Device and system for liquid delivery to a surface of an eye
Patent Information
- Application Number
- HK62026125618
- Authority / Receiving Office
- HK · HK
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-17
- Filing Date
- 2026-07-02
- Publication Date
- 2026-09-25
- Estimated Expiration
- 2044-06-10
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480040232.1 (22) Application Date 2024.06.11 (30) Priority Data 63 / 628,075 2023.06.17 US (85) PCT International Application Entering National Phase Date 2025.12.16 (86) PCT International Application Application Data PCT / US2024 / 033411 2024.06.11 (87) PCT International Application Publication Data WO2024 / 263442 EN 2024.12.26 (71) Applicant Topnotch, Inc. Address California, USA (72) Inventor Ehud Ifri (74) Patent Agency Beijing Wanhuida Law Firm 11111 Patent Attorney Yang Qian (51) Int.Cl. A61F 9 / 00 (2006.01) A61J 1 / 05 (2006.01) A61J 1 / 22 (2006.01) (54) Title of Invention Apparatus and System for Delivering Liquid to the Surface of the Eye (57) Abstract Method, system, apparatus and device for dispensing a predetermined amount of fluid to the surface of the eye. A dispensing system includes one or more bottle assemblies, each bottle assembly including a bottle housing and a cup-shaped member coupled to the bottle housing to form an hermetically sealed fluid compartment within the bottle housing for retaining fluid. The one or more bottle assemblies also include a dispensing mechanism coupled to the cup-shaped member and configured to dispense a predetermined amount of fluid. The dispensing system also includes a reusable electrically operated dispensing actuator configured to be removably coupled to the bottle assembly in the one or more bottle assemblies by sliding into the cup-shaped member and actuating the dispensing mechanism to draw fluid from the hermetically sealed fluid compartment and dispense fluid through a dispensing tip.Claims 2 pages, Description 8 pages, Drawings 7 pages, CN 121335685 A 2026.01.13 CN 1 21 33 56 85 A 1. An apparatus for dispensing a predetermined amount of fluid to the surface of an eye, the apparatus comprising: a bottle assembly including: a bottle housing having an opening and configured to retain fluid; a cup-shaped member extending through the opening of the bottle housing into the bottle housing, dividing an interior space of the bottle housing into a first compartment and a second compartment, the first compartment being an airtight fluid compartment defined by a volume between an inner surface of the bottle housing and the cup-shaped member, the second compartment being an interior volume within the cup-shaped member; and a dispensing mechanism coupled to the cup-shaped member and configured to dispense the predetermined amount of fluid; and an electrically operated dispensing actuator configured to: be removably coupled to the bottle assembly by sliding into the second compartment, and engage and actuate the dispensing mechanism to draw fluid from the first compartment and dispense fluid through a dispensing tip. 2. The apparatus of claim 1, wherein the electrically operated dispensing actuator comprises: a housing comprising: an eccentric wheel coupled to a motor; a timer circuit coupled to the motor; and one or more batteries coupled to the timer circuit and the motor; and an instantaneous switch configured to, when actuated by a user, initiate rotation of the eccentric wheel by the motor for a period of 50-100 milliseconds (msec). 3. The apparatus of claim 2, wherein the dispensing mechanism comprises: a solid structure having a hemispherical cavity sealed by a diaphragm; a ball member concentrically aligned with the hemispherical cavity and tangentially engaged with the diaphragm, and configured to periodically displace the diaphragm within the hemispherical cavity; an inlet conduit located within the hemispherical cavity and configured to be in fluid communication with the first compartment; and an outlet conduit located within the hemispherical cavity and configured to be in fluid communication with the dispensing tip, the dispensing tip being a one-way valve. 4. The apparatus of claim 3, wherein: the diaphragm is flat and covers the hemispherical cavity; and the electrically operated dispensing actuator actuates the dispensing mechanism by rotating the eccentric wheel to cause the ball member and the diaphragm to periodically oscillate 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 electrically operated dispensing actuator is inserted into the second compartment within the cup-shaped member. 6. The apparatus of claim 1, wherein the dispensing mechanism includes 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 of claim 6, wherein the dispensing tip includes a one-way valve.8. The device of claim 1, wherein the dispensing tip comprises a duckbill valve and one or two spring members that increase the closing force of the duckbill valve. 9. The device of claim 1, wherein both the bottle housing and the cup-shaped member have a cylindrical shape. 10. The device of claim 1, wherein the electrically operated dispensing actuator comprises a tilt sensor configured to prevent operation of the electrically operated dispensing actuator when the bottle assembly is tilted relative to its upright position by more than a predetermined angle. 