Nozzles for fluid delivery devices

Abstract

The goal is to deliver fluid to a portion of the user. [Solution] A non-gravity fluid delivery device is provided for delivering fluid to a user's eye. The device has a cartridge including a container and a nozzle coupled to the container. The container defines an inner container chamber configured to contain fluid. The head includes opposing first and second walls that collectively define both the nozzle and a nozzle opening extending through the nozzle. The first wall is at least partially formed from a deformable material. The second wall is at least partially formed from a rigid material. Fluid is selectively delivered from the fluid delivery device to the eye through the nozzle opening. The nozzle opening extends in the fluid delivery direction between the first and second walls. The nozzle opening is selectively transitioned between an open state and a closed state via selective operation of the first wall.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims priority to U.S. Patent Application No. 18 / 196,849, filed on May 12, 2023, the entire disclosure of which is hereby incorporated by reference.

[0002] (Field of the Invention) The present disclosure generally relates to nozzles for fluid delivery devices. The present disclosure also generally relates to non - gravitational fluid delivery devices for delivering fluid to a user's eye.

Background Art

[0003] Non - gravitational fluid delivery devices for the non - gravitational delivery of fluids (e.g., ophthalmic agents and / or viscous ophthalmic agents) to a part of a user (e.g., the user's eye, nose, and / or mouth) are known. For example, U.S. Patent Application No. 15 / 931,482, filed on May 13, 2020, by Stowe and titled "Non - Gravitational Fluid Delivery Device For Ophthalmic Applications" (hereinafter, the "'482 application", the subject matter of which is hereby incorporated by reference in its entirety) discloses a non - gravitational fluid delivery device. Known non - gravitational fluid delivery devices typically include a nozzle that is completely formed from a rigid material.

Summary of the Invention

[0004] In one embodiment, a non-gravity fluid delivery device is configured to deliver fluid to a user's eye, either alone or in combination with any other embodiment. The device includes a cartridge comprising a cartridge container and a cartridge head coupled to the cartridge container. The cartridge container defines an inner container chamber configured to contain fluid. The cartridge head includes opposing first and second walls that collectively define both a nozzle and a nozzle opening extending through the nozzle. The first wall is at least partially formed from a deformable material. The second wall is at least partially formed from a rigid material. The head also includes a nozzle opening through which fluid is selectively delivered from the fluid delivery device to the eye. The nozzle opening extends in the fluid delivery direction between the first and second walls. The nozzle opening is selectively transitioned between an open state and a closed state via selective operation of the first wall. When the nozzle opening is in the open state, it is at least partially open to allow fluid to flow through it. When the nozzle opening is in the closed state, it is at least partially closed to restrict the flow of fluid through it.

[0005] In one embodiment, a nozzle for a fluid delivery device includes, alone or in combination with any other embodiment, opposing first and second walls. The first wall is at least partially formed from a deformable material. The second wall is at least partially formed from a rigid material. The nozzle also includes a nozzle opening through which fluid is selectively delivered from the fluid delivery device to a target site. The nozzle opening is defined by the first and second nozzle walls and extends in the fluid delivery direction between the first and second walls. The nozzle opening is selectively transitioned between an open state and a closed state via selective manipulation of the first wall. When the nozzle opening is in the open state, it is at least partially open to allow fluid to flow through it. When the nozzle opening is in the closed state, it is at least partially closed to restrict the flow of fluid through it. [Brief explanation of the drawing]

[0006] For a better understanding, please refer to the attached drawings. [Figure 1] This is a front perspective view of a non-gravity fluid delivery device according to one aspect of the present invention, including components in an open state. [Figure 2] This is a partial front perspective view of the elements of the embodiment shown in Figure 1, including the elements in the first configuration. [Figure 3] This is a schematic cross-sectional view of a portion of the elements in Figure 2. [Figure 4] This is a schematic cross-sectional view of the element in Figure 2 in the second state. [Figure 5] This is a top view of a portion of the element shown in Figure 2 in an exemplary usage state. [Figure 6] A schematic diagram of an exemplary closure sequence for a portion of the elements in Figure 2 is shown. [Figure 7] A schematic diagram of an exemplary closure sequence for a portion of the elements in Figure 2 is shown. [Figure 8] This is a schematic cross-sectional view of a portion of the elements in Figure 2, which is in another exemplary configuration. [Figure 9] Figure 1 is a schematic diagram of an exemplary fluid delivery system including the device. [Figure 10] This is a front perspective view of the non-gravity fluid delivery device of Figure 1, including the components of Figure 1 in a closed state. [Figure 11] This is a partial cross-sectional view taken along line 11-11 in Figure 10. [Figure 12] This is a flowchart showing an example of how the device in Figure 1 operates. [Figure 13] This is a schematic cross-sectional view of another exemplary configuration of a part of the embodiment shown in Figure 11. [Figure 14] This is a partial front perspective view of another exemplary configuration of the elements in Figure 2, which includes elements that are at least partially open. [Modes for carrying out the invention]

[0007] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in which this disclosure relates.

[0008] As used herein, the term “user” can be used interchangeably to refer to an individual who prepares, assists, and / or performs the operation of a tool procedure, and / or a procedure.

