Patent Publication Number: US-2023142812-A1

Title: Vibrational oral appliance with mandibular advancements

Description:
FIELD OF DISCLOSURE 
     The present disclosure is directed to an oral appliance. The oral appliance advances the mandible to provide temporary relief from sleep disordered breathing, sleep apnea and/or snoring. 
     BACKGROUND 
     Sleep apnea is a serious, chronic disease that adversely impacts millions of people. Over the years, many treatments and devices have been developed to help patients deal with the symptoms of sleep apnea. In addition, some researchers have devoted time and energy to finding ways to attack the root cause of the disease. For example, U.S. Pat. No. 7,887,324 describes a protocol for correcting common orthodontic and craniofacial abnormalities that lead to sleep apnea and other breathing disorders. The protocol of U.S. Pat. No. 7,887,324 uses a vibrational orthopedic-orthodontic appliance that induces craniofacial homeostasis by triggering a patient&#39;s genome. This treatment protocol changes the shape of the airway and upper and lower jaws of the patient. As a result of the treatment, a patient&#39;s breathing disorder could be significantly reduced in a life-changing way. 
     However, this protocol to correct the airway and jaw of the patient takes some time. During treatment, the patient still suffers from a breathing disorder and needs short term relief. Many devices for short term relief are available on the market, including devices that force the advancement of the mandible during sleep. Yet because the appliance of U.S. Pat. No. 7,887,324 is worn at night, its use conflicts with using other devices for short-term relief while sleeping. Moreover, adaptations of the appliance of U.S. Pat. No. 7,887,324 to provide short term relief have drawbacks. 
     Therefore, there is a need in the art for an improved device that provides short term relief from breathing disorders and also addresses the root cause of the disease. 
     The present disclosure provides an oral appliance that provides short term relief from breathing disorders and also addresses the root cause of the disease. In particular, the oral appliance advances the mandible to provide temporary relief from sleep disordered breathing, sleep apnea and/or snoring. 
     BRIEF DESCRIPTION OF THE DISCLOSURE 
     In one aspect, provided herein is an oral appliance comprising: 
     an upper tray configured to be positioned over an upper dental arch of a patient, the upper tray including first and second posts located bilaterally on a buccal side of a posterior of the upper tray wherein the first post extends from the right-side of the upper tray and the second post extends from the left-side of the upper tray; 
     a lower tray configured to be positioned over a lower dental arch of the patient, the lower tray including third and fourth posts located bilaterally on a labial side of an anterior of the lower tray wherein the third post extends from the right-side of the lower tray and the fourth post extends from the left-side of the lower tray; and 
     a first adjustable hinge arm and a second adjustable hinge arm, wherein the first adjustable hinge arm is removably coupled between the first and third posts and the second adjustable hinge arm is removably coupled between the second and fourth posts, wherein the first adjustable hinge arm and the second adjustable hinge arm are each individually configured to be held in place by O-rings and, when held in place, interlock the upper tray and the lower tray together to produce a desired amount of mandibular advancement; 
     wherein the upper and lower trays are each individually coupled to at least one axial spring configured to contact a palatal/lingual surface of at least one tooth, wherein the at least one axial spring of the upper tray and the at least one axial spring of the lower tray are each individually configured to produce and transmit intermittent, cyclic forces to the palatal/lingual surface of the at least one tooth; and 
     wherein the upper and lower trays each individually comprise at least two sections coupled by an expansion mechanism to enable adjustment of the size of the upper and lower trays to account for palatal expansion and upper and lower jaw development. 
     In another aspect, provided herein is an oral appliance comprising: 
     an upper tray configured to be positioned over an upper dental arch of a patient, the upper tray including first and second posts located bilaterally on a buccal side of a posterior of the upper tray wherein the first post extends from the right-side of the upper tray and the second post extends from the left-side of the upper tray; 
     wherein the first post is configured to receive a first adjustable hinge arm and the second post is configured to receive a second adjustable hinge arm, wherein the first and second adjustable hinge arms are optionally non-permanently attached to the first and second posts, respectively, with O-rings; 
     wherein the upper tray comprises at least one axial spring configured to contact a palatal/lingual surface of at least one tooth, wherein the at least one axial spring is coupled to the upper tray, wherein the at least one axial spring is configured to produce and transmit intermittent, cyclic forces to the palatal/lingual surface of the tooth; and 
     wherein the upper tray comprises at least two sections coupled by an expansion mechanism to enable adjustment of the size of the upper tray to account for palatal expansion and upper jaw development. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the present invention can be more easily understood and further advantages and uses thereof more readily apparent, when considered in view of the description of the various embodiments and the following figures in which: 
         FIG.  1 A  is a perspective view of an oral appliance shown positioned on a set of teeth according to one embodiment of the present invention. 
