WO2018057745A1

WO2018057745A1 - Methods and devices for positioning of a mandible of a subject for determining and manipulating an airway opening

Info

Publication number: WO2018057745A1
Application number: PCT/US2017/052731
Authority: WO
Inventors: William H. Hanewinkel; Michael Brendan GLEESON; Jinesh Jain
Original assignee: Kosmo Technologies, Inc.
Priority date: 2016-09-23
Filing date: 2017-09-21
Publication date: 2018-03-29

Abstract

A method and tools for fitting oral appliances to treat obstructive sleep apnea. Gauges may be utilized to position a mandible of a subject for measuring an airway opening of the subject. Methods may include manipulating the mandible to determine and measure an optimized airway with a gauge. Such combinations of a gauge and airway measurement may provide the medical practitioner with immediate airway feedback when fitting oral appliances.

Description

TITLE

METHODS AND DEVICES FOR POSITIONING OF A MANDIBLE OF A SUBJECT FOR DETERMINING AND MANIPULATING AN AIRWAY OPENING

PRIORITY CLAIM

This application claims the benefit under 35 U.S.C. §119(e) of the filing date of United States Provisional Patent Application Serial No. 62/399,198, filed September 23, 2016, for "Methods and Devices for Positioning of a Mandible of a Subject for Determining and Manipulating an Airway Opening," the disclosure of which is hereby incorporated herein in its entirety by this reference.

TECHNICAL FIELD

The application relates generally to medical devices and positioning of a mandible of a subject for determining and manipulating an airway opening, for use in treating, for example, breathing disorders involving a patient's airway (e.g. , snoring, sleep apnea, upper respiratory syndrome, etc.). More particularly, but not by way of limitation, the disclosure relates to apparatuses and methods for mandibular manipulation and instant and/or segmented feedback on airway patency using a technique, such as, for example, the noninvasive forced oscillation technique (FOT), impulse oscillometry system (IOS), or another appropriate airway measurement technique.

BACKGROUND

In the field of treating the malady of sleep disorders, oral appliances have been shown to be successful in treating mild to moderate cases. The fitting of an oral appliance through a dentist is thought to pull the tongue forward and prevent the tongue from falling back and creating an airway blockage during sleep.

Generally, obstructive sleep apnea (OSA) is identified through either a Pulmonologist or a Sleep Lab. Additionally, preferred treatment measures for OSA were to prescribe the patient with a continuous positive airway pressure (CPAP) system. In recent years, oral appliance therapy (OAT) has become a known and generally accepted treatment.

Over the past two decades, OAT has been getting wider recognition as an alternative to positive airway pressure (PAP) devices to treat mild-to-moderate OSA. Oral appliances require no electrical power and are cost effective, quiet, and portable. OAT can be used as a first line treatment, or after patient refusal or intolerance of PAP therapies, or in combination with PAP. Studies show PAP compliance is problematic, ranging from 29% to 83% using their devices less than four hours per night while the hours of sleep could increase to 5.2 hours/night with active intervention. Many patients prefer OAT to PAP. Side effects of OAT are low, if fitted correctly, but can include excessive salivation as well as mouth and/or teeth discomfort. Adherence rates for OAT are at least equal to PAP when the oral appliance is fitted properly.

Barriers to effective use of OAT by practitioners are twofold. Practitioners receive no feedback regarding airway patency during mandibular titration to ensure not only improved airway patency, but also a comfortable and good fit of the appliance to the patient. Thus, patients must return to a provider for repeated fitting adjustments. This trial and error procedure becomes time consuming, costly, and potentially discouraging to the patient.

Further, because there is no immediate or quick feedback indicating a successfully improving patient airway patency for the medical practitioner, the fitting of an oral appliance is currently a trial and error method that requires either multiple visits to a patient's dentist to adjust the appliance or utilize a self-adjusting oral appliance. Therefore, a need exists for a more efficient methodology to identify optimal airway patency in real-time while having the ability to manipulate the mandible. Additionally, it is important to identify a mandibular setting that is comfortable for the patient, for compliancy, and does not place stress on the temporal mandibular joint (TMJ) to cause any temporal mandibular disorders (TMD) that could produce negative long-term effects.

