Pulmonary Delivery Device

Abstract

The pulmonary delivery device has a first chamber for evaporating a first fluid to form a first vapor, a second chamber (102) adapted to atomize a second fluid to form a second vapor, which may be provided in a mouthpiece attachable to the device, and an outlet through which a user can inhale the first and second vapors, the second chamber being in fluid communication with air, the second chamber including a substrate (100) having at least one fragrance or aroma, the fragrance / aroma being inhaled by drawing air through the second chamber, and the second chamber further comprising at least one of an air flow obstruction member (110) and an air flow diverting member to increase uptake of the fragrance or aroma during inhalation of air.

Description

[Technical Field]

[0001] The present invention relates to pulmonary delivery devices, particularly but not exclusively, suitable for delivering active molecules and / or drugs to a user, such as nicotine, cannabinoids, peptides, proteins, and other pulmonary-deliverable drugs, and other vape products. [Background technology]

[0002] Pulmonary delivery devices have wide application in modern medicine due to their ability to deliver drugs and medications directly to a user's lungs. Furthermore, because drugs delivered to the lungs enter the bloodstream directly, the user feels the effects of the drug almost immediately, compared to via the body's metabolism as with oral delivery systems, particularly in pain relief or drug withdrawal applications. Another major advantage of pulmonary delivery devices is their ability to deliver drugs without the use of needles.

[0003] Existing pulmonary delivery systems may take a variety of forms, including inhalation sprays, nebulizers, metered-dose inhalers in which the medication is administered in the form of a mist that is inhaled by the lungs, and vapor delivery systems in which the medication is mixed into an inhalable vapor (often a water-containing vapor).

[0004] Vapor pulmonary delivery systems comprise a carrier liquid, often water or a water-glycol mixture (the glycol serves to stabilize the water droplets in vapor form), into which the desired medication is mixed. The carrier liquid can be vaporized in a variety of ways, such as by spraying through a nozzle, but more often it is simply heated to form a vapor comprising the carrier liquid and the desired medication. The resulting vapor is inhaled by the user to deliver the medication. However, heating the medication can result in the formation of undesirable by-products that can be inhaled by the user. This can reduce the accuracy of the dose of medication inhaled.

[0005] An example of one type of pulmonary delivery system is an electronic cigarette, which a user smokes to inhale nicotine. A nicotine solution ("e-liquid") is provided in a reservoir (often in the form of a removable cartridge) and travels along a wick to a heating element, where it is vaporized and can be inhaled by the user. Typically, a length of resistive wire connected to a power source, such as a battery, is wrapped around the wick. When activated, the wire heats up, converting the e-liquid into vapor, which is inhaled by the user. Such devices offer clear advantages over traditional cigarette smoking, as users inhale far fewer compounds and are safer than regular cigarettes. However, regular users have noted that e-cigarettes do not provide the same "satisfaction" as traditional cigarettes. This is because the moist vapor rapidly condenses in the user's mouth, allowing most of the nicotine to be absorbed through the mucous membranes of the nose, throat, and airways before reaching the lungs. In contrast, with traditional cigarette smoking, nicotine travels directly to the lungs and is rapidly absorbed into the bloodstream, providing a corresponding "fast hit."

[0006] An alternative type of e-cigarette is the atomizing inhaler. This type of device uses cool, pressurized vapor instead of heated vapor, thereby avoiding significant condensation of the vapor on the mucous membranes of the nose and throat, resulting in better and more rapid absorption of nicotine. However, the cool, dry sensation provided by this type of device makes the overall experience significantly different from smoking traditional cigarettes, and therefore such devices are less popular than vaping e-cigarettes and have lower or insufficient adherence rates.

[0007] Applicant's prior PCT patent publication no. WO 2015 / 079197 provides a solution to this problem by providing a first chamber having a heat source adapted to thermally vaporize a quantity of carrier liquid to form a heated first vapor, a second chamber adapted to atomize a quantity of second liquid containing an active molecule or agent to form a mist of second vapor having a lower temperature than the first vapor without heating the second liquid, and an outlet through which a user can inhale a mixture of the first and second vapors during use, thereby achieving rapid absorption of the active molecules contained in the second vapor while providing the user with the desirable warm sensation on inhalation provided by the vapor of the "warm" first liquid.

[0008] Electronic nicotine delivery systems (ENDS) are often provided to deliver flavors along with vaporized nicotine. However, problems exist due to the risk of inhaling flavoring ingredients, such as oils, which may be carcinogenic if vaporized or delivered to the lungs. Furthermore, it is difficult to change the flavor of the system without leaving residue or contamination in the body of the system. Coffee, tobacco, mint, and fruit flavors are often difficult to replace due to their characteristic aromas. Currently, flavors are an integral part of the propylene glycol / water carrier liquid, which contaminates the body of the device.

[0009] Applicant's prior publication WO2019 / 030602A1 provides a mouthpiece for a pulmonary delivery device having a separate chamber for flavor delivery, which has its own air intake, ensuring that the flavor does not come into contact with the device's heat source. This not only prevents contamination of the main device, but also prevents flavor degradation. This device has also been shown to improve the quantity and quality of flavor delivered to the user. However, it is desirable to further improve the device to maximize the amount of flavor delivered to the user.

[0010] It is an object of the present invention to provide an improved pulmonary delivery device and / or mouthpiece for the device that maximizes flavor delivery to the end user. Summary of the Invention

[0011] Accordingly, a first aspect of the present invention provides a pulmonary delivery device comprising a first chamber adapted to vaporize a quantity of a first fluid to form a first vapour, a second chamber adapted to atomise a quantity of a second fluid to form a second vapour, and an outlet through which, in use, a user can inhale a mixture of the first and second vapours, wherein the second chamber comprises a passive nebuliser, the second chamber is in fluid communication with air selectively or continuously, the second chamber comprises a substrate having at least one fragrance or aroma, the fragrance / aroma being inhaled by drawing air through the second chamber, and the second chamber further comprises at least one of an air flow obstruction member and an air flow diverting member to increase uptake of the fragrance or aroma during inhalation of air.

