Vented multi-dose eye drop delivery system

Abstract

A handheld dispensing system device is disclosed. An embodiment of the dispensing device includes a first passageway that directs liquid from an ampoule to a chamber having an opening through which liquid from the ampoule can be dispensed. The device includes an actuator that vibrates a membrane to dispense liquid through the membrane. The device further includes a second passageway that communicates with the interior of the ampoule and the atmosphere to equalize pressure within the ampoule as liquid is dispensed. The second passageway can be designed to sufficiently prevent liquid from flowing out of the second passageway.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 337,372, filed May 2, 2022, the disclosure of which is incorporated herein by reference in its entirety, for all subject matter common to both applications.

[0002] The present disclosure relates to the topical intraocular administration of ophthalmic drugs. [Background technology]

[0003] Currently, pharmaceutical fluids are commonly administered to the ocular surface using eye drop bottles. This method has several drawbacks: (1) patients are unable to aim at the eye and often miss their eye; (2) the volume of the drop from the bottle is not properly defined (on the order of 50 pL), which is too large for the tear film on the cornea to absorb—the tear film can only hold approximately 7 pL or less; and (3) patients often blink during eye drop administration, causing part of the drop to fall onto their eyelid and the remainder to be wiped off the cornea. Summary of the Invention

[0004] The present disclosure provides methods and devices that address these problems by (1) administering an essentially precise amount of fluid or liquid, (2) administering a minute volume (e.g., less than 10 μL) that can be retained by the tear film, (3) administering the volume of liquid within the blink reflex time (e.g., approximately 100 ms), and (4) using a visual aiming structure for precise self-administration of the liquid.

[0005] In one embodiment, a handheld device for dispensing a liquid into a patient's eye is provided. The device includes a first passageway for directing the liquid from an ampoule to a chamber, the chamber having a) an opening through which the liquid from the ampoule can be dispensed, and b) a membrane designed to hydrodynamically excite the liquid to dispense through the opening. The device also includes an actuator designed to vibrate a rod engaging the membrane such that the membrane hydrodynamically excites the liquid to open the opening and allow the liquid to be dispensed therethrough. The device further includes a second passageway having a first end in fluid communication with at least one of the first passageway and the ampoule, a second end exposed to the atmosphere, and a stopper designed to prevent fluid from exiting through the second end of the second passageway.

[0006] In some embodiments, the chamber may further include a valve member extending from the membrane. The valve member is engaged in the opening in a closing configuration and disengaged from the opening when the actuator oscillates the connecting rod. In embodiments, the valve member and the membrane may be a unitary piece.

[0007] In some embodiments, the device may further include a cap designed to cover the opening, and the cap may include a plug designed to enter the opening and displace liquid within the opening.

[0008] In some embodiments, the second passageway may further include an air filter designed to sterilize air entering the ampoule from the atmosphere as liquid is dispensed. In embodiments, the air filter may be designed to remove particles larger than 0.22 microns. In some embodiments, the air filter may be designed to remove contaminants and microorganisms from the air entering the ampoule. In embodiments, the air filter may be a hydrophobic material such that contact between the air filter and the liquid in the ampoule has minimal effect on air filtration and airflow into the ampoule.

[0009] In some embodiments, the stopper may be a one-way valve designed to prevent liquid in the ampoule from flowing out of the passageway. In embodiments, the second passageway may be sealed. In some embodiments, the second passageway may further be designed to equalize pressure.

[0010] In another embodiment, a handheld device for dispensing a liquid to a target site is provided. The device includes a first passageway for directing the liquid from an ampoule to a chamber, the chamber having a) a membrane and a pin designed to hydrodynamically excite and dispense the liquid, and b) a sealable opening through which the liquid from the ampoule can be dispensed, with the pin received within the opening to seal the opening. The device also includes an actuator designed to vibrate the membrane and the pin to disengage the pin from the opening and dispense the liquid therethrough. The device further includes a second passageway, the second passageway having a first end in fluid communication with at least one of the first passageway and the ampoule, a second end exposed to the atmosphere, and a stopper designed to prevent fluid from flowing out of the second end of the second passageway regardless of the orientation of the liquid within the ampoule.

