Nasal Irrigation Apparatus and Kit
20190184088 ยท 2019-06-20
Inventors
Cpc classification
A61M3/0245
HUMAN NECESSITIES
A61M11/008
HUMAN NECESSITIES
International classification
Abstract
An apparatus for nasal irrigation comprising a resiliently compressible bottle component and a spout having a proximal end for demountable engagement with the bottle component. The distal end of the spout may be molded for sealable engagement with a user's nostril. Alternatively, the distal end of the spout may be threaded for demountable sealable engagement with a nasal tip molded for sealable engagement with a user's nostril. The tip may be configured for delivering a solution in the form of a stream, or a spray, or a misting. A kit comprising the nasal irrigation apparatus and one or more selected volumes of one or more nasal irrigation solutions. The kit may additionally comprise one or more nasal tips. The nasal irrigation solution may comprise one or more of an antibiotic, an antihistamine, a steroid, a vasoconstrictor, an emollient, and an ion.
Claims
1. An apparatus for delivering a single-use volume of a nasal irrigation solution, comprising: a resiliently compressible cylindrical container having a curvilinear body, said container having at least one pair of opposed channels molded thereinto; and a spout; wherein the container has a threaded open end, and the spout has a threaded proximal end for demountable sealingly engagement with the threaded open end of the container,
2. The apparatus according to claim 1, wherein the pair of opposed channels molded into the container extend around the curvilinear body from the range of about 15% to about 50% of a circumference of the curvilinear body.
3. The apparatus according to claim 1, wherein the curvilinear body of the cylindrical container has a round shape or an elliptical shape or an asymmetrical shape.
4. The apparatus according to claim 1, wherein the spout is formed in a shape of a shepherd's crook.
5. The apparatus according to claim 1, wherein the spout has a straight linear shape.
6. The apparatus according to claim 1, wherein the nasal tip is integrally molded with the spout.
7. The apparatus according to claim 1, wherein the spout has a threaded distal end for demountable sealingly engagement with a threaded proximal end of a nasal tip.
8. The apparatus according to claim 7, wherein the nasal tip has a distal end with one of a circular orifice, a rectangular orifice, and a plurality of small-diameter misting orifices.
9. A nasal irrigation kit comprising the apparatus of claim 1.
10. The nasal irrigation kit according to claim 9, comprising a first spout with a shape of a shepherd's crook and a second spout with a straight linear shape.
11. The nasal irrigation kit according to claim 9, additionally comprising one or more nasal tips.
12. The nasal irrigation kit according to claim 9, comprising a spout with an integrally molded nasal tip.
13. The nasal irrigation kit according to claim 9, wherein the resiliently compressible container has been filled with a volume of a nasal irrigation solution, said filled container sealed with a tamper-proof seal.
14. The nasal irrigation kit according to claim 9, additionally comprising a bottle filled with a volume of a nasal irrigation solution, said bottle sealed with a tamper-proof seal.
15. The nasal irrigation kit of claim 9, comprising one or more containers of one of a nasal irrigation solution, an antibiotic-containing nasal irrigation solution, an antihistamine-containing nasal irrigation solution, a steroid-containing nasal irrigation solution, an emollient-containing solution, and an antioxidant-containing nasal irrigation solution.
16. The nasal irrigation kit of claim 15, wherein the nasal irrigation solution additionally contains a vasoconstrictor.
17. The nasal irrigation kit of claim 15, wherein the nasal irrigation solution additionally contains one or more ions selected from the group consisting of potassium, rubidium, magnesium, calcium, zinc, sulfate, and bromide.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0010] The present disclosure will be described in conjunction with reference to the following drawings in which:
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DETAILED DESCRIPTION
[0024] The embodiments of the present disclosure relate to apparatus for self-administered delivery of nasal irrigation solutions by a user. According to one aspect, an exemplary apparatus disclosed herein comprises: (i) a resiliently compressible container with a cylindrical body having at least one plurality of molded finger grip channels extending partially around the container, (ii) a molded spout having a shepherd's hook shape wherein the proximal end of the spout is demountably and sealingly engageable with the container, and (iii) a nasal tip for sealingly engaging a user's nostril, wherein the nasal tip is demountably and sealingly engageable with the distal end of the molded spout. Alternatively, the distal end of the spout may have a molded tip shaped to demountably and sealingly engage a user's nostril.
