WO2017011361A1

WO2017011361A1 - Collapsible liquid irrigation container

Info

Publication number: WO2017011361A1
Application number: PCT/US2016/041669
Authority: WO
Inventors: Brian M. MILLER
Original assignee: Miller Brian M
Priority date: 2015-07-10
Filing date: 2016-07-09
Publication date: 2017-01-19

Abstract

A disposable, collapsible, squeeze-dispensing container (1) carrying a preloaded amount of a nasal irrigation solution (17) and having a bottom-supplied feed tube (24) connected to a spout (10) adapted to form a seal against a user's nostril and inject solution through the spout while the container is being squeezed in a substantially upright orientation. The spout can be shaped and fitted with a resiliently compressible material band to comfortably seal against the tissues surrounding a user's nostril. A locking mechanism can prevent resealing an opened container.

Description

Collapsible liquid irrigation container

Prior Application

This application claims the benefit of U.S. Provisional Patent Application Serial No. 62191005, filed 2015-07-10, incorporated herein by reference.

Field of the Invention

The invention relates to collapsible, disposable liquid containers and accessories, and more specifically to containers used to dispense irrigating liquids to the body.

Background

A vessel containing a lukewarm saline solution has been used for rinsing a person's nasal cavities. Such vessels particularly adapted to that function are often called neti pots. Cacka et al., U.S. Patent No. 8486029, incorporated herein by reference, describes a device in which the user can heat the irrigation solution and readily grasp the vessel to tilt it to facilitate a flow of solution into a nostril.

These devices can be difficult to properly orient to the user's nostril and can require significant skill to properly regulate the flow. In addition, such vessels are often intended to be reused and thus should be kept properly clean to avoid the growth of harmful bacteria or other potentially harmful microbes. Sometimes, users are required to prepare their own solution, for example, by mixing proper proportion of table salt and water. It can be difficult to properly measure the amounts necessary for a proper amount of solution. Lastly, because gravity is primarily responsible for determining the flow of liquid from the vessel, it can be difficult to easily control that flow depending on the amount of liquid remaining in the vessel.

Similarly, it is useful to discourage reuse of containers intended to be disposable in order to avoid exposure to potentially harmful microbes.

A brief discussion of the paranasal sinus physiology can be useful. As disclosed in Becker, U.S. Patent No. 8317816, incorporated herein by reference, the mucosa of the nasal cavity and paranasal sinuses contains secretory elements (mucosal glands and goblet cells) and a dense ciliary layer. The secretory cells can produce a large volume of mucus that is normally actively transported by the cilia from the sinus through the opening between the sinus and the nasal cavity (sinus ostium). The mucus typically carries cellular debris and bacteria from the sinus cavity through the ostium into the nose. Inflammation of the sinus and nasal mucosa can cause hyperemia, lymphatic swelling, stasis in the blood and lymphatic pathways, which can lead to increased secretion of mucus and reduced mucociliary transport. The inflammation may be caused by allergies, noxious agents, nasal polyps, and other factors. Over time there is often a pathologic increase in inflammatory cells, ground substance, and fibers with a permanent disruption of mucociliary transport and lymphatic drainage. An obstruction of the narrow ducts and ostia between the paranasal sinuses and nasal cavity can develop, resulting in a vicious cycle of increased secretions, edema, and ultimately organized connective tissue and mucosal hyperplasia. Bacteria are not cleared from the sinuses and multiply in the fertile inflammatory environment worsening the chronic sinus inflammation (sinusitis). Treatment with antibiotics, corticosteroids in nasal sprays or systemically, and antihistamines may result in resolution of sinusitis.

Regular rinsing of the sinuses and nasal cavity can help treat the above problems.

Sterile rinses are often performed to clean and treat other body parts such as eyes, and to flush and treat wounds.

Collapsible, disposable prefilled drinking bottles such as Capri Sun brand fruit drinks, available from Kraft Food Group, Inc. of Northfield, Illinois have been commercially available for many years.

Therefore there is a need for a liquid irrigation container which addresses some or all of the above identified inadequacies.

