Patent Application
20230047226
The present invention pertains to systems and methods for diagnosing and treating sleep bruxism events in obstructive sleep apnea (OSA) patients, and, in particular, to adapting positive airway pressure (PAP) equipment used to treat OSA to additionally detect bruxism activity for diagnostic purposes and/or to adjust the settings of PAP therapy in order to prevent future bruxism events or stop or minimize current bruxism events.
Bruxism is a condition where a patient grinds, gnashes, and/or clenches his or her teeth, and is commonly associated with airway disturbance conditions such as sleep apnea and gastric reflux. Bruxism is typically an unconscious behavior and can occur both while awake and sleeping. Common symptoms of bruxism include worn tooth structure and flattening of the teeth, increased tooth sensitivity, jaw soreness, tenderness of the facial muscles, and dull headaches. In some instances, tooth grinding may be loud enough that it can be heard by others when the patient is asleep. The prevalence of bruxism in OSA patients is about 55%.
OSA is usually caused by an obstruction of the upper airway. It is characterized by repetitive pauses in breathing during sleep and is usually associated with a reduction in blood oxygen saturation. Non-invasive ventilation and pressure support therapies involve the placement of a patient interface device including a mask component on the face of a patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or a full face mask that covers the patient's face. The patient interface device interfaces a ventilator or pressure/flow generating device with the airway of the patient, so that a flow of breathing gas can be delivered from the ventilator or pressure/flow generating device to the airway of the patient. It is known to maintain such devices on the face of a wearer by a headgear having one or more straps adapted to fit over/around the patient's head. Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive pressure is provided to the airway of the patient in order to splint open the patient's airway, and variable airway pressure such as BiPAP, wherein the pressure provided to the airway of the patient is varied with the patient's respiratory cycle.
It is unclear if bruxism is an isolated neurological disorder or if it is triggered by increased sympathetic tone due to another cause. For example, a positive association has been found between the occurrence of micro-arousals from the four minutes preceding sleep bruxism (SB) onset, and, in general, a shift in sympatho-vagal balance towards increased sympathetic activity has been found to start eight minutes preceding SB onset in moderate to severe SB subjects. During the grinding of the teeth, a higher muscle activity of the tongue and the masseter muscles can be measured by electromyography (EMG) sensors. A higher muscle tone in the upper airway will tense the palatal and pharyngeal muscles, which will consequently increase the airway patency. Higher pharyngeal muscle tone is beneficial, as it stabilizes the upper airway and protects the upper airway from a narrowing or collapse caused by negative pressure during inspiration. However, it is not known if the higher sympathetic activity and the muscle activity in the mouth has an impact on the muscle tone in the upper airway.
In addition, currently, there are no means to measure the impact on the cross-section and the pressure related modulation of the airway patency during the respiration cycle. During a polysomnogram (PSG), the masticatory muscle activity (MMA) can be measured by superficial EMG sensors; however, superficial EMG activity is insufficient to distinguish between MMA activity and other muscles activity (OMA). There is thus room for improvement in systems and methods for diagnosing and treating sleep bruxism in OSA patients.
Accordingly, it is an object of the present invention to provide, in one embodiment, a set of positive airway pressure therapy (PAP) gear for recognizing sleep bruxism events in a patient during therapy for obstructive sleep apnea. The system comprises: a patient interface structured to be coupled to an airway of the patient, headgear coupled to the patient interface and structured to secure the patient interface to a head of the patient, at least one sensor is integrated into the patient interface and the headgear, and a controller electrically and operatively coupled to the sensor(s) and configured to be electrically and operatively coupled to a pressurized air generator. The sensor(s) is configured to detect physiological signals related to bruxism events, and the controller is configured to change an output of the pressurized air generator based on the signals detected by the sensor(s).
In another embodiment, a patient during therapy for obstructive sleep apnea comprises a pressurized air generator, a patient interface structured to be coupled to an airway of the patient, a conduit coupled at a first end to an output of the pressurized air generator and coupled at a second end opposite the first end to the patient interface, headgear coupled to the patient interface and structured to secure the patient interface to a head of the patient, at least one sensor is integrated into the patient interface and the headgear, and a controller electrically and operatively coupled to the sensor(s) and to the pressurized air generator. The sensor(s) is configured to detect physiological signals related to bruxism events, and the controller is configured to decide whether to change an output of the pressurized air generator or propose alternative OSA or dental treatment modalities based on the signals detected by sensor(s).
