slice" is planarized at the atomic level and can be etched to produce a precise surface roughness. Precise surface roughness can be used to obtain better adhesion for mechanical bonding using adhesives or other materials. Silicon carbide is a preferred material due to its high strength and toughness. In the mesh of the push-mode embodiment of the present invention, a key advantage of using a semiconductor process to fabricate the hole structure from a single-crystal wafer "slice" is that the contact angles between the holes and the surface are precise without the variability seen in conventional ejector plates using meshes made from electrolytic deposition or laser cutting. The mesh may be fixed in II or suspended in I, as shown in Table 9 (Table 13), and the film is coupled to an optimized vibrating member using thin-film sputtering of a non-reactive metal, such as a palladium or gold member tip section, to further improve biocompatibility.

[0149]

[0305] Hole structures in other embodiments are formed using semiconductor processes such as photolithography and isotropic and anisotropic etching, laser cutting, femtosecond laser cutting, electron beam drilling, EDM (Electrical Discharge Machining) drilling, and diamond slurry grinding. See also Figures 109 and 110.

[0150]

[0306] [Table 13]

[0151]

[0307] The meshes of these embodiments may have hydrophobic coatings, hydrophobic etching, hydrophilic etching, hydrophilic coatings, roughening etching, or a combination thereof.

[0152]

[0308] In other embodiments, Figures 97-108 show various implementations of polymer mesh used in push mode I and II devices.

[0153]

[0309] Laminar flow element

[0310] In a push mode embodiment of the present invention, a laminar flow element 1600, as shown in Figure 1B, is preferably fixed within the discharge port prior to the mouthpiece port of the droplet delivery device. In a preferred embodiment, the laminar flow element includes a plurality of porous openings. In some embodiments, the laminar flow element includes a blade-shaped wall defining the plurality of porous openings. In another embodiment, one or more of the plurality of porous openings have a triangular prism shape, a square prism shape, a pentagonal prism shape, a hexagonal prism shape, a heptagonal prism shape, or an octagonal prism shape. Figures 84A to 84Q show various embodiments of the laminar flow element.

[0154]

[0311] Prevention of oxygen diffusion

[0312] Referring to Figure 95, in an embodiment in which the ejector bracket and container assembly are integrated as a single assembly, the droplet delivery device including a membrane cooperating with a mesh preferably further includes within this single assembly at least one superhydrophobic vent communicating with the reservoir and the fluid, which is covered during storage by a removable aluminum-treated polymer tab 3300 to help prevent oxygen diffusion into the fluid in the reservoir during storage. In another embodiment of the invention in push mode, in an embodiment in which the ejector bracket and container assembly are integrated as a single assembly, the droplet delivery device including a membrane cooperating with a mesh preferably further includes a removable aluminum-treated polymer tab 3300 connected to the outer surface of the membrane adjacent to the mesh during storage to help prevent oxygen diffusion into the fluid in the reservoir during storage.

[0155]

[0313] In another embodiment of the invention in push mode, a droplet delivery device 10 having a membrane 25 cooperating with a mesh 22 includes a pre-assembly step of removing a sealed packaging including aluminum and / or an aluminum coating that incorporates a reservoir having fluid, preferably here the reservoir is contained within a container assembly which is similarly packaged for storage within the sealed packaging.

[0156]

[0314] Decrease in large droplets in aerosols

[0315] In the push mode embodiment of the present invention, it is desirable to reduce the formation of large droplets and to facilitate the delivery of smaller droplet sizes outside the droplet delivery device and within the aerosol stream.

[0157]

[0316] In one embodiment, a hydrophilic core material may be provided in line with the mouthpiece of the droplet delivery device. Droplets formed on the outer edge of the mesh exit portion are absorbed by the hydrophilic core material, reducing the likelihood of larger droplets detaching from the surface of the mesh exit portion and moving forward. By absorbing larger droplets in this way, the reproducibility of MMAD is improved and liquid buildup is prevented.

[0158]

[0317] In another embodiment, a one-dimensional hydrophilic grid (see laminar flow element 1600, which is a cross-section) or a series of one-dimensional hydrophilic grids may be used to absorb larger droplets that might "fly out" of the mesh if water were to accumulate.

[0159]

[0318] Tests of droplet generation in push mode revealed that aerosol fog can remain inside the mouthpiece tube after inhalation. This fog can lead to the mesh being pulled along the outer circumference. Such pulling occurs because there is no admixture air to pull the trailing end of the aerosol discharge outwards. The droplet device can be programmed to begin spraying when the airflow rate reaches a threshold, via electronic programming and monitoring through a microcontroller or microchip integrated into or connected to the droplet delivery device, with the droplet delivery device detection and control unit recording the maximum air intake every 2ms. The droplet delivery device is programmed to stop spraying when the flow rate decreases to a certain percentage of the maximum flow rate achieved during inhalation. In several embodiments, a parameter labeled "pressure cutoff" may be added to the graphical user interface (GUI) for control / programming of the droplet delivery device, resulting in the manufacturer or other device operator changing the stop state parameter for spraying.

