Optimization of droplet delivery device with ejector plate

Abstract

A droplet delivery device includes an ejector plate (300) with a plurality of apertures (301), a ejector plate carrier (2302) holding the ejector plate (300) in place at an about 3-degree angle relative to a plane perpendicular to an airflow path (100) through the device that that exits through a mouthpiece (700), and a vibrating member (800) coupled to a membrane (401) that contacts the ejector plate (300).

Description

Attorney Docket No. 086123-825405OPTIMIZATION OF DROPLET DELIVERY DEVICE WITH EJECTOR PLATECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Pat. App. Nos. 63 / 704,445 filed October 7, 2024 and 63 / 735,780 filed December 18, 2024, which are incorporated herein by reference in their entireties.FIELD OF THE INVENTION

[0002] This disclosure relates to droplet delivery devices with an ejector plate for droplet delivery devices, especially for the delivery of fluids that are inhaled into mouth, throat, nose, and / or lungs. This disclosure incorporates by reference herein in their entireties the disclosures of U.S. Pat. No. 11,793,945, Publication No. WO 2020 / 264501, and Provisional Pat. App. Nos. 63 / 701,563 and 63 / 701,564.SUMMARY OF THE INVENTION

[0003] This disclosure relates to optimizing droplet delivery with droplet delivery devices. Much of the optimization is focused around using a piezoelectric transducer (801) indirectly coupled with an ejector plate (300); however, this disclosure cannot be limited to only that application.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The drawings are provided to illustrate exemplary embodiments and are not intended to be limiting. The drawings are schematic and not necessarily to scale. Like reference numerals designate like elements throughout the several views.

[0005] FIG. 1 is a schematic diagram illustrating an exemplary pathway of air bubbles (2500) displaced from a liquid path during a vibration mode of a droplet delivery device.

[0006] FIG. 2 is a diagrammatic plan view illustrating representative dome (200) geometries on an ejector plate (300) of a droplet delivery device, including differing dome heights and diameters.

[0007] FIG. 3 is a diagrammatic view illustrating an ejector plate (300) of a droplet delivery device having multiple aperture (301) sizes.

[0008] FIG. 4 is a schematic perspective view of an ejector bracket (400 retaining an ejector plate (300) and a membrane (401) with O-rings (402) of a droplet delivery device.

[0009] FIG. 5 is a schematic cross-sectional diagram of a push-mode droplet delivery device (500).

[0010] FIG. 6 is a schematic cross-sectional diagram of a ring-mode ejector bracket (601) and cartridge (602) of a droplet delivery device.Attorney Docket No. 086123-825405

[0011] FIGS. 7A-7H and 8A-8H are schematic perspective views illustrating alternative mouthpiece (700) configurations of a droplet delivery device having different exit-aperture (701) geometries affecting pressure drop.

[0012] FIGS. 9A and 9B are schematic diagrams of vibrating-member (800) assemblies including a piezoelectric transducer (801) and a horn (802).

[0013] FIGS. 10A and 10B are diagrammatic plan views of an ejector plate (300) showing an active area (900) and an embodiment (FIG. 10B) with a peripheral annulus (901).

[0014] FIGS. 11A and 11B are diagrammatic plan views of an ejector plate (300) including a support bracket (1000) (FIG. 1 IB) to protect the plate and localize vibration.

[0015] FIGS. 12A and 12B are schematic perspective views of two cartridge (1100) embodiments, one with cartridge vents (1101) (FIG. 12B) and one without (FIG. 12A).

[0016] FIG. 13 is a schematic cross-sectional diagram of a lower ejector bracket (1200) with a wick (1201), membrane (401), and ejector plate (300), showing ejector bracket vents (1202).

[0017] FIG. 14 is a schematic cross-sectional diagram of a lower ejector bracket (1200) illustrating spacing between apertures (301) and the wick (1201).

[0018] FIG. 15 is a schematic cross-sectional diagram of a lower ejector bracket (1200) with reduced wick (1201) material around the membrane (401).

[0019] FIG. 16 is a schematic cross-sectional diagram of a lower ejector bracket (1200) having slits in the wick (1201) to reduce liquid supply.

[0020] FIG. 17 is a schematic cross-sectional diagram of a droplet delivery device including a microfluidic pump (1601).

[0021] FIGS. 18A and 18B are schematic cross-sectional diagram of blockage plugs (1700) in an ejector bracket (400) of a droplet delivery device that limit static liquid pressure on the ejector plate (300).

[0022] FIGS. 19A and 19B are schematic cross-sectional diagrams of alternative blockage-plug (1700) placements proximal to the ejector plate (300).

[0023] FIGS. 20 is diagrammatic view of a vibrating member (800) cooperating with an angled, domed ejector plate (300), showing alignment relative to a central axis (1901) and angle (1902).

[0024] FIG. 21 is a diagrammatic view of a level ejector plate (300) with an angled vibrating-member (800) tip.Attorney Docket No. 086123-825405

[0025] FIGS. 22A-22C are diagrammatic views showing off-centre alignment between the ejector plate (300) and the vibrating member (800).

[0026] FIGS. 23A-23D are diagrammatic views of a concave dome (200) on the ejector plate (300) with different contact locations of the vibrating-member (800) tip (edge and dome tip).

[0027] FIG. 24 are schematic airflow diagrams illustrating airflow in the aerosol pathway (2300) over a curved ejector plate carrier (2302) from air inlets (2303).

[0028] FIGS. 25A-25C are diagrammatic plan views of ejector plates (300) having concave (FIG. 25A), convex (FIG. 25B), and flat (FIG. 25C) annuli (901), respectively.

[0029] FIGS. 26A-26C are schematic cross-sectional diagrams of ejector plate carriers (2302) holding the ejector plate (300) with an O-ring (402) above (FIG. 26A), below (FIG. 26B), or on both sides (FIG. 26C) of the plate, respectively.

[0030] FIGS. 27 is schematic cross-sectional diagrams of a cartridge (1100) of a droplet delivery device with an inline fdter (2600) at different positions within the aerosol pathway (2300).

[0031] FIG. 28 is a schematic airflow diagram of an airflow path (100) merging into an aerosol pathway (2300) near the ejector plate (300) and exiting the mouthpiece (700) of a droplet delivery device.DETAILED DESCRIPTION

[0032] This disclosure concerns a device configured to generate aerosol / vapor / droplets, hereby referred to as aerosol. This device is aimed to be used for human use, meaning that the aerosol is inhaled, sprayed onto the human body, or otherwise used by a human. This technology may be applied to several areas for those knowledgeable in the art.

[0033] This device is capable of delivering water-based aerosol without the use of heat. This capability results in minimal thermal degradation byproducts being created in comparison to conventional droplet delivery devices that use heat and combustion techniques that cause chemicals being generated and inhaled in droplet form to degrade and include unwanted byproducts.

[0034] Ejector plate designs

[0035] There is a need for ejector plates (300) to have a longer lifetime. A longer ejector plate (300) lifetime decreases waste, cost for manufacturers, and cost for consumers. An ejector plate (300) comprises a thin plate with a plurality of apertures (301). In a preferred embodiment, the ejector plate (300) is made from palladium nickel alloy.Attorney Docket No. 086123-825405

[0036] In other embodiments, the ejector plate (300) may be made from any metal or metal alloy.

[0037] In another embodiment, the ejector plate (300) is made from PEEK.

[0038] In another embodiment, the ejector plate (300) is made from polyimide.

[0039] In another embodiment, the ejector plate (300) may be made from any plastic or polymer.

[0040] Lifetime of the ejector plate (300) may be linked to the ratio of the thickness of the ejector plate (300) to the amplitude of its vibrations. Thicker ejector plates (300) that have smaller amplitudes last longer.