Summary

The principal and secondary objects of the utilitarian aspects of the invention are to provide an improved vessel for performing irrigation of body parts. These and other objects are achieved by a disposable, collapsible, squeeze-dispensing container carrying a preloaded amount of irrigation solution and having a bottom supply tube connected to spout that can eject solution through the spout while the container is in various orientations including a substantially upright orientation.

The original text of the original claims is incorporated herein by reference as describing features in some embodiments.

In some embodiments the spout is adapted to form a seal against a user's nostril.

In some embodiments there is provided a disposable nasal irrigation device comprises: an oblong collapsible container carrying an amount of a liquid irrigation solution in an internal chamber; said container having a proximal closed end and a distal dispensing end; an openable spout structure sealing said dispensing end and including a nozzle having an outlet port; an oblong feed tube having an inlet port proximate said closed end and open to said internal chamber; and, a passageway extending from said inlet port to said outlet port; whereby squeezing said container while said container is in a dispensing-end-upward orientation creates an overpressure of said liquid irrigation solution within said internal chamber causing a flow of said liquid irrigation solution into said inlet, through said passageway, and out of said outlet.

In some embodiments said spout structure further comprises said nozzle having an outer surface surrounding said outlet port.

In some embodiments said outer surface is shaped and dimensioned to intimately contact and comfortably form a seal against a nostril of a user.

In some embodiments said outer surface is outwardly convex.

In some embodiments said outer surface is outwardly concave.

In some embodiments said device further comprises a band of resiliently compressible material supporting said outer surface.

In some embodiments said nozzle is moveable from a closed position in which flow is prevented, and an open position in which flow is permitted.

In some embodiments said device further comprises a locking mechanism preventing closure of said nozzle when said nozzle is in said open position.

In some embodiments said locking structure comprises a snap ring biased to engage a slot on a surface of said spout when said nozzle is moved into an open position.

In some embodiments said spout structure is opened by rotating said nozzle in a first direction; and wherein said locking structure comprises a ratchet mechanism limiting rotation in a direction opposite said first direction.

In some embodiments said tube comprises a substantially cylindrical sidewall and wherein said inlet port comprises a bottom orifice and at least one radial hole through said sidewall proximate said bottom orifice, whereby liquid from said chamber can enter said inlet port while said bottom orifice is blocked and said radial orifice is open.

In some embodiments said device further comprises a gasket made from a resiliently compressible material surrounding said bottom orifice.

In some embodiments said distal dispensing end is located opposite said closed end.

In some embodiments said nozzle is removably fastened to said spout along a threaded refill opening. In some embodiments said liquid irrigation solution comprises a pre-filled amount of saline solution.

In some embodiments said liquid irrigation solution further comprises a chemical component selected from the group consisting of an antimicrobial agent, a preservative agent, an anti-inflammatory agent, an analgesic agent, and a pharmaceutical agent.

In some embodiments said device further comprises a protective cap removeably covering said nozzle.

In some embodiments said protective cap is retained by a frangible retaining ring.

In some embodiments there is provided a method for rinsing the nasal cavity of a user, said method comprises: selecting a collapsible container preloaded with a liquid irrigation solution; inserting a nozzle having an opening to the solution into a nostril of the user; sealing a surface surrounding said opening to the skin surrounding said nostril; and, squeezing the container while keeping the container in an upright orientation; thereby injecting said solution into the nasal cavity of the user.

Brief Description of the Drawings

FIG. 1 is a diagrammatic, cross-sectional, front view of a filled, collapsible, disposable nasal irrigation container according to an exemplary embodiment of the invention.

FIG. 2 is a side view thereof.

FIG. 3 is a diagrammatic cross-sectional side view of a spout structure having a flexible nostril-engaging skirt according to an alternate exemplary embodiment of the invention.

FIG. 4 is a diagrammatic cross-sectional side view of a spout structure having a resilient band surrounding a dispensing outlet according to an alternate exemplary embodiment of the invention.

FIG. 5 is a diagrammatic top view of a spout structure having a resilient concave outer surface surrounding a dispensing outlet according to an alternate exemplary embodiment of the invention.

FIG. 6 is a diagrammatic partial cross-sectional side view of the spout structure of Fig.

5.

