Device and system for delivering liquid to the surface of an eye

Abstract

Methods, systems, devices, and apparatus for dispensing a predetermined amount of fluid to a surface of an eye. A dispensing system includes one or more vial assemblies, each vial assembly including a vial housing and a cup-shaped member coupled to the vial housing to form a hermetically sealed fluid compartment within the vial housing for holding a fluid. The one or more vial assemblies also include a dispensing mechanism coupled to the cup member and configured to dispense a predetermined amount of fluid. The dispensing system also includes a reusable electrically powered dispensing actuator configured to be removably coupled to a vial assembly of the one or more vial assemblies by sliding into the cup member and activate the dispensing mechanism to draw fluid from the hermetically sealed fluid compartment and dispense fluid through the dispensing tip.

Description

[0001] Cross-references to related applications This application claims priority and benefits to U.S. Provisional Patent Application No. 63 / 628,075, filed June 17, 2023, the entire contents of which are incorporated herein by reference. Background Technology 1. Technical Field This specification relates to systems, apparatuses, and / or methods for dispensing a quantity of fluid or liquid as one or more discrete droplets onto the surface of the eye, and more specifically, to apparatuses capable of generating one or more discrete droplets for optimal and convenient administration of a predetermined dose of fluid.

[0003] 2. Description of related technologies Conventional methods of administering aqueous solutions (e.g., eye drops) to the eyes typically utilize squeeze bottle dispensers. The administration of eye drops usually requires the recipient to tilt their head (e.g., from a vertical to a horizontal position), which leads to inefficiency, discomfort, and uncertainty regarding the amount of eye drops actually reaching the target (e.g., the recipient's eye).

[0004] Applying eye drops to the eyes using a squeeze bottle dispenser also produces large droplets, which triggers a blink reflex, leading to significant waste of the applied liquid medication and drainage through the tear ducts and / or onto the skin surface. Some devices attempt to overcome this problem by using electronically controlled dispensing systems that generate a stream of droplets with a defined dose volume. U.S. Patent Nos. 9,801,757, 2014 / 0336618A1, and 11,011,270 describe a dispensing device that uses a piezoelectric or electromechanical dispensing system to generate a jet or spray to the eye. These systems include electronic control circuitry and a battery, which makes the device larger and less portable compared to pocket-sized squeeze bottle dispensers that typically include vials with a volume of 10-30 ml. Size and portability are particularly important for patients requiring several treatments throughout the day, thus pocket-sized devices are preferred. Furthermore, existing devices can be expensive because the entire device must be replaced when depleted.

[0005] Therefore, there is a need for a system, apparatus, and / or method for distributing a certain amount of fluid or liquid as one or more discrete droplets onto the surface of the eye. Summary of the Invention

[0006] This invention discloses a system or apparatus that utilizes an electromechanical dispensing system, but maintains the shape factor, size, and shape of the apparatus substantially similar to a small 10 ml or 15 ml squeeze bottle dispenser, thus offering the advantages of both portability and ease of use, while still providing the same number of doses processed within the apparatus. Furthermore, the electromechanical dispensing system is reusable, and the fluid container can be removed and replaced without compromising the sterility of the system, thus further providing a cost-effective solution.

[0007] This invention discloses a delivery device for dispensing small amounts of liquid solutions or suspensions onto the surface of the eye. The delivery device may have substantially the same size and shape factor as a small squeeze bottle dispenser and the same number of therapeutic doses, but the delivery device may also include an electronically controlled dispensing actuator that enables convenient delivery of micro-dose, without having a large size and / or volume, and without requiring inconvenient head tilting.

[0008] It is known that the volume of eye drops dispensed from a squeeze bottle dispenser is much larger than the volume retained on the surface of the eye. For example, U.S. Patent No. 5,630,793 states that when 30-50 microliters (μL) of eye drops are applied to the eye, only 5-7 microliters (μL) are actually retained at the target site, indicating that less than 1 / 3 of the volume of liquid effectively remains on the eye, while more than 2 / 3 of the volume is wasted. However, the delivery device of this application can use an electronically controlled dispensing system that effectively delivers micro-dose volumes of 10 microliters (μL), thus reducing the total fluid volume stored in the bottle to 1 / 3 of that used by a standard squeeze bottle dispenser, while maintaining the same number of doses.

[0009] The delivery device utilizes the remaining two-thirds of the bottle volume to house a compartment for holding the micro-dose dispensing actuator, its battery, and electronic circuitry. As a result, the delivery device maintains a form factor, size, and shape substantially the same as a small squeeze bottle dispenser, yet is effectively sufficient to hold the micro-dose dispensing actuator and the same volume of liquid for dose processing as a squeeze bottle dispenser of similar size. This delivery device eliminates the need to repackage the dispensing system, electronic circuitry, and battery in a special housing, as described in, for example, U.S. Patents 11,011,270 and 8,684,980.