         FIG.  1 B  is a perspective view of the oral appliance of  FIG.  1 A . 
         FIG.  2    is a perspective view of one embodiment of an upper tray of the oral appliance of  FIG.  1   . 
         FIG.  3 A  is a bottom view of the upper tray of  FIG.  2   . 
         FIG.  3 B  is a close-up view of a palatal expansion system of the upper tray of  FIG.  2   . 
         FIG.  3 C  is a bottom view of an upper tray of the oral appliance of  FIG.  1    with a first palatal expansion system according to one embodiment of the present invention. 
         FIG.  3 D  is a bottom view of an upper tray of the oral appliance of  FIG.  1    with a second palatal expansion system according to one embodiment of the present invention. 
         FIG.  4    is a perspective view of one embodiment of a lower tray of the oral appliance of  FIG.  1   . 
         FIG.  5 A  is a bottom view of the lower tray of  FIG.  4   . 
         FIG.  5 B  is a close-up view of a palatal expansion system of the lower tray of  FIG.  4   . 
         FIG.  6 A  is a front view of a three dimensional (3-D) axial spring according to one embodiment of the present invention. 
         FIG.  6 B  is a perspective view of a three dimensional (3-D) axial spring according to one embodiment of the present invention. 
         FIG.  6 C  is a side view of a three dimensional (3-D) axial spring according to one embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of specific illustrative embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that logical, mechanical and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
     Oral Appliance: Overview 
     Oral appliances in accordance with the present disclosure provide short term relief from breathing disorders and also address the root cause of the disease. Generally, the oral appliances advance the mandible to provide temporary relief from sleep disordered breathing, sleep apnea and/or snoring. 
       FIG.  1 A  depicts a perspective view of one embodiment of a vibrational oral appliance with mandibular advancement, indicated generally at  100 , and constructed according to the present invention. Oral appliance  100  is designed to perform at least two functions. First, oral appliance  100  uses vibrational elements (such as 3-D axial springs, as described in more detail below) to promote palatal and upper/lower jaw development. This function makes physical changes to the patient for long-term correction of breathing disorders. Second, oral appliance  100  is configured to be used as a sleep aide to provide immediate relief for patients suffering from sleep-disordered breathing, including, but not limited to, obstructive sleep apnea (OSA) and snoring. To accomplish this, oral appliance  100  includes a mechanism for mandibular advancement. In some embodiments, this mechanism is a removable part that, when inserted, controls the relative position of the upper and lower jaws of the patient (referred to as mandibular advancement). Thus, the same oral appliance performs two functions: (1) it promotes palatal and upper/lower jaw development, and (2) it provides mandibular advancement for temporary relief from symptoms of sleep-disordered breathing and/or sleep apnea. 
     In some embodiments, the mechanism for mandibular advancement is used only during sleep. In some embodiments, the mechanism for mandibular advancement is removed from the oral appliance, and the oral appliance continues to perform the first function to promote palatal and upper/lower jaw development. 
     In some embodiments, oral appliance  100  includes an upper tray  102  and a lower tray  104 . Generally, upper tray  102  is configured to be positioned over an upper dental arch  106 . Generally, lower tray  104  is configured to be positioned over a lower dental arch  108 . 
     In some embodiments, oral appliance  100  comprises one hinge arm, two hinge arms, three hinge arms, four hinge arms, or more than four hinge arms. In some embodiments, oral appliance  100  comprises removable hinge arms  110  located on opposite sides of oral appliance  100 . Only one hinge arm is fully visible in  FIG.  1 A  because of the perspective view. In some embodiments, oral appliance  100  comprises removable hinge arms  110  that interlock upper tray  102  and lower tray  104  when installed. 
