WO2017136087A1 - Dispositif d'administration de traitement nasal comprenant du dioxyde de carbone et une solution saline, et méthodes, comprenant de faibles débits - Google Patents

Dispositif d'administration de traitement nasal comprenant du dioxyde de carbone et une solution saline, et méthodes, comprenant de faibles débits Download PDF

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Publication number
WO2017136087A1
WO2017136087A1 PCT/US2017/000009 US2017000009W WO2017136087A1 WO 2017136087 A1 WO2017136087 A1 WO 2017136087A1 US 2017000009 W US2017000009 W US 2017000009W WO 2017136087 A1 WO2017136087 A1 WO 2017136087A1
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WO
WIPO (PCT)
Prior art keywords
dosage
carbon dioxide
main housing
saline
per
Prior art date
Application number
PCT/US2017/000009
Other languages
English (en)
Inventor
Kenneth P. Glynn
Original Assignee
Clover Hill Heal Thealthcare, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/998,704 external-priority patent/US20170224936A1/en
Priority claimed from US14/999,292 external-priority patent/US10052464B2/en
Application filed by Clover Hill Heal Thealthcare, Inc. filed Critical Clover Hill Heal Thealthcare, Inc.
Priority to EP17747890.6A priority Critical patent/EP3411094A4/fr
Priority to CA3013821A priority patent/CA3013821C/fr
Publication of WO2017136087A1 publication Critical patent/WO2017136087A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/008—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised by squeezing, e.g. using a flexible bottle or a bulb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0208—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0031—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up by bursting or breaking the package, i.e. without cutting or piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0681—Sinus (maxillaris)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0262—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb

Definitions

  • the present invention relates generally to healthcare, and specifically to the treatment of head ailments. More specifically, the present invention relates to intranasal delivery methods and devices fui UeaUiie ls' with mixtures of carbon dioxide, carbonic acid and saline, as well as methods of treatment utilizing these devices. b. Description of Related Art
  • United States Patent No. 8,007,842 B2 to Rau describes a composition for providing aromatherapy, and in particular, symptomatic relief of nasal and sinus congestion in unit dosage format.
  • the composition includes a penetrating aromatic vapor whose release from a preparation of warm water is augmented by an effervescent component which reacts in the warm water to promote release of the aromatic fragrance, or sustained over time by tableting or gelatin encapsulation. As the fragrance is inhaled, symptomatic relief is obtained.
  • the composition of matter may be rendered ingestible, so that the warm water containing the composition is consumed following inhalation.
  • the release of the penetrating aromatic fragrance persists over time.
  • United States Patent No. 7,959,597 B2 to Baker et al. describes an irrigation and aspiration system.
  • the system can be configured to aspirate and irrigate alone, sequentially or concurrently.
  • the system can be configured to aspirate and irrigate the nasal cavity.
  • the system can be manually controlled.
  • the system can have removable and easily clcanable reservoirs for aspirant and irrigant.
  • United States Patent No. 7,858,650 B2 to Yamamoto et al. describes a medicinal composition for inhalation containing a continuous-release type pro-drug of an EP2 agonist which topically exhibits a prolonged broncho-dilating and anti-inflammatory effects.
  • the medicinal composition for inhalation containing a continuous-release type pro-drug of an EP2 agonist is useful as a safe preventive and/or a remedy for respiratory diseases (for example, asthma, pulmonary injury, pulmonary fibrosis, pulmonary emphysema, bronchitis, chronic obstructive pulmonary disease, adult respiratory distress syndrome, cystic fibrosis, pulmonary hypertension or the like) without causing any systemic effect such as lowering blood pressure.
  • respiratory diseases for example, asthma, pulmonary injury, pulmonary fibrosis, pulmonary emphysema, bronchitis, chronic obstructive pulmonary disease, adult respiratory distress syndrome, cystic fibrosis, pulmonary hypertension or the like
  • United States Patent No. 7,845,348 B2 to Rasor et al. describes apparatus, methods, and kits for treating symptoms associated with common ailments, such as headaches, rhinitis, asthma, epilepsy, nervous disorders and the like.
  • the apparatus comprises dispensers for carbon dioxide and other therapeutic gases.
  • the methods comprise delivering small volumes of these gases to patients in a manner where the gas infuses into a body region in order to bathe the mucous membranes therein. It has been found that even very short exposure of patients to small volumes and high concentrations of such gases can provide significant relief from symptoms.
  • United States Patent No. 7,836,883 B2 to Rasor et al. describes apparatus, methods, and kits for treating symptoms associated with common ailments, such as headaches, rhinitis, asthma, epilepsy, nervous disorders and the like.
  • the apparatus comprises dispensers for carbon dioxide and other therapeutic gases.
  • the methods comprise delivering small volumes of these gases to patients in a manner where the gas infuses into a body region in order to bathe the mucous membranes therein. It has been found that even very short exposure of patients to small volumes and high concentrations of such gases can provide significant relief from symptoms.
  • United States Patent No. 7,827,986 B2 to Rasor et al. describes apparatus, methods, and kits for treating symptoms associated with common ailments, such as headaches, rhinitis, asthma, epilepsy, nervous disorders and the like.
  • the apparatus comprises dispensers for carbon dioxide and other therapeutic gases.
  • the methods comprise delivering small volumes of these gases to patients in a manner where the gas infuses into a body region in order to bathe the mucous membranes therein. It has been found that even very short exposure of patients to small volumes and high concentrations of such gases can provide significant relief from symptoms.
  • United States Patent No. 7,017,573 Bl to Rasor et al. describes apparatus, methods, and kits for treating symptoms associated with common ailments, such as headaches, rhinitis, asthma, epilepsy, nervous disorders and the like.
  • the apparatus comprises dispensers for carbon dioxide and other therapeutic gases.
  • the methods comprise delivering small volumes of these gases to patients in a manner where the gas infuses a body region in order to bathe the mucous membranes therein. It has been found that even very short exposure of patients to small volumes and high concentrations of such gases can provide significant relief from symptoms.
  • United States Patent No. 5,609,581 to Fletcher, et al. describes the combination comprising a container for a product having a puncturable diaphragm at one end thereof, an applicator of elongated parabolic shape including means for detachably mounting it on the container, an internal piercing element in the applicator aligned with the diaphragm and a plurality of discharge openings in the applicator, the applicator actuatable between an unarmed position wherein the piercing element is spaced from the diaphragm in an armed position where it punctures the diaphragm to permit discharge of the contents through the piercing element and the discharge openings in the applicator.
  • United States Patent No. 3,221,945 Bl to Davis describes medication dispensers of the squeeze bottle type for treatment of nasal and sinus infections that have specific valving with resilient wall bottles.
  • United States Patent Application No. 2012/0179122 Al to Eliat et al describes device for applying an ophthalmologic medicament to a patient's eye.
  • the device comprises spectacles defined by a frame and at least one lens; at least one container adapted for accommodating the ophthalmologic medicament; the container is incorporated into the frame; dosing mechanism adapted to control doses of the medicament; and at least one nozzle in a fluid interconnection with the medicament container; the nozzle is secured mechanically to the frame; the nozzle is adapted for providing a medicament mist flow.
  • the nozzle is placed in front of a peripheral portion of a patient's eye slot and adapted to provide the mist flow in front of the patient's eye.
  • United States Patent Application No. 2011/0233232 Al to Greiner-Perth et al describes a discharging device for pharmaceutical liquids having an actuator for carrying out a discharging operation of a pharmaceutical liquid.
  • a first subordinate unit of the actuator has a discharge orifice, and a second subordinate unit is displaceable relative to the first subordinate unit for carrying out the discharging operation.
