APPARATUS FOR DELIVERING A LIQUID AEROSOL
 TO ORAL CAVITY SURFACES
FIELD OF THE INVENTION
The present invention is in the field of aerosol generation, in particular for the delivering flavors and fresheners to the oral cavity.
BACKGROUND TO THE INVENTION
Spraying of aerosols into the mouth makes it possible to impart taste and sensation to the oral cavity while using relatively little material or flavored substance. Such aerosols may comprise either powder particles or liquid droplets, typically 10 to 100 microns in diameter. The large surface area per unit of volume of the particles or droplets greatly intensifies the flavor sensation relative to the same volume of liquid administered unsprayed.
 A recent example of such an aerosol-type product, in powder form, was the AeroLife™ product (from AeroDesigns Inc., Cambridge, MA), which provided consumers with a way to taste chocolate, coffee and other flavors. The particle size of the powder, typically in the 10 micron to 50 micron range, enabled a user's puff to entrain the particles into the airflow through the device, and thus to draw the powder into the mouth. The powder particles did not reach the lungs, as respiration of particles or droplets generally occurs only for those under 5 microns in diameter. By puffing on the device and drawing in the particles, a pleasant taste was delivered.
 US patent 8,4959,98 discloses a breath-actuated inhaler comprising a canister of pressurized fluid. The canister contains nicotine and a propellant whose release is triggered by a puff of the user. The propellant propels these droplets forward for delivery into the consumer's mouth.
SUMMARY OF THE INVENTION While use of a propellant is common for medical inhalers, consumer tests of propellant-driven devices for nicotine delivery were not successful, as a sudden propelling of pressurized fluid into the mouth typically caused a user to recoil from the product.  Furthermote, unlike with e-cigarettes, where vapor is typically delivered throughout the length of a puff, the propellant delivers the aerosol for only a brief moment at one point in the breathing cycle. Furthermore, when using an inhaler as disclosed in the US '5998 patent, the user manually performs a cocking action between each puff. The user thus does not enjoy puffing action similar to a cigarette, where repeated puffs provide a focus for activity of the fingers and mouth, and a pleasurable sensation with each puff.
 An aspect of the present invention is directed toward a device for generating a liquid aerosol drawn into the mouth by a puffing action of a user at a mouthpiece of the device; and toward liquid compositions delivered to the oral cavity using the device.
 Unlike a nebulizer where (a) droplets produced are of respirable size (smaller than 5 microns in diameter) and are intended for pulmonary delivery and (b) aerosol generation operates continually without correlation to a user's inhaling during use; in the device of the present invention droplets produced are of non-respirable size and they are generated in response to puffing of a user. The device operates based on sensing of puffing action by the user through the mouthpiece and, in response, spraying a small volume of a liquid as an aerosol into a chamber. Suction from the puffing action is applied to one side of the chamber and draws a flow of air, through an air inlet at another side, into the chamber. The airflow propels the aerosol droplets, and the droplets are sucked with the air through the mouthpiece and delivered into the oral cavity of the user. Spraying and delivery of the aerosol continue for the duration that the sensor senses the puff.
 An e-cigarette has a heating coil to vaporize a liquid when a breathing sensor senses a puff. The vapor is respired into the pulmonary tract by the puff. An apparatus of the present invention, in contrast, produces aerosol droplets larger than resiprable size that settle on surfaces of the oral cavity. Therefore, the apparatus is particularly suited for users not wishing to inhale foreign matter into their lungs. Additionally, vaporization of the liquid in an e-cigarette can create reaction byproducts liable to be toxic, such as acetaldehyde. In contrast, an apparatus of the present invention creates injects an aerosol into an airflow by spraying a liquid, with no heating and no chemical reactions of the liquid, and without producing toxic byproducts. In a preferred embodiment, the volume of aerosol generated is proportional to the volume of air drawn into the mouth, in order to maintain a relatively constant concentration of aerosol within the airflow. The resulting consistency of taste sensation is a property an apparatus of the present invention may share with cigarettes and e-  cigarettes, but, in contrast, without inhalation of foreign and potentially toxic substances into the lungs.
