Ventilated multi-dose ocular fluid delivery system

Abstract

The invention discloses a handheld dispensing system device. Some aspects of the dispensing device include a first passage for directing liquid from an ampoule to a chamber provided with an orifice through which liquid from the ampoule can be dispensed. The device includes an actuator to oscillate the membrane to dispense the liquid through the membrane. The device also includes a second passage in fluid communication with the interior of the ampoule and the atmosphere to balance pressure in the ampoule when dispensing the liquid. The second passage may be sufficiently configured to prevent liquid from escaping through the second passage.

Description

[0001] Cross - reference to related applications

[0002] This application claims the priority and benefit of U.S. Provisional Application No. 63 / 337,372, filed on May 2, 2022, which relates to all the subject matters common to two applications. The disclosure of this provisional application is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention relates to the topical ocular delivery of ophthalmic drugs. Background Art

[0004] Currently, a dropper bottle is commonly used to deliver a medicinal fluid to the ocular surface. This method has many drawbacks. (1) Patients cannot aim well and often miss the eye; (2) the volume of the droplets in the bottle is not well - defined and is too large (on the order of about 50 μL (microliters)) for the tear film on the cornea to absorb it - the tear film can only accommodate no more than about 7 μL, (3) during the droplet delivery process, patients often blink, causing some of the droplets to land on the eyelid and the rest to skim over the cornea. Summary of the Invention

[0005] The present disclosure provides methods and devices for solving these problems by (1) delivering a substantially precise amount of fluid or liquid, (2) delivering a micro - dose (e.g., <10 μL) that the tear film can accommodate, (3) delivering a liquid dose within the blink reflex time (e.g., about 100 ms (milliseconds)), and (4) using a visual aiming structure for precise self - administration of the liquid.

[0006] In one embodiment, a handheld device for dispensing a liquid to a patient's eye is provided. The device includes a first passage for guiding the liquid from an ampoule / vial to a chamber, the first passage being provided with: a) an orifice through which the liquid from the ampoule can be dispensed, and b) a membrane configured to hydrodynamically agitate the liquid and dispense the liquid through the orifice. The device further includes an actuator configured to oscillate a rod engaged with the membrane such that the membrane can hydrodynamically agitate the liquid to open the orifice and dispense the liquid through the orifice. The device further includes a second passage having a first end in fluid communication with at least one of the first passage and the ampoule, a second end exposed to the atmosphere, and a stopper configured to prevent the liquid from escaping through the second end of the second passage.

[0007] In certain embodiments, the chamber may further include a valve member extending from the membrane, wherein the valve member engages within the orifice in a closed configuration and disengages from the orifice when the actuator oscillates the connecting rod. In one embodiment, the valve member and the membrane may be an integral part.

[0008] In some embodiments, the device may further include a cap configured to cover the orifice, where the cap may include a plug configured to enter the orifice to discharge the liquid in the orifice.

[0009] In some embodiments, the second passageway may further include an air filter for disinfecting the air flowing into the ampoule from the atmosphere during liquid dispensing. In one embodiment, the air filter may be configured to remove particles larger than 0.22 μm. In some embodiments, the air filter may be configured to remove contaminants and microorganisms from the air entering the ampoule. In one embodiment, the air filter may be a hydrophobic material such that air filtration and the air flow rate into the ampoule are minimally affected by contact between the air filter and the liquid within the ampoule.

[0010] In some embodiments, the stop may be a one-way valve configured to prevent the liquid in the ampoule from leaving through the passageway. In one embodiment, the second passageway may be sealed. In some embodiments, the second passageway may be further configured to balance pressure.

