Pulmonary delivery devices

Abstract

A lung delivery device (300) includes: a first chamber (206) adapted to thermally vaporize a first fluid to form a relatively warm first vapor; and a second chamber (208) adapted to atomize a second fluid without heating to form a mist of a relatively cool second vapor. The device further includes an outlet through which a user can inhale a mixture of the first and second vapors during use. The second chamber is in the form of a passive nebulizer, wherein the second chamber is selectively or continuously in fluid communication with air, and the second chamber includes at least one flavoring agent or fragrance agent, wherein the flavoring agent is inhaled by drawing air through the chamber.

Description

[0001] This application is a divisional application of the invention patent application entitled "Lung Delivery Device", with an international filing date of July 27, 2018, international application number PCT / IB2018 / 055626, and national application number 201880064455.6. Technical Field

[0002] The present invention relates to lung delivery devices, and particularly, but not exclusively, to lung delivery devices suitable for delivering active molecules and / or pharmaceuticals (such as nicotine, cannabinoids, peptides, proteins and other lung-deliverable pharmaceuticals and other electronic vape products) to a user. Background Technology

[0003] Lung delivery devices have wide applications in modern medicine because they allow drugs and medications to be delivered directly to the user's lungs. Moreover, because drugs delivered to the lungs enter the bloodstream directly, rather than being metabolized by the body (as is often the case with oral delivery systems), the user experiences the benefits of the medication almost immediately, especially in pain relief or drug-weaning applications. Another major benefit of lung delivery devices is their ability to deliver medications without the use of needles.

[0004] Existing lung delivery systems take various forms, including inhaled nebulizers, nebulizers, and metered-dose inhalers, in which the medication is administered as a mist inhaled by the lungs and a vapor delivery system, thereby mixing the medication into inhalable vapor (usually water vapor).

[0005] Vapor delivery systems for the lungs typically include a carrier liquid, usually water or a water-glycol mixture (where glycol is used to stabilize the water droplets when present in vapor form), to which the desired medication is mixed. The carrier liquid can be vaporized in various ways, such as by spraying it through a nozzle; however, in many cases, the carrier liquid is simply heated to form a vapor comprising the carrier liquid and the desired medication. The user then inhales the resulting vapor to deliver the medication. However, heating the medication can lead to the formation of undesirable byproducts, which are then inhaled by the user. This can also reduce the accuracy of the inhaled medication dosage.

[0006] An example of a vapor-based lung delivery system is an electronic cigarette, which vaporizes nicotine for inhalation by a user. A nicotine solution (“e-cigarette liquid”) is provided in a reservoir (typically in the form of a removable cartridge) and delivered along the coil to a heating element, where the nicotine solution is vaporized and inhaled by the user. Typically, a resistance wire connected to a power source (such as a battery) is wound around the coil. When activated, the wire heats up, converting the e-cigarette liquid into vapor, which is then inhaled by the user. Such a device offers significant advantages over conventional cigarettes because the user inhales far less and is safer than when smoking regular tobacco cigarettes. However, users have generally noted that e-cigarettes do not “hit the spot” in the same way as conventional tobacco cigarettes. This is because the wet vapor condenses rapidly in the user's mouth, resulting in most of the nicotine being absorbed through the nose, throat, and mucous membranes of the airways leading to the lungs. Conversely, when smoking regular cigarettes, nicotine enters directly into the lungs, leading to rapid absorption into the bloodstream and producing a corresponding "quick hit."

[0007] The alternative to e-cigarettes is the vaping inhaler. Because it uses cold, pressurized vapor instead of heated vapor, this type of device provides better, faster nicotine absorption, thus avoiding significant condensation of vapor in the mucous membranes of the throat and nose. However, the cold, dry sensation provided by this type of device results in an overall experience significantly different from smoking regular cigarettes, making such devices less popular than vapor-based e-cigarettes, leading to poor or no compliance.

[0008] The applicant's co-pending PCT patent publication WO 2015 / 079197 addresses this problem by providing a first chamber, a second chamber, and an outlet. The first chamber has a heat source suitable for thermally vaporizing a certain amount of carrier liquid to form a heated first vapor. The second chamber is suitable for atomizing a certain amount of a second liquid containing active molecules or agents without heating the second liquid to form a mist of the second vapor at a temperature lower than that of the first vapor. In use, the user can inhale a mixture of the first vapor and the second vapor through the outlet. In this way, rapid absorption of the active molecules contained in the second vapor is achieved, while providing the user with the desired thermal sensation from the "warm" vapor of the first liquid upon inhalation.

[0009] Electronic nicotine delivery systems (ENDS) are typically provided to deliver flavorings bound to vaporized nicotine. However, problems exist due to the risks associated with inhaling flavoring components (such as oils), some of which may be carcinogenic upon vaporization or delivery to the lungs. Furthermore, it is difficult to alter the flavorings of the system without causing residues or contaminants in the system itself. Flavorings for coffee, tobacco, mint, and fruit are often difficult to alter due to their unique aromas. Currently, flavorings form components of a propylene glycol / water carrier liquid, which contaminates the body of the device.

[0010] The object of the present invention is to provide an improved lung delivery device that overcomes or at least mitigates the above-mentioned disadvantages. Summary of the Invention

[0011] Therefore, the present invention provides a lung delivery device comprising: a first chamber adapted to thermally vaporize a certain amount of a first fluid to form a relatively warm, humid first vapor; a second chamber adapted to atomize a certain amount of a second fluid without heating it to form a mist of a relatively cold second vapor; and an outlet through which a user can inhale a mixture of the first vapor and the second vapor during use, wherein the second chamber includes a passive nebulizer, wherein the second chamber is selectively or continuously in fluid communication with air, the second chamber containing at least one flavoring agent or fragrance and optionally an active molecule or agent, wherein the flavoring agent / fragrance and optionally other active molecules or agents are inhaled by drawing air through the second chamber.