 The puffing action by a user of a device of the present invention is detected by an electronic sensor located within the device, and aerosol starts to be emitted into the chamber following this trigger. The sensor preferably operates by one or more of sensing low pressure, detecting an acoustic signature of a puff (e.g., through the inlet), or sensing airflow through the device (e.g., with a flow sensor). In preferred embodiments, the emission of the aerosol into the chamber continues as long as the sensor detects puffing action, so continues for substantially the same duration as a puff.
 During smoking, a puff typically comprises the drawing in of a volume of between 25mL and 50mL over a period of 1-3 seconds, and the user takes one puff approximately once per minute. In prior art devices (see above), an aerosol is fired towards the user's mouth by a propellant and therefore a large aerosol volume is generated, causing the user to recoil. In contrast, in the device of the present invention, (a) the total volume of aerosol added over the 1-3 seconds of the puff is typically of the order of 50 μL to 300 μL, which represents under 1% of a 30mL breath volume, and (b) the aerosol is not propelled directly into the mouth but rather flows tangentially with the airflow into the mouth. A relatively small added volume of aerosol, together with addition of aerosol taking place tangentially to the airflow through the device prevents the "recoiling" effect seen with prior art devices. In a preferred embodiment of the device, the volume added is less than 5% of the volume of the puff, and there is no direct jet of fluid from the nozzle outlet into the user's mouth. The device is thus designed to exhibit sensory aspects or "user experience" associated with conventional cigarettes, while providing a pleasurable effect in the mouth.
 In a preferred embodiment, the bulk of aerosol droplets fall within a range of 10 to 50 microns in diameter, ensuring delivery of the droplets to surfaces of the oral cavity (an inhaler, in contrast, is intended for pulmonary delivery). In a further preferred embodiment, the majority of the volume of the aerosol droplets fall within the 10 to 20 micron range. Such a distribution weighted to smaller droplet sizes increases the total surface area of aerosol droplets, thereby the contact area of the droplets with the oral cavity, further intensifying taste sensation.  In one aspect of the invention, the liquid sprayed into the oral cavity is an alcoholic one such as whiskey, brandy, vodka or mead. Due to the high surface area of the liquid droplets, the spraying of such liquids causes a momentary alcohol absorption of a relatively high fraction of the amount of alcohol delivered. Advantageously, the brief "alcohol high" experienced as a result of this absorption has no lasting intoxication. Accordingly, if the user employs the device in place of conventional drinking, the device of the present invention may well contribute to reducing the harm caused by excessive alcohol consumption.
 In another aspect of the invention, the liquid includes a stimulant such as caffeine, nicotine, taurine or a familiar taste element such as tobacco or tobacco-mimicking flavors. Both caffeine and nicotine are absorbed within the oral cavity, as is well known from the effectiveness of gums and lozenges containing these compounds. With respect to nicotine, an effect known as "throat hit" occurs when droplets (or vapor) containing nicotine impact on the throat; this effect is often highly sought by smokers. In the present invention, the distribution of liquid droplet sizes can include droplets which reach the throat as a result of the puffing action, thereby causing the "throat hit" effect.
 In most western markets nicotine cannot easily be added to an orally-delivered product such as the device of the present invention. In such cases, in another aspect of the invention, the liquid delivered by the device may contain natural substances which, in combination, function as a nicotine replacement as they have an action similar that of nicotine, for example "BioNic," from Valeo Laboratories GmbH, Germany. Such actions can include the creation of a "throat hit" effect, which is one of the features of nicotine-based e-cigarettes.
 In another aspect of the invention, the liquid delivered as an aerosol by the device contains a combination of the above named stimulants, for example nicotine and caffeine, caffeine and nicotine, caffeine and alcohol, etc. The combination can have a synergistic effect. For example it has been reported that the caffeine-mediated blockade of adenosine A2A receptors can potentiate the effects of alcohol-induced dopamine release (Journal of Caffeine Research, Volume 1, Number 3, 2011).
 In another aspect of the invention, the apparatus can act as a drug delivery device for pharmaceutical purposes. Alternatively, such the apparatus can deliver a liquid intended to minimize withdrawal symptoms caused by smoking cessation.  In another aspect of the invention, the liquid aerosol can contain substances contributing to breath freshness.