[0011] In another embodiment, a handheld device for dispensing a liquid to a site of interest is provided. The device includes a first passageway for guiding the liquid from an ampoule to a chamber, the first passageway being provided with: a) a membrane and plunger member configured to hydrodynamically agitate and dispense the liquid, and b) a sealable orifice through which the liquid from the ampoule can be dispensed, wherein the plunger is received within the orifice to seal the orifice. The device further includes an actuator configured to oscillate the membrane and plunger member to disengage the plunger from the orifice and dispense the liquid through the orifice. 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 stop configured to prevent liquid from escaping through the second end of the second passageway regardless of the orientation of the liquid in the ampoule.

[0012] In some embodiments, the device may further include a cap configured to cover the orifice, where the cap may include a plug configured to enter the orifice to discharge the liquid in the orifice.

[0013] In some embodiments, the second passageway may include an air filter for disinfecting the air flowing into the ampoule from the atmosphere during liquid dispensing. In one embodiment, the air filter may be configured to remove particles larger than 0.22 μm. In some embodiments, the air filter may be configured to remove contaminants and microorganisms from the air entering the ampoule. In one embodiment, the air filter may be a hydrophobic material such that air filtration and the air flow rate into the ampoule are minimally affected by contact between the air filter and the liquid within the ampoule.

[0014] In some embodiments, the stop may be a one-way valve configured to prevent liquid in the ampoule from leaving through the second passage. In one embodiment, the second passage may be hermetically sealed. In some embodiments, the second passage may be further configured to balance pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] These and other features of the present disclosure will be more fully understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:

[0016] Figure 1 A geometric shape for delivering liquid to a patient's eye according to one embodiment is shown.

[0017] Figure 2 is an external view according to one embodiment.

[0018] Figure 3A is a cross-sectional view according to one embodiment.

[0019] Figures 3B - 3C Shows Figure 3A the operation of an embodiment according to one implementation.

[0020] Figures 4A - 4B An example of ventilation / exhaust according to one embodiment is shown.

[0021] Figure 5 is a cross-sectional view according to one embodiment.

[0022] Figure 6 A conical spring according to one embodiment is shown.

[0023] Figure 7 An embodiment with anti-clogging features according to one embodiment is shown.

[0024] Although the above drawings illustrate embodiments of the present disclosure, other embodiments are also contemplated as discussed. The present disclosure presents illustrative embodiments in a representative, but not limiting, manner. Those skilled in the art can design many other modifications and embodiments that fall within the scope and spirit of the principles of the embodiments of the present disclosure. DETAILED DESCRIPTION

[0025] The present disclosure generally relates to a handheld device for dispensing a liquid to a desired location or site of interest, such as an eye of a patient. For example, the present disclosure relates to a device having an ampoule for containing a liquid, and a component having a membrane that, when actuated, can create a hydrodynamic pressure / hydrodynamic pressure in the liquid towards an orifice that is sealed by a member. An actuator can be provided to oscillate a sealing member connected to the membrane to create a hydrodynamic excitation in the liquid while opening the orifice by the oscillation provided to the sealing member so that the liquid can be dispensed through the orifice.

[0026] Regarding Figures 1 - 7 , in which like parts are always denoted by like reference numerals, there are shown one or more embodiments of a device for dispensing a liquid to an eye in accordance with the present disclosure. Although the present disclosure will be described with reference to one or more exemplary embodiments shown in the drawings, it should be understood that many alternative forms can also implement the present disclosure. Those skilled in the art will additionally envision different ways of varying the parameters (e.g., dimensions, shapes, or types of elements or materials) of the disclosed embodiments while still complying with the spirit and scope of the present disclosure.

[0027] Figure 2 A perspective view of a liquid ejection unit according to one embodiment is shown. The liquid ejection unit 200 can be adapted to deliver a liquid, such as a preservative-free pharmaceutical liquid, to the surface of an eye. Optionally, the liquid ejection unit 200 can be used with any desired liquid. In one embodiment, the liquid ejection unit 200 can include a thermoplastic body 206 that is formed with a liquid chamber 216 and is connected to a liquid supply ampoule 202. In one embodiment, as Figure 2 shown, the ejection unit 200 can also include a nozzle or orifice 208 through which a liquid stream 210 can be dispensed.

