Membrane-actuated hydrodynamic dispensing system

Abstract

A membrane-actuated hydrodynamic dispensing system device is disclosed. Each embodiment of the dispensing device includes an ampoule assembly and an actuator. The ampoule assembly contains a liquid to be dispensed and includes an actuated membrane, one or more flexible openings, and a stationary member sealing the openings. The actuator is configured to vibrate the membrane to hydrodynamically excite a fluid contained within the ampoule assembly. When the fluid is sufficiently hydrodynamically excited, the liquid is dispensed from the opening.

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 / 323,859, filed March 25, 2022, for all subject matter common to both applications, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to devices for dispensing fluid medications, and more particularly to such devices for storing and delivering preservative-free eye drops that are specifically configured to enhance ease of use and patient compliance with medication administration instructions. [Background technology]

[0003] There are numerous prescription medications available for topical application to the eye to treat various illnesses, diseases and conditions. The standard applicator for eye drops is a traditional eyedropper. When using a dropper, the medication is always taken from the same bottle without any control over foreign particulates entering the bottle. When a traditional eyedropper is used, a high level of dexterity and control may be required to accurately and properly apply the drops to the eye. Compounding this problem is that when the eye needs the medication, it is not operating at its usual efficacy, further reducing the user's accuracy. This can result in mis-application of eye drops and not administering the intended amount of medication. For example, a user may administer too much medication, i.e., too many drops, or not administer enough medication due to mis-application.

[0004] Ease of dispensing fluid medications and compliance with dosing instructions are major concerns for all patients. For example, dispensing bottles, such as ophthalmic squeeze dispensers, typically require higher actuation forces due to valve mechanisms that seal the dispensing nozzle to prevent bacterial ingress and contamination. Such systems require very high pressures to operate, which in turn necessitates very high squeeze forces. Furthermore, prior art dispensing bottles dispense in only one up-down direction, which requires cumbersome head manipulation, which, combined with the higher actuation forces, further reduces usability.

[0005] Alternatively, the medication may be dripped by gravity, dropping droplets or small drops into the eye, and after the droplets have been delivered, a portion of the medication may be sucked back into the container by the negative pressure in the dropper when it is released, which may introduce microorganisms and unwanted dirt or particles into the container.

[0006] Another concern is the shelf life of eye drops. To increase the shelf life of these eye drops and to combat any infectious agents, preservatives and other agents are introduced into the eye drops. These additives can have various negative side effects experienced by the patient or end user of the eye drops. For example, some of the most commonly used preservatives can cause itching, dry eye syndrome, affecting tear production and tear film maintenance, among others.

[0007] Thus, there is currently a pressing need for a solution that allows for accurate delivery of eye drops while still allowing for the use of a preservative-free solution. Summary of the Invention

[0008] In some aspects, the technology described herein relates to a handheld device for dispensing a liquid into a patient's eye, the device including an ampoule containing a liquid to be dispensed, an assembly connected to and in fluid communication with the ampoule, the assembly having (a) one or more flexible openings to allow dispensing of fluid from the ampoule, (b) a member for sealing engagement with the one or more flexible openings, and (c) a membrane that, when acted upon, generates pressure towards the one or more flexible openings to disengage the one or more flexible openings from the member and cause liquid to be dispensed therethrough from the ampoule, and an actuator removably coupled to the assembly, the actuator designed to impart vibrations to the membrane such that sufficient pressure can be generated to disengage the one or more flexible openings from the member and force fluid through the one or more flexible openings to cause fluid to be dispensed from the assembly.

[0009] In some aspects, the technology described herein relates to a device, wherein one or more flexible openings define a fluid exit passageway that decreases in diameter from its proximal end to its distal end.

[0010] In some aspects, the technology described herein relates to a device where a reduction in the diameter of a fluid exit passage increases fluid velocity as the fluid travels along the exit passage and out through one or more flexible openings.

[0011] In some aspects, the technology described herein relates to a device, wherein the member is stationary relative to the assembly to maintain a force on the one or more flexible openings in sealing engagement.

[0012] In some aspects, the technology described herein relates to a device, wherein the member has a tip designed to fluid-tightly engage one or more flexible openings.

[0013] In some aspects, the technology described herein relates to a device, wherein the membrane is actuable by an actuator to have an oscillation frequency of greater than 80 cycles per second, with an amplitude of less than 0.2 mm.