  • the two subordinate units together delimit a buffer chamber from which a liquid passageway leads to the discharge orifice.
  • a liquid-containing bag is accommodated in the buffer chamber and has film-like walls.
  • the actuator and the bag are coordinated such that displacement of the subordinate units of the actuator relative to each other causes opening of the bag and reduction in the volume of the buffer chamber with consequent volume reduction of the liquid-containing bag and discharge of liquid through the discharge orifice.
  • United States Patent Application No. 2010/0305130 Al to Phillips describes a single- use sprayer for nasal anesthesia is disclosed.
  • the single-use sprayer includes a single dose of anesthetic and a delivery system adapted to dispense the single dose of anesthetic into a nostril.
  • the single-use sprayer prevents patient-to-patient contamination, is easy to use and allows for self-administration, and has a simple, disposable configuration so as to lower the production cost.
  • United States Patent Application No. 2008/0169047 Al to Connolly et al. describes a hand-held, low-flow dispenser which comprises an enclosure holding a gas cartridge.
  • a spring- biased needle is advanced to puncture a septum on the gas cartridge, and a separate spring-biased ball valve is used to turn the resulting gas flow off and on as well as to control the flow rate.
  • United States Patent Application No. 2008/0114310 A 1 to Kamen, et al. describes a method for packaging an agent for delivery within a body cavity.
  • a reservoir within a package contains a specified quantity of the agent and is either contiguous with, or coupled to, a dispensing node such as a swab.
  • Depth of insertion of the dispensing node into the body cavity is restricted to a specified depth by a penetration-restricting feature that forms part of the package.
  • United States Patent Application No. 2008/0078382 Al to LeMahieu et al. describes systems and methods for delivery of a drug to the respiratory system of a patient in a stream of purified air are provided.
  • the drugs are delivered to the respiratory system of the patient at a positive air pressure relative to atmospheric pressure.
  • medication available in a variety of forms is introduced in a controlled fashion into the air stream in aerosol, nebulized, or vaporized form.
  • United States Patent Application No. 2008/0066741 Al to LeMahieu et al. describes systems and methods for delivery of a drug to the respiratory system of a patient, where the drug is supplied in purified air at a positive pressure relative to atmospheric pressure.
  • medication available in a variety of forms is introduced in a controlled fashion into the purified air stream in aerosol, nebulized, or vaporized form.
  • United States Patent Application No. 2008/0066739 Al to LeMahieu et al. describes systems and methods for delivery of a drug to the respiratory system of a patient where the drug is supplied at a positive pressure relative to atmospheric pressure.
  • the drugs are delivered to the respiratory system of a patient who is capable of unassisted breathing.
  • medication available in a variety of forms is introduced in a controlled fashion into the air stream in aerosol, nebulized, or vaporized form.
  • United States Patent Application No. 2008/0029086 Al to Harlan, et al. describes a nasal passage washing device includes a pliable body including an open top; and an applicator cap removably attached to the pliable body to cover and uncover the open top.
  • the applicator cap includes an applicator tip having a substantially frustoconical configuration sized and shaped for receipt at least partially within a nostril of a user for sealing engagement therewith, the applicator tip including a hole to transfer washing solution there through, a washing solution transfer tube in communication with the hole of the applicator tip and a bottom of an inside of the pliable body to transfer washing solution from the bottom of the inside of the pliable body to the hole of the applicator tip, and a one-way air valve that only allows air flow into the pliable body through the one-way air valve and does not allow air flow and washing solution flow out of the pliable body through the one-way air valve.
  • United States Patent Application No. 2006/0172017 Al to Rasor et al. describes an apparatus and methods to deliver vasoconstrictive agents simultaneously with capnic gases.
  • the capnic gases can enhance the effectiveness of the vasoconstrictive agent, lower the dosage of drug or concentration of agent necessary to achieve a therapeutic result, or both.
  • Exemplary capnic gases include carbon dioxide, nitric oxide, nitrous oxide, and dilute acid gases.
  • United States Patent Application No. 2004/0009126 Al to Pilkiewicz et al. describes an inhalation system comprising an anti-infective agent in particle form, the anti-infective agent being directed toward prevention and treatment of intracellular infection, and an inhalation device, and a method of use of the system.
  • United States Patent Application No. 2002/0174864 Al to Alchas describes a nasal delivery device for delivering substances such as liquid drugs, vaccines and the like to a nasal passage.
  • the nasal delivery device preferably comprises a drug container such as syringe and a separable spray nozzle.
  • the spray nozzle includes a rigid plastic cap having a spray aperture at a distal end of the nozzle for delivering the liquid substance to the nasal passage. Attachment means is provided for attaching the spray nozzle to the syringe at the time of the delivery of the liquid substance to the nasal passage.
  • the nozzle defines a conduit that allows fluid
  • the nozzle includes an internal valve between the spray aperture and the syringe for allowing only pressurized liquid substance to flow through the conduit and the aperture so that a mist or spray is delivered through the spray aperture.
  • United States Patent Application No. 2002/0040205 Al to Rasor et al. describes methods and devices for transcutaneous and transmucosal application of carbon dioxide in the form of gas and in the form of a capnic solution (such as carbonated water) for the relief of pain, including musculoskeletal disorders, neuralgias, rhinitis and other ailments.
  • Gaseous carbon is applied to the skin for at least three minutes, and the capnic solution may be held on the skin for at least three minutes, which provides relief of symptoms.
  • the capnic solution may be sprayed onto mucous membranes such as the nose for relief of symptoms such as allergic rhinitis.
  • Filter paper disks were placed on the nasal septum to deliver a sham challenge followed by 2 increasing doses of either grass or ragweed allergen.
  • Secretions were collected from both sides of the septum to evaluate the nasonasal reflex and were assayed for Wstarnine. Nasal and eye symptoms were recorded.
  • the primary outcome measure was the contralateral, reflex, secretory response to allergen as measured by secretion weights.
  • Ipsilateral secretion weights were numerically reduced. Histamine levels in ipsilateral nasal secretions increased significantly when the subjects received sham treatment but did not increase after pretreatment with CO(2). Treatment with nasal CO(2) resulted in partial reduction of the acute response to allergen challenge. Reflex responses were reduced, supporting an effect on neuronal mechanisms, which predict usefulness in the treatment of allergic rhinitis.
  • the present invention is directed to a method of treating head ailments via application of one or more dosages of a treatment to the nasal cavity wherein the dosage includes dissolved carbon dioxide gas, dissolved in a saline solution.
  • the saline solutions further include carbonic acid, which acts to lower pH and inhibit or destroy bacteria.
  • the dosage also contains one or more additional active components (flavorings, minerals, vitamins, medicines, or other physiologically or psychologically beneficial to the user (patient or consumer)).
  • additional active components flavorings, minerals, vitamins, medicines, or other physiologically or psychologically beneficial to the user (patient or consumer)
  • Specified flow rates of the delivery device for the dissolved carbon dioxide, carbonic acid and saline dosage with and without other active additives, for treating ailments in a patient in need thereof.
  • the present invention device includes: a) a main housing having a proximal and a distal end and having a hollow central area containing a dosage that includes a saline fluid and a gas containing carbon dioxide; b) a dosage dispenser head located at the distal end of the main housing, the dosage dispenser head having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and to external of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head adapted to permit flow of the dosage from the main housing and through the dosage dispenser head in response to increased pressure against the dosage; and d) a pressure- changing moveable component located on the main housing.
  • the dosage dispenser head of the device When the dosage dispenser head of the device is placed in a treatment area of a patient, such as at or in a nasal cavity and the pressure-changing moveable component is activated by movement toward the dosage, the dosage is at least partially forced through the dosage release control component and through the dosage dispenser head for application of the dosage to the patient, e.g., to a nasal cavity wall.
