Abstract:
An oral appliance device and method are provided for slowing the ingestion of food thereby triggering an increase in the feeling of satiety for a given amount of food. The appliance affixes to the maxillary teeth and mandibular teeth, and restricts the distance the wearer can open the mouth. The appliance includes upper and lower attachable portions which affix to the upper and lower teeth, and a flexible element that connects the upper and lower parts. The restricted opening distance can be adjusted, by either lengthening the flexible part of the appliance, or re-positioning the upper and lower affixable part(s). The appliance allows the patient to perform oral hygiene and speak normally. The appliance allows patients to chew food, but at a slower rate. The appliance decreases the amount of food a wearer can put into his/her mouth at any single time, increasing the amount of time it takes to eat.

Description:
[0001]    This application claims the benefit of U.S. Provisional Patent Application No. 60/326,417 filed Oct. 1, 2001.  
         BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The invention is related to the art of weight control devices and more specifically, dental appliances operative to assist a patient in reducing the intake of food. The invention restricts mandibular movement and therefore slows the rate of food ingestion. The device also decreases the amount of food in the mouth at any given time, due to the constriction of opening, resulting in a decrease in volume. Slowing the rate of food ingestion allows the body time to respond to the ingestion of food with a sensation of satiety. The patient feels full after consuming a reduced amount of food. Therefore, the patient eats less and loses weight.  
           [0004]    2. Description of Related Art  
           [0005]    A number of dental appliances have been described as aiding a patient in achieving weight loss through the restriction of mandibular movements. For example, U.S. Pat. No. 6,138,679 to Renders, et al. discloses a mandibular restraint that includes a pain-inducing device. The pain-inducing device can be a bar shaped element with a thickened portion that is said to press against a gum or jaw of the patient as the patient attempts to open the mouth beyond a threshold position. Alternatively, or additionally, the pain-inducing device delivers a painful electric shock to the gum or tooth of the patient.  
           [0006]    Russian Patent SU 1602507 A1 shows interlocking rings attached to opposing upper and lower teeth. The rings appear to limit mandibular movement.  
           [0007]    These prior art devices have several disadvantages. For example, patients object to being shocked or painfully poked. Additionally, rubbing, poking or pressing the gums as described above can lead to abrasions, cuts and infection. Furthermore, in order to reduce a risk that mandibular movements may dislodge the teeth that the movement limiting apparatus are attached to, more than one apparatus should be installed. For example, two or four sets of teeth should be involved in limiting the opening of the jaw. Involving additional sets of teeth requires that the restraints be synchronized, or set to apply equal amounts of restraining tension, so that the teeth share the load of jaw restraint evenly. The prior art does not include a method or apparatus for restraint synchronization.  
         BRIEF SUMMARY OF THE INVENTION  
         [0008]    For the forgoing reasons, a system and method for helping a patient lose weight has been developed. The system includes restraining elements or fibers operative to be attached to, mounted to or associated with upper and lower teeth. The restraining elements or fibers prevent the mouth from opening beyond a predetermined restraint distance. The method includes procedures for synchronizing a plurality of restraining elements. Synchronizing the elements allows the elements and the teeth that they are attached to, or associated with, to share the load of jaw restraint equally, thereby minimizing a risk of tooth movement. Optionally the system includes brackets that assist in the synchronization procedure. In one embodiment the bracket includes a plastic pawl. The pawl releasably catches on notches in a restraining fiber tab. In another embodiment the bracket includes a buckle clasp type member for frictionally holding a restraining fiber tab. Another embodiment includes a locking button bracket. The button includes frictional grooves for intertwining and locking a restraining fiber. In yet another embodiment a bracket and bracket cap include interlocking convolutions. A restraining fiber is frictionally captured within the convolutions. Still other embodiments include a plurality of holes punched, molded or formed into tabs of restraining fibers or elements. Associated brackets include pins or bolts for lockable insertion through a selected one of the holes. One embodiment includes a gear or wheel for frictionally capturing and positioning a restraining fiber. Another embodiment includes a bracket with a slotted bolt. A fiber is threaded through the slot and secured with a locking nut. 
       
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0009]    The invention may take form in various components and arrangements of components, and in various procedures and arrangements of procedures. The drawings are only for purposes of illustrating preferred embodiments, they are not to scale, and are not to be construed as limiting the invention.  
         [0010]    [0010]FIG. 1 is a front view of restraining element bonded to upper and lower molars of a patient&#39;s mouth. The mouth is closed.  
         [0011]    [0011]FIG. 2 is a side view of a bonded restraining element of FIG. 1.  
         [0012]    [0012]FIG. 3 is a front view of restraining element bonded to upper and lower molars of a patient&#39;s mouth. The mouth is open a maximum or restrained distance.  
