Abstract:
The present invention relates to intra oral devices for treating overweight and obesity by reducing and/or limiting the mouth opening “and/or slowing down the rate of chewing and more specifically to such devices handled by the user with or without the need for professional help, a method and use thereof. Said intra oral device of the present invention consists of a restraining device ( 8 ) which is being anchored in the upper and lower jaws, consisting of an elastic element which is inserted into two respective inter-proximal spaces (IPSs) of said upper and said lower jaws and reduces and/or limits the mouth opening and/or slows down the rate of chewing.

Description:
TECHNICAL FIELD OF THE INVENTION 
       [0001]    The present invention relates to intra oral devices for treating overweight and obesity by reducing and/or limiting the mouth opening and/or slowing down the rate of chewing and more specifically to such devices handled by the user with or without the need for professional help, a method and use thereof. 
       BACKGROUND OF THE INVENTION 
       [0002]    Overweight and obesity are some of the most common health and social problems. Millions of people suffer from overweight, which is considered to be a main cause for diseases and early death. In developed countries obesity is becoming a national public health problem because no single treatment is available for treating the condition satisfactorily. The International Health Organization refers to overweight as an epidemic, and has formed a special task force to treat one of the biggest risks threatening human health. 
         [0003]    Overweight occurs when there is an excess of energy consumption in relation to energy release. The cause for overweight differ from patient to patient, and it is commonly believed to be associated with several genetic, psychological, social, behavioral and environmental factors. 
         [0004]    People who suffer from overweight tend to belong to risk groups prone to stress, obesity associated disorders, heart attacks, diabetes, strokes, gall bladder diseases, sleep death, respiratory problems and depression. The goals of overweight treatment are to reduce the risks of developing related disease or the aggravation of existing ones, to lengthen life expectancy and to improve the way and quality of life. Treating overweight usually involves diets, psychological treatments, psychiatric treatments, and use of drugs, alternative medicine, physical activity and surgical intervention. The challenge of treating moderate obesity is to find an effective approach which is effective in maintaining reduced weight because after weight reduction, people are often prone to regain the weight. This is where behavioral therapy is effective. 
         [0005]    In recent years researchers have reached the conclusion that the most successful approach for the treatment of obesity is a multi-disciplinary one. To succeed in the long term, a combination of behavioral therapy (changing eating habits) and other treatments is required. According to the National Institutes of Health&#39;s Guide to Behavior Change, slowing the rate of eating to may allow satiety (fullness) signals to begin to be transmitted by the end of the meal. Recent studies show that dietary behavioral modifications and exercise are the most efficient methods for managing body weight. The present invention is related to a device designed to aid weight loss by controlling the amount of food a person bites and the rate of the mastication, e.g. reduces and/or limits the mouth opening and/or slows down the rate of chewing. 
         [0006]    Slow and thorough chewing enables better and more complete absorption of the food in the stomach, and decreases the hunger feeling. To the contrary, fast eating promotes incomplete food absorption and encourages the eater to consume more in order to feel satiety. Another way to eat less and feel full is to give the brain time to get the message that the stomach is full. Because it takes 15 minutes or more to get the signal to the brain, eating slowly, as well as chewing and grinding slowly, are effective in this respect. 
         [0007]    Oral devices and more specifically dental appliances have been used to control weight by slowing the rate of food mastication. The body is allowed time to respond to the ingestion of food with a sensation of satiety. The user is supposed to feel full after consuming a reduced amount of food. Therefore, the patient eats less and as a result he loses weight. 
         [0008]    A number of dental appliances have been described as aiding a user in achieving weight loss through the restriction of mandibular movements. 
         [0009]    For example, U.S. Pat. No. 4,471,771 discloses an oral weight control apparatus. The apparatus includes a guard apparatus, net, or other sieve-like blocking means secured in the mouth of the user. Liquids and finely ground material inside the mouth may freely pass through the guard or sieve but solid foods may not. In the preferred embodiment, the blocking means functions as a one way valve, blocking solid foods from entering the stomach through the mouth. 
