WO2019116110A1

WO2019116110A1 - Non-invasive removable habit-breaking intra oral palatal

Info

Publication number: WO2019116110A1
Application number: PCT/IB2018/050904
Authority: WO
Inventors: Mathangi YESHPAL
Original assignee: Yeshpal Mathangi
Priority date: 2017-12-15
Filing date: 2018-02-14
Publication date: 2019-06-20

Abstract

A non-invasive intra oral habit breaking palatal appliance has been described. The appliance is a bio compatible retentive device that attaches to the palate surface, affixed to the hard and soft tissues. A non-invasive placement of therapeutic agent has been prescribed onto the appliance for furthering the mechanism of a generic drug delivery. Such appliance is useful across many existing issues, typically in curbing addictions to alcohol, nicotine, tobacco, eating disorders, obsessive compulsive disorders etc. Regular usage of the appliance along with the therapeutic agent cultivates a positive habit breaking and therapy by controlled yet easy-to-remove facility of the appliance. Such a device is a success to an oral rehabilitation therapy in terms of time consumption, affordability by curbing any unhealthy craving disorders, and gives an individual a dignified chance to rectify from illicit habit as opposed to any rehabilitation homes or correctional facilities.

Description

TECHNICAL FIELD

This invention relates to a palate device for a controlled release of drug orally to human body, more particularly via therapeutic agents embedded on bio mechanical retentive device, affixed to the palate for controlled release of drug over an extended period of time. Such a device facilitates various oral therapeutic conditions and for oral rehabilitation process and treat addictions such as tobacco, nicotine, alcohol by the way of slow and perpetual oral habit breaking system and bringing about positive reinforcement via behavior modification. Such a device primarily connects with the central nervous system (CNS), refer to figure 100 for Trigeminal nerve, which centers influence over homeostatic control as well as cognitive and behavioral control (Habit influencing) functions, thereby providing extrinsic neural inputs that regulate, modulate, and facilitates control functions.

Habit formation is a process by which new behaviors become automatic. For instance, if one reaches for a cigarette the moment they wake up in the morning, it’s a habit. By the same token, if one is inclined to lace up your running shoes and hit the streets, this is also a habit. Old habits are hard to break, and new habits are hard to form. That's because the behavioral patterns we repeat most often are literally etched into our neural pathways. Addiction in layman terms means a continued habit. Medically it is defined as a chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences. Addiction as defined in Stedman's medical dictionary, 26 ed, 1995, as the habitual psychological and physiological dependence on a substance or practice that is beyond voluntary control it is considered a brain disease because drugs change the brain— they change its structure and how it works. These brain changes can be long- lasting, and can lead to the harmful behaviors seen in people who abuse drugs. Addiction is a lot like other diseases, such as heart disease. Both disrupt the normal, healthy functioning of the underlying organ, have serious harmful consequences, and are preventable and treatable, but if left untreated, can last a lifetime or can be fatal. Substance abuse refers to the harmful or hazardous use of psychoactive substances, including tobacco (smoke and smokeless), alcohol and illicit drugs. Psychoactive substance use can lead to dependence syndrome - a cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal state. The first use of any drug, be it alcohol, tobacco or nicotine consumption, people may perceive what seem to be positive effects, leading to believe one can control their use. However, drugs can quickly take over a person's life. Over time, if drug use continues, other pleasurable activities become less pleasurable, and taking the drug becomes necessary for the user just to feel “normal.^" They may then compulsively seek and take drugs even though it causes tremendous problems for themselves and their loved ones. Some people may start to feel the need to take higher or more frequent doses, even in the early stages of their drug use. These are the telltale signs of an addiction. Even relatively moderate drug use poses dangers. Consider how a social drinker can become intoxicated, get behind the wheel of a car, and quickly turn a pleasurable activity into a tragedy that affects many lives. The initial decision to take drugs is typically voluntary. However, with continued use, a person’s ability to exert self-control can become seriously impaired; this impairment in self-control is the hallmark of addiction. Brain imaging studies of people with addiction show physical changes in areas of the brain that are critical to judgment, decision making, learning and memory, and behavior control. Scientists believe that these changes alter the way the brain works and may help explain the compulsive and destructive behaviors of addiction. Other habits include cravings for unhealthy food. These symptoms can interfere with ail aspects of life, such as work, school, and personal relationships. Obsessions are repeated thoughts, urges, or mental images that cause anxiety. Common symptoms include Fear of germs or contamination, Unwanted forbidden or taboo thoughts involving sex, religion, and harm Aggressive thoughts towards others or seif and keeping things in symmetrical or in a perfect order, uncontrollable thoughts or behaviors and experiences significant problems in their daily life due to these thoughts or behaviors. Behavior modification is a treatment approach, based on the principles of operant conditioning, that replaces undesirable behaviors with more desirable ones through positive or negative reinforcement. Behavior modification therapy offers practical solutions to the complicated problems of drug abuse and dependence. Behavior modification has been applied to a broad spectrum of risky health behaviors, from substance abuse to smoking, overeating and compulsive gambling. Behavior modification has also been used to reduce the symptoms of attention deficit hyperactivity disorder and other behavioral conditions. This therapeutic approach is based on the idea that if destructive habits can be learned, they can also be changed using a system of positive and negative reinforcement. The inception of behavior modification through scientific rationale of treatment was theorized by Sigmund Freud. He believed that the mind is responsible for both conscious and unconscious decisions based on drives and forces. Unconscious desires motivate people to act accordingly. The Freud's Psychoanalytic Theory of Motivation and Pleasure: (Theory of Personality Development) says that the oral stimulation such as nail-biters, finger- chewers, and thumb suckers could lead to an oral fixation later life as smokers. Oral personalities engage in such oral behaviors, particularly when under stress as described in the book McLeod, S. A. (2008). By being stuck in the oral stage, a person might take up smoking, chewing tobacco or be a victim of substance abuse. Freud's Psychoanalytic theory of non-nutritive sucking (NNS) as pleasurable stimulation of lips and mouth, the child derives a biologic pleasure by oral cavity and any disturbance in this stage may precipitate in smoking/chewing tobacco/alcohol dependence at adult stage. Further, according to Learning theory, NNS is adaptive response, for instance, an infant associates sucking with such pleasurable feelings as hunger, satiety, and being held. These events will be recalled by transferring the sucking action to the most suitable object available namely to thumb or fingers, and this response is continuously rewarded and eventually becomes a learned habit and if not treated, the patient is at risk of symptom-substitution at adult