[0014] In some aspects, the technology described herein relates to a device that further includes a cover positioned over the one or more flexible openings to prevent particulates and debris from collecting in the one or more flexible openings when the device is not in use, the cover being adjustable to an open position when the device is in use.

[0015] In some aspects, the technology described herein relates to a device, wherein the cover further comprises a plug disposed in the cover designed to be inserted into one or more flexible openings to seal and clean the one or more flexible openings.

[0016] In some aspects, the technology described herein relates to a device, wherein the coupling of the actuator to the assembly comprises an interference fit.

[0017] In some aspects, the technology described herein relates to a device further comprising a first tubular boundary member disposed near the membrane and a second tubular boundary member disposed near the actuator, the second tubular boundary member designed to mate with the first tubular boundary member to mechanically couple the assembly and the actuator.

[0018] In some aspects, the technology described herein relates to a device, the device further comprising an ergonomically designed housing enclosing the device, the housing having an opening that allows liquid to be dispensed from one or more flexible openings while the device is contained within the housing, the housing comprising two parts that are bonded together such that the assembly is removable from within the housing.

[0019] In some aspects, the technology described herein relates to a system for dispensing a liquid to a target location, the system including a first assembly having (a) an ampoule containing a liquid to be dispensed, (b) an opening allowing liquid from the ampoule to be dispensed to the target location, (c) a stationary member disposed within the ampoule to seal the opening, and (d) a membrane designed to excite the liquid in the ampoule to dispense the liquid through the opening, and a second assembly mechanically coupled to the first assembly, the second assembly having an actuator that vibrates to excite the membrane and dispense the liquid through the opening.

[0020] In some aspects, the technology described herein relates to a system, wherein the stationary member has a tip that is in fluid-tight engagement with the opening when the actuator is not vibrating.

[0021] In some aspects, the technology described herein relates to a system, wherein the opening defines a fluid exit passageway that decreases in diameter from its proximal end to its distal end.

[0022] In some aspects, the technology described herein relates to a system where a reduction in the diameter of a fluid exit passage increases the fluid velocity as the fluid travels along the exit passage and out through the opening.

[0023] In some aspects, the technology described herein relates to a system, the system further comprising an ergonomically designed housing enclosing the system, the housing having an opening that allows liquid to be dispensed from the opening, the housing comprising two parts coupled to each other such that a first assembly is removable from within the housing.

[0024] In some aspects, the technology described herein relates to a system that further includes a cover positioned over the opening to prevent particulates and debris from collecting in the opening when the system is not in use, the cover being adjustable to an open position when the system is in use.

[0025] In some aspects, the technology described herein relates to a system, wherein the cover further comprises a plug disposed on the cover designed to be inserted into the opening to seal and clean the opening.

[0026] In some aspects, the technology described herein relates to a system, wherein coupling of the first assembly to the second assembly comprises an interference fit.

[0027] In some aspects, the technology described herein relates to a system, wherein the membrane is actuable by an actuator to have an oscillation frequency of greater than 80 cycles per second, with an amplitude of less than 0.2 mm.

[0028] 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 description of the drawings]

[0029] [Figure 1] FIG. 1 is a cross-sectional view of an embodiment of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view of the embodiment showing the valve in an open state. [Diagram 3] FIG. 3 is a cross-sectional view of the dispensing embodiment with a removable pivot actuator of FIG. 1 with a removable oscillator. [Figure 4A] 4A is a cross-sectional view of a first assembly of the removable actuator of FIG. 3. FIG. [Figure 4B] 4B is a cross-sectional view of a second assembly of the removable ampoule of FIG. [Diagram 5] FIG. 5 is a side view of the housing embodiment. [Figure 6] FIG. 6 is a side view of the housing embodiment showing the removable ampoule. [Figure 7] FIG. 7 is an illustration of the consistency of dose per drop among various devices. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] While the above drawings illustrate embodiments disclosed herein, other embodiments are contemplated, as set forth in the description. This disclosure presents exemplary embodiments by way of example and not by way of limitation. Numerous other variations and embodiments can be devised by those skilled in the art, all of which fall within the scope and spirit of the principles of the embodiments disclosed herein.