[0012] The one or more airflow obstruction or diverting members function to optimize air velocity through the chamber, increase contact of the air with a greater surface area of ​​the substrate, and / or recirculate air through the chamber to increase fragrance uptake in the substrate during inhalation.

[0013] At least one airflow obstruction element is preferably provided upstream of the substrate in the second chamber. This creates turbulence in the airflow before it enters the substrate, slowing down the airflow through the substrate and increasing the uptake of fragrance. Preferably, each of the first chamber and the second chamber has at least one air inlet, and the device is provided with at least one outlet, preferably a single outlet. In the context of the present disclosure, the term "upstream" means the direction toward the air inlet, and "downstream" means the direction toward the outlet.

[0014] The at least one airflow obstruction member may comprise a baffle extending at least partially across the chamber, the baffle preferably having at least one air passage therethrough in the form of a hole. More preferably, the baffle comprises a disk having a plurality of bore holes therethrough. Multiple airflow obstruction members may be provided within the chamber to regulate the airflow through the substrate. For example, multiple disks having bore holes may be provided within the chamber, preferably with the bore holes of adjacent disks out of phase. Multiple substrates may be provided in the chamber, for example sandwiched between the airflow obstruction members.

[0015] Additionally or alternatively, the second chamber of the mouthpiece is configured to direct airflow through as wide a portion of the substrate as possible, thereby increasing fragrance uptake and resistance to inhalation.In one embodiment, the substrate may be contained in a cage suspended within the chamber, the cage having an end cap at the upstream end of the device and an outlet at the downstream end.The cage may have a plurality of spaced openings on its side that serve as entry points for airflow into the substrate.In this way, the air is directed through as wide a portion of the substrate as possible by passing over the initial portion of the substrate via the end cap and entering through the plurality of inlet openings.

[0016] Also, baffles or vanes may be provided downstream of the end cap near the beginning of the substrate to further increase airflow to the substrate. Additionally (or alternatively), a downstream end cap may be provided at the exit end of the substrate, having at least one opening, preferably located approximately in the center of the cap.

[0017] It should be understood that the mouthpiece or pulmonary delivery device may be provided with a combination of the above features, for example a combination of both a cage and a disc, to enhance flavor absorption and / or resistance to draw.

[0018] Additionally or alternatively, at least one air diversion member may include at least one auxiliary channel or conduit extending around a portion of the chamber housing the substrate to allow recirculation of air through the substrate, thereby improving air saturation with fragrance and increasing resistance to draw. Preferably, one or more side or auxiliary conduits, each having a cross-sectional diameter narrower than the chamber, extend from a junction where the chamber branches off before the substrate to a junction beyond the substrate. This allows a portion of the air that has passed through the substrate to flow back along the auxiliary channel and be recirculated through the substrate.

[0019] In one embodiment, multiple auxiliary channels are provided, extending from the chamber at the upstream junction of the substrate to the downstream junction of the substrate. The chamber and auxiliary conduits are configured to ensure that air is recirculated through the substrate without bypassing it. This can also be achieved or improved by optimizing the cross-sectional area of ​​the auxiliary channels relative to the cross-sectional area of ​​the chamber outlet to ensure that air velocity is sufficient to prevent bypassing the chamber. Alternatively, air flow obstructions and / or diverters can be provided at the inlet or outlet of the auxiliary conduit to block flow from the chamber to the upstream inlet of the auxiliary channel while encouraging air flow through the downstream inlet to the auxiliary channel.

[0020] In one embodiment, at least one disk having at least one opening is provided within the chamber where the downstream junction meets the chamber, and a funnel and duct are provided where the upstream junction meets the chamber, the disk assisting in branching the flow into auxiliary channels, and the funnel and duct intercept the flow into the channel and direct the flow through the substrate.

[0021] In a preferred embodiment of the invention, the first chamber is adapted to evaporate a quantity of a first fluid to form a relatively warm, moist first vapor, for example by providing a heat source in the first chamber, and the second chamber is adapted to spray a quantity of a second fluid to form a relatively cool second vapor without heating. Additionally or alternatively, both chambers may be provided with a heat source. Preferably, the heat source for one or each chamber may be switched on and off.

[0022] It will be appreciated that any of the described embodiments may be incorporated into the second chamber of a mouthpiece having first and second chambers connectable to a body portion of a pulmonary delivery device, the body portion optionally having a heat source, such as a heating element, for example. The first chamber is preferably provided with or connected to a heat source for producing a first "warm" vapor by evaporation of the first fluid.

[0023] To this end, a second aspect of the present invention provides a mouthpiece for a pulmonary delivery device, the mouthpiece having a first inlet end and a second outlet end, comprising a first mouthpiece chamber adapted to be received within a body of a pulmonary delivery device at the inlet end of the mouthpiece, and a second mouthpiece chamber adapted to receive at least one substrate carrying at least one fragrance or aroma, the second chamber having at least one air inlet at the inlet end thereby being in fluid communication with air selectively or continuously to allow inhalation of the fragrance / aroma by drawing air through the second chamber, the second chamber further comprising at least one of an air flow obstruction member and an air flow diverting member to increase uptake of the fragrance or aroma during inhalation of air.

[0024] The fragrance or aroma-containing substrate is preferably foam-like. The foam may be polyurethane, polyethylene, or other suitable medical-grade composition with suitable porosity for optimal flavor delivery. The foam may be placed within a chamber to form a mouthpiece or a second chamber of a pulmonary delivery device. However, other porous materials may also function as the substrate.

[0025] Flavorings and / or aromas may be derived from the essential oils of dried flowers, buds, leaves, stems, fruits, seeds, peels, bark, or roots, such as peppermint, spearmint, eucalyptus, wintergreen, clove, cardamom, cinnamon, bitter almond, coriander, caraway, ginger, juniper, orange, bitter orange, lemon, grapefruit, bergamot, thyme, fennel, rosemary, or from fruits, berries, nuts, spices, mint, tobacco, cocoa, coffee, tea, vanilla, licorice, caramel, toffee, or The flavors and aromas may be selected from natural flavors and aromas which are essential oils or concentrates of naturally occurring flavor components such as honey, wine, liqueur, and beer; synthetic flavors and aromas which are composed of mixtures of chemicals comprising hydrocarbons, alcohols, aldehydes, esters, ketones, ethers, and oxides formulated to match the natural flavor of fruits, berries, nuts, spices, mint, tobacco, cocoa, coffee, tea, vanilla, licorice, caramel, toffee, honey, wine, liqueur, or beer; and mixtures thereof.

