Adjustable oral appliance for sleep apnea to be used with orthodontic appliances

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 portion that extends over a user's upper front teeth and two orthodontic wires, one extending from each side of the upper base portion. The lower appliance portion has a lower base portion that extends over the user's lower front teeth and two orthodontic wires, one extending from each side of the upper base portion. The lingual portion of each wire extends posteriorly from a proximal end on the lingual side of the user's teeth, around the user's posteriormost tooth, and then extends forward along the buccal sides of the user's teeth to the distal end of the wire, and when worn, the wires are positioned between the brackets and the user's gum line.

Description

[Technical Field]

[0001] Sleep apnea is a disorder characterized by abnormal cessation of breathing or abnormal hypopnea during sleep. These pauses in breathing, called apneas, can last from a few seconds to several minutes (usually 20-40 seconds) and can occur 5-30 or more times per hour. Sleep apnea occurs when a person's airway becomes partially or completely blocked. As the velocity of air through the airway increases, dynamic pressure rises and static pressure correspondingly decreases. This decrease in static pressure can sometimes cause the jaw or tongue to retract, blocking the airway. This blockage can escalate to a complete obstruction, at least temporarily preventing breathing.

[0002] In general, being overweight or having conditions such as diabetes, high blood pressure, and chronic nasal congestion increases the risk of sleep apnea. However, there are various factors that can cause sleep apnea. For example, if a person's upper and / or lower jaw is narrow, the amount of air in the oral cavity decreases, and the tongue tends to be pushed back into the posterior airway cavity during sleep, causing obstructive sleep apnea.

[0003] Orthodontics is a branch of dentistry focused on realigning teeth and jaws for therapeutic, cosmetic, or other reasons, such as due to dental "overcrowding." Orthodontic procedures typically require the continued use of mechanical devices, such as orthodontic braces or dental appliances, over a period of time to achieve results. The use of orthodontic appliances precludes the simultaneous use of oral appliances currently available for the treatment of sleep apnea. Therefore, there remains a need for improved devices and methods for treating sleep apnea in subjects undergoing orthodontic treatment and who have sleep apnea. Summary of the Invention

[0004] The adjustable sleep appliance of the present invention is designed for use with orthodontic braces and generally includes an upper appliance portion 100 for use with the upper dentition of a user wearing orthodontic braces, and a lower appliance portion 200 for use with the lower dentition of a user wearing orthodontic braces. Upper appliance portion 100 includes an upper base portion 150 including an upper right wire 172, an upper left wire 174, an upper receptacle 160, and a downwardly extending projection 400. Upper base portion 150 further has a right side 152, a left side 154, an anterior side 151, a posterior side 153, an upper side 156, and a lower side 158. Upper right wire 172 and upper left wire 174 each have a proximal end 71, a distal end 73, a lingual wire portion 76, a buccal wire portion 78, and a medial portion 75, where: (i) the proximal end 71 of the upper right wire 172 is attached to the right side 152 of the upper base portion 150, and the proximal end 71 of the upper left wire 174 is attached to the left side 154 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 medial portion 75, the medial portion 75 of the upper right wire 172 extends laterally, the buccal wire portion 78 of the upper right wire 172 extends anteriorly from the medial portion 75 to the distal end 73, the lingual wire portion 76 of the upper left wire 174 extends posteriorly from the proximal end 71 to the medial portion 75, the medial portion 75 of the upper left wire 174 extends laterally, and the buccal wire portion 78 of the upper left wire 174 extends anteriorly from the medial portion 75 to the distal end 73; (iii) Upper right wire 172 and upper left wire 174 are adapted to fit between the brackets of orthodontic appliances attached to the teeth of a user of appliance 10 and the user's gum tissue.

[0005] Upper receptacle 160 has an upper surface 66 and comprises a thermoplastic material 90. A downwardly extending projection 400 has a proximal end 402, a distal end 404, a front side 401, and a rear side 403, and is attached to and extends downwardly from lower surface 158 of upper base portion 150.

