CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. provisional application no. 63/280,717, filed November 18, 2021 , the disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present application incorporates the contents of (a) Provisional Patent Application No. 63/280,643 filed November 18, 2021 , entitled “PUSH MODE DROPLET DELIVERY DEVICE”, (b) Provisional Patent Application No. 63/256,546 filed October 16, 2021 , entitled “DROPLET DELIVERY DEVICE WITH MEMBRANE- DRIVEN AEROSOLIZATION”, (c) Provisional Patent Application No. 63/256,245 filed October 15, 2021 , entitled “DROPLET DELIVERY DEVICE WITH HEATED AIRSTREAM”, (d) Provisional Patent Application No. 63/213,634 filed June 22, 2021 , entitled “ULTRASONIC BREATH ACTUATED PULMONARY DROPLET DELIVERY DEVICE AND METHODS OF USE”, and (e) U.S. Patent No. 11 ,110,000 entitled “SPRAY EJECTOR MECHANISMS AND DEVICES PROVIDING CHARGE ISOLATION AND CONTROLLABLE DROPLET CHARGE, AND LOW DOSAGE VOLUME OPHTHALMIC ADMINISTRATION” issued September 7, 2021 , together herein by reference in their entirety (including such publications and patent applications, herein also included by reference in their entirety, as are cited and incorporated by reference or relied upon in the foregoing disclosures).

SUMMARY OF THE INVENTION

[0003] Push mode technology as disclosed in Provisional Patent Application No. 63/280,643 filed November 18, 2021 , entitled “PUSH MODE DROPLET DELIVERY DEVICE,” is adapted for ophthalmic delivery of fluids in embodiments of the present invention. In embodiments, push mode technology presents an improved and biocompatible option for delivery of fluids to the eyes compared to other technologies for delivering fluid droplets, such as therapeutic and medicinal fluids, to the eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The invention will be more clearly understood from the following description given by way of example, in which:

[0005] FIG. 1 illustrates a cross-sectional view of an eye treatment device incorporating push mode technology in a droplet delivery device according to one embodiment of the present invention.

[0006] FIG. 2 illustrates a cross-sectional view of the ejector and bracket of the eye treatment device of FIG. 1 according to one embodiment of the present invention. [0007] FIG. 3 illustrates a schematic view of a laser system according to one embodiment of the present invention.

DETAILED DESCRIPTION

[0008] In one embodiment shown in FIG. 1 , an eye treatment device 10 includes an enclosure 1512 and an LED light 1220 or light ring that, when seen by the user, properly aligns the eye with the ejector components of the device 10. The eye treatment device 10 then ejects a spray/aerosol comprised of droplets preferably having a size greater than or equal to 18 pm by Volume Median Diameter (VMD). The fluid is held in a reservoir 32 that is positioned above the membrane 25 and mesh 22 interface. The fluid is supplied to the membrane 25 and mesh 22 interface. The device 10 is preferably initiated by pressing a button on the handpiece. A cap can be placed over the guard 1202 to prevent contamination of the mesh 22 and the fluid. A spiral ventilation system keeps evaporation low while allowing for pressure equalization, helping prevent pooling.

[0009] Key components of the ejector bracket to generate precise aerosol include the mesh 22, gasket 1212 (such as an O-ring), membrane 25, vent material 1204, light emitting source 1220 (including LED or laser), and guard 1202. The membrane 25 is positioned such that the membrane 25 face is held parallel to the mesh 22 face, or at a small precise angle. The ejector bracket also has two hollow spikes 28 protruding out of the top that pierce the lower container 1210. One spike is for piercing the fluid reservoir 32 for fluid supply, and the other spike provides a ventilation path for air generated by ejection. On the side of the ejector bracket with the air ventilation spike, there is an opening covered by vent material 1204 to help relieve pressure and build-up of air. The guard 1202 is positioned following the face of the mesh 22, to keep the cartridge components a distance away from the eye.