  • the present invention is a method for treating head ailments in a patient in need thereof, the method comprising: directing a therapeutic, non-inhaled dosage to at least one nasal cavity of the patient through a flow regulating device having a flow channel, the dosage including: (a) a saline fluid, (b) dissolved carbon dioxide gas, (c) carbonic acid, (and in some embodiments: (d) at least one additional active component), wherein the therapeutic dosage is delivered at a flow rate through the flow channel of the combined components (with or without the one or more additional active additives), does not exceed 5.0 cc per second, and the carbon dioxide therein does not exceed 1.0 % by weight based on the entire weight of the dosage.
  • the present method is for treatments of head ailments selected from the group consisting of rhinitis, conjunctivitis, common cold and sinusitis. In other embodiments, the method is for treatments head ailment selected from the group consisting of allergic rhinitis and headache.
  • the flow regulating device is selected from the group consisting of a single dose dispenser with a pressure control valve for released flow regulation and a multiple dose dispenser with a pressure control valve for released flow regulation.
  • the flow regulating device is a multiple dose dispenser with a pressure control valve for released flow regulation and the multiple dose dispenser further includes a dosage amount control mechanism and activator to limit dosage release amount for each activation.
  • the duration of spraying each dosage is 1/2 to 10 seconds per nasal cavity, especially less than 4 seconds, and preferrd in some cases, 2 seconds. In some embodiments of the present invention method, the dose is repeated from 1 to 10 times.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.2 cc per second to 5.0 cc per second and the carbon dioxide therein is in the range of 0.1 % to 1.0 % by weight based on the entire weight of the dosage.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.4 cc per second to 4.0 cc per second and the carbon dioxide therein is in the range of 0.2 % to 0.8 % by weight based on the entire weight of the dosage.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.4 cc per second to 2 cc per second and the carbon dioxide therein is in the range of 0.2 % to 0.6 % by weight based on the entire weight of the dosage.
  • the present invention method includes embodiments that are the same as all of those stated above in all of the various Summary paragraphs above, having the saline, dissolved carbon dioxide gas and carbonic acid, but without any other active components.
  • This present invention method for treating head ailments in a patient in need thereof includes: directing a therapeutic, non-inhaled dosage to at least one nasal cavity of the patient through a flow regulating device having a flow channel, the dosage including: (a) a saline fluid, and (b) dissolved carbon dioxide gas, and (c) carbonic acid, wherein the gaseous carbon dioxide is dissolved in the saline fluid, and wherein the therapeutic, non-inhaled dosage is delivered at a flow rate through the flow channel of the combined saline fluid and gaseous carbon dioxide does not exceed 5.0 cc per second and the carbon dioxide therein does not exceed 1.0 % by weight based on the entire weight of the dosage .
  • the present invention also includes a treatment delivery device with the dissolved carbon dioxide gas, saline, carbonic acid and at least one additional active component, for treating ailments in a patient in need thereof, including: a) a main housing having a proximal and a distal end and having a hollow central area containing at least one releasable nasal treatment dosage that includes a saline fluid and gaseous carbon dioxide and at least one additional active component ; b) a dosage dispenser head located at the distal end of the main housing, the dosage dispenser head having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and to external of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head adapted to permit a flow rate of the dosage from the main housing and through the dosage dispenser head flow channel in response to increased pressure against the dosage, wherein the dosage release control component is set to achieve a flow rate through the flow channel of the combined saline fluid,
  • the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
  • the main housing is an open ended tube with the dosage release control component and the dosage dispenser located at the distal end uf Ihe main housing and the pressure-changing moveable component is located at the proximal end of the main housing.
  • the pressure-changing moveable component is a flexible squeeze member and a seal float.
  • the pressure-changing moveable component is a push-up piston.
  • the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
  • the main housing is a tube having an open distal end and a closed proximal end, with the dosage release control component and the dosage dispenser head being located at the distal end of the main housing, and at least a portion of the tube is flexible and constitutes the pressure-changing moveable component.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.2 cc per second to 5.0 cc per second and the carbon dioxide therein is in the range of 0.1 % to 1.0 % by weight based on the entire weight of the dosage.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.4 cc per second to 4.0 cc per second and the carbon dioxide therein is in the range of 0.2 % to 0.8 % by weight based on the entire weight of the dosage.
  • the flow rate through the flow channel of the combined saline fluid, gaseous carbon dioxide and the at least one additional active component is in the range of 0.4 cc per second to 2 cc per second and the carbon dioxide therein is in the range of 0.2 % to 0.6 % by weight based on the entire weight of the dosage.
  • the present invention device includes embodiments that are the same as all of those stated above in all of the various Summary device-defining paragraphs above, utilizing the dosage having saline, dissolved carbon dioxide gas and carbonic acid, but without any other active components.
  • the present invention device includes: a) a main housing having a proximal and a distal end and having a hollow central area containing at least one releasable nasal treatment dosage that includes a saline fluid dissolved carbon dioxide gas and carbonic acid wherein the gaseous carbon dioxide is dissolved in the saline fluid; b) a dosage dispenser head located at the distal end of the main housing, the dosage dispenser head having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and to external of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head adapted to permit
  • a releasable nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof, comprised of: a) a main housing having a proximal and a distal end and having a hollow central area containing a releasable nasal treatment dosage that includes a saline fluid and gaseous carbon dioxide, wherein the gaseous carbon dioxide is dissolved in the saline fluid; b) a dosage dispenser head located at the distal end of the main housing, the dosage dispenser head having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and externally of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head adapted to permit flow of the dosage comprising the saline fluid and the gaseous carbon dioxide from the main housing and through the dosage dispenser head in response to increased pressure against the dosage release control component wherein the permitted flow has controlled release at a flow rate of
  • the main housing further contains at least one additional active component.
  • the flow rate is in the range of 0.01 to 1 cubic centimeter per second.
  • the flow rate is in the range of 0.08 to 1 cubic centimeter per second.
  • the flow rate is in the range of 0.1 to 1 cubic centimeter per second.
  • the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
  • the main housing is an open ended tube with the dosage release control component and the dosage dispenser head is located at the distal end of the main housing and the pressure-changing moveable component is located at the proximal end of the main housing.
  • the pressure-changing moveable component is selected from the group that consists of: a flexible squeeze member and a seal float; and, a push-up piston.
  • the main housing is a tube with an open distal end and a closed proximal end, with the dosage release control component and the dosage dispenser head are located at the distal end of the main housing, and at least a portion of the tube is flexible and constitutes the pressure-changing moveable component.
  • a nasal treatment delivery device containing dissolved carbon dioxide and saline fluid which is comprised of: a) providing the releasable nasal treatment delivery device; and, b) directing at least a portion of the nasal treatment dosage of the device to at least one nasal cavity of the patient through the flow regulating device.
  • the flow regulating device of the releasable nasal treatment delivery device is set to deliver at a flow rate in the range of 0.01 to 1 cubic centimeter per second.
  • the flow regulating device of the releasable nasal treatment delivery device is set to deliver at a flow rate is in the range of 0.08 to 1 cubic centimeter per second.
  • the flow regulating device of the releasable nasal treatment delivery device is set to deliver at a flow rate is in the range of 0.1 to 1 cubic centimeter per second.