         [0010]    U.S. Pat. No. 4,825,881 discloses an apparatus for inhibiting the intake of food. The apparatus comprises first and second spaced adhesive strips applied above and below the upper and lower lips of the user which are interconnected by wires which provide relatively normal movement of the mouth to permit normal speech, while at the same time inhibiting, but not totally preventing the intake of solids and liquids. 
         [0011]    is U.S. Pat. No. 6,138,679 discloses a mandibular restraint that includes a pain-inducing device. The pain-inducing device may be a bar shaped element with a thickened portion that is intended to press against the gums or jaws of the patient should the patient attempt to open the mouth beyond a threshold position. Alternatively, or additionally, the pain-inducing device delivers a painful electric shock to the gums or teeth of the patient. 
         [0012]    US 23075186 A1 discloses a device for affixing the teeth of a user by engaging a plurality of individual teeth of the mandible with the opposite respective teeth of the maxilla. The affixation is carried out separately for each pair of teeth (upper and lower) involving the application of a resin to anchor an elastic element to the teeth. 
         [0013]    US 2003/0059737 four frames are being secured to the upper and lower right and left dental arches and are connected to magnets on each frame. 
         [0014]    ES 2164570 discloses a closing system for teeth. It consists of rings that are fixed to the teeth and a chain that will pass through the rings to close the teeth as much as possible and an electronic part. 
         [0015]    U.S. Pat. No. 4,218,611 discloses a method and apparatus for controlling a person&#39;s eating behavior using a counter on the table next to the food being eaten. The counter displays the number of bites to be taken at each meal, displays the actual number of bites while the bites are being taken during a meal, provides a cadence signal from which the person can pace his chewing rate, determines the size of the bite taken and the time between bites, and provides an exercise between bites which forces the person to break the eating chain by pushing a button to increment the counter. 
         [0016]    Moreover there is known a device known as “Jaws”. Said device joins the upper and lower jaws by a metal wire which is applied by a dentist. However said device is very dangerous and is not allowed for use anymore. 
         [0017]    Today it is obvious that losing weight concerns firstly changing eating habits which is done under guidance. None of the above Patents gives a solution for said need. 
         [0018]    Moreover in order to insert the restraining device, in some cases a helping instrument is required. A number of helping instruments such as applicators have been described as helping to insert certain devices into the oral cavity but most of them are used by the dentist (usually an orthodontist) to fix said devices on orthodontic appliances or are applicators that help the patient (usually an orthodontic patient) to put orthodontic devices in their proper brackets. 
         [0019]    U.S. Pat. No. 5,575,643 describes an orthodontic tool wherein an elastic band can be stretched and affixed onto the hooks of an orthodontic apparatus affixed within the mouth. 
         [0020]    U.S. Pat. No. 4,127,940A describes a dentist&#39;s instrument used to facilitate the application of an elastic arch wire-retaining band to an arch wire-supporting bracket. 
         [0021]    U.S. Pat. No. 4,472,137A described an orthodontic instrument which is provided for attaching elastic retainer rings or bands to the brackets attached a patient&#39;s teeth. 
         [0022]    U.S. Pat. No. 4,512,739A describes an orthodontic instrument which is designed for use by patients to help them to put and to remove the elastics on/from orthodontic hooks that are cemented on orthodontic brackets. 
         [0023]    US 19670685555 describes an applicator for the placement of elastic bands on orthodontic appliances. 
         [0024]    None of the above Patents gives a solution for the restraining device according to the present invention. 
       SUMMARY OF THE INVENTION 
       [0025]    The present invention thus consists of a restraining device which is being anchored in the upper and lower jaws, consisting of an elastic element which is inserted into two respective inter-proximal spaces (IPSs) of said upper and said lower jaws and reduces and/or limits the mouth opening and/or slows down the rate of chewing. 
