Multiple factors can contribute to tobacco cigarette addiction. Some of the factors include addiction to nicotine or psychological factors including the smell, taste, or social associations of tobacco cigarette smoking. One factor that can drive cigarette addiction is the sensory cues associated with the inhalation and exhalation of smoke itself. Some electronic cigarettes create a large amount of vapor to simulate tobacco cigarette smoke. To avoid vapor deposition in the lung and to preclude exhalation of the vapor, some known devices provide aerosol particles between 0.2 microns and 0.6 microns. Aerosol particles in this size range can be too small to gravitationally settle in the lung during regular breathing. Consequently, they tend to be inhaled and then are subsequently exhaled.
Smokers can exhibit a wide range of inhalation profiles. Variation exist among smokers in inhalation rates and the total volume inhaled. Inhalation rates can also vary in different ways from the peak inhalation rate that the smoker achieves to the actual profile (e.g. an inhalation rate that starts slow compared to one that starts rapidly. The efficiency of deep lung deposition can be dependent on many factors such as aerosol particle size, the timing of the delivery of the aerosol to the lung (where in the inhalation volume—early vs. late) and inhalation rates. Inhalation profiles can also affect where aerosols are deposited in the respiratory tract. A more rapid inhalation rate can cause larger aerosol particles to deposit in the back of the throat, mouth and upper airway due to inertial impaction. Shallow breathers, with lower total inhalation volumes, can benefit from aerosol delivered earlier in the inhalation volume, allowing the aerosol to be chased into the deep lung without leaving aerosol in the mouth, throat and upper airway.
These factors create engineering challenges in designing an electronic cigarette or other vaporization device that replicates the tobacco cigarette smoking experience. There is a need for new methods and devices for administering compounds, such as nicotine, to a user. In particular, there is a need for methods and devices for delivery of compounds to a user where the compounds are aerosolized to fall within a specified particle size range. For example, there is a need for improved methods and devices to deliver nicotine to a user in specified doses and in a specified particle range size without the carcinogens and other chemicals associated with tobacco products.
A device for generating a vapor or condensation aerosol has a heater, such as a wire coil, around a tube in a vaporization chamber between an upstream inlet and a downstream outlet. A reservoir in the device holds a liquid. A pump supplies liquid from a reservoir into the tube. The liquid, which may include nicotine, flows onto the heater via outlets in the tube. The vaporization chamber is part of an airflow passageway which may be configured to produce a condensation aerosol having a particle diameter from about 1 μm to about 5 microns.
The pump may optionally be completely or partially within the reservoir, or the pump may have a drive motor located outside of the reservoir. The drive motor may operate with a solenoid coil magnetically coupled to one or more magnets within the pump.
The airflow path through the vaporization chamber may have a second inlet configured to permit a substantially laminar flow of air into the airflow path, wherein the second inlet is downstream of the heater. The air flow path and/or openings into the air flow path may be changed to change the particle size of a condensation aerosol produced in the vaporization chamber, and/or to change the amount of visible vapor emitted from the device.
The device may have an inlet adjuster to control the size of the upstream first inlet. The inlet adjuster may be a slide configured to slidably cover the upstream first inlet, or a removable orifice configured to modify the upstream first inlet. The removable orifice, if used, is optionally configured to insert into the upstream first inlet. An opening of the removable orifice may have a cross-sectional area that is less than a cross-sectional area of the upstream first inlet.
The inlet adjuster may be electronically-controlled. A user interface may be provided in electronic communication with the inlet adjuster, with the user interface configured to allow a user to select a condensation aerosol particle size to be produced by the device. Multiple upstream first inlets may be used with the inlet adjuster to change the number of inlets used. The outlet may be in a mouthpiece connecting with the vaporization chamber, and a plurality of inlets upstream of the heater. A baffle may be located upstream of the heater, with the baffle configured to slide within the vaporization chamber, optionally based on a user input.
