Abstract:
A device and method for treating stress-induced habits including smoking, drinking, overeating and the like, is disclosed. The invention consists of an adult pacifier made of a flavored or unflavored resilient material, orthodontically shaped to fit inside the mouth and on the tongue of the user. In moments of stress or when the urge to smoke, overeat, or drink arises, the device is placed on the tongue in the mouth and sucked. This simultaneous suction and tongue undulation, much like the stimulation caused by smoking cigarettes and the like, encourages deep breathing and causes salivation, gastric acid secretion and stimulation of the cranial nerve endings in the tongue.

Description:
RELATED APPLICATION 
     This application claims priority from U.S. Provisional Patent Application No. 60/064,669, filed Oct. 13, 1997 which application Ser. No. 09/170,500 is a continuation, filed Oct. 13, 1998 now U.S. Pat. No. 6,179,864. The entire disclosure of the provisional application is considered to be part of the disclosure of the accompanying application and is hereby incorporated by reference. 
    
    
     FIELD OF INVENTION 
     The present invention is used to aid in the cessation of the smoking habit. It is designed to take the place of an actual cigarette, allowing sucking, holding something in the mouth, holding something in the hand, the ceremonial hand-to-mouth process, deep breathing and gastric stimulation. 
     PRIOR ART AND GENERAL BACKGROUND 
     People who try to stop smoking, overeating, nail biting, thumb sucking and/or drinking try a myriad of programs and products to try to break their addictions. Many people try programs like Smoke Enders, Weight Watchers and Alcoholics Anonymous. Smokers also often try a variety of products including nicotine inhalers, nicotine flavored patches, nicotine flavored gum, artificial cigarettes and/or oral substitutes such as hard candy and gum. 
     Unfortunately, group programs are often expensive. Nicotine flavored products are often addictive, often causing side effects such as mouth or throat irritation or cough, and are limited in the duration of their usage, and artificial cigarettes so closely emulate the ceremonial hand-to-mouth process that they often fail to make the user stop smoking. Sucking on hard candy can cause weight gain and sucking hard candy and chewing gum can cause tooth decay. 
     One theory as to why people smoke is that they were weaned too early, that they were not allowed a long enough period to suck, suggesting the continuing need for humans to suck. A straw or an artificial cigarette gives a smoker an object on which to suck but does not activate the same stimulation of chemical responses as the placement of a cigarette or a pacifier in the mouth. 
     Studies on newborns show that during circumcisions, “stimulation with the pacifier significantly reduced crying” (“The Effects of a Pacifying Stimulus,” Gunnar et al., 1984.) According to another study on newborns, “crying and heart rate declined more rapidly in the pacifier condition than in swaddling,” (Campos, 1989.) Doctors also found that pacifiers that had been flavored with sucrose were even more effective in calming babies: “Specifically, control infants who underwent a standard circumcision procedure without intervention cried 67% of the time. A water-moistened pacifier reduced crying to 49%. Crying was reduced further by providing infants with a sucrose-flavored pacifier to suck,” (Blass, et al, 1991). Sucking on an unflavored pacifier is antinociceptive to infants, and this antinociception is enhanced by sucrose. 
     Studies on pacification have been restricted to the newborn period and have neglected to address the effectiveness of pacification at older ages. For an adult in our society, sucking on a thumb is a deconditioned activity. Sucking on a cigarette is disdained by the majority, but is allowed. People who smoke, however, develop the habitual need to suck. 
     There is therefore a need for a smoking cessation device and method that, without the use of addictive drugs, enables a smoker to cease smoking within a reasonable time period. There is a further need for a device for adults that assists them in stopping oral habits such as obsessive eating, nail biting and thumb sucking. 
    
    
     BRIEF DESCRIPTION OF THE FIGURES 
     FIGS. 1A-1C show various embodiments of the invention where an appendage is formed integral with the tongue engaging body. 
     FIG. 1D is a side view of the end of the tongue engaging body. 
     FIGS. 2A-2C show various views of the invention wherein the handle portion is removable from the tongue engaging body. 
     FIG. 2D is a side view of a tubular opening into which the movable appendage is inserted. 
