Improved adherence eye dropper devices and methods

Abstract

Provided herein is an automated eye drop dispensing device that may feature an electromechanical actuation with closed-loop sensor control for precise medication delivery. The device may comprise a housing receiving a pump head assembly that threads directly onto standard eye drop bottles. An electromechanical actuator, coupled via a shuttle mechanism, may control pump chamber operation. A sensor system may monitor the dispensing tip to detect drop formation and release, enabling real-time closed-loop control that compensates for variations in medication properties and device orientation. The system may operate through a three-state sequence: detecting drop absence, formation, and release, automatically stopping upon successful dispensing. The device may include wireless communication for transmitting sensor-verified usage data to smartphone applications and healthcare systems. Additional features may include orientation sensors ensuring proper positioning, alignment aids with LED indicators, programmable dosing schedules, compatibility adapters for various bottle types, and integration with a companion mobile application.

Description

Atty. Docket No. SUB22-43197.601IMPROVED ADHERENCE EYE DROPPER DEVICES AND METHODSTECHNICAL FIELD

[0001] The present disclosure relates to the field of medical devices and medication dispensing systems. More particularly, the disclosure pertains to a portable, electronically- controlled device for accurately administering liquid ophthalmic medications. This technology addresses the challenges in precise dosing, proper administration technique, and patient adherence associated with eye drop medications.BACKGROUND

[0002] The administration of ophthalmic medications in the form of eye drops has long been a standard treatment for various ocular conditions. However, this method of drug delivery presents several challenges for patients and healthcare providers alike.

[0003] Traditionally, patients manually administer eye drops using squeeze bottles, which often leads to inconsistent dosing. Many patients struggle with proper technique, frequently missing the eye or applying too many drops. This can result in medication waste, reduced efficacy, and potential side effects from over-application. Additionally, patient adherence to prescribed eye drop regimens is notoriously poor. Factors contributing to non-adherence include difficulty remembering dosing schedules, physical limitations in administering drops, and discomfort associated with the application process.

[0004] Current solutions in the market have attempted to address some of these issues. For example, simple eye drop guides have been developed to assist with aim, but these do not solve dosing inconsistencies or adherence problems. More advanced electronic reminder systems exist, but they typically do not integrate with the medication delivery itself. Furthermore, the storage and handling of eye medications can impact their efficacy. Some medications require refrigeration or specific temperature control, which is difficult to maintain with conventional bottles.

[0005] There is a clear need for an integrated solution that addresses the multiple challenges associated with eye drop administration. An ideal device would ensure precise dosing, facilitateAtty. Docket No. SUB22-43197.601 proper application technique, promote adherence to medication schedules, and incorporate features for optimal medication storage and handling. The present disclosure aims to address these unmet needs in ophthalmic medication delivery, providing a comprehensive solution to improve patient outcomes and quality of life for those requiring regular use of eye drops.SUMMARY

[0006] The present disclosure provides, in at least one aspect, eye drop delivery devices comprising, a pump head assembly comprising a pump chamber with an inlet valve and an outlet valve, an eye drop bottle connected to the pump head assembly, a housing configured to receive the pump head assembly with the attached eye drop bottle, and an actuator mechanism operatively coupled to the pump chamber to control expansion and compression of the pump chamber for drawing and expelling medication.

[0007] In some embodiments, the actuator mechanism comprises an electromechanical actuator coupled to the pump chamber via a shuttle mechanism.

[0008] In some embodiments, the actuator mechanism comprises a mechanical actuation system including a button, cams, and springs configured to expand and compress the pump chamber. In some embodiments, the device further comprises, a sensor positioned to monitor a dispensing tip of the device, and a control system configured to operate the electromechanical actuator in a closed-loop manner based on feedback from the sensor to detect drop formation and release.

[0009] In some embodiments, the sensor is selected from the group consisting of a time-of- flight sensor, an infrared sensor, an optical sensor, and a combination thereof.

[0010] In some embodiments, the control system is configured to detect absence of a drop at the dispensing tip and command the actuator to continue expelling liquid, detect formation of a drop and continue expelling liquid, and detect release of the drop and command the actuator to stop expelling liquid.

[0011] In some embodiments, the pump head assembly is configured as a disposable unit that can be replaced while retaining the housing and actuator.Atty. Docket No. SUB22-43197.601

[0012] In some embodiments, the device further comprises an orientation sensor, wherein the control system only permits dispensing when the device is detected to be in an inverted position.

[0013] In some embodiments, the device further comprises a snap-fit adapter configured to accommodate eye drop bottles with non-standard threading.

[0014] In some embodiments, the shuttle mechanism translates rotational motion from the actuator into linear motion to compress and expand the pump chamber.

[0015] The present disclosure provides, in at least one aspect, methods for dispensing eye drops comprising threading an eye drop bottle onto a pump head assembly, inserting the pump head assembly with attached bottle into a device housing, activating an electromechanical actuator to draw medication from the bottle into a pump chamber, monitoring a dispensing tip with a sensor while expelling medication from the pump chamber, detecting drop formation at the tip using the sensor, continuing to expel medication while the drop forms, detecting drop release from the tip using the sensor, automatically stopping the actuator upon detecting drop release, and recording sensor-verified dispensing data.

[0016] In some embodiments, the method further comprises verifying device orientation before permitting dispensing, and providing user feedback if improper orientation is detected.

[0017] In some embodiments, the method further comprises transmitting the sensor-verified dispensing data to a smartphone application or healthcare provider system.

[0018] In some embodiments, the sensor operates by measuring at least one of distance changes, reflected light intensity changes, or optical signatures of liquid drops.

[0019] In some embodiments, the method further comprises calibrating the sensor before dispensing to account for ambient conditions.