[0012] The flavoring and / or aroma agents may be selected from: essential oils of dried flowers, buds, leaves, stems, fruits, seeds, peels, bark, or roots, such as peppermint oil, spearmint oil, eucalyptus oil, wintergreen oil, clove oil, cardamom oil, cinnamon oil, bitter almond oil, coriander oil, caraway oil, ginger oil, juniper oil, orange oil, bitter orange oil, lemon oil, grapefruit oil, bergamot oil, thyme oil, fennel oil, rosemary oil, etc.; and from, for example, fruits, berries, nuts, spices, peppermint, tobacco, cocoa, coffee, tea, vanilla, licorice, caramel, toffee. Natural flavorings and aromas of sugar, honey, fruit wine, spirits, and brews, having concentrates of essential oils or flavoring ingredients of natural origin; synthetic flavorings and aromas of mixtures of chemicals, including hydrocarbons, alcohols, aldehydes, esters, ketones, ethers, and oxides, which are mixed to match the natural flavors of, for example, fruits, berries, nuts, spices, mint, tobacco, cocoa, coffee, tea, vanilla, licorice, caramel, toffee, honey, fruit wine, spirits, or brews, and mixtures thereof.

[0013] Preferably, the first chamber is provided with or connected to a heat source for vaporizing the first fluid, thereby producing a "warm" first vapor. Preferably, the active molecules or agent are contained in the second fluid that forms the "cold" vapor. In this way, rapid absorption of the active molecules contained in the second vapor is achieved, while providing the user with the desired thermal sensation from the vapor of the "warm" first fluid upon inhalation. Alternatively, the active molecules or agent may be contained in the first fluid to form "hot vapor."

[0014] The first fluid may include a carrier liquid (i.e., a liquid capable of forming a stable vapor), and the carrier liquid may be an inactive substance (a non-pharmaceutical carrier liquid), such as water or a water-glycol mixture.

[0015] Preferably, the flavoring agent is provided in the second chamber in a suitable dosage form, in solid or semi-solid form. Preferably, the volume of air inhaled through the second chamber can be selectively adjusted, thereby allowing the amount of inhaled flavoring agent to be altered and deposited in the mouth to enhance flavor and avoid thermal decomposition, thereby avoiding carcinogenic degradation products.

[0016] More preferably, the device is provided with an outlet in the form of a mouthpiece, which is preferably reversibly detachable from the first chamber and / or the second chamber. In this way, a flavoring agent can be provided in the mouthpiece to allow for easy replacement, for example, to change to a different flavoring agent or to allow for the addition of a flavoring agent. The mouthpiece preferably includes a first mouthpiece chamber and a second mouthpiece chamber. Preferably, the flavoring agent, in solid or semi-solid form, is provided in the second mouthpiece chamber. In a preferred embodiment, the mouthpiece includes a central first mouthpiece chamber and concentric, external second mouthpiece chambers, the second mouthpiece chamber having at least one air inlet. Preferably, a flavoring agent block is provided in the second mouthpiece chamber.

[0017] It should be understood that the lung delivery device may contain only the first chamber, wherein the mouthpiece provides the second chamber, and preferably the mouthpiece provides an extension of the first chamber in addition to providing the second chamber, wherein the second chamber preferably surrounds the extension of the first chamber.

[0018] Preferably, the central first chamber of the mouthpiece is sized to be received within a main first chamber in the lung delivery device that generates heated steam or warm steam. Suitable attachment means are provided for attaching the mouthpiece to the main device. For example, the end of the first mouthpiece chamber may be threaded or include a snap-fit ​​mechanism. An external second mouthpiece chamber may terminate in a flange having at least one air inlet, wherein the flange is received on the top surface of the main first chamber of the lung delivery device body. Preferably, a plurality of air inlets are provided at spaced intervals at the bottom of the second chamber, the plurality of air inlets preferably being equidistant. This provides optimized airflow control for controlled flavoring or flavorless delivery.

[0019] Alternatively, an annular flange may extend laterally from the area of ​​the first nozzle chamber that contacts the body of the device, the flange being provided with holes to allow air to enter a second nozzle chamber surrounding the first chamber.

[0020] Preferably, the air intake through the inlets can be controllable and / or variable. For example, the number of air inlets open can be adjustable to suit user preferences. Any suitable mechanism can be employed to allow the opening and closing of one or more of the multiple air inlets.

[0021] In one embodiment, the nozzle may include two parts, one part forming a first chamber at the center, at least a portion of the first chamber including an air inlet in fluid communication with a second chamber formed by a second part surrounding the first part. Preferably, the second part is at least partially rotatable relative to the first part to close or open one or more air inlets disposed in the first part. Alternatively, the first part is rotatable relative to the second part.

[0022] Alternatively, the mouthpiece may include means for simultaneously closing a portion of the air inlets (e.g., all air inlets in half or a quarter of the chamber). In this way, the mouthpiece may provide different flavorings in the second chamber, and the user may select the flavoring according to their preference. For example, two semi-cylindrical flavoring blocks may be provided on opposite sides of the second mouthpiece chamber, and the air inlets may be selectively opened on the side of the chamber containing the desired flavoring.

[0023] It should be understood that the composition of the mixture can be controlled by controlling the amount of steam released from one or each of the main chamber or nozzle chambers. Suitablely, the delivery device may include a controller adapted to control the composition of the first and / or second steam in the mixture during use, that is, by controlling the relative amounts of the first and second steam in the mixture, or controlling the ratio between the two. The controller may be adapted to turn one or the other of the vaporizers on or off, thereby providing the option to deliver one or the other of the liquids in steam form.

[0024] The first main chamber of the lung delivery device preferably includes a vaporizer in the form of an electric heater, such as a battery-powered resistance heating wire or coil. The current supplied to the resistance heating wire or coil can be used to control the temperature of the wire or coil, and thus to regulate and / or control the heating and vaporization of the liquid. In one embodiment of the invention, the heater comprises a hydrophilic or superhydrophilic foil covered with a film of the liquid to be vaporized. Current can be passed through the coil to heat it, thereby vaporizing the liquid. Alternatively, a ceramic heater can be used as the heat source. Heaters using ceramic heaters or other suitable materials are preferred because they reduce the likelihood of metal being delivered / inhaled into the user's lungs (i.e., exposure of metal components to high temperatures could lead to the delivery of harmful metal residues to the lungs).

[0025] Feedback circuits can be configured to thermostatically regulate the temperature or temperature profile of the heater. For example, a circuit can be configured to monitor the resistance of the wire or coil (which depends on the temperature of the wire or coil) and regulate the current in the wire or coil to control the resistance and thus the temperature.