[0009] As used herein, the singular forms “a,” “an,” and “the” may also include the plural forms unless otherwise clearly indicated in the context. The terms “comprise” and / or “comprising,” as used herein, may specify the presence of a described feature, step, action, element, and / or component, but it will be further understood that they do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof.

[0010] As used herein, the term "and / or" may include any combination of one or more of the related enumerated items.

[0011] As used herein, phrases such as "between X and Y" and "about between X and Y" can be interpreted as including X and Y.

[0012] When used herein, the phrase “at least one of X and Y” can be interpreted as including X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, that element may, at any given time, include X, Y, or a combination of X and Y, and the choice may vary from time to time. In contrast, the phrase “at least one of X” can be interpreted as including one or more X's.

[0013] When an element is described as being "attached" to another element, "connected" to another element, "joined" to another element, or "in contact" with another element, it will be understood that the element may be directly attached to, connected to, or joined to another element, or that an intervening element may exist. In contrast, when an element is described as being, for example, "directly attached" to another element, "directly connected" to another element, "directly fixed" to another element, or "in direct contact" with another element, there is no intervening element. Furthermore, a reference to a structure or feature positioned "adjacent" to another feature will be understood by those skilled in the art that it may not have any overlapping or underlying portion with the adjacent feature.

[0014] Spatially relative terms such as "over" are used herein to facilitate explanation and to describe the relationship between one element or feature and another, as shown in the figures. It will be understood that spatially relative terms encompass different orientations of the device in use or operation, in addition to the orientation depicted in the figures. For example, if the device in the figure is inverted, the element described as "over" of another element or feature would then be oriented "under" of the other element or feature.

[0015] In this specification, terms such as “first” and “second” may be used to describe various elements, but it will be understood that these elements should not be limited by these terms. These terms are used solely to distinguish one element from another. Thus, the “first” element considered below may be called the “second” element without departing from the teachings of this disclosure. The order of operations (or processes) is not limited to the order presented in the claims or drawings unless otherwise specifically indicated.

[0016] Throughout this disclosure, various aspects of the invention can be presented in a range format. The description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. It should be understood that the description of a range is to be regarded as specifically disclosing not only the individual numerical values within that range but also all possible sub-ranges. For example, a description of a range such as 1 to 6 is to be regarded as specifically disclosing sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, as well as the individual numbers and fractional numbers within that range, such as 1, 2, 3, 4, 5, 5.5, and 6. This applies regardless of the width of the range.

[0017] The present invention includes, consists of, or consists essentially of any combination of the following features.

[0018] FIG. 1 shows a non-gravitational fluid delivery device 100 designed in accordance with the present disclosure. As mainly described herein, the device 100 is configured to selectively deliver fluid to the user's eye. However, the device 100 may be configured to deliver fluid to any other part of the user, such as, for example, the user's nose, mouth, ear, limb, head, neck, and / or torso. The device 100 includes a cartridge 102 and an applicator 104 for removably receiving the cartridge 102 therein.

[0019] As shown in FIGS. 1 - 2, the cartridge 102 includes a cartridge container 106 and a cartridge head 108 coupled longitudinally adjacent to the cartridge container 106. The term "longitudinally" is used herein to indicate a direction substantially perpendicular to the orientation in FIGS. 1 - 2 and is shown as "LO" in the figures. The cartridge container 106 defines an inner container chamber 110 in which fluid is enclosed. The fluid may be an ophthalmic agent, a viscous ophthalmic agent, any other fluid (viscous or otherwise), or any combination thereof.

[0020] As shown in Figures 2-3, the cartridge head 108 includes a rigid head portion 212 that connects the cartridge head 108 to the cartridge container 106. The rigid head portion 212 may be at least partially formed from, for example, polyethylene (high density or otherwise), polypropylene, any other rigid material, or any combination thereof. The rigid head portion 212 may include an air inlet port 214 formed therein. The air inlet port 214 may be substantially an air inlet port(s) of application '482, or substantially a modified version of the air inlet port of application '482. A filter 216 may be positioned above the air inlet port 214. The filter 216 may be made from a porous polypropylene material having passages of 0.1 μm to 0.2 μm. The filter 216 may be welded, bonded, molded, or otherwise directly connected to the rigid head portion 212.

[0021] The cartridge head 108 also includes a deformable head portion 218 which is welded, bonded, molded, or otherwise connected to the rigid head portion 212. The deformable head portion 218 may be formed at least partially from a deformable material. The deformable material may be an elastomer such as, but is not limited to, silicone, ethylene propylene rubber, any other elastically deformable material, or any combination thereof. The deformable head portion 218 includes a deformable striking wall 220 which is sufficiently “squeezable” or flexible to elastically deflect in response to an applied striking force.

[0022] As shown in Figures 2 and 3, the rigid head portion 212 and the deformable head portion 218 collectively form the nozzle 222. In particular, the nozzle 222 is defined by opposing first walls 224 and second walls 226 that converge toward each other to form the nozzle 222. The first wall 224 is part of the deformable head portion 218 and is therefore at least partially formed from a deformable material. On the other hand, the second wall 226 is part of the rigid head portion 212 and is therefore at least partially formed from a rigid material.