[0011] In some embodiments, the device may further include a cap designed to cover the opening, and the cap may include a plug designed to enter the opening and displace liquid within the opening.

[0012] In some embodiments, the second passageway may include an air filter designed to sterilize air entering the ampoule from the atmosphere as liquid is dispensed. In embodiments, the air filter may be designed to remove particles larger than 0.22 microns. In some embodiments, the air filter may be designed to remove contaminants and microorganisms from the air entering the ampoule. In embodiments, the air filter may be a hydrophobic material such that contact between the air filter and the liquid in the ampoule has minimal effect on air filtration and airflow into the ampoule.

[0013] In some embodiments, the stopper may be a one-way valve designed to prevent liquid in the ampoule from flowing out of the second passageway. In embodiments, the second passageway may be sealed. In some embodiments, the second passageway may further be designed to equalize pressure.

[0014] These and other features of the present disclosure will be more fully understood by reference to the following detailed description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 illustrates a geometry for administering a liquid to a patient's eye, according to an embodiment. [Figure 2] FIG. 2 is an external view according to the embodiment. [Figure 3A] FIG. 3A is a cross-sectional view according to an embodiment. [Figure 3B] FIG. 3B illustrates operation of the embodiment of FIG. 3A according to an embodiment. [Figure 3C] FIG. 3C illustrates operation of the embodiment of FIG. 3A according to an embodiment. [Figure 4A] FIG. 4A shows an example of ventilation according to an embodiment. [Figure 4B] FIG. 4B shows an example of ventilation according to an embodiment. [Figure 5] FIG. 5 shows a cross-sectional view according to an embodiment. [Figure 6] FIG. 6 shows a conical spring according to an embodiment. [Figure 7] FIG. 7 shows an embodiment having an anti-clogging configuration according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0016] While the above-identified drawings illustrate embodiments disclosed herein, other embodiments are contemplated as set forth in the description. The present disclosure presents exemplary embodiments by way of example and not limitation. Numerous other variations and embodiments may be devised by those skilled in the art which fall within the scope and spirit of the principles of the embodiments disclosed herein.

[0017] The present disclosure generally relates to a handheld device for dispensing a liquid to a desired location or target area, such as a patient's eye. For example, the present disclosure relates to a device having an ampoule containing a liquid and an assembly having a membrane that, when actuable, can generate hydrodynamic pressure in the liquid toward an opening sealed by the membrane. An actuator can be provided to vibrate a sealing member connected to the membrane to generate hydrodynamic excitation of the liquid, while unsealing the opening through vibrations applied to the sealing member so that the liquid can be dispensed through the opening.

[0018] 1-7, in which like parts are designated with like numerals throughout, there are shown exemplary embodiments or embodiments of a device for dispensing a liquid into an eye in accordance with the present disclosure. While the present disclosure will be described with reference to the exemplary embodiment or embodiments shown in the drawings, it should be understood that numerous alternative forms may embody the present disclosure. Those skilled in the art will further appreciate various ways to modify the parameters of the disclosed embodiments, such as the size, shape, or type of elements or materials, in a manner that is still consistent with the spirit and scope of the present disclosure.

[0019] FIG. 2 illustrates a perspective view of a liquid dispensing unit according to an embodiment. The liquid dispensing unit 200 may be suitable for use in administering a liquid, such as a preservative-free medicinal solution, to the surface of the eye. Alternatively, the liquid dispensing unit 200 may be used with any desired liquid. In one embodiment, the liquid dispensing unit 200 may include a thermoplastic body 206 configured with a liquid chamber 216 and connected to a liquid supply ampoule 202. In an embodiment, as shown in FIG. 2, the dispensing unit 200 may also include a nozzle, i.e., an opening 208, through which a liquid stream 210 can be dispensed.

