WO2010025276A1

WO2010025276A1 - Container and dispenser

Info

Publication number: WO2010025276A1
Application number: PCT/US2009/055225
Authority: WO
Inventors: Joel Ira Ivers; Jacob Griggs; Gilbert Gonzales
Original assignee: Drug Enhancement Company Of America, Llc
Priority date: 2008-08-27
Filing date: 2009-08-27
Publication date: 2010-03-04

Abstract

The invention describes containers and dispensers for delivery of a variety of compositions, as well as devices for nasal delivery of the compositions. The compositions may be useful in preventing, treating and/or reducing the risk of an infection in a subject in need thereof. In certain embodiments the composition comprises oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCl) and sodium chloride (NaCl).

Description

CONTAINER AND DISPENSER

FIELD OF THE INVENTION

The invention relates to the Held of containers and dispensers for a variety of compositions.

BACKGROUND OF THE INVENTION

All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

There are countless pharmaceuticals, medicants and other agents that are or may be used by consumers, patients, physicians, heath care workers, paramedics, first responders, military personnel and emergency workers. A variety of storage systems are available in the art for these agents, and may be used by an individual to transport and/or administer a small quantity of the agent. For instance, a small bottle with a pump sprayer and cap might be used to transport a volume of a therapeutic agent that can be sprayed in a person^'s mouth. Devices for the nasal delivery of pharmaceuticals, medicants and other agents are available in the art. and tend to include a single spray nozzle outlet generally oriented to dispense its contents upward into the nostril of a user. The pharmaceutical, medicant or other agent thereby travels into the nasal cavity and/or pharynx (or back of the throat) where it is absorbed. Various ailments exist that benefit from the application of a pharmaceutical, medicant or other agent to the nostril itself (i.e.. the "nose-picking zone"). One such ailment is a Staphylococcus aureus infection, such as with Methicϋlin-resistant Staphylococcus aureus (''MRSA^"). in the nose. The aforementioned delivery devices are suboptimal -- and indeed, may be wholly ineffectual — in treating such ailments.

Selection of a storage system for a particular agent may be based on a variety of factors, such as the durability, cost, ease of manufacturing or functionality of the storage system. However, the chemical properties of the agent and the relationship of those properties to the storage system must also be considered. So, too. must one consider the setting in which the storage svslem will be utilized.

Some agents can be stored in any number of storage sy stems, because their chemical properties are such that the agents do not substantially degrade within, permeate through, react with or otherwise experience deleterious effects as a result of the storage system; or. more particularly, as a result of a chemical interaction with the materials used to construct the storage system. Other agents are more discriminating. They might become altered, seep out of. interact with or otherwise be affected by the storage system material in such a manner that the agents lose their medicinal efficacy or the like. Thus, particularly in connection with pharmaceutical and medicinal agents, care must be exercised in selecting an appropriate storage system and materials to construct the same.

Regarding the setting in which a storage system may be used, it might not be desirable to use, for example, a storage system constructed of a material that is easily breakable when the system is to be carried by an emergency worker in the field. There, the performance of even routine tasks may compromise the integrity of the storage system. It might become inoperative or shatter and spill its contents.

Storage and delivery systems currently available in the art that enable individuals to conveniently transport small quantities of pharmaceuticals, medicants and other agents are frequently constructed from plastic, rubber and/or similar materials. However, as described above, many agents cannot be stored in such containers without losing efficacy or experiencing other undesirable effects. Moreover, the environment in which such storage and delivery systems may be used necessitates, in some cases, the use of a system that can withstand the exertion of anything from minor jostling to severe blunt force.

There is therefore a need in the art for a storage and delivery system that overcomes the aforementioned challenges.

SUMMARY OF THE INVENTION Embodiments of the present invention provide for an apparatus, comprising: a unitary assembly to contain an agent: and a dispenser assembly to dispense the agent from the unitary assembly, the dispenser assembly mechanically affixed to the unitary assembly, and the dispenser assembly including elements that come into contact with the agent irrespective of actuation, wherein the unitary assembly and the elements that come into contact with the agent irrespective of actuation consist essentially of materials that are inert or non-reactive with the agent. In certain embodiments, the unitary assembU comprises a vial nonremovably affixed within a barrel. hi one embodiment, the apparatus may further comprise a closed base, an open lop and dn external screw threading surrounding the open top to enable the mechanical interaction of the unitary assembly with a corresponding internal screw threading on the dispenser assembly, fn another embodiment, the apparatus may further comprise a washer between the open top and the dispenser assembly.

In another embodiment, the apparatus may further comprise a cap configured with a receiving element configured to mechanically interact with a locking element on the exterior surface of the unitary assembly to keep the cap and the unitary assembly affixed to one another until the cap is removed from the unitary assembly by a user. In certain embodiments, the cap may further comprise a tab configured with a locking element and a receiving element configured to allow the user to remove the cap from the unitary assembly by dislodging the locking element from the receiving element, ϊn one embodiment, the tab may comprise a forward portion affixed to one side of the cap, a rear portion configured to receive a mechanical force from the user to separate the cap from the unitary assembly, and an intermediate portion therebetween, ϊn a particular embodiment, an angle between the forward portion and the axis of the cap may be from about 0° to about 10°, an angle between the intermediate portion and the axis of the cap may be from about 45° to about 55°. and an angle between the rear portion and the axis of the cap may be from about 0° to about 8°. In another embodiment, the rear portion of the tab comprises a surface configured to receive a finger of the user, wherein a generally radial force of which upon the surface is capable of dislodging the cap from the unitary assembly. In one embodiment, the dispenser assembly may be a pump sprayer configured with a spray head, a plunger, a spring, a ball and a hole. In another embodiment, the dispenser assembly may be a pump sprayer configured with an insert portion configured to extend axially from the portion of the pump sprayer that remains external to the vial, into the interior of the vial where the agent is contained. In certain embodiments, the unitary assembly and the insert portion may each be constructed of a material selected from the group consisting of plastic, metal, stainless steel. glass, polytetrafluoroethylene (PTFE), perfJuoroalkoxy (PFA), chemically-modified PTFE, aluminum, polyetherehterketone (PEEK), fluorinated ethylene propylene (FHP), fluoro- treated high-density polyethylene (HDPE), and combinations thereof. In another embodiment, the apparatus may further comprise a quantity of the agent.