[0020] The present disclosure provides, at least in one aspect, eye drop delivery systems comprising a housing, a pump assembly comprising a chamber with valves, wherein an eye drop bottle threads directly onto the pump assembly before insertion into the housing, an actuator mechanically coupled to the pump assembly, a drop detection sensor having a field of view encompassing a drop formation zone at a dispensing tip, firmware configured to control the actuator based on real-time sensor feedback, and a data logging system configured to record verified medication dispensing events.Atty. Docket No. SUB22-43197.601

[0021] In some embodiments, the firmware implements a three-state detection sequence comprising a first state detecting absence of a drop, a second state detecting drop formation, and a third state detecting drop release.

[0022] In some embodiments, the system further comprises an alignment feature selected from the group consisting of angled chutes with LEDs visible only at correct positioning, a motion sensor with position indicators, a camera system with computer vision algorithms; and distance sensors for positioning relative to an eye.

[0023] In some embodiments, the system further comprises a companion mobile application providing one feature selected from a list consisting of: usage history visualization, medication schedule management, refill reminders, educational content, and adherence pattern analysis using artificial intelligence.

[0024] In some embodiments, the actuator and sensor system automatically compensate for variations in at least one of medication viscosity, ambient temperature, device angle, and dispense pressure to ensure consistent drop formation and release.

[0025] Other aspects of the disclosure will become apparent by consideration of the detailed description and accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. l is a visual illustration of a conventional method for administrating liquid ophthalmic medications.

[0027] FIG. 2 is a perspective view of an eye dropper delivery device in accordance with the present disclosure.

[0028] FIG. 3 is a cross-sectional view of the eye dropper delivery device of FIG. 2.

[0029] FIG. 4 is a cross-sectional view of the pump head assembly portion of the eye dropper delivery device of FIG. 2.

[0030] FIG. 5 is a diagram of an alignment feature of an eye dropper delivery device in accordance with the present disclosure.Atty. Docket No. SUB22-43197.601

[0031] FIG. 6A is an exemplary view of a misaligned alignment device in accordance with the present disclosure.

[0032] FIG. 6B is an exemplary view of a correctly aligned alignment device in accordance with the present disclosure.

[0033] FIG. 7 is a flow chart depicting an exemplary method for delivering eye drops in accordance with the present disclosure.

[0034] FIG. 8A is a perspective view of an alternate embodiment of a disclosed eye dropper delivery device in accordance with the present disclosure.

[0035] FIG. 8B is a visual flowchart depicting an exemplary method of how a user might use the device of FIG. 8A.

[0036] FIG. 9A is a perspective view of an alternate embodiment of a disclosed eye dropper delivery device in accordance with the present disclosure.

[0037] FIG. 9B is a visual flowchart depicting an exemplary method of how a user might use the device of FIG. 9A.

[0038] FIG. 10A is a perspective view of an alternate embodiment of a disclosed eye dropper delivery device in accordance with the present disclosure.

[0039] FIG. 10B is a visual flowchart depicting an exemplary method of how a user might use the device of FIG. 10A.

[0040] FIG. 11 A is a perspective view of an alternate embodiment of a disclosed eye dropper delivery device in accordance with the present disclosure.

[0041] FIG. 1 IB is a visual flowchart depicting an exemplary method of how a user might use the device of FIG. 11 A.

[0042] FIG. 12 is a cross-sectional view of an electromechanical embodiment of the eye dropper delivery device showing the actuator, shuttle mechanism, and sensor arrangement in accordance with the present disclosure.

[0043] FIG. 13 is a detailed view of the drop detection sensor system and dispensing tip area of the electromechanical embodiment of FIG. 12.Atty. Docket No. SUB22-43197.601

[0044] FIG. 14 is a flow chart depicting the closed-loop drop detection and dispensing process for the electromechanical embodiment.

[0045] FIG. 15 is an exploded view showing the assembly sequence of the bottle threading onto the pump assembly before insertion into the device housing.

[0046] Before any embodiments are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.DETAILED DESCRIPTION

[0047] The present disclosure provides various embodiments of an eye drop delivery device that addresses the longstanding challenges associated with ophthalmic medication administration. The device fundamentally comprises a pump head assembly that interfaces with standard eye drop bottles, a housing that receives this assembly, and an actuation mechanism for controlled medication dispensing. While some embodiments utilize purely mechanical actuation systems with springs and cams, preferred embodiments employ electromechanical actuators operating in conjunction with drop detection sensors to create a closed-loop control system that ensures precise, single-drop dispensing regardless of medication properties or user technique. The device may incorporate various alignment features to guide proper positioning, reminder systems to improve adherence, cooling mechanisms for temperature-sensitive medications, and wireless communication capabilities for usage tracking and healthcare provider integration. Multiple form factors are disclosed, ranging from single-tube designs to binocular-style configurations, each optimized for different user preferences and physical capabilities. The following detailed description presents these various embodiments, with the understanding that features from different embodiments may be combined or modified without departing from the core inventive concepts.

[0048] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, theAtty. Docket No. SUB22-43197.601 present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present disclosure. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0049] The terms “substantially” or “generally” are used to provide flexibility by recognizing that a given characteristic need not be perfectly embodied to have the desired result. Those of ordinary skill in the art will recognize that many characteristics described herein may be essentially present without strict adherence to the characteristic’s definition.

[0050] The term “coupled,” as used herein, is defined as “connected,” although not necessarily directly, and not necessarily mechanically. The term coupled is to be understood to mean physically, magnetically, chemically, fluidly, electrically, or otherwise coupled, connected or linked and does not exclude the presence of intermediate elements between the coupled elements absent specific contrary language.

[0051] The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. The singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. The present disclosure also contemplates other embodiments “comprising,” “consisting of’ and “consisting essentially of,” the embodiments or elements presented herein, whether explicitly set forth or not.

[0052] As used herein, the term “subject” broadly refers to any animal, including but not limited to, human and non-human animals (e.g., dogs, cats, cows, horses, sheep, poultry, fish, crustaceans, etc.). As used herein, the term “patient” or “user” typically refers to a subject that is being treated for a disease or condition.

