Assembly and method for delivering small volume droplets from a squeeze bottle

Abstract

A method and assembly for attachment to a container configured to reduce the volume of a droplet of fluid extruded from the container, the assembly being securable to the container without modifying the container, and reducing the volume of the droplet on the order of microliters. The assembly (10) includes a base (20) for securing a neck (84) of a container (80), a tip (40) for securing over a dispensing outlet of the container (80), and optionally a cap (60) for securing over the tip (40) and connecting to the base (20).

Description

[Technical Field]

[0001] The present invention relates to an assembly for attachment to a container and a delivery tip for delivering droplets of fluid therefrom. More specifically, the assembly is securable to a squeeze bottle and is configured to reduce the size of droplets of fluid delivered therefrom. [Background technology]

[0002] Ophthalmic solutions, including eye drops, are supplied in multi-dose or single-dose glass and / or plastic dropper bottles that deliver drops in volumes ranging from 25 to 70 μL, with an average drop volume of approximately 40 to 50 μL. Summary of the Invention [Problem to be solved by the invention]

[0003] The precorneal tear film volume of the human eye is small, and for some medications, the optimal drop volume may be very close to approximately 10 μL or less. Therefore, a significant amount is wasted with each drop. Furthermore, if the solution is a prescription medication, excess volume will generally come into contact with the delicate skin near the eye, and the contents may irritate the area around the eye.

[0004] Many squeeze bottles typically deliver droplets of approximately 50 μL volume, much of which runs down the user's face after application, which not only uses up the container's contents more quickly but can also cause the user's makeup to run and require post-use grooming.

[0005] In the pharmaceutical industry in particular, attempts have been made to repackage medications into bottles that dispense smaller droplet sizes, however, no consumer products exist in the form of adapters or attachments to current dropper bottles. [Means for solving the problem]

[0006] One aspect of the present disclosure relates to an assembly for attachment to a container configured to reduce the volume of a droplet of fluid extruded from the container, the assembly being an aftermarket assembly that can be secured to the container without modifying the container, whereby the volume of the droplet is reduced on the microliter scale.

[0007] In one embodiment, the assembly includes a base for securing the neck of the container, a tip for securing onto the dispensing outlet of the container, and optionally a cap for securing onto the tip and connecting to the base.

[0008] The base is a ring having an opening configured to receive the tip therethrough and secure the tip around the bottom opening to the neck of the container. The tip has an internal cavity configured to fit over the dispensing outlet of the container, and the top of the tip has an outlet for extruding reduced volume droplets. The cap includes a mechanism for sealing the tip outlet to prevent leakage and contamination of the container and to prevent clogging of the outlet.

[0009] The container can be a squeeze container, and the assembly is configured to reduce the volume of the extruded droplet per squeeze to a volume of less than about 15 μL, hi one embodiment, the assembly is configured to reduce the volume of the extruded droplet per squeeze to a volume of less than about 10 μL.

[0010] In a further embodiment, the tip may be conical in shape. The tip may be constructed from a soft, resilient material such as medical grade silicone.

[0011] The base includes an inner surface for engaging the outer surface of the tip and an outer surface for engaging the inner surface of the cap to form an assembly configured to secure to the container, which may be a squeeze bottle for dispensing eye drops.

[0012] Another aspect of the present disclosure relates to a method for reducing the volume of droplets of fluid extruded from a container, the method including providing an aftermarket assembly for attachment to the container, the assembly being configured to reduce the volume of droplets of fluid extruded from the container, the assembly having an outlet through which the volume of the droplets is reduced on the microliter scale, and securing the assembly to the container around an original dispensing mechanism of the container such that the assembly covers the original dispensing mechanism of the container.

[0013] In one embodiment, securing the assembly to the container includes inserting the original dispensing mechanism of the container through an opening in the base portion of the assembly and into a cavity in the tip portion of the assembly.

[0014] In one embodiment, securing the assembly to the container includes positioning a tip portion of the assembly over an original dispensing mechanism of the container and operably securing the tip portion to the container at the base portion by coupling the base portion to or near the neck portion of the container.

