Abstract:
The present invention provides several smoking and tobacco use cessation devices and methods which entirely eliminate the requirement of ignition and burning of substances which emit harmful substances and vapors while simultaneously providing therapeutically efficacious amounts of nicotine and/or nicotine substitutes, and optionally tobacco aroma and taste and/or other undesirable habit inhibiting compounds and antagonists and other desirable orally ingestible substances.

Description:
FIELD OF THE INVENTION  
       [0001]     The present inventive product and method is directed to smoking cessation devices, and particularly to cigarette props and facsimiles and/or other oral devices comprising nicotine replacement products and/or other anti-habit or habit combating substances, and any orally deliverable substance.  
       BACKGROUND OF THE INVENTION  
       [0002]     Cigarette smoking and other forms of tobacco use, including snuff and the like, are known to be major causes of otherwise preventable disease and death throughout the world. In fact, tobacco use is thought by some to be the most dangerous of habits as it kills more people each year than any other drug or addicting habit, with one of its major dangers being the conversion of nicotine, the most prevalent alkaloid found in tobacco, by the body into chemicals that have been shown to cause various diseases including lung cancer. See, for example, Proceedings of the National Academy of Sciences 2000; 97:12493-12497, suggesting pathways the body may use to metabolize this addicting agent with the production of aminoketones which are direct contributors to the formation of NNK, a known tobacco-specific cause of lung cancer. In this study extracts from human live cells were shown to convert nicotine to aminoketone which was further broken down into products found in a smoker&#39;s urine.  
         [0003]     Nicotine is only part of the problem; however, as tobacco leaves contain many complex chemicals thought to be in excess of four thousand. When tobacco is burned in the smoking process, such as through smoking cigarettes, a pipe or a cigar, these chemicals undergo transformation into such compounds as arsenic, hydrogen cyanide, hydrogen sulfide, and other dangerous byproducts including carbon monoxide. Carbon monoxide is particularly dangerous as it has a stronger affinity to hemoglobin than oxygen and will reduce the amount of available oxygen in a person&#39;s blood supply, including those in contact with second hand smoke. It has been estimated, for example, that smoking as little as one pack of cigarettes a day may result in as much as 15% carbon monoxide saturation of the blood. Some adverse effects of such oxygen replacement, or “starvation”, of the body may be hindered muscle and mental function, as well as the development of various lung diseases including emphysema, asthma, chronic bronchitis, lung cancer, cystic fibrosis, pneumoconiosis, pneumonia, congestive heart failure and generally diminished lung capacity. Tobacco users can also expect to be at extreme risk of developing cancer of the lung, throat, mouth and esophagus, stoke, coronary heart disease, circulation problems and many other diseases.  
         [0004]     Smoking tobacco in any form is also well known to endanger all those in close proximity or in contact with smoking byproducts which pollute the air, otherwise known as secondhand smoke. Among a myriad of noxious compounds, second hand smoke contains formaldehyde, arsenic, cyanide, radioactive compounds, known carcinogens such as benzene and other polycyclic aromatic hydrocarbons, and carbon monoxide. The United States Surgeon General in 1990 has in fact issued a warning that passive inhalation of secondhand smoke by non-smokers is extremely harmful. Several corroborating reports have concluded that secondhand smoke is indeed responsible for causing, inter alia, thousands of lung and throat cancer deaths per year, asthma attacks and respiratory problems, especially in children, heart disease and aggravation of pre-existing heart disease, cervical cancer, brain tumors, birth defects, and may even be a cause of Sudden Infant Death Syndrome (SIDS).  
         [0005]     Tobacco use, especially smoking, also has many adverse consequences besides health deterioration, such as adverse economic effects in the form of outrageously expensive and highly taxed cigarettes, high insurance premiums, cleaning, productivity, ventilation and accident costs.  
         [0006]     However, despite the well documented extreme adverse effects of smoking, and tobacco use in general, many thousands of people who would like not to smoke or use tobacco simply cannot overcome the powerfully addictive nature of nicotine, or additionally, perhaps, customs, social behavior, moors, behavioral habits and other activities typically, or traditionally, associated with smoking and tobacco use. To this end, an entire industry has evolved to combat and end tobacco use, or at least curtail its use, or in some instances to provide “safer” cigarettes.  
         [0007]     Various smoking cessation devices are known to exist in several forms including some in which nicotine replacement methods are employed. For example, nicotine laden lollipops have recently been very popular, and have apparently been effective in a number of peoples&#39; efforts to reduce smoking. Such devices are available in a number of flavors with various dosages of nicotine being present. These devices are fairly simple in nature to manufacture, are widely available and known, and can be custom compounded by a number of pharmacies. Typically, when the need or desire to smoke a cigarette or cigar manifests itself the smoker will place the device in her mouth with available nicotine being adsorbed/absorbed into mouth tissues and thereafter the blood stream until the person&#39;s desire for nicotine has been satisfied. The device is then replaced into its wrapper until the next session. However, the many acts associated with smoking, such as holding a cigarette or cigar and the like with associated hand to mouth actions, and which are oftentimes as much a habit as smoking itself, are noticeably missing.  
         [0008]     Some forays into the smoking cessation industry, or more aptly put, the so-called “safer cigarette” industry, by the major brands have been, for example, Liggett and Myers efforts to market a cigarette containing, inter alia, various additives such as palladium, a metal used in automobile catalytic converters, which supposedly removes carcinogens from smoke and combustion products. Apparently, the release of this product was halted because its presence would have implied that smoking cigarettes and the like was indeed hazardous. In any event, some years later a successor company of Liggett and Myers introduced the Omni brand of cigarette which supposedly controls the amount of polycyclic aromatic hydrocarbons (PAH&#39;s) and Tobacco Specific Nitrosomines (TSNA&#39;s) (one of the most deadly carcinogens in tobacco smoke) created during the combustion process. This introduction of this product, however, would seem to confirm the inherently deadly nature of cigarettes and other tobacco combustion devices for those who have previously thought otherwise.  