[0028] Figure 3AFIG. shows a cross-sectional view of a liquid ejection device 300 according to an embodiment. Similar to the liquid ejection unit 200, in one embodiment, the liquid ejection device 300 may include a thermoplastic body 206 that defines a chamber 316 connected to a liquid supply ampoule 202 containing a liquid 302. In one embodiment, the liquid ejection device 300 may further include an orifice 208 through which the liquid 302 may be ejected. In one embodiment, the device 300 may further include a membrane 308 disposed on a side of the chamber 316 opposite the orifice 208. In one embodiment, the membrane 308 may include an integral needle 306 or valve member such that they may be a single component or a single integral part. Alternatively, the needle 306 may not be integral with the membrane 308. In some embodiments, the needle 306 and the membrane 308 may be connected to an electromagnetic transducer 310 by a linkage member 318. In some embodiments, the electromagnetic transducer 310 may be any suitable actuator, for example, a button cell motor / flat motor. In one embodiment, when an electrical pulse is applied to the electromagnetic transducer 310, current may flow through the coil 312 and a magnetic force may be generated that may overcome the action of the spring 320 and pull the plunger 314 backward. Figure 3A The direction 304 in which the liquid 302 flows from the ampoule 202 to the chamber 316 is shown.

[0029] According to one embodiment, Figure 3B is shown after an electrical pulse is applied to the electromagnetic transducer 310. Figure 3A device. As a result of the magnetic force, the plunger 314 may be actuated such that the electromagnetic transducer 310 may pull the plunger 314 in the direction shown by the arrow 315. The membrane 308 may be connected to the plunger 314 by a linkage member 318 and may also be pulled back. Figure 3C The situation where the electromagnetic transducer 310 may be de-energized is shown. In the illustrated embodiment, the spring 320 pushes the membrane 308 back to its initial position, so that the orifice 208 may be closed and the chamber may be sealed to prevent the entry of microorganisms. This actuation may be repeated many times quickly and continuously to eject the liquid 302 from the device 300.

[0030] For example, in one embodiment, the electromagnetic transducer 310 can be energized by a pulsed or alternating current (AC) to cause the membrane 308 to oscillate, generating pressure in the liquid 302. The pressure in the liquid 302 can then cause a liquid flow 210 to eject from the orifice 208. In one embodiment, the operating frequency can range from about 10 Hz to about 500 Hz, more specifically from about 50 Hz to about 200 Hz. In one embodiment, the membrane 308 can be made of silicon having a Shore hardness / durometer hardness between about 50 (Shore A) and about 70 (Shore A), and the displacement of the plunger 314 can be about 200 μm. In some embodiments, the flow of the liquid 302 can be generated only in the outward direction, as shown by the liquid flow 210, such that the flow of the liquid 302 can prevent microorganisms from entering, even when the orifice 208 can be opened.

[0031] In some embodiments, as Figures 4A - 4B shown, the liquid injection device 300 can include a venting device to balance the pressure within the ampoule 202 with the ambient atmospheric pressure. Here, Figure 4A a cross-sectional view taken along Figure 4B line E-E is shown. In one embodiment, the venting system can include an air inlet vent tube 404 that can extend above the level of the liquid 302 in the ampoule 202. It should be noted that in Figures 4A - 4B any orientation of the device 300, the vent tube 404 can be placed above the height of the liquid 302. In the illustrated embodiment, the vent tube 404 can be connected to a vent outlet 406 that can lead to the atmosphere. The vent tube 404 in fluid communication with the atmosphere and the ampoule 202 can balance the pressure within the ampoule 202 to prevent a pressure vacuum from being created when the liquid 302 can be dispensed through the orifice 208. In one embodiment, a filter 408 can be placed in the vent outlet 406 such that the exhaust air flowing into the ampoule 202 can be filtered to prevent potential airborne contaminants (such as microorganisms) from entering. In one embodiment, the filter 408 can filter out particles larger than 1 μm, more preferably larger than 0.5 μm, and even more preferably larger than 0.2 μm. In this way, the system can be isolated from microbial contamination, even when air 402 can enter the ampoule 202 as the liquid is ejected.

