Abstract:
A tongue grasping and restraining device holds the tongue securely during sleep in order to minimize the risk of the tongue slipping back and blocking the throat, a condition known as obstructive sleep apnea. Plural tongue gripping projections are coupled to upper and lower supports. The projections engage and hold the tongue. The upper and lower supports are biased toward one another into a tongue engaging position. The upper support is coupled to the user&#39;s upper jaw, for example, to a denture, dental appliance or by upper teeth engaging mechanisms. The lower support can be hinged or otherwise joined to the upper support or can be separate therefrom. A tube and rod mechanism in one embodiment couples the upper and lower supports together. Exemplary methods of manufacturing tongue gripping projections are also disclosed.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a Continuation of U.S. patent application Ser. No. 11/986,044, filed Nov. 17, 2007, entitled “Tongue Grasping and Restraining Apparatus and Methods”, which application is a National Stage entry of PCT/US2006/019759, filed May 18, 2006, entitled “Tongue Grasping and Restraining Apparatus and Methods”, which application claims the benefit of U.S. Provisional Application Ser. No. 60/684,849, filed May 19, 2005, entitled “Tongue Grasping and Restraining Device for Preventing Sleep Apnea”; and also claims the benefit of U.S. Provisional Application Ser. No. 60/758,603, filed Jan. 13, 2006, entitled “Specialized Tongue Grasping Surfaces for Tongue Restraining Device”, all of which applications are incorporated herein by reference in their entirety. 
     
    
     FIELD 
       [0002]    The technology disclosed herein relates to apparatus for holding an individual&#39;s tongue and to methods of manufacturing such apparatus. 
       BACKGROUND 
       [0003]    The prior art describes a number of devices designed to prevent snoring and/or obstructive sleep apnea by holding the lower jawbone forward. Holding the lower jawbone forward creates some additional space in the pharynx, however, generally, obstructive sleep apnea is caused not by lack of pharyngeal space, but by the tongue dropping back and blocking the pharyngeal airway. Holding the lower jaw forward exerts some forward influence on the resting position of the tongue, since the tongue is attached to the lower jawbone. However, the tongue is only loosely attached to lower jawbone, so holding the lower jawbone forward does not necessarily hold the tongue far enough forward to prevent obstructive sleep apnea. Studies have shown that lower jawbone protrusion is a valuable tool in the treatment of obstructive sleep apnea. However, this approach alone would not be effective in many cases. 
         [0004]    There is a need for an improved apparatus for holding an individual&#39;s tongue forward to reduce the risk of sleep apnea. 
       SUMMARY 
       [0005]    In certain embodiments, an apparatus grasps an individual&#39;s tongue by squeezing it from above and below between tongue gripping surfaces. The device then restrains the tongue from retrusion by coupling to the upper jaw, such as by engaging the upper teeth. Because of the effectiveness of the tongue gripping surfaces, the device can hold the tongue securely all night without compressing the tongue sufficiently to cause pain or discomfort. For example, although variable, tongue compression forces of less than from one to two pounds, for example one-half pound or even less can be sufficient to restrain the tongue. The tongue gripping surfaces can be comprised of projections, such as a large number of densely arranged points or blades. These projections can project at an angle toward the tip of the tongue. The biasing force to squeeze the tongue gripping surfaces against the tongue can be provided by suitable biasing mechanisms, such as springs or rubber bands. The attachment to the upper jaw can be provided by mechanisms, such as an upper dental appliance or denture, a mouthpiece, an adjustable arm which terminates in a flange abutting the front surfaces of one or more upper front teeth, or a length of the material, such as dental floss fastened to one or more of the upper front teeth. 
         [0006]    The tongue gripping surfaces in exemplary embodiments can be curved to more closely follow the contour of the tongue, especially the upper surface of the tongue. 
         [0007]    Mechanisms can also be provided in embodiments to assist in separating the upper and lower tongue gripping surfaces to facilitate the insertion and removal of the tongue. 
         [0008]    In accordance with some embodiments, an apparatus grasps an individual&#39;s tongue by squeezing it from above and below between tongue gripping surfaces. The apparatus of such embodiments is desirably coupled to the upper jaw, such as by a mechanism that engages the upper teeth to minimize the risk of retrusion of the tongue. 
         [0009]    The tongue gripping surfaces can be comprised of plural projections, such as a large number of densely arranged points or blades. The projections, or selected portions thereof, can be supported at a forwardly extending angle toward the tip of the tongue. A biasing force desirably urges the tongue gripping surfaces toward one another to grip the tongue. Exemplary biasing mechanisms comprise springs, elastic bands, or the resiliency of material comprising the apparatus. Coupling to the upper jaw can be provided by suitable jaw coupling mechanisms, such as an upper dental appliance or denture, an arm, that can be adjustable, the arm terminating in a flange abutting the front surfaces of upper front teeth, an elongated tie such as a length of dental floss fastened to one or more of the upper front teeth, and/or a molded upper teeth engaging mouthpiece. 
         [0010]    In one exemplary embodiment, the upper and lower tongue gripping surfaces are carried by upper and lower dental appliances which are biased together, such as by elastic bands. Telescoping mechanisms, such as tube and rod mechanisms, can be used to position the lower jaw in a protruded position. 
         [0011]    In another exemplary embodiment, the upper tongue gripping surface is carried by an upper support comprising a dental appliance, mouthpiece or upper denture and the lower tongue gripping surface is supported by a lower support that is coupled to and movable relative to the upper support, such as by a hinge or other coupler. The upper and lower supports can be biased together, such by elastic bands or springs. In one form, the coupler comprises at least one, and desirably plural torsion springs. In another embodiment, the upper and lower supports are coupled together by a coupler that resiliently urges the supports and tongue gripping surfaces together. 
         [0012]    In another embodiment, upper and lower tongue gripping surfaces comprise portions of a resilient clamp that is biased closed by the resiliency of the material, such as by a flat spring portion of material that couples the upper and lower tongue gripping surfaces together. 
         [0013]    In yet another embodiment, upper and lower tongue gripping surfaces are incorporated into, or comprise portions of, a resilient pouch-like structure. The pouch-like structure in one form can be opened by squeezing inwardly at its sides. 
         [0014]    Various approaches can be used in manufacturing the tongue gripping surfaces. One exemplary approach comprises forming a flexible mold by injecting a rubber molding material onto, and a few millimeters into, a surface comprised of the tips of a large number of pins set in a base, wetting the resulting mold thoroughly with acrylic monomer, and then adding powdered acrylic polymer to the mold until a base thickness of acrylic is established. Other materials can be used in this approach. Another exemplary manufacturing method comprises inserting numerous small staples into a base that, for example can be of flexible material, such as fabric. The base can be adapted to fit the contours of a user&#39;s dental appliance, and affixed to the appliance, such as by embedding the base into dental acrylic. As a further exemplary manufacturing approach, multiple small areas of a substrate or panel can be partially cut out, leaving a hinge portion coupled to the panel, these cut areas can be pushed out, such as by using a stamping process so as to protrude as multiple projections from the surface of the panel. The projections can be angled toward the tip of the tongue. Yet another approach comprises cutting, or etching, transverse grooves in a substrate or panel to create a textured surface of projecting blades. As a further approach, strips of wire mesh can be cut to leave exposed mesh tips after embedding or fastening the strips to a base. The strips are yet another form of blade or tongue engagement projections. 
         [0015]    Desirably, exemplary embodiments are fully intraoral (totally within the mouth without protruding beyond an individual&#39;s lips) although this would not be required in less desirable embodiments. 
         [0016]    Exemplary embodiments can restrain the tongue from retruding beyond its normal resting posture and can be worn comfortably during sleep. These embodiments desirably grasp the tissue of the tongue so effectively that little compressive force is needed to hold the tongue securely for an extended time period, such as all night. Exemplary embodiments are desirably easily openable for insertion or removal of the tongue, and desirably possess mechanisms for coupling to an individual&#39;s upper jaw, for example, via the upper teeth or an upper denture. 
         [0017]    Various embodiments can be comprised of combinations and subcombinations of the following features and aspects. 