         [0013]    [0013]FIG. 4 is a top and front view of a stationary arch installed on a lingual side of a set of teeth.  
         [0014]    [0014]FIG. 5 is a side view of a restraining element bonded to upper and lower teeth in conjunction with magnets. The magnets are also bonded to the upper and lower teeth.  
         [0015]    [0015]FIG. 6 is a front view of restraining elements attached to brackets. The brackets are bonded to upper and lower molars of a patient&#39;s mouth. The mouth is closed.  
         [0016]    [0016]FIG. 7 is a side view of a mounted restraining element of FIG. 6.  
         [0017]    [0017]FIG. 8 is a front view of restraining elements attached to brackets. The brackets are bonded to upper and lower molars of a patient&#39;s mouth. The mouth is open a maximum or restrained distance.  
         [0018]    [0018]FIG. 9 is a side view of a restraining element bonded to upper and lower magnets. The magnets are, in turn, bonded to the upper and lower teeth.  
         [0019]    [0019]FIG. 10 is a front view of an ordinary orthodontic bracket.  
         [0020]    [0020]FIG. 11 is a set of views of a gear or wheel bracket and an associated restraining fiber.  
         [0021]    [0021]FIG. 12 is a set of views of a cable tie style bracket and an associated restraining fiber.  
         [0022]    [0022]FIG. 13 is a set of views of a buckle clasp bracket and an associated restraining fiber.  
         [0023]    [0023]FIG. 14 is a set of views of a pin clasp bracket and an associated restraining fiber.  
         [0024]    [0024]FIG. 15 is a front view of a nut and bolt bracket and an associated restraining fiber.  
         [0025]    [0025]FIG. 16 is a set of side views of a capped bracket and an associated restraining fiber.  
         [0026]    [0026]FIG. 17 is a set of views of a locking button bracket and an associated restraining fiber.  
         [0027]    [0027]FIG. 18 is a set of views of a slotted nut and bolt bracket and an associated restraining fiber.  
         [0028]    [0028]FIG. 19 is a view of a first semi permanent restraining system.  
         [0029]    [0029]FIG. 20 is a view of a first semi permanent restraining system.  
         [0030]    [0030]FIG. 21 is a view of a first semi permanent restraining system.  
         [0031]    [0031]FIG. 22 Is a view of a temporary restraining system.  
         [0032]    [0032]FIG. 23 is a flow chart outlining a method operative to help a patient lose weight. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]    Referring to FIG. 1 and FIG. 2, which are front and side views respectively, a restraining device  114  is installed between portions of an upper jaw  118  and a lower jaw  122  of a weight loss patient (not shown). In the illustrated embodiment the restraining device includes first  126  and second  130  strips. A means for attaching the strips  126 ,  130  to respective portions of the maxilla or upper jaw  118  and mandible or lower jaw  122  of the patient, includes an adhesive  132 . In the illustrated embodiment the respective portions of the maxilla or upper jaw  118  and mandible or lower jaw  122  are selected teeth  134 ,  136 ,  138 ,  140 .  
         [0034]    The first and second strips  126 ,  130  are made of any appropriate dental or orthodontic material. Preferably the strips are cut lengths of ultra high strength plastic mesh reinforcing material, such at that disclosed in U.S. Pat. No. 5,829,979 to Kobashigawa et al. or that disclosed in U.S. Pat. No. 5,176,951 to Rudo. These materials are very strong, while at the same time being relatively comfortable for the patient to wear. For example, these materials do not include sharp edges, and have no offensive taste. Alternatively, the strips  126 ,  130  are cut or stamped pieces of plastic or metal sheet or ribbon. In some embodiments, the strips  126 ,  130  are made of material such as, memory metal, having, for example, a preformed bow toward the cheek side of the mouth. Such a buccal bow helps prevent the strips from folding toward the teeth and being bitten when, for example, the patient chews food. As will be described in greater detail below, in some embodiments the strips are made of molded or stamped plastic, that coil or bend out of the way of chewing teeth.  
         [0035]    As mentioned above, the strips are bonded to the teeth with an adhesive  132  such as, a dental or orthodontic resin. For example, ends  148  of the strips  126 ,  130  are dipped in or brushed with a low viscosity thermosetting resin such as that manufactured by Kerr Corporation under its trademark Porceline® or any orthodontic bracket or band cement, or self-curing, light or time activated, bis-GMA resin, similar to 3M Unitek Transbond (R) or other cements, similar to a glass ionomer cement, etc. is used to bond the brackets  632  to the selected teeth  634 ,  636 ,  638 ,  640 . The saturated or coated tips are then placed against respective ones of the selected teeth  134 ,  136 ,  138 ,  140  and the adhesive is cured. For example, the adhesive  148  is exposed to an ultraviolet light, which causes the adhesive to harden. Of course, central portions of the strips are to remain flexible and unbonded. Therefore, adhesive is not used on the central portions of the strips  126 ,  130 .  