[0026] A vaporizer suitable for use in the first chamber of the lung delivery device according to the invention may include an electric heater adapted to vaporize a certain amount of vaporizable liquid in contact therewith, the vaporizer further including circuitry configured to apply a time-dependent heating and / or cooling profile by temporarily controlling the current in the heater in response to a measured temperature of the heater.

[0027] Such a configuration (i.e., time-dependent heating and / or cooling profiles) appropriately, more precisely, and reproducibly controls the vaporization of a liquid or multiple liquids and / or improves the lifespan of a heater, which is suitably a heating wire, foil, coil, or ceramic tube.

[0028] Similarly, other heating devices can be used, such as thermionic emitters, Peltier devices, infrared emitters, etc., and the present invention is not limited to resistance heating wires, foils, or coils.

[0029] A second liquid is vaporized by atomizing the liquid or forcing it through a nozzle or orifice to form a stable, cold vapor or mist. This not only provides the user with rapid absorption of the active molecules but also avoids the potential degradation of the active ingredients or excipients (such as flavoring agents), which could expose the user to potentially harmful byproducts.

[0030] Any suitable atomizer for forming the mist of the second vapor can be incorporated into the device, such as an aerosol dispensing system, an ultrasonic vibrator, a compressor, and electro-vibration mesh technology. Preferably, the particles in the mist provided by the second chamber, produced using a suitable dosage form, have an average diameter of 5 to 50 μm, more preferably 8 to 35 μm. Flavoring agents and / or active molecules are provided in a suitable dosage form to provide the desired particle size. For example, a suitable dosage form may include viscosity enhancers, surfactants, stabilizers, and / or humectants to optimize sensory stimulation properties.

[0031] By incorporating flavoring agents and optionally active molecules or agents in a cold chamber, the dosage of active agents can be more accurately controlled with reproducible dosing, i.e., by designing atomization more accurately and reproducibly without exposing the active molecules or agents to high temperatures. Furthermore, the potential flavoring agents are not heated to produce harmful byproducts (degradation products) and do not enter the stomach.

[0032] It should be understood that drug delivery to the user's lungs can be controlled and / or altered by selecting the particle droplet size and velocity of the second vapor.

[0033] In one embodiment of the invention (e.g., a nicotine reduction device), the lung delivery system resembles a cigarette, pipe, or cigar. In this case, the first fluid may comprise an inactive mixture of water and ethylene glycol, and the second fluid may comprise a mixture of propellant, flavoring agent, and / or desired medication (in this case, liquid nicotine). Thus, the device can be programmed to deliver a dose of medication (nicotine) in each "puff" of the device or over a given period of time (e.g., a day). However, nicotine may also be provided in the first fluid as needed, and in practice, in some cases, it may be preferred that the second fluid discharged from the second chamber contains only a flavoring agent.

[0034] In one embodiment, the vaporizer of the first main chamber of the lung delivery device suitably includes a reservoir for maintaining a certain amount of liquid during use and a conveyor adapted to deliver the liquid from the reservoir to the heater during use. In an embodiment of the invention, the reservoir includes a vial, and the conveyor includes a core extending from the interior of the vial between the vial and the heater. Suitably, a resistance heating wire (such as the resistance heating wire described herein) may be wound or coiled around the core to vaporize the liquid. The conveyor may include a capillary extending between the vial and the heater.

[0035] The first and / or second fluid may suitably include solvents and stabilizers in a appropriately designed dosage form / formulation. The stabilizer is suitably adapted to stabilize droplets of solvent in air. The carrier liquid may include any one or more of the group consisting of:

[0036] Solubilizers, solvents, and mixtures thereof, such as water; alcohols, such as glycerol, propylene glycol, polyethylene glycol, vegetable oils, mineral oils, lipids, cyclodextrins, etc. Surfactants, such as anionic surfactants having carboxylate, sulfate, and sulfonate groups; cationic surfactants; nonionic surfactants, such as polyol ethers, polyoxyethylene esters and polyoxyethylene ethers, poloxamer; amphoteric surfactants, natural emulsifiers, sucrose esters, and alkyl polyglucosides;

[0037] Antioxidants, such as ascorbic acid and its salts and derivatives, tocopherol (vitamin E), thiol derivatives, such as cysteine ​​and acetylcysteine, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium bisulfite, sodium metabisulfite, and sodium thiosulfate.

[0038] Absorption enhancers, such as alcohol and azone;

[0039] Chelating agents, such as EDTA and gallate;

[0040] Minerals, such as fluorides;

[0041] Propellants, such as hydrofluorocarbons (HFA), chlorofluorocarbons (CFC), carbon dioxide, etc.; sweeteners, such as artificial sweeteners, such as saccharin and its sodium and calcium salts, aspartame, acesulfame potassium and its potassium salts, sematrandez and glycyrrhizin, polyols (such as sorbitol, xylitol, mannitol and glycerol), glucose, fructose, galactose, sucrose, lactose, maltose and mixtures thereof;

[0042] as well as

[0043] pH adjusters and buffers, such as sodium hydroxide, potassium hydroxide or calcium hydroxide; bicarbonates, citrates and phosphates, etc.

[0044] One or both of the first or second fluid suitably include an active molecule or a pharmaceutical agent. The active molecule, excipient, or pharmaceutical agent may comprise any one or more pharmacologically active compounds selected from the group consisting of:

[0045] Peptides and proteins;

[0046] H2 receptor antagonists, such as cimetidine; and ranitidine;

[0047] Prostaglandin analogues, such as misoprostol;

[0048] Proton pump inhibitors, such as lansoprazole, omeprazole, and pantalazole;

[0049] Medications used to treat food allergies, such as sodium cromoglycate;

[0050] Cardiac glycosides, such as digoxin;

[0051] Diuretics, such as amiloride; bendroflumethiazide; indapamide; furosemide; hydrochlorothiazide; and sipamide;

[0052] Drugs used for arrhythmias, such as procainamide; lidocaine; propranolol; atenolol; bisoprolol; carvedilol; indolol; and nebivolol;

[0053] Antihypertensive drugs and medications used to treat angina, such as cilazapril, lisinopril, ramipril, quintopril, amlodipine-losartan, nitroglycerin, isosorbide mononitrate, amlodipine, diltiazem, felodipine, isadipine, lacidipine, etc.

