EP3043650A2 - Carbon dioxide and saline nasal delivery methods and delivery devices - Google Patents
Carbon dioxide and saline nasal delivery methods and delivery devicesInfo
- Publication number
- EP3043650A2 EP3043650A2 EP13893220.7A EP13893220A EP3043650A2 EP 3043650 A2 EP3043650 A2 EP 3043650A2 EP 13893220 A EP13893220 A EP 13893220A EP 3043650 A2 EP3043650 A2 EP 3043650A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- dosage
- carbon dioxide
- saline
- patient
- nasal
- Prior art date
- Legal status (The legal status 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 status listed.)
- Ceased
Links
Classifications
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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
- A61M11/007—Syringe-type or piston-type sprayers or atomisers
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- 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
Definitions
- This invention relates generally to healthcare, and specifically to the treatment of head ailments. More specifically, the present invention relates to intranasal delivery methods and treatments with carbon dioxide and saline; and with carbon dioxide, saline and other active components, as well as to devices used in these methods. These treatment methods and devices result in reduction of nasal passage swelling and congestion and treatment of causes of such swelling and congestion. 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 cleanable 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 prodrug of an EP2 agonist which topically exhibits a prolonged bronchodilating and antiinflammatory effects.
- the medicinal composition for inhalation containing a continuous-release type prodrug 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
- [0007J 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 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. 2008/0078382 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. 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. 2002/0040205 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 histamine. 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 for treating ailments in a patient in need thereof. It includes the step of directing a therapeutic, non-inhaled dosage to at least one nasal cavity of the patient through a flow regulating device.
- the dosage includes a saline fluid and a gas containing carbon dioxide, and I some embodiments, at least one additional active component, wherein the therapeutic, non-inhaled dosage is delivered at a flow rate from 1 cc/sec to 20 cc/sec for a duration of 2 to 30 seconds.
- the invention includes the step of having the patient substantially refrain from inhaling while the fluid is being released.
- the head ailment is rhinitis.
- the head ailment is conjunctivitis.
- the head ailment is the common cold.
- the head ailment is sinusitis.
- the head ailment is a headache.
- the flow regulating device is a single 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.
- the multiple dose dispenser further includes a dosage amount control mechanism and activator to limit dosage release amount for each activation.
- the duration is 5 to 10 seconds per nasal cavity.
- the duration is 2 to 15 seconds per nasal cavity.
- the dose is repeated from 1 to 10 times.
- the method for treating ailments in a patient in need thereof, is for treating rhinitis and the rhinitis is allergic rhinitis.
- the flow rate is from 2 cc/sec to 10 cc/sec.
- the flow rate is from 1 cc/sec to 5 cc/sec.
- the flow rate is from 4 cc/sec to 5 cc/sec.
- the gas includes at least 50% carbon dioxide.
- the gas includes at least 70% carbon dioxide.
- the gas includes at least 95% carbon dioxide.
- the gas includes at least 100% carbon dioxide.
- the present invention is directed to a nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof, comprising: 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 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 a nasal cavity wall.
- the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof is an open ended tube with the dosage release control component and the dosage dispenser 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 nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof the pressure-changing moveable component is a flexible squeeze member and a seal float.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof the pressure-changing moveable component is a push-up piston.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof 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 nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof the dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof has a plurality of flow channels.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof has a circular shape from a top viewpoint.
- the nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof comprising: 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 nose guard flange connected to and extending from at least one of the main housing and the dosage dispenser head; d) 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; e) a pressure-changing move
- Figure la and Figure lb are block diagrams of embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments, with and without one or more additional active components; [00055] All of the following Figures are described as carbon dioxide and saline solutions, it being understood that this means with and without at least one additional active component;
- Figure 2 is a block diagram showing head ailments treated by various embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments;
- Figure 3 is a block diagram showing durations for therapeutic non-inhaled dosage in some preferred embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments;
- Figure 4 is a block diagram of another embodiment of the present invention carbon dioxide 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 additional preferred embodiments of the present invention carbon dioxide 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 preferred embodiments of the present invention carbon dioxide and saline nasal delivery methods and treatments;
- Figure 7 illustrates a block diagram showing monodose and multidose dispensers that may be used in the present invention methods
- 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; and,
- 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.
- Saline and “saline solution” as used herein means water containing salt. 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.
- NaCl sodium chloride
- 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.
- the beneficial therapeutic effects of saline treatment and carbon dioxide treatment are combined with the beneficial effects of 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.
- 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.
- 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.
- At least one additional active component may be any of one or more beneficial additions that are compatible with saline and have some medicinal, curative, pain relieving or moisturizing effect on the sinus cavity walls, vascular system or upper respiratory system.
- beneficial additions include, but are not limited to, moisturizers, humectants, over the counter drugs and prescription drugs.
- Such drugs may be antihistamines, infection treatments, antioxidants, cell growth accelerators, antiinflammatories, vasoconstrictors, nasal decongestants, or other nasal cavity, wall or upper respiratory treatments.