         [0009]     RJR, noting that many carcinogenic compounds are produced in greater quantity relative to higher combustion temperatures, has attempted to produce controlled heat products. One such device called Premier is a glycerine based product with tobacco flavoring designed to look like a cigarette, and which contains a fuel element in a heating ring, all of which is contained in an aluminum cylinder. The aluminum cylinder contains beads of alumina coated with nicotine, glycerine and flavoring. The beads are heated by the fuel element with the heated glycerine condensing into nicotine-laced smoke or vapor. According to smoking instructions provided with the product, a butane lighter is required to ignite the carbon fuel element. Again, the inherently deadly nature of smoking tobacco combustion products is corroborated by the development and presence of this product. The Premier brand eventually evolved into a product called Eclipse, a true cigarette, in which a heating element is provided to heat sheet tobacco laced with glycerine to emit tobacco flavor without creating ash and smoke, and to provide a cigarette which burns at a lower temperature, supposedly to reduce carcinogenic combustion products. However, public health officials subsequently showed that Eclipse, when compared to so-called “light” brands such as Now and Carlton, produced almost four times as much carbon monoxide and higher levels of other carcinogenic PAH&#39;s.  
         [0010]     The Philip Morris Co., has made its contribution with its Accord brand which is inserted into a specially designed electronic heating device, said to look like a kazoo, and which is equipped with sensors that supposedly heat a layer of sheet tobacco only to a point that results in reduced carcinogenic compound production, and with reduced side stream smoke. To smoke a cigarette, a smoker sucks on the device and a microchip which senses the puff sends a burst of heat to the cigarette. This product can only be smoked in its special electronic device, which is cumbersome and impractical for use to say the least, and still produces deadly carcinogenic combustion products.  
         [0011]     In another exemplified system, U.S. patent Publication No. 2003/0111088, Jun. 19, 2003, discloses a method and device for treating combination of dependencies. As described, a medication delivery device is provided which introduces non-burning nicotine as a replacement for cigarettes (commonly referred to as nicotine replacement therapy or “NRT”) along with another drug in a “non-irritating” solution form to offer both oral and tactile stimulation. The combination formulation is said to be particularly useful for the administration of nicotine and naltrexone to treat patients who are smokers and also suffer from another drug dependency, such as alcoholism. The device includes a tubular chamber with a first end suitable for taking in a liquid from an external source and a second end suitable for oral application or suction. The tubular chamber contains nicotine and a second drug other than nicotine, such as naltrexone, with a retainer preventing the release of the drugs. Upon oral suction by the user liquid enters the first end of the chamber from an external source, and apparently delivers the nicotine and second drug in solution or suspension form to the user. In another embodiment, the nicotine and second drug may be present in a pre-formulated solution which is delivered to a user&#39;s mouth upon suction.  
         [0012]     In somewhat similar manner to that above U.S. Pat. Nos. 6,083,962; 5,861,422; 5,703,101; and 5,574,052 describe an agonist-antagonist combination to reduce the use of nicotine and other drugs. In this product and method, there is initially administered to a subject a drug, such as nicotine or another agonist of the drug, in an amount which would normally provide the desired pharmacological effects, or therapeutic amount to satiate the needs of the drug by the user. Also administered is an antagonist to the drug or its other agonist in an amount sufficient to at least partially block the pharmacological effects of the drug or its other agonist while there is a substantial amount of the drug or its other agonist present in the system of the user. In a preferred operation the drug and the antagonist are simultaneously administered in an attempt to occupy a substantial portion of the receptors of the user for the drug to block or attenuate the effects of any further intake of the drug or other agonist. A preferred mode of administration of the agonist and antagonist is by transdermal patch, or administration of the antagonist by an artificial smoking device which can function as a disposable cigarette or a reusable device equipped with a rechargeable ampoule. This reference also unfortunately recommends an embodiment of doping a conventional cigarette with an antagonist, such as mecamylamine, which can be produced in an aerosolized form for inhalation by the user from the burning cigarette. Such an activity, of course, will actually encourage tobacco smoking or use, thereby defeating an object of the present invention to stop or curtail smoking.  
         [0013]     Next, U.S. Pat. No. 6,041,789 discloses a cigarette substitute device for non-pyrolytic use which, in response to suction supplied by a user, delivers to the user&#39;s lungs a nicotine-simulating vapor mixture, in place of nicotine vapor, in which the mixture has a cigarette-like taste and aroma. As described, the cigarette substitute has a structure similar to that of conventional cigarettes and prior-art non-pyrolytic cigarette substitute devices, and comprises an elongated tube with a passageway for drawing air through the device and a porous polymeric material disposed within the tube. A volatile liquid composition is present as being adsorbed within the porous polymeric material, and in which there is present a pharmaceutically acceptable liquid carrier medium of a volatile nicotinomimetic agonist in an amount effective for its released vapors to satisfy the physiological needs for nicotine of the user. There is also present one or more volatile palatability enhancing agents in amounts effective for their released vapors to neutralize any unpleasant taste and aroma of the cigarette-like taste and aroma to the released vapor mixture. This liquid composition is referred to as “DEANATE”. As is known, the nicotinomimetic agonist is a compound effective to mimic the action of nicotine by binding to nicotinic or cholinergic receptors to release adrenergic receptors, such as epinephrine, norepinephrine and dopamine, and to simulate the action of nicotine vapors to enable the action of the substitute cigarette device by satisfying the physiological needs for nicotine of the user without contributing to nicotine dependency, as do other disadvantage methods and products such as described above.  
         [0014]     In another simulated cigarette device disclosed in U.S. Pat. No. 5,042,510 there is provided a cigarette-like device that contains no tobacco, is not intended to be lit, and includes a simulated filter/regulator and a barrel portion. This device is said to combat the urge to light up by satisfying various physiological needs such as holding, fondling, and placing the cigarette device between the lips of the user, along with sucking, puffing or drawing. The device is actually designed to simulate the drawing sensation by placing transverse openings in a simulated filter/regulator or tip which are in air communication with a longitudinal passageway, which is a separate component from the barrel This arrangement is said to be a safeguard in the event the fake cigarette is accidentally lit to prevent flames, smoke or hot gasses from passing through the air regulator and reaching the mouth of the user. The barrel material is formed of non-toxic, self-extinguishing polymeric material which will not carry a flame in the event of accidental ignition. This device is purely a prop or simulated cigarette and is not a drug delivery product or method, such as a nicotine replacement or other drug delivery devices discussed above, and will not replace chemical dependency to satisfy the tobacco addict for long term cessation of tobacco use.  