[0031] The present disclosure relates to a handheld device for dispensing a liquid to a desired location, for example, to 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 can be acted upon to generate a hydrodynamic pressure towards an opening sealed by a member. An actuator can impart vibrations to the membrane to generate a hydrodynamic excitation in the fluid. When the excitation reaches a predetermined threshold, the opening can be deformed such that it can be separated from the member or pin and the liquid can be dispensed therethrough.

[0032] 1-6 show exemplary embodiments or embodiments of a device for dispensing liquid to an eye according to the present disclosure, with like parts designated with like numerals throughout. Although the present disclosure will be described with reference to the exemplary embodiments or embodiments shown in the drawings, it should be understood that many alternative forms may be used to embody the present disclosure. Those skilled in the art will further appreciate the various ways in which the parameters of the disclosed embodiments, such as the size, shape or type of elements or materials, may be modified while still remaining consistent with the spirit and scope of the present disclosure.

[0033] With reference to FIG. 1, in some embodiments, the present disclosure provides a handheld device 100 for dispensing a liquid 104, such as an eye drop or other therapeutic agent, to a patient's eye or target site. Generally, the liquid dispensing device 100 may include an ampoule 102 for containing a liquid 104 to be dispensed to the ocular surface or target site. The handheld device 100 may include a chamber 106 that may be connectable to and in fluid communication with the ampoule 102 by a channel, i.e., fluid passageway 116. In embodiments, the liquid 104 may be drawn through the fluid passageway 116, for example, by gravity, into the chamber 106 for dispensing. In embodiments, the dispensed liquid 104 has a volume of about 5 μl to about 30 μl. In some embodiments, the dispensed liquid may have a volume of about 12 μl.

[0034] To prevent the creation of a pressure vacuum within the ampoule 102 as fluid passes from the ampoule 102 to the chamber 106, in some embodiments, a vent 118 may be included in the device 100, which can equalize the pressure within the ampoule 102 through the introduction of air from the vent 118. The vent 118 is connectable to atmospheric pressure at a vent outlet 120. A filter 124 may be included at the vent outlet 120 to prevent the introduction of most, if not all, contaminants or bacteria. The filter 124 may include any or a combination of filters known in the art for filtering microorganisms or other unwanted particulates from the air.

[0035] Alternatively or additionally, to prevent ingress of contaminants into the handheld device 100, the device 100 may include a sealing engagement between an aperture plate, i.e., plate 109, and a member, i.e., pin 108. The sealing engagement of the aperture plate and pin 108 may provide a selectively blocked seal at an outlet, i.e., opening 110, to the chamber 106. The sealing engagement of the chamber 106 may be akin to a check valve. As seen in FIG. 1, the plate 109 may include an opening 110 for dispensing the liquid 104 therethrough. The sealing engagement between the pin 108 and opening 110 may form a hermetic liquid-tight seal. However, the sealing engagement between the pin 108 and opening 110 may be opened, i.e., disengaged, when a hydrodynamic excitation of the liquid 104 in the chamber 106 reaches a threshold value, opening the opening 110. When the pin 108 and opening 110 are disengaged, the liquid 104 may be dispensed through the opening 110. When the pressure is below the threshold, the liquid 104 in the chamber 106 may be sealed in the chamber 106 or may pass through the passageway 116 to the ampoule 102. In some embodiments, when the pressure in the chamber 106 exceeds about 0.014 MPa to about 0.04 MPa, the opening 110 may disengage from the pin 108. In some embodiments, the plate 109 may be made of a flexible elastomer for sealing engagement. In embodiments, the elastomer may be silicone rubber. Other elastomers may be used that may have a Young's modulus of elasticity of about 0.1 to about 1.2 GPa. In some embodiments, the plate 109 may include two or more openings 110. In other embodiments, the seal between the pin 108 and the opening 110 may be any seal.

[0036] As can be seen in FIG. 1, in some embodiments, the opening 110 may be conical and extend through the plate 109. In other embodiments, the opening 110 may extend through a sidewall of the chamber 106. The conical opening 110 may have a large inlet opening 128 in fluid communication with the chamber 106 and a small outlet opening 130 through which the liquid 104 can be dispensed. The conical shape allows the pin 108 to engage the opening 110 and more controlled dispensing of the liquid 104 through the opening 110 as the opening 110 disengages from the pin 108. The conical shape of the opening 110 may have a diameter of about 0.1 mm to about 0.6 mm at the small end, i.e., the outlet opening 130, and a diameter of about 0.7 mm to about 1.0 mm at the large end, i.e., the inlet opening 128. In an embodiment, the conical shape of the opening 110 may have a diameter of about 0.2 mm at the exit opening 130 and a diameter of about 0.8 mm at the entrance opening 128. Alternatively, in some embodiments, the openings may have a tubular, tapered, or other shape. The decreasing diameter of the fluid exit passage within the opening 110 may provide an increase in fluid velocity as the fluid travels along the exit passage out through the opening 110.