In one embodiment, the agent may comprise about 99,99% oxidized water, sodium hypochlorite (NaOCl). hypochlorous acid (HOCl) and sodium chloride (NaCl).

Embodiments of the present invention also provide for a device for nasal deliv er) of a composition, comprising: a vial, and a dispenser assembly comprising a head, wherein the head includes one or more spray noz/les configured to dispense the composition within the nose of a user. In certain embodiments, the device may comprise a barrel, within which the vial and dispenser assembly are fitted. In some embodiments, the barrel may further comprise a series of flanges to retain the vial within the barrel. In other embodiments, the vial and the barrel may exist as a unitary assembly wherein the vial is nonrcmovably affixed within the barrel.

In various embodiments, the spray head may be generally contoured in shape suitable for partial insertion into a nostril of a user, In other embodiments, the spray head may be further configured with a generally disk-shaped lower edge to prevent the spray head from being inserted too far in the nostril. In particular embodiments, the lower edge may extend to form a lower lip.

In one embodiment the device may further comprise a closed base, an open top and an external screw threading surrounding the open top to enable the mechanical interaction of the vial with a corresponding internal screw threading on the dispenser assembly. In another embodiment, the device may further comprise a washer between the open top and the dispenser assembly.

In another embodiment, the device may further comprise a cap with a receiving element configured to mechanically interact with a locking element on the exterior surface of the barrel to keep the cap and the barrel affixed to one another until the cap is removed from the barrel by the user. In some embodiments, the cap may further comprise a tab configured with a locking element and a receiving element configured to allow the user to easily remove the cap from the barrel by dislodging the locking element from the receiving element.

In certain embodiments, the tab may comprise a forward portion affixed to one side of the cap. a rear portion configured to receive a mechanical force from the user to separate the cap from the unitary assembly, and an intermediate portion therebetween. In various embodiments, an angle between the forward portion and the axis of the cap may be from about 0° to about 10°. an angle between the intermediate portion and the axis of the cap may be from about 45° to about 55°, and an angle between the rear portion and the axis of the cap may be from about 0° to about 8°. In certain embodiments, the rear portion of the tab may comprise a surface configured to receive a finger of the user, wherein a generally radial force of which upon the surface is capable of dislodging the cap from the unitary assembh .

In various embodiments the dispenser assembly may be a pump spraver configured with a spra> head, a plunger, a spring, a bail and a hole. In other embodiments, the dispenser assembly may be a pump sprayer configured with an insert portion configured to extend axially from the portion of the pump sprayer that remains external to the vial, into the interior of the vial where the agent is contained.

In various embodiments, the via! and the insert portion may each be constructed of a material selected from the group consisting of plastic, metal, stainless steel, glass, polytetrafluoroethylene (PTFE). perflυoroalkoxy (PFA). chemically-modified PTFE. aluminum, polyetherehterketone (PEEK), fluorinated ethylene propylene (FEP), fluoro- treated high-density polyethylene (HDPE). and combinations thereof.

In certain embodiments, the device may further comprise a quantity of a composition effective in mitigating the effects of pathogens. In some embodiments, the composition may comprise about 99.99% oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCl) and sodium chloride (NaCl).

In other embodiments, the vial and dispenser assembly may form a squeeze-type spray bottle configured to allow a user to exert pressure on the vial to spray the composition into the nostril.

The invention also provides for a method of preventing, treating and/or reducing the risk of an infection in a subject in need thereof, comprising: providing an apparatus of the present invention; and dispensing an agent onto a surface of the subject to prevent, treat and/or reduce the risk of the infection. The invention also provides for a method of preventing, treating and/or reducing the risk of an infection in a subject in need thereof, comprising: providing a device of the present invention; and dispensing a composition into an inner surface of a nostril to prevent, treat and/or reduce the risk of the infection.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

Figure 1 depicts a perspective view of a vial and dispenser assembly in accordance with an embodiment of the present invention.

Figure 2 depicts an exploded, perspective view of the vial and dispenser assembly shown in Figure 1 , in accordance with an embodiment of the present invention.

Figure 3 depicts a cross-sectional of the vial and dispenser assembly shown in Figure 1. in accordance with an embodiment of the present invention. Figure 4 depicts a perspective view of the vial and dispenser assembly shown in Figure 1 in combination with a barrel and cap (the cap is in the open position), in accordance with an embodiment of the present invention.

Figure 5 depicts an exploded, perspective view of the via! and dispenser assembly with the barrel and cap shown in Figure 4. in accordance with an embodiment of the present invention.

Figure 6 depicts a cross-sectional view of the via! and dispenser assembly with the barrel and cap (the cap is in the closed position) shown in Figure 4. in accordance with an embodiment of the present invention, Figure 7 depicts a top perspective view of a barrel, in accordance with an embodiment of the present invention.

Figure 8 depicts a bottom perspective view of a cap, in accordance with an embodiment of the present invention.

Figure 9 depicts a perspective view of a vial and dispenser assembly in accordance with an embodiment of the present invention.

Figure 10 depicts a perspective view of the vial and dispenser assembly shown in Figure 9 in combination with a barrel, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described.