[0023] The first wall 224 includes a first contact surface 228 facing the second contact surface 230 of the second wall 226. A portion of the first contact surface 228 is fixedly attached to a portion of the second contact surface 230 such that a nozzle opening 232 extending transversely through the nozzle 222 is defined between the first contact surface 228 and the second contact surface 230. The term “transverse” is used herein to indicate a direction substantially perpendicular to the “longitudinal” direction, which in the orientation of Figure 3 is shown as a substantially horizontal direction and is indicated as “TR” in the figure. In some circumstances, the transverse direction may be the fluid delivery direction of the device 100.

[0024] As shown in Figure 2, the first contact surface 228 includes a first end portion 234 that is laterally separated from the second end portion 236 by a central portion 238. The term “later” is used herein to indicate a direction substantially perpendicular to the “longitudinal” and “transverse” directions, and in the orientation of Figure 2 it is shown as a substantially horizontal direction, indicated in the figure as “LA”. Similarly, the second contact surface 230 includes a first end portion 240 that is laterally separated from the second end portion 242 by a central portion 244.

[0025] The first end portion 234 of the first contact surface 228 and the first end portion 240 of the second contact surface 230 are fixedly attached to each other. The second end portion 236 of the first contact surface 228 and the second end portion 242 of the second contact surface 230 are also fixedly attached to each other. However, the central portion 238 of the first contact surface 228 and the central portion 244 of the second contact surface 230 are not directly fixed to each other in many applications of the device 100. These lateral central portions 238, 244 substantially define the nozzle opening 232, while the first and second end portions 234, 240, 236, 242 can at least partially define the lateral ends of the nozzle opening 232. Therefore, the nozzle opening 232 extends in the fluid delivery direction between the central portion 238 of the first contact surface 228 and the central portion 244 of the second contact surface 230, and thus extends in the fluid delivery direction between the first wall 224 and the second wall 226.

[0026] Furthermore, since the central portion 238 of the first contact surface 228 is deformable and not directly fixed to the central portion 244 of the second contact surface 230, the central portion 238 can be selectively manipulated relative to the rigid central portion 244 of the second contact surface 230. Through this manipulation, the nozzle opening 232 can be selectively transitioned between an open state and a closed state. The first wall 224 of the nozzle 222 may be configured to bias the nozzle opening 232 into a closed state. As shown in Figures 2 and 3, when the nozzle opening 232 is in a closed state, the central portion 238 of the first contact surface 228 contacts the central portion 244 of the second contact surface 230. The contact between the central portions 238 and 244 is such that the nozzle opening 232 is substantially (or, in certain configurations, at least partially) closed, restricting the flow of fluid through it.

[0027] As shown in Figure 4, when the nozzle opening 232 is open, the central portion 238 of the first contact surface 228 is spaced apart from the central portion 244 of the second contact surface 230. This spacing allows the nozzle opening 232 to be substantially (or, in certain configurations, at least partially) open, enabling fluid to flow through it. Thus, when the nozzle opening 232 is open, the fluid ( schematically represented as arrow "F" in Figure 4) can be selectively delivered in the fluid delivery direction from the device 100 to the user's eye.

[0028] As shown in Figures 3 and 4, in addition to defining the nozzle 222 and the nozzle opening 232, the rigid head portion 212 and the deformable head portion 218 also define the inner head chamber 346 of the cartridge head 108. The striking wall 220 is spaced transversely away from the nozzle 222 to position the head chamber 346 transversely between the striking wall 220 and the nozzle 222. The head chamber 346 is in fluid communication with the container chamber 110, at least temporarily, so that fluid flows selectively from the container chamber 110 to the head chamber 346.

[0029] During use, when the nozzle opening 232 is in the closed position, a striking force (indicated as arrow "S" in Figure 4) can be selectively applied to the striking wall 220. This striking force elastically deflects the striking wall 220 toward the nozzle 222. Since the nozzle opening 232 can be substantially closed before and / or at the start of the application of the striking force, the fluid pressure in the head chamber 346 increases as the striking wall 220 is deflected. The fluid pressure increases to a level that overcomes the biasing of the nozzle / nozzle opening 222 / 232. In other words, the increased fluid pressure elastically deforms the first wall 224 (and the central portion 238 of its first contact surface 228) at least partially, causing the nozzle opening 232 to move at least partially toward an open position against its internal bias. The applied striking force and the deflection of the striking wall 220 also push the fluid through the nozzle opening 232, which is now open from the head chamber 346.

[0030] As fluid flows out of the head chamber 346 through the nozzle opening 232, the fluid pressure within the head chamber 346 is reduced to a level that allows the biasing of the first wall 224 (i.e., the central portion 238 of the first contact surface 228) to elastically return the nozzle opening 232 to a closed position. Once the nozzle opening 232 is at least partially closed, the impact wall 220 can elastically return to its pre-deflection position (see Figure 3). The return of the impact wall 220 to its pre-deflection position generates at least partially a vacuum force within the head chamber 346, which draws a predetermined amount of fluid (e.g., a medically predetermined dose of fluid) from the container chamber 110 into the head chamber 346.