[0020] FIG. 3A illustrates a cross-sectional view of a liquid ejection device 300 according to an embodiment. Similar to the liquid ejection unit 200, the liquid ejection device 300 may, in embodiments, include a thermoplastic body 206 defining a chamber 316 connected to a liquid supply ampoule 202 containing a liquid 302. The liquid ejection device 300 may, in embodiments, also include an opening 208 through which the liquid 302 can be ejected. The device 300 may, in embodiments, further include a membrane 308 disposed on the opposite side of the chamber 316 from the opening 208. The membrane 308 may, in embodiments, include an integral needle 306, i.e., a valve member, which may be a single or integral part therewith. Alternatively, the needle 306 may not be integral with the membrane 308. In some embodiments, the needle 306 and membrane 308 may be connectable to an electromagnetic transducer 310 via a link member 318. In some embodiments, the electromagnetic transducer 310 may be any suitable actuator, such as a coin cell battery motor. In an embodiment, when an electrical pulse is applied to the electromagnetic transducer 310, a current flows through the coil 312, generating a magnetic force that pulls the plunger 314 backward against the spring 320. Figure 3A shows the direction 304 of flow of the liquid 302 from the ampoule 202 into the chamber 316.

[0021] FIG. 3B shows the device of FIG. 3A after application of an electrical pulse to the electromagnetic transducer 310, according to an embodiment. As a result of the magnetic force, the plunger 314 becomes actuatable such that the plunger 314 can be pulled by the electromagnetic transducer 310 in the direction indicated by arrow 315. The membrane 308, connected to the plunger 314 by a link member 318, can be further pulled backward. FIG. 3C shows the state when the electromagnetic transducer 310 is de-energized. In the illustrated embodiment, a spring 320 urges the membrane 308 back to its original position, thereby closing the opening 208 and sealing the chamber to prevent the entry of microorganisms. This actuation can be repeated to expel the liquid 302 from the device 300 multiple times in rapid succession.

[0022] For example, in embodiments, electromagnetic transducer 310 can be energized with a pulsed or alternating current (AC) current to vibrate membrane 308 and generate pressure within liquid 302. The pressure within liquid 302 can then generate stream 210 that is expelled from opening 208. In embodiments, the operating frequency can be about 10 to about 500 Hz, more specifically about 50 to about 200 Hz. In embodiments, membrane 308 is made of silicone having a durometer of about 50 to about 70 (Shore A), and plunger 314 can have a displacement of about 200 μm. In some embodiments, the flow of liquid 302 can be generated only outward, as shown by stream 210, so that the flow of liquid 302 can prevent the entry of microorganisms even when opening 208 is open.

[0023] In some embodiments, as shown in FIGS. 4A-4B, the liquid dispensing device 300 can include a venting arrangement for equalizing pressure within the ampoule 202 with atmospheric pressure. Here, FIG. 4A shows a cross-sectional view taken along line E-E in FIG. 4B. In embodiments, the venting system can include an air inlet vent tube 404 that can extend above the level of the liquid 302 within the ampoule 202. Note that the vent tube 404 can be positioned above the level of the liquid 302 in either orientation of the device 300 of FIGS. 4A-4B. In the illustrated embodiment, the vent tube 404 can be connected to a vent outlet 406 that can be open to the atmosphere. The vent tube 404, when in fluid communication with the atmosphere and the ampoule 202, can equalize pressure within the ampoule 202 and prevent a pressure vacuum from forming when the liquid 302 is dispensed through the opening 208. In embodiments, a filter 408 may be disposed at the vent outlet 406 so that the vented air flowing through the ampoule 202 may be filtered to prevent the ingress of potential airborne contaminants, such as microorganisms. In embodiments, the filter 408 may filter out particles greater than 1 μm, more preferably greater than 0.5 μm, and even more preferably greater than 0.2 μm in size. In this manner, the system may be isolated from microbial contamination even if air 402 enters the ampoule 202 when the liquid is allowed to be released.