[0010] Advantageously, the dispensing actuator is reusable, allowing empty bottles to be removed and replaced with pre-filled, airtight bottles without the risk of cross-contamination, thus providing a more economical and cost-effective solution.

[0011] In one example, an apparatus for dispensing a predetermined amount of fluid to the surface of an eye is disclosed. The apparatus may include a bottle assembly. The bottle assembly may include a bottle housing having an opening and configured to retain fluid. The bottle assembly may include a cup-shaped member extending through the opening into the bottle housing, dividing the interior space of the bottle housing into a first compartment and a second compartment. The first compartment is a hermetically sealed fluid compartment defined by the volume between the inner surface of the bottle housing and the cup-shaped member, and the second compartment is an internal volume within the cup-shaped member. The bottle assembly may include a dispensing mechanism coupled to the cup-shaped member and configured to dispense a predetermined amount of fluid. The apparatus may include an electrically operated dispensing actuator. The actuator may be configured to be removably coupled to the bottle assembly by sliding into the second compartment and to engage and actuate the dispensing mechanism to draw fluid from the first compartment and dispense fluid through a dispensing tip.

[0012] In one example, a dispensing mechanism for ophthalmologically delivering a fluid drug to the surface of the eye is disclosed. The dispensing mechanism may include a hemispherical cavity sealed by a diaphragm, and includes an inlet conduit in fluid communication with a fluid compartment and an outlet conduit in fluid communication with a one-way valve. The dispensing mechanism may include a ball member concentrically aligned with the hemispherical cavity and tangentially engaged with the diaphragm, and configured to periodically displace the diaphragm into the hemispherical cavity.

[0013] In this example, a dispensing system for dispensing a predetermined amount of fluid to the surface of an eye is disclosed. The system may include multiple bottle assemblies. Each of the multiple bottle assemblies may include a bottle housing with an opening. Each of the multiple bottle assemblies may include a cup-shaped member configured to extend through the opening in the bottle housing into the bottle housing to form a hermetically sealed fluid compartment within the bottle housing for retaining fluid. Each of the multiple bottle assemblies may include a dispensing mechanism coupled to the cup-shaped member and configured to dispense a predetermined amount of fluid. The system may include an electrically operated dispensing actuator configured to be removably coupled to one of the bottle assemblies by sliding into the cup-shaped member. The actuator may be configured to engage and actuate the dispensing mechanism to draw fluid from the hermetically sealed fluid compartment and dispense fluid through a dispensing tip. The actuator may be configured to be removably coupled to another of the multiple bottle assemblies when the fluid in the bottle assembly is depleted. Attached Figure Description

[0014] Other systems, methods, features, and advantages of this disclosure will become apparent to those skilled in the art after studying the following figures and detailed description. The components shown in the figures are not necessarily to scale and may be enlarged to better illustrate the essential features of this disclosure. In the figures, the same reference numerals denote the same components in different views.

[0015] Figure 1A and Figure 1B Side views of example dispensing systems relative to a 10 ml (mL) (0.33 fl oz) squeeze bottle dispenser are shown.

[0016] Figure 2A and Figure 2B They are shown respectively Figure 1A Perspective view and exploded view of the bottle component of an exemplary dispensing system.

[0017] Figure 3A and Figure 3B It shows Figure 2A The bottle assembly, wherein the dispensing actuators are pulled out from the bottle assembly and inserted into the bottle assembly respectively.

[0018] Figure 4A and Figure 4B It shows Figure 1A A cross-sectional view of an exemplary distribution system, showing the diaphragm in a first distribution state and a second distribution state, respectively.

[0019] Figure 5A A perspective view of an exemplary allocation system is shown.

[0020] Figure 5B It shows Figure 5A A perspective cross-sectional view of an exemplary distribution system, showing an eccentric wheel.

[0021] Figure 5C It shows the relationship with Figure 5A The exemplary distribution system has a separate distribution actuator. Figure 5A A perspective view of the bottle component of an exemplary dispensing system.

[0022] Figure 6A An exemplary dispensing tip (or nozzle) assembly with a one-way valve is shown.

[0023] Figure 6B The assembly in the housing is shown. Figure 6A The allocation of the tip component.

[0024] Figure 6C Showing mounted on the bottle assembly Figure 6B The allocation of the tip component. Detailed Implementation

[0025] This document discloses systems, apparatus, devices, and methods for dispensing a quantity of fluid or liquid onto the surface of an eye in the form of one or more discrete droplets. A dispensing system may include an electromechanical dispensing device for delivering a fluid (e.g., a fluid pharmaceutical agent) to the surface of an eye (e.g., a user's eye). The dispensing system may also include a bottle assembly and / or one or more alternative bottle assemblies. The electromechanical dispensing device may be coupled to the bottle assembly and / or configured to be removably coupled to the bottle assembly. The bottle assembly may be freestanding. In an example, the bottle assembly may be similar in size and / or shape to a 10 ml (mL) squeeze bottle dispenser.