 In another aspect of the invention, some or all of the liquid aerosol may be absorbed via the oral mucosa.
 The above and further aspects of the present invention are described below in conjunction with the figures depicting a preferred embodiment of the device.
 It is therefore an object of the present invention to overcome the disadvantages of the prior art by providing a pleasure-inducing consumer-oriented device which uses repeated puffing to create a liquid droplet aerosol which is drawn into the mouth by the user's puffing action (as opposed to being forced as a jet into the mouth).
 It is a further object of the invention that said aerosol comprise non-respirable liquid droplets, such that said device delivers the aerosol droplets to the mouth and throat, as opposed to functioning as an inhaler (which is designed to deliver an aerosol to the lungs).
 It is a further object of the invention to enable said aerosol to be absorbed either via the oral mucosa or by swallowing, or both.
 It is a further object of the present invention to deliver alcoholic liquids, energy drinks constituents or other stimulants to the oral cavity as a liquid-droplet aerosol, whether in an aqueous base, an alcohol one, or a combination thereof.
 It is a further object of the invention to deliver compositions which combine an alcoholic liquid with an additional stimulant such as caffeine, nicotine or taurine.
 It is a still further object of the present invention to maintain as much as possible of the "user experience" factors associated with smoking cigarettes or e-cigarettes.
 It is a still further objective of the present invention to provide a product which enhances release of dopamine, whether just for enjoyment or for the purpose of smoking- replacement.
BRIEF DESCRIPTION OF THE DRAWINGS
Figures la and lb show an exterior and interior view, respectively, of an apparatus for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.  Figure 2 shows an enlargement of an end of the apparatus comprising a mouthpiece, a mixing chamber and a nozzle.
 Figure 3 shows an exploded view of an apparatus for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.
 Figure 4 shows a replacement cartridge detached from the remainder of an apparatus for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.
DETAILED DESCRIPTION OF THE FIGURES
Reference is now made to FIG la, showing an external view of an apparatus 100 for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention. Apparatus 100 comprises a housing composed of a lower shell 1 and an upper shell 2, and terminated at one end by a mouthpiece 17.
 Reference is now made to FIG lb, showing an internal view of an apparatus 100 for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.
 Apparatus 100 comprises a mouthpiece 17, a nozzle 22, a mixing chamber 9 with an air inlet 21, a reservoir 20 containing a liquid to be delivered as an aerosol, a pumping mechanism comprising a motor 10 and a drive cam 18, a sensor 12 and a printed circuit board (PCB) 7 comprising a controller. Apparatus 100 is configured such that sensor 12 detects a user's puff applied at the mouthpiece and, in response, the controller on PCB 7 activates said pumping mechanism, such that said liquid is emitted from nozzle 21 into mixing chamber 9 as an aerosol; whereby at least a part of the aerosol becomes incorporated in the airflow from air inlet 21 through mixing chamber 9 to said mouthpiece 17, thereby entering an oral cavity of a user sucking at mouthpiece 17.
 Motor 10 preferably has a high power-to-volume ratio; as, for example model ADM 0620 Series Stepper Motor (Faulhaber Minimotor SA, Croglio, Switzerland).
 Rotational motion of motor 10 is activated in apparatus 100 when suction is applied to mouthpiece 17, typically from the mouth of a user of apparatus 100 (details of motor activation are further described herein). The rotational motion is transmitted to a drive cam  18. As drive cam 18 rotates, drive cam 18 presses against a tube 5. Drive cam 18 pressing against tube 5 peristaltically pumps liquid in tube 5. Liquid is drawn from a reservoir 20, which can be housed in a replaceable cartridge 4. Liquid is compelled towards a mixing chamber 9.
 Reference is now also made to Figure 2, showing an enlargement of an end of apparatus 100 comprising mouthpiece 1.7, mixing chamber 9, and nozzle 22.
 Liquid pumped through tube 5 toward mixing chamber 9 forces liquid to pass through nozzle 22 connected to tube 5. Nozzle 22 sprays liquid, which exits nozzle 22 as an aerosol into mixing chamber 9.