[0024] In the above example, the diaphragm, i.e., membrane 308, can be actuated by a solenoid. In an alternative embodiment, as shown in FIG. 5, membrane 308 can be actuated using a coin-type vibration motor 502. More specifically, needle 306 can be engaged with membrane 308. The needle 306 and membrane 308 assembly, in embodiments, can be overmolded with a magnetic steel pin 510. In one embodiment, coin-type vibration motor 502 can be manufactured by JINLONG MACHINERY & ELECTRONICS CO., LTD., model number #C1026B002F. In embodiments, motor holder 504 can be a plastic molded part that holds motor 502 so that it can slide along a rail. Rail guide part 506 can be a plastic molded part that can provide the rail guide for motor holder 504 to slide within. In some embodiments, magnetic steel pin 510 can be molded into the membrane 308 and needle 306 assembly. A housing 512 may, in an embodiment, hold all of the components together.

[0025] In one embodiment, an electromagnetic transducer 310 may be mounted in the housing 512 and, when energized, may pull the membrane 308 backward within the chamber 316 against a spring 320. In embodiments, when the electromagnetic transducer 310 is turned off, the spring 320 closes the opening 208 and returns the membrane 308 to its original position. In embodiments, when the electromagnetic transducer 310 is energized with a pulsed or alternating current, the membrane 308 may result in vibration, which generates pressure within the liquid 302. At the appropriate frequency, the pressure may be sufficient to eject a stream of the liquid 302 from the opening 208. In this embodiment, a typical range of frequencies may be from about 10 Hz to about 500 Hz, more optimally from about 50 Hz to about 200 Hz. The diameter of the opening 208, the ejection rate of the liquid 302, and the duration of the electromagnetic burst may, in embodiments, be optimized to dispense a desired amount of the liquid 302 within a desired time period. According to one embodiment of the present invention, the actuation pulse duration may be about 250 ms or less, and in some embodiments, about 100 ms or less. It should be understood that "actuation pulse duration" refers to the length of time that the electromagnetic transducer may be energized to withdraw the needle 306 from the opening 208 with a single actuation pulse.

[0026] In an alternative embodiment, the actuator may be a coin-shaped vibration motor 502 that may have an eccentric weight offset from its axis of rotation (the axis of rotation may be perpendicular to the plane of FIG. 5 ). Because the weight may be offset from the axis, the unbalanced weight causes the motor 502 to vibrate primarily in the plane of FIG. 5 as the motor rotates. By placing the coin-shaped vibration motor 502 in a plastic motor holder 504 that fits into a corresponding rail (in rail guide assembly 506), the coin-shaped vibration motor 502 is constrained so that, in embodiments, it can only move in a straight line, as indicated by arrow 514 (e.g., left to right in FIG. 5 ). As a result of this physical constraint, in the illustrated embodiment, as the motor 502 rotates, it can only vibrate from left to right, rather than vibrating in a plane. The coin-shaped vibration motor 502 is coupled to the membrane 308, so that as the motor 502 vibrates from left to right, the membrane 308 can also vibrate from left to right. Again, in the illustrated embodiment, the ejected liquid stream 210 is generated in the same manner as above, i.e., the needle 306 moves back and forth within the opening 208 to eject the liquid 302. In some embodiments, the tip of the needle 306 and / or the opening 208 it engages may include or consist of an antimicrobial material.