[0054] Lipid-regulating drugs, such as statins;

[0055] Drugs that act on the respiratory system, such as salbutamol, terbutaline, and bambuterol;

[0056] Antihistamines, such as cinnarazine, promethazine, perphenazine, and prochlorperazine;

[0057] Sleeping pills, such as zolpidem; zopiclone; chloromethathiazole;

[0058] Anti-anxiety medications, such as benzodiazepines; buspirone;

[0059] Antipsychotic medications, such as bensulfanilamide, fluphenazine, pimozide, and amisulpride;

[0060] Antidepressants, such as tricyclic antidepressants; mirtazapine; monoamine oxidase inhibitors (MAOIs); serotonin reuptake inhibitors (SRIs); reboxetine, etc.

[0061] Central nervous system (CNS) stimulants, such as methylphenidate;

[0062] Medications used to treat nausea include antihistamines; domperidone; metoclopramide; 5HT3 antagonists; scopolamine and betahistine;

[0063] Opioid analgesics, such as morphine, buprenorphine, and fentanyl;

[0064] Anti-migraine medications, such as 5HT1 agonists and ergot alkaloids;

[0065] Medications used to treat Parkinson's disease include apomorphine, bromocriptine, ergot urea, haloperidol, and ergot alkaloids.

[0066] Drugs used for substance dependence, such as nicotine and buprenorphine;

[0067] Medications used for dementia, such as rivastigmine; dihydroergotamine; dihydroergotamine and dihydroergotamine;

[0068] Antibiotics; antifungal drugs; antiviral drugs and antimalarial drugs;

[0069] Medications used to treat diabetes;

[0070] Treatment with glucocorticoid steroids such as betamethasone and dexamethasone;

[0071] Male and / or female hormones, such as estradiol; norethindrone; progesterone; testosterone and esters;

[0072] Pituitary hormones, such as vasopressin and desmopressin;

[0073] Drugs that affect bone metabolism, such as calcitonin and bisphosphonates;

[0074] Endocrine medications, such as bromocriptine and cabergoline;

[0075] Contraceptives, such as estrogen; progestins and combinations thereof;

[0076] Medications used for urinary frequency and bedwetting, such as oxybutyrate and desmopressin;

[0077] Medications used for erectile dysfunction, such as apomorphine and sildenafil;

[0078] Drugs used for malignant diseases and immunosuppression, such as busulfan; antimetabolites; alkaloids; corticosteroids; hormones; and interferon;

[0079] Nonsteroidal anti-inflammatory drugs, such as diclofenac, piroxicam, and refoxicab;

[0080] Medications used to treat gout, such as colchicine;

[0081] Drugs used for neuromuscular disorders, such as neostigmine and pyridostigmine;

[0082] Muscle relaxants, such as diazepam and tizanidine;

[0083] Vaccines delivered subcutaneously;

[0084] Medications used to treat nicotine withdrawal symptoms, such as nicotine; and cannabinoids.

[0085] At least one active compound can be a nutritionally active compound. A "nutritionally active compound" is a compound derived from a natural source (animal or plant) that has beneficial and / or therapeutic effects on the human or animal body in the treatment of a ailment. Such a compound can be considered a nutrient.

[0086] Suitable nutrient-active compounds can be natural products extracted from animals or plants. Examples of suitable nutrient-active compounds include:

[0087] Carotenoids, such as lycopene, lutein, astaxanthin, and carotene; glucosamine or alkylglucosamine (Nacylglucosamine); ubiquinone;

[0088] Vitamins, such as vitamins A, C, D and E; rosmarinic acid; and magnolol; honokiol; chlorogenic acid; oleuropein; methanesulfonylmethane (“MSM”); collagen and chondroitin; frankincense and boswellic acid; aescin and aescin; turmeric extracts, such as curcuminoids and tetrahydrocurcuminoids; gingerol and gingerone; triterpenes, such as ursolic acid and oleanolic acid; diterpenes, such as asiaticoside, sericoside and ruscosaponin; hydroxycitric acid (“HCA”) and nicotinamide hydroxycitric acid; trigonelline; and corosolic acid; saw palmetto; and St. John's wort.

[0089] The device suitably includes a battery, such as a disposable battery or a rechargeable battery, for powering the heater and / or control circuitry of the first chamber.

[0090] A switch is used to properly turn the heater on or off. The switch is preferably an automatic switch triggered by a user inhaling onto the device. Therefore, the switch may include a pressure-activated switch associated with the outlet of the device, whereby the switch is activated when the user inhales onto the device, thereby automatically turning on the heater, and thus the heater is turned off again when the user stops inhaling onto the device. Preferably, the device further includes a second pressure-sensitive switch for monitoring the pressure of the ambient air.

[0091] The second main chamber of the lung delivery device, which contains the second fluid, can also be a respiratory-initiated type.

[0092] Another aspect of the invention provides a mouthpiece for a lung delivery device, the mouthpiece having a first inlet end and a second outlet end and comprising: a first mouthpiece chamber adapted to be received at the inlet end of the mouthpiece within a body of the lung delivery device; and a second mouthpiece chamber preferably concentrically surrounding the first chamber, the second chamber adapted to receive at least one flavoring agent or fragrance and having at least one air inlet at the inlet end, wherein the second chamber is selectively or continuously in fluid communication with air.

[0093] It should be understood that the mouthpiece can be permanently attached to the lung delivery device, for example, forming part of the device, but more preferably, the mouthpiece is a separate component.

[0094] The first and second mouthpiece chambers are preferably provided by concentric cylindrical walls. Preferably, the first chamber of the mouthpiece extends beyond the end of the second mouthpiece chamber at its inlet end. The outlet ends of the chambers preferably have a generally common end. Preferably, the inlet end of the second chamber is provided with an annular flange extending generally perpendicularly from the second chamber, the flange having at least one air inlet in fluid communication with the second chamber. A portion of the first chamber extends beyond the flange for reception within the body of the lung delivery device, and the flange is adapted to rest on or engage with the side of the body, wherein the air inlet of the second chamber is located outside the side of the body. Preferably, a plurality of air inlets are provided at the inlet end of the second chamber, the plurality of air inlets preferably being equidistantly spaced around the periphery of the second chamber. Preferably, the air inlets are adjacent to the portion of the first chamber extending beyond the flange.