[0041] Additionally, domes (200) (including convex domes that arch outward away from a vibrating member cooperating with the ejector plate and concave domes that arch inward toward the vibrating member cooperating with the ejector plate) may be put into the ejector plate (300) to isolate and / or increase the amplitude of the vibrations to the dome (200) area. Having a dome (200) may increase the ejected mass and consistency of the ejected mass.

[0042] Table 1 illustrates an exemplary embodiment of some exemplary dome (200) sizes on an ejector plate (300). There are multiple dome heights (201) and dome diameters (202) shown, which are listed in the table below, along with the ejector plate diameter (203).

[0043] Table 1. Exemplary Dome Sizes of an Ejector Plate

[0044] An ejector plate (300) with a dome diameter (202) of 3.3 mm lasts longer than an ejector plate (300) with a dome diameter (202) of 3.0 mm.

[0045] In a preferred embodiment, the dome diameter (202) is 3.3 mm.

[0046] In another embodiment, the dome diameter (202) is 3.0 mm.

[0047] In another embodiment, the dome diameter (202) is 2.5 mm.

[0048] In another embodiment, the dome diameter (202) is 3.5 mm.Attorney Docket No. 086123-825405

[0049] In another embodiment, the dome diameter (202) is 4.0 mm.

[0050] In further embodiments, a dome diameter (202) may be from 2.5 mm to 4.0 mm.

[0051] In one embodiment, for a push mode droplet delivery device (500) as shown in FIG. 5, the ejector plate is contacted by the tip of a vibrating member (800). The tip of the vibrating member (800) transfers the vibrations to the ejector plate (300). The ejector plate (300) vibrates up and down. Each time it vibrates downward, the ejector plate (300) pushes against the liquid on the underside of the ejector plate (300) and forces liquid through the apertures. The liquid flows through the aperture to the air side of the ejector plate, creating a droplet. The liquid droplet is then carried away by the airflow.

[0052] In one embodiment, the diameter of the vibrating member (800) tip is 3.56 mm. The dome (200) is preferably as large as possible without being larger than the tip of the vibrating member (800). The vibrating member (800) may contact the ejector plate (300) at a flat portion, and not a curved portion of the dome (200). In a preferred embodiment, the diameter of the dome is from 75% to 95%, and preferably 93%, of the diameter of the vibrating tip.

[0053] In another embodiment, the ejector plate (300) dome (200) to vibrating member tip (800) diameter ratio can be 1 : 1.

[0054] In another embodiment, the ejector plate (300) dome (200) has a diameter that is no more than 95% of the diameter of the vibrating member tip (800).

[0055] In another embodiment, the ejector plate (300) dome (200) has a diameter that is no more than 90% of the diameter of the vibrating member tip (800).

[0056] In another embodiment, the ejector plate (300) dome (200) has a diameter that is no more than 85% of the diameter of the vibrating member tip (800).

[0057] In another embodiment, the ejector plate (300) dome (200) has a diameter that is no more than 80% of the diameter of the vibrating member tip (800).

[0058] In another embodiment, the ejector plate (300) dome (200) has a diameter that is no more than 75% of the diameter of the vibrating member tip (800).

[0059] The diameter of the ejector plate (300) can affect the diameter length of the dome (200). In a preferred embodiment, the diameter of the ejector plate (300) is 6.5 mm and the dome diameter (202) is 51% of the ejector plate diameter (203).

[0060] In another embodiment, the dome diameter (202) is between 50% and 75% of the ejector plate diameter (203).Attorney Docket No. 086123-825405

[0061] In another embodiment, the dome diameter (202) is between 75% and 95% of the ejector plate diameter (203).

[0062] In another embodiment, the dome diameter (202) is between 20% and 50% of the ejector plate diameter (203).

[0063] In another embodiment, the dome diameter (202) is between 5% and 25% of the ejector plate diameter (203).

[0064] The height of the dome (200) is measured from the top of the flat portion of the ejector plate (300) to the tip of the dome (200) on the ejector plate (300). In a preferred embodiment, the dome height (201) is 140 pm.

[0065] In another embodiment, the dome height (201) is between 140 pm and 200 pm.

[0066] In another embodiment, the dome height (201) is between 200 pm and 300 pm.

[0067] In another embodiment, the dome height (201) is between 100 pm and 140 pm.

[0068] In another embodiment, the dome height (201) is between 5 pm and 100 pm.

[0069] In another embodiment, the dome height (201) is less than 5% of the dome diameter (202). In another embodiment, the dome height (201) is less than 4.5% of the dome diameter (202) (e.g., 0.14 mm dome height with 3.3 mm dome diameter).

[0070] In another embodiment, the dome height (201) is less than 10% of the dome diameter (202).

[0071] Table 2. The table below illustrates an exemplary embodiment of three second ejected mass data collected on different dome sizes, ejector plate thicknesses, and aperture spacing (pitch).Attorney Docket No. 086123-825405

[0072] The curvature of the dome (200) is a major factor in the longevity of the ejector plate (300). A gentle curve strains the material less and therefore helps the ejector plate (300) to last longer. The dome height (201) and the dome diameter (202) factor into the curvature of the dome (200). Optimizing the dome height (201), the dome diameter (202), and the ratio of the dome diameter (202) to the diameter of the tip of the vibrating member (800) are major factors to consider.

[0073] Additionally, the thickness of the ejector plate is a key factor in the longevity of the ejector plate. Thicker ejector plates have a longer lifetime; however, thicker ejector plates do not eject as much liquid, as seen in Table 2.

[0074] In another embodiment, there is no dome (200) in the ejector plate (300), and the ejector plate (300) is all flat.

[0075] In a preferred embodiment, the dome (200) is convex, meaning that the apex of the dome (200) is pointing outward away the exit side of the ejector plate (300) toward an inhalation outlet, such as of a mouthpiece or nasal piece, of a droplet delivery device. This also means the dome (200) is pointing toward the aerosol pathway (2300).

[0076] In another embodiment, the dome (200) is concave, meaning that the apex of the dome (200) is pointing inward from the liquid entry side of the ejector plate (300) toward the vibrating member (800) of a droplet delivery device. This also means that the apex of the dome (200) is pointing away from the aerosol pathway (2300).

[0077] In further embodiments, the ejector plate (300) may be coated or treated to be hydrophobic (water contact angle of greater than 90-degrees) or hydrophilic (water contact angle of less than 90-degrees). As there are two opposite surfaces to the ejector plate (300) (liquid entrance facing side and exit airflow facing side) and 3 different types of surfaces (non-treated, hydrophobic, and hydrophilic), there are 9 combinations of different surfaces. Of which, three are most notable: both sides hydrophobic, exit side hydrophobic with the entrance side non-treated, and exit side hydrophobic with a hydrophilic entrance side.

[0078] Ejector plate apertures

[0079] Ejector plate aperture (301) size assists in the defining of the droplet sizes that are produced upon aerosolization. Aperture (301) sizes around 1 to 2 pm in diameter are used to get mass median aerodynamic diameter (MMAD) particle sizes small enough for users to inhale without irritation.Attorney Docket No. 086123-825405This also yields greater than 90% respirable fractions, meaning that most of the aerosol is being deposited into the lungs and are less than 5.6 pm. Examples of respirable fractions are in Table 3.

[0080] Table 3. The table below illustrates an exemplary embodiment of respirable fractions for an albuterol solution and a nicotine solution being delivered through the device.

[0081] In other embodiments, larger aperture (301) sizes may be utilized to target delivering droplets to the mouth and lungs. These aperture (301) size ranges may be from 2 to 15 pm and anything in between. This may especially be important with a smoking cessation and / or nicotine replacement device that does not have nicotine in the solution. This is configured to deliver larger droplets of a flavor or sensate (such as menthol) to provide sensation for the user. This is needed because without nicotine, the user does not feel the aerosol as much.