[0032] In the foregoing example, the diaphragm or membrane 308 can be driven by a solenoid. In an alternative embodiment, as Figure 5As shown, the membrane 308 can be driven by using a flat vibration motor 502. More specifically, the needle 306 can engage the membrane 308. In one embodiment, the needle 306 and membrane 308 assembly can be overmolded with a magnet steel dowel 510. In one embodiment, the flat vibration motor 502 can be a product of Jinlong Jidian Co., Ltd. with model number #C1026B002F. In one embodiment, the motor holder 504 can be a plastic molded part that holds the motor 502 such that the motor 502 can slide along a track. In one embodiment, the track guiding part 506 can be a plastic molded part that can provide the above-mentioned track-type guide for the motor holder 504 to slide therein. In some embodiments, the magnet steel dowel 510 can be molded into the assembly composed of the membrane 308 and the needle 306. In one embodiment, the housing 512 can hold all the components together.

[0033] In one embodiment, the electromagnetic transducer 310 can be attached to the housing 512. After being energized, it can pull the membrane 308 backward against the action of the spring 320 in the chamber 316. In one embodiment, when the electromagnetic transducer 310 can be turned off, the spring 320 returns the membrane 308 to its initial position where the orifice 208 is closed. In one embodiment, when the electromagnetic transducer 310 can be excited by a pulsed or alternating current, the membrane 308 can thus oscillate, which in turn generates pressure in the liquid 302. At the correct frequency, the pressure is sufficient to eject a stream of the liquid 302 from the orifice 208. In this embodiment, the typical frequency range can be in the range of about 10 Hz to about 500 Hz, more preferably about 50 Hz to about 200 Hz. In one embodiment, the diameter of the orifice 208, the speed of the liquid 302 ejection, and the duration of the electromagnetic pulse can be optimized to deliver the required amount of the liquid 302 within the required time. According to one embodiment of the present invention, the actuation pulse duration can be about 250 ms or shorter, and in some embodiments can be about 100 ms or shorter. It should be understood that the "actuation pulse duration" refers to the length of time that the electromagnetic transducer can be excited to pull the needle 306 out of the orifice 208 in a single actuation pulse.

[0034] In an alternative embodiment, the actuator can be a flat vibration motor 502, which can have an eccentric weight offset from its axis of rotation (the axis of rotation can be perpendicular to Figure 5 the plane). Since the weight / center of gravity can be offset from the axis, when the motor rotates, the unbalanced weight causes the motor 502 to mainly move in Figure 5In-plane vibration. In one embodiment, by placing the flat vibration motor 502 in a plastic motor holder 504 that is fitted into corresponding tracks (in the track guiding member 506), the flat vibration motor 502 can be constrained so that it can only move linearly, as shown by arrow 514 (e.g., from left to right in Figure 5 ). As a result of this physical constraint, in the illustrated embodiment, when the motor 502 can rotate, it is only allowed to oscillate / reciprocate from left to right and not vibrate in the plane. The flat vibration motor 502 can be coupled to the membrane 308, so that when the motor 502 oscillates from left to right, the membrane 308 can also vibrate from left to right. Similarly, in the illustrated embodiment, the ejected liquid stream 210 can be generated in the same manner as described above, i.e., the needle 306 moves back and forth in the orifice 208 to eject the liquid 302. In some embodiments, the tip of the needle 306 and / or the orifice 208 that engages therewith can include or be made of an antibacterial material.

