WO2025030038A1

WO2025030038A1 - A fluid delivery device

Info

Publication number: WO2025030038A1
Application number: PCT/US2024/040589
Authority: WO
Inventors: Alexandre R. TUMLINSON
Original assignee: Twenty Twenty Therapeutics Llc
Priority date: 2023-08-03
Filing date: 2024-08-01
Publication date: 2025-02-06

Abstract

Pistons are manipulated into a rest position in which first and second piston heads of the first and second pistons, respectively, contact one another. An ejection volume of an ejection chamber being substantially zero when the first and second piston heads contact one another. The pistons are manipulated into a filling position from the rest position, fluid being drawn into the ejection volume of the ejection chamber. The pistons are manipulated into a loaded position from the filling position, the ejection chamber being aligned with an ejection port when the first and second pistons are in the loaded position, and into an ejecting position where the fluid from the ejecting chamber is urged out through the ejection port. Other aspects are also described and claimed.

Description

A FLUID DELIVERY DEVICE

Background

[0001] Typically, conventional preservative-free eye droppers provide only for a substantially “vertical” delivery of preservative-free fluid. In certain cases, a differently angled--e.g., substantially “horizontal”--delivery of the preservative-free fluid may be more desirable.

Brief Description of the Drawings

[0002] For a better understanding, reference may be made to the accompanying drawings, in which:

[0003] Fig. 1 is a schematic front view of a fluid delivery device according to one aspect of the present invention;

[0004] Fig. 2 is a schematic exploded view of the aspect of Fig. 1 ;

[0005] Figs. 3-7 schematically illustrate an example sequence of operation for a portion of the aspect of Fig. 1 ;

[0006] Fig. 8 is a schematic front view of a first structural implementation of the aspect of Fig. 1 , including the first structural implementation in a first condition;

[0007] Fig. 9 is a schematic front view of the aspect of Fig. 8, including the first structural implementation in a second condition;

[0008] Figs. 10-16 schematically illustrate an example sequence of operation for a portion of the aspect of Fig. 8;

[0009] Fig. 17 is a schematic front view of a second structural implementation of the aspect of Fig. 1 ;

[0010] Fig. 18 is a schematic front view of a third structural implementation of the aspect of Fig. 1 , including the third structural implementation in a first condition;

[0011] Fig. 19 is a schematic front view of the aspect of Fig. 18, including the third structural implementation in a second condition; and

[0012] Fig. 20 is a schematic perspective side view of a fourth structural implementation of the aspect of Fig. 1. [0013] Fig. 21 is a diagram showing basic components of another fluid delivery device.

[0014] Fig. 22 shows a sequence of basic component motions for a fluid delivery device.

[0015] Fig. 23 depicts an example external user interface.

[0016] Fig. 24 depicts another example external user interface.

[0017] Fig. 25 shows an example external user interface using mixed mechanical interface.

[0018] Fig. 26 illustrates an example mechanical engine to enforce piston motion.

[0019] Fig. 27 is a diagram of an example mechanical engine that uses rotary motion.

Description of Aspects of the Disclosure

[0020] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0021] As used herein, the term “user” can be used interchangeably to refer to an individual who prepares for, assists with, and/or performs the operation of a tool procedure, and/or to an individual who prepares for, assists with, and/or performs a procedure.

[0022] As used herein, the singular forms “a,” “an” and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” as used herein, can specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. [0023] As used herein, the term “and/or” can include any and all combinations of one or more of the associated listed items.

[0024] As used herein, phrases such as “between X and Y” can be interpreted to include X and Y.

[0025] As used herein, the phrase “at least one of X and Y” can be interpreted to include 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, the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time. In contrast, the phrase “at least one of X” can be interpreted to include one or more Xs.

[0026] It will be understood that when an element is referred to as being “on,” “attached” to, “connected” to, “coupled” with, “contacting,” etc., another element, it can be directly on, attached to, connected to, coupled with, or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly attached” to another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may not have portions that overlap or underlie the adjacent feature.

[0027] It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or Figures unless specifically indicated otherwise.

[0028] The invention comprises, consists of, or consists essentially of the following features, in any combination.

[0029] Figs. 1-2 schematically depict an example fluid delivery device 100 designed in accordance with the present disclosure. The device 100, as described herein, is configured for delivering fluid to an eye of a user. However, the device 100 may be configured to deliver fluid to any other portion of the user, such as, for example, the user’s nose, mouth, ear(s), limb(s), head, neck, and/or trunk. The device 100 includes a container 102 and an applicator 104. [0030] The container 102 defines an inner container chamber 106 in which a fluid F (e.g., multiple doses of the fluid F) is accommodated. The fluid F may be an ophthalmic drug, a viscous ophthalmic drug, any other fluid (viscous or otherwise), or any combination thereof. While the device 100 is constructed such that the fluid F may be free of preservatives, the device 100 is also applicable to deliver fluids containing preservatives. The fluid F may flow out from the container 102 through an exit port 108. The container 102 may be configured such that fluid F may flow freely from the container chamber 106 through the exit port 108 in response to gravitational force, negative pressure, positive pressure, any other force suitable for causing the fluid F to flow out from the container 102, or any combination thereof. The container 102 may also include a flow restricting device (e.g., a one-way valve) that may be caused to “open” and permit fluid F to flow out from the container 102 and/or toward the exit port 108 in response to certain conditions (e.g., in response to a predetermined amount of negative pressure).