[0015] Squeezing the container to force a droplet through an aperture in the tip of the assembly, the droplet having a fluid volume of about 15 μL or less. In some embodiments, first removing a cap portion of the assembly that covers the tip and seals the aperture allows for the dispense of a reduced volume droplet of fluid. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of an assembly for use with a squeeze bottle to deliver a liquid or suspension held within the bottle. [Figure 2] FIG. 1 is a side view of the assembly in use. [Figure 3] 3 is a cross-sectional view of the assembly in use taken along line BB in FIG. 2. [Figure 4] FIG. 10 is a side view of the base portion of the assembly. [Figure 5] 5 is a cross-sectional view of the base taken along line AA in FIG. 4. [Figure 6] FIG. [Figure 7] FIG. 10 is a perspective view of the distal end portion of the assembly. [Figure 8] FIG. [Figure 9] 9 is a cross-sectional view of the base taken along line AA in FIG. 8. [Figure 10] FIG. 11(10) is a cross-sectional view of the cap taken along line AA. [Figure 11] FIG. 10 is a side view of the cap portion of the assembly. [Figure 12] FIG. DETAILED DESCRIPTION OF THE INVENTION

[0017] Described herein is an assembly for attaching to a fluid container to modify the volume of fluid delivered therefrom. More specifically, the assembly is connectable to a fluid container and configured to reduce the volume of droplets extruded from the fluid container. The assembly reduces the volume of droplets extruded from the container without requiring modification of the container, e.g., the assembly fits onto the container as an aftermarket attachment. No part of the container needs to be modified or removed in order for the assembly to be attached to the container and reduce the volume of droplets therefrom. The assembly fits onto or otherwise connects to the container as manufactured.

[0018] The assembly is configured to attach to a container having elastically deformable walls, such as a plastic squeeze bottle. Containers configured to dispense droplets of fluids, including suspensions such as eye drops, and other squeeze-type dropper bottles, are within the scope of this disclosure. The assembly is configured to deliver a controlled, reduced droplet size (by volume) of fluid, such as medicated, prescription, or non-prescription ophthalmic fluids, including eye drops, when the assembly is placed on the container and the container is squeezed. The terms "bottle" and "container" are used interchangeably throughout this disclosure.

[0019] The assemblies described herein can be provided to consumers who use medications dispensed from squeeze dropper bottles or containers, such as medicated and non-medicated eye drops. That is, the assemblies can be aftermarket attachments to the bottles. In one embodiment, the assemblies can be configured to fit over an existing dispensing mechanism or dispensing tip, such as a nozzle, of a container so that the dispensing mechanism or nozzle is not removed when the assembly is installed. Thus, the assemblies can work with existing delivery mechanisms to deliver droplets having microliter-scale volumes. Adapting the mechanism without removing the existing delivery mechanism reduces the possibility of contamination or desterilization of the container contents, eliminates the need to modify the original container, and improves the ease of use of the assemblies with a variety of existing containers.

[0020] An assembly for securing to an elastic container, such as a squeeze bottle, is shown generally at 10 in FIGS. 1-3. Assembly 10 is configured to deliver controlled droplet volumes from the container on the microliter scale. Assembly 10 delivers droplets of a substantially consistent volume from the container. Assembly 10 is configured for aftermarket consumer attachment to the container.

[0021] Referring generally to the drawings, assembly 10 includes base 20, tip 40, and cap 60. As shown in FIGS. 1-3, assembly 10 can be secured to container 80 without removing nozzle 82 or other dispensing mechanisms of container 80.

[0022] As shown in FIGS. 4-6 , the base 20 has a first end 22 configured to attach to the container 80 and a second end 24 configured to engage the tip 40 to secure the tip 40 to the container 80 and to engage the cap 60 to retain the cap 60. In the illustrated embodiment, the base 20 is a ring for engaging the container 80 at or near the neck 84 of the container or at the junction of the reservoir and dispensing tip 82 of the container 80. The lower portion 22 of the base engages the container 80. For example, the inner surface 26 of the lower portion 22 of the ring may have internal threads for securing the base 20 to the container 80. It is also contemplated that the base 20 may have other features for frictionally engaging or otherwise securing the base 20 to the container at or near the neck 84 or near the base of the dispensing tip 82 of the container 80. The base 20 may have various internal dimensions to enable the base 20 to connect with various standard eye drop delivery bottles 80, etc. The exterior surface 28 of the base 20 may have a perimeter shape that allows the base to be easily gripped during installation and removal of the assembly 10 .