[0037] With further reference to FIG. 1 , the pin 108 in sealing engagement with the opening 110 may be stationary relative to the chamber 106 to maintain a force on the opening 110 in sealing engagement. The opening 110 may disengage from the pin 108 when a hydrodynamic pressure in the chamber 106 exceeds a threshold value upon actuation of the device 100. In the illustrated embodiment, the stationary pin 108 may have an “L” shape and be fixed to the bottom of the chamber 106 to form a sealing engagement with the opening 110. Alternatively, in other embodiments, the stationary pin 108 may be straight and positioned opposite the opening 110. In yet other embodiments, the pin 108 may be positioned anywhere that may maintain a sealing engagement with the opening 110.

[0038] In some embodiments, the pin 108 may have a ball-shaped tip designed to be received in the opening 110. The ball-shaped tip of the pin 108 may form a sealing engagement with the opening 110 that may be more controllably disengaged to dispense the liquid 104 through the opening 110. In some embodiments, the ball-shaped tip of the pin 108 and the conical opening 110 may engage in a complementary manner. In alternative embodiments, in place of the ball-shaped tip of the pin 108, any complementary geometric tip is contemplated, for example, a conical tip or a tubular tip. In still other embodiments, non-complementary surfaces or tips may be used. In some embodiments, the ball-shaped member may include an antimicrobial coating or be made of an antimicrobial material.

[0039] In some embodiments, to hydrodynamically excite the liquid 104 in the chamber 106, the device 100 may include a membrane 114 that may generate fluid momentum in the liquid 104 when actuated or activated. The fluid momentum in the liquid 104 may increase the hydrodynamic pressure of the fluid in the chamber 106. To generate the fluid momentum, the membrane 114 may be oscillated, vibrated, or actuated by an actuator 112. With reference to FIG. 2, the vibration 212 or oscillation imparted to the membrane 114 may generate multiple cycles of hydrodynamic pulses to generate momentum in the liquid 104, causing the aperture 110 to disengage from the pin 108 as the fluid pushes against the aperture 110. For example, in some embodiments, the pulse displacement of the membrane 114 may be about 100 microns to about 200 microns, with a pulse width of about 100 ms. The aperture 110 may be resealed by the pin 108 when the fluid pressure is reduced. Alternatively, in some embodiments, the membrane 114 may be a rigid wall, a semi-rigid wall, a wall of an actuator 112, or any wall that can be acted upon or vibrated to hydrodynamically excite the liquid 104.

[0040] With further reference to FIG. 2, a cross-sectional view of the handheld device 100 in a dispensing configuration can be seen. In some embodiments, the device 100 can include an actuator 112 removably coupled to the chamber 106, where the actuator 112 can be designed to impart vibrations 212 to the membrane 114. The vibrations 212 to the membrane 114 can increase the pressure in the chamber 106, disengaging the aperture 110 from the pin 108 and dispensing the liquid 104 therethrough. The actuator 112 can be connected to the membrane 114 through a connecting member, i.e., a connecting rod 122. As the actuator 112 oscillates along an actuator track 210, the connecting rod 122 can impart vibrations 212 to the membrane 114, hydrodynamically exciting the liquid 104 in the chamber 106, as indicated by arrow 208. In some embodiments, this actuation allows the liquid 104 to be dispensed as droplets 206 or as a continuous stream of the liquid 104. In an embodiment, the connecting rod 122 may be designed to modulate the vibrations from the actuator 112 to provide a more stable application of force from the actuator 112 .