DISCLOSURE

Described are methods, devices and systems for positioning of a mandible of a subject for determining and manipulating an airway opening and for measuring and adjusting an amount of airflow through an airway of a subject. Such methods typically include adjusting a position of the subject's mandible with a dental gauge in at least one axis of direction and measuring an airway impedance of the subject utilizing an airway evaluation technique. Devices and systems as disclosed herein may be utilized to perform such methods.

Described is an apparatus including an airflow measurement tube with an open end configured to form an airtight seal within the mouth and lip surfaces of a subject. The apparatus may include a dental device coupled with the airflow measurement tube and configured to position a mandible of the subject with respect to a maxilla of the subject. The apparatus may also include at least one sensor coupled with the airflow measurement tube and configured to measure at least one of an airflow through the airflow measurement tube or a pressure within the airflow measurement tube.

In some embodiments, the dental device may be configured to alter the position of the mandible with respect to the maxilla in at least one orthogonal direction (e.g. , two orthogonal directions). In some embodiments, the beginning measurement of airway impedance is triggered at the crossover from the subject's expiration to inspiration. In addition, the dental device may be configured to lock in place to maintain the position of the mandible with respect to the maxilla. In some embodiments, at least two orthogonal directions define an anterior/posterior position of the mandible with respect to the maxilla and a vertical position of the mandible with respect to the maxilla. In other embodiments, the dental device is configured to adjust and position the mandible with respect to the maxilla in the anterior/posterior direction, the vertical direction, and either side of the sagittal plane. In addition, the open end of the airflow measurement tube may be configured to form an airtight seal simultaneously to the subject's mouth and the subject's nasal passages. In some embodiments, at least one sensor may include a differential pressure sensor or a pitot tube, utilizing a differential pressure sensor. In some embodiments, the apparatus may further include an acoustic wave emitter coupled with the airflow measurement tube and configured to induce pressure waves within the airflow measurement tube. In addition, the acoustic wave emitter may be configured to induce sinusoidal pressure waves of a single frequency within the airflow measurement tube, to induce pressure waves with a composed pseudo-random waveform or pseudorandom frequencies within the airflow measurement tube, or to induce a single custom waveform shape pressure waves of a single frequency within the airflow measurement tube. In some embodiments, the dental device is sealed and the airway impedance measurement may be taken through the subject's nasal passages.

Also described are methods of measuring and adjusting an amount of at least one airflow or pressure through an airway of a subject. Such a method typically includes positioning the subject's mandible in a first position with a dental device, performing a first airway measurement of the subject's airway with the subject's mandible in the first position, positioning the subject's mandible in a second position with the dental device, performing a second airway measurement of the subject's airway with the subject's mandible in the second position, and comparing the first airway measurement and the second airway measurement.

In some embodiments, positioning the subject's mandible in the first position includes positioning the subject's mandible at a vertical distance from the subject's maxilla. Other embodiments include performing a first airway measurement and performing a second airway measurement comprise measuring a first airway impedance and a second airway impedance using a forced oscillation technique or an impulse Oscillometry spirometer system or an occlusion-type airway measurement technique. In addition, the airway impedance measurement may be conducted through the nasal passages while the dental device is sealed. In some embodiments, positioning the subject's mandible in the first position includes positioning the subject's mandible at a vertical distance between front incisors and holding that position while an airway impedance measurement is conducted. In other embodiments, the airway impedance breathing measurement is triggered (i.e., started) at the crossover from the subject's expiration to inspiration and may be made and reported while the subject is asleep. In addition, the oscillating waveform may be recorded in a digital format and played back on a codec circuit card through an amplifier. In some embodiments, the vertical position of the mandible or the anterior/posterior position of the mandible may be established to find the lower FOT measurement. In other embodiments, the mandible position is used to find the remaining mandible position by a lower FOT measurement. For example, with a nose clamp in place and starting in the habitual bite position, a base line impedance measurement may be taken of the airway of a subject. A second impedance measurement may then be taken at a selected vertical position (e.g., the 6 mm vertical position). Sequential higher vertical positions may be taken while comparing impedance measurements focusing on the lowest measurement and a respective position. Anterior/posterior positions may be started from the lowest impedance vertical position to determine if such a position further lowers the impedance. Such measurements may be performed while the subject is in the awake state and seated. In addition, the comparison of known airway impedance with habitual breathing may result in an ability to screen for obstructive sleep apnea illness.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing out and distinctly claiming what are regarded as embodiments of the disclosure, various features and advantages of disclosed embodiments may be more readily ascertained from the following description when read with reference to the accompanying drawings, in which:

