Patent Description:
During sleep the muscles of the airway become relaxed. The relaxation of these muscles in turn reduces the diameter of the airway. Typically, the airway of a person with sleep related breathing disorders is already restricted or reduced in size, and this natural relaxation reduces the airway further. The most common sleeping disorder is obstructive sleep apnea (OSA), which is characterized by recurring collapse of the upper airway during sleep, resulting in sleep fragmentation and oxygen desaturation. OSA is defined as the occurrence of <NUM> or more episodes of complete (apnea) or partial (hypopnea) upper airway obstruction per hour of sleep (apnea-hypopnea index [AHI]) and is estimated to occur in around <NUM>% of middle-aged men and <NUM>% of women. The gold standard treatment for OSA is to pneumatically splint open the upper airway during sleep using continuous positive airway pressure (CPAP) devices. Although CPAP is highly efficacious in preventing upper airway collapse, patient acceptance, tolerance, and adherence is often low, thereby reducing effectiveness. Therefore, there is a significant need for effective alternative treatments.

Oral appliances have emerged as an alternative to CPAP for OSA treatment. Oral appliances are designed to improve upper airway configuration and prevent collapse through alteration of jaw and tongue position. The most common mechanism of action is to hold the lower jaw in a more anterior position. These appliances are variously termed "mandibular advancement devices (MAD)," "mandibular advancement splints (MAS)," or mandibular repositioning appliances (MRA). " MAD are generally customized devices fabricated from dental casts of a patient's dentition and bite registrations by a dentist. Generally the greater the level of advancement, the better the treatment effect, although this must be balanced against potential increase in side effects (dryness, jaw pain, bite changes, etc.).

However, above <NUM>% of maximum advancement of the jaw there is an associated increase in reported side effects. A titration approach to determine optimal level of advancement with gradual increments over time is thought to optimize treatment outcome, although no standardized titration procedure currently exists. There is also little knowledge of how often to follow-up patients on MAD treatment for device adjustment. More information about these aspects of MAD therapy could help improve long-term effectiveness and adherence. A significant advance in single-night titration methodology has occurred with the recent development of a commercially available remotely controlled mandibular protrusion device. This protrusion device connects to upper and lower dental trays containing impressions of the patient's dentition and advances the mandible by moving forward the lower tray during polysomnographic monitoring. During the sleep titration a technician manually initiates forward movement of the lower dental tray in <NUM>-<NUM> increments in response to the appearance of apnea events. The technician continues with the advancement (within the patient's predetermined range of motion) until apnea events are eliminated from sleep or until the patient's maximal allowed protrusive level is reached.

Such single-night titration results in mandibular advancement that is set for the entire duration of sleep and this advancement is unaltered for the entire time-period MAD as used for treating sleep apnea.

However, sleep is a dynamic physiological phenomenon. There is significant night-night variability in duration, depth of sleep and sleep posture, all of which directly correlate with the number and severity of apnea events. Given this dynamic nature of sleep, a static MAD maintaining advanced mandibular posture for extend periods of time, could elevate the risk for side effects in the process of improving sleep quality.

For example, peer-reviewed studies have reported that the avoidance of supine positions leads to a decrease in the number and severity of obstructive episodes. In supine posture, the upper airway caliber and resistance are greater and thus, the tendency for the upper airway to collapse further is greater in the supine position compared to the lateral position. Sleep stages (REM vis NonREM) also similarly correlate with the severity of apnea events in a night's sleep.

<CIT> relates to systems and methods for automatically and continuously regulating the amount of mandibular displacement to an optimal value during obstructive sleep apnea treatment. Obstructive sleep apnea therapy is implemented by a device which automatically reevaluates an applied mandibular displacement and continually searches for a minimum displacement required to adequately distend a patient's pharyngal airway.

<CIT> relates to health monitoring systems and, in certain embodiments, to take-home monitoring systems designed for oral appliance monitoring. Embodiments include a method for obtaining data from an oral appliance. The method comprises placing an oral appliance comprising embedded electronics in an oral cavity, wherein the embedded electronics collect data, and transmitting data to a reader, wherein the reader comprises a computer, tablet computer, smart device, reader box, relay transmitter, or a combination thereof.