11. The device of claim 1, wherein the volume of the bottle housing is 10-30 ml. 12. The device of claim 1, wherein the predetermined amount of fluid dispensed through the dispensing tip during each actuation is 5-20 μL. 13. The device of claim 1, wherein the predetermined amount of fluid dispensed through the dispensing tip during each actuation is less than 30 μL. 14. A dispensing mechanism for delivering a fluid ophthalmic drug to the surface of the eye, comprising: a hemispherical cavity sealed by a diaphragm and including: an inlet conduit in fluid communication with a fluid compartment and an outlet conduit in fluid communication with a one-way valve; and 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. 15. A dispensing system for dispensing a predetermined amount of fluid to the surface of an eye, the system comprising: a plurality of bottle assemblies, each bottle assembly including: a bottle housing having an opening; a cup-shaped member configured to extend through the opening of the bottle housing into the bottle housing to form an hermetically sealed fluid compartment within the bottle housing for retaining fluid; and a dispensing mechanism coupled to the cup-shaped member and configured to dispense the predetermined amount of fluid; and an electrically operated dispensing actuator configured to: be removably coupled to one of the plurality of bottle assemblies by sliding into the cup-shaped member; engage and actuate the dispensing mechanism to draw fluid from the hermetically sealed fluid compartment and dispense fluid through a dispensing tip; and be removably coupled to another of the plurality of bottle assemblies when the fluid in the bottle assembly is depleted. Claims 2 / 2 Page 3 CN 121335685 A Apparatus and System for Delivering Liquid to the Surface of the Eye
[0001] Cross-Reference 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 Art
[0002] 1. Technical Field This specification relates to systems, apparatuses, and / or methods for dispensing a quantity of fluid or liquid into one or more discrete droplets onto the surface of the eye, and more specifically, the apparatus is capable of generating one or more discrete droplets for optimal and convenient administration of a predetermined dose of fluid.
[0003] 2. Description of Related Art Conventional methods of administering aqueous solutions (e.g., eye drops) to the eye typically utilize squeeze bottle dispensers. Administration of eye drops usually requires the recipient to tilt their head (e.g., from a vertical to a horizontal position), which results in inefficiency, discomfort, and uncertainty regarding the amount of eye drops actually reaching the target (e.g., the recipient's eye).
[0004] Administering eye drops to the eye using squeeze bottle dispensers also produces large droplets, which triggers a blink reflex, leading to significant waste of the administered liquid medication and drainage through the lacrimal 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 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, device, and / or method for dispensing a quantity of fluid or liquid as one or more discrete droplets onto the surface of the eye.
[0006] The present 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 possessing the advantages of both portability and ease of use, while still having the same number of doses processed in 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] The present 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 capable of conveniently delivering micro-dose, while the delivery device does not have a large size and / or volume, and does not require 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, as stated on page 1 / 8 of the specification, 4 CN 121335685 A. For example, U.S. Patent No. 5,630,793 states that when 30-50 microliters (μL) of eye drops are applied to the eye, the actual amount retained at the target site is only 5-7 microliters (μL), indicating that less than 1 / 3 of the volume of liquid is effectively retained on the eye, while more than 2 / 3 of the volume of liquid 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 dose processing times.
[0009] The delivery device utilizes the remaining 2 / 3 of the bottle volume to house a compartment for holding the micro-dose dispensing actuator, its battery, and electronic circuitry. As a result, the shape factor, size, and shape of the delivery device remain substantially the same as those of a small squeeze bottle dispenser, but are also effectively sufficient to hold the micro-dose dispensing actuator and have the same volume of liquid for dose treatment as a squeeze bottle dispenser of similar size. This delivery device does not require repackaging 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 the empty bottle to be removed and replaced with a pre-filled, hermetically sealed bottle without the risk of cross-contamination, thus further providing an economical and cost-effective solution.
[0011] In one example, an apparatus for dispensing a predetermined amount of fluid onto the surface of the 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 into the bottle housing through an opening therein, 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 the internal volume inside 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 device 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 an example, a dispensing mechanism for ophthalmologically delivering a fluid medication 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 a hemispherical cavity and tangentially engaged with a diaphragm, and configured to periodically displace the diaphragm into the hemispherical cavity.