FIG. 1 depicts a titration mouthpiece applied to a patient;

FIG. 2 is a top perspective view of the titration mouthpiece including a lower incisor slide;

FIG. 3 is a bottom perspective view of the titration mouthpiece;

FIG. 4A is a bottom view of the titration mouthpiece;

FIG. 4B is a bottom view of the titration mouthpiece including a lower incisor slide; FIG. 5 is a side view of the titration mouthpiece;

FIG. 6 is an end view of the titration mouthpiece;

FIG. 7 is a side view of the lower incisor slide;

FIG. 8 is an end view of the lower incisor slide;

FIG. 9 is a bottom view of the lower incisor slide;

FIG. 10 is a schematic description of an FOT device including connections to a dental gauge and a personal computer; and

FIG. 11 depicts the titration mouthpiece and several lower incisor slides.

MODE(S) FOR CARRYING OUT THE INVENTION This disclosure includes both a method for the practice of manipulating the mandible for an oral appliance fitting while also describing the devices to provide the immediate feedback of the airway opening and the device for manipulating the mandible. Through this method and device, the medical practitioner now has the means to determine the ideal mandible position that creates the optimal airway opening when fitting a patient for an oral appliance to treat obstructive sleep apnea. Kosmo Technologies, Inc. created this methodology initially using their Andra Gauge™. Such a mandibular manipulator is disclosed in U.S. Patent 8,226,407, assigned to Kosmo Technologies, Inc., the disclosure of which is hereby incorporated herein in its entirety by this reference. However, as disclosed herein, such methods may be practiced with other devices that offer similar flexibility and convenience with immediate feedback regarding the airway opening while manipulating the mandible of a subject.

In some embodiments, the disclosure also improves the forced oscillation technique (FOT) device in two ways to minimize its size and weight. One involves the pneumotachograph and the other the acoustic wave emitter. In older designs of pneumotachographs, the pressure sensors were sensitive to humidity, movement of the vinyl tubing, and turbulent airflow. These pneumotachographs utilized electric heaters to prevent condensation and very fine mesh and large diameter screens to create laminar flow. Embodiments of the instant disclosure utilize LDE Series pressure sensors from First Sensor AG of Berlin, Germany. Utilizing these high impedance pressure sensors allows creation of a smaller tube/orifice for the pneumotachograph while eliminating the heater and any laminar flow mechanism. First Sensor LBA Series sensors also create a much improved signal strength and accuracy. Such systems are disclosed in PCT Application Publication WO 2016/004004 US, filed June 30, 2015, the disclosure of which is hereby incorporated herein in its entirety by this reference.

The FOT method can be used to determine patient candidacy for oral appliance therapy and to predict effectiveness. This is a major question that insurance companies are trying to answer because there is no way for them to know the effectiveness of an oral appliance on a per-patient basis before incurring the expense of a custom oral appliance plus titration and follow-up sleep study. The FOT technique offers an objective way to determine the treatment plan for all OSA patients. Embodiments of the disclosure offer the potential to answer major questions that third party payers, clinicians, and dentists are trying to answer while fitting oral appliances as a treatment for sleep disorder breathing. The mandible has at least three degrees of freedom and the vertical opening of the mouth is associated with the rotation and sliding of the temporal mandibular joint. There have been multiple scientific research projects to study the effects of a vertical opening with protrusion of the oral cavity with mixed results. A pilot study indicates that both vertical and protrusion mandibular manipulation in combination can produce significant airway patency when adjusted with a snoring sound as a feedback mechanism. By creating an immediate feedback metric of the airway while performing mandible titration (e.g. , anterior/posterior, vertical, and/or sagittal), the practitioner now has the tools to confidently create an oral appliance that is both effective and comfortable generally in one office visit.

