Adjustable sleep apnea orthodontic appliance for use with orthodontic braces

Abstract

An oral appliance for treating snoring and / or apnea includes an upper appliance portion and a lower appliance portion. The upper appliance portion has an upper base extending over anterior teeth of the upper jaw of the user and two orthodontic wires, one extending from each side of the upper base portion, while the lower appliance portion has a lower base portion extending over anterior teeth of the lower jaw of the user and two orthodontic wires, one extending from each side of the upper base portion. The lingual portion of each wire extends rearwardly around the rearmost teeth of the user from a proximal end on the lingual side of the teeth of the user and then forwardly along the buccal side of the teeth of the user to a distal end of the wire, where the wire is positioned between the bracket and the gingival wire of the user when worn.

Description

Background Art

[0001] Sleep apnea is a disorder characterized by abnormal pauses in breathing or abnormally low breathing during sleep. Each pause in breathing, called an apnea, can last from a few seconds to several minutes (usually lasting 20 to 40 seconds) and can occur 5 to 30 times or more hours. Sleep apnea is caused by partial to complete obstruction of the subject's airway. The increased air velocity through the airway causes an increase in dynamic pressure and a corresponding decrease in static pressure. In some cases, the reduced static pressure can pull back the jaw and tongue, thereby blocking the airway. This obstruction may increase to the point of becoming complete, which at least temporarily interrupts breathing.

[0002] If the subject is overweight or has a condition such as diabetes, high blood pressure, or chronic nasal congestion, they are generally at greater risk for sleep apnea. However, there are multiple factors that may lead to sleep apnea, including a narrow maxilla and / or mandible in the subject, which reduces the volume of air in the mouth and tends to force the tongue back into the posterior airway space, leading to obstructive sleep apnea during sleep.

[0003] Orthodontics is a field of dentistry that focuses on the repositioning of a subject's teeth and jaws for therapeutic, aesthetic, or other reasons, such as due to "overcrowding" of the subject's teeth. Orthodontic methods generally require the subject to use a mechanical device, such as braces or dental appliances, continuously for a period of time in order to achieve results. The use of braces precludes the simultaneous use of currently available oral appliances for the treatment of sleep apnea. Therefore, there remains a need for improved devices and methods for treating sleep apnea in subjects who are undergoing orthodontics and who experience sleep apnea. Summary of the invention

[0004] The adjustable sleep brace of the present invention is designed to be used with orthodontic braces and generally includes an upper brace portion 100 for the maxillary dentition of a user wearing the braces and a lower brace portion 200 for the mandibular dentition of the user. The upper brace portion 100 includes an upper base portion 150, which includes a right upper wire 172, a left upper wire 174, an upper container 160, and a downwardly extending protrusion 400. The upper base portion 150 also has a right side 152, a left side 154, a front side 151, a rear side 153, an upper side 156, and a lower side 158. The right upper wire 172 and the left upper wire 174 each have a proximal end 71, a distal end 73, a lingual wire portion 76, a buccal wire portion 78, and a middle portion 75, wherein:

[0005] (i) the proximal end 71 of the right upper wire 172 is attached to the right side 152 of the upper base portion 150, and the proximal end 71 of the left upper wire 174 is attached to the left side 154 of the upper base portion 150;

[0006] (ii) the lingual wire portion 76 of the right upper wire 172 extends posteriorly from the proximal end 71 to the middle portion 75, the middle portion 75 of the right upper wire 172 extends laterally, and the buccal wire portion 78 of the right upper wire 172 extends forwardly from the middle portion 75 to the distal end 73; the lingual wire portion 76 of the left upper wire 174 extends posteriorly from the proximal end 71 to the middle portion 75, the middle portion 75 of the left upper wire 174 extends laterally, and the buccal wire portion 78 of the left upper wire 174 extends forwardly from the middle portion 75 to the distal end 73; and

[0007] (iii) The upper right wire 172 and the upper left wire 174 are adapted to fit between the brackets of an orthodontic brace fixed to the teeth of the user of the appliance 10 and the gum tissue of the user.

[0008] The upper container 160 has an upper surface 66 and includes a thermoplastic material 90. A downwardly extending protrusion 400 has a proximal end 402, a distal end 404, a front surface 401 and a rear surface 403 and is attached to the underside 158 of the upper base portion 150 and extends downwardly therefrom.