[0095] Preferably, a flavoring block is provided in the second mouthpiece chamber.

[0096] In an alternative embodiment, the annular flange forms part of the inner mouthpiece chamber, and the flange is provided with a series of holes for forming an air inlet to the second mouthpiece chamber surrounding the first chamber.

[0097] The nozzle preferably includes means for selectively opening and closing an air inlet to the second chamber, thereby enabling regulation of the volume of air entering the second chamber. For example, the second chamber may be at least partially rotatable relative to the first chamber to open and close the air inlet, and vice versa. The wall of the cylinder forming the second chamber may be provided with spaced-apart protrusions or tabs that extend above the air inlet and close it depending on the degree of rotation of the second cylinder relative to the first chamber. However, it should be understood that other means may be provided to allow the opening and closing of desired selective air inlets.

[0098] In another embodiment, the second chamber is provided with a plurality of flavoring blocks, and an air inlet can be opened to allow flavor only from the desired flavoring block. For example, the flavoring block may comprise two halves, each half containing a different flavoring, and the nozzle is provided with means for opening only the air inlet adjacent to one of the halves, for example, by providing a rotatable or sliding baffle. In another example, flavoring can be provided in an inner concentric ring and an outer concentric ring within the second chamber, and air inlets are provided in the corresponding inner and outer concentric rings, wherein the nozzle is provided with means for selectively opening and closing the inner or outer concentric ring. Attached Figure Description

[0099] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0100] Figure 1 A perspective view of a lung delivery device according to the prior art;

[0101] Figure 2 for Figure 1 An exploded view of the lung delivery device;

[0102] Figure 3A for Figure 1 A plan view of the lung delivery device;

[0103] Figure 3B for Figure 3A A close-up view of a portion;

[0104] Figure 4 A plan view of another lung delivery device that forms part of the prior art;

[0105] Figure 5 A schematic diagram of the lung delivery device and user interface;

[0106] Figure 6AA cross-sectional view of a mouthpiece for attachment to a lung delivery device according to an embodiment of the present invention;

[0107] Figure 6B for Figure 6A The perspective view of the mouthpiece shown shows the flavoring block fully inserted into the second chamber;

[0108] Figure 6C for Figure 6A The perspective view of the mouthpiece shown shows the flavoring block partially inserted into the second chamber;

[0109] Figure 6D for Figure 6A A perspective view of the mouthpiece, showing the air inlet of the second chamber;

[0110] Figure 7 A perspective view of a prior art lung delivery device and a mouthpiece according to the present invention; and

[0111] Figure 8A , Figure 8B as well as Figure 8C The figures shown are a perspective view, a partial sectional view, and a top view of a mouthpiece for attachment to a lung delivery device according to another embodiment of the present invention. Detailed Implementation

[0112] Refer to the attached diagram. Figure 1 , Figure 2 as well as Figures 3A to 3B The prior art lung delivery device 10 includes a generally cylindrical body portion 12 adapted to resemble a cigarette. The body portion 12 includes a tubular filter chamber 14 enclosing dual vaporizer chambers 15, 16, and a tubular battery chamber 18 enclosing a rechargeable battery 20. The tip 22 of the body 12 is closed by a translucent end cap 24, behind which is an LED indicator 26 that illuminates when the device 10 is in use. A control circuit 28 is included within the body 12, comprising programmable circuitry for controlling the operation of the device 10 during use.

[0113] Go to Figure 2 As shown in Figure 3, the device 10 includes a first pressure sensor (not visible) located within a filter chamber 14, which has an outlet orifice 30 through which a user can inhale the vapor generated by the device 10 during use. When the user inhales onto the filter chamber 14, the pressure sensor (not visible) activates a first vaporizer 15 and / or a second vaporizer 16 to form a mixed vapor to be inhaled, comprising a first and / or a second liquid.

[0114] The dual vaporizer chambers 15 and 16 include a pair of separate reservoirs, each containing a first liquid and a second liquid, respectively. The first reservoir 15 contains the first liquid and includes a capillary wick 31 that absorbs the liquid and whose end contacts a heater element in the form of a pyramidal superhydrophilic foil 35, which is wetted by the first liquid during use (see in particular). Figure 3B The heater element 35 may alternatively include a resistance heating coil wound around the core 31. In any case, the heater element 35 is connected to the battery 20 under the control of the control circuit 28.

[0115] The second reservoir 16 contains a second liquid, which is maintained under pressure within the reservoir, and includes a pressure relief valve or flow control valve (not shown). When a user aspirates onto the filter chamber, a pressure sensor actuates the valve to discharge the second liquid as a mist or vapor from the second reservoir. No heating element is present to allow cold vapor to be released from the second reservoir.

[0116] Therefore, when the heater 35 is turned on, the first chamber acts as a “warm steam chamber”, in which the first liquid evaporates and forms warm steam B inside the filter chamber 14. At the same time, cold steam A is released from the second reservoir (“cold steam chamber”) into the interior of the chamber 14, thereby allowing the warm steam B and cold steam A to mix in the hollow space of the filter chamber before being drawn in by the user through the outlet port 30 of the device.

[0117] The first liquid comprises a mixture of glycerol and water, and the second liquid comprises nicotine and a suitable propellant. Preferably, the particles forming the mist of the second liquid have a diameter of less than 10 μm, more preferably less than 5 μm. In this way, nicotine (or other active molecules provided in the second liquid) is delivered deep into the lungs so that the nicotine can be rapidly absorbed into the bloodstream via the lungs. However, the simultaneous delivery of warm, moist vapor in the form of vaporized first liquid provides the user with a sensation more similar to that experienced during the inhalation of conventional tobacco cigarettes. The active molecules do not come into direct contact with the heater element, thereby reducing the likelihood of thermal degradation of the active molecules, which could lead to the inhalation of harmful byproducts by the user. Conversely, only glycerol and water come into contact with the heater element, and the glycerol and water do not produce harmful byproducts upon thermal degradation.