[0025] According to an embodiment, the cylindrical body may have two pluralities of adjacent molded finger grip channels ending partially, or alternatively completely, around the circumference of the resiliently compressible container.
[0026] According to another embodiment, the cylindrical body may have three pluralities of adjacent molded finger grip channels ending partially, or alternatively completely, around the circumference of the resiliently compressible container.
[0027] According to yet another embodiment, the cylindrical body may have four pluralities of adjacent molded finger grip channels ending partially, or alternatively completely, around the circumference of the resiliently compressible container.
[0028] According to an embodiment, the cylindrical body of the resiliently compressible container may have a round shape, alternatively an elliptical shape, or alternatively, an asymmetrical shape.
[0029] According to an embodiment, the spout may have a linear form along a single axis without any curvatures.
[0030] According to an embodiment, the nasal tip may have a circular orifice at its distal end to provide a stream of irrigation solution into a user's nostril when the resiliently compressible container is squeezed by the user. According to another aspect, the nasal tip may have a rectangular orifice with rounded ends at its distal end to provide a spray of irrigation solution into a user's nostril when the resiliently compressible container is squeezed by the user. According to another aspect, the nasal tip may have a plurality of small-diameter orifices at its distal end to provide a mist of irrigation solution into a user's nostril when the resiliently compressible container is squeezed by the user.
[0031] Other embodiments of the present disclosure relate to nasal irrigation solutions compositions formulated to provide a selected type of relief to a user. For example, a nasal irrigation solution may be formulated to provide a cleansing flow to loosen and flush dried phlegm and/or mucus. Alternatively, a nasal irrigation solution may be formulated to deliver one or more emollients for moisturizing and/or soothing irritated mucosal cells. Alternatively, a nasal irrigation solution may be formulated to deliver a medicant, for example an antibiotic, a sleep aid, a motion sickness antidote, an energy and/or alertness aid, and the like.
[0032] One example of an embodiment of a nasal irrigation apparatus 10 disclosed herein is shown in
[0033] The spout 25 (
[0034] Another suitable spout 50 for demountable sealingly engagement with the male-threaded open top 21 of the container 15 (
[0035] An example of a suitable nasal tip 60 for use with the nasal irrigation apparatus disclosed herein is shown in
[0036] Another example of a suitable nasal tip 70 for use with the nasal irrigation apparatus disclosed herein is shown in
[0037] Another example of a suitable nasal tip 80 for use with the nasal irrigation apparatus disclosed herein is shown in
[0038] Another example of an embodiment of a nasal irrigation apparatus 100 according to the present disclosure is shown in
[0039] It is particularly suitable for the container components of the nasal irrigation apparatus disclosed herein, to be sized to provide a single-use dosage volume of a nasal irrigation solution. For example, a suitable volume may be selected from the range of 50 mL to 200 mL, 75 mL to 200 mL, 100 mL to 200 mL, 125 mL to 200 mL, 150 mL to 200 mL, 175 mL to 200 mL, and therebetween.
[0040] The shepherd's hook shape of the spout 25 (
[0041] It is suitable for the nasal tip 60 to be made with a soft, pliable and compressible material to enable the user to insert the nasal tip partially into a nostril opening and then to compress the nasal tip against the nostril so that there is no leakage of irrigation solution between the nostril opening and the nasal tip when the user squeezes the resiliently compressible container 15 to force the irrigation solution from the container into the user's nasal passage.
[0042] It is within the scope of the present disclosure for the containers, the spouts, and the nasal tips to be made with any suitable resilient polymeric materials. It is suitable to use biobased polymers that may be compostable and/or biodegradable.
[0043] Accordingly, one embodiment of a nasal irrigation apparatus disclosed herein may be a single-use apparatus comprising a container with a total volume capacity of 250 mL, a spout, and a nasal tip, all made from one or more biodegradable and/or compostable polymers. According to an aspect, the container may have markings to show one or more of 50 mL, 75 mL, 100 mL, 125 mL, 150 mL, 175 mL, 200 mL, and 250 mL. After use, the apparatus may then be disposed of and recycled.