[0082] In another embodiment, an ejector plate (300) embodies both larger and smaller aperture (301) sizes, as shown in FIG. 3. As a non-limiting example, an ejector plate (300) could comprise mostly apertures (301) that are around 1.6 pm in diameter, with roughly 5% of the apertures being around 3 pm in diameter. This is configured to provide much of the aerosol to the lungs for lung delivery, but some of the aerosol to the mouth and throat for taste and sensation.

[0083] In further embodiments, there may be many different aperture (301) sizes in the same ejector plate (300). This may range from 1 to 15 pm with any combination. Meaning there may be two aperture (301) sizes where one size encompasses 1 to 99% of the apertures (301) and the other aperture (301) size encompasses the other 1 to 99%. There may be three or four or more different aperture (301) sizes.

[0084] Ejector plate carrier design

[0085] In some embodiments of a push mode type droplet delivery device (500), an ejector plate (300) is held in place with an ejector plate carrier (2302). This ejector plate carrier (2302) holds and seals the ejector plate (300)\ as illustrated in FIGS. 26A-26C. The carrier (2302) properly positions the ejector plate (300) and ensures that no leaking occurs around the edges of the ejector plate (300).Attorney Docket No. 086123-825405

[0086] Additionally, the ejector plate carrier (2302) preferably holds the ejector plate (300) tight. During actuation, the ejector plate (300) vibrates. The ejector plate carrier (2302) isolates the vibrations to the ejector plate (300), and the ejector plate carrier (300) preferably avoids absorbing any of the vibrational energy. If energy is transferred to the ejector plate carrier (2302), it dampens the vibrations on the ejector plate (300), lowering the efficiency of the push mode droplet delivery device (500), and creates heat in the ejector plate carrier (2302). Therefore, a tight hold is preferable to be provided by the ejector plate carrier (2302).

[0087] Zero energy transfer into the ejector plate carrier (2302) is not reasonably possible, but limiting the vibration is possible. It has been found that using one or two O-rings (402) significantly helps to hold the ejector plate (300). Two O-rings (402) may be used having one on top of the other as shown in FIG. 26C. One O-ring (402) may be used either on the top of the ejector plate (300) or on the bottom of the ejector plate (300) as shown in FIGS. 26A and 26B. The O-ring(s) (402) is / are pressed onto the ejector plate (300) with top and bottom ejector plate carrier (2302) pieces. Top or bottom ejector plate carrier (2302) pieces may be made out of plastic, polymer, metal, or metal alloy. In a preferred embodiment the top and bottom ejector plate carrier (2302) pieces are made from polyphenyl sulfone (PPSU). The ejector plate carrier (2302) pieces are then ultrasonically welded together.

[0088] Table 4. The table below illustrates an exemplary embodiment of ejected mass data for different O-ring placements. Each averaged data point is the average of 18 ejector plates tested in 4 sets of 3 ejections.

[0089] In other embodiments, the ejector plate carrier (2302) pieces have a snap feature to secure them together. Other embodiments have a twist feature to secure the ejector plate carrier (2302) pieces together.Attorney Docket No. 086123-825405

[0090] Additionally, in other embodiments, the ejector plate carrier (2302) pieces are made from polycyclohexylendimethylene terephthalate glycol (PCTG), cyclic olefin copolymer (COC), polyimide, polyether ether ketone (PEEK), acrylic, acrylonitrile butadiene styrene, nylon, polyamide, polycarbonate, polyethylene, polyoxymethylene, polypropylene, polystyrene, thermoplastic elastomer, thermoplastic polyurethane, and the like.

[0091] In additional embodiments, the ejector plate carrier (2302) pieces are made out of a metal or metal alloy such as aluminum, aluminum alloy, copper, copper alloy, brass, bronze, nickel alloy, stainless steel alloy, zinc alloy, zinc, titanium, titanium alloy, and the like.

[0092] In a preferred embodiment, the ejector plate carrier (2302) is made of PPSU, and an O-ring (402) seals the ejector plate (300) in place. It limits the amount of energy transferred to the ejector plate carrier (2302) pieces. The limited energy that gets transferred to the ejector plate carrier (2302) pieces is acceptable due to the high glass transition temperature of the PPSU at 220 °C. Additionally, the O-ring(s) (402) seal(s) the ejector plate (300) to eliminate leaking around the ejector plate (300). This increases the longevity of the ejector plate carrier (2302) and ejector plate (300) and increases the amount of ejected mass.

[0093] Annulus / annuli / protective structure on ejector plate

[0094] In some embodiments, it may be necessary to put an annulus (901) on the ejector plate (300). This annulus (901 ) is used to protect the ejector plate (300). It limits the amount of vibrations where the annulus (901) is located and isolates them to the ejector plate (300). In a push mode (500) type embodiment, the annulus (901) may be configured to cover the area at which the vibrating member (800) tip contacts the ejector plate (300). This increases the structural integrity of the ejector plate (300) at the point of contact. The annulus (901) is used to increase the life of the ejector plate (300) as well as isolate the vibrations to the center of the ejector plate (300).

[0095] FIGS. 10A and 10B illustrate exemplary embodiments of an ejector plate (300) with an active area (900) containing the ejector plate apertures (301). FIG. 10B illustrates an exemplary embodiment of an ejector plate (300) with an annulus (901) around the edge.

[0096] The annulus (901) may be made from plastic or metal. In a preferred embodiment, the annulus (901) is made from titanium. In other embodiments the annulus (901) is made from a different metal, metal alloy, or plastic.

[0097] In additional embodiments, a secondary annulus (901) may be used to position the ejector plate (300) between two annuli (901).Attorney Docket No. 086123-825405

[0098] In another embodiment, the annuli (901) are used as the ejector plate carrier (2302) to hold the ejector plate (300). This may be flat, concave, or convex, see FIGS. 24A-24C.

[0099] In further embodiments, a protective structure that is not an annulus is used. The ejector plate may have a smaller annulus (901) in the center, but have support brackets (1000) that reach out to another, larger, annulus.

[0100] FIG. 11A illustrates an exemplary embodiment of an ejector plate (300) with an active area (900) containing the ejector plate apertures (301). FIG. 1 IB illustrates an exemplary embodiment of an ejector plate (300) with a support bracket (1000) on it. The support bracket (1000) helps protect the ejector plate (300) and isolates the vibrations to the center of the ejector plate (300). The vibrating member (800) tip should contact the ejector plate (300) at the support bracket (1000).

[0101] These types of support brackets (1000) or annuli (901) may also be used on ejector plates (300) made from a plastic and not just a metal or metal alloy.

[0102] Pressure drop and ejector plate bending

[0103] In a push mode droplet delivery device (500) involving an ejector plate (300), the pressure drop across the ejector plate (300) may influence the droplet characteristics. This includes, but is not limited to, the total amount of ejected mass and the particle size of the ejected droplets. This is because the majority of the ejection from a push mode droplet delivery device (500) is from vibrations on the ejector plate (300). If there is a pressure drop across the ejector plate (300), the plate is configured to be pulled outward and dampen the vibrations. Additionally, a pressure drop across the ejector plate (300) could cause liquid to be pulled through the apertures (301) and settle on the exterior of the ejector plate (300). This is configured to cause large droplets to pop off the ejection plate (300) during ejection, or it could minimize the ejection all together.

[0104] A few methods may be used to decrease the amount of pressure drop across the ejector plate (300) such as, but not limited to, opening vents or adding more air channels on the handpiece (1600), mouthpiece (700) or cartridge (1100).

[0105] Another method is to put the pressure drop in the airflow path after the ejector plate (300). The airflow path (100) before the ejector plate (300) preferably does not have too high of a pressure drop. The pressure drop before the ejector plate (300) should be less than 100 Pa, less than 50 Pa, less than 25 Pa, less than 10 Pa, less than 5 Pa, or less than 1 Pa.Attorney Docket No. 086123-825405

[0106] An additional embodiment would narrow the entire airflow path (100) after the ejector plate (300). Another embodiment would have the entire airflow path (100), before and after the ejector plate (300), open with minimal pressure drop.