[0118] The device may also be provided with a suitable control circuit 28, which can control the delivery of the first and / or second steam from their respective chambers. Compared to nicotine delivery using heated steam methods, the ability of the device of the present invention to deliver nicotine from a pressurized chamber without heating allows for more accurate nicotine dosing. It should be understood that the delivery of wet warm steam and cold steam can be controlled, and the content of the mixed steam can be adjusted as needed.

[0119] For example, the delivery of heated steam can be controlled using a resistance sensor operatively connected to heater element 35, which measures the resistance of the heater and thereby infers the heater temperature. Control circuitry 28 further includes a current limiting circuit for limiting the current to heater 35, and is programmed to heat the heater according to a predetermined, time-dependent heating / cooling profile.

[0120] When the user draws through the filter chamber 14, a pressure switch (invisible) triggers the control circuit 28 to heat the heater 35. The control circuit 28 then connects the battery 20 to the heater 35 in a controlled and reproducible manner. This controls the time and temperature of the heater 35, thereby regulating the vaporization of the first liquid from the core 31.

[0121] The control circuit 28 can also be operatively connected to the second pressure sensor 39. Figure 2 The second pressure sensor measures the ambient air pressure. As described above, the control circuit 28 is configured to turn on the heater 35 only when the first pressure switch is triggered.

[0122] Thus, steam is formed near the heater in the hollow internal space (mixing chamber) (i.e., the space between the vaporizer chamber 15 and the outlet port 30), which is positioned toward the tip of the filter chamber 14 when the device 10 is assembled.

[0123] The outlet orifice from the "cold steam chamber" is small enough to control (by mass limit) the amount of second liquid that can escape in each dispensing, and this outlet orifice is selectively closed and / or opened by a control valve (not shown). The control valve is connected to control circuitry 28, allowing it to be controlled independently of the heater element. Therefore, control circuitry 28 can be configured to open the valve a given number of times at each start-up, thereby incrementally controlling the dosage of the dispensed liquid (the dosage is constant at each start-up due to the size of the outlet orifice). Thus, the device can accurately control the ratio of the first and second liquids dispensed at each start-up, and therefore accurately control the dosage of a specific agent or mixture of agents in the first and second liquids. This ratio can be adjusted by control circuitry 28 according to a pre-programmed dosing scheme.

[0124] Although the aforementioned device can precisely control the dosage delivered in each chamber, if the active molecule or agent is contained only in the "cold steam" chamber, the dosage delivered in that chamber can be precisely controlled only. This allows for simpler dosage control compared to dispensing the active molecule or agent in warm steam.

[0125] Figure 4 This illustrates an alternative lung delivery device that forms part of the prior art. Figure 4 In this arrangement, the first and second chambers are not side-by-side, but rather end-to-end along the longitudinal axis of the device, thus providing a slender form. For simplicity, they are... Figure 1 Features identical to those described in Figure 3 are given the same reference numerals. Chambers 15 and 16 are disposed within a hollow cylindrical pressure vessel comprising a double-ended aerosol container having an aerosol outlet at each end, the container being surrounded by a housing 14 having an outlet 30. A cold vapor chamber 16 is disposed in the intended top of the aerosol container near the outlet 30, and a warm vapor chamber 15 extends from the bottom of chamber 16 in the bottom end of the aerosol container. A heating element 35 is disposed in a straight line with the bottom of the aerosol container. A second liquid containing active molecules is dispensed from the upper chamber (A), and a first liquid is dispensed from the lower chamber onto the heating element 35 (B). This heats the second vapor, which is then passed upward (B) through the channel between the housing and the container to the outlet 30, thereby allowing the hot and cold vapors (B, A) to be mixed before they exit through the outlet and are inhaled by the user.

[0126] In this example, the control circuit can be programmed to initiate the vaporization of the first liquid in the warm steam chamber a few milliseconds before releasing steam from the cold steam chamber, thereby ensuring that the warm steam and cold steam are released simultaneously.

[0127] It should be understood that alternative arrangements for the warm and cold steam chambers in the apparatus can be provided. For example, the apparatus may include a dual-chamber structure with a hollow cylindrical pressure vessel comprising a central divider that divides its interior into two separate reservoirs for a first liquid and a second liquid. Pressurized propellant gas occupies the remaining space in one reservoir, and a heater element and core are disposed in the other reservoir, with an outlet orifice providing a means for the liquid to escape from its respective reservoir under the influence of the pressurized propellant and the heater.

[0128] Ceramic heaters can be used to heat the first liquid in the first chamber. This reduces the likelihood of users inhaling harmful metal residues from metal heating elements.

[0129] Alternative types of "cold steam" chambers may include a spring-loaded injector comprising a tubular body portion forming a reservoir for holding a second liquid. A piston is slidably movable within the body and is sealed to the body by an O-ring seal. A hyperelastic spring cooperates between the back of the piston and an end cap of the body to push the piston along the body, and thus expel the liquid contained within the body through an outlet orifice. An outlet flow control valve is also provided to open and close the outlet orifice. The hyperelastic spring is compressed within its hyperelastic range, and as long as the hyperelastic spring operates within this range, the liquid pressure remains constant, thereby accurately regulating the amount of liquid dispensed during each valve actuation.

[0130] The apparatus containing this type of "cold steam" vaporizer will of course also include a "warm steam" chamber with heating elements for releasing warm steam, and optionally include control circuitry 28 to control the delivery of liquid.

[0131] In the attached diagram Figure 5 The dose control system 100 is shown in the diagram. Figure 5 In the middle, the lung delivery device 10 (e.g., Figures 1 to 3B , Figure 4 or Figures 6A to 7 The lung delivery device 10 shown is wirelessly connected 102 to a user's smartphone, tablet, or PC 104, and wirelessly connected to the Internet 106 via a Wi-Fi access point 108 (such as a broadband router). Internet-connected computers 110, 112 (local or remote) can therefore wirelessly connect to the device 10, or the user can connect themselves. Wi-Fi and / or Bluetooth are connected via control circuitry 28. RTM The interface provides wireless connectivity, thereby providing a graphical user interface (GUI) 120 on any of the devices 104, 110, and 112 for interacting with device 10.