[0023] The second end 24 of the base 20 has an inner surface 30 configured to engage with the inlet portion 44 of the tip 40 to secure the tip 40 to the base 20. The second end 24 also has an outer surface 32 configured to mate with the inner surface of the cap 60 to secure the cap 60 over the tip 40 and to the base 20. For example, the inner surface 30 may be a ledge that fits over a portion of the tip 40 to hold the tip 40 when the assembly 10 is installed in the container 80. The dimensions of the second end 24 at or near the inner surface 30 may provide an opening 31 having dimensions smaller than the dimensions of the lower end 48 of the tip 40 to securely hold the tip 40 therein. The outer surface 32 may also be a ledge or other surface configured to mate with or bond to a corresponding surface on the cap 60 to hold the cap 60 in place on the base 20.

[0024] For example, the exterior surface of base 20 may have one or more exterior dimensions that decrease in size, such as first end 22 being larger than third intermediate portion 23 which is larger than second end 24. Internally, base 20 dimensions include an opening 31 that is larger than opening 33 in base 20. Tip 40 is secured at its base at least partially inside opening 31, which also receives neck 84 of container 80. Tip 40 extends into or through opening 33, as does delivery mechanism 82, depending on the size and style of delivery mechanism 82.

[0025] The tip is a flexible member having an internal cavity for receiving a dispensing mechanism with a container therein. There may be minimal open space in the internal cavity between the inner surface of the tip and the container's dispensing mechanism. The tip is generally constructed of a flexible, resilient material, allowing the tip to fit over the dispensing mechanism of various containers and to reduce the volume of droplets extruded from the container through the tip outlet.

[0026] More specifically, as shown in Figures 7-9, tip 40 has an interior cavity 42 configured to fit over dispensing mechanism 82 of container 80. It is also contemplated that tip 40 can function in substantially the same manner as described herein with containers having one of a variety of nozzle, tip, or dispensing mechanism styles, and can be adapted for use with containers of various outlet sizes. Tip 40 is a strong, yet flexible tip 40 that fits over and covers dispensing mechanism 82.

[0027] The tip 40 is a unitary hollow structure having an inlet end 44 and an outlet end 46. The inlet end 44 is configured to secure to the container 80 and has sufficient dimensions to allow the inlet end 44 to receive a dispensing mechanism, tip, or nozzle 82 on the container 80 within the cavity 42. The inlet end 44 may have a lip 48 or other peripheral ring that extends outward from an opening 50 in the inlet end 44 and engages the base 20. The inlet end 42 is positionable at or near the base of the dispensing mechanism 82 on the container 80 and is held in place by the lip 48 engaging the inner surface 30 of the upper portion 24 of the base 20. For example, the inner surface 30 may be a shelf that rests or provides downward pressure on the upper surface of the lip 48, compressing the lip 48 between the base 20 and the surface of the container 80 to removably but securely hold the tip 40 in place upright relative to the container 80.

[0028] The outlet end 46 of the tip 40 has a tapered apex 52 having an aperture 54 (opening) substantially centered therein for dispensing micro-sized droplets of fluid from a container 80 therethrough. The aperture 54 has a smaller dimension than the opening at the inlet end 42. More specifically, fluid from the container enters the inlet side of the aperture 54 and exits the outlet side of the aperture, where the aperture 54 has a tubular or conical surface area between the inlet and outlet ends of the aperture 54. The length of this surface area corresponds to the wall thickness of the tip 40, such that the aperture 54 provides a fluid flow regulation mechanism, where the wall surface area prevents fluid from flowing freely through the aperture 54. In one embodiment, the cross-sectional dimension of the inlet side of the aperture 54 differs from the cross-sectional dimension of the outlet side of the aperture 54 to control the flow of fluid from the container 80 through the tip 40 and out of the aperture 54. For example, the outlet side of the aperture 54 may be smaller or larger than the inlet side of the aperture 54. The surface area of ​​the aperture 54 defines the drop volume by controlling the surface tension of the extruded fluid.