[0027] To assist the needle 306 in sealing the opening 208, the embodiment of FIG. 5 may include a Belleville spring 320. The spring 320 is slightly deformable out of plane during assembly and acts to transfer a force to the needle 306. This force, or load, can keep the needle 306 pressed against the orifice, i.e., the opening 208, closing the flow path. In the illustrated embodiment, without the spring 320, too little force would be required to urge the needle 306 open the opening 208, which would result in leakage of the liquid 302. Additionally, the spring 320 has a spring constant that is important to ensure the proper frequency and amplitude of oscillation of the needle 306 when the motor 502 is energized. Also important to the illustrated embodiment is that without the spring 320 maintaining the opening 208 in the closed, sealing position with the needle 306, the only force keeping the needle 306 and opening 208 in the closed position would be the stiffness of the membrane 308. In embodiments, membrane 308 may be made of an elastomer. Most elastomers have large variations in mechanical properties over even moderate temperature changes. In embodiments with spring 320, the majority of the load applied to needle 306 comes from spring 320 rather than membrane 308. Adding a spring to the illustrated embodiment may result in more consistent system performance because the mechanical properties of spring steel (e.g., the material of spring 320) may be more consistent over the same temperature change.

[0028] In an alternative embodiment, the coin-shaped vibration motor 502 may be coupled to the diaphragm or membrane 308 via an optional magnet 508. The magnet 508 may be secured to a motor holder 504 that may be affixed to the coin-shaped vibration motor 502. When the magnet 508 approaches a magnetic steel pin 510, in this embodiment, the two may lock together, thereby coupling the motor 502 to the membrane 308. This may be an advantageous assembly feature for the embodiment because the motor 502 may be easily added to a system without requiring tight tolerances, and the motor 502 may be added at multiple different steps in the assembly process depending on manufacturing requirements.

[0029] In an alternative embodiment, the Belleville spring 320 of FIG. 5 may be replaced with a conical spring 600, as shown in FIG. 6. In the illustrated embodiment, the conical spring 600 may be similar to a traditional compression spring made of wire, but rather than being wound at a constant diameter, the diameter may start at a larger diameter 604 and taper to a smaller diameter 602 so that the spring has a conical shape. In an embodiment, when the conical spring 600 is fully compressed, the coils 606 nest within each other, causing the spring 600 to flatten and become only as thick as the diameter of the wire 608 around which it is wound. Thus, a fully compressed conical spring 600 may fit in a similar form factor and perform the same function as the Belleville spring 320 of FIG. 5. The conical spring 600 is less expensive and easier to obtain over a wide range of spring constants and operating excursions compared to the Belleville spring 320.

[0030] For convenient aiming of the liquid dispensing device 102, the device 102 may be positioned near the eye without contacting the user's eyelashes or eyebrows. Thus, with reference to FIG. 1, the device 102 may be approximately L=1-10 cm from the eye, more optimally about 2-6 cm. The cornea may have an approximate diameter D=12 mm, i.e., a radius of about 6 mm. To ensure that the liquid 104 can be dispensed approximately at the center of the cornea, the ejected jet of liquid 104 may not deflect more than about half the radius of the cornea under gravity, i.e., about h=3 mm or less. As shown in FIG. 1, the vertical deflection h of a projectile ejected horizontally at a velocity v over a distance L is calculated as h=g×L / (2v), where g is gravity. 2 ) To ensure that the vertical deflection does not exceed h, the horizontal ejection velocity is v = L × (g / 2L) 0.5 For example, L=5cm, g=9.8m / s 2 For L=5 cm and h=1 mm, the velocity should be approximately v=3.6 m / s, and for L=10 cm and h=1 mm, the velocity should be v=7.2 m / s. Overall, therefore, the jet velocity can range from about 1 to 10 m / s, more optimally from about 2 to 4 m / s. Velocities higher than these can cause discomfort to the patient and may damage the cornea.