[0044] Another embodiment of a nasal irrigation apparatus disclosed herein may be a single-use apparatus comprising a container with a total volume capacity of 200 mL, a spout, and a nasal tip, all made from one or more biodegradable and/or compostable polymers. According to an aspect, the container may have markings to show one or more of 50 mL, 75 mL, 100 mL, 125 mL, 150 mL, 175 mL, and 200 mL. After use, the apparatus may then be disposed of and recycled.
[0045] Another embodiment of a nasal irrigation apparatus disclosed herein may be a single-use apparatus comprising a container with a total volume capacity of 150 mL, a spout, and a nasal tip, all made from one or more biodegradable and/or compostable polymers. According to an aspect, the container may have markings to show one or more of 50 mL, 75 mL, 100 mL, 125 mL, and 150 mL. After use, the apparatus may then be disposed of and recycled.
[0046] Another embodiment of a nasal irrigation apparatus disclosed herein may be a single-use apparatus comprising a container with a total volume capacity of 100 mL, a spout, and a nasal tip, all made from one or more biodegradable and/or compostable polymers. According to an aspect, the container may have markings to show one or more of 50 mL, 75 mL, and 100 mL. After use, the apparatus may then be disposed of and recycled.
[0047] Another embodiment of a nasal irrigation apparatus disclosed herein may be a single-use apparatus comprising a container with a total volume capacity of 90 mL, a spout, and a nasal tip, all made from one or more biodegradable and/or compostable polymers. According to an aspect, the container may have markings to show one or more of 50 mL, 70 mL, and 90 mL. After use, the apparatus may then be disposed of and recycled.
[0048] Another embodiment of a nasal irrigation apparatus disclosed herein may be a reusable apparatus comprising a sterilisable container, a sterilisable spout, and a disposable nasal tip. After use, the nasal tip may be discarded and recycled while the container and spout are washed and then sterilized using a suitable method exemplified by boiling in water and/or washing in a hydrogen peroxide solution and/or washing in an alcohol solution (for example ethanol or isopropanol and the like). The container and spout should then be rinsed to remove traces of the hydrogen peroxide solution or washing in an alcohol solution.
[0049] It is to be noted that it is optional if so desired, for the open end of the resiliently compressible container to be provided with an internal female-threaded element and the proximal end of the spout to have a male-threaded component for demountable sealingly engagement with the internal female-threaded element of the open end of the resiliently compressible container. It is also optional, if so desired, for the distal end of the spout to have a female-threaded component, and for the proximal end of the nasal tip to have a male-threaded component for demountable sealingly engagement with the female-threaded element at the distal end of the spout.
[0050] Another embodiment of the present disclosure relates to nasal irrigation kits. The kits may be single-use kits or reusable kits. One example of a suitable kit comprises: (i) a resiliently compressible container pre-filled with a selected volume of a nasal irrigation solution and then sealed with a tamper-proof seal and a screw-on cap, (ii) a spout, and (iii) at least one nasal tip. A user would assemble the kit by removing the cap and the tamper-proof seal from the container, sealingly engage the female-threaded orifice of the spout with the male-threaded opening of the container, sealingly engage the nasal tip with the male-threaded distal end of the spout, after which, the nasal irrigation apparatus is ready for use. This embodiment of a kit may additionally comprise an extra bottle containing one or more single-use volumes of a selected nasal irrigation solution.
[0051] Another embodiment of a suitable kit may comprise: (i) an empty resiliently compressible container, (ii) a spout, and (iii) at least one nasal tip. A user would add a selected volume of a selected nasal irrigation solution, then sealingly engage the female-threaded orifice of the spout with the male-threaded opening of the container, sealingly engage the nasal tip with the male-threaded distal end of the spout, after which, the nasal irrigation apparatus is ready for use. This embodiment of a suitable kit may additionally comprise a tamper-proof sealed bottle containing one or more single-use volumes of a selected nasal irrigation solution.
[0052] The kits disclosed herein may comprise a spout with a shepherd's crook or alternatively, a straight linear spout, or alternatively may comprise both types of spouts. The kits may comprise one nasal tip or a plurality of nasal tips. The plurality of nasal tips may include one tip or multiple tips with a circular orifice, and/or one tip or multiple tips with a rectangular orifice, and/or one tip or multiple tips with a plurality of small-diameter misting orifices.