         [0015]     In U.S. Pat. No. 5,003,995 there is disclosed compositions and articles for simulating taste receptors in the form of smoking and non-smoking materials, which are described as comprising a volatile-releasing substrate, adapted for size, configuration and material make-up for insertion, at least partially, into the buccal cavity of humans. The composition is also composed of a taste-receptor simulation proportion of volatilizable distillers dried soluble coated on the substrate. Thus, the main point of this device is to satisfy stimulation of the human taste receptors with such compositions as byproducts of the liquor distillation process, such as distiller&#39;s dried grain with soluble (“DDGS”). DDGS is a product obtained from drying stillage or “slop”, the residue after distillation and removal of alcohol from beer and fermented grain mash. In a smoking embodiment of this device distiller&#39;s dried soluble (“DDS”), a concentrated liquid component of DDGS, is homogeneously mixed with a smokable tobacco form, such as used in cigarette and pipe-smoking blends. The use of typical tobacco additives, such as flavorants ( e.g. menthol), binders, humectants (propylene glycol, sorbitol and the like), mold inhibitors, extenders and fillers (hydroxymethylcellulose), flavor enhancers and the like is also recommended. As discussed, when smoked, the DDS is volatilized and the vapor is brought into contact with the user&#39;s taste buds and smell receptors. While this device can hardly be said to be a viable non-smoking aid, or smoking cessation device, the disclosed distillery byproduct by itself (without, of course, the propylene glycol and other additives) perhaps may be used as a taste stimulant for nicotine replacement products, cigarette props, facsimiles and the like-as smoking cessation aids.  
         [0016]     In yet another simulated smoking aid, U.S. Pat. No. 4,911,181 discloses a plastic mouthpiece for simulated smoking which is said to enable the user to experience the taste and aroma as well as the tactile sensations of smoking a tobacco cigarette, but without the presence of smoke, without combustion, and without inhalation of harmful carcinogenic substances into a user&#39;s lungs. This device consists of a plastic mouthpiece containing a plug of chewing tobacco connected to a plastic tube with an axial duct extending to a sealed end where a pumping chamber is located and existing in the form of a flexible accordion-like, or bellows-type configuration or spring-loaded ball or position. In another form, the device consists of a conventional mouthtip filter, or tubular body with a flexible collapsible sidewall sealed at the far end, and a tobacco insert. As explained, in use repeated suction cycles by the user initially draw saliva through the tobacco insert to flavor it with nicotine, and then to re-circulate it back to the user&#39;s mouth on successive suction cycles, allowing the user to taste and smell the nicotine. As also disclosed, inserts other as tobacco may also be used, such as menthol, various medications and the like.  
         [0017]     In U.S. Pat. No. 4,807,648 there is disclosed yet another non-burning tobacco substitute in the form of a material which comprises a non-cellulose carrier homogeneously mixed with a flavor enhancing proportion of distiller&#39;s dried grain with solubles. Unlike U.S. Pat. No. 5,003,995 discussed above, this non-burning composition is devoid of tobacco, and is presented purely for the taste sensation of the distillery byproducts and to simulate a cigarette in a manner to give a user pleasure and oral gratification.  
         [0018]     U.S. Pat. No. 5,732,168 describes a smoking article employing heat conductive fingers, in the form of a cigarette-like article which is said to be cabable of producing substantial quantities of an aerosol, both initially and over the useful life of the product, and preferably without significant thermal degradation of the aerosol formed, and without the presence of substantial pyrolysis or incomplete combustion products or side-stream smoke. The user is said to be provided with the sensations and benefits of cigarette smoking without the necessity of burning tobacco. In structure,.the device is an elongated, cigarette-type smoking article equipped with a short carbonaceous fuel element and a physically separate aerosol generating means, including an aerosol-forming material which is in a conductive heat exchange relationship with the fuel element. The aerosol generating means is contained within a unitary heat conductive chamber having two or more finger-like extensions, each of which is in contact with some portion of the fuel element. In use, conductive transfer of heat from the burning fuel element to the aerosol generating means causes volatilization of the aerosol forming material which in turn is delivered to the user in the form of a “smoke-like” aerosol through the mouth end of the article. Thus, an ignitable, burning fuel element is required by this disclosed device, which generates the heat necessary to volatilize the aerosol forming substance. As described, a short, hot burning fire cone is employed which is maintained and fueled with oxygen from puffs from the user, and which are molded or extruded from comminuted tobacco, reconstituted tobacco, or tobacco substitute materials, such as molded cellulosic materials or degraded pre-pyrolized tobacco. As further explained, the fuel element preferably includes combustible carbon compounds such as one would obtain by the pyrolysis or carbonization of cellulosic materials, including wood, cotton, rayon, tobacco, coconut, and paper, along with burn enhancing additives. Additionally, the aerosol produced is described as preferably consisting essentially of air, water, oxides of carbon, the aerosol former, and any desired flavors or other desired volatile materials, with trace amounts of other materials. The aerosol forming substance can be present in heat rupturable microcapsules, or as, for example, a solid aerosol forming substance, which can be polyhydric alcohols or a mixture of polyhydric alcohols, such as glycerin, triethylene glycol and propylene glycol. As shown, such a device and method is undesirable on several fronts as it requires a burning section and the vaporized release of harmful chemicals, including such harmful byproducts from burning tobacco with nicotine as above described.  