[0010] Key components of the container parts to maintain consistent aerosol are an upper container 1206, lower container 1210, vent material 1204, a spiral air exchange outlet 30, septa 1226, and septa caps 1228. The vent material 1204 is positioned between the fluid in the fluid reservoir 32 and the spiral air exchange outlet 30. The spiral outlet 30, which minimizes evaporation of fluid through the vent material 1204, is created by the upper container 1206 and vent spacer 1208. The vent spacer 1208 is bonded onto the top of the upper container 1206 to create the sealed spiral air exchange outlet 30 with an opening to the inside of the container assembly and another opening to atmosphere. The septa 1226 are at the bottom of the lower container 1210. The septa 1226 are placed into a cavity in the lower container 1210 and held in place with septa caps 1228 that are bonded onto the lower container 1210. When the ejector bracket and container are assembled together, the spikes on the ejector bracket pierce the septa 1226 on the lower container 1210. The ejector bracket and container are shown in FIG. 2.

[0011] A device cap (not shown) is preferably placed on the guard 1202 and is designed to create a firm seal around the cartridge after each use. An O-Ring 1212 is seated on a spring-loaded plastic piece, i.e. faceplate 1224, which lightly compresses onto the cartridge assembly when the cap is closed, generating a seal between the cartridge and open atmosphere. There are preferably clips in the cap that lock into the guard 1202 to ensure the cap stays secure. Another embodiment includes a screw lock instead of clips. Another embodiment incudes a hinge cap instead of clips.

[0012] Assembly of the device is performed by pushing the container components into the ejector bracket system, which is then pushed into the eye treatment device. In some embodiments, the ejector bracket is not removeable from the eye treatment device.

[0013] Referring again to FIG. 1 , push mode technology in the eye treatment device 10 utilizes a vibrating member and transducer 1502 that couple to and work in conjunction with a membrane 25 and mesh 22 to aerosolize fluid from reservoir 32 and supplied to the mesh 22 using various methods in different embodiments (e.g., wick material, hydrophilic coatings, capillary action, etc.). The vibrating member and transducer 1502 interact with the membrane 25 to push fluid through the mesh 22. The transducer may consist of one or more of a variety of materials (e.g., PZT, etc.). The vibrating member may be made of one or more of a variety of different materials (e.g., titanium, etc.). The mesh 22 may be one or more of a variety of materials (e.g., palladium nickel, polyimide, etc.). The transducer oscillates as it converts electrical energy into mechanical energy. The oscillation is transferred to the vibrating member and membrane 22. As the vibrating member oscillates, an aerosolized spray is formed as fluid is “pushed” by the membrane 25 through the through the mesh 22. In embodiments of push mode, the vibrating member and transducer 1502 are isolated from the fluid from fluid reservoir 32 by membrane 25, thereby enhancing the biocompatibility of the device 10. In another embodiment, the device contains wicking material to assist in the delivery of fluid to the mesh.

[0014] The mesh 22 may have hydrophilic or hydrophobic treatments on either side in any combination to mitigate leaking. By using such treatments and different hole sizes (0.5um-100um) on either side of the mesh 22, the ejection can be made to have a more uniform droplet size.

[0015] The device 10 is tunable and precise. The device can be optimized for individual user preferences or needs. The aerosol mass ejection, plume geometry, and MMAD can be tuned to desired parameters via the mesh hole size, mesh treatment, membrane design, vibrating member design, airflow, manipulation of power to the transducer, etc. to meet users’ needs.

[0016] In one embodiment, there is a base that the device 10 can be placed to charge and recharge the battery with electrode 1506 connected to printed circuit board (PCB) 1508 though an electronic connection 1510, such as LISB-C. The device can be inductively charged using the base, allowing it to be waterproof.

[0017] Referring to FIG. 3, in one embodiment, once the device is turned on, there is a photosensor 1514 looking for the reflection of the light emitting source 1516, such as an LED or laser. This is shown together as one light emitting source unit 1220 in FIG. 2. When the eye is detected to be adequately aligned, such as when aligned to a pupil that does not produce a reflection, ejection is initiated automatically. The photosensor and light emitting source 1516 are connected to the PCB 1508. The software tells the circuit to turn the light emitting source 1516 on. The software reads the photosensors until the correct reading is measured. At that point, the ejection is initiated automatically.

[0018] In one embodiment, the light emitting source 1516 is in the infrared spectrum. [0019] In another embodiment, a laser-based system can be used to characterize certain conditions in the eye.

[0020] In another embodiment, a laser-based system (see FIG. 3) or LED as the light emitting source 1516 works alone or in conjunction with a photodetector 1514. [0021] In one embodiment, a laser system has an array of lasers and sensors to create a map of the eye as shown in FIG 3. In another embodiment, there is a laser coupled to or integrated in device 10 that uses lidar to build a map of the eye to diagnose and record treatment of glaucoma, the information is send to the physician. [0022] In another embodiment, the device uses a digital micromirror device (DMD) in conjunction with the laser system to create a map of the eye to help in glaucoma diagnosis and treatment.