  • Figure 1 is a block diagram of an embodiment of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments;
  • Figure 2 is a block diagram showing head ailments treated by various embodiments of the present invention carbon dioxide, carbonic acid and saline nasal delivery devices;
  • Figure 3 is a block diagram showing durations for therapeutic non-inhaled dosage in some preferred embodiments of the present invention carbon dioxide, carbonic acid and saline nasal delivery devices;
  • Figure 4 is a block diagram of another embodiment of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments, showing the additional step of repeating the other steps;
  • Figure 5 is a block diagram showing flow rates in some preferred embodiments of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments;
  • Figure 6 is a block diagram showing the percentage of carbon dioxide present in the gas in some additional preferred embodiments of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments; and,
  • Figure 7 illustrates a diagrammatic view of various present invention nasal treatment delivery device components and options
  • Figure 8 illustrates a front partially cut view of one embodiment of a present invention nasal treatment delivery device with a pressure release mechanism
  • Figure 9 illustrates a view of one embodiment of a present invention nasal treatment delivery device that is a squeeze to release device
  • Figure 10 shows a front partially cut view of a present invention nasal treatment delivery device with a piercing channel, with the device being held in a hand using two fingers and a thumb to activate release of the medicinal treatment;
  • Figures 11, 12 and 13 illustrate front partially cut views of one embodiment of a present invention nasal treatment delivery device with a frangible internal medicine capsule that may be used for a monodose or multidose using replacement cartridges.
  • the three Figures show the device in different stages of use;
  • Figures 14 and 15 show alternative types of dosage dispenser heads that may be used in present invention devices, one showing multiple release ports and the other showing multiple release ports with a soft contact sheath; and, [00076]
  • Figure 16 is a graphic representation showing present invention dosages that are cleansing biofilms and killing bacteria after one hour versus regular saline treatment and no treatment;
  • Figure 17 is a block diagram of an embodiment of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments;
  • Figure 18 is a block diagram showing head ailments treated by various embodiments of the present invention carbon dioxide, carbonic acid and saline nasal delivery devices;
  • Figure 19 is a block diagram showing durations for therapeutic non-inhaled dosage in some preferred embodiments of the present invention carbon dioxide, carbonic acid and saline nasal delivery devices;
  • Figure 20 is a block diagram of another embodiment of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments, showing the additional step of repeating the other steps;
  • Figure 21 is a block diagram showing flow rates in some preferred embodiments of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments.
  • Saline and “saline solution” as used herein mean water containing salt. Water may be sea water or not sea water. For human use, both sea water and fresh water are purified before consumption. Salt is sodium chloride. Saline solutions are used in a wide variety of medical applications. For example, "normal saline” is the commonly used term for a solution of 0.90% w/v of sodium chloride (NaCl). Normal saline is frequently used in intravenous drips for patients unable to take fluids orally to prevent dehydration. Normal saline is also used to flush wounds and skin abrasions. Another application of saline solution is as a rinse for contact lenses. Saline is also used as a nasal cleanser, but does not inhibit or reduce the causes of nasal congestion, such as rhinitis or sinusitis.
  • Saline solution also is frequently used in nasal washes to treat some of the symptoms of the common cold or other ailments adversely affecting the nasal cavities. By irrigating the nasal passages with saline, inflammation can be reduced. Also, more concentrated
  • hypothalamic solutions of NaCl can have therapeutic uses.
  • 7% NaCl/water solutions are considered mucoactive agents and as such are used to hydrate thick secretions (mucous) in order to make it easier to cough up and out (expectorate).
  • Another chemical substance useful in medical treatments is carbon dioxide.
  • One example is the use of diluted carbon dioxide by inhalation for treating symptoms related to headaches, allergies, asthma, nervous disorders, and other common ailments, which was demonstrated in the 1940s and 1950s.
  • Another example is the use of high-concentration, non- inhaled carbon dioxide, delivered to the nasal passages locally. This type of treatment may provide fast relief without the adverse side effects of systemic drugs that are inhaled, ingested, or injected.
  • Carbon dioxide when dissolved in water, and, as in the present invention, when dissolved in saline, will dissolve so as to include dissolved gas, as well as some in situ formed carbonic acid and some possible other ionic constituents.
  • This formed carbonic acid functions as a separate active so as to aid in the reduction of the pH of the dosage and to thus function as an antibacterial agent and with efficacy in disrupting biofilms.
  • carbonic acid is formed when the carbon dioxide is dissolved, and in some embodiments no additional carbonic acid is added, whereas in other embodiments, additional carbonic acid is added to the dosage.
  • the amount of carbonic acid depends upon temperature, pressure, pH and carbon dioxide dissolved- then it is the amount that forms for that stoichiometry at equilibrium. If additional carbonic acid is added, then equilibrium shifts and the amount of carbonic acid in the dosage is increased above in situ formation equilibrium.
  • About 0.01 % up to and including 0.4 % by weight of carbonic acid based on the total weight of the dosage is the desired range, although more or less could be included.
  • Preferred range of carbonic acid is 0.01 % to 0.1%, and most preferred is 0.02% to 0.08% by weight based on the total weight of the dosage.
  • the present invention involves combining the beneficial therapeutic effects of saline treatment and carbon dioxide/carbonic acid treatment that, relative to either component, is an improved and synergistic therapy with unexpected favorable consequences.
  • the beneficial effects of the saline such as reduced inflammation and expectoration of mucous
  • carbon dioxide therapy such as relief from headaches, allergies, asthma, nervous disorders, and other common ailments.
  • the saline moisturizes the nasal cavities and acts as a base host for the carbon dioxide as it acts on the nasal cavity walls. (It is hypothesized that at least some of the carbon dioxide is adsorbed by the saline.)
  • the saline reduces any slight burning that might otherwise be felt from the carbon dioxide.
  • the benefits of saline treatment are supplemented by the benefits of carbon dioxide treatment, and the benefits of carbon dioxide treatment are supplemented by the benefits of saline treatment.
  • This combination of utilizing the saline to perform at least moisturizing and other beneficial affects while carrying and enhancing the delivery of the carbon dioxide is an unexpected synergistic result thereof.
  • unexpected results are obtained. Specifically, much smaller dosages of carbon dioxide (orders of magnitude less) are used to obtain better results than gaseous carbon dioxide, and the kill rate as shown by biofilm independent testing is evident versus saline, wherein no kill rate is observed.
  • the present invention device using carbon dioxide and saline nasal delivery methods and treatments have other synergistic benefits that are not available from either saline treatment or carbon dioxide treatment alone.
  • the presence of dissolved carbon dioxide in the saline solution means that the solution will be carbonated; the effervescent effect of the carbon dioxide helps the saline solution to mix more energetically against the interior surface of the nasal cavity or cavities. This improved mixing allows the saline treatment to be more effective.
  • Another potential advantage of combining carbon dioxide and saline treatments is that in some embodiments, with sufficient pressure and a proper nozzle, the carbon dioxide can act as a carrier gas for the saline, allowing the saline solution to be aerosolized. This means that a more well-distributed delivery occurs.
  • the combination of controlled delivery carbon dioxide and saline provides the following: it cleanses the nasal cavity removing allergens and particulates that cause inflammation and congestion; its special formula shields nasal mucosa from viruses; it soothes and moisturizes irritated mucosa; its unique buffering system neutralizes inhaled irritants such as oxidative free radicals and endogenous cytotoxins which cause inflammation and damage to the sensitive mucosa and muco-cillary hairs in the nasal cavity; it enhances mucous clearance and flow by reducing mucus viscosity; its superior safety profile gives it broader application than corticosteroids and decongestants and can be used safely in children 6 months of age and adults, even with co-morbidities such as diabetes, hypertension, suppressed immune systems and pregnant and nursing females; and its exceptional safety profile allows for flexible dosing. In addition, it will inhibit and even destroy the causes of such ailments as rhinitis and sinusitis, unlike
  • W-l 4 (Hypotonic D) Purif. Water 98.6% 0.8 % 0.3% ⁇ 0.2% micronutrients W-15 (Hypertonic A) Purif. Water 97.9% 1.8 % 0.3% 0%
  • Choice can be any one or more additional active additives, including, but not limited to mineral supplements, vitamin supplements, micronutrients such as are found in sea water or otherwise added, humectants, decongestants and others. Choice may include one or more of these or as otherwise set forth in the above tables, as well as Table 3, below.