         [0019]     Finally, a smoking blend said to be effective to discourage the cigarette smoking habit is discussed in U.S. Pat. No. 4,492,239. In this product, a smoking blend mixture comprises tobacco or a tobacco substitute material and a chemical substance which is formaldehyde (formol or formalin) absorbed on the tobacco or a tobacco substitute, or paraformaldehyde of the formula (HCHO)n in which n is equal to or greater than 3. In use this product, whether in powered, granulated, or solution form, when ignited and burned is said to be capable of providing by sublimation during the combustion of the cigarette a gaseous product acting on the main respiratory organs in such a way as to cause in the smoker an annoying, though purportedly harmless, feeling as well as advantageous antiseptic and soothing effects. As must be obvious to anyone, however, smoking formaldehyde or any other embalming fluid is not thought to be particularly desirable, or advisable.  
         [0020]     Other conventional tobacco smoking cessation aids are available in the form of patches which, while no doubt are at least somewhat effective, are oftentimes ignored or left unused as they do not provide nor oral or tactile stimulus, and are foreign to rituals associated with cigarette use. Cessation aids in the form of gum, lozenges, and drinkable concoctions also lack the, perhaps pivotal, mannerisms and rituals of hand-to-mouth behaviors which smokers are used to and most likely desire.  
         [0021]     Therefore, as shown above from a sampling of conventional products and methods there is an important need for a tobacco smoking or using cessation aid and method which does not involve the ignition and combustion of noxious chemicals and compounds, and which does not introduce noxious fumes to the user or others within reach of the fumes. There is also a great need for such a device which is effective to aid in substantially reducing, and preferably eliminating, a person&#39;s habit of tobacco smoking and/or use of tobacco in any form. There is an additional great need for such tobacco use cessation aids in the form of a cigarette prop or facsimile which effectively masquerades and/or otherwise substantially mimics a conventional cigarette or other tobacco smoking device in appearance and/or use to a degree which at least satisfies the user thereof in moors, mannerisms and rituals associated with such cigarette use.  
       SUMMARY OF THE INVENTION  
       [0022]     In accordance with that set forth above there is provided by the present invention novel smoking and tobacco cessation devices and methods which entirely eliminate the requirement of ignition and burning of substances which emit harmful vapors, while simultaneously providing therapeutically efficacious amounts of nicotine and/or nicotine substitutes, and optionally other undesirable habit inhibiting compounds and antagonists, and other orally ingestible substances. The inventive cessation aid also simultaneously provides and satisfies, with the use of each of such devices, learned or otherwise acquired collateral or ancillary activities and rituals associated with smoking behaviors including the initiation and consummated act and process of lighting up, smoking and inhaling tobacco products.  
         [0023]     More specifically, to this end there is provided a tobacco smoking and/or using cessation product and method comprising a mouthpiece means suitable for use with cigarettes, cigars and/or pipes or props or facsimiles thereof, and wherein said mouthpiece means comprises a mouth tissue dissolvable substance, such as hard candy, which itself comprises nicotine and/or other addiction-inhibiting compounds and/or orally deliverable compounds for delivery to a user and the user&#39;s bloodstream. In different embodiments the inventive mouthpiece means can be used by itself when the desire for oral delivery of nicotine is present, or it may be used in conjunction with any of the myriad of cigarette, cigar or pipe makes and brands available on the market or other tobacco smoking devices by simply fitting the device to the orally deployable end of a tobacco smoking device, such as a cigarette, for almost immediate nicotine consumption and fulfillment for a desired period without being subjected to nicotine combustion products in any way.  
         [0024]     In other embodiments the inventive mouthpiece may be used in conjunction with an inventive simulated tobacco smoking device which may, in some embodiments, comprise the dimensions and/or design of conventional cigarettes or cigars, and which may also comprise an array of flavors and/or designs, or any sort of color scheme or pattern, or graphic display.  
         [0025]     In additional embodiments, the inventive mouthpiece means may be used in conjunction with an inventive cylindrical elongated member, preferably in the form and shape of a conventional cigarette, such as the simulated tobacco smoking device, or other smoking device, and manufactured of paper products and/or materials having the look and feel of conventional cigarette products, or smoking products. The cylindrical member comprises a first end which mimics the burning end of a cigarette or cigar and a second end which mimics the orally deployed end of a conventional cigarette or cigar, and wherein there is situated within the cylindrical elongated member in a position contiguous to the first end, or substantially juxtaposed thereto, a heat generating means, and further comprising within said elongated member in communication with heat generated from an actuated heat generating means a source of tobacco, nicotine or nicotine substitute. Optionally, the inventive elongated member, as well as the inventive simulated tobacco-smoking device, may additionally comprise any one or more of several habit inhibiting compounds and/or antagonists deliverable in therapeutic amounts to the user during use of the inventive product and method to combat tobacco use cessation simultaneously with treating the user for inhibition of alcohol consumption and/or gambling tendencies and/or narcotic use, or other maladies as desired.  
         [0026]     Further options include the delivery from the inventive mouthpiece and/or simulated tobacco smoking device and/or elongated member any orally deliverable substance which can be orally ingested, such as vitamins, neutraceuticals, energy enhancers, aspirin, diet aids, weight loss additives, caffeine, breath enhancers and the like, for any desired effect imaginable.  
         [0027]     The invention is more fully explained and will be more fully understood with reference to the following Detailed Discussion of Preferred Embodiments with accompanying drawings.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0028]     FIG. 1  is a perspective view of a design of a mouthpiece means for use in the present invention.  
         [0029]     FIG. 2  is a perspective view of yet another design of a mouthpiece means for use in the present invention.  
         [0030]     FIG. 3  illustrates in perspective view a user of the inventive mouthpiece means applying same to a conventional cigarette for the user&#39;s nicotine intake and enjoyment without the cigarette&#39;s combustion.  
         [0031]     FIG. 4  illustrates in perspective view an embodiment of the inventive simulated tobacco smoking device for use with the mouthpiece means of  FIGS. 1 through 3 ,  
         [0032]      FIG. 5  is a lateral side schematic cross sectional view of an inventive smoking cessation device of the present invention for use with the inventive mouthpiece means of  FIGS. 1 and 2 .  