[0041] In some embodiments, the oscillation frequency of the actuator 112, which may be a vibration motor or a coin cell motor, may actuate the membrane 114 at about 80 revolutions per second or more with an amplitude of about 0.2 mm to about 0.5 mm to generate the fluid momentum required to open the opening 110. Alternatively, the amplitude may be less than about 0.2 mm. In some embodiments, if the membrane 114 is actuated at less than about 50 cycles per second, the liquid 104 may be transferred backward from the chamber 106 through the passageway 116 to the ampoule 102 rather than being dispensed through the opening 110. This embodiment may prevent the ingress of microorganisms into the chamber 106 by preventing unintended disengagement of the opening 110 from the pin 108. Alternatively, in other embodiments, any actuator 112 or motor having similar functionality may be substituted for the actuator 112. For example, in some embodiments, the actuator 112 may be a concealed motor assembly, such as a coin-type vibration motor, such as part number DM-B1002-30, manufactured by Zhejiang Dongyang Dmegc Chengji Electronics Co., Ltd (China). In other embodiments, the membrane vibration may be generated by an electromagnetic or piezoelectric transducer.

[0042] In an embodiment, the actuator 112 may be controlled by a microprocessor to generate consistent flow rate and dose output across various configurations of the device 100. The dose consistency across various devices is illustrated in FIG. 7. For example, the microprocessor may detect the currently configured actuator 112 through a known database and use the database to determine how to control the actuator 112 to deliver a fixed volume of liquid 104. Pulse width modulation (PWM) may be used to control the actuator 112. In some embodiments, control may be by limiting the voltage being supplied to the actuator 112. For example, in some embodiments, the input voltage may be from about 8 volts to about 12 volts. The input voltage may vary depending on the viscosity of the liquid 104. In some embodiments, the ON time for the actuator may be less than about 100 ms. Additionally, a sensor (not shown) may be included in the device 100 to provide feedback to the microprocessor. The sensor may detect the speed, rotation or vibration rate of the actuator 112 and provide this measurement to the microprocessor. The measurements can be used by the microprocessor to limit or increase the speed of actuation of the actuator 112. In some embodiments, the microprocessor can be a PIC16F1509T- / SO microprocessor manufactured by Microchip Technology Chandler, Arizona, USA.

[0043] 3, an alternative embodiment is illustrated showing a device 300 that is separable into a first assembly, i.e., actuator assembly 302, and a second assembly, i.e., ampoule assembly 303. This modular design may have many advantages. For example, another way for microorganisms to enter the liquid 104 in the device 100 may be by refilling the ampoule 102 by the patient or user. To prevent this microbial entry, in some embodiments, it may be beneficial to provide a disposable ampoule assembly 303 for replacing an ampoule 102 that has run out of liquid 104. In this way, it can be seen that the separability of the ampoule assembly 303 and actuator assembly 302 may provide health benefits by preventing unnecessary waste from having to replace the entire device 300, while preventing the negative consequences that can result from having the user refill the ampoule 102. In some embodiments, the entire device 300 may alternatively be disposable. However, separation of the actuator assembly 302 and ampoule assembly 303 can reduce waste by reusing the actuator assembly 302 with a replaceable ampoule assembly 303. Reusing the actuator assembly 302 can prevent waste and reduce the cost of the device 300. Replacing the ampoule assembly 303 eliminates a path of microbial ingress into the device 300. In some embodiments, the ampoule assembly 303 can be disposable, while in other embodiments the actuator assembly 302 can be disposable. The handheld dispensing system or device 300 can also be designed to facilitate separation of the ampoule assembly 303 and the actuator assembly 302. For example, in some embodiments, the actuator assembly 302 can be coupled to the ampoule assembly 303 by an interference fit. In other embodiments, the actuator assembly 302 can be fastened or secured to the ampoule assembly 303 using other mechanical fasteners, such as magnets, springs, pivotable pins, etc., that can still facilitate removal.

[0044] 4A and 4B, in some embodiments, the device 300 may include a first cylindrical boundary member 422 disposed on the ampoule assembly 303 near the membrane 114, and a second cylindrical boundary member 416 disposed on the actuator assembly 302 near the actuator 112. The second cylindrical boundary member 416 may be designed to mate with the first cylindrical boundary member 422 to mechanically or operatively couple to each other by engagement of the first cylindrical boundary member 422 and the second cylindrical boundary member 416. The cylindrical shapes of the first cylindrical boundary member 422 and the second cylindrical boundary member 416 may facilitate attachment while providing sufficient force to maintain their engagement. Alternatively, in other embodiments, any shape or combination of shapes or coupling mechanisms may be used in addition to or in place of the first cylindrical boundary member 422 and the second cylindrical boundary member 416.