[0035] To assist in sealing the orifice 208 with the needle 306, Figure 5 embodiments can include a Belleville spring / disc spring 320. During assembly, the spring 320 can be slightly deformed out of plane to transfer a force to the needle 306. This force or load can hold the needle 306 pressed against the opening or orifice 208 to close the flow path. In the illustrated embodiment, without the spring 320, the force required to push the needle 306 and open the orifice 208 can be very low, which may cause leakage of the liquid 302. Additionally, the spring 320 has a spring constant that is important for ensuring the correct oscillation frequency and amplitude of the needle 306 when the motor 502 is energized. Also important for the illustrated embodiment is that if there is no spring 320 to hold the orifice 208 and the needle 306 in the closed and sealed position, the only force holding the needle 306 and the orifice 208 in the closed position can be the stiffness of the membrane 308. In one embodiment, the membrane 308 can be made of an elastomer. For most elastomers, even a small change in temperature can result in a large difference in mechanical properties. In embodiments with the spring 320, most of the load applied to the needle 306 comes from the spring 320 rather than the membrane 308. Since the mechanical properties of spring steel (e.g., the material of the spring 320) can be more consistent / stable for the same temperature change, adding a spring to the illustrated embodiment can make the system performance more consistent / stable.

[0036] In an alternative embodiment, the flat vibration motor 502 can be coupled to the diaphragm or membrane 308 by an optional magnet / magnet 508. The magnet 508 can be fixed to the motor holder 504, and the motor holder 504 can be fixed to the flat vibration motor 502. In this embodiment, when the magnet 508 can be close to the magnet steel dowel 510, the two can be locked together, and the motor 502 can thus be coupled to the membrane 308. For one embodiment, this can be an advantageous assembly feature because the motor 502 can be easily added to the system without strict tolerances, and the motor 502 can be added at several different steps in the assembly process according to manufacturing requirements.

[0037] In an alternative embodiment, Figure 5 the disc spring 320 in can be replaced with a conical spring / tapered disc spring 600, as Figure 6 shown. In the embodiment shown, the conical spring 600 can be similar to a conventional compression spring made of wire, but instead of being wound with a constant diameter, the diameter can start at the large diameter 604 and can gradually decrease to the small diameter 602, such that the spring has a conical shape. In one embodiment, when the conical spring 600 can be fully compressed, the coils 606 can nest within each other, so that the spring 600 can become flat and only as thick as the diameter of the wire 608 that can wind it. Thus, the fully compressed conical spring 600 can be assembled in a form similar to that of Figure 5 the disc spring 320 of and can perform the same function. Compared with the disc spring 320, the conical spring 600 can be cheaper and can more easily obtain a wide range of spring constants and operating deflections.

[0038] For the convenience of aiming the liquid dispenser device 102, the device 102 can be placed close to the eye but not touching the user's eyelashes or eyebrows. Thus, referring to Figure 1 , the device 102 can be in the range of approximately L = 1 cm - 10 cm from the eye, or more preferably approximately 2 cm - 6 cm. The diameter of the cornea can be approximately D = 12 mm, i.e., the radius is approximately 6 mm. To ensure that the liquid 104 can be delivered to approximately the middle of the cornea, the jet of the ejected liquid 104 will not deflect by more than approximately half of the radius of the cornea under the action of gravity, i.e., not more than approximately h = 3 mm. As Figure 1 shown, the vertical deflection h of a projectile ejected horizontally at a speed v over a distance L is: h = g * L / (2v 2 ), where g is the acceleration due to gravity. To ensure that the vertical deflection does not exceed h, the horizontal jet velocity can exceed v = L * (g / 2h) 0.5 . For example, at L = 5 cm and g = 9.8 m / s 2, when h = 3 mm, we obtain v = 2 m / s. For L = 5 cm and h = 1 mm, the speed should be approximately v = 3.6 m / s, and for L = 10 cm, h = 1 mm, the speed v = 7.2 m / s. Thus, overall, the jet velocity can be in the range of approximately 1 m / s - 10 m / s, more preferably approximately 2 m / s - 4 m / s. Speeds higher than this may cause discomfort to the patient and may damage the cornea.

