Abstract:
An intraoral orthosis device that has a maxillary and mandibular bite tray connect by a telescoping arm or releasable fasteners. The configuration of the telescoping arm makes it very easy for a user to adjust the length of the telescoping arm. Another object of the invention is the use of an anchor that attaches the telescoping arm to the maxillary or mandibular bite. Yet another object of the invention is a spacer that allows the user to easily adjust the positions of the telescoping arms. 
     Accordingly another aspect of the present invention is to provide a method to manufacture an intraoral orthosis device. The method utilizes an analyzer, an articulator, and a sander. The new method ensures that the shape and angles of the intraoral orthosis device meet the specification while reducing the amount to time to manufacture the device.

Description:
FIELD OF THE INVENTION 
       [0001]    This invention relates to a device and method for manufacturing the device which prevents inference with normal breathing during sleeping, and more particularly to a device which alleviates snoring and sleep apnea. 
       BACKGROUND 
     PRIOR ART 
       [0002]    Sleep apnea occurs when the muscles and tissues in the back of a person&#39;s throat relax and collapses the person&#39;s airway during sleep. As air attempts to pass through this collapsed airway, tissues vibrate and causes snoring. Sometimes this collapse prohibits airflow so severely that a person may briefly stop breathing. The person&#39;s body may automatically responds and wakes the person up, allowing airflow to resume. This pattern of air deprivation and breath resumptions is known as sleep apnea. Sleep apnea can cause multiple complications, including chronic fatigue, high blood pressure, depression, heart attack and more. 
         [0003]    The United States of America, Food and Drug Administration (FDA) has approved two different devices to eliminate or reduce sleep apnea. This first device is a continuous positive airway pressure most commonly known as a CPAP. A CPAP devices opens a blocked airway by forcing air down a person&#39;s throat through a mask to keep the airway open and eliminating or reducing sleep apnea. There are several limitations to the CPAP device. Many people find a CPAP extremely uncomfortable and loud. Many users stop using the CPAP device. 
         [0004]    The second device is an oral appliance device or a month piece. Traditionally, the intraoral orthosis devices comprised of a maxillary bite tray and a mandibular bite tray. The maxillary bite tray and the mandibular bite tray are connected by either a rod or a releasable fastening surface. The intraoral orthosis devices opens a blocked airway by sustaining the bottom jaw forward while ones sleep, maintaining the airway open, and allowing air to flow freely. 
         [0005]    There are several limitations of the existing intraoral orthosis devices to control sleep apnea. The temporomandibular joint is a hinge joint that connects the lower jaw to the temporal bones of the skull. As the temporomandibular joint opens, the distance between the crowns of the back of the maxillary and mandibular teeth becomes increasing smaller with respects to the distance between the crowns of the front of the maxillary and mandibular teeth thus creating an angle. 
         [0006]    Determining the angle of the temporomandibular joint is essential in constructing intraoral orthosis devices. Due to the complexity of getting the proper temporomandibular angle, manufactures build up acrylic on the crown of the back molar of the mandibular bite tray. When the patient bites down with the maxillary and mandibular bite trays inserted over the teeth, the force of biting down is placed 100% on the back molar where the buildup of acrylic was placed. This causes sore muscles, sore back molars and other problems. Many times the user may simply stop using the intraoral orthosis devices. 
         [0007]    Yet another limitation is the placement of locking devices. Due to the technician not being able to get the proper temporomandibular angle, locking devices that connect the mandibular bite tray and the maxillary bite tray are connected on the anterior or interior of the teeth causing irritation and pain to the gums or tongue. 
         [0008]    Yet another limitation is the material and hardware utilized to manufacture an intraoral orthosis devices. To connect the rod or any other locking device to the bite tray, technicians generally install anchors in the bite trays. The technician place an anchor on the anterior of the back molar of the mandibular bite tray and on the anterior of the canine of the maxillary bite tray by applying acrylic and acrylic liquid around the anchors, teeth and gums. With the maxillary and mandibular bite trays placed in a normal biting position, the mandibular and maxillary bite trays are connected together by a rod screwed into the anchors. If the length between the anchor placed on the back molar of the mandibular and the anchor placed on the canine of the maxillary is longer or shorter than the rod, the technician has to reconstruct the bite trays and replace the anchors with acrylic. Also, if the acrylic on the mandibular or maxillary bite trays protrude from the bite trays in a fashion that does not allow the arm to connect the mandibular bite tray and the maxillary bite tray, the technician has to either shave down the acrylic to allow the arm to connect to the bite trays or has to reconstruct the two trays building the anchors further away from the teeth. In addition, because the majority of bite trays are constructed of acrylic, it is very difficult to make adjustments. 