         [0033]     FIG. 6  is a side perspective view of the smoking cessation device of the present invention of  FIG.5 .  
         [0034]     FIG. 7  is an additional perspective view of a user of the presently inventive smoking cessation device as depicted in the act of initiating use of the device of  FIGS. 5 and 6 .  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0035]     All patent references, published patent applications and literature references referred to or cited herein are hereby expressly incorporated by reference to the same extent as if each were specifically and individually indicated to be incorporated by reference. Any inconsistency between these publications and the present disclosure is intended to and shall be resolved in favor of the present disclosure.  
         [0036]     Turning now to the present invention, in its broadest sense there is provided a temporary alternate source of nicotine in any dosage regimen required or desired without exposing the user to well documented hazardous effects of tars, carbon monoxide, and other combustion products produced in cigarette smoke, or from burning tobacco products in general. Referring to the example embodiments of  FIGS. 1 and 2 , as shown, there is provided an inventive mouthpiece means for use by itself or with any conventional cigarette, cigar or pipe means, or tobacco combustion and inhaling means in general, or props or facsimiles thereof, including additional aspects and embodiments of the invention as discussed in detail below. The mouthpiece means may be composed, at least in part, of any mouth tissue dissolvable substance, and is preferably manufactured or comprised of a dissolvable hard candy flavored substance, and which itself comprises an amount of nicotine, preferably a mouth tissue dissolvable form of nicotine, and/or other addiction-inhibiting compounds or orally ingestible compounds in general, for delivery to a user and a user&#39;s blood stream. In a preferred embodiment, the inventive mouthpiece can be compared to a flavored lollipop laden with predetermined amounts of nicotine which allows a smoker to get nicotine into her bloodstream when a craving manifests itself. As discussed in the Background of the Invention, lollipops laden with nicotine are well known, as well as their manufacture, and are oftentimes manufactured from nicotine salicylate, natural sweeteners, such as Stevia, flavorings, sorbitol and other additives. These products can be provided in any flavor imaginable, including without limitation, cherry, cinnamon, grape, apple, lemon-lime, orange, peppermint, raspberry, root beer, strawberry, pina colada, coca-cola, chocolate and the like. Such compounds and methods of manufacture, including that for any possible hard candy-nicotine laden substance, are contemplated for use in the fabrication of the presently inventive mouthpieces, which can be formed or cast into any shape or configuration desired or contemplated, as shown, for example, in FIGS.  1  and  2 , and to fit in a male-female fashion, or in any contemplated fitting means arrangement, to the orally deployable ends of any conventional cigarette, cigar, pipe or other tobacco smoking means.  
         [0037]     The inventive mouthpiece means may be fabricated to contain any dosage level of nicotine as desired for delivery of any nicotine dosage regimen as desired to a user&#39;s bloodstream. For example, 2 mg of nicotine is thought to be a typical dosage of nicotine delivered from a conventional cigarette. This amount, of course, is subject to wide variation as contemplated for use in the many forms and embodiments of the invention. Thus, for example, the inventive mouthpiece means can be made stronger or weaker in nicotine delivery as desired, and may, in some embodiments, be provided in packages comprising a multiple of such mouthpieces of varying degrees of nicotine dosage or strength for a user&#39;s gradual weaning in reduced intake of nicotine with such use as desired.  
         [0038]     It is also contemplated that in other embodiments the mouthpiece means may comprise in addition to nicotine, or without nicotine, other anti-addiction compounds, discussed in detail below, and/or one or more of any orally deliverable and ingestible substances, such as aspirin, neutraceuticals, caffeine, diet aids, weight reduction aids, sleeping aids, cholesterol reduction compounds, such as from the statin family of drugs, anticoagulants, vitamins, energy boosting compounds and mixtures, breath enhancers, complexion aids, and the like to achieve any desired effect.  
         [0039]     As can be envisioned, the inventive mouthpiece means, used alone or in combination with a tobacco smoking device, which is unlit, helps to control nicotine cravings by rapidly delivering nicotine (or other medicine and substances) to help relieve even the worst withdrawal symptoms, with nicotine being adsorbed/absorbed directly through mouth tissues as the mouthpiece delivery device contacts mouth tissues and is dissolved itself. Additionally, for those who fear weight gain upon smoking cessation the inventive devices may be manufactured of sugar-free material to check caloric intake, or, as mentioned, any of the several known weight reduction aids and/or substances may be administered through the dissolvable inventive mouthpiece means.  
         [0040]     Also contemplated for use with the present inventive mouthpiece is an indicator means, such as a colormetric reaction (color changing reaction) or graduated scale inscribed on the mouthpiece, which manifests itself when the desired dosage amount of nicotine is administered, or when the amount of nicotine originally present is depleted to a point signaling, or at least symbolically signaling, the finish of nicotine use in or with the device, such as simulating the completion of smoking a cigarette.  
         [0041]     For those who must comport to the traditional mannerisms associated with smoking, such as the acts of holding a cigarette and the like in the hands, and hand-to-hand mouth activity, the inventive mouthpiece means may be cast or shaped to fit any conventional cigarette, cigar, pipe or any tobacco smoking mechanism or device, which can be utilized, preferably unlit, in a traditional manner while the user ingests non-combusted dosages of nicotine, or other substances described herein, for personal satisfaction without engaging in a dangerous activity. See, for example, the perspective view of a user of the inventive device in  FIG. 3 .  
         [0042]     In some preferred embodiments, the mouthpiece means may be a preformed shape (a “perform”) manufactured from cardboard, composite material, plastic, wood/wood products, paper, glass, or really anything safe for oral deployment, and which comprises a coating of a mouth tissue dissolvable substance which itself comprises a form of nicotine and/or other medication and/or other orally deliverable substances. Such preforms can be coated by any conventional method, such as dipping or spray coating and the like with hardening dissolvable nicotine laced substances, and other substances as desired.  
