JP2016529082A - Nasal delivery method and delivery device for carbon dioxide and saline - Google Patents

Abstract

A method for treating a patient's illness includes directing a therapeutic non-inhalation dose to at least one nasal cavity of a patient by a flow regulator, during which time the patient refrains from inhaling. The dose includes a liquid containing salt, a gas containing carbon dioxide, and depending on the dose, at least one additional active ingredient, and the therapeutic non-inhaled dose is delivered at a specific flow rate, including a delivery device. [Selection] Figure 1a

Description

REFERENCE TO RELATED APPLICATIONS This application is a previously filed US patent application: 2012 entitled “Carbon Dioxide, Saline and Additional Active Nasal Delivery Methods and Treatments” by the same inventors as the present specification. USSN 13 / 506,425 filed April 18 (reference number GTI-132A); April 18, 2012 entitled "Carbon Dioxide and Saline Nasal Delivery Methods and Treatments" by the same inventor as this specification. USSN 13 / 506,426 (reference number GTI-131A) filed on the same day; and "Nasal Treatment De ivery Device For Carbon to Dioxide and Saline "and entitled June 4, 2012 based on the filed USSN13 / 507,112 (Docket No. GTI-131A). No priority is claimed.

a. FIELD OF THE INVENTION This invention relates generally to medicine, and specifically to the treatment of head ailments. More specifically, the invention relates to methods and treatments for intranasal delivery using carbon dioxide and saline, and using carbon dioxide, saline, and other active ingredients, as well as such methods. It is related with the apparatus used in. Such treatment methods and devices reduce nasal swelling and congestion and treat the causes of such swelling and congestion.

b. Description of Related Art The following patents and applications are representative of various types of nasal drug delivery devices.

  Rau, U.S. Patent No. 5,677,086 describes aromatherapy, in particular a composition for reducing signs of nasal congestion and sinus congestion in unit dosage forms. The composition contains an osmotic aroma vapor, and the release of this vapor upon preparation of hot water is increased by a foaming component that reacts in hot water to promote the release of an aromatic fragrance, or by tableting or gelatin encapsulation. Retained over time. If the aroma is inhaled, the symptoms are reduced. The composition of matter may be taken into the body so that warm water containing the composition is consumed after inhalation. In a preferred embodiment, the release of the permeable aromatic scent lasts over time.

  Baker et al., U.S. Patent No. 6,057,086, describes an irrigation and suction system. The system can be configured to aspirate and irrigate alone, sequentially or simultaneously. The system can be configured to aspirate and irrigate the nasal cavity. The system can be controlled manually. The system can be removable and can be a readily cleanable reservoir for aspirators and irrigators.

  Yamamoto et al., US Pat. No. 5,677,059, describes a pharmaceutical composition for inhalation comprising a continuous release prodrug of an EP2 agonist that locally exhibits long-term bronchodilation and anti-inflammatory effects. That is, a pharmaceutical composition for inhalation containing a continuous release prodrug of an EP2 agonist does not cause any systemic effects such as a decrease in blood pressure, and does not cause respiratory diseases (eg, asthma, lung injury, lung fibrosis) , Emphysema, bronchitis, chronic obstructive pulmonary disease, adult respiratory distress syndrome, cystic fibrosis, pulmonary hypertension and the like). Thus, a safe and useful treatment for respiratory diseases is provided.

  Rasor et al., US Pat. No. 6,057,086, describes devices, methods, and kits for treating symptoms associated with common illnesses such as headache, rhinitis, asthma, epilepsy, and neuropathy. The device includes a dispenser for carbon dioxide and other therapeutic gases. The method includes delivering a small amount of gas to the patient in such a manner that such gas is injected into the body region to soak the mucosa inside the body. It has been found that symptom relief can be greatly alleviated by exposing a patient to such a small amount and high concentration of gas for a very short time.

  Rasor et al., US Pat. No. 6,057,059, describes devices, methods, and kits for treating symptoms associated with common ailments such as headache, rhinitis, asthma, epilepsy, and neuropathy. The device includes a dispenser for carbon dioxide and other therapeutic gases. The method includes delivering a small amount of gas to the patient in such a manner that such gas is injected into the body region to soak the mucosa inside the body. It has been found that symptom relief can be greatly alleviated by exposing a patient to such a small amount and high concentration of gas for a very short time.

  Rasor et al., US Pat. No. 6,057,086, describes devices, methods, and kits for treating symptoms associated with common illnesses such as headache, rhinitis, asthma, epilepsy, and neuropathy. The device includes a dispenser for carbon dioxide and other therapeutic gases. The method includes delivering a small amount of gas to the patient in such a manner that such gas is injected into the body region to soak the mucosa inside the body. It has been found that symptom relief can be greatly alleviated by exposing a patient to such a small amount and high concentration of gas for a very short time.

  Connolly et al., US Pat. No. 5,677,059 describes a portable low flow rate dispenser that includes a housing that holds a gas cartridge. A spring-biased needle is advanced to pierce the septum on the gas cartridge, and another spring-biased ball valve facilitates and deflects the resulting gas flow, and the like Used to control the flow rate.

  LeMahieu et al., US Pat. No. 6,057,086, describes a system and method for delivering a drug to a patient's respiratory system with a purified air flow. In particular, the medicament is delivered to the patient's respiratory system at a positive air pressure relative to atmospheric pressure. Using the systems and methods of the present disclosure, drugs available in various forms are introduced into the air stream in a controlled manner in aerosol, nebulized and vaporized forms.

  U.S. Patent No. 6,053,009 to LeMahieu et al. Describes a system and method for delivering a drug to a patient's respiratory system, where the drug is delivered in air purified at a positive pressure relative to atmospheric pressure. Using the systems and methods of the present disclosure, drugs available in various forms are introduced into the purified air stream in a controlled manner in aerosol, nebulized and vaporized forms.

  U.S. Patent No. 6,053,009 to Le Mahieu et al. Describes a system and method for delivering a drug to a patient's respiratory system, where the drug is delivered at a positive pressure relative to atmospheric pressure. In particular, the medication is delivered to the respiratory system of a patient who can breathe on his own. Using the systems and methods of the present disclosure, drugs available in various forms are introduced into the air stream in a controlled manner in aerosol, nebulized and vaporized forms.