[0053] Tn the foregoing description of preferred embodiments, specific terminology has been resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. TermsAtty. Docket No. SUB22-43197.601 such as “top” and “bottom”, “front” and “rear”, “inner” and “outer”, “above”, “below”, “upper”, “lower”, “vertical”, “horizontal”, “upright” and the like are used as words of convenience to provide reference points.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present disclosure. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0055] FIG. 1 provides a visual illustration of method 10 for administrating liquid ophthalmic medications. Such methods typically involve the use of an eye dropper 20 or a squeeze bottle to deliver medication directly to the surface of a patient’s eye 30. These conventional approaches generally require the patient to tilt their head 40 back, hold the eye 30 open, and attempt to accurately place one or more drops onto the eye 30. Common issues with existing methods include difficulty in accurately targeting the eye, challenges in controlling drop size and number, dosing schedule adherence, and difficulty in self-administration, particularly for elderly patients or those with limited dexterity. Thus, a need persists for improved devices and methods for the administration of liquid ophthalmic medications. This detailed description outlines various embodiments and potential modifications of the present disclosure, which should not be construed as limiting its scope.

[0056] FIG. 2 provides a perspective view of an eye dropper device 100 in accordance with the present disclosure, while FIG. 3 provides a cross-sectional view of the same device. The device 100 comprises a housing 105 configured to receive an eye drop bottle 110 (shown in silhouette). This housing 105 may be constructed from a wide range of materials, including but not limited to medical-grade plastics, metals, alloys, or composite materials, each selected for their durability, biocompatibility, and suitability for medical applications. The housing 105 can accommodate various sizes and shapes of eye drop bottles 110 to ensure compatibility with a broad spectrum of ophthalmic medications. On the outside of housing 105 is the activation button 115 for the patient to control the dispensing of the ophthalmic medication.Atty. Docket No. SUB22-43197.601

[0057] The attachment mechanism 120 of the present embodiment is configured to secure the pump head assembly 130 to the eye drop bottle 110. In preferred embodiments, the bottle 110 is first threaded directly onto the pump head assembly 130 using threads that match the same thread size and pitch as the bottle manufacturer’s cap. This threaded connection establishes fluid communication between the bottle 110 and the pump chamber 135. After the bottle 110 is secured to the pump head assembly 130, this complete assembly is then inserted into the housing 105 where it is retained by mechanical means such as snap-fit features, bayonet mounts, or other securing mechanisms. This two-step assembly process ensures proper sealing and alignment of all components.

[0058] For even greater sealing reliability, some embodiments might incorporate a vacuum- assisted sealing mechanism that activates upon assembly, using the device’s own pumping action to enhance the seal. This could be particularly beneficial for ensuring the integrity of sterile medications or for use in challenging environments.

[0059] In some embodiments, housing 105 includes ergonomic features, such as contoured surfaces, textured grip areas, or adjustable components enhancing handling and stability during use. These features are particularly beneficial for patients with limited dexterity or hand tremors, a common concern in elderly populations who frequently require ophthalmic medications. The housing 105 may also incorporate a transparent or semi-transparent section, allowing users and caregivers to visually inspect the eye dropper bottle 110 without disassembling the device. This feature can help prevent unexpected medication administration and improve adherence to treatment regimens.

[0060] As shown in FIG. 3, in some embodiments, device 100 includes a pump head assembly 130, which attaches to the housing 105 and is primarily responsible for the precise dispensing of medication. This assembly includes a pump chamber 135 in fluid communication with the eye drop bottle 110, designed to create a partial vacuum that draws a precise amount of medication for dispensing when expanded. The volume and geometry of this pump chamber 135 can be customized based on the specific medication being used, allowing for versatility in dosing requirements. For instance, medications requiring smaller doses may utilize a pump chamber with a reduced volume, while those with higher viscosities might benefit from a conical or otherwise specialized geometry to facilitate more efficient fluid flow.Atty. Docket No. SUB22-43197.601

[0061] The pump head assembly 130 includes a sealing gasket 136 formed from a flexible material. When the bottle 110 is threaded onto the pump head assembly 130, the gasket 136 is compressed against the top of the bottle 110, forming a tight seal. The gasket 136 could be formed of a variety of materials, such as silicone rubber, to conform to slight irregularities in the bottle shape, further ensuring a tight seal. In some embodiments, the gasket could be formed of fluroelastomer, i.e. FKM rubber, to limit gas permeability. Spring-loaded sealing mechanisms could accommodate variations in bottle dimensions while maintaining consistent sealing pressure.

[0062] As shown in greater detail in FIG. 4, the pump chamber 135 of the present embodiment is equipped with two one-way valves 140, 145, positioned at its inlet and outlet. The inlet valve 140, located between the eye drop bottle 110 and the pump chamber 135, allows fluid to flow only from the bottle 110 into the chamber during expansion of the pump chamber 135, but prevents fluid from flowing into the bottle from the pump chamber during compression. Conversely, the outlet valve 145, disposed at the dispensing end of the pump chamber 135, only allows fluid flow from the chamber to the device tip 150 and towards the eye during compression of the pump chamber 135 and prevents air from flowing into the pump chamber 135 during expansion. This dual-valve configuration ensures precise control over medication flow, preventing backflow and maintaining dosage accuracy. The one-way valves are designed to respond to minimal pressure differentials, enabling smooth operation even with low-viscosity medications. Additionally, the valves’ materials and construction can be tailored to accommodate various medication properties, ensuring compatibility and longevity across a wide range of ophthalmic solutions.

[0063] In some embodiments, the pump head assembly 130 may incorporate various additional features to enhance its functionality and address specific medical needs. A multichamber system could allow for the delivery of combination therapies or the mixing of medications at the point of delivery. For medications requiring strict sterility, the assembly might feature disposable or easily sterilizable components. In particular embodiments, the entire pump head assembly 130 may be configured as a disposable unit that can be replaced periodically to maintain sterility and optimal performance. A self-cleaning mechanism, such as a UV-C LED or electrochemical sterilizing system, could be integrated to maintain hygiene between uses. ForAtty. Docket No. SUB22-43197.601 medications requiring precise dosing, the incorporation of microfluidic channels could offer even higher dosing accuracy.