[0031] Therefore, the nozzle 222 and nozzle opening 232 function similarly to a duckbill valve. In particular, both the nozzle opening 232 and a typical duckbill valve open in response to a predetermined amount of fluid pressure to allow fluid to pass through. However, when the fluid pressure decreases or is removed, both the nozzle opening 232 and the duckbill valve return to their closed positions, preventing backflow and / or contaminants from entering the system, at least partially. Typically, known duckbill valves are formed entirely from elastomers (such as silicone) and therefore require relatively high fluid pressure to open. Thus, these fully elastic duckbill valves generally take several hundred milliseconds to open. Furthermore, the injection dynamics of the fluid ejected from this type of duckbill valve can be slowed down due to the significant fluid pressure and energy losses resulting from having to force open a fully elastic duckbill valve.

[0032] However, the nozzles 222 and nozzle openings 232 shown and described herein are designed and operate to overcome, at least partially, the complexities of these fully elastic duckbill valves. In particular, to provide faster opening times and faster injection dynamics than previously possible, the nozzles 222 and nozzle openings 232 are formed only partially from deformable material. In other words, compared to a typical fully elastic duckbill valve, the nozzles 222 and nozzle openings 232 provide a smaller force required to open, less fluid pressure and energy loss, and a faster operating speed (including opening time and fluid distribution time). Thus, unlike known fully elastic duckbill valve designs, device 100 can open the nozzle opening 232 and deliver fluid to the user's eye in less than 100 milliseconds, which is fast enough to neutralize the blink reflex of the user's eye.

[0033] As shown in Figures 2 and 5, the first and second walls can be configured such that both the nozzle 222 and the nozzle opening 232 are arched along the lateral length of the nozzle 222. This arched shape of the nozzle 222 and nozzle opening 232 facilitates the formation of a more fan-shaped form after the fluid F exiting the nozzle opening 232 exits. That is, the fluid F exiting from the opposing lateral edges of the nozzle opening 232 exits at an angle that is not perpendicular to the central transverse axis TA of the nozzle opening 232. Thus, by arching the nozzle 222 and nozzle opening 232, the device 100 can generate a relatively large fan-shaped liquid sheet from a relatively small nozzle 222 and cartridge head 108. Furthermore, the arched shape of the nozzle 222 and nozzle opening 232 may encourage the resulting droplet footprint to have a more elliptical or eccentric stadium shape, rather than a more rounded or oval contour, over longer travel distances to the eye.

[0034] As shown in Figures 6 and 7, the first wall 224 and the second wall 226 may be configured so that the nozzle opening 232 gradually closes from the inner nozzle side 648 toward the outer nozzle side 650 of the nozzle opening 232 as the nozzle opening 232 selectively transitions from an open state to a closed state. In particular, the central portion 238 of the first contact surface 228 and the central portion 244 of the second contact surface 230 can be angled relative to each other so that the nozzle opening 232 gradually closes from the inner nozzle side 648 toward the outer nozzle side 650. The “zipper-like” gradual closure of the nozzle opening 232 can at least partially prevent air from entering the nozzle opening 232 and / or at least partially prevent small amounts of fluid residue from re-entering the head chamber 346. This feature may be particularly useful in nozzles that do not contain preservatives.

[0035] As shown in Figures 2 to 4, the striking wall 220 and the first wall 224 may be separate from the rigid head portion 212 and then integrally formed together as a single monolithic component that is subsequently connected to the rigid head portion 220. Alternatively, as shown in Figure 8, the striking wall 220 and the first wall 224 may instead be separated from each other.

[0036] Figure 9 is a schematic diagram of a fluid delivery system 951 having an applicator 104, a remote device 952, and a cradle 954 capable of selectively housing the applicator 104. Each of the applicator 104, the remote device 952, and the cradle 954 communicates via a network 956. As shown, the cradle 954 includes at least one of a transmitter 958, a power supply 960, and a controller 962. The applicator 104 includes at least one of a transmitter 964, a power supply 966, a controller 968, a blink detector 970, a sterilizer 972, and a trigger 974. The controller 968 can be operably coupled to at least one of the blink detector 970, the power supply 966, the transmitter 964, the sterilizer 972, and the trigger 974.

[0037] Referring to Figure 10, the applicator 104 includes an applicator housing 1076, an applicator cap 1078, and a mechanical actuation button 1080. The applicator housing 1076 is sized to accommodate at least one of the following: a cartridge 102, a transmitter 964, a power supply 966, a transmitter 964, a sterilizer 972, and a trigger 974. In some configurations, the applicator 104 is an “intelligent” applicator 104 that enables additional user conveniences such as, but not limited to, horizontal non-gravity spraying, a visual aiming LED, a blink detection sensor, trigger distribution on eyelid opening, and / or full cloud connectivity for compliance monitoring. The applicator 104 may have a replaceable cartridge 102 configured for reusability, but the applicator 104 is intended to be configured for single use by instead providing a non-removable cartridge 102.