[0039] The liquid flow 104 can reach the eye within a few milliseconds at the moment of dispensing (t = L / v, ranging from about 1 ms - 100 ms). Once the liquid 104 can contact the cornea or the eye 106, it can trigger the blink reflex, which typically takes about T = 100 ms. To prevent the drug from being blocked by the eyelid, the liquid 104 can be delivered before the eye 106 closes. For the required volume V delivered at the jet velocity V within the time T, the jet cross-sectional area can be S = V / (T*v). Since for a circular orifice 208, S = π*d 2 / 4, its diameter d = (4V / (πT*v)) 0.5 . For example, for v = 2 m / s, T = 100 ms, V = 10 μL, we obtain d = 250 μm. For v = 1 m / s, d = 350 μm, and for v = 7 m / s, d = 130 μm. Thus, the aperture diameter of the device 102 can be in the range of approximately 200 μm - 600 μm, and more preferably approximately 400 μm - 550 μm. Alternatively, several orifices 208 can be used to generate several parallel liquid flows for faster delivery.

[0040] Another feature of this system embodiment is to prevent microbial intrusion into the contained liquid 302 during storage or use. As with any closed system, since the liquid 302 can be ejected, air should be introduced to replace the ejected volume to balance the pressure within the ampoule 202 (ventilation). To prevent microbes from entering, in one embodiment, air can be introduced through a specific inlet preferably having a 0.2 μm filter. Ideally, the device should operate such that the liquid 302 can be ejected through the orifice at any time it can be opened, thus preventing air from entering through it.

[0041] Now referring to Figure 7 , to achieve this pressure balance, an alternative ventilation system can be provided. For the sake of brevity, similar parts described in the previous embodiments will not be described again. Figure 7The illustrated alternative ventilation system embodiments can provide aseptic ventilation of ambient air into the ampoule 202 by providing a passageway or ventilation path 120 that is in fluid communication with the interior of the ampoule 202 and the atmosphere. The ventilation path 120 can have an air outlet 121 located within the ampoule 202 and an external air inlet 122 that leads to the atmosphere. In the illustrated embodiment, the path of the ventilation path 120 can be shown by a dashed line. In alternative embodiments, the ventilation path 120 can be located at different positions, such as on the side, top, or bottom of the ampoule 202. Additionally, although illustrated as curved, in alternative embodiments, the ventilation path 120 can extend along a path of any shape. For example, the ventilation path 120 can be a straight line. In one embodiment, the ventilation path 120 can equalize the pressure between the ampoule 202 and the atmosphere. In the previous embodiment, the vent tube 404 can be disclosed and can perform a similar function. Figure 7 The illustrated embodiment has the additional benefit that it does not require a vent tube, which requires the top of the tube 404 to be positioned above the liquid 302. Additionally, removing the vent tube 404 can provide a greater volume for the liquid 302 within the ampoule 202.

[0042] In some embodiments, a stopper or valve 150 can be provided in the ventilation path 120 that allows air to flow into the ampoule 202 while preventing the liquid 302 from spilling out when the liquid 302 is dispensed through the orifice 208, regardless of the orientation of the device 100. In one embodiment, the stopper in the ventilation path 120 can include a one-way valve 150 or check valve located between the filter member 140 and the external air inlet 122. In one embodiment, the valve 150 can be a duckbill valve of model DU02.001SD.v1 manufactured by MiniValve. In alternative embodiments, the check valve can be a ball check valve, diaphragm check valve, stop check valve, or other similar one-way valve. In one embodiment, during assembly, the valve 150 can be disposed in the ventilation path 120 and the filter member 140 can be welded or otherwise secured to the surface 122A to seal the ventilation path 120 at the external air inlet 122. Although welding the filter member 140 to the surface 122A can be one way to seal the ventilation path 120, in alternative embodiments, the one-way valve 150 can create its own seal without welding the surfaces together. Any sealing structure or 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 the liquid from being released through the valve can be used.