[0013] In an example, a dispensing system for dispensing a predetermined amount of fluid to the surface of an eye is disclosed. The system may include a plurality of bottle assemblies. Each of the plurality of bottle assemblies may include a bottle housing with an opening. Each of the plurality of bottle assemblies may include a cup-shaped member configured to extend through the opening in the bottle housing to form an hermetically sealed fluid compartment within the bottle housing for retaining fluid. Each of the plurality of 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 a bottle assembly among the plurality of 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 can be configured to be removably coupled to another bottle assembly among the plurality of bottle assemblies when the fluid in the bottle assembly is depleted. Brief Description of the Drawings
[0014] Other systems, methods, features, and advantages of this disclosure will become apparent to those skilled in the art after studying the following drawings and detailed description. The components shown in the drawings are not necessarily to scale and may be enlarged to better illustrate important features of this disclosure. In the drawings, the same reference numerals denote the same components in different views. Specification 2 / 8 pages 5 CN 121335685 A
[0015] Figures 1A and 1B respectively show side views of an example dispensing system relative to a 10 ml (mL) (0.33 fl oz) squeeze bottle dispenser.
[0016] Figures 2A and 2B respectively show perspective views and exploded views of the bottle assembly of the exemplary dispensing system of Figure 1A.
[0017] Figures 3A and 3B show the bottle assembly of Figure 2A, wherein the dispensing actuators are pulled out from and inserted into the bottle assembly, respectively.
[0018] Figures 4A and 4B show cross-sectional views of the exemplary dispensing system of Figure 1A, showing the diaphragm in a first dispensing state and a second dispensing state, respectively.
[0019] Figure 5A shows a perspective view of the exemplary dispensing system.
[0020] Figure 5B shows a perspective cross-sectional view of the exemplary dispensing system of Figure 5A, showing the eccentric wheel.
[0021] Figure 5C shows a perspective view of the bottle assembly of the exemplary dispensing system of Figure 5A, separated from the dispensing actuator of the exemplary dispensing system of Figure 5A.
[0022] Figure 6A shows an exemplary dispensing tip (or nozzle) assembly with a one-way valve.
[0023] Figure 6B shows the dispensing tip assembly of Figure 6A assembled in a housing.
[0024] Figure 6C shows the dispensing tip assembly of Figure 6B mounted on the bottle assembly.Detailed Description
[0025] This document discloses systems, apparatuses, devices, and methods for dispensing a quantity of fluid or liquid onto the surface of an eye in 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 may be 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 ml (mL) dose produced by a squeeze bottle dispenser. The delivery of micro-dose volumes proportionally reduces the total fluid volume required to obtain the same dose as, for example, a 10 ml (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 micro-dose dispensing actuator, thus having substantially the same form factor, size, and / or shape as a squeeze bottle dispenser, but also including a reusable micro-dose 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 making the micro-dose dispensing actuator reusable 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 expel 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 Liquids,” which is incorporated herein by reference for all purposes.
[0029] Figures 1A and 1B illustrate a dispensing system 100 (also referred to as dispensing device 100) relative to a conventional squeeze bottle dispenser 150 (e.g., a 10 ml (mL) (0.33 fluid specification 3 / 8 pages 6 CN 121335685 A oz (fl oz))). 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 electrically operated dispensing actuator) 108. For clarity, FIG1A shows a bottle 102 with a cutout to show the internal components of the bottle 102. In an example, the bottle 102 may have a cylindrical shape. In an example, the bottle 102 may have an internal volume of about 10 milliliters (mL). The dispensing actuator 108 may be configured to deliver a micro-volume 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 of 1 / 3 that of the squeeze bottle dispenser 150, and a corresponding 1 / 3 of the internal volume.
[0030] The dispensing system 100 may also include a cup-shaped member 103. At least a portion of the remaining two-thirds of the internal volume of bottle 102 (i.e., the internal volume of bottle 102 not used to contain fluid) may be provided for a housing for cup-shaped member 103. Cup-shaped member 103 may provide a housing for dispensing actuator 108. In the example, cup-shaped member 103 may have a cylindrical shape. Cup-shaped member 103 may extend into bottle 102 through opening 213 (not shown, labeled in FIG. 2B) to divide the internal volume of bottle 102 into a fluid compartment (or first volume or subspace) 104 and a dispensing actuator compartment (or second volume or subspace) 211 (not shown, labeled in FIG. 2A). Fluid compartment 104 may be an hermetically sealed space having, for example, a fluid volume of 3.33 ml (mL) between the inner wall 109 of bottle 102 and cup-shaped member 103. The fluid compartment 104 may be defined by the volume between the inner surface of the bottle 102 and the cup-shaped member 103. The fluid compartment 104 may define a hermetically sealed housing for storing fluid 105 (e.g., 3.33 ml of eye drops). In this example, the dispensing system 100 may have a fluid compartment 104 volume of approximately 3.33 ml and be capable of delivering approximately 333 doses, each dose being approximately 10 μL of fluid 105. Thus, the dispensing system 100 can conveniently handle the same number of doses obtained from a 10 ml squeeze bottle dispenser 150, which delivers approximately 333 doses, each dose being approximately 30 μL of fluid. In this 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 μL or less than 30 μL.