[0160]

[0319] Referring to Figures 111A-111C, in another embodiment, the baffle 4000 is inserted into the aerosol path. The baffle 4000 may comprise a plastic piece with fins 4050 for holding the baffle 4000 in place within the aerosol tube of the droplet delivery device. This plastic piece has a cylindrical cavity for holding an absorbent plug 4100 (e.g., porous polyester or other core material). The plug 4100 is inserted into the baffle cavity and has sufficient length to extend beyond the opening of the cavity. The absorbent plug faces the ejector mesh 22. On the side of the baffle opposite the mesh 22, the plastic baffle 4000 has a teardrop shape for guiding airflow and preventing vortex formation. The baffle 4000 is designed to inertially filter the aerosol by trapping larger droplets within the absorbent plug 4100 upon ejection. Initial data using three ejectors are shown in the table below. As can be seen in Table 10 (Table 14), the baffle 4000 reduced the MMAD by approximately 0.1 μm to 0.2 μm in each ejector. This inertial filtration creates a smoother intake experience with reduced irritation. The plastic pieces and absorbent plugs 4100 of the baffle 4000 can be of various lengths and / or dimensions.

[0161]

[0320] [Table 14]

[0162]

[0321] As explained, it is important to remove all small droplets from the mouthpiece. Small droplets have a very short stopping distance, and therefore the airflow must get close enough to the ejector plate to carry them away. One design was tested in which an airflow director was used to direct the airflow away from the mesh and towards the end of the mouthpiece. As shown in Figure 112, the airflow path with the airflow director generates a vortex at the rear, and this vortex holds the small droplets along the ejector plate. Removing the airflow director helped the airflow to capture some of the small droplets, but the airflow still left some of the small droplets behind. The holder for the ejector plate is sloped, thereby helping to guide the airflow to the ejector plate. This facilitates the air capturing most of the small droplets and sending them to the middle of the mouthpiece tube, but the ejector still creates undesirable larger droplets.

[0163]

[0322] Figure 113 shows the result when the insertable baffle 4000 is positioned in the middle of the mouthpiece tube. This baffle holds the core material. When the airflow is drawn to the middle of the mouthpiece tube, the air flows around the baffle. Droplets follow the airflow, but larger droplets have excessive momentum and cannot bend to flow around the baffle. The larger droplets collide with the core material. The core material holds the liquid, thereby preventing it from falling back onto the ejector plate. Thus, the liquid can evaporate from the core material.

[0164]

[0323] Figure 114 shows additional results when the insertable baffle 4000 is used in conjunction with an airflow director. In this test, the results showed that the airflow passed through the airflow director and struck the side of the baffle. Similarly, vortices formed in the middle of the mouthpiece tube, and these vortices pushed smaller droplets back onto the ejector plate. These vortices also caused larger droplets to flow around the baffle, preventing inertial filtration.

[0165]

[0324] While the present invention of the push mode has been described with reference to illustrative embodiments, those skilled in the art will understand that various variations can be made without departing from the scope of the present invention of the push mode, and that equivalents can be substituted for its elements. In addition, many modifications can be made to adapt this teaching to specific situations or materials without departing from the essential scope of the invention. Accordingly, the present invention of the push mode is not intended to be limited to the specific embodiment disclosed as the best mode contemplated for carrying out the invention, and the present invention of the push mode is intended to include all embodiments within the scope of the appended claims.

Claims

1. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket having fluid communication with the reservoir, wherein the ejector bracket includes a mesh having a membrane operably connected to a vibrating member connected to or integrally formed with the electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the reservoir including a self-sealing pairing mechanism configured to be connected to a fluid discharge pairing mechanism of the ejector bracket, the mesh including a plurality of openings formed to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

2. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket in fluid communication with the reservoir, wherein the ejector bracket includes a mesh comprising a membrane operably connected to a vibrating member connected to or integrally formed with the electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the membrane including an inclined upper surface configured to contact the fluid supplied from the reservoir, the mesh including a plurality of openings formed to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

3. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket having fluid communication with the reservoir, wherein the ejector bracket includes a mesh comprising a membrane operably connected to a vibrating member connected to or integrally formed with an electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the vibrating member including a ring-shaped tapered tip, the mesh including a plurality of openings formed to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

4. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket having fluid communication with the reservoir, wherein the ejector bracket includes a mesh having a membrane operably connected to a vibrating member connected to or integrally formed with an electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the vibrating member including a ring-shaped non-gradient tip, the mesh including a plurality of openings formed to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

5. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket in fluid communication with the reservoir, wherein the ejector bracket includes a mesh comprising a membrane operably connected to a vibrating member connected to or integrally formed with the electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the mesh having a bottom surface configured as non-parallel to the upper surface of the membrane, the mesh including a plurality of openings formed so as to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

6. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket in fluid communication with the reservoir, wherein the ejector bracket includes a mesh comprising a membrane operably connected to a vibrating member connected to or integrally formed with the electronic transducer, the membrane being between the vibrating member and the mesh, the membrane being in contact with the mesh, the mesh having a bottom surface configured as non-parallel to the upper surface of the membrane, the mesh including a plurality of openings formed so as to pass through the thickness of the mesh, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device comprising, The droplet delivery device further has a central axis through which the discharge channel and the membrane passes, and the vibrating member includes a tip portion connected to the membrane at a position offset from the central axis, Droplet delivery device.

7. A container assembly equipped with a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly, configured to supply a certain volume of fluid, An ejector bracket in fluid communication with the reservoir, wherein the ejector bracket includes a mesh comprising a membrane operably connected to or integrally formed with the electronic transducer, wherein the membrane lies between the vibrating member and the mesh, the membrane is in contact with the mesh, and the outer surface of the membrane facing the surface in the lower layer of the membrane that is in contact with the vibrating member includes a hydrophilic coating, the mesh includes a plurality of openings formed so as to pass through the thickness of the mesh, the transducer is connected to a power source and is operable to vibrate the vibrating member and the membrane, thereby generating an ejection stream of droplets through the mesh, Discharge channels within the container assembly are configured to guide the discharge stream of droplets from the mesh to the outlet, A droplet delivery device equipped with the following features.

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