[0026] The electromechanical dispensing device may also include an electromechanical microdose dispensing actuator and a horizontal dispensing tip. The electromechanical dispensing device can deliver a microdose of approximately 10 microliters (μL), which is known to have the same therapeutic effect as a 30-50 milliliters (mL) dose produced by a squeeze bottle dispenser. The delivery of the microdose volume proportionally reduces the total fluid volume required to obtain the same dose as, for example, a 10 milliliters (mL) squeeze bottle dispenser, and thus provides a certain amount of space savings within the bottle assembly. The electromechanical dispensing device utilizes the space-saving compartment for a reusable microdose dispensing actuator, thus having substantially the same form factor, size, and / or shape as a squeeze bottle dispenser, but also including a reusable microdose dispensing actuator that conveniently delivers smaller doses while allowing the recipient to face forward rather than having to tilt their head.

[0027] Furthermore, the dispensing system and / or electromechanical dispensing device provide a cost-effective solution by enabling the reusability of micro-dose dispensing actuators without the risk of cross-contamination, while the bottle assembly can be disposed of and replaced with a new, pre-filled, hermetically sealed bottle assembly. Additionally, the dispensing system may include multiple pre-filled, hermetically sealed bottle assemblies.

[0028] Various terms may be used in this disclosure, and the following definitions will apply to these terms: “jet dispensing,” as used herein and sometimes referred to as “dispensing,” refers to a non-contact application process that utilizes a fluid jet to form one or more droplets and discharge them from a dispensing tip or nozzle. The above terms are also used in U.S. Patent No. 9,039,666, entitled “Method and Apparatus for Dispensing Liquid,” which is incorporated herein by reference for all purposes.

[0029] Figure 1A and Figure 1BA dispensing system 100 (also referred to as dispensing device 100) is shown relative to a conventional squeeze bottle dispenser 150 (e.g., a 10 ml (mL) (0.33 fluid ounces (fl oz)) squeeze bottle dispenser). The dispensing system 100 and the conventional squeeze bottle have substantially the same physical dimensions and volume. The dispensing system 100 may include a bottle (or bottle housing) 102 and a dispensing actuator (or microdose dispensing actuator assembly) (or electric dispensing actuator) 108. For clarity, Figure 1A A bottle 102 with a cutout to show the internal components of the bottle 102 is shown. In the example, the bottle 102 may have a cylindrical shape. In the example, the bottle 102 may have an internal volume of about 10 milliliters (mL). The dispensing actuator 108 may be configured to deliver a trace amount of fluid (e.g., about 10 microliters (μL)) known to have the same therapeutic effect as a dose of 30 microliters (μL) typically produced by a conventional squeeze bottle dispenser 150. Thus, for the same dose of fluid, the dispensing system 100 may require a fluid volume relative to 1 / 3 of that of the squeeze bottle dispenser 150, and a corresponding 1 / 3 of the internal volume.

[0030] The dispensing system 100 may further include a cup-shaped member 103. At least a portion of the remaining two-thirds of the internal volume of the bottle 102 (i.e., the internal volume of the bottle 102 not used to contain fluid) may be provided for a housing for the cup-shaped member 103. The cup-shaped member 103 may provide a housing for the dispensing actuator 108. In this example, the cup-shaped member 103 may have a cylindrical shape. The cup-shaped member 103 may be accessible through an opening 213 (not shown) in the bottle 102. Figure 2B The middle mark extends into the bottle 102, thereby dividing the internal volume of the bottle 102 into a fluid compartment (or a first volume or subspace) 104 and a dispensing actuator compartment (or a second volume or subspace) 211 (not shown, in...). Figure 2A(See Chinese label). The fluid compartment 104 can be an hermetically sealed space having, for example, a volume of 3.33 ml (mL) of fluid 105 between the inner wall 109 of the bottle 102 and the cup-shaped member 103. The fluid compartment 104 can be defined by the volume between the inner surface of the bottle 102 and the cup-shaped member 103. The fluid compartment 104 can define a hermetically sealed shell for storing the fluid 105 (e.g., 3.33 ml (mL) of eye drops). In the example, the dispensing system 100 can have a fluid compartment 104 volume of about 3.33 ml (mL) and be capable of delivering about 333 doses, each dose being about 10 microliters (μL) of fluid 105. Thus, the dispensing system 100 can conveniently handle the same number of doses obtained from a 10 ml (mL) squeeze bottle dispenser 150, which delivers about 333 doses, each dose being about 30 microliters (μL) of fluid. In the example, the dispensing system 100 may be configured to dispense a predetermined amount of fluid each time the dispensing system 100 is actuated through the dispensing end 115. For example, the predetermined amount of fluid may be approximately 5-20 microliters (μL) or less than 30 microliters (μL).