The invention relates to a container and dispenser for a composition. The invention also relates to a container and nasal dispenser for the composition. The composition may be a medicant. pharmaceutical product, cosmetic or personal care product (e g , perfume, repellant, deodorant, antiperspirant, hairspray, sunscreen), household product, cleaner or any liquid, solution, dispersion, gel or other fluid for which it might be beneficial to contain within and/or dispense with a device with components that are substantially inert or non- reactive therewith. Λs such, those of skill in the art will recognize numerous fluids that may be used in connection with alternate embodiments of the present invention. Λs used herein, the term "agent" is meant to include any of the aforementioned items, and in various embodiments of the present invention, all or substantially all of the components of the container or dispenser that are in contact with the agent are constructed of an inert or otherwise non-reaclive material, with respect Io the agent. In various embodiments, the container and dispenser, or the container and nasal dispenseR may be useful for dispensing an agent to prevent, treat, and/or reduce the chance of experiencing a harmful effect from exposure to a pathogen. "'Pathogen^'' as used herein refers to a microorganism that causes a harmful effect on a mammal. Examples of pathogens include, but are not limited to, bacteria, viruses, fungi, archaea, protists (e.g.. Cryptosporidium parvum), protozoas (e.g., Kinetoplastids, Apicomplexa, Plasmodium [e.g., Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariaej), vectors, endospores, and spores. "Bacteria^'' as used herein include bacteria, bacterial spores, and bacterial endospores.

Examples of bacteria include, but are not limited to. Acinetobacter (e.g., A. baumanniϊ), Bacillus (e.g., B. anthracis)_^ Bacteroides (e.g.. B. fragilis). Bordetella (e.g., pertussis), Brucella (e.g.. B. melitensis), Burkholderia (e.g., B. mallei, B. pseudomallei). Chlamydia (e.g.. C. psittacϊ). Clostridium (e.g., C. difficile, C. botulinum, C. perfringens), Coxiella (e.g., C. burnetii), Enterobacter (e.g. , E. aerogenes). Enterυcoccus (e.g.. E. faecal is), Enterococcus (e.g., E. faecium), Escherichia (e.g., E. colt), Francisella (e.g.. F. tularensis), Haemophilus (e.g., H. influenzae), Listeria (e.g., L monocytogenes), Klebsiella (e.g., K. oxytoca, K. pneumoniae), Micrococcus (e.g., M. luteus), Mycobacterium (e.g., M. tuberculosis), Neisseria (e.g., N. gonorrhoreae, N. meningitidis). Proteus (e.g., P. mirabilis), Pseudomonas (e.g., P aeruginosa), Rickettsia (e.g., R. prowazekii). Salmonella (e.g., S. bongori, S. enterica).

Serratia (e.g., S. marcescens), Shigella (e.g., S. boydii, S. dysenteriae, S. flexneri, S. sonnei), Staphylococcus (e.g., S. aureus [including Methicillin-resistant Staphylococcus aureus ('"MRSA^1")], S. epidermidis, S. haemolyticus, S, hominis, S. saprophyticus), Streptococcus (e.g., S. pneumoniae, S. pyogenes), Vibrio (e.g., V. cholerae, V. vulnificus), and Yersinia (e.g., Y. pestis).

Examples of fungi include, but are not limited to, Candida albicans, Malassezia (also known as Pityrosporum, and causes dandruff), Microsporum (e.g., M. audouinii, M. canis, M. amis var distortwn. M. cookei, M. equinum, M. ferrugineum, M. fulvum. M. gallinae. M. gypseum. M. nanurn, M persicolor). Trichophyton (e.g., T afelloi, T. concentricum, T. equinum. T. flavescens. T glυriae, T megnini, T. mentagrophyles var. erinacei T mentagrophytes var. inter digitale, T. phaseoliforme . ϊ nώnim, T. nώrum downy strain, T. nibrum granular strain. T. schoenleinii, T. simii, T. soudanense, T. terrestre, T. tonsurans, T vanhremeghemii. T vcrrucosum. T violaceum, T yaoundei) and Epidermophyton (e g.. E. floccosiniL a cause of tinea corporis (ringworm), lined cruris, tinea pedis (athlete s foot), and tinea unguium, (a fungal infection of the nail bed), Candida (e.g , Candida albicans). Cryptυcoccus neυ for mans, and Aspergillus.

Examples of viruses include, but are not limited to, Picornavirus (e g , Hepatovirus genus, hepatitis A virus species), Hepadnaviridae family {e.g., Orthohcpadnavirus genus [e.g.. Hepatitis B virus species)). Flavivjridae family (e.g., Hepacivirus genus \e g.. Hepatitis C virus species), Flavivirus genus [e.g . Yellow fever virus species), cold virus, Orthomyxoviridae family (e.g . human influenza viruses. avian influenza viruses [e.g. , H5N1 j). Herpesviridae family (e.g., Alphaherpesvirinae Subfamily. Simplexvirus Genus [e.g.. herpes simplex virus type 1 (HSV-I) species, herpes simplex vims type 2 (HSV-2) species]), variola major species. Henipavirus genus (e.g., Nipah virus species). Bunyaviridae family (e.g, hantavirus genus. Nairovirus genus [e.g . Crimean-Congo hemorrhagic fever virus]), Filoviridae family (e.g. Ebolavirus genus [e.g , Ebola virus species], Marburgvirus genus, [e.g., Marburg virus species)). Arenaviridae family (e.g., Arenavirus genus [e.g., Lassa virus species. Junin virus species (causing Argentine hemorrhagic fever)]), Retroviridae family (e g., Lentivirus genus [e.g., human immunodeficiency virus ("HIV^") species],

Coronavirus genus (e.g., SARS-associated coronavirus ("SARS-CoV") species), viruses that cause pneumonia. Paramyxoviridae family (e.g., Morbiili virus species (causing measles)), and Togaviridae family (e g., Rubivirus genus \e.g. Rubella virus species (causing German measles)]). "Harmful effect" as used herein includes, but is in no way limited to, any detrimental effect to a mammal's health. Examples of harmful effects include, but are not limited to, infection by the pathogen (acute or chronic), a disease caused by the pathogen, a disease condition caused by the pathogen, becoming a carrier of the pathogen (and thereby potentially imparting a harmful effect to another mammal), alteration of the microbial flora in or on a physiological structure of the mammal (e.g. , organs such as heart, lungs, brain, eyes, stomach, spleen, bones, pancreas, kidneys, liver, intestines (small and large), skin, bladder, uterus and testicles; systems such as digestive, respiratory, nervous, circulatory, endocrine, lymphatic, reproductive, urinary, skeletal and muscular; and membranes such as mucus, basement and serous), pain, discomfort, swelling, inflammation, psychological effects, fear. panic, and death.

