Droplet delivery device using push ejection

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 to U.S. Provisional Patent Application No. 63 / 280,643, filed November 18, 2021, U.S. Provisional Patent Application No. 63 / 256,546, filed October 16, 2021, U.S. Provisional Patent Application No. 63 / 256,245, filed October 15, 2021, and U.S. Provisional Patent Application No. 63 / 213,634, filed June 22, 2021, all of which are incorporated by reference in their entirety into this specification.

[0002] The present disclosure relates to a droplet delivery device with an ejector mechanism, and more particularly to a droplet delivery device for delivery of an inhaled fluid into the mouth, throat, nose, and / or lungs. [Background technology]

[0003]

[0003] The use of droplet generating devices for delivery of substances to the respiratory system is an area of ​​considerable interest. A major challenge is to provide a device that delivers an accurate, consistent and verifiable amount of a substance with a droplet size suitable for successful delivery of the substance to a 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 or ultrasonically driven devices, generally produce high velocity droplets with a wide range of droplet sizes, including large droplets with high momentum and kinetic energy. Droplet plumes with larger size distributions and large momentum do not reach target areas in the respiratory system, but rather are deposited throughout the lung passages, mouth, and throat. Such off-target deposition can be undesirable for many reasons, including improper dosing and undesirable 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 materials onto the device surfaces as a result of high velocity ejection and rapid expansion of the propellant carrying the material. Blockage of the device surface by deposited material residue is also a problem.

[0006]

[0006] Furthermore, conventional droplet delivery devices for the delivery of nicotine, including vape pens and the like, typically require that the fluid to be inhaled be heated to temperatures that adversely affect the liquid being aerosolized. Specifically, such heating levels can create undesirable toxic by-products, as reported and documented in the literature. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0007] Therefore, there is a need for an improved droplet delivery device that delivers droplets in the appropriate size range, avoids surface fluid deposition and blockage of the aperture, avoids the production of undesirable chemical by-products via heating, and in consistent and reproducible quantities. [Means for solving the problem]

[0008] In one embodiment of the present invention, a "push mode" droplet delivery device does not require heating, which may result in undesirable by-products, and includes a container assembly with a mouthpiece port, a reservoir disposed within or in fluid communication with the container assembly to deliver a volume of fluid, an ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh with a membrane operatively coupled to an electronic transducer, the membrane being between the transducer and the mesh, the mesh including a plurality of openings formed through a thickness of the mesh, the transducer coupled to a power source and operable to vibrate the membrane and generate an ejection stream of droplets through the mesh, and an ejection channel in the container assembly configured to direct the ejection stream of droplets from the mesh to an outlet. The vibrating membrane that "pushes" the liquid through the mesh is referred to herein as a "push mode" ejection, and the device in the push mode embodiment 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 comprises an ultrasonic transducer as the electronic transducer, preferably an ultrasonic transducer comprising a piezoelectric material.

[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 present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes an ejector bracket configured to be releasably coupled to the container assembly, and the ejector bracket is further configured to be releasably coupled to an enclosure system including an electronic transducer and a power source.

[0012]

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

[0013]

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

[0014]

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

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

[0016]

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

[0017]

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

[0018]

[0018] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a vibration member having a sloped tip contacting an underlying surface opposite the sloped upper surface of the membrane.

[0019]

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

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

[0021]

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

[0022]

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

[0023]

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

[0024] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further comprises a fluid in the reservoir comprising a therapeutic agent for treating or preventing a medical or damaging condition.

[0025] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further comprises a laminar flow element disposed in the discharge channel of the container assembly prior to the mouthpiece port of the delivery device. In a preferred embodiment, the laminar flow element comprises a plurality of porous openings. In some embodiments, the laminar flow element comprises 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.

[0026]

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

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

[0028]

[0028] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a mesh made of at least one of the following materials: polyetherketone, polyetherimide, polyvinylidene fluoride, ultra-high molecular weight polyethylene, Ni, NiCo, Pd, Pt, Nipd, and a metal alloy.

[0029] In other embodiments, the mesh can be made of single crystal or polycrystalline materials such as silicon, silicon carbide, aluminum nitride, or germanium, with hole structures formed using semiconductor processes such as photolithography and isotropic and anisotropic etching. When using photolithography and isotropic and / or anisotropic etching, a variety of hole shapes can be formed with great precision in the single crystal wafer. When using sputtering, a film can be deposited on the surface with a variety of contact angles. The thin layer formed or deposited on the surface will, in certain embodiments, 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 atomically flattened and can be etched to create a precise surface roughness to aid in mechanical bonding with adhesives or other materials. Silicon carbide is a preferred material due to its high strength and toughness. A key advantage of using semiconductor processes to fabricate the hole structures from single crystal wafer "slices" in the mesh of push mode embodiments of the invention is that the holes and surface contact angles are precise without the variations seen in conventional ejector plates that use mesh made from electrolytic deposition or laser cutting.

[0030]

[0030] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a membrane made of at least one of the following materials: polyethylene naphthalate, polyethyleneimine, and polyether ketone.

[0031] In another embodiment of the invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a membrane made of at least one of the following materials: metal membrane, metallized polymer, threaded polymer, threaded nylon, threaded polymer coated with a polymer or metal, threaded nylon coated with a polymer or metal, threaded metal, threaded SiC, threaded graphite composite, metallized graphite composite, graphite composite coated with polymer, carbon fiber filled polymer sheet, carbon fiber filled polyetherketone, SiC fiber filled polymer sheet, ceramic fiber or metal fiber filled polymer sheet, ULPA filter media, Nitto Denko Temic Grade filter media, Nitto Denko polymer sheet, threaded polymer bonded to a polymer sheet, nylon fabric bonded to polyetherketone 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 present invention in push mode, the 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 a particular embodiment, the tip of the vibrating member includes titanium of about 99% purity or higher sputtered onto an outer layer providing a smooth tip surface configured to contact the underlying bottom surface of the membrane opposite the outer top surface of the membrane disposed closest to the mesh, thereby helping to reduce wear on the membrane and improve the life and operational consistency of the membrane (and potentially the tip portion of the vibrating member).

[0033] In another embodiment of the invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes an exterior surface of the membrane, opposite the underlying surface of the membrane that contacts the vibration member, having a hydrophobic coating, thereby helping to reduce wear on the membrane and improve the life and operational consistency of the membrane (and potentially the tip portion of the vibration 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 exterior surface of the membrane opposite the underlying surface of the membrane that contacts the vibration member, the exterior surface having a hydrophilic coating.

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

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

[0037]

[0037] In another embodiment of the present invention in push mode, the 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] In another embodiment of the present invention in push mode, the droplet delivery device having a membrane cooperating with a mesh further includes a membrane having an operational life of greater than or equal to 55,000 aerosol generation activations by the transducer.

[0039]

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

[0040]

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

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

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

[0043] The invention in push mode will be more clearly understood from the following description, given by way of example. [Brief description of the drawings]

[0044] [Figure 1A]

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

[0045] FIG. 1 is a cross-sectional view illustrating major components of a droplet delivery device according to an embodiment of the present disclosure. [Diagram 2]

[0046] FIG. 13 is a schematic diagram showing a mesh bonded to a stainless steel ring that supports an elastic sealing ring of a droplet delivery device according to an embodiment of the present disclosure referred to as Push Mode II. [Diagram 3]

[0047] FIG. 1C is a schematic diagram showing a mesh supported by inner and outer tablet rings and an 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] FIG. 1 is a cross-sectional view illustrating certain dimensions of an exit port and a mouthpiece port of a droplet delivery device according to an embodiment of the present disclosure. [Diagram 5]

[0049] FIG. 1 is a cross-sectional view illustrating fluid flow paths of a droplet delivery device including a two-part cartridge according to an embodiment of the present disclosure. [Figure 6]

[0050] 6A and 6B are diagrams illustrating the airflow of a droplet delivery device with a two-part cartridge according to an embodiment of the present disclosure. [Figure 7]

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

[0052] FIG. 4 is an exploded view illustrating a push mode I droplet delivery device (utilizing the mesh support shown in FIG. 3) according to an embodiment of the present disclosure. [Figure 9]