The device may include a flow sensor electrically connected to an electronic controller which receives and stores an inhalation profile of a user of the device, with the device configured to modify a characteristic of the device based on the inhalation profile. The device may further include a user interface configured to permit a user to modify a characteristic of the device, which may provide more efficient delivery of the condensation aerosol to a deep lung of a user; cause a user of the device to exhale a lower fraction of the condensation aerosol; and/or adjust a sensory effect, such as mouth feel or appearance of the aerosol.
Alternatively, the modified characteristic may be an amount of liquid vaporized by the heater; an amount of current applied to the heater; or a size of the inlet. The flow sensor may be a hot wire or vane type flow meter or a pressure transducer configured to measure an inhalation vacuum. The pressure transducer, if used, may be configured to calculate an inhalation rate. The electronic controller may include a microprocessor and/or a wireless communication device. The device can be configured to calculate optimum parameters for condensation aerosol generation based on an inhalation profile of a user. In this case, the modified characteristics can include the aerosol particle size; the timing of aerosol generation in a user inhalation volume; a resistance to air flow through the device, or an inhalation rate of a user of the device.
The inhalation profile may include inhalation rates of a user over a period of time; a total volume of air inhaled; or a peak inhalation rate of a user of the device. The device may be programmed to automatically modify a characteristic of the device based on the inhalation profile, or to allow manual modification of a characteristic of the device by a user based on the inhalation profile.
In the example shown, a battery 56 and a liquid reservoir 60 are contained within the housing 32. The liquid reservoir 60 contains a liquid, such as a liquid nicotine formulation. A pump 64 is located behind or within the reservoir 60. The pump (e.g., a piston pump or diaphragm pump) can be mechanically or magnetically coupled to a pump motor 80. A check valve 82 allows a volume of liquid to flow from the reservoir 60 to the pump 64 for subsequent delivery to a heater 70. The heater 70 may be in the form of a wire coil. The reservoir may have floating end cap that moves to prevent vacuum conditions in the reservoir as liquid is consumed.
Alternatively, the heater may be provided in the form of a cylinder or plate of a screen or ceramic material, or a honeycomb or open lattice framework. The heater 70 is positioned within a aerosolization chamber 74 leading from an air inlet 78 to a duct 88 connecting to the outlet 52. The outlet 52 can optionally be in a mouthpiece 84 which is removable from the housing 32. The inlet 78 can be a single hole or a plurality of holes or slots. As shown in
The pump motor 80 may be located outside of the reservoir 60 and is mechanically or magnetically coupled to a piston 120 moveable within the pump. In operation, the pump motor 80 moves the piston 120 to deliver a volume of a liquid from the reservoir 60 onto the heater 70, with the heater 70 vaporizing the liquid. Air flowing through the air inlet 78 causes the vaporized liquid to condense forming an aerosol having a desired particle diameter within the vaporization chamber, prior to the aerosol flowing through the outlet 52. The pump motor 80 can be a magnetic motor designed to oscillate at a slow frequency (e.g., between 1 and 10 Hz). The volume pumped per stroke is determined by the preset stroke length and the diameter of the piston chamber. The electronic controller 46 can control for variability in battery condition and ensure consistent heating by direct measurement of resistance through the heater to control for changes in battery voltage/charge.
In
Referring to
As further shown in
Referring back to
The region of the tube 100 over which the piston 120 slides can have an outer diameter of 1 mm. In sliding over the tube 100, the piston 120 can travel about 0.5 to 1 mm or about 0.75 mm such that a volume of about 0.4 to 0.6 ml of a liquid is pumped with each stroke of the pump, with volumes per stroke of about 0.3 to 0.7 ml typical. With the pump operating at 5 Hz, 2 ml/second of liquid are supplied to the heater 70 in the example shown.