[0031] The stream of liquid 104 can reach the eye within a few milliseconds from the moment of dispensing (t=L / v, in the range of about 1-100 ms). As soon as the liquid 104 contacts the cornea or eye 106, it triggers a blink reflex, which can typically take T=about 100 ms. To avoid blocking the medication by the eyelid, the liquid 104 can be administered before the eye 106 closes. For the required volume V to be administered at a jet velocity v within time T, the jet cross-sectional area is S=V / (T×v). Thus, for a round aperture 208, S=π×d 2 / 4, its diameter d = (4V / (πT × v)) 0.5 For example, for v=2 m / s, T=100 ms, and V=10 μL, d=250 μm. For v=1 m / s, d=350 ms, and for v=7 m / s, d=130 ms. Thus, the aperture diameter of device 102 may range from about 200 to 600 μm, more optimally from about 400 to 550 μm. Alternatively, multiple apertures 208 may be used to generate multiple parallel streams for faster administration.

[0032] Another attribute of system embodiments can be to prevent the ingress of microorganisms into the contained liquid 302 during storage or use. As with any closure system, air should be introduced to equalize (vent) the pressure within the ampoule 202 by replacing the dispensed volume as the liquid 302 is dispensed. To exclude the ingress of microorganisms, air can be introduced in embodiments through a special inlet, preferably with a 0.2 μm filter. Ideally, the device operates such that whenever the opening is open, the liquid 302 can be dispensed through the opening, thereby preventing the ingress of air through the opening.

[0033] Referring now to FIG. 7 , an alternative venting system may be provided to achieve this pressure equalization. For simplicity, portions similar to those described in the previous embodiment will not be described. The alternative venting system embodiment shown in FIG. 7 may provide sterile venting of ambient air within ampoule 202 by providing a passageway, i.e., vent channel 120, that may communicate between the interior of ampoule 202 and the atmosphere. Vent channel 120 may have an air outlet port 121 within ampoule 202 and an outside air inlet port 122 that may be open to the atmosphere. In the illustrated embodiment, the path of vent channel 120 is shown with a dashed line. In alternative embodiments, vent channel 120 may be located in various locations, such as on the side, top, or bottom of ampoule 202. Also, while vent channel 120 is shown as a curve, in alternative embodiments, it may extend along a path of any shape. For example, vent channel 120 may be straight. In embodiments, vent channel 120 may equalize pressure between ampoule 202 and atmospheric pressure. In the previous embodiment, a vent tube 404 was disclosed and may provide a similar function. The embodiment shown in Figure 7 has the additional advantage of not requiring a vent tube, which would require the top of tube 404 to be positioned above liquid 302; further, removal of tube 404 allows for a larger volume for liquid 302 within ampoule 202.

[0034] In some embodiments, there may be a stopcock, i.e., valve 150, within vent channel 120 that may prevent liquid 302 from flowing out regardless of the orientation of device 100, while allowing air flow into ampoule 202 when liquid 302 is available for dispensing through opening 208. In one embodiment, the stopcock within vent channel 120 may include a one-way valve 150 or check valve positioned between filtration member 140 and ambient air inlet port 122. In an embodiment, valve 150 may be a duckbill valve manufactured by MiniValve, model number DU02.001SD.vl. In alternative embodiments, the check valve may be a ball check valve, a diaphragm check valve, a stop check valve, or other similar one-way valve. Once assembled, valve 150, in embodiments, is placed within vent channel 120 and filter member 140 is welded or secured to surface 122A, thereby sealing vent channel 120 at ambient air inlet port 122. While welding filter member 140 to surface 122A can be one method for sealing vent channel 120, in alternative embodiments, one-way valve 150 can form a seal by itself without welding the surfaces together. Any sealing structure, i.e., valve 150, can be used. In other words, any one-way valve or check valve that allows air to flow through the valve while preventing liquid from escaping through the valve can be used.

[0035] The vent system, in embodiments, may further include a filter element 140 capable of filtering out particles larger than approximately 0.22 μm. The filter element may be made of a hydrophobic material such that contact of the filter element 140 with aqueous solutions minimizes the impact on air filtration and airflow. In such embodiments, resistance to airflow is unaffected by contact with the liquid 302 or aqueous solutions due to the hydrophobic 0.22 micron filter. The hydrophobic filter may provide sterility assurance, high flow rate, and high throughput. In embodiments, the filter element may be made of polyvinylidene fluoride (PVDF), which can reliably filter out contaminants and microorganisms. Alternatively, the filter element may be made of metal, ceramic, or other plastic, as long as the filter element 140 can effectively sterilize the air introduced into the ampoule 202 through the vent channel 120. In some embodiments, the vent channel 120 may have a one-way valve 150 positioned between the filter element 140 and the ambient air inlet port 122, so that the valve 150 can be used to preclude physical contact of the liquid 302 with the filter element.

