Claims for Patent: 9,682,205

Summary for Patent: 9,682,205

Title:	Nasal delivery device
Abstract:	The present invention provides a method for delivering a substance to the nasal cavity of a subject in which drawing air from a mouthpiece triggers release of a substance to a subject\'s nasal cavities. The device comprises a container for containing the substance in fluid communication with a nosepiece, a valve with an active configuration and an inactive configuration, and a trigger mechanism to reconfigure the valve from its inactive configuration to its active configuration and vice versa. Drawing air from the mouthpiece, e.g., when the subject takes in air by mouth, activates the trigger mechanism, thereby reconfiguring the valve from its inactive configuration to its active configuration for a predetermined period of time and delivering the substance from the device to a nasal cavity of the subject.
Inventor(s):	Shahaf; Daniel (M.P. Emek Ha-Yarden, IL), Hadash; Joseph (Lapid, IL)
Assignee:	SIPNOSE LTD. (Yokne\'am Ilit, IL)
Application Number:	14/977,679
Patent Claims:	1. A method for delivering a substance to a nasal cavity of a subject, said method comprising steps of: a. providing an air-intake actuated device configured for delivering a substance to a nasal cavity of a subject, said device comprising: (i) a container for containing said substance; (ii) a nosepiece extending from said device for placement in proximity to a nose of said subject, said nosepiece being in fluid communication with said container; (iii) a valve mechanically connectable to said container, characterized by at least two configurations: (i) an active configuration in which said valve enables delivery of predetermined amount of said substance from said container via said nosepiece to said nasal cavity; and, (ii) an inactive configuration, in which said valve prevents delivery of said predetermined amount of said substance from said container to said nasal cavity; (iv) a mouthpiece extending from said device for placement in a mouth of said subject; and, (v) a trigger mechanism configured to reconfigure said valve from said active configuration to said inactive configuration, and vice versa; wherein said trigger mechanism is activated by means of said subject taking in air through said mouthpiece; further wherein said trigger mechanism is configured to reconfigure said valve from said inactive configuration to said active configuration for a predetermined period of time in response to said subject's intake of air; b. placing said nosepiece in or around the nose of said subject; c. placing said mouthpiece in the mouth of said subject; and, d. taking air through said mouthpiece into said mouth of said subject, said intake of air activating said trigger mechanism; thereby: (i) reconfiguring said valve from said inactive configuration to said active configuration for said predetermined period of time; and, (ii) fluidly connecting said container to said nosepiece to enable delivery of said predetermined amount of said substance from said container to said nosepiece. 2. The method for delivering a substance to a nasal cavity of a subject according to claim 1, further comprising step of reconfiguring said valve via said trigger mechanism from said active configuration to said inactive configuration when said intake ceases. 3. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising selecting at least one set of steps from a group consisting of (a) providing said trigger mechanism with a flexible membrane, said membrane is in mechanical communication with said valve; intaking air through said mouthpiece, thereby relocating said membrane from its initial position and opening said valve; and (b) providing said device with an intermediate compartment and filling said intermediate compartment with said predetermined amount of said substance; such that said delivery of said substance is from said intermediate compartment. 4. The method for delivering a substance to a nasal cavity of a subject according to claim 1, further comprising step of configuring said trigger mechanism such that operation of said trigger mechanism is synchronizable with said take of air by said subject. 5. The method for delivering a substance to a nasal cavity of a subject according to claim 1, further comprising step of providing said trigger mechanism with a pulsation mechanism configured to reconfigure said valve from said inactive configuration to said active configuration and vice versa in sequence of pulses, each of which is characterized by a predetermined length of pulse, said valve configured to deliver said predetermined amount of said substance according to said sequence of pulses; further comprising step of delivering in each said pulse at least two doses of said predetermined amount of said substance. 