[0006] Lower appliance portion 200 comprises a lower base portion 250 including a lower right wire 272, a lower left wire 274, and a lower receptacle 260. Lower base portion 250 further 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. Lower receptacle 260 has a lower side 68 and comprises a thermoplastic material 90. Lower right wire 272 and lower left wire 274 each have a proximal end 71, a distal end 73, a lingual wire portion 76, a buccal wire portion 78, and a medial portion 75, where: (i) the proximal end 71 of the lower right wire 272 is attached to the right side 252 of the lower base portion 250, and the proximal end 71 of the lower left wire 274 is attached to the left side 254 of the lower base portion 250; (ii) a lingual wire portion 76 of the lower right wire 272 extends posteriorly from the proximal end 71 to a medial portion 75, a medial portion 75 of the lower right wire 272 extends laterally, a buccal wire portion 78 of the lower right wire 272 extends anteriorly from the medial portion 75 to the distal end 73, a lingual wire portion 76 of the lower left wire 274 extends posteriorly from the proximal end 71 to the medial portion 75, a medial portion 75 of the lower left wire 274 extends laterally, and a buccal wire portion 78 of the lower left wire 274 extends anteriorly from the medial portion 75 to the distal end 73; (iii) Lower right wire 272 and lower left wire 274 are adapted to fit between brackets of orthodontic appliances secured to the teeth of a user of appliance 10 and the gum tissue of the user, and are adapted to fit between brackets of orthodontic appliances secured to the teeth of a user of appliance 10 and the gum tissue of the user.

[0007] Anterior surface 401 of protrusion 400 is adapted to contact posterior surface 253 of lower base portion 250 during use of the appliance, thereby limiting forward movement of upper appliance portion 100 relative to lower appliance portion 200. Additionally, upper right wire 172, upper left wire 174, lower right wire 272, and lower left wire 274 are preferably elastically deformable and adapted to contact the user's teeth under tension.

[0008] The thermoplastic material of the appliance can be reversibly deformed to accommodate changes in the position of the user's teeth. In one embodiment, the upper and lower base portions 150, 250 can be formed entirely from thermoplastic material. Alternatively, the upper and lower base portions 150, 250 can include both a hard plastic material portion that contacts the user's teeth and a thermoplastic material portion.

[0009] Preferably, one or more of the upper right wire 172, upper left wire 174, lower right wire 272, and / or lower left wire 274 include a clasp. The clasp is a projection or flange that extends inwardly from the buccal wire portion 78 or outwardly from the lingual wire portion 76 and is adapted to extend over the occlusal surfaces of the user's teeth.

[0010] In one embodiment, lower instrument portion 200 may further 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 lower base portion 250 and is configured to be secured to receiver 280. The front side 311 of insert 300 and the rear side 253 of lower instrument portion 250 may be provided with interlocking locking elements, such as tongue and groove locking elements, to secure insert 300 to receiver 280.

[0011] This embodiment can include multiple inserts 300, each with a rearward side 313 that extends rearward a different distance when held in receiver 280, and each of the multiple inserts is reversibly securable to lower instrument portion 250. Because the inserts thus extend rearward a different distance, the inserts can be used to adjust the anterior-posterior position of upper instrument portion 100 relative to lower instrument portion 200. The distance each insert extends rearward can vary, for example, from 0.5 mm to 1.0 mm.

[0012] The device can be used to treat snoring and sleep apnea. In such a treatment method, the device of the present invention is applied (worn) to a subject in need thereof. The method preferably further comprises the following steps: (a) heating the upper appliance portion to soften the thermoplastic material of the upper appliance portion and taking an impression of the subject's maxillary anterior dentition; (b) heating the lower appliance portion to soften the thermoplastic material of the lower appliance portion and taking an impression of the subject's anterior mandibular dentition; (c) Repeating steps (a) and (b) every 1 to 3 days. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a front left perspective view of one embodiment of the device attached to a model of a subject's teeth. [Figure 2] FIG. 2 is a front left perspective view of an embodiment of the upper appliance portion of the appliance on a model of a subject's teeth. [Figure 3] FIG. 3 is a rear view of the upper appliance portion of an embodiment of the appliance attached to a model of a subject's teeth. [Figure 4] FIG. 4 is a front left perspective view of an embodiment of the lower appliance portion of the appliance on a model of a subject's teeth. [Figure 5] FIG. 5 is a top view of one embodiment of the appliance attached to a model of a subject's teeth. [Figure 6] FIG. 6 is a top view of an embodiment of the lower device portion of the device and an insert therefor. [Figure 7] FIG. 7 is a top and bottom plan view of several inserts having different lengths for use in the device of FIG. [Figure 8] FIG. 8 is a left side perspective view of an embodiment of the upper device portion of the device. [Figure 9] FIG. 9 is a front perspective view of an embodiment of the upper device portion of the device. [Figure 10] FIG. 10 is a top view of an embodiment of the lower device portion of the device. [Figure 11] FIG. 11 is a front perspective view of an embodiment of the lower appliance portion of the appliance. DETAILED DESCRIPTION OF THE INVENTION

[0014] definition As used herein, the following terms and variations thereof shall have the meanings indicated below unless the context in which the term is used clearly indicates otherwise.