[0038] The blink detector 970 may be substantially the blink detector(s) of the '482 application, or substantially a modified version of the blink detector of the '482 application. Thus, similar to the blink detector of the '482 application, the blink detector 970 shown in Figure 1 includes one or more reflective optical proximity infrared sensors 182, 184 (shown here as two sensors 182, 184) to verify a suitable eye target and detect blinking. The controller 968 may be configured to distribute fluid from the device 100 based on signals received from the blink detector 970. In particular, the blink detector 970 and the controller 968 may be configured to distribute fluid from the device 100 for a predetermined period after a blink event is detected via the blink detector 970, or when the eyelids open at the end of a blink detection event.

[0039] As shown in Figure 11, the trigger 974 may be substantially the trigger of the '482 application, or a substantially modified version of the trigger of the '482 application. In such a case, the trigger 974 may be, or include, an electromechanical solenoid 1185 coupled to an arm that strikes the striking wall 220 or a latch trigger 1186. Generally, the trigger 974 is actuated by an electrical signal, thereby causing a rigid tip object (e.g., a solenoid or a part of the latch trigger 1186) to apply a striking force through contact with the striking wall 220, deforming the striking wall 220, and in response, the fluid pressure in the head chamber 346 increases, imparting a positive displacement of the fluid in the head chamber 346 through the nozzle 222.

[0040] The sterilizer 972 in Figure 9 may be substantially the sterilizer of the '482 application, or substantially a modified version of the '482 application. Thus, the sterilizer 972 may include at least one ultraviolet ("UV") light-emitting diode ("LED") positioned relative to the nozzle 222 such that the nozzle 222 is exposed to a predetermined amount of UV light when the UV LED is on. Since constant power to the UV LED can use a considerable amount of energy from the power source, the UV LED may be turned on by the controller 968 for only a few seconds after the fluid has been ejected from the device 100.

[0041] Power source 966 may be a rechargeable battery such as a small coin cell battery or a LiPo battery. Alternatively, power source 966 may be a non-rechargeable ("disposable") battery.

[0042] Transmitter 964 of applicator 104 communicates electronically with transmitter 958 of cradle 954. Electronic communication between transmitters 954 and 964, and / or between transmitters 954 and 964 and remote device 952, enables tracking of device 100 usage. Electronic communication and connectivity between cradle 954, applicator 104, and / or remote device 952 may enable tracking of medication dates and times, synchronization between device 100 and similar or identical different devices, automatic medication reordering, provision of battery recharge reminders, provision of medication adherence reminders to users, physician / user sharing, improvement of telemedicine options, and / or tracking of treatment compliance. Electronic communication and connectivity between cradle 954, applicator 104, and / or remote device 952 may enable training of applicator 104 based on historical data. Examples of applicator training may include, but are not limited to, updating algorithms and / or calculations using data on scleral baseline proximity reflexes, skin reflexes, off-axis movement and centering signals, blinking temporal dynamics, or any combination thereof.

[0043] As shown in Figure 10, the applicator cap 1078 is coupled to the applicator housing 1076 and is movable relative to the applicator housing 102. For example, the applicator cap 1078 is selectively movable from an open position (Figure 1) to a closed position (Figure 10). When the applicator cap 1078 is in the open position, at least a portion of the interior of the applicator housing 1076 is accessible. For example, the cartridge 102 can be inserted into and / or removed from the applicator housing 1076 when the applicator cap 1078 is in the open position. However, when the applicator cap 1078 is moved to the closed position, insertion of or removal of the cartridge 102 from the applicator housing 1076 is substantially prevented.

[0044] The mechanical actuation button 1080 is for selectively activating device 100, making device 100 usable, and / or, accordingly, for ejecting fluid from the nozzle 222 of cartridge 102 and discharging it from device 100 through the applicator opening 1088 of applicator housing 1076. Applicator 104 may also include a dust cover extending over or across the applicator opening 1088. The dust cover may be substantially the dust cover of application '482, or a substantially modified version thereof. If a dust cover is provided, the mechanical actuation button 1080 may be operably coupled to the dust cover to responsively move the dust cover away from the applicator opening 1088.

[0045] An exemplary sequence 1289 for operating device 100 is shown in Figure 12. As shown, sequence 1289 may include at least one of the following steps: in step 1290, insert / load cartridge 102 into applicator 104; in step 1292, manually activate applicator 104; in step 1294, detect blinking and dispense dose; in step 1296, record data related to the dispensed dose; in step 1298, sterilize nozzle 222; and in step 12100, communicate the recorded data via transmitters 958, 964.

[0046] In step 1290, the cartridge 102 is loaded into the applicator 104. The step of loading the cartridge 102 may include one or both of the steps of inserting the cartridge 102 into the applicator 104 and filling the head chamber 346 with fluid from the container chamber 110. The head chamber 346 may be filled fluidly via gravity and / or vacuum force. In some embodiments, the cartridge 102 is disposable. Therefore, in some configurations, under certain circumstances, the step of inserting the cartridge 102 into the applicator 104 may include the step of removing a previously used cartridge 102 and inserting a new or different cartridge 102 into the applicator 104.