[0026] The flavors may be configured to mimic the taste of different foods and / or beverages. Examples include sweet and salty flavors. Such flavors are particularly beneficial for use in enteral feeding, which delivers food directly to the stomach and intestines, where flavors are lost. Thus, the device of the present invention provides patients / subjects with enhanced satisfaction through flavor delivery to the mouth during enteral feeding. This can be further enhanced by delivering warm or cold steam, depending on whether the food is normally served warm or cold. In the heating option, where a heat source is activated in one of the chambers, the flavor is accompanied by a warm sensation in the mouth to mimic a warm meal, while in the non-heating option, where the heat source is switched off, only the flavor is delivered to mimic a cold food.

[0027] The first fluid may comprise a carrier liquid (i.e., a liquid capable of forming a stable vapor), which may be inert (non-drug carrier liquid), such as water or a water-glycol mixture. An active ingredient, such as nicotine, may be contained in the first fluid. Alternatively, the active ingredient may be contained in the second chamber.

[0028] Preferably, the flavor is provided in a solid or semi-solid form in the second chamber in a suitable formulation. Optionally, the amount of air inhaled through the second chamber may be selectively adjustable, thereby varying the amount of flavor inhaled and depositing in the mouth to enhance the flavor and avoid thermal degradation, thereby avoiding carcinogenic degradation products.

[0029] Preferably, the mouthpiece according to the second aspect forms an outlet for the pulmonary delivery device and is preferably reversibly removable. In this way, a flavor is provided within the mouthpiece and can be easily replaced or replenished for changing to a different flavor, for example, a different food flavor. The second chamber of the mouthpiece preferably at least partially surrounds the first chamber, the second chamber having at least one air inlet, and the flavor is provided within the second chamber. In one embodiment, the second chamber comprises multiple chambers extending along both sides of the first chamber. In another embodiment, the mouthpiece comprises a central first mouthpiece chamber and a concentric outer second mouthpiece chamber, the second chamber having at least one air inlet.

[0030] It should be understood that while the mouthpiece may be permanently attached to the pulmonary delivery device, eg form part of the device, preferably the mouthpiece is a separate component.

[0031] The pulmonary delivery device may include only a first chamber and the mouthpiece may provide a second chamber, and preferably the mouthpiece, in addition to providing an extension to the first chamber, also provides a second chamber that preferably surrounds the extension to the first chamber.

[0032] Preferably, the first chamber of the mouthpiece is sized to be received within a primary first chamber provided in a pulmonary delivery device, preferably for generating heated or warm vapor. Suitable attachment means are provided for attaching the mouthpiece to the main device. For example, the end of the first mouthpiece chamber may have a thread or a snap-fit ​​configuration. The outer, second mouthpiece chamber may terminate in a flange having at least one air inlet, which is received on the upper surface of the primary first chamber of the main body of the pulmonary delivery device.

[0033] Alternatively, an annular flange may extend laterally from the area of ​​the first mouthpiece chamber that interfaces with the body of the device, the flange being provided with holes to allow air to enter a second mouthpiece chamber that surrounds the first chamber.

[0034] The air flow through the inlets may be manually or automatically controllable and / or variable. For example, the number of open air inlets may be adjustable to suit a user's preferences. Any suitable mechanism may be used to enable opening and closing of one or more of the multiple inlets.

[0035] It is understood that the composition of the mixture can be controlled by controlling the amount of vapor released from one or each of the main chamber or mouthpiece chambers. Suitably, the delivery device may comprise a controller adapted to control the composition of the first and / or second vapor in the mixture during use by controlling the relative amounts or ratios of the first and second vapors in the mixture. The controller may be adapted to provide the option of delivering one or the other liquid in vapor form by manually or automatically switching one or the other vaporizer on or off. Automatic control may be via an externally controllable device, such as a smartphone, computer, etc.

[0036] In embodiments in which the first chamber is provided with a heat source, the formation of the relatively warm, moist first vapor is provided by the first chamber adapted to thermally evaporate a quantity of the first fluid to form vapor at a higher temperature than the vapor formed by the second chamber, e.g., by providing a heat source to the first chamber, which does not need to have a heat source and therefore provides a relatively cooler second vapor.

[0037] The first main chamber of the pulmonary delivery device preferably includes a vaporizer in the form of an electronic heater, such as a battery-powered resistive heating wire or coil. Electrical current supplied to the resistive heating wire or coil can be used to regulate and / or control the heating and evaporation of the liquid by controlling the temperature of the wire or coil. In an embodiment of the present invention, the heater includes a hydrophilic or superhydrophilic foil coated with a film of the liquid to be evaporated. Electrical current is passed through the coil to heat it, thereby evaporating the liquid. Alternatively, a ceramic heater can be used as the heat source. The use of a ceramic or other suitable material heater may be preferred to reduce the possibility of metals being delivered / inhaled into the user's lungs; i.e., metal elements exposed to high temperatures can cause harmful metal residues to be delivered to the lungs.

[0038] A feedback circuit may be provided to thermostatically regulate the temperature or temperature profile of the heater. For example, circuitry may be provided to monitor the resistance of the wire or coil (resistance being dependent on the temperature of the wire or coil) and adjust the current in the wire or coil so that the resistance and temperature are controlled.

[0039] Preferably, the heat source can be switched on or off.

[0040] A vaporizer suitable for use in the first chamber of a pulmonary delivery device according to the present invention may comprise an electronic heater adapted to vaporize a quantity of evaporable liquid in contact therewith, the vaporizer further comprising circuitry configured to apply a time-dependent heating and / or cooling profile by time-controlling current flow in the heater in response to a measured temperature.

[0041] Such a configuration, i.e., a time-dependent heating and / or cooling profile, provides more accurate, repeatable and suitable control of the evaporation of one or more liquids and / or improves the life of the heater, which is suitably a wire, foil, coil or ceramic tube.