[0015] "Above" refers to the relative position of the device or its component parts near or toward the upper portion of the subject's body when the device is in use; "Lower" refers to the relative position of the opposite side of the device or component thereof, nearer to or toward the lower portion of the subject's body when the device is in use.

[0016] "Anterior" and "forward" mean toward or adjacent the front portion (opening) of the subject's mouth when the device is worn on the subject. "Apnea" and "sleep apnea" generally refer to the temporary cessation of breathing and / or shallower, less frequent breathing during sleep caused by an obstruction of a subject's airway (called obstructive sleep apnea).

[0017] "Orthodontics" refers to a series of brackets and wires used to change the position of teeth or the shape of the jaw.

[0018] "Brackets" are mechanical components that are typically secured to a subject's teeth by bonding material and connected to wires that distribute forces to the subject's teeth during orthodontic treatment. Brackets are typically secured to the buccal surfaces of the subject's teeth.

[0019] "Buccal" refers to a direction toward or towards a subject's cheek. References to a subject's teeth mean the side of the teeth facing the cheek.

[0020] "Clasp" refers to the mechanical part of the appliance that helps to grip and hold the appliance on the user's teeth during use.

[0021] "Downward" and "downwardly" mean toward or towards the lower part of the subject's body when the device is worn. "Upward" and "upwardly" mean the opposite direction, i.e., toward or towards the upper part of the subject's body. "Hard plastic" refers to polymeric materials that do not elastically deform, such as poly(methyl methacrylate) (also known as acrylic), polycarbonate, and acrylonitrile butadiene styrene (ABS). Hard plastics used in the devices of the present invention are non-toxic and compatible for use in the subject's mouth. Hard plastics used in orthodontic applications are known in the art and can be used in the devices.

[0022] "Horizontal" in reference to the present appliance refers to alignment within 15 degrees of a plane approximately parallel to the subject's occlusal plane, i.e., approximately perpendicular to the subject's sagittal and / or coronal planes.

[0023] "Lateral" refers to a position or direction toward the right or left side of the device when it is worn on a subject and / or toward the outside of the subject's mouth, i.e., buccal.

[0024] "Lingual" means on, toward, or adjacent to a subject's tongue. In terms of a subject's teeth, this refers to the sides or insides of the front teeth that face the tongue.

[0025] "Lower" refers to the relative location of parts of the device that are closer to or toward the lower part of the subject's body when the device is in use.

[0026] "Mandible" refers to the lower jaw.

[0027] "Maxilla" refers to the upper jaw.

[0028] "Inner" refers to a position or direction toward the central portion of the appliance when it is worn by a subject and / or toward the inside of the subject's mouth, i.e., the tongue side.

[0029] "Occlusal surface" refers to the surface of the teeth that comes into contact with each other.

[0030] "Orthodontic" refers to devices or components thereof that change the position of a subject's teeth and / or jaws.

[0031] "Orthodontic wire" refers to a length of metal wire of the type used in orthodontic treatment.

[0032] "Posterior" and "rear" mean toward, towards, or adjacent to the rear of the subject's oral cavity when the subject is wearing the appliance.

[0033] "Right" refers to the right side of the device when in use, i.e., to the right of the subject's sagittal center as seen from the subject. "Left" refers to the opposite side, i.e., the left side of the device.

[0034] "Subject" refers to the user of the device, typically a human user.

[0035] "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, e.g., by heat, and rehardened, e.g., by cooling, in a reversible physical process. One such material is THERMACRYL (a polymer available from Airway Management, Inc., Farmers Branch, Texas), and another is ethylene vinyl acetate (EVA).

[0036] The thermoplastic material used in some parts of the device retains its shape at 100°F and preferably becomes soft (deformable) at temperatures below 212°F.

[0037] "Upper" refers to the relative location of the device's components that are closer to or toward the upper part of the subject's body when in use.

[0038] "Vertical" refers to a plane or direction perpendicular to a horizontal plane or direction.

[0039] As used herein, terms of relative position or orientation, such as "above," "below," "between," etc., refer to the relative location of one layer with respect to another layer. Thus, 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, unless otherwise specified herein.

[0040] Variations of terms such as "comprise" and "comprising" and "comprises" do not exclude other additives, components, integers or steps. The terms "a," "an," "the," and similar referents used herein should be interpreted as including both the singular and the plural, unless the context requires otherwise. Ranges expressed as "between" two values ​​include the stated values.