 Nozzle 22 can be of a type used in perfume dispensers designed to produce a fine mist of aerosol droplets with desirable dimensions for the present invention. For example, the VP4 series from Valois SAS (Le Neuborg, France).
 Mixing chamber 9 includes an air inlet 21. The suction applied to mouthpiece 17 induces an airflow though the mixing chamber 9. The airflow passes from air inlet 21, through mixing chamber 9, and to the mouthpiece 17. As the airflow passes through mixing chamber 9, the airflow gathers up and takes with it the aerosol produced by nozzle 22. The aerosol cloud is mixed into the output airflow.
 In preferred embodiments, nozzle 22, mixing chamber 9, and mouthpiece 17 are geometrically arranged to minimize the possibility of a direct jet of aerosol droplets entering the user's mouth. Axes of mouthpiece 17 and nozzle 22 can be non-collinear, e.g. angled. As aerosol droplets are sprayed from nozzle 22, the aerosol droplets are redirected by the airflow to paths tangential to the airflow. Airflow is funneled into mouthpiece 17 and aerosol vapor is drawn into the user's mouth. The user experience is similar to that of using an e- cigarette, where the vapor is drawn into the mouth in response to the puffing action performed by the user. Optionally, the exit area of mouthpiece 17, inside of the mouth when apparatus 100 is in use, is outside an emission cone of aerosol spray from nozzle 22.
 The volume of liquid sprayed into the oral cavity should be sufficient to provide a taste, stimulant, and/or alcoholic effect without being so large a volume as to cause the patient to swallow. Preferred volumes are in the range 50 μL to 500 μL, distributed over an interval of 1-5 seconds while the puff continues. More preferably, 100 μL to 300 μL is delivered over 2-3 seconds. Air from the airflow mixes with the volume of sprayed liquid,  which is a few percent or less of the mixed air. Therefore, the added liquid is unlikely to cause a "recoiling" that occurs when a sudden pressure is directed into the user's mouth.
 Air inlet 21 provides a constant, unobstructed source of airflow. Thus the user will not feel like he is sucking against a vacuum at any point. Airflow from air inlet 21 to mouthpiece 17 will start immediately upon the start of puffing, and only once the aerosol emission starts will aerosol start to be incorporated in the airflow.
 In preferred embodiments, air inlet 21 has an opening area set so as to create an extent of suction resistance to which consumers of cigarettes and e-cigarettes are accustomed.
 Controller on PCB 7 can be configured so that spraying of aerosol can be delayed after an initial detection of a puff. In some preferred embodiments, a delay time of 50 ms to 300 ms may be implemented. A delay time can help to focus the user on puffing for some time before receiving a "reward" of the added aerosol.
 Reference is now made to FIG 3, showing an exploded view of an apparatus 100 for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.
 A printed circuit board (PCB) 7 (or plurality thereof) comprises a controller for apparatus 100 and drive circuitry for powering motor 10. PCB 7 can be powered by an internal rechargeable battery 11. Battery 11 can be recharged from an external power source connected via a connector 15 such as a micro-USB connector.
 Apparatus 100 further comprises a sensor 12, in electrical connection with PCB 7, for detecting a puff. PCB 7 activates motor 10 after receiving a signal from sensor 12 corresponding to a detected puff.
 Sensor 12 can be an acoustic sensor. Sensors of this type are known in the art from the field of e-cigarettes. Alternatively, sensor 12 can be a flow pressure sensor detecting the low-pressure caused by a puff or a flow sensor detecting airflow caused by puffing action.
 In preferred embodiments, motor 10 is coupled by a coupling 6 to a DIN straight level gear 13. Straight level gear 13 drives a base 3 of a pump mechanism which (as shown in Figure 2a) operates by pressing a drive cam 18 against the tube 5 as said drive cam 18 rotates. Liquid is pumped from reservoir 20 along tube 5 towards mixing chamber 9. The  pumping mechanism can alternatively be implemented by a number of other pump types, including but not limited to a syringe pump, where reservoir 20 is located within a barrel of the syringe pump, and a lead screw pushes a plunger along the barrel.
