# Patent

## Title
Vaporized Lobelia product and method of use

## Abstract

In one embodiment, a method for lobelia delivery is provided comprising: providing a lobelia solution suitable for vaporization in a compact handheld device; providing the compact handheld device; vaporizing the lobelia solution at a low temperature upon activation by a user such that an effective serving of lobelia is provided to the user. In various aspects of this embodiment the lobelia solution comprises propylene glycol, water, alcohol and glycerin, the step of vaporizing the lobelia solution comprises using a vaporizer to vaporize the lobelia solution, and the effective serving of lobelia is provided to the user in less than 20 activations, less than 15 activations, less than 10 activations, less than 5 activations, or between about 8-10 activations.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Patent Application No. 61/234,562, filed Aug. 17, 2009, which is incorporated by reference herein in its entirety.


BACKGROUND
Smokers report a number of difficulties with current smoking tonics and smoking substitutes on the market. Smoking tonics and substitutes refers to products that are used by smokers not looking to quit the activity, but instead have something that they can use or do which substitutes for or addresses the activity or condition in places or situations where they cannot smoke by law, regulation or common courtesy. Some of these products include gums, lozenges or smokeless devices that do not contain nicotine, which is often used in nicotine replacement therapies (“NRT”) for smoking cessation. Government regulation of nicotine products is unclear. For example, the FDA is currently studying whether or not products containing nicotine can be sold without a new drug application (“NDA”) and without going through clinical studies and a formal FDA approval process. Smoking tonics and substitutes are distinguished from FDA-approved smoking cessation products.
There are a number of traditional, established dietary supplement and/or herbal remedies that offer effective tonics or substitutions for smokers in environments where they otherwise cannot smoke. One of these is the herb Lobelia, also known as Indian Tobacco.
Lobelia is currently sold by herbalists and by retailers specializing in herbal remedies and dietary supplements as a “Respiratory Tonic.” Descriptions of the herb in an online pharmacopeia published by the University of Maryland states this, “Lobelia (Lobelia inflata), also called Indian tobacco, may be used as an herbal remedy for respiratory conditions such as asthma, bronchitis, pneumonia, and cough. Native Americans historically have smoked lobelia as a treatment for asthma. In the 19th century, American physicians prescribed lobelia to induce vomiting in order remove toxins from the body. Because of this, it earned the name “puke weed.” Today, lobelia is considered effective in helping clear mucus from the respiratory tract, including the throat, lungs, and bronchial tubes. Although few studies have evaluated the safety and effectiveness of lobelia, some herbalists today incorporate lobelia into a comprehensive treatment plan for asthma.
Various herbalists and naturalists have traditionally recommended that lobelia be vaporized using heat in order to avoid the by products of ignition and burning that accompany smoking and absorption of the herbal supplement. And, various retailers offer the advice to vaporize the supplement and sell heat implemented vaporizers. These vaporizers utilize heat to produce an ingestible vapor-like mist. And, these vaporizers are large, bulky and difficult to use in environments where smokers can no longer smoke, for example, social or workplace environments. As a result, lobelia vaporization is not considered a suitable or appropriate smoking tonic or substitute.
Accordingly there is a need in the art for an improved lobelia vaporization product and method of use.
SUMMARY
In one embodiment, a method for lobelia delivery is provided comprising: providing a lobelia solution suitable for vaporization in a compact handheld device; providing the compact handheld device; vaporizing the lobelia solution without the addition of heat for activation by a user such that an effective serving of lobelia is provided to the user. In various aspects of this embodiment the lobelia solution comprises propylene glycol, water, alcohol and glycerin, the step of vaporizing the lobelia solution comprises using a low temperature vaporization element to vaporize the lobelia solution, and the effective serving of lobelia is provided to the user in less than 20 activations, less than 15 activations, less than 10 activations, less than 5 activations, or between about 8-10 activations.
In another embodiment, a portable handheld device for lobelia delivery is provided comprising: a disposable cartridge, the disposable cartridge comprising a solution reservoir, the solution reservoir comprising a lobelia solution suitable for vaporization without the addition of heat to the lobelia solution; a vaporization mechanism releasable coupled to the disposable cartridge, wherein the vaporization mechanism vaporizes the lobelia solution at a low temperature to deliver an effective serving of lobelia to a user.
In another embodiment, a lobelia solution for use in a vaporization delivery mechanism comprising: water; alcohol; propylene glycol; and tincture of lobelia, wherein the lobelia solution is formulated such that it can be vaporized at a low temperature in a sufficient quantity to provide an effective serving of lobelia to a user.
In another embodiment, a disposable cartridge for use in a lobelia delivery device is provided comprising: a solution reservoir comprising a lobelia solution, wherein the lobelia solution is formulated such that it can be vaporized at a low temperature in a sufficient quantity to provide an effective serving of lobelia to a user.
Other features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating the preferred embodiments of the present invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the present invention will become apparent to those skilled in the art from this detailed description.