         [0043]     Also as desired, a faux smoking device or prop mimicking a genuine smoking device, such as a fake cigarette, may also be used in conjunction with the inventive mouthpiece. As described above, a wide variety of such devices are known and available. However, some such faux or facsimile devices and props are more desirable than others, and provide advantages to the person intent upon smoking cessation or reduction which others do not. Referring now to  FIG. 4 , there is illustrated in perspective view an embodiment of an inventive simulated tobacco smoking device for use with the mouthpiece means of  FIGS. 1 through 3 . As shown, in some preferred embodiments, the simulated smoking device may comprise the dimensions and/or design of conventional cigarettes (or cigars). The simulated smoking device may also comprise an array of flavors and/or designs or any sort of color scheme or pattern, or a graphic display, such as “I don&#39;t have to smoke anymore”, or perhaps “I quit”, or any message or advertisement. Since nothing is combusted, slogans, messages, and advertisements and the like are not destroyed upon use, or used up, such as the mouthpiece means, but remain present until discarded. It is envisioned that such inventive devices left in various places or receptacles, such as ashtrays, when finished with by a user are able to provide a lasting and potent advertising means for the cessation of using combusted tobacco means.  
         [0044]     The simulated tobacco smoking device may be provided with the inventive mouthpiece means, attached or separate, in conventional packages, such as twenty or twenty-five units, or in any packaging means as desired to simulate that of conventional cigarettes and cigars, produced as customary in any country or location.  
         [0045]     Further, the simulated smoking device may also comprise any other convenient feature(s), such as a circumferentially protruding ring or lip surrounding a portion near the orally deployable end of the device. When placed upon a table, or any surface, the device provided with such a feature will not sit in a flush relationship with the surface, and will serve to prevent the orally deployable end, such as fitted with the mouthpiece means, from coming in contact with any surface or undesirable source. The device may be composed of any conventional material, with some nonlimiting examples including paper, plastic, wood, food material, metal, ceramic material, composites, glass, and the like.  
         [0046]     Referring now in detail and by reference characters to  FIGS. 5 through 8 , illustrated are several other practical embodiments of additional aspects of the present invention which can be used in conjunction with the inventive mouthpiece means, and which are designed to be particularly effective to deliver the, aromatic aroma and taste of hot or heated tobacco products, and optionally a nicotine dose, to the user without the noxious fumes and byproducts associated with or produced from tobacco combustion, or combustion of any material. These embodiments and additional aspects of the present invention also rely on the ability to effectively simulate the initiation and use of a conventional cigarette, or other tobacco smoking devices such as cigars, through similar acts of, for example, reaching for a cigarette, initiating the use thereof by tapping the end of the device on a surface or flicking or pinching a portion of the cigarette by hand or other hand-device coordinated initiation, holding the cigarette for an intended use period, and taking a drag and inhaling hot or warm tobacco laced vapors, and optionally simultaneously tasting and ingesting a nicotine dose, all while simulating puffing on a cigarette. In other modes, such aspects and embodiments of the invention are employed as an oral medication delivery device which is effective to reduce, or eliminate, the incidence of tobacco smoking and/or using while simultaneously treating a second dependency in a person, such as alcoholism, drug (especially opiate) addition, and gambling addiction in a person.  
         [0047]     As shown in  FIG. 5 , in this aspect of the invention, there is provided an inventive device which may mimic or otherwise approximate in dimensional size characteristics of length, width, shape, and preferably weight, a conventional cigarette (or cigar, which is not shown herein). Referring to the figures, the device comprises an elongated tubular or cylindrical chamber  2  with a first end  6  which, in this example, mimics the ignitable and burning end of a cigarette (or cigar) and a second end  8  which mimics the orally deployed end of a conventional cigarette, and adapted for oral suction. Typical dimensions of the chamber may be, for example, from about 7 to about 11 cm long, and having a diameter of from about 7 to about 10 mm.  
         [0048]     Material construction of the chamber may be from any conventional materials used to manufacture cigarettes, or cigars, and may include by way of non-limiting examples, paper, plastic, such as propylene/styrene copolymers, polypropylene, polyethylene, high density polyethylene, low density polyethylene, ethylene vinyl acetate copolymer, and the like, ceramics, wood, bamboo, natural and synthetic fibers, and any and all combinations thereof.  
         [0049]     Again turning to the figures, situated within the elongated cylindrical or tubular chamber  2 , preferably in a position contiguous, or substantially juxtaposed, to the first end  6  is a heat generating means  10 , which can undergo an exothermic reaction to liberate a quantity of heat, preferably a substantial quantity, to heat the surrounding air or atmosphere within the tubular chamber  2  to a noticeable degree.  
         [0050]     Heat generating means  10  may be any material or composition known in the art which is capable of undergoing an exothermic reaction and generating heat, such as, for example, an anhydrous form of an inorganic hydrate-forming salt which releases heat upon taking up water of hydration, inclusive of, without limitation, anhydrous calcium chloride, sodium sulfate, aluminum chloride, magnesium carbonate, and the like. Other exemplified heat generating means may be various iron comprising compositions, such as, for example, powdered iron mixed with activated carbon, water, salt, and wood fiber, such as cellulose, which upon contact with oxygen in air undergoes an exothermic reaction, such as used in heat generating means and devices used by athletes or persons undergoing exercise activities. Additional examples of heat generating means may be of the type which is in a liquid or semi-liquid state and which upon crystallization, such as instigated by a frictional or clicking means undergo an exothermic transformation and liberate heat. Such devices, which can comprise sodium acetate or food grade salt and water, are well known, and are the basis for providing heat generation in many conventional heating pad means and the like.  
         [0051]     The heat generating means  10  may be present as dispersed throughout a porous material, or porous matrix material, known in the art, such as clay or vermiculite particles, or throughout a polymeric matrix support material, such as a plurality of fused polymer particles to provide a supporting structure having a dispersion of microscopic-sized interconnecting voids and spaces therethrough. Preferably, in such an embodiment, the heat generating means  10  is dispersed evenly throughout the porous material, and is present in the tubular chamber  2  such that upon actuation of the heat generating means  10  heat is substantially, homogeneously emitted or liberated within chamber  2 . There is also present in another embodiment, preferably situated about the circumferential boundary  1  or periphery of the heating means  10 , and situated between boundary  1  and chamber  2 , a longitudinally disposed air passageway  3  which will allow air to pass into end  8  and past the heating means  10  through tubular chamber  2 , and past all other components to deliver hot tobacco aroma laced air and whatever else is intended, such as a nicotine dose or other substance, to the user when she has activated the cigarette prop device and takes a drag, or otherwise sucks on end  6 .  