A “De-Addiction device" or a “Palatal De-addiction device" or a "Oral rehabilitation device" is a device devised as per Freud’s theory, which is non- invasive, removable, habit-breaking, intra oral, drug delivery, and a palatal appliance. The pleasure principle is the idea that the patient need will be met Immediately. And by the positive reinforcement principle, it is the idea that the desires of the patient’s immediate pleasurable needs will be satisfied or replace ill habits (Smoking, chewing tobacco, alcohol and drugs with oral manifestations) in a method that is both socially psychologically appropriate and realistic. The shorter the amount of time between a craving habit and presenting positive reinforcement, the stronger the connection will be and if a long period elapses between the behavior and the reinforcement, the weaker the connection will be. The pleasure principle is the idea that the patient need will be met immediately. For example, a pacifier is device used for comforting or quieting young babies, the present invention relates to similar pacifying action in Adults curbing abnormal cravings. It is also noted that the mouth has a special status within the somatosensory system as described in the flowchart, referred to as flowchart in figure 300. For example, in the case of nicotine addiction, nicotine acts on a class of cholinergic receptors which are ligand-gated ion channels called the Nicotine acetylcholine receptors (nAChR). These kinds of receptors are structurally similar to the ones operated by gamma-Aminobutyric acid (GABA), glycine, glutamate, 5-HT3, etc., which is the chief inhibitory neurotransmitter in the central nervous system. Nicotine binding to the nAChR opens the channel and increases its ionic permeability for monovalent cations (Na+, K+) and divalent cations (Ca2+, g2+), The nAChRs in the CNS are localised both in posfsynaptic and presynaptic neural membranes. Studies in recent years have shown that the primary site of nicotine action is presynaptic, and that nAChRs facilitate the release of neurotransmitters when localised in non- cholinergic terminals. The main effect of nicotine (besides its action on the cholinergic system) is the presynaptic release in the brain of neurotransmitters such as acetylcholine, noradrenaline, dopamine, serotonin, glutamate, GABA and opioid peptides. This allows the possibility that many compounds may modify the action of nicotine on the presynaptic nicotine receptors, and consequently modify the activity of nicotine in the brain. Nicotine exposure produces adaptive changes in the CNS leading to an addictive process characterized by compulsive tobacco use, loss of control over tobacco consumption despite the harmful effects, the appearance of withdrawal symptoms upon the cessation of tobacco smoking, and relapse after periods of abstinence as described in McLellan et ai. 2000. As in other addictive processes, the initiation of nicotine addiction has been related to Its capacity to induce rewarding/reinforcing effects. Palatal De-addiction device with sustained drug deliver affects this receptors and helps in calming illicit habit/ drug withdraw! symptoms. The neurobiology of nicotine addiction is a complex phenomenon in which various transmitter systems are involved as described in Berrendero et al. 2010. First, it is one of the most densely innervated parts of the body, in terms of peripheral receptors. This sensory richness is linked to the key role of oral sensorimotor control in eating, drinking, and speaking, as well as to the vivid nature of many oral sensations. Second, the mouth contains a large range of different tissue types (skin, muscle, teeth) in dose proximity and therefore, is always in constant interaction. These generate very rich patterns of somatosensory afferent input. Third, being a cavity, it has some somatosensory properties typical of the external surfaces of the body, and others more characteristic of the internal milieu. Thus, oral sensations provide an important interface experience, of both the objects in the mouth, and of the states and movements of the mouth itself. Figure 300 shows a simple model of somatosensory perception (Longo et al , 2010), adapted for the specific case of the mouth. The model presents a hierarchy of three stages of sensory processing, reflecting identified levels in the somatosensory pathway. The first level is somatosensation proper as referred to figure 300. This refers to the awareness of individual afferent events, such as touches, noxious stimuli, etc. Studies of the ability to detect electric shocks applied to the skin, or directly to the nerve (Dong et al., 1993; Fried et al., 2011 ; Robertson et al. , 2003; Trulsson and Essick, 1997) measure this level of awareness. The second level, which we call somafoperception refers to the processing of several sensory inputs to form a percept of a specific object or stimulus source. A crucial feature of this level is the integration and combination of information from different receptor types, and different regions of the receptor surface. For example, one can explore the teeth with the tongue in order to perceive a newly-chipped tooth, or the asperity of a filling. The third and final level of the somatosensory hierarchy is somatorepresentation. This refers to the representation of the body as an object in itself. Through continued somatosensory and other inputs, we gradually build a representation of what our body is like, i.e. , a conscious image of the body as a physical object. Palatal De-addiction device with sustained drug deliver affects this receptors and helps in calming illicit habit/ drug withdraw! symptoms. Based on such existing uncontrollable drug withdrawl symptoms and the alarming rise of addiction to psychoactive substances, the need to address such problems in the manner of behavior modification and habit-breaking mechanism is described. Illicit habit addiction comes with great expense. It is expensive economically to the patient, to his health including birth defects in one’s offspring as these drugs are known to be teratogenic the side effects are harmful to one’s family, to the society and to the environment. The present invention is a device and system for intra oral drug release combating any ailment of oral origin that needs to be systemidy treated in a patient friendly and affordable manner, and which also helps in rehabilitation of oral cavity locally which has been traumatized by illicit oral habits. There are numerous patent literature in the prior art discussing ora! drug delivery mechanisms. US Patent No. US4764377 describes therapeutic agent delivery device is placed within the periodontal pocket in such a manner that the diseased pocket regions come in intimate contact with it. The patent application EP0244118 describes a controlled release drug delivery system for placement in the periodontal pocket. The system comprises a plurality of drug-containing microparticles or microcapsules, between 10 and 500 microns in size, suspend in a pharmaceutically acceptable carrier medium, and is capable of maintaining an effective level of drug in the periodontal pocket for longer period. US patent no USRE33093 describes a bio-adhesive extruded single or multi-layered thin film, especially useful in intra-oral controlied- releasing delivery, having a water soluble or swell-able polymer matrix bio adhesive layer which can adhere to a wet mucous surface and which bio adhesive layer consists essentially of [ 40-95.] .!add 20-92. Iaddend.% by weight of a hydroxypropyi cellulose 5-60% of a homopolymer of ethylene oxide, 0-10% of a water-insoluble polymer such as ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and 2-10% of a plasticizer, said film having incorporated therein a medicament, e.g. anaesthetics, analgesics, anti-caries agents, anti-inflammatories, antihistamines, antibiotics, anti bacterial, fungi stats, etc. US patent no US5137449 describes a system for long term releasing of medication in the mouth, and especially an intra-oral fluoride releasing system (IFRS) for releasing fluoride over a long term for inhibiting the formation of caries in the teeth. The system uses a holder for retaining and protecting intra-oral fluoride tablets or other intra-oral medicament in the form of fluoride releasing devices (IFRD). The system causes a level of fluoride to be maintained over a long term within the mouth which has been found chemically effective for caries control and without causing severe irritation to oral tissues. US patent no. US5614223 discloses the controlled rate-release devices for releasing a pharmaceutically active agent into the oral cavity by the dissolving action of the saliva, a process of preparing such devices and methods of preventing/treating conditions/ diseases in a mammal by delivering a pharmaceutically active substance into the oral cavity. US patent no. US5827525 discloses a unidirectional buccal delivery system for the delivery of therapeutic agents over an extended period of time. The delivery system includes a matrix for releasing the drug into the oral cavity at a sustained rate and a means for securing the matrix to the palate or other adequate regions in the oral cavity. US patent no. US6210699 describes a device and method for the oral trans mucosal delivery of active substances to the oral cavity utilizing an unpiasticized polyvinyl pyrrolidone polymer as the primary mucoadhesive. The device is applied and adheres to the mucosa of the oral cavity without causing side effects or leaving an unpleasant taste. Preferably the device is a bilayer tablet having a mucoadhesive layer and an overlying active substance containing layer. The mucoadhesive layer may contain PVP as the only adhesive or may be combined with other hydrophilic polymeric substances. The active layer also contains a hydrophilic polymer carrier. US Patent no. US7878801 discloses an apparatus for monitoring orthodontic treatment compliance includes an appliance adapted to be worn over one or more teeth; and a compliance indicator mounted on the appliance to indicate compliance. The appliance is effective in repositioning teeth when