[0029] The tip 40 may be tapered along its height, as shown, or may be conical. The tip 40 is constructed from a durable yet flexible material, examples of which include, but are not limited to, medical-grade silicone. The tip 40 may be elongated at the inlet end 42 to fit a stock or standard-sized squeeze bottle 80, forming a seal around the neck portion 84 of the bottle 80 and minimizing dead space around the dispensing mechanism 82 of the bottle 80. The tapered or conical shape of the tip 40 from the inlet end 42 to the outlet end 44 allows for a reduction in the volume dispensed per droplet when the squeeze bottle is squeezed for fluid delivery. That is, the size of the droplets delivered per squeeze is reduced. For example, the outlet aperture 54 of the tip 40 may have an inner diameter approximately the size of a 20- to 22-gauge needle to dispense droplets therethrough with each squeeze of the bottle 80 to which the tip 40 is secured.

[0030] Tip 40 may be configured with dimensions of outlet aperture 54 sufficient to dispense droplet volumes in the range of about 5 μL to about 30 μL per droplet, more specifically in the range of about 7 μL to about 20 μL, and even more specifically in the range of about 9 μL to about 15 μL. Aperture 50 dimensions may also produce droplets per squeeze having volumes less than about 30 μL per droplet, more specifically less than about 20 μL, and even more specifically less than about 15 μL. Furthermore, tip 40 is configured to deliver droplets of consistent size (volume) when secured to container 80 by base 30.

[0031] As shown in more detail in FIGS. 10-12 , cap 60 is configured to removably secure over tip 40 and connect to base 20. Cap 60 is a hollow structure, which may be tubular or conical, and has an open lower portion 62 for fitting over tip 40 and engaging base 20. Cap 60 has a tapered interior cavity 64 such that the portion of cap 60 intended to cover tip 40 has dimensions configured to at least partially mate with and contact upper portion 46 of tip 40. An interior surface 66 of upper portion 68 of cap 60 is configured with a tip sealing feature 70, which may be a tab, plug, protrusion, film, flange, or other feature that engages with or otherwise covers, seals, or obstructs aperture 54 of tip 40 to provide a watertight seal for tip 40.

[0032] In the illustrated embodiment, the sealing mechanism 70 is a tab having exterior dimensions that match the interior dimensions of the aperture 54 so that the sealing mechanism captures and blocks the aperture 54 when the cap 60 is secured to the base 20. The cap 60 may be constructed from a plastic material, such as high-density polyester (HDPE) or other plastic or similar material. The sealing mechanism 70 may also prevent clogging of the aperture 54, as some of the fluids expelled from the container in which the assembly may be placed include suspensions and colloids, and particles, including salts, that can clog the outlet after repeated use. The sealing mechanism may also clear clogging from the aperture 54 to prevent clogging.

[0033] The top portion 68 of the cap 60 may be configured with an ergonomic exterior to provide for easy gripping and installation or removal of the cap 60 .

[0034] The lower portion 62 of the cap 60 is a peripheral ring for the cavity 64, with one or more tabs or slits 63 provided therein and spaced along the periphery of the lower portion 62. As shown, the slits 63 allow the cap 60 to couple to the outer surface 32 of the base 20 at the lower portion 62. Thus, the cap 60 is removable from the base 20.

[0035] As shown in the embodiments described herein, the assembly includes three separable components: a base 20, a tip 40, and a cap 60. The base 20, the tip 40, and the cap 60 are all removably securable to a container as an aftermarket assembly. That is, the assembly 10 can be used, and in some embodiments, reused, with various sizes and styles of squeezable containers without removing the original dispensing mechanism or nozzle of the container 80.