<CIT> relates to oral appliances and methods of using oral appliances for treatment of sleep disorders and conditions.

<CIT> relates to a method for treating a patient with obstructive sleep apnea including measuring apnea severity of the patient during a treatment period, and selectively changing a position of the patient's lower jaw after the treatment period is complete based on the apnea severity measured during the treatment period.

<CIT> relates to a method and apparatus for performing system validation and providing predictive criteria during remote titration of mandibular protrusion, and to methods and apparatus for providing predictive criteria during remote titration of mandibular protrusion.

Accordingly, there is a need for an oral appliance that solves the aforementioned problems associated with conventional devices and methods for treating sleep related disorders. In particular there is a need for an intelligent oral appliance that results in patients having less pain and fewer complications by not having to have their jaws protrude forward unnecessarily leading to improved compliance. Continuous gathering of data may also lead to optimal management of the sleep disorder.

The invention is defined by independent claim <NUM>, to which reference should now be made. Optional features of the invention are defined in dependent claims. Aspects, embodiments or examples falling outside the scope of the appended independent claims are not part of the invention, and are merely included for illustrative or explanatory purposes.

The problems outlined above are addressed by the system and method for a sensor driven oral appliance device in accordance with the invention. The system monitors changes in physiological parameters in real-time and appropriately advances the mandible to treat sleep related disorders. Also, as opposed to a human technician manually titrating the device, the invention relies on a machine driven algorithm to change the position of the mandible thus ensuring a greater degree of accuracy.

The system for improving a sleep disorder in accordance with the invention includes an oral appliance having a mandibular occlusal plate operably coupled to a maxillary occlusal plate, the plates molded to fit an individual's jaw; an actuator including a motor, a gear assembly and one or more sensors in communication therewith for sensing physiologic parameters of a user, said actuator operably coupled to said maxillary occlusal plate for linearly advancing or retracting said mandibular occlusal plate; a knowledge base that provides data on a plurality of sleep disorder conditions and normative data necessary to correct said sleep disorder conditions; a processing device in operable communication with the one or more sensors and said knowledge base, the processing device configured to (a) receive said physiologic parameter measurements from the user; (b) cross reference said physiologic parameter measurements with said knowledge base to generate a cross referenced data result indicative of a presence and/or severity of a sleep disorder event; (c) calculate a determined amount of linear movement necessary to improve the sleep disorder event to return to a normative condition; (d) transmit said determined amount to said motor; and (e) cause said maxillary occlusal plate to linearly advance or retract said mandibular occlusal plate by said determined amount to improve said sleep disorder.

A method for improving a sleep disorder is also provided. The method includes providing an oral appliance including a mandibular occlusal plate operably coupled to a maxillary occlusal plate, said plates molded to fit an individual's jaw; providing an actuator including a motor, a gear assembly and one or more sensors in communication therewith for sensing physiologic parameters of a user, said actuator operably coupled to said maxillary occlusal plate for linearly advancing or retracting said mandibular occlusal plate; providing a knowledge base that provides data on a plurality of sleep disorder conditions and normative data necessary to correct or improve said sleep disorder conditions; providing a processing device in operable communication with said one or more sensors and said knowledge base, said processing device configured to (a) receive said physiologic parameter measurements from said one or more sensors; (b) cross reference said physiologic parameter measurements with said knowledge base to generate a cross referenced data result indicative of a presence and/or severity of a sleep disorder event; (c) calculate a determined amount of linear movement necessary to correct the sleep disorder event to return to a normative condition; (d) transmit said determined amount to said motor; and (e) cause said maxillary occlusal plate to linearly advance or retract said mandibular occlusal plate by said determined amount to correct said sleep disorder.

For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:.

Referring now to <FIG> a schematic of the system <NUM> in accordance with the invention is illustrated. The system broadly includes sensor <NUM> for sensing various physiologic parameters during an individual's sleep state. For example sensor <NUM> may include a pulse oximeter that detects changes in an individual's oxygen saturation. Sensor <NUM> may also be a position sensor that detect whether the patient is lying in a supine or lateral position. Sensor transmits physiologic parameters collected during the sleep cycle to microprocessor or controller <NUM>. Controller <NUM> is powered by a source of power <NUM>. Those of skill in the art will appreciate that source of power <NUM> may include one or more batteries or may include an AC source of power.