     FIGS. 3A-3C are various views of one embodiment of the invention where an elastic mechanism is relied upon to eject the tongue engaging member from the housing. 
     FIGS. 4A-4C depict top, side and bottom views of another embodiment of the invention where the tongue engaging member can be slid out of a housing for engagement with a user&#39;s mouth. 
     FIGS. 5A-5C show yet another embodiment where the tongue engaging member is reversibly slidable into a housing. 
     FIGS. 6A-6C show top, side and bottom views of the present invention with the tongue engaging member connected to a neck encircling device. 
     FIGS. 7A-7C show top, side and bottom views of the tongue engaging member connected to an appendage which is itself connected to another component, such as a key ring. 
     FIGS. 8A-8C depict top, side and bottom views of the tongue engaging member connected to a finger encircling device. 
     FIGS. 9A-9C show embodiments where the tongue engaging member can be fitted onto a user&#39;s finger or thumb or other article (e.g., pen, pencil, etc.) and then inserted into the user&#39;s mouth. 
     FIGS. 10A-10C show clips that are attached to the tongue engaging member in order to hold the device in a user&#39;s mouth by engagement with the user&#39;s teeth. 
     FIGS. 11A-11C show embodiments where a flavor cartridge is used in coordination with the tongue engaging device. 
     FIGS. 12A-12C depict the tongue engaging member connected to a lip engaging member which is itself connected to a component for manual manipulation by a user. 
     FIGS. 13A-13C depict the tongue engaging member with medical instrumentation devices associated therewith, such as an temperature gauge. 
     FIG. 13D is a side view of the invention with the end of the tongue engaging member filled in. 
     FIGS. 14A-14C depict the tongue engaging member with teeth engaging indentures. 
     FIG. 14D shows a hollow end of the tongue engaging member through which handles of various sizes and shapes can be inserted. 
     FIGS. 15A-15C depict a tongue engaging member with a “NUK” platform. 
     FIGS. 16A-16C depict a tongue engaging member with ridges along at least one side of the member. 
     FIGS. 17A-17C depict a tongue engaging member with a mouth guard and/or swallow guard barrier associated therewith. 
     FIGS. 18A-18C depict a balloon shaped tongue engaging member. 
     FIG. 19A-19C depict a tongue engaging member having a gel cartridge internally residing therein. 
     FIGS. 20A-20C depict a tongue engaging member having an integral handle associated therewith. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention  30  fulfills the need for adults to suck and because of the shape, the flavor, the size and the placement in the mouth of the present invention, it fulfills certain chemical responses similar to those created by a cigarette. The adult pacifier  30  allows smokers to suck on a flavored or unflavored resilient pacifier in place of a cigarette, food and/or alcoholic beverage thus encouraging deep breathing, and encouraging stimulating salivation, gastric acid secretion, and the cranial nerve endings of the tongue encouraging deep breathing?. 
     The adult pacifier of the present invention  30  comprises a unit made up any suitable material such as latex, rubber, silicone, plastic, edible candy sucker material or any material that is FDA approved and can go into the mouth. The material comprising the present device can be flexible or rigid and can be made to have hollow compartments or may be of solid construction. In one embodiment, the tongue can flex the material; in another embodiment, the tongue is unable to flex said material. 
     In a preferred embodiment, the pacifier is made of a malleable material which molds to the shape of the user&#39;s mouth and is constructed of flexible material that is tough enough to be chewed on. The pacifier  30  is able to be shaped and reshaped to fit individual mouths with individual orthodontic considerations. 
     In another embodiment, the adult pacifier  30  is edible and made of a sugary sucker formula. In still other embodiments, the material is not edible, but is impregnated with a flavor, such as wintergreen, spearmint, cinnamon, almond, bubble gum, watermelon, cherry, apple, lime and the like. For example, the material can be dipped in a flavored oil, or flavored with at least one drop of flavored oil such as wintergreen, spearmint, cinnamon, almond, bubble gum, cherry, apple, lime and the like, preferably a flavor that freshens one&#39;s breath or that tastes good. 