     In some embodiments, the length of hinge arm  110  is adjustable. In some embodiments, the length of hinge arm  110  is set for a patient so that the lower jaw (mandible) of the patient is advanced to an appropriate position to open the airway to provide temporary relief from obstructive sleep apnea (OSA), snoring, and/or other sleep disordered breathing. 
     Generally, hinge arm  110  may be selected from any suitable hinge arm or interlocking mechanism known in the art. In some embodiments, hinge arm  110  is a Herbst-style arm or appliance that has an adjustable length. The specific interlocking arm shown in  FIGS.  1 A and  1 B  is shown by way of example and not by way of limitation. 
     In some embodiments, oral appliance  100  comprises one post, two posts, three posts, four posts, or more than four posts. In some embodiments, oral appliance  100  comprises at least one hinge arm  110  coupled between at least two posts. 
     In the example shown in  FIGS.  1 A and  1 B , hinge arm  110  is coupled between two posts, post  114  and post  116 . Post  114  is positioned on the buccal side of the posterior of upper tray  102  such that post  114  extends from the left-side of the upper tray  102 . In some embodiments, a second post  114  on the other side of the jaw (not visible in  FIGS.  1 A and  1 B , but shown in  FIG.  2   ) extends from a similar position on the right-side of upper tray  102 . In some embodiments, post  116  is positioned on the labial side of the anterior of lower tray  104  such that post  116  extends from the left-side of the lower tray. In some embodiments, a second post  116  (not visible in  FIGS.  1 A and  1 B , but shown in  FIGS.  4  and  5 A ) extends from a similar position on the right-side of the lower tray  104 . Generally, when the hinge arm  110  is attached to the upper and lower trays  102  and  104 , hinge arm  110  is held in place by an attachment mechanism selected from any suitable attachment mechanism known in the art. In some embodiments, when the hinge arm  110  is attached to the upper and lower trays  102  and  104 , hinge arm  110  is held in place by one or more O-rings. In some embodiments, such as the embodiments shown in  FIGS.  1 A and  1 B , when the hinge arm  110  is attached to the upper and lower trays  102  and  104 , hinge arm  110  is held in place by O-rings  118  and  120 , respectively. 
     Generally, upper tray  102  and lower tray  104  are held in place with any suitable means known in the art. In some embodiments, upper tray  102  and lower tray  104  are held in place with labial bows  122 . In some embodiments, labial bow  122  is formed of an arch wire that wraps around the front of the teeth. In some embodiments, upper tray  102  and lower tray  104  are held in place with clasps  124 . In some embodiments, upper tray  102  and lower tray  104  are held in place with labial bows  122  and clasps  124 . 
     In some embodiments, oral appliance  100  uses three-dimensional (3-D) axial springs  126  and an expansion mechanism  128  to promote correction to the airway and upper and lower jaw of the patient using the techniques described in U.S. Pat. No. 7,887,324. U.S. Pat. No. 7,887,324 is incorporated herein by reference. One example of an expansion mechanism  128  is shown in  FIG.  3 B . One embodiment of 3-D axial springs is described below and is shown in  FIGS.  6 A- 6 C . 
     Upper Tray of Oral Appliance 
     As shown in  FIG.  2   , upper tray  102  includes base plate  130 . Generally, base plate  130  is formed of any suitable material for manufacture of oral applications known in the art. In some embodiments, base plate  130  is formed of a hard acrylic material. 
     In some embodiments, base plate  130  is formed from one part, two parts, three parts, or more than three parts. In some embodiments, the part(s) of base plate  130  are adjustable with an expansion mechanism. Generally, the expansion mechanism may be selected from any suitable expansion mechanism known in the art. In some embodiments, the expansion mechanism is configured to enable upper tray  102  to change in size to accommodate growth and changes in the upper dental arch/palate of the patient. In some embodiments, the expansion mechanism is selected from jackscrews, wires, wires bent with omega-shaped loops, and combinations thereof 
     In some embodiments, the part(s) of base plate  130  are adjustable with at least one jackscrew. In some embodiments, the part(s) of base plate  130  are adjustable with at least two jackscrews. 