         [0026]    The elastic element in accordance with the present invention may be referred to as a spring, a slab, an elastic band, an elastic rubber a cluster of fibers etc. Moreover it may be entirely, partially or partly elastic. 
         [0027]    In a further embodiment of the present invention said restraining device i.e. the elastic element is inserted via any helping instrument such as an applicator, a retainer etc. 
         [0028]    The applicator according to the present invention consists of at least one handle which in turn is connected to at least two arms; wherein each arm has at least one anchoring part for placing the restraining device; and wherein said handle and arms may consist as one unit. 
         [0029]    In yet another embodiment of the present invention, restraining device i.e. the elastic element may be anchored into the two respective inter-proximal spaces (IPSs) of said upper and lower jaws respectively, via any connecting device such as orthodontic wires, hooks, implants, e.g. mini-implants in the bones of the upper jaw and the lower jaw [hereafter “connecting device”]. All of the above connecting devices may be known devices or manufactured especially for the present invention etc. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0030]    The restraining device of the present invention, i.e. the elastic element in accordance with the present invention, may be an open or closed structure. Moreover, it may comprise varied and different sizes, lengths, thicknesses, and may have different shapes such as circles, squares, rectangles, ellipses, polygons etc. 
         [0031]    However, in accordance with one embodiment of the present invention the is elastic element comprises three parts, e.g. at least one inter-dental part, at least one slow-down chewing part and at least one stopper; wherein said parts may be separate parts connected to each other or some of the parts thereof combined into one compound part. 
         [0032]    The inter-dental part in accordance with the present invention is the part which is inserted between two adjoining teeth, e.g. IPSs, and passes through the touching points of the adjoining teeth or to the connecting device. The thickness of this part may vary in accordance with the requirement. However in one embodiment the thickness may be 0.25 mm to 1.5 mm. This part may be cut in the form of a circle, a rectangle an ellipse or the like. Said part may be made of rubber, of silicon, of nylon or may be inter-woven with cotton, with flax fibers or with any other fiber which is not elastromeric such as dental floss material or combinations thereof or may be manufactured as one component having different characteristics etc. 
         [0033]    The inter-dental part may be either flexible or inflexible. 
         [0034]    The stopper in accordance with the present invention is the part which is used for anchoring the restraining device i.e. the elastic element, which prevents the elastic element from being dislocated either from between the teeth or from the connecting device. Said stopper is preferably located at the ends of the restraining device, i.e. the elastic element. 
         [0035]    Should the elastic element be open, there exist at least two stoppers (one for the upper jaw and the other for the lower jaw). However the present invention is not restricted to two stoppers only, and in another embodiment four stoppers are present in the open elastic element. 
         [0036]    The stopper may have a triangular shape, but its geometrical shape may be triangular, circular, ring-like, disk-shaped (like a button), trapezoidal, rectangular, square, elliptical etc. 
         [0037]    While chewing, the restraining device is stretched, at which time it pulls the stopper in such a way as to trap restraining device behind the teeth which action impedes the restraining device from coming free. 
         [0038]    The stopper&#39;s diameter may comprise various diameters. 
         [0039]    The stopper may be inserted between the teeth and/or placed on two adjoining teeth or on the connecting device. 
         [0040]    The slow-down chewing part in accordance with the present invention is a flexible part which is stretched between the upper jaw and the lower jaw when opening the mouth. The dimensions of said part depend upon the force required for stopping the mouth from being opened. Said slow-down chewing part may have the form of a ring, a rectangle or any other form, either hollow or solid. 
         [0041]    The restraining device i.e. the elastic element may be further selected from among the following possibilities. However, it is not restricted to said possibilities:
   A. One open continuous element, wherein the inter-dental part and the slow-down chewing part are one unit with one stopper connected to each side.   B. One open continuous element wherein each part of the elastic element has a different thickness; wherein the slow-down chewing part is connected on both sides to the inter-dental part; and wherein each inter-dental part is connected to a stopper.   C. An elastic element as described in possibility B wherein the angle is 90° between the inter-dental part and the slow-down chewing part.   D. An elastic element as described in possibility C wherein four stoppers are present.   E. One closed continuous element like a ring.   