[0031] The applicator 104 includes a receiving portion 110 for removably or permanently receiving the container 102 therein. The receiving portion 110 may, for example, include a collar 112 at least partially defining a receiving cavity 114 into which the container 102 may be longitudinally inserted. The term “longitudinal” is used herein to indicate a substantially vertical direction, in the orientation of Figs. 1- 2, and is indicated as “LO” in the Figures. The collar 112 may include internal threads for threadably engaging external threads of the container 102 to selectively maintain the container 102 in the receiving cavity 114.

[0032] Alternatively, instead of receiving a separate container 102 therein, the applicator 104 itself may define a container. As one example, the receiving portion 110 (e.g., the collar 112) may at least partially form a container, with the receiving cavity 114 functioning as an inner container chamber that directly accommodates the fluid F therein. Once the receiving cavity 114 is filled with the fluid F, the receiving portion 110 may be (removably or permanently) capped or sealed to maintain the fluid F in the receiving cavity 114. Therefore, when the applicator 104 defines/includes an integral container, the separate container 102 may be omitted from the device 100.

[0033] The applicator 104 also includes an ejection portion 116 having an ejection tube 118. The ejection tube 118 may be formed at least partially from one or more plastics, though the ejection tube may be formed from any desired material or combination of materials. The ejection tube 118 defines an inner ejection passage 120, an input port 122 in fluid communication with the ejection passage 120, and an ejection port 124 in fluid communication with the ejection passage 120. The input port 122 extends longitudinally through a longitudinal end 126 of the ejection tube 118 so that the input port 122 may be aligned with and longitudinally adjacent to the exit port 108 when the container 102 is coupled to the applicator 104. The longitudinal end 126 of the ejection tube 118 may thus define a portion of the receiving cavity 114. The collar 112 and the ejection tube 118 may be integrally formed as a single monolithic piece or may be formed separately from one another and subsequently connected together.

[0034] The ejection port 124 extends transversely through the ejection tube 118 such that fluid F enters the ejection tube 118 substantially in the longitudinal direction and exits the ejection tube 118 substantially in a transverse direction. The term “transverse” is used herein to indicate a direction substantially perpendicular to the “longitudinal” direction, is shown as a direction that extends substantially perpendicular to the plane of the page in the orientation of Figs. 1-2 and is indicated at “TR” in the Figures. The extension of the ejection port 124 thus is perpendicular to the extension of the input port 122. The ejection port 124 may also be located on the ejection tube 118 such that it is laterally offset from the input port 122. The term “lateral” is used herein to indicate a direction substantially perpendicular to the “longitudinal” and “transverse” directions, is shown as a substantially horizontal direction in the orientation of Figs. 1-2 and is indicated at “LA” in the Figures.

[0035] Alternatively, the device 100 may be configured such that, instead of the fluid F entering the ejection tube 118 in the longitudinal direction, the fluid F may enter the ejection tube 118 substantially in the transverse direction. For example, the input port 122 may transversely extend through the ejection tube 118 on a side of the ejection tube 118 that is transversely opposite to the ejection port 124. The transversely extending input port 122 may also be laterally offset from the ejection port 124. Therefore, in such a configuration, the fluid F enters and exits the ejection tube 118 substantially in the transverse direction. The container 102, when separate from the applicator 104, may be configured to cooperate with the transversely extending input port 124 such as, for example, by having the exit port 108 extend in the transverse direction instead of the longitudinal direction. Similarly, the applicator 104, when the applicator 104 defines/includes an integral container, may be configured such that at least a portion of the container chamber is aligned with and transversely adjacent to the transversely extending input port 124.

[0036] The ejection port 124 may be formed in the ejection tube 118 (as is shown in Figs. 1-2), separately formed, and attached directly to the ejection tube 118 such that the ejection port 124 and the ejection passage 120 are in direct fluid communication, or separately formed and indirectly fluid ically connected to the ejection passage 120 via one or more passageways. The surface properties and/or the geometry of the ejection port 124 may be selected to achieve a desired spray pattern/shape and to substantially prevent an undesirable egress of fluid F from the ejection tube 118. As shown in Figs. 1-2, the ejection port 124 may comprise a plurality of slit openings 128, though the ejection port 124 may comprise any desired number of openings having any desired shape.

[0037] A sealing member 230 (e.g., an O-ring) may be provided on the ejection tube 118 proximate to the input port 122. The sealing member 230 may be interposed between the container 102 and the ejection tube 118 during use to help form a fluid-tight seal between the container 102 and the ejection tube 118.

Although the sealing member 230 has been shown as being provided on the ejection tube 118, the sealing member 230 may also or instead be provided on the container 102 proximate to the exit port 108. Alternatively or additionally, an area of the container 102 proximate the exit port 108 may be formed from an elastic and/or deformable material such that the elastic and/or deformable portion of the container 102 may conform to the exterior geometry of the ejection tube 118 adjacent the input port 122 to form a fluid-tight seal between the container 102 and the ejection tube 118.

[0038] A first piston 132 extends laterally into a first end 134 of the ejection tube 118, while a second piston 136 extends laterally into an opposite second end 138 of the ejection tube 118 such that first and second piston heads 140, 142 of the first and second pistons 132, 136, respectively, are located in the ejection passage 120 adjacent one another. The first and second piston heads 140, 142 may be configured such that a fluid-tight seal is formed between an inner tube surface 144 of the ejection tube 118 and each of the first and second piston heads 140, 142. Because of this fluid-tight seal, the inner surface 144 of the ejection tube 118 and the first and second piston heads 140, 142 selectively define an ejection chamber 146 in the ejection tube 118.

[0039] The first and second pistons 132, 136 may also have first and second piston shafts 148, 150, respectively, attached to the first and second piston heads 140, 142. The first and second piston heads 140, 142 may be formed from an elastic and/or deformable material (e.g., rubber) and the first and second piston shafts 148, 150 may be formed from a rigid material (e.g., a hard plastic), though, the first and second piston heads 140, 142 and the first and second piston shafts 148, 150 may be formed from any desired material or combination of materials.