         [0018]    One embodiment comprises an apparatus for grasping and restraining the tongue of a user, the apparatus comprising: a first upper support; the first upper support comprising a first tongue gripping surface, the first tongue gripping surface comprising a plurality of tongue engaging projections that extend toward the upper surface of the tongue of a user; an upper jaw coupler adapted to couple the first support to the upper jaw of the user; a second lower support; the second lower support comprising a second tongue gripping surface, the second tongue gripping surface comprising a plurality of tongue engaging projections that extend toward the lower surface of the tongue of a user; and at least one biasing member coupled to the first and second supports and adapted to urge the first and second tongue gripping surfaces together with the user&#39;s tongue positioned therebetween so as to grasp and restrain the tongue of the user. 
         [0019]    In accordance with the one aspect, the entire apparatus, when in use by a user, can be fully positioned within the user&#39;s mouth behind the lips of the user and thereby in accordance with this aspect is entirely intraoral. 
         [0020]    In accordance with an aspect, at least one biasing mechanism urges first and second tongue gripping surfaces together with a light compressive force, such as from about one to two pounds or less on a user&#39;s tongue positioned therebetween. 
         [0021]    In accordance with another aspect, a first upper support can comprise a base portion with tongue engaging projections extending outwardly away from the base portion. 
         [0022]    As a further aspect, an upper jaw coupler can comprise at least one of the following: a dental appliance, a mouthpiece, a denture, a tooth or teeth engaging projection, and an elongated tie for coupling to one or more teeth. In a specific exemplary form, the upper jaw coupler can comprise a tooth or teeth engaging projection that is coupled to the first upper support for movement relative to the first upper support to vary the distance between the tooth or teeth engaging projection and the first tongue gripping surface. 
         [0023]    In accordance with additional aspects, the first and second tongue gripping surfaces can comprise one or more of the following types of projections or combinations thereof: multiple needle-like projections, multiple flat triangular projections, multiple blades, multiple frustoconical projections, tips of multiple staples, and the tips of severed mesh screen. As another aspect, at least a plurality of tongue engaging projections extending toward the upper surface of the tongue of a user can be of a different shape than at least a plurality of the tongue engaging projections that extend toward the lower surface of the tongue of a user. As yet another aspect, multiple tongue gripping projections that extend toward the upper surface of the user&#39;s tongue can have tips or edges sized for insertion between filliform papillae of a user&#39;s tongue. 
         [0024]    In accordance with a more specific example, at least a major portion of the first tongue gripping surface can comprise densely arranged multiple points having a density of at least 500 points per square inch. In accordance with yet another example, the tongue engaging projections of at least the first tongue gripping surface can comprise sharp points having a length of from about 0.05 inch to about 0.1 inch and a maximum base cross-sectional dimension of from about 0.02 inch to about 0.04 inch. 
         [0025]    As yet another more specific example, at least one of the first and second tongue gripping surfaces can comprise a plurality of spaced apart blades having a distal edge with a thickness of from about 0.01 inch to about 0.03 inch. 
         [0026]    In accordance with another aspect, the tongue engaging projections of at least one of the first and second tongue gripping surfaces can comprise a plurality of parallel blades. As a specific example, the tongue engaging projections of at least one of the first and second tongue gripping surfaces can comprise a first set of parallel blades, a second set of parallel blades and a third set of parallel blades, the blades of the first set being non-parallel to the blades of the second and third sets, the blades of the second set being non-parallel to the blades of the first and third sets, and the blades of the third set being non-parallel to the blades of the first and second sets. 
         [0027]    As yet another aspect, the first and second tongue gripping surfaces can each have a front portion located adjacent to or nearest to the tip of the user&#39;s tongue and a back portion located nearest to the base of the user&#39;s tongue, and wherein at least a plurality of the tongue engaging projections of at least one of the first and second tongue gripping surfaces are angled forwardly toward the tip of the tongue. As a more specific example, at least a plurality of the tongue engaging projections of said at least one of the first and second tongue gripping surfaces can be angled forwardly at an angle of from about 45 degrees to about 85 degrees. 
         [0028]    In accordance with another aspect, at least a portion of the first tongue gripping surface can be concavely curved in a transverse direction relative to a user&#39;s mouth so as to more closely follow the contour of a the upper surface of user&#39;s tongue. In an additional aspect, at least a portion of the first tongue gripping surface can be concavely curved in a front-to-back direction to more closely follow the shape of the upper surface of a user&#39;s tongue. As a further aspect, at least a portion of the second tongue gripping surface can be curved in front-to-back direction and/or a transverse direction to more closely follow the contour of the lower surface of the user&#39;s tongue. 
         [0029]    As yet a further aspect, the upper support can be mounted directly to or combined with the upper jaw coupler. 
         [0030]    As another aspect, biasing members usable in the apparatus can comprise one or more of a spring, an elastic band, such as of rubber, or combinations thereof. As an example, at least one biasing member can comprise a flat spring member joining the first upper support to the second lower support at a location forwardly of the user&#39;s tongue. As another example, at least one biasing member can comprise at least one torsion spring positioned to join a forward portion of a first upper support to a forward portion of a second lower support. 
         [0031]    As a further example of an aspect, the first upper support, the second lower support, and the flat spring can comprise portions of a monolithic sheet of material. As a further aspect, the tongue engaging projections of the first tongue gripping surface and the tongue engaging projections of the second tongue gripping surface can be formed from the same sheet of material used to form the first upper support, the second lower support and the flat spring. 
         [0032]    As yet another aspect, the first upper support and second lower support can each comprise a respective portion of a pouch. In one form, the pouch can be annular. In one form, the pouch can be split along at least one of its sides with side-edge portions of the split side or sides of the pouch overlapping one another. 
         [0033]    As a still further aspect, the first upper support and the second lower support can each comprise respective portions of a generally U-shaped clamp. 
         [0034]    As yet another aspect, the second lower support can be provided with a notch that is sized and positioned to accommodate the lingual frenum of the user&#39;s tongue. 
         [0035]    As yet another aspect, the apparatus can also comprise a second jaw coupler adapted to couple the second support to a lower jaw of the user. The second support and second jaw coupler can be comprised together, such as in a dental appliance. This form of apparatus can also comprise first and second telescoping mechanisms, such as tube and rod mechanisms positioned along respective sides of and coupled to the first upper and second lower supports. Each of the tube and rod mechanisms can comprise first and second end portions coupled at one of the first and second end portions to one of the first upper and second lower supports and coupled at the other of the first and second end portions to the other of the first upper and second lower supports. As a more specific example, in one form, each tube and rod mechanism can comprise a first sleeve portion having a rod receiving bore, a rod slideably received by the rod receiving bore, a second threaded sleeve portion mounted to the first sleeve portion and a threaded support coupler threaded into the second sleeve portion, wherein rotation of the threaded support coupler shifts the threaded support coupler into and out of the second threaded sleeve portion depending upon the direction of rotation of the threaded support coupler to thereby adjust the length of the rod and tube mechanism. As a more specific aspect of an exemplary tube and rod mechanism, the first sleeve portion can comprise at least one first anti-rotation surface within the bore and the rod can comprise at least one second anti-rotation surface, the first and second anti-rotation surfaces engaging one another to prevent rotation of the rod relative to the sleeve. 
         [0036]    As yet another more specific aspect of an embodiment, first and second bias element engaging projections can be coupled to the first upper support and extend outwardly at opposed locations adjacent to the front of a user&#39;s mouth, the apparatus can comprise third and fourth bias element engaging projections coupled to the second lower support and extending outwardly at opposed locations adjacent to the front of the user&#39;s mouth, wherein at least one first biasing member, such as one or more elastic bands, can be coupled between the first and third bias element engaging projections and at least one second biasing member, such as one or more elastic bands can be coupled between the second and fourth bias element engaging projections. 
         [0037]    The disclosure is directed to all novel and non-obvious features and method as disclosed herein alone and in various combinations and sub-combinations as set forth in the claims below. There is no requirement that specific or all advantages set forth herein need to be addressed in any one embodiment. The embodiment disclosed herein are exemplary and do not limit the scope of this disclosure. 
         [0038]    The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0039]      FIG. 1  shows a side elevational view of one embodiment outside of user&#39;s mouth. 