[0132] The GUI 120 has a secure login system 122 to prevent unauthorized reconfiguration of the device 10 and allows the user to select between three main operating modes, namely a "wean" mode 124, in which the dosage 126 of a given drug can be reduced over time 128, as shown on the dose-time graph 130 of the GUI. This graph has draggable control points 132 that allow adjustment of the shape of the curve to change the weaning curve 124, i.e., to change the severity, duration, delay, etc., of the weaning process.

[0133] Another option from the drop-down menu is to select control program 134, which ensures that the required amount of medication is applied over a period of time. Therefore, the dose corresponding to each aspiration is controlled to ensure that the medication is applied evenly and relatively uniformly over a period of time.

[0134] The third option is to set an upper limit of 136, which may be useful in analgesic applications. This procedure prevents the delivery of the maximum dose per unit time, but allows for under-application.

[0135] The GUI 120 includes a configuration settings menu 138, which allows the user to configure the GUI according to the liquids 140, 142 in the device. A history table 144 is also provided, which provides a summary of the number of administrations 146, the amount of drug delivered 147, and the total number of runs 148. This data is presented on a historical basis 150, an actual basis 152, and a target basis 154 to facilitate monitoring of drug delivery to the user.

[0136] The device is not limited to the details of the foregoing examples. For example, the shape and construction of the device can be changed, as can the manufacturing materials, the combination of vaporizer technologies used, the combination of heaters used, and other features (such as start / stop switches, control valves, etc.).

[0137] For example, a first “warm steam” reservoir containing a non-reactive liquid (such as a water-glycol mixture) that forms inhalable vapor can be consumed by the user without restriction. The device has a pressure switch located within a filter tube 14 that detects when the user inhales the vapor through the device. The pressure switch is connected to a control circuit 28, which is adapted to switch current from the battery 20 to a resistance heating coil wound around the end of a core. This resistance heating coil causes the first liquid to evaporate to form vapor, which can be drawn from the device via a vaporizer outlet and the device's main outlet port 30.

[0138] The device may additionally include a push-button switch accessible from the outside of the device, which the user can press to actuate the valve in the "cold vapor" chamber during use. Therefore, the user can use the device freely and select when to administer a dose of medication or active ingredient (such as nicotine) contained in the second reservoir by pressing the button during inhalation.

[0139] Compared to previous lung delivery devices, the above-described device offers several potential advantages. The active ingredient (such as nicotine or cannabinoids) is inhaled as small particles (<10 μm), allowing for deep delivery into the user's lungs and rapid absorption into the bloodstream. Simultaneous delivery of warm, inactive vapor enhances flavor and inhalation sensation. The active ingredient is not thermally degraded, reducing any harmful byproducts and improving dosage accuracy and reproducibility.

[0140] In the attached diagram Figures 6A to 6D , Figure 7 as well as Figures 8A to 8C The diagram illustrates an apparatus according to an embodiment of the invention. This apparatus is a modification of the apparatus described above and addresses the problems associated with delivering flavoring agents (e.g., oils) using hot, moist steam, as well as the contamination of the lung delivery device by the flavoring agent.

[0141] This invention overcomes the significant regulatory burden of inhalation toxicology for various flavoring compounds in which inhalation data are unknown or the risk of inhalation is significantly greater than that of oral deposition.

[0142] This invention provides the delivery of flavoring agents or fragrances using "cold" atomized vapor. This contrasts with prior art devices that utilize a carrier liquid (such as water or a water-glycol mixture) from a heated chamber to deliver flavoring agents or fragrances. Therefore, in Figure 1 and Figure 4 In the lung delivery device shown, the flavoring agent or flavoring agent is provided in a second chamber, which may optionally contain active molecules, rather than in a first chamber that provides relatively warm steam relative to the second chamber. This ensures that the flavoring agent is delivered to the mouth and prevents the flavoring agent from degrading into harmful byproducts that may occur when heated.

[0143] Providing flavorings in warm steam according to existing techniques can also lead to contaminants or residues in the canister / chamber system of the device. Embodiments of the present invention enable the alteration of the flavorings in ENDS without causing contaminants or residues in the canister system. Coffee, tobacco, mint, and fruit flavorings are often difficult to alter due to their unique aromas. For example, in Figures 6A to 6D , Figure 7 as well as Figures 8A to 8CAs described herein, the present invention enables the use of flavoring blocks within an atomization chamber, utilizing simple switching to reduce or eliminate cross-contamination of flavorings between different uses. Currently, flavorings are components of propylene glycol / water in available devices.

[0144] Figures 6A to 6D The embodiment shown is for attachment to a conventional lung delivery device (e.g., Figure 7 The mouthpiece 200 of the device 300 shown has a first inlet end 202 and a second outlet end 204. The mouthpiece has a central first chamber 206 composed of a cylindrical tube, the first chamber being adapted to be received at the inlet end 202 into the body of the lung delivery device 300. A second chamber 208 concentrically surrounds the first chamber, the second chamber being adapted to receive at least one flavoring or fragrance agent 210, and has at least one air inlet 212 at the inlet end.

[0145] The first chamber 206 of the mouthpiece extends beyond the inlet end of the second chamber. The outlet ends 204 of the chambers generally have a common end. The inlet end of the second chamber is provided with an annular flange 220 extending vertically from the second chamber, the flange having at least one air inlet 212 in fluid communication with the second chamber. A portion 202a of the first chamber extends beyond the flange for reception within the body of the lung delivery device, and the flange is adapted to rest on or engage with the side of the body, wherein the air inlet of the second chamber is located outside the side of the body. A filter tip 302 may also be received at the outlet end 204 of the mouthpiece (see...). Figure 7 ).

[0146] It should be understood that a plurality of air inlets 212 may be provided at the entrance end of the second chamber, the plurality of air inlets 212 preferably being equidistantly spaced around the perimeter of the second chamber in order to optimize the airflow into the second chamber. Ideally, the air inlets 212 are adjacent to the portion of the first chamber that extends beyond the flange.