 
         [0047]    The restraining device, i.e. the elastic element, should be manufactured from a material which fulfills at least the following conditions:
   A. A strong material which cannot be torn while being inserted into the mouth.   B. A flexible material which enables the opening and closing of the mouth.   
 
         [0050]    In a preferred embodiment said material is a bio-compatible material. 
         [0051]    The restraining device, i.e. the elastic element, may have a hardness in accordance with the requirements of the rate of slow-down. In one embodiment of the present invention, the hardness is 33.2 shore, the stress is 106 kg/cm and an elongation is 865%. 
         [0052]    The restraining device, i.e. the elastic element, may be manufactured from a range of materials, such as latex or artificial rubbers, natural or synthetic rubbers, thermoplastic polymers, polystyrene, silicon, acetyl polymers such as Delrin®, nylon resins etc. Moreover the elastic element may be made of an elastic material or of one or more springs. Furthermore, the elastic element may be interwoven from threads and different materials in order to strengthen the element and to prevent it from being torn. In yet a further embodiment, the elastic element may be made from flexible/soft materials of varying densities and a combination of the above. 
         [0053]    The restraining device, i.e. the elastic element, may vary in diameter in different parts along the elastic element in order to control slowing down the action of opening the mouth. 
         [0054]    Guiding the restraining device, i.e. the elastic element, into the intended crevices between the teeth i.e. the IPSs may be done using the fingers, with the user standing before a mirror if required. However in accordance with the preferred embodiment of the present invention, the restraining device, i.e. the elastic element, is inserted into its intended places with a helping instrument such as an applicator, without inserting the fingers into the mouth. 
         [0055]    The applicator according to the present invention consists of at least one handle which in turn is connected to at least two arms; wherein each arm has at least one anchoring part for placing the restraining device; and wherein said handle and arms may consist as one unit. 
         [0056]    The anchoring part may be any part which will anchor the device, such as a groove, a channel, a furrow, a rut, an indentation, a rough area, combinations thereof etc. 
         [0057]    In accordance with a further embodiment of the present invention the applicator may have also pulling and releasing means, preferably pulling and releasing limb[s], which is connected to and/or part of the arm. 
         [0058]    The applicator&#39;s handle according to the present invention serves as a grasping means for the user and/or for activating the restraining device, i.e. the elastic element. 
         [0059]    The applicator&#39;s handle&#39;s shape enables motion, e.g. by pressing the handle it also changes its shape. In the place where the handle is connected the thickness varies to form flexibility for bending and pressing. 
         [0060]    The applicator&#39;s handle may further have the following characters:
       The handle responds to bending activity, e.g. the purpose of the applicator is to move and to bend the arms in order to stretch the restraining device, i.e. the elastic element;   The handle responds to pressing action;   The handle may be comprised of different shapes which enable movement;   The handle may be comprised of different shapes, e.g. elliptical shape, round shape, arced shape etc;   The handle is made of stiff material or it may be made of soft material;   The handle may be hollow or solid;   The handle may be one closed unit or open at the end;   The handle may be made of plastic, of metallic or of silicon material;   The handle&#39;s thickness may continue to grow as the handle reaches the arms;   In the handle may be parts which direct the user to the pressing point;   The handle may be parallel to the arms or positioned at different angles such as 30°/60°/90°; and/or   The handle is connected to the arms—the connection between the arms may be along the surface of different areas of the arms in such a configuration as an X shape.       
 
         [0073]    The applicator&#39;s arms according to the present invention are used for grasping the restraining device, i.e. the elastic element. The arms may be straight or bent or in varied shapes. The shapes of the arms enable the arms to bend and to part from one another so that the restraining device, i.e. the elastic element, is stretched over two or more arms. 