DETAILED DESCRIPTION
In order to fully understand the manner in which the above-recited details and other advantages and objects according to the invention are obtained, a more detailed description of the invention will be rendered by reference to specific embodiments thereof.
In one embodiment, a lobelia delivery method is provided comprising providing a lobelia solution, and providing a mechanism for vaporization of the lobelia solution such that a user can absorb the vaporized solution via activation. Said embodiment is configured to deliver an effective serving of lobelia to a user. An active ingredient in the lobelia plant, lobeline, is similar to nicotine in its effect on the body. Like nicotine, it stimulates nerves in the central nervous system.
While an effective serving of lobelia may vary depending upon the particular physiology of the user, for example, the user's weight or body make-up, as used herein, the phrase means an amount sufficient such that the user experiences the intended positive effects experienced when lobelia is delivered through other known methods. In one aspect of this embodiment the effective serving can be delivered in as little as one activation by the user, and in other aspects the effective serving may be delivered through multiple activations by the user over 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more minutes of use in a manner similar to the use associated smoking a tobacco product such as a cigarette or cigar.
Alternatively, the effective serving can be delivered over a specified number of activations by the user. Further, the number of activations can occur over a specified time period. For example, delivery of an effective serving can be provided with 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 activations. For example, the effective does may be delivered in 1-20 activations, 5-15 activations, 12-20, activations, 12-18 activations or about 15 activations, any of which can occur in a 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 20 minute period. Some embodiments will be formulated and/or configured such that the effective does is delivered as quickly as possible, and other embodiments can be formulated and/or configured such that the effective does is delivered in about the same time and manner as if one was smoking a typical tobacco cigarette to simulate a typical smoking experience.
In various embodiments, a single serving may be delivered in less than 50 activations, about 1-50 activations, about 1-20 activations, 5-15 activations or about 8-10 activations. The single serving may include greater than 0.5 mg, between about 0.5-100 mg, between about 0.5-50 mg, between about 0.5-20 mg between about 0.5-10 mg between about 5-10 mg, or about 5 mg of lobelia solution.
In one aspect of this embodiment the lobelia solution comprises tincture of lobelia. In another aspect of this embodiment the lobelia solution is prepared by combining a tincture of lobelia with a first solution. In another aspect, the lobelia solution is prepared by contacting lobelia with a first solution. In another aspect of this embodiment, the first solution comprises one or more of water, alcohol, flavoring, and an inert non-reactive compound, e.g., propylene glycol, such that the lobelia solution can be vaporized for activation by a user. The first solution can comprise about 0.01%-20% water, 2-18% water, 5-15% water, or about 10% water, about 0.01%-20% alcohol, 2-18% alcohol, 5-15% alcohol, or about 10% alcohol, with the balance being propylene glycol. In another aspect of this embodiment, the solution further comprises glycerin, including from about 1-30%, 5-20%, 5-10%, or 10-15% glycerin.
Without being limited by theory, it is believed that the addition of glycerin provides a more robust vapor upon vaporization of the product.
In some embodiments the lobelia solution is formulated such that an effective serving of lobelia can be delivered to a user in a specified time period when the lobelia solution is vaporized and inhaled by a user. In one aspect of this embodiment the effective serving can be delivered over a specified time period when the solution is vaporized without the addition of heat.
In other embodiments the first solution may be any solution sufficient to form a lobelia solution such that the lobelia solution can be vaporized for activation by a user.
In another embodiment, a lobelia delivery method is provided comprising contacting lobelia with a first solution such that the constituents of the lobelia leach or are extracted to form a lobelia solution. The lobelia solution is then vaporized by a vaporization mechanism and inhaled by the user.
To promote the leaching or extracting of the constituents of the lobelia to form the lobelia solution, various methods may be employed to contact the lobelia with the solution, including maximizing the surface area of the lobelia. In one embodiment the lobelia is formed in the shape of a mesh screen through which a first solution is passed. In other configurations, the lobelia is formed to provide the maximum surface area for contact with the first solution yet still allow flow of the first solution through lobelia and into a vaporization mechanism. Examples of other configurations for use in maximizing the surface area of the lobelia for contact with a first solution include spirally wound lobelia, lobelia pellets, and lobelia powder, or encapsulating the lobelia in a porous, filter-like material, which will allow the solution to flow through the lobelia-encapsulate and the constituents of the lobelia to leach into the solution. Leaching and or extracting may also be promoted through modifying the temperature of the first solution or the pressure under which the first solution is contacted with the lobelia. 