[0040] Each of the first and second pistons 132, 136 may be selectively moved laterally (e.g., via the first and second piston shafts 148, 150) relative to one another and to the ejection tube 118. Such relative movement may responsively alter an ejection volume 152 of the ejection chamber 146. Furthermore, when desired, fluid F may be ejected from the device 100 by controlling the movements of the first and second pistons 132, 136. One or more lubricants (e.g., silicone oil) may be provided in the ejection tube 118 and/or on at least one of the first and second pistons 132, 136 to at least partially help reduce friction between the inner tube surface 144 and at least one of the first and second pistons 132, 136 so that the at least one first and second pistons 132, 136 may slide more “smoothly” within the ejection tube 118.

[0041] Figs. 3-7 illustrate an example dispensing sequence (i.e., a fluid ejection cycle) for the device 100. As shown in Fig. 3, the container 102 is received in the applicator 104 such that the exit port 108 is laterally aligned with the input port 122. The first and second pistons 132, 136 are also in a rest position in which the first and second piston heads 140, 142 are in contact with one another. When the first and second piston heads 140, 142 are in such a position, the ejection volume 152 of the ejection chamber 146 is eliminated or reduced to a substantially minimal volume (e.g., substantially zero). One of the benefits of such a rest position is that bacteria has limited room to inhabit or grow within the ejection chamber 146 when the ejection volume 152 is eliminated or is of a substantially minimal size. Therefore, via the device’s particular design and operation, the device 100 may be utilized as a multi-dose delivery device for preservative-free fluid. [0042] Although the ejection chamber 146 and/or the contacting first and second pistons 132, 136 are shown as being substantially laterally aligned with the input port 122 when the first and second pistons 132, 136 are in the rest position, the contacting first and second pistons 132, 136 and/or the ejection chamber 146 defined therebetween may be laterally offset from each of the input port 122 and the ejection port 124 when the first and second pistons 132, 136 are in the rest position. Such a rest position may at least partially help to minimize the amount of time the ejection chamber 146 is exposed to the input port 122 (and, thus, the container chamber 106) and the ejection port 124 (and, thus, the surrounding environment outside the device 100).

[0043] The first and second pistons 132, 136 may remain in the rest position until such time that the delivery of fluid F is desired. When delivery of the fluid F is desired, the first and second pistons 132, 136 move to a filling position. In particular, at least one of the first and second pistons 132, 136 are moved laterally such that the first and second piston heads 140, 142 are spaced from one another and the ejection volume 152 of the ejection chamber 146 is increased to a predetermined ejection volume. In the example configuration shown in Fig. 4, the first piston 132 moves in a first lateral direction away from the second piston 136 and the second piston 136 remains stationary to achieve the filling position. Increasing the ejection volume 152 generates negative pressure in the ejection chamber 146, which responsively draws the fluid F from the container chamber 106, through the exit and input ports 108, 122, and into the ejection chamber 146. The movement of the first and second pistons 132, 136 to the filling position thus fills the ejection volume 152 of the ejection chamber 146 with the fluid F. When the container 102 includes the flow restricting device, the fluid F may be flow into the ejection chamber 146 only after the negative pressure reaches the predetermined negative pressure value and responsively causes the flow restricting device to “open.”

[0044] The amount of fluid F drawn into the ejection chamber 146 may be equal to the predetermined ejection volume or slightly less than the predetermined ejection volume. In any case, the predetermined ejection volume and/or the amount of fluid F drawn into the ejection chamber 146 during the filling operation may be standardized or user-specific. [0045] It should be appreciated that the fluid F takes a relatively simple path from the container chamber 106 to the ejection chamber 146. In particular, the fluid F travels substantially in the longitudinal direction when filling the ejection chamber 146 as the exit port 108, the input port 122, and the ejection chamber 146 are all laterally aligned. However, it is contemplated that the travel path of the fluid F may be made more complex or labyrinthine by laterally offsetting at least one of the exit port 108, the input port 122, and the ejection chamber 146 with respect to at least one other of the exit port 108, the input port 122, and the ejection chamber 146.

[0046] Once the ejection chamber 146 is filled, the first and second pistons 132, 136 move to a loaded position. As shown in the example configuration of Fig. 5, each of the first and second pistons 132, 136 are moved in a second lateral direction, which is opposite the first lateral direction, from the filling position to the loaded position. The first and second pistons 132, 136 may travel concurrently to the loaded position such that the ejection volume 152 remains constant as the first and second pistons 132, 136 move laterally in the second direction. Once in the loaded position, the ejection chamber 146 is laterally offset from the input port 122, laterally aligned with the ejection port 124, and transversely adjacent to the ejection port 124. Therefore, the ejection chamber 146 (and the fluid F therein) is laterally offset from the ejection port 124 prior to the first and second pistons 132, 136 assuming the loaded position.

[0047] Although the fluid F in the ejection chamber 146 is aligned with the slit openings 128 of the ejection port 124, the fluid F may be substantially prevented from undesirably flowing out through the ejection port 124 as a result of surface tension of the fluid F, an ejection chamber pressure in the ejection chamber 146, and/or the ejection port’s 124 geometry. For example, the ejection chamber pressure in the ejection chamber 146 may be substantially equal to atmospheric pressure following the filling procedure. The ejection chamber pressure may then remain substantially constant as the first and second pistons 132, 136 move concurrently to the loaded position. Because the ejection chamber pressure is substantially balanced with the atmospheric pressure, the surface tension of the fluid F urges the fluid F to remain in the ejection chamber 146 when the ejection chamber 146 is aligned with the ejection port 124. Alternatively, or additionally, the ejection port 124 (e.g., the slit openings 128 of the ejection port 124) may be sized or otherwise configured so that the surface tension of the fluid F substantially prevents the fluid F from undesirably flowing out through the ejection port 124.