[0042] Other heating devices may equally be used, such as thermionic emitters, Peltier elements, infrared emitters, etc., and the present invention is not limited to resistive heater wire, foil, or coils.

[0043] Preferably, the particles produced using a suitable formulation in the mist provided by the second chamber have an average diameter of 5 to 50 μm, preferably 8 to 35 μm. The flavor is provided in a suitable formulation to provide the desired particle size. For example, a suitable formulation may include viscosity enhancers, surfactants, stabilizers, and / or humectants to optimize sensory properties.

[0044] In embodiments of the present invention, for example, in the case of a nicotine withdrawal device, the pulmonary delivery system resembles a cigarette, pipe, or cigar. In such cases, the first fluid may comprise an inert mixture of water and glycol, and the second fluid may contain a mixture of propellant, flavoring, and / or a desired medicament, in this case, liquid nicotine. Thus, the device can be programmed to deliver a specific dose of medicament (nicotine) with each "inhale" of the device or over a given period of time, e.g., a day. However, nicotine may be provided in the first fluid if desired, and indeed, in certain cases, it is preferred that the second fluid expelled from the second chamber contain only flavoring.

[0045] In one embodiment, the vaporizer of the first main chamber of the pulmonary delivery device suitably comprises a reservoir for holding a quantity of each liquid during use, and a conveyor adapted to transport the liquid from the reservoir to the heater during use. In an embodiment of the invention, the reservoir comprises a vial, and the conveyor comprises a wick extending between the interior of the vial and the heater. Suitably, a resistive heating wire, for example as described herein, may be wrapped or wound around the wick to vaporize the liquid. The conveyor may comprise a capillary tube extending between the vial and the heater.

[0046] The first and / or second fluids may suitably comprise a solvent and a stabilizer in a suitably designed combination / recipe, the stabilizer being suitably adapted to stabilize the solvent droplets in air. The carrier liquid may comprise any one or more of the group comprising: Solubilizers, solvents, and mixtures thereof, such as water, glycol, propylene glycol, polyethylene glycol, vegetable oil, mineral oil, lipids, alcohols such as cyclodextrin, etc. Surfactants such as anionic surfactants with carboxylate ions, sulfate groups, and sulfonate groups, cationic surfactants, polyol ethers, polyoxyethylene esters and ethers, nonionic surfactants such as poloxamers, amphoteric surfactants, natural emulsifiers, sucrose esters, and alkyl polyglucosides; Antioxidants such as ascorbic acid and its salts and derivatives tocopherol (vitamin E), thiol derivatives such as cysteine ​​and acetylcysteine, butylated hydroanisole (BHA), butylated hydroxytoluene (BHT), sodium hydroxide sulfate, sodium metazincate, and sodium thiosulfate; absorption enhancers such as alcohol, azone; chelating agents such as EDTA and gallates; minerals such as fluoride; Propellant such as hydrofluoroalkanes (HFAs), chlorofluorocarbons (CFCs), carbon dioxide, etc.; artificial sweeteners such as saccharin and its sodium and calcium salts, aspartame, acesulfame and its potassium salt, thaumatin, and glycyrrhizin, polyhydric alcohols such as sorbitol, xylitol, mannitol, and glycerol, glucose, fructose, galactose, sucrose, lactose, maltose, and mixtures thereof; and pH adjusters and buffers such as sodium, potassium, or calcium hydroxide, bicarbonate, citrate, and phosphate.

[0047] One or both of the first or second fluids suitably comprises an active molecule or agent. The active molecule, excipient or agent may comprise any one or more of the following groups of pharmacologically active compounds: peptides and proteins; H2 receptor antagonists such as cimetidine and ranitidine; prostaglandins themselves, such as misoprostol; proton pump inhibitors such as lasonsoprazole, omeprazole, and pantaprazole; food allergy medications such as sodium cromoglycate; cardiac glycosides such as digoxin; diuretics such as amiloride, bendroflumethizide, indapamide, furosemide, hydrochlorothiazide, and xipamide; antiarrhythmic medications such as procainamide, lidocaine, propranolol, atenolol, bisoprolol, carvedilol, pindolol, and nebivolol; Antihypertensive and antianginal medications such as crizapril, lisinopril, ramipril, trandalapril, amlodipine, losartan, nitroglycerin, isosorbide mononitrate, amlodipine, diltiazem, felodipine, ilaradipine, and lacidipine; lipid-regulating drugs such as statins; Respiratory medications such as salbutamol, terbutaline, and bambuterol; antihistamines such as sinarezin, promethazine, perphenazine, and prochlorperazine; hypnotics such as zolpidem, zopiclone, and clomethiazole; anti-anxiety medications such as benzodiazepines and buspirone; antipsychotics such as benperidol, fluphenazine, pimozide, and amisulpride; Antidepressants such as tricyclic antidepressants, mianserin, MAOIs, SRIs, and reboxetine; central nervous system (CNS) stimulants such as methylphenidate; Medications used to treat nausea, such as antihistamines, domperidone, metoclopramide, 5HT3 antagonists, hyoscine, and betahistine; opioid pain medications such as morphine, buprenorphine, and fentanyl; antimigraine medications such as 5HT1 agonists and ergoalkaloids; Medications used to treat Parkinson's disease, such as apomorphine, bromocriptine, lisuride, haloperidol, and ergoalkaloids; medications used in substance dependence treatment, such as nicotine and buprenorphine; Medications used to treat dementia, such as rivastigmine, dihydroergotamine, dihydroergocristine, and dihydroergocryptine; antibiotics, antifungals, antivirals, and antimalarials; medications used to treat diabetes; glucocorticoid therapy using steroids such as betamethasone and dexamethasone; Male and / or female hormones such as estradiol, norethisterone, progesterone, testosterone, and esters; pituitary hormones such as vasopressin and desmopressin; drugs that affect bone metabolism, such as calcitonin and bisphosphonates; endocrine medications such as bromocriptine and cabergoline; birth control pills such as estrogen, progesterone, and combinations thereof; Medications used for frequent urination and bedwetting, such as oxybutynin and desmopressin; Medications used for erectile dysfunction, such as apomorphine and sildenafil; drugs used in malignant diseases and immunosuppression, such as busulfan, antimetabolites, alkaloids, corticosteroids, hormones, and interferons; nonsteroidal anti-inflammatory drugs such as diclofenac, piroxicam, and rofecoxib; Medications used to treat gout, such as colchicine; Medications used in neuromuscular diseases such as neostigmine and pyridostigmine; muscle relaxants such as diazepam and tizanidine; Subcutaneously administered vaccines; Medications for drug withdrawal symptoms, such as nicotine withdrawal; and cannabinoids.