it is placed over the patient’s teeth. Although easy and convenient to wear, the patient may not wear the appliance as prescribed by the doctor or orthodontist. US patent no. US6607382 discloses the device, system and methods for orthodontic treatment using repositioning appliances, typically elastic polymeric shells, while concurrently delivering substances to the teeth or gums, for example, to provide dental and periodontal and/or cosmetic therapies. Such therapies are traditionally provided with the use of a variety of accessories and devices which are applied using separate appliances, materials, etc. when the repositioning appliance is removed from the patient's mouth it eliminates the need for such removal and additional devices by incorporating these therapies into the repositioning appliance. While the appliances will be particularly intended for repositioning teeth, most often when used in systems ofmultiple aligners, they may in some instances be useful as drug or substance delivery devices without the concurrent repositioning of teeth. US patent no. US6955538 discloses a device for placing a s!ow-re!ease supply in the oral cavity, typically in a tooth filling or dental prosthesis. The device includes a sleeve having an opening at least at one end and adapted to be inserted in a recess of the filling or prosthesis, and which is substantially cylindrical in shape. At the end which is to be place deepest within the filling or prosthesis, the sleeve has a diameter which is somewhat larger than the remainder of the sleeve in order to form a groove. US patent no. US8505541 discloses a dental device has a U-shaped carrier with at least one channel for embracing an arch of teeth. The carrier has recessed inserts in the channel. Discrete inserts carrying a beneficial agent can fit info the inserts and release the agent gradually. The device may be used in a therapeutic application and as an athletic mouth guard. Temporary blanks may be initially fitted in the inserts while a portion of the mouth guard is softened before an arch of teeth is pressed into the channel to make a custom impression. The inserts possess different physical properties than the carrier and may be positioned and shaped to mechanically buffer teeth of the arch from mechanical shocks as well as release beneficial agents. The inserts may be replaced or refreshed to maintain the beneficial agent A dental device having a core carrying a beneficial agent inside a liquid-permeable shell functions as an infant's teething device. Methods and devices in accordance with the foregoing can chemically and physically protect a person's teeth and gingiva. An oral device (“mouth-guard/carrier”) or method of the foregoing type can directly apply agents to the teeth and, in one embodiment, provide for the mechanical protection of the teeth from trauma as a mouth guard. This mouth guard/ carrier preferably contains individual undercut inserts adjacent to each tooth or groups of teeth into which will be placed therapeutic agents contained in, for example, a hydrogel vehicle as described hereinafter. The number of inserts per tooth may vary, ranging from one to three (or more) to accommodate the lingual/palatal, buccal and occlusal surfaces. The patent application US2G040158194 describes drug dosage that are housed in oral devices, and methods for controlled drug release are provided. The oral devices are permanently or removably inserted in the oral cavity and refilled or replaced as needed. The controlled drug release may be passive, based on the dosage form, or electronically controlled, for a high-precision, intelligent, drug delivery. Additionally, the controlled release may be any one of the following: release in accordance with a preprogrammed schedule, release at a controlled rate, delayed release, pulsatile release, chronotherapeutic release, closed-loop release, responsive to a sensor’s Input, release on demand from a personal extracorporeal system, release in accordance with a schedule specified by a personal extracorporeal system, release on demand from a monitoring center, via a personal extracorporeal system, and release in accordance with a schedule specified by a monitoring center, via a personal extracorporeal system. Drug absorption in the oral cavity may be assisted by an electro-transport mechanism. The patent application US8439674 describes a system for enabling drugs or therapeutic agents to be delivered through the mouth. The system provides ideal drug delivery for certain diseases relating to periodontics, tooth surface, endodontics, and diseases associated with cancer and medical conditions. A small amount of therapeutic agent required under these conditions, typically a few milligrams, greatly reduces the effect of the therapeutic agent at distal sites within the body, thereby greatly decreasing the potential for systemic side effects. Thus, a high degree of effectiveness is achieved using a relatively small amount of drug. The patent application US2012G22G986 describes a system comprising a removable device comprising a drug to be delivered, wherein the drug is delivered based on osmotic pressure generated in the removable device. Further, the system comprises a receptacle to hold the removable device in an oral cavity, and a base station configured to dock the removable device for determining information about one or more characteristics of the removable device. The patent application US2GQ9G210032 describes manufacturing and testing methods of electronic intraorai devices for diagnose, monitor and treat local and systemic diseases and conditions for humans and animals. More specifically, deals with manufacturing techniques, testing methods and a testing apparatus of mainly three types of intra-oral devices: (a) electro- stimulators for various applications such as treatment of dry mouth by stimulating saliva secretion, apnea, sleeping disorders, eating disorders (obesity, anorexia, etc.) dysphagia and others, (b) drug delivery devices; and (c) bio-sensing and monitoring devices. The common parts or the devices are: (1) art electronic module embedded in the device: (2) o a power source being embedded in the device; (3) the devices (or part of them) being placed in the oral cavity. The present invention overcomes the listed prior art in the following manner. US Patent No. US4764377 describes therapeutic agent delivery device is placed within the periodontal pocket in such a manner that the diseased pocket regions come in intimate contact with it. The present invention is a U- shaped dental appliance wherein the intra oral drug wherein the therapeutic agent is placed on the palate for slow release of the drug, which in turn contacts with the saliva and aids in further treatment, with easy-fo-remove capability as and when necessary. The patent application EPG244118 describes a controlled release drug delivery system for placement in the periodontal pocket. The system comprises a plurality of drug-containing microparticles or microcapsules, between 10 and 500 microns in size, suspend in a pharmaceutically acceptable carrier medium, and is capable of maintaining an effective level of drug in the periodontal pocket for longer period whereas the present invention is a U-shaped dental appliance wherein the intra oral drug wherein the therapeutic agent is placed on the palate for slow release of the drug, which in turn contacts with the saliva and aids in further treatment, with easy-to- remove capability as and when necessary. USRE33093 describes a bio-adhesive extruded single or multi-layered thin film, especially useful in intra-oral controlled-releasing delivery, having a water soluble or swell-able polymer matrix bio-adhesive layer which can adhere to a wet mucous surface and which bio-adhesive layer consists essentially of [. 40-95.] .ladd.20-92. Iaddend.% by weight of a hydroxypropyl cellulose 5-60% of a homopolymer of ethylene oxide, 0-10% of a water-insoluble polymer such as ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and 2- 10% of a plasticizer, said film having incorporated therein a medicament, e.g. anaesthetics, analgesics, anti-caries agents, anti-inflammatories, antihistamines, antibiotics, anti-bacterial, fungi stats, etc. , whereas the present invention does not concern with the polymer matrix bio-adhesive layer but concerns with the apparatus intra oral drug wherein the therapeutic agent is placed on the palate for slow release of the drug, which in turn contacts with the saliva and aids in further treatment, , with easy-to-remove capability as and when necessary. US patent no US5137449 describes a system for long term releasing of medication in the mouth, and especially an intra-oral fluoride releasing system (IFRS) for releasing fluoride over a long term for Inhibiting the formation of caries in the teeth. The system uses a holder for retaining and protecting intra-oral fluoride tablets or other intra-oral medicament in the form of fluoride releasing devices (IFRD). The system causes a level of fluoride to be maintained over a long term within the mouth which has been found chemically effective for caries control and without causing severe irritation to oral tissues whereas the present invention stands alone from just oral care as described in the prior art. US5137449 dearly discloses the fluoride releasing system, which concerns with hardening of teeth whereas the present invention has no chemical treatment and outsets beyond oral relief, concerning with treatment of any ailment, mainly battling addiction of any substance/drug or compulsive disorder. US patent no. US5614223 discloses the controlled rate-release devices for releasing a pharmaceutically active agent into the oral cavity by the dissolving action of the saliva, a process of preparing such devices and methods of prevenfing/treating conditions/diseases in a mammal by delivering a pharmaceutically active substance Into the oral cavity whereas the present invention with the apparatus intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment, , with easy-to- remove capability as and when necessary. US patent no. US5827525 discloses a unidirectional buccal