[0031] Dispensing system 100 may have a height A and a width B. In an example, the height A of dispensing system 100 may be approximately 20 mm to approximately 60 mm. In another example, the height A of dispensing system 100 may be approximately 45 mm. Squeeze bottle dispenser 150 may have a height C of approximately 55 mm and a width D of approximately 25 mm. Therefore, dispensing system 100 may deliver the same amount or more dose as squeeze bottle dispenser 150, while being similar in size to or smaller than squeeze bottle dispenser 150. Bottle 102 may be sized similar to... Figure 1B The squeeze bottle dispenser 150 shown is similar to the 10 ml (mL) bottle 151. In this example, the dispensing system 100 may include a larger bottle 102, such that the bottle 102 can hold more than 3.33 ml (mL) of fluid 105 (e.g., 5-10 ml (mL)). In this example, the dispensing system 100 may include a bottle 102 having the shape factor and / or volume of a conventional eye drop dispenser having, for example, a volume of 10-30 ml (mL).

[0032] The dispensing system 100 may also include a dispensing end 115, a suction tube 107, and / or a conduit 433 (not shown) between the dispensing end 115 and the suction tube 107. Figure 4A (Middle mark). When the momentary switch 101 is activated (e.g., by being pressed by a user), the draw tube 107 and conduit 433 can deliver fluid 105 to the dispensing end 115 to dispense droplets 106. In the example, the dispensing end 115 may include one or more threads configured to receive a threaded cap 311 (not shown in the image). Figure 3A(marked in the middle).

[0033] Figure 2A and Figure 2B The bottle assembly 200 and its exploded view are shown respectively. The bottle assembly 200 may include a bottle 102 and a cup-shaped member 103. Figure 2A A cup-shaped component 103 fully assembled onto bottle 102 is shown. As described above, the cup-shaped component 103 divides the internal volume of bottle 102 into two compartments, including a fluid compartment 104 and a dispensing actuator compartment 211. The fluid compartment 104 can be an airtight, sealed compartment inside bottle 102 and outside cup-shaped component 103. The fluid compartment 104 can be used to store fluid 105 (e.g., liquid medicine).

[0034] Dispensing actuator compartment 211 may be an open space within cup-shaped member 103, such that cup-shaped member 103 defines dispensing actuator compartment 211. Dispensing actuator compartment 211 may be an internal volume within cup-shaped member 103. In an example, dispensing actuator compartment 211 may have a volume of approximately 6 milliliters (mL). Dispensing actuator compartment 211 may be configured to store a removable dispensing actuator 108 (or an electrically operated dispensing actuator) including electronic circuitry and / or one or more batteries. Dispensing actuator 108 may be configured to be removably coupled to bottle 102 by sliding into dispensing actuator compartment 211 and to engage and actuate dispensing mechanism (or dispensing assembly) 400 to draw fluid 105 from fluid compartment 104 and dispense fluid 105 through dispensing tip (or check valve or horizontal valve) 356.

[0035] Dispensing actuator compartment 211 can be configured to be stored and / or removably coupled to dispensing actuator 108. By making dispensing actuator 108 removable, dispensing system 100 retains the form factor, shape, and / or size of a standard squeeze bottle dispenser 150, but has the additional benefit of allowing dispensing actuator 108 to be reused after removal from bottle assembly 200. Bottle assembly 200 provides a cost-effective enclosure for fluid 105 and dispensing actuator 108. The potentially relatively heavy dispensing actuator 108 is stored within a cup-shaped member 103 extending into bottle 102, thus bringing the center of gravity of dispensing system 100 closer to the bottom 202 of bottle 102, thereby keeping bottle 102 stable and upright.

[0036] The cup-shaped member 103 may further include a flange 209 surrounding the opening 203 of the cup-shaped member 103. In the example, during assembly, the cup-shaped member 103 may be fastened by a threaded engagement such that the flange 209 is positioned tightly against a sealing lip 205 that projects around the opening 213 of the bottle 102, thereby forming a hermetically sealed fluid compartment 104. For example, the cup-shaped member 103 may include one or more threads 210 configured to screw into one or more threads 212 of the bottle 102. Alternatively, in the example, the cup-shaped member 103 may be attached to the bottle 102 by any means (e.g., adhesive, thermal bonding, etc.) that utilizes an interference fit of a snap-lock or creates a hermetically sealed fluid encapsulation or compartment within the bottle 102.