[0107] The pressure drop also determines the amount of air that comes into the aerosol path (2300) during an inhalation. If the pressure drop is high, less air comes into the aerosol path. If the pressure drop is low, more air comes into the aerosol path. This affects the user’s sensory experience. When there is more air in with the aerosol, the user does not experience the aerosol as much. When there is less air in with the aerosol, the user feels the aerosol more.

[0108] Additionally, in some embodiments, the pressure drop may be adjusted by the user through various means. As a non-limiting example, a device may include an adjustable slider or valve on the handpiece, ejector bracket, or cartridge that would allow the user to change the amount of airflow they experience during inhalation. As another non-limiting example, a device may be compatible with multiple mouthpieces, each of which provide different airflow characteristics.

[0109] FIGS. 7A-7G and 8A-8G illustrate embodiments of multiple mouthpiece (700) designs with corresponding aperture sizing of the exit aperture (701) (shown by double arrow between respective sizing and corresponding design). Each design has a different exit aperture (701) size. This exit aperture (701) size controls the pressure drop the user experiences. A smaller exit aperture (701) has a higher pressure drop and a bigger exit aperture (701) has a smaller pressure drop. A bigger exit aperture (701) reduces the pressure drop across the ejector plate (300).

[0110] FIG. 28 illustrates an exemplary embodiment of the airflow path (100) and the aerosol pathway (2300). The airflow path (100) is defined as any path the air takes through the device. The aerosol pathway (2300) is the path the aerosol takes through the device. The airflow path (100) flows into the aerosol pathway (2300) near the ejector plate (300). They both flow together to the exit of the mouthpiece (700).[0U1] Removable battery

[0112] In some embodiments, the push mode type droplet delivery device (500) comprises a removable battery (2400). The battery is removable with or without standard tools. The battery may be secured with a screw, a toggle, a sliding lock, an electronic lock, a tab secure feature, or any other securing mechanism. This is done to easily and safely remove the battery for secure disposal. The battery may be underneath a cover or be encased in a protective structure. The cover or protective structure may be made from a metal, a metal alloy, or a polymer.Attorney Docket No. 086123-825405

[0113] In some embodiments of the ring mode type droplet delivery device (FIG. 6) there is a removable battery (2400). The battery is removable with or without standard tools. The battery may be secured with a screw, a toggle, a sliding lock, an electronic lock, a tab secure feature, or any other securing mechanism. This is done to easily and safely remove the battery for secure disposal. The battery may be underneath a cover or be encased in a protective structure. The cover or protective structure may be made from a metal, a metal alloy, or a polymer.

[0114] Airflow path

[0115] The airflow path (100) is important for a push mode type droplet delivery device (500) with an ejector plate (300). Ensuring the airflow path (100) passes by the ejector plate (300) to scoop up the droplets from the plate is pivotal. For example, an airflow path (100) can cooperate with the ejector plate (300) and extend over a curved ejector plate carrier (2302) that helpa guide air flowing in the airflow path (100) as shown in FIG. 24. Preferably some pressure drop is needed to create sufficient airflow. Keeping the pressure drop low enough to have minimal effect on the ejector plate (300) but high enough for the airflow to scoop droplets is key. Pressure drop may be in the range of 1 Pa to 5 Pa, 5 Pa to 10 Pa, 10 Pa to 25 Pa, 25 Pa to 50 Pa, 50 Pa to 75 Pa, 75 Pa to 125 Pa, 125 Pa to 200 Pa, 200 Pa to 300 Pa, 300 Pa to 500 Pa.

[0116] The aerosol path (2300) tube after the ejector plate (300) is an important aspect in further embodiments. The diameter of the exit aerosol path (2300) tube determines the flight time of the droplet. A larger diameter aerosol path (2300) tube slows the droplet down and therefore increases the amount of evaporation that occurs. The smaller diameter aerosol path (2300) tube increases the speed of the droplet and delivery time to the user. In a preferred embodiment, the diameter of the aerosol path (2300) tube is 6 mm. In other embodiments, the diameter of the aerosol path (2300) tube is 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, or 30 mm.

[0117] Membrane sealing

[0118] The membrane (401) separates the liquid and ejector plate (300) from the horn (802) and piezoelectric transducer (801). This membrane (401) is important to keep heavy metals out of the pathway of the liquid and to ensure ejection still happens. The membrane (401) is shaped similarly to the tip of the vibrating member (800). It is parallel to the vibrating member (800) tip. On one side, the membrane (401) touches the ejector plate (300), and on the other side, the membrane (401) touches the vibrating member (800). The membrane (401) is held in place at the lower ejectorAttorney Docket No. 086123-825405 bracket (1200). The lower ejector bracket (1200) has a ring that positions the membrane (401) in place. An O-ring (402) or O-rings (402) is / are used to seal the membrane (401). One O-ring (402) is used preferably on the liquid side of the membrane (401). One O-ring (402) may be used on the other side of the membrane (401). When two O-rings (402) are used, one is placed on each side of the membrane (401). The O-ring (402) that positions the membrane (401) against the lower ejector bracket (1200) may be press fit, snap fit, twist fit, or ultrasonically welded into place.

[0119] FIG. 4 illustrates an exemplary embodiment of an ejector bracket (400) with an O-ring (402) around the membrane (401).

[0120] Leak prevention

[0121] Depending on several factors, liquid may leak through the ejector plate (300) onto its exterior portion. These factors include, but are not limited to, physical properties of the liquid, aperture (301) size of the ejector plate (300), length of time sitting without being used, pressure changes.

[0122] There are several things that may help mitigate leaking. One thing is removing one or more of the cartridge vents (1101) or ejector bracket vents (1202). The original push mode type droplet delivery device (500) design had two cartridge vents (1101) and two ejector bracket vents (1202). Removal of one or more of the cartridge vents (1101) or ejector bracket vents (1202) decreases the probability of leaking.

[0123] Removal of the cartridge vents (1101) provides other benefits as well. Removing the cartridge vents (1101) decreases the number of parts that are needed to build the cartridge (1100). Additionally, the cartridge vents (1101) are ultrasonically welded into place. Removing the cartridge vents (1101) removes that additional step. It simplifies the cartridge (1100) design as well, reducing the total number of parts from ten pieces to four pieces in a preferred embodiment. It also reduces the cost of the cartridge (1100) by an estimated 56%.

[0124] FIGS. 12A and 12B illustrate exemplary embodiments of different cartridge (1100) designs. The cartridge (1100) shown in FIG. 12B has cartridge vents (1101) (depicted as faint holes at the top of the cartridge) to assist in pressure equalization. The cartridge (1100) shown in FIG. 12A does not have cartridge vents. The cartridge without cartridge vents requires fewer parts for manufacturing. It also does not require an ultrasonic weld.

[0125] The ej ector bracket vents (1202) (FIG. 13) are in different embodiments of droplet delivery devices more important for ejection than the cartridge vents (1101). The ejector bracket ventsAttorney Docket No. 086123-825405(1202) help facilitate the air exchange during ejection. The vibrations on the ejector plate (300) are the primary reason for ejection. As the ejector plate (300) vibrates downward toward the liquid, liquid is forced through the apertures (301), creating droplets. As the ejector plate (300) vibrates upward, away from the liquid, air comes in to fill that area. That air must be replaced by liquid. The wicks (1201) do this job of forcing liquid in this area. Additionally, the space between the ejector plate (300) and the membrane (401) is such to create capillary action, pulling liquid between the two parts. Most of the air is forced back into the cartridge (1100) through the spike that has no wick (1201). However, there is some air exchange at the ejector bracket vents (1202) to help facilitate equalized pressure in the ejector bracket (400) throughout ejection. Removal or sealing of these ejector bracket vents (1202) may create a decrease in ejected volume. It is not always the case but is only experienced when the ejector bracket vents (1202) are removed. The probability of leaking is even less with the ejector bracket vents (1202) removed.