[0031] The dispensing system 100 may have a height A and a width B. In the example, the height A of the dispensing system 100 may be approximately 20 millimeters (mm) to approximately 60 millimeters (mm).In the example, the height A of the dispensing system 100 may be approximately 45 mm. The squeeze bottle dispenser 150 may have a height C of approximately 55 mm and a width D of approximately 25 mm. Therefore, the dispensing system 100 can deliver the same amount or more dose as the squeeze bottle dispenser 150, while being similar in size to or smaller than the squeeze bottle dispenser 150. The size of the bottle 102 may be similar to the 10 mL bottle 151 of the squeeze bottle dispenser 150 shown in Figure 1B. In the example, the dispensing system 100 may include a larger bottle 102, such that the bottle 102 can hold more than 3.33 mL of fluid 105 (e.g., 5–10 mL). In the example, the dispensing system 100 may include a bottle 102 having the shape factor and / or volume of a conventional eye drop dispenser, which has a volume of, for example, 10–30 mL.
[0032] The dispensing system 100 may also include a dispensing end 115, a draw tube 107, and / or a conduit 433 (not shown, labeled in FIG. 4A) between the dispensing end 115 and the draw tube 107. When the momentary switch 101 is activated (e.g., by being pressed by a user), the draw tube 107 and the conduit 433 may deliver fluid 105 to the dispensing end 115 to dispense droplets 106. In an example, the dispensing end 115 may include one or more threads configured to receive a threaded cap 311 (not shown, labeled in FIG. 3A).
[0033] FIG. 2A and FIG. 2B show exploded views of the bottle assembly 200 and the bottle assembly 200, respectively. The bottle assembly 200 may include a bottle 102 and a cup-shaped member 103. FIG. 2A shows the cup-shaped member 103 fully assembled onto the bottle 102. As described above, the cup-shaped member 103 may divide the internal volume of the bottle 102 into two compartments, including a fluid compartment 104 and a dispensing actuator compartment 211. Fluid compartment 104 may be an airtight compartment within bottle 102 and outside cup-shaped member 103. Fluid compartment 104 may be used to store fluid 105 (e.g., liquid medicine). Specification 4 / 8 pages 7 CN 121335685 A
[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 for dispensing actuator 108.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 may be configured to store and / or be removably coupled to dispensing actuator 108. By making dispensing actuator 108 removable, dispensing system 100 maintains the form factor, shape, and / or size of standard squeeze bottle dispenser 150, but has the further benefit of making dispensing actuator 108 reusable after removal from bottle assembly 200. Bottle assembly 200 provides cost-effective closure for fluid 105 and dispensing actuator 108. The relatively heavy dispensing actuator 108 is stored within a cup-shaped member 103 extending into the bottle 102, thus bringing the center of mass of the dispensing system 100 closer to the bottom 202 of the bottle 102, thereby keeping the bottle 102 stable and self-standing.