[0037] Figure 3A An exploded view of a dispensing system 100 including a dispensing actuator 108 and a bottle assembly 200 is shown. The cup-shaped member 103 may also include a nozzle assembly 355. The nozzle assembly 355 may include a dispensing end 115, a dispensing tip (or a one-way valve or a horizontal valve) 356, and / or a vent 357 extending from the fluid compartment 104 to an air filter leading to the atmosphere. The vent 357 allows the pressure within the fluid compartment 104 to be equalized with atmospheric pressure. In an example, the vent 357 may functionally resemble the ventilation system described in U.S. Patent No. 9,238,532 or U.S. Patent Publication No. 2014 / 0336596, both of which are incorporated herein by reference. The vent 357 may include, for example, an air filter of 0.2 micrometers (μm) capable of removing particles and microorganisms, thereby preventing contamination of the fluid compartment 104 by particles and microorganisms. In the example, vent 357 may be connected to fluid compartment 104 via duct (or ventilation path) 322 and / or opening 321 in cup-shaped member 103.

[0038] The distribution actuator 108 may include an actuator housing 330. The distribution actuator 108 and / or the actuator housing 330 may include an electric motor 303 (e.g., a DC motor) coupled to an eccentric wheel 305. The distribution actuator 108 may also include one or more batteries 354 (e.g., one or two button batteries, one or more rechargeable batteries, etc.) electrically connected to the motor 303 and at least partially located within the actuator housing 330. The distribution actuator 108 may also include a momentary switch 101. The momentary switch 101 may be configured to be finger-actuated. The distribution actuator 108 may also include a printed circuit board (PCB) (or electronic circuitry) 306 electrically connected to the motor 303, one or more batteries 354, and / or the momentary switch 101. The PCB 306 may be at least partially located within the actuator housing 330. The PCB 306 may include timer circuitry configured to control the start, duration, and / or rotation speed of the motor 303. In the example, when the momentary switch 101 is actuated, the PCB 306 can, when actuated by the user, initiate the rotation of the eccentric wheel 305 via the motor 303 for a duration of 50-100 milliseconds (ms). In a preferred embodiment, the dispensing actuator 108 delivers a dose of approximately 10 microliters (μL) in less than approximately 100 milliseconds (ms).

[0039] The dispensing actuator 108 can be inserted, for example, by a user, into the dispensing actuator compartment 211 and mechanically engages with the bottle assembly 200 to dispense fluid 105. When inserted, the dispensing actuator 108 does not come into contact with the fluid 105 within the hermetically sealed bottle assembly 200. The dispensing actuator 108 can be removed from an empty bottle assembly and inserted into a second pre-filled bottle assembly without the risk of cross-contamination.

[0040] Figure 3B A dispensing system 100 is shown, wherein a dispensing actuator 108 is fully inserted into a dispensing actuator compartment 211 within a bottle assembly 200. Upon activation of the momentary switch 101, a flow of droplets 106 can be dispensed from the dispensing tip 356.

[0041] Figure 4A and Figure 4BA cross-sectional view of a bottle assembly 200 is shown, including a dispensing mechanism (or dispensing component) 400 configured to draw fluid 105 upward from the bottom 202 of the bottle 102 to a dispensing tip 356 for dispensing the fluid 105. In the example, the dispensing mechanism 400 may be within or at least partially within a nozzle assembly 355. The dispensing mechanism 400 may fill the fluid path (or passage) 410 by drawing air and filling the fluid path 410 with fluid 105. The fluid path 410 may include a suction tube 107 and / or a conduit 433. The dispensing mechanism 400 may also include means that allow the removal and insertion of an eccentric wheel (or dispensing actuator wheel) 305 by sliding engagement, making it easy to replace an empty bottle assembly 200.