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

[0054] FIG. 4 is a schematic diagram showing a push mode I droplet delivery device mesh suspension system (not required in FIG. 3) within an embodiment of the present disclosure. [Figure 11]

[0055] FIG. 4 is a perspective view showing a lower ejector bracket including vent holes located on the narrow side of each of the brackets of a push mode I droplet delivery device (utilizing the mesh support shown in FIG. 3) within an embodiment of the present disclosure. [Figure 12]

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

[0057] FIG. 3 is an exploded view illustrating a push mode II droplet delivery device (utilizing the mesh support shown in FIG. 2) within an embodiment of the present disclosure. [Figure 14]

[0058] FIG. 3 is a schematic diagram illustrating a push mode II droplet delivery device mesh suspension system (also shown in FIG. 2) within an embodiment of the present disclosure. [Figure 15]

[0059] FIG. 3 is a perspective view showing a lower ejector bracket including vent holes located on each broad side of the bracket of a push mode II droplet delivery device (utilizing the mesh support shown in FIG. 2) within an embodiment of the present disclosure. [Figure 16]

[0060] FIG. 3 illustrates a lower container of a push mode II droplet delivery device (utilizing the mesh support shown in FIG. 2) within an embodiment of the present disclosure. [Figure 17]

[0061] FIG. 4 illustrates a lower container of a push mode I droplet delivery device (utilizing the mesh support shown in FIG. 3) according to an embodiment of the present disclosure. [Figure 18]

[0062] FIG. 13 is a perspective view illustrating a wand tip design for a vibration member of a droplet delivery device according to one embodiment of the present disclosure. [Figure 19]

[0063] FIG. 13 is a perspective view illustrating a ring tip design for a vibration member of a droplet delivery device according to one embodiment of the present disclosure. [Figure 20]

[0064] FIG. 13 is a cross-sectional view illustrating a single-part cartridge design with a long vibration member in a droplet delivery device according to one embodiment of the present disclosure. [Figure 21]

[0065] 21A and 21B are cross-sectional views illustrating a single-part cartridge design with a short vibration member in a droplet delivery device according to one embodiment of the present disclosure. [Figure 22]

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

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

[0068] FIG. 1 is an isolated cross-sectional view illustrating a two-part cartridge design in a droplet delivery device according to one embodiment of the present disclosure. [Diagram 25]

[0069] FIG. 1 is a perspective view showing a droplet delivery device adapted for pharmaceutical use (but potentially other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 26]

[0070] FIG. 1 is an exploded view showing a droplet delivery device adapted for pharmaceutical use (but potentially other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 27]

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

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

[0073] FIG. 1 is an exploded view showing the cap of a droplet delivery device adapted for pharmaceutical use (but potentially other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Diagram 30]

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

[0075] FIG. 1 is a cross-sectional view of a vibration member enclosure of a droplet delivery device adapted for pharmaceutical use (but potentially other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Diagram 32]

[0076] FIG. 15 is a cross-sectional view showing an ejector bracket adapted for pharmaceutical use (but potentially other uses in other embodiments) according to one embodiment of the present disclosure, utilizing a mesh suspension system following the structure and function of the mesh support shown in FIG. [Diagram 33]

[0077] FIG. 11 is a cross-sectional view showing an ejector bracket adapted for pharmaceutical use (but potentially other uses in other embodiments) according to one embodiment of the present disclosure, utilizing a mesh suspension system following the structure and function of the mesh support shown in FIG. [Diagram 34]

[0078] 34A and 34B are side and front cross-sectional views showing a droplet delivery device adapted for pharmaceutical use (but which may have other uses in other embodiments) and utilizing membrane-driven aerosolization (i.e., "push mode functionality"), having two heating elements positioned below a vibration member on either side of an ejector bracket, according to one embodiment of the disclosure. [Diagram 35]

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

[0080] FIG. 1 illustrates a cross-sectional view of a droplet delivery device having a bottom heating element and speaker with a single-part cartridge design according to an embodiment of the present disclosure. [Figure 37]

[0081] FIG. 13 is a cross-sectional view illustrating airflow paths for a droplet delivery device with an internal heating element having a two-part cartridge design according to an embodiment of the present disclosure. [Figure 38]

[0082] FIG. 13 is a cross-sectional view illustrating airflow paths for a droplet delivery device with an internal heating element having a single-part cartridge design according to an embodiment of the present disclosure. [Figure 39]

[0083] FIG. 13 is a cross-sectional view illustrating airflow paths for a droplet delivery device with an external heating element having a single-part cartridge design according to an embodiment of the present disclosure. [Diagram 40]

[0084] FIG. 1 is a cross-sectional view illustrating a droplet delivery device having a heated air stream including a temperature sensor used with a closed loop system to maintain a constant temperature of the air stream and further avoid overheating and injury to the user, according to one embodiment of the present disclosure. [Diagram 41]

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

[0086] FIG. 1 shows an elongated nasal inhalation port of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Diagram 43]

[0087] FIG. 1 shows the inhalation port of a shorter version of a droplet delivery device adapted for nasal inhalation and utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Diagram 44]

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

[0089] FIG. 1 illustrates a mesh with an attached plate having multiple openings for receiving liquid in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 46]

[0090] FIG. 1 is a cross-sectional view showing a capacitance cartridge having two parallel plates positioned across a liquid next to a mesh-membrane region in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 47]

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

[0092] 48A-C show perspective, vibration amplitude map perspective, and vibration amplitude top views of a non-slotted or untuned natural mode vibrating member tip and resulting vibration amplitude maps in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 49]

[0093] 49A-49C show perspective, vibration amplitude map perspective, and vibration amplitude top views of a slotted natural mode vibrating member tip and resulting vibration amplitude maps within a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 50]

[0094] FIG. 1 illustrates a vibration member having a curved shape in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 51]

[0095] FIG. 1 illustrates a plunger vibration member in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 52]

[0096] FIG. 1 illustrates a sensor carrier vibrating member in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 53]

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

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

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

[0100] FIGS. 56A and 56B show an optimized bar vibrating member and resulting vibration amplitude map in a droplet delivery device utilizing membrane-driven aerosolization (i.e., "push mode functionality") according to one embodiment of the present disclosure. [Figure 57]

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

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

[0103] 59A-59C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 60]

[0104] 60A-60C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 61]

[0105] 61A-61C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 62]

[0106] 62A-62C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 63]

[0107] 63A-63C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 64]

[0108] 64A-64C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 65]

[0109] 65A-65D are perspective, top, front and cross-sectional views along AA of FIG. 65B showing an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 66]

[0110] 66A-66C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 67]

[0111] 67A-67C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 68]

[0112] 68A-68D are perspective, top, front, and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 69]

[0113] 69A and 69B are perspective and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 70]

[0114] 70A-70C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 71]

[0115] 71A-71C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 72]

[0116] 72A-72C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 73]

[0117] 73A-73C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 74]

[0118] 74A-74C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 75]

[0119] 75A-75C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 76]

[0120] 76A-76C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 77]

[0121] 77A-77D are perspective, top, front, and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 78]

[0122] 78A-78C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 79]

[0123] 79A-79C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 80]

[0124] 80A-80D are perspective, top, front, and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 81]

[0125] 81A-81D are perspective, top, front, and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 82]

[0126] 82A-82D are perspective, top, front, and side views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Figure 83]

[0127] 83A-83C are perspective, top, and front views illustrating an alternative vibration member coupled to a transducer of a droplet delivery device according to an embodiment of the present disclosure. [Fig. 84A]

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

[0129] FIG. 1 illustrates an ultrasonic transducer including a vibrating member tip portion in a droplet delivery device according to an embodiment of the present disclosure. [Fig. 85B]

[0130] FIG. 85B is a partial cross-sectional view showing the ultrasound transducer of FIG. 85A coupled to a membrane in a droplet delivery device according to an embodiment of the present disclosure. [Fig. 85C]

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

[0132] FIG. 1B is a partial cross-sectional top view illustrating an ultrasound transducer coupled to a membrane in a droplet delivery device according to an embodiment of the present disclosure. [Figure 86B]

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

[0134] FIG. 1C is a partial cross-sectional top view illustrating a droplet delivery device including an ultrasonic transducer with a vibrating member tip portion offset from a central axis of the droplet delivery device passing through a tilted membrane and a mesh, according to an embodiment of the present disclosure. [Figure 88]

[0135] FIG. 88A is a partial cross-sectional top view illustrating an ultrasound transducer with a non-graded ring-shaped vibrating member tip portion coupled to a tilted mesh in a droplet delivery device according to an embodiment of the present disclosure.