[0036] The cup-shaped member 103 may further include a flange 209 surrounding an opening 203 of the cup-shaped member 103. In the example, when assembled, the cup-shaped member 103 may be threadedly fastened such that the flange 209 is positioned tightly against a sealing lip 205 that protrudes around the opening 213 of the bottle 102, thereby forming an 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 coupled 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] FIG3A shows an exploded view of a dispensing system 100 including a dispensing actuator 108 and a bottle assembly 200. 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 may allow the pressure within the fluid compartment 104 to be equalized to atmospheric pressure. In the example, the vent 357 may be functionally similar to the ventilation system described in U.S. Patent No. 9,238,532 or U.S. Patent Publication No. 2014 / 0336596. Both patents are incorporated herein by reference. Vent 357 may include, for example, an air filter of 0.2 micrometers (μm) capable of removing particles and microorganisms, thereby preventing particle and microbial contamination of fluid compartment 104. In an 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 dispensing actuator 108 may include an actuator housing 330. The dispensing actuator 108 and / or the actuator housing 330 may include an electric motor 303 (e.g., a DC motor) coupled to the eccentric wheel 305. The dispensing 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 may be at least partially located within the actuator housing 330. The dispensing actuator 108 may also include a momentary switch 101. The momentary switch 101 may be configured to be finger-actuated. The dispensing 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 contact the fluid body 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] FIG3B shows a dispensing system 100 in which 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] FIGS. 4A and 4B show cross-sectional views of a bottle assembly 200 including a dispensing mechanism (or dispensing component) 400 configured to draw fluid 105 upward from the bottom 202 of the bottle 102 to the dispensing tip 356 to dispense the fluid 105. In an example, the dispensing mechanism 400 may be within or at least partially within a nozzle assembly 355. The dispensing mechanism 400 can 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 for removing and inserting the eccentric wheel (or dispensing actuator wheel) 305 by sliding engagement, making it easy to replace the 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 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 of the hemispherical cavity 435. The dispensing mechanism 400 may also include a ball member 430 tangentially engaged at the center of the diaphragm 432 on one side of the ball member 430 and engaged with the eccentric wheel 305 on the opposite side of the ball member 430. The ball member 430 may be concentrically aligned with the hemispherical cavity 435 and tangentially engaged with the diaphragm 432. By deforming the diaphragm 432 from the flat or planar shape shown in FIG. 4A to the hemispherical or substantially hemispherical shape 432a shown in FIG. 4B, 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. Referring to FIG. 4B, it can be seen that the diaphragm 432 with the hemispherical shape 432a can have a radius of curvature substantially the same as that of the cavity 435. In this way, the displacement of the ball member 430 reduces the volume of the cavity 435 to zero or near zero, and therefore the pressure and negative pressure caused by the displacement of the diaphragm 432 are maximized and sufficient to fill the fluid path 410. This principle is based on Polly's law, where the pressure change in cavity 435 is inversely proportional to the change in volume of cavity 435. In the example, the volume of cavity 435 shown in FIG4A may be approximately 8 cubic millimeters (mm3), which is reduced to zero or near zero, thus maximizing the volume ratio and sufficient to generate suction or negative pressure to fill fluid path 410.
[0043] Referring to FIG4A, it can be seen that cavity 435 is connected to fluid path (or inlet conduit) 410. Cavity 435 may be in fluid communication with fluid compartment 104 via fluid path 410. In addition, cavity 435 may 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 displacement of diaphragm 432 into cavity 435, as shown in FIG4B, causes fluid 105 to be displaced through dispensing tip 356 of dispensing body of dispensing droplets (or liquid particles) 106. The dispensing tip 356 can be and / or used as a check valve.The movement of diaphragm 432 into cavity 435 can also generate flow into fluid path 410; however, the flow resistance through dispensing tip 356 is lower than the flow resistance through fluid path 410, so fluid 105 flows and is primarily dispensed through dispensing tip 356 and minimally through fluid path 410. In an example, fluid path 410 may include a second one-way valve 434 that completely stops the flow of fluid into fluid path 410. The fluid 105 transferred through dispensing tip 356 creates a negative pressure within fluid path 410, which draws more fluid 105 from bottle 102.
[0044] In a preferred embodiment, the radius of spherical member 430 is approximately 2.5 mm, and the thickness of diaphragm 432 is approximately 0.5 mm; therefore, the radius of deformed diaphragm 432a shown in FIG. 4B is approximately 3.0 mm, which is the same as the radius of hemispherical cavity 435. In the example, the displacement of the ball member 430 is approximately 0.7 millimeters (mm).
[0045] Referring to Figures 3A, 4A, and 4B, the eccentric wheel 305 may be included in a reusable dispensing actuator 108, which can be removed from a used bottle assembly 200 and inserted into a new pre-filled bottle assembly 200. Figure 4A shows the eccentric wheel 305a disengaged from the ball member specification page 6 / 8 9 CN 121335685 A 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 from the ball member 430 are indicated by arrow 440. The eccentric wheel 305 can slide on the surface of the ball member 430 without interference, which allows 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 may 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 may allow the eccentric wheel 305 to engage and disengage without interference 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 draw tube 107 is not immersed in the fluid 105, there is a risk that the dispensing mechanism 400 will draw air into the fluid path 410 and its normal operation will be interrupted or the dispensing accuracy will be affected.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 or similar to the Wurth Elektronik sensor with part number 2533020201601. 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] FIG5A shows a perspective view of a dispensing system (or device) 500 including a bottle assembly 503 and a removable dispensing actuator 502. The dispensing system 500 may include some or all of the functions discussed herein regarding the dispensing system 100. The dispensing actuator 502 may include a momentary switch 504 that initiates a dispensing cycle.