[0126] Spirals may be put on cartridge vents (1101) and / or ejector bracket vents (1202) to decrease evaporation rates through the cartridge vents (1101) and / or ejector bracket vents (1202). The diameter of the spiral and the length of the spiral may be adjusted. A bigger diameter spiral allows for easier air and pressure changes. A longer length of spiral decreases the evaporation.

[0127] Additionally, leaving the ejector bracket vents (1202) in place assists in the pressure equalization experienced in changes in atmospheric pressure (i.e., altitude and weather changes). For example, this helps eliminate leaking when the push mode type droplet delivery device (500) is in the car with someone as they drive up a mountain; the push mode type droplet delivery device (500) is configured to not leak due to atmospheric pressure changes.

[0128] Another thing that may help prevent leaking through the ejector plate (300) is putting a hydrophobic treatment on the surface of the ejector plate (300). The hydrophobic treatment may be on either side of the ejector plate (300) or both sides of the ejector plate (300). The hydrophobic treatment may be a coating, an etching, or something done to the surface.

[0129] Hydrophobic treatment can provide a layer of resistance for the liquid when the ejector plate (300) is sitting idle. An ejector plate (300) with a hydrophobic treatment may hold back up to five times more pressure than a non-treated ejector plate (300). The hydrophobic treatment may also allow for greater mass ejection. This is because the liquid is not held on the edges of the apertures (301) at the exit side of the ejector plate (300). The liquid may slip through the apertures (301) during actuation. This also causes the droplets to be slightly larger. When a non-treatedAttorney Docket No. 086123-825405 ejector plate (300) has ejection, the liquid is held back all around the edge of the apertures (301). The center of the liquid keeps going and eventually separates from the liquid that is being held back. When a treated ejector plate (300) has ejection, the liquid is not held back all around the edge of the apertures (301); therefore, the liquid may fully slide out of the apertures (301). The key is that when the actuation is not occurring, the liquid is held back, but when ejection is occurring, liquid easily flows through. Note that this result only applies to when the ejector plate(300) is treated on the entrance.

[0130] In some embodiments, the ejector plate (300) may be treated only on the exit side of the ejector plate (300). This still limits the leaking through the ejector plate (300). The treatment holds the liquid back into the apertures (301).

[0131] Another method to limit the leaking through the ejector plate (300) is to make the aperture(301) sizes in the ejector plate (300) smaller. The smaller the aperture (301) sizes, the less likely the leaking is configured to occur — or, the more pressure it is configured to take to force leaking to occur.

[0132] In some embodiments, a droplet device comprises a microfluidic pump (1601), as shown in FIG. 17. The microfluidic pump (1601) may be used to put liquid behind the ejector plate (300) only during actuation. The microfluidic pump (1601) may be a part of the ejector bracket (400) or part of the handpiece (1600). The fluid can connect to the microfluidic pump (1601) and once the handpiece (1600) recognizes air flow to create ejection, the microfluidic pump (1601) pushes liquid behind the ejector plate (300).

[0133] A blockage plug (1700) can also be used to stop liquid flow to the ejector plate while it is not actuating. In one embodiment, the blockage plug (1700) gets pulled out with the pressure from the inhalation of the user. This allows the liquid to flow to the ejector plate (300) only while ejection is occurring. In another embodiment, the blockage plug (1700) is always in place inhibiting the fluid flow slightly, while allowing some amount of fluid through.

[0134] As a non-limiting example, FIGS. 18A and 18B illustrate an exemplary embodiment of a blockage plug (1700) in the ejector bracket (400) to limit the amount of pressure that the liquid may exert on the ejector plate (300). The blockage plugs (1700) may act like a plug, blocking liquid flow from the cartridge (1100) to the ejector plate (300). During inhalation, the blockage plugs (1700) would pull outward from the pressure drop across the blockage plugs (1700). Then, liquid would may flow to the ejector plate (300) from the cartridge (1100) but only during theAttorney Docket No. 086123-825405 inhalation. FIG. 18A illustrates an exemplary embodiment of the blockage plugs (1700) in their closed positions, prohibiting liquid flow. FIG. 18B illustrates an exemplary embodiment of the blockage plugs (1700) having been pulled outward during an inhalation, allowing liquid flow.

[0135] As a non-limiting example, FIGS. 19A and 19B illustrate an exemplary embodiment of another embodiment of the blockage plugs (1700). In this embodiment, the blockage plugs (1700) are closer to the ejector plate (300) than in the embodiment shown in FIGS. 18A and 18B. These blockage plugs (1700) act in the same manner as that shown in FIGS. 18A and 18B. It seals the liquid away from the ejector plate (300) when it is not in use. During inhalation, the blockage plugs (1700) are pulled outward and allow liquid to flow to the ejector plate (300) from the cartridge (1100). FIG. 19A illustrates an exemplary embodiment of the blockage plugs (1700) in their closed positions, prohibiting liquid flow. FIG. 19B illustrates an exemplary embodiment of the blockage plugs (1700) having been pulled outward during an inhalation, allowing liquid flow.

[0136] In another embodiment, the blockage plug(s) are replaced with valve(s).

[0137] In another embodiment, the blockage plug(s) are replaced with a pressure sensitive valve, wicking system, or the like.

[0138] Another method to limit the leaking of the liquid is by slimming down the wick or removing part of the wick material. This is configured to slow the liquid flow from the cartridge (1100) to the ejector plate (300) limiting the probability of leaking.

[0139] FIG. 13 illustrates an exemplary embodiment of a lower ej ector bracket (1200) with a wick (1201) and membrane (401). It illustrates an exemplary embodiment of how close the wick (1201) is to the membrane (401) and therefore the ejector plate (300). The lower ejector bracket (1200) in FIG. 13 also illustrates an exemplary embodiment of ejector bracket vents (1202) located on the sides of the bracket.

[0140] FIG. 14 illustrates an exemplary embodiment of a cross-sectional view of a lower ejector bracket (1200) with the membrane (401), wick (1201), and ejector plate (300). It illustrates an exemplary embodiment of the distance between the apertures (301) in the ejector plate (300) and the wick (1201).

[0141] As a non-limiting example, FIG. 15 illustrates an exemplary embodiment of a lower ejector bracket (1200) with the membrane (401) and a wick (1201) with less material than the embodiment shown in FIG. 12. This reduction in wick material is around the membrane and creates more space between the wick (1201) and the ejector plate (300).Attorney Docket No. 086123-825405

[0142] As another non -limiting example, FIG. 16 illustrates an exemplary embodiment of a lower ejector bracket (1200) with the membrane (401) and a wick (1201) with less material than the embodiment shown in FIG. 13. This reduction in wick material is in the form of slits throughout the wick (1201). This reduces the overall ability of the wick (1201) to supply liquid to the ejector plate (300).

[0143] Filter design

[0144] In one embodiment, an inline filter (2600) is used in the aerosol pathway (2300). The inline filter blocks or breaks up larger droplets resulting in a smaller MMAD. FIG. 27 illustrates an exemplary embodiment of a cartridge (1100) with an inline filter (2600).

[0145] In one embodiment, the pore density of the filter is 45 pores per inch (ppi) and 3 mm thick. The filter is located 5 to 30 mm away from the ejector plate (300).

[0146] Pressurized liquid

[0147] In another embodiment, the liquid is pressurized or forced up against the ejector plate (300). This may be accomplished by a spring, a compressible flexible ampule cartridge, a screw, a piston, or an electromagnetic plug.