6. The method for delivering a substance to a nasal cavity of a subject according to claim 1, wherein said nosepiece is in fluid communication with said valve by means of a spray nozzle; further wherein said spray nozzle is characterized by a diameter which influences said predetermined period of time. 7. The method for delivering a substance to a nasal cavity of a subject according to claim 1, further comprising step of providing said device with a cap configured to cover at least a portion of the components of said device for sterilization purposes; wherein said cap comprises an opening. 8. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising steps of connecting said container to an external container, and filling said container by said external container with a predetermined dose of said substance. 9. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising steps of providing said container with indicating means configured to indicate the amount of said substance within said container; and providing said indicating means as a transparent window located on a side of said container. 10. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising steps of selecting said substance to be a drug and selecting said drug from a group consisting of: Anti-Angiogenesis agents, Antisense, anti-ulcer, butorphanol, Calcitonin and analogs, COX-II inhibitors, desmopressin and analogs, dihydroergotamine, Dopamine agonists and antagonists, Enkephalins and other opioid peptides, Growth hormone and analogs, growth hormone releasing hormone, Growth hormone antagonists, IgE suppressors, Insulin, insulinotropin and analogs, Ketamine, Kytril, Leutenizing hormone releasing hormone and analogs, lidocaine, metoclopramide, Midazolam, Narcotic analgesics, neuraminidase inhibitors, nicotine, Non-steroid anti-inflammatory agents, Oligosaccharides, ondansetron, Parathyroid hormone and analogs, Parathyroid hormone antagonists, Prostaglandin antagonists, Prostaglandins, Recombinant soluble receptors, scopolamine, Serotonin agonists and antagonists, Sildenafil, Terbutaline, vasopressin, and any combination thereof. 11. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising steps of selecting said substance from a vaccine with or without carriers or adjuvant and selecting said vaccine from a group consisting of: Prophylactics and therapeutic antigens, subunit protein, peptide and polysaccharide, polysaccharide conjugates, toxoids, genetic based vaccines, live attenuated reassortant, inactivated whole cells, viral and bacterial vectors for the treatment of arthritis, Lactobacillus species: Lactobacillus acetotolerans, Lactobacillus acidifarinae, Lactobacillus acidipiscis, Lactobacillus acidophilus (Doderlein bacillus), Lactobacillus agilis, Lactobacillus algidus, Lactobacillus alimentarius, Lactobacillus amylolyticus, Lactobacillus amylophilus, Lactobacillus amylotrophicus, Lactobacillus amylovorus, Lactobacillus animalis, Lactobacillus antri, Lactobacillus apodemi, Lactobacillus aviarius, Lactobacillus bifermentans, Lactobacillus brevis, Lactobacillus buchneri, Lactobacillus camelliae, Lactobacillus casei, Lactobacillus catenaformis, Lactobacillus ceti, Lactobacillus coleohominis, Lactobacillus collinoides, Lactobacillus composti, Lactobacillus concavus, Lactobacillus coryniformis, Lactobacillus crispatus, Lactobacillus crustorum, Lactobacillus curvatus, Lactobacillus delbrueckii, Lactobacillus delbrueckii subsp. Bulgaricus, Lactobacillus delbrueckii subsp. Lactis, Lactobacillus diolivorans, Lactobacillus equi, Lactobacillus equigenerosi, Lactobacillus farraginis, Lactobacillus farciminis, Lactobacillus fermentum, Lactobacillus fornicalis, Lactobacillus fructivorans, Lactobacillus frumenti, Lactobacillus fuchuensis, Lactobacillus gallinarum, Lactobacillus gasseri, Lactobacillus gastricus, Lactobacillus ghanensis, Lactobacillus graminis, Lactobacillus hammesii, Lactobacillus hamsteri, Lactobacillus harbinensis, Lactobacillus hayakitensis, Lactobacillus helveticus, Lactobacillus hilgardii, Lactobacillus homohiochii, Lactobacillus iners, Lactobacillus ingluviei, Lactobacillus intestinalis, Lactobacillus jensenii, Lactobacillus johnsonii, Lactobacillus kalixensis, Lactobacillus kefiranofaciens, Lactobacillus kefiri, Lactobacillus kimchii, Lactobacillus kitasatonis, Lactobacillus kunkeei, Lactobacillus leichmannii, Lactobacillus lindneri, Lactobacillus malefermentans, Lactobacillus mali, Lactobacillus manihotivorans, Lactobacillus mindensis, Lactobacillus mucosae, Lactobacillus murinus, Lactobacillus nagelii, Lactobacillus namurensis, Lactobacillus nantensis, Lactobacillus oligofermentans, Lactobacillus oris, Lactobacillus panis, Lactobacillus pantheris, Lactobacillus parabrevis, Lactobacillus