         [0009]    Another limitation is the current methods of manufacturing the intraoral orthosis devices are extremely costly and time consuming. Currently, to manufacture an intraoral orthosis devices requires extensive hand work by a skilled technician. The technician will usually make several measurements of the bite trays and attempts to remove any excess material. If the technician removes too much material, the technician is required to add material and start the process over. The process of removing and adding material may take a skilled technician hours to create a single intraoral orthosis device. Due to the cost, many individuals whom would benefit from using an intraoral orthosis device cannot afford it. 
         [0010]    Although the prior art did attempt to minimize the described limitations, the prior art did not resolve the limitation adequately. There remains a need for an intraoral orthosis device that is comfortable to wear. In addition, the device needs to be easily manufactured to decrease the cost. 
       SUMMARY OF THE INVENTION 
       [0011]    An intraoral orthosis device that has a maxillary and mandibular bite tray connected by two telescoping arms. The telescoping arm consists of an arm rod, an arm sleeve, and an arm screw. The configuration of the telescoping arm makes it very easy for a user or technician to adjust the length of the arm. Another object of the invention is the use of an anchor that attaches the telescoping arm to the maxillary or mandibular bite. Yet another object of the invention is a spacer that allows the user or technician to easily adjust the positions of the telescoping arms from the bite tray. 
         [0012]    Accordingly, another aspect of the present invention is to provide a method to manufacture an intraoral orthosis device. The method utilizes thermoplastic material that is formed using an analyzer, an articulator, and a sander. The new method ensures that the shape and angles of the intraoral orthosis device meet the specification while reducing the manufacturing time. The new method may utilize the telescoping arms or a releasable fastener. The releasable fastener to be placed between the crown on the mandibular and maxillary bite trays from the back molar to the canine 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0013]    The invention may take form in certain parts and arrangement of parts, and preferred embodiment of which will be described in detail in the specification and illustrated in the accompany drawing, which for a part hereof: 
           [0014]      FIG. 1  shows a prospective side view showing a telescopic arm connecting a maxillary bite tray to a mandibular bite tray with an adjustment pin; 
           [0015]      FIG. 2  shows a prospective side view showing a releasable fastener connecting the maxillary bite tray to the mandibular bite tray; 
           [0016]      FIG. 2A  shows an enlarged view of a portion of the releasable fastener connecting the maxillary bite tray to the mandibular bite tray; 
           [0017]      FIG. 3  shows a top prospective view of the invention relative to a user&#39;s teeth, with the telescopic arm connecting the maxillary bite tray to the mandibular bite tray, the dotted lines shows the location of an anchors imbedded in the maxillary bite tray and the mandibular bite tray; 
           [0018]      FIG. 4  shows a top prospective view of the invention relative to a user&#39;s teeth, with the telescopic arm, an attachment screw and an spacer exploded from the maxillary bite tray and the mandibular bite tray; 
           [0019]      FIG. 5  shows a side view of the anchor the dash lines illustrate the location of an interior threaded core; 
           [0020]      FIG. 6  shows a top view of the anchor with multiple petals; 
           [0021]      FIG. 7  shows side view of the spacers illustrating the different parts of the spacer comprising a bottom, a transition and a cylindrical pivot, in this Fig. the transition is fillet for the comfort of the user; 
           [0022]      FIG. 8  shows side view of multiple spacers illustrating the varying heights of the spacers; 
           [0023]      FIG. 9  shows a cross section and the relationship of an anchor, the spacer and an attachment screw; 
           [0024]      FIG. 10  shows a top view of a bite tray relative to a user&#39;s teeth showing the typical location of the anchors imbedded into the bite tray; 
           [0025]      FIG. 11  shows a side view of the telescopic arm with an arm screw, an arm sleeve, and an arm rod; 
           [0026]      FIG. 12  shows an exploded view of the telescopic arm showing the arm screw, the arm sleeve, a bolt, the arm rod and an adjustment pin; 
           [0027]      FIG. 13  shows a cross section of the telescopic arm and the relationship of the arm screw, the arm sleeve, the bolt and the arm rod; 
           [0028]      FIG. 14  shows a side view of multiple arm rod and the varying lengths of the arm rods; 