[0041] Equipment and Instructions The sleep appliance of the present invention is designed to be worn by patients undergoing orthodontic treatment. When wearing orthodontic appliances, brackets are typically secured to the outer surfaces of the patient's teeth as anchors for applying and distributing forces through wires. The brackets are typically secured to the buccal surfaces of the teeth, and a wire (archwire) is mechanically connected to the brackets. The wire extends between the brackets and other brackets attached to other teeth, possibly other upper or lower teeth, to apply and distribute forces between the teeth. The brackets are typically attached relatively centrally in the area of ​​the teeth outside the gums (periodontal tissue), i.e., so that there is a space between the brackets and the patient's gums.

[0042] The appliance 10 includes an upper appliance portion 100 and a lower appliance portion 200, each of which includes a base 50 for receiving a user's anterior teeth (e.g., incisors), i.e., an upper appliance portion base 150 and a lower appliance portion base 250. The base portion 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 receptacles 60 for contacting and / or receiving the outer surfaces of the user's anterior teeth of the appliance 10. The upper base portion 150 is disposed on the anterior portion 41 of the upper appliance portion 100, and the lower base portion 250 is disposed on the anterior portion 41 of the lower appliance portion 200. The upper base portion 150 and the lower base portion 250 cooperate to limit forward movement of the user's upper jaw.

[0043] Specifically, upper appliance 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, with an upper receptacle 160 disposed on upper base portion upper side 156 for receiving the user's upper (maxillary) teeth. An upper right wire 172 extends from right side 152, and an upper left wire 174 extends from left side 154. Lower appliance 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, with a lower receptacle 260 disposed on lower base portion lower side 258 for receiving the user's mandibular teeth. A lower right wire 272 extends from right side 252, and a lower left wire 274 extends from left side 254.

[0044] The upper receptacles 160 of the upper appliance base 150 extend across at least the incisal portions, including the incisal surfaces, of the user's maxillary anterior teeth, for example, covering and contacting or receiving two to six teeth, and the lower receptacles 260 similarly extend across at least the incisal portions of the user's mandibular anterior teeth, for example, covering and receiving two to six teeth, with preferably three or four teeth at least partially covered by the receptacles 60 of each base 50. Preferably, the receptacles 60 do not cover more than one-third of the anterior and posterior (i.e., buccal and lingual) surfaces of the incisal portions of the user's teeth, i.e., the upper one-third of the mandibular teeth and the lower one-third of the maxillary teeth.

[0045] The receptacle portion 60 of each base 50 can be formed from a hard plastic material and is configured to accommodate the user's teeth in various positions expected during orthodontic treatment. However, the receptacle 60 preferably comprises a thermoplastic (soft plastic) material such as THERMACRYL laminate (an acrylic thermoplastic material). Such a thermoplastic material retains its shape when used by the subject and therefore preferably remains solid at least at body temperature, and preferably remains solid even at elevated temperatures, such as 110°F, 120°F, or higher. However, the thermoplastic material is deformable at elevated temperatures, up to the temperature of boiling water (212°F), and is preferably plasticized by placing it in boiling water. While the receptacle plastic material is in such a deformable state, the user can press the material against the upper or lower dentition, as the case may be. As the material cools, it conforms to the shape of the user's dentition, forming a stable support (i.e., a secure seat) for the user's teeth within the receptacle 60, thereby maintaining the base 50 securely on the user's dentition.

[0046] If the receptacle 160 of the upper base portion 150 includes the thermoplastic material 90, the thermoplastic material is present on the upper surface 66 of the receptacle, as shown in FIG. 9 . In this manner, the outer surface 96 of the thermoplastic material 90 can receive an impression of the user's upper teeth when the material softens. Similarly, if the receptacle 260 of the lower base portion 250 includes the thermoplastic material 90, the thermoplastic material is present on the lower surface 68 of the receptacle, as shown in FIG. 11 . In this manner, the outer surface 96 of the thermoplastic material 90 can receive an impression of the user's lower teeth when the material softens. The use of the thermoplastic material 90 improves the fit with the user's anterior teeth and provides greater stability for the appliance 10 in the user's mouth. Preferably, the receptacles 60 of the upper and lower bases 50 are used to take impressions of the user's teeth on a daily or two-to-three-day basis to accommodate steady changes in the position of the user's teeth during orthodontic treatment. In an advantageous embodiment, the base 50 of the appliance can be formed from a single material, preferably a thermoplastic material. Such materials would also preferably be 3D printable for ease of manufacturing.