[0048] At least one active ingredient may be a nutraceutical compound. A "nutraceutical compound" is a compound of natural origin (animal or plant origin) that has a beneficial and / or therapeutic effect on humans or animals in the treatment of disease. Such compounds may be considered nutrients.

[0049] Suitable nutraceutical compounds may be natural products extracted from animals or plants. Examples of suitable nutraceutical compounds include: Carotenoids such as lycopene, lutein, astaxanthin, and beta-carotene, glucosamine or N-acylglucosamine, and ubiquinone; Vitamins such as Vitamin A, C, D, and E, rosmarinic acid, honokiol, magnolol, chlorogenic acid, oleuropein, methylsulfonylmethane ("MSM"), collagen and chondroitin, boswellin and boswellic acid, escin and esculin, turmeric extract such as curcuminoids and ethhydrocurcuminoids, gingerol and zingerone, triterpenes such as ursolic acid and oleanolic acid, diterpenes such as asiaticoside, sericoside, and ruscogenin, hydroxycitric acid ("HCA") and niacinamide hydroxycitric acid, trigonelline, corosolic acid, saw palmetto, and St. John's wort.

[0050] The device suitably comprises a battery, for example a disposable or rechargeable battery, for powering the heater and / or control circuitry of the first chamber.

[0051] The heater is suitably switched on or off using a switch. The switch is suitably an automatic switch that is triggered by the user inhaling on the device. Thus, the switch may comprise a pressure-activated switch associated with the outlet of the device, whereby when the user inhales on the device, the switch turns on, thereby automatically switching the heater on, and when the user stops inhaling on the device, the heater is switched off again. Suitably, the device further comprises a second pressure-sensitive switch for monitoring the pressure of the ambient air. [Brief explanation of the drawings]

[0052] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of a pulmonary delivery device according to the prior art. [Figure 2] FIG. 2 is an exploded view of the pulmonary delivery device of FIG. 1. [Figure 3A] FIG. 1 is a cross-sectional view of a mouthpiece for a pulmonary delivery device according to the prior art. [Figure 3B] 3B is a perspective view of the mouthpiece shown in FIG. 3A with a flavor block fully inserted into the second chamber. FIG. [Figure 3C] 3B is a perspective view of the mouthpiece shown in FIG. 3A with a flavor block partially inserted into the second chamber. FIG. [Figure 3D] FIG. 3B is a perspective view of the mouthpiece of FIG. 3A showing the air inlet of the second chamber. [Figure 4] FIG. 1 is a perspective view of a prior art pulmonary delivery device and mouthpiece. [Figure 5] 1 shows the airflow velocity through the flavor substrate / block provided in the chamber. [Figure 6A] FIG. 2 is a schematic diagram of a second chamber for a mouthpiece according to one embodiment of the present invention. [Figure 6B] 6B shows the velocity of airflow through the second chamber shown in FIG. 6A. [Figure 6C]FIG. 6C is an enlarged view of FIG. 6C in the region of the flavor block. [Figure 7A] FIG. 10 is a schematic diagram of a second chamber for a mouthpiece according to another embodiment of the present invention. [Figure 7B] 7B shows the second chamber shown in FIG. 7A with the flavor block removed. [Figure 7C] 7B shows the velocity of airflow through the second chamber shown in FIG. 7A. [Figure 7D] FIG. 7C is an enlarged view of FIG. 7C in the region of the flavor block. [Figure 8A] 10 is a schematic view of a second chamber for a mouthpiece according to yet another embodiment of the present invention, with a side portion of the chamber wall removed. [Figure 8B] FIG. 8B is an enlarged cross-sectional view of a portion of the second chamber shown in FIG. 8A. [Figure 8C] 8C shows the velocity of airflow through the second chamber shown in FIG. 8B. [Figure 9A] FIG. 10 is a schematic view of a second chamber for a mouthpiece according to a further embodiment of the invention, with a side portion of the chamber wall removed. [Figure 9B] FIG. 9B is an enlarged cross-sectional view of a portion of the second chamber shown in FIG. 9A. [Figure 9C] 9C shows the airflow velocity through the second chamber shown in FIG. 9B. [Figure 10] FIG. 10 is a schematic diagram of a second chamber for a mouthpiece according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0053] 1 and 2 of the accompanying drawings, a prior art pulmonary delivery device 10 comprises a generally cylindrical body 12, optionally adapted to resemble a cigarette. Body 12 comprises a tubular filter chamber 14 housing dual vaporizer chambers 15, 16, and a tubular battery chamber 18 housing a rechargeable battery 20. The distal end 22 of body 12 is closed by a transparent end cap 24, behind which is located an LED indicator light 26 that is illuminated when device 10 is in use. A control circuit 28 comprising programmable circuitry for controlling the operation of device 10 during use is housed within body 12.

[0054] Device 10 includes a first pressure sensor (not shown) located within filter chamber 14 having an outlet opening through which, during use, vapor generated by device 10 may be inhaled by a user. When a user draws air into filter chamber 14, air enters the device via at least one inlet, and the pressure sensor (not shown) activates first and / or second vaporizers 15, 16 to form a mixed vapor comprising the first and / or second liquid, which is inhaled.

[0055] The dual vaporizer chambers 15, 16 comprise a pair of independent reservoirs containing first and second liquids, respectively. In the illustrated embodiment, one of the chambers has a heat source, while the other does not. For example, the first reservoir 15 contains the first liquid and includes a capillary wick that absorbs the liquid, the end of which contacts a heating element in the form of a pyramidal, superhydrophilic foil that is wetted with the first liquid during use. Alternatively, the heating element may comprise a resistive heating coil wrapped around the wick. In either case, the heating element is connected to the battery 20 under the control of the control circuit 28.