[0147] Any desired flavoring block 210 can be provided within the second chamber 208. In this way, when the mouthpiece 200 is attached to the lung delivery device and the user inhales through the mouthpiece, warm, moist steam enters the first chamber 206 of the mouthpiece from the main body of the device. Simultaneously, air can enter the second chamber through the air inlet 212 to atomize the flavoring agent in the flavoring block. This allows the user to mix the warm, moist steam with the cold steam containing the flavoring agent, thus addressing the cold sensation associated with the delivery of some nicotine products or other active agents, while eliminating the possibility of harmful components of the flavoring agent being ingested and deposited.

[0148] This arrangement is not only harmless to health (because flavorings such as oils are not heated), but also makes it easy to change mouthpieces for mouthpieces with different flavoring blocks without causing any contamination to the main lung delivery device.

[0149] Ideally, but not necessarily, nicotine or other active agents are also delivered via a cold chamber. This combination of unheated gas and heated aerosol (usually odorless) is believed to improve customer satisfaction and may bring the product closer to customer expectations for nicotine-containing products.

[0150] Figures 6A to 6D as well as Figure 7 The embodiment shown is preferably formed by a simple two-piece construction. The mouthpiece can be discarded after use and replaced with a new mouthpiece, or the flavoring block can be removed, the mouthpiece cleaned, and a new flavoring block inserted. Therefore, this provides the user with an easy mechanism to change the flavoring or the device for changing the flavoring, for example, from cherry to mint.

[0151] exist Figures 8A to 8C Another embodiment of the mouthpiece according to the invention is shown. The mouthpiece 400 is similar to... Figures 6A to 6D The mouthpiece shown is an annular flange 420 formed as part of a molded portion forming a first chamber 406 of the mouthpiece, and a cylindrical sleeve 408a rests on the flange to form a second chamber 408. An air inlet 412 is disposed through the flange, and the portion of the first chamber of the mouthpiece extending beyond the inlet end 402 of the second chamber is threaded for engagement with a heated chamber of a lung delivery device (not shown). The sleeve is preferably made of a more ductile material than the rest of the mouthpiece to increase user comfort.

[0152] In a preferred embodiment of the invention, the number of air inlets leading to the second chamber can be selectively adjusted to change the airflow through that chamber. This allows the user to select the amount of flavoring agent to be inhaled and mixed with the hot vapor. Alternatively or additionally, more than one type of flavoring agent can be provided in the second chamber, wherein the user can select which air inlets to open depending on which flavoring agent to inhale.

[0153] For example, the nozzle may have means for opening and closing the air inlet to the second chamber, thereby enabling regulation of the volume of air entering the second chamber (not shown). For example, the second chamber may be at least partially rotatable relative to the first chamber to open and close the air inlet, or vice versa. The wall of the cylinder forming the second chamber may be provided with spaced-apart protrusions or tabs that extend above the air inlet and close the air inlet depending on the degree of rotation of the second cylinder relative to the first chamber.

[0154] In another embodiment, the second chamber is provided with multiple flavor blocks and an air inlet can be opened to allow flavor only from the desired flavor block. For example, the flavor block may comprise two halves, each with a different flavor, and the mouthpiece is provided with means for opening an air inlet adjacent only to one of the halves, such as by providing a rotatable or sliding baffle. In another example, flavor can be provided in inner and outer concentric rings within the second chamber, and the second chamber has air inlets disposed in corresponding arrangements of the inner and outer concentric rings, wherein the mouthpiece is provided with means for selectively opening and closing the air inlets of the inner or outer concentric rings. This allows the user to easily select a specific flavor without having to change the mouthpiece. This is ideal because many users quickly become accustomed to a flavor and may want to alternate flavors throughout the day, such as cherry and mint.

Claims

1. A lung delivery device including a mouthpiece, the lung delivery device comprising: The body has a first chamber, the first chamber having a heating element adapted to thermally vaporize a certain amount of first fluid to form a relatively warm, humid first steam; exit; The mouthpiece is connected to the body via the outlet, the mouthpiece including an extension of the first chamber of the body for a passage of the first vapor, and the mouthpiece having a second chamber adapted to receive at least one flavoring agent or fragrance, wherein the second chamber is selectively or continuously fluidly communicated with air to provide a passive atomizer for atomizing a quantity of flavoring agent or fragrance without heating, wherein the flavoring agent or fragrance is drawn in by drawing air through the second chamber.

2. The lung delivery device according to claim 1, wherein, The flavoring agent is provided in the second chamber in solid or semi-solid form.

3. The lung delivery device according to claim 1 or 2, wherein, It can selectively adjust the volume of fluid passing through the second chamber.

4. The lung delivery device according to claim 1 or 2, wherein, The mouthpiece is reversibly detachable from the main body of the lung delivery device.

5. The lung delivery device according to claim 1, wherein, The second chamber at least partially surrounds an extension of the first chamber.

6. The lung delivery device according to claim 5, wherein, The mouthpiece includes a central extension comprising a first chamber and a concentric outer second chamber having at least one air inlet.

7. The lung delivery device according to claim 6, wherein, The external second chamber terminates in a flange having at least one air inlet, wherein the flange is received on the top surface of the body of the lung delivery device.

8. The lung delivery device according to claim 6, wherein, An annular flange extends laterally from the extension of the first chamber providing the mouthpiece, the flange having at least one air inlet leading to the second chamber surrounding the first chamber.

9. The lung delivery device according to claim 6, wherein, Multiple air inlets are provided leading to the second chamber, and the intake of air through these air inlets is adjustable.

10. The lung delivery device according to claim 9, wherein, The number and / or size of the air inlets leading to the second chamber are adjustable.

11. The lung delivery device according to claim 9 or 10, wherein, The nozzle comprises two parts, a first part forming a central first chamber, at least a portion of the first chamber including an air inlet in fluid communication with a second chamber formed by the second part, the second part surrounding the first part, and the first part and the second part being rotatable at least partially relative to each other to close or open one or more air inlets disposed in the first part.

12. The lung delivery device according to claim 6, wherein, The mouthpiece includes means for selectively and simultaneously closing a portion of the air inlet.

13. The lung delivery device according to claim 12, wherein, It is possible to open one half of the air inlet while closing the other half.

14. The lung delivery device according to claim 12 or 13, wherein, Two semi-cylindrical flavoring blocks are provided on opposite sides of the second chamber of the mouthpiece, wherein half of the air inlet can be opened simultaneously and temporarily on the side of the chamber containing the desired flavoring.

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