  Rasor et al., US Pat. No. 6,057,059, describes an apparatus and method for delivering vasoconstrictors simultaneously with carbonic gas. Carbon dioxide can enhance the effectiveness of vasoconstrictors and reduce the dose of the drug, or the concentration of the drug required to achieve the therapeutic result, or both. Typical carbon dioxide includes carbon dioxide, nitric oxide, nitrous oxide, and dilute acid gases.

  Pirkiewicz et al., US Pat. No. 6,057,086, describes particulate forms of anti-infective drugs intended for the prevention and treatment of intracellular infections, inhalation systems including inhalation devices, and methods of using the systems.

  Rasor et al., US Pat. No. 6,057,049, describes the transdermal application of carbon dioxide in the form of gases and carbonated solutions (such as carbonated water) and oral A method and apparatus for mucosal application is described. Gaseous carbon may be applied to the skin for at least 3 minutes and the carbonic acid solution may be held on the skin for at least 3 minutes, thereby alleviating symptoms. The carbonic acid solution may be sprayed onto the mucous membrane of the nose to alleviate symptoms such as allergic rhinitis.

  Non-patent document 1 of Casale et al. Examines the safety and effectiveness of nasal carbon dioxide against the symptoms of perennial allergic rhinitis.

  Non-patent document 2 by Barody et al. Describes a study in which intranasal carbon dioxide (CO (2)) has been shown to relieve symptoms of seasonal allergic rhinitis (SAR). This study was designed to evaluate the effect of CO (2) on nasal allergen load. We conducted a controlled crossover study randomized to 12 subjects in SAR except for the pollen season. After 30 minutes exposure to CO (2), 30 minutes, or 30 minutes without any exposure to CO (2), the subject received a local nasal allergen load on only one side. A filter paper disc was placed in the nasal septum to deliver a false load, followed by two incremental doses of either grass or ragweed allergen. Secretions were collected from both sides of the septum to assess nasal reflex and analyzed for histamine. Nose and eye symptoms were recorded. The primary endpoint was the contralateral reflex secretion response to the allergen as measured by secretion weight. Secondary endpoints included ipsilateral nasal secretion weight, nasal and eye symptoms, histamine levels in nasal secretions, and eosinophils in nasal abrasions. The subject reported a temporary burning sensation during exposure to CO (2). Compared to no treatment, active treatment is sneezing (p = 0.05), contralateral secretion weight (p = 0.04), and bilateral nasal discharge symptoms (p = 0.01). Was significantly reduced. The ipsilateral secretion weight decreased numerically. The histamine concentration in the ipsilateral nasal secretions was significantly increased when the subject received a simulated treatment, but not after the pretreatment with CO (2). Treatment with nasal CO (2) partially reduced the acute response to allergen load. The reflex response is diminished in favor of effects on neuronal mechanisms, which predicts its usefulness in the treatment of allergic rhinitis.

  Non-Patent Document 3 of Pagani et al. Investigates the potential in vivo effects of inhalation of carbon dioxide-rich water in patients with allergic rhinitis.

  Casale, Romero, and Spielings [4] study whether non-inhaled intranasal C02 is effective in treating seasonal allergic rhinitis.

  Despite the prior art, the present invention is not taught in the prior art and is therefore not apparent.

US Patent No. 8,007,842B2 US Patent No. 7,959,597B2 US Patent No. 7,858,650B2 US Pat. No. 7,845,348B2 US Pat. No. 7,836,883B2 US Pat. No. 7,827,986B2 US Patent Application No. 2008 / 0169047A1 US Patent Application No. 2008 / 0078382A1 US Patent Application No. 2008 / 0066741A1 US Patent Application No. 2008 / 0066739A1 US Patent Application No. 2006 / 0172017A1 US Patent Application No. 2004 / 0009126A1 US Patent Application No. 2002 / 0040205A1

“Nasal Carbon Dioxide for the Symptomatic Treatment of Perennial Allergic Rhinitis” (Ann Allergy Asthma Immunol., Oct. 2011, pp. 364-370). “The Effect of Intrabasal Carbon Dioxide on the Accurate Response to Nasal Challenge with Allergen” (Allergy Asthma Proc, May-Jun. “Carbon Dioxide-Enriched Water Inhalation in Patents With Allergic Rhinitis and it's Relationship Whistle Nasal Fluid Cytokine / Chemokine Release M “Intranasal Noninhaled Carbon Dioxide for the Symptomatic Treatment of Season Allergic Rhinitis” (J Allergy Clin Immunol., Jan. 2008, 105 pp. 105).

  The present invention is directed to treating a patient's illness. The method includes directing a therapeutic non-inhalation dose to at least one nasal cavity of a patient by a flow control device. The dose comprises a saline fluid, a gas comprising carbon dioxide, and in some embodiments at least one additional active ingredient, and a therapeutic non-inhalation dose of 1 cc / sec-20 cc over 2-30 seconds Delivered at a flow rate of / sec. The present invention includes the step of causing the patient to substantially refrain from inhaling while saline is being released.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the head condition is rhinitis.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the head condition is conjunctivitis.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the head condition is a common cold.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the head condition is sinusitis.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the head condition is a headache.

  In some preferred embodiments of the method of the present invention for treating a patient's head condition, the flow regulator is a single dose dispenser with a pressure control valve for regulating the discharged flow.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the flow regulator is a multi-dose dispenser with a pressure control valve for regulating the discharged flow. In some preferred embodiments of the methods of the invention for treating a patient's head condition, a multi-dose dispenser is used to limit the dose release for each activation, in order to limit the dose release mechanism and activators. Further included.

  In some preferred embodiments of the method of the invention for treating a patient's head condition, the duration is 5-10 seconds per nasal cavity.

  In some preferred embodiments of the method of the invention for treating a patient's head condition, the duration is 2 to 15 seconds per nasal cavity.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the dosage is repeated 1 to 10 times.