[0045] In some embodiments, the device 300 may include an actuator 112, such as a vibration motor, as shown in FIGS. 1 and 2. Alternatively, the actuator 112 may be a pivot actuator 112, as shown in FIGS. 3, 4A, and 4B. The pivot actuator 112 may be disposed within an actuator assembly 302 and may generally include a pivot pin 310 disposed on the actuator 112 through a base member 304. The pivot actuator may further include a rocker member 306 pivotally disposed on the pivot pin 310 such that the rocker member 306 is rotatable about the pivot pin 310. As the rocker member 306 rotates about the pivot pin 310, the rocker member 306 may vibrate the membrane 114 due to the impact of the rocker member 306 against the membrane 114. The rotation of the rocker member 306 may be in a direction indicated by a rocker member movement 418. In an embodiment, the rocker member angular movement 418 may be less than a fraction of a degree.

[0046] In some embodiments, the actuator 112 of the handheld device 300 may include a first magnet 412 disposed on the rocking member 306 and a second magnet 420 disposed on the membrane 114. The first and second magnets 412, 420 may be disposed such that they are coaxial or aligned such that they contact each other. For example, the first magnet 412 may engage with the second magnet 420 disposed on the membrane 114 such that as the rocking member 306 is actuated, the first magnet 412 magnetically pushes and pulls the second magnet 420. As the rocking member 306 is rotated about the pivot pin 310, the distance between the first magnet 412 and the second magnet 420 may change to increase or decrease the magnetic force imparted to the second magnet 420. In some embodiments, the first magnet 412 and the second magnet 420 can further provide a buffering force from the actuator 112 to the membrane 114 to prevent excessive force on the membrane 114. Additionally, the first magnet 412 can be operably engaged with the second magnet 420 when the actuator assembly 302 and the ampoule assembly 303 are connected or engaged. This allows for a reduction in the tolerance required for the coupling mechanism between the actuator assembly 302 and the ampoule assembly 303, since the magnetic force between the first magnet 412 and the second magnet 420 will maintain the connection between the actuator assembly 302 and the ampoule assembly 303. In embodiments, the amplitude of the magnetic movement 414 can be less than about 0.5 mm. Alternatively, in other embodiments, any mechanism or adhesive that can allow for attachment or detachment of the actuator assembly 302 and the ampoule assembly 303 may be substituted.

[0047] 3 and 4B, in some embodiments, the device 300 may include a cover 312, i.e., a cap, secured to the exterior of the chamber 106 to cover the opening 110 when the device 300 is not in use. The cover 312 is removable when the device 300 is in use. The cover 312 may prevent dust, particles, sediment, or any other unwanted residue from adhering to or potentially entering the opening 110 when the device is not in use. To prevent unwanted entry of particles or microorganisms, the cover 312 may be a screw cap or lid, in some embodiments, that may be removably secured to cover the opening 110. In alternative embodiments, the cover 312 may serve as an ergonomic guide to position the device 300, for example, as an initial alignment method to align the opening 110 with a target to receive the dispensed liquid 104. It should be understood that although cover 312 is described as a separable cover 312, in alternative embodiments it may be hinged to the exterior of device 300 or any other structural means for achieving the same functional purpose described above.

[0048] In some embodiments, the cover 312 may include a plug 314 extending from an inner surface of the cover 312. The plug 314 may be designed to be inserted into the opening 110 to additionally seal and clear the opening 110. To clear the opening 110, the plug 314 may push or displace the liquid 104 out of the opening 110 to prevent accumulation of fluid residue within the opening 110. This may be beneficial when the liquid 104 is highly viscous and may leave solid or dried residue in or on the opening 110. Additionally, the plug 314 may prevent clogging by removing debris and particulates from the opening 110. To prevent clogging, the plug 314 may enter the opening 110 when the cover 312 may be in an occluded configuration. This may also increase the sealing engagement between the opening 110 and the pin 108, relieving mechanical stress on the pin 108 and the opening 110. In alternative embodiments, the cover 312 may be a sliding door, a flap that can be attached at one end, or any other structural element capable of blocking the opening 110 as described above.