[0064] Referring again to FIG. 3, the actuation mechanism 160 of device 100 is primarily responsible for creating the partial vacuum necessary to draw and dispense the fluid drop upon activation by the user. This mechanism 160 can take various forms, in some embodiments, the mechanism 160 is a purely mechanical system, consisting of a button 115, cams 165, and set of internal springs 170, 175. When the button 115 is depressed, it makes contact with the cams 165 and expands the pump chamber 135, while internal springs 170,175 return the mechanism 160 to its starting position after dispensing.

[0065] In preferred embodiments, as detailed further in FIGS. 12-14, electromechanical actuation methods are employed, allowing for precise control and programmable dosing schedules. These methods may include a rotational motor (such as a servo motor or stepper motor) driving a rack and pinion assembly, offering smooth and controlled actuation. An electromagnetic linear actuator could provide rapid and precise movements, allowing for adjustable force profdes to accommodate different medication viscosities. Memory alloy actuators may be employed to offer silent operation and simplified mechanics due to their shapechanging properties.

[0066] In some embodiments, the actuation mechanism 160 may incorporate piezoelectric elements for ultra-precise, high-frequency dispensing. Hydraulic or pneumatic systems may be employed to offer power amplification in a compact form factor. A magnetic levitation system could provide frictionless, wear-free operation, potentially extending the device’s lifespan and maintaining consistent performance over time.

[0067] In some embodiments, to prevent vacuum locking and ensure smooth operation, the device 100 may incorporate an air channel extending to the tip of the eye drop bottle 110. This channel opens and closes based on the position of the actuation mechanism 160, allowing air to flow back into the bottle 110 as needed. For hygiene and to reduce the risk of contamination, an air filtration system can be integrated into this channel. This system could employ multi-stage filtration, including HEPA and activated carbon filters, to remove a wide range of potential contaminants from the incoming air. An electrostatic precipitation stage could capture ultra-fine particles, further enhancing the filtration efficiency. To simplify maintenance and ensureAtty. Docket No. SUB22-43197.601 consistent performance, the filtration system could utilize a replaceable cartridge design, allowing users to easily swap out filters as needed.

[0068] In some embodiments, the vacuum lock-prevention system may be a tip seal 136 comprised of a rubber with high gas permeability that allows for makeup air to return to the bottle when not in use.

[0069] The air channel and its components could also incorporate antimicrobial materials to provide an additional layer of protection against potential contaminants. In some embodiments, a positive pressure system could be implemented to continuously push filtered air through the device, creating a protective barrier against external contaminants even when the device is not in active use.

[0070] As shown in FIG. 5, in some embodiments device 100 may include an alignment feature 180 positioned near the device’s tip 150. This feature is designed to guide the user in positioning the device 100 correctly over their eye 30. In some embodiments, this alignment feature might comprise a motion sensor to detect the orientation of the device 100, coupled with an LED indicator that activates when the device is within an acceptable range of angles. In some embodiments, the device 100 is configured to only dispense a drop when the motion sensor determines the device is within this acceptable range of angles. In the present embodiment, the device employs a series of angled chutes 182 and LEDs 184 sized and configured in such a way as to ensure that the light from the LED 184 is only visible when the user is looking directly down each chute 182 at the correct position, providing intuitive guidance for users. The alignment feature may include multiple sets of chutes 182 and LEDs 184 in various arrangements and oriented at angles 185 between 1 and 90 degrees. In the present embodiment, the alignment feature 180 includes two pairs of chutes 182 in a cross pattern along two axes, with each pair oriented at a twenty degree angle 185 to each other. FIG. 6A provides an illustration of what a misaligned device 100 would appear from the point of view of a user (where at least one of the LEDs is partially obscured), while FIG. 6B provides an illustration of a properly aligned device (where each LED is fully in view).

[0071] In some embodiments, the alignment feature 180 could incorporate other alignment methods. In some embodiments, a lens positioned within the chute could be designed to come into focus at a specific focal point, ensuring that the device 100 is held at an exact predeterminedAtty. Docket No. SUB22-43197.601 distance from the user’s eye 30. A miniature camera system using computer vision algorithms could provide real-time eye detection and tracking, potentially adjusting the device’s position automatically or providing more detailed guidance to the user. An augmented reality (AR) display could offer visual cues projected onto the user’s field of view, making the alignment process more intuitive and interactive.

[0072] In some embodiments, other potential alignment aids could be utilized, including ultrasonic or infrared distance sensors for precise positioning relative to the eye 30, a physical guide that gently contacts the user’s face to ensure consistent placement, a voice guidance system providing audio cues for proper alignment, or a haptic feedback mechanism indicating correct positioning through vibrations. These various approaches to alignment guidance can be mixed and matched to create a system that is both highly effective and user-friendly, potentially adapting to the specific needs and preferences of individual users.

[0073] In some embodiments, the device includes a reminder system. This system may feature an LED reminder light 190 positioned on the housing, programmable to activate according to a predetermined dosing schedule. In some embodiments, the reminder system may be configured to integrate with smart home systems or mobile devices could allow for more diverse and contextual reminders, such as audio alerts through a home speaker system or notifications on a smartphone. An e-ink or OLED display on device itself could show detailed dosing information, including the time of the next scheduled dose, the name of the medication, or even personalized messages from healthcare providers.

[0074] In some embodiments, the system could offer customizable vibration patterns or integrate with wearable devices to provide tactile alerts. In some embodiments, an Al-driven system could learn the user’s routine over time and suggest optimal dosing times based on their habits and schedule. For situations where visual reminders are preferred but the device itself may not always be in view, a projection system could display reminder information onto nearby surfaces, ensuring that the user remains aware of their medication schedule.