[0009] The lower appliance portion 200 has a lower base portion 250 including a right lower wire 272, a left lower wire 274, and a lower container 260. The lower base portion 250 also includes a right side 252, a left side 254, an anterior side 251, a posterior side 253, an upper side 256, and a lower side 258. The lower container 260 has a lower surface 68 and includes a thermoplastic material 90. The right lower wire 272 and the left lower wire 274 each have a proximal end 71, a distal end 73, a lingual wire portion 76, a buccal wire portion 78, and a middle portion 75, wherein:

[0010] (i) the proximal end 71 of the right lower wire 272 is attached to the right side 252 of the lower base portion 250, and the proximal end 71 of the left lower wire 274 is attached to the left side 254 of the lower base portion 250;

[0011] (ii) the lingual wire portion 76 of the right lower wire 272 extends posteriorly from the proximal end 71 to the middle portion 75, the middle portion 75 of the right lower wire 272 extends laterally, and the buccal wire portion 78 of the right lower wire 272 extends forwardly from the middle portion 75 to the distal end 73; the lingual wire portion 76 of the left lower wire 274 extends posteriorly from the proximal end 71 to the middle portion 75, the middle portion 75 of the left lower wire 274 extends laterally, and the buccal wire portion 78 of the left lower wire 274 extends forwardly from the middle portion 75 to the distal end 73; and

[0012] (iii) The right lower wire 272 and the left lower wire 274 are suitable for fitting between the brackets of the orthodontic braces fixed to the teeth of the user of the braces 10 and the gum tissue of the user, and are suitable for fitting between the brackets of the orthodontic braces fixed to the teeth of the user of the braces 10 and the gum tissue of the user.

[0013] The front surface 401 of the protrusion 400 is adapted to contact the rear side 253 of the lower base portion 250 when the brace is in use, thereby limiting the forward movement of the upper brace portion 100 relative to the lower brace portion 200. In addition, the upper right wire 172, the upper left wire 174, the lower right wire 272, and the lower left wire 274 are preferably elastically deformable and adapted to contact the user's teeth under tension.

[0014] The thermoplastic material of the aligner can be reversibly deformed to adapt to the changing tooth position of the user's teeth. In one embodiment, the upper base portion 150 and the lower base portion 250 can be formed entirely of thermoplastic material. Alternatively, the upper base portion 150 and the lower base portion 250 can include both a hard plastic material portion and a thermoplastic material portion for contacting the user's teeth.

[0015] Preferably, one or more of the upper right wire 172, the upper left wire 174, the lower right wire 272, and / or the lower left wire 274 include a clasp. The clasp is a protrusion or flange that extends medially from the buccal wire portion 78 or laterally from the lingual wire portion 76 and is adapted to extend over the biting surfaces of the user's teeth.

[0016] In one embodiment, the lower orthotic portion 200 may also include an insert 300 having a right side 312, a left side 314, a front side 311, a rear side 313, an upper side 316, and a lower side 318. The insert has a receiving portion in the lower base portion 250 and is configured to be secured to the receiving portion 280. The front side 311 of the insert 300 and the rear side 253 of the lower orthotic portion 250 may be provided with mutually cooperating locking elements, such as tongue and groove locking elements, to secure the insert 300 to the receiving portion 280.

[0017] This embodiment may include a plurality of inserts 300, wherein the rear side 313 of each of the plurality of inserts extends rearwardly a different distance when held in the receiving portion 280, and each of the plurality of inserts can be reversibly secured to the lower orthotic portion 250. In this manner, the anterior-posterior positioning of the upper orthotic portion 100 can be adjusted relative to the lower orthotic portion 200 by using the inserts because they extend rearwardly different distances. The distance each insert extends rearwardly can differ, for example, by 0.5 mm to 1.0 mm.

[0018] The corrector of the present invention can be used to treat snoring or sleep apnea. In such a treatment method, the corrector of the present invention is applied (worn) to a subject in need. The method preferably further comprises the following steps:

[0019] (a) heating the upper appliance portion to soften the thermoplastic material of the upper appliance portion and to make an impression on the front maxillary dentition of the subject;

[0020] (b) heating the lower appliance portion to soften the thermoplastic material of the lower appliance portion and to impress the anterior mandibular dentition of the subject;

[0021] (c) Repeat steps (a) and (b) every 1 to 3 days. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a front left perspective view of an embodiment of an appliance of the present invention on a model of a subject's teeth.

[0023] Figure 2 is a front left perspective view of an embodiment of an upper appliance portion of an appliance of the present invention on a model of a subject's teeth.

[0024] Figure 3 is a posterior view of an upper appliance portion of an embodiment of an appliance of the present invention on a model of a subject's teeth.

[0025] Figure 4 is a front left perspective view of an embodiment of a lower appliance portion of an appliance of the present invention on a model of a subject's teeth.

[0026] Figure 5 is a top view of an embodiment of an appliance of the present invention on a model of a subject's teeth.

[0027] Figure 6 is a top plan view of an embodiment of a lower orthotic portion of an orthotic device and its insert of the present invention.

[0028] Figure 7 is used for Figure 6 Plan views of the superior and inferior sides of an orthosis with multiple inserts of varying lengths.

[0029] Figure 8 is a left side perspective view of an embodiment of an upper orthotic portion of an orthotic of the present invention.

[0030] Fig. 9 is a front perspective view of an embodiment of an upper aligner portion of an orthosis of the present invention.

[0031] Fig.10 is a top plan view of an embodiment of a lower orthotic portion of an orthotic device of the present invention.

[0032] Fig.11 is a front perspective view of an embodiment of a lower orthotic portion of an orthotic of the present invention.

[0033] The reference numerals in the drawings have the following meanings:

[0034]

[0035]

[0036] DETAILED DESCRIPTION

[0037] definition

[0038] As used herein, the following terms and variations thereof have the meanings given below, unless the context in which such terms are used clearly intends a different meaning.