Additionally, by decreasing the upper airway resistance there is an increase in oxygen intake with the use of an OAT fitted with a FOT method. This can directly contribute to increased performance and recovery for athletes, breathing help in elderly patients, and oxygen uptake in pregnant women. All would benefit from improved oxygen intake with each inspiration.

Referring to FIG. 1, a patient 6 has titration mouthpiece 1 within their mouth such that lips of the patient 6 ensures an airtight seal around the mouthpiece 1. In the normal testing method, the patient 6 may wear a nasal clamp 5, such as, for example, part no. 5R, which is produced by and commercially available from ARK Therapeutic Services, Inc. of Columbia, SC. A cylindrical end 2 would adapt to a similar shape in an airtight manner as it connects to a forced oscillation technique (FOT) device. Although there are several FOT devices produced since 1956, such a device may be used, for example, the RESMON PRO™, which is produced by and commercially available from MGC Diagnostics, of St. Paul, MN. An arrow 7 indicates a bidirectional flow of breathing performed by the patient 6 through the titration mouthpiece 1. A lower incisor slide 30 may include a tongue depressor 3, which may slide with the mandible of the patient 6 in the direction of arrow 4 relative to the titration mouthpiece 1.

FIG. 2 is a top perspective view of the titration mouthpiece 1, which may include a breathing tube 20 and the lower incisor slide 30. The breathing tube 20 and the lower incisor slide 30 may communicate via a dovetail slot 14 such that the breathing tube 20 moves relative to the lower incisor slide 30 in a direction of arrow 24. As discussed below, the lower incisor slide 30 may include a number of lower incisor slides 30, each of which provide various positioning of the subject's mandible in one or more of a vertical direction, to either side of the sagittal plane, or in the anterior/posterior direction. For example, each lower incisor slide 30 may provide a differing distance X (e.g., vertical distance) between the incisor slots 17 and 18 when the lower incisor slide 30 is coupled to the titration mouthpiece 1. In other embodiments, each lower incisor slide 30 may provide a differing distance between the incisor slots 17 and 18 when the lower incisor slide 30 moves in other axes, such as to either side of the sagittal plane or in the anterior/posterior direction 24.

FIGS. 3, 4A, 5, and 6 include a bottom perspective view, bottom view, side view, an end view, respectively, of the titration mouthpiece 1, and FIG. 4B is a bottom view of the titration mouthpiece 1 including the lower incisor slide 30. The cylindrical end 2 may transition to an oval shape 13 and may be entirely hollow to create a through tube. An open end 15 may be configured to form an airtight seal within the mouth and lip surfaces of the patient 6. The oval shape 13 and flanges 8 and 9 may be configured to insert into the mouth of the patient 6. A sliding block 10 may be held within an annular space of the oval shape 13 by braces 11, 12, 21, and 22. The dovetail slot 14 runs through the sliding block 10. Incisor slots 17 and 18 may be located bottom and top of the sliding block 10 to engage incisors of the patient 6.

In addition, a cutaway 16 may create an opening in the oval shape 13 to allow the patient 6 lower incisor anterior/posterior motions so as to not have incisor teeth interfere with the oval shape 13. The incisor slots 17 and 18 are spaced to have a nominal 2 mm thickness between them for an initial measurement of habitual airway impedance. As shown in FIG. 4B, portions of lower incisor slide 30 may align with markings in order to obtain a measurement reading. For example, graduated scales or gradation markings or indicators may be marked in the body of the titration mouthpiece 1 in order to accurately quantify the relative position of the lower incisor slide 30. In other embodiments, the relative position may be provided by electronic feedback of the positions to be recorded by data logger or other computer recording, thus allowing for an automatic record of the relative position of the relative positions to be recorded by data logger or other computer recording, thus allowing for an automatic record of the measurements.