  In some preferred embodiments of the methods of the invention for treating a disease of the patient's head, the method is for treating rhinitis and the rhinitis is allergic rhinitis.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the flow rate is from 2 cc / sec to 10 cc / sec.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the flow rate is from 1 cc / second to 5 cc / second.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the flow rate is from 4 cc / sec to 5 cc / sec.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the gas comprises at least 50% carbon dioxide.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the gas comprises at least 70% carbon dioxide.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the gas comprises at least 95% carbon dioxide.

  In some preferred embodiments of the methods of the invention for treating a patient's head condition, the gas comprises at least 100% carbon dioxide.

  The present invention is directed to a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, the device comprising: a) a proximal end and a distal end; And a main housing having a hollow central region containing a dosage comprising a liquid containing salt and a gas containing carbon dioxide; b) a dispensing dispenser head located at the distal end of the main housing; A dose dispenser head having at least one flow path for moving the dose from the main housing through the dose dispenser head and out of the dose dispenser head; c) in response to an increase in pressure against the dose Main housing, suitable to allow the dose to flow from the main housing and through the dose dispenser head Dose release control component located between the dose dispenser head with; and, d) the components of the movable to vary the pressure that is on the main housing. When the dose dispenser head of the device is placed in the nasal cavity and activated by a movable component that varies pressure moving toward the dose, the dose is at least through the dose release control component and the dose dispenser head. Partially extruded and dose applied to nasal wall.

  In some embodiments of the invention, a nasal treatment delivery device for mixed carbon dioxide and saline for treating a patient's head condition, wherein the dose release control component comprises a friable member, Selected from the group consisting of pierceable members and one-way valves.

  In some embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, wherein the main housing is remote from the dose release control component. An open tube with a distal dose dispenser head, with a movable component that varies pressure located at the proximal end of the main housing.

  In some embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, wherein a movable component that varies pressure is acceptable. A squeeze member with flexibility and a seal float.

  In some embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, wherein the movable component that fluctuates the pressure is pushed up It is a piston of the type.

  In some embodiments of the invention, a nasal treatment delivery device for mixed carbon dioxide and saline for treating a patient's head condition, wherein the dose release control component comprises a friable member, Selected from the group consisting of pierceable members and one-way valves.

  In some embodiments of the present invention, a nasal treatment delivery device for mixed carbon dioxide and saline for treating a patient's head condition, wherein the main housing is open distal end and near closed mouth A tube having a distal end, the dose release control component and the dispenser dispenser head being at the distal end of the main housing, and at least a portion of the tube is flexible and includes a movable component that varies pressure. Configure.

  In some embodiments of the invention, a nasal treatment delivery device for mixed carbon dioxide and saline for treating a patient's head condition, wherein the dose release control component comprises a friable member, Selected from the group consisting of pierceable members and one-way valves.

  In some embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, the dosing dispenser head having a plurality of channels.

  In some embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition, wherein the dosing dispenser head is circular as viewed from above. It has the shape of

  In some other embodiments of the present invention, a mixed carbon dioxide and saline nasal treatment delivery device for treating a patient's head condition has: a) a proximal end and a distal end A main housing having a hollow central region containing a dose comprising a liquid containing salt and a gas containing carbon dioxide; b) a dose dispenser head located at the distal end of the main housing; A dose dispenser head having at least one flow path for moving a dose from the main housing through the dose dispenser head and out of the dose dispenser head; c) at least one of the main housing and dose dispenser head A nose guard flange connected to and extending from at least one of these; d) above the pressure on the dose And a dose release control component located between the main housing and the dose dispenser head, suitable to allow a dose to flow from and through the dose dispenser head; e Including a movable component in the main housing that varies pressure, the device dispenser head being placed in the nasal cavity and activated by movement of the movable component that varies pressure toward the dose Sometimes the dose is at least partially extruded through the dose release control component and the dose dispenser head to apply the dose to the nasal wall. In this particular embodiment including a nose guard flange, all other details and features described in the previous paragraph may be included.

  Additional features, advantages, and embodiments of the invention may be set forth or apparent from consideration of the following detailed description, drawings, and claims. Further, it is understood that both the foregoing summary of the invention and the following detailed description are exemplary and are intended to provide further explanation without limiting the scope of the claimed invention. Let's be done.

  The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and, together with the detailed description, It plays a role in explaining the principle.

FIG. 1a is a block diagram of an embodiment of the method and treatment of nasal delivery of carbon dioxide and saline of the present invention with and without one or more additional active ingredients. FIG. 1b is a block diagram of an embodiment of the method and treatment of nasal delivery of carbon dioxide and saline of the present invention with and without one or more additional active ingredients. FIG. 2 is a block diagram illustrating head illness treated by various embodiments of nasal delivery methods and treatments of carbon dioxide and saline of the present invention. FIG. 2 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 3 is a block diagram illustrating the time period for therapeutic non-inhalation doses in some preferred embodiments of the nasal delivery method and treatment of carbon dioxide and saline of the present invention. FIG. 3 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 4 is a block diagram of another embodiment of the method and treatment of nasal delivery of carbon dioxide and saline of the present invention, showing additional steps that repeat other steps. FIG. 4 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 5 is a block diagram illustrating the flow rate in some additional preferred embodiments of the nasal delivery method and treatment of carbon dioxide and saline of the present invention. FIG. 5 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 6 is a block diagram showing the percentage of carbon dioxide present in a gas in some preferred embodiments of the nasal delivery method and treatment of carbon dioxide and saline of the present invention. FIG. 6 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 7 illustrates a block diagram illustrating a single dose dispenser and a multi-dose dispenser that can be used in the method of the present invention. FIG. 7 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 8 illustrates a partial front cutaway view of one embodiment of the nasal treatment delivery device of the present invention with a pressure release mechanism. FIG. 8 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient. FIG. 9 illustrates a diagram of one embodiment of a nasal treatment delivery device of the present invention that is a squeezing member to a release device. FIG. 9 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient. FIG. 10 shows a front partial cutaway view of a nasal treatment delivery device of the present invention with a piercing channel, which is held by hand using two fingers and a thumb, Trigger the release of therapy. FIG. 10 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 11 illustrates a partially cut away front view of one embodiment of the nasal treatment delivery device of the present invention with a friable internal medicinal capsule that can be used in a single dose or multiple doses using a replacement cartridge. FIG. 11 shows an apparatus in a stage having different applications. FIG. 11 is described as carbon dioxide and saline, which is understood to mean that with and without at least one additional active ingredient. FIG. 12 illustrates a front partial cutaway view of one embodiment of a nasal treatment delivery device of the present invention with a friable internal medicinal capsule that can be used in a single dose or multiple doses using a replacement cartridge. FIG. 12 shows the apparatus at different stages of application. FIG. 12 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient. FIG. 13 illustrates a partial front cutaway view of one embodiment of the nasal treatment delivery device of the present invention with a friable internal medicinal capsule that can be used in a single dose or multiple doses using a replacement cartridge. FIG. 13 shows an apparatus in a stage having different applications. FIG. 13 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient. FIG. 14 shows an alternative type of dispenser head that can be used in the device of the present invention, showing multiple discharge ports. FIG. 14 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient. FIG. 15 shows an alternative type of dispenser head that can be used in the device of the present invention, showing multiple discharge ports with a soft contact sheath. FIG. 15 is described as carbon dioxide and saline, which is understood to mean using and not using at least one additional active ingredient.