[0043] In one embodiment, the venting system may further include a filter member 140 capable of removing particles larger than about 0.22 μm. The filter member may be made of a hydrophobic material, so that the contact of the filter member 140 with the aqueous solution has a minimal impact on air filtration and flow rate. In this embodiment, the resistance to the air flow is not affected by the liquid 302 or the contact of the aqueous solution with the 0.22-μm hydrophobic filter. The hydrophobic filter may provide aseptic assurance, high flow rate, and high throughput. In one embodiment, the filter member may be made of polyvinylidene fluoride (PVDF) capable of reliably eliminating contaminants and microorganisms. Optionally, the filter member may be made of metal, ceramic, or another plastic, as long as the filter member 140 can effectively disinfect the air introduced into the ampoule 202 through the venting path 120. In some embodiments, the venting path 120 may position a check valve 150 between the filter member 140 and the external air inlet 122. Such a valve 150 can be used to eliminate the physical contact of the liquid 302 with the filter member.

[0044] Still referring to Figure 7 , the illustrated embodiment of the dispensing device 100 may further include means for preventing clogging of the dispensing orifice 130. This arrangement may be particularly effective when the liquid 302 may leave solid residues in the orifice 130. In one embodiment, the anti-clogging system may include an elongated dispensing port or orifice 130 through which droplets may be dispensed, and also include a helical cap with a concentric pin 161 or plug. The helical cap may be shown in a rear view 160R and a front view 160F, respectively. In one embodiment, when the cap may engage with the dispensing system, the pin 161 may enter the dispensing orifice 130 so that the residual liquid 302 in the dispensing port may be discharged. In one embodiment, the pin 161 and the orifice 130 may be cylindrical or slightly tapered. In alternative embodiments, the pin 161 and the orifice 130 may be any complementary surfaces such that the pin 161 discharges the residual liquid 302 from the orifice 130. In alternative embodiments, the orifice 130 may be flat, geometrically shaped, or any shape facilitating the dispensing of the liquid 302 therefrom.

[0045] In one method of use, an embodiment of device 100 can be actuated to initiate actuator or transducer 310, which can cause oscillation of membrane 308 and needle 306. These oscillations of membrane 308 and needle 306 can hydrodynamically excite liquid 302 within chamber 316 and open orifice 130, allowing device 100 to dispense liquid 302 through orifice 130. As liquid 302 is being dispensed, air flows through venting pathway 120 and into ampoule 202. In this way, the pressure within ampoule 202 can equal atmospheric pressure while the device dispenses liquid 302, preventing a pressure vacuum from occurring. Once dispensed, or while being dispensed, liquid 302 can flow from ampoule 202 into chamber 316, replacing the dispensed liquid 302 so that the process can continue and repeat as described.

[0046] As used herein, the terms "comprising" and "consisting of" 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 construed as representing or not representing a preferred or advantageous configuration relative to other configurations. As used herein, the terms "about," "generally," and "approximately" are intended to encompass variations that may exist in the upper and lower limits of a subjective or objective range of values, such as variations in properties, parameters, size, and dimensions. In one non-limiting example, the terms "about," "generally," and "approximately" mean equal to 10%, or plus or minus 10% 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" means the complete or near complete extent or degree of an action, characteristic, property, state, structure, item, or result, as understood by one of ordinary skill in the art. For example, an object that is "substantially" circular will mean that the object is completely circular or nearly circular within mathematically determinable limits, as recognized or understood by one of ordinary skill in the art. However, generally speaking, near completion will have the same overall result as achieving or obtaining absolute and complete completion. As understood by one of ordinary skill in the art, when used in a negative sense to mean the complete or near complete absence of an action, characteristic, property, state, structure, item, or result, "substantially" is equally applicable.