delivery system for the delivery of therapeutic agents over an extended period of time. The delivery system includes a matrix for releasing the drug into the oral cavity at a sustained rate and a means for securing the matrix to the palate or other adequate regions in the oral cavity whereas the present invention the apparatus intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. US patent no. US6210699 describes a device and method for the oral trans mucosal delivery of active substances to the oral cavity utilizing a plasticized polyvinyl pyrrolidone polymer (PVP) as the primary mucoadhesive. The device is applied and adheres to the mucosa of the oral cavity without causing side effects or leaving an unpleasant taste. Preferably the device is a bi!ayer tablet having a mucoadhesive layer and an overlying active substance containing layer. The mucoadhesive layer may contain PVP as the only adhesive or may be combined with other hydrophilic polymeric substances. The active layer also contains a hydrophilic polymer carrier whereas the present invention neither concerns with cavity affixture nor does it concern with the material of the device. The present invention the apparatus intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. US Patent no US7878801 discloses an apparatus for monitoring orthodontic treatment compliance Includes an appliance adapted to be worn over one or more teeth; and a compliance indicator mounted on the appliance to indicate compliance. The appliance is effective in repositioning teeth when it is placed over the patient^'s teeth whereas the present invention does not concern with monitoring orthodontic treatment. The present invention outsets beyond oral care by the way of intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. . US patent no US6607382 discloses the device, system and methods for orthodontic treatment using repositioning appliances, typically elastic polymeric shells, while concurrently delivering substances to the teeth or gums, for example, to provide dental and periodontal and/or cosmetic therapies. Such therapies are traditionally provided with the use of a variety of accessories and devices which are applied using separate appliances, materials, etc. when the repositioning appliance is removed from the patient's mouth. It eliminates the need for such removal and additional devices by incorporating these therapies into the repositioning appliance. While the appliances will be particularly intended for repositioning teeth, most often when used in systems of multiple aligners, they may in some instances be useful as drug or substance delivery devices without the concurrent repositioning of teeth whereas the present invention does not concern with teeth repositioning. The present invention outsets beyond oral care by the way of intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. US patent no US6955538 discloses a device for placing a s!ow-re!ease supply in the oral cavity, typically in a tooth filling or dental prosthesis. The device includes a sleeve having an opening at least at one end and adapted to be inserted in a recess of the filling or prosthesis, and which is substantially cylindrical in shape. At the end which is to be place deepest within the filling or prosthesis, the sleeve has a diameter which is somewhat larger than the remainder of the sleeve in order to form a groove whereas the present invention outsets beyond oral care by the way of infra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-fo-remove capability as and when necessary. . US patent no. US8505541 discloses a dental device has a U-shaped carrier with at least one channel for embracing an arch of teeth. The carrier has recessed inserts in the channel. Discrete inserts carrying a beneficial agent can fit info the inserts and release the agent gradually. The device may be used in a therapeutic application and as an athletic mouth guard. Temporary blanks may be initially fitted in the inserts while a portion of the mouth guard is softened before an arch of teeth is pressed into the channel to make a custom impression. The inserts possess different physical properties than the carrier and may be positioned and shaped to mechanically buffer teeth of the arch from mechanical shocks as well as release beneficial agents. The inserts may be replaced or refreshed to maintain the beneficial agent. A dental device having a core carrying a beneficial agent inside a liquid-permeable shell functions as an infant's teething device. Methods and devices in accordance with the foregoing can chemically and physically protect a person's teeth and gingiva. An oral device (“mouth-guard/carrier”) or method of the foregoing type can directly apply agents to the teeth and, in one embodiment, provide for the mechanical protection of the teeth from trauma as a mouth guard. This mouth guard/carrier preferably contains individual undercut inserts adjacent to each tooth or groups of teeth into which will be placed therapeutic agents contained in, for example, a hydrogel vehicle as described hereinafter. The number of inserts per tooth may vary, ranging from one to three (or more) to accommodate the lingual/palatal, buccal and occlusal surfaces whereas the present invention does not mere concern with mechanical protection of the teeth from trauma as a mouth guard, but outsets beyond oral care by the way of intra oral drug wherein the therapeutic agent is placed on the palate. The patent application US2004G158194 describes drug dosage that are housed in oral devices, and methods for controlled drug release are provided. The oral devices are permanently or removably inserted in the oral cavity and refilled or replaced as needed. The controlled drug release may be passive, based on the dosage form, or electronically controlled, for a high-precision, intelligent, drug delivery. Additionally, the controlled release may be any one of the following: release in accordance with a preprogrammed schedule, release at a controlled rate, delayed release, pulsatile release, chronotherapeutic release, closed-loop release, responsive to a sensor’s input, release on demand from a personal extracorporeal system, release in accordance with a schedule specified by a personal extracorporeal system, release on demand from a monitoring center, via a personal extracorporeal system, and release in accordance with a schedule specified by a monitoring center, via a personal extracorporeal system. Drug absorption in the oral cavity may be assisted by an electro-transport mechanism. The present invention eliminates the need for an electro-transport mechanism and outsets beyond oral care by the way of intra oral drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. The patent application US8439674 describes a system for enabling drugs or therapeutic agents to be delivered through the mouth. The system provides ideal drug delivery for certain diseases relating to periodontics, tooth surface, endodontics, and diseases associated with cancer and medical conditions. A small amount of therapeutic agent required under these conditions, typically a few milligrams, greatly reduces the effect of the therapeutic agent at distal sites within the body, thereby greatly decreasing the potential for systemic side effects. Thus, a high degree of effectiveness is achieved using a relatively small amount of drug. The present invention does not concern with just oral relief but is an apparatus beyond oral care by the way of intra drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary The patent application US20120220986 describes a system comprising a removable device comprising a drug to be delivered, wherein the drug is delivered based on osmotic pressure generated in the removable device. Further, the system comprises a receptacle to hold the removable device in an oral cavity, and a base station configured to dock the removable device for determining information about one or more characteristics of the removable device whereas the present invention does not concern with osmotic pressure drug delivery system. The present invention is an apparatus targeting beyond oral care of intra drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-remove capability as and when necessary. The patent application US20090210032 describes manufacturing and testing methods of electronic intraoral devices for diagnose, monitor and treat local and systemic diseases and conditions for humans and animals. More specifically, the it deals with manufacturing techniques, testing methods and a testing apparatus of mainly three types of intra-oral devices: (a) electro- stimulators for various applications such as treatment of dry mouth by stimulating saliva secretion, apnea, sleeping disorders, eating disorders (obesity, anorexia, etc.) dysphagia and others, (b) drug delivery devices; and (c) bio-sensing and monitoring devices. The common parts or the devices are: (1) art electronic module embedded in the device: (2) or a power source being embedded in the device; (3) the devices (or part of them) being placed in the oral cavity it is submitted that the prior art herein deals with manufacturing techniques, testing methods and a testing apparatus of intra-oral devices but is an apparatus targeting beyond oral care of infra drug wherein the therapeutic agent is placed on the palate and not in oral cavity, for slow release of the drug, which in turn contacts with the saliva and aids in further treatment. This way, there is no contact with the teeth directly for injecting drug, with easy-to-re ove capability as and when necessary Thus, any person skilled in the present art would conclude that the synergistic properties of the de-addiction palatal appliance is a value-added appliance to combat the aforementioned problems in the society. Such a device is intra oral and thereby reacts on the immediately on tissues thereby enhancing efficacy to the prior art. Therefore, prior art does not teach the making or manufacture of the present invention. None of the prior art patents discussed herein, taken either singly or in combination, is seen to describe the instant invention as claimed.