[0039] "Above" refers to the relative position of the orthosis of the present invention or a component thereof, which is closer to or toward the upper part of the subject's body when the orthosis is used, while "below" refers to the relative position of the orthosis of the present invention or a component thereof, which is closer to or in the direction of the lower part of the subject's body when the orthosis is used.

[0040] "Front" and "forward" refer to a direction toward or adjacent to the front (opening) of a subject's mouth when the subject is wearing an appliance of the present invention.

[0041] "Apnea" and "sleep apnea" refer to temporary cessations of breathing and / or episodes of shallow or infrequent breathing during sleep, usually caused by a blockage in the subject's airway (known as obstructive sleep apnea).

[0042] "Braces" refers to dental braces, i.e., a series of brackets and wires used to reposition teeth and / or reshape the jaw.

[0043] A "bracket" is a mechanical component that is anchored to a subject's teeth, typically by a bonding material, and is connected to a wire that distributes forces between the subject's bracketed teeth during orthodontic treatment. The bracket is typically secured in position on the buccal side of the subject's teeth.

[0044] "Buccal" means in the direction of or towards a subject's cheek. With respect to a subject's teeth, this refers to the side of the teeth facing the cheek.

[0045] "Clasp" refers to the mechanical portion of the aligner of the present invention that grips and helps hold the aligner on the teeth of the user when in use.

[0046] "Downward" and "downwardly" refer to the direction of the subject's body or toward the lower portion of the subject's body when the corrector of the present invention is worn. "Upward" and "upwardly" refer to in the opposite direction, i.e., in the direction of or toward the upper portion of the subject's body.

[0047] "Hard plastic" refers to a polymer material that is not elastically deformable, such as poly(methyl methacrylate) (also known as acrylic), polycarbonate, acrylonitrile butadiene styrene (ABS), etc. The hard plastic used in the braces of the present invention is non-toxic and suitable for use in the mouth of a human subject. Hard plastics used in orthodontic applications are known in the art and can be used in the braces of the present invention.

[0048] "Horizontal" with respect to the appliances of the present invention means disposed in a plane generally parallel to the subject's occlusal surface, ie, within 15 degrees of a plane generally perpendicular to the subject's sagittal and / or coronal planes.

[0049] "Lateral" refers to a position or direction toward the right or left side of an appliance of the present invention and / or toward the outer portion of the subject's mouth when the appliance is worn by the subject, i.e., on the buccal side.

[0050] "Lingual" means in the direction of, toward, or adjacent to the subject's tongue. With respect to a subject's teeth, this refers to the side of the front teeth that faces the tongue, i.e., inwardly.

[0051] "Lower" refers to the relative position of the components of the device that are closer to or toward the lower part of the subject's body when the device is in use.

[0052] "Mandibular" refers to the lower jaw.

[0053] "Maxillary" refers to the upper jaw.

[0054] "Medially" refers to a position or direction toward the middle portion of an appliance of the present invention and / or toward an interior portion of a subject's mouth when worn by a subject (ie, lingually).

[0055] "Occlusal surface" refers to the biting surface of a tooth.

[0056] "Orthodontic" refers to devices, or components thereof, that reposition the teeth and / or jaws of a subject.

[0057] "Orthodontic wire" means a length of metal wire of the type used in orthodontic treatment.

[0058] "Posterior" and "posteriorly" mean in the direction of or toward or adjacent to the back of the subject's mouth when the subject is wearing the aligners.

[0059] "Right" refers to the right side of the brace of the present invention when in use, that is, the right side of the subject's mid-sagittal plane from the subject's perspective. "Left" refers to the other side, that is, the left side of the brace.

[0060] "Subject" refers to a user of an orthotic device of the present invention, typically a human user.

[0061] "Thermoplastic" and "soft plastic" refer to materials, typically polymeric materials, that are elastically deformable at temperatures between room temperature and the boiling point of water. Such plastics can be softened in a reversible physical process, such as by heating, and then rehardened, such as by cooling. One such material is THERMACRYL (a polymer available from Airway Management, Inc., Farmers Branch, TX), while another is ethylene vinyl acetate (EVA). Thermoplastic materials used in some components of the orthosis of the present invention retain their shape at 100° F., and preferably become soft (deformable) at temperatures of 212° F. or less.

[0062] "Upper" refers to a relative position where components of the orthosis are closer to or toward the upper portion of a subject's body when the orthosis of the present invention is in use.

[0063] "Vertical" refers to a plane or direction that is perpendicular to the horizontal plane or direction.

[0064] As used herein, the terms "above," "below," "between," and other terms of relative position or orientation refer to the relative position of one layer with respect to other layers. Thus, unless otherwise described herein, a layer deposited or disposed above or below another layer may be in direct contact with the other layer or may have one or more intervening layers.

[0065] The term "includes" and variations of the term, such as "comprising" and "having", are not intended to exclude other additives, components, integers or steps. The terms "a", "an", and "the" and similar referents used herein should be interpreted as covering both the singular and the plural, unless their use in the context indicates otherwise. A range described as being "between" two values ​​includes the indicated values.