[0053] The nasal irrigation kits disclosed herein may comprise one or more different types of nasal irrigation solutions.
[0054] According to one embodiment, the kits may comprise a nasal irrigation solution for lavage of the nasopharynx and sinus cavities. Suitable irrigation solutions for nasal lavage are exemplified by isotonic saline solutions, isotonic phosphate-buffered solutions, Ringer's solution, and the like. A particularly suitable composition for nasal lavage is Ringer's solution. It is optional to add one or more ions to the Ringer's solution. Suitable ions include potassium (K.sup.+), rubidium (Rb.sup.+), magnesium (Mg.sup.2+), calcium (Ca.sup.2+), zinc (Zn.sup.2+), sulfate (SO.sub.4.sup.2), bromide (Br.sup.), and the like.
[0055] According to another embodiment, the kits may comprise a nasal solution for delivery of an antibiotic to the nasopharynx and sinus cavities for nasal lavage by a user while they are experiencing cold or flu symptoms. A suitable nasal irrigation solution for delivery of an antibiotic may be based on Ringer's solution, alternatively isotonic saline solutions or isotonic phosphate-buffered solutions, to which has been added an antibiotic. Examples of suitable antibiotics include amikacin, amoxicillin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, tobramycin, geldanamycin, herbimycin, carbacephem (loracarbef), ertapenem, doripenem, imipenem, cefadroxil, cefazolin, cefalotin, cephalexin, cefaclor, cefamandole, cefoxitin, cefprozil, cefuroxime, cefixime, cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime, ceftobiprole, clarithromycin, clavulanic acid, clindamycin, colistimethate teicoplanin, azithromycin, dirithromycin, erythromycin, troleandomycin, telithromycin, aztreonam, ampicillin, azlocillin, bacampicillin, carbenicillin, cloxacillin, dicloxacillin, flucloxacillin, mezlocillin, meticillin, nafcillin, norfloxacin, oxacillin, penicillin G, penicillin V, piperacillin, pvampicillin, pivmecillinam, ticarcillin, bacitracin, colistin, colimycin, polymyxin B, ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, ofloxacin, trovafloxacin, grepafloxacin, sparfloxacin, afenide, prontosil, sulfacetamide, metronidazole, sulfamethizole, sulfanilimide, sulfamethoxazole, sulfisoxazole, trimethoprim, trimethoprim-sulfamethoxazole, demeclocycline, doxycycline, oxytetracycline, tetracycline, arsphenamine, chloramphenicol, chlorhexidine, lincomycin, ethambutol, fosfomycin, furazolidone, isoniazid, linezolid, mupirocin, nitrofurantoin, platensimycin, pyrazinamide, quinupristin/dalfopristin, rifampin, thiamphenicol, rifampicin, minocycline, sultamicillin, sulbactam, sulphonamides, mitomycin, spectinomycin, spiramycin, roxithromycin, meropenem, azithromycin and sulfamethoxazole/trimethoprim, and the like. It is optional to add a vasoconstrictor to the present antibiotic nasal irrigation solutions. Examples of suitable vasoconstrictors include phenylephrine, pseudoephedrine, and the like. It is optional to add one or more ions to the present antibiotic nasal irrigation solutions. Suitable ions include K.sup.+, Rb.sup.+, Mg.sup.2+, Ca.sup.2+, Zn.sup.2+, SO.sub.4.sup.2, Br, and the like.