           [0040]      FIG. 2  shows a vertical sectional side-view through a portion of the embodiment of  FIG. 1  positioned in a user&#39;s mouth. 
           [0041]      FIG. 3  shows a transverse cross sectional frontal view of the embodiment of  FIG. 1  positioned in a user&#39;s mouth. 
           [0042]      FIG. 3A  shows an example of filliform papillae of a user&#39;s tongue in the process of engagement by projections of one form of an upper tongue gripping surface. 
           [0043]      FIGS. 3B, 3C and 3D  illustrate exemplary tongue gripping surfaces. 
           [0044]      FIG. 4  shows a top view of the lower tongue gripping surface of the embodiment of  FIG. 1 . 
           [0045]      FIG. 5  shows a side view of the mold used in one exemplary manufacturing approach used to fabricate one form of upper tongue gripping surface. 
           [0046]      FIG. 6  shows a vertical sectional side view of another embodiment, with upper and lower tongue gripping supports in an open tongue receiving position. 
           [0047]      FIG. 7  shows the embodiment of  FIG. 6  after it has been allowed to close to grip the user&#39;s tongue. 
           [0048]      FIG. 8  shows a top view of another form of lower tongue gripping surface. 
           [0049]      FIG. 9  shows a perspective view of yet another embodiment. 
           [0050]      FIG. 10  shows a top view of an exemplary substrate, such as a panel, that can be used in manufacturing the embodiment of  FIG. 10 . 
           [0051]      FIG. 10A  shows a top view of an alternative form of substrate usable in manufacturing another embodiment. 
           [0052]      FIG. 10B  shows an enlarged view of a portion of the upper tongue gripping substrate portion of the  FIG. 10B  embodiment. 
           [0053]      FIG. 10C  shows an embodiment similar to that of  FIG. 10  with one form of tool engageable opening assisting mechanism. 
           [0054]      FIG. 10D  shows exemplarily opening mechanisms that can be included in the embodiment of  FIG. 10A  for assisting in opening the embodiment to release the user&#39;s tongue. 
           [0055]      FIG. 11  shows a perspective view of a still further embodiment. 
           [0056]      FIG. 12  shows a front view of the embodiment of  FIG. 11  in a tongue gripping position. 
           [0057]      FIG. 13  shows a front view of the embodiment of  FIG. 11  in a tongue releasing or open position. 
           [0058]      FIG. 14  shows a top view of an exemplary substrate that can be used to manufacture the embodiment of  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION 
       [0059]    A number of exemplary embodiments of tongue grasping and restraining devices are described below. Two examples can be custom devices, which are typically made in a dental laboratory to fit the upper teeth or edentulous ridge. Two other examples can comprise relatively inexpensive devices that may be suitable for “over-the-counter” markets. The latter two devices in one form comprise examples of tongue clamps that can be independently attached or coupled to the upper teeth of a user. Generally, the upper teeth can be used as a source of anchorage for restraining the grasped tongue, because the upper teeth and jaw are fixed to the underside of the front of the skull, while the lower jaw is a single mobile bone. In users who lack upper teeth, an upper denture plate can be used as an upper jaw coupling mechanism. 
         [0060]    In this disclosure, the terms “a”, “an”, and “at least one” means both the singular and the plural. Thus, if two of a particular element are present, there is also a, an, and at least one of these elements that is present. In addition, the term “coupled” means both direct connections between elements and indirect connections of elements through one or more other elements. Also, a component is “embedded” in another component if at least a portion of the component is inserted into the other component. Also, the term “plural” encompasses two or more and the term “multiple” means many (e.g. at least one hundred). 
         [0061]    An exemplary lower jaw protrusion embodiment shown in  FIGS. 1-3  is one embodiment that typically would be made by a dentist for a person with a full or nearly full dentition. 
         [0062]    With reference to  FIGS. 1-3 , an upper jaw coupler is shown in the form of a dental appliance or mouthpiece having teeth receiving portions  102  for receiving the teeth of the user. A cross-piece, plate or palate portion  104  is joined to the teeth receiving portion and comprises one form of an upper tongue gripping surface support. An upper tongue gripping surface  110  is affixed to support  104  of appliance  100 . In this example, the appliance  100  is designed to cover a user&#39;s upper teeth, including teeth along the respective sides of the user&#39;s mouth. Also, in this example a lower jaw coupler  140  is shown. The coupler  140  is shown in the form of a dental appliance or mouthpiece having teeth receiving portions  142  and a cross-piece, plate or lower palate portion  144 . In this example, the dental appliance  140  is designed to cover the user&#39;s lower teeth, including teeth along the respective sides of a lower jaw. In operation, the lower dental appliance  140  is held, along with the entire lower jaw bone of a user when teeth are received therein, in a protruded position, such as by telescopic mechanisms positioned along the respective sides of the apparatus. One specific example of such telescopic mechanisms comprises first and second tube and rod mechanisms (one being indicated at  150  in  FIG. 1 ) along the sides of the teeth receiving portions of the appliances.  FIG. 3  illustrates a portion of a second such tube and rod mechanism  152 . 
         [0063]    A lower tongue gripping surface  120  is affixed to the lower jaw coupler  140 . One advantage of attaching the tongue gripping surfaces to a dental appliance, such as appliances  100 ,  140 , is that appliances that cover the teeth, or at least a majority of such teeth, prevent unwanted tooth movement in response to the forces generated by holding the lower jaw bone forward. Dental appliances are usually able to distribute forces evenly the along the teeth they cover. Appliances that cover the teeth of both upper and lower dental arches prevent adverse movement of all the teeth while also being able to hold the lower jaw bone forward relative to the upper jaw by means such as telescoping tube and rod mechanisms and/or by interlocking inclines. 
         [0064]    In the  FIGS. 1-3  embodiment, the lower jaw is held in protrusion by two tube and rod telescopic mechanisms  150 ,  152 . With reference to  FIG. 1 , one of such tube and rod mechanisms  150  will be described. The mechanism comprises a first sleeve  160  that is elongated and defines a longitudinally extending bore  162  therethrough. A rod  164  is slideably received within bore  162 . An end portion  166  adjacent to lower appliance  140 , and near the forward end of the appliance, can comprise a hook that engages a loop of an anchor  168  embedded within the appliance. A second sleeve  170  is mounted to sleeve  160 , such as by welding, and can be stacked above the first sleeve. Sleeve  170  has a longitudinally extending bore  172  that is desirably threaded. A coupler  174  has an externally threaded shank portion that is threadedly received by the sleeve  170 . Coupler  174  can be shaped to form a hook  176  at one end thereof. Hook  176  can engage a loop portion of an anchor  180  embedded in appliance  100 . With hook  176  disconnected from the anchor, the coupler  174  can be rotated in a first direction to shift hook  176  away from sleeve  170  to telescopingly lengthen the tube and rod mechanism. In contrast, rotation of coupler  174  in the opposite direction shifts hook  176  toward sleeve  170  and shortens the length of the tube and rod mechanism. Although this construction is advantageous, other telescoping mechanisms, such as other forms of tube and rod mechanisms can also be used. 
         [0065]    With reference to  FIG. 3 , the illustrated rod  164  has at least one anti-rotation surface, and in  FIG. 3  the rod is rectangular in cross-section and thus has four such surfaces. In addition, the bore  162  also has at least one anti-rotation surface, for example surfaces formed by the generally oval cross-sectional shape of the interior of the bore  162 . Consequently, the interior of the bore surfaces engage flat surfaces of the rod and restrict the rod  162  against rotation relative to the sleeve  160 . Thus, anti-rotational cooperating surfaces are provided in this tube and rod instruction. The tube and rod mechanisms couple the upper dental appliance  100  to the lower dental appliance  140  in a manner that allows extensions/contraction of the appliances relative to one another. In this example, the anchors  168 ,  180  can be embedded in acrylic on the outer portions of the teeth receiving components of the appliances. When the upper and lower components of the tube and rod mechanisms are engaged in the user&#39;s mouth, the rod  164  projects through open ends of the sleeve  160  so as to permit telescopic reciprocation of the rod within the sleeve. As the user&#39;s mouth closes, the rod slides into the sleeve until the forward most open end of the sleeve abuts the hook  166  and halts the inward movement of the rod within the sleeve. This thereby halts the retrusive movement of the lower jaw bone relative to the upper jaw. 