[0042] The dispensing mechanism 400 may include a solid structure having a hemispherical or substantially hemispherical cavity (or pump cavity) 435, which is sealed and / or covered by a diaphragm (or flat diaphragm) 432. The hemispherical cavity 435 may have a hemispherical or substantially hemispherical surface 437 at one end. The dispensing mechanism 400 may also include a ball member 430 tangentially engaged on one side of the ball member 430 at the center of the diaphragm 432 and engaged on the opposite side of the ball member 430 with an eccentric wheel 305. The ball member 430 may be concentrically aligned with the hemispherical cavity 435 and tangentially engaged with the diaphragm 432. By causing the diaphragm 432 to... Figure 4A The flat or planar shape shown is deformed as Figure 4B The hemispherical or substantially hemispherical shape 432a shown is such that the rotation of the eccentric wheel 305, caused by the motor 303, causes the ball member 430 to periodically shift or oscillate into the cavity 435 and / or toward the hemispherical surface 437. The dispensing actuator 108 activates the dispensing mechanism 400 by rotating the eccentric wheel 305 to cause the ball member 430 and the diaphragm 432 to periodically oscillate toward the hemispherical surface 437 of the hemispherical cavity 435. (Refer to...) Figure 4B As can be seen, the diaphragm 432 with a hemispherical shape 432a can have a radius of curvature that is substantially the same as that of the cavity 435. Thus, the displacement of the spherical member 430 reduces the volume of the cavity 435 to zero or near zero, thereby maximizing the pressure and negative pressure caused by the displacement of the diaphragm 432 and sufficient to fill the fluid path 410. This principle is based on Polley's law, where the pressure change in the cavity 435 is inversely proportional to the change in the volume of the cavity 435. In the example, Figure 4A The volume of cavity 435 shown may be approximately 8 cubic millimeters (mm³). 3 The volume is reduced to zero or near zero, so the volume ratio is maximized and sufficient to generate suction or negative pressure to fill the fluid path 410.

[0043] refer to Figure 4AIt can be seen that cavity 435 is connected to fluid path (or inlet conduit) 410. Cavity 435 can be in fluid communication with fluid compartment 104 via fluid path 410. Additionally, cavity 435 can be in fluid communication with dispensing tip 356 via outlet conduit 438. Thus, the negative pressure generated in cavity 435 draws fluid 105 from bottle 102 into cavity 435, while the diaphragm 432 displaces within cavity 435 as... Figure 4B The dispensing tip 356 of the dispensing body, which displaces fluid 105 through the dispensing droplets (or liquid particles) 106, is shown. The dispensing tip 356 can be and / or function as a one-way valve. Movement of the diaphragm 432 into the cavity 435 can also generate flow into the fluid path 410; however, the flow resistance through the dispensing tip 356 is lower than the flow resistance through the fluid path 410, so fluid 105 flows and is primarily dispensed through the dispensing tip 356, and minimally dispensed through the fluid path 410. In this example, the fluid path 410 may include a second one-way valve 434 that completely stops the flow of fluid into the fluid path 410. The fluid 105 diverted through the dispensing tip 356 creates a negative pressure within the fluid path 410, which draws more fluid 105 from the bottle 102.

[0044] In a preferred embodiment, the radius of the spherical member 430 is approximately 2.5 mm, and the thickness of the diaphragm 432 is approximately 0.5 mm. Therefore, Figure 4B The deformable diaphragm 432a shown has a radius of approximately 3.0 millimeters (mm), which is the same as the radius of the hemispherical cavity 435. In this example, the displacement of the spherical member 430 is approximately 0.7 millimeters (mm).

[0045] refer to Figure 3A , 4A And 4B, the eccentric wheel 305 can be included in the reusable dispensing actuator 108, which can be removed from the used bottle assembly 200 and inserted into a new pre-filled bottle assembly 200. Figure 4A An eccentric wheel 305a is shown disengaged from the ball member 430. The ball member 430 is configured to engage with the eccentric wheel 305 when the dispensing actuator 108 is inserted into the dispensing actuator compartment 211 within the cup-shaped member 103.

[0046] The engagement and disengagement of the eccentric wheel 305 with the ball member 430 are indicated by arrow 440. The eccentric wheel 305 can slide without interference on the surface of the ball member 430, allowing for convenient replacement of the bottle assembly 200 by pulling the removable dispensing actuator 108 from the bottle assembly 200. The ball member 430 may have two or more functions. For example, the ball member 430 can deform the diaphragm 432 into a hemisphere 432a having a radius of curvature substantially the same as that of the cavity 435, thereby generating sufficient suction to fill the fluid path 410. Furthermore, the ball member 430 allows for uninterrupted sliding engagement and disengagement of the eccentric wheel 305 when the dispensing actuator 108 is pulled out or inserted into the bottle assembly 200. This method enables convenient and cost-effective replacement of empty bottles with pre-filled bottles.

[0047] When the dispensing system 100 is actuated and the suction tube 107 is not immersed in the fluid 105, there is a risk that the dispensing mechanism 400 may draw air into the fluid path 410, interrupting its normal operation or affecting dispensing accuracy. To ensure that the dispensing system 100 operates only in a substantially vertical direction, the PCB 306 may include a 3-axis accelerometer or tilt sensor that senses the orientation of the dispensing system 100 and prevents operation when the axis of the bottle 102 is tilted away from the gravitational acceleration vector by more than about 30 degrees. In the example, the sensor may be made of the Wurth Elektronik sensor with part number 2533020201601 or similar. In the example, the tilt sensor may be configured to prevent operation of the dispensing actuator 108 when the bottle assembly 200 is tilted relative to its upright position by more than a predetermined angle.