[0148] General structure

[0149] FIG. 5 illustrates an exemplary embodiment of a push mode type droplet delivery device. The push mode type droplet delivery device (500) has an ejector plate (300) held by a ejector plate carrier (2302) and preferably positioned at a 3 degree angle measured relative to a plane perpendicular to the airflow path (100). A membrane (401) is on the backside of the ejector plate (300) and touching the ejector plate (300). A vibrating member (800) is on the other side of the membrane (401). The vibrating member (800) tip touches the membrane (401). It contacts the membrane (401) and puts a force onto the ejector plate (300). When the piezoelectric transducer (801) vibrates, it transfers the energy to the horn (802) and to the ejector plate (300). The vibrating member (800) tip transfers the energy through the membrane (401) to the ejector plate (300). The ejector plate (300) vibrates. The vibrating member (800) tip also creates some pressure and pushes liquid into the ejector plate (300). The vibrating member (800) may also be creating a pumping action to pump liquid to the ejector plate (300).

[0150] In other embodiments, the angle at which the ejector plate (300) is positioned relative a plane perpendicular to the airflow path (100) is 0°, 1°, 2°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, and so on, up to 30°Attorney Docket No. 086123-825405

[0151] In one embodiment, the vibrating member (800) tip and the ejector plate (300) are centered along a centralized axis. The tip of the vibrating member (800) is flat or perpendicular to the central axis.

[0152] In other embodiments, the vibrating member (800) is not centered along a centralized axis and the ejector plate (300) is centered along a centralized axis. The vibrating member (800) may be off-center by 0.1mm to 3mm in any direction from the center. This dimension is mostly concerned with the separation of the ejector plate (300) central axis and the vibrating member (800) central axis.

[0153] In other embodiments, the ejector plate (300) is not centered along a centralized axis and the vibrating member (800) is centered along a centralized axis. The ejector plate (300) may be off-center by 0.1mm to 3mm in any direction from the center.

[0154] In other embodiments, the vibrating member (800) tip is not flat and is at an angle to the central axis. This angle may be anywhere between 1 -degree to 30-degrees.

[0155] In preferred embodiments, the membrane (401) is centered with the vibrating member (800). The membrane (401) may be flat if the vibrating member (800) tip is angled, or the membrane (401) may be angled with the vibrating member (800) tip. It may also be angled at a different angle to the vibrating member (800).

[0156] In another embodiment, the ejector plate (300) and the vibrating member (800) tip are both angled with or against each other.

[0157] FIGS. 20-23D illustrate exemplary embodiments of the interface between the vibrating member (800) and ejector plate (300). It should be noted that these images are simplified drawings and aspects of the device are not shown, including the membrane (401), which separates the vibrating member from the ejector plate.

[0158] FIG. 20 illustrates an exemplary embodiment of a vibrating member (800) with an angled ejector plate (300), wherein the vibrating member (800) has a flat and level tip, and the ejector plate (300) has a convex dome (200). The ejector plate (300) and vibrating member (800) are aligned along a central axis (1901). The angle (1902) of the ejector plate (300) may be between 0.1-degrees to 15-degrees with a preferred embodiment of 3-degrees.

[0159] FIG. 22A illustrates an exemplary embodiment of a level ejector plate (300) with an angled vibrating member (800) tip. The angle (1902) of the vibrating member (800) tip may be between 0.1-degrees to 15-degrees.Attorney Docket No. 086123-825405

[0160] FIGS. 22B and 22C illustrate an exemplary embodiment of an ejector plate (300) and a vibrating member (800) that are off-center from each other. Either the ejector plate (300) or the vibrating member (800) may be centered along a central axis (1901) of the device. When the ejector plate (300) and vibrating member (800) are off-center, the vibrating member (800) tip may contact the ejector plate (300) towards the edge of the ejector plate (300) with the center of the ejector plate (300) still over top of the vibrating member (800) tip, as illustrated in FIG. 22B. The vibrating member (800) tip may contact the ejector plate (300) near the edge of the ejector plate (300) with the center of the ejector plate (300) positioned off to the side of the vibrating member (800) tip, as illustrated in the bottom image in FIG. 22C. Additionally, the tip of the vibrating member (800) may contact the ejector plate (300) at the curve of the dome (200) or in the dome (200) of the ejector plate (300), as illustrated in the middle image of FIG. 21.

[0161] FIGS. 23A-23D illustrate exemplary embodiments of a concave dome (200) on the ejector plate (300). The dome (200) faces inwards toward the vibrating member (800). The vibrating member (800) tip may contact the ejector plate (300) at the edge of the ejector plate (300), as illustrated in images 23A and 23D. The vibrating member (800) tip may contact the ejector plate (300) on the tip of the dome (200), as illustrated in image 23B. The vibrating member (800) tip may contact the ejector plate (300) on the edge of the dome (200), as illustrated in image 23C. Additionally, the dome (200) may be positioned over the vibrating member (800) or off to the side of the vibrating member (800).

[0162] One piece ejector bracket and handpiece

[0163] In some embodiments, the ejector bracket (400) and the handpiece (1600) may be one piece. This means the ejector plate (300), the ejector plate carrier (2302), the membrane (401), the vibrating member (800), the circuitry, and battery would be all in one piece. This decreases the number of assemblies the user needs to have from three (cartridge (1100), ejector bracket (400), and handpiece (1600)) to two (cartridge (1100) and handpiece (1600)).

[0164] There is a need forthe ejector plate (300) to be properly aligned with the vibrating member (800). When the ejector bracket (400) is separate from the handpiece (1600), steps must be taken to ensure proper alignment and contact force between the vibrating member (800) in the handpiece (1600) and the ejector plate (300) in the ejector bracket (400). This includes tight dimensional integrity and precision parts. It also means having systems in place to ensure that each time the ejector bracket (400) is placed onto the handpiece (1600), it rests in the correct position. With theAttorney Docket No. 086123-825405 ejector bracket (400) combined with the handpiece (1600), these systems may be less precise. The handpiece (1600) is configured to be assembled with the ejector plate (300) in a manufacturing facility. Its assembly would be quality checked to ensure proper positioning, rather than relying on the systems of the design.

[0165] Vibrating member bonding

[0166] FIGS. 9A and 9B illustrate exemplary embodiments of a vibrating member (800) assembly and the components of the vibrating member (800) assembly. The components include a piezoelectric transducer (801) (piezo) and a horn (802). The bonding of a piezoelectric transducer (801) to a horn (802) is key to a well working vibrating member (800). The bond is preferably electrically conductive. The bond should be strong enough to hold through vibrations. It can’t be brittle such that it is configured to crack under vibrations, and it can’t have too low of a Young’s modulus such that it absorbs energy. Ideally, the material used for the bond is acoustic impedance matched to the piezoelectric transducer (801) and the horn (802). However, impedances are typically too different to be matched. The epoxy or glue used for the bond is typically too different from the piezoelectric transducer (801) and horn (802). Additionally, the thickness of the glue should preferably be a quarter wavelength of the resonant frequency for optimum performance. This thickness is also typically not possible as the thickness would need to be around 5 mm thick and would absorb too much energy. To overcome these challenges, using as thin of a bond as possible for optimum performance is preferred. In a preferred embodiment, the thickness of the bond is 10 pm. In other embodiments, the bond thickness may be 1 pm, 2 pm, 3 pm, 4 pm, 5 pm, 6 pm, 7 pm, 8 pm, 9 pm, 12 pm, 15 pm, 17 pm, 20 pm, 25 pm, and so on.

[0167] To have a good bond, the parts must be clean and have the correct surface roughness. A good cleaning procedure should be used, such as isopropyl alcohol and a detergent to remove machining oil from the horn (802). Then, sandblasting the base of the horn (802) where the bond will be present is conducted to preferably get a between 1.5-3.0, and preferably 2.0, pm surface roughness.