         [0066]    One or more biasing mechanisms can be provided for biasing upper and lower dental appliances  100 ,  140  toward one another. For example, elastic bands, such as rubber bands  150 ,  152  can engage and be stretched between biasing member coupling extensions. Thus, for example, lower lingual buttons  200 ,  206  can project outwardly at opposed locations from an outer surface of appliance  140  with such buttons  200 ,  206  being positioned toward the front of the user&#39;s mouth. Similarly, lingual buttons  202 ,  208  can project outwardly from appliance  100  in opposed directions with such buttons  202 ,  208  being located toward the front of user&#39;s mouth such as slightly forwardly of buttons  200 ,  206  in this example. Elastic bands  190 ,  192 , extend between respective pairs of the lingual buttons (e.g., band  190  extends between buttons  200 ,  202  and band  192  extends between buttons  206 ,  208 ). Lingual buttons are commonly used in orthodontics for attaching rubber bands. Other mechanisms can alternatively be used to attach biasing members, such as rubber bands or other biasing members, to upper and lower dental appliances. Examples comprise lingual cleats, loops of wire, and structural or anchoring components that are part of a dental appliance. The attachment mechanisms can be located on the outer aspects of the appliances to allow the tongue to fit comfortably between the rubber bands or other biasing mechanisms when they are stretched taut. Plural rubber bands can be used as exemplary biasing mechanisms on each side of the appliances. Orthodontic elastic bands have been found particularly useful. As a specific example, four two ounce (light) force ⅛ inch long latex elastic bands from Dexta Corporation of Napa, Calif. have been found to apply sufficient biasing force to urge the tongue gripping surfaces  110 ,  120  together for holding the tongue securely without causing pain or ischemia. 
         [0067]    In the lower jaw protrusion embodiment of  FIGS. 1-3 , the tongue gripping surfaces  110 ,  120  are separated for insertion or removal of the tongue simply by opening the user&#39;s mouth. This makes insertion and removal of the tongue easy, but does not preclude the possibility of the user&#39;s mouth opening and allowing the tongue to slip out of the space between the tongue gripping surfaces when the user is asleep. 
         [0068]    The tongue gripping surfaces  110 ,  120  can be equipped with various mechanisms for frictionally engaging and grasping the user&#39;s tongue therebetween. The tongue gripping mechanisms desirably comprise a plurality of projections and most desirably include a multiplicity of such projections. The projections of tongue gripping surface  110  can be different from, identical to, or similar in part to, the projections of tongue gripping surface  120 . Also, combinations of different types of projections can be used on either or both of the tongue gripping surfaces  110 ,  120 . 
         [0069]    With reference again to  FIGS. 1-3 , the downward or tongue facing portion of upper tongue gripping surface  110  is desirably comprised of a large number of projections. These projections can be needle-like and can be configured to fit between the filliform papillae which occupy most of the upper (dorsal) surface of the front half of the tongue. These needles can be of any suitable material, such as of plastic or metal, with acrylic and stainless steel being specific examples.  FIG. 2  illustrates projections of tongue gripping surface  110  bearing against the upper surface of the user&#39;s tongue  250  and projections of the gripping surface  120  bearing against the under surface of the tongue.  FIG. 3A  illustrates exemplary needle-like projections, some being numbered as  260 , shown being positioned between filliform papillae  262  of the user&#39;s tongue as the tongue gripping surface  120  engages the upper surface of the tongue. 
         [0070]    The projections can take many forms, in one specific example, like the filliform papillae, the needles can be about 0.1 inch long and about 0.03 inch in diameter at their bases. With such small diameters, two or three thousand of the needles can fit on a surface the size of upper tongue gripping surface  120 . Desirably, the density of such projections is at least about 500 per inch. Although the ends of the individual needles can be very sharp, the large number of such needles provides a “bed of nails” effect that make them safe to apply to the tissue of the upper surface of the tongue without the danger of cutting the tissue. In  FIG. 3A , the projections each comprise a right cylindrical base portion  270  and a tapered conical needle-like tip portion  272 . In the embodiment of  FIG. 3B , the projections comprise conical projections  280  projecting from a base  282 . In  FIG. 3C , the projections comprise frustoconical projections  284  projecting from a base  286 . In  FIG. 3D , the projections comprise a plurality of staples, two of which are numbered as  290  in  FIG. 3D . The staples of this example extend upwardly through a flexible base  292 , such as a fabric with the crowns  294  (shown for two of such staples) being embedded in material, such as acrylic  296 , coating and impregnating the fabric  292 . Additional acrylic can be placed above the fabric as well. The construction of  FIG. 3D  can be affixed to, for example, the support  104  of the appliance  100 . Other examples of suitable projections are described below. Although desirable, the embodiments are not limited to the specific types or shapes of projections described herein. 
         [0071]      FIG. 3  illustrates a cross-section, in a transverse plain through the lower jaw protrusion embodiment. As can be seen in  FIG. 3 , at least a portion of the tongue gripping surface  110  in this embodiment is concave so that the tongue gripping surface more closely follows the curved curvature of the upper surface of the tongue  250 . In the embodiment of  FIG. 3 , the lower tongue gripping surface  120  is shown as being straight in transverse cross-section. However, this surface can similarly be concave at least in part to more closely fit the contour of the undersurface of the user&#39;s tongue. With reference to  FIG. 2 , at least a portion of the upper tongue gripping surface  110  can also be concave in a front to back direction to again closely follow the contour of the user&#39;s tongue. In addition, a portion of the lower gripping surface  120  can also be curved, for example concave, in a front to rear direction to more closely fit the lower surface of the user&#39;s tongue. It should be noted that these curvatures are not required but do assist in providing a greater surface area of the tongue gripping surfaces in contact with the tongue to thereby enhance the retention of the tongue between the tongue gripping surfaces. Thus, in this exemplary form, the projections forming the upper tongue gripping surface generally follow the same curve as the top of the tongue or the underside of the hard palate of the user. Desirably, the upper tongue gripping surface shown in  FIG. 3  extends laterally to fill the area bounded by the upper teeth and rearwardly back to roughly the location of the first molar of the user&#39;s mouth. It is to be understood that the tongue gripping surface  110  can also extend laterally onto and over the biting surfaces of some of the teeth. 
         [0072]    The projections of the upper and lower tongue gripping surfaces, or at least a plurality of such projections, can be angled forwardly to assist in tongue retention. 
         [0073]      FIG. 4  illustrates a top view of an exemplary form of lower tongue gripping surface  120  that can be mounted to the lower dental appliance. The tongue gripping surface of  FIG. 4  is comprised of numerous rows of blade-like projections, some of which are numbered at  300  in  FIG. 4 . In  FIG. 4 , the projecting blades  300  are shown parallel to one another. Desirably, although not required, the edges of the blades are angled toward the tip of the tongue as they emerge from their supporting base so that the tongue cannot easily move backward from engagement in the space between the upper and lower tongue gripping surfaces. The upper projections and lower blades can, for example, project toward the tongue tip at a desirable angle. A specific example of a projection angle is an angle of from about 45 degrees to 85 degrees, with a 75 degree angle being a more specific example. The blades can have an edge which is desirably very thin, for example 0.1 inch or less with a specific example being 0.05 inch. The edges of the blades that contact the lower surface of the tongue can also be beveled to create a sharper edge that faces the tip of the tongue. 
         [0074]    With reference to  FIG. 2 , some of the user&#39;s upper teeth are shown with numbers 31, 32, 33, 34, 35 and 36. In addition, some of the user&#39;s lower teeth are shown with numbers 41, 42, 43, 44, 45, 46 and 47. With reference to  FIGS. 1 and 2 , it can be seen in this exemplary embodiment that there is a change in the angle of the plane or direction of the lower tongue gripping surface  120  at the location corresponding to teeth  46  and  47 . To enhance the grip, the lower tongue gripping surface  120  can follow the natural curve of the underside of the tongue posteriorly down toward the base of the tongue in the user&#39;s neck. In  FIG. 3 , the lower tongue gripping surface  120  is depicted as flat, however it is understood that tongue gripping surface  120  can also have a concavity to fit the natural contour of the underside of the tongue. 