As illustrated in Hgures 1-3. in one embodiment, the invention include* a vial 101 with a dispenser assembly 102 An agent 103 may be stored in the v ial 101 and delivered by operation of the dispenser assembly 102, In an embodiment of the present invention, the agent 103 contains a pharmaceutically active ingredient in a carrier. In another embodiment, the agent 103 is a composition Io prevent and/or treat and/or reduce the risk of an infection. In another embodiment, the agent 103 is antimicrobial, antiviral, antimycobacterial. antifungal and/or sporieidal. In another embodiment, the agent 103 is substantially non-irritating to the eyes, ears, mouth, nose. wounds, mucous membranes and/or non-mucous membranes of a human subject. In another embodiment, the agent 103 is substantially alcohol-free. In another embodiment, the agent 103 contains a solution of oxychlorine compounds. In another embodiment, the agent 103 comprises hypochlorous acid (HOCl) and hypochlorite ions (OCT). In another embodiment, the agent 103 comprises oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCl) and sodium chloride (NaCl). In another embodiment, the agent 103 contains about 99.99% oxidized water, sodium hypochlorite (NaOCl). hypochlorous acid (HOCl) and sodium chloride (NaCl).

In another embodiment, the agent 103 is Microcyn® OTC Wound Care (available from Oculus Innovative Sciences. Inc.). In another embodiment, the agent 103 is among the products described in U.S. Patent No. 7,090,753. or U.S. Patent Application Publication Nos. 2005/0142157, 2005/0139808, 2005/0196462, 2006/0235350, 2006/0241546, 2006/0253060, 2006/0272954. 2007/0173460, 2007/0173755. 2007/0196357, or 2007/0196434, each of which is incorporated by reference herein in its entirety as if fully set forth. In another embodiment, the agent 103 is a Sterilox^rM solution (available from PuriCore pic). In another embodiment, the agent 103 is among the products described in U.S. Patent Nos. 5,427,667. 5,540,819, 5,628,888, 5.635,040, 5,783,052, 5,871 ,623. 5,985,110, 6,004.439, 6,843,895, 6.632.347, 7,276,255, 6,528.214, 6,296.744. 6,752.757. 7.303,660 or U.S. patent application publication Nos. 2004/0060815, 2006/0124453, 2006/0249375, 2006/0278585, 2007/0017820. 2007/0051640. 2007/0108064. 2008/0075832. 2008/0156674, 2008/0160612, 2008/0156674. or 2008/0075832. each of which is incorporated by reference herein in its entirety as if fully set forth.

The agents described above generally impart the therapeutic effect by the oxychlorine compounds^" ability to deacti\ate the pathogen's essential enzymes and structures, rendering them non-viable. (See, e.g , Landa-Solis et al . Microcyn^%: a novel super-oxidized water with neutral pH and disinfectant activity J. I IOSP iNf-ro 2005:61(4):291 -299: ^'ϊ anaka et al.. Antimicrobial activity of super-oxidized water J \ IOSP IM tci. 1996;34( 1 ):43-49: Da! Ia Paola et a!.. L st? of Dermacyn^* , a mm antiseptic for the local treatment of diabetic foot ulcers. J WOUND 1 Ii AUNG 2005:2:201 ; Λltamirano. Λ.. Reducing Bacterial Infectious ( 'ompltcatiom from Burn Wounds. A look at the use of Ocnlus Microcyn^*' to treat wounds in Mexico. WOLNDS. 2006, Supp:17-19: Gutierrez, A.. Super-Oxidized Water Kills Bacteria; Demonstrates Potential for Healing, DERMATOLOGY TIMES. 26(6). June 2005: Nakae et ah. Effectiveness of electrolyzed oxidized water irrigation in a burn-wound infection model J. TRAUMA. 2000:49(3):51 1 -514; Ie Due et al. , A C ^Cytotoxic Analysis of Antiseptic Medication on Skin Substitutes and Autograft. BRΓΠSΠ JOURNAL OF DERMATOLOGY. March 2007; Davis et al., An In Vitro Comparison of the Antimicrobial Effects of Various Endodontic Medicaments on Enterococcus faecalis. JOURNAL o^ ENDODONTICS. 33(5), May 2007; Zahumensky. E., infections and diabetic foot syndrome in field practice. VNITR LEK. 2006:52:41 1-416; and Veverkova et al. , Melhicilin-resistent Staphylococcus aureus - problem in health care. J WOUND HEALING. 2005, 2:201-202.)

The agents can generally be produced by the electrolysis of water and salt, resulting in the following chemical reaction to generate the active agents:

NaCl + H₂O = NaOCl + HOCl = Na⁺ + II^r + OCl^" Hypochlorous acid (HOCl) and hypochlorite ions (OCi^") react with a wide range of biological molecules. Notably, hypochlorous acid (HOCl) is produced by neutrophils in the human body in its defense against microorganisms and thus, is a suitable agent to use in the prevention, treatment and/or reduction of the chance of experiencing a harmful effect by a pathogen in accordance with various embodiments of the present invention. Furthermore, in one embodiment, the pH of the agent can be neutral because both acids and bases are present creating a buffered solution.