  “Saline” and “saline solution” as used herein means water containing salt. Saline is used in a wide variety of medical applications. For example, “normal saline” is a commonly used term for a 0.90% w / v sodium chloride (NaCl) solution. Normally, saline is frequently used by intravenous infusion for patients who cannot take fluids orally to prevent dehydration. Usually saline is also used for wound washing and skin abrasion. Another application of saline is as a rinse for contact lenses.

  Saline is also frequently used in nasal rinses to treat some of the symptoms of colds, adversely affect the nasal passages, or other illnesses. Inflammation can be reduced by washing the nasal passages with saline. Also, a more concentrated (“hypertonic”) solution of NaCl may have therapeutic use. For example, a 7% NaCl / water solution is considered a mucoactive agent, and thus a dense secretion to make it easier to up and out (expectate). Used to hydrate liquid (mucus).

  Another chemical useful for medical treatment is carbon dioxide. An example is the use of diluted carbon dioxide by inhalation to treat symptoms associated with headaches, allergies, asthma, neuropathy, and other common illnesses, as demonstrated in the 1940s and 1950s. Another example is the use of high concentrations of non-inhaled carbon dioxide delivered locally to the nasal passages. This type of treatment can result in faster relief without the side effects of systemic drugs that are inhaled, ingested or infused.

  Treatment is improved by combining the beneficial therapeutic effects of saline treatment and carbon dioxide treatment. Thus, the beneficial effects of saline, such as mucus inflammation and reduction of sputum, are beneficial for carbon dioxide therapy, such as relief from headaches, allergies, asthma, neuropathy, and other common illnesses. Combined with effect. In addition, saline acts as a base host for carbon dioxide to wet the nasal cavity and to act on the walls of the nasal cavity (assuming that at least a portion of the carbon dioxide is adsorbed by the saline. ) In addition, saline reduces any small burning that may be sensed from carbon dioxide. The benefit of saline treatment is supplemented with the benefit of carbon dioxide treatment, and the benefit of carbon dioxide treatment is supplemented with the benefit of saline treatment. This combination of utilizing saline to deliver and enhance carbon dioxide while providing at least moisturizing and other beneficial effects is the result of its unexpected synergistic effect.

  In addition to the benefits listed above, the method and treatment of nasal delivery of carbon dioxide and saline of the present invention has other synergistic effects not available from either saline treatment or carbon dioxide treatment alone. There are benefits. For example, the presence of dissolved carbon dioxide in saline means that the saline is carbonated, and the foaming effect of carbon dioxide makes the saline more vigorous against the nasal cavity or the inner surface of the cavity. Will help to mix. This improved mixing makes the saline treatment more effective. Another potential advantage of the combination of carbon dioxide treatment and saline treatment is that in some embodiments, having sufficient pressure and appropriate nozzles makes carbon dioxide a carrier gas for saline. It can work, thereby allowing the aerosolization of saline.

  To summarize the advantages and benefits of the present invention, the combination of controlled delivery carbon dioxide and saline provides the following: It purifies the nasal cavity and removes allergens and particulates that cause inflammation and congestion Its special formulation protects the nasal mucosa from viruses; it relieves mucous membrane irritation and moisturizes it; its unique buffer system is sensitive mucosa and mucociliary bodies in the nasal cavity; neutralize inhaled stimuli such as oxidized free radicals and endogenous cytotoxins, causing inflammation and damage to hairs; it enhances mucus clearance and flow by reducing mucus viscosity Its superior safety profile is more widely applied than corticosteroids and decongestants, Can be safely used in 6-month-old children and adults, even with comorbidities such as urinary disease, hypertension, suppressed immune system, pregnant women and lactating women; An excellent safety profile allows flexible dosing.

  In addition to beneficial carbon dioxide and saline, as described above, some preferred embodiments of the present invention further include at least one additional active ingredient. These active ingredients are compatible with saline and contain one or more beneficial additive ingredients that have some medical, therapeutic, analgesic or moisturizing effect on the sinus wall, vascular system or upper respiratory system. It can be either. These include, but are not limited to, humectants, wetting agents, over-the-counter medicines and prescription drugs. Such agents include antihistamines, infection treatments, antioxidants, cell growth promoters, anti-inflammatory agents, vasoconstrictors, nasal decongestants, or other nasal, wall or upper respiratory treatments. May be treatments. Preferred actives are moisturizers, decongestants, antihistamines, infection treatments and anti-inflammatory agents. Examples of humectants and wetting agents are glycerin, propylene glycol (MW 400-8000), maltodextrin (liquid), honey, pectin, hydroxypropylmethylcellulose, and carboxymethylcellulose. Examples of topical decongestants are ephedrine, levomethamphetamine, naphazoline, oxymetazoline, phenylephrine, pseudoephedrine, tramazoline, and xylometazoline. The active ingredient may also be fragrance sensations or other fragrances with other benefits such as eucalyptus, menthol or lavender.

  Referring now to the drawings, wherein like reference numerals designate corresponding parts throughout the several views, various embodiments of the invention are shown.