         [0075]    In  FIG. 4 , it can be seen that a notch  310  is provided along the rearmost edge of lower tongue gripping surface  120  with a notch  310  being centrally positioned relative to the illustrated lower tongue gripping surface support. The notch  310  is shown as triangular, but it can be of other shapes. This notch is provided to accommodate the lingual frenum, a fiberous attachment between the underside of the tongue and the lower jaw bone. Alternatively, the support for the tongue gripping surface  120  can be shortened in the rearward direction to terminate forwardly of the lingual frenum with a notch then not being provided. As yet another alternative, a flexible membrane or other flexible component can be provided at such location to accommodate the lingual frenum. 
         [0076]    Various approaches can be used to fabricate the projections of tongue gripping surfaces  110 ,  120 . One exemplary approach for fabricating needle-like projections of the upper tongue gripping surface  110  of the embodiment of  FIG. 1  will be described in connection with  FIG. 5 . With reference to  FIG. 5 , a plurality of mold forming pins, some of which are numbered as  320  in  FIG. 5 , are supported to project upwardly from a mold pin supporting base  322 . Flexible molding material  324  is utilized in this approach to take an impression of the surface formed by the collection of pin points or tips of the pins  320 . Although not shown in  FIG. 5 , the pins  320  can be supported parallel to one another and angled in one direction relative to the base  322  (this results in the molding of tongue engaging projection pins angled forwardly toward the tip of the tongue when the mold is used). The base  322  can be a rigid base, such as one made of plaster and wax which holds the pins so that they do not pull out of the base when the fully set molding material  324  is pulled off the collection of pin points. However, base  322  can also be a flexible base, such as a tightly woven nylon fabric, held under a collection of pins  320  which are tightly enclosed by a surrounding framework, such as by a thick rubber band, so that the pins can freely move up and down relative to each other and thereby the plane of the pin tips can be adjusted to fit any desired surface contour by simply placing flexible base supporting such pins on a surface with the appropriate contour. 
         [0077]    In one approach to manufacturing the mold  324 , a flexible molding material, such as polyvinylsiloxane, is placed or expressed onto and about 1 mm to 3 mm into the surface of the pin points of pins  320 , allowed to set, and removed. A base material, such as fabric cloth, can be placed over the polyvinylsiloxane after it has been expressed onto the pin points to receive some of the molding materials and give the mold tensile strength to facilitate removal of the mold without tearing it. 
         [0078]    The resulting mold  324  can then be used to form a tongue gripping surface. For example, the mold  324  can be used to form a tongue gripping surface of acrylic or other plastic. As a specific example, the mold can be thoroughly wetted with acrylic monomer or other plastic solvent or polymerizing agent. A brush can be used to release trapped air bubbles from the mold. A powdered polymer can then be added to the wetted mold until a sufficiently thick mix of polymerized plastic, such as acrylic, is built up within the mold. Thus, a tongue gripping surface resulting from the use of the mold comprises plural needle-like points supported on an acrylic base. Adding polymer to a mold surface that has already been thoroughly wetted with monomer allows the material, such as acrylic, to reach the full depth made by the impression of the pin points in the mold and thereby create tongue gripping points that are almost as sharp as the pins  320 , which can be comprised of steel, used to make the mold. Vibration can also be used to enhance the distribution of the powdered polymer into the monomer in the ends of the pin point mold depressions. A vacuum can be used to assist in removing trapped air bubbles. The pins  320  can be of other shapes at their tips to result in a tongue gripping surface having alternative shapes. 
         [0079]    In one approach for making a tongue gripping surface, such as lower tongue gripping surface  120  comprised of numerous parallel blades, numerous narrow parallel cuts of from about 0.005 inch to 0.01 inch deep in a panel of a thickness of 0.010 inch to 0.030 inch can be made. The sheet, for example, can be sheet metal such as 300 series stainless steel. Other metals or plastics can also be used. To increase the resistance to rearward movement of the tongue from between the tongue gripping surfaces, the ends of the blades can be beveled so that their edges are proclined toward the tip of the tongue when in use in a user&#39;s mouth. Alternatively, the blades can also be set, such as in parallel, in a resin or other base. Small serrated blades such as jewelers saw blades mounted in a base have been found to be very effective. Alternatively, plastic blades, such as of acrylic, can be fabricated by making a mold having a surface of saw blades, wetting the mold with acrylic monomer, and then filling the mold with polymer in the same manner as described above in connection with making needle-like projections on a tongue gripping surface. As yet another approach, strips of stainless steel mesh can be cut. The cut side edge of such strips will have projecting mesh wires. The opposite side edge can be embedded or secured to a base to comprise a tongue gripping surface of blades formed of such mesh strips. 
         [0080]      FIGS. 6-8  illustrate yet another embodiment of a tongue gripping and restraining apparatus. This embodiment is particularly useful for people who have no upper teeth. However, this embodiment can also be used for other individuals. For individuals without upper teeth, a suitable mechanism for attaching the tongue restraining apparatus to the upper jaw can be by means of an upper denture or base plate that maintains a good fit against the palate and edentulous ridge. The lack of upper teeth provides a great deal of clearance space for accommodating biasing mechanisms, such as torsion springs or other hardware in an upper denture or base plate. Also, a well fitting upper denture or base plate provides sufficient anchorage to the upper jaw to resist retrusion of the tongue when the apparatus is in use. 
         [0081]    In the embodiments of  FIGS. 6-8 , the numbered teeth correspond to teeth of a denture. In this embodiment, the upper tongue gripping surface  120  is mounted to or coupled to a denture  400  that includes the illustrated denture teeth. A base plate, normally used to fabricate a denture, can alternatively be used. Also, for a user with teeth, a dental appliance, mouthpiece, or other jaw coupler can be used. The tongue in this embodiment is held up against the underside of the upper denture and against tongue gripping surface  120  by a biasing mechanism such as first and second spaced apart torsion springs  402  (only one of them being shown in these figures). As a specific example, the torsion springs can be five coil, 0.030 inch thick wire stainless steel torsion springs (part TO-5041 from Century Spring Corp., of Los Angeles, Calif.). Spring  402  is shown in  FIG. 6 , while its counterpart at the opposite side of the device is not shown. The springs can be anchored in any convenient manner to portions of the illustrated device. For example, each spring  10  can include a first leg portion  406  embedded in the upper denture  400  and a second leg portion  408  embedded in a lower support  410  that carries the lower tongue gripping surface  120 . The lower tongue gripping surface support  410  can comprise, for example, a plate. The surfaces  110  and  120  can have contours as previously described. 
         [0082]    In this  FIG. 6-8  example, the lower tongue gripping surface  120  is not attached or coupled to the lower jaw of the user. Consequently, opening the jaw will not pull the lower tongue gripping surface  120  away from the upper tongue gripping surface  110 . As a result, other approaches can be utilized to separate the tongue gripping surfaces so that the tongue can be inserted and removed from between such surfaces. In one specific approach, the tongue gripping surfaces can be separated for insertion or removal of the tongue by the user grasping a handle  420  on the underside of lower support  410 , such as between two fingers, and simply pulling downwardly on the handle  420 . Handle  420  can take any suitable form. In one specific example, the handle comprises a piece of stainless steel right-angle that is perforated at locations such that the perforations and the handle can be embedded in acrylic. The handle can be otherwise attached to or coupled to lower support  410 . A wide variety of mechanical mechanisms can be used to separate the tongue gripping surfaces to facilitate insertion or removal of the tongue. Other approaches can include the user simply grasping the sides of the lower support  410  to pull lower support downwardly and away from the upper support. As another alternative, tools or other mechanisms can be used for this purpose. Thus, for example, a length of dental floss can be coupled to the lower support  410  at a location spaced rearwardly of torsion spring  402  and pulled to separate the upper and lower tongue gripping surfaces  110 ,  120 . 