It is an object of the present invention is to provide a non-invasive intra ora! therapeutic palatal appliance to enable placement of palatable therapeutic agents on palate. It is an object of the present invention is to provide a non-invasive intra oral therapeutic palatal appliance which can adhere to the inner palate for the delivery of pharmacologically active palatable therapeutic substances It is another object of the present invention to provide non-invasive intra oral therapeutic palatal appliance for the delivery of pharmacologically active palatable therapeutic substances utilizing a bio mechanical device that is non- soluble in the secretions present in oral cavity without having an objectionable taste or cause any irritation. . It is another object of the present invention to provide non-invasive infra oral therapeutic palatal appliance that is stationary, and immovable once affixed on the palate. . It is another object of the present invention to provide non-invasive intra oral therapeutic palatal appliance to have oral administration of the therapeutic agent’s delivery without hindering daily activities of an individual. . It is yet another object of the present invention to provide a non-invasive intra oral therapeutic palatal appliance for a personalized treatment option with or without the therapeutic agent. . It is yet another object of the present invention to provide a non-invasive infra oral therapeutic palatal appliance with therapeutic agent coating to tackle the disease specific to a patient's requirement. . It is yet another object of the present invention to provide a non-invasive intra oral therapeutic palatal appliance wherein the device is composed of biocompatible materials like Silicone or poly ethylene acetate or Ethylene- vinyl acetate. . It is a further object of the present invention to provide a non-invasive intra oral therapeutic palatal appliance for a slow and delayed release of palatable therapeutic agents. It is yet another object of the present invention to provide a non-invasive infra oral therapeutic palatal appliance having micro-holes for sustained and controlled released of the palatable therapeuticagents. It is a further object of the present invention to provide a non-invasive infra oral therapeutic palatal appliance and controlled release infra oral drug delivery dental appliance foreasy-to-remove/affix as and when necessary. It is a further object of the present invention to provide a non-invasive intra oral therapeutic palatal appliance for curbing substance addiction, cravings, and obsessive and compulsive disorders of oral ramifications through oral behavior modifications and positive reinforcements.