[0023] In another embodiment, a camera coupled to on integrated in the device 10 that takes an image of the user’s eye and sends it to the physician and health care provider. In embodiments time lapse imagery may be made of the treated eye.

[0024] In another embodiment, the device is coupled to or has integrated lidar (or radar) to determine how far away the ejection port is from the eye.

[0025] In another embodiment, the device has a beeping sound that beeps quickly or slowly to guide the user in aligning the ejection port with the user’s eyes.

[0026] In one embodiment, the lidar works in conjunction with the sound system to optimize delivery distance from the ejector to the eye.

[0027] In another embodiment, the device is connected to an app that helps the user, physician, and health care provider record and track dosage information of delivery of the fluid droplets.

[0028] In another embodiment, the device uses replaceable batteries (such as AAA, AA, button, lithium and the like) instead of a rechargeable battery.

[0029] In one embodiment, the device has a system that can zero the charge of the droplets in the aerosol. In addition, the device has a system that can intentionally charge the droplets in the aerosol to the opposite charge of the eye. Both systems work to ensure deposition onto the eye which increases bioavailability (refer to Corinthian patent application publication no. LIS20140336618 incorporated herein by reference).

[0030] Preferable parts and features in an embodiment of the invention with corresponding reference numerals that are described and illustrated herein include the following set forth in Table 1 : [0031] Table 1 [0032] One embodiment of the invention, as shown in FIG. 1 , includes a droplet delivery device including an upper cartridge portion and lower handle portion; an outlet with an adjacent eye alignment guide extending outward from the device and a light emitting source adjacent the alignment guide at the upper cartridge portion of the delivery device; an ejection generator in fluid communication with the outlet, the ejection generator including a mesh with a membrane operably coupled to an electronic vibrating member with the membrane between the vibrating member and the mesh, wherein the mesh includes a plurality of openings formed through the mesh’s thickness and wherein the vibrating member is coupled to a power source in the lower handle portion and is operable to oscillate the membrane and generate an ejected stream of droplets through the mesh; and a fluid reservoir positioned above the ejection generator when the lower handle portion is positioned below the outlet, wherein the fluid reservoir is in fluid communication with the mesh and membrane.

[0033] In embodiments, the vibrating member includes a central axis that is not coaxial to a central axis of the lower handle portion. In other words, the vibrating member has a different positional orientation with a central axis that is not parallel to central axis of the handle portion. Preferably the vibrating member and outlet are generally aligned horizontally with respect to the upper cartridge and the lower handle portion is generally aligned vertically with respect to the upper cartridge when the device is positioned with the upper cartridge on top of the device and above the lower handle portion (see FIG. 1 ).

[0034] In embodiments, the light emitting source is operatively coupled to a photosensor.

[0035] In further embodiments, the light emitting source includes a LED or laser.

[0036] In some embodiments, a droplet delivery device for eye treatment in a push mode configuration includes an array of light emitting sources.

[0037] In one embodiment, a droplet delivery device for eye treatment in a push mode configuration produces produce fluid droplets having a droplet size greater than or equal to 18 pm by Volume Median Diameter.

[0038] In further embodiments, a droplet delivery device for eye treatment in a push mode configuration includes an eye proximity sensor coupled to a sound notification speaker to notify a user when the eye is positioned properly. In some embodiments, the eye proximity sensor includes radar or lidar detection. [0039] In preferable embodiments, a droplet delivery device for eye treatment in a push mode configuration includes a cap that seals over the guide. In some embodiment the device further includes a spring-loaded component coupled to the cap and compressing onto the cartridge assembly when the cap is closed to create a seal between the cartridge and open atmosphere.

[0040] In preferable embodiments a fluid reservoir of an eye treatment droplet delivery device includes a therapeutic fluid that treats eyes. Therapeutics fluids may include pharmaceuticals, medicinal compositions, DNA, RNA and gene therapies, lubricants, cleansers, and like fluids providing beneficial treatment of eyes. [0041] Various embodiments of the invention have been described. It will, however, be evident that various modifications and changes may be made thereto, and additional embodiments may be implemented, without departing from the broader scope of the invention as set forth by the claims. This specification is to be regarded in an illustrative rather than a restrictive sense.