Controller <NUM> includes memory including a knowledge database of sleep disorders, one or more software algorithms operable to compare the data transmitted by sensor <NUM> to the sleep disorder knowledge database and predict the presence and/or severity of a sleep disorder event such as apnea. Controller may also include safety controls such as maximum and minimum advancement limits. Controller <NUM> may be an <NUM>-bit or <NUM>-bit microcontroller.

Controller <NUM> is in operable communication with actuator <NUM> and transmits a signal to actuator <NUM> to increase or decrease the protrusion of an individual's mandible <NUM> (as best seen in <FIG>) by an amount that will improve the symptoms of the sleep disorder. Actuator <NUM> may be a micro motor such as a DC motor, pancake, stepper, servo or piezo motor. Actuator <NUM> may comprise two actuators, one each for the left and right sides of the individual's mandible.

The system <NUM> may also include a patient web or desktop application <NUM> whereby data is transmitted (wired or wirelessly) from data transmission unit <NUM> to the web application <NUM> to provide an individual patient or their care team (dentist, sleep specialist and the like) with feedback regarding sleep disorder events on any particular night and how the oral appliance <NUM> responded. Alerts may be generated based on activity deemed outside the normal functioning range and shared among the patient and authorized care team members. Data may be transmitted via a wired set-up or may use wireless Bluetooth, WiFi and/or cellular means.

The system <NUM> in accordance with the invention may also include a status indicator, such as a display, that visually indicates the sleep patterns and/or the operation and/or performance and/or efficacy of the system <NUM>, the oral appliance <NUM> or both.

Referring now to <FIG>, one aspect of an intelligent oral appliance <NUM> in accordance with the invention is depicted. Oral appliance <NUM> could be custom molded or fabricated using CAD-CAM models. Oral appliance <NUM> includes a maxillary occlusal plate <NUM> that is fitted to an individual's maxillary dentition <NUM> and a mandibular occlusal plate <NUM> that is fitted to an individual's mandibular dentition. The mandibular occlusal plate <NUM> is structured to engage the maxillary occlusal plate via connector <NUM>. Connector <NUM> may be integrally molded with mandibular occlusal plate <NUM> or may be a separate piece that snap fits with mandibular occlusal plate <NUM>. Maxillary occlusal plate <NUM> includes a bilateral advancement screw <NUM> operably coupled thereto. Bilateral advancement screw <NUM> includes motor <NUM> which may comprise a DC, pancake, stepper, servo or piezo motor. Bilateral advancement screw <NUM> includes electronics <NUM>, such as a motor drive and one or more sensors to sense position, airflow and the like, that are structured to transmit data to controller <NUM> and receive commands from controller <NUM> to impart different amounts of mandibular advancement to the mandibular occlusal plate <NUM>. Controller <NUM> may also be connected to additional sensors such as pulse oximeter, EEG and the like to sense related physiological parameters. Those of skill in the art will appreciate that one or more sensors may be embedded in the motor drive board while other sensors (including EEG, plus oximeter) may be attached via connectors/cables to the controller which then communicates with the motor. Upon receiving data from the sensors, the controller <NUM> compares the data to knowledge base stored in memory to determine the amount of movement required to improve the sleep disorder. Controller <NUM> then sends a signal to motor <NUM> to moveably advance or retract by the determined amount. If the command is to advance, screw <NUM> is driven by motor <NUM> to push against connector <NUM> which in turn moves the mandibular occlusal plate <NUM> forward by the determined amount. If the command is to retract, motor <NUM> drives screw <NUM> backwards which releases the force against connector <NUM> which allows the mandibular occlusal plate <NUM> to retract and move backwards. Those of skill in the art will appreciate that bilateral advancement screw <NUM> includes a counterpart screw on the opposite side of the maxillary occlusal plate <NUM>. As seen the screw advancement device is coupled to via cable <NUM> to controller <NUM> and source of power <NUM>.

