Oral appliances and methods of use

Abstract

Provided herein are oral appliances and methods of using oral appliances for treatment of sleep disorders and conditions.

1 . A device for treatment of a sleep disorder or condition in a subject, comprising:
 a. an upper portion configured to receive at least one maxillary tooth of the subject;   b. a lower portion configured to receive at least one mandibular tooth of the subject;   c. wherein the upper and lower portions are engageable such that the portions maintain a restricted orientation relative to each other when engaged; and   d. wherein the engaged restricted orientation is configured to maintain the mandible of the subject in a predetermined clinically beneficial orientation relative to the maxilla.   
     
     
         2 . The device of  claim 1 , wherein the sleep disorder or condition is selected from the group consisting of sleep apnea, obstructive sleep apnea, central sleep apnea, high upper airway resistance and snoring. 
     
     
         3 . The device of  claim 1 , wherein the upper and lower portions have a fixed predetermined geometry. 
     
     
         4 . The device of  claim 3 , wherein the fixed predetermined geometry of the upper and lower portions position the mandible of the subject in the predetermined clinically beneficial orientation relative to the maxilla when the upper and lower portions are engaged. 
     
     
         5 . The device of  claim 3 , wherein the fixed predetermined geometry of the upper and lower portions are based on a data set obtained from the subject when the mandible of the subject is positioned into the clinically beneficial orientation relative to the maxilla. 
     
     
         6 . The device of  claim 5 , wherein the data set is obtained while the subject is sleeping. 
     
     
         7 . The device of  claim 5 , wherein the data set is obtained with the use of a titration device. 
     
     
         8 - 14 . (canceled) 
     
     
         15 . The device of  claim 1 , wherein the restricted orientation maintains a minimal level of repositioning of mandible relative to the maxilla in at least one degree of freedom. 
     
     
         16 . The device of  claim 15 , wherein the restricted orientation maintains a minimal level of repositioning of mandible relative to the maxilla in two, three, four, five or six degrees of freedom. 
     
     
         17 . The device of  claim 1 , wherein the engaged restricted orientation maintains a minimal level of mandibular protrusion in the subject. 
     
     
         18 . (canceled) 
     
     
         19 . The device of  claim 17 , wherein the minimal level of protrusion orients the mandible and maxilla of the subject such that at least one symptom of the sleep disorder or condition is reduced or eliminated when the device is used in the subject. 
     
     
         20 - 25 . (canceled) 
     
     
         26 . The device of  claim 1 , wherein the upper portion comprises an upper tray configured to house one or more teeth of the subject. 
     
     
         27 . The device of  claim 1 , wherein the lower portion comprises a lower tray configured to house one or more teeth of the subject. 
     
     
         28 . (canceled) 
     
     
         29 . The device of  claim 26 , wherein the upper tray has a geometry configured to communicate with a plurality of the maxillary teeth of the subject and wherein said geometry is at least partially based on a digital scan of the maxillary teeth. 
     
     
         30 . The device of  claim 27 , wherein the lower tray has a geometry configured to communicate with a plurality of the mandibular teeth of the subject and wherein said geometry is at least partially based on a digital scan of the mandibular teeth. 
     
     
         31 . (canceled) 
     
     
         32 . A method for producing a device for treatment of a sleep disorder or condition, comprising:
 a. positioning the mandible of the subject in a clinically beneficial orientation relative to the maxilla of the subject;   b. registering the position of the mandible relative to the maxilla; and   c. using the registered position to manufacture a device that positions the mandible in the clinically beneficial orientation relative to the maxilla.   
     
     
         33 - 42 . (canceled) 
     
     
         43 . The method of  claim 32 , further comprising using the registered position to manufacture at least a second device that positions the mandible in the clinically beneficial orientation or into a second or additional clinically beneficial orientation. 
     
     
         44 . The method of  claim 32 , further comprising:
 a. positioning the mandible of the subject into a second clinically beneficial orientation relative the maxilla of the subject;   b. registering the second position of the mandible relative to the maxilla; and   c. using the registered second position to manufacture a device that positions the mandible in the second clinically beneficial orientation relative to the maxilla.   
     
     
         45 . The method of  claim 32 , further comprising obtaining a digital scan of one or more maxillary teeth of the subject wherein the digital scan of the one or more maxillary teeth is used with the registered position to manufacture the device. 
     
     
         46 . The method of  claim 32 , further comprising obtaining a digital scan of one or more mandibular teeth of the subject wherein the digital scan of the one or more mandibular teeth is used with the registered position to manufacture the device. 
     
     
         47 . The method of  claim 32 , further comprising obtaining a digital scan of one or more maxillary teeth of the subject wherein the digital scan of the one or more maxillary teeth is used to manufacture at least a second device that positions the mandible in the clinically beneficial orientation or into a second or additional clinically beneficial orientation. 
     
     
         48 . The method of  claim 32 , further comprising obtaining a digital scan of one or more mandibular teeth of the subject wherein the digital scan of the one or more mandibular teeth is used to manufacture at least a second device that positions the mandible in the clinically beneficial orientation or into a second or additional clinically beneficial orientation. 
     
     
         49 . A method for treatment of a sleep disorder or condition in a subject, comprising:
 a. positioning an oral appliance in the mouth of the subject, wherein the oral appliance comprises an upper portion configured to receive at least one maxillary tooth of the subject and a lower portion configured to receive at least one mandibular tooth of the subject;   b. wherein the upper and lower portions are engageable such that the portions maintain a restricted orientation relative to each other when engaged; and   c. wherein the engaged restricted orientation maintains the mandible of the subject in a predetermined clinically beneficial orientation relative to the maxilla of the subject.   
     
     
         50 - 82 . (canceled)