In another embodiment, the agent 103 is a SteriFx ^ft composition and/or solution (available from SteriFx" , Inc.); for example, FreshFχ^κ Antimicrobial Solution, VetFx* Wound Care Spray, CTeanseFx^1* Antimicrobial Skin Cleanser, DeconFx™ Decontamination Solution, Fx HSD Disinfectant and the compositions and/or solutions contained in the

Personal Decontamination Kits available from SteriFx . Jn another embodiment, the agent 103 is among the products described in U.S. Patent No. 6,375,976, which is incorporated by reference herein in its entirety as if fully set forth. In another embodiment, the agent 103 is among the products described in U.S. Patent Publication Nos. 2004/0211935 and 2002/0182264. each of which is incorporated by reference herein in its entirety as if fully set forth.

In another embodiment, the agent 103 is among the products described in U.S. Patent NJo. 7.374.645.

Ia another embodiment- the agent 103 is an organosilane compound. In another embodiment, the agent 103 is among the products described in U.S. Patent Nos. 5.959,014. 6.632,805. 6.221 ,944, 5,954,869, 6.1 13.815, 6.120.587. 6,469.120, or 6.762, 172, each of which is incorporated by reference herein in its entirety as if fully set forth.

The vial 101 illustratively depicted in Figures 1-3 is generally cylindrical along its axis, with a closed base 104 and an open top 105. External screw threading 106 surrounds the open top 105. to enable the mechanical interaction of the vial 101 with corresponding internal screw threading 107 on the dispenser assembly 102. The mechanical interaction of the external screw threading 106 on the vial 101 with the internal screw threading 107 on the dispenser assembly 102 may create a substantially fluid-tight seal between these elements. A washer 108 may be included between the open top 105 and the dispenser assembly 102 to provide an additional (and in some cases less permeable) fluid seal. The washer may be constructed from any suitable material, as will be readily appreciated by those of skill in the art. such as, alone or in combination, an elastomeric material, rubber, silicone, plastic, polytetrafluoroethylene (PTFE; available under the trade name Teflon© from DuPont Corporation), the fluoropolymer PFΛ (e.g.. perfluoroalkoxy polymer resin: also available under the trade name Teflon© from DuPont Corporation), the Dyneon™ TFM^{1 M} range of chemically-modified PTFE (available from 3M), aluminum, poiyetheretherketone (PEEK). fluorinated ethylene propylene (FEP), fluoro -treated high-density polyethylene (HDPE). and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. In alternate embodiments of the present invention, different mechanisms may be used to affix the dispenser assembly 102 to the vial 101 ; for example, but in no way limited to, a snap fitting, a pressure fitting, a heat seal, a chemical adhesive or any number of other mechanical or chemical mechanisms readily known to those of skill in the art.

In alternate embodiments of the present invention, the vial 101 may be selected from any of a variety of shapes, such as, alone or in combination, cylindrical, rectangular, spheroid or any other desirable geometric configuration. In alternate embodiments, the vial 101 may have a shape that remains consistent or changes in cross-section along its axis, such as circular, elliptical, square, rectangular, rhomboid, trapezoidal, triangular, pentagonal, hexagonal, octagonal, and so on. As noted above, as illustratively depicted in Figures 1-3, the vial 101 is generally cylindrical and thus retains a generally circular shape along the entirety of its axis.

The vial 101 may be constructed from any suitable material. The material may be selected based upon, among other things, the chemical properties of the agent 103 that is to be contained in the v ial 101 . Specifically, it may be desirable to select a material that does not have a deϊeterious impact on the chemical composition, medicinal efficacy, stability or other properties of the agent 103: particularly insofar as the agent 103 is to be stored in the via! 101 for any appreciable amount of time, as may be necessitated by the intended use of the present invention. By way of example, in some embodiments the vial 101 may be constructed from various types of plastic, metal, stainless steel, glass (e.g.. borosilicate glass), PTFE. the fluoropolymer PFA (e.g. , pcrfluoroalkoxy polymer resin), the Dyneon™ TFM™ range of chemically-modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FKP). fluoro-treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. Λs will be readily appreciated by those of skill in the art, a variety of different materials may be used to construct the vial 101 and may be desirable based on the selection of various agents 103, and such materials are all contemplated as being within the scope of the present invention and can be readily used in alternate embodiments thereof without undue experimentation. The dispenser assembly 102 may be selected from any apparatus useful to dispense the agent 103 from the vial 101. Those of skill in the art will recognize numerous such apparatuses, which may include, but are no way limited to, pump sprayers, squeeze tops (e.g., those akin to the end of a conventional tube of toothpaste), aerosol sprayers, eye-droppers and applicator pads. As illustratively depicted in Figure 1. in one embodiment of the present invention, the dispenser assembly 102 is a pump sprayer, and is configured with conventional components, including a spray head 102a, a plunger 102b, a spring 102c, a ball 102d and a hole 102e. The components may be constructed from any desirable materials, which, in some embodiments, are inert with respect to the agent 103. The ball I02d may be constructed from any desirable material, which, in one embodiment, is stainless steel. Because certain components of the dispenser assembly 102 only come into contact with the agent 103 upon actuation (i.e.. when a user dispenses the agent 103 from the vial 101). such components may need not be constructed of materials that are inert with respect to the agent. In those embodiments of the invention where the dispenser assembly 102 is a pump sprayer, the components that do not come into contact with the agent 103 until actuation may include the spray head 102a. plunger 102b. spring 102c and/or ball 102d.