In some embodiments the first solution and the lobelia are contacted immediately prior to vaporization. In other embodiments the first solution and lobelia can be contacted over an extended period of time prior to vaporization. For example, the lobelia can be provided immersed in the first solution such that the first solution has been in contact with the lobelia for an extended period of time prior to vaporization. In said examples, the leaching or extraction of the lobelia constituents can be promoted by varying the conditions or other parameters during contact of the first solution with the lobelia. The lobelia can be removed from the formed lobelia solution prior to providing the lobelia solution to the end consumer for inclusion in a device for vaporization, or immediately prior to vaporization by draining the lobelia solution from the lobelia. 
The lobelia solution is then vaporized for activation by the user. One example of a mechanism that may be used to vaporize the lobelia solution is disclosed in U.S. patent application Ser. Nos. 10/587,707 and 10/547,244, incorporated herein by reference. Other mechanisms may be used which including atomizers or other vaporizers known in the art or combinations thereof. Vaporization or atomization can be performed with or without the additional of heat to the solution. For example, the solution to be vaporized can first be atomized providing for ease of vaporization without the addition of heat. In one aspect a low temperature vaporizer is provided, including vaporization at temperatures from about 180° C. to about 280° C., from about 180° C. to about 250° C., from about 180° C. to about 225° C., from about 180° C. to about 200° C., wherein the temperature indicates the temperature at which the solution is vaporized. It is understood that the temperature of the vaporization element may be higher.
In another embodiment, a device for implementing the lobelia delivery methods set forth herein is provided comprising a shell, a mouthpiece, an air inlet provided on the external wall of the shell; a cell, an electronic circuit board, a normal pressure cavity, a sensor, an atomizer, a solution reservoir; a lobelia reservoir, a solution stream passage, a negative pressure cavity provided in the sensor, an atomization cavity arranged in the atomizer, and an aerosol passage, wherein the solution reservoir is in contact with the lobelia reservoir and the atomizer, and the air inlet, normal pressure cavity, atomizer, aerosol passage, gas vent and mouthpiece are interconnected.
In another embodiment, a device for implementing the lobelia delivery methods set forth herein is provided comprising a shell, a mouthpiece, an air inlet provided on the external wall of the shell; a cell, an electronic circuit board, a normal pressure cavity, a sensor, an atomizer, a solution reservoir; a solution stream passage, a negative pressure cavity provided in the sensor, an atomization cavity arranged in the atomizer, and an aerosol passage, wherein the solution reservoir is in contact with the atomizer, and the air inlet, normal pressure cavity, atomizer, aerosol passage, gas vent and mouthpiece are interconnected. The solution reservoir may be configured to retain a lobelia solution and lobelia, or lobelia solution that has previous been contacted with lobelia. 
In some embodiments the device is provided in the configuration of a cigar or cigarette. In other embodiments the device is provided in other configurations such that the device can be readily distinguished from a cigar or cigarette.
In some embodiments, the delivery device is a hand-held, personal portable device that is disposable. Moreover, in some embodiments the method of vaporization does not use heat, rather it uses piezoelectric elements to atomize the lobelia solution.
Some embodiments provided herein produce a vapor containing the key constituents of lobelia without components created through burning the lobelia. Moreover, said embodiments do not create “second hand smoke” or have other possible negative social appearances.
In another embodiment, a lobelia solution is provided for use in the methods and devices disclosed herein. The lobelia solution comprises lobelia constituents in a form suitable for vaporization. The lobelia solution may be formed by contacting a first solution as set forth herein with lobelia as set forth herein to form a lobelia solution. The concentration of the lobelia constituents of the lobelia solution can be varied by varying the method for making the lobelia solution. For example, one can vary the contact time between the first solution and the lobelia, the temperature at which the contact occurs, or the pressure at which the contact occurs. The lobelia solution may be provided with or without lobelia in contact with the lobelia solution.
In another embodiment, a lobelia solution is provided comprising a tincture of lobelia combined with a first solution as set forth herein to form a lobelia solution suitable for vaporization for use in the methods and devices set forth herein.
In another embodiment a disposable cartridge is provided comprising a lobelia solution or lobelia and a first solution as set forth herein. The cartridge can include one or more servings of lobelia as set forth herein. In one aspect of this embodiment the cartridge can include between about 5-50 servings, between about 5-25 servings, between about 10-25 servings, between about 10-50 servings, between about 10-20 servings of lobelia. 
Accordingly, some embodiments herein provide smokers or other users with an easy-to-use, convenient lobelia product. Said embodiments will provide smokers an easy-to-use, convenient and cost-effective smoking substitute that effectively replicates the physical attributes of smoking tobacco with a formulation that is both legal, from a regulatory standpoint, and effective as a respiratory tonic for smokers. Additionally, some embodiment also provide bronchial dilation that will provide temporary respiratory relief for conditions due to bronchitis and asthma.
Although the invention has been described with respect to specific embodiments and examples, it will be readily appreciated by those skilled in the art that modifications and adaptations of the invention are possible without deviation from the spirit and scope of the invention. Accordingly, the scope of the present invention is limited only by the following claims.