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

[0137] FIG. 1B is a partial cross-sectional top view illustrating an ultrasonic transducer with a gradient ring-shaped vibrating member tip portion coupled to a gradient membrane in a droplet delivery device according to an embodiment of the present disclosure. [Figure 89B]

[0138] FIG. 89B illustrates a tilted membrane cooperating with the ultrasound transducer and mesh shown in FIG. 89A. [Figure 89C]

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

[0140] FIG. 89B shows an ultrasonic transducer having a tapered ring-shaped vibrating member tip portion of FIG. 89A. [Figure 90]

[0141] FIG. 90A is a partial cross-sectional top view illustrating an ultrasound transducer with a non-beveled ring-shaped vibrating member tip portion coupled to a membrane and in contact with a mesh in a droplet delivery device according to an embodiment of the present disclosure.

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

[0143] FIG. 91A is a partial cross-sectional top view showing an ultrasound transducer with a gradient ring-shaped vibrating member tip portion coupled to a gradient membrane with a space between the mesh and the membrane in a droplet delivery device according to an embodiment of the present disclosure.

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

[0145] 1 is a schematic diagram illustrating an ultrasound transducer with a non-graded ring-shaped vibrating member tip portion coupled to a membrane with a space between the mesh and the membrane in a droplet delivery device according to an embodiment of the present disclosure, which can be used with either push mode I or II mesh carriers. [Figure 93A]

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

[0147] FIG. 1 is a schematic diagram of a droplet delivery device showing an ultrasound transducer having a wide ring-shaped tip portion with a membrane and mesh according to an embodiment of the present disclosure. [Figure 94B] 94B is a cross-sectional cutaway view taken along line BB of FIG. 94A showing an ultrasound transducer having a wide ring-shaped tip portion with a membrane and mesh according to an embodiment of the present disclosure; [Fig. 94C] FIG. 1 illustrates an isolated view of an ultrasound transducer having a wide ring-shaped tip portion with a membrane and mesh according to an embodiment of the present disclosure. [Fig. 94D] A cross-sectional view along line AA of FIG. 94C showing an ultrasound transducer having a wide ring-shaped tip portion with a membrane and mesh according to an embodiment of the present disclosure. [Figure 95]

[0148] FIG. 2 is a schematic block diagram illustrating an aluminized polymer tab in an embodiment of the present disclosure. [Figure 96]

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

[0150] FIGS. 97A and 97B are cross-sectional and close-up views showing a polymer mesh supported by a stainless steel annulus at an elevated position in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. [Figure 98]

[0151] FIGS. 98A and 98B are cross-sectional and close-up views showing a polymer mesh supported by a stainless steel annulus at a low position in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. [Figure 99]

[0152] 99A and 99B are cross-sectional and enlarged views of a polymer mesh in a droplet delivery device according to an embodiment of the present disclosure, associated with a membrane and transducer connected to a vibration member having a tip portion, supported by a first stainless steel ring at an elevated position, and further having a second stainless steel ring as a reinforcement connected on top of the first ring, such as by gluing with an adhesive or glue. [Figure 100]

[0153] 100A and 100B are cross-sectional and enlarged views of a polymer mesh in a droplet delivery device according to an embodiment of the present disclosure, associated with a membrane and transducer connected to a vibrating member having a tip portion, supported by a first stainless steel ring at a lower position, and further having a second stainless steel ring as a reinforcement connected below the first stainless steel ring, such as by bonding with an adhesive or glue. [Figure 101]

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

[0155] 102A to 102C are enlarged views showing FIGS. 101A, 101B, and 101C. [Figure 103]

[0156] 103A and 103B are cross-sectional and close-up views of a polymer mesh and a stainless steel capillary plate with openings in the plate underlying the polymer mesh between the membrane covering the vibrating member tip portion and the mesh in a droplet delivery device according to an embodiment of the present disclosure.

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

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

[0159] FIG. 1 is a schematic diagram showing a polymer mesh and capillary plate, where in a droplet delivery device according to an embodiment of the present disclosure, the capillary plate is made of PEN material as a membrane covering a vibration 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] 105A and 105B are cross-sectional and enlarged views showing a polymer mesh with a plastic or silicone ring-shaped type bracket (d) connected to a stainless steel annulus having a downward-rising shape in a direction toward a central portion of the annulus, which is connected to the polymer mesh in association with 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. [Fig. 106]

[0161] 106A and 106B are cross-sectional and close-up views showing a polymer mesh with a ring-shaped type bracket central portion of an annular plastic or silicone connected to the polymer mesh, associated with a membrane and transducer connected to a vibration member having a tip portion, in a droplet delivery device according to an embodiment of the present disclosure. [Figure 107]

[0162] 107A-107D are cross-sectional views showing a polymer mesh with a plastic or silicone ring-shaped type bracket coupled to a double-reinforced stainless steel annulus (similar to FIGS. 99 and 100). In FIG. 107A, the polymer mesh is raised at the brace extending further on its upper side in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In FIG. 107B, the polymer mesh is raised at the brace extending further on its upper side in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In FIG. 107C, the polymer mesh is lowered at the brace extending further on its lower side in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. In FIG. 107D, the polymer mesh is lowered at the brace extending further on its lower side in association with a membrane and transducer coupled to a vibrating member having a tip portion in a droplet delivery device according to an embodiment of the present disclosure. [Figure 108]

[0163] 108A to 108D are enlarged views showing FIGS. 107A to 107D. [Fig. 109]

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

[0165] FIG. 13 is a cross-sectional close-up view of a crystalline silicon or silicon carbide "wafer" type mesh with well-type openings that start larger through the thickness of the mesh and terminate or are finished to have smaller openings within the opening (which may be further angled by semiconductor engineering processing) within a mesh within a liquid droplet delivery device embodying the present disclosure. [Figure 111]

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

[0167] 1 is a streamline velocity field graphical map showing the airway path of a droplet delivery device including an airway director without baffles, according to an embodiment of the present disclosure. [Figure 113]

[0168] 13 is a streamline velocity field graphical map showing the airway path of a droplet delivery device including a baffle with a wicking material and without an airway director in accordance with an embodiment of the present disclosure. [Fig. 114]

[0169] 1 is a streamline velocity field graphical map illustrating the airway path of a droplet delivery device including a baffle with a wicking material and further including an airway director in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045]

[0170] Push Mode Overview

[0171] The push mode was developed as a reduced risk product for delivering (i) nicotine, cannabinoids, and other non-therapeutic agents (the device described herein as "BlueSky" is suitable for use with these substances), as well as (ii) therapeutic and prescription drug products (the device described herein as "Norway" is suitable for use with these products). The push mode device is designed to deliver a safe and controlled dosage to the user. The push mode droplet delivery device 10 can deliver liquid and non-liquid drugs and suspensions at room temperature. Macromolecular formulations, whether water soluble or not, can also be delivered using this technology. Harmful chemical by-products and other substances commonly found with heated nicotine are eliminated in the push mode device, making it a safer option for aerosol delivery.