         [0036]    While restraints are shown attached to two teeth, any appropriate number of teeth can be enlisted in to the restraint. Preferably, the restraint is symmetric within the mouth. For example, where a set of left molars is selected, a set of left right molars is also selected.  
         [0037]    The selected teeth  134 ,  136 ,  138 ,  140  are determined based on the oral health of the patient. Preferably the selected teeth are upper and lower first and second molars. Molars are preferably selected because molars provide a relatively large surface area for bonding and have an extensive root system. It is preferable to select teeth that are firmly held within the jaw because significant withdrawing or uprooting forces are applied to the selected teeth when, as shown in FIG. 3, the patient opens his or her mouth. This is especially true just after installation, before the patient has developed a significant muscle memory or learned the new limits of mouth opening. Additionally, unconscious mouth movements, made, for example, while the patient sleeps, can apply tooth-loosening forces to the selected teeth.  
         [0038]    Where healthy molars are not available, other teeth may be used. For example narrower strips may be applied to non-molars and additional teeth can be selected and employed.  
         [0039]    Referring to FIG. 4, stationary arches are installed in the mouth of the patient in order to combat, or compensate for these tooth loosening forces. For example, a casting is made of the maxillary  414  and mandibular (not shown) arches of the patient. The castings are used as a measure of the shape and locations of the teeth of the patient. The castings are used to form upper and lower stationary arches. The upper stationary arch is installed to support the selected teeth  134 ,  138  of the upper jaw. For example, an upper stationary arch  418  formed from orthodontic wire, is bonded to the lingual side of teeth that make up the maxillary arch  414 , including the upper selected teeth  134 ,  138  shown in FIG. 1 and FIG. 2 as well as other selected upper teeth  434 ,  438  on the other side of the mouth of the patient. The upper stationary arch is bonded to the teeth with a bonding agent  422  in a manner known in the art. A similar arch, a lower stationary arch (not shown), is similarly installed and attached to teeth of the mandibular arch.  
         [0040]    Alternatively, abbreviated stationary arches or arch segments are used. For example, it may not be necessary or possible to call on the front teeth for support of the selected teeth. In that case a stationary segment is bonded to the selected teeth and a few neighboring or available teeth. For example, where the selected teeth are molars, a stationary segment may be only bonded to, for example, the molars, wisdom teeth and premolars.  
         [0041]    The restraining device is operative to control the size of bites of food taken by the patient. In addition, the restraining device hampers the eating process by making it more difficult to chew. For example, the strips  126 ,  130  make it difficult to transfer a bolus of food to the buccal or cheek side of the teeth. Additionally the strips make it difficult to get large pieces of food between the teeth for chewing and grinding purposes. Making eating more difficult in this way slows the rate at which food is ingested. As is known in the art of weight control, the sensation of satiety is somewhat delayed. Given enough time, a small volume of food will provide the sensation of satiety. However, many weight loss patients eat quickly. Such patients do not allow enough time for the nervous system to register the ingestion of the small volume of food, before eating an additional volume of food. Therefore, these patients eat more food than would otherwise be required to satisfy their appetites.  
         [0042]    While the restraining device described thus far serves to reduce bite size, and thus tends to slow the eating process, some patients may learn to compensate for reduced bite size by increasing bite frequency. For such patients, a more elaborate restraining device is required.  
         [0043]    Referring to FIG. 5, an upper magnet  514  and a lower magnet  518  are attached to respective upper  522  and lower  526  selected teeth. As illustrated, the magnets are located on the buccal side of the selected teeth. However, other mounting arrangements are possible. For example, the magnets may be located on the lingual side of the teeth. The magnets  514 ,  518  are oriented so that an attractive force exists between them. That is, a north pole of one magnet faces a south pole of the other magnet. With this arrangement, each attempt to open the mouth, made by the patient is initially resisted. The patient must overcome this resistance with each chew. Therefore, the chewing process is slowed.  
         [0044]    The magnets may be coated or jacketed in order to provide a minimum gap between pole surfaces. The inclusion of such a gap producing covering is operative to attenuate the magnetic force between the magnets. Other attenuation schemes are based on magnetic material selection and magnet shape and size design.  
         [0045]    As shown in FIG. 5 the magnets  514 ,  516  are bonded to the teeth  522 ,  526  with an adhesive (not shown). Additionally, a restraint strip  530  is separately bonded to the same teeth  522 ,  526 . However, other arrangements are contemplated and within the scope of the invention. For example, restraint strips and magnets may be bonded to different selected teeth. Orthodontic bands or brackets may be used to mount the magnets and /or the strips. The strips may be bonded or otherwise attached to the magnets instead of directly to the teeth.  