## Claims

1. A method for lobelia delivery comprising:
providing a lobelia solution suitable for vaporization in a compact handheld device;
providing the compact handheld device;
vaporizing the lobelia solution at a low temperature upon activation by a user such that an effective serving of lobelia is provided to the user, wherein the low temperature is from approximately 180 degrees C. to approximately 280 degrees C., wherein the lobelia solution further comprises water at a concentration of approximately 0.01% to approximately 20%, alcohol at a concentration of approximately 0.01% to approximately 20%, glycerin at approximately 1% to approximately 30%, and propylene glycol.

2. The method of claim 1 wherein the step of vaporizing the lobelia solution comprises using a low temperature vaporizer element to vaporize the lobelia solution at the low temperature.

3. The method of claim 2 wherein the effective serving of lobelia is greater than 0.5 mg.

4. The method of claim 2 wherein the effective serving of lobelia is from approximately 0.5 mg to approximately 100 mg.

5. The method of claim 2 wherein the effective serving of lobelia is from approximately 0.5 mg to approximately 50 mg.

6. The method of claim 2 wherein the effective serving of lobelia is from approximately 0.5 mg to approximately 20 mg.

7. The method of claim 2 wherein the effective serving of lobelia is from approximately 5 mg to approximately 10 mg.

8. The method of claim 1 wherein the lobelia solution comprises water at a concentration of approximately 2% to approximately 18%.

9. The method of claim 1 wherein the lobelia solution comprises water at a concentration of approximately 5% to approximately 15%.

10. The method of claim 1 wherein the lobelia solution comprises alcohol at a concentration of approximately 2% to approximately 18%.

11. The method of claim 1 wherein the lobelia solution comprises alcohol at a concentration of approximately 5% to approximately 15%.

12. The method of claim 1 wherein the lobelia solution comprises glycerin at a concentration of approximately 5% to approximately 20%.

13. The method of claim 1 wherein the lobelia solution comprises glycerin at a concentration of approximately 5% to approximately 10%.

14. The method of claim 1 wherein the lobelia solution comprises glycerin at a concentration of approximately 10% to approximately 15%.

15. The method of claim 1 wherein the low temperature ranges from approximately 180 degrees C. to approximately 250 degrees C.

16. The method of claim 1 wherein the low temperature ranges from approximately 180 degrees C. to approximately 225 degrees C.

17. The method of claim 1 wherein the low temperature ranges from approximately 180 degrees C. to approximately 220 degrees C.

18. The method of claim 1 wherein the lobelia solution is provided in a disposable cartridge to consistently deliver the effective serving of lobelia per activation.

19. The method of claim 1 wherein the lobelia solution is extracted from lobelia that is configured to maximize a surface area of the lobelia , wherein the configuration is selected from the group consisting of lobelia in a shape of a mesh screen, lobelia that is spirally wound, lobelia in pellet form, lobelia in powder form, and lobelia encapsulated in a filter-like material.