[0046]

[0172] The push mode utilizes a vibration member 1708 and a transducer 26 working with the membrane 25 and mesh 2 to aerosolize the fluid 901, which is held in the reservoir 1200 and delivered to the mesh 22 using various methods (e.g., wicking, hydrophobic coating, capillary action, etc.). Preferably, the vibration member is coupled to the transducer by bonding (such as adhesives), welding, gluing, and physical connections (e.g., brackets and other mechanical connectors), etc. The transducer and vibration 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 contact the mesh and still "push" the fluid through the holes in the mesh, and in other cases can be separated without contacting the mesh to push the liquid through the holes in the mesh. The transducer can include one or more of a variety of materials (e.g., PZT, etc.). In certain embodiments, the transducer is made of lead-free piezoelectric material to avoid the production of undesirable or toxic substances in a droplet delivery device intended for human inhalation. The vibrating member can be made of one or more of a wide variety of materials (e.g., titanium, etc.). The mesh can be one or more of a wide variety of materials (e.g., palladium nickel, polyimide, etc.). After the fluid is forced through the mesh, a droplet spray is formed and expelled through the mouthpiece port, entrained by the entrained air.

[0047]

[0173] The device is adjustable and precise. The device can be optimized for individual user preferences or requirements. The aerosol mass emission and mass median aerodynamic diameter (MMAD) can be adjusted to meet desired parameters through mesh pore size, mesh treatment, membrane design, vibrating member design, airflow, manipulation of power to the transducer, etc. The design creates an aerosol composed of droplets with a high respirable fraction, so that the lungs can most efficiently absorb the aerosol.

[0048]

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

[0049]

[0175] Element code table

[0176] The designations of objects, structures, and parts for convenient reference in connection with the descriptions and figures provided herein are presented in Table 1.

[0177] [Table 1]

[0050]

[0178] [Table 2]

[0051]

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

[0052]

[0180] "BlueSky" embodiment

[0181] 1A and 1B, the BlueSky push mode device 10 includes the following main components: a container assembly 12, an ejector bracket 15, and an enclosure system 17. Currently, two embodiments of BlueSky push modes I and II have been fabricated and tested as prototypes. With reference to FIG. 2, the inclusion of a mesh supported by a stainless steel ring and an elastic sealing ring in the droplet delivery device 10 is referred to herein as "push mode II". With reference to FIG. 3, the inclusion of an upper and lower mesh carrier and a mesh supported by an elastic sealing ring in the droplet delivery device 10 is referred to herein as "push mode I".

[0053]

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

[0054]

[0183] Some embodiments use a two-component cartridge system to prevent fluid contact with the mesh during storage. This design involves two spikes, one of which contains a wicking material in one part of the cartridge, which is the ejector bracket. The other part of the cartridge, which is the container, houses the fluid reservoir and two septa. The user presses the ejector bracket and container together, and the spike pierces the septa, thereby creating a path for the fluid to flow to the mesh. The wicking material in one spike helps deliver the fluid to the mesh. The other spike, which does not contain the wicking material, allows air to enter the container for pressure equalization. Vents covered by venting 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 pressure equalization.

[0055]

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

[0056]

[0185] BlueSky iPush Mode

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

[0057]

[0187] FIG. 8 provides an exploded view of components from a Push Mode I embodiment.

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

[0058]

[0189] 11, in the Push Mode I embodiment, 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 pieces. Two bulkheads 1210 are held between the center and lower container pieces. A container ring is glued to the upper container piece 1206 and the center container piece 1208, and the mouthpiece 1202 is snap-fit ​​onto the upper container piece 1206.

[0059]

[0190] BlueSkyII Push Mode

[0191] 12A and 12B show a rendering and a schematic diagram, respectively, of a push mode II embodiment. The overviews of Figs. 12A and 12B show, from left to right, the container assembly 12, the ejector bracket 15, and the enclosure assembly 17.

[0060]

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

[0193] In a Push Mode II embodiment, a stainless steel ring carrier 1518 is glued to the mesh 22. A gasket 1513 is placed over 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 of a Push Mode II embodiment.

[0061]

[0194] 15, two vents are located on the wide side of the lower ejector bracket 1504. The spikes are located on the upper ejector bracket 1502.

[0062]

[0195] Similar to Push Mode I, the container housing the fluid reservoir includes three COC pieces. The lower container for the Push Mode II embodiment extends further than Push Mode I, with the tubular portion extending into the upper ejector bracket.

[0063]

[0196] Figure 16 (Push Mode II) and Figure 17 (Push Mode I) show a comparison of the lower container of 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 located lower compared to I. Two bulkheads are held between the middle container and the lower container. A container ring is glued to the upper and lower container pieces, and a mouthpiece is snap-fitted to the upper container piece.

[0064]

[0197] BlueSky vibration members and membranes

[0198] The push mode has multiple vibrating member and membrane designs. Tables 2 and 3 contain descriptions of the vibrating member and membrane designs, respectively, that have been fabricated and tested as prototypes. With reference to Figures 18 and 19, there are currently two different tips for the vibrating member bar tip and ring tip, respectively.

[0065]

[0199] [Table 6]

[0066]

[0200] [Table 7]

[0067]

[0201] The transducer requires a large amount of power during the operation of the device. As the power usage increases, so does the heat generated by the printed circuit board assembly (PCBA). The thermal effects are mitigated through several design features in the PCBA. The four-layer PCBA improves anti-interference and heat dissipation capabilities. The PCBA further incorporates a large amount of copper foil, which contributes to heat dissipation. The MOSFET that drives the transducer adopts a high-current package to avoid damage from heating during long periods of continuous operation. The autotransformer for increasing the voltage output is suspended to be isolated from the rest of the PCBA. These features allow the device to operate for days without concerns of overheating or being subjected to electrical noise.

[0068]

[0202] BlueSky Life Test

[0203] A life test was performed on prototype BlueSky push mode embodiments I and II. The life test consisted of repeated 3 second doses with 1 second rest intervals over several days. Mass emissions were performed before and after the life test. Mass emissions are defined as the mass that the device aerosolizes over one 3 second dose. Mass emissions data before the life test are listed in Table 4 (Table 8) and data after the life test are listed in Table Table 5 (Table 9). Mass emissions for one embodiment remained constant before and after 55,000 doses and likely could continue beyond that. This embodiment is a II push mode with H4 and M11 has a stainless steel mesh carrier. There is a second embodiment, an I push mode with a mesh carrier of COC plastic. The plastic mesh carrier distorted during testing when subjected to heat from the extreme dosing cycles. This resulted in a decrease in mass emissions after the life test. However, the stainless steel carrier of the II push mode did not distort due to heat, allowing it to remain constant after testing. Both I and II have improved thermal management with a 4-layer PCBA with more than standard amounts of copper and high current MOSFET drivers. The test conditions are not representative of normal consumer use. In normal everyday use without extreme overheating, both embodiments I and II show constant mass displacement. Tables 2 and 3 provide details of the referenced vibrating members and membranes, respectively.

[0069]

[0204] [Table 8]

[0205] [Table 9]

[0206] Comparison of Push Mode and Prior Art Ring Mode

[0207] As described in Example 1 below, BlueSky I and II push mode prototypes were tested and compared to a conventional technology referred to as BlueSky ring mode (such as that described and shown in WO2020 / 264501 along with respective test data for this technology, which is provided below).

[0070]

[0208] <Example 1>

[0209] An ejector with a pore size of 2.0 μm was tested with each device. Half of the ejectors tested had hydrophilic inlet and hydrophobic outlet sections (R). The other half had hydrophobic inlet and hydrophobic outlet sections (W). Testing was performed using a TSI Mini-MOUDI Model 135 and a Thermo Fisher Vanquish UHPLC. Eight different design combinations (vibrating member, membrane, ejector treatment) were tested with BlueSky I and II. Based on the results of the testing, push mode I is considered to be the preferred implementation liquid for push mode. The push mode I design resulted in more consistent mass discharge and MMAD values ​​compared to II. Seven of the eight design combinations had comparable mass discharge and MMAD. One outlier, H5 with M12 and R treated ejector, showed significantly higher mass discharge than the others. Comparing the I push mode to the BlueSky ring mode, I delivers higher and more consistent mass discharge and lower MMAD. Tables 6, 7, and 8 provide data obtained from ring mode, I push mode, and II push mode, respectively. The data in the tables includes micrograms of nicotine dispensed, MMAD, geometric standard deviation (GSD), and percentage of dispensed liquid for stage 1 and stage 2 of the mini-MOUDI. All combinations of vibration member and membrane tested using I push mode as seen in Table 7 performed well in both ejector processes. As can be seen in Table 8, the best performing combinations using II push mode were H4 with M11 and H5 with M12, both using the W process ejector.