         [0046]    Another alternate embodiment is depicted in FIG. 6-FIG. 8. In this embodiment a restraining device  614  is also installed between portions of an upper jaw  618  and a lower jaw  622  of a weight loss patient (not shown). The restraining device  614  includes first  626  and second  630  filaments or wires. A means for attaching the filaments to portions of the upper and lower jaw includes brackets  632 . The brackets are bonded to selected teeth  634 ,  636 ,  638 ,  640  of the maxilla or upper jaw  618  and mandible or lower jaw  622  of the patient.  
         [0047]    The first and second filaments or wires  626 ,  630  are made of any appropriate dental or orthodontic material. Preferably the filaments or wires are cut lengths of orthodontic wire or plastic. In some embodiments, the wires  626 ,  630  are made of material such as, memory metal, having, for example, a preformed bow toward the cheek side of the mouth. As mentioned above, such a buccal bow helps prevent the filaments from folding toward the teeth and being bitten when, for example, the patient chews food.  
         [0048]    The brackets  632  are bonded to the teeth with an adhesive  644  such as, a dental or orthodontic resin. For example, a low viscosity thermosetting resin such as that manufactured by Kerr Corporation under its trademark Porceline® or any orthodontic bracket or band cement, or self-curing, light or time activated, bis-GMA resin, similar to 3M Unitek Transbond (R) or other cements, similar to a glass ionomer cement, etc. is used to bond the brackets  632  to the selected teeth  634 ,  636 ,  638 ,  640 . Alternatively, the brackets are attached to portions of the upper and lower jaw by some other means. For example, orthodontic bands can be used to attach brackets to teeth. Arch banding devices, such as depicted in U.S. Pat. No. 6,086,365 to Fields can be used to provide tie point for the filaments or wires  626 ,  630 . Alternatively, interdental brackets such as those disclosed in U.S. Pat. No. 4,968,248 to McColgan et al. can be used to provide tie points at the spaces between teeth. These attachment means are exemplary only. As will be described below, other bracketing and attachment schemes can be used and stay within the scope of the invention.  
         [0049]    Referring to FIG. 7, in the illustrated embodiment the filaments or wires  626  are looped around and tied to the brackets  632 . However other attachment methods can be used and stay within the scope of the invention.  
         [0050]    Again, the selected teeth  634 ,  636 ,  638 ,  640  are determined based on the oral health of the patient. Preferably the selected teeth are upper and lower first and second molars. Molars are preferable because of the extent of the molar root system. It is preferable to select teeth that are firmly held within the jaw because significant withdrawing or uprooting forces are applied to the selected teeth when, as shown in FIG. 8, the patient opens his or her mouth. Where healthy molars are not available, other teeth may be used. For example brackets may be applied to or between non-molars and more teeth can be selected and used to spread the load.  
         [0051]    Again, where necessary, upper and lower stationary arches or arch segments are installed as described in reference to FIG. 4.  
         [0052]    Referring to FIG. 9, in order to further slow the chewing process an upper magnet  914  and a lower magnet  918  are attached to respective upper  922  and lower  926  selected teeth. As illustrated, the magnets are located on the buccal side of the selected teeth. However, other mounting arrangements are possible. For example the magnets may be located on the lingual side of the teeth. The magnets  914 ,  918  are oriented so that an attractive force exists between them. That is, a north pole of one magnet faces a south pole of the other magnet. With this arrangement, each attempt to open the mouth, made by the patient, is initially resisted. The patient must overcome this resistance with each chew. Therefore, the chewing process is slowed.  
         [0053]    The magnets may be coated or jacketed in order to provide a minimum gap between pole surfaces. The inclusion of such a gap producing covering is operative to attenuate the magnetic force between the magnets. Other attenuation schemes are possible. Some other attenuation schemes are based on magnetic material selection and magnet shape and size design.  
         [0054]    As shown in FIG. 9 the magnets  914 ,  916  are bonded to the teeth  922 ,  926  with an adhesive (not shown). Additionally, a restraint filament  930  is attached to the magnets. In some embodiments the filament  930  is adhesively bonded to the magnets. In other embodiments the magnets or magnet jackets (not shown) are formed to include a filament attachment member, such as, for example, a tie point. Additionally, other arrangements are contemplated and within the scope of the invention. For example, restraint filaments and magnets may be bonded to different selected teeth. Orthodontic bands or brackets may be used to mount the magnets and /or the filaments. The filaments may be bonded or otherwise attached directly to the teeth instead of to the magnets.  