- moisturizers are moisturizers, decongestants, antiWstamines, infection treatments and anti-inflammatories.
- moisturizers and humectants are: glycerin, propylene glycols (MW 400 to 8000), maltodextrins (liquid), honey, pectin,
- topical decongestants are: ephedrine, levomethamphetarnine, naphazoline, oxymetazoline, phenylephrine,
- the actives may also be fragrance sensations or fragrance with other benefits, such as eucalyptus, menthol or lavender.
- Figure la is a block diagram of an embodiment of the present invention carbon dioxide, saline and additional active component(s) nasal delivery methods and treatments.
- Figure la illustrates a therapeutic non-inhaled dosage 1, containing saline fluid 3, a carbon dioxide-containing gas 5 and at least one additional active 17.
- the saline fluid 3 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 3 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
- 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. If the therapeutic non-inhaled dosage 1 containing saline fluid 3 and the gas 5 is kept under pressure, 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 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 is between 1 cubic centimeter per second (cc/sec) and 20 cc/sec.
- the flow rate is adjustable to any value between 1 cc/sec and 20 cc/sec.
- 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 2 and 30 seconds.
- the flow duration is adjustable to any value between 2 and 30 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 in the saline solution 3 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. This is important, even critical, when the therapeutic non-inhaled dosage 1 contains a gas 5 that is substantially 100% carbon dioxide to prevent carbon dioxide poisoning (hypercapnia). Even mild hypercapnia can cause uncomfortable mental and physical effects. Also, when the concentration of salt in the saline solution 3 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 15 of instructing the patient not to breathe accomplishes these goals.
- FIG. 2 a block diagram, block 20, shows some of the medical conditions that can be treated using the present invention carbon dioxide and saline (with and without additional actives) 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.
- 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 2 and 30 seconds.
- the duration 31 lasts between 2 and 15 seconds.
- the duration 33 lasts between 5 and 10 ten seconds. Durations of less than 2 seconds and more than 30 seconds are also considered to be within the scope of the invention.
- Figure 4 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 Figures la and lb, and identical blocks are identically numbered.
- Figure 4 illustrates a therapeutic non-inhaled dosage 1 containing saline fluid 3 and a gas 5.
- the saline fluid 3 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 3 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 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. If the therapeutic non-inhaled dosage 1 containing saline fluid 3 and the gas 5 is kept under pressure, 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 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 is between 1 cubic centimeter per second (cc/sec) and 20 cc/sec.
- the flow rate is adjustable to any value between 1 cc/sec and 20 cc/sec.
- 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 2 and 30 seconds.
- the flow duration is adjustable to any value between 2 and 30 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. 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 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. This is important, even critical, when the therapeutic non-inhaled dosage 1 contains a gas 5 that is substantially 100% carbon dioxide to prevent carbon dioxide poisoning (hypercapnia). Even mild hypercapnia can cause uncomfortable mental and physical effects. Also, when the concentration of salt in the saline solution 3 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 15 of instructing the patient not to breathe accomplishes these goals.
- the dose is repeated 35.
- the dose is repeated 35 between one and ten times. In still other embodiments, 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.
- FIG. 5 a block diagram, block 50, shows flow rates used in some embodiments of the present invention carbon dioxide 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.
- a rate 37 between 1 cc/sec and 20 cc/sec is used.
- a flow rate 39 between 2 cc/sec and 10 cc/sec is used.
- a flow rate 41 between 1 cc/sec and 5 cc/sec is used.
- a flow rate 43 between 4 cc/sec and 5 cc/sec is used. In still other preferred embodiments, a flow rate 45 of approximately 10 cc/sec is used. Embodiments with flow rates of less than 1 cc/sec or more than 20 cc/sec are also considered to be within the scope of the invention.
- FIG. 6 a block diagram, block 60, shows levels of carbon dioxide in the gases used in some embodiments of the present invention.
- 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.
- Figure 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 devices.
- Block 73 shows that the flow regulating device used in the present invention methods 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, until it stops flowing.
- the various types of mechanisms for driving the contents from the container to the nasal cavity are also exemplified. 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.
- block 75 illustrates the use of a multidose dispenser with a pressure control valve for flow rate regulation.
- the rate of flow is set in accordance with the ranges set forth above.
- Block 77 shows one multidose dispenser option wherein the user controls the release time, so that there is variable dosage.
- an activator such as a push button or a squeeze mechanism to release the dosage, and the user may be directed to dispense for a time, e.g., dispense for eight to ten seconds.
- an auto-controlled release mechanism may be used, e.g., a spring return release that closes a valve based on set timing, or a dual spring device with one being reverse spring mechanism that returns a lever to control the time of release.
- Timed valving is well known in the field of medicine dispensing and any available multidose fixed time dispensing mechanism may be utilized.