[0047] Extending from each side of the base 50 of the appliance portion 40 are wires 70, namely, a right wire 72 and a left wire 74. The proximal end 71 of each wire is secured to the respective 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 accomplished, for example, by heating the polymer material and then inserting the proximal end 71 of the wire 70 into the softened plastic. A lingual portion 76 of each wire 70 extends posteriorly from the proximal end 71 of the wire on the lingual side of the user's mouth when worn by a user. The lingual portion 76 of each wire 70 is configured to contact or be directly adjacent the lingual side of the user's teeth and be away from the gingiva (gums). An inner portion 75 of the wire 70 extends around the posterior surface of the subject's rearmost (most posterior) tooth on the right or left side of the subject's mouth, as appropriate, and is bent around the rearmost tooth, with the buccal portion 78 of the wire then extending anteriorly along the buccal side of the user's teeth. The buccal portion 78 of each wire 70 is configured to contact or directly abut the buccal side of the subject's tooth, between the bracket and the gum line. The buccal portion 78 extends forward to the distal end 73 of the wire. The distal end 73 is preferably capped, blunted, or otherwise protected to prevent the user from being irritated or injured by the distal end of the wire. In the illustrated embodiment, the distal end of the wire is formed into a loop, with the rounded portion of the loop located at the distal end of the wire 70. The lingual and buccal portions 76 and 78 of each wire are preferably each shaped to conform to the shape of the adjacent teeth over at least a portion of the wire 70 to better hold the appliance 10 in place against the user's dentition.

[0048] 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 150 along the lingual sides of the subject's upper teeth below the gums, fits around the rearmost teeth, and then extends anteriorly below the gums but above the brackets secured to the teeth on the buccal side, as shown, for example, in Figures 2 and 3. Similarly, in the lower appliance portion 200, each of the right and left wires 272, 274 of the lower appliance portion 200 extends posteriorly from the lower base 250 along the lingual sides of the subject's upper teeth below the gums, fits around the rearmost teeth, and then extends anteriorly above the gums but below the brackets secured to the teeth on the buccal side, as shown, for example, in Figures 4 and 5. Thus, on the lingual side, the wire 70 exits the base 50 and is designed to fit closely against the lingual surfaces of all of the posterior teeth. Preferably, wire 70 is positioned at the cement-enamel junction (CEJ), not in contact with the gum tissue, but just above or below the gum tissue, between the gum tissue and the brackets on the user's teeth, so that wire 70 is held in place by the brackets.

[0049] As shown in FIG. 5, one or more of upper right wire 172, upper left wire 174, lower right wire 272, and / or lower left wire 274 may advantageously include fasteners 83. Fasteners 83 include flanges like the wire portions extending from wires 272 and 274 shown in FIG. 5. Such wire portions extend inward from buccal wire portion 78 or outward from lingual wire portion 76 and are adapted to extend over the occlusal surfaces of the user's teeth. The fasteners help to retain appliance 10, and particularly wire 70, on the user's teeth.

[0050] Each wire 70 is positioned to be in intimate contact with the user's teeth so that the respective appliance portion can be held on either the subject's upper or lower jaw. To attach the upper or lower appliance portion 100 or 200 to the user's teeth, the appliance portion 40 is placed in the user's mouth and the receptacles 60 of the base portion 50 are placed over the front teeth. The distal end 73 of each wire 70 is then forced laterally outward so that the distal end 73 and buccal wire portions 76 are further away from the respective lingual wire portions 78, i.e., the distance between each lateral buccal wire portion 76 and lingual wire portion 78 is increased, allowing the wire 70 to fit over all brackets. The wire 70 is then guided below the brackets on the mandibular dentition or above the brackets on the maxillary dentition, as appropriate, after which the outward force on the wire is released, allowing the wire to partially or fully return to its tensioned configuration. Preferably, the wire 70 contacts the lingual and / or buccal surfaces of a plurality of the user's teeth under tension to better hold the appliance portions 40 on the user's teeth; i.e., it is under tension while the appliance portions 40 are worn, preventing the wire from returning to a fully pre-tensioned configuration so as to exert a force on at least a portion of the user's teeth. The wire 70 preferably has a modulus of elasticity that allows the wire 70 to bend elastically in this manner and returns to its pre-bent shape after the appliance portions are positioned in the subject's mouth. The wire 70 is spring-loaded to maintain its position above a bracket (upper appliance portion) or below a bracket (lower appliance portion 200). When the appliance portions 40 are positioned in this manner, the brackets of the user's orthodontic appliance operate to prevent vertical displacement of the appliance portions.