[0036] With further reference to FIG. 7 , the illustrated embodiment of dispensing device 100 may further include means for preventing clogging of dispense opening 130. This configuration may be particularly effective when liquid 302 leaves solid residue within opening 130. The clogging prevention system, in embodiments, may include an elongated dispense port, i.e., opening 130, through which droplets can be dispensed, and further includes a screw-on cap having a concentric pin 161, i.e., plug. The screw-on cap is shown in rear view 160R and front view 160F, respectively. In embodiments, when the cap is engaged with the dispensing system, pin 161 may enter dispense opening 130 so that residual liquid 302 within the dispense port can be displaced. In one embodiment, pin 161 and opening 130 may be cylindrical or slightly tapered. In alternative embodiments, pin 161 and opening 130 may have any complementary surfaces such that pin 161 displaces residual liquid 302 from opening 130. In alternative embodiments, the opening 130 may be flat, geometric, or any shape that facilitates dispensing of the liquid 302 therethrough.

[0037] In one method of use, an embodiment of device 100 can be operable to actuate actuator or transducer 310, causing vibrations of membrane 308 and needle 306. These vibrations of membrane 308 and needle 306 hydrodynamically excite liquid 302 within chamber 316, opening opening 130 and allowing device 100 to dispense liquid 302 through opening 130. As liquid 302 is dispensed, air flows into ampoule 202 through vent channel 120. In this manner, the pressure inside ampoule 202 can equalize to atmospheric pressure while the device is dispensing liquid 302, preventing a pressure vacuum from occurring. Once dispensed or during dispensing, liquid 302 can flow from ampoule 202 into chamber 316, replacing the dispensed liquid 302 so that the process can continue and be repeated as described above.

[0038] As used herein, the terms "comprise" and "comprising" are intended to be interpreted as inclusive and not exclusive. As used herein, the terms "exemplary," "example," and "illustrative" are intended to mean "serving as an example, instance, or illustration" and should not be interpreted as indicating or not indicating a preferred or advantageous configuration over other configurations. As used herein, the terms "about," "generally," and "approximately" are intended to encompass variations that may exist at the upper and lower limits of a range of subjective or objective values, such as variations in characteristics, parameters, sizes, and dimensions. In one non-limiting example, the terms "about," "generally," and "approximately" mean plus or minus 10 percent or less. In one non-limiting example, the terms "about," "generally," and "approximately" mean close enough to be considered included by one of ordinary skill in the relevant art. As used herein, the term "substantially" refers to the perfect or nearly perfect degree or extent of an action, feature, characteristic, state, structure, item, or result as would be understood by one of ordinary skill in the art. For example, a "substantially" circular object would mean that the object is either perfectly circular to mathematically determinable limits, or nearly circular as would be recognized or understood by one of ordinary skill in the art. The precise acceptable degree of deviation from absolute perfection may depend on the specific context in some cases. However, in general, the proximity to perfection will be such that the same overall result would be obtained if absolute and total perfection were achieved or obtained.The use of "substantially" is equally applicable when used in the negative to refer to the complete or nearly complete absence of an action, feature, characteristic, state, structure, item, or result, as would be understood by one of ordinary skill in the art.