- block 73 shows the main housing and dosage. It contains a dosage of saline fluid and carbon dioxide gas 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 deb very 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.
- 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.
- 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 At top 93 is 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. Typically 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. Alternatively, a built-in timer could automatically control the dose. For example, 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 115 at its top 113. There is a stop 117 and threads 109 and a tapered dispensing tip 119 designed for nasal cavity insertion. There is a flow control valve 112 that regulates the rate of delivery.
- liquid/gas mixture is contained within the main housing 111 and is dispensed by a user inserting and squeezing while holding his/her breath.
- Figure 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 heminspherical 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 11, 12 and 13.
- 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.
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Abstract
Description
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Application Number | Priority Date | Filing Date | Title |
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PCT/US2013/000207 WO2015038092A2 (en) | 2013-09-10 | 2013-09-10 | Carbon dioxide and saline nasal delivery methods and delivery devices |
Publications (2)
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EP3043650A2 true EP3043650A2 (en) | 2016-07-20 |
EP3043650A4 EP3043650A4 (en) | 2017-11-08 |
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Application Number | Title | Priority Date | Filing Date |
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EP13893220.7A Ceased EP3043650A4 (en) | 2013-09-10 | 2013-09-10 | Carbon dioxide and saline nasal delivery methods and delivery devices |
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EP (1) | EP3043650A4 (en) |
JP (1) | JP2016529082A (en) |
AU (1) | AU2013400183B2 (en) |
CA (1) | CA2923793C (en) |
MX (1) | MX2016002968A (en) |
WO (1) | WO2015038092A2 (en) |
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CA3013821C (en) * | 2016-02-05 | 2022-05-10 | Clover Hill Healthcare, Inc. | Nasal treatment delivery device with carbon dioxide and saline, and methods, including low flow rates |
US11712523B2 (en) | 2018-09-28 | 2023-08-01 | Achilleus LLC | Secure device for delivering medications |
GB2586301B (en) * | 2020-04-07 | 2021-08-25 | Splash Tm Gmbh | Stable-Foam inhalation Device and Cartridge |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
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JPH06312019A (en) * | 1993-04-30 | 1994-11-08 | Shinko Kagaku Kk | Liquid medicine spray receptacle |
AU777257B2 (en) * | 1999-07-12 | 2004-10-07 | Capnia Incorporated | Methods and apparatus for relieving headaches, rhinitis and other common ailments |
JP2003040766A (en) * | 2001-07-26 | 2003-02-13 | Kao Corp | Tool for cleaning nasal cavity |
DE20121474U1 (en) * | 2001-09-26 | 2003-01-16 | Zellner, Gerhard, Dr., 83435 Bad Reichenhall | Composition for preventing and treating respiratory tract disorders, e.g. bronchitis or colds, comprising aqueous liquid containing dissolved carbon dioxide |
IL160936A0 (en) * | 2004-02-05 | 2004-08-31 | Scott A Cordray | Nasal spray and wash |
CN1669559A (en) * | 2004-03-15 | 2005-09-21 | 刘展欣 | Medicine for treating rhinitis |
US7874467B2 (en) * | 2005-11-03 | 2011-01-25 | Reseal International Limited Partnership | Metered drop push button dispenser system |
US7875001B2 (en) * | 2008-02-25 | 2011-01-25 | Americo Michael Minotti | Multi medication nasal spray device and method |
JP5959269B2 (en) * | 2011-05-10 | 2016-08-02 | 伸晃化学株式会社 | Spray container |
EP2717855A4 (en) * | 2011-06-07 | 2014-11-12 | Parion Sciences Inc | Methods of treatment |
AU2012328605B9 (en) * | 2011-10-28 | 2017-08-03 | Ampio Pharmaceuticals, Inc. | Treatment of rhinitis |
IN2014DN07474A (en) * | 2012-02-16 | 2015-04-24 | Capnia Inc |
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2013
- 2013-09-10 EP EP13893220.7A patent/EP3043650A4/en not_active Ceased
- 2013-09-10 JP JP2016541940A patent/JP2016529082A/en active Pending
- 2013-09-10 AU AU2013400183A patent/AU2013400183B2/en not_active Ceased
- 2013-09-10 CA CA2923793A patent/CA2923793C/en active Active
- 2013-09-10 WO PCT/US2013/000207 patent/WO2015038092A2/en active Application Filing
- 2013-09-10 MX MX2016002968A patent/MX2016002968A/en unknown
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AU2013400183A1 (en) | 2016-03-17 |
WO2015038092A2 (en) | 2015-03-19 |
CA2923793A1 (en) | 2015-03-19 |
WO2015038092A3 (en) | 2015-07-16 |
MX2016002968A (en) | 2016-12-02 |
CA2923793C (en) | 2018-02-27 |
JP2016529082A (en) | 2016-09-23 |
EP3043650A4 (en) | 2017-11-08 |
AU2013400183B2 (en) | 2017-04-27 |
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