         [0055]    Referring to FIG. 10, any orthodontic bracket  1010  can be used to obtain sufficient retention of restraining filaments, elements, or strips. The size of orthodontic brackets useful in restraining mandibular movement can vary. Typically, useful brackets are between 5 mm and 3 mm. This dimension is dictated by the surface of the selected tooth. Preferably, brackets are not so large as to interfere with normal jaw function, nor so small that the bonding area does not allow for sufficient retention or bonding force.  
         [0056]    The brackets should include a pad or rear surface operative to bond to a tooth or tooth side. The bonding surface of the pad is rough or mesh like so that it allows a bonding material or adhesive to affix to the pad, thereby helping the adhesive bond the bracket to the tooth. Brackets can be made from any metal or suitably strong plastic, compatible with the fluids of the oral cavity, and that are not toxic to the body.  
         [0057]    While ordinary orthodontic brackets can be used as part of a jaw restraint, as with direct bonding of restraining filaments, the use of ordinary orthodontic brackets does not facilitate the precise adjustment of the fiber to accommodate precision fixation or synchronization. Precision fixation is the synchronized activation or engagement of a plurality of restraining elements, during jaw opening.  
         [0058]    Preferably, the components of the jaw restraint make adjustment and restraint synchronization easy.  
         [0059]    Referring to FIG. 11, a gear bracket  1110  incorporates a small wheel/allan wrench type key system. A fiber  1116  is placed into a curved slot  1122  behind a wheel or gear  1114 . The fiber  1116  is frictionally engaged between the wheel  1114  and a wall of the groove. Alternatively, the fiber  1116  includes slots or notches for engaging teeth of the gear  1114 . In either case, turning the wheel or gear  1114  (for example, with an allan wrench) advances the fiber  1116  into or out of the gear bracket, thereby providing for precision fixation. Optionally, the fiber  1116  includes a molded or cast coil portion  1118 . The molded or cast coil takes up slack in the fiber when the jaw (not shown) is in a closed position.  
         [0060]    Referring to FIG. 12 a cable tie clasp bracketing assembly  1210  incorporates a female  1214  “cable tie” element for bonding to a tooth  1218 . A male “cable tie” end included on a fiber can then be fit into the female  1214  element and be adjusted. For example, the female element  1214  includes a pawl (not shown) that falls into and catches on notches  1222  on a male portion  1226  of a restraining fiber  1230 . Optionally, the female element includes a release mechanism that moves the pawl and allows the male portion  1226  to be withdrawn. Each fiber  1230  includes two male portions  1226 . Preferably a fiber distance  1234  between the two male portions  1226  is about five millimeters. Optionally, the fiber  1230  includes a molded or cast coil portion  1238 . The molded or cast coil takes up slack in the fiber when the jaw (not shown) is in a closed position.  
         [0061]    Referring to FIG. 13, a buckle clasp bracket  1310  incorporates pivoting pressure element  1314  that when engaged, tightens down on a fiber  1318 . Releasing the pressure element allows the fiber to be easily adjusted in the mouth. Engaging the element frictionally traps the fiber  1318  in a desired position. Optionally, the fiber  1318  includes pressure pads or tabs  1322  for engaging the pressure element  1314 . Also optionally, the fiber  1318  includes a molded or cast coil portion  1326 . The molded or cast coil  1326  takes up slack in the fiber  1318  when the jaw is in a closed position.  
         [0062]    Referring to FIG. 14 a pin clasp bracket  1410  incorporates a pin  1414  that when engaged, fits directly into small holes  1418  pre-punched, molded or formed in tabs  1422  of a fiber  1426 . Removing the pin  1414  allows the position of the tabs  1422  and fiber  1426  to be easily adjusted. Installing the pin  1414  in one of the holes  1418  captures the fiber  1426  into a fixed position. Optionally, the fiber  1426  includes a molded or cast coil portion  1430 . The molded or cast coil  1430  takes up slack in the fiber  1426  when the jaw (not shown) is in a closed position.  
         [0063]    Referring to FIG. 15, a nut and bolt bracket  1510  is similar to the pin clasp bracket  1410 . The nut and bolt bracket  1510  incorporates a threaded bolt  1514  that projects outward. The bolt is placed through one of a plurality or pre-punched or molded holes  1518  in a tab  1522  of a restraining fiber  1526 . A sealing nut  1530  is placed over the bolt  1514 , to hold the fiber  1526  in place and prevent the bolt  1514  from harming a cheek of a patient (not shown). Optionally, the fiber  1526  includes a molded or cast coil portion  1534 . The molded or cast coil  1534  takes up slack in the fiber  1526  when the jaw (not shown) is in a closed position.  