[0075] In some embodiments, the device may include a cooling mechanism. This feature could be particularly beneficial for medications that are more comfortable to administer when chilled or for those whose efficacy is temperature-dependent. The cooling mechanism could take various forms, such as a thermoelectric (Peltier) cooler. This type of cooler could offer preciseAtty. Docket No. SUB22-43197.601 temperature control and the ability to quickly adjust the cooling effect, or a phase-change material (PCM) cooling system to provide a passive cooling method that could maintain a consistent temperature for extended periods, potentially beneficial for medications requiring constant cooling.

[0076] In some embodiments, other cooling solutions may be employed, including a miniature vapor compression refrigeration cycle for medications requiring significant temperature reduction. In some embodiments, thermoelectric cooling arrays could be distributed throughout the device and could provide uniform temperature control, ensuring that the entire medication volume is cooled consistently. Some embodiments might feature a reversible system capable of both cooling and warming the medication, accommodating a wider range of temperature-sensitive formulations.

[0077] The cooling mechanism could be made programmable, allowing users or healthcare providers to set specific cooling times, temperatures, and whether to cool the entire bottle or just the dispensed drop. This level of customization could help optimize the medication’s efficacy and the user’s comfort, potentially improving treatment adherence.

[0078] In some embodiments, the device 100 incorporates advanced wireless communication capabilities. These may include Bluetooth, Wi-Fi, cellular, or other wireless protocols, allowing the device 100 to transmit usage data to relevant parties. This data may include time of use, number of drops dispensed, type of drop, temperature of the eye drops, and adherence to prescribed dosing schedules. Such information may be utilized by healthcare providers in monitoring treatment efficacy and patient compliance, and for caregivers in ensuring proper medication administration. In some embodiments, machine learning algorithms could analyze usage patterns to predict and prevent missed doses, potentially sending proactive reminders or alerts to healthcare providers when adherence issues are detected.

[0079] In some embodiments, the device 100 could be configured to interface directly with electronic health records (EHR) systems, automatically updating patient records with medication usage data. In clinical or long-term care settings, a mesh network capability could allow multiple devices to communicate and share data, providing a comprehensive overview of medication usage across a patient population.Atty. Docket No. SUB22-43197.601

[0080] Tn some embodiments, the device 100 includes a power delivery system including a rechargeable battery utilizing standard USB charging methods. Other embodiments may include wireless charging capabilities. In other embodiments, a kinetic charging system could harvest energy from the device’s movement during use, providing a constant trickle charge. Solar cells integrated into the housing could provide supplementary charging when the device is not in use, particularly beneficial in well-lit environments or for users in areas with limited access to electrical power.

[0081] FIG. 12 provides a cross-sectional view of an electromechanical embodiment 700 of the eye dropper delivery device. In this embodiment, an electromechanical actuator 710 (such as a servo motor, stepper motor, or linear actuator) is mechanically coupled to the pump head assembly 730 by means of a shuttle mechanism 720. The pump chamber 735 incorporates an inlet valve 740 positioned between the bottle 110 and the chamber interior, and an outlet valve 745 at the dispensing end leading to the tip 750. These valves 740, 745 work in coordination with the shuttle mechanism 720 to control unidirectional fluid flow during the pumping cycle. A sealing gasket 736 is visible at the interface between the pump head assembly 730 and the bottle threads, ensuring a leak-proof connection when the bottle is fully threaded onto the assembly. The shuttle 720 translates the rotational or linear motion of the actuator 710 into controlled movement of the pump chamber 735 to draw and expel fluid. In the pictured embodiment, this is accomplished through the use of a screw mechanism 715. The device 700 is designed to operate in an inverted orientation (upside down) when held by a human hand, with the dispensing tip 750 pointing downward toward the eye.

[0082] The electromechanical embodiment 700 incorporates a closed-loop control system utilizing a drop detection sensor 760 positioned to monitor the dispensing tip 750. The sensor 760, which may be a time-of-flight (TOF) sensor, infrared sensor, optical sensor, or other suitable detection technology, continuously monitors the tip area to detect the formation and release of medication drops. The sensor 760 is mounted within the housing 705 at a position that provides an unobstructed view of the tip 750 while being protected from contamination or damage.

[0083] When the activation button 715 is pressed while the device 700 is in the proper orientation and being held by a user, the device’s firmware initiates a precise dispensingAtty. Docket No. SUB22-43197.601 sequence. The firmware controls the actuator 710 to first draw fluid from the bottle 110 into the pump chamber 735 by expanding the chamber volume. During this expansion phase, the inlet valve 740 opens to allow fluid entry while the outlet valve 745 remains closed, preventing air from entering through the tip 750. When the actuator 710 reverses to compress the pump chamber 735, the inlet valve 740 closes to prevent backflow into the bottle while the outlet valve 745 opens to permit fluid expulsion toward the dispensing tip 750. Subsequently, the actuator 710 compresses the pump chamber 735 to expel the fluid toward the tip 750. The closed-loop nature of the system compensates for variability in dispense angle, drop viscosity, and other factors that would make open-loop control unreliable.

[0084] FIG. 13 provides a detailed view of the drop detection sensor system 800 and dispensing tip area. The sensor 760 is positioned at an optimal angle to detect drop formation at the tip 750. The sensor’s field of view 810 encompasses the critical drop formation zone 820 where medication accumulates before releasing as a discrete drop. The sensor 760 may utilize various detection methodologies, including but not limited to measuring distance changes as a drop forms, detecting changes in reflected light intensity, or identifying the optical signature of a forming liquid drop.