  • the preferred salt is sodium chloride
  • other nasal cavity-acceptable and functional salts may partially or fully replace the sodium chloride.
  • active additives could be significantly higher in content, such as analgesics or vitamins that have optimal efficacy at 5 % could be included, wherein water/salt content would be reduced accordingly.
  • the carbon dioxide therein does not exceed 1.0 % by weight based on the entire weight of the dosage.
  • the carbon dioxide therein is in the range of 0.1 % to 1.0 % by weight based on the entire weight of the dosage.
  • the carbon dioxide therein is in the range of 0.2 % to 0.8 % by weight based on the entire weight of the dosage.
  • the carbon dioxide therein is in the range of 0.2 % to 0.6 % by weight based on the entire weight of the dosage.
  • Table 3 illustrates numerous active additives that may be included in the saline/carbon dioxide solutions of the present invention. Many specifics can now be realized from Table 3 without enumerating thousands upon thousands of potential additives.
  • Figure 1 is a block diagram of an embodiment of the present invention device and carbon dioxide, carbonic acid and saline nasal delivery methods and treatments.
  • Figure 1 illustrates a therapeutic non-inhaled dosage 1 containing saline fluid 3,a gas containing carbon dioxide 5 and carbonic acid 6.
  • the saline fluid 3 contains water and at least one salt.
  • the salt is sodium chloride. In other words, the salt is sodium chloride.
  • the concentration of salt in the saline fluid is approximately isotonic with the salt concentration of bodily fluids.
  • the concentration of salt in the saline fluid is less than the concentration of salt in bodily fluids, i.e., is hypotonic (less than human bodily fluid salt content).
  • the concentration of salt in the saline fluid is hypertonic, meaning that it has a salt concentration higher than that of bodily fluids.
  • the saline solution is saturated with salt.
  • the gas 5 contains some portion of carbon dioxide, and is preferably all carbon dioxide into the saline, but dissolves in the saline and also carbonic acid 6 is formed in situ. Additional carbonic acid may optionally be added to lower pH further. Human tolerable acid pH levels are desirable and may range in the area of 3.5 to 4.6. When the gas 5 containing carbon dioxide is added to the saline fluid 3, the saline fluid 3 becomes carbonated.
  • the pressure can later be released (for example by opening a valve, e.g., by pushing or pressing), which causes some of the carbon dioxide to bubble out with the solution for a well dispersed mixture of the gas and liquid. This sudden release of carbon dioxide in the saline creates effervescence in the therapeutic non-inhaled dosage.
  • the therapeutic non-inhaled dosage travels through a flow-regulating device 7.
  • the flow-regulating device 7 controls the flow rate 9 of the therapeutic non-inhaled dosage 1 at a rate that is safe and comfortable for the patient.
  • the flow rate 9 of the therapeutic non-inhaled dosage that contains the combined saline fluid, dissolved carbon dioxide, carbonic acid and optional at least one additional active component 12 (through an exit flow channel) does not exceed 5 cubic centimeter per second (cc/sec) and the carbon dioxide therein does not exceed 1.0 % by weight based on the entire weight of the dosage.
  • this flow rate is in the range of 0.2 cc per second to 5.0 cc per second for the combined saline fluid, dissolved gas carbon dioxide, carbonic acid and optional at least one additional active component, and the carbon dioxide therein is in the range of 0.1 % to 1.0 % by weight based on the entire weight of the dosage. More preferably, in some embodiments, this flow rate is in the range of 0.4 cc per second to 4.0 cc per second for the combined saline fluid, dissolved gas carbon dioxide, carbonic acid and optional at least one additional active component and the carbon dioxide therein is in the range of 0.2 % to 0.8 % by weight based on the entire weight of the dosage.
  • this flow rate is in the range of 0.4 cc per second to 2 cc per second for the combined saline fluid, dissolved gas carbon dioxide, carbonic acid and optional at least one additional active component and the carbon dioxide therein is in the range of 0.2 % to 0.6 % by weight based on the entire weight of the dosage.
  • Excellent results have been obtained with present invention overall flow rates of about 1 ⁇ 2 to 1 cc/sec, and carbon dioxide flowing based on percentages such as shown above and as in Tables 1 and 2 above.
  • Figure 1 also clearly shows optional additional active additives, block 12, and may be any, in any combination as described elsewhere herein.
  • the therapeutic non-inhaled dosage 1 has a flow duration 11.
  • the flow duration 11 is the length of time during which the therapeutic non-inhaled dosage flows through the flow regulating device into at least one nasal cavity 13 of a patient.
  • the flow duration 11 is shown as lasting between 1/2 and 10 seconds.
  • the flow duration is adjustable to any value based on the lime the user depresses or pushes on the valve activator or other release mechanism. Excellent results have been obtained with single shots and multiple shots to the nasal cavity of 1 ⁇ 2 to 3 seconds.
  • the therapeutic non-inhaled dosage 1 After the therapeutic non-inhaled dosage 1 leaves the flow regulating device 7, it enters at least one nasal cavity 13 of a patient.
  • the therapeutic non-inhaled dosage 1 is adsorbed by the nasal tissue and subsequently absorbed by the body. This adsorption and subsequent absorption can have a beneficial effect on many head ailments, some of which are shown in Figure 2.
  • the effervescent effect of the gas 5 containing carbon dioxide causes better contact between the salt and carbonic acid in the saline solution 3 and the nasal tissue.
  • the gas helps in the creation of more of a mist than when there is no gas, distribution is broader and gentler; the transport phenomena are enhanced- the gas holds the liquid up and there is less dripping, likewise, the gas increases the surface area of the liquid, and the liquid holds the gas in place in the nasal cavity.
  • FIG. 2 a block diagram, block 20, shows some of the medical conditions that can be treated using the present invention device with carbon dioxide and saline nasal delivery methods and treatments.
  • the carbon dioxide and saline nasal delivery methods and treatments treat rhinitis 17, a swelling of some internal parts of the nose.
  • the present invention treats allergic rhinitis 19.
  • the present invention treats conjunctivitis 21, an inflammation of the conjunctiva also known as pink-eye.
  • the common cold 23 is treated.
  • sinusitis 25 an inflammation of the sinuses, is treated.
  • the present invention is used to treat headaches 27. It is important to recognize that in some embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments, multiple conditions can be treated simultaneously. For example, a patient may be suffering from both sinusitis and headache simultaneously; the present invention can alleviate both conditions at the same time.
  • the present invention can treat any ailment shown in Figure 2 or any combination of those ailments. It should also be recognized that the present invention may be useful in treating other ailments, particularly head ailments. The treatment of other ailments on which the present invention carbon dioxide and saline nasal delivery methods and treatments is effective are considered to be within the scope of the invention.
  • FIG. 3 a block diagram, block 30, shows the durations of therapeutic non-inhaled dosage used in some embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments.
  • the durations listed in Figure 3 are ranges, so the actual duration can be any value between the low end of the range and the high end of the range, inclusive.
  • the duration 29 lasts between 0.5 and 10 seconds.
  • the duration 31 lasts between 0.5 and 4 seconds.
  • the duration 33 lasts between 1 and 4 seconds.