[0051] One advantage of the present appliance 10 is that it can be used to treat snoring and apnea during sleep without interfering with the ongoing orthodontic process of moving the teeth and jaw. Because the wire 70 does not contact the brackets or orthodontic wires, it does not interfere with the application of tooth- and jaw-moving forces to the teeth. Instead, it is positioned between the tooth bracket and the gums above or below the bracket. An additional feature for avoiding interference with the orthodontic process is the use of a thermoplastic material for at least the receptacle 60, so that the shape of the receptacle 60 can change over time in response to changes in the position of the anterior teeth received by the receptacle 60. As mentioned above, users of the appliance of the present invention can soften the polymeric material of the receptacle 60 periodically, such as weekly, every other day, or more preferably daily, to accommodate the movement of the anterior teeth covered by the receptacle 60 due to the user's use of the orthodontic appliance.

[0052] To position the user's jaw and thereby treat snoring and / or apnea, the upper appliance portion 100 includes a rigid protrusion 400 extending downwardly from the underside 158 of the upper base 150. The protrusion 400 has a proximal end 402, a distal end 404, an anterior side 401, and a posterior side 403. The proximal (upper) end 402 of the protrusion 400 is attached to the upper base 150, such as by being integrally molded therewith. As described below, the anterior-posterior position of the lower jaw relative to the maxilla can be adjusted in some embodiments using an insert 300 attached to the lower base 250 of the lower appliance portion 200.

[0053] The distal end 404 of the protrusion 400 extends downwardly beyond the upper portion 256 of the lower base 250 such that a portion of the distal end 404 of the protrusion 400 is positioned lingually relative to the posterior side 253 of the lower base 250 when the appliance 10 is worn on the subject. Thus, the anterior surface 401 of the protrusion 400 abuts or is adjacent to the posterior surface 253 of the lower appliance portion 200 when the appliance 10 is worn on a user, and the protrusion 400 is positioned posteriorly relative to the lower base 250. This positioning limits posterior movement of the lower appliance portion 200, and therefore limits movement of the user's lower jaw (mandible) relative to the upper appliance portion 100 and the user's upper jaw (maxilla) when the appliance 10 is worn, thereby maintaining the user's jaw in an orientation conducive to the prevention or amelioration of sleep apnea and / or snoring.

[0054] The protrusion 400 is preferably positioned in the anterior portion of the upper base 150, i.e., relatively toward the cheek, such as below the user's upper incisors. This positioning creates space in the anterior palate of the user's mouth, allowing the user's tongue to be positioned in that area during sleep. This prevents snoring and apnea, which can occur when the subject's tongue drops to the back of the mouth and blocks the airway. Because the tongue is attached to the mandible, extending the mandible forward prevents the tongue from dropping into the airway.

[0055] To accommodate different relative positions of a subject's upper and lower jaws, the base 250 of the lower appliance portion 200 is provided with an insert 300, which connects to the posterior surface 253 of the lower base 250 and extends posteriorly at different distances, as shown in FIGS. 6 and 7 , to control the relative anterior-posterior position of the upper and lower jaws of a user of the appliance 10. By selecting an insert 300 with the appropriate posterior extent, the lower appliance portion 200 can be fitted to the user and the user's jaw can be properly positioned. Previous appliance designs used inserts in the upper appliance tray to adjust the position of downwardly extending protrusions relative to the lower appliance tray, but this approach resulted in the insert occupying space in the upper part of the user's mouth and tending to block the user's tongue. For the treatment of snoring and apnea, it is preferable to position the user's tongue so that it touches the roof of the user's mouth. Therefore, the insert 300 is advantageously provided in the lower appliance portion 200, rather than the upper appliance portion 100, to encourage the user's tongue to rest against the anterior palate.

[0056] To attach the device 10 to a subject, the insert 300 is preferably reversibly securable (attachable) to the lower base portion 250, such as via a mechanical connector 350. In the embodiment shown in FIG. 6, the connector 350 extends forward from the insert 300 and has an attachment end (in this case, forward end 351) adapted to be retained by the lower base portion 250. For example, interlocking locking elements on the front side 311 of the insert 300 can be configured to mate and be retained by matching elements on the receptacle 280 of the lower base 250 to retain the insert 300 on the lower base 250. In the example shown in FIG. 6, the attachment end 351 of the connector 350 can engage a mating portion 289 on the rear side 253 of the base 250 of the lower instrument portion 200. The mating element may be a tongue and groove configuration as shown in FIGS. 6 and 7, with the tongue of mounting end 351 sized to fit into the upper groove (mating portion) of receiver 280 on rear side 253 of base 250. In this example, the wedge-shaped side forms an interference fit with the groove or recess of receiver 280 to securely retain insert 300. In this case, insert 300 may be formed from an elastomeric material, with the tongue sized slightly larger than the recess so that when pressed into the recess, it exerts an outward force that helps retain it in the recess. Other known methods of attaching insert 300 to lower base 250 of lower instrument portion 200 may also be used, such as attaching insert 300 to lower instrument portion 200 with screws or other mechanical attachment means.