     In one embodiment, the device has a replaceable flavor ampule or cartridge  32  that is provided in the hollow part of the device or in the handle that supports the device. The device can be designed to accept an ampule or cartridge in the hollow part of the device to release various replaceable flavor, medicinal and/or pain reliever packets from the encapsulated part. The adult pacifier can also be soaked or impregnated with a flavored and/or medicated substance (e.g., a nicotine-substitute solution such that it slowly releases a nicotine-substitute solution as it is being sucked). 
     In a preferred configuration the present invention comprises an orthodontically suited hump  34  with a tongue groove  36  on the bottom which contacts with a user&#39;s tongue. The groove  36  is preferably of a design such that it allows the tongue to find resistance in the pacifier when the pacifier is being sucked. The hump-shaped part  34  touches the roof of the mouth and the tongue-groove  36  provides tension and resiliency for the tongue. In one embodiment the hump-shaped part  34  of the device has minuscule grooves on the hump shape to match the grooves on the roof of the mouth. A hollow or solid neck  38  is joined to the hump/tooth grove part of the device and fits between the upper and lower teeth. At the end of the neck  38  is a tubular or other shaped handle  40  that is used to extricate the neck and hump/ tongue groove from the mouth. These appendages  40  may be a multitude of shapes. They can look like and have the dimensions of cigarettes, cigars, pipe holders, cigarette holders, letters or other suitable designs. In one embodiment, the appendage  40  (whatever shape it is) is made integral (FIG. 1) with the tongue engaging portion of the device  30 . Such an appendage may be entirely enclosed in a user&#39;s mouth when the lips are closed or it can extend out of the mouth, about the length and width of a cigarette. If an appendage handle  40  is used it is preferably designed to be reversibly insertable into the adult pacifier so that the adult pacifier may be used with or without the cigarette-like appendage (FIG.  2 ). Other embodiments, however, lack an appendage and/or have the handle  40  integral with the device (e.g., FIG.  20 ). 
     In another embodiment, the device is compressed into a pen-like cartridge  42  and is pushed via a spring mechanism  44  or pushed manually into the user&#39;s mouth with the pressing of a button  46  (FIG.  3 ). The tongue engaging portion can be compressed into a pen-like cartridge  42  and slid into the user&#39;s mouth with the sliding of a button  46  on the side of the pen-like cartridge  42  (FIG.  4 ), operable by a user&#39;s tongue. 
     In still another embodiment, the adult pacifier  30  folds into a tube  48  so that it can be pushed out by a smaller  50  tube that is inserted into the bigger tube  48  (FIG. 5) (e.g., a telescoping appendage). 
     The present invention can be designed so as to hang on a neck-encircling device  52  around a user&#39;s neck (FIG.  6 ). For example, it can hang on a key ring via an appendage (FIG.  7 ), extend off of a finger-encircling device  56  worn around the user&#39;s finger (FIG.  8 ), and/or be designed to fit on the user&#39;s thumb or fingers to be inserted into the mouth (FIG.  9 ). 
     In a further embodiment, the device  30  may comprise edible material and may rest on the user&#39;s tongue like a mint. Other designs incorporate the use of a plastic, rubber, or wooden stick  40  (FIG. 2) to support the device and to facilitate manual manipulation of the device. Still other embodiments use one or more clips  58  to hold the device next to a user&#39;s teeth (FIG.  10 ). The appendage itself may contain flavored or medicinal compounds so that when the hump/tongue groove part is sucked on, it releases a flavor and/or medicine to the hump/tongue groove. A cartridge can be inserted into the adult pacifier  30  or a stick  40  can be provided with an ampule attached to the end of it which fits inside the hump-shaped/tongue groove part of the adult pacifier (FIG.  11 ). 
     In one embodiment, the tongue engaging member  30  has a rounded convex or concave plastic end  50  that comfortably rests on the user&#39;s lips and is attached to a stick  40  or ring (FIG.  12 ). The end of the unit can remain hollow or may be plugged with any suitable material, such as natural rubber, silicone, latex, plastic and the like. 
     In still another embodiment, the hump/tongue groove part of the device  30  can contain small medical instrumentation  62  to, for example, measure temperature, blood pressure, and the like (FIG.  13 ). 