[0071]

[0210] [Table 10]

[0072]

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

[0075]

[0214] [Table 12]

[0076]

[0215] Based on the results of the tests, I push mode is the preferred embodiment compared to II.

[0077]

[0216] BlueSky's single-piece cartridge and low cost of sales 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 show a two-piece cartridge embodiment. The embodiment shown in Figure 20 includes a long vibration member with a fluid reservoir that resides under the mesh. In this design, the container is two pieces that are assembled during manufacturing.

[0078]

[0218] In another embodiment, there is a short vibrating member with a fluid reservoir above the mesh (see Figures 21A and 21B). In this design, the container is made up of three pieces that are assembled during manufacturing. After the fluid reservoir is filled, the mouthpiece is snapped onto the container with the container ring in between.

[0079]

[0219] The vibrating member and transducer work in conjunction with the membrane and mesh as in the above described embodiment of the BlueSky Push mode. The membrane also serves to isolate the vibrating member and transducer from the fluid. A mesh carrier is used in both designs. A magnet at the bottom of the container holds the cartridge within the enclosure.

[0080]

[0220] Further embodiments of a single piece cartridge, shown in Figures 22A and 22B, have a simpler design that reduces the number of injection molded parts and glued parts, thereby reducing the COGS of manufacture. Figure 22A shows a simplified version of the design of Figure 21A, but with a long vibrating member. The design of Figure 22A reduces the number of ultrasonic welds and injection molded parts. Figure 22B further simplifies the design of Figure 21A by reducing the number of ultrasonic welds and injection molded parts.

[0081]

[0221] The low COGS design shown in Figures 23A and 23B is a simplified form 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 cartridge shown in Figures 22A-22B and 24 eliminates the exhaust port leading to a 10mm mouthpiece port. The preferred exhaust and mouthpiece port lengths are the same as described above, 0mm to 50mm.

[0082]

[0222] BlueSky two-part cartridge

[0223] Figure 24 shows a two piece cartridge design for the long vibrating member. The container and ejector bracket are swapped so that the ejector bracket is now connected to the mouthpiece and the container is at the bottom. The spikes on the ejector bracket face down towards the bulkhead on the container.

[0083]

[0224] Formulation / treatment practice (Norway)

[0225] The push mode embodiment of Norway is similar in most respects to its BlueSky counterpart, except that it is geared towards prescription and medical use. Very similar to the BlueSky, Norway features a releasable cartridge that houses a fluid reservoir and an ejector bracket. The device may also be used to assess lung health using spirometry. Figure 25 shows one push mode embodiment of Norway.

[0084]

[0226] Patients diagnosed with lung disease can use the Norway device to track their medication dosage and to perform pulmonary function tests to enable them to evaluate their treatment progress. Patients can perform pulmonary function tests and view their medication dosage history via a phone app that pairs with the Norway device using Bluetooth. The device stores pressure sensor measurements from each dose of medication. Inspiratory flow measurements can be calculated from the pressure sensor measurements, ensuring that the user inhales their medication at the flow rate that most efficiently delivers the liquid medication. The device can also perform pulmonary function tests to measure the patient's forced expiratory volume in one second, forced vital capacity, peak expiratory flow rate, and other lung capacity measurements. Data from the dosage tracking and pulmonary function tests is uploaded to the cloud, allowing patients and doctors to view the patient's progress.

[0085]

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

[0086]

[0228] The mouthpiece for the Norway embodiment has a preferred length of 15mm. There are two slits in the side of the mouthpiece, which have dimensions of 9mm x 3mm, and a 27mm 2 The length of the mouthpiece can be anywhere from 5mm to 3mm. The area of ​​the mouthpiece is 1mm. 2 From 100mm 2 The mouthpiece opening has dimensions of 14 mm x 24 mm and can be up to 336 mm 2 The mouthpiece opening has an area of ​​10 mm 2 From 500mm 2 It can 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 perimeter of the mesh against a stainless steel annulus when closed to prevent evaporation through the mesh. This is the face seal. The device features voice coaching and LED lights to instruct the user during ejection inhalation. There is an LCD screen to display dose counts and other necessary information. Figure 26 shows an exploded view of one embodiment of the Norway push mode.

[0088]

[0230] 27A-D, the cartridge assembly (FIG. 27A) is composed of three parts: a container (FIG. 27B), a cartridge spacer (FIG. 27C), and an ejector bracket (FIG. 27D). The cartridge spacer keeps the ejector bracket separated from the container, thereby preventing fluid from contacting the mesh during storage prior to initial use in push mode.

[0089]

[0231] The cartridge spacer can be removed so that the container can be pushed down onto the ejector bracket so that the spike pierces the septum, thereby breaking the cartridge into one piece. The cartridge can then be pushed into the device body, thereby completing the device. This process is shown in FIG.

[0090]

[0232] The cap of the Norway embodiment is designed to make a tight seal around the cartridge after each use. An O-ring sits on a spring loaded plastic piece that presses lightly onto the cartridge assembly when the cap is closed, thereby forming a seal between the cartridge and the open atmosphere. The components of the cap are shown isolated as illustrated in FIG.

[0091]

[0233] The very important components for precise aerosol generation of the ejector bracket include mesh, gasket, membrane, venting material, and mouthpiece. The membrane is positioned so that the face of the membrane is held parallel or at a small precise angle to the face of the mesh. The ejector bracket further has two spikes protruding outward from the top to penetrate the container. One spike is for fluid delivery and the other spike is for providing a vent path for the air generated by the ejection. On the side of the ejector bracket with the venting spike, there is an opening covered with venting material to help relieve pressure and increase air. The mouthpiece is positioned to follow the face of the mesh.

[0092]

[0234] The critical components of the container to maintain a constant aerosol are the vent material, the spiral, the septum, and the septum cap. The vent material is placed between the fluid and the spiral. The spiral is made by the upper container and a vent spacer that minimizes the evaporation of the fluid through the vent material. The vent spacer is glued onto the top of the upper container, thereby creating a sealed spiral with an opening to the push mode interior of the container assembly and another opening to the atmosphere. The septum is at the bottom of the container. The septum is placed in a cavity in the lower container and is held in place with a septum cap glued onto the lower container. The critical 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 contains the vibrating member and transducer assembly. In one embodiment, the vibrating member-transducer assembly is housed by the vibrating member front cover and the vibrating member rear cover, as shown in FIG. 31. 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 placed into the vibrating member device bracket. The vibrating member enclosure allows the spring to press the vibrating member-transducer assembly against the membrane.

[0094]

[0236] An additional embodiment of the Norway push mode includes a different suspension system to hold the mesh within the cartridge, similar to the BlueSky push mode system. With 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 within a vibrating member enclosure, nor does it require a vibrating member device bracket.

[0095]

[0237] Additional embodiments of the Norway push mode device include a heating element that raises the push mode inhalation air temperature to about 50° C. to make administration more comfortable. As with the BlueSky design that includes a heating element, the temperature of the heated air is maintained below thermal degradation levels, so that the push mode integrity of the formulation is maintained and no harmful by-products are created. This can be achieved because, like the BlueSky, the device does not rely on heat to perform aerosolization. Figures 34A and 34B show one design that includes two heating elements located below the vibration member on either side of the ejector bracket. As can be seen in Figures 34A and 34B, air enters through an opening in the bottom of the ejector bracket, passes through the heating elements, and exits toward the mouthpiece. In addition, warmer air minimizes evaporation of the aerosolized fluid, thereby reducing the MMAD.