           [0029]      FIG. 15  is a flow diagram illustrating the steps of manufacturing of an intraoral orthosis device; 
           [0030]      FIG. 16  shows a perspective side view of an articulator attached to a sander with a cast attached to the articulator and an analyzer; 
           [0031]      FIG. 17  shows a side view of the cast attached to the articulator utilizing the analyzer to adjust the setting of the articulator; 
           [0032]      FIG. 18  shows a perspective side view of the sander with the cast attached to the articulator and a bite tray placed on the cast; 
           [0033]      FIG. 19 . Shows a perspective bottom view of the bite tray and the cast; 
           [0034]      FIG. 20  shows a perspective side view of a technician attaching the anchor to a cast with an adhesive substance; 
           [0035]      FIG. 21  shows a side view of a technician applying material to the cast to create a platform; 
           [0036]      FIG. 22  shows a prospective side view of a vacuum forming machine before the thermoplastic material is draped over the with the cast, the platform and the anchor; 
           [0037]      FIG. 23  shows a prospective side view of the technician molding the thermoplastic material; 
           [0038]      FIG. 24  shows a prospective side view of the technician molding the thermoplastic material; 
           [0039]      FIG. 25  shows a prospective side view the bite tray and cast with the technician sanding and forming the bite tray to exposes the top of the anchor and forming the bite tray for the comfort of the user; 
           [0040]      FIG. 26  shows a prospective side view of the technician installing a releasable fastener to the crow of the bite tray. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0041]    The following discussion describes embodiments of the invention and several variations of these embodiments. This discussion should not be construed, however, as limiting the invention to these particular embodiments. Practitioners skilled in the art will recognize numerous other embodiments as well. It is not necessary that the mill have all the features described below with regard to the specific embodiment of the invention shown in the figures. 
         [0042]    In the following description of the invention, certain terminology is used for the purpose of reference only, and is not intended to be limiting. Terms such as “upper”, “lower”, “above”, and “below,” refer to directions in the drawings to which reference is made. Terms such as “inwards” and “outward” refer to directions towards and away from, respectively, the geometric center of the component described. Terms such as “side”, “top”, “bottom,” “horizontal,” and “vertical,” describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology includes words specifically mentioned above, derivatives thereof, and words of similar import. 
         [0043]    Referring generally to  FIG. 1 , an intraoral orthosis device  2  embodying features of the present invention comprising two bite trays  3 . In practiced there will be a maxillary bite tray  5 , or a mandibular bite tray  4 . The maxillary bite tray  5  and the mandibular bite tray  4  are formed to substantially conform to the contours of a user&#39;s teeth. The maxillary bite tray  5  and the mandibular bite tray  4  are connected by a telescoping arm  110 . As shown in  FIGS. 1, 3, and 4  the telescoping arms  110  are attached to an anchor  50  embedded into the mandibular bite tray  4  and the maxillary bite tray  5  by an attachment screw  92 .  FIG. 2  shows another embodiment of the invention with the maxillary bite tray  5  and the mandibular bite tray  4  connected by a releasable fastener  21 . The releasable fastener  21  is attached to the crown of the mandibular bite tray  4  and the maxillary bite tray  5 . Generally, the releasable fastener  21  is attached by an adhesive material such as glue. 
         [0044]    As shown in  FIGS. 5 and 6 , the anchor  50  comprises a base  51 , a shaft  52 , and an interior threaded core  53 . As shown in  FIGS. 3 and 4 , the base  51  is imbedded into the interior of the mandibular bite tray  4  and the maxillary bite tray  5 . The shaft  52  extends from the interior of the bite tray  3  to the exterior. The end of the shaft  52  is generally even with the outer surface of bite tray  3 . The interior threaded core  53  is for receiving the attachment screw  92 . As shown in  FIG. 9 , the interior threaded core  53  extends through the shaft  52  and may extend through the base  51 . Generally, the anchor  50  is placed on the back molar of the mandibular bite tray  4  and near the canine of the maxillary bite tray  5 . Preferably, the anchor  50  is manufactured from stainless steel, although any ridged material may be utilized. While the figures show the anchors  50  utilizing the telescoping arm  110 , the anchors  50  made be utilized by any device connecting the mandibular bite tray  4  and the maxillary bite tray  5 . 