         [0064]    Referring to FIG. 16, a capped bracket  1610  includes a first convoluted portion  1614 . A frictionally engaging bracket cap  1618  includes a second convoluted portion  1622 . When the cap  1618  is installed on the capped bracket  1610 , the first convoluted portion  1614  mates in an interlocking manner with the second convoluted portion  1622 . In use, before the cap  1618  is placed on the bracket  1610  a fiber  1626  is properly positioned and placed between the cap  1618  and bracket  1610 . The act of placing the cap  1618  onto the bracket  1610  forces the fiber  1626  to bend and conform to the shape of the mating convolutions. Wedged between the first  1614  and second convolutions  1622  the fiber  1626  is frictionally captured in position between the cap  1618  and the bracket. Optionally, the fiber  1626  includes a molded or cast coil portion  1634 . The molded or cast coil  1634  takes up slack in the fiber  1626  when the jaw (not shown) is in a closed position.  
         [0065]    Referring to FIG. 17, a locking button bracket  1710  includes a button element  1714 . The button element includes a plurality of threading grooves  1718 . In use, a restraining filament  1726  is properly positioned and wrapped once or twice around a shaft  1722  attaching the button to the bracket  1710 . A free end of the filament  1726  is then wedged into one or more of the threading grooves  1718 . The threading grooves frictionally capture the fiber. Popping the filament  1726  back out of the threading grooves  1718  allows the position of the fiber to be readjusted. Optionally, the fiber  1726  includes a molded or cast coil portion  1730 . The molded or cast coil  1730  takes up slack in the fiber  1736  when the jaw (not shown) is in a closed position.  
         [0066]    Referring to FIG. 18, a slotted nut and bolt bracket  1810  includes a slotted bolt  1814 . In use, a restraining fiber  1818  is threaded through a slot  1822  in the slotted bolt and held in an appropriate position. A nut  1826  is then threaded onto the slotted bolt  1814  and tightened down onto the fiber  1818 . The nut  1826  frictionally holds the fiber  1818  against the bracket  1810 . Loosening the nut  1826  allows the position of the fiber to be readjusted. Optionally, the fiber  1818  includes a molded or cast coil portion  1830 . The molded or cast coil  1830  takes up slack in the fiber  1818  when the jaw (not shown) is in a closed position.  
         [0067]    Some patients may object to having their jaw movement permanently restrained for the entire weight loss program. For these patients, a semi-permanent jaw restraint may be sufficient.  
         [0068]    For example, referring to FIG. 19, a set of orthodontic brackets  1910 ,  1914  are mounted to upper and lower teeth as described above. The brackets  1910 ,  1914  include connector elements such as, for example, female portions or rings  1918 ,  1922 . A temporary restraint element  1926  includes connectors such as, for example, releasable “lobster claw” clips  1930 ,  1934  for releaseably connecting the restraint element  1926  to the rings  1918 ,  1922 . The clips  1930 ,  1934  are linked together by a restraint  1938 . The restraint  1938  can be a chain, fiber, memory metal band, or similar to any of the other restraining elements described above. As described above in reference to the more permanent installations, symmetric sets of brackets  1910 ,  1914  are preferably installed on either side of the mouth. Restraint synchronization is carried out in a manner similar to that described above. For example, a bite block is sized or adjusted and the patient is asked to bite down on it. Where the restraint  1938  is a fiber, the fiber can then be cut to size and tied to the clips  1930 ,  1934 . Where the restraint  1938  is a chain, the chain is sized by selecting the appropriate number of links and coupling the restraint  1938  to the clips  1930 ,  1934 . Similar procedures can be followed with regard to memory metal bands and the other kinds of restraint elements such as those described above.  
         [0069]    The clips  1930 ,  1934  allow the patient to connect and disconnect the restraint element  1926 , thereby removing some of the inconvenience of the restraint when it isn&#39;t necessary and providing the useful function of the restraint when it is beneficial. For example, the patient can clip the restraint elements  1926  into the sets of brackets  1910 ,  1914  before each meal, or, for example, once each day. For example, the clips  1930 ,  1934  are snapped into the female portions or rings  1918 ,  1922  of the brackets  1910 ,  1914  and held in place by a latching mechanism (not shown).  
         [0070]    Due to imperfections in the symmetry of the mouth and/or the symmetry of the installation of the brackets  1910 ,  1914  on either side of the mouth, it may be that the restraint element  1926  associated with each set of brackets  1910 ,  1914  is a different length. Therefore, since the restraints  1938  are removable, the patient should be aware of which restraint is associated with which set of brackets. For example, the restraints  1938  can be color coded or otherwise tagged. Alternatively, the patient should test restraint synchronization each time the restraint elements  1926  are installed. If one restraint  1926  appears to engage for one or more other restraint elements  1926 , the patient should make another attempt to properly locate the restraint elements  1926 .  