[0056] The second reservoir 16 contains a second liquid held under pressure within the reservoir and includes a pressure release or flow control valve (not shown). When a user draws on the filter chamber, a pressure sensor activates the valve, propelling the second liquid from the second reservoir as a fine mist or vapor. In the absence of a heating element, cool vapor would be emitted from the second reservoir.

[0057] Thus, when the heater is turned on, the first chamber acts as a "warm vapor chamber" and the first liquid evaporates to form warm vapor inside the filter chamber 14. Simultaneously, relatively cool vapor A is released from a second reservoir (the "cold vapor chamber") into the interior of the chamber 14, causing the warm and cool vapors to mix in the hollow space of the filter chamber before being inhaled by the user through the outlet opening of the device.

[0058] The first liquid may comprise, for example, a mixture of glycerol, propylene glycol, and water, and the second liquid may comprise nicotine and a suitable propellant. Preferably, the particles forming the mist of the second liquid are less than 10 μm in diameter, and more preferably less than 5 μm. In this way, nicotine (or other active molecules provided in the second liquid) can be delivered deep into the lungs and rapidly absorbed into the bloodstream through the lungs. However, by simultaneously delivering warm, moist vapor in the form of evaporated first liquid, the user experiences a sensation closer to that experienced while smoking a conventional cigarette. Because the active molecules do not come into direct contact with the heating element, the possibility of thermal decomposition, which could result in the user inhaling harmful by-products, is reduced. In contrast, only glycerol and water come into contact with the heating element, and they do not produce harmful by-products upon thermal decomposition.

[0059] The device may also be provided with suitable control circuitry 28 that can control the delivery of the first and / or second vapors from their respective chambers. The ability to deliver nicotine from pressurized chambers without heating allows for more precise dosing of nicotine using the device of the present invention compared to delivery of nicotine using heated vapor methods. It will be appreciated that the delivery of the warm moist vapor and cool vapor may be controlled and the composition of the mixed vapor adjusted as needed.

[0060] The prior art devices described above offer a number of potential advantages over conventional pulmonary delivery devices: Active ingredients, such as nicotine and cannabinoids, are inhaled as small particles (<10 μm), thereby delivering them deep into the user's lungs, allowing for rapid absorption into the bloodstream; the simultaneous delivery of a warm inert vapor enhances the taste and sensation of the inhalation; the active ingredients are not subject to thermal degradation, reducing harmful by-products and improving dosage accuracy and reproducibility.

[0061] However, delivering flavors, such as oils and other extracts, in hot, moist steam poses problems of device contamination and flavor degradation. Mouthpieces, which can be integral with the rest of the device or detachable, have been developed to contain the flavor and have their own air inlet, avoiding flavor degradation and preventing contamination of other parts of the device. These devices deliver flavors or aromas in a "cool" mist of steam. This delivers the flavor to the mouth and prevents flavor degradation due to harmful by-products that can occur when heated. It is also possible to change the flavor of an ENDS without contaminating or leaving residue in the tank system. Coffee, tobacco, mint, and fruit flavors are often difficult to change due to their distinctive aromas. This device uses flavor blocks within the aerosolization chamber, allowing for simple switching to reduce or eliminate cross-contamination of flavors between uses.

[0062] An example of a prior art mouthpiece is shown in Figures 3A-3D and 4. This mouthpiece 200 is attached to a conventional pulmonary delivery device, such as device 300 shown in Figure 4. However, it should be understood that the mouthpiece may form an integral part of the entire device. The mouthpiece has a first inlet end 202 and a second outlet end 204 having a first central chamber 206 comprised of a cylindrical tube adapted to be received within the body of pulmonary delivery device 300 at inlet end 202 of the mouthpiece. A second chamber 208 concentrically surrounds the first chamber and is adapted to receive at least one flavor or aroma 210 and has at least one air inlet 212 at the inlet end.

[0063] The first chamber 206 of the mouthpiece extends beyond the inlet end of the second chamber. The outlet ends 204 of the chambers terminate at approximately the same location. The inlet end of the second chamber is provided with an annular flange 220 extending perpendicularly 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 to be received within the body of the pulmonary delivery device, and the flange is adapted to interface with or engage the side of the body, such that the air inlet of the second chamber is located beyond the side of the body. A filter tip 302 may be received at the outlet end 204 of the mouthpiece (see FIG. 4).

[0064] Any desired flavor block 210 is provided within the second chamber 208. In this manner, when a mouthpiece is attached to the pulmonary delivery device and a user inhales on the mouthpiece, warm, moist vapor flows from the body of the device into the first chamber 206 of the mouthpiece. Simultaneously, air flows into the second chamber via the air inlet 212, allowing the flavor within the flavor block to be atomized. As a result, the user ingests a mixture of warm, moist vapor and cool, flavor-laden vapor, achieving the cooling sensation of delivery of some nicotine products and other active ingredients while eliminating the potential for harmful components of the flavoring to deposit in the oral cavity.

[0065] This configuration not only poses fewer adverse health effects since flavorings, such as oils, are not exposed to heat, but also allows the mouthpiece to be easily changed for one with a different flavor block without contaminating the pulmonary delivery device body.

[0066] While suitable for their purpose, it is desirable to increase the amount of flavor delivered to the user per puff and increase the resistance to draw with each puff to enhance the user's smoking experience. The present invention addresses these issues by introducing one or more obstructions / restrictions and / or flow diverters to modify the airflow before it enters the flavor substrate / block. Additionally or alternatively, air can be circulated through the flavor block multiple times before inhalation. The obstructions / restrictions create turbulence in the airflow before it enters, slowing the airflow through the block and exposing the air to a larger surface area of ​​the flavor substrate and / or recirculating the air passing through the flavor substrate to maximize air saturation.