         [0074]    The applicator&#39;s arms may further have the following characteristics:
       The arms are made of stiff material, e.g. plastic, metal;   The arms may be of different lengths;   The arms may be of different distances one from the other; and/or   The arms may vary in thickness, i.e. the upper part may be thicker than the lower part and vice versa. The cut of the upper arm may be made in various shapes e.g. round, rectangular, square, elliptic etc.       
 
         [0079]    In one embodiment of the present invention on the arms which are close to the handle there is an anchoring part such as a groove in a different cut than in the arms that are far from the handle. Thus its shape enables the arms to bend and part from one another, e.g. the restraining device, i.e. the elastic element, is being stretched. 
         [0080]    The anchoring parts such as grooves or rough areas of the arm according to the present invention are located at the end of the arms. Said parts serve to anchor the restraining device, i.e. the elastic element, to stretch it. The parts are found in different sizes and in different shapes, e.g. straight cut, trapezoidal cut, triangular cut, etc. The role of the parts is to anchor the restraining device, i.e. the elastic element, to the arms and to allow it to stretch. 
         [0081]    The applicator allows the user to insert the restraining device, i.e. the elastic element, between the teeth in a comfortable and user-friendly way before the meal. After the restraining device, i.e. the elastic element, is inserted in its designated place and thereafter the applicator is removed easily. 
         [0082]    The applicator is an instrument:
   A. Which stores the restraining device, i.e. the elastic element, preferably in a stretched position, e.g. in a package, before it is being used;   B. Which assists a person in inserting the restraining device, i.e. the elastic element, into the mouth, and in positioning it where it should be, e.g. in assisting the user to insert the restraining device, i.e. the elastic element, into its place in the mouth cavity; and   C. Which assists the user in activating, e.g. in stretching a bit longer, the restraining device, i.e. the elastic element, by means of pressing a small bit upon the applicator&#39;s arms.   
 
         [0086]    The applicator is made of stiff material but has flexible attributes. 
         [0087]    The applicator may consist of one unit or more than one unit. 
         [0088]    The device of the present invention restricts mandibular movement and therefore reduces the mouth-opening rate and slows down chewing rate of the food which is ingested. A particular aspect of the present invention is the anchoring of the device on each jaw. Because of the placement of the device, is e.g. of the elastic element, directly or via a connecting device as herein before defined in an IPS space, the anchoring of each jaw is associated directly with two adjacent teeth. 
         [0089]    The device of the present invention is easily applied by the user with or without the intervention of any medical personnel. A user who may wish to do so, may remove the device, e.g. the elastic element, e.g. one or more worn simultaneously), at any time. Reapplication is easy and there is no limit to the number of reapplications which may be carried out. The relative comfort of the application is conducive to the tendency of a person to use the device. The use of the device of the present invention, such as the use of one or more devices, would limit bite intake, promote slow chewing and limit the absorption of food. 
         [0090]    More particularly, the applicator and the elastic element of the present invention may be used in accordance with the following method. However, it is not restricted to said method.
   A. The applicator comes with the elastic element partially expanded upon it;   B. The user grasps the applicator&#39;s handle and brings it close to his mouth;   C. The user presses on the handle which causes the elastic element to expand to its maximum capacity and enables easier preparation in order to insert the elastic element into the space between the two teeth [IPSs]; alternatively the handle is used as a handle per se; and   D. The user inserts the applicator into the mouth cavity with the elastic element expanded, e.g. pressing steadily on the handle as stated in point C. above, on the side comfortable to him, e.g. the right side or the left side; or alternatively should the handle be a handle per se, by pressing the pulling and releasing means; or combinations thereof;   E. The user bites the elastic element until it enters between the teeth by the force of the bite and locates itself between two adjacent teeth in is the upper jaw and in the lower jaw, like dental floss;   F. The user releases the pressure on the handle and in such a way frees the applicator from the restraining device, i.e. the elastic element; and   G. The user removes the applicator without the restraining device, i.e. the elastic element, from the mouth cavity.   