         [0045]    As shown in  FIG. 6 , the base  51  consists of several petals  61  extending from the longitude axis of the base  51 . When the attachment screw  92  is installed, a rotational force or torque is applied to the anchor  50 . The petals  61  provide additional surface area for securing the anchor  50  to the bite tray  3  to resist the rotational force. In practice, three petals  61  are utilized, however, one skilled in the art will recognize that the size, length and number of petals may vary. 
         [0046]    As stated above, the maxillary bite tray  5  and the mandibular bite tray  4  are connected by at least one telescoping arm  110 , in practice two telescoping arms  110  would be utilized. As illustrated in  FIG. 12 , the telescoping arm  110  includes an arm screw  111 , an arm sleeve  113 , a bolt  122 , and an arm rod  116 . 
         [0047]    The arm screw  111  is generally a cylindrical shape rod with screw threads located along the outer diameter of the longitudinal axis. Located at the end of the arm screw  111  is an arm screw eyelet  112 . The arm rod  116  is generally a cylindrical tube. The outer surface of the arm rod  116  is smooth, the inner portion has an internal threads  124  along the longitudinal axis. Located at the end of the arm rod  116  is an arm rod eyelet  117 . 
         [0048]    The arm sleeve  113  is generally a cylindrical shape tube. As seen in  FIG. 13 , the arm sleeve  113  has an interiorly threaded cylindrical portion  121  and an interiorly smooth cylindrical portion  123 . The interiorly threaded cylindrical portion  121  is for receiving the arm screw  111 . The interiorly smooth cylindrical portion  123  is for receiving the arm rod  116 . The interiorly smooth cylindrical portion  123  is comprises of two different diameters widths creating a narrow portion  125  and a wide portion  126 . The narrow portion  125  is located near the end of the arm sleeve  113 . The wide portion  126  is located near the center of the arm sleeve  113 . The junction at the narrow portion  125  and the wide portion  126  creates a ledge  124 . 
         [0049]    As illustrated in  FIG. 13 . the bolt  122  secures the arm rod  116  to the arm sleeve  113 . The head of the bolt  122  has a diameter which is smaller than the wide portion  126  and a diameter larger than the narrow portion  125 . The bolt  122  interactions with the ledge  124  and secures the arm rod  116  to the arm sleeve  113 . An opening  127  is created between the bolt  122  and the arm screw  111 . The bolt  122  and the arm rod  116  freely slide within the length of the wide portion  126 . The arm rod  116  may also slide freely along the longitudinal axis of the arm sleeve  113  within the opening  127 . 
         [0050]    As seen in  FIG. 12 , the outer diameter of the arm sleeve  113  is uniform except at the arm sleeve expansion  126  where the outer diameter increases and flairs outwards from the longitudinal axis of the arm sleeve  113 . The arm sleeve expansion  126  is located near the interiorly threaded cylindrical portion  121 , as seen in  FIG. 13 . 
         [0051]    As seen in  FIG. 1 , the maxillary bite tray  5  and mandibular bite tray  4  are situated in the natural biting position. Because each user&#39;s mouth is unique and the location of the anchors  50  may vary, the length of the telescoping arm  110  may be adjusted. As shown in  FIG. 11 , the arm rod  116  and arm screw  111  maybe completely covered by the arm sleeve  113 . However, as shown in  FIG. 13  the arm rod  116  and arm screw  111  may extend out of the arm sleeve  113 . As seen in  FIG. 12 , the arm sleeve expansion  123  has at least one adjustment port  114 . The adjustment port  114  allows the user to place an adjustment pin  125  in the adjustment port  114 . As shown in  FIG. 1 , when a force is applied to the adjustment pin  125 , the forces causes the arm sleeve  113  to rotate. Dependent on which way the arm sleeve  113  is rotated, the arm screw  111  will either extend out of the arm sleeve  113  or descend into the arm sleeve  113 . The adjustment of the depth of the arm screw  111 , affects the overall length of the telescoping arm  110 . Located on the outer diameter of the arm sleeve  113  is an inscription  115 . The inscription  115  provides directions to the user on which way to rotate the arm sleeve  113  with the adjustment pin  125  to adjust the length. 
         [0052]    A user or technical may also adjust the length of the telescoping arm  110 , by utilizing different length arm rods  116 . The length of the arm rods  116  may vary, as seen in  FIG. 14 , there is an extended arm rod  131  and a reduced arm rod  132 . The user may extent the length of the telescoping arm  110 , by utilizing the extended arm rod  131 . Reduce the length of the telescoping arm  110 , the user would utilize the reduce arm rod  132 . By utilizing the different arms rod  116  and by adjusting the depth of the arm screw  111 , the user can fine tune the length of the telescoping arm  110  for maximum comfort. 