         [0083]      FIG. 6  illustrates a side view of this embodiment in an open position ready for insertion of a user&#39;s tongue.  FIG. 7  shows this embodiment after it has been allowed to close around a user&#39;s tongue  250 . The tongue  250  is shown slightly compressed in the areas located directly between the upper and lower tongue gripping surfaces  110 ,  120 . As a specific example, the compressive force applied by the torsion spring is approximately one-half of a pound. This force can be increased by using additional biasing mechanisms, such as elastic bands, attached to the upper denture  400  and to the lower support  410 , much like the bands used to bias some examples of the  FIG. 1  embodiment. Other biasing mechanisms can be used to provide this additional biasing force. 
         [0084]    The upper tongue gripping surface  110  and the lower tongue gripping surface  120  of the embodiments of  FIGS. 6-8  can be like those previously described in connection with the embodiments of  FIG. 1-3 . As another specific example, numerous parallel densely arranged 0.01 inch thick stainless steel wires projecting downwardly from a base or from the denture can be used. As a specific example, at least several hundred lengths of wire protruding downwardly into the tissue at the top of the tongue from a base affixed to the upper denture  400  can be used. Wires of up to 0.05 inch in diameter can also be used, as well as other cross sectionally dimensioned wires, but larger numbers of smaller diameter wires are more desirable. Such small wires more effectively engage the upper surface of the tongue because they fit between the filliform papillae which occupy most of the tongue upper surface. 
         [0085]      FIG. 8  illustrates a top view of an alternative form of lower tongue gripping surface  120  that can be used in the embodiments of  FIGS. 6-8  as well as in the embodiments of  FIGS. 1-3 . In the embodiment of  FIG. 8 , the lower tongue gripping surface  120  is comprised of long curving blades, some of which are assigned the number  430  in this figure. Such blades can generally follow the outer border of the sides of the tongue. The blades can, for example, be embedded in or formed as a part of a support plate  432 . Dental acrylic or other resins can be used as well as other materials, to accomplish such embedding. The support plate  432  can then be mounted to the lower support  410 . 
         [0086]    The upper tongue gripping surface  110  can be made in any convenient manner, such as previously described in connection with  FIGS. 1-3 . As a specific example, the approach described previously in connection with  FIG. 3B  can be used. Thus, in accordance with this example, the upper tongue gripping surface  110  of  FIG. 6  can be fabricated to fit the contour of the top of the user&#39;s tongue or the downwardly facing surface of the user&#39;s palate for an upper denture by first penetrating a flexible support, such as of fabric, with miniature staples and then embedding the fabric or support with the connecting portions (the crowns) of each staple in the acrylic of the denture. The staples can be made of stainless steel wire that is roughly, for example, 0.01 inch in diameter. The legs of the staples can be about 0.12 to 0.2 inches long and the crowns of the staples can be about 0.12 inch long. These dimensions can be varied. Although a specific example of a staple supporting base is fabric, the base can be made of any suitable material such as a poured resin. The base is fixed or mounted to the downwardly facing surface of the upper denture or support  400 , such as in a dental laboratory by embedding the base and crowns of the staples in dental acrylic. 
         [0087]    The lower tongue gripping surface can be prefabricated in stock sizes by bending a length of narrow (for example 0.02 inch wide) stainless steel shim stock, that is, for example, 0.004 inch thick, into curves. These curves for example can form a flat or gradually curved plane of generally parallel blades. One side of the edge of the blades can be secured to, such as embedded into, a base, for example of plastic. A single length of shim stock is shown in the illustration of  FIG. 8 . It is understood that a smaller number of somewhat shorter lengths can be used for convenience. The blades can be mounted or coupled to a base, for example set into a thermoplastic base, or a resin base can be poured around the blades. The shim stock can be serrated like a saw blade or given other contours to better grip the lower surface of the tongue. Other mechanisms for manufacturing blade-like tongue restraining structures and embedding them in a support can also be used. 
         [0088]    Desirably, the use of upper and lower tongue gripping surfaces provides a frictional engagement of the tongue. No vacuum is required to hold the tongue in place using these devices. 
         [0089]      FIG. 9  illustrates another embodiment of a tongue gripping and restraining apparatus. This embodiment in one form comprises a flat spring embodiment that can be prefabricated in a relatively inexpensive version that can be provided in stock sizes, such as for over-the-counter distribution. However, such devices can also be distributed by dental professionals, or by others who have been trained to do so. 
         [0090]    In the embodiments of  FIGS. 9-10D , an upper support portion  480  is shown from which tongue gripping surface  110  projects or is carried. Also, a lower support  482  is shown from which upwardly projecting tongue gripping surface  120  projects or is carried. The support  480  can be secured to, coupled to, or embedded in a dental appliance, denture, mouthpiece, or other jaw coupler. In the illustrated example, this has not been done. Instead, supports  480 ,  482  are joined together at a forward end portion of the apparatus by a portion  490  so that elements  480 ,  482  are in effect a clamp. That is, the spacing of the tongue gripping surfaces  110 ,  120  is less than the thickness of the user&#39;s tongue (and can be adjusted by simply bending the member  490  in this example more or less. Member  490  desirably comprises resilient material and thus acts as a flat spring to maintain compressive forces that urge the surfaces  110  and  120  together when a tongue is positioned therebetween. The tongue gripping surfaces  110 ,  120  are simply spread apart to permit insertion of the user&#39;s tongue. The clamp-like structure, which can be generally U-shaped in longitudinal section, is thus of a relatively simple construction. The clamp can be opened against the bias of the flat front spring portion  490  to permit insertion of the tongue and then allowed to close against the tongue. 
         [0091]    The components  480 ,  482  and  490  can be formed of a single monolithic piece of material, such as from sheet material. In addition, the projections of the tongue gripping surfaces  110 ,  120  can also be formed from the same sheet of material. As a specific example, stainless steel sheet material can be used. The bias can be provided by spring portion  490 . If portion  490  is not a spring, the bias can be provided or enhanced by another biasing mechanism, such as attached to the supports  480 ,  482  to urge such supports toward one another. For example, elastic bands attached to the upper and lower tongue gripping supports can be used for this purpose, or elastic bands entirely surrounding the upper and lower supports  480 ,  482  can be used. The tongue gripping surfaces  110 ,  120  can be provided with curved contours to better fit the general curve of the gripped tongue surfaces. For example, in  FIG. 9 , the upper tongue gripping surface  110  has at least a portion thereof that is curved in a transverse (side to side) direction to better fit the general curve of the upper surface of the tongue. 
         [0092]    Portions  480 ,  482  can include handles or points of selective attachment or engagement by a user&#39;s fingers or by tool to assist in spreading the tongue gripping surfaces to facilitate insertion of a tongue into and removal of the tongue from the space between the tongue gripping surfaces. As described in greater detail below, sheet stock can be used in one approach for manufacturing devices such as that shown in  FIG. 9 . With references to  FIG. 10A , a plurality of finger engaging tab portions  500 ,  502  and  504 ,  506  are provided. Tab portions  500  and  502  in this example are included in the support portion  480 . In addition, tab portions  504  and  506  in this example are included in support portion  402 . These tab portions can be bent along fold lines in a direction away from the respective tongue gripping surfaces  110 ,  120 . This can be best seen with reference to  FIG. 10D . By exerting inwardly directed forces in the direction of arrows  510  and  512  against the tab portions, for example by using the fingers of the user of the device, the gripping surfaces  110 ,  120  are spread apart to facilitate insertion and removal of the tongue. With the tongue in place between the tongue gripping surfaces, removal of side forces applied in the direction of arrows  510  and  512  allows the tongue gripping surfaces  110 ,  120  to again close and grip the tongue therebetween. 
         [0093]    With reference to  FIG. 10C , an upper slot defining tool engaging projection  520  is centrally positioned along the upper surface of support  480  and is coupled to this support. In addition, a second slot defining tool engaging projection  522  is coupled to the lower surface of support portion  482 . A leg  524  of a tong-like tool  528  can be inserted into the slot defined by projection  520 . In addition, a leg  526  of the tool  528  can be inserted into the slot defined by projection  522 . In this example, the legs  524 ,  526  are pivoted together at a location  530  and have respective handle portions  531 ,  533  extending beyond the pivot. Applying forces in the direction of arrows  532 ,  534  to the respective handles  531 ,  533  causes the legs  524 ,  526  to move apart and spread the tongue gripping surfaces  110 ,  120  away from one another. Thus, the squeezing of extraoral handles  531 ,  533  together produces an intraoral separation force between the upper and lower tongue gripping surfaces. 