  • Figure 4 is a block diagram of an embodiment of the present invention carbon dioxide, carbonic acid and saline nasal delivery methods and treatments that incorporates many aspects shown in Figure 1, and identical blocks are identically numbered.
  • Figure 4 illustrates a therapeutic non-inhaled dosage 1 containing saline fluid 3, a C0 2 gas 5 and carbonic acid 6.
  • the saline fluid 3 contains water and at least one salt.
  • the salt is sodium chloride.
  • the concentration of salt in the saline fluid is approximately isotonic with the salt concentration of bodily fluids. In other preferred
  • the concentration of salt in the saline fluid is less than the concentration of salt in bodily fluids.
  • the concentration of salt in the saline fluid is hypertonic, meaning that it has a salt concentration higher than that of bodily fluids.
  • the saline solution is saturated with salt.
  • the gas 5 contains some portion of carbon dioxide.
  • the gas 5 containing carbon dioxide is added to the saline fluid 3, the saline fluid 3 becomes carbonated and, as well, in situ formation of carbonic acid in an equilibrium amount, is formed. If the therapeutic non-inhaled dosage 1 containing saline fluid 3, carbonic acid 6 and the gas 5 is kept under pressure, the pressui e can later be released (for example by opening a valve), which causes some of the carbon dioxide to bubble out of the solution. This sudden release of carbon dioxide creates
  • the therapeutic non-inhaled dosage travels through a flow-regulating device 7.
  • the flow-regulating device 7 controls the flow rate 9 of the therapeutic non-inhaled dosage 1 at a rate that is safe and comfortable for the patient.
  • the flow rate 9 of the therapeutic non-inhaled dosage does not exceed the specified upper limit for both the total content (all) and there is a specified limit for the carbon dioxide (based on wt.).
  • the therapeutic non-inhaled dosage 1 has a flow duration 11.
  • the flow duration 11 is the length of time during which the therapeutic non-inhaled dosage flows through the flow regulating device into at least one nasal cavity 13 of a patient.
  • the flow duration 1 1 is shown as lasting between 0.5 and 10 seconds. In preferred embodiments of the present invention, the flow duration is adjustable to any value between those two range ends.
  • the therapeutic non-inhaled dosage 1 After the therapeutic non-inhaled dosage 1 leaves the flow regulating device 7, it enters at least one nasal cavity 13 of a patient.
  • the therapeutic non-inhaled dosage 1 is adsorbed by the nasal tissue. This adsorption can have a beneficial effect on many head ailments, some of which are shown in Figure 2.
  • the effervescent effect of the gas 5 containing carbon dioxide causes better contact between the salt in the saline solution 3, the carbonic acid 6 therein, and the nasal tissue.
  • the additional step 15 of instructing the patient to refrain from inhaling protects the patient from accidently inhaling the therapeutic non-inhaled dosage 1, but is not essential and breathing may occur during use.
  • the dose is repeated 35.
  • the dose is repeated 35 between one and ten times.
  • the dose is repeated more than ten times.
  • the step 35 of repeating the dose can be used if a single application of the therapeutic non- inhaled dosage 1 is insufficient to alleviate the head ailment or ailments from which the patient suffers.
  • the present invention has numerous applications including, but not limited to, daily cleansing, event cleansing, cold treatments, allergy treatments, etc.
  • the number of repeat dosing may also depend on the intended purpose. For example, if daily cleansing is intended, only a single dose is usually sufficient. On the other hand, if a patient with extreme allergies has just come in from a romp in the fields or a baseball game in the springtime when pollen and other allergens are in full force, multiple dosing is recommended for more effective relief.
  • FIG. 5 a block diagram, block 50, shows flow rates used in some embodiments of the present invention device carbon dioxide, carbonic acid and saline nasal delivery methods and treatments.
  • the flow rates used in Figure 5 are shown as ranges, and the actual rate of the flow may any value between the low end of the range and the high end of the range, inclusive. In this Figure, these rates are for saline, carbonic acid and carbon dioxide, as well as the embodiments that include one or more other actives. The rates are the same as those elaborated upon supra.
  • FIG. 6 a block diagram, block 60, shows levels of carbon dioxide in the gases used in some embodiments of the present invention devices.
  • the levels of carbon dioxide are expressed as a percentage of the gas (3 in Figures 1 and 4) used in the therapeutic non-inhaled dosage (1 in Figures 1 and 4).
  • the amount of carbon dioxide 47 in the gas is at least 50%.
  • the amount of carbon dioxide 49 in the gas is at least 70%.
  • the amount of carbon dioxide 51 in the gas is at least 95%.
  • the amount of carbon dioxide 53 in the gas is substantially 100%. Gases with a percent composition of less than 50% carbon dioxide are also considered to be within the scope of the invention. Although 100% carbon dioxide is preferred, when less than 100% carbon dioxide is used, the other gas or gases may be nitrogen, oxygen, or otherwise.
  • Nitrogen is preferred.
  • FIG. 7 illustrates a block diagram showing nasal treatment delivery devices that may be used in the present invention methods.
  • block 71 illustrates the caption of the Figure, namely, nasal treatment delivery device.
  • the present invention device 71 may be a single dose dispenser (monodose) with a pressure control valve for flow rate regulation. The rate of flow is set in accordance with the ranges set forth above.
  • a monodose dispenser the entire dose is dispensed, so that time of dispensing does not need to be controlled- it is just the controlled flow rate over time it takes to unload the dose.
  • a monodose dispenser may controllably release a pressurized mixture of the carbon dioxide and the saline with or without the addition of actives , until it stops flowing.
  • a plural or multidose dispenser may be used, and needs dispensing on/off control such as a spring return push mechanism/valve, otherwise the entire contents could be unnecessarily released in one shot.
  • driver 75 and block 77 The various types of mechanisms for driving the contents from the container to the nasal cavity are represented as driver 75 and block 77 provides specific examples. These include squeeze mechanisms where the squeeze component or bulb is below the content so that external squeeze pressure forces out the content, much like a turkey baster; squeeze mechanisms where the squeeze component is the actual dose holding aspect of the container, like a nasal
  • decongestant squeeze spray container push mechanisms that physically operate much like syringes but may have more complex internal aspects, such as piercers or counter-biased valving; and others, referring to any known controlled flow mechanism available to the artisan, e.g., a pressurized container with a push release mechanism..
  • block 73 shows the main housing and dosage. It contains a dosage of saline fluid, carbonic acid and carbon dioxide, with or without other actives, according to parameters as more specifically set forth above.
  • Block 79 shows that the main housing 73 may have two open ends or one open end. In the case of one open end, the top end would include the release control and dispenser head mechanisms, with a closed bottom. In the case of a main housing with two open ends, one end would have the release control and dispenser head mechanisms and the other end would contain a moveable drive mechanism such as a pressure release mechanism, a piercer or a plunger (drive piston).
  • Block 81 shows that the main housing 73 may be at least partially flexible or it may be inflexible. If the driver is the squeezing of the main housing, it must be flexible. If the driver a moveable component attached to the main housing 71 (a push or squeeze mechanism), then the main housing 71 is preferably inflexible.
  • Block 83 shows the dosage release control component.
  • Block 85 illustrates the options for the dosage release control component, which are: frangible, puncturable, one-way valve, or gate.
  • Block 87 shows the dosage dispenser head, which Block 89 then shows the options for, which are: perforated, hard, soft, or delivery cover (sponge, foam, cotton batting, or other).
  • Block 74 shows the optional nose guard flange for the nasal treatment delivery device 71.