         [0053]    To prevent the telescoping arm  110  from contacting the bite tray  3 , a clearance  31  is required. As shown in  FIGS. 3 and 4 , located between the telescoping arm  110  and the anchor  50  is a spacer  70 . The spacer  70  allows the user or technician to create the correct clearance  31 . The spacers  70  height may vary, as illustrated in  FIG. 8 , there is an elongated spacer  75  and a petite spacer  76 . The user or technician may attach the tall spacer  75  and the petite spacer  76  to adjust the clearance  31  to the bite tray  3  as shown in  FIG. 3 . 
         [0054]    As shown in  FIG. 7 , the spacer  70  comprises of a bottom  71 , a transition  72  and a cylindrical pivot  73 . The transition  72  may be fillet for the comfort of the user. The height of the bottom  71  may vary between 0.5 mm to 20 mm. As shown in  FIG. 3 , the bottom  71  is located next to the bite tray  3  and the anchor  50 . 
         [0055]    The cylindrical pivot  73  is utilized to allow the telescoping arm  110  to rotate or pivot freely around the spacer  70 . As shown in  FIG. 3 , the inner diameter of the arm screw eyelet  112  and arm rod eyelet  117  is larger than the outer diameter of the cylindrical pivot  73 , such that when the cylindrical pivot  73  is placed inside the arm screw eyelet  112  or arm rod eyelet  117 , the telescoping arm  110  is free to rotate and pivot. However, the space between the arm screw eyelet  112  and the cylindrical pivot  73  is small enough that it prevents the user&#39;s tissue from becoming pinched. 
         [0056]    As shown in  FIG. 9 , the center of the spacer  70  has a conduit  91  for the attachment screw  92 . Preferably, the spacer  70  is manufactured from stainless steel, although any ridged material may be utilized. 
         [0057]      FIG. 15  illustrates the steps taken by a user or technician to manufacture the intraoral orthosis device  2 .  FIG. 19  shows an impression  190  is made of the user&#39;s upper and lower teeth (step  100 ).  FIG. 20  show that from the impressions  190 , a cast  200  of the mandibular teeth and the maxillary teeth are fabricated (step  102 ). In addition,  FIG. 19 , shows the technical attaching the anchors  50  to the anterior of the back molar of the mandibular cast  200 . For the maxillary cast  200 , the anchor  50  would be attached to the anterior of the canine The material utilized to attached the anchors  50  is generally an ethylene-vinyl acetate polymer. Ethylene-vinyl acetate is a polymer that is an elastomeric material which is soft and flexible, yet can be processed like other thermoplastics. A hot glue gun  212  is used to melt and apply the ethylene-vinyl acetate. However, other material that has the same properties as ethylene-vinyl acetate may be utilized. 
         [0058]    As shown in  FIG. 21 , the technician creates a platform  211  using ethylene-vinyl acetate on the crown of the canine back molar with the glue gun  212  (step  104 ). As illustrated in  FIG. 22 , the cast  200  with the anchors  50  and platform  211  is placed on a vacuum forming machine  220  (step  106 ). In a vacuum forming machine  220 , heat is applied a thermoplastic material  221 . As shown in  FIG. 23  after the thermoplastic material  221  is heated, the thermoplastic material  221  is draped over the cast  200 , anchor  50  and the platform  211 . A vacuum and heat is applied to the bottom side of the thermoplastic material  221 . The vacuum causes the thermal plastic material  221  to wrap and shrink tightly over the cast  200 , anchor  50  and platform  211 , forming the bite tray  3 . The glue utilized to attach the anchor  50  and build the platform  211  fuses with the thermoplastic material  221 . The anchor  50  is now embedded into the bite tray  3 . 
         [0059]    While the thermoplastic material  221  is still malleable, a technician utilizes a forming tool  231  shapes the thermoplastic to the correct shape around the cast  200 , anchors  50  and platform  211  as illustrated in  FIGS. 23 and 24 . The cast  200  and newly formed bite tray  3  with the anchor  50  is removed from the vacuum forming machine  220 . 
         [0060]    As shown in  FIG. 25 , excess thermoplastic is removed and the thermoplastic material  221  covering the end of shaft  52  of the anchor  50  is removed with a dermal  241  exposing the tip of the shaft  52 . The bite tray  3  is removed from the cast  200  (step  108 ). 