  FIG. 1a is a block diagram of an embodiment of a method and treatment for nasal delivery of carbon dioxide, saline and additional active ingredients of the present invention. However, because the present invention includes dosages with and without other active ingredients, this additional additive in FIG. 1a is excluded in FIG. 1b, and both FIGS. 1a and 1b are discussed in conjunction with FIG. 1a. It is understood that FIG. 1b illustrates the invention without additional additives, otherwise both figures are the same, except for the additional active ingredients, FIG. The following discussion also applies to FIG.

  FIG. 1a illustrates a therapeutic non-inhalation dose (1) containing a salty liquid (3), a carbon dioxide containing gas (5) and at least one additional active ingredient (17). . The liquid (3) containing salt contains water and at least one salt. In some preferred embodiments of the invention, the salt is sodium chloride. In other embodiments of the invention, other salts may be used, but it is important that all salts used in the salt-containing liquid (3) must be safe for intranasal use. is there. In some preferred embodiments of the invention, the concentration of salt in the salt-containing liquid is approximately isotonic with the salt concentration of bodily fluids. In other preferred embodiments, the concentration of the salt in the fluid containing the salt is less than the concentration of the salt in the body fluid. In yet another preferred embodiment, the concentration of salt in the salt-containing liquid is hypertonic, meaning that it has a higher salt concentration than the concentration of bodily fluids. In yet another preferred embodiment, the saline is saturated with salt.

  The gas (5) contains some carbon dioxide. When the gas (5) containing carbon dioxide is added to the salt-containing liquid (3), the salt-containing liquid (3) is carbonated. If a therapeutic non-inhaled dose (1) containing a salty liquid (3) and a gas (5) is maintained under pressure, the pressure is later released (eg by opening a valve), This causes some of the carbon dioxide to bubble out of the solution. This sudden release of carbon dioxide creates a foam at a therapeutic non-inhalation dose.

  The therapeutic non-inhalation dose travels through the flow regulator (7). In a preferred embodiment, the flow regulator (7) controls the flow rate (9) of the therapeutic non-inhalation dose (1) at a rate that is safe and comfortable for the patient. In the embodiment shown in FIG. 1a, the therapeutic non-inhalation dose flow rate (9) is between 1 cubic centimeter per second (cc / sec) and 20 cc / sec. In the preferred embodiment of the invention shown in FIG. 1a, the flow rate is adjustable to a value between 1 cc / sec and 20 cc / sec.

  The therapeutic non-inhalation dose (1) has a flow duration (11). Flow duration (11) is the length of time during which a therapeutic non-inhaled dose flows through the flow regulator to at least one nasal cavity (13) of the patient. In the embodiment shown in FIG. 1a, the flow duration (11) is shown as lasting between 2 and 30 seconds. In a preferred embodiment of the invention, the flow duration can be adjusted to a value between 2 and 30 seconds.

  The therapeutic non-inhaled dose (1) exits the flow regulator (7) and then enters at least one nasal cavity (13) of the patient. The therapeutic non-inhaled dose (1) is absorbed by the nasal tissue and subsequently absorbed by the body. This adsorption and subsequent absorption can have beneficial effects on many head diseases, some of which are shown in FIG. The foaming effect of the gas containing carbon dioxide (5) results in a better contact between the salt in the saline (3) and the nasal tissue.

  An additional step (15) instructing the patient not to inhale prevents the patient from accidentally inhaling a therapeutic non-inhaled dose (1). This is important, especially when the therapeutic non-inhalation dose (1) contains a gas (5) that is almost 100% carbon dioxide to prevent carbon dioxide poisoning (hypercapnia). Serious. Even mild hypercapnia can cause unpleasant mental and physical effects. It is also desirable to limit patient exposure to salt when the concentration of salt in saline (3) exceeds isotonicity (particularly when salts other than sodium chloride are used). The step (15) instructing the patient to stop breathing achieves these goals.

  Referring now to FIG. 2, a block diagram (Block (20)) is treated using the carbon dioxide and saline (with and without additional active ingredients) nasal delivery methods and procedures of the present invention. Here are some of the medical conditions that can be done. In some embodiments of the invention, methods and treatments for nasal delivery of carbon dioxide and saline treat rhinitis (17) (some internal swelling of the nose). In another embodiment, the present invention treats allergic rhinitis (19). In yet another embodiment, the present invention treats conjunctivitis (21) (conjunctival inflammation also known as infectious conjunctivitis). In yet another embodiment of the invention, the cold (23) is treated. In another embodiment of the invention, sinusitis (25) (nasal inflammation) is treated. In yet another embodiment, the present invention is used to treat headache (27). In some embodiments and treatments of nasal delivery methods and treatments of carbon dioxide and saline of the present invention, it is important to recognize that multiple diseases can be treated simultaneously. For example, a patient may suffer both sinusitis and headache at the same time; the present invention can alleviate both diseases at the same time. The present invention can treat any of the diseases shown in FIG. 2 or any combination of those diseases. It should also be appreciated that the present invention may be useful in the treatment of other illnesses, particularly head ailments. Other illness treatments where the carbon dioxide and saline nasal delivery methods and treatments of the present invention are effective are considered to be within the scope of the present invention.

  Referring now to FIG. 3, a block diagram (Block (30)) illustrates a therapeutic non-inhalation dose used in some embodiments of the nasal delivery method and treatment of carbon dioxide and saline of the present invention. Indicates the duration of. The duration shown in FIG. 3 is a range such that the actual duration can be any value between the lowest and highest values of the range. In some embodiments of the invention, the duration (29) lasts 2-30 seconds. In another embodiment of the invention, the duration (31) lasts 2-15 seconds. In yet another embodiment of the invention, the duration (33) lasts 5-10 seconds. Durations of less than 2 seconds and greater than 30 seconds are also considered to be within the scope of the present invention.