[0048] Once in the loaded position, the first and second pistons 132, 136 move to an ejecting position. As shown in the example configuration of Fig. 6, each of the first and second pistons 132, 136 are moved toward (e.g., rapidly toward) one another from the loaded position to the ejecting position, though the device 100 may be configured such that only one of the first and second pistons 132, 136 may be moved toward the other of the first and second pistons 132, 136 when transitioning to the ejecting position. The speed at which the first and second pistons 132, 136 move to the ejecting position may be such that the ejection volume 152 is rapidly decreased to cause a rapid increase in ejection chamber pressure that urges or forces fluid F from the ejection chamber 146 transversely out through the ejection port 124 toward the user’s eye. The first and second pistons 132, 136, once in the ejecting position, may be in contact with one another once in the ejecting position. This contact helps expel all or substantially all the fluid F out from the ejection chamber 146 as the first and second pistons 132, 136 move to the ejecting position.

[0049] After the fluid F is expelled, the first and second pistons 132, 136 move back to the rest position. As shown in the example configuration of Fig. 7, the first and second pistons 132, 136 may remain in contact with one another as they move back in the first lateral direction toward the rest position. This contact between the first and second pistons 132, 136 at least partially helps prevent air or environmental contaminants into the ejection tube 118 and/or the ejection chamber 146 after the dispensing event. Therefore, for at least this additional reason, the device 100 may be particularly useful as a delivery device for preservative-free fluid.

[0050] As schematically shown in Figs. 1-2, the applicator 104 may include a motion engine 154 via which the first and second pistons 132, 136 are moved between the various positions of the fluid ejecting cycle described above and shown in Figs. 3-7. The motion engine 154, for example, may be connected to the first and second pistons 132, 136 via the first and second piston shafts 148, 150. The construction and general operation of the motion engine 154 may be application specific. However, generally, the motion engine 154 may be any desired component or system of components that are operable to provide motive force (automatic, manual, etc.) to the first and second pistons 132, 136 (e.g., via the first and second piston shafts 148, 150) to transition the first and second pistons 132, 136 between the various positions of the fluid ejecting cycle. The motion engine 154 may also include any desired component or system of components that are used in conjunction with the motive force-providing component(s) to transition the first and second pistons 132, 136 through the fluid ejecting cycle. The motion engine 154 thus may include cams, follower arms, springs and/or spring-based energy storage devices, moveable substrates, tracks, rotatable and/or non-rotatable portions of the applicator 104, linkages, motors, or other structures (not shown) attached directly or indirectly to the first and second pistons 132, 136 that cause the first and second pistons 132, 136 to transition through the fluid ejecting cycle.

[0051] Figs. 8-9 depict the device 100 having a first configuration of the motion engine 154 (referred to hereinafter as the “first motion engine” and indicated as 154a in the Figures). When the device 100 has the first motion engine 154a, the user may apply a force to an actuation button 856 of the device 100 in a single longitudinal direction that results in the first motion engine 154a cycling the first and second pistons 132, 136 from the rest position to the ejecting position. Release of the actuation button 856 responsively results in the first motion engine 154a moving the first and second pistons 132, 136 from the ejecting position back to the rest position.

[0052] Figs. 10-16 schematically illustrate an example sequence of how the first motion engine 154a may be configured to cycle the device 100 through the fluid ejecting cycle. In other words, Figs. 10-16 schematically illustrate how the first motion engine 154a may be configured to translate the longitudinally applied user force and subsequent release into movement of the first and second pistons 132, 136 from the rest position to the ejecting position and back. The first motion engine 154 may include cams having follower arms that are attached directly or indirectly to the first and second pistons 132, 136 (e.g., to the first and second piston shafts 148, 150). The arrows 1058 shown in Figs. 10-16 represent the cam paths that the follower arms attached to the first and second pistons 132, 136 take as they move the first and second pistons 132, 136 through the fluid ejecting cycle. The first motion engine 154a may include a moveable substrate 1060 having one or more tracks thereon that define the cam paths 1058. The substrate 1060 may be attached to or formed on a portion actuation button 856 such that the longitudinal movement of the actuation button 856 longitudinally moves the substrate 1060. Therefore, as the user provides the longitudinal force to the actuation button 856, the substrate moves longitudinally. The longitudinally moving substrate 1060 responsively causes the follower arms to follow the tracks and thus travel their respective cam paths 1058. As the follower arms and their corresponding pistons move in accordance with their respective cam paths, the pistons are transitioned through the fluid ejecting cycle.

[0053] The first motion engine 154a may also include a spring that is compressed by the movement of the first and second pistons 132, 136 and/or the follower arms as the first and second pistons 132, 136 transition from the rest position to the loaded position. Once the first and second pistons 132, 136 reach the loaded position the compression force may be alleviated from the spring, which responsively results in the spring suddenly expanding and the first and second pistons 132, 136 being rapidly transitioned to the ejecting position (directly or indirectly) by the expanding spring.

[0054] It is contemplated that the first motion engine 154a may include one or more cams, follower arms, springs, or other structures (not shown) attached directly or indirectly to the first and second pistons 132, 136 (e.g., to the first and second piston shafts 148, 150) that permit the first and second pistons 132, 136 to travel along their respective paths even as the actuation button 856 moves only in the longitudinal direction; one of ordinary skill in the art can readily configure a mechanical linkage as desired for a particular use environment. As manual force is applied to move the plate (at the large arrows) containing the cam paths, the pistons move slowly along diagonal cam paths, sometimes applying compression to a spring (sinusoidal line) which is relieved when the cam path reaches a point that is parallel to the spring force, resulting in a sudden release of the piston.