FIG. 7 is a diagrammatic cross-sectional side view of a spout structure having a threadedly removable stem portion according to an alternate exemplary embodiment of the invention. FIG. 8 is a diagrammatic cross-sectional side view of a spout structure having a locking mechanism in a pre-opened position according to an alternate exemplary embodiment of the invention.

FIG. 9 is a diagrammatic cross-sectional side view of the spout structure of Fig. 8 in its open position.

FIG. 10 is a diagrammatic cross-sectional side view of a spout structure having a twisting opening nozzle and locking mechanism according to an alternate exemplary

embodiment of the invention.

FIG. 11 is a diagrammatic cross-sectional top view of the spout structure of Fig. 10 taken along line 11-11.

FIG. 12 is a diagrammatic cross-sectional side view of a collapsible container having a feed tube inlet adapted to accept flow when its bottom orifice is blocked according to an alternate exemplary embodiment of the invention.

Description of the Exemplary Embodiments

Referring now to the drawing, there is shown in Figs. 1-2 a handheld, collapsible, squeeze-dispensing, disposable liquid irrigation container 1 having a base 12 at a bottom, closed end 9 and an opposite a top, dispensing end 10. The container 1 includes a pair of

commensurately shaped panels 2,3 of a durable, flexible, hermetic sheet material such as a plastic laminate of sheets of polyethylene terephthalate (PET), nylon, and polypropylene (PP). Each panel has a pair of opposite lateral side edges 5,6 which, as they extend upwardly, both gently curve inwardly toward a central vertical axis 4 to form a generally stylized, bullet-shaped border which is substantially symmetric with respect to a center plane containing the central vertical axis. Each panel further includes a substantially fiat, horizontal bottom edge 7 and an opposite, top crowning apical edge or simply apex 8. The shape is further selected so that the widest lateral dimension occurs proximate the bottom edge, which facilitates a bottom inwardly convex vaulted panel or diaphragm 13 which at its center is substantially perpendicular to the central vertical axis. The diaphragm pushes the medial part 14 of the bottom edge of each panel outwardly away from the opposing panel to form the base 12 for supporting the container on a hard flat surface, such as a tabletop, in a dispensing-end-upward orientation.

The panels are bonded face-to-face along a peripheral hermetic seam 15 to form an inner chamber 16 for holding the irrigation liquid contents 17 until the liquid is dispensed. The container can be sold containing a preloaded amount specialized irrigation liquid such as a sterile saline solution for enhanced convenience to the consumer. The seam separates to seal against a spout structure 20 located at the dispensing, top end of the container at the apex 8. The spout structure can include a substantially eye-shaped flange 27, an axial stem 21 carrying an axial lumen 23 leading to a distal outlet 22 and having outer threads 27 for carrying a removable outlet-sealing screw cap 19. Although a screw cap is shown, other means known in the art can be used to releasably open and close the spout such as a pop-up spout shown in Figs. 8-9.

The stem 21 of the spout structure 20 includes an outlet 22 for dispensing a flow of the liquid therethrough. The outlet can have a diameter D of at least 0.6 centimeter (0.25 inch) in order to accommodate a larger volume of liquid at a slower velocity to more comfortably and effectively deliver the solution to the user. A substantially cylindrical central axial lumen 23 extends from the distal dispensing outlet through the stem of the spout and into an elongated feed tube 24 terminating an inlet 25 located at the proximal end 26 of the tube. The lumen forms a fluid connection from the inner chamber 16 with the outside of the container, and thus the user's nose when in use. The proximal end 26 of the tube can have a spacing S apart from the inner surface of the diaphragm 13 so that an adequate gap is formed allowing liquid from the inner chamber into the inlet. Thus, the lumen is in fluid communication between the inner chamber and the outside of the container. The spout structure has a generally eye-shaped outer flange 27 which provides for a more durable hermetic seal to each panel 2,3 along the apex 8 by providing gradual transitions to the panel seam 15. In this way, the outlet can form the only exit path for over-pressurized liquid in the container. The feed tube 24 is shown as an integral extension of the proximal end of the spout structure 20, however, the tube can be a separately manufactured component that is bonded to the spout structure directly or through one or more intermediate structures.