[0066] Orthotics and how to use them

[0067] The present sleep correction device is designed to be worn by a subject wearing braces. When wearing braces, brackets are typically fixed to the outer surface of the subject's teeth as anchors for applying and distributing force through wires. The brackets are typically fixed to the buccal surfaces of the teeth, and then the wires (arch wires) are mechanically connected to the brackets. The wires extend between the brackets and other brackets on other teeth, other upper teeth or other lower teeth as appropriate, to apply and distribute force between the teeth. The brackets are typically placed in a relatively central portion of the tooth area outside the gums (gum tissue), i.e., so that there is space between the gums of the subject and the brackets.

[0068] The brace 10 of the present invention includes an upper brace portion 100 and a lower brace portion 200, and the brace portions 40 each include a base portion 50 for receiving the front teeth (e.g., incisors) of a user, namely, an upper base portion 150 of the brace and a lower base portion 250 of the brace, respectively. The base 50 has a right side 52, a left side 54, a front side 51, a rear side 53, an upper side 56, and a lower side 58, and includes a receptacle 60 for contacting and / or receiving the outer surface of the front teeth of the user of the brace 10. The upper base portion 150 is positioned in the front portion 41 of the upper brace portion 100, and the lower base portion 250 is positioned in the front portion 41 of the lower brace portion 200. The upper base portion 150 and the lower base portion 250 cooperate to limit the forward movement of the upper jaw of the user.

[0069] Specifically, the upper brace portion 100 includes an upper base portion 150 having a right side 152, a left side 154, a front side 151, a rear side 153, an upper side 156, and a lower side 158, wherein an upper receptacle 160 is positioned on the upper side 156 of the upper base portion for receiving the upper (maxillary) teeth of the user. Extending from the right side 152 is a right upper side wire 172, and extending from the left side 154 is a left upper side wire 174. The lower brace portion 200 similarly includes a lower base portion 250 having a right side 252, a left side 254, a front side 251, a rear side 253, an upper side 256, and a lower side 258, and having a lower receptacle 260 on the lower side 258 of the lower base portion for receiving the mandibular teeth of the user. Extending from the right side 252 is a right lower side wire 272, and extending from the left side 254 is a left lower side wire 274.

[0070] The upper receptacle 160 of the upper base portion 150 of the appliance extends through and contacts or receives at least the incisor portion of the user's front teeth on the upper jaw, including the incisor surface, for example, covering between 2 and 6 teeth, and the lower receptacle 260 similarly extends through and receives at least the incisor portion of the user's front teeth, for example, covering between 2 and 6 teeth, wherein at least a portion of 3 or 4 teeth are preferably covered by the receptacle 60 of each base 50. The receptacle 60 preferably covers no more than one-third of the front and back surfaces (i.e., buccal and lingual surfaces) of the incisor portion of the user's teeth, i.e., the upper one-third of the mandibular teeth and the lower one-third of the maxillary teeth.

[0071] The container 60 portion of each base 50 can be formed of a hard plastic material and is configured to accommodate the user's teeth that are expected to be positioned in different positions during the orthodontic treatment process. However, the container 60 preferably includes a thermoplastic (soft plastic) material, such as a THERMACRYL laminate (an acrylic-based thermoplastic material). Such thermoplastic materials retain their shape when used by a subject, and are therefore preferably solid at least at body temperature, but preferably also at slightly higher temperatures (such as at 110°F, 120°F or higher). However, thermoplastic materials can be deformed at higher temperatures, such as boiling water (212°F) or lower, and are preferably made into plastic by being placed in boiling water. When the plastic material of the container is in such a deformable state, the user can squeeze the material with their upper or lower teeth, as the case may be, and once the material cools, it will thereby conform to the shape of the user's teeth, thereby creating a stable support (i.e., a positive seat) for the user's teeth in the container 60, and helping to stably hold the base 50 on the user's teeth.

[0072] When the container 160 of the upper base portion 150 includes the thermoplastic material 90, the thermoplastic material is present on the upper surface 66 of the container, such as Fig. 9 In this manner, when the material softens, the outer surface 96 of the thermoplastic material 90 can receive an impression of the upper teeth of the user. Similarly, when the container 260 of the lower base portion 250 includes the thermoplastic material 90, the thermoplastic material is present on the lower surface 68 of the container, as shown. Fig.11As shown. In this way, when the material softens, the outer surface 96 of the thermoplastic material 90 can receive an impression from the user's lower teeth. The use of thermoplastic material 90 provides a better fit with the user's front teeth and therefore provides a more stable seat for the braces 10 in the user's mouth. Preferably, the containers 60 of the upper base and lower base 50 receive impressions of the teeth of the user of the braces of the present invention on a regular basis (e.g., every day or every 2 or 3 days) to accommodate changes in the positioning of the user's teeth, which change positionally during the course of orthodontic treatment. In an advantageous embodiment, the base 50 of the braces of the present invention can be formed from a single material, preferably a thermoplastic material. Such a material is also preferably 3D printable for ease of manufacturing.