  Referring now to FIG. 4, another embodiment of the method and procedure for nasal delivery of carbon dioxide and saline of the present invention is shown. FIG. 4 is a block diagram of an embodiment of the method and treatment of carbon dioxide and saline nasal delivery of the present invention that incorporates many aspects shown in FIGS. 1a and 1b, with the same reference to the same block The code | symbol is provided. FIG. 4 illustrates a therapeutic non-inhalation dose (1) containing a salty liquid (3) and a gas (5). The liquid (3) containing salt contains water and at least one salt. In some preferred embodiments of the invention, the salt is sodium chloride. In other embodiments of the invention, other salts may be used, but it is important that all salts used in the salt-containing liquid (3) must be safe for intranasal use. is there. In some preferred embodiments of the invention, the concentration of salt in the salt-containing liquid is approximately isotonic with the salt concentration of bodily fluids. In other preferred embodiments, the concentration of the salt in the fluid containing the salt is less than the concentration of the salt in the body fluid. In yet another preferred embodiment, the concentration of salt in the salt-containing liquid is hypertonic, meaning that it has a higher salt concentration than the concentration of bodily fluids. In yet another preferred embodiment, the saline is saturated with salt.

  The gas (5) contains some carbon dioxide. When the gas (5) containing carbon dioxide is added to the salt-containing liquid (3), the salt-containing liquid (3) is carbonated. If a therapeutic non-inhaled dose (1) containing a salty liquid (3) and a gas (5) is maintained under pressure, the pressure is later released (eg by opening a valve), This causes some of the carbon dioxide to bubble out of the solution. This sudden release of carbon dioxide creates a foam at a therapeutic non-inhalation dose.

  The therapeutic non-inhalation dose travels through the flow regulator (7). In a preferred embodiment, the flow regulator (7) controls the flow rate (9) of the therapeutic non-inhalation dose (1) at a rate that is safe and comfortable for the patient. In the embodiment shown in FIG. 1a, the therapeutic non-inhalation dose flow rate (9) is between 1 cubic centimeter per second (cc / sec) and 20 cc / sec. In the preferred embodiment of the invention shown in FIG. 1a, the flow rate is adjustable to a value between 1 cc / sec and 20 cc / sec.

  The therapeutic non-inhalation dose (1) has a flow duration (11). Flow duration (11) is the length of time during which a therapeutic non-inhaled dose flows through the flow regulator to at least one nasal cavity (13) of the patient. In the embodiment shown in FIG. 1a, the flow duration (11) is shown as lasting between 2 and 30 seconds. In a preferred embodiment of the invention, the flow duration can be adjusted to a value between 2 and 30 seconds.

  The therapeutic non-inhaled dose (1) exits the flow regulator (7) and then enters at least one nasal cavity (13) of the patient. The therapeutic non-inhalation dose (1) is adsorbed by the nasal tissue. This adsorption can have beneficial effects on many head diseases, some of which are shown in FIG. The foaming effect of the gas containing carbon dioxide (5) results in a better contact between the salt in the saline (3) and the nasal tissue.

  An additional step (15) instructing the patient not to inhale prevents the patient from accidentally inhaling a therapeutic non-inhaled dose (1). This is important, especially when the therapeutic non-inhalation dose (1) contains a gas (5) that is almost 100% carbon dioxide to prevent carbon dioxide poisoning (hypercapnia). Serious. Even mild hypercapnia can cause unpleasant mental and physical effects. It is also desirable to limit patient exposure to salt when the concentration of salt in saline (3) exceeds isotonicity (particularly when salts other than sodium chloride are used). The step (15) instructing the patient to stop breathing achieves these goals.

  In the embodiment shown in FIG. 4, the administration is repeated (35) after the therapeutic non-inhaled dose (1) has entered the patient's at least one nasal cavity (13) through the flow regulator (7). In some preferred embodiments, administration is repeated between 1 and 10 times (35). In yet other embodiments, the administration is repeated more than 10 times. If a single single application of the therapeutic non-inhalation dose (1) is insufficient to alleviate the head illness or the illness that the patient suffers, a repeated administration step (35) may be used.

  Referring now to FIG. 5, a block diagram (block (50)) illustrates the flow rates used in some embodiments of the nasal delivery method and procedure of carbon dioxide and saline of the present invention. The flow rate used in FIG. 5 is shown as a range, and the actual flow rate can be any value between the lowest and highest values of the range. In some embodiments, a flow rate between 1 cc / sec and 20 cc / sec is used (37). In other embodiments, a flow rate between 2 cc / sec and 10 cc / sec is used (39). In other preferred embodiments, a flow rate between 1 cc / sec and 5 cc / sec is used (41). In yet another preferred embodiment, a flow rate between 4 cc / sec and 5 cc / sec is used (43). In yet another preferred embodiment, a flow rate of approximately 10 cc / sec is used (45). Embodiments with flow rates less than 1 cc / second or greater than 20 cc / second are also considered to be within the scope of the present invention.

  Referring now to FIG. 6, a block diagram (block (60)) shows the level of carbon dioxide in a gas used in some embodiments of the present invention. The level of carbon dioxide is expressed as a percentage of the gas ((3) in FIGS. 1a, 1b and 4) used in the therapeutic non-inhaled dose ((1) in FIGS. 1a, 1b and 4). . In some embodiments of the nasal delivery method and treatment of carbon dioxide and saline of the present invention, the amount of carbon dioxide in the gas is at least 50% (47). In other embodiments, the amount of carbon dioxide in the gas is at least 70% (49). In yet other embodiments, the amount of carbon dioxide in the gas is at least 95% (51). In another preferred embodiment, the amount of carbon dioxide in the gas is approximately 100% (53). Gases having a percent composition of carbon dioxide of less than 50% are also considered to be within the scope of the present invention.

  FIG. 7 shows a block diagram illustrating a nasal treatment delivery device that may be used in the method of the present invention. Here, block (71) shows the figure, ie the heading of the nasal treatment delivery device. Block (73) shows that the flow regulator used in the method of the present invention can be a single dose dispenser (single dose) with a pressure control valve for flow regulation. The flow rate is set according to the above range. In the case of a single dose dispenser, the flow rate is simply controlled over the time it takes to unload the dose so that it is not necessary to adjust the time to dispense the dose. Thus, a single dose dispenser may controllably release a pressurized mixture of carbon dioxide and saline until it stops flowing. Various types of mechanisms for driving the contents from the container to the nasal cavity are also illustrated. These include a squeezing component or valve below the contents so that the external squeezing pressure pushes out the contents, such as Turkey Bayster; the squeezing components are nasal decongestant squeezed sprays A squeezing mechanism, which is an embodiment that holds the actual dose of the container, like a container; works more physically like a syringe, but more complex internals such as a perforator or counter-biased valve Push mechanisms; and others referring to any known controlled flow mechanism available to those skilled in the art.