The spout structure 20 further includes a nostril-engaging tip 28 having an outer surface 29 shaped and dimensioned to intimately and substantially sealingly close a single nostril of a user. By sealing against only one nostril, the other nostril is left open to allow drainage of the liquid after it has irrigated the nasal passages. As shown in Fig. 1, the outer surface 29 of the tip can be convex and completely surround the outlet 22 of the lumen 23 thus spacing the outlet radially away from the nostril walls thereby enhancing the flow of liquid during irrigation. The tip can be sized so that when it is pushed lightly against the nostril, the seal is capable of withstanding pressures of the injected liquid without substantial leaking.

As shown in Fig. 3 an alternate embodiment of the spout structure provides a dispensing tip 38 including an outer contact surface 39 formed upon a resiliently cantilevered skirt 31 extending radially outwardly from the central axis 34, and is conveniently made from the same material as the rest of the tip material and so can be made form a unitary piece of injection molded plastic. The skirt is shaped and dimensioned to enhance its mechanical flexibility by having a tapered disk shape which becomes thinner towards its peripheral edge. This allows the skirt to deflect 35 (shown in dotted line) under forceful contact with the nostril, thus allowing for a resilient seal with nostrils having a larger range of sizes.

As shown in Fig. 4 an alternate embodiment of the spout structure provides a dispensing tip 48 including an outer contact surface 49 made from a band 47 of resiliently conforming material such as such as synthetic rubber, or flexible polyurethane. The band material can have a durometer of between about 30A and 70A. The band can be secured to the spout by a tongue and groove structure 45 and/or adhesive or other means known in the art. The resiliently conforming material better allows the tip to seal more comfortably against the skin surrounding the nostril in a wide range of orientations and differently shaped and sized nostrils.

As shown in Figs. 5-6 an alternate embodiment of the spout structure provides a dispensing tip 58 including an outer contact surface 59 that has a concave shape surrounding the outlet 56. The concave shape can form a more rugged, and comfortable seal against the nostril along a more radially outward zone of contact, thus accommodating a larger range of nostril sizes and avoiding the potentially uncomfortable deep insertion of the distal tip of the nozzle into the nostril. A band 57 of resiliently conforming material such as synthetic rubber such as polysiloxanes, or flexible polyurethane can form the outer contact surface. The band can be secured to the spout by adhesive or other means known in the art.

As shown in Fig. 7 an alternate embodiment of the spout structure provides a threaded opening 61 in the flange portion 62 which can be engaged by a commensurately threaded separate stem potion 63 connected at its proximal end to the feed tube 64 and having a distal nozzle 65. The threaded engagement between the flange and stem can allow for more rapid pre- filling of the container during manufacturing. Further, by disengaging the stem from the flange the container can be refilled and is therefore reusable. In this way, the nozzle is removably fastened to the flange portion by way of the threaded refill opening. Those skilled in the art of liquid containers will appreciate other means for fastening the stem to the flange such as snap fittings and adhesives.

As shown in Figs. 8-9 an alternate embodiment of the spout structure provides a locking mechanism 70 for preventing closure of the nozzle once it has been opened. The spout includes a flange portion 71 hermetically sealed to the container 72 and a separate stem portion 73 carrying a moveable nozzle portion 74. The nozzle can be moved axially along an axis 69 from a lower, pre-opened, closed position shown in Fig. 8 where the substantially circular outlet port 75 is sealed by a penetrating substantially cylindrical stopper 76, to an upper, open position shown in Fig. 9 where the stopper 76 has been disengaged from the outlet 75, allowing pressurized liquid to flow from the container through the outlet port passageway.

The locking mechanism 70 can include a radially inwardly biased snap ring 81 carried within a retaining groove 82 set into an inner surface of the nozzle 74 which retains the axial position of the ring with respect to the nozzle as it slides axially over part of the outer surface of the stem portion 73.

As shown in Fig. 9, once the nozzle has been moved to the open position, the snap ring 81 can snap radially inwardly into a slot 83 set into the outer surface of the stem portion 73. The snap ring engages both the groove and the slot simultaneously, thereby preventing further axial movement of the nozzle with respect to the stem portion, and locking it in place. The locked nozzle in the open position discourages reuse of the container.