         [0061]    As shown in  FIG. 16 , the cast  200  is attached to an articulator  161  (step  110 ). The articulator  161  is a mechanical device used in dentistry that holds the cast  200 . The articulator  161  is attached to a sander  162  by means of a hinge joint  163  that allows the technician to rotate the articulator  161  away from the sander  162 . 
         [0062]    As shown in  FIG. 17 , utilizing the articulator  161 , the crown of the mandibular cast  200  is placed against the sander  162 . An analyzer  171  is placed between the sander  162  and the cast  200 . The analyzer  171  creates a first angle  172  between the horizontal plain of the sander  162  and the crown of the cast  200 . The first angle  172  has a similar vertex as the temporomandibular joint. Achieving the proper angle and vertex is essential for comfort to the user. 
         [0063]    If the first angle  172  is set correctly, the maxillary bite tray  5  ( FIG. 1 ) and the mandibular bite tray  4  has a constant contact from the back molar to the canine teeth. The preferred angle of the first angle  172  is between 0.5 and 10 degrees from the horizontal plane of the sander  162  as shown in  FIG. 17 . The analyzer  171  is manufactured from any ridged or semi-ridged material such as plastic or metal. The user locks the first angle  172  with articulator  116  (step  112 ). 
         [0064]    As illustrated in  FIG. 18 , the bite tray  3  is placed on the cast  200  and the analyzer  171  is removed (step  114 ). The mandibular bite tray  4  is sanded until approximately 0.5 to 2 mm of material is left between the back molar and the top of the platform (step  116 ). The locked articulator  161  prevents over sanding of the platform  173  and ensures the correct angle and vertex. The bite tray  3  is removed from the cast  200 . 
         [0065]    The user or technician is to repeat steps  102  through  116  to create both the maxillary bite tray  5  and the maxillary bite tray  5  (step  118 ). 
         [0066]    To fabricate an intraoral orthosis device  2  with telescoping arms  110  as shown in FIG.  1 , the mandibular bite tray  4  and the maxillary bite tray  5  are situation in the natural bite position. As illustrated in  FIG. 3 , the telescoping arms  110  and spacers  70  are connected to the mandibular bite tray  4  by inserting the attachment screw  92  through the arm rod eyelet  117  of the telescoping arm  110 , through the conduit  91  of the spacer  70  and tightening the attachment screw  92  to the anchor  50 . Then the telescoping arms  110  and spacers  70  are connected to the maxillary bite tray  5  by inserting the attachment screw  92  through the arm screw eyelet  112  of the telescoping arm  110 , through the conduit  91  ( FIG. 9 ) of the spacer  70  and tightening the attachment screw  92  to the anchor  50 . 
         [0067]    If the telescoping arm  110  is too short or too long to connect the mandibular bite tray  4  and maxillary bite tray  5 , the length may be adjusted by employing a different length arm rod  116  or adjusting the arm sleeve  113  (step  120   a ). 
         [0068]    As described above and shown in  FIG. 3 , to attain the clearance  31  required between the telescoping arm  110 , the mandibular bite tray  4 , and maxillary bite tray  5 , the spacer  70  is placed between the telescoping arm  110  and the anchor  50 . To adjust the width of the clearance  31 , different sized spacer  70  as seen in  FIG. 8  may be utilized (step  122   a ). 
         [0069]    To fabricate an intraoral orthosis device  2  with releasable fastener  2 l as shown in  FIG. 2 , a technician attaches the releasable fastener  21  to the crown of mandibular bite tray  4  and another releasable fastener  21  to the crown of the maxillary bite tray  5  (step  120   b ) 
         [0070]    A variety of different permutations of the invention is contemplated, and not meant to be limited by this disclosure. The present invention is not limited to the preferred embodiments described in this section. The embodiments are merely exemplary, and one skilled in the art will recognize that many others are possible in accordance with this invention. Having now generally described the invention, the same will be more readily understood through references to the above descriptions and drawings, which are provided by way of illustration, and are not intended to be limiting of the present invention, unless so specified. Any element in a claim that does not explicitly state “means” for performing a specified function or “step” for performing a specified function, should not be interpreted as a “means” or “step” clause as specified in 35 U.S.C. §112. 
         [0071]    All features disclosed in the specification, including the claims, abstracts, and drawings, and all the steps in any method or process disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. Each feature disclosed in the specification, including the claims, abstract, and drawings can be replaced by alternative features serving the same, equivalent, or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.