[0039] Numerous modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in light of the foregoing description. Accordingly, this description is to be construed as illustrative only, and is for the purpose of teaching those skilled in the art the best mode of carrying out the disclosure. Details of construction may vary without materially departing from the spirit of the present disclosure, and the exclusive use of all modifications that fall within the scope of the following claims is reserved. While embodiments have been described herein in a manner permitting a clear and concise specification, it is intended and to be understood that the embodiments can be variously combined or separated without departing from the invention. It is intended that the present disclosure be limited only to the extent required by the following claims and the applicable rules of law.

Claims

1. 1. A handheld device for dispensing a liquid into a patient's eye, comprising: a first passageway for directing the liquid from the ampoule to a chamber, the chamber having a) an opening through which the liquid from the ampoule can be dispensed, and b) a membrane designed to hydrodynamically excite the liquid to dispense through the opening; an actuator designed to vibrate a rod engaging the membrane such that the membrane hydrodynamically excites the liquid to open the opening and allow the liquid to be dispensed therethrough; a second passageway having a first end in fluid communication with at least one of the first passageway and the ampoule, a second end exposed to the atmosphere, and a plug designed to prevent the fluid from exiting through the second end of the second passageway; A device comprising:

2. The chamber comprises:

10. The device of claim 1, further comprising a valve member extending from the membrane, the valve member being engaged in a closing configuration within the opening and disengaging from the opening when the actuator vibrates the rod.

3. 3. The device of claim 2, wherein the valve member and the membrane are one piece.

4. 10. The device of claim 1, further comprising a cap designed to cover the opening, the cap including a plug designed to enter the opening and displace the liquid within the opening.

5. The second passageway includes:

10. The device of claim 1, further comprising an air filter designed to sterilize air that enters the ampoule from the atmosphere as the liquid is dispensed.

6. 6. The device of claim 5, wherein the air filter is designed to remove particles larger than 0.22 microns.

7. 6. The device of claim 5, wherein the air filter is designed to remove contaminants and microorganisms from air entering the ampoule.

8. 6. The device of claim 5, wherein the air filter is a hydrophobic material such that contact between the air filter and the liquid within the ampoule minimizes the effect on air filtration and air flow into the ampoule.

9. 10. The device of claim 1, wherein the stopper is a one-way valve designed to prevent the liquid in the ampoule from flowing out of the passageway.

10. The device of claim 1 , wherein the second passage is sealed.

11. The device of claim 1 , wherein the second passageway is designed for pressure equalization.

12. 1. A handheld device for dispensing a liquid to a target site, comprising: a first passageway for directing the liquid from the ampoule to a chamber having a) a membrane and a pin designed to hydrodynamically excite and dispense the liquid, and b) a sealable opening through which the liquid from the ampoule can be dispensed, the pin being received within the opening to seal the opening; an actuator designed to vibrate the membrane and the pin to disengage the pin from the opening and dispense the liquid therethrough; a second passageway having a first end in fluid communication with at least one of the first passageway and the ampoule, a second end exposed to the atmosphere, and a plug designed to prevent the fluid from exiting through the second end of the second passageway regardless of the orientation of the liquid within the ampoule; 1. A device comprising:

13. 13. The device of claim 12, further comprising a cap designed to cover the opening, the cap including a plug designed to enter the opening and displace the liquid within the opening.

14. The second passageway includes:

13. The device of claim 12, further comprising an air filter designed to sterilize air that enters the ampoule from the atmosphere as the liquid is dispensed.

15. 15. The device of claim 14, wherein the air filter is designed to remove particles larger than 0.22 microns.

16. 15. The device of claim 14, wherein the air filter is designed to remove contaminants and microorganisms from air entering the ampoule.

17. 15. The device of claim 14, wherein the air filter is a hydrophobic material such that contact between the air filter and the liquid within the ampoule minimizes the effect on air filtration and air flow into the ampoule.

18. 13. The device of claim 12, wherein the stopper is a one-way valve designed to prevent the liquid in the ampoule from flowing out of the second passageway.

19. The device of claim 12 , wherein the second passage is sealed.

20. The device of claim 12 , wherein the second passageway is designed for pressure equalization.

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