It is important to note that the above locking mechanism reduces unwanted litter by avoiding the use of any separate pull-tabs or removed caps. In other words the container remains wholly discardable.

Figs. 10-11 show an alternate embodiment of the spout structure 100 which provides a locking mechanism 101 for preventing closure of the nozzle once it has been opened. The spout includes a threaded stem 102 supported by a flange 110 which is bonded to the container panels similarly to the embodiment of Figs. 1-2. A threaded nozzle 103 threadingly engages the commensurate threads of the stem so that the nozzle is screwingly mounted to the stem. A removeable cap 107 covers the outer surface of the nozzle portion and is removed before use. The cap can be held in place by a frangible retaining ring 108. Once the cap is removed, the nozzle can be twisted causing it to move axially distally from the stem portion along an axis 104 from a lower, pre-opened, closed position (as shown in Fig. 10) where the substantially circular outlet port 105 is sealed by a penetrating substantially cylindrical stopper structure 106, to an upper, open position (not shown) where the stopper has been disengaged from the outlet port, allowing pressurized liquid to flow from the container through the open outlet port passageway. It is important to note that the stopper structure can be formed integrally with a cylindrical adapter 112 which can be friction fitted or otherwise bonded to the feed tube 113 to allow for automated mounting of the feed tube to the spout during manufacture and allow for automated pre-filling of the container with the irrigation solution. The locking mechanism 101 can include a unidirectional rotation inhibiting structure which prevents the nozzle 103 from rotating with respect to the stem 102. Specifically, the locking mechanism can be a ratchet wherein the nozzle can carry a resiliently deflectable angled pawl 115 oriented to bear against a wall 116 extending radially from the stem. In the freely rotating direction, the pawl is resiliently pushed radially distally from the wall. In the rotation prevented direction the pawl catches upon the wall limiting further rotational movement.

Referring now to Fig. 12, the inlet 91 of the supply tube 92 can be located proximal to the bottom panel 93 of the container 94. The inlet can include a bottom orifice 99 and one or more radial holes 95 through the sidewall of the tube proximate said bottom orifice. In this way, liquid from the chamber 96 can enter the tube through one or more of the holes when the bottom orifice is blocked. Optionally, the rim 98 surrounding the bottom orifice can be covered by a gasket 97 made from resilient material to protect the bottom panel 93 from accidental puncture by the rim of the tube. Alternately, the rim can be formed to have a rounded surface.

It shall be noted that the spout can be located at the apex of the container, and the apex can be located proximate the central axis, and the lumen oriented coaxially with the axis of the container shape.

The collapsible container can be adapted to dispense an irrigating liquid having the consistency near than of liquid water which can be dispensed through the spout by the user squeezing the container to collapse and reduce the volume of the inner chamber to create an over-pressure of the liquid contents and thus force out an amount of the contents through the outlet. By adjusting the tightness of her grip, a user can more easily regulate the flow of solution into the nostril regardless of the volume of solution remaining in the container.

The liquid irrigation solution can be pre-filled in the container during manufacture. The liquid irrigation solution can be distilled water, sterile saline solution, or one of a number of other commonly used nasal rinses or their combination. The type of solution can be preselected to address various concerns resulting in a pre-filled container which the user can purchase for a specific use. For example, a container can be pre-filled with about 240 milliliters of 0.9% by weight sodium chloride solution and water, and marketed as nasal wash, an eye wash, or a wound rinse.

The liquid irrigation solution can be augmented to contain other chemical components for various purposes. For example, an 11% solution of xylitol with 0.65% saline can be used to stimulate the washing of the nasopharynx and can help diminish nasal pathogenic bacteria. Thus the addition of xylitol as a chemical component can be seen as adding a antimicrobial agent to the irrigation solution.

Other chemical components can be added to the above 240 milliliters saline in order to fulfill other functions. For example, 4.0 milligrams of disodium edetate can be added as a preservative agent. For example, 100 milligrams of DL-Menthol can be added as an analgesic and/or anti-inflammatory agent. For example, 0.5 milligram of budesonide steroid can be added as a medicinal or pharmaceutical agent.

Some complex solutions may be useful as the irrigating solution such as a topical wound management formation disclosed in Cloonan, U.S. Patent Application Publication No.