[0049] 5 and 6, in some embodiments, device 100 or device 300 may include an ergonomically designed housing 502 that encloses device 100. Housing 502 may have an opening (not shown) that allows liquid 104 to be dispensed from opening 110. In some embodiments, housing 502 may include two pieces that are coupled together such that ampoule assembly 303 may be removable from housing 502 while actuator assembly 302 is secured within housing 502. In other embodiments, housing 502 may be three or more pieces. In alternative embodiments, housing 502 may not completely enclose device 100, but may only cover certain portions of device 100, such as, for example, only actuator assembly 302. In general, housing 502 may provide ergonomic enclosure of internal components of device 100, such as actuator assembly 302 and ampoule assembly 303. For example, housing 502 may be manufactured in some embodiments such that it is ergonomically designed to be held by hand. For example, the shape of the housing 502 can be manufactured to improve the accuracy of the delivery of the liquid 104 to the target site. The accuracy can be improved by, by way of example only, integrating the cover 312 in a manner that can guide the user to the proper or recommended use of the device 100. By way of illustration, the cover 312 can be a flap that can be used as an alignment technique to accurately deliver the liquid 104 to the eye. In an embodiment, the housing 502 can be designed to accommodate a rotatable cap or cover 504 and a threaded portion 506. The rotatable cap or cover 504 can be attached to the housing 502 to cover the opening 110 to prevent debris or other particulates from entering or blocking the opening 110, and can be removed when dispensing the liquid 104 through the opening 110.

[0050] 6, an embodiment of the housing 502 is shown with the ampoule assembly 303 removed from the housing 502. In some embodiments, the housing 502 has a wall that may be removable, which may allow access to the ampoule assembly 303. The removable wall allows a user to replace the ampoule assembly 303 when desired, rather than refilling the ampoule 102 with liquid 104. Having the ampoule assembly 303 replaceable may prevent bacteria or contaminants from entering the system, as described above. The housing 502 may have an opening (not shown) or may be separated into multiple pieces, which allows the ampoule assembly 303 to be removed from the housing 502. In some embodiments, the housing 502 may include electronic circuitry, a printed circuit board, and a battery (not shown).

[0051] Use of an embodiment of the handheld dispenser device 100 will now be described. A user may remove the cover 312, or cap, from in front of the opening 110. In other embodiments, the cover 312 remains partially secured to the device 100. For example, a user may utilize the cover 312 to orient or align the device 100. A button (not shown) may be engaged to actuate the actuator 112. The actuator 112 may initiate oscillation of the membrane 114, thereby hydrodynamically exciting the liquid 104 and imparting momentum to the liquid 104 contained in the chamber 106. When the pressure within the chamber 106 exceeds a threshold value, the opening 110 will disengage from the pin 108, dispensing a volume of the liquid 104 contained in the chamber 106. As the pressure within the chamber 106 drops or decreases, the opening 110 will re-engage with the pin 108 to form a hermetic liquid-tight seal and prevent further liquid 104 from being dispensed. The user can optionally return the cover 312 to the closed configuration or dispense an additional partial or complete dose of liquid 104 .

[0052] This method may be repeated until ampoule assembly 303 needs to be replaced. A user may wish to replace ampoule assembly 303 or switch dispensing solutions since a predetermined amount of liquid 104 has been dispensed. To replace ampoule assembly 303, a user may remove ampoule assembly 303 from housing 502 or actuator assembly 302 and replace ampoule assembly 303 with a new ampoule assembly 303. As can be appreciated, the methods described herein are exemplary and are not meant to limit or inhibit the present disclosure or any embodiments disclosed herein.

[0053] The terms "comprise" and "comprising" as used herein are intended to be interpreted as inclusive and not exclusive. The terms "exemplary," "example," and "illustrative" as used herein are intended to mean "to serve as an example, instance, or illustration" and should not be interpreted as indicating or not indicating a preferred or advantageous configuration over other configurations. The terms "about," "generally," and "approximately" as used herein 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. The term "substantially" as used herein refers to a perfect or nearly perfect degree or extent of an operation, 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 the limits that can be mathematically determined, or nearly circular as would be recognized or understood by one of ordinary skill in the art. The exact 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 a complete or nearly complete lack of an action, feature, characteristic, state, structure, item or result, as would be understood by one of ordinary skill in the art.