Certain components of the dispenser assembly 102 may remain in fluid communication with the agent 103. irrespective of device actuation (e g . during such time as the agent 103 is stored in the vial 101 ). For instance, in those embodiments of the present invention when the dispenser asscmbh 102 is a pump spra\er (as depicted in ϊ igures 1-3 and 5). an insert portion 109 thereof may extend axiaily from the portion of the pump sprayer that remains external to the vial 101, into the interior of the vial 101 where the agent 103 is contained, in certain embodiments of the present invention it may be desirable for the insert portion 109 to be constructed of a material that does not have a deleterious impact on the chemical composition, medicinal efficacy or other properties of the agent 103. Therefore, in particular embodiments of the present invention, the insert portion 109 may be constructed from various types of glass (e.g., borosilicate glass), PTFE. the fluoropolymcr PFΛ (e.g.. perfluoroalkoxy polymer resin), the Dyneon™ TF M™ range of chemically-modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP). fluoro- treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. The insert portion 109 may be substantially rigid and configured to reach a region of the vial 101 near its closed base 104, such that most, if not substantially all of the agent 103 contained in the vial 101 may be dispensed through operation of the dispenser assembly 102. In various embodiments of the present invention, the radial dimensions of the insert portion 109 may vary along its length, or, alternatively, remain substantially constant. In the embodiment illustratively pictured in Figures 1 -3 and 5, the insert portion 1Θ9 includes exterior radii of different dimensions along its length, as well as interior radii of increasingly narrow dimension from the end of the insert portion 109 nearest the open top 105 of the vial 101 to its closed base 104. Among other things, such a configuration may serve to accommodate the various components of the dispenser assembly 102 and/or minimize the amount of material needed to manufacture the insert portion 109. In an embodiment, the insert portion 109 is a unitary item, rather than several segments that are manufactured separately and adhered or otherwise affixed to one another; although both alternatives are envisioned as being within the scope of the instant invention.

In another embodiment of the present invention, as depicted in Figures 4-7. the vial 101 and dispenser assembly 102 may be fitted within a barrel I tO and cap l i t . The vial 101 may be stabilized within the barrel by a series of support elements 112 in mechanical contact with the closed base 104 on one end, and a series of flanges 113 that grasp the vial about its open top 105 beneath the external screw threading 106. The series of flanges 113 may be configured to separate in a radial direction from one another to allow the \ ial 101 to be inserted into the barrel 110, Once inserted, the flanges 113 may pro\ ide the aforementioned grasping force to retain the vial 101 within the barrel 1 10. such that it cannot be easily removed therefrom or slide out of the barrel 110 during normal operation In an alternate embodiment, the flanges 113 exert substantially minimal force on said vial 101. but instead retain the vial 101 within the barrel 110 by virtue of having a circuniferenee generally smaller than that of the outer surface of the vial 101; such that the vial 101 cannot slide through the flanges 113 without substantial force. The flanges 113 may have locking elements 114 on their exterior surface configured to mechanically interact with receiving elements 115 on the interior surface of the cap 111 (Figure 8). The mechanical interaction of the locking elements 114 with the receiving elements 115 may keep the cap 111 and barrel 110 affixed to one another until such time as the cap 111 is intentionally removed from the barrel 110 by a user. As illustrated in Figure 6, when the cap 111 and barrel 110 are locked together, the dispenser assembly 102 is protected from inadvertent use.

In another embodiment, the cap U l may include a tab 116, configured to allow a user to easily remove the cap 111 from the barrel 110 by dislodging the locking elements 114 from the receiving elements 115. As illustrated in Figure 6. in one embodiment, the tab 116 includes a forward portion 117 affixed to one side of the cap 11 L a rear portion 118 configured to receive a mechanical force from a user to separate the cap 111 from the barrel 110, and an intermediate portion 119 therebetween. The angle between the forward portion 117 and the axis of the cap 111 may be from about 0° to about 10°; the angle between the intermediate portion 119 and the axis of the cap 111 may be from about 45° to about 55°, and in one embodiment, about 50°; and the angle between the rear portion 118 and the axis of the cap 111 may be from about 0° to about 8°. The rear portion 118 may include a surface 120 configured to receive the finger of a user, the generally radial force (i.e., including, at most, a minimal longitudinal component) of which upon the surface 120 may dislodge the cap 111 from the barrel 110. In an alternative embodiment, the vial 101 and barrel 110 exist as a unitary assembly, rather than separate components that are affixed to one another. In one embodiment, the dispenser assembly 102 is fitted directly onto the unitary assembly. For instance, the unitary assembly may have an external screw threading surrounding the open top (not shown) similar to the external screw threading 106 that is on the vial 101 described above, to enable the mechanical interaction of the unitary assembly with the corresponding internal screw threading 107 on the dispenser assembly 102. The mechanical interaction of the external screw threading on the unitary assembh with the internal screw threading 107 on the dispenser assembly 102 may create a substantial]} fluid-tight seal between these elements. A washer 108 may be included between the open top and the dispenser assembly 102 to provide an additional (in some cases less permeable) fluid seal. The unitary assembly may be constructed from any suitable material. The material may be selected based upon, among other things, the chemical properties of the agent 103 that is to be contained in the unitary assembly. Specifically, it may be desirable Io select a material that does not have a deleterious impact on the chemical composition, medicinal efficacy, stability or other properties of the agent 103: particularly insofar as the agent 103 is to be stored in the unitary assembly for any appreciable amount of time, as may be necessitated by the intended use of the present invention. By way of example, in some embodiments the unitary assembly may be constructed from various types of plastic, metal, stainless steel, glass (e.g.. borosilicate glass), PTFE, the fluoropolymer PFA (e.g., perfluoroalkoxy polymer resin), the Dyneon™ TFM™ range of chemically-modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), fluoro-treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. As will be readily appreciated by those of skill in the art. a variety of different materials may be used to construct the unitary assembly and may be desirable based on the selection of various agents 103, and such materials are all contemplated as being within the scope of the present invention and can be readily used in alternate embodiments thereof without undue experimentation.

In another embodiment of the invention, the dispenser assembly 102 may be configured for nasal delivery of an agent 103. irrespective of device actuation (e.g., during such time as the agent 103 is stored in the vial 101). It may thus include one or more spray nozzles 102f configured for application of the agent to the inner surfaces of the nostril. In the embodiment depicted in Figures 9-10, the spray head 102a includes four spray nozzles 102f; one at the top of the spray head 102a to dispense the agent upwards into the nostril and three positioned equal distances from one another (i.e. , 120°) about the circumference of the spray head 102a to dispense the agent against the inner surfaces of the nostril. As will be readily appreciated by those of skill in the art, greater or fewer spray nozzles may be included in the spray head 102a: for instance, it may be advantageous to eliminate the spray nozzle at the top of the spray head and/or to include more or less spray nozzles about the circumference of the spray head 102a.