[0073] Extending from each side of the base 50 of the aligner portion 40 is a wire 70, namely a right wire 72 and a left wire 74. The proximal end 71 of each wire is fixed to the corresponding side of the base 50 to which it is attached. Preferably, the proximal end 71 of the wire is embedded in the polymer material forming the base 50, which can be achieved, for example, by heating the polymer material and then inserting the proximal end 71 of the wire 70 into the softened plastic. Then, when the user wears it, the lingual portion 76 of each wire 70 extends backward from the proximal end 71 of the wire on the lingual side of the user's mouth. The lingual portion 76 of each wire 70 is constructed to contact or directly adjacent to the lingual teeth of the user and away from the gums (gingiva). The middle portion 75 of the wire 70 extends on the right or left side of the subject's mouth around the rear surface of the most posterior (most posterior) teeth of the subject, as the case may be, and bends around the most posterior teeth so that the buccal portion 78 of the wire then extends forward along the buccal side of the user's teeth. The buccal portion 78 of each wire 70 is constructed to contact or directly adjacent to the buccal side of the subject's teeth between the bracket and the gum wire. The buccal portion 78 extends forward to the distal end 73 of the wire. The distal end 73 is preferably covered, blunted or otherwise protected so that the user is not stimulated or injured by the distal end of the wire. In the illustrated embodiment, the distal end of the wire is formed as a ring so that the circular portion of the ring is positioned at the distal end of the wire 70. The lingual portion 76 and the buccal portion 78 of each wire are preferably each shaped to conform to the shape of their adjacent teeth at least on a portion of the wire 70, so that the brace 10 is better maintained on the user's dentition.

[0074] In the upper appliance portion 100, each of the right and left wires 172, 174 of the upper appliance portion 100 extends posteriorly from the upper base portion 150 along the lingual side of the subject, subgingivally, fits around the rearmost teeth, and then extends forwardly below the gums but above any brackets affixed to the teeth on the buccal side, such as in Figure 2 and Figure 3Likewise, in the lower appliance portion 200, each of the right and left wires 272, 274 of the lower appliance portion 200 extends from the lower base portion 250 posteriorly along the lingual side of the subject to below the gums, fits around the rearmost teeth, and then extends anteriorly above the gums but below any brackets affixed to the teeth on the buccal side, such as in Figure 4 and Figure 5 . Thus, on the lingual side, the wire 70 exits the base 50 and is designed to fit tightly on the lingual surface of all posterior teeth. The wire 70 is preferably located at the cement-enamel junction (CEJ) and is not in contact with the gum tissue, just above or below the tissue and between the gum tissue and any brackets on the user's teeth. The wire 70 is thus held in place by the bracket.

[0075] like Figure 5 As shown, one or more of the upper right wire 172, the upper left wire 174, the lower right wire 272, and / or the lower left wire 274 may advantageously include a clasp 83. The clasp 83 includes a flange, such as from Figure 5 The wire portions shown are extended from the wires 272 and 274. Such wire portions extend medially from the buccal wire portion 78 or laterally from the lingual wire portion 76 and are adapted to extend over the occlusal surfaces of the user's teeth. The clasp helps to hold the appliance 10, and in particular the wire 70, on the user's teeth.

[0076] Each wire 70 is placed in close contact with the teeth of the user so that the corresponding brace portion can be maintained on the upper or lower jaw of the subject. In order to place the upper brace portion 100 or the lower brace portion 200 on the teeth of the user, the brace portion 40 is placed in the user's mouth and the container 60 of the base portion 50 is placed on the front teeth. The distal end 73 of each wire 70 is then pushed laterally outward so that the distal end 73 and the buccal wire portion 76 extend further away from its corresponding lingual wire portion 78, that is, so that the distance between the buccal wire portion 76 and the lingual wire portion 78 on each outer side is increased so as to allow the wire 70 to be fitted on any bracket. The wire 70 is then guided below the bracket on the mandibular dentition or above the bracket on the maxillary dentition, as the case may be, and the outward force on the wire is subsequently released, thereby allowing the wire to partially or completely return to its pre-tensioned configuration. Preferably, the wire 70 contacts the lingual and / or buccal surfaces of the teeth of multiple users under tension so as to better hold the brace portion 40 on the teeth of the user, i.e., so that the wire is held under tension and exerts a force on at least some of the teeth of the user so that the wire does not fully return to the pre-tensioned configuration when the brace portion 40 is worn. The wire 70 should have an elastic modulus that allows the wire 70 to bend elastically in this manner so that after the brace portion is positioned in the subject's mouth, the wire 70 will return to its configuration before bending. The wire 70 is thus spring-loaded so that it can maintain its position above the bracket (in the upper brace portion) or below the bracket (in the lower brace portion 200). Once the brace portion 40 is positioned in this manner, the brackets of the user's braces operate to prevent the brace portion from shifting vertically.