In another embodiment, a method for recognizing sleep bruxism events and stopping said sleep bruxism events in a patient during positive airway pressure (PAP) therapy for obstructive sleep apnea comprises coupling a patient interface integrated with at least one sensor to an airway of the patient, electrically and operatively coupling a controller to the sensor(s) and electrically and operatively coupling the controller to a pressurized air generator, configuring the sensor to detect physiological signals related to bruxism events, and configuring the controller to decide whether to change an output of the pressurized air generator or propose alternative OSA or dental treatment modalities based on the signals detected by the sensor(s).
These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.
As used herein, the singular form of “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.
As used herein, the term “controller” shall mean a number of programmable analog and/or digital devices (including an associated memory part or portion) that can store, retrieve, execute and process data (e.g., software routines and/or information used by such routines), including, without limitation, a field programmable gate array (FPGA), a complex programmable logic device (CPLD), a programmable system on a chip (PSOC), an application specific integrated circuit (ASIC), a microprocessor, a microcontroller, a programmable logic controller, or any other suitable processing device or apparatus. The memory portion can be any one or more of a variety of types of internal and/or external storage media such as, without limitation, RAM, ROM, EPROM(s), EEPROM(s), FLASH, and the like that provide a storage register, i.e., a non-transitory machine readable medium, for data and program code storage such as in the fashion of an internal storage area of a computer, and can be volatile memory or nonvolatile memory.
As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, “directly coupled” means that two elements are coupled in direct contact with each other. As used herein, “fixedly coupled” or “fixed” means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other. As used herein, “movably coupled” means that two components are coupled so as to allow at least one of the components to move in a manner such that the orientation of the at least one component relative to the other component may change without the components being uncoupled.
As used herein, the statement that two or more parts or components are “integrated” shall mean that the parts or components are produced separately and subsequently joined together to produce a larger body. As used herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality). As used herein, the word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.
Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
The present invention, as described in greater detail herein in connection with various particular exemplary embodiments, pertains to improvements in systems and methods for diagnosing, preventing, and treating OSA-related bruxism events in patients who use PAP therapies to treat OSA. While bruxism is often considered by dentists to be a singular disorder, it is considered to be both a neurological disorder and a compensation mechanism in sleep medicine. Consequently, dentists tend to approach bruxism from a treatment perspective, often recommending a dental device comprising a cap resting on the lower or upper teeth to protect the teeth from mechanical abrasion that results from nocturnal grinding of the teeth in order to treat the symptoms and eliminate the side effects of bruxism. In contrast, the present invention utilizes gear used for PAP therapy in the treatment of OSA to monitor metrics related to bruxism events in order to prevent subsequent bruxism events and/or stop a current bruxism event.
Imaging modalities and acoustical measurements obtained by techniques, such as pharyngometry and rhinometry, enable validation of airway patency and measurement of the cross-section of the upper airway during teeth grinding, and the present invention seeks to utilize these modalities and measurements to prevent and/or mitigate bruxism events by monitoring the physiological symptoms resulting from sympathetic activity associated with OSA. Acoustical rhinometry involves generating an acoustic pulse from a speaker and transmitting the sound pulse to the nasal cavity along a tube. The sound pulse is reflected back to a microphone, and the cross-sectional area of the nasal cavity can be determined by relating changes in the local acoustic impedance to cross-sectional area of the nasal cavity. Similarly, acoustical pharyngometry involves generating an acoustic pulse from a speaker and transmitting the sound pulse to the upper airway along a tube. The sound pulse is reflected back to a microphone, and the cross-sectional area of the upper airway can be determined by relating changes in the local acoustic impedance to cross-sectional area of the upper airway and defining cross-sectional area of the upper airway as a function of distance from the oral opening.
The ability to measure the effect of bruxism on the upper airway during sleep using PAP therapy gear in accordance with the systems and methods of the present invention leads to benefits such as: providing insights into the effect of bruxism on OSA and which therapy or combination of therapies is needed for a specific patient; establishing whether bruxism events have a positive or negative effect on airway patency, or alternatively adjusting PAP therapy settings to provide acceptable pressures during bruxism events or adjusting mandibular protrusion (either with an oral device or by a positional maneuver of the head or trunk); and identifying a more suitable teeth protection device which would not interfere with a potentially positive influence on airway patency. In one example, muscle tone increases during teeth grinding and the increased sympathetic activity also increases the tone in the upper airway (e.g. tongue base and palatal area), hence, less pressure would be needed during PAP therapy to gain airway patency. In another example, in a specific population afflicted with bruxism and OSA, when people in said population start to grind their teeth, the systems and methods of present invention would increase the PAP pressure so that less compensation by the body would occur, which is beneficial because it is believed that lesser compensation may reduce sympathetic activity, which in turn may stop teeth grinding.