         [0052]     In some embodiments heat generating means  10  may be a solid, or semisolid, composition which is capable of liberating heat simply upon exposure to the atmosphere, such as when a ruptureable or breakable barrier or containerized portion in which it is situated is opened to the atmosphere. Such compositions are well known and available, and are conveniently used in this aspect of the invention. In other embodiments heat generating means  10  may be separated in chamber  2  from an enclosed water delivery source (not shown) used to actuate the chemical(s) in the heat generating means  10 , as the case may be, by a rupturable, or breakable water impervious film in communication with, or within reaction forming or reaching distance, to heat generating means  10 . In another contemplated embodiment, a plurality of tiny water reservoirs or delivery sources, preferably in microspheres, and each enclosed by a breakable water impervious film, is present in reactive communication with heat generating means  10 , such as in a surrounding manner or configuration, or dispersed throughout a porous matrix in which is also dispersed heat generating means  10 , such that rupture of reservoirs will mix water with heat generating means  10  to initiate or produce an exothermic heat generating reaction, to thereby liberate a quantity of heat within tubular member  2 . Various other embodiments are contemplated for the placement and form of the heat generating means  10  and water reservoirs(s) or sources  12 , if required, within tubular chamber  2 , some exhibiting better or less effectiveness in the present invention than others, and any of which may be used in the invention.  
         [0053]     Also situated within tubular chamber  2  is a source of tobacco  14  and/or a tobacco substitute and/or nicotine and/or a nicotine substitute, which is within communication of heat generated from heat generating means  10  and heated air from air passageway  3  upon actuation thereof. Preferably, the tobacco source, or equivalents and other substances and the like, is disposed about a confined space in chamber  2  and can be held in place by any retaining means, such as an air pervious paper or polymer matrix. In use of the inventive device, upon actuation of heat generating means  10  and the subsequent liberation of heat, a user will place the second end  8  of tubular chamber  2  in her mouth in a simulation of smoking a cigarette and draw or suck on end  8  as she would a cigarette, and receive a rush of heated air laced with tobacco aroma and taste. This action may be performed alone or in conjunction with the inventive nicotine laden mouthpiece means, to both realistically simulate smoking a cigarette while simultaneously receiving a person satisfying amount, dosage or supply of nicotine, and without receiving tobacco combustion products of any kind.  
         [0054]     In other embodiments, whether used alone or with the nicotine laden mouthpiece, a person-satisfying amount of nicotine may also be present within the tubular chamber  2  in a position effective to reach the mouth of the faux smoker upon suction of end  8  in an cigarette drag and inhaling action to provide a satisfying dose of nicotine along with the heated aroma of tobacco, in similar manner as a conventional cigarette, but without the toxic and dangerous combustion byproducts emitted from conventional cigarettes. Such deliverable store of nicotine may be present and contained in chamber  2  for delivery by any conventional means used for delivery of nicotine replacement to a user for consumption. What is meant by “person satisfying amount” as used herein is an amount or quantity of nicotine delivered to a user upon application of oral suction which is sufficient to reduce a smoker&#39;s need from burnt or combusted tobacco, and is generally known in the art. Typical ranges can be from about 1 mg to about 40 mg of nicotine provided from the inventive devices which may be used several times throughout a twenty-four hour period in place of conventional cigarettes to deliver a recommended total daily dose of nicotine of approximately 480 mg for the average smoker, as published, for example, in U.S. patent Publication No. 2003/0111088. This level will greatly vary, of course, depending upon the person and a probable host of other factors which is not the focus of this invention. In any event, nicotine intake per person per dose using any form or embodiment of the present invention can be conveniently monitored, as blood levels of nicotine can be readily determined by gas chromatography with nitrogen phosphorous detection as described in, for example, Jacob,  Chromatography,  222:61-70(1981).  
         [0055]     The source of nicotine used in this aspect of the invention may be present in any useful form, such as levo nicotine, dextro nicotine, or as a racemic mixture thereof. Pharmaceutically acceptable salt forms of nicotine are also suitable for use, with non-limiting examples being dihydrochloride, sulfate, bitartrate, salicylate, hydrogen tartrate, and hemisulfate forms. The term “nicotine” as used herein also includes all known analogs of nicotine, which may or may not have a similar pharmacological effect to nicotine produced from conventional cigarettes. A convenient source of nicotine, analogs and various salt forms is Sigma-Aldrich Co., Inc., St. Louis. Mo. Additionally, it is contemplated that nicotine be present in granulated form, or in small grain form so as not to be noticed in the mouth of a user, or it may be present in powered form or incorporated into microspheres.  
         [0056]     Tobacco substitutes and/or nicotine substitutes may also be used in the present invention in conjunction with or in place of tobacco and/or nicotine. Such tobacco substitutes are well known.  
         [0057]     In embodiments where the heat generating means  10  is capable of undergoing an exothermic reaction to liberate heat upon exposure to the atmosphere, such means may be enclosed by a breakable film or barrier prior to use, and placed at the first end  6  of tubular chamber  2 , which may be ruptured or opened and heat generated upon tapping the device, flicking or pinching its end, or other action such as in preparing to smoke a cigarette. In other embodiments, by placement of a water source substantially juxtaposed to the heat generating means  10  at the first end  6  of tubular chamber  2 , the faux smoker may tap the device on a surface, or flick or pinch it, as one would a conventional cigarette, to rupture water reservoirs(s) to enable water to reach and react with heat generating means  10 , such as to mimic a conventional cigarette lighting up operation, and proceed to take a drag or suck on the device, as with a conventional cigarette, with the user receiving a heated tobacco aroma laced stream of air and optionally a satisfying dose of nicotine, to thereby mimic the ritual of smoking a cigarette, or cigar as the case may be.  