     A teeth indentation ditch and/or cavity  64  can also be on the top and/or the bottom sides of the neck portion  38  of the adult pacifier  30  to hold it in place during use. This teeth-engaging device  64  acts to secure the adult pacifier  30  in the mouth while the hump-shaped/tongue groove shape at the back of the mouth (in a hollow embodiment) deflates and returns to its natural shape, depending on the strength of the sucking (FIG.  14 ). 
     The adult pacifier  30  must be of a dimension suitable to fit into a user&#39;s mouth. Thus, it must be long enough to fit on the user&#39;s tongue and preferably it has a length that facilitates a user to easily grasp it so as to insert/remove it from their mouth. The present device can therefore be as long as a cigarette/cigar or alternatively only as long as the user&#39;s mouth soas to be entirely concealed when a user&#39;s closes his/her lips. It is designed to have a thickness that comfortably rests on the tongue and comfortably fits in the mouth without impairing normal breathing and swallowing functions. In a preferred embodiment, the top of the pacifier is hump-shaped  34  and conforms to the rounded shape of the roof of the mouth. A tongue groove  36  is preferably provided that is recessed and hollow on its bottom side (the part of the pacifier which rests against the tongue) and that provides a surface against which the tongue pushes and presses. Tongue pressure on this part of the adult pacifier causes the bottom of the pacifier to collapse (in hollow embodiments) so that it touches the inside top part of the pacifier. When tongue pressure is lessened, the tongue groove  36  resumes its natural shape and position. When being sucked on, the tongue groove flexes and seemingly inflates and deflates like a small balloon based on the resiliency of the material. 
     The tongue-groove  36  on the bottom of the device  30  preferably extends from the back of the mouth to right behind the user&#39;s teeth. In another embodiment, the tongue-groove  36  extends only half that length from the back of the mouth to the middle of the mouth. 
     The neck of the device  38  (e.g., the portion nearest the lips when in use) is preferably of a size to fit comfortably in the mouth opening and is big enough in some cases to accept an appendage. The neck of the device can be configured so that it fits comfortably between the teeth and lips. It is preferably constructed of a material that is tough enough that the teeth can grind and chew upon it. 
     In one embodiment, the adult pacifier  30  simply rests on the user&#39;s tongue with the neck  38  only slightly extending outside the user&#39;s lips. In another embodiment, it fits inside the user&#39;s mouth, simply resting on the user&#39;s tongue with the neck resting against the back of the teeth of the user. In yet a further embodiment, the adult pacifier  30  fits comfortably inside the adult user&#39;s oral cavity and is attached to both the left and right side by an orthodontic metal clip or clips  58  which engage the unit in the user&#39;s mouth by fastening the unit to the user&#39;s teeth. In a preferred embodiment, the adult pacifier  30  is long enough to extend past the teeth and past the lips of the user with the hump-shaped part  34  touching the roof of the mouth, and the tongue-groove  36  providing tension and resiliency for the tongue. 
     Other embodiments relate to the use of a spring mechanism  44  inside a pen-like cartridge  42  so that the tongue engaging member can be reversibly inserted and when retracted, can be easily carried by a user. In one embodiment, the neck end is wide and open enough to fit over the thumb, finger, pen, pencil or similar article of the user, allowing the user to suck on the hump-shaped/tongue groove part while manipulating the tongue on and around the tongue-groove. 
     One particular aspect of the present invention relates to a method for treating a person&#39;s desire to smoke cigarettes, cigars and/or pipes, such method comprising the following steps: 
     1. Having a user insert into their mouth a tongue engaging member  30  having a substantially curved upper surface  34  and a lower surface  36  with a groove to comfortably conform to a user&#39;s tongue; 
     2. When the desire to smoke arises, having the user suck said member, thereby reducing the user&#39;s desire to smoke. 
     The present method may also include the use of an appendage  40  to be operationally associated with the tongue engaging member  30  to permit a user to reversibly insert and remove the tongue engaging member  30  from their mouth. As described in more detail hereinbelow, the appendage associated with the tongue engaging member  30  can be of any shape or size to facilitate such reversible insertion and removal and in particular, can include a finger encircling member  56 , a handle or stick  40 , and in particular, can include objects simulating the size and weight and feel of a cigarette/cigar/pipe. A further element of the inventive method includes the simulation of the hand-to-mouth movements associated with normal smoking. As such, the method for using the present device includes the repeated insertion and removal of the tongue engaging member  30  to mimic manipulations of a cigarette/cigar/pipe during a conventional smoking exercise. 