[0085] The drop detection sequence operates through three distinct states. First, the system recognizes that no drop is present at the tip 750 and continues to expel liquid from the pump chamber 735. The sensor’s field of view 810 is positioned to avoid interference from the outlet valve 745 mechanism while maintaining clear visibility of the drop formation zone 820 immediately below the tip 750 Second, the sensor 760 detects that a drop is forming based on predetermined threshold values for the chosen sensing modality, and the system continues to expel liquid to ensure proper drop size. Third, the sensor 760 detects that the drop has been released (no longer present at the tip), at which point the firmware immediately commands the actuator 710 to stop expelling liquid. This precise control ensures consistent single-drop dispensing regardless of medication properties or device orientation variations.

[0086] In some embodiments, the sensor system 800 may incorporate multiple sensors or sensor arrays to provide redundancy and improved accuracy. The sensor data may be processed using algorithms that account for ambient lighting conditions, medication opacity, and otherAtty. Docket No. SUB22-43197.601 environmental factors that could affect detection accuracy. The system may also include selfcalibration routines that run periodically or before each use to maintain optimal performance.

[0087] FIG. 14 depicts a flowchart of the closed-loop drop detection and dispensing process 900. The process begins when the user activates the device (910), triggering the firmware to check device orientation using integrated accelerometers or gyroscopes (920). If the device is not in the proper inverted position, the system may provide feedback to the user through visual or auditory indicators (925). Once proper orientation is confirmed, the actuator draws medication into the pump chamber (930). The system then begins expelling medication while continuously monitoring the sensor output (940). The sensor checks for drop formation (950), and if no drop is detected, continues expelling (955). Once drop formation is detected, the system continues controlled expulsion while monitoring for drop release (960). When the sensor detects that the drop has been released from the tip, the actuator immediately stops (970), and usage data including timestamp, drop count, and sensor readings are recorded for tracking and transmission (980).

[0088] FIG. 15 provides an exploded view illustrating the assembly sequence 1000 of the device. The eye drop bottle 110 is first threaded directly onto the pump head assembly 130 using matching threads that correspond to the bottle manufacturer’s cap specifications (1010). This threaded connection compresses the sealing gasket 136 against the bottle opening, creating a fluid-tight seal. The combined bottle and pump assembly is then inserted as a complete unit into the device housing 705, where it is secured by retention features such as snap-fit tabs, twist-lock mechanisms, or spring-loaded detents (1020). This assembly method ensures proper alignment of all components and maintains the integrity of the fluid path from bottle to dispensing tip.

[0089] The device housing 705 comprises two halves 705a, 705b connected by an integral hinge mechanism 765 along one edge, allowing the housing to open in a clamshell configuration for receiving the bottle and pump assembly. The hinge mechanism 765 may be a living hinge molded directly into the housing material, or alternatively may comprise separate pin-and-socket hinges for added durability. Once the combined bottle 110 and pump head assembly 730 are positioned within the first housing half 705a, the second housing half 705b pivots about the hinge mechanism 765 to close around the assembly. Complementary latching features 770 on the opposing edges of the housing halves 705a, 705b secure the housing in the closed position,Atty. Docket No. SUB22-43197.601 completing the assembly sequence (1030). In the pictured embodiment, the latching features are magnets that hold the two halves 705a, 705b in place. This hinged design allows for tool-free assembly while ensuring precise alignment of the shuttle mechanism 720 with the actuator 710 and proper positioning of the sensor 760 relative to the dispensing tip 750.

[0090] In some embodiments, the device may include a snap-fit adapter that accommodates bottles with non-standard threading or alternative closure systems. The adapter may feature multiple thread patterns or adjustable gripping mechanisms to ensure compatibility with a wide range of medication bottles. The adapter may be constructed from materials that provide both structural support and chemical compatibility with various ophthalmic medications.

[0091] The device 100 may further include a companion smartphone application that communicates with the device via the wireless communication circuitry. The application provides enhanced functionality including medication schedule management, usage history visualization, refill reminders, and sharing of adherence data with healthcare providers. The application may utilize push notifications to remind users of upcoming doses, provide educational content about their medications, and offer troubleshooting assistance for device operation. Advanced features of the application may include integration with pharmacy systems for automatic refill ordering, video tutorials for proper eye drop administration technique, and gamification elements to encourage adherence in younger patients.

[0092] In some embodiments, the smartphone application may incorporate artificial intelligence algorithms to analyze usage patterns and provide personalized recommendations for improving adherence. The application could detect patterns such as consistently missed evening doses and suggest schedule adjustments or provide targeted reminders. The application may also include a caregiver mode that allows family members or healthcare professionals to monitor multiple patients’ devices and receive alerts for missed doses or device malfunctions.

[0093] The electromechanical embodiment provides several advantages over purely mechanical systems. The precise control offered by the actuator and closed-loop sensor system ensures consistent drop size regardless of user technique or medication properties. The system can automatically adjust for variations in fluid viscosity, ambient temperature, and device angle that would affect drop formation in open-loop systems. The sensor data provides verification thatAtty. Docket No. SUB22-43197.601 medication was actually dispensed, addressing a key limitation of traditional adherence monitoring that can only track device activation without confirming successful administration.

[0094] Furthermore, the electromechanical system enables advanced features such as multidrop dispensing for medications requiring higher doses, programmable flow rates for comfort optimization, and automatic priming sequences to ensure the fluid path is filled before the first use. The system can also detect and alert users to potential issues such as empty bottles, clogged tips, or mechanical failures that would prevent proper medication delivery.

[0095] As outlined in FIG. 7, the present disclosure also provides method 200 for administering eye drops using an eye drop delivery device. The method begins with the user threading a compatible eye drop bottle onto the pump head assembly (210) which comprises a pump chamber. This threaded connection establishes fluid communication between the pump chamber and the bottle while creating a sealed system. The combined pump head and bottle assembly is then inserted and secured into the housing (220). The housing is designed to securely hold various standard sizes of eye drop bottles through the use of the pump head assembly as an intermediary component. The device may incorporate a programmable timer linked to a reminder LED disposed on the housing. At predetermined intervals based on the user’s prescribed dosing schedule, the LED activates (230), providing a visual cue to the user that it is time to administer the eye drops.