         [0071]    Referring to FIG. 20, a second semi-permanent restraint system includes orthodontic brackets  2010 ,  2014 , which are mounted to selected teeth of a patient by any of the means described above. The brackets  2010 ,  2014  include female portions or pockets  2018 ,  2022 . Temporary restraint elements  2026  include male end pieces  2030 ,  2034  for being received in the pockets  2018 ,  2022 , respectively. For example, the male end pieces  2030 ,  2034  are rectangular tabs. The rectangular tabs are linked together by a restraint  2038 . For example, the restraint  2038  is similar to the restraint  1938  described in reference to FIG. 19 and is sized and installed accordingly. Similarly, symmetric sets of brackets  2010 ,  2022  and restraint elements  2026  are preferably installed on either side of the mouth. Before each meal, or, for example, once each day, the patient installs the restraint elements  2026  into the brackets  2010 ,  2014 . For example, the male end pieces  2030 ,  2034  are snapped into the female portions  2018 ,  2022  of the brackets  2010 ,  2014  and held in place by a latching mechanism (not shown). For example, end caps can hold the male end pieces in the pockets  2018 ,  2022 . Alternatively, camming style latches or other kinds of latching mechanisms can grasp the end pieces  2030 ,  2034 . After the meal, or a bed time, the patient can remove the temporary restraining element  2026 . For example, the patient can remove the end caps, overcome the forces of a latching mechanism or activate a release device. Of course, the cautionary comments made regarding restraint synchronization in reference to FIG. 19 apply to the embodiment described in reference to FIG. 20.  
         [0072]    A third semi-permanent restraining system includes orthodontic brackets  2110 ,  2124  which include female portions or pockets  2118 ,  2122  and a temporary restraint element  2126 . The temporary restraint element  2126  includes male end pieces  2130 ,  2134 . The male end pieces  2130 ,  2134  are linked together by a restraint  2138 . The restrains is similar to the restraints described in reference to FIG. 19 and FIG. 20. The shape of the male end pieces  2130 ,  2134  and the female portions or pockets  2118 ,  2114  are different than the shape of the male end pieces  2030 ,  2034  and female portions or pockets  2018 ,  2022 . For example, the male end pieces  2130  and  2134  are in the form of circular tabs, and the female portions  2118 ,  2114  are shaped to receive them. However, in installation, operation, and most other respects, the third semi-permanent restraint system is the same as the system described in reference to FIG. 20.  
         [0073]    Some patients may object to the bonding of brackets to their teeth. For those patients, removable trays can be employed to restraint jaw movement.  
         [0074]    Referring to FIG. 22, an impression is made of the upper and lower teeth of the patient. The impression is used to make a tightly fitting custom set of trays  2210  for the patient. The trays snap over the teeth and are firmly held in place by the custom molded, interlocking nature of the trays with contours or undercuts of the teeth. An upper tray  2214  is linked to a lower tray  2218  by restraints  2222 ,  2226 . Due to the perspective nature of FIG. 22, the restraints appear to be different lengths. However, the restraints  2222 ,  2226  are sized for synchronization so that the load of jaw restraining is shared as equally as possible between the two restraints  2222 ,  2226  and their associated trays and teeth. While the illustrated embodiment includes only a single upper tray  2214  and a single lower tray  2218 , it is not always necessary to include the front or anterior teeth in the restraining system. In those cases, the anterior portion of the trays may be removed (or not included in the molding operation) leaving two upper trays and two lower trays for fitting over, for example, the left and right upper molars and the left and right lower molars, respectively. In any event, the upper and lower trays can be removed along with their linking restraints  2222 ,  2226  at the discretion of the patient. For example, the patient can install the trays before every meal or upon waking. The trays can be removed after every meal or, for example, before going to sleep.  
         [0075]    Magnets can be associated with the brackets  1910 ,  1914 ,  2010 ,  2014 ,  2110 ,  2114  in manners and for purposes similar to those described above in reference to the more permanent type installations. Furthermore, similar magnets can be associated with the trays  2210 ,  2214 .  
         [0076]    Additionally, if the restraints are iron  1938 ,  2038 ,  2138 ,  2238  based, for example, made of stainless steal, or other wise magnetic, magnets can be included in association with the brackets, restraints or trays to help coil up the restraints when the mouth of the patient is closed. For example, the clips  1930 ,  1934 , or male tabs  2030 ,  2034 ,  2130 , and  2134  can comprise magnets or magnets can be included in the brackets  1910 ,  1914 ,  2010 ,  2014 ,  2110 ,  2114 . Coiling magnets can also be molded into the trays  2210 ,  2214 .  