[0047] In step 1292, the applicator 104 is manually activated with mechanically or electrically loaded energy in preparation for striking the striking wall 220. The applicator 104 may also be manually activated by the user pressing the mechanical activation button 1080. Although the applicator 104 may be activated via the pressed mechanical activation button 1080, the device 100 does not have to "fire" until the blink detector 970 determines that the applicator 104 is correctly positioned relative to the user's eye and in response to a detected blink. However, in a configuration in which the blink detector 970 is omitted from the device 100, the fluid may be distributed from the device 100 in response to the pressing of the mechanical activation button 1080, regardless of the applicator's position and the user's eye / blinking state.

[0048] The dust cover (if provided) may also be moved away from the applicator opening 1088 when the mechanical actuation button 1080 is pressed during step 1292.

[0049] In step 1294, a blink is detected and the dose is distributed. As described above, the blink detector 970 determines that the nozzle 22 is aligned with the eye and detects a blink. Upon detecting a blink, the controller 962 sends a signal to the trigger 974 to distribute the dose. In response, the arm or latch trigger 1186 moves from the loading position (the arm or latch trigger 1186 is separated from the striking wall 220) to the striking position, striking / contacting the striking wall 220 and deflecting the striking wall 220 toward the nozzle 222. By deflecting the striking wall 220, the fluid pressure in the head chamber 346 increases, in response to which the nozzle opening 232 opens and the fluid in the head chamber 346 is pushed / pushed out through both the nozzle opening 232 and the applicator opening 1088 toward the user's eye. After the fluid has been distributed, the fluid pressure in the head chamber 346 is at least partially relieved so that the nozzle opening 232 can return to the closed position. Furthermore, the impact wall 220 is able to transition from its deflected state to a non-deflected state after the fluid has been distributed. When the impact wall 220 transitions to a non-deflected state, at least a relatively small vacuum force can be generated within the head chamber 346. Since the nozzle opening 232 is closed, air is substantially prevented from being drawn into the head chamber 346 through the nozzle opening 232 by the vacuum force. Instead, the vacuum force draws the fluid from the container chamber 110 into the head chamber 346, at least partially.

[0050] In step 1296, the controller 962 records data related to the distributed doses. The controller 962 can record data detected by the blink detector 970 and data detected or generated by the trigger 974. Thus, the controller 962 can detect and record the timing of each dose distribution. The control unit 962 may also detect and record the user's blinking speed.

[0051] In step 1298, the sterilizer 972 sterilizes the nozzle 222. For example, in response to the detection of a fluid distribution event by the controller 962, the controller 962 may activate the sterilizer 972 for a predetermined period of time to sterilize a portion of the nozzle 222. If a dust cover is provided, sterilization of the nozzle 222 may be performed after the dust cover has returned to a position where it substantially covers the applicator opening 1088.

[0052] In step 12100, the recorded data may be communicated via transmitters 958 and 964. For example, the recorded data may be transmitted electronically to transmitter 958 and / or remote device 952. Alternatively or additionally, the data may be transmitted from transmitter 958 of cradle 954 to transmitter 964 of applicator 104. The recorded data may be stored in controller 962 of cradle 954. However, the recorded data may also be stored or received by remote device 952 via network 956. Controller 968 of applicator 104 can upload and update the recorded data to a cloud-based database via controller 962 of cradle 954. This recorded data may be used to update, customize, and generate predictive models to improve dry eye management over a period of several hours to several days. The models may include various factors, including historical, current, and expected or predicted external factors, which may be used to generate predictive models. Alternatively, the recorded data may be stored onboard device 100 for later retrieval and / or access, as desired and in any appropriate manner.

[0053] Instead of opening only in response to fluid pressure in the head chamber 346, the nozzle opening 232 may be configured to open at least partially via a nozzle actuator 13102 of the applicator 104. As shown in Figure 13, the nozzle actuator 13102 is selectively or substantially permanently mounted to the first wall 224. In particular, the nozzle actuator 13102 may be selectively or substantially permanently mounted to a projection 13104 extending from the first wall 224. As shown in Figure 13, the projection 13104 is formed integrally with the first wall 224 as a single monolithic component, although the projection 13104 may be formed separately and then mounted to the first wall 224. Alternatively, the nozzle actuator 13102 may be directly, selectively or substantially permanently mounted to the first wall 224.

[0054] The nozzle actuator 13102 is selectively movable between a first position (Figure 13) and a second position. As shown in Figure 13, when the nozzle actuator 13102 is in the first position, the nozzle opening 232 is closed. During the distribution operation, the nozzle actuator 13102 is moved from the first position to the second position. When the nozzle actuator 13102 moves to the second position, the nozzle actuator operates the first wall 224 via the projection 13104 so that the nozzle opening 232 moves toward an open state. For example, when the nozzle actuator 13102 moves to the second position, the nozzle actuator 13102 can push or retract at least partially open the central portion 238 of the first contact surface 228 via the projection 13104. Thus, when the nozzle actuator 13102 is in the second position, the nozzle opening 232 is open.

[0055] The nozzle actuator 13102 opens the nozzle opening 232 either by itself or in conjunction with the fluid pressure in the head chamber 346, thereby reducing, at least partially, the amount of fluid pressure required to open the nozzle opening 232, and thus further reducing fluid pressure and energy losses within the device 100. Furthermore, the nozzle actuator 13102, which at least partially pushes the nozzle opening 232 toward an open state, may be useful when residual fluid in the nozzle opening 232 would otherwise at least partially prevent the nozzle opening 232 from opening as desired.