[0036] The assembly 10 described herein is configured to attach to a container 80. One method of operably and securely attaching or coupling the assembly to the container 80 is described below, however, alternative methods of operably and securely attaching or coupling the assembly to the container are contemplated and are within the present disclosure. Securing the assembly may include snapping or rotating the base to attach the base to the container, or otherwise frictionally engaging the assembly 10 with the container 80.

[0037] In one embodiment, a method for securing the assembly 10 to the container 80 includes connecting the tip 40 to the base 20 by inserting the tip 40 into the base 20. The lip 48 frictionally engages and is retained by the base 20. The cap 60 is then secured over the tip 40 and engaged or connected to the base 20. The base 20 is placed over the delivery mechanism 82 of the container 80, thereby also placing the tip 40 over the delivery mechanism 82. The base 20 is secured around the neck 84 of the container 80. For example, the base 20 may be rotated to tighten the base 20 around the neck 84. The cap 60 can then be removed and the container 80 squeezed to deliver a microliter-per-drop volume of contents from the container 80. The assembly 10 can be secured to an existing squeeze bottle without exposing the tip 40 and without removing or otherwise manipulating the delivery tip 82 of the container 80 prior to use. When the base 20 is secured onto or around the neck 84 of the container 80, the lip 48 of the tip 40 stretches and / or compresses around the neck 84 of the container 80 between the container 80 and the base 20 to provide a seal and an airtight connection between the assembly 10 and the container 80.

[0038] The assembly provided may include cap 60 already secured over tip 40, with lower portion 62 of cap 60 engaging base 20, thus providing a capped and sealed assembly to container 80. This prevents leakage of fluid from container 80 and prevents contamination of the contents of container 80 as well as tip 40, thus maintaining the sterility of the contents.

[0039] Cap 60 is removable and reservoir 80 is squeezable to deliver droplets through the tip having volumes in the ranges noted above, more specifically, in the range of about 9 μL to about 15 μL. Cap 60 is replaceable between uses.

[0040] In one embodiment, the base 20, tip 40, and cap 60 may also include washable components so that the assembly 10 can be removed, cleaned, and reused with the next bottle 80 of fluid.

[0041] In one embodiment, the base 20, tip 40, and cap 60 may be disposable components such that they can be removed and discarded after using the assembly 10 with a bottle 80 of fluid.

[0042] The assemblies described herein allow for a reduction in overdosing, which can cause adverse side effects ranging from mild discomfort, such as an unpleasant taste or smudging of makeup, to serious systemic effects on cardiac health, such as causing bradycardia and arrhythmia. The reduction in droplet volume to the microliter scale described herein also reduces user exposure to preservatives contained in many ophthalmic fluids for treating various conditions that are delivered via the squeeze bottles described herein.

[0043] The illustrated embodiment is a one size fits most assembly 10 for securing to a plastic dropper bottle 80. However, the assembly may similarly be installed on a variety of elastomeric containers for fluid dispensing, where the container is a squeeze or similar container, and is not limited to use in connection with eye drops or ophthalmic medications.

[0044] Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.

Claims

1. 1. An assembly configured to reduce the volume of droplets of fluid expelled from a container, the container being an eye drop delivery bottle, the assembly having a flexible, resilient tip for attachment to the container, the assembly comprising: the assembly is removably securable to the container without modifying the container; the assembly, wherein the tip has an internal cavity and a dispensing aperture therein, and is configured to reduce the volume of a droplet of fluid extruded from the container to a volume in a range of about 5 μL to about 30 μL each time the container is squeezed and passed through the assembly, such that the volume of the droplet of fluid extruded from the container is reduced on the scale of microliters; the assembly is configured to reduce droplets of fluid extruded from a nozzle tip of the container; an inner circumferential surface of the internal cavity of the tip of the assembly fits over an outer circumferential surface of a nozzle of the container; the assembly comprising: a base for fastening to the neck of the container; said tip for fixing onto the dispensing outlet of said container; a cap for securing onto the tip and connecting to the base; Including the assembly.

2. the base is a ring configured to receive the tip therethrough and secure the tip to the neck of the container around a bottom opening of the tip; The assembly of claim 1 .