The spray head 102a may be generalh contoured in a shape suitable for partial insertion into the nostril of a user: for instance, it may have a generally rounded top and cussed sides. As illustrated in Figures 9-10, it may additional!} include a generally disk- shaped lower edge 102g that prevents the spray head 102a from being inserted too far into a user^'s nostril. The lower edge 102g may come into contact with the external portion of a user^'s nostril: thereby preventing further insertion of the spray head 102a. The lower edge 102g may also provide a convenient surface for a user to grab with his fingers to actuate the dispenser assembly 102 and deliver the agent 103.

In an alternative embodiment, the spray head may further be contoured in a shape suitable for a user to grip the spray head 102a when using the device, for instance, the lower edge 102g may further extend form a lower lip (not shown), or the bottom of the spray head may additionally include a wing-shaped lower edge (not shown). For example, this can allow a user to place two fingers on the top side of the lower lip or wing-shaped lower edge to assist in gripping the device to spray a quantity of the agent into a nostril.

In another embodiment, the vial 101 and dispenser assembly 102 form a squeeze-type spray bottle and thus, constructed from any suitable material that also allows it to be flexible or elastic, to allow a user to exert pressure on the vial 101 (e.g., squeeze) to spray the agent 103 into the nostril. The spray assembly 102 may also be configured to include one or more spray nozzles configured for application of the agent to the inner surfaces of the nostril as described above.

EXAMPLE 1 Elimination of Microorganisms, Reduction of Bacterial and/or Viral Titers. Germ-Killing and/or Antifungal/Sporicidal Activity on a Surface Area of a Human Subject A device as described herein is provided, including a unitary assembly with a pump sprayer, wherein the elements of the pump sprayer that are in direct contact with the agent contained in the device irrespective of device actuation are made from an inert material with respect to the agent. The unitary assembly includes a volume of an agent containing about 99.99% oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCl) and sodium chloride (NaCl). The unitary assembly and pump sprayer are fitted with a cap; the cap includes a tab with a surface configured to receive a user^'s finger.

A user exerts a generally radial force on the tab surface; thereby releasing the cap from the unitary assembly. ^'I he user then sprays a quantity of the agent onto a wound, into his eyes, into his ears, into his mouth and/or onto any additional surfaces of his body after being contacted by a substance believed to contain pathogens. The agent prevents, treats and/or reduces the risk of an infection on the surfaces to which it is applied. EXAMPLE 2

Elimination of Microorganisms, Reduction of Bacterial and/or Viral Titers. Gerro-Kill.ij.ig and/or Antifungal/Sporicidal Activity on the Nasal Surface Area of a Human Subject

A device as described herein is provided, including a PFA vial with a pump sprayer. wherein the elements of the pump sprayer that are in direct contact with the agent contained in the device irrespective of device actuation are made from an inert material with respect to the agent. The pump sprayer includes a spray head with four spray nozzles configured equal distances from one another (i.e., 90°) about the circumference of the spray head. The PFA vial includes a volume of an agent containing about 99.99% oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCl) and sodium chloride (NaCl). The PFA vial and pump sprayer are fitted within a plastic barrel and cap assembly; the cap is removably affixed to the barrel with screw threading,

A user removes the cap from the barrel by unscrewing it, unsnapping it, or otherwise removing the cap from the barrel. The user then inserts the spray head into his nostril until a lower edge of the spray head comes to rest on the outer surface of the nostril. The user then sprays a quantity of the agent into the nostril; whereby the orientation of the spray nozzles causes the agent to reach the inner surfaces of the nostril. The agent prevents, treats and/or reduces the risk of an infection in the nostril, including a MRSA infection,

Various embodiments of the invention are described above in the Detailed

Description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the purview of this description are intended to be included therein as well. Unless specifically noted, it is the intention of the inventors that the words and phrases in the specification and claims be given the ordinary and accustomed meanings to those of ordinary- skill in the applicable art(s).

The foregoing description of various embodiments of the invention known to the applicant at this time of filing the application has been presented and is intended for the purposes of illustration and description. The present description is not intended to be exhaustive nor limit the invention to the precise form disclosed and many modifications and variations are possible in the light of the above teachings. The embodiments described serve to explain the principles of the invention and its practical application and to enable others skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out the invention.

While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from this invention and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of this invention. It will be understood by those within the art that, in general, terms used herein are generally intended as "open'^* terms (e.g., the term "including" should be interpreted as "including but not limited to,^** the term ''having" should be interpreted as ''having at least," the term "includes"' should be interpreted as "includes but is not limited to.^" etc.).

Furthermore, no limitations are intended to the details of construction or design herein shown other than as described in the claims below. It is, therefore, evident that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention. Accordingly, the protection sought herein is as set forth in the claims below.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. An apparatus, comprising: a unitary assembly to contain an agent: and a dispenser assembly to dispense the agent from the unitary assembly, the dispenser assembly mechanically affixed to the unitary assembly, and the dispenser assembly including elements that come into contact with the agent irrespective of actuation, wherein the unitary assembly and the elements that come into contact with the agent irrespective of actuation consist essentially of materials that are inert or non- reactive with the agent.

2. The apparatus of claim 1 , wherein the unitary assembly comprises a vial nonremovably affixed within a barrel.

3. The apparatus of claim 1. further comprising a closed base, an open top and an external screw threading surrounding the open top to enable the mechanical interaction of the unitary assembly with a corresponding internal screw threading on the dispenser assembly,

4. The apparatus of claim 3. further comprising a washer between the open top and the dispenser assembly.

5. The apparatus of claim 1 , further comprising a cap configured with a receiving element configured to mechanically interact with a locking element on the exterior surface of the unitary assembly to keep the cap and the unitary assembly affixed to one another until the cap is removed from the unitary assembly by a user.