     In one particular aspect of the present inventor, the tongue engaging member  30  that is enclosed within a housing  48  is utilized. The housing can be of a pen-shaped cylinder  48  for concealing with adult pacifier within the housing when not in use. The housing can be connected to the tongue engaging member in a spring-like fashion  44  so that operation of the spring mechanism  44  can act to extend the tongue engaging member outside of the housing  48 , thus facilitating a user sucking on the tongue engaging member  30  while holding onto the housing which extends from the lips of the user. The housing can  48  conform and appear as a cigarette, cigar and/or pipe for this purpose. 
     Another aspect of the present invention relates to the delivery of a desired compound through the use of the present device. For example, the present method includes provision of a flavor, medicine or vitamin formulation impregnated or injected or otherwise brought into contact into the tongue engaging member  30  and/or affiliated therewith (e.g., by an ampule and/or cartridge) so that a user can extract desired amounts of such formulations on a periodic basis and be in some control of such dosage over an extended time period. Various embodiments of the tongue engaging member  30  can be designed having micro pores to facilitate transport of various desired formulations from the interior of the tongue engaging member so that it can be absorbed through the oral cavity of the user. 
     Another use for the present invention relates to cessation of other undesirable habits such as children that thumb suck, people that suck their tongues, lip suckers and people that suffer from TMJ and various other mouth and jaw maladies. For example, the tongue engaging member  30  can be designed in various configurations to exercise the tongue and jaw in a fashion that provides desirable muscle enhancement to overcome such maladies. Another possible effect of sucking on the present invention is the release of endorphins in the bloodstream. Also the adult pacifier gives the user something to hold and to habitually move to and from the mouth, thus satisfying physical and psychological needs. The present device finds use not only in assisting in cessation of smoking, but also in assisting in termination of undesired oral habits such as nail biting and thumb sucking. It has been found that by using the present device, these and other similar undesired oral habits are ameliorated given the ability to satiate the need for sucking and/or biting an object. 
     In other embodiments of the present invention, the tongue engaging member  30  can have various shapes (e.g., FIG. 15 with a “NUK” configuration) and/or various textured surfaces such as ridges  66  running either parallel or perpendicular to the direction of a person&#39;s tongue (e.g., see FIG.  16 ). Other embodiments include a mouth guard and/or swallow guard  68  associated with the tongue engaging member (e.g., see FIG. 17) as well as balloon shapes (FIG. 18) and embodiments having a longer integral handle  40  (e.g., FIG. 20) associated with the tongue engaging member  30 . 
     Still other embodiments include cavities within the tongue engaging member  30  to hold a cartridge, such as a gel cartridge, that may contain a flavor packet, a vitamin packet, nicotine, packet, etc. Thus, in various embodiments of the present invention the tongue engaging member  30  may have one or more separate portions or cavities into which various materials can be provided. In one particular embodiment, a gel cartridge  33  is positioned within the tongue engaging member in such a manner that a small hole or friable wall is provided in a partition (not shown) and upon depression of the gel cartridge  32 , the gel cartridge  32  material is forced through the aperture/wall into a desired cavity, thus providing the user with an ability to gauge the amount of material coming into contact with the user&#39;s tongue. Thus, the present invention provides a device to allow for the slow and/or controlled release of particular formulations at desired rates of administration. 
     An advantage of the adult pacifier  30  relates to the suction created by the orthodontic shape, and the intensity of the suction affirmed by the resiliency of the material, which combined, produce a soothing effect. 
     Because many varying and different embodiments may be made within the scope of the inventive concept herein taught, and because many modifications may be made in the embodiments herein detailed in accordance with the descriptive requirements of the law, it is to be understood that the details herein are to be interpreted as illustrative and not in a limiting sense.