The advantages and features of the present invention will become better understood with reference to the following more detailed description and claims taken in conjunction with the accompanying drawings, in which like elements are identified with like part numbers. Figure 100 is the trigeminal nerve stemming from brain and showcasing the connection to sensory receptors on face sinuses and teeth. Ophthalmic nerve is indicated by 102, maxillary nerve is indicated by 104, mandibular nerve is indicated by 106. The combination of 102, 104 and 106 are trigeminal nerve. 108 showcases the motor, also to referred as muscles of mastication. Mastication or chewing is the process by which food is crushed and ground by teeth. Figure 200 is the perspective view of the trigeminal nerve. 202 is the trigeminal nerve, that splits unto 204 as maxillary nerve, which supplies sensory fibers to the skin areas of the middle part of the face, the upper jaw and its teeth, and the mucous membranes of the palate, nasal cavities, and nasopharynx, and 206 as mandibular nerve, which supplies sensory fibers to the lower jaw, the floor of the mouth, the anterior two-thirds of the tongue, and the lower teeth and supplies motor fibers to the muscles of mastication. 208 is the lingual nerve, which is a branch of the mandibular division of the trigeminal nerve that supplies sensory innervation to the anterior 2/3 of the tongue. Figure 300 is the flowchart of ora! somatosensory awareness when the palatal de-addiction device is placed in the mouth. The communication within the somatosensory system after the device is placed, its phenomenology is explained in the tabular form on the right. Figure 400 is the schematic general overview of the sensory innervation of the oral cavity. The trigeminal nerve is represented as 402. Three nerve fibers are used as an example. (1) A discriminative touch nerve fiber 408 on the tongue, (1) a pain/thermoceptive fiber 404 in the tooth pulp and (3) a proprioceptive nerve fiber 406 in the muscles of mastication. Axons from touch and pain fibers in the lower jaw have their cell bodies in the trigeminal ganglion, which they enter through the mandibular division of the trigeminal nerve. The touch fibers then synapse with second-order neurons in the principal sensory nucleus in the brain stem. The mesencephalic nucleus 410 is involved with proprioception of the face, that is, the feeling of position of the muscles, Indicated as motor nucleus as 412. These fibers cross to the opposite, and ascend to the thalamus via the medial lemniscus 420 as well as through the spinothalamic tract indicated as 418. Small-diameter pain and temperature fibers have their cell bodies in the trigeminal ganglion indicated as 416. From there, they descend down to the most caudal division of the trigeminal spinal nucleus indicated as 414 (also referred to as nucleus caudalis), where they synapse with second-order neurons. These fibers then synapse in the trigeminal motor nucleus, thereby influencing orofacial motor responses. Figure 500 is the schematic overview specific of the sensory innervation of the oral cavity when the palatal de-addiction device 530 is placed. The device is impressed upon the gum on the upper jaw, whereby the trigeminal nerve is activated, as indicated 502. Three nerve fibers are used as an example. (1) A discriminative touch nerve fiber 508 on the tongue, (2) a pain/thermoceptive fiber 504 in the tooth pulp and (3) a proprioceptive nerve fiber 506 in the muscles of mastication. Axons from touch and pain fibers in the lower jaw have their ceil bodies in the trigeminal ganglion, which they enter through the mandibular division of the trigeminal nerve. The touch fibers then synapse with second-order neurons in the principal sensory nucleus in the brain stem. The mesencephalic nucleus 510 is involved with proprioception of the face, that is, the feeling of position of the muscles, indicated as motor nucleus as 512. These fibers cross to the opposite, and ascend to the thalamus via the medial lemniscus 520 as well as through the spinothalamic tract indicated as 518. Small-diameter pain and temperature fibers have their cell bodies in the trigeminal ganglion indicated as 516. From there, they descend down to the most caudal division of the trigeminal spinal nucleus indicated as 514 (also referred to as nucleus caudalis), where they synapse with second-order neurons. These fibers then synapse in the trigeminal motor nucleus, thereby influencing orofacial motor responses. Figure 600 is the top view of the palatal de-addiction device. 600a is the bio compatible layer made of Silicone, poly ethylene acetate or Ethylene-viny! acetate, adjusted upon the gums. 600b is the impression of the teeth that comfortably sits upon the upper jaw. 600c is the cavity for the placement of the therapeutic palatable agent. Figure 700 is the perspective view of the palatal de-addiction device. 700a is the bio compatible layer made of Silicone, poly ethylene acetate orEthylene- viny! acetate, adjusted upon the gums. 700b is the elevation that affixes comfortably upon placement on the upper jaw of the teeth. 700c is the cavity for the placement of the therapeutic palatable agent. 70Qd is the micro holes provided in and around for slow and sustained acceptance of the therapeutic agent. Figure 800 is the side view of the palatal de-addiction device. 800a is the bio compatible layer made Silicone, poly ethylene acetate or Ethylene-vinyl acetate, adjusted upon the gums. 800b is the elevation along with the rear end that affixes comfortably upon placement on the upper jaw of the teeth. 800c is the cavity for the placement of the therapeutic palatable agent. Figure 900 is the flip view of the palatal de-addicfion device. 900a is the bio compatible layer made of Silicone, poly ethylene acetate or Ethylene-vinyl acetate, adjusted upon the gums. 900b showcasing the crease of the elevation that affixes comfortably upon placement on the upper jaw of the teeth. 900c is the cavity for th© placement of the therapeutic palatable agent. 90Qd is the micro holes provided in and around for slow and sustained acceptance of the therapeutic agent.