[0077] One of the advantages of the brace 10 of the present invention is that it can be used to treat snoring or apnea during sleep without interfering with the ongoing orthodontic process of tooth and jaw movement. The wire 70 does not contact any brackets or any orthodontic wires and therefore does not interfere with the tooth or jaw moving forces applied to the teeth, but is positioned between the brackets on the teeth and the gums above or below the brackets. Another feature for avoiding interference with the orthodontic process is the use of a thermoplastic material in at least the container 60, as the construction of such material can change over time to correspond to the changing positioning of the front teeth received by the container 60. As described above, a user of the brace of the present invention can soften the polymer material of the container 60 periodically, such as weekly, every other day, or more preferably daily, to accommodate the movement of the front teeth covered by the container 60 due to the user's use of the orthodontic device.

[0078] To position the jaw of the user and thereby treat snoring and / or apnea, the upper brace portion 100 includes a downwardly extending rigid protrusion 400 extending downwardly from the underside 158 of the upper base portion 150. The protrusion 400 has a proximal end 402, a distal end 404, a front surface 401, and a rear surface 403. The proximal (upper) end 402 of the protrusion 400 is attached to the upper base portion 150, such as by being integrally molded with the upper base portion 150. As described below, in some embodiments, the relative anterior-posterior positioning of the mandible with respect to the maxilla can be adjusted by using an insert 300 attached to the lower base portion 250 of the lower brace portion 200.

[0079] When the brace 10 is worn by a subject, the distal end 404 of the protrusion 400 extends downwardly beyond the upper side 256 of the lower base portion 250, so that a portion of the distal end 404 of the protrusion 400 is positioned in line with the rear side 253 of the lower base portion 250. Therefore, when the user wears the brace 10, the front surface 401 of the protrusion 400 contacts or is adjacent to the rear side 253 of the lower brace portion 200, and the protrusion 400 is positioned lingually and rearwardly relative to the lower base portion 250. This positioning limits the rearward movement of the lower brace portion 200, and therefore also limits the movement of the user's lower jaw (mandible) relative to the upper brace portion 100 and the user's upper jaw (maxilla) when wearing the brace 10 of the present invention, thereby maintaining the user's jaw in an orientation that helps prevent or improve sleep apnea and / or snoring.

[0080] The protrusion 400 is preferably positioned in the front portion of the upper base portion 150, i.e., in a relatively buccal orientation, such as below the upper incisors of the user. This positioning provides space in the anterior palate region of the user's mouth and encourages placement of the user's tongue in this region during sleep. This helps avoid snoring and apnea, which may occur if the subject's tongue falls behind the user's mouth and blocks the subject's airway. Because the tongue is attached to the lower jaw, keeping the lower jaw forward can prevent the tongue from falling back into the airway.

[0081] In order to provide different relative positioning of the upper and lower jaws of the patient, the lower base portion 250 of the lower aligner portion 200 can be provided with an insert 300 that is connected to the rear side 253 of the lower base portion 250 and extends rearwardly at different distances, such as Figure 6 and Figure 7As shown, in order to control the relative anterior-posterior position of the maxilla and mandible of a user of the brace 10 of the present invention. The selection of an insert 300 having an appropriate posterior range allows the lower brace portion 200 to be fitted to the user and produce the correct positioning of the user's jaw. In existing brace designs, inserts in the upper brace tray have been used to adjust the position of the downwardly extending protrusion relative to the lower brace tray, however, with this approach, the insert occupies space in the upper portion of the interior of the user's mouth and tends to block the user's tongue. Preferably, the user's tongue is positioned so that it contacts the user's palate during the treatment of snoring or apnea, and the insert 300 is therefore advantageously disposed in the lower brace portion 200 rather than the upper brace portion 100, so as to encourage the user's tongue to rest on the anterior palate.

[0082] In order to fit the orthosis 10 of the present invention to a subject, the insert 300 is preferably reversibly fixable (attachable) to the lower base portion 250, such as by a mechanical connector 350. Figure 6 In the illustrated embodiment, the connector 350 extends forwardly from the insert 300 and has an attachment end (in this case, the front end 351) adapted to be retained by the lower base portion 250. For example, cooperating locking elements in the front side 311 of the insert 300 may be configured to engage with and be retained by matching elements in the receiving portion 280 of the lower base portion 250 to retain the insert 300 on the lower base portion 250. Figure 6 In the example shown, the attachment end 351 of the connector 350 can engage with the mating portion 289 in the rear side 253 of the base 250 of the lower orthotic portion 200. The mating element can be, for example, Figure 6 and Figure 7 The insert 300 is shown in a tongue-and-groove arrangement in which the tongue in the attachment end 351 is sized to fit into a groove (mating portion) of the receiving portion 280 in the rear side 253 of the base 250. In this example, the sides of the wedge form an interference fit with the groove or recess of the receiving portion 280 so as to securely retain the insert 300. In this case, the insert 300 can be formed of an elastomeric material, and the tongue can be formed to have a slightly larger size than the recess so that when the tongue is pushed into the recess, it applies an outward force that helps to retain it within the recess. Other known ways of attaching the insert 300 to the lower base portion 250 of the lower corrector portion 200 can also be used, for example, the insert 300 can be attached to the lower corrector portion 200 with screws or other mechanical attachments.