[0049] FIG5B shows a dispensing system 500 including two cutouts. A first cutout 520 in the bottle 501 of the bottle assembly 503 shows a cup-shaped member 560 inserted into the bottle 501. A second cutout 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] FIG5C shows the dispensing actuator 502 pulled out from the compartment 560 in the bottle assembly 503. The dispensing actuator 502 can be pulled out from an empty bottle assembly and inserted into a new pre-filled bottle assembly. The ball member 562 allows the eccentric wheel 531 to slide into and out of the ball member 562, thereby activating the dispensing mechanism 400, as shown in FIGS. 4A and 4B. The eccentric wheel 531 may be part of the dispensing actuator 502, which may 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 within the bottle assembly 503, thus allowing the dispensing actuator 502 to be replaced without the risk of cross-contamination.
[0051] The features of the examples in Figures 5A-5C can be used alone or in combination with any other examples herein.
[0052] Figure 6A illustrates the dispensing tip assembly 600. The dispensing tip assembly 600 can be positioned at the outlet conduit 438 (labeled in Figure 4B). In the example, the dispensing tip assembly 600 can be coupled to the nozzle assembly 355 (labeled in Figures 3A and 5C). The dispensing mechanism 400 (labeled in Figures 4A and 4B) can generate a rapid cycle of pressure fluctuations, which includes continuous cycles of pressure and negative pressure, wherein a one-way valve 601 (e.g., dispensing tip 356 labeled in Figure 3A) opens during the pressure cycle to allow flow 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 impending negative pressure cycle will draw contaminants into bottle assembly 503 (or bottle assembly 200). Preferably, valve 601 should be small and light, so that the reflective inertia of the moving lip 609 of valve 601 will be minimized. In an example, valve 601 may be or may 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. Specification of spring members 602a, 602b, pages 7 / 8, 10 CN 121335685 A. The first free end 603a and the second free end 603b may press against valve lip 609 and apply a predetermined force that increases 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 to 20 grams (g) to the 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 the individual duckbill valve lip 609 may be insufficient or inconsistent. However, spring members 602a and 602b overcome this problem. Spring members 602a and 602b can increase the closing force of the duckbill valve.
[0054] Figure 6B shows a dispensing tip assembly 600 that further includes a cylindrical member 610. Cylindrical member 610 may support dispensing tip assembly 600, wherein one-way valve 601 and spring members 602a, 602b are at least partially assembled or positioned within cylindrical member 610.
[0055] FIG6C illustrates dispensing tip assembly 600 attached to dispensing device 620 (e.g., any dispensing device or system disclosed herein).
[0056] Features of the examples in FIG6A-6C may be used individually or in combination with any other examples herein.
[0057] In the examples, multiple bottles or bottle assemblies may be used, which may be configured similarly to the bottles or bottle assemblies disclosed herein. Actuators as disclosed herein may be configured to be removably coupled to another bottle assembly among the multiple bottle assemblies when fluid in the bottle assembly is depleted.
[0058] Exemplary embodiments of the method / system 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 are intended to be included within the scope of this patent, which reasonably fall within the scope of the improvements thus contributed to the art, and that the scope should not be limited except in accordance with the appended claims and their equivalents. Instruction manual page 8 / 8 11 CN 121335685 A Figure 1A Figure 1B Instruction manual illustration page 1 / 7 12 CN 121335685 A Figure 2A Figure 2B Instruction manual illustration page 2 / 7 13 CN 121335685 A Figure 3A Figure 3B Instruction manual illustration page 3 / 7 14 CN 121335685 A Figure 4A Figure 4B Instruction manual illustration page 4 / 7 15 CN 121335685 A Figure 5A Figure 5B Instruction manual illustration page 5 / 7 16 CN 121335685 A Figure 5C Figure 6A Instruction manual illustration page 6 / 7 17 CN 121335685 A Figure 6B Figure 6C Instruction manual illustration page 7 / 7 18 CN 121335685 A.
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.