[0055] Fig. 17 schematically depicts the device 100 having a second configuration of the motion engine 154 (referred to hereinafter as the “second motion engine” and indicated as 154b in the Figures). When the device 100 has the second motion engine 154b, the user may apply a force to a rotatable portion of the applicator 104 in one rotational direction (i.e., clockwise, or counterclockwise) that results in the second motion engine 154b cycling the first and second pistons 132, 136 through the fluid ejecting cycle. For example, as shown in Fig. 17, the applicator 104 and/or the second motion engine 154b may include an inner component 1762 that is fixed to the container 102 and an outer component 1764 that is rotatable relative to the inner component 1762. The inner component 1762 may include a pivot 1766 and a barrel 1768 in the form of a toroidal cylinder. The pivot 1766 is connected to a torsion spring coil 1770 such that a center of the pivot 1766 is also a center of the spring 1770. The first and second pistons 132, 136 thus may follow arcuate paths around the center of the pivot 1766.

[0056] The first and second piston shafts 148, 150 may also be connected to first and second linkages 1772, 1774, respectively. The outer component 1764 may include first and second relief tracks 1776, 1778 in which a portion of the first and second linkages 1772, 1774, repetitively, travel as the outer component 1764 rotates relative to the inner component 1762. A full turn of the outer component 1764 (e.g., a 360 degree turn of the outer component 1764) relative to the inner component 1762 responsively causes the first and second pistons 132, 136 to transition through the fluid ejecting cycle.

[0057] By making the first and second linkages 1772, 1774 different lengths, the first and second linkages 1772, 1774 may travel along independent portions (i.e., different relief tracks 1776, 1778) of the outer component 1764 and have complex independent motions. Because it may be desirable for the first and second piston heads 140, 142 to be in contact during some portions of the fluid ejecting cycle, the motions of the first and second pistons 132, 136 may be at least partially constrained by the contact between the first and second piston heads 140, 142.

[0058] The motion of the first and second linkages 1772, 1774 (and, thus, the first and second pistons 132, 136) may also be at least partially defined by the geometry (e.g., height and/or length) of the first and second relief tracks 1776, 1778. For example, the radial height of the first and second relief tracks 1776, 1778 may vary in the circumferential direction such that the first and second linkages 1772, 1774 move radially inward as the first and second pistons 132, 136 move from the rest position to the loaded position. The first and second linkages 1772, 1774 may be directly or indirectly connected to the torsion spring coil 1770 so that the radially inward movement of the first and second linkages 1772, 1774 compresses the torsion spring as the first and second pistons 132, 136 move from the rest position to the loaded position. Once the first and second pistons 132, 136 reach the loaded position, further rotational movement of the outer component 1764 responsively causes the first and second linkages 1772, 1774 to fall radially outward off circumferential ends of the first and second relief tracks 1776, 1778. This radially outward drop off alleviates the compression force on the torsion spring coil 1770 and permits the torsion spring coil 1770 to rapidly expand. The rapidly expanding torsion spring coil 1770 responsively directly (e.g., via direct connection between the first and second pistons 132, 136 and the torsion spring coil 1770) or indirectly (e.g., via the first and second linkages 1772, 1774) causes the first and second pistons 132, 136 to rapidly transition to the ejecting position.

[0059] It is contemplated that the second motion engine 154b may include one or more cams, or other structures (not shown) to connected to the first and second linkages 1772, 1774 and/or the first and second pistons 132, 136 that permit first and second pistons 132, 136 to travel in through the fluid ejection cycle as the outer component 1764 rotates in a single rotational direction; one of ordinary skill in the art can readily configure a mechanical linkage as desired for a particular use environment.

[0060] Figs. 18-19 schematically depict the device 100 having a third configuration of the motion engine 154 (referred to hereinafter as the “third motion engine” and indicated as 154c in the Figures). When the device 100 has the third motion engine 154c, the user may apply a force to a rotatable portion of the applicator 104 in one rotational direction (i.e., clockwise, or counterclockwise) that results in the third motion engine 154c cycling the first and second pistons 132, 136 from the rest position to the loaded position. Once in the loaded position, the user may apply a longitudinal force to an actuation button 856 to responsively cause the first and second pistons 132, 136 to transition to the ejecting position and then back to the rest position. The third motion engine, utilizing both rotational and longitudinal movements, may utilize any of the features of the first and second motion engines 154a, 154b or other suitable features to cycle the first and second pistons 132, 136 through the fluid ejecting cycle.

[0061] Although the motion engines 154 (e.g., the first, second, and third motion engines 154a, 154b, 154c) have been shown and/or described as being manually operated directly via a user applied force, the motion engines 154 and/or the device 100 may be configured to operated “automatically.” For example, the device 100 shown in Fig. 20 is configured for the automatic dispensing of the fluid F. The device 100 of Fig. 20 thus includes an actuation button 856. After the user presses the actuation button 856, a processing unit 2080 may receive sensor inputs from an optical sensor 2082. Via at least the sensor inputs, the processing unit 2080 may determine the likelihood that fluid F ejected from the device 100 will land in the user’s eye. For example, based on at least the sensor inputs, the processing unit 2080 may determine if the user’s eye is open and/or if the user’s eye is properly aligned with the ejection port 124, and then use these determinations to establish the likelihood that fluid F ejected from the device 100 will land in the user’s eye. Examples of such uses of sensors and sensor inputs can be found in, for example, U.S. Patent Application Serial No. 17/319,987, filed 13 May 2021 by Stowe and titled “OCULAR PHARMACEUTICAL APPLICATOR WITH LIGHT-ASSISTED ALIGNMENT AND AIMING”, U.S. Provisional Patent Application Serial No. 63/467,236, filed 17 May 2023 by Rumyantsev et al. and titled “FLUID DELIVERY DEVICE”, and U.S. Provisional Patent Application Serial No. 63/399,353, filed 19 August 2022 by Sinha et al. and titled “CAMERA-BASED DROPLET GUIDANCE AND DETECTION”, the subject matter of each of which is incorporated by reference in its entirety.