  On the other hand, multiple or multi-dose dispensers may be used, which require on / off control of dispensing, otherwise the entire contents may be unnecessarily released at once. Thus, block (75) illustrates the use of a multi-dose dispenser with a pressure control valve for flow regulation. The flow rate is set according to the above range. Block (77) shows one multi-dose dispenser option where the user controls the release time so that the dose can be adjusted. For example, there may be an activator such as a push button or squeezing mechanism to release the dose, and the user may be directed to dispense for a period of time, for example 8-10 seconds. Alternatively, an automatically controlled release mechanism may be used, as shown in block (79), for example to control a spring return starter that closes the valve based on a set timing, or the time of release. Therefore, the double spring device includes a reversing spring mechanism for returning the lever. Timed valves are well known in the field of mechanical dispensing and any available multi-dose scheduled dispensing mechanism may be utilized.

  In FIG. 7, block (73) shows the main housing and dose. It encompasses salted liquid and carbon dioxide gas doses, depending on the parameters as described more specifically above. Block (79) indicates that the main housing (73) may have two open ends or one open end. In the case of one open end, the top end includes a discharge control and dispenser head mechanism with a low and a high. In the case of a main housing with two open ends, one end has a discharge control and dispenser head mechanism, and the other end has a movable drive mechanism such as a pressure release mechanism, punch, or plunger (drive piston). Include. Block (81) indicates that the main housing (73) is at least partially flexible or not flexible. If the driver is a main housing iris, it must be flexible. If the driver is a movable component (push or squeeze mechanism) attached to the main housing (71), the main housing (71) is preferably not flexible.

  Block (83) shows the components that control the release of the dose. Block (85) shows an option for the component that controls the release of the dose, which is a friable, pierceable, one-way valve, or gate. Block (87) shows the dosing dispenser head and block (89) shows the options for it, which is a perforated, hard, soft or delivery cover (sponge, foam, purified cotton, or others). Block (74) shows an optional nose guard flange for the nasal treatment delivery device (71).

  FIG. 8 shows a front, partially cutaway view of one embodiment of the nasal treatment delivery device (90) of the present invention. It comprises a main housing (91) with a top (93) having a hollow central region containing a dose of the drug of the present invention. This storage area may be within the main housing, or may be one or more subunits within the main housing, ie, the main compartment, capsule, tank, pouch, etc.

  In this embodiment, the main housing (91) has a dose-controlling component attached to its distal end, which component is within the scope described in the claims of the present invention, and A spray discharge nozzle (95) set to a predetermined flow rate as described above. The inner bag container (105) contains the liquid / gas mixture of the present invention, and the external pressure on the bag (105) is created by a pressurized gas located in the space (107) inside the main housing (91). The top (93) is a dosing dispenser head, in this case a push dispenser mechanism (97) comprising a discharge hole (101), an actuation tube (99), and a push pad (103). The user inserts the push dispenser mechanism (97) into the nasal cavity at its distal end (hole (101)), while holding the nasal delivery device (90) and releasing the contents Press the push pad (103). The flow rate adjustment is set to an allowable range that is relatively easy for the user. This may include a range of about 1 cc / second to 10 cc / second. Typically this is a multi-dose device, where the user is instructed to dispense for a specified time and not to breathe during that time, eg, one nostril twice a day as needed. 3 seconds per full depression. Alternatively, a built-in timer can automatically control the dose. For example, the device may include a slow spring closure that requires reset and re-push for restart.

  FIG. 9 shows an alternative nasal treatment delivery device (110). This is an insertion and squeezing device comprising a body (111) with a flexible wall and a dispensing nozzle at its top (113). There is a stop (117), thread (109), and a tapered dispersive tip (119) designed for insertion into the nasal cavity. There is a flow control valve (112) that controls the rate of delivery. Additional valves such as duckbill valves may also be provided. The liquid / gas mixture of the present invention is contained within the main housing (111) and is dispensed by the user inserting and squeezing while holding his breath.

  FIG. 10 shows a front, partially cutaway view of the nasal treatment delivery device (120) of the present invention being held in a hand using two fingers and a thumb as shown. There is a main housing (121) and a vertically movable piston (131). A rigid, semi-flexible or flexible container or pouch (123) contains the liquid / gas mixture of the present invention and the perforated tube (125) is connected to a flow control valve (127). . The user holds the nasal treatment delivery device (120) as shown, inserts it into the nasal cavity and pushes the piston (131) upwards without breathing, while the valve (127 on the nasal cavity wall is shown. ) To rupture the pouch (123) by the perforated tube (125).

  11, 12, and 13 show a nasal treatment delivery device (150) of the present invention comprising a drug (175), a friable internal medicinal capsule (171) containing a mixture of the gas and liquid described above. FIG. 3 shows a partially cut away view of the front of one embodiment. The device (150) may be used for single or multiple doses using exchange capsules. The three figures show the device at different stages of use. The same numbers are used for all three drawings, and the device (150) is described generally for all of these drawings.

  Device (150) is a push device that relies on friable capsules (171) to deliver medicine (175) by breaching and opening the top (173) of friable capsules (171). The device (150) comprises a main housing (151) designed with an open top and an open bottom, as shown. Permanently, a dose dispenser head (161) with a discharge tube (165) and a control valve (153) is inserted into the open top of the main housing (151). The dispensing dispenser head (161) has a downward hemispherical end (163) for piercing the top (173) of the capsule (171) (eg, a foil top). A circular platform or double projection, such as platform (167), functions as a finger grip and is attached to the main housing (151). The capsule (171) may be permanently attached to the main housing (151) or may be removably disposed therein for later insertion of the capsule, the former being a single dose device, The latter is a multi-dose device.