 
         [0098]    In accordance with a preferred embodiment of the present invention, the handle is a handle per se and the elastic element is extended on the applicator. The pressing/biting actuates the pulling limb which in turn expends the elastic element further and allows it to be inserted between the teeth; with further pressing/biting, the releasing means releases the elastic means. The same pressing/biting performs both above actions. 
         [0099]    The restraining device, i.e. the elastic element, may be removed by the following method. However it is not restricted to said method. After using the restraining device, i.e. the elastic element, the user, with the help of his finger, removes the restraining device, i.e. the elastic element, and pulls it from the mouth cavity. 
         [0100]    The restraining device, i.e. the elastic element, may be anchored into the two respective inter-proximal spaces (IPSs) of said upper and lower jaws respectively, directly or via any connecting device such as orthodontic wires, hooks, implants, e.g. mini-implants in the bones of the upper jaw and the lower jaw (hereafter “connecting device”). All of the above connecting devices may be known devices or manufactured especially for the present invention etc. In this case the connecting device may be connected by any connecting means to an applicator such as a groove, a notch etc. 
         [0101]    The restraining device of the present invention is to be dispensed either as a kit with separate restraining devices, i.e. elastic elements or, if desired, as a kit of with restraining devices, i.e. elastic elements and helping instruments, i.e. applicators and/or with connecting devices. By use of color coding, different sizes may be indicated and similarly, different elasticity values may be marked. 
         [0102]    As described above, the device of the present invention promotes the restriction of food intake and therefore helps the prone individual to overcome excessive food intake. 
         [0103]    The restraining device of the present invention may be used as an instructional and/or as a teaching instrument for alteration of eating habits by reducing and/or limiting the mouth opening and/or slowing down the rate of chewing. 
         [0104]    The restraining device may also serve as a game for youths and teenagers, e.g. if the elastic element falls it is a sign that the youth/teenager has opened the mouth too widely and has eaten too quickly etc. The elastic element may also serve as an ornament or as a piece of jewelry, e.g. if it comes in various colors, if a gem will be mounted on the stopper or on the slowing-down part etc. 
         [0105]    Continuous use of the restraining device of the present invention helps train the user to achieve a proper chewing rate and promotes satiety without overeating. The use of the device of the present invention promotes a direct solution to dietary problems and also promotes the prone individual to acquire proper eating habits. By applying the restraining device, the user may determine the size of the bite in such a way that a smaller amount of food is consumed in a given period of time. As a result, the user eats less and loses weight. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0106]    The present invention will now be illustrated with reference to the accompanying drawings and examples without being limited by them. Identical parts are marked by the same numerals. 
           [0107]    In said drawings: 
           [0108]      FIG. 1  is a schematic description of the oral environment in which the restraining device, i.e. the elastic element, is implemented; 
           [0109]      FIG. 2A  is a schematic side description of the restraining device, i.e. the elastic element; 
           [0110]      FIG. 2B  is a schematic side description of another restraining device, i.e. the elastic element, in accordance with the present invention; 
           [0111]      FIG. 2C  is a schematic side description of another restraining device, i.e. the elastic element, in accordance with the present invention; 
           [0112]      FIG. 2D  is a schematic perspective description of another restraining device, i.e. the elastic element, in accordance with the present invention; 
           [0113]      FIG. 2E  is a schematic side description of another restraining device, i.e. the elastic element, in accordance with the present invention; 
           [0114]      FIG. 3  shows two adjacent teeth having the restraining device, i.e. the elastic element, stopper, between them; 
           [0115]      FIG. 4  is a schematic side description of the applicator in accordance with the present invention having the restraining device, i.e. the elastic element; 
           [0116]      FIG. 5  is a schematic perspective description of another applicator in accordance with the present invention having the restraining device, i.e. the elastic element; 
           [0117]      FIG. 6  is a schematic perspective description of another applicator before use, in accordance with the present invention having the restraining device, i.e. the elastic element; 
           [0118]      FIG. 7  is a schematic perspective description of another applicator in accordance with the present invention; 
       
    
    
     DETAILED DESCRIPTION OF DRAWINGS 
       [0119]    The device of the present invention is a restraining device.  FIG. 1  describes schematically the oral environment in which the device of the present invention is applied. The teeth in upper jaw  1  (maxilla) in a mouth are disposed in opposition to the teeth of the lower jaw (mandible)  2 . In each jaw, each tooth typically forms a single contact point with an adjacent tooth on each side, allowing for a substantially triangular space limited by adjacent teeth and gum  50 . Such a space is known in the art as inter-proximal space (IPS). Between tooth  3  and tooth  4 , and between tooth  5  and tooth  6 , two respective IPSs are indicated, namely IPS  7  and  7 ′ respectively. Restraining device  8 , namely the elastic element as applied, is described schematically in  FIG. 1 . 