[0083] The insert 300 can be formed with different posterior lengths to control the anterior-posterior position of the maxilla and mandible of the user. Figure 6 and Figure 7As shown, the insert has a right side 312, a left side 314, a front side 311, and a rear side 313. In the illustrated embodiment, the front contact portion 315 of the lower side 318 of the insert 300 fits on the upper surface of the receiving portion 280, and the base contact front surface 319 contacts and covers the rear side 253 of the lower base portion 250, so that when the insert 300 is attached to the lower base portion 250, the rear side 313 of the insert 300 effectively becomes the rear side 253 of the lower base portion 250 and contacts the front surface of the protrusion 400 of the upper base portion 150.

[0084] like Figure 7 As shown, the extent to which the rear side of the insert 300 extends rearwardly can vary. In the illustrated embodiment, the difference in extent is illustrated by the distance (d) between the base contact front surface 319 (adjacent the rear side 253 of the lower base portion 250 when the insert is inserted into the lower base portion) and the rear side 313 of the insert 300, particularly in the central portion of the rear side 313 that will contact the protrusion 400 of the upper base portion 150. This distance increases from a relatively small distance for the insert 301 to a larger (longer) distance for the insert 302 and a larger distance for the insert 303, such that the distance d2 of the insert 303 is greater than the distance d1 of the insert 302. When the inserts are attached to the base 250, the insert 302 is used to position the mandible of the user in a relatively more posterior position relative to the maxilla, compared to the longer insert 303, wherein the insert 302 provides jaw positioning between the inserts 301 and 303 due to its mid-length (in the anterior-posterior direction) compared to the mid-length of the inserts 301 and 303. For example, the length of the inserts (i.e., the distance d) can be different in increments of 1 mm (millimeter), 0.5 mm, or 0.25 mm.

[0085] The base portion 50 of the brace 10 of the present invention can be formed of various oral compatible materials used to make orthodontic braces, typically polymers such as acrylic. The wire portion of the brace 10 can be formed of various orthodontic wires, typically light orthodontic wires, which can be made of, for example, stainless steel or cobalt-chromium alloys, nickel-titanium alloys, or beta-titanium alloys. The diameter of the wire is typically between 0.016 and 0.050 inches (0.41 mm to 1.27 mm), preferably between about 0.020 and 0.040 inches (0.51 mm to 1 mm), and in one embodiment is about 0.030 inches (0.76 mm) in diameter. The wire may have a typical orthodontic wire modulus, such as about 14x10 4 MPa to 20x10 4 The wires must have sufficient bending resistance to maintain their shape during use, but also have sufficient elasticity to recover their shape after bending for insertion into or removal from the user's mouth.

[0086] The examples set forth herein are provided to illustrate certain concepts of the present disclosure. The devices, apparatuses or components described above may be configured to perform one or more of the methods, features or steps described herein. Those of ordinary skill in the art will appreciate that these are essentially merely illustrative, and other examples may fall within the scope of the present disclosure and the appended claims. Based on the teachings herein, it should be understood by those skilled in the art that the aspects disclosed herein may be implemented independently of any other aspects, and two or more of these aspects may be combined in various ways. For example, any number of aspects set forth herein may be used to implement a device or practice method. In addition, such a device may be implemented, or other structures other than those set forth herein or other than those set forth herein may be used to practice such a method. The various features described above may also be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, certain steps or features may be omitted in some embodiments. All patents, patent publications and other publications mentioned herein are incorporated herein by reference as a whole.