  • Figure 8 illustrates a front partially cut view of one embodiment of a present invention nasal treatment delivery device 90. It includes a main housing 91 with a top 93 having a hollow central area containing a dosage of the present invention medicine. This storage area may be the inside of the main housing, or it may be one or more subunits- compartments, capsules, tanks, pouches, etc, within the main housing. [000120] In this embodiment, the main housing 91 has attached to its distal end a dosage control component that is a spray release nozzle 95 that is set for prescribed flow rates within the ranges set forth in the present invention claims and as described above.
  • a dosage control component that is a spray release nozzle 95 that is set for prescribed flow rates within the ranges set forth in the present invention claims and as described above.
  • Internal bag container 105 contains the liquid/ gas mixture of the present invention and external pressure on bag 105 is created by pressurized gas located in space 107 inside main housing 91.
  • a dosage dispenser head in this case, a push dispenser mechanism 97 that includes release orifice 101, actuation tube 99 and push pad 103.
  • a user inserts push dispenser mechanism 97 into a nasal cavity at its distal end (orifice 101) while holding nasal treatment delivery device 90 and then pressing push pad 103 to release the contents.
  • the flow regulation is set to an acceptable range so as to be relatively gentle to the user. This may include ranges in the order of 1 cc/sec to 10 cc per second.
  • this is a multidose device wherein the user is given instructions to dispense for a specified time period while not breathing, e.g., three seconds at full depression per nostril twice a day as needed.
  • a built-in timer could automatically control the dose.
  • the device could have a slow spring closure that would require reset and re-push to reactivate.
  • Figure 9 shows an alternative nasal treatment delivery device 110.
  • This is an insert and squeeze device that includes a main body 111 with flexible walls and a dispensing nozzle 11 at its top 113.
  • FIG. 10 shows a front partially cut view of a present invention nasal treatment delivery device 120 being held in a hand using two fingers and a thumb, as shown.
  • a main housing 121 and a vertically moveable piston 131.
  • a rigid, semi-flexible or flexible container or pouch 123 contains the liquid/gas mixture of the present invention and piercing tube 125 is connected to flow control valve 127.
  • a user holds nasal treatment delivery device 120 as shown, inserts it into a nasal cavity, and while not breathing, pushes piston 131 upwardly to force pouch 123 to rupture via piercing tube 125 for medicine release through valve 127 to the nasal cavity walls.
  • Figures 11, 12 and 13 illustrate front partially cut views of one embodiment of a present invention nasal treatment delivery device 150 with a frangible internal medicine capsule 171 containing medicine 175-the gas and liquid mixtures described above.
  • Device 150 may be used for a monodose or multidose using replacement capsules.
  • the three Figures show the device in different stages of use. Identical number is used for all three of the figures and the device 150 is described collectively for all of these figures.
  • Device 150 is a push device that relies upon a frangible capsule 171 to deliver the medicine 175 by breaking open the top 173 of the frangible capsule 171.
  • Device 105 includes a main housing 151 designed with both an open top and an open bottom, as shown. Permanently inserted into the open top of main housing 151 is a dosage dispensing head 161, with release tube 165 and control valve 153. Dosage dispensing head 161 has a downward hemispherical end 163 for puncturing the top 173 (e.g., a foil top) of capsule 171.
  • Capsule 171 may be permanently installed in main housing 151, or it may be removably placed therein so that subsequent capsules may be inserted, the former being a monodose and the latter being a multidose device.
  • capsule 171 may be fully frangible, but is preferably so only at its top 173.
  • Capsule 171 could have different shape, such as a hemispherical bottom to correspond to the shape of the end 163 of the dosage dispensing head 161. Or both could have other shapes and be the same or different, e.g., a chisel shaped end/bottom.
  • Plunger 157 has a sealed pistonl59 at its distal end and a widened finger rest at its proximal end. Plunger 157 may be inserted at its distal end permanently or removably, and its piston 159 may be any shape, but is preferably the same or similar to the bottom of the capsule.
  • the piston 159 is used to drive the capsule 171 into breaker end 163, as shown sequentially in Figures 1 1, 12 and 13.
  • Figure 1 1 a user's thumb and first two fingers are shown embracing the plunger 157 and the platform 167, respectively.
  • the frangible top 173 is broken and the gas/liquid medicine begins release from the device 150 (Figure 12).
  • the medicine is nearly fully expended by the time the plunger 157 is pushed maximally and the top 163 is near or at the bottom of the capsule 171 ( Figure 13), to deliver the medicine to the user effectively.
  • Figures 14 and 15 show alternative types of dosage dispenser heads that may be used in present invention device one has multiple release ports and the other has multiple release ports with a soft contact sheath.
  • Figure 14 shows a cut front view of one dosage dispenser head 180 that may be used in conjunction with a present invention device. It includes a control valve 181 to regulate release of medicine to be within the proscribed ranges set forth above. Upstream from control valve 181 is a main flow channel 183 with branches 185, 187, 189, 191,193 and 195 to show a diverse multiport manifold head for diverse. This dosage dispensing head will direct the gas/liquid medicine in many directions simultaneously to more evenly and quickly coat the sinus cavity wall.
  • Figure 15 shows a similar present invention dosage dispensing head 200, but with a soft pad for nasal wall comfort.
  • This pad does not cover the ports and may be made of soft pervious or impervious materials such as various foams or skins. Alternatively, they may be previous and cover the parts so as to create wetting foams or sponges to effect broad based medicine placement in the nasal cavity.
  • the ratio of carbon dioxide to salt may be any therapeutic amount. However, typically carbon dioxide saturated saline or close to saturation may be used. Alternatively, levels of carbon dioxide may be below saturation or supersaturated, as mentioned, and the levels of actives added to the solution are a matter of choice.
  • the additive(s) are added to the saline and then the carbon dioxide is injected or otherwise added. Alternatively, the additives may be already in the solution and others may optionally be added, such as sea water with natural additives to which vitamins are further added.
  • Figure 16 shows comparative graph bars for present invention sparkling saline products A, B, C, D and E, and for a reference product (conventional prior art saline without the carbon dioxide and carbonic acid of the present invention).
  • the tests were performed by an independent testing lab and consistent biofilms (normalized to match) of staph bacteria (24 hour growth s. aureus biofilm).
  • Identical spays of present invention products A through E and the Reference Prior Art saline (0.9% isotonic) were used in the experiment.
  • the solid bars represent relative populations of the bacteria one half hour after treatment, and the dotted diamond bars represent relative populations of the bacteria after one hour.
  • Figure 17 is a block diagram of an embodiment of the present invention low flow rate device carbon dioxide and saline nasal delivery methods and treatments.
  • Figure 17 illustrates a therapeutic non-inhaled dosage 301 containing saline fluid 303 and a gas 305.
  • the gas 305 includes carbon dioxide and is most preferably only carbon dioxide, dissolved in the saline fluid.
  • the saline fluid 303 contains water and at least one salt.
  • the salt is sodium chloride.
  • other salts may be used, but it is important that any salt used in the saline fluid 303 must be safe for intranasal use.
  • the concentration of salt in the saline fluid is approximately isotonic with the salt concentration of bodily fluids. In other preferred embodiments, the concentration of salt in the saline fluid is less than the concentration of salt in bodily fluids. In still other preferred embodiments, the concentration of salt in the saline fluid is hypertonic, meaning that it has a salt concentration higher than that of bodily fluids. In still other preferred embodiments, the saline solution is saturated with salt.
  • the gas 305 contains some portion of carbon dioxide.
  • the gas 305 containing carbon dioxide is added to the saline fluid 303, the saline fluid 303 becomes carbonated.
  • the pressure can later be released (for example by opening a valve), which causes some of the carbon dioxide to bubble out of the solution. This sudden release of carbon dioxide creates effervescence in the therapeutic non-inhaled dosage.
  • the therapeutic non-inhaled dosage travels through a flow-regulating device 307.