         [0058]     As in any conventional cigarette, or tobacco smoking device in general, various features may be included in the present inventive device, such as the incorporation of one or more lumens to provide a plurality of smaller cross-sectional flow paths in an attempt to optimize flow velocity and flow volume of tobacco aroma laced heated air, and/or nicotine or other drugs if present, in a rapid and uniform delivery from tubular chamber  2  to a user. In another contemplated embodiment the nicotine may be conveniently located in one or more lumens, which may be of the same or varying sizes.  
         [0059]     It is additionally contemplated that the nicotine be present in a preformulated solution or as a nicotine suspension for dosage delivery to a user of any amount of nicotine desired, for example, a contemplated daily 24-hour dosage and the number of inventive devices contemplated for faux smoking within that time frame. The user taking a drag on the inventive device, sucking in the heated air by the user and drawing same through the tubular chamber  2  will facilitate delivery of nicotine solution through end  4  into the user&#39;s mouth.  
         [0060]     As described above, it is also contemplated in this aspect of the invention that the device comprising tubular chamber  2  in some embodiments be equipped or used with the inventive mouthpiece means, for example, as a simulated “filter” portion, which, as discussed above, may comprise nicotine, or otherwise a substance effective to act upon and/or activate nicotine receptors in a user thereof, and which may be embedded with, or having otherwise incorporated therein, any amount and kind of flavoring means to cut the acrid taste of tobacco and other products while still playing a ritual with the inventive faux cigarette device, and perhaps optionally receiving a dose of nicotine or other habit-inhibiting drug or antagonist, or other orally ingestible substance, all of which is explained in greater detail hereinbelow. In such embodiments, the elongated tube may or may not comprise nicotine or a nicotine receptor-active substance, or other substances, and be employed solely to pass heated tobacco aroma to the user.  
         [0061]     In some embodiments a flavoring means may be incorporated anywhere within the tubular chamber  2 , including the tubular chamber itself, such that the device tastes pleasant to the user before, during or after activation of the device. Some examples of flavoring may be sugar, cinnamon, spearmint, peppermint, wintergreen, bubble gum, fruit, chocolate, anise, nut, coffee, tobacco of course, or any combination as desired.  
         [0062]     In some additional embodiments of this invention the device is effective to deliver drugs and/or orally ingestible substances other than nicotine, or such drugs and/or substances along with nicotine, to successfully treat or at least medicate an array of habit disorders along with reducing the incidence of nicotine use or smoking. Some non-limiting examples include the addition of naltrexone and/or naloxone or other opiate antagonist, which are known as efficacious for decreasing alcohol consumption and for treating gambling disorders as well. Such treatment and various dosage regimens of these drugs for various indications are reported in the art. See, for example, Krystal,  N. England J. Med.,  345: 1734-1739(2001); Anton,  J. Clin. Psychopharmacol.,  21:72-77(2001); and Heinala,  J. Clin. Psychophararmacol.,  21:287-292(2001). Such drugs and orally ingestible substances may be present and made available for delivery to a user by any conventional means.  
         [0063]     As nothing is combusted in the present inventive device it is contemplated that virtually any drug or drug combination and/or orally ingestible substance may be administered by the device for treatment of a plurality of indications, maladies, diseases and the like, along with reducing the incidence of smoking. Here, some non-limiting examples include aspirin, any cholesterol lowering drug such as of the statin family, e.g. lipitor, neutraceuticals, antidepressants such as Prozac and Wellbutrin, a smoking incidence inhibitor itself, caffeine, weight reduction aids, breath enhancers, cold medication, and anything that can be orally deliverable and orally ingestible by humans to treat, affect, effect or satisfy any desire or end result.  
         [0064]     It is further contemplated for inclusion in the present inventive tubular chamber  2  a cold generating means which when actuated will undergo an endothermic reaction to chill the surrounding incoming air in air passageway  3  such that a user will receive cooled or chilled air laced with tobacco aroma and optionally a dose of nicotine or nicotine substitute and/or other substance(s) as described herein. The cold generating means may be employed by itself or in conjunction with the heat generating means discussed herein, such that a user may have a choice of which to actuate, or perhaps both simultaneously, depending on flavor preferences. The cold generating means may composed of any material known in the art to be capable of undergoing an endothermic reaction which absorbs heat from a surrounding environment to chill surrounding air, objects or substances it is in contact with. One non-limiting example includes the mixture of ammonium nitrate and water. In this embodiment a water source is present in an impervious, breakable membrane as described above, which when ruptured by a user&#39;s actions, such as pinching or tapping, releases water to come in contact with a near or adjacent source of ammonium nitrate to create an endothermic reaction. Microcapsules of water are also contemplated, or any reservoir means such as described above. Another non-limiting example is the use of ammonium chloride and urea, which when mixed produces an endothermic reaction.  
         [0065]     As will be readily appreciated by anyone knowledgeable of or associated with tobacco use in any way, whether it be an actual user or observers thereof, the smoking cessation devises and methods of the present invention, their production, distribution, sale, offering for sale, licensing and/or advertising, or advertising in conjunction therewith affords many advantages, not heretofore available, to conducting business or businesses, especially to those persons and businesses associated with the smoking reduction and/or smoking cessation industry, and the safe cigarette industry in general. Many of those persons associated with the health and insurance industries, and fire prevention industries and/or security industries, will also appreciate the business advantages afforded by the present invention including all of its various aspects and possible embodiments.  
         [0066]     It will be further appreciated by those persons skilled in the art that the embodiments described herein are merely exemplary of the principals of the invention. While some preferred embodiments have been described herein, modification in any way may become apparent to those of ordinary skill in the art following the teaching of the invention, without departing from the spirit and scope of the invention as set forth in the appended claims. Additionally, any and all embodiments described herein are merely for illustrative purposes only and are specifically not intended to limit the scope of the invention and/or claims in any way.