[0096] As discussed in more detail above, the device features an alignment feature, such as a contoured eyepiece or guide markings, which assists the user in properly positioning the device in relation to their eye (240). This ensures optimal placement for accurate drop delivery and minimizes the risk of misapplication. Once aligned, the user engages an actuation mechanism (250), such as a button or lever, which activates the pump chamber. In electromechanical embodiments, this activation triggers the actuator to begin the closed-loop dispensing sequence, with the sensor system ensuring precise single-drop delivery. This action creates precise pressure within the pump chamber, forcing a measured amount of liquid from the eye drop bottle through a delivery nozzle. As a result, a single drop of the medication is expelled from the nozzle and accurately delivered into the user’s eye.

[0097] Upon successful administration of the eye drop, the reminder LED is deactivated (260), either automatically through a sensor that detects the actuation of the pump chamber orAtty. Docket No. SUB22-43197.601 completion of the dispensing cycle, or manually by the user pressing a designated button. This final step resets the reminder system for the next scheduled dose. This method provides a systematic and user-friendly approach to eye drop administration, enhancing medication compliance and reducing the potential for errors in dosage or application. In some embodiments, the method also includes collecting and transmitting usage data from the eye drop delivery device via wireless communication circuitry (270). Such data may be used by users or healthcare providers to ensure proper adherence to a dosage regimen and may include sensor verification that drops were successfully formed and released.

[0098] In addition to the embodiments described above, the present disclosure also includes several alternative embodiments, each designed to address specific user needs and preferences. All of these additional embodiments may be configured to be used with a charging base that plugs into a standard wall outlet, providing a convenient and consistent power source for the devices. In some embodiments, the device is configured to be charged directly using a standard USB cable.

[0099] In a first alternative embodiment shown in FIG. 8A, the device 300 features a housing 305 that completely encloses the prescription bottle and includes a removable cap 315 covering a dropper tip 320, which maintains cleanliness between uses. The dropper tip 320 is recessed within device 300 to prevent accidental eye contact, prioritizing user safety. A plastic hood 325 projects over the dropper tip 320, containing an LED (shown in FIG. 8B) that is visible only when the user’s head is tilted back and the dropper tip 320 is directly aligned over the eye. This alignment mechanism ensures accurate positioning for drop administration. A lever 330 is provided for dispensing the eye drop when the LED transitions from red to green, indicating proper alignment.

[0100] FIG. 8B provides a visual step by step visual flowchart of how a user might use the device 300. To use this embodiment, the user first removes the device 300 from the charger. The device 300 is then held in front of the eye (350). In some embodiments, the hood 325 is configured to rest against the user’s brow. The user looks up and tilts the device 300 until the LED turns green, signaling correct positioning (360). At this point, the user pulls down their lower eyelid and depresses the lever 330 to dispense the drop (370). During use, the user rollsAtty. Docket No. SUB22-43197.601 their eye upward and looks for the LED on the inside surface of the hood 325. The head should be tilted back, and the lower eyelid pulled down to create an optimal surface for drop application.

[0101] A second alternative embodiment 400 is provided in FIG. 9A and takes inspiration from binocular design, featuring separate tubes 405, 410 for each eye. This configuration includes a cushioned pad 415 that rests against the bridge of the nose, providing comfort and stability during use. One tube 405 contains the prescription bottle 110 with a recessed dropper tip 425, while the other tube 410 remains open, allowing the user to see through it. A slider 430 on the dropper tube 405, when pulled and released, activates a series of LEDs (shown in FIG. 9B) in the open tube 410. These LEDs change from yellow to green as they approach the user’s eye, providing a visual guide for alignment. When the LEDs turn green, a drop is automatically dispensed, ensuring precise timing and positioning.

[0102] FIG. 9B provides a visual step by step visual flowchart of how a user might use the device 400. The usage procedure for this embodiment 400 begins with the user removing the device from the charger and placing the nose pad 415 on the bridge of their nose (450). The user then tilts their head back and adjusts the device 400 until they can see straight through the open tube 410. After pulling down the lower eyelid, the user activates the slider 430 (460) and follows the LED “runway” lights on the top surface of the open tube 410 with their gaze until the LEDs turn green and a drop is dispensed (470). This guided process ensures proper alignment and timing for drop administration. An advantageous feature of this design is its ability to dose both eyes without significant repositioning; the user simply flips the device 400 upside down to treat the other eye, repeating the same process.

[0103] A third alternative embodiment 500 is provided in FIG. 10A and features a housing 505 that fully encloses the prescription bottle and a protective cap 515 that rotates to reveal the dropper tip 520. This embodiment introduces an arm feature 525 similarly shaped as an oversized matchstick to assist in keeping the eyelid pulled down during drop administration. The device 500 is held with a pistol-grip handle 530, positioning the matchstick feature 525 between the user’s thumb and index finger for intuitive use. Drop dispensing is controlled by a trigger mechanism 535, allowing for user actuation.

[0104] FIG. 10B provides a visual step by step visual flowchart of how a user might use the device 500. To operate this embodiment 500, the user first disconnects the charging cord andAtty. Docket No. SUB22-43197.601 rotates the protective cap 515 to expose the dropper tip 520. The soft tip of the matchstick feature 525 is gently placed under the eye, allowing the user to pull down slightly on the lower eyelid (550). With the head tilted back, the user carefully rotates the device 500, pivoting on the matchstick 525, until the dropper tip 520 is centered over the eye (560). The user then looks up and depresses the trigger 535 to dispense the drop, ensuring optimal placement on the eye’s surface (570).