FIGS. 7, 8, and 9 depict a side view, end view, and bottom view, respectively, of the lower incisor slide 30. The lower incisor slide 30 may further include a protrusion 19 (i.e., tenon) for engaging the dovetail slot 14 (i.e., mortise) of the titration mouthpiece 1, which may be secured by various couplings, for example, retaining pin, interlocking clip, friction or interference fit, etc.

FIG. 10 is a schematic description of an FOT device including connections to a dental gauge and a personal computer. In use, a flex hose 101 may be attached to the titration mouthpiece 1, at a distal end opposite a proximal insertion end of the titration mouthpiece 1 and may be configured to provide an airway path. In addition, a bio- filter 102 may be associated with the airway path. In some embodiments, the bio-filter 102 may be connected to the flex hose 101. In other embodiments, the bio-filter 102 may be associated within or proximal the titration mouthpiece 1 (e.g. , may be formed as a unitary unit). A pressure port 103 (e.g., static pressure port) may be operatively connected to the flex hose 101. A sensor, for example, a pitot tube 104 (e.g., a bi-directional pitot tube 104) or a differential pressure sensor, may be located along the airway path, and may be located in proximity to the flex hose 101. By way of non-limiting example, the bi-directional pitot tube 104 may be located interior or adjacent to the flex hose 101 and may be configured to measure the relative velocity and/or pressure of the airflow.

In some embodiments, a wye fitting 105 may be associated with the flex hose 101, a bypass port 106, and an acoustic collector 110. The acoustic collector may be connected to a loudspeaker 120 (e.g., sub-woofer) using a gasket 111. The loudspeaker 120 may be similar to or larger or smaller than, for example model TS-W161, 60, which is commercially available from Pioneer of Des Moines, IA. Since some embodiments of this disclosure may not require the low frequency response of the loudspeaker 120 (e.g., around 5 Hz), the device can use a smaller coin size speaker exciter. In some embodiments, an amplifier circuit card 112, a codec circuit card 1 13 and/or micro storage media 114 may be in electrical communication with the loudspeaker 120.

In addition, the pressure port 103 may be in proximity to the bi-directional pitot tube 104, which may be operatively coupled to at least one vinyl tubing 116, which in turn is operatively coupled to at least one pressure sensor 118 associated with a controller circuit card 107. The controller circuit card 107 may be in communication with a processor 108 (e.g., a personal computer) using, for example, a universal serial bus (USB) cable 109. In other embodiments, the controller circuit card 107 may communicate with the processor 108 wirelessly. The personal computer may include a display 119 (e.g., a graphical user interface) and may be equipped with software 115. The software 115 may be generic in nature or may be specifically configured to interact with the system and to record, store and analyze measurements. For example, the processor 108 may be provided with feedback that represents data from the patient 6. In some embodiments, real-time physical information of the patient 6 may be utilized by the software 1 15. Finally, data transfer 100 may be accomplished either by direct connection or wirelessly between the processor 108 and a central storage unit (not shown). It may be appreciated that any inputs received may be recorded, analyzed, and used as part of a method to indicate a prescribed outcome for the patient by the physician or dentist.

FIG. 11 depicts the titration mouthpiece 1 , along with several sizes of lower incisor slides 30. As discussed above, the lower incisor slide 30 may include a number of lower incisor slides 30, each of which provide various positioning of the subject's mandible in one or more of a vertical direction, to either side of the sagittal plane, or in the anterior/posterior direction.

Once being apprised of the instant systems and devices for mandibular manipulation and feedback on airway patency, one of ordinary skill in the art will be readily able to make and assemble such systems and devices, along with the software to control and evaluate the result from such devices.