         [0120]    Device  8  is inserted between two adjacent teeth in upper jaw  1  and two adjacent teeth in lower jaw  2  through contact point  9 . 
         [0121]    Several versions of device  8 , namely of the elastic elements, is shown in  FIGS. 2A ,  2 B,  2 C,  2 D and  2 E. 
         [0122]    In  FIGS. 2A ,  2 B,  2 C and  2 D is shown device  8  comprising two stoppers  10  which are connected by slow-down chewing part  11 . In  FIG. 2B , stopper  10  has the form of a ring. In  FIGS. 2C and 2D  slow-down chewing part  11  has varying widths. In  FIGS. 2A ,  2 B,  2 C and  2 D slow-down chewing part  11  consists also of the inter-dental part. In  FIG. 2E  are shown four stoppers  10  wherein each pair of stoppers  10  are connected to one another by inter-dental part  12 . 
         [0123]      FIG. 3  shows two adjacent teeth, tooth  3  and tooth  4 , having between them stopper  10  of device  8 . 
         [0124]      FIG. 4  shows applicator  20  by itself when it is attached to device  8 . Applicator  20  comprises handle  21 , which in turn is connected to arms  22  and  23 . Grooves  24  are located at the ends of both arms  22  and  23  and serve to hold device  8  in place so that it will not be harmed. Another purpose of handle  21  is to stretch device  8 . After the user bites down on the part of device  8  located between arms  22  and  23 , the user removes applicator  20  from his mouth. 
         [0125]      FIG. 5  shows another applicator  20  with device  8  stretched upon it, which comprises arms  22  and  23  having at their ends grooves  24  assembled side by side rather than one in front and one in back. During use, biting on device  8  brings arms  22  and  23  closer together and as a result device  8  is stretched. After the bite the user removes applicator  20  and the device  8  stays between the teeth. 
         [0126]      FIG. 6  shows another applicator  20  before use with device  8  stretched upon it. Said applicator  20  has only one handle  21  which is not meant to operate device  8  but only to hold it. Said handle  21  is connected to arms  22  and  23 . 
         [0127]    Arm  22  in turn and arm  23  in turn have pulling limb  26  and releasing limb  27 . Pulling limb  26  serves for stretching device  8  and releasing limb  27  serves for releasing it. 
         [0128]    After the user bites down on device  8 , pulling limb  26  stretches device  8  in order to insert it between the teeth (not shown). When pulling limb  26  descends, it activates releasing limb  27  which releases device  8  from applicator  20  and makes it possible to remove applicator  20  from the mouth while device  8  remains between the upper and lower jaws. 
         [0129]      FIG. 7  shows another applicator  20  alone without device  8  (not shown), having handle  21  which is substantially 90° to arms  22  and  23  having at their upper side grooves  24 . Said applicator  20  is inserted into the mouth from the front whereas applicator  20  in other figures is inserted from the side. When pressing arms  22  and  23  they are drawn closer together and as a result device  8  (not shown) is stretched.