[0096]

[0238] Biocompatibility

[0239] In the push mode design, the vibrating member and transducer are completely isolated from the inhaled liquid in the push mode by a membrane. The transducer, which usually contains heavy metals, is located behind the vibrating member, so that the transducer is completely removed from the discharge area and the fluid reservoir. The membrane separates the fluid reservoir from the vibrating member, thereby presenting a chemically inert barrier that allows little or no diffusion and subsequent evaporation. In one embodiment, a palladium-nickel alloy mesh is used to nebulize the fluid. Polyimide mesh has also been tested and shown to be a viable option. The use of a polymer mesh would significantly reduce manufacturing costs and potentially improve the extractable / leachable profile of the device. The non-metallic components in the prototyped embodiment are primarily composed of cyclic olefin copolymer (COC) and silicone, both of which are widely accepted materials used in the medical device industry.

[0097]

[0240] Heated Air Design

[0241] 35A-35C through 38 show an embodiment including a heating element to raise the inhalation air temperature in push mode I to about 50° C. to make administration more comfortable. Air passes vertically through the heating element, thereby heating most efficiently. The temperature of the heated air is maintained below thermal degradation levels, thus maintaining the formulation integrity in push mode and not creating harmful by-products. Furthermore, the specific heat of the fluid is significantly higher than air, and therefore the temperature of the aerosolized fluid increases only minimally. 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, evaporation of the aerosolized fluid is minimized in the case of warmer air, thereby reducing the MMAD. Finally, the heating element will be surrounded by insulating material to insulate all components of the device from heat.

[0098]

[0242] Because the heating element is breath actuated, it only heats the air when the user inhales. This allows the battery to have a much longer life. Furthermore, because the heating element is not always on, a much safer device is made. This can be achieved by the push mode incorporating a small diameter wire. In this way, the wire heats up very quickly and therefore the heating element responds immediately when the user inhales.

[0099]

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

[0100]

[0244] Referring to Figure 36, speakers may also be incorporated into any of the heated air BlueSky embodiments, allowing for additional sensory experiences for the user (i.e., lung rumble / heating upon inhalation).

[0101]

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

[0102]

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

[0103]

[0247] In another embodiment of a heated air push mode device, closed loop control is used to manage the power provided to the heating element. The power is adjusted to maintain the air stream temperature constant at a safe level. Referring to Figure 40, the air stream temperature is measured by a temperature sensor such as an RTD. The power provided to the heating element is varied 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 provided to the heating element. The power is adjusted to maintain the air stream temperature constant. The pressure drop from the suction is sensed. Due to the change in pressure drop, the amount of power that needs to be provided to the heating element to maintain the air stream temperature constant is known. A look-up table is created to determine the amount of power that needs to be provided to the heating element to maintain the air stream temperature constant based on the pressure sensor value.

[0105]

[0249] In another embodiment of the heated air push mode device, one or more of the internal device components in contact with the heated air in the push mode are preferably made of metal (i.e., aluminum, Inconel, etc.), which 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 be degraded by heated air are preferably made of metal (i.e., titanium, aluminum, Inconel, etc.) These components include, but are not limited to, the mouthpiece, the 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 in contact with the heated air are preferably made of a material with low thermal conductivity, such as Inconel.

[0108]

[0252] In one embodiment of a heated air push mode device, 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 airflow inlet. The airflow inlet can be opened or closed using a sleeve or adjustable opening. In this way, the resistance experienced by the user can be adjusted to suit 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 airflow inlet, thereby increasing the resistance felt by the user. In addition, the airflow in the mouthpiece changes as the position of the sleeve changes. This in turn results in a change in the MMAD of the dose due to the change in airflow flow.

[0110]

[0255] Nasal Device Embodiments

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

[0111]

[0257] Additional Features

[0258] Hydrophilic / Hydrophobic Tube

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

[0112]

[0260] Another embodiment of the push mode incorporates a tube with no core and a hydrophilic interior that delivers fluid from the fluid reservoir to the mesh, thereby allowing a wider range of suspensions and liquid drug types to be delivered from the device, and a hydrophobic tube on the opposite side that facilitates gas transfer from the fluid delivery area between the membrane and the mesh.

[0113]

[0261] Polymer mesh holes

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

[0114]

[0263] Tidal Breathing

[0264] Another embodiment of the push mode uses a periodic breathing system that can be used for pediatric treatment. The push mode technology delivers the aerosol to a mask similar to the Aero Chamber Plus Z-Stat Pediatric Mask (Monaghan Medical). This allows for long-term treatment. When the user inhales, the device will start to expel, and when the user exhales, the device will stop expel. The robustness of the push mode makes it a very effective device for long-term treatment.

[0115]

[0265] Capacitance Cartridge

[0266] In another embodiment, two parallel plates 1528 surround the fluid next to the mesh and membrane area. These two parallel plates measure the capacitance of the fluid. The capacitance of the dispensed 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 will prevent unauthorized fluids 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 a geometry of a vibrating member and a membrane at its coupling interface that functions as both a nebulizer and a microfluidic pump in applications where a wicking material is not incorporated for the preferred embodiment for certain suspensions, liquids, and other medical, therapeutic, and consumer applications. The tip of the vibrating member is coupled to the membrane, conforming to a desired geometry that allows fluid to enter between the mesh and the membrane while facilitating any gas to freely exit. 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 the appropriate amount of fluid and the appropriate amount of pressure between the mesh and membrane when powered on, such as at set intervals to ensure proper dosing when actuated by breath.

[0118]

[0270] Optimizing the geometry of vibrating members

[0271] The vibrating member of these embodiments will be made of a material that features suitable 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 vibrating member tip section. According to industry leaders, titanium has the best acoustic properties of the high strength alloys, as well as high fatigue strength that allows it to withstand high cycle rates at high amplitudes, and is harder than aluminum, thereby improving its robustness. The appropriate material must be selected, and the vibrating member must be designed with its balance tuned for the required amplitude, and precisely tuned to match the specific frequency. One aspect of tuning is to ensure that the vibrating member has a suitable elongated length. Another aspect of tuning is to ensure that the vibrating member is compatible with the mesh and has a suitable gain ratio. An improperly tuned vibrating member can damage the power supply and will not resonate at the optimal frequency of the device, thereby reducing mass displacement and shortening life. (See also Ultrasonic Vibrating member catalog-Emerson. Catalog-Ultrasonic Vibrating member(2014), available at https: / / www.emerson.com / documents / automation / catalog-ultrasonic-vibrating member-branson-en-us-160126.pdf (accessed November 2, 2021), which is incorporated herein by reference.)

[0119]

[0272] For example, the Ti7-4 material has a more uniform wave propagation in one direction (axial direction) compared to Ti6-4.

[0120]

[0273] Multiple embodiments should have a vibrating member with appropriate elastic modulus, acoustic properties, acoustic velocity, mechanical properties, molecular structure, etc., such as Ti Grade 23, Ti Grade 5, greater than 99.9% pure Ti, 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 such as sapphire (Al2O3 aluminum oxide), single crystal silicon, etc., that have suitable elastic moduli, acoustic properties, acoustic velocities, mechanical properties, molecular structure, etc.

[0122]

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

[0123]

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

[0124]

[0277] 48 and 49, a rectangular vibrating member tip combined with a conical section and a cylindrical section can effectively improve the output amplitude gain, utilizing the bandgap characteristics of the structure to effectively suppress the lateral vibration of the vibrating member tip, thereby improving the amplitude distribution uniformity 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), available at https: / / www.mdpi.com / 2073-4352 / 10 / 1 / 21 / htm. (Accessed November 2, 2021), incorporated herein by reference.)

[0125]

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

[0126]

[0279] Referring to FIG. 50, the vibration member may be curved to closely contact the geometry of the membrane.

[0127]

[0280] Referring to FIG. 51, the plunger member has a nodally mounted plunger that can be used to exert pressure on a given surface of the member that contacts the vibrating member.

[0128]

[0281] Referring to Fig. 52, the sensor carrier vibrating member features an internal cavity that partially or completely encapsulates a nodal based mounted sensing device that is coupled to a sensor control unit that outputs a signal to the PCBA that can be used to disable aerosol generation in the event of an attempt to use a mismatched, improper or unauthorized cartridge, etc.