[0057] The insert 300 is formed with different rear lengths, allowing the anterior-posterior position of the user's upper and lower jaws to be controlled. As shown in Figures 6 and 7, 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 onto the upper surface of the receiver 280, and the base-contacting front side 319 contacts and covers the rear side 253 of the lower base 250. Therefore, when the insert 300 is attached to the lower base 250, the rear side 313 of the insert 300 substantially becomes the rear side 253 of the lower base 250 and contacts the front side of the protrusion 400 of the upper base 150.

[0058] As shown in FIG. 7 , insert 300 can vary the extent to which its rear side extends posteriorly. In the illustrated embodiment, this difference is indicated by the distance (d) between the front side 319 that contacts the base (adjacent the rear side 253 of lower base 250 when the insert is inserted into the lower base) and the rear side 313 of insert 300, specifically the central portion of rear side 313 that contacts protrusion 400 of upper base 150. This distance increases from a relatively small distance for insert 301 to a large (long) distance for insert 302 to an even larger distance for insert 303, with distance d2 for insert 303 being greater than distance d1 for insert 302. Insert 302 positions the user's lower jaw relatively posteriorly relative to the upper jaw when attached to base 250 compared to the longer insert 303, and insert 302, due to its intermediate length (in the anterior-posterior direction) compared to inserts 301 and 303, provides a jaw position intermediate between those of inserts 301 and 303. The length of the insert (ie, distance d) can be varied, for example, in increments of 1 mm (millimeter), 0.5 mm, or 0.25 mm.

[0059] The base portion 50 of the appliance 10 can be formed from a variety of oral compatible materials used in the manufacture of orthodontic appliances, typically polymers such as acrylic. The wire portion of the appliance 10 can be formed from a variety of orthodontic metal wires, typically lightweight orthodontic wires, such as stainless steel or alloys of cobalt chromium, nickel titanium, or beta titanium. The wire diameter is generally 0.016 to 0.050 inches (0.41 mm to 1.27 mm), preferably about 0.020 to 0.040 inches (0.51 mm to 1 mm), and in one embodiment, about 0.030 inches (0.76 mm). The wire modulus of elasticity is that of typical orthodontic wires, e.g., about 14×10 4 MPa~20×10 4 The wire must be sufficiently bend-resistant to retain its shape during use, but also sufficiently elastic to restore its shape after being bent for insertion into or removal from the user's mouth.

[0060] The examples described herein are provided to illustrate certain concepts of the present disclosure. The illustrated devices, apparatus, or components described above can be configured to perform one or more of the methods, features, or steps described herein. Those skilled in the art will appreciate that these are merely exemplary in nature and that other examples may be within the scope of this disclosure and the accompanying claims. Based on the teachings herein, those skilled in the art will appreciate that aspects disclosed herein may be practiced independently of other aspects, or that two or more of these aspects may be combined in various ways. For example, an apparatus may be implemented or a method may be implemented using any number of the aspects defined herein. Furthermore, such an apparatus may be implemented using other structures in addition to or other than those defined herein, and such a method may be implemented using other structures in addition to or other than those defined herein. The various features described above may also be combined in various ways. All possible combinations and subcombinations are intended to be within the scope of the present disclosure. Additionally, certain steps or functions may be omitted in some embodiments. All patents, patent publications, and other publications mentioned herein are incorporated by reference in their entirety. [Explanation of symbols]

[0061] The reference numbers in the figure have the following meaning: Component Subcomponent Code Equipment 10 Equipment part 40 Right side 42 Left side 44 Front part 41 rear part 43 Base 50 Right side 52 Left side 54 Front side 51 Posterior side 53 Top side 56 Lower side 58 Receptacle 60 Receptacle Wall 65 Receptacle upper surface 66 Receptacle bottom surface 68 Wire 70 Right Wire 72 Left Wire 74 Proximal end 71 Distal end 73 inner part 75 Lingual wire section 76 Buccal wire section 78 Rear wire section 79 Front wire section 81 Occlusal fasteners 83 Thermoplastic Materials 90 Thermoplastic outer surface 96 Upper equipment part 100 Base part 150 Right side 152 Left side 154 Front side 151 Posterior side 153 Top side 156 Lower side 158 Upper Receptacle 160 Upper right wire 172 Upper left wire 174 Lower equipment part 200 Base 250 Right side 252 Left side 254 Front side 251 Posterior side 253 Top side 256 Lower side 258 Lower Receptacle 260 Lower right wire 272 Lower left wire 274 Receptor 280 Connector fitting part 289 Insert 300 Multiple Inserts 301, 302, 303 Right side 312 Left side 314 Front side 311 Posterior side 313 Contact part 315 Upper side 316 Lower side 318 Base contact surface 319 Connector 350 Connector Mounting End / Part 351 Downward extending protrusion 400 Proximal end 402 Distal end 404 Front side 401 Posterior side 403 Bracket 500