         [0077]    The brackets  1910 ,  1914 ,  2010 ,  2014 ,  2110 ,  2114  and trays  2210 ,  2214  can also be used in conjunction with stationary arches.  
         [0078]    While the invention has been described, up until now, in terms of direct bonding of fibers and the use of brackets bonded to teeth, other mounting apparatus can be used. For example, interdental brackets that involve a mounting pin or wire inserted through an interdental space between teeth can also be used. A nut and a bracket mounted on the pin sandwich portions of teeth on either side of the interdental space. The nut and bracket act as clamping elements. The bracket can be any bracket, such as, for example, modified versions of the brackets described above in reference to FIG. 10-FIG. 22. Alternatively, brackets can be mounted with orthodontic bands. The bands are wrapped around the entire circumference of the tooth. The band replaces the bracket pad and adhesive. Any of the bracket mechanism, including those described above, in reference to FIG. 10-FIG. 22 can be attached to the band.  
         [0079]    In summary, a method  2310  operative to help a patient lose weight should include a consultation  2314 . In the consultation, the patient is told about the method and apparatus. The various apparatus options are described. The purpose of the apparatus is also explained and the patient&#39;s level of motivation is evaluated. If the patient indicates a desire to use the apparatus as an aid in losing weight, the oral health of the patient is evaluated  2318 .  
         [0080]    The oral health evaluation includes  2318 , for example, a standard medical/dental status review and documentation procedure. The evaluation involves a blood work up, vital signs (height, weight, blood pressure, temperature), and a general dental evaluation of the teeth and gums. The oral health evaluation  2318  facilitates a treatment plan design. For example, the oral health evaluation aids in the selection of the best teeth to receive the appliance. The oral heath evaluation  2318  also uncovers any contraindications that may be associated with the patient.  
         [0081]    Contraindications to the use of the appliance may include, for example, a lack of posterior teeth, a lack of any teeth at all, rotted or decayed teeth, and severe gum disease.  
         [0082]    If no contraindications are noted in the oral health evaluation  2318 , measurements are taken  2322  related to the mouth of the patient. For example, a centric relation and a maximum speech distance measurement are taken. The centric relation is a measurement of the relation of the teeth when the mandibular condyle is in the most anterior superior position. The maximum speech distance measurement is the maximum distance a patient needs be able to move the jaw in order to complete every sound needed during speech. This distance may be a practical limit on an amount of jaw movement restriction that can be provided to the patient. These measurements and a consideration of the patients eating habits and life style are taken into consideration when selecting a restrained distance.  
         [0083]    The oral health evaluation  2318  and measurement collection  2322  can also be helpful in selecting teeth  2326  or positions within the mouth for attaching restraining fibers or mounting restraining brackets. Preferably, upper and lower first and second molars are selected. However, if one or more of those teeth are unavailable or contraindicated, bicuspids can also be used. Selecting more anterior teeth has some drawbacks. For example, the anterior teeth have a reduced root surface area. This reduced surface area leads to a reduction in tooth anchorage and an increased risk of tooth loosening and movement. Selecting more anterior teeth also has cosmetic drawbacks in that others can more easily see the appliance.  
         [0084]    Where indicated, or where extra precautions are desired, stationary arches or arch segments are designed and formed  2330 . Preferably, stationary arches are formed by first taking impressions of the upper and lower jaws. The impressions are sent to an orthodontic lab. The lab fabricates lingual holding arches. This procedure may be initially bypassed, and only used in cases where unwanted tooth movement is noted. When used, the arches are, of course, installed  2334 . Preferably, the arches or arch segments are installed on the lingual side of the teeth.  
         [0085]    Restraining fibers or brackets are then mounted or bonded to the selected teeth. Where brackets are used restraining fibers or elements are installed in the brackets. In order to install the restraining fibers or elements, the patient&#39;s mouth is positioned at a selected restricted maximal opening. Preferably, the opening is not less that the maximum speech opening distance. However, preferably the restricted maximal opening distance is otherwise as small as can be tolerated by the patient. The patient&#39;s mouth is held at the restricted maximal opening by placing an adjustable bite block into the patient&#39;s mouth. The bite block is selected or adjusted to correspond to the selected restricted maximal opening. The patient is asked to bite down on the block, and the restraining fibers are installed and synchronized either by direct bonding or through the use of brackets that facilitate fiber adjustment and synchronization such as those described in reference to FIG. 10-FIG. 22.  
         [0086]    The invention has been described with reference to particular embodiments. Modifications and alterations will occur to others upon reading and understanding this specification. It is intended that all such modifications and alterations are included insofar as they come within the scope of the appended claims or equivalents thereof.