[0129]

[0282] Referring to FIG. 53, the spool oscillatory member is a cylindrical member with no slots that features undercut sides behind the face to form a spool shape. This spool shape improves the uniformity of the face amplitude. Because the spool oscillatory member does not have slots, its stresses are significantly reduced over a comparable circular oscillatory member with slots, which significantly reduces machining costs. A very uniform amplitude is obtained across the face of the member by using cavities, slots, and back extensions to optimize the axial resonance. The member is half the wavelength of the axial resonance as indicated by one node that is generally transverse to the primary direction of vibration. The spool oscillatory member typically has a gain of about 1:1, although somewhat greater gains are possible.

[0130]

[0283] Referring to FIG. 54 (optimized) and FIG. 55 (non-optimized), the slotted cylindrical vibrating member features a longitudinal slot that is 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 very non-uniform amplitude across the face or may resonate in other than axial directions. The vibrating member further has a face 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 one node that is generally transverse to the main direction of vibration. The slotted cylindrical vibrating member generally has low to moderate gain (1:1 to 2:1).

[0131]

[0284] Referring to Figure 56 (optimized) and Figure 57 (non-optimized), the rod vibrating members are rectangular with no slots or slots only in the thickness direction. Special design techniques provide optimal surface amplitude uniformity. The thickness of the vibrating members is reduced at the blade section to provide moderate gain. The vibrating members are half the wavelength of the axial resonance as indicated by one node that is generally transverse to the main direction of vibration. The rod vibrating members generally have low to moderate gain (1:1 to 4:1).

[0132]

[0285] Referring to FIG. 58, the booster is a coupling resonating device placed between the transducer and the vibrating member to vary the amplitude of the member and / or as a means of supporting the resonating stack. The booster body is rigidly supported by collars glued to the nodes of the booster. This rigid booster has excellent axial and lateral stiffness because it is constructed of metal only (no flexible elastomers). If stiffness is to be improved, a second collar can 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 displacing booster, where the coolest colors indicate 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] 59-83, another alternative embodiment of a vibrating member 1708 is shown comprising a vibrating member tip 170 coupled to a transducer 26 of a droplet delivery device 10 according to various embodiments of the present disclosure.

[0134]

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

[0288] In other embodiments, the vibrating member 1708 can have other shapes, and the membrane 25 can have alternative shapes as well. For example, FIG. 85A shows an ultrasonic transducer coupled to a rod-shaped vibrating member tip portion 170. FIG. 85 shows the vibrating member of FIG. 85A coupled to a membrane 25 with a central raised or protruding portion in a droplet delivery device 10. FIGs. 85C and 85D show the ultrasonic transducer 26 and membrane 25 of FIG. 85B in an alternative embodiment, where the mesh 22 includes a first fixation mechanism in FIG. 85C (see FIG. 2 and the accompanying description) and a second fixation mechanism in FIG. 85D (see FIG. 3 and the accompanying description).

[0135]

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

[0136]

[0290] FIG. 87 shows an alternative embodiment of a droplet delivery service including an ultrasonic transducer 26 with a rod-shaped vibrating member tip portion 170 offset from a central axis 220 of a droplet delivery device passing through a discharge channel 23, an inclined / sloping membrane 25, and 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-graded ring-shaped vibrating member tip portion 170 coupled to an angled mesh 22 in contact with a membrane 25 having a generally flat outer top surface (closest to the mesh 22).

[0138]

[0292] In another embodiment shown in Figure 89A, an ultrasonic transducer 26 with a gradient ring-shaped vibration member tip portion 170 may be coupled to an inclined / sloping membrane 25 that contacts the membrane 25 in a droplet delivery device 10. Figure 89B shows the gradient membrane 25 of Figure 89A, and Figure 89E shows an ultrasonic transducer with a gradient ring-shaped vibration 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 fixation mechanism in Figure 89C (see Figure 2 and the accompanying description) and a second fixation mechanism in Figure 89D (see Figure 3 and the accompanying description).

[0139]

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

[0140]

[0294] 91A and 91B show an ultrasonic transducer 26 comprising a tapered ring-shaped vibrating member tip portion 170 coupled to an inclined / sloping membrane 25 with a space between the membrane 25 and the mesh 22. FIG.

[0141]

[0295] 90A and 92B show, in another embodiment, an ultrasonic transducer 26 having a non-graded ring-shaped vibrating tip portion 170 coupled to a membrane 25 having a substantially flat outer surface that is not in contact with and is substantially parallel to the underlying fluid-facing flat surface of the mesh 22.

[0142]

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

[0143]

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

[0144]

[0298] film

[0299] The membrane 25 in these embodiments is made of materials characterized by robustness and suitable acoustic and mechanical properties, such as polyethylene naphthalate, polyethyleneimine, polyetherketone, polyamide, polymethylmethacrylate, polyetherimide, polyvinylidene fluoride, and ultra-high molecular weight polyethylene.

[0145]

[0300] The membranes of these embodiments can have a hydrophobic coating, a hydrophobic etch, a hydrophilic etch, a hydrophilic coating, a roughening etch.

[0146]

[0301] In some embodiments, such as the embodiment shown in Figures 96A-96D, the membrane can include a variety of shapes and surface textures, including "protrusions" in one embodiment.

[0147]

[0302] mesh

[0303] The mesh 22 in these embodiments is made from materials characterized by robustness and suitable acoustic and mechanical properties, such as polymethylmethacrylate, polyetherketone, 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 single or polycrystalline materials such as silicon, silicon carbide, aluminum nitride, boron nitride, silicon nitride, or aluminum oxide. A variety of hole shapes can be formed in the single crystal wafer through high-precision photolithography with or without grayscale masks, and isotropic and / or anisotropic etching. Sputtered films can be deposited on the mesh to modify the wettability of the surface. Thin layers formed or deposited on the surface will, in certain embodiments, have significantly better adhesion than films deposited on metal meshes formed by electrolytic deposition or polymer meshes formed by laser cutting. The surface on the single crystal wafer "slice" is atomically flattened and can be etched to create a precise surface roughness. The precise surface roughness can be used to obtain better adhesion for mechanical bonding with adhesives or other materials. Silicon carbide is a preferred material due to its high strength and toughness. A key advantage of using semiconductor processes to fabricate the hole structure from a single crystal wafer "slice" in the mesh of the push mode embodiment of the invention is that the holes and surface contact angles are precise without the variations seen in conventional ejector plates that use mesh made from electrolytic deposition or laser cutting. The mesh can be fixed in II or suspended in I, as described in Table 9, and the membrane is coupled to an optimized vibration member using thin film sputtering of a non-reactive metal such as palladium or gold member tip section to further improve biocompatibility.

[0149]

[0305] In other embodiments, hole structures 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, diamond slurry grinding, etc. See also Figures 109 and 110.

[0150]

[0306] [Table 13]

[0151]

[0307] The mesh of these embodiments may have a hydrophobic coating, a hydrophobic etch, a hydrophilic etch, a hydrophilic coating, a roughening etch, or the like, or a combination thereof.

[0152]

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

[0153]

[0309] Laminar Flow Elements

[0310] In push mode embodiments of the invention, a laminar flow element 1600 as shown in FIG. 1B is preferably fixed in an ejection port before the mouthpiece port of a droplet delivery device. In preferred embodiments, the laminar flow element comprises a plurality of porous openings. In some embodiments, the laminar flow element comprises a blade-shaped wall defining the plurality of porous openings. In another embodiment, one or more of the plurality of porous openings has 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-84Q show various embodiments of laminar flow elements.

[0154]

[0311] Preventing oxygen diffusion

[0312] 95, a droplet delivery device including a membrane cooperating with a mesh in an embodiment where the ejector bracket and container assembly are integrated as a single assembly preferably further includes at least one superhydrophobic vent in fluid communication with the reservoir that is covered with a removable aluminized polymer tab 3300 during storage to help prevent oxygen diffusion into the fluid in the reservoir during storage. In another embodiment of the invention in push mode, a droplet delivery device including a membrane cooperating with a mesh in an embodiment where the ejector bracket and container assembly are integrated as a single assembly preferably further includes a removable aluminized polymer tab 3300 coupled to an exterior 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, the droplet delivery device 10 having a membrane 25 cooperating with a mesh 22 includes a pre-assembly step of removing the hermetic packaging including aluminum and / or an aluminum coating that houses a reservoir having a fluid, preferably where the reservoir is contained within a container assembly that is also packaged for storage within the hermetic packaging.