 Reference is now made to FIG 4, showing a replacement cartridge 4 detached from the remainder of an apparatus 100 for delivering a liquid aerosol to oral cavity surfaces, according to some embodiments of the invention.
 In preferred embodiments, replaceable cartridge 4 is clicked out of position when reservoir 20 therein (see FIG la) is empty (or liquid therein insufficient for an adequate supply of aerosol), and a new replaceable cartridge 4 clicked in.
 In preferred embodiments, reservoir 20 can be a bladder with an elastic skin under tension, keeping liquid in apparatus under compression and therefore preventing entry of air into nozzle 22 and hose 5; air-bubbles are thereby prevented from developing within tube 5 after priming of the pump. Prevention of air entry can thus enables apparatus 100 to be used and stored in any orientation. Additionally, prevention of air entry enables use of apparatus 100 for delivery of oxygen-sensitive compounds that would otherwise be oxidized during storage.
 Reference is now also made again to FIG lb. Apparatus 1.00 further comprises a septum 1.9, providing a fluid connection to collapsible reservoir 20 (a bladder) in cartridge 4. When the cartridge 4 is full, the bladder expands to reach the inner walls of cartridge 4. As the contents of the bladder are pumped out (as described above), the bladder 20 gradually collapses, going through an intermediate state (as shown), through to the point of total evacuation as cartridge 4 is depleted. Suitable materials for the bladder 20 include rubber, latex, and polychloroprene.
 While the design shown in preferred embodiments described a peristaltic-pump approach to drive the aerosol generation, a number of further embodiments are of course possible. For example, and as stated above, the motor could be used to drive a plunger which enters a syringe, where the inside of the syringe serves as the liquid reservoir. However, in such further embodiments, the key principle remains that the device senses the puff and then electronically activates the pumping mechanism - whether based on a peristaltic-pump, a syringe-design, or otherwise.  Suitable liquids for delivering in the manner described above from the apparatus 100 of the present invention include aqueous liquids, including both alcoholic and non-alcoholic drinks. In a preferred embodiment, an alcoholic drink comprise one or more of whiskey, vodka, brandy, sake and mead. Delivery such an alcoholic drink by apparatus 1.00 provides a brief alcohol high of a very brief duration, providing the user satisfaction.
 Other liquid ingredients suitable for delivery by apparatus 100 as an aerosol, as described above, include liquids causing some other kind of stimulation, such as caffeine, taurine, energy drinks, tobacco-mimicking flavors, and any combination thereof; for example, a spray combining vodka and Red Bull, or, for example, Yunker Fanti which combines caffeine with taurine. Caffeine and alcohol are a synergistic combination for generating satisfaction, as a caffeine-mediated blockade of adenosine A2A receptors can potentiate effects of alcohol-induced dopamine release.
 Additional substances that can advantageously be delivered using the aerosol-type delivery of the present invention include ginger and/or capsaicin for pain relief, ginseng for diabetes and respiratory infections, ginkgo for anxiety, passionflower for anxiety and insomnia, and chamomile for anxiety and GI problems. Accordingly, mixtures of the above can be developed that will serve as (non-medical) products to help relaxation and/or improve concentration.
 The effect of spraying these liquids in the mouth can involve a major taste-burst or physiological response. First, because delivery to the mouth involves sudden contact between the oral mucosa and a large surface area of the aerosol droplets. Second, to the extent that absorption of the liquid is at least partially through the oral mucosa, uptake into the body (and associated euphoria) is attained very rapidly.
 All the above physiologic responses serve to supplement a dopamine response that occurs simply as a result of a puffing sucking operation; the response explaining in large degree the popularity of smoking cigarettes and e-cigarettes.
 Further candidates for delivery by the device of the present invention include liquid sprays serving to clean or freshen the mouth, or medical substances.
 As some liquids cause throat irritation when sprayed into the oral cavity in the manner described above, in a preferred embodiment a liquid used in apparatus 100 can have  a soothing agent or demulcent, for example honey, added to them. In this regard, a choice of mead as the liquid, or use of a blend of whiskey and honey, have an inherent advantage.
TABLE OF FEATURES