Referring now to <FIG> another aspect of an intelligent oral appliance <NUM> is depicted. Like pieces are numbered with like numerals. Oral appliance <NUM> includes a maxillary occlusal plate <NUM> that is fitted to an individual's maxillary dentition <NUM> and a mandibular occlusal plate <NUM> that is fitted to an individual's mandibular dentition <NUM>. Oral applicance <NUM> includes a front screw driven device <NUM> operably coupled to the maxillary occlusal plate <NUM>. Front screw driven device <NUM> includes a rotating screw shaft <NUM>, a gear <NUM> operably coupling the screw shaft <NUM> to a motor <NUM>. Those of skill in the art will appreciate that motor <NUM> may comprise a DC, pancake, stepper, servo or piezo motor. Front screw driven device <NUM> also includes electronics <NUM>, such as a motor drive, and one or more sensors to sense oxygen saturation, EEG, sleep position, airflow and the like that are structured to transmit data to controller <NUM> and receive commands from controller <NUM>. Those of skill in the art will appreciate that one or more sensors may be embedded in the motor drive board while other sensors (including EEG, plus oximeter) may be attached via connectors/cables to the controller which then communicates with the motor.

The mandibular occlusal plate <NUM> includes a receptacle <NUM> such as a lingual bar or lingual slot that traverses left and right sides of the mandibular occlusal plate <NUM>. In the case of a lingual bar <NUM>, it may be integrally molded with mandibular occlusal plate <NUM> or may be a separate piece that snap fits with mandibular occlusal plate <NUM>. Maxillary occlusal plate <NUM> includes a front advancement screw <NUM> operably coupled thereto. Front advancement screw <NUM> includes a mating piece <NUM> that is structured to engage receptacle <NUM>. Mating piece <NUM> may comprise a hook or clasp. Hook or clasp <NUM> is operably coupled to the rotating screw shaft and receives commands through electronics to moveably advance or retract which in turn causes advancement and retraction of mandibular occlusal plate <NUM> via engagement with receptacle <NUM>. Those of skill in the art will appreciate that the male and the female hook/clasp and receptacle/bar/slot assembly can be interchangeably positioned between the two arches so as to have the male piece in the mandibular plate and the female receptacle in the maxillary plate. Other implementations may include a ball-clasp like structures. As shown, cable <NUM> operably couples motor <NUM> and electronics <NUM> to controller <NUM>. However, those of skill in the art will appreciate that controller <NUM> may wirelessly communicate with motor <NUM> and electronics <NUM>.

Referring now to <FIG> an alternative aspect of the oral appliance in accordance with the invention is depicted. Like pieces are numbered with like numerals. Oral appliance <NUM> includes a maxillary occlusal plate <NUM> that is fitted to an individual's maxillary dentition <NUM> and a mandibular occlusal plate <NUM> that is fitted to an individual's mandibular dentition <NUM>. Oral applicance <NUM> includes a front screw driven device <NUM> operably coupled to the maxillary occlusal plate <NUM>. Front screw driven device <NUM> includes a rotating screw shaft <NUM>, a gear <NUM> operably coupling the screw shaft <NUM> to a motor <NUM>. Those of skill in the art will appreciate that motor <NUM> may comprise a DC, pancake, stepper, servo or piezo motor. An elastomeric or non-elastomeric headband <NUM> supports an electronics board <NUM> having a microprocessor, battery and other electronics thereon. Headband <NUM> also supports at least one sensor such as a pulse oximeter, body position and/or sleep position sensor. As shown, cable <NUM> operably couples electronics board <NUM>, including microprocessor, with motor <NUM>. However, those of skill in the art will appreciate that cable <NUM> may be eliminated and microprocessor may wirelessly communicate with motor <NUM>. Front screw driven device <NUM> may also include and additional source of electronics <NUM>, such as a motor drive, and one or more additional sensors to sense EEG, sleep position, airflow and the like that are structured to transmit data to controller <NUM> and receive commands from controller <NUM>. Alternatively, all sensors may be located in the headband <NUM>. The mandibular occlusal plate <NUM> includes lingual bar or lingual slot <NUM> that traverses left and right sides of the mandibular occlusal plate <NUM>. If a lingual bar <NUM> is used, it may be integrally molded with mandibular occlusal plate <NUM> or may be a separate piece that snap fits with mandibular occlusal plate <NUM>. Those of skill in the art will appreciate that a lingual slot <NUM> will necessarily be molded into the mandibular occlusal plate <NUM>. Maxillary occlusal plate <NUM> includes a front advancement screw <NUM> operably coupled thereto. Front advancement screw <NUM> includes hook <NUM> that is structured to engage lingual bar <NUM> and that is moveably advanceable. Hook <NUM> is operably coupled to the rotating screw shaft and receives commands through electronics <NUM> or <NUM> to moveably advance or retract which in turn causes advancement and retraction of mandibular occlusal plate <NUM> via engagement with lingual bar <NUM>.