2012/0328537, incorporated herein by reference.

It shall be noted that the disclosed container is readily scalable between different volume containers such as between a 0.25 liter (8 fluid ounce) container which may be particularly adapted to a nasal rinse, and a 0.35 liter (12 fluid ounce) container which may be more useful as a wound wash.

The above described collapsible irrigation containers can be used an a method for rinsing the nasal cavity of a user. The method can be performed by first selecting a collapsible container preloaded with a liquid nasal rinse solution. The container having a nozzle having an opening to the solution in the container can be inserted into a nostril of the user. The surface of the nozzle surrounding the opening can be sealed to the skin surrounding said nostril by applying a slight axial pressure. Once sealed to the nostril, the container is squeezed while keeping the container in an upright orientation thereby ejecting the solution into the nasal cavity of the user.

While the preferred embodiments of the invention have been described, modifications can be made and other embodiments may be devised without departing from the spirit of the invention and the scope of the appended claims.

What is claimed is:

Claims

1. A disposable nasal irrigation device comprises:

an oblong collapsible container carrying an amount of a liquid irrigation solution in an internal chamber;

said container having a proximal closed end and a distal dispensing end;

an openable spout structure sealing said dispensing end and including a nozzle having an outlet port;

an oblong feed tube having an inlet port proximate said closed end and open to said internal chamber; and,

a passageway extending from said inlet port to said outlet port;

whereby squeezing said container while said container is in a dispensing-end-upward orientation creates an overpressure of said liquid irrigation solution within said internal chamber causing a flow of said liquid irrigation solution into said inlet, through said passageway, and out of said outlet.

2. The device of Claim 1, wherein said spout structure further comprises said nozzle having an outer surface surrounding said outlet port.

3. The device of Claim 2, wherein said outer surface is shaped and dimensioned to intimately contact and comfortably form a seal against a nostril of a user.

4. The device of Claim 2, wherein said outer surface is outwardly convex.

5. The device of Claim 2, wherein said outer surface is outwardly concave.

6. The device of Claim 2, which further comprises a band of resiliently compressible material supporting said outer surface.

7. The device of Claim 1, wherein said nozzle is moveable from a closed position in which flow is prevented, and an open position in which flow is permitted.

8. The device of Claim 7, which further comprises a locking mechanism preventing closure of said nozzle when said nozzle is in said open position.

9. The device of Claim 8, wherein said locking structure comprises a snap ring biased to engage a slot on a surface of said spout when said nozzle is moved into an open position.

10. The device of Claim 8, wherein said spout structure is opened by rotating said nozzle in a first direction; and wherein said locking structure comprises a ratchet mechanism limiting rotation in a direction opposite said first direction.

11. The device of Claim 1, wherein said tube comprises a substantially cylindrical sidewall and wherein said inlet port comprises a bottom orifice and at least one radial hole through said sidewall proximate said bottom orifice, whereby liquid from said chamber can enter said inlet port while said bottom orifice is blocked and said radial orifice is open.

12. The device of Claim 11, which further comprises a gasket made from a resiliency compressible material surrounding said bottom orifice.

13. The device of Claim 1, wherein said distal dispensing end is located opposite said closed end.

14. The device of Claim 1, wherein said nozzle is removably fastened to said spout along a threaded refill opening.

15. The device of Claim 1, wherein said liquid irrigation solution comprises a pre-filled amount of saline solution.

16. The device of Claim 15, wherein said liquid irrigation solution further comprises a chemical component selected from the group consisting of an antimicrobial agent, a preservative agent, an anti-inflammatory agent, an analgesic agent, and a pharmaceutical agent.

17. The device of Claim 1, which further comprises a protective cap removeably covering said nozzle.

18. The device of Claim 17, wherein said protective cap is retained by a frangible retaining ring.

19. A method for rinsing the nasal cavity of a user, said method comprises:

selecting a collapsible container preloaded with a liquid irrigation solution;

inserting a nozzle having an opening to the solution into a nostril of the user;

sealing a surface surrounding said opening to the skin surrounding said nostril; and, squeezing the container while keeping the container in an upright orientation;

thereby injecting said solution into the nasal cavity of the user.