  Furthermore, the capsule (171) may be completely friable, but preferably only its top (173) is friable. The capsule (171) may have different shapes, such as a hemispherical bottom to correspond to the shape of the end (163) of the dosing dispenser head (161). Alternatively, both may have other shapes and may be the same or different, for example a chisel shaped end / bottom. Plunger (157) has a closed piston (159) at its distal end and an enlarged finger rest at its proximal end. The plunger (157) may be permanently or removably inserted into its distal end and its piston (159) may be any shape, but is the same or similar to the bottom of the capsule It is preferable. As shown sequentially in FIGS. 11, 12 and 13, the piston (159) is used to move the capsule (171) to the breaker end (163). In FIG. 11, the user's thumb and the first two fingers are shown including a plunger (157) and a platform (167), respectively. By placing the device (150) in the desired nasal cavity, pushing the plunger upwards while stabilizing the device and the user holding his breath, the friable top (173) is destroyed and the gas / liquid The drug begins to release from the device (150) (FIG. 12). The drug is almost completely used up until the plunger (157) is pushed to the maximum, and is the top (163) in the vicinity of the capsule (171) to effectively deliver the drug to the user? Or at the bottom (FIG. 13).

  14 and 15 show an alternative type of dispensing dispenser head that can be used in the device of the present invention, one with multiple discharge ports and the other with multiple discharge ports with a soft contact sheath. FIG. 14 shows a cutaway front view of one dosing dispenser head (180) that may be used with the device of the present invention. It comprises a control valve (181) for controlling the release of the drug so that it is within the above-mentioned proscribed range. Upstream of the control valve (181) are bifurcations (185), (187), (189), (191), (193), and (195) to show the heads of various multi-port manifolds. There is a main flow channel (183) with. This dosing dispenser head simultaneously orients gas / liquid medication in many directions to more uniformly and quickly cover the sinus wall.

  FIG. 15 shows a similar dispensing dispenser head (200) of the present invention, but with a soft pad for nasal wall comfort. The pad does not cover the port and may be made of a soft permeable or impermeable material such as various foams or skins. Alternatively, they may be permeable and cover ports to produce wettable foams or sponges, so as to achieve extensive drug placement in the nasal cavity. Good.

  While specific embodiments of the present invention have been described in detail herein with reference to the accompanying drawings, the present invention is not limited to these specific embodiments, and various changes and modifications can be made. It should be understood that this may be accomplished by one of ordinary skill in the art without departing from the scope or spirit of the invention as defined in the following claims.

Claims (20)

A method for treating a disease in a patient's head, comprising:
The method
Directing a therapeutic non-inhalation dose to at least one nasal cavity of said patient by a flow regulator,
The dose includes (a) a salt-containing liquid and (b) carbon dioxide-containing gas,
A therapeutic non-inhalation dose is delivered at a flow rate of 1 cc / sec-20 cc / sec over a period of 2-30 seconds, during which time the patient substantially refrains from inhaling.   The method of claim 1, wherein the head condition being treated is selected from the group consisting of rhinitis, conjunctivitis, common cold, and sinusitis.   The method of claim 1, wherein the method is for treating rhinitis, and the rhinitis is allergic rhinitis.   The method of claim 1, wherein the head condition is a headache.   The method of claim 1, wherein the flow regulator is a single dose dispenser with a pressure control valve for regulating the discharged flow.   6. The method of claim 5, wherein the flow regulator is a multi-dose dispenser with a pressure control valve for regulating the discharged flow.   The method of claim 1, wherein the multi-dose dispenser further comprises a dose control mechanism and an activator to limit the dose release for each activation.   The method of claim 1, wherein the gas comprises at least 70% carbon dioxide.   The method of claim 1, wherein the gas comprises substantially pure carbon dioxide.   2. The method of claim 1, wherein the dosage further comprises (c) at least one additional active ingredient. A nasal treatment delivery device for mixed carbon dioxide and saline for treating a condition in a patient's head, comprising:
a) a main housing having a hollow central region having a proximal end and a distal end and containing a releasable nasal treatment dose comprising a salt-containing liquid and a carbon dioxide-containing gas;
b) a dose dispenser head located at the distal end of the main housing, at least for moving the dose from the main housing through the dose dispenser head and out of the dose dispenser head A dosing dispenser head having one flow path;
c) the main housing and the dose dispenser adapted to allow the dose to flow from the main housing and through the dose dispenser head in response to an increase in pressure on the dose; A dose release control component located between the head,
d) a movable component in the main housing that varies pressure,
When the dose dispenser head of the device is placed in the nasal cavity and the movable component that varies the pressure is activated by moving toward the dose, the dose is determined by the dose release control component and the A nasal treatment delivery device that is at least partially extruded through a dose dispenser head to apply a dose to the nasal wall.   The nasal treatment delivery device of claim 11, wherein the dose release control component is selected from the group consisting of a friable member, a pierceable member, and a one-way valve.   The main housing is an open tube comprising the dose release control component and the dosing dispenser head at the distal end of the main housing, and the movable component that varies the pressure is the main housing 12. A nasal treatment delivery device according to claim 11, located at the proximal end of the nasal treatment.   12. The nasal treatment delivery device of claim 11, wherein the movable components that vary the pressure are a flexible squeeze member and a sealing float.   The nasal treatment delivery device according to claim 11, wherein the movable component that varies the pressure is a push-up piston.   The nasal treatment delivery device further includes e) a nose guard flange connected to at least one of the main housing and the dosing dispenser head and extending from at least one of the main housing and the dosing dispenser head. The nasal treatment delivery device according to claim 11.   The main housing is a tube having an open distal end and a closed proximal end, the dose release control component and the dosing dispenser head are at the distal end of the main housing, and at least a portion of the tube is acceptable. 12. The nasal treatment delivery device according to claim 11, wherein the nasal treatment delivery device comprises a movable component having flexibility and varying the pressure.   12. A nasal treatment delivery device according to claim 11, wherein the dosage further comprises at least one additional active ingredient. A method for treating a patient's head condition using a mixed carbon dioxide and saline nasal treatment delivery device comprising:
a) providing a flow control device and a nasal treatment delivery device having a releasable nasal treatment dose contained therein, including a liquid containing salt and a gas containing carbon dioxide;
b) directing at least a portion of a nasal treatment dose to at least one nasal cavity of the patient by the flow regulator.   20. The method of claim 19, wherein the dosage further comprises at least one additional active ingredient.