parabuchneri, Lactobacillus paracollinoides, Lactobacillus parafarraginis, Lactobacillus parakefiri, Lactobacillus paralimentarius, Lactobacillus paraplantarum, Lactobacillus pentosus, Lactobacillus perolens, Lactobacillus plantarum, Lactobacillus pontis, Lactobacillus psittaci, Lactobacillus rennini, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus rimae, Lactobacillus rogosae, Lactobacillus rossiae, Lactobacillus ruminis, Lactobacillus saerimneri, Lactobacillus sakei, Lactobacillus salivarius, Lactobacillus sanfranciscensis, Lactobacillus satsumensis, Lactobacillus secaliphilus, Lactobacillus sharpeae, Lactobacillus siliginis, Lactobacillus spicheri, Lactobacillus suebicus, Lactobacillus thailandensis, Lactobacillus ultunensis, Lactobacillus vaccinostercus, Lactobacillus vaginalis, Lactobacillus versmoldensis, Lactobacillus vini, Lactobacillus vitulinus, Lactobacillus zeae, Lactobacillus zymae, Probiotics selected from a group consisting of Lactic acid bacteria (LAB) and bifidobacteria, and any combination thereof; said substance is used for the treatment of at least one selected from a group consisting of cholera, moraxella catarrhali, cocaine addiction, Hib, meningococcus, measles, mumps, rubella, varicella, yellow fever, Respiratory syncytial virus, pneumococcus, streptococcus, typhoid, influenza, hepatitis, including hepatitis A, B, C and F, polio, HIV, parainfluenza, rotavirus, CMV, chlamydia, non-typeable haemophilus, moraxella catarrhalis, human papilloma virus, tuberculosis including BCG, gonorrhoea, asthma, atheroschlerosis, malaria, otitis media, E-coli, Alzheimer's disease, H. Pylori, salmonella, diabetes, cancer, herpes simplex, Staphylococcus aureus, Streptoccocus, and any combination thereof. 12. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising step of selecting said substance for treatment of at least one selected from a group consisting of cholera, moraxella catarrhali, cocaine addiction, Hib, meningococcus, measles, mumps, rubella, varicella, yellow fever, Respiratory syncytial virus, pneumococcus, streptococcus, typhoid, influenza, hepatitis, including hepatitis A, B, C and F, polio, HIV, parainfluenza, rotavirus, CMV, chlamydia, non-typeable haemophilus, moraxella catarrhalis, human papilloma virus, tuberculosis including BCG, gonorrhoea, asthma, atheroschlerosis, malaria, otitis media, E-coli, H. Pylori, salmonella, diabetes, cancer, herpes simplex, Staphylococcus aureus, Streptoccocus, CNS disorders, brain disorders such as: brain cancer, acute brain injury, spinal cord injury, Alzheimer's disease, Neurogenesis, Parkinson's disease, depression, Epilepsy, schizophrenia by the delivery of substances such as: Neurotrophins, BDNF, GDNF, anti EGF receptor AB, Enzymes such as Lysosomal enzyme, Neuregulin and any combination thereof. 13. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising steps of selecting said substance to be a therapeutic substance and selecting said therapeutic substance from a group consisting of: Agents for the common cold, Anti-addiction, anti-infectives, analgesics, anesthetics, anorexics, antiarthritics, anti-allergy agents, antiasthmatic agents, anticonvulsants, anti-depressants, antidiabetic agents, anti-depressants, anti-diuretics, anti-emetics, antihistamines, anti-inflammatory agents, antimigraine preparations, antimotion sickness preparations, antinauseants, antineoplastics, anti-obesity, antiosteoporeteic, antiparkinsonism drugs, antipruritics, antipsychotics, antipyretics, anticholinergics, benzodiazepine antagonists, bone stimulating agents, central nervous system stimulants, hormones, hypnotics, immunosuppressives, prostaglandins, proteins, peptides, polypeptides and other macromolecules, psychostimulants, rhinitis treatment, sedatives, sexual hypofunction, tranquilizers and vitamins including B12, probiotics, natural oils, natural ingredients, peptide or protein therapeutic agent such as cytokines, hormones, clotting factors, vaccines, monoclonal antibody, natural oils; Mint oils, Peppermint oil, Spearmint oil, Menthol, Olive oil, Eucalyptus oil, Amino acids, fatty acids and any combination thereof. 14. The method for delivering a substance to a nasal cavity of a subject according to claim 1, additionally comprising step of delivering said substance to said nasal cavity in a form selected from a group consisting of: a powder; a granule; a cachet; a capsule; a tablet; a paste; a cream; a gel; an ointment; a salve; a foam; a paste; a lotion; a cream; an oil suspension; a spray; a suspension; a solution; an emulsion; a patch; a stick; a spray, preferably a nasal spray, or a buccal spray; a mouth wash; an aerosol from a Venturi effect, and a drink.

Details for Patent 9,682,205

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-02-26