In operation, a user inhales on the outlet 52 of the device 30 such that the inhalation can be sensed by the sensor 50. Upon detection of the inhalation, the sensor 50 activates the heater 70 through the electronic controller 4. Additionally, upon detection of inhalation, the electronic controller 46 activates the pump 64 to deliver a volume (i.e., dose) of the liquid from the reservoir 60 into the tube 100. As shown in
After the liquid is pumped into the tube 100, the dose of liquid is moved through the tube by positive displacement from the pump 64. A chamber section or portion 106 of the tube 100 is disposed within the aerosolization chamber 74 and surrounded by the coil heater 70. The liquid is pumped out of the tube 100 through the tube outlets 102 in the chamber section 106 of the tube. The outlets 102 act as ejection ports such that the fluid pressure from the pump ejects the liquid through the outlets 102 and onto the heater 70. The tube 100 can have 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 tube outlets 102, with the outlets having a diameter of from 0.2 to 0.5 mm. Three tube outlets 1012 are used in the example shown.
Referring to
The air then flows into the entrance of the airway and across the heater, perpendicular to the longitudinal axis of the heater. Finally the air flows through the duct 88 downstream of the heater with the vaporized nicotine mixture and out of the outlet 52. The inhalation resistance of the device in this example is approximately equal to the flow resistance of a tobacco cigarette, and thereby facilitated a mouth breathing maneuver (i.e., puffing) from the user of the device.
Upon movement of the dose of liquid through the tube outlets 102, the liquid contacts the heater 70 and is vaporized. The vaporized liquid flows through the chamber 74 in the inhaled air stream i.e., in air flowing between the inlet 78 and outlet 52. The air flows at a flow rate (about 1 to about 10 lpm) effective to condense the vaporized liquid into an aerosol having a diameter (MMAD) of from about 1 micron to about 5 microns. Subsequently, the flows through the outlet 52 of the device and is inhaled to the deep lungs of the user.
The device 30 may be designed to produce an aerosol with a particle size in the 1 micron to 3 micron range. Aerosol particles in the 1 micron to 3 micron range can settle in the lung much more efficiently than smaller particles and are not readily exhaled. The devices and methods described here provide an electronic cigarette that can more closely replicate the nicotine deposition associated with tobacco cigarettes. The device 30 can provide a nicotine pharmacokinetics profile (PK) having the sensory effects associated with tobacco cigarette smoking.
The device 30 may be designed to produce particles having a mass median aerodynamic diameter (MMAD) of from about 1 to about 5 μm. The particles can have a geometric standard deviation (GSD) of less than 2. The aerosol can be generated from a formulation having a pharmaceutically active substance. The formulation can be in a liquid or solid phase prior to vaporization. The substance may be nicotine, optionally stabilized using one or more carriers (e.g., vegetable glycerin and/or propylene glycol). The liquid formulation can have 69% propylene glycol, 29% vegetable glycerin and 2% nicotine).
The device 30 can have an flow resistance that is low enough to enable the user to inhale directly into the lung. Low flow resistance can be generally advantageous for deep lung delivery of an substance, such as nicotine, and to enable rapid nicotine pharmacokinetics (PK). tobacco cigarettes can have a high enough flow resistance to preclude direct to lung inhalation thereby requiring the user to inhale, or puff, by using a mouth breathing maneuver.
The aerosol can be further entrained in an entrainment flow of air supplied by one or more secondary passageways or inlets coupled to the chamber 74, as further described below relative to
The amount of the liquid formulation delivered by the pump may be controlled by setting a pump rate such that a specific pump rate corresponds to a specific volume delivered by the pump. Adjusting the pump rate from a first pump rate to a second pump rate can result in the pump delivering a different amount or volume of liquid formulation. The pump can be set at a first controlled rate such that a first amount of liquid is delivered to the heater which generates a first aerosol having a first size (e.g., diameter) and the pump rate is then changed to operate at a second controlled rate such that a second amount of the liquid is delivered to the heater which generates a second aerosol having a second size (e.g., diameter).
The first and second aerosols can have different sizes (e.g., diameters). The first aerosol can have a size (e.g., diameter) suitable for delivery and absorption into the deep lungs, i.e., about 1 μm to about 5 μm (mass median aerodynamic diameter or visual mean diameter). The second aerosol can have a size (e.g., diameter) suitable for exhalation from a user of the device such that the exhaled aerosol is visible, i.e., less than about 1 μm. Alteration of the rates of the pump can occur during a single puff or use of the device by a user. Alteration of the pump rate during a single use can occur automatically or manually, or during separate uses of the device by a user.