[0105] A fourth additional embodiment 600 is provided in FIG. HA with a housing design 605 that allows the prescription bottle 110 to be visible from the back of the device after loading. This embodiment features a recessed dropper tip 615 housed within a dome-shaped, clear eyecup 620 on the underside of the device 600. The eyecup 620 is designed to contact the user’s brow and cheekbone (and potentially the nose), effectively centering the dropper tip 615 over the eye. A notch 625 at the bottom of the eyecup 620 allows the user to insert a finger to pull down the eyelid, facilitating easier drop application. This design incorporates three buttons 630, any of which can be activated to dispense a drop, providing flexibility in use and accommodating various hand positions and user preferences.

[0106] FIG. 1 IB provides a visual step by step visual flowchart of how a user might use the device 600. The usage procedure for this final embodiment 600 involves removing the device from its charger and placing the eyecup 620 over the eye, ensuring contact with the face (650). The user then visually confirms that the dropper tip 615 is aligned with their eye. After tilting the head back, a finger is inserted into the notch 625 of the eyecup 620 to pull down the lower eyelid (660). The user then presses any of the three buttons 630 to dispense the drop (670). This embodiment 600 is designed to be held in a manner similar to a computer mouse, providing a familiar and comfortable grip for many users. For optimal results, users are instructed to roll their eye upward before activating the dispensing mechanism.

[0107] These additional embodiments showcase the versatility of the invention, offering various ergonomic designs and user interaction methods to accommodate a wide range of user preferences and physical abilities. Each design aims to simplify the process of administering eye drops, potentially improving medication adherence and treatment efficacy. By providing multiple options for drop administration, the invention seeks to address the diverse needs of patients,Atty. Docket No. SUB22-43197.601 potentially increasing the likelihood of consistent and correct medication use across a broader population of users.

[0108] It should be understood that the above-described embodiments are merely possible examples of implementations, set forth for a clear understanding of the principles of the invention. Many variations and modifications may be made to the above-described embodiments without departing substantially from the spirit and principles of the invention. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

Claims

Atty. Docket No. SUB22-43197.601CLAIMS1. An eye drop delivery device comprising: a pump head assembly comprising a pump chamber with an inlet valve and an outlet valve; an eye drop bottle connected to the pump head assembly; a housing configured to receive the pump head assembly with the attached eye drop bottle; and an actuator mechanism operatively coupled to the pump chamber to control expansion and compression of the pump chamber for drawing and expelling medication.

2. The device of claim 1, wherein the actuator mechanism comprises an electromechanical actuator coupled to the pump chamber via a shuttle mechanism.

3. The device of claim 1, wherein the actuator mechanism comprises a mechanical actuation system including a button, cams, and springs configured to expand and compress the pump chamber.

4. The device of claim 2, further comprising: a sensor positioned to monitor a dispensing tip of the device; and a control system configured to operate the electromechanical actuator in a closed-loop manner based on feedback from the sensor to detect drop formation and release.

5. The device of claim 4, wherein the sensor is selected from the group consisting of a time- of-flight sensor, an infrared sensor, an optical sensor, and a combination thereof.

6. The device of claim 4, wherein the control system is configured to: detect absence of a drop at the dispensing tip and command the actuator to continue expelling liquid; detect formation of a drop and continue expelling liquid; and detect release of the drop and command the actuator to stop expelling liquid.Atty. Docket No. SUB22-43197.6017. The device of claim 1, wherein the pump head assembly is configured as a disposable unit that can be replaced while retaining the housing and actuator.

8. The device of claim 1, further comprising an orientation sensor, wherein the control system only permits dispensing when the device is detected to be in an inverted position.

9. The device of claim 1, further comprising a snap-fit adapter configured to accommodate eye drop bottles with non-standard threading.

10. The device of claim 1, wherein the shuttle mechanism translates rotational motion from the actuator into linear motion to compress and expand the pump chamber.

11. A method for dispensing eye drops comprising: threading an eye drop bottle onto a pump head assembly; inserting the pump head assembly with attached bottle into a device housing; activating an electromechanical actuator to draw medication from the bottle into a pump chamber; monitoring a dispensing tip with a sensor while expelling medication from the pump chamber; detecting drop formation at the tip using the sensor; continuing to expel medication while the drop forms; detecting drop release from the tip using the sensor; automatically stopping the actuator upon detecting drop release; and recording sensor-verified dispensing data.

12. The method of claim 11, further comprising: verifying device orientation before permitting dispensing; and providing user feedback if improper orientation is detected.Atty. Docket No. SUB22-43197.60113. The method of claim 11 , further comprising transmitting the sensor-verified dispensing data to a smartphone application or healthcare provider system.

14. The method of claim 11, wherein the sensor operates by measuring at least one of distance changes, reflected light intensity changes, or optical signatures of liquid drops.

15. The method of claim 11, further comprising calibrating the sensor before dispensing to account for ambient conditions.

16. An eye drop delivery system comprising: a housing; a pump assembly comprising a chamber with valves, wherein an eye drop bottle threads directly onto the pump assembly before insertion into the housing; an actuator mechanically coupled to the pump assembly; a drop detection sensor having a field of view encompassing a drop formation zone at a dispensing tip; firmware configured to control the actuator based on real-time sensor feedback; and a data logging system configured to record verified medication dispensing events.

17. The system of claim 16, wherein the firmware implements a three-state detection sequence comprising: a first state detecting absence of a drop; a second state detecting drop formation; and a third state detecting drop release.

18. The system of claim 16, further comprising an alignment feature selected from the group consisting of: angled chutes with LEDs visible only at correct positioning; a motion sensor with position indicators; a camera system with computer vision algorithms; and distance sensors for positioning relative to an eye.Atty. Docket No. SUB22-43197.60119. The system of claim 16, further comprising a companion mobile application providing one feature selected from a list consisting of: usage history visualization; medication schedule management; refill reminders; educational content; and adherence pattern analysis using artificial intelligence.

20. The system of claim 16, wherein the actuator and sensor system automatically compensate for variations in at least one of medication viscosity, ambient temperature, device angle, and dispense pressure to ensure consistent drop formation and release.

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