[0062] Once the processing unit 2080 determines that the there is a high likelihood (e.g., at least a 90 percent chance) that fluid F ejected from the device 100 will land in the user’s eye, the processing unit 2080 activates an actuator 2084 (e.g., a solenoid or motor) to drive a motion engine 154. The driven motion engine 154 cycles the first and second pistons 132, 136 through the fluid ejecting cycle to deliver the fluid F to the user’s eye. The motion engine 154 of Fig. 20 may be one of the motion engines 154 described above, a combination of the motion engines 154 described above, or any other motion engine configured to transition the first and second pistons 132, 134 through the fluid ejecting cycle. At least one of the processing unit 2080, the optical sensor 2082, the actuator 2084, and the motion engine 154 may be powered via a battery 2086.

[0063] By operably controlling the first and second pistons 132, 134 via the processing unit 2080 and/or the actuator 2084, the volume of fluid F dispensed from the device 100 and/or the speed at which the fluid F is ejected from the device 100 may be adjusted/customized as desired. [0064] The automatic device 100 of Fig. 20 may be configured such that the device 100 is “primed” prior to use. In such case, the user may press the actuation button 856 and responsively cause fluid F to be ejected from the device 100 before using the device 100 to apply the fluid F to their eye. Once the device 100 has been primed, the user may use the device 100 to deliver the fluid F to their eye in the manner as described above. The user may be instructed to prime the device 100 prior to the first use of the device 100 and/or the container 102, and/or if a predetermined amount of time has passed since the last dispensing event.

[0065] It is contemplated that the container 102 may be a “standard” or preservative-free eye dropper bottle of any desired configuration that is commercially available, such as via prescription or over-the-counter, and the applicator 104 may be selectively joined to the container 102. Alternatively, the container 102 may be customized specifically for the applicator 104.

[0066] It is contemplated that, in one commercial implementation the device 100, the device 100 is distributed having the container 102, which holds multiple doses of the fluid F, and the applicator 104, which acts as a “cap” for the container 102.

[0067] It is contemplated that, in one example configuration of the device 100, the applicator 104 may include a means to equalize air pressure in the container 102 to replace ejected fluid F with filtered air (e.g., via an air filter system).

[0068] It is contemplated that, at least in one example configuration of the device 100, certain features of the device 100 may be configured to be reused, while certain other features (e.g., the container 102) may be configured to be replaced.

[0069] Figs. 21-27 include further details on several example implementations of the systems and methods described herein, and in particular a pump for forcefully ejecting a drop from a preservative free eyedrop bottle.

[0070] A valve and pump system are disclosed for extracting a drop from a multidose liquid reservoir and ejecting it through an aperture to deliver it to an eye. The pump may be configured to deliver horizontal aiming of a drop. The pump may be configured to deliver drops of various size and viscosity. The pump may be configured to act as a one-way valve within a cap for a multidose reservoir. The pump consists of a piston barrel with an input port to connect to the reservoir, an exit port toward the eye, and two mobile pistons enclosing a chamber volume within the piston barrel. The pistons seal tightly to the barrel as plungers facing each other within an open ended syringe barrel. The motion of the two pistons is controlled so as to extract a drop from the eyedropper, translate the drop towards the exit port and forcibly eject the droplet. The pump device may be included as a portion of a disposable multidose packaging, as an add-on cap to a multidose packaging, or as a module of a complex system including dose tracking, and droplet aiming, etc.

[0071] A solution for horizontal delivery of preservative free multidose eyedrops is needed. Current horizontal eyedropper solutions use specialized packaging which currently do not support preservative free implementation. Current preservative free droppers are not configured to forcefully eject a fixed volume of drug. To use a standardized PF bottle, a horizontal dropper must first get the drop out of the bottle, and then handle it in a clean way until it can be directed toward the eye of the user.

[0072] Regarding Fig. 21 , a horizontal firing multidose preservative free eyedropper (1 ) consists a multidose preservative free reservoir (10) and a horizontal firing adapter cap (20). The multidose PF reservoir (10) has an exit port (11 ) from which a drop may be pulled by applying a vacuum when the bottle is oriented such that the exit port is down with respect to gravity. The drop reservoir may allow liquid to flow freely into the pump or may have additional fluid restricting devices such as a one way valve with a cracking pressure to allow fluid to flow toward its exit port. The adapter cap (20) is shown in an exploded view on the right. A piston barrel (22) has a barrel input port (23) and an ejection port (24). These components may be molded including a thread adapter (21 ) that centers the barrel input port against the exit port of the dropper (11 ) For some bottle types (10) the exit port (11 ) may consist a compliant material which can make a good airtight seal against the barrel input port

(23). In other implementations the, cap (21 ) may additionally include a compliant component (29) such as an O-ring to assist in making this seal. The ejection port