         [0094]    In use, the tongue gripping surfaces  110 ,  120  of the  FIGS. 9, 10C and 10D  embodiments can be open by pulling apart the upper and lower tongue gripping surfaces. The user&#39;s tongue can then be placed into the space between the tongue gripping surfaces. The tongue can be positioned all the way into a curved transition section  490  of the apparatus. With the tip of the tongue (a particularly tender area) pushed all of the way against the curved area  490 , the tongue tip is protected from compressive forces experienced between upper and lower tongue gripping surfaces  110 ,  120 . 
         [0095]    In the embodiment of  FIG. 9 , various jaw couplers can be used to couple the embodiment to the upper jaw. These couplers can be adjustable to allow forward and rearward shifting of the tongue gripping surfaces in the user&#39;s mouth. In one specific example, a projecting arm  550  extends forwardly and is provided with an upwardly projecting tooth or teeth engaging element, such as a flange  552 . The flange  552  is positioned forwardly of one or more front teeth (and desirably entirely intraorally behind the lips of the user) to couple the  FIG. 9  apparatus to the upper jaw of the user. The projection  550  in one specific form is adjustable to vary the space between the tongue gripping surface  110  and the front of the user&#39;s mouth. For example, projection  550  can comprise a first arm portion  554  and a second arm portion  556 . A plurality of apertures, two of which are indicated at  558  in  FIG. 9  are provided in arm section  554 . Apertures  558  can be internally threaded. In addition, a plurality of apertures, two of which are indicated at  560 , are provided through arm portion  556 . The arm portion  556  can be moved forwardly or rearwardly relative to arm portion  554  and positioned to align respective apertures  560  and  558 . Fasteners, such as one or more set screws  562 , can be used to join arm portion  556  to arm portion  554  to fix the tooth engaging projection  552  at a desired location relative to the tongue gripping surface  110 . The flange  552  desirably projects perpendicularly upwardly from arm portion  556  so as to closely fit the forward facing surface of one or more teeth, such as the tooth  570  shown in dashed lines in  FIG. 9 . This partial coupling or attachment to one or more front teeth prevents retrusive movement of the apparatus relative to the upper front teeth while the projection is engaged. The arm  554  can be coupled to the support  480  in any convenient manner, such as by welding or soldering. 
         [0096]    Again, the embodiment of  FIG. 9  can be coupled to the upper jaw of a user by various mechanisms, such as by embedding or securing upper portion  480  to a dental appliance or mouthpiece (such as a rubber boil and bite-type of appliance commonly used for stock athletic mouth guards), in a resin which is directly molded to fit the mouth (such as Tak thermoplastic, or in an upper denture or an upper dental appliance. In addition, other mechanisms can be utilized to couple the apparatus to the upper jaw of the user. For example, an elongated tie, such as dental floss, can be secured (e.g., through openings provided in support  480  to one or more teeth of the user to prevent retrusion of the apparatus). 
         [0097]    In the embodiments of  FIG. 9-10D , the tongue gripping surfaces can be as previously described. As another example, the upper tongue gripping surface  110  can be comprised of numerous small points projecting from a single substrate or panel, such as support  480 . The points can be angled forwardly relative to the tip of the tongue, such as previously described. In one specific approach, the points comprise apices of small triangular elements of the panel which have been bent or pushed out of the plane of the panel, leaving only the bases or hinge points of the elements joined to the panel. The points can be small enough to fit fully down between the filliform papillae of the upper surface of the tongue. The tongue gripping surface  110  can be shaped in a curve which approximates the shape of the top (dorsal) surface of the tongue or the under surface of the palate. 
         [0098]    With reference to  FIG. 10B , a plurality of V-shaped slits, some of which are numbered  580  in  FIG. 10B , have formed in the substrate or panel  480 , these slits can be formed, for example, by laser cutting or by chemical etching. Although the slits can be varied in shape, V-shaped slits are shown in this example. The illustrated slits have a thickness T of about 0.006 inch with a base between the lower portion of each slit being of a distance d that, for example, can be about 0.025 inch. These dimensions can be varied. Following the formation of the slits, stamping or other processes can be used to bend the resulting tongue gripping projections away from substrate  480  and toward the upper surface of the user&#39;s tongue when the apparatus is in use. 
         [0099]    As can best be seen in  FIGS. 9, 10 and 10A , the lower tongue gripping surface  120  can be comprised of a plurality of blade-like structures projecting from the surface of substrate or support  482 . With reference to  FIG. 10 , the illustrated lower tongue gripping surface  120  comprises a first set  600  of plural parallel spaced apart blades  602 . In addition, this tongue gripping surface comprises a second set  604  of parallel spaced apart blades, some of which are indicated by the number  606 . Also, the illustrated tongue gripping surface  120  comprises a third set  608  of parallel spaced apart blades, some of which are indicated by the number  610 . In the construction of  FIG. 10 , the blades of set  600  are perpendicular to a longitudinal axis  612  of the apparatus. In addition, the blades of set  604  and of set  608  are skewed relative to the longitudinal axis. In addition, in this illustrated example, the blades  600  of the first set are not parallel to the blades of either the second or third sets  604 ,  608 . In addition, the blades of the second set  604  are not parallel to the blades of the first and third sets  600 ,  608 . In addition, the blades of the third set  608  are not parallel to the blades of either the first or second sets  600 ,  604 . The blades of the various sets can also be angled forwardly. The blades in the front set  600  of this example are transversely oriented relative to longitudinal axis  612 . In contrast, the blades of the second set of  604  are angled relative to the longitudinal axis and generally parallel an edge  616  of a lingual frenum accommodating notch  614 . Also, the blades of set  608  in this example are skewed relative to the longitudinal axis  612  and are oriented generally parallel to an edge  618  of the lingual frenum accommodating notch  614 . Other projection and blade orientations can be used. 
         [0100]    This configuration of projections of lower tongue gripping surface  120  assist in minimizing excessive sideways movement of the tongue as well as retrusive movement and thus may be particularly desirable in some exemplary situations, such as for use by users who sleep primarily on their sides. Because of the ease of altering the configuration of blades in this exemplary embodiment, the blades can be arranged in custom configurations for certain situations, such as for users who only sleep on one side. Again, various combinations of different types of projections can be used for the tongue gripping surfaces  110 ,  120 . 
         [0101]    The embodiments of  FIG. 9-10D  are relatively inexpensive to fabricate. For example, such embodiments can be made from a single monolithic panel of sheet metal, such as 300 series stainless steel approximately 0.006 inch thick. Although variable, the elongated panel illustrated in  FIGS. 10 and 10A  has opposed parallel planner surfaces and has an overall length dimension of about 3 inches long and width dimension of about 1 inch. These exemplary embodiments are divided into respective end portions separated by a relatively narrow central portion  490 . The notch  614 , if provided, is desirably sized, positioned and configured to fit or accommodate the lingual frenum. The panels of  FIGS. 10A and 10B  can be perforated or slit along numerous V-shaped cuts in the area to form upper tongue gripping surface  110 . In addition, the panel can be perforated along numerous perpendicular cuts in the area that will become the lower tongue gripping surface  120 . In this example, the illustrated cuts in the upper tongue gripping surface forming area outline multiple triangles on two of their three sides. Also, the cuts that form the projections of the illustrated lower tongue gripping surface outline multiple rectangles on three of their four sides. The perforations or cuts can be made, for example, by a YAG laser or by photo chemical etching. 