Automatic alteration of the pump rate can be accomplished by electrically coupling the pump to a circuit configured to switch the pump rate during operation of the device. The circuit can be controlled by a control program. The control program can be stored in the electronic controller 46, which may be programmable. A user of the device can select a desired aerosol size or sets of aerosol sizes by selecting a specific program on the electronic controller 46 prior to use of the device 30.
A specific program can be associated with a specific pump rate for delivering a specific volume of a liquid formulation in order to produce an aerosol having a desired size. If the user desires an aerosol with a different size (e.g., diameter) for a subsequent use, then the user can select a different program associated with a different pump rate for delivering a different volume of the liquid formulation in order to produce an aerosol with the newly desired size (e.g., diameter). A specific program may be associated with specific pump rates for delivering specific volumes of a liquid formulation in order to produce multiple aerosols having desired sizes. Each of the specific pump rates in a specific program can deliver in succession a specific volume of the liquid in order to produce a succession of aerosols of differing sizes (e.g., diameters) during a single use of the device.
Manual alteration of the pump rate can be accomplished by the user of the device pressing a button or switch 54 on the device during use of the device. Manual alteration can occur during a single use of the device or between separate uses of the device. The button or switch is electrically coupled to the electronic controller 46. The electronic controller 46 can have program(s) designed to control the operation of the pump such that the pressing the button or switch 54 causes the electronic controller to alter the operation (e.g., pump rate) of the pump in order to affect delivery of a differing volume of the liquid formulation. The user of the device can press the button or flip the switch 54 while using the device or between uses of the device.
The aerosol generating device may be configured to produce an aerosol having a diameter of from about 1 μm to about 1.2 μm. Upon inhaling from an outlet of the device, a user can perform a breathing maneuver in order to facilitate delivery of the aerosol having a diameter of from about 1 μm to about 1.2 μm into the user's deep lungs for subsequent absorption into the user's bloodstream. The user can hold the breath during the breathing maneuver following inhalation of the aerosol and subsequently exhaling. The breath-hold can be for 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 seconds. The breath-hold can be from about 2 to about 5 seconds. Alternatively, the user can inhale and directly exhale the aerosol having a diameter of from about 1 μm to about 1.2 μm. Inhalation followed by direct exhalation can cause the generation of a visible vapor since a large percentage of the aerosol can be exhaled.
The user may select whether or not the user wants an aerosol generated by the aerosol generating device to be delivered to said user's deep lungs (e.g., alveoli) or be exhaled as a visible vapor. The device 30 may be configured to produce an aerosol size (e.g., aerosol diameter of about 1 micron) such that if a user of the device exhales directly without performing a breath hold, a majority or significant amount of the aerosol is exhaled as a visible vapor. The majority or the significant amount can be more than or greater than 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99%. In this manner, the user of the aerosol generating device can choose during use of the device if they desire deep lung delivery and/or production of a visible vapor.
As shown in
In the example shown in
In methods for aliquoting an substance (e.g., nicotine) to ensure dose-to-dose uniformity, an element having porous materials can wick out fluid at a particular rate in order to measure out a dose to provide dose-to-dose uniformity. A tube, e.g., a capillary tube can be used to measure out a dose, with heat used for ejecting a dose. A material or geometry of a device can be used to measure out a dose providing dose consistency controls for variability in environment and device. Inhalation flow control ensures that variability in inhalations by a user are controlled and corrected for, which can result in dose-to-dose consistency and predictable and desirable aerosol particle sizes.
The liquid may be metered out into a pre-vaporization area in a device (dosing mechanism) through capillary action. The metering can occur between inhalations of a user of a device. Upon inhalation by a user, liquid can be drawn into a vaporization chamber or onto a heater. The liquid can be drawn or metered out into a vaporization chamber or onto a heater upon inhalation by a user.