(24) is displaced a short distance along the barrel (22) from the input port(23). An input closing piston (25) enters one end of the barrel (22) and an ejection closing piston (26) enters another end of the barrel. The pistons (25,26) form airtight seals with the walls of the barrel (22). The space in the barrel between the pistons is a chamber with a controlled volume (28- not labeled). A mechanical engine (27) drives the motion of the pistons. [0073] Re Fig. 22, by controlling the motion of the pistons relative to each other and the ports of the barrel, the mechanical engine (27) achieves the pumping action of the device. At REST, the piston faces are in contact with each other and the volume of the chamber (28) between them is exceedingly small. This provides an extremely low volume of substrate on which bacteria may feed and breed. When the user wishes to dispense a drop, the engine moves through a series of motions. In the first step LOAD the interior faces of both pistons are located adjacent to the input port (23). The chamber volume between the two pistons is increased when the mechanical engine (27) causes one or both pistons to move in a direction away from the other piston. In Fig. 22, the input closing piston (25) is shown moving away from a static ejection closing piston (26). This increase in volume of the chamber will decrease the pressure within it. If the drop reservoir (10) does not contain an independent one way valve, fluid will flow into the space created between the pistons (28). If the drop reservoir (10) contains a one way valve, when the pressure difference between the chamber and the air inside the reservoir exceeds the cracking pressure of the one way valve, fluid will flow from the PF dropper (10) into the chamber between the pistons (28). In the next step TRANSLATE the mechanical engine (27) causes both pistons to translate together, maintaining a constant volume, and interior chamber pressure approximately equivalent to the atmospheric pressure. When the ejection closing piston translates (26) past the ejection port (24) the chamber pressure is balanced such that the drop does not want to exit the port, nor does air tend to enter the port. Generally, the surface tension of the liquid holds the fluid inside the barrel under this balanced pressure. When the drop has been translated to the ejection port, the mechanical engine can cause the EJECT phase to begin. In this phase the pistons must move rapidly toward each other to reduce the volume of the chamber (28) and push the drop out through the ejection port (24). The piston faces are pushed into contact to completely expel any drop between them. Finally, the mechanical engine should return the pistons to the REST position by moving them together and maintaining the low volume between them, without aspirating any environmental contaminant back into the system.

[0074] The pistons may be formed similarly to the plungers of syringes, while the barrel may be formed as the barrel of a syringe. For example, the pistons may be formed of molded rubber which fits onto a linkage made of a harder molded plastic. The barrel may be molded from a variety of plastics. Lubricants may be used to improve the motion and sealing characteristics between the pistons and barrel such as silicone oil. The ejection port nozzle may be molded into the barrel wall, separately molded, and interested in the barrel wall or connected via a small passageway. The surface properties and geometry of the ejection port nozzle may be modified to achieve the spray pattern desired and to maintain the fluid held within the chamber (28) during the TRANSLATE step. Slit shaped openings are preferred.

[0075] The mechanical engine (27) to direct the motion of the pistons can be achieved in diverse ways and the solution chosen largely depends on the desired user interface. Several potential user interfaces are described in Figs. 23, 24 and 25. In Fig. 24, a system is described where a portion of the cap is twisted to arm the device, moving from the REST state, and through the LOAD, and TRANSLATE steps. The user then aligns the dropper in front of their eye and finally presses a button on the end of the cap to move through the EJECT and RETURN states. Fig. 25 shows a system where an application of force in a single direction moves the device from REST, through LOAD, TRANSLATE, and EJECT phases, and the release of force allows the device to move back through the RETURN to rest state. Fig. 26 shows a highly automated device where the user switches the device on by pressing a button (B). The processing unit then takes inputs from an optical sensor to determine when to activate an actuator such as solenoid or motor which drives the mechanical engine (non-disposable) to drive the disposable portion including the piston assembly. Such a system may then fire a droplet when it is sure that the eye is open and aligned in such a way to guarantee a successful delivery of the drop.

[0076] Fig. 26 illustrates a mechanical engine that translates a reciprocating linear motion input into the required piston actions. The ends of the piston linkages follow tracks cut in a sliding substrate in the direction indicated on each arrow. Methods well known in the art of latching mechanisms can force the cam to follow in a single direction around the track, such as by applying a step in direction orthogonal to the viewing angle at a location where there is any ambiguity about the motion as viewed from the shown viewing angle.

[0077] As tracks or raceways can be followed by cams on the piston linkages in the simple translating block of Fig. 26. Similar latch cam systems can be implemented with rotary components, with the advantage that these may inherently return to their starting point without a reverse in direction, simply by turning a full circle. Fig. 27 illustrates a system where the cylinder barrel is implemented as a toroidal section such that the pistons follow arcuate paths around a hinge center that is also the center of a torsion spring coil. The other end of each piston linkage arm ‘reads’ the interior surface relief of a cylinder cap as it is rotated. A full turn of the cap returns the cycle of piston motion to its beginning. By making the arms of the two pistons different lengths they may read independent portions of the cap interior and have arbitrarily complex independent motions. Note that it is desirable at times for the two pistons to be in contact in some phases. In such case, the motions are constrained by the piston faces in addition to the relief height of the tracks These systems have a common characteristic in that the move slowly in proportion to the driving velocity and slope of the cam tracks except for the point where the drop is ejected. At this point, the cam essentially free falls under the spring and delivers the full force of the spring to the piston and is slowed primarily by the hydraulic resistance of the drop passing through ejection port nozzle(s).

[0078] An electronically controlled implementation may directly control the pistons such as by connecting them to solenoids or stepper actuators. This could provide a great deal of customizable control to the drop volume and ejection rate but is likely cost prohibitive for most implementations.

[0079] The division of components, and inclusion of additional components, in a system depends largely on clinical and commercial needs of the product, for example as shown in Figs. 23,24 and 25.