     In the embodiments shown in  FIG.  2    and  FIGS.  3 A- 3 B , base plate  130  is formed in three parts, namely left part  130 -A, right part  130 -B and center part  130 -C. As shown in  FIG.  3 A , left part  130 -A and right part  130 -B of base plate  130  are connected by an intervening midline jackscrew  128  that enables upper tray  102  to expand to account for palatal growth due to the use of 3-D axial springs  126 . Additionally, in this embodiment, upper tray  102  also includes jackscrew  132  that couples center part  130 -C to the rest of base plate  130  to account for changes in the front of the patient&#39;s upper dental arch. By adjusting jackscrew  132 , center part  130 -C of base plate  130  moves anteriorly and posteriorly to fit upper tray  102  to the patient&#39;s dental arch. Similarly, by adjusting jackscrew  128 , left and right parts  130 -A and  130 -B move away from or toward the centerline of the dental arch to further fit the upper tray to the dental arch of the patient. The expansion mechanisms illustrated by jackscrews  128  and  132  are shown by way of example and not by way of limitation. 
     In some embodiments, such as the embodiment shown in  FIG.  3 A , base plate  130  also includes extensions or overlays  137  of the plate body that symmetrically overlay the biting (occlusal) surfaces of at least two of the patient&#39;s teeth in the space where those teeth would normally contact the opposing teeth from the lower jaw. The thickness of the occlusal coverage ranges from approximately 0.5 mm to approximately 5.0 mm, as determined by orthodontic equilibration, and may be absent in certain locations or spots, if required. The base plate body itself has a thickness that varies, and ranges from about 1.0 mm to about 5.0 mm, depending upon the components embedded within it. 
     In some embodiments, the base plate  130  of upper tray  102  is configured in other ways to accommodate changes in the palate and upper and lower jaw. In some embodiments, the base plate  130  includes one portion, two portions, three portions, or more than three portions. In some embodiments, the base plate  130  is divided into four portions such as shown, for example, in  FIG.  3 C  and  FIG.  3 D . In the embodiment shown in  FIG.  3 C , the posterior of base plate  130  is divided into two halves: first portion  130 -A and second portion  130 -B. First half  130 -A and second half  130 -B are interconnected by an intervening jackscrew assembly  128 . Additionally, the anterior portion of base plate  130  is also divided into two halves: third portion  130 -C 1  and fourth portion  130 -C 2 . Third portion  130 -C 1  is interconnected with second portion  130 -B by intervening jackscrew assembly  129 - 2 . Fourth portion  130 -C 2  is interconnected with first portion  130 -A by intervening jackscrew assembly  129 - 1 . In yet another embodiment, shown in  FIG.  3 D , base plate  130  includes first and second portions  130 -A and  130 -B that are interconnected by an expansion mechanism  128 . In this embodiment, expansion mechanism  128  is a wire bent with an omega-shaped loop to allow expansion of the upper tray  102 . Additionally, base plate  130  also includes third and fourth portions  130 -C 1  and  130 -C 2  that are interconnected by expansion mechanism  129 . In this embodiment, expansion mechanism  129  is a wire bent with an omega-shaped loop to allow for further expansion of upper tray  102 . 
     In some embodiments, for example as shown in  FIG.  1 A , the upper tray  102  also includes at least one post  114  that controls mandibular advancement for oral appliance  100 . In some embodiments, post  114  enables interlocking of upper tray  102  with lower tray  104  through one or more removable, adjustable hinge arms  110 . In some embodiments, such as the embodiment shown in  FIG.  2   , post  114  includes a cylindrical body  131  that is embedded in the side of base plate  130 . Adjacent to the base plate  130 , cylindrical body of post  114  has a first diameter. At an end of post  114  opposite the base plate  130 , post  114  includes an end cap  135  and a segment  133  of post  114  that includes a second, reduced diameter compared to the first diameter of cylindrical body  131  adjacent to the base plate  130 . The end cap  135  and the segment of reduced diameter  133  provide a mechanism for O-ring  118  to hold adjustable hinge arm  110  in place on upper tray  102 , as shown in  FIGS.  1 A,  1 B, and  2   ). 
     Lower Tray of Oral Appliance 
       FIG.  4    is a perspective view of one embodiment of the lower tray  104  of oral appliance  100 . Lower tray  104  comprises adjustable hinge arms  110  attached to posts  116 . Lower tray  104  includes base plate  140 . 