  • the flow-regulating device 307 controls the flow rate 309 of the therapeutic non-inhaled dosage 301 at a rate that is safe and comfortable for the patient.
  • the flow rate 309 of the therapeutic non-inhaled dosage is a low flow rate of less than 1 cubic centimeter per second (cc/sec).
  • the flow rate is adjustable to any value below 1 cc/sec that will provide some efficacy. This is discussed in further detail below.
  • the therapeutic non-inhaled dosage 301 has a flow duration 311.
  • the flow duration 311 is the length of time during which the therapeutic non-inhaled dosage flows through the flow regulating device into at least one nasal cavity 313 of a patient.
  • the flow duration 311 is shown as lasting between 0.4 and 16 seconds, inclusive. In preferred embodiments of the present invention, the flow duration is adjustable to any value between 0.4 and 16 seconds.
  • the therapeutic non-inhaled dosage 301 After the therapeutic non-inhaled dosage 301 leaves the flow regulating device 307, it enters at least one nasal cavity 313 of a patient.
  • the therapeutic non-inhaled dosage 301 is adsorbed by the nasal tissue and subsequently absorbed by the body. This adsorption and subsequent absorption can have a beneficial effect on many head ailments, some of which are shown in Figure 18.
  • the effervescent effect of the gas 305 containing carbon dioxide causes better contact between the salt in the saline solution 303 and the nasal tissue.
  • An optional additional step of instructing the patient to refrain from inhaling 315 protects the patient from accidently inhaling the therapeutic non-inhaled dosage 301. This is important, for a number of reasons, and one is that if the user inhales, some of the dosage bypasses the nasal cavity where it is most effective if left to dwell there. However, holding one's breathe is not essential, but preferred. Also, when the concentration of salt in the saline solution 303 is greater than isotonic (particularly if salts other than sodium chloride are used), it is desirable to limit the patient's exposure to the salts. The step 315 of instructing the patient not to breathe accomplishes these goals.
  • FIG 18, a block diagram, block 320, shows some of the medical conditions that can be treated using the present invention device with carbon dioxide and saline nasal delivery methods and treatments.
  • the carbon dioxide and saline nasal delivery methods and treatments treat rhinitis 317, a swelling of some internal parts of the nose.
  • the present invention treats allergic rhinitis 319.
  • the present invention treats conjunctivitis 321, an inflammation of the conjunctiva also known as pink-eye.
  • the common cold 323 is treated.
  • sinusitis 325 an inflammation of the sinuses, is treated.
  • the present invention is used to treat headaches 327. It is important to recognize that in some embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments, multiple conditions can be treated simultaneously. For example, a patient may be suffering from both sinusitis and headache simultaneously; the present invention can alleviate both conditions at the same time.
  • the present invention can treat any ailment shown in Figure 18 or any combination of those ailments. It should also be recognized that the present invention may be useful in treating other ailments, particularly head ailments. The treatment of other ailments on which the present invention carbon dioxide and saline nasal delivery methods and treatments is effective are considered to be within the scope of the invention.
  • a block diagram, block 330 shows the durations of therapeutic non-inhaled dosage used in some embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments.
  • the durations listed in Figure 19 are ranges, so the actual duration can be any value between the low end of the range and the high end of the range, inclusive.
  • the duration 329 lasts between 0.4 and 16 seconds.
  • the duration 331 lasts between 0.5 and 8 seconds.
  • the duration 333 lasts between 0.8 and 4 ten seconds. Durations of less than 0.4 seconds and more than 16 seconds are also considered to be within the scope of the invention.
  • FIG 20 is a block diagram of an embodiment of the present invention carbon dioxide and saline nasal delivery methods and treatments that incorporates many aspects shown in Figure 17, and identical blocks are identically numbered.
  • the dose is repeated 335.
  • the dose is repeated 335 between one and ten times.
  • the dose is not repeated or repeated only once. While it is shown here that multiple repeat dosages can be administered, it is preferred that single doses be administered for normal use.
  • the step 335 of repeating the dose can be used if a single application of the therapeutic non-inhaled dosage 301 is insufficient to alleviate the head ailment or ailments from which the patient suffers.
  • a block diagram, block 350 shows flow rates used in some embodiments of the present invention device carbon dioxide and saline nasal delivery methods and treatments.
  • the flow rates used in Figure 21 are shown as ranges, and the actual rate of the flow may any value between the low end of the range and the high end of the range, inclusive.
  • a rate 337 less than 1 cc/sec is used.
  • a flow rate 339 between 0.01 cc/sec and less than 1 cc/sec is used.
  • a flow rate 341 between 0.08 cc/sec and up to(less than) 1 cc/sec is used.
  • still other preferred embodiments are shown as ranges, and the actual rate of the flow may any value between the low end of the range and the high end of the range, inclusive.
  • a rate 337 less than 1 cc/sec is used.
  • a flow rate 339 between 0.01 cc/sec and less than 1 cc/sec is used.
  • a flow rate 341 between 0.08 cc/
  • a flow rate 343 between 0.1 cc/sec and up tol cc/sec is used.
  • a flow rate 345 of 0.3 to 0.8 cc/sec is used.
  • active additives refer to additional active components that are inherent or are added during preparation and have an additional function.
  • a solution from a natural spa would have micronutrients in addition to the salt and water.
  • sea water may be purified and selectively reconstituted to have controlled levels of salt, as well as other natural additives, such as beneficial minerals and metals.
  • delivery devices described herein are shown for nasal passage delivery, these same devices with the same contents claimed could be otherwise used, for example, to clean ears or other bodily cavities, to rinse mouths, or even to flush and/or treat wounds.

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Abstract

La présente invention concerne une méthode associée à un dispositif de traitement et d'administration d'un mélange de dioxyde de carbone, d'acide carbonique, d'une solution saline et d'additifs actifs facultatifs pour le traitement d'affections de la tête qui comprend l'administration d'une dose du traitement à des débits spécifiés, au moyen a) d'un logement principal comportant une zone centrale creuse contenant ladite dose ; b) d'une tête de distributeur de dose située à l'extrémité distale du logement principal, et comprenant au moins un canal d'écoulement pour le déplacement de la dose du logement principal à travers la tête du distributeur de dose et vers l'extérieur de la tête de distributeur de dose ; c) d'un composant de commande de libération de dose situé entre le logement principal et la tête de distributeur de dose pour permettre l'écoulement de la dose à travers la tête de distributeur de dose en réponse à une augmentation de la pression en fonction de la dose ; et d) d'un composant mobile à pression variable sur le logement principal.
PCT/US2017/000009 2016-02-05 2017-01-31 Dispositif d'administration de traitement nasal comprenant du dioxyde de carbone et une solution saline, et méthodes, comprenant de faibles débits WO2017136087A1 (fr)

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EP17747890.6A EP3411094A4 (fr) 2016-02-05 2017-01-31 Dispositif d'administration de traitement nasal comprenant du dioxyde de carbone et une solution saline, et méthodes, comprenant de faibles débits
CA3013821A CA3013821C (fr) 2016-02-05 2017-01-31 Dispositif d'administration de traitement nasal comprenant du dioxyde de carbone et une solution saline, et methodes, comprenant de faibles debits

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US14/998,704 2016-02-05
US14/998,704 US20170224936A1 (en) 2016-02-05 2016-02-05 Nasal treatment delivery device with carbon dioxide and saline, and methods
US14/999,292 US10052464B2 (en) 2012-06-04 2016-04-22 Low flow rate nasal treatment delivery device for mixed carbon dioxide and saline
US14/999,292 2016-04-22

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CA3013821A1 (fr) 2017-08-10

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