DETAJLED DESCRjPTlON

It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of“including”,“comprising” or“having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms“a” and“an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms“first”,“second", and“third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. “Active substance”,“drugs”, or“therapeutic agents”, or“agents” refer to all functional compounds which are desirable to be delivered via oral cavity, either charged or non-charged, including but not limited to, medicaments for oral diseases, diseases of the teeth and also systemic diseases, oral odorants such as breath freshening agents, saliva stimulants, nutritional supplements such as vitamins, herb extracts or minerals, and mixtures thereof. Active substances to be delivered by the device of the present invention includes ionic or non-ionic drugs for oral or systemic diseases, for example, peptide drugs (e.g. calcitonin, DDAVP), analgesics and anti-inflammatory agents (e.g indomethacin, ibuprofen), mouth disinfectants (chlorohexidine hydrochloride, hexyiresorcine), cardiovascular agents (e.g. nitroglycerin, isosorbide dinitrate, nifedipine), anti-asthmatics (e.g. disodium cromogiycate), antibiotics (e.g. penicillin, erythromycin), chemotherapeutics (e.g. su!fathiazo!e, nitrofurazone), local anesthetics (e.g. benzocaine), cardiotonic (e.g digitalis, digoxin), antitussives and expectorants (e.g. Codeine phosphate, isoproterenol hydrochloride), agents affecting digestive organs, antihistamines, anti inflammatory steroids, hemostatic, sexual hormones, sedatives, antitumor agents, or the like. One of the preferred embodiment is the drug delivery via an oral drug delivery system which includes a matrix containing a therapeutic agent for release into the palate. The matrix releases the therapeutic agent at a sustained rate into the palate. The term "sustained rate" as used herein means release of the drug for an extended period of time ranging from about few minutes to hours or about days. One of the preferred embodiment is the drug delivery via an oral drug delivery system which includes a matrix containing a therapeutic agent for release into the palate. The matrix releases the therapeutic agent at a sustained rate into the palate. The term "sustained rate" as used herein means release of the drug for an extended period of time ranging from a few minutes to hours and up to days. For example, onset of release may be delayed following placement of the delivery system within the body cavity, or a substance may be released at different rates over time, or in pulses with intervening periods in which essentially no release occurs. Alternatively, two or more substances may be sequentially released, with or without an intervening period in which no substance is released. The working mechanism of the bio mechanical retaining device is to primarily bypass the first pass metabolism. First pass metabolism occurs in the gut and the liver, and as the drug when absorbed from the gastrointestinal tract passes via the portal vein into the liver, certain content of the drug is metabolized. Often, the result of the first pass metabolism enables only a proportion of drug reaching the circulation. To bypass the first pass metabolism, the device in the present invention depends on primarily connecting with the central nervous system (CNS), which centers influence over homeostatic control as well as cognitive and behavioral functions, thereby providing extrinsic neural inputs that regulate, modulate, and facilitates control functions. The working mechanism of the device in the present invention begins with the oral sensory receptors as shown in figure 300. When the device in the present invention is affixed securely to the palate, the oral receptors stimulate and react to the palatable agent in the manner described. The oral sensory receptors that project to the brain via the trigeminal nerve are in figure 200. The trigeminal nerve is the fifth cranial nerve located within the brain, and is primarily responsible for transmitting sensations from the face to the brain. It is composed of three branches: the ophthalmic, maxillary, and mandibular. Each branch connects nerves from the brain to different parts of the face. The trigeminal nerve is responsible for transmitting sensations to the mouth, teeth, face, and nasal cavity. It is also the nerve that controls the muscles used for chewing as shown in Figure 200. The working of the trigeminal neuralgia is shown in figure 400. It occurs when a blood vessel, either a vein or artery, puts pressure on the nerve at the base of the brain. In rare circumstances, trigeminal neuralgia is caused by a tumor. Symptoms include bouts of severe, stabbing, facial pain, which may be triggered by facial touch, chewing, or talking. Treatment for trigeminal neuralgia can include the use of medications (such as anticonvulsants or muscle-relaxers), alcohol injections, or surgery. Surgical options include applying radiation to the base of the trigeminal nerve to reduce pain or moving blood vessels that are compressing the nerve. The physical events transduced by these different classes of receptors must be conveyed to the brain in order to produce conscious sensation. The main sensory nerve innervating the orofacial area is the trigeminal nerve. It is a mixed nerve containing both sensory and motor fibers. The sensory nerve endings innervate the teeth, tongue, oral mucosa, masticatory muscles and facial skin. The working mechanism of the device in the present invention is then dealt by the mechanoreceptors. When the device in the present invention is affixed securely to the palate as shown in figure 500, the mechanoreceptors stimulate and react to the palatable agent in the manner described. Mechanoreceptors convey information regarding a range of mechanical sensory events, including touch, pressure, vibration and proprioception. Different types of mechanoreceptors innervate a wide range of oral tissues, including the tongue, the periodontal ligament, the gingiva and the palate. Mechanoreceptors can be classified according to their morphology for example, Merkel discs, free nerve endings or Ruffins endings. These different receptor types are associated with different responses of afferent fibers to continuous stimulation. Slowly adapting (SA) fibers show a persistent discharge in response to a static mechanical stimulus. Rapidly adapting (RA) fibers show only an initial response at stimulus onset. Finally, the activation of different fiber types produces different qualities of tactile sensations, such as light touch, flutter, sustained pressure. Sensory abilities vary greatly and systematically across the facial and oral structures. This variation is ascribed to differences in the density of sensory afferent endings in different tissues. The perioral and midline structures generally have high mechanoreceptor innervation density, and correspondingly lower thresholds for two-point tactile discrimination. It is also innervated by mechanoreceptors, which project to the brainstem via the trigeminal ganglion. These respond to stimuli applied to the palate that the ligament supports. The primary function of these receptors appears to be in regulating the forces applied by the teeth in occlusion, mastication, and biting. Thereby aiding the mechanoreceptors, the device in the present invention causes an impression over the upper jaw, furthering the secure affixation and slow yet sustained delivery of the palatable therapeutic agent. The working mechanism of the device in the present invention is then dealt by the nociceptors. When the device in the present invention is affixed secureiy to the palate as shown in figure 500, the nociceptors stimulate and react to the palatable agent in the manner described. Nociceptors primarily deal with the pain emerging from mouth. Pain is a further phenomenally strong signal arising from the mouth. The general function of the nociceptive system is to detect potentially noxious mechanical, thermal or chemical stimuli. Many nociceptive fibers originate in free nerve endings in the tongue, gums, palate and other oral tissues. The tooth pulp also houses nociceptive sensory fibers. In healthy teeth, these show strong discharges only when high forces are applied to the crown, or unusually hot or cold temperatures are experienced on the tooth. The working mechanism of the device in the present invention is then dealt by the thermoreceptors as shown in figure 500. When the device in the present invention is affixed secureiy to the palate, the thermoreceptors stimuiate and react to the palatable agent in the manner described. The oral tissues are subject to frequent changes in temperature. Thermal sensations in the oral cavity can be of a noxious or non-noxious nature. Trigeminothalamic neurons more frequently responded to warming in the noxious range (above 45 °C) than to warming in the non-noxious range (35-45 °C). These thermoceptive neurons were judged to receive pain or temperature 404 and 504 as input. The number of neurons recruited increased with temperature, with more of these neurons responding at increasing temperatures. The sensory fibers pass from the periphery within the 3 main divisions of the nerve (ophthalmic, maxillary, and mandibular) as shown in figure 200 to their cell bodies in the trigeminal ganglion situated on the floor of the middle cranial fossa. From the ganglion, the sensory nerve fibers pass centrally to the trigeminal nuclei in the brainstem at the level of the pons, and thence to the thalamus and cortex. Understanding the organization of afferents from the mouth to primary somatosensory cortex is therefore important for the basis of oral somatosensory awareness. Somaesthesis, also known as“the mouth feel”, is a striking feature of oral somatosensory awareness is the general states of affective feeling within the entire mouth, in the apparent absence of any particular stimulation. Everyone recognizes, for example, that the mouth can feel fresh, dean, dirty, dry, “yucky”, and so on. These sensations have a systemic quality: they are poorly localized, and appear to include the entire oral environment. In figure 300, we therefore show this evaluative form of oral somatosensory awareness in parallel with the main somatosensory processing hierarchy. The current section deals with qualitative feeling of the entire oral environment, rather than quantitative perception of spatial properties of individual tissues. In order to combat each of the receptors i.e. oral receptors, mechanoreceptors, nociceptors and thermoreceptors, the bio mechanical retention device in the present invention facilitates by stabilizing each nerve sensation by acting on neurophysiological basis of oral habit addiction (tobacco, (smoke and smokeless tobacco), alcohol and drugs with oral ramifications) and satisfies patient’s urge for habit is physically met (positive reinforcement) with the device but without the actual illicit habit. Most oral originated habits are addictive due to complex oral receptor mechanism. Hence, oral habit cessation needs oral centered intervention. In psychophysical studies, the first step in understanding a‘feeling’ or sensation is to identify the underlying stimulus that causes the sensation. Somaesthesis is linked both to the physical state of the oral tissue, and to more general homeostatic states. For example, dry mouth feel reflects the level of saliva and other liquids in the mouth. Further, unpleasant feel in the mouth may occur during illness, and can form a strong part of the phenomenology of aversive conditioning: after food poisoning the thought or sight of food is sufficient to induce unpleasant mouth feel. The bio mechanical retention device, also known as the“De-Addiction device” in the instant invention is represented in figures 600, 700, 800 and 900 as top view, perspective view, side view and flip view respectively. The device consists of an elastic oral maxillary shield (e.g. fabricated by thermoforming technique) that is be custom made for individual patients. Fixation wires may be attached at the molar area if any further retention is to be needed. Its elasticity permits sufficient chewing motions and offers a high comfort for the patient. As it is connected to the maxilla, the shield is always properly positioned in the oral vestibule - even if the mouth is open. The delivery system in the present invention includes a means for securing the matrix to the palate or other adequate regions in the oral cavity such as the oral mucosa or tooth. The means for securing the matrix to the oral mucosa may be a thin film/patch 600a, 700a, 800a and 900a that adheres to the palate or other adequate regions in the oral cavity. The securing means also serves as a barrier to prevent penetration of the drug into the mucosa from the matrix, thereby achieving sustained release delivery of the drug 7G0d and 9QGd via micro holes in the device, into the oral cavity. The delivery system in the present invention may optionally contain a control membrane which is adjacent to the matrix and at the opposite surface from the means for securing. The control membrane is used for better control of the drug release as in the case when the release of the therapeutic agent 600c, 700c, 800c and 900c from the matrix has to be accurately controlled. For example, for very potent drugs or drugs with a narrow therapeutic window. To exert control on drug release, the permeation of the drug through the control membrane has to be slower than through the matrix. Examples of therapeutic agents for use with the present invention are those which have a specific regional absorption i.e., those therapeutic agents which are absorbed from a small section of the gastrointestinal tract or therapeutic agents which have short half-lives. The term "short half-life" or "short half- lives" as used herein refers to half-lives less than 6 (six) hours and preferable less than 3 (three) hours. While the above description contains many specificities, these are not to be construed as limitations on the scope of the invention, but rather as one preferred embodiment thereof. Many variations are possible. For example, the present invention will be available in different sizes as they are custom-made as per patient’s need and requirement. In addition, the present invention could include its utility via placing the device on the tongue, making an impression on the lower jaw. In such a case, though rate of delivery will be quite rapid due to high sensory receptors and saliva content, the aim and scope of the invention is unbiased and unchanged. Thereby equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result. It is believed that the device in the present invention and many of its advantages will be understood by the foregoing description. It is also believed that it will be apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely exemplary and explanatory embodiment thereof. It is the intention of the following claims to encompass and include such changes.