[0067] Experiments were conducted to determine the effect of airflow on flavor uptake and resistance to drawing through channels provided in the substrate. Figure 5 of the accompanying drawings shows airflow A passing through a flavor substrate 100, such as a flavor-containing foam sponge, which may be placed within tubular chamber 102 to form the second chamber of the mouthpiece as described above. The lines shown before and after substrate 100 represent slower airflow (up to about 0.4 m / s in the illustrated example), while the airflow through the substrate was found to be faster, about 0.5-1.0 m / s, due to the presence of channels formed in the substrate.

[0068] One embodiment of the present invention includes a second chamber configured to increase the velocity of air particles into the substrate 100 to create turbulence as they enter the substrate and / or expose the air to a larger surface area of ​​the substrate. Referring to Figures 6A-6C of the accompanying drawings, upstream of the flavor block 100 is provided a disk 110 having a series of bore holes 112. This functions to increase the velocity of the air flow to over 2 m / s as it enters the disk 110 (see X in Figures 6B and 6C) and to slow the air flow through the substrate to approximately 0.5 m / s by creating turbulence T in the air as it exits the disk and enters the substrate 100 (see Figure 6C), thereby improving flavor absorption and increasing resistance to draw.

[0069] Flavor uptake and resistance to draw can be further enhanced by incorporating multiple disks 110 and substrates 100, as shown in FIGS. 7A-7D. Similar features as described above in connection with FIGS. 6A-6C are given the same reference numerals. Several flavor-containing substrates 100 (not shown in FIG. 7B) are provided within chamber 102, with disks 110 provided at the ends of and between each substrate. Again, this serves to increase air velocity at X before entering each substrate, creating turbulence and thereby reducing airflow Y within the substrate. Ideally, the airflow jets generated by the bore holes 112 in each disk 110 are provided out of phase (see FIG. 7B), resulting in a more chaotic airflow and further improving resistance to airflow through substrate 100.

[0070] In an alternative embodiment of the present invention, the second chamber of the mouthpiece is configured to increase flavor absorption and resistance to draw by directing airflow through as much of the substrate 100 as possible. Figures 8A-8C and 9A-9C show two embodiments of a chamber 402 that maximize the substrate surface area in contact with the airflow through the unit. In Figures 8A-8C, the flavor substrate 400 is housed within a cylindrical cage 404, which has a cap 406 at the upstream end of the device and an open downstream end. The sides of the cage are provided with a plurality of spaced openings 408 that serve as entry points for airflow into the substrate. In this manner, air is directed past the initial portion of the substrate by the cap 406 and enters through the multiple inlet openings 408, thereby directing air through as much of the substrate as possible, as shown in Figure 8C.

[0071] This embodiment can be further modified to increase flavor absorption from the substrate 400 and enhance the resistance to draw, as shown in Figures 9A-9C. The airflow rate to the substrate can be further increased by adding baffles or vanes 410 near the beginning of the substrate. Additionally (or alternatively), a downstream end cap 412 having a central opening 414 can be provided at the exit end of the substrate 400 to draw additional air from its center. This embodiment provides a more uniform and focused airflow across the entire surface area of ​​the substrate, as shown by arrow Z in Figure 9C.

[0072] It should be understood that the mouthpiece or pulmonary delivery device may be provided with a combination of the above features to enhance flavor absorption and / or resistance to draw, such as, for example, a combination of both a cage and a disc.

[0073] Alternatively or additionally, the second chamber of the mouthpiece containing the flavor block may be provided with at least one auxiliary loop having a junction with the second chamber before or after the substrate / block to allow air recirculation through the substrate, thereby improving flavor air saturation and increasing draw resistance. In its most basic form (not shown), one or more side or auxiliary conduits of narrower cross-sectional diameter than the chamber extend from a junction branching from the chamber before the substrate and extending beyond the substrate to a junction. This causes a portion of the air that has passed through the substrate to flow back along the auxiliary channel and be recirculated through the substrate.

[0074] Figure 10 of the accompanying drawings shows one embodiment of a second chamber 502 provided with such a recirculation flow. Four auxiliary channels 504 are provided, extending from the chamber at a junction before the substrate 500 and continuing to a junction beyond the substrate. In the illustrated embodiment, a disk 510 with openings is provided within the chamber at the point where the downstream junction meets the chamber, and a funnel and duct 512 are provided at the point where the upstream junction meets the chamber. These features aid in the recirculation of air through the auxiliary channels by encouraging air flow into the auxiliary channels through the downstream inlet while preventing flow from the chamber 502 to the upstream inlet into the auxiliary channels. Air entering the chamber 502 might otherwise flow into the upstream inlet and bypass the substrate 500 entirely.

[0075] It is therefore important to ensure that the configuration of the chamber and auxiliary conduit(s) recirculates the air back through the substrate rather than forcing the air to bypass the substrate so that the flavor in the air is reduced rather than increased. This can also be achieved or improved by optimizing the cross-sectional area of ​​the auxiliary channel relative to the cross-sectional area of ​​the chamber outlet, and ensuring that the air velocity is sufficient to not bypass the chamber.

[0076] Any of the above-described embodiments can be incorporated into the second chamber of a pulmonary delivery device, preferably in the form of a mouthpiece having first and second chambers connectable to a body portion of the pulmonary delivery device having a heating element as described above. This allows the mouthpiece to be easily replaced or cleaned, and the flavor block to be easily removed and replaced by a new flavor block. Thus, a simple mechanism is provided for the user to change flavors or devices, for example, from cherry to menthol.

[0077] The device of the present invention improves flavor delivery to the user. Any desired flavor can be incorporated into the chamber. For example, flavors can be provided that mimic the flavor of a particular food or beverage, such as sweet or salty, or a particular meal or dessert. Such flavors are particularly suitable for use in devices for delivering flavors in enteral nutrition, where food is delivered directly to the patient's stomach via a tube, preventing the patient from enjoying the flavor of the food. Use of the device of the present invention provides the patient with an improved sense of satisfaction during nutritional intake, as the flavor is delivered to the mouth, stimulating the taste buds and improving digestion.