[0047] In view of the foregoing description, those skilled in the art will be clear about various modifications and alternative embodiments of the present disclosure. Therefore, this description should be construed as merely illustrative and is for the purpose of teaching those skilled in the art the best mode of implementing the present disclosure. Without departing from the spirit of the present disclosure, the details of the structure can vary significantly, and the exclusive use of all modifications within the scope of the appended claims is reserved. In this specification, the embodiments have been described in a manner that enables a clear and concise specification to be written, but it should be understood that the embodiments can be combined or separated differently without departing from the invention. It is intended to limit the present disclosure only within the scope required by the appended claims and the applicable legal rules.

Claims

1. A handheld device for dispensing a liquid to a patient's eye, the device comprising: A first passage for guiding liquid from an ampoule to a chamber, the chamber being provided with: a) an orifice through which liquid from the ampoule can be dispensed, and b) a membrane configured to hydrodynamically agitate the liquid and dispense the liquid through the orifice; An actuator configured to oscillate a rod engaged with the membrane, such that the membrane can hydrodynamically agitate the liquid to open the orifice and dispense the liquid through the orifice; And A second passage having a first end in fluid communication with at least one of the first passage and the ampoule, a second end exposed to the atmosphere, and a stop configured to prevent liquid from escaping through the second end of the second passage.

2. The device according to claim 1, wherein, The chamber further comprises: A valve member extending from the membrane, wherein the valve member engages within the orifice in a closed configuration and disengages from the orifice when the actuator oscillates the rod.

3. The device according to claim 2, wherein, The valve member and the membrane are an integral part.

4. The device according to claim 1, wherein, The device further comprises: A cap configured to cover the orifice, wherein the cap includes a plug configured to enter the orifice to drain liquid from the orifice.

5. The device according to claim 1, wherein, The second passage further comprises: An air filter for disinfecting air flowing from the atmosphere into the ampoule during liquid dispensing.

6. The device according to claim 5, wherein, The air filter is configured to remove particles larger than 0.22 μm.

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

8. The device according to claim 5, wherein, The air filter is a hydrophobic material such that air filtration and the air flow rate into the ampoule are minimally affected by contact between the air filter and the liquid within the ampoule.

9. The device according to claim 1, wherein, The stop is a one-way valve configured to prevent liquid in the ampoule from leaving through the passage.

10. The device according to claim 1, wherein, The second passage is sealed.

11. The device according to claim 1, wherein, The second passage is configured for pressure equalization.

12. A handheld device for dispensing a liquid to a site of interest, the device comprising: A first passage for guiding liquid from an ampoule to a chamber, the chamber being provided with: a) a membrane and a plunger member configured to hydrodynamically agitate and dispense the liquid, and b) a sealable orifice through which liquid from the ampoule can be dispensed, wherein the plunger is received within the orifice to seal the orifice; An actuator configured to oscillate the membrane and the plunger member to disengage the plunger from the orifice and dispense the liquid through the orifice; and A second passage having a first end in fluid communication with at least one of the first passage and the ampoule, a second end exposed to the atmosphere, and a stop configured to prevent liquid from escaping through the second end of the second passage regardless of the orientation of the liquid in the ampoule.

13. The device according to claim 12, wherein, The device further comprises: A cap configured to cover the orifice, wherein the cap includes a plug configured to enter the orifice to drain liquid from the orifice.

14. The device according to claim 12, wherein, The second passage further comprises: An air filter for disinfecting air flowing from the atmosphere into the ampoule during liquid dispensing.

15. The device according to claim 14, wherein, The air filter is configured to remove particles larger than 0.22 μm.

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

17. The device according to claim 14, wherein, The air filter is a hydrophobic material such that air filtration and the air flow rate into the ampoule are minimally affected by contact between the air filter and the liquid within the ampoule.

18. The device according to claim 12, wherein, The stop is a one-way valve configured to prevent liquid in the ampoule from leaving through the second passage.

19. The device according to claim 12, wherein, The second passage is sealed.

20. The device according to claim 12, wherein, The second passage is configured to equalize pressure.

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