[0168] Elimination of air in a push mode type droplet delivery device having wicking

[0169] In some embodiments, the push mode type droplet delivery device (500) includes a vibration mode to eliminate air bubbles in the liquid pathway. This vibration mode is similar to the vibration mode of a cellphone. The vibration could be produced by, but is not limited to, any of the following, which would be housed in the handpiece (1600) of the push mode type dropletAttorney Docket No. 086123-825405 delivery device (500): vibration motor, linear resonant actuator, solenoid actuator, haptic engine. This vibration mode could be activated by the user pressing the button in a specified manner (e.g., press and hold button for 3 seconds) while the push mode type droplet delivery device (500) is held with the mouthpiece (700) pointing up. The handpiece (1600) is configured to then vibrate for a certain amount of time. This vibration is configured to force any air bubbles out of the liquid flow path, into the fluid reservoir, and, if cartridge vents (1101) are present, up to the cartridge vents (1101) located at the top of the cartridge (1100). If no cartridge vents (1101) are present, the air bubbles is configured to be forced to the dead space at the top of the cartridge (1100) above the fluid level. The vibration is meant to aid in maintaining consistent ejection. Air bubbles, particularly any behind the ejector plate (300), could disrupt ejection or cause inconsistent ejection. FIG. 1 illustrates an exemplary embodiment of the potential pathway of air bubbles (2500).

[0170] Biocompatibility

[0171] In a vibrating ejector plate (300) droplet delivery device, a piezoelectric transducer (801 ) (piezo) is most often used to create the vibrational energy. Most piezoelectric transducers (801) are made with lead and other heavy metals. In a ring mode type droplet delivery device (600), the piezoelectric transducer (801) has direct contact with the fluid pathway. FIG. 6 illustrates an exemplary embodiment of an example of a ring mode droplet delivery device, with a ring mode ejector bracket (601) connected to a ring mode cartridge (602). In FIG. 6, the piezoelectric transducer (801) is bonded to the ejector plate (300). Sometimes the piezoelectric transducer (801) is encapsulated to try to mitigate the lead leaching into the fluid; however, the chance of getting lead from the piezoelectric transducer (801) into the fluid is never zero. When doing a leachable and extractables study, lead is configured to always be found. This includes extra preventative measures that may be taken, such as, raw piezoelectric ceramic wash, glued plates and annuli, polymer (PTFE) coatings, sputtered coatings, and the like.

[0172] Since ring mode type droplet delivery device produce aerosol that is meant to be inhaled, lead and other heavy metals would have the chance to go directly to the lungs. The FDA has limits on the amount of heavy metals a person may intake for one day; however, inhaled heavy metals is configured to most definitely affect the human body differently than ingested heavy metals. Ingestion of heavy metals is configured to go through purification processes in the body, such as the liver. Inhaled heavy metals is configured to go directly into the bloodstream. The FDA has notAttorney Docket No. 086123-825405 specified a limit on inhaled heavy metals. It is believed that this level should be orders of magnitude less than the limit on ingested heavy metals.

[0173] In a push mode type droplet delivery device (500), the piezoelectric transducer (801) is removed from the fluid pathway. The piezoelectric transducer (801) is attached to a horn (802) to form a vibrating member (800). The vibrating member (800) is separated from the fluid pathway by a membrane (401). The piezoelectric transducer (801) is multiple degrees away from the fluid pathway, thus removing the chance for any heavy metals to leach into the fluid. FIG. 5 illustrates an exemplary embodiment of an example of a push mode type droplet delivery device (500).

[0174] While described with reference to specific embodiments herein, the invention is intended to extend in scope to the full extent of the disclosure. It should be appreciated that the embodiments described herein are exemplary and may be varied, modified, or adapted by those skilled in the art without departing from the spirit and scope of the present invention. The terminology used herein is for the purpose of description and should not be regarded as limiting. The terms 'comprising,' 'including,' and 'having' are intended to be open-ended, and unless otherwise indicated, the use of singular terms includes the plural forms thereof.

[0175] Table 5. The table below lists the element names and the associated element number:Attorney Docket No. 086123-825405

Claims

Attorney Docket No. 086123-825405CLAIMSWhat is Claimed:

1. A droplet delivery device comprising: an ejector plate (300) with a plurality of apertures (301); a ejector plate carrier (2302) in place at an angle; an airflow path (100) that exits through a mouthpiece (700), wherein the angle of the ejector plate (300) is measured relative to a plane perpendicular to the airflow path (100); and a vibrating member (800) coupled to a membrane that contacts the ejector plate (300).

2. The droplet delivery device of claim 1, wherein the angle of the ejector plate (300) is about 3 degrees.

3. The droplet delivery device of claim 1 , wherein the angle of the ejector plate (300) is between 0 and 30 degrees.

4. The droplet delivery device of any of claims 1-3, wherein the space between the ejector plate (300) and the membrane (401) is such that capillary action is enabled to pull liquid from the liquid pathway to between the ejector plate (300) and membrane(401).

5. The droplet delivery device of any of claims 1-4, wherein the ejector plate (300) has a thickness of between about 27 pm and about 31 pm.

6. The droplet delivery device of any of claims 1-5, wherein the ejector plate (300) has a dome (200) feature, wherein the dome (200) height that is less than or about 5% of the dome (200) diameter.

7. The droplet delivery device of claim 6, wherein the dome (200) feature is concave.Attorney Docket No. 086123-8254058. The droplet delivery device of claim 6, wherein the dome (200) feature is convex.

9. The droplet delivery device of any of claims 1-5, wherein the ejector plate (300) does not have a dome (200).

10. The droplet delivery device of any of claims 1-9, wherein the ejector plate (300) comprises palladium nickel.

11. The droplet delivery device of any of claims 1-9, wherein the ejector plate (300) comprises a polymer such as polyether ether ketone or polyimide.

12. The droplet delivery device of any of claims 1-11, wherein the apertures (301) in the ejector plate (300) average about 1 to 2 pm in diameter.

13. The droplet delivery device of any of claims 1-11, wherein the apertures (301) in the ejector plate (300) average about 2 to 5 pm in diameter.

14. The droplet delivery device of any of claims 1-11, wherein the apertures (301) in the ejector plate (300) are greater than 5 pm in diameter.

15. The droplet delivery device of any of claims 1-11, wherein the apertures (301) in the ejector plate (300) comprise two or more diameters.

16. The droplet delivery device of any of claims 1-15, wherein the ejector plate carrier (2302) holds the ejector plate (300) in place with one or two o-rings (402).

17. The droplet delivery device of any of claims 1-16, wherein the ejector plate carrier (2302) comprises a material with a high glass transition temperature.Attorney Docket No. 086123-82540518. The droplet delivery device of claim 17, wherein the ejector plate carrier (2302) further comprises polyphenylsulfone.

19. The droplet delivery device of any of claims 1-18 configured with a pressure drop through the mouthpiece (700).

20. The droplet delivery device of claim 19, wherein the pressure drop is adjustable by the user.

21. The droplet delivery device of any of claims 1-20, wherein the membrane (401) is sealed with one or two o-rings (402).

22. The droplet delivery device of any of claims 1-21, wherein the ejector plate carrier (2302) holds an annulus (901) with the ejector plate (300).

23. The droplet delivery device of any of claims 1-22, wherein the device includes a support bracket (1000) for an ejector plate (300).

24. The droplet delivery device of any of claims 1-23, wherein the device has a central axis and the vibrating member (800) and ejector plate (300) are both centered relative to the central axis of the device.

25. The droplet delivery device of any of claims 1-24, wherein the device has a central axis and the vibrating member (800) and ejector plate (300) are both off-center relative to the central axis of the device.

26. The droplet delivery device of any of claims 1-24, wherein the device has a central axis and the vibrating member (800) is off-center relative to the central axis of the device.

27. The droplet delivery device of any of claims 1-24, wherein the device has a central axis and the ejector plate is off-center relative to the central axis of the device.Attorney Docket No. 086123-82540528. The droplet delivery device of any of claims 1-27, wherein vibrating member (800) has a central axis and the membrane (401) is centered relative to the central axis of the vibrating member (800) .