[0048] Figure 5A A perspective view of a dispensing system (or apparatus) 500 including a bottle assembly 503 and a removable dispensing actuator 502 is shown. The dispensing system 500 may include some or all of the functions discussed herein with respect to the dispensing system 100. The dispensing actuator 502 may include a momentary switch 504 for initiating a dispensing cycle.

[0049] Figure 5B A dispensing system 500 including two cuts is shown. A first cut 520 in the bottle 501 of the bottle assembly 503 shows a cup-shaped member 560 inserted into the bottle 501. A second cut 521 in the dispensing actuator 502 shows an eccentric wheel 531 engaging with a ball member 562. The bottle 501 includes a bottom 522.

[0050] Figure 5CA dispensing actuator 502 is shown pulled out of compartment 560 in bottle assembly 503. Dispensing actuator 502 can be pulled out of an empty bottle assembly and inserted into a new pre-filled bottle assembly. Ball member 562 allows eccentric wheel 531 to slide into and disengage from ball member 562, thereby actuating dispensing mechanism 400, as shown. Figure 4A and Figure 4B As shown. The eccentric wheel 531 can be part of the dispensing actuator 502, which can be removed from the bottle assembly 503 in the direction indicated by arrow 570. The dispensing actuator 502 does not have any physical contact with the fluid 105 that is hermetically sealed in the bottle assembly 503, so the replacement of the dispensing actuator 502 can be completed without the risk of cross-contamination.

[0051] Figures 5A-5C The features of the examples can be used alone or in combination with any other examples here.

[0052] Figure 6A The dispensing tip assembly 600 is shown. The dispensing tip assembly 600 can be positioned in the outlet pipe 438 (in... Figure 4B (marked in the middle). In the example, the tip assembly 600 can be coupled to the nozzle assembly 355 (in the middle). Figure 3A and 5C (Marked in the middle). Distributor 400 (in Figure 4A and Figure 4B (The marked area) can generate a rapid cycle of pressure fluctuations, which includes continuous cycles of pressure and negative pressure, wherein the check valve 601 (e.g., in...) Figure 3A The dispensing tip 356 (marked in the middle) opens during pressure cycling to allow outflow and closes rapidly at the start of the next negative pressure cycle. If valve 601 does not respond quickly enough, there is a risk that the upcoming negative pressure cycle will draw contaminants into bottle assembly 503 (or bottle assembly 200). Preferably, valve 601 should be small and lightweight so that the reflective inertia of the moving lip 609 of valve 601 will be minimized. In the example, valve 601 can be, or can be similar to, the one-way valve model DU047.001 SD duckbill valve manufactured by MiniValve International.

[0053] In a preferred embodiment, the closing force of valve 601 is increased by two spring members, including a first spring member 602a and a second spring member 602b, one of which is on each side of valve lip 609. The first free ends 603a and 603b of spring members 602a and 602b can respectively press against valve lip 609 and apply a predetermined force to increase the minimum pressure required to open valve 601 and allow outflow. Spring members 602a and 602b may be U-beams and may be made of spring steel, and can typically apply a force of 5 grams (g) to 20 grams (g) to valve lip 609. The advantage of valve 601 as a duckbill (or horizontal) valve compared to conventional valves for ocular fluid administration is that valve 601 does not have a residual volume of fluid outside the outlet nozzle, as shown, for example, in U.S. Patent No. 9,238,532 and U.S. Patent Publication 2014 / 0336596. In some cases, the closing force of individual duckbill valve lips 609 may be insufficient or inconsistent. However, spring components 602a and 602b overcome this problem. Spring components 602a and 602b can increase the closing force of the duckbill valve.

[0054] Figure 6B A dispensing tip assembly 600 is shown that further includes a cylindrical member 610. The cylindrical member 610 may support the dispensing tip assembly 600, wherein the one-way valve 601 and spring members 602a, 602b are at least partially assembled or positioned within the cylindrical member 610.

[0055] Figure 6C A dispensing tip assembly 600 is shown attached to a dispensing device 620 (e.g., any dispensing device or system disclosed herein).

[0056] Figures 6A-6C The features of the examples can be used alone or in combination with any other examples in this article.

[0057] In the examples, multiple bottles or bottle assemblies may be used, which can be configured similarly to the bottles or bottle assemblies disclosed herein. The actuators disclosed herein can be configured to be removably coupled to another bottle assembly among the multiple bottle assemblies when the fluid within the bottle assembly is depleted.

[0058] Exemplary embodiments of the methods / systems have been disclosed in an illustrative manner. Therefore, the terminology used throughout should be read in a non-limiting manner. While those skilled in the art may make minor modifications to the teachings herein, it should be understood that all such embodiments that reasonably fall within the scope of the improvements thus contributed to the art are intended to be included within the scope of this patent, and that the scope should not be limited except as provided in the appended claims and their equivalents.