3. 3. The assembly of claim 2, wherein the tip has the internal cavity configured to fit over the dispensing outlet of the container, and an upper portion of the tip has an outlet for extruding reduced volume droplets.

4. the cap includes a mechanism for sealing the outlet of the tip to prevent leakage or contamination of the container; 4. The assembly of claim 3.

5. The tip is conical. The assembly of claim 1 .

6. The tip is made of a flexible and resilient material. The assembly of claim 1 .

7. The tip is made of medical grade silicone. The assembly of claim 1 .

8. the base including an inner surface for engaging an outer surface of the tip and an outer surface for engaging an inner surface of the cap; The assembly of claim 1 .

9. the tip includes a dispensing aperture having dimensions configured to control the flow of droplets per squeeze of the container and to control the volume of droplets expelled therefrom; The assembly of claim 1 .

10. the assembly is an aftermarket assembly for securing to the container without modifying the container; The assembly of claim 1 .

11. 1. A method for reducing the volume of droplets of fluid extruded from a container, which is an eye drop delivery bottle, comprising: The method comprises: providing a multi-component assembly for removably mounting to the container over an original dispensing mechanism of the container, the multi-component assembly having an outlet configured to reduce the volume of the droplet of fluid expelled from the container, the outlet reducing the volume of the droplet on the microliter scale; securing the multi-component assembly to the container around the original dispensing mechanism of the container such that the multi-component assembly covers the original dispensing mechanism of the container; Including, the multi-component assembly includes an interconnectable base and a tip, the tip including a lip, the base removably engaging the lip to secure the tip to the container; the multi-component assembly is configured to reduce droplets of fluid extruded from a nozzle tip of the container; an inner circumferential surface of an internal cavity of the tip of the multi-component assembly fits onto an outer circumferential surface of a nozzle of the container; The method comprises: squeezing the container to force a droplet from the original dispensing mechanism of the container into an interior cavity of the tip and through an aperture in the tip of the multi-component assembly, the squeezing further comprising reducing the volume of the droplet so that the droplet has a fluid volume in the range of about 5 μL to about 30 μL. method.

12. securing the multi-component assembly to the container includes inserting the original dispensing mechanism of the container through an opening in a base portion of the multi-component assembly and into a cavity in a tip portion of the multi-component assembly; The method of claim 11.

13. and securing the multi-component assembly to the container includes placing a tip portion of the multi-component assembly over the original dispensing mechanism of the container and operably securing the tip portion to the container at the base portion by coupling a base portion to or near a neck portion of the container. The method of claim 11.

14. and further comprising first removing a cap portion of the multi-component assembly covering the tip and sealing the aperture. The method of claim 11.

15. The tip is made of silicone. The method of claim 11.

16. 1. An assembly for attachment to a container, the container being an eye drop delivery bottle, configured to reduce the volume of droplets of fluid expelled from the container, the assembly comprising: a base for fastening to the neck of the container; a flexible dispensing tip having an internal cavity and an aperture for securing onto an original nozzle of the container, the internal cavity and the aperture reducing the volume of droplets extruded from the container on the microliter scale so that the droplets have a fluid volume in the range of about 5 μL to about 30 μL when extruded through the aperture of the dispensing tip; a cap for securing onto the tip and connecting to the base; Equipped with The base is an opening configured to receive the tip and the nozzle; a surface for securing the periphery of a lip of a bottom opening of the tip against the neck of the container so that the tip is removably secured on the nozzle by the base; and and the assembly is configured to reduce droplets of fluid extruded from a nozzle tip of the container; an inner circumferential surface of the internal cavity of the dispensing tip configured to fit over an outer circumferential surface of a nozzle of the container; assembly.

17. the base, the tip, and the cap are separable components provided as the assembly; At least one of the base and the cap is made of a different material than the tip.

17. The assembly of claim 1 or claim 16.

18. 17. The assembly of claim 16, wherein the lip portion of the tip is stretched or compressed between the container and the base of the assembly to provide an airtight connection between the assembly and the container.

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