6. The apparatus of claim 5, wherein the cap further comprises a tab configured with a locking element and a receiving element configured to allow the user to remove the cap from the unitary assembly by dislodging the locking element from the receiving element.

7. The apparatus of claim 6. wherein the tab comprises a forward portion affixed to one side of the cap. a rear portion configured to receive a mechanical force from the user to separate the cap from the unitary nbsembh. and an intermediate portion therebetween.

8. ^'The apparatus of claim 1.. wherein an angle between the forward portion and the axis of the cap is from about 0° io about 10°. an angle between the intermediate portion and the axis of the cap is from about 45° to about 55°, and an angle between the rear portion and the axis of the cap is from about 0° to about 8°.

9. The apparatus of claim 7. wherein the rear portion of the tab comprises a surface configured to receive a finger of the user, wherein a generally radial force of which upon the surface is capable of dislodging the cap from the unitary assembly.

10. The apparatus of claim 1 , wherein the dispenser assembly is a pump sprayer configured with a spray head, a plunger, a spring, a ball and a hole.

1 3 . The apparatus of claim 1 , wherein the dispenser assembly is a pump sprayer configured with an insert portion configured to extend axially from the portion of the pump sprayer that remains external to the vial, into the interior of the vial where the agent is contained.

12. The apparatus of claim 11. wherein the unitary assembly and the insert portion are each constructed of a material selected from the group consisting of plastic, metal, stainless steel, glass, polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA). chemically-modified PTFE, aluminum, polyetherehterketone (PEEK), fluorinated ethylene propylene (FEP), fluoro-treated high-density polyethylene (ϊ IDPE), and combinations thereof.

13. The apparatus of claim 1 , further comprising a quantity of the agent.

14. The apparatus of claim 13. wherein the agent comprises about 99.99% oxidized water, sodium hypochlorite (NaOCl). hypochlorous acid (FIOCl) and sodium chloride (NaCl).

15. A device for nasal delivery of a composition, comprising: a vial: and a dispenser assembly comprising a head, wherein the head includes one or more spray nozzles configured to dispense the composition within the nose of a user.

16. The device of claim 15. further comprising a barrel, within which the vial and dispenser assembly are fitted.

17. The device of claim 16. wherein the barrel further comprises a series of flanges to retain the via! within the barrel.

18. The device of claim 16, wherein the via! and the barrel exist as a unitary assembly wherein the \ial is nonremovabl) affixed within the barrel.

19. The device of claim 15. wherein the spra> head is generally contoured in shape suitable for partial insertion into a nostril of a user.

20. fhe dc\ ice of claim 19. wherein the spray head is further configured with a general K disk-shaped lower edge to prevent the spray head from being inserted too far in the nostril.

21. The device of claim 20, wherein the lower edge extends to form a lower lip.

22. The device of claim 15, further comprising a closed base, an open top and an external screw threading surrounding the open top to enable the mechanical interaction of the vial with a corresponding internal screw threading on the dispenser assembly.

23. The device of claim 22, further comprising a washer between the open top and the dispenser assembly.

24. The device of claim 16. further comprising a cap with a receiving element configured to mechanically interact with a locking element on the exterior surface of the barrel to keep the cap and the barrel affixed to one another until the cap is removed from the barrel by the user.

25. The device of claim 24, wherein the cap further comprises a tab configured with a locking element and a receiving element configured to allow the user to easily remove the cap from the barrel by dislodging the locking element from the receiving element.

26. The device of claim 25, wherein the tab comprises a forward portion affixed to one side of the cap, a rear portion configured to receive a mechanical force from the user to separate the cap from the unitary assembly, and an intermediate portion therebetween.

27. The device of claim 26, wherein an angle between the forward portion and the axis of the cap is from about 0° to about 10°. an angle between the intermediate portion and the axis of the cap is from about 45° to about 55°, and an angle between the rear portion and the axis of the cap is from about 0° to about 8°.

28. The device of claim 26. wherein the rear portion of the tab comprises a surface configured to receive a finger of the user, wherein a generally radial force of which upon the surface is capable of dislodging the cap from the unitary assembly.

29. The device of claim 15. wherein the dispenser assembly is a pump sprayer configured with a spray head, a plunger, a spring, a ball and a hole.

30. The device of claim 15, wherein the dispenser assembly is a pump sprayer configured with an insert portion configured to extend axially from the portion of the pump sprajer that remains external to the vial, into the interior of the vial where the agent is contained.

31. fhe device of claim 30, wherein the vial and the insert portion are each constructed of a material selected from the group consisting of plastic, metal, stainless steel, glass, polyteirafluoroethyiene (PTFE). perfluoroalkoxy (PFA). chemically-modified PTFE. aluminum, polyetherehterketone (PEIiK), fluorinated ethylene propylene (FEP). fluoro-treated high-density polyethylene (HDPE). and combinations thereof.

32. The device of claim 15, further comprising a quantity of a composition effective in mitigating the effects of pathogens,

33. The device of claim 32. wherein the composition comprises about 99.99% oxidi/ed water, sodium hypochlorite (NaOCl). hypochlorous acid (HOCl) and sodium chloride (NaCl).

34. The device of claim 15. wherein the vial and dispenser assembly form a squeeze-type spray bottle configured to allow a user to exert pressure on the vial to spray the composition into the nostril.

35. Λ method of preventing, treating and/or reducing the risk of an infection in a subject in need thereof, comprising: providing the apparatus of claim 13; and dispensing the agent onto a surface of the subject lo prevent, treat and/or reduce the risk of the infection.

36. A method of preventing, treating and/or reducing the risk of an infection in a subject in need thereof, comprising: providing the device of claim 32; and dispensing the composition into an inner surface of a nostril to prevent, treat and/or reduce the risk of the infection.