[0078] In one embodiment, the device or mouthpiece may be provided with a heat source in one or both chambers, which may be turned on or off. More preferably, the primary first chamber has a heat source that may be activated as desired. In this manner, the heat source may be turned on when the flavor mimics a food or beverage that is normally served hot, but may be turned off when the flavor is of a food or beverage that is normally served cold.

[0079] Further modifications to pulmonary delivery devices and mouthpieces for such devices may be made without departing from the principles embodied in the examples described and illustrated herein.

Claims

1. 1. A pulmonary delivery device comprising: a first chamber adapted to vaporize a quantity of a first fluid to form a first vapor; a second chamber adapted to atomize a quantity of a second fluid to form a second vapor; and an outlet through which, in use, a user can inhale a mixture of the first and second vapors, wherein the second chamber comprises a passive nebulizer; the second chamber is in selective or continuous fluid communication with air; the second chamber comprises a substrate having at least one fragrance or aroma, the fragrance / aroma being inhaled by drawing air through the second chamber; and the second chamber further comprises at least one of an airflow obstruction member and an airflow diverting member to increase uptake of the fragrance or aroma during inhalation of the air.

2. The device of claim 1 , wherein the device includes at least one airflow obstruction member disposed upstream of the substrate in the second chamber.

3. 3. The device of claim 1 or claim 2, wherein the at least one airflow obstruction member may comprise a baffle extending at least partially across the chamber.

4. The device of claim 3 , wherein the baffle has at least one air passage therethrough in the form of a hole.

5. 5. The device of claim 3 or claim 4, wherein the baffle comprises a disk having a plurality of bore holes therethrough.

6. The device of any one of claims 1 to 5, wherein a plurality of airflow obstructions can be provided within the chamber to regulate airflow through the substrate.

7. 7. The device of claim 6, wherein a plurality of disks having bore holes are provided within the chamber, the bore holes of adjacent disks being out of phase.

8. 8. A device according to claim 6 or claim 7, wherein the chamber is provided with a plurality of substrates, preferably sandwiched between the airflow obstruction members.

9. 9. The device of claim 1, wherein the second chamber of the mouthpiece includes at least one air flow diverting device configured to direct air flow through as large a portion of the substrate as possible, thereby increasing fragrance uptake and resistance to draw.

10. 10. The device of claim 9, wherein the substrate is contained within a cage suspended within the chamber, the cage having an end cap at an upstream end of the device and an outlet at a downstream end.

11. The device of claim 10 , wherein the cage has at least one side with a plurality of spaced apart openings that serve as entry points for airflow into the substrate.

12. 12. The device of claim 10 or claim 11, further comprising at least one baffle or vane located downstream of the end cap and near the beginning of the substrate.

13. 13. The device of claim 10, 11, or 12, further comprising a downstream end cap having at least one opening disposed at an outlet end of the substrate.

14. The device of claim 13 , wherein the at least one opening is located substantially in the center of the end cap.

15. 15. The device of any one of claims 1 to 14, comprising at least one air diverting member with at least one auxiliary channel extending around a portion of the chamber containing the substrate to allow recirculation of air through the substrate, thereby improving air saturation with fragrance and increasing resistance to draw.

16. 16. The device of claim 15, wherein the at least one auxiliary channel has a narrower cross-sectional diameter than the chamber and extends from a junction where it branches off from the chamber before the substrate to a junction beyond the substrate, allowing a portion of the air that has passed through the substrate to flow back along the auxiliary channel and be recirculated through the substrate.

17. The device of claim 16 , wherein a plurality of auxiliary channels are provided extending from the chamber at a near junction of the substrate and extending to a far junction of the substrate.

18. 18. A device according to claim 16 or claim 17, wherein the cross-sectional area of ​​the at least one auxiliary channel relative to the cross-sectional area of ​​the outlet of the chamber is optimised to ensure that air velocity is sufficient to prevent bypassing of the chamber.

19. 19. The device of claim 16, 17, or 18, wherein at least one of the inlets or outlets of the at least one auxiliary channel is provided with at least one airflow obstruction and / or diverter to block flow from the chamber to an upstream inlet to the auxiliary channel while encouraging airflow through a downstream inlet to the auxiliary channel.

20. 20. The device of claim 19, wherein at least one disk having at least one opening is provided within the chamber at a location where a downstream junction meets the chamber, and a funnel and duct are provided at a location where an upstream junction meets the chamber, such that the disk helps to branch flow into the auxiliary channels, and the funnel and duct block flow into the channels and direct flow through the substrate.

21. A device according to any preceding claim, wherein at least one chamber is provided with a heat source.

22. 1. A mouthpiece for a pulmonary delivery device, the mouthpiece having a first inlet end and a second outlet end, comprising: a first mouthpiece chamber adapted to be received within a body of a pulmonary delivery device at the inlet end of the mouthpiece; and a second mouthpiece chamber adapted to receive at least one substrate carrying at least one fragrance or aroma, the second chamber having at least one air inlet at the inlet end thereby selectively or continuously in fluid communication with air to allow inhalation of the fragrance / aroma by drawing air through the second chamber, the second chamber further comprising at least one of an air flow obstruction member and an air flow diverting member to increase uptake of the fragrance or aroma during inhalation of the air.

23. 23. The mouthpiece of claim 22, wherein the mouthpiece includes at least one airflow obstruction member disposed within the second chamber upstream of the substrate.

24. 24. A mouthpiece according to claim 22 or claim 23, wherein the at least one airflow obstruction member may comprise a baffle extending at least partly across the chamber, the baffle having at least one air passage therethrough in the form of a hole, preferably the baffle comprises a disc having a plurality of bore holes therethrough.

25. 25. The mouthpiece of claim 22, 23, or 24, wherein the mouthpiece includes at least one air diverting member with at least one auxiliary channel extending around a portion of the chamber containing the substrate to allow recirculation of air through the substrate, thereby improving air saturation with flavorant and increasing resistance to draw.

26. 26. The mouthpiece of claim 25, wherein the at least one auxiliary channel is of narrower cross-sectional diameter than the chamber and extends from a junction where it branches off from the chamber before the substrate to a junction beyond the substrate, allowing a portion of air that has passed through the substrate to flow back along the auxiliary channel and be recirculated through the substrate.

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