Any of the appliances disclosed above and set forth in <FIG>, <FIG> and <FIG> may be used to record bruxism based on the input gathered from the controller <NUM>. The oral appliance may also be used to alter the user's position in the event of prolonged apnea. The oral appliance for example could include an auditory or other type of alarm. For example, prolonged supping posture may lead to increased severity of the apnea and after a set threshold, the appliance may buzz or vibrate or sound an audio-visual alarm to wake and prompt the user to shift positions. In addition the web/mobile/desktop application may include a cognitive behavioral training module that is customized to the user based on the data gathered from the intelligent oral applicance.

Referring now to <FIG> an exemplary logic flow chart with a single sensor input is depicted. In the initial state <NUM> the motor <NUM> advance the screw <NUM>, <NUM> to allow the mandibular plate <NUM> to counter a patient's overbite. Sp02 is checked for apena events within a defined period of time <NUM>. If apnea events are absent the microprocessor via sensors continues to check Sp02 <NUM>. If apnea
events are detected <NUM> the motor <NUM> causes the screw <NUM>, <NUM> to advance the mandible in predetermined increments without exceeding a pre-determined maximum protrusion limit <NUM>. The microprocessor continues to monitor Sp02 for apnea events <NUM> with a defined interval <NUM>. If an apnea event has not been detected <NUM> then the microprocessor <NUM> transmits a command or signal to the motor to move the mandible back in predetermine increments not to exceed the distance to counter the overbite. The cycle continues with the microprocessor monitoring Sp02 for apnea events <NUM>.

As will further be appreciated by those skilled in the art, the processes herein described may be embodied as a system, method or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to as a "circuit," "module" or "system. " Furthermore, the present invention may take the form of a computer program product embodied in any tangible medium of expression having computer usable program code embodied in the medium.

The processes comprising the method of the present invention have been described with reference to flow diagrams illustrating exemplary steps. It will be understood that each block of the flowchart diagrams, and combinations of blocks in the flowchart diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart diagram block or blocks.

These computer program instructions may also be stored in a computer-readable medium that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instruction means which implement the function/act specified in the flowchart block or blocks.

Claim 1:
A system (<NUM>) for improving a sleep disorder comprising:
a. an oral appliance (<NUM>) including a mandibular occlusal plate (<NUM>) operably coupled to a maxillary occlusal plate (<NUM>), said plates (<NUM>, <NUM>) molded to fit an individual's jaw;
b. an actuator (<NUM>) including a motor, a gear assembly and one or more sensors in communication therewith for sensing physiologic parameters of a user, said actuator (<NUM>) operably coupled to said maxillary occlusal plate (<NUM>) for linearly advancing or retracting said mandibular occlusal plate (<NUM>); characterized by
c. a knowledge base that provides data on a plurality of sleep disorder conditions and normative data necessary to correct said sleep disorder conditions;
d. a processing device in operable communication with said one or more sensors and said knowledge base, said processing device configured to (a) receive said physiologic parameter measurements from said one or more sensors; (b) cross reference said physiologic parameter measurements with said knowledge base to generate a cross referenced data result indicative of a severity of a sleep disorder event; (c) calculate a determined amount of linear movement necessary to improve the sleep disorder event to return to a normative condition; (d) transmit said determined amount to said motor; and (e) cause said maxillary occlusal plate (<NUM>) to linearly advance or retract said mandibular occlusal plate (<NUM>) by said determined amount to improve said sleep disorder.