[0054] Numerous variations and alternative embodiments of the present disclosure should be apparent to those skilled in the art in light of the above description. This description is therefore to be construed as illustrative only, and is for the purpose of teaching those skilled in the art the best mode for carrying out the present disclosure. Details of construction may vary without substantially 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. Although embodiments have been described herein in a manner that permits a clear and concise description, it is intended and should 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: an ampoule containing the liquid to be dispensed; an assembly connected to and in fluid communication with the ampoule, the assembly having: (a) one or more flexible openings to allow dispensing of fluid from the ampoule; (b) a member for sealing engagement with the one or more flexible openings; and (c) a membrane that, when acted upon, creates pressure against the one or more flexible openings to disengage the one or more flexible openings from the member to allow the liquid to be dispensed therethrough from the ampoule; an actuator removably coupled to the assembly, the actuator designed to impart vibrations to the membrane such that sufficient pressure can be generated to disengage the one or more flexible openings from the member and to force the fluid through the one or more flexible openings to cause the fluid to be dispensed from the assembly; and 16. A device comprising:

2. The device of claim 1 , wherein the one or more flexible openings define a fluid exit passageway that decreases in diameter from its proximal end to its distal end.

3. 3. The device of claim 2, wherein the reduction in diameter of the fluid exit passage increases fluid velocity as the fluid travels along the exit passage and out through the one or more flexible openings.

4. The device of claim 1 , wherein the member is stationary relative to the assembly to maintain a force on the one or more flexible openings in sealing engagement.

5. The device of claim 1 , wherein the member has a tip designed to fluidly engage the one or more flexible openings.

6. 10. The device of claim 1, wherein the membrane is actuable by the actuator with an oscillation frequency of greater than 80 cycles per second and an amplitude of less than 0.2 mm.

7. 10. The device of claim 1, further comprising a cover positioned over the one or more flexible openings to prevent particulates and debris from collecting in the one or more flexible openings when the device is not in use, the cover being adjustable to an open position when the device is in use.

8. 8. The device of claim 7, wherein the cover further comprises a plug disposed in the cover designed to be inserted into the one or more flexible openings to seal and clean the one or more flexible openings.

9. The device of claim 1 , wherein the coupling of the actuator to the assembly comprises an interference fit.

10. a first cylindrical boundary member disposed adjacent the membrane; a second cylindrical boundary member disposed adjacent the actuator, the second cylindrical boundary member designed to mate with the first cylindrical boundary member to mechanically couple the assembly and the actuator; The device of claim 1 further comprising:

11. and an ergonomically designed housing surrounding the device, the housing having an opening that allows the liquid to be dispensed through the one or more flexible openings while the device is contained within the housing; The device of claim 1 , wherein the housing includes two parts that are bonded together such that the assembly is removable from within the housing.

12. 1. A system for dispensing a liquid to a target location, comprising: a first assembly having: (a) an ampoule containing the liquid to be dispensed; (b) an opening that allows liquid from the ampoule to be dispensed to the target location; (c) a stationary member disposed within the ampoule to seal the opening; and (d) a membrane designed to energize the liquid within the ampoule to cause the liquid to be dispensed through the opening; a second assembly having an actuator for exciting the membrane to vibrate and dispensing the liquid through the opening, the second assembly being mechanically coupled to the first assembly; A system comprising:

13. The system of claim 12 , wherein the stationary member has a tip that is in fluid-tight engagement with the opening when the actuator is not vibrating.

14. The system of claim 12 , wherein the opening defines a fluid exit passageway that decreases in diameter from its proximal end to its distal end.

15. 15. The system of claim 14, wherein the reduction in diameter of the fluid exit passage increases fluid velocity as the fluid travels along the exit passage and out through the opening.

16. and an ergonomically designed housing enclosing the system, the housing having an opening to allow the liquid to be dispensed through the opening. The system of claim 12 , wherein the housing includes two parts coupled together such that the first assembly is removable from within the housing.

17. 13. The system of claim 12, further comprising a cover positioned over the opening to prevent particulates and debris from collecting in the opening when the system is not in use, the cover being adjustable to an open position when the system is in use.

18. 20. The system of claim 17, wherein the cover further comprises a plug disposed on the cover designed to be inserted into the opening to seal and clear the opening.

19. The system of claim 12 , wherein the coupling of the first assembly to the second assembly comprises an interference fit.

20. 13. The system of claim 12, wherein the membrane is actuable by the actuator to have an oscillation frequency of greater than 80 cycles per second and an amplitude of less than 0.2 mm.

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