Accordingly, the present invention pertains to a clinical decision support system 1 (described in more detail herein with respect to
Referring to
PAP equipment 2 is operatively coupled to a PAP machine 6 comprising a controller 8 and a pressurized air generator 10. Controller 8 is in electrical communication with pressurized air generator 10 and is configured to enable a user to adjust the settings of the PAP therapy provided to patient P, to receive and transmit data from the sensors 3, and to automatically adjust the settings of the PAP therapy provided to patient P based on data received from the sensors 3, as explained in more detail herein with respect to method 100. While controller 8 is depicted as being part of the PAP machine 6, controller 8 can optionally instead be part of a remote platform (e.g., cloud engine or any other remote device) in electrical communication with pressurized air generator 10. System 1 further comprises a data server 12, which is a cloud server in an exemplary embodiment of the present invention. Controller 8 and data server 12 are in electrical communication with one another. In exemplary embodiments of the disclosed concept, data server 12 is additionally configured to communicate with a clinician dashboard 14 and a remote device 16.
Communications between data server 12 and clinician dashboard 14 enable a practitioner (including but not limited to, a sleep engineer, physician, and/or other clinicians monitoring the PAP treatment of patient P) to monitor bruxism and OSA activity and to adjust the PAP therapy settings of patient P. Remote device 16 is a personal communication device of patient P and can comprise, for example and without limitation, a mobile phone. Communications between data server 12 and remote device 16 enable alerts to be sent to patient P if action needs to be taken based on the data collected by the controller 8 from the sensors 3. In one non-limiting illustrative example, controller 8 can be programmed to send an alert to remote device 16 in order to advise patient P to see a dentist if tooth grinding has been detected by system 1 for a period of a two weeks and/or to advise patient P to see a sleep physician if the PAP device settings are insufficient to eliminate or lower the number of bruxism events during sleep. It will be appreciated that controller 8, data server 12, clinician dashboard 14, and remote device 16 can all be considered controllers, and as such, controller 8 may sometimes be referred to hereinafter as “treatment controller 8” in order to differentiate it from data server 12, clinician dashboard 14, and remote device 16.
Referring now to
Three main categories of uses of the various sensors coupled to PAP equipment 2 are embodied in the present invention. In a first exemplary embodiment of the present invention, an acoustical rhinometer (which uses sound reflection to quickly assess the cross-sectional area of the upper airway) and/or an acoustical pharyngometer which uses sound reflection to quickly assess the cross-sectional area of the nasal cavity) are used to take measurements in order to determine airway patency. For acoustical rhinometry, a sensor 30 comprising a microphone and loudspeaker are integrated into either a nasal interface or nasal cushions. In the case of a nasal interface (such as interface 20 shown in
Still referring to
Still referring to
In addition, EMG sensors, inertial measurement units (IMU), and/or accelerometers can be placed at the chinbone or masticatory muscles to monitor MMA in this embodiment, in the approximate locations where sensors 36 are positioned in
After PAP settings are adjusted at step 104 and PAP machine 6 operates using the adjusted PAP settings at step 105, the efficacy of the adjusted PAP settings is evaluated at decision point 106. If controller 8 determines, based on the measured bruxism-related physiological signals, that tooth grinding has been prevented by the new PAP settings implemented at step 105, then method 100 returns to step 105 to continue using the adjusted PAP settings. If controller 8 determines that tooth grinding has not been prevented, controller 8 then issues an alert at step 107 that alternative PAP, other OSA modalities, or dental therapy/treatment/modalities for OSA-related bruxism should be implemented (such alert being communicated to server 12 such that dashboard 14 and/or remote device 16 can access or receive the alert). In an exemplary embodiment, controller 8 additionally automatically initiates scheduling of an appointment with a dentist or other clinician when issuing an alert at step 107.
In an alternative exemplary embodiment, patient P may be using a MAD 4 as shown in
In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.
Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
This patent application claims the priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63/233,368, filed on Aug. 16, 2021, the contents of which are herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63233368 | Aug 2021 | US |