[0056] The nozzle actuator 13102 may also be configured to operate the first wall 224 to at least partially assist in closing the nozzle opening 232. In other words, the nozzle opening 232 may be selectively moved from a second position to a first position after the fluid has been distributed. When the nozzle actuator 13102 moves to the first position, the nozzle actuator 13102 operates the first wall 224 via the projection 13104 so that the nozzle opening 232 moves toward a closed position. For example, when the nozzle actuator 13102 moves to the first position, the nozzle actuator 13102 may push or press at least partially the central portion 238 of the first contact surface 228 toward a closed position via the projection 13104.

[0057] The ability of the nozzle actuator 13102 to close the nozzle opening 232 is particularly useful when the nozzle opening 232 is biased to an open configuration. Figure 14 depicts a nozzle 222 and nozzle opening 232 configured to be biased to an open state by having progressive parabolic tails 14106, 14108 at each lateral end of the nozzle opening 232. Since the nozzle opening 232 is biased to an open state, the nozzle actuator 13102 can selectively apply a closing force directly or indirectly to the first wall 224 when it is in a second position. The closing force closes the nozzle opening 232 against its bias by at least partially pushing the central portion 238 of the first contact surface 228 into contact with the central portion 244 of the second contact surface 230. If desired, the nozzle actuator 13102 can be moved to a first position to at least partially stop the application of the closing force. The nozzle opening 232 can elastically return to an open state when the closing force is removed. As the nozzle actuator 13102 moves to the first position, it may also push or pull at least partially the central portion 238 of the first contact surface 228 toward the open position in order to at least assist the nozzle opening in returning to the open position.

[0058] While aspects of this disclosure are illustrated and described in particular with reference to the exemplary aspects described above, it will be understood by those skilled in the art that various additional aspects may be contemplated. For example, the specific methods for using the apparatus described above are merely illustrative. Those skilled in the art will be able to readily determine other means / options for arranging any number of tools, process sequences, or the apparatus or its components described above in substantially the same positions as those illustrated and described herein. For the sake of clarity in the drawings, certain components among the illustrated overlapping components are not specifically numbered, but those skilled in the art will understand, based on the numbered components, the element numbers that should be associated with the unnumbered components. Distinction between similar components is not intended or implied solely by the presence or absence of element numbers in the drawings. Any of the described structures and components may be formed integrally as a single unit or integral part, or may consist of separate sub-components, and any of these configurations may involve any suitable stock or custom-made components and / or any suitable material or combination of materials. However, some of the selected materials should be biocompatible for many applications. Any of the described structures and components may be disposable or reusable as desired for a particular usage environment. Any component may be provided with user-perceptible markings to indicate the material, construction, at least one dimension, etc., relating to that component, and user-perceptible markings may, in some cases, assist the user in selecting one component from an array of similar components for a particular usage environment. A “predetermined” condition may be determined at any point before the structure being operated actually reaches that condition, and “default” is made no later than immediately before the structure achieves the predetermined condition. The term “substantially” is used herein to indicate a quality that is not necessarily complete but is largely of the specified quality, and “substantially” quality acknowledges the possibility of some relatively small inclusion of non-quality items.While certain components described herein are shown having specific geometric shapes, all structures in this disclosure may have any preferred shape, size, configuration, relative positions, cross-sectional area, or any other physical properties desired for a particular application. Any structure or feature described with reference to one aspect or configuration may be provided in any other aspect or configuration, either alone or in combination with other structures or features, for it would not be practical to describe each of the aspects and configurations considered herein as having all the options considered with respect to all the other aspects and configurations. Any device or method incorporating any of these features should be understood to fall within the scope of this disclosure, as determined by the following claims and any equivalents thereof.

[0059] Other aspects, purposes, and advantages may be derived from the drawings, this disclosure, and the appended claims.

Claims

1. A non-gravity fluid delivery device for delivering fluid to a user's eye, A cartridge comprising a container and a cartridge head coupled to the cartridge container, wherein the cartridge container defines an inner container chamber configured to contain a fluid, The aforementioned cartridge head is A set of opposing first and second walls that collectively define both the nozzle and the nozzle opening extending through the nozzle, wherein the first wall is at least partially formed from a deformable material and the second wall is at least partially formed from a rigid material, A device comprising: a nozzle opening through which a fluid is selectively delivered from the fluid delivery device to the eye, the nozzle opening extending in the fluid delivery direction between a first wall and a second wall, and selectively transitioning between an open state and a closed state via selective operation of the first wall, at least partially open when in the open state to allow fluid to flow through there, and at least partially closed when in the closed state to restrict fluid flow through there.

2. The device according to claim 1, wherein the cartridge head includes a deformable striking wall that is spaced transversely apart from the nozzle and forms an inner head chamber, and the head chamber is in fluid communication with the container chamber such that the fluid flows selectively from the container chamber to the head chamber.