[0156]

[0314] Reduction of large droplets in aerosols

[0315] In push mode embodiments of the invention, it is desirable to reduce the formation of large droplets, as well as to promote the delivery of smaller droplet sizes out of the droplet delivery device and within the aerosol stream.

[0157]

[0316] In one embodiment, a hydrophilic wick material may be provided in line with the mouthpiece of the droplet delivery device. Droplets that form on the outer edge of the mesh outlet section are absorbed by the hydrophilic wick material, reducing the likelihood of larger droplets detaching and moving forward from the surface of the mesh outlet section. This absorption of larger droplets by the wick material improves the reproducibility of the MMAD and prevents pooling of liquid.

[0158]

[0317] In another embodiment, a one-dimensional hydrophilic lattice (see laminar flow element 1600, but this is a cross section) or a series of one-dimensional hydrophilic lattices can be used to absorb larger droplets that may "jump out" of the mesh if water pools.

[0159]

[0318] Testing of push mode droplet generation has shown that a fog of aerosol can remain in the mouthpiece tube after inhalation. This fog can lead to pulling the mesh along the circumference. Such pulling occurs due to the absence of entrained air to pull the tail of the aerosol discharge outwards. Through electronic programming and monitoring through a microcontroller or microchip integrated or connected to the droplet delivery device, the droplet device can be programmatically controlled to start nebulization when the airflow rate reaches a threshold, and then the droplet delivery device detection control device records the maximum air intake every 2 ms. The droplet delivery device is programmed to stop nebulization when the flow rate decreases to a certain percentage of the maximum flow rate achieved during inhalation. In some embodiments, a parameter labeled "pressure cutoff" can be added to a graphical user interface (GUI) for controlling / programming the droplet delivery device, so that the manufacturer or other device operator can change the stop state parameter for nebulization.

[0160]

[0319] 111A-111C, in another embodiment, a baffle 4000 is inserted into the aerosol path. The baffle 4000 can comprise a plastic piece with fins 4050 to hold the baffle 4000 in place in the aerosol tube of the droplet delivery device. The plastic piece has a cylindrical cavity that holds an absorbent plug 4100 (e.g., porous polyester or other wicking material). The plug 4100 is inserted into the baffle cavity and has a length sufficient 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 to guide airflow and prevent vortex formation. The baffle 4000 is designed to inertially filter the aerosol by trapping large droplets in the absorbent plug 4100 as it is ejected. Initial data using three ejectors is shown in the table below. As can be seen in Table 10, the baffle 4000 reduced the MMAD at each ejector by approximately 0.1 μm to 0.2 μm. This inertial filtration creates a smoother inhalation experience with less irritation. The plastic pieces of the baffle 4000 and the absorbent plug 4100 can be of various lengths and / or dimensions.

[0161]

[0320] [Table 14]

[0162]

[0321] As explained, it is important to get all the small droplets out of the mouthpiece. Small droplets have a very short stopping distance, so the airflow must get close enough to the ejector plate to carry the small droplets. One design was tested, where an airflow director was used to direct the airflow away from the mesh and towards the end of the mouthpiece. As shown in FIG. 112, the airflow path with the airflow director creates a vortex at the back that traps the small droplets along the ejector plate. Removing the airflow director helped the airflow 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, which helps guide the airflow to the ejector plate. This helps the air capture most of the small droplets and send them to the middle of the mouthpiece tube, but the ejector still creates undesirable large droplets.

[0163]

[0322] FIG. 113 shows the result when an insertable baffle 4000 is placed in the middle of the mouthpiece tube. The baffle retains the wick material. When an airflow is drawn to the middle of the mouthpiece tube, the air flows around the baffle. Droplets follow the airflow, but the larger droplets have too much momentum to bend enough to flow around the baffle. The larger droplets impact the wick material. The wick material retains the liquid, thereby preventing it from falling back to the ejector plate. Thus, the liquid can evaporate from the wick material.

[0164]

[0323] FIG. 114 shows additional results when the insertable baffle 4000 is also used with an airflow director. This test resulted in airflow passing through the airflow director and hitting the side of the baffle. Similarly, vortices also formed in the middle of the mouthpiece tube, which pushed small droplets back to the ejector plate. These vortices also caused larger droplets to flow around the baffle, preventing inertial filtration.

[0165]

[0324] Although the push mode invention has been described with reference to exemplary embodiments, those skilled in the art will recognize that various changes may be made and equivalents may be substituted for the elements thereof without departing from the scope of the push mode invention. In addition, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope of the invention. Thus, it is intended that the push mode invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out the invention, but rather that the push mode invention includes all embodiments falling within the scope of the appended claims.

Claims

1. A container assembly having a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly and configured to supply a fluid of a constant volume, An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably coupled to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, the reservoir including a self-sealing mating mechanism configured to be coupled to a fluid discharge mating mechanism of the ejector bracket, the mesh including a plurality of openings formed therethrough in the thickness of the mesh, the transducer being coupled to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets discharged through the mesh, an ejector bracket, A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet, A droplet delivery device comprising.

2. A container assembly having a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly and configured to supply a fluid of a constant volume, An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably coupled to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and 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 therethrough in the thickness of the mesh, the transducer being coupled to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets discharged through the mesh, an ejector bracket, A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet, A droplet delivery device comprising.

3. A container assembly having a mouthpiece port, A reservoir disposed within the container assembly or in fluid communication with the container assembly and configured to supply a fluid of a constant volume, An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably connected to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, the vibrating member including a ring-shaped tapered tip, the mesh including a plurality of openings formed therethrough, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets exiting through the mesh, an ejector bracket; A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet; A droplet delivery device comprising.

4. A container assembly having a mouthpiece port; A reservoir disposed within or in fluid communication with the container assembly and configured to supply a fixed volume of fluid; An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably connected to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, the vibrating member including a ring-shaped non-tapered tip, the mesh including a plurality of openings formed therethrough, the transducer being connected to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets exiting through the mesh, an ejector bracket; A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet; A droplet delivery device comprising.

5. A container assembly having a mouthpiece port; A reservoir disposed within or in fluid communication with the container assembly and configured to supply a fixed volume of fluid; An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably coupled to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, the mesh having a bottom surface that is non-parallel to the upper surface of the membrane, the mesh including a plurality of openings formed therethrough, the transducer being coupled to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets exiting through the mesh, an ejector bracket; A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet; A droplet delivery device comprising. **Claim 6**: A container assembly comprising a mouthpiece port; A reservoir disposed within the container assembly or in fluid communication with the container assembly and configured to supply a fixed volume of fluid; An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably coupled to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, the mesh having a bottom surface that is non-parallel to the upper surface of the membrane, the mesh including a plurality of openings formed therethrough, the transducer being coupled to a power source and operable to vibrate the vibrating member and the membrane to generate a stream of droplets exiting through the mesh, an ejector bracket; A discharge channel within the container assembly configured to direct the stream of droplets from the mesh to an outlet; The droplet delivery device further having a central axis passing through the discharge channel and the membrane, the vibrating member including a tip coupled to the membrane at a position offset from the central axis; A droplet delivery device comprising. **Claim 7**: A container assembly comprising a mouthpiece port; A reservoir disposed within the container assembly or in fluid communication with the container assembly and configured to supply a fixed volume of fluid; An ejector bracket in fluid communication with the reservoir, the ejector bracket including a mesh having a membrane operably coupled to a vibrating member coupled to an electronic transducer, the membrane being between the vibrating member and the mesh, an outer surface of the membrane facing a surface underlying the membrane in contact with the vibrating member including a hydrophilic coating, the mesh including a plurality of openings formed therethrough, the transducer being coupled to a power source and operable to vibrate the vibrating member and the membrane to generate an ejection stream of droplets through the mesh, and an ejector bracket; A discharge channel within the container assembly configured to direct the ejection stream of droplets from the mesh to an outlet; A droplet delivery device comprising.

Images