         [0102]    After the desired cuts have been made in the elongated panel, the partially cut small areas can be forced out beyond the plane of the rest of the panel. This can be accomplished by means of a stamping or other process, which leaves small elements hinged at and projecting from base portions where they attach to the panel. These projections can be angled, for example, toward the narrowed midsection  490  of the apparatus. In the upper tongue gripping surface  110 , the apices of the triangles that form projections can face toward the tip of the tongue when the apparatus is in use. The angle at which the pointed projections project from the panel can be varied, with a range of from about 45 degrees to about 85 degrees being one example, and with a specific example being 75 degrees. In addition, instead of triangles and rectangles, many other shapes of areas, such as truncated triangles, squares and other shapes can be partially cut out and then bent out from the plane of the panel to create tongue engaging projections. An elongated apparatus forming sheet is desirably bent at its midsection  490  until the portions  480  and  482  are roughly in parallel planes directly opposite to each other. For example, they may be separated by a gap of about ⅜ inch and joined together by the section  490 . At the same time, the support  480  can be bent into a curve that more closely fits the shape of the upper surface of a user&#39;s tongue or the underside of a palate. 
         [0103]      FIGS. 11-14  illustrate yet another embodiment of a tongue grasping and restraining device. This embodiment is shown assembled in  FIGS. 11-13  into a pouch-like or pouch structure. This embodiment can also be manufactured relatively inexpensively and can be distributed in any suitable manner, such as using over-the-counter distribution. In addition, exemplary embodiments in accordance with these figures can be manufactured from a single panel. Less desirable, they can be assembled form plural compounds. 
         [0104]    In the embodiment of  FIGS. 11-13 , a pouch  690  is provided. The illustrated body is generally annular with a front edge portion  693 , that is positioned toward the front of the user&#39;s mouth when the apparatus is in use and a rear edge portion  691 , that is positioned adjacent to the rear of a user&#39;s mouth when the apparatus is in use. The rear edge portion can have a lingual frenum accommodating notch  695 , such as previously described. When assembled, the body has a tongue receiving opening  692  and an opposed opening  694  through which the tip of the tongue can protrude. Also, the body can be split from front to rear along one side edge portion with side edges  697  and  699  positioned in an overlapping relationship. As can be seen in  FIG. 12 , in one specific form, the body can be generally oval in cross-section. Also, the body desirably narrows from rear to front, although this is not required. An upper tongue gripping surface  110  is supported by or formed as a part of an upper support portion  700  of the body. A lower tongue gripping surface  120  is supported by or formed as a part of a lower support portion  702  of the body. 
         [0105]    As can be seen in  FIG. 12 , when assembled the exemplary apparatus is somewhat flattened. The spacing between the upper and lower tongue gripping surfaces  110 ,  120  is slightly less than the thickness of the tongue of a would be user. Desirably the body  690  is comprised of a resilient material, such as stainless steel, as in one example of  FIG. 9 . Thus, the resiliency of the body provides compressive forces against the tongue. To open the apparatus to permit insertion and removal of the tongue, inwardly directed side forces, such as applied in the direction of arrows  710 ,  712  in  FIG. 13 . These applied forces cause the tongue gripping surfaces  110  and  120  to separate so as to permit insertion and/or removal of the tongue. Removal of the inwardly directed side forces  710 ,  712  allows the apparatus to return to the configuration shown in  FIG. 12 . Rather than utilizing the resiliency of the material to accomplish compression, other biasing mechanisms can be used. For example, one or more elastic bands can surround the body to urge tongue gripping surfaces  110  and  120  together. 
         [0106]    Upper jaw coupling mechanisms can be used in the embodiment of  FIGS. 11-14 , such as previously described in connection with the embodiments of  FIGS. 9-10D . Thus, for example, an arm structure such as structure  550  and flange  552  ( FIG. 9 ) can be utilized in the embodiment of  FIGS. 11-13  to engage the upper teeth of the user. Alternatively, portions of the body (for example upper support portion  700 ) can be embedded otherwise secured to a mouthpiece, dental appliance, denture or otherwise coupled to the upper jaw of the user. As another alternative, an elongated tie, such as a length of dental floss or line can be coupled between one or more of the user&#39;s upper teeth and holes or other attachment projections provided through or coupled to the body  690 . 
         [0107]    Although other approaches can be used, a single sheet, an example being shown in  FIG. 14  can be used to form a structure like that shown in  FIGS. 11-13 . The tongue gripping surfaces  110 ,  120  in  FIG. 14  are shown as being identical and comprise triangular shaped projections that can be formed in the manner described above in connection with  FIGS. 10 and 10A . Again, other combinations of projections can be used for these tongue gripping surfaces  110 ,  120 . The shape of the pouch-like body  690  can be generally oval in cross-section with a smaller dimension oval at the opening  694  closer to the front of the mouth than at the rear  692 . As a result, the apparatus tends to fit the natural taper of the tongue toward the tip of the tongue. However, a wide variety of shapes can also be used due to the malleable nature of the shape of the tongue. 
         [0108]    The projections formed in the sheet  FIG. 14  can be formed in the same manner as the projections formed in the sheets  10  and  10 A, and can comprise tongue gripping surfaces comprised of multiple points. Such points can be sized or configured to fit between the filliform papillae on the upper surface of the tongue and also can operate to grip the mucus membrane on the under surface of the tongue very effectively. A multiplicity of such points provides a “bed-of-nails” coupling effect. 
         [0109]    As in the embodiment described above in connection with  FIGS. 9-10B , a flat sheet, such as of stainless steel, can be processed by partially severing small area and then forcing them out of the plane of the sheet to form the tongue gripping projections. These tongue gripping projections can project at an angle that are positioned to face partially toward the front of the tongue to assist in gripping the tongue. 
         [0110]      FIG. 14  illustrates a top view of one exemplary panel after the cuts have been made and before the panel has been bent into a pouch-like shape. The area  720  of the panel connecting the perforated tongue gripping surface forming areas  110 ,  120  can be bent so as to position areas  110 ,  120  at locations above and below the user&#39;s tongue. The partially cut areas of the tongue gripping surfaces can be stamped or otherwise processed to project outwardly toward the opposite tongue gripping surface and can be angled forwardly, such as previously described, toward the tip of the tongue. The sheet sections  697  and  699  are also typically bent to provide a gradual curve where such areas overlap. The bends in area  720  and in areas  697  and  699  can be generally parallel to one another and extend from the back edge  691  of the panel toward the front edge of  693  of the panel. The overlapping side sections  697  and  699  can be secured together, such as by spot welding or soldering. The area of overlap of sections  697 ,  699  can be in the shape of a generally C-shaped curve, that can be the mirror image of the curve of the area  720 . Alternative approaches can also be use to provide upper and lower tongue gripping surfaces, such as coupling separately produced tongue gripping surface containing supports to the pouch-like body structure. In addition, the pouch can be constructed of a material of sufficient resiliency to hold the tongue between the upper and lower tongue gripping surfaces while allowing opening of the structure by pushing in on the sides of the structure. 
         [0111]    In the above description, various types of biasing mechanisms can be used, in addition to or in combination with torsion and flat springs, the resiliency of material, and elastic bands to provide biasing forces to urge upper and lower tongue gripping surfaces together. In some cases, the only biasing mechanism necessary to hold the tongue against retrusion can be the passive stretch of jaw closing muscles, especially when large portions of the tongue are held by the apparatus between the teeth so that the teeth are forced apart significantly (at least ¼ of an inch). In addition, alternative manufacturing techniques can be used to provide tongue gripping surfaces. For example, in addition to approaches previously described, small spike-like tongue gripping projections can be made by hot stamping of a plastic panel or by using miniature round punches in a metal panel. In addition, for people with pierced tongues, the source of biasing between upper and lower tongue gripping surfaces can be a bolt or other mechanical fastener which engages upper and lower tongue gripping surfaces and extends through the pierced portion of the tongue. 
         [0112]    Having illustrated and described the principles of my invention with reference to a number of embodiments, it should be apparent of those of ordinary skill in the art that these embodiments may be modified in arrangement in detail without departing from such principles. I claim all such embodiments and modifications that fall within a scope of any one or more of the following claims. 
         [0113]    Having illustrated and described the principles of my invention with reference to a number of embodiments, it should be apparent to those of ordinary skill in the art that these embodiments may be modified in arrangement in detail without departing from such principles. I claim all such embodiments and modifications that fall within a scope of any one or more of the following claims.