Claims

1. An apparatus for dispensing a predetermined amount of fluid onto the surface of an eye, the apparatus comprising: Bottle assembly, comprising: The bottle shell has an opening and is configured to retain fluid. A cup-shaped component extends into the bottle shell through the opening therein, dividing the internal space of the bottle shell into a first compartment and a second compartment. The first compartment is an airtight fluid compartment defined by the volume between the inner surface of the bottle shell and the cup-shaped component. The second compartment is the internal volume inside the cup-shaped component. A dispensing mechanism, coupled to the cup-shaped member and configured to dispense the predetermined amount of fluid; and The electric distributor actuator is configured as follows: It is removably coupled to the bottle assembly by sliding into the second compartment, and Engage and activate the dispensing mechanism to draw fluid from the first compartment and dispense the fluid through the dispensing tip.

2. The apparatus of claim 1, wherein the electrically operated distributor actuator comprises: Housing, the housing comprising: The eccentric wheel, which is connected to the motor, A timer circuit, which is connected to the motor, and One or more batteries are connected to the timer circuit and the motor; and An instantaneous switch is configured to, when actuated by a user, initiate the rotation of the eccentric wheel via the motor for a period of 50-100 milliseconds (msec).

3. The apparatus according to claim 2, wherein the dispensing mechanism comprises: A solid structure with a hemispherical cavity sealed by a diaphragm; A spherical component, which is concentrically aligned with the hemispherical cavity and tangentially engaged with the diaphragm, and is configured to periodically displace the diaphragm within the hemispherical cavity; An inlet conduit is located within the hemispherical cavity and is configured to be in fluid communication with the first compartment; as well as An outlet conduit, located within the hemispherical cavity and configured to be in fluid communication with the dispensing tip, which is a one-way valve.

4. The apparatus according to claim 3, wherein: The diaphragm is flat and covers the hemispherical cavity; and The electric dispensing actuator actuates the dispensing mechanism by rotating the eccentric wheel to cause the ball component and the diaphragm to oscillate periodically toward the hemispherical surface of the hemispherical cavity.

5. The apparatus of claim 3, wherein the ball member is configured to engage the eccentric wheel when the electric dispensing actuator is inserted into the second compartment within the cup-shaped member.

6. The apparatus of claim 1, wherein the dispensing mechanism comprises a cavity, a fluid inlet conduit extending from the cavity to the first compartment, and an outlet conduit extending to the dispensing tip.

7. The apparatus according to claim 6, wherein, The dispensing tip includes a one-way valve.

8. The apparatus according to claim 1, wherein, The dispensing tip includes a duckbill valve and one or two spring components that increase the closing force of the duckbill valve.

9. The apparatus according to claim 1, wherein, Both the bottle shell and the cup-shaped component have a cylindrical shape.

10. The apparatus according to claim 1, wherein, The electric dispensing actuator includes a tilt sensor configured to prevent operation of the electric dispensing actuator when the bottle assembly is tilted more than a predetermined angle relative to its upright position.

11. The apparatus according to claim 1, wherein, The volume of the outer shell of the bottle is 10-30 ml (mL).

12. The apparatus according to claim 1, wherein, The predetermined amount of fluid dispensed through the dispensing tip during each actuation is 5-20 microliters (μL).

13. The apparatus according to claim 1, wherein, The predetermined amount of fluid dispensed through the dispensing tip during each actuation is less than 30 microliters (μL).

14. A dispensing mechanism for delivering fluid ophthalmic drugs to the surface of the eye, comprising: A hemispherical cavity, sealed by a diaphragm, comprising: The inlet conduit in fluid communication with the fluid compartment, and An outlet conduit in fluid communication with a check valve; and A spherical component is concentrically aligned with the hemispherical cavity and tangentially engaged with the diaphragm, and is configured to periodically shift the diaphragm into the hemispherical cavity.

15. A dispensing system for dispensing a predetermined amount of fluid onto the surface of an eye, the system comprising: Multiple bottle components, each bottle component including: A bottle shell with an opening. A cup-shaped member configured to extend through the opening in the bottle housing into the bottle housing to form an airtight fluid compartment within the bottle housing for retaining fluid. A dispensing mechanism, coupled to the cup-shaped member and configured to dispense the predetermined amount of fluid; and The electric distributor actuator is configured as follows: The bottle assembly is removably connected to the plurality of bottle assemblies by sliding into the cup-shaped member. Engage and activate the dispensing mechanism to draw fluid from the hermetically sealed fluid compartment and dispense the fluid through the dispensing tip. When the fluid in the bottle assembly is depleted, it can be removably connected to another bottle assembly among the plurality of bottle assemblies.

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