Claims

1. In a sleep aid (10) for use with orthodontic appliances, (1) The upper part of the appliance (10) for use on the upper dentition of the user of the appliance (10), (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) An upper right wire (172) having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and an medial portion (75), (i) The proximal end (71) of the upper right wire (172) is attached to the right side (152) of the upper base section (150), (ii) The lingual wire portion (76) of the upper right wire (172) extends posteriorly from the proximal end (71) to the medial portion (75), the medial 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 medial portion (75) to the distal end (73), (iii) An upper right wire (172) fitted to fit between the bracket of the orthodontic appliance attached to the user's teeth and the user's gingival tissue, (c) An upper left wire (174) having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and an medial portion (75), (i) The proximal end (71) of the upper left wire (174) is attached to the left side surface (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 medial portion (75), the medial portion (75) of the upper left wire (174) extends laterally, and the buccal wire portion (78) of the upper left wire (174) extends anteriorly from the medial portion (75) to the distal end (73), (iii) An upper left wire (174) which is fitted to fit between the bracket of the orthodontic appliance attached to the user's teeth and the user's gingival tissue, (d) An upper receptacle (160) having an upper surface (66), comprising a thermoplastic material (90), (e) A projection (400) having a proximal end (402), a distal end (404), an anterior surface (401), and a posterior surface (403), extending downward, which is attached to the lower surface (158) of the upper base portion (150) and extends downward therefrom, An upper device portion (100) having, (2) A lower appliance portion (200) for use in the mandibular dentition of the user of the appliance (10), (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) having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and a medial portion (75), (i) The proximal end (71) of the lower right 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 medial portion (75), the medial portion (75) of the lower right wire (272) extends laterally, and the buccal wire portion (78) of the lower right wire (272) extends anteriorly from the medial portion (75) to the distal end (73), (iii) A lower right wire (272) is fitted to fit between the bracket of the orthodontic appliance attached to the user's teeth and the user's gum tissue, (c) A lower left wire (274) having a proximal end (71), a distal end (73), a lingual wire portion (76), a buccal wire portion (78), and a medial portion (75), (i) The proximal end (71) of the lower left wire (274) is attached to the left side surface (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 medial portion (75), the medial 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 medial portion (75) to the distal end (73), (iii) A lower left wire (274) which is fitted to fit between the bracket of the orthodontic appliance attached to the user's teeth and the user's gingival tissue, (d) A lower receptacle (260) having a lower surface (68), comprising a lower receptacle (260) containing a thermoplastic material (90), It comprises a lower device portion (200) having the following, The front surface (401) of the projection (400) is adapted to contact the rear surface (253) of the lower base portion (250) when the device is in use, thereby restricting the forward movement of the upper device portion (100) relative to the lower device portion (200). The aforementioned thermoplastic material is a sleeping device that can be reversibly deformed to accommodate changes in the user's tooth position.

2. The aforementioned lower device portion (200) is further, 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 sleeping device according to claim 1, further comprising a receiving portion (280) provided on the lower base portion (250) and configured such that the insert (300) is fixed thereon.

3. The sleep device according to claim 2, further comprising a plurality of inserts (300), the rear surface (313) of each of the plurality of inserts extending rearward by a different distance when held in the receiving portion (280), and each of the plurality of inserts being reversibly fixed to the lower device portion (250).

4. The sleep device according to claim 3, wherein the distance each insert extends backward differs by 0.5 mm to 1.0 mm.

5. The sleep device according to claim 2, wherein the front surface (311) of the insert (300) and the rear surface (253) of the lower device portion (250) are provided with locking elements that fit together with each other in order to fix the insert (300) to the receiving portion (280).

6. The sleep device according to claim 5, wherein the mutually interlocking locking elements are the tongue and groove locking elements.

7. The sleeping 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 sleeping device according to claim 1, wherein the upper base portion (150) and the lower base portion (250) are formed from a thermoplastic material.

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

10. The sleep device according to claim 1, further comprising a fastener extending from one or more of the upper right wire (172), upper left wire (174), lower right wire (272), and / or lower left wire (274), wherein the fastener extends inward from the buccal wire portion (78) or outward from the lingual wire portion (76) and is adapted to extend over the occlusal surface of the user's teeth.

11. A sleep device according to claim 1, used for the treatment of snoring or sleep apnea.

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