The vaporization device may include elements for separating out and reducing large aerosol particles to a size that can navigate to the deep lung of a user. In the deep lung, the particles can settle and be rapidly absorbed. For example, the aerosol size control can result in rapid, cigarette-like nicotine absorption, which can help to satisfy nicotine cravings. Aerosol particles having nicotine produced by the device can achieve peak plasma concentrations similar to peak plasma concentrations achieved by smoking a cigarette.
The device 30 may allow the user to vary the flow resistance, to better provide either deep lung delivery or replicate the puffing of a tobacco cigarette. By varying both the size of the inlet that controls the flow through the vaporization region and the size of the bypass or secondary inlet, the user can control the flow resistance through the device and the resultant aerosol particle size. The flow resistance can be varied over time, for example over a month, days, hours, or minutes. The flow resistance can be varied within the same “smoking session.”
For example, a user can select a high flow resistance and small particle size to more closely replicate the sensation, perception or the nicotine pharmacokinetics (PK) associated with smoking a tobacco cigarette. A user can select or alter a flow resistance/particle size after several initial deep inhalations. A user can select the flow resistance/particle size to: maximize the nicotine hit or sensation within a series of inhalations (e.g., thereby reducing nicotine cravings), or to focus more on the sensory aspects of the vaping experience, e.g., to produce a large visible cloud of vapor. It can be advantageous in some settings to use a larger aerosol with little or no visible exhaled vapor.
As shown in 17 and 18, the pump can be a pump having a first elastomeric membrane 154 which vibrates or oscillates back and forth. The pump can be completely or partially housed within the reservoir 144. As shown in
As shown in
A user may choose a larger particle size (1-3 um) to more closely replicate the nicotine deposition of cigarettes, as well as vape in a more discrete manner, and in another case they may choose a 0.5 um aerosol to more closely mimic the visual aspects of exhaling a visible vapor, like smoking. This can be accomplished by a user manipulated movable adjusting element such as a slide 1106 or other method of varying the entrance opening size as shown in
A user can switch the inhalation flow resistance and/or particle size characteristics of the vapor to focus more on the sensory aspects of the vaping experience. It can be advantageous in some settings to use a larger aerosol with little or no exhaled evidence where blowing huge plumes and smoke rings is socially unacceptable. In the device of
As shown in
The device may be capable of modifying a size of the outlet 1112 and/or the inlet 1104 and/or the secondary inlet 1110 via an adjusting element such as the baffle slider 1130. The adjusting element may alternatively be a flow restrictor or a fixed or movable baffle, which may be located upstream of the heater, and optionally configured to slide within the vaporization chamber. A vaporization chamber 1102 can be configured to limit a flow of a gas through the airflow path 1150 to permit condensation of a vaporized liquid formulation.
As shown in
The solenoid coil can be made from 36 gage magnet wire. In some cases, the solenoid coil comprises 36 gauge magnet wire that has a resistance of around 10-11 Ohms. The 10-11 Ohms resistance of the solenoid coil can be achieved with a solenoid coil having 400 wraps. The battery may supply a current of about 0.34 amps through the solenoid coil such that the pump is driven at about 2 to 10 or 4-6 Hz such that the liquid formulation is pumped at about 1-4 or 2-3 mg/second. Pump frequencies of 1 up to about 100 may be used depending on the pump design. Piston diameters of 0.5 to 5 mm may be used. The magnet in the pump may be a ring magnet with an interior diameter of 1-2 or 1.5 mm, an outside diameter of 4-6 mm or 4.7 mm, and a length of 1-2 mm or 1.5 mm. The distance between successive coils or the pitch of the heater coil may be from about 0.2 to 5 or 0.2 to 0.8 mm.
While preferred embodiments have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions can of course be made without departing from the spirit and scope of the invention. The invention, therefore, should not be limited, except by the following claims and their equivalents.
This application claims priority to U.S. Provisional Patent Application Nos. 62/106,679, filed Jan. 22, 2015; 62/153,463, filed Apr. 27, 2015; and 62/192,377 filed Jul. 9, 2015 and incorporated herein by reference.
Number | Date | Country | |
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62106679 | Jan 2015 | US | |
62153463 | Apr 2015 | US | |
62192377 | Jul 2015 | US |