     Generally, base plate  140  is formed of any suitable material for manufacture of oral applications known in the art. In some embodiments, base plate  140  is formed of a hard acrylic material. 
     In some embodiments, base plate  140  is formed from one part, two parts, three parts, or more than three parts. In some embodiments, the part(s) of base plate  140  are adjustable with an expansion mechanism. Generally, the expansion mechanism may be selected from any suitable expansion mechanism known in the art. In some embodiments, the expansion mechanism is selected from jackscrews, wires, wires bent with omega-shaped loops, and combinations thereof 
     In the embodiment of  FIG.  4   , base plate  140  is formed in two parts, namely left part  140 -A, and right part  140 -B. As shown in  FIGS.  5 A and  5 B , left part  140 -A and right part  140 -B of base plate  140  are connected by an intervening midline jackscrew  142  that enables lower tray  104  to expand to account for palatal growth due to the use of 3-D axial springs  126 . By adjusting jackscrew  142 , left and right parts  140 -A and  140 -B move away from or toward the centerline of the dental arch to fit the lower tray to the dental arch of the patient. 
     In some embodiments, for example as shown in  FIGS.  5 A and  5 B , base plate  140  includes extensions or overlays  144  of the plate body that symmetrically overlay the biting (occlusal) surfaces of at least two of the patient&#39;s teeth in the space where those teeth would normally contact the opposing teeth from the upper jaw. The thickness of the occlusal coverage ranges from approximately 0.5 mm to approximately 5.0 mm, as determined by orthodontic equilibration, and may be absent in certain locations or spots, if required. The base plate body itself has a thickness that varies, and ranges from about 1.0 mm to about 5.0 mm, depending upon the components embedded within it. 
     In some embodiments, posts  116  of lower tray  104  have a structure that is similar to posts  114  of upper tray  102 . 
     Three-Dimensional (3-D) Axial Springs 
     In some embodiments, the upper tray  102  and the lower tray  104  each individually comprise at least one spring. Generally, the spring is selected from any suitable spring known in the art to provide cyclic intermittent signaling that stimulates a patient&#39;s genome during function. In some embodiments, the at least one spring comprises at least one 3-D axial spring, such as those described in U.S. Pat. No. 7,887,324. 
     In some embodiments, at least one of the upper tray  102  and the lower tray  104  include 3-D axial springs. In some embodiments, both the upper tray  102  and the lower tray  104  include 3-D axial springs. In some embodiments, the 3-D axial springs are constructed as shown in  FIGS.  6 A- 6 C  and as described below with reference to those figures. It is understood that the 3-D axial springs shown and described below with respect to  FIGS.  6 A- 6 C  are provided by way of example and not by way of limitation. 
       FIG.  1 B  shows a perspective view of the oral appliance  100 , which includes 3-D axial springs  126 . Both the upper tray  102  and the lower tray  104  include 3-D axial springs  126 . 
     In some embodiments, such as the embodiment shown in  FIG.  6 A , the 3-D axial spring  126  used in upper tray  102  and lower tray  104  of the oral appliance  100  of  FIG.  1 B  includes an active (compression-extension) axis  154 . During use, active axis  154  of the 3-D axial spring  126  is orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root, instead of lying approximately parallel to the transverse axis of the palatal/lingual surface of the crown of said tooth and/or root. 
     In some embodiments, such as the embodiment shown in  FIG.  6 A , 3-D axial spring  126  includes a continuous spring body with an arm portion  150  at a proximal end  151  and a head portion  152  at a distal end  153 . Arm portion  150  includes initial arm  155  that is embedded in an acrylic baseplate of upper tray  102  or lower tray  104 , and a terminal arm  156  that is also embedded in the same acrylic baseplate. Both initial arm  155  and terminal arm  156  have approximately the same vertical axis: active axis  154 . 