Additional non-limiting example embodiments of the disclosure are set forth below. Embodiment 1 : An apparatus comprising: an airflow measurement tube with an open end configured to form an airtight seal within a mouth and lip surfaces of a subject; a dental device coupled with the airflow measurement tube and configured to position a mandible of the subject with respect to a maxilla of the subject; and at least one sensor coupled with the airflow measurement tube and configured to measure at least one of an airflow through the airflow measurement tube or a pressure within the airflow measurement tube.

Embodiment 2: The apparatus of Embodiment 1, wherein the dental device is configured to alter the position of the mandible of the subject with respect to the maxilla of the subject in at least two orthogonal directions.

Embodiment 3: The apparatus of Embodiment 1 or Embodiment 2, wherein the dental device is configured to lock in place to maintain the position of the mandible of the subject with respect to the maxilla of the subject.

Embodiment 4: The apparatus of Embodiment 2, wherein the at least two orthogonal directions define an anterior/posterior position of the mandible of the subject with respect to the maxilla of the subject and a vertical position of the mandible of the subject with respect to the maxilla of the subject.

Embodiment 5: The apparatus of Embodiment 4, wherein the dental device is configured to adjust and position the mandible of the subject with respect to the maxilla of the subject in the anterior/posterior direction, the vertical direction, and either side of a sagittal plane of the subject.

Embodiment 6: The apparatus of any of Embodiments 1 through 5, wherein a beginning measurement of airway impedance is triggered at a crossover from expiration to inspiration of the subject.

Embodiment 7: The apparatus of any of Embodiments 1 through 6, wherein the open end of the airflow measurement tube is configured to form an airtight seal simultaneously to the mouth and nasal passages of the subject.

Embodiment 8: The apparatus of any of Embodiments 1 through 6, wherein the dental device is configured to be sealed such that an airway impedance measurement is taken through nasal passages of the subject.

Embodiment 9: The apparatus of Embodiment 1, wherein the at least one sensor comprises a differential pressure sensor.

Embodiment 10: The apparatus of Embodiment 1, wherein the at least one sensor comprises a pitot tube.

Embodiment 11 : The apparatus of Embodiment 1, further comprising an acoustic wave emitter coupled with the airflow measurement tube and configured to induce pressure waves within the airflow measurement tube. Embodiment 12: The apparatus of Embodiment 11, wherein the acoustic wave emitter is configured to induce sinusoidal pressure waves of a single frequency within the airflow measurement tube.

Embodiment 13: The apparatus of Embodiment 11, wherein the acoustic wave emitter is configured to induce pressure waves with a composed pseudo-random waveform within the airflow measurement tube.

Embodiment 14: The apparatus of Embodiment 11, wherein the acoustic wave emitter is configured to induce a single custom waveform shape pressure waves of a single frequency within the airflow measurement tube.

Embodiment 15: A method of measuring and adjusting an amount of airflow through an airway of a subject, the method comprising: positioning a mandible of the subject in a first position with a dental device; performing a first airway measurement of the airway of the subject with the mandible of the subject in the first position; positioning the mandible of the subject in a second position with the dental device; performing a second airway measurement of the airway of the subject with the mandible of the subject in the second position; and comparing the first airway measurement and the second airway measurement.

Embodiment 16: The method of Embodiment 15, wherein positioning the mandible of the subject in the first position comprises positioning the mandible of the subject at a vertical distance from a maxilla of the subject.

Embodiment 17: The method of Embodiment 15 or Embodiment 16, wherein performing the first airway measurement and performing the second airway measurement comprise measuring a first airway impedance and a second airway impedance using a forced oscillation technique or an impulse Oscillometry spirometer system.

Embodiment 18: The method of Embodiment 15 or Embodiment 16, wherein performing the first airway measurement and performing the second airway measurement comprise measuring a first airway impedance and a second airway impedance using an occlusion-type airway measurement technique.

Embodiment 19: The method of any of Embodiments 15 through 18, wherein performing the first airway measurement and performing the second airway measurement comprise conducting each of the first airway measurement and the second airway measurement through nasal passages of the subject while the dental device is sealed.