29. The droplet delivery device of any of claims 1-28, further comprising a housing for the ejector plate (300) and ejector plate carrier (2302) , wherein the housing further comprises ejector bracket vents (1202).

30. The droplet delivery device of claim 29, wherein the cartridge vents (1101) and / or ejector bracket vents (1202) contain a spiral configured to limit evaporation of liquid through the cartridge vents (1101) and / or ejector bracket vents (1202).31 . The droplet delivery device of any of claims 1 -30, wherein the device is configured to reduce heavy metals leeching into the fluid pathway.

32. A droplet delivery device comprising: an ejector plate (300) for generating a stream of droplets; and a mechanism to resist leaking through the plurality of apertures (301).

33. The droplet delivery device of claim 33, wherein the device includes a cartridge(l 100) to hold liquid and is free of any cartridge vents (1101).

34. The droplet delivery device of any of claims 33 and 34, wherein the ejector plate (300) has a hydrophobic treatment on one or more of its surfaces.

35. The droplet delivery device of any of claims 33-35, wherein the device includes a plurality of wicks (1201)and each wick (1201) is shaped and positioned with space between said wick (1201) and the ejector plate (300).

36. The droplet delivery device of any of claims 33-36, wherein the ejector plate (300) has small apertures (301).Attorney Docket No. 086123-82540537. The droplet delivery device of any of claims 33-37, wherein the device includes a microfluidic pump (1601).

38. The droplet delivery device of any of claims 33-38, wherein the device includes a blockage plug (1700) that is pressure actuated.

39. A droplet delivery device comprising: an ejector plate (300) for generating a stream of droplets; and a microfluidic pump (1601) configured to supply liquid to the ejector plate. (300)40. A droplet delivery device comprising a wicking system between a liquid supply and an ejector plate (300) to control liquid flow to the ejector plate (300), further comprising a mechanism to eliminate air in the liquid flow pathway.

41. The droplet delivery device of claim 41, wherein the mechanism comprises a vibration mode configured to force air bubbles out of the liquid flow pathway.

42. A droplet delivery device comprising: an ejector plate (300) with a plurality of apertures (301); an ejector plate carrier (2302) holding the ejector plate (300) in place; and a vibrating member (800) coupled to a membrane (401) that contacts the ejector plate (300), wherein the ejector plate (300), ejector plate carrier (2302), vibrating member (800), and membrane (401) comprise one piece, wherein the ejector plate (300) is not removably coupled to the vibrating member (800).

43. A droplet delivery device comprising: an ejector plate (300) with a plurality of apertures (301); an ejection channel and droplets outlet; an airflow path(lOO) that exits into the ejection channel at an airflow outlet;Attorney Docket No. 086123-825405 an ejector plate carrier (2302) holding the ejector plate (300) that is positioned near the airflow outlet and with a curved surface to encourage airflow path (100) across the ejector plate (300).

44. A droplet delivery device comprising: a piezoelectric transducer(801) and a horn (802) bonded together to form a vibrating member (800); the horn (802) having its surface roughened to about 2 pm surface roughness; the bond layer is between 10 to 20 pm thick; and the bond material is conductive.

45. A droplet delivery device comprising: an ejector plate (300) with a plurality of apertures (301); a central axis through the center of the device; an ejector plate carrier (2302) holding the ejector plate (300) in place perpendicular to the central axis; an airflow path(lOO) that exits through a mouthpiece (700), wherein the angle of the ejector plate (300) is measured relative to a plane perpendicular to the airflow path (100); a vibrating member (800) with a tip that is angled to the central axis; and a membrane (401) that is coupled to the vibrating member (800) and contacts the ejector plate (300).

46. The droplet delivery device of claim 45, wherein the angle of the ejector plate (300) is about 3 degrees.

47. The droplet delivery device of claim 45, wherein the angle of the ejector plate (300) is between 0 and 30 degrees.Attorney Docket No. 086123-82540548. The droplet delivery device of any of claims 45-47, wherein the space between the ejector plate (300) and the membrane (401) is such that capillary action is enabled to pull liquid from the liquid pathway to between the ejector plate (300) and membrane(401).

49. The droplet delivery device of any of claims 45-48, wherein the ejector plate (300) has a thickness of between about 27 pm and about 31 pm.

50. The droplet delivery device of any of claims 45-49, wherein the ejector plate (300) has a dome (200) feature, wherein the dome (200) height that is less than or about 5% of the dome (200) diameter.

51. The droplet delivery device of claim 50, wherein the dome (200) feature is concave.

52. The droplet delivery device of claim 50, wherein the dome (200) feature is convex.

53. The droplet delivery device of any of claims 45-49 wherein the ejector plate (300) does not have a dome(200).

54. The droplet delivery device of any of claims 45-53, wherein the ejector plate (300) comprises palladium nickel.

55. The droplet delivery device of any of claims 45-53, wherein the ejector plate (300) comprises a polymer such as polyether ether ketone or polyimide.

56. The droplet delivery device of any of claims 45-56, wherein the apertures (301) in the ejector plate (300) average about 1 to 2 pm in diameter.

57. The droplet delivery device of any of claims 45-56, wherein the apertures (301) in the ejector plate (300) average about 2 to 5 pm in diameter.Attorney Docket No. 086123-82540558. The droplet delivery device of any of claims 45-56, wherein the apertures (301) in the ejector plate (300) are greater than 5 pm in diameter.

59. The droplet delivery device of any of claims 45-56, wherein the apertures (301) in the ejector plate (300) comprise two or more diameters.

60. The droplet delivery device of any of claims 45-59, wherein the ejector plate carrier (2302) holds the ejector plate (300) in place with one or two O-rings (402).

61. The droplet delivery device of any of claims 45-60, wherein the ejector plate carrier (2302) comprises a material with a high glass transition temperature.

62. The droplet delivery device of claim 61, wherein the ejector plate carrier (2302) further comprises polyphenylsulfone.

63. The droplet delivery device of any of claims 45-62 configured with a pressure drop through the mouthpiece (700).

64. The droplet delivery device of claim 63, wherein the pressure drop is adjustable by the user.

65. The droplet delivery device of any of claims 45-64, wherein the membrane (401) is sealed with one or two o-rings (402).

66. The droplet delivery device of any of claims 45-65, wherein the ejector plate carrier (2302) holds an annulus (901) or annuli (901) with the ejector plate (300).

67. The droplet delivery device of any of claims 45-66, wherein the device includes a support bracket (1000) and / or support brackets (1000) for an ejector plate (300).Attorney Docket No. 086123-82540568. The droplet delivery device of any of claims 45-67, wherein the device has a central axis and the vibrating member (800) and ejector plate (300) are both centered relative to the central axis of the device.

69. The droplet delivery device of any of claims 45-68, wherein the device has a central axis and the vibrating member (800) and ejector plate (300) are both off-center relative to the central axis of the device.

70. The droplet delivery device of any of claims 45-68, wherein the device has a central axis and the vibrating member (800) is off-center relative to the central axis of the device.

71. The droplet delivery device of any of claims 45-68, wherein the device has a central axis and the ejector plate (300) is off-center relative to the central axis of the device.

72. The droplet delivery device of any of claims 45-71, wherein vibrating member (800) has a central axis and the membrane (401) is centered relative to the central axis of the vibrating member (800) .

73. The droplet delivery device of any of claims 45-72, further comprising a housing for the ejector plate (300) and ejector plate carrier (2302) , wherein the housing further comprises ejector bracket vents (1202).

74. The droplet delivery device of claim 73, wherein the ejector bracket vents (1202) and / or cartridge vents (1101) contain a spiral configured to limit evaporation of liquid through the ejector bracket vents (1202) and / or cartridge vents (1101).

75. The droplet delivery device of any of claims 45-74, wherein the device is configured to reduce heavy metals leeching into the fluid pathway.

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