3. The device according to claim 2, further comprising an applicator configured to house the cartridge, the applicator including a trigger movable between a loading position and a striking position, the trigger being separated from the striking wall when in the loading position, and the trigger being in contact with the striking wall and deflected toward the nozzle when in the striking position, the selective deflection of the striking wall pushing the fluid out of the head chamber through the nozzle opening.

4. The device according to claim 3, wherein the fluid pressure in the head chamber increases as the impact wall is deflected, and the increased fluid pressure deforms the first wall at least partially, causing the nozzle opening to transition at least partially from the closed state to the open state.

5. The device according to claim 2, wherein the cartridge head includes a rigid head portion and a deformable portion, the rigid head portion includes the second wall, and the deformable head portion is connected to the rigid head portion and includes the first wall and the striking wall.

6. The device according to claim 5, wherein the first wall and the striking wall are separate from the rigid head portion and are integrally formed together as a single monolithic component that is subsequently connected to the rigid head portion.

7. The device according to claim 1, wherein the first wall and the second wall are configured such that both the nozzle and the nozzle opening are arc-shaped along the lateral length of the nozzle.

8. The device according to claim 1, wherein the first and second walls are configured to gradually close the nozzle opening from the inside to the outside of the nozzle opening as the nozzle opening is selectively transitioned from the open state to the closed state.

9. The device according to claim 1, further comprising an applicator configured to house the cartridge, the applicator comprising a nozzle actuator configured to selectively operate the first wall, the nozzle actuator being selectively movable between a first position and a second position, the nozzle opening being in the closed state when the nozzle actuator is in the first position, and the nozzle opening being in the open state when the nozzle actuator is in the second position.

10. The device according to claim 1, wherein the first wall includes a first contact surface facing a second contact surface of the second wall, and a portion of the first contact surface is fixedly attached to a portion of the second contact surface such that the nozzle opening is defined between the first contact surface and the second contact surface.

11. The device according to claim 10, wherein the lateral central portion of the first contact surface is in contact with the second contact surface when the nozzle opening is in the closed state, and the central portion of the first contact surface is separated from the second contact surface when the nozzle opening is in the open state.

12. The first contact surface of the first wall includes a first end portion separated laterally from the second end portion by a central portion, and the second contact surface of the second wall includes a first end portion separated laterally from the second end by a central portion. The first end portion of the first contact surface and the first end portion of the second contact surface are fixedly attached to each other, and the second end portion of the first contact surface and the second end portion of the second contact surface are fixedly attached to each other. When the nozzle opening is in the closed state, the central portion of the first contact surface and the central portion of the second contact surface are in contact with each other. The device according to claim 10, wherein when the nozzle opening is in the open state, the central portion of the first contact surface and the central portion of the second contact surface are spaced apart from each other.

13. The device according to claim 12, wherein the central portion of the first contact surface and the central portion of the second contact surface are angled relative to each other such that the nozzle opening gradually closes from the inside to the outside of the nozzle opening as the nozzle opening is selectively transitioned from the open state to the closed state.

14. A nozzle for a fluid delivery device, wherein the nozzle is Opposing first and second walls, wherein the first wall is at least partially formed from a deformable material, and the second wall is at least partially formed from a rigid material, A nozzle opening through which a fluid is selectively delivered from the fluid delivery device to a target site, comprising: a nozzle opening defined by a first nozzle wall and a second nozzle wall, extending between the first wall and the second wall in the fluid delivery direction, selectively transitioning between an open state and a closed state via selective operation of the first wall, at least partially open when in the open state to allow the fluid to flow through there, and at least partially closed when in the closed state to restrict the fluid to flow through there.

15. The device according to claim 14, wherein a selective increase in the fluid pressure within the fluid delivery device deforms the first wall, causing the nozzle opening to transition at least partially from the closed state to the open state.

16. The device according to claim 14, wherein the first wall and the second wall are configured such that both the nozzle and the nozzle opening are arc-shaped along the lateral length of the nozzle.

17. The device according to claim 14, wherein the first and second walls are configured to gradually close the nozzle opening from the inside to the outside of the nozzle opening as the nozzle opening is selectively transitioned from the open state to the closed state.

18. The device according to claim 14, wherein the first wall includes a first contact surface facing a second contact surface of the second wall, and a portion of the first contact surface is fixedly attached to a portion of the second contact surface such that the nozzle opening is defined between the first contact surface and the second contact surface.

19. The device according to claim 18, wherein the lateral central portion of the first contact surface is in contact with the second contact surface when the nozzle opening is in the closed state, and the central portion of the first contact surface is separated from the second contact surface when the nozzle opening is in the open state.

20. The first contact surface of the first wall includes a first end portion separated laterally from the second end portion by a central portion, and the second contact surface of the second wall includes a first end portion separated laterally from the second end portion by a central portion. The first end portion of the first contact surface and the first end portion of the second contact surface are fixedly attached to each other, and the second end portion of the first contact surface and the second end portion of the second contact surface are fixedly attached to each other. When the nozzle opening is in the closed state, the central portion of the first contact surface and the central portion of the second contact surface are in contact with each other. The device according to claim 18, wherein when the nozzle opening is in the open state, the central portion of the first contact surface and the central portion of the second contact surface are spaced apart from each other.

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