     In some embodiments, such as the embodiment shown in  FIG.  6 A , initial arm  155  and terminal arm  156  are connected by a plurality of undulating U-bends  165  that form the body or head  152  of the 3-D axial spring  126 . The plurality of U-bends  165  may vary in amplitude, thereby being bigger or smaller in size relative to each other. The plurality of U-bends  165  may vary in frequency, being many or few in number. The plurality of U-bends  165  may vary in characteristic, being differently shaped, such as a ‘Z’ formation, a square waveform, a sinewave, a triangular wave, or any other appropriate shape that extends from side to side relative to the central axis, namely active axis  154 . The plurality of U-bends  165  in the initial arm  155  and the terminal arm  156  of head portion  152  of 3-D axial spring  126  lie in close proximity with respect to each other for the entire length of active axis  154  of 3-D axial spring  126 . During use, 3-D axial spring  126  lies on palatal/lingual surface of the contiguous oral structures (mucosa) orientated at an angle approximately parallel to the long axis of the palatal/lingual surface of the tooth and/or root. The head portion  152  of 3-D axial spring  126  intimately contacts the long axis of said palatal/lingual surface of said tooth. 
     As shown in  FIG.  6 B  and  FIG.  6 C , the head portion  152  includes a first wave-shaped segment  158  (made from a plurality of U-bends  165 ) extending from the proximal end  151 . As shown in  FIG.  6 C , the head portion  152  has an active axis coincident with a long axis (active axis  154 ) of the 3-D axial spring  126 , and the head portion  152  further includes a second wave-shaped segment  162  (made from a series of U-shaped bends  165 ) extending from the proximal end  151  and having an axis  160  arranged about 90-degrees from the active axis  154 . 
     In many embodiments, the 3-D axial springs  126  comprise a resilient material. Generally, the 3-D axial springs  126  may comprise a resilient material composed of any suitable material known in the art. In some embodiments, the resilient material is selected from stainless steel, Titanium-Niobium-Aluminum (Ti—Nb—Al) alloys, Cobalt-Chromium-Nickel alloys (e.g. a Cobalt-Chromium-Nickel alloy known under the trade name “Elgiloy™” available from Elgiloy Specialty Alloys of Elgin, Ill., USA), Nickel-Titanium (Ni—Ti) alloys, Ni—Ti wires that exhibits “super-elasticity”, Nickel-free beta-Titanium (Ni-free β-Ti) Alloys, and combinations thereof. 
     In some embodiments, the 3-D axial springs  126  are formed from a wire composed of a single strand of alloy. In some embodiments, the 3-D axial springs  126  are constructed from a braided wire composed of a plurality of strands of a single alloy. In other embodiments, the 3-D axial springs  126  are constructed from a braided wire composed of a plurality of strands of a plurality of alloys. 
     Function of the Oral Appliance 
     Generally, oral appliance  100  performs at least two functions. First, oral appliance  100  enables changes to the form of the jaw and facial bones of a patient. Second, oral appliance  100  functions to provide immediate relief from disordered breathing such as sleep apnea and snoring through mandibular advancement. 
     In some embodiments, to treat a patient, oral appliance  100  is placed within the mouth of a patient so that overlays  137  and  144  contact at least one tooth and the remainder of the plate body  130  or  140  is spaced from the patient&#39;s tissue, including the palate. Overlays  137  and  144  prevent the patient&#39;s jaws from fully closing. Without being bound to any particular theory, it is believed that this contact of the teeth with the overlay causes intermittent forces to be applied to the body plate  130  or  140  and through the body plate  130  or  140  to the 3-D axial springs  126  and to the teeth. This cyclic intermittent signaling stimulates the patient&#39;s genome during function, essentially each time the patient speaks, swallows, chews, smiles etc., which is estimated to be about 2,000 to 3,000 times per day/night. This frequent cyclic intermittent signaling on the facial and alveolar bones is believed to cause development of the facial and jaw bones where jaw development did not fully occur during childhood. This bone development may include a descent of the palate (i.e., remodeling of the vault of the palate downwardly toward the lower jaw); a widening of the palate; an upward and outward remodeling of the body of the maxilla; and an increase in palatal length, if necessary. 
     In some embodiments, upper tray  102  includes a lever arm coupled to a vibrational meso-motor (not shown in the figures) capable of producing intermittent, cyclic signaling under control of a processor (not shown in the figures) to be applied to the 3-D axial springs. The motor provides intermittent cyclic signaling to at least one of the 3-D axial springs. In some embodiments, the motor provides intermittent cyclic signaling to all of the 3-D axial springs of upper tray  102 . In some embodiments, the vibrational meso-motor produces ultrasonic cyclic signaling. In some embodiments, a meso-motor is incorporated into the lower tray  104  as well to provide intermittent cyclic signaling under control of a processor to the 3-D axial springs of the lower tray  104 . 