Claims

CLAIMS We claim:

1. A non-invasive intra oral habit breaking palatal appliance comprising a matrix of:

a bio mechanical retentive device for secured affixture to palate;

a cavity for placement of a therapeutic agent for a controlled release and delivery of the therapeutic agent;

2. The appliance of claim 1 wherein, the therapeutic agent released from the matrix into the oral cavity, away from the securing means, for an extended period of time.

3. The appliance of claim 1 wherein, the release of the therapeutic agent is as per the prescription of medical practitioner or palatable vitamins.

4. The appliance of claim 1 wherein, the delivery of the active therapeutic agents utilizing the bio mechanical device that are fully soluble in the secretions present in oral cavity without having an objectionable taste or causing irritation.

5. The appliance of claim 1 wherein, the appliance utility is in curbing substance abuse and addictions such as tobacco (smoke and smokeless), illegal, addictive and psychoactive drugs, alcohol, curb cravings to eating disorders, and address to curing obsessive and compulsive disorders through behavior modifications and positive reinforcements.

6. The appliance of claim 1 wherein, the appliance is effective route of drug delivery for pharmacologically active palatable therapeutic substances for medical conditions where indicated as it is easy-to-remove and easy-to-affix as and when necessary when one experiences any side effects.

7. The appliance of claim 1 wherein, the appliance is composed of biocompatible materials like Silicone, poly ethylene acetate or Ethylene-vinyl acetate along with therapeutic agent coating (Drug).

8. The appliance of claim 1 wherein, the appliance is composed of biocompatible materials like Silicone, poly ethylene acetate or Ethylene-vinyl acetate along without any therapeutic agent coating (Placebo effect).

9. The appliance of claim 1 wherein, the appliance is patient friendly, affordable, risk-free physically and mentally, in comparison to rehabilitation centres.