Claims

1. A sleep brace (10) for use with orthodontic braces, the sleep brace comprising: (1) an upper orthotic portion (100), which is used on the maxillary dentition of a user of the orthotic device (10), and comprises: (a) an upper base portion (150) having a right side (152), a left side (154), a front side (151), a rear side (153), an upper side (156) and a lower side (158); (b) a right upper wire (172), the right upper wire having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78) and a middle portion (75), wherein: (i) the proximal end (71) of the upper right wire (172) is attached to the right side (152) of the upper base portion (150); (ii) the lingual wire portion (76) of the upper right wire (172) extends posteriorly from the proximal end (71) to the middle portion (75), wherein the middle portion (75) of the upper right wire (172) extends laterally, and the buccal wire portion (78) of the upper right wire (172) extends anteriorly from the middle portion (75) to the distal end (73); and (iii) the upper right wire (172) is adapted to fit between the bracket of the orthodontic braces fixed to the teeth of the user of the brace (10) and the gum tissue of the user; (c) an upper left wire (174), the upper left wire having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78) and a middle portion (75), wherein: (i) the proximal end (71) of the left upper wire (174) is attached to the left side (154) of the upper base portion (150); (ii) the lingual wire portion (76) of the upper left wire (174) extends posteriorly from the proximal end (71) to the middle portion (75), the middle portion (75) of the upper left wire (174) extends laterally, and the buccal wire portion (78) of the upper left wire (174) extends forwardly from the middle portion (75) to the distal end (73); and (iii) the upper left wire (174) is adapted to fit between the bracket of the orthodontic braces fixed to the teeth of the user of the brace (10) and the gum tissue of the user; (d) an upper container (160) having an upper surface (66), wherein the upper container (160) comprises a thermoplastic material (90); and (e) a downwardly extending protrusion (400) having a proximal end (402), a distal end (404), a front surface (401), and a rear surface (403), wherein the protrusion is attached to the underside (158) of the upper base portion (150) and extends downwardly from the underside of the upper base portion (150); and (2) a lower orthotic portion (200) for use on the mandibular dentition of a user of the orthotic device (10), the lower orthotic portion comprising: (a) a lower base portion (250) having a right side (252), a left side (254), a front side (251), a rear side (253), an upper side (256) and a lower side (258); (b) a lower right wire (272), the lower right wire having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and a middle portion (75), wherein: (i) the proximal end (71) of the right lower wire (272) is attached to the right side (252) of the lower base portion (250); (ii) the lingual wire portion (76) of the lower right wire (272) extends posteriorly from the proximal end (71) to the middle portion (75), the middle portion (75) of the lower right wire (272) extends laterally, and the buccal wire portion (78) of the lower right wire (272) extends forwardly from the middle portion (75) to the distal end (73); and (iii) the lower right wire (272) is adapted to fit between the bracket of the orthodontic braces fixed to the teeth of the user of the brace (10) and the gum tissue of the user; (c) a lower left wire (274), the lower left wire having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and a middle portion (75), wherein: (i) the proximal end (71) of the left lower wire (274) is attached to the left side (254) of the lower base portion (250); (ii) the lingual wire portion (76) of the lower left wire (274) extends posteriorly from the proximal end (71) to the middle portion (75), the middle portion (75) of the lower left wire (274) extends laterally, and the buccal wire portion (78) of the lower left wire (274) extends anteriorly from the middle portion (75) to the distal end (73); and (iii) the lower left wire (274) is adapted to fit between the bracket of an orthodontic brace fixed to the teeth of the user of the brace (10) and the gum tissue of the user; and (d) a lower container (260) having a lower surface (68), wherein the lower container (260) comprises a thermoplastic material (90), wherein the front surface (401) of the protrusion (400) is adapted to contact the rear side (253) of the lower base portion (250) when the corrector is in use, thereby limiting the forward movement of the upper corrector portion (100) relative to the lower corrector portion (200), and Wherein, the thermoplastic material is reversibly deformable to adapt to the changing tooth position of the user's teeth.

2. The sleep correction device according to claim 1, wherein: The lower orthotic portion (200) further comprises: an insert (300) having a right side (312), a left side (314), a front side (311), a rear side (313), an upper side (316), and a lower side (318); and A receiving portion is provided in the lower base portion (250), wherein the insert (300) is configured to be secured to the receiving portion (280).

3. The sleep correction device according to claim 2, further comprising: A plurality of inserts (300), wherein a rear side (313) of each of the plurality of inserts extends rearwardly a different distance when retained in the receiving portion (280), and wherein each of the plurality of inserts is reversibly securable to the lower orthotic portion (250).

4. The sleep correction device according to claim 3, wherein: The distance that each of the inserts extends rearward differs by 0.5 mm to 1.0 mm.

5. The sleep correction device according to claim 2, wherein: The front side (311) of the insert (300) and the rear side (253) of the lower orthotic portion (250) are provided with mutually cooperating locking elements so as to secure the insert (300) to the receiving portion (280).

6. The sleep correction device according to claim 5, wherein: The cooperating locking elements are tongue and groove locking elements.

7. The sleep correction device according to claim 1, wherein: The upper right wire (172), the upper left wire (174), the lower right wire (272) and the lower left wire (274) are elastically deformable and adapted to contact the user's teeth under tension.

8. The sleep correction device according to claim 1, wherein: The upper base portion (150) and the lower base portion (250) are formed of a thermoplastic material.

9. The sleep correction device according to claim 1, wherein: The upper base portion (150) and the lower base portion (250) also include a hard plastic material.

10. The sleep rectifier according to claim 1, further comprising: A clasp extending from one or more of the upper right wire (172), the upper left wire (174), the lower right wire (272) and / or the lower left wire (274), wherein the clasp extends medially from the buccal wire portion (78) or laterally from the lingual wire portion (76) and is adapted to extend on the occlusal surface of the user's teeth.

11. The sleep remedy according to claim 1, wherein the sleep remedy is used to treat snoring or sleep apnea.

12. A method of treating snoring or sleep apnea, the method comprising the step of applying the sleep remedy according to claim 1 to a subject in need thereof.

13. The method according to claim 12, further comprising the steps of: (a) heating the upper appliance portion so as to soften the thermoplastic material of the upper appliance portion and to make an impression of the front maxillary dentition of the subject; (b) heating the lower appliance portion to soften the thermoplastic material of the lower appliance portion and to make an impression of the anterior mandibular dentition of the subject; (c) Repeat steps (a) and (b) every 1 to 3 days.

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