     In some embodiments, to provide relief from disordered breathing, sleep apnea and/or snoring, oral appliance  100  includes adjustable hinge arms  110 . In some embodiments, hinge arms  110  are set to a length appropriate to cause the lower jaw of the patient to be brought forward (i.e., mandibular advancement) to enlarge the airway of the patient. The patient&#39;s airway and jaw are modified as oral appliance  100  is worn. Thus, the length of adjustable hinge arms  110  will be adjusted from time-to-time so that the same beneficial effect can be maintained to improve the patients breathing when the oral appliance is worn. 
     In some embodiments, hinge arms  110  are removeable by removing the O-rings  118  and  120  so that the oral appliance can be worn without forcing the lower jaw into a specific position with respect to the upper jaw (i.e., no mandibular advancement). This allows, for example, upper tray  102  to be worn without lower tray  104  during the day, and then, the upper tray  102  and lower tray  104  can be worn together at night to provide relief from disordered breathing through mandibular advancement by use of adjustable hinge arms  110 . In some embodiments, upper tray  102  is worn without lower tray  104 . In some embodiments, upper tray  102  is worn with lower tray  104 . 
     Use Tracking 
     For oral appliance  100  to be effective, the patient needs to use the oral appliance  100  as instructed by the provider. To assist the provider in tracking this use, in some embodiments, appliance  100  includes a compartment (not shown) formed on a side of one of the upper tray  102  and the lower tray  104 . In some embodiments, the compartment includes an opening (not shown) configured for receiving a compliance tracker (not shown). Generally, the compliance tracker measures patient treatment compliance using sensors. Generally, the compliance tracker may be selected from any suitable compliance tracker known in the art. In some embodiments, the compliance tracker is a DentiTrac compliance tracker from Braebon. 
     In some embodiments, the compliance tracker is configured and/or operated as described in U.S. Patent Publication 2015/0169845, which is incorporated herein by reference. In some embodiments, the compliance tracker tracks and records the use of the appliance by the patient. In some embodiments, the data recorded by the compliance tracker can be downloaded and processed using a software program run by a provider to determine the level of compliance in the patient&#39;s use of appliance  100 . 
     Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement, which is calculated to achieve the same purpose, may be substituted for the specific embodiment shown. This application is intended to cover any adaptations or variations of the present invention. Therefore, it is manifestly intended that this invention be limited only by the claims and the equivalents thereof. 
     This written description uses examples to illustrate the present disclosure, including the best mode, and also to enable any person skilled in the art to practice the disclosure, including making and using any compositions or systems and performing any incorporated methods. The patentable scope of the disclosure is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have elements that do not differ from the literal language of the claims, or if they include equivalent elements with insubstantial differences from the literal language of the claims. 
     As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains”, “containing,” “characterized by” or any other variation thereof, are intended to cover a non-exclusive inclusion, subject to any limitation explicitly indicated. For example, a composition, mixture, process or method that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, mixture, process or method. 
     The transitional phrase “consisting of” excludes any element, step, or ingredient not specified. If in the claim, such would close the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith. When the phrase “consisting of” appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole. 
     The transitional phrase “consisting essentially of” is used to define a composition or method that includes materials, steps, features, components, or elements, in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristic(s) of the claimed invention. The term “consisting essentially of” occupies a middle ground between “comprising” and “consisting of”. 
     Where an invention or a portion thereof is defined with an open-ended term such as “comprising,” it should be readily understood that (unless otherwise stated) the description should be interpreted to also describe such an invention using the terms “consisting essentially of” or “consisting of.” 
     Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). 
     Also, the indefinite articles “a” and “an” preceding an element or component of the invention are intended to be nonrestrictive regarding the number of instances (i.e. occurrences) of the element or component. Therefore “a” or “an” should be read to include one or at least one, and the singular word form of the element or component also includes the plural unless the number is obviously meant to be singular. 
     As used herein, the term “about” means plus or minus 10% of the value.