[0080] In a preferred implementation the described pump system is combined as the primary capping system to a multidose preservative free reservoir for distribution. In this case the molding for the cap may include a means to equalize air pressure in the reservoir to replace ejected drops with a filtered air system such as is common on existing preservative free multidose vertical eyedrop packages. This drop reservoir for distribution may be used as a disposable module within a reusable electronic dispenser system. The pistons, and barrel and ejections port are included in the cap, as they are required to maintain a seal, and should be regularly replaced at the same time as the reservoir of drug. [0081] All or part of the motion engine to drive the pistons may be separated to the reusable component. This potentially reduces cost without sacrificing cleanliness of the critical drug pathway. On the other hand, a greater portion of the motion engine may be included in the disposable component to allow for differences in the dosage and force delivery without requiring modifications to the reusable component. For example, the electronic system may provide a mechanical interface to provide a linear drive for a mechanical system such as shown in Fig. 26. For different drugs, the tracks may be adjusted to provide for a different drop volume, and the spring forces may be adjusted to provide an ejection force tuned to the viscosity of the drug formulation. It is possible to achieve a similar change in drop volume without changing the stroke length of the pistons by changing the diameter of the pistons and barrel. Such a change in piston diameter would require a change in force on the pistons to achieve the same pressure within the drop. This might be achieved by modifying the size or type of spring in Fig. 26. By packaging these changed components with the drop reservoir, this change is inherent to the formulation and does not depend on the reusable component.

[0082] Alternatively, the reusable component may contain the entire motion control engine. A modular approach where a generic reusable device is modified by adjustment with reusable motion engine adapter tuned for specific prescribed formulations is also possible.

[0083] In a system including an electronic firing mechanism, the processor may enforce the firing of drops away from the eye prior to use, to ensure the device is properly primed for use, such as at the beginning of a bottle or if some time threshold has passed since last use. This may help clear away contamination on the outside of the applicator tip. Likewise, such a system may ensure that the device has received an appropriate shaking acceleration to dislodge a droplet.

[0084] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means/options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and/or any suitable material or combinations of materials. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified--a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof. [0085] Other aspects, objects, and advantages may be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

I claim:

1 . A method for delivery fluid to an eye of a user, the method comprising: manipulating first and second pistons into a rest position in which first and second piston heads of the first and second pistons, respectively, contact one another, an ejection volume of an ejection chamber being substantially zero when the first and second piston heads contact one another, the ejection chamber being at least partially defined by the first and second piston heads; manipulating the first and second pistons into a filling position from the rest position, the first and second heads being spaced from one another and the ejection volume being a predetermined ejection volume when the first and second pistons are in the filling position, fluid being drawn into the ejection volume of the ejection chamber as the first and second pistons are manipulated into the filling position; manipulating the first and second pistons into a loaded position from the filling position, the ejection chamber being aligned with an ejection port when the first and second pistons are in the loaded position; and manipulating the first and second pistons into an ejecting position from the loaded position, the fluid from the ejecting chamber being urged out through the ejection port in response to at least one of the first and second pistons moving toward the other of first and second pistons as the first and second positions are manipulated into the ejecting position.

2. The method of claim 1 , further comprising manipulating the first and second pistons into the rest position from the ejecting position.

3. The device of claim 1 , wherein the fluid is a preservative-free fluid.

4. A fluid delivery device configured to carry out the method of claim 1.

5. A fluid delivery device for delivering fluid to an eye of a user, the device comprising: a container defining an inner container chamber in which the fluid is accommodated; and an applicator having an ejection tube defining an inner ejection passage, an input port in fluid communication with the ejection passage, and an ejection port in fluid communication with the ejection passage, the fluid from the container chamber selectively flowing into the ejection tube via the input port, a first piston extending into a first end of the ejection tube, and a second piston extending into an opposite second end of the ejection tube such that first and second piston heads of the first and second pistons, respectively, are located in the ejection passage adjacent one another, the first and second piston heads selectively defining an ejection chamber therebetween in the ejection passage of the ejection tube, the first and second pistons being selectively manipulable relative to one another and to the ejection tube to selectively urge the fluid into the ejection chamber from the container chamber and selectively urge the fluid out from the ejection chamber through the ejection port.

6. The device of claim 5, wherein the applicator defines the container and the inner container chamber.

7. The device of claim 5, wherein the container is separate from and selectively received in the applicator, the container having exit port through which fluid selectively exits the inner container chamber.

8. The device of claim 7, wherein the input port faces in a longitudinal direction and the ejection port faces in a transverse direction, the exit port being longitudinally adjacent to the input port when the container is received in the receiving portion.

9. The device of claim 5, wherein the fluid is a preservative-free fluid.

10. A method for delivery fluid to an eye of a user, the method comprising: providing the device of claim 5; manipulating the first and second pistons into a rest position in which the first and second piston heads of the first and second pistons, respectively, contact one another, an ejection volume of the ejection chamber being substantially zero when the first and second piston heads contact one another; manipulating the first and second pistons into a filling position from the rest position, the first and second heads being spaced from one another and the ejection volume being a predetermined ejection volume when the first and second pistons are in the filling position, the fluid being drawn from the container chamber into the ejection volume of the ejection chamber as the first and second pistons are manipulated into the filling position; manipulating the first and second pistons into a loaded position from the filling position, the ejection chamber being aligned with the ejection port when the first and second pistons are in the loaded position; and manipulating the first and second pistons into an ejecting position from the loaded position, the fluid from the ejecting chamber being urged out through the ejection port in response to at least one of the first and second pistons moving toward the other of first and second pistons as the first and second positions are manipulated into the ejecting position.

11 . The method of claim 10, further comprising manipulating the first and second pistons into the rest position from the ejecting position.