[0056] According to another embodiment, the kits may comprise a nasal solution for delivery of an antihistamine and/or a steroid to the nasopharynx and sinus cavities for nasal lavage by a user while they are experiencing allergy symptoms. A suitable nasal irrigation solution for delivery of an antibiotic may be based on Ringer's solution, alternatively isotonic saline solutions or isotonic phosphate-buffered solutions, to which has been added an antibiotic. Examples of suitable antihistamines include Hi-antihistamines. Suitable Hi-antihistamines include acrivastine, azelastine, bilastine, brompheniramine, buclizine, bromodiphenhydramine, carbinoxamine, chlorpromazine, cyclizine, chlorphenamine, chlorodiphenhydramine, clemastine, cyproheptadine, dexbrompheniramine, dexchlorpheniramine, dimenhydrinate, dimetindene, diphenhydramine, doxylamine, ebastine, embramine, fexofenadine, hydroxyzine, loratadine, meclozine, mirtazapine, olopatadine, orphenadrine, phenindamine, pheniramine, phenyltoloxamine, promethazine, quetiapine, rupatadine, tripelennamine, triprolidine, and the like. Examples of suitable steroids include triamcinolone and its derivatives (particularly the diacetate, hexacetonide, and acetonide), betamethasone and its derivatives (including particularly the dipropionate, benzoate, sodium phosphate, acetate, and valerate), dexamethasone and its derivatives (particularly the dipropionate and valerate), flunisolide, prednisone and its derivatives (particularly its acetate), prednisolone and its derivatives (particularly its acetate, sodium phosphate and tebutate), methylprednisolone and its derivatives (particularly its acetate and sodium succinate), fluocinolone and its derivatives (particularly the acetonide), diflorasone and its derivatives (particularly the diacetate), halcinonide, desoximetasone (desoxymethasone), diflucortolone and its derivatives (particularly the valerate), flucloronide (fluclorolone acetonide), fluocinonide, fluocortolone, fluprednidene and its derivatives (particularly the acetate), flurandrenolide (flurandrenolone), clobetasol and its derivatives (particularly the propionate), clobetasone and its derivatives (particularly the butyrate), alclometasone, flumethasone and its derivatives (particularly the pivalate), fluocortolone and its derivatives (particularly the hexanoate), amcinonide, beclometasone and its derivatives (particularly the dipropionate), fluticasone and its derivatives (particularly the propionate), difluprednate, prednicarbate, flurandrenolide, mometasone and desonide. It is optional to add a vasoconstrictor to the present allergy-relief nasal irrigation solutions. Examples of suitable vasoconstrictors include phenylephrine, pseudoephedrine, and the like. It is optional to add one or more ions to the present allergy-relief nasal irrigation solutions. Suitable ions include K.sup.+, Rb.sup.+, Mg.sup.2+, Ca.sup.2+, Zn.sup.2+, SO.sub.4.sup.2, Br, and the like.
[0057] According to another embodiment, the kits may comprise a nasal irrigation solution for lavage of the nasopharynx and sinus cavities for the purpose of soothing irritated mucous membranes, for example, after periods of nasal inflammation or after allergy attacks or after a cold or flu. A suitable nasal irrigation solution for soothing irritated mucosal membranes may be based on Ringer's solution, alternatively isotonic saline solutions or isotonic phosphate-buffered solutions, to which has been added an emollient. Examples of suitable emollients include glycerol, mineral oil, mixtures of mineral oil and lanolin alcohols, cetyl alcohol, cetostearyl alcohol, petrolatum, petrolatum and lanolin alcohols, cetyl esters wax, cholesterol, glycerin, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lecithin, allyl caproate, althea officinalis extract, arachidyl alcohol, argobase EUC, butylene glycol, dicaprylate/dicaprate, acacia, allantoin, carrageenan, cetyl dimethicone, cyclome hicone, diethyl succinate, dihydroabietyl behenate, dioctyl adipate, ethyl laurate, ethyl palmitate, ethyl stearate, isoamyl laurate, octanoate, PEG-75, lanolin, sorbitan laurate, walnut oil, wheat germ oil, super refined almond, super refined sesame, super refined soyabean, octyl palmitate, caprylic/capric triglyceride, glyceryl cocoate, and the like. It is optional to add to such nasal soothing solutions, an antioxidant. Examples of suitable antioxidants include a citric acid, butylated hydroxytoluene (BHT), ascorbic acid, glutathione, retinol, a-tocopherol, -carotene, a-carotene, ubiquinone, butylated hydroxyanisole, ethyl enediaminetetraacetic acid, selenium, zinc, lignan, uric acid, lipoic acid, N-acetylcysteine, and the like. It is optional to add a vasoconstrictor to the present nasal soothing irrigation solutions. Examples of suitable vasoconstrictors include phenylephrine, pseudoephedrine, and the like. It is optional to add one or more ions to the present nasal soothing irrigation solutions. Suitable ions include K.sup.+, Rb.sup.+, Mg.sup.2+, Ca.sup.2+, Zn.sup.2+, SO.sub.4.sup.2, Br, and the like.