Embodiment 20: The method of any of Embodiments 15 through 19, wherein positioning the mandible of the subject in the first position comprises positioning the mandible of the subject at a vertical distance between front incisors and holding that position while an airway impedance measurement is conducted.

Embodiment 21 : The method of any of Embodiments 15 through 20, wherein each of the first airway measurement and the second airway measurement is triggered at a crossover from expiration to inspiration of the subject.

Embodiment 22: The method of any of Embodiments 15 through 21, wherein performing the first airway measurement and performing the second airway measurement comprise performing and reporting the first airway measurement and the second airway measurement while the subject is asleep.

Embodiment 23: The method of Embodiment 15, further comprising recording an oscillating waveform in a digital format and playing back the oscillating waveform on a codec circuit card through an amplifier.

Embodiment 24: The method of any of Embodiments 15 through 23, wherein positioning the mandible of the subject comprises establishing a vertical position or an anterior/posterior position of the mandible of the subject to find a lower forced oscillation technique measurement.

Embodiment 25: The method of Embodiment 24, wherein establishing the vertical position or the anterior/posterior position of the mandible of the subject comprises using the lower forced oscillation technique measurement to find a remaining mandible position.

Embodiment 26: The method of Embodiment 15, further comprising comparing known airway impedance with habitual breathing of the subject to enable screening for obstructive sleep apnea illness.

As used herein, the term "substantially" in reference to a given parameter means and includes to a degree that one skilled in the art would understand that the given parameter, property, or condition is met with a small degree of variance, such as within acceptable manufacturing tolerances. For example, a parameter that is substantially met may be at least about 90% met, at least about 95% met, or even at least about 99% met.

Although the foregoing description contains many specifics, these are not to be construed as limiting the scope of the disclosure, but merely as providing certain exemplary embodiments. Similarly, other embodiments of the disclosure may be devised that do not depart from the spirit or scope of the disclosure. For example, features described herein with reference to one embodiment also may be provided in others of the embodiments described herein. The scope of the disclosure is, therefore, indicated and limited only by the appended claims and their legal equivalents, rather than by the foregoing description. All additions, deletions, and modifications to the disclosed embodiments, which fall within the meaning and scope of the claims, are encompassed by the disclosure.

Claims

What is claimed is: 1. An apparatus comprising:

an airflow measurement tube with an open end configured to form a substantially airtight seal with a mouth of a subject;

a dental device coupled with the airflow measurement tube and configured to position a mandible of the subject with respect to a maxilla of the subject; and

at least one sensor coupled with the airflow measurement tube and configured to measure at least one of an airflow through the airflow measurement tube or a pressure within the airflow measurement tube.

2. The apparatus of claim 1 , wherein the dental device is configured to alter the position of the mandible of the subject with respect to the maxilla of the subject in at least two orthogonal directions.

3. The apparatus of claim 2, wherein the dental device is configured to lock in place to maintain the position of the mandible of the subject with respect to the maxilla of the subject.

4. The apparatus of claim 2, wherein the at least two orthogonal directions define an anterior/posterior position of the mandible of the subject with respect to the maxilla of the subject and a vertical position of the mandible of the subject with respect to the maxilla of the subject.

5. The apparatus of claim 4, wherein the dental device is configured to adjust and position the mandible of the subject with respect to the maxilla of the subj ect in the anterior/posterior direction, the vertical direction, and either side of a sagittal plane of the subject.

6. The apparatus of claim 1 , wherein a control system of the apparatus is configured to trigger a beginning measurement of airway impedance at a crossover from expiration to inspiration of the subject.

7. The apparatus of claim 1, wherein the open end of the airflow measurement tube is configured to form a substantially airtight seal simultaneously to the mouth and nasal passages of the subject.

8. The apparatus of claim 1, wherein the dental device is configured to be sealed such that an airway impedance measurement is taken through nasal passages of the subject.

9. The apparatus of claim 1, wherein the at least one sensor comprises a differential pressure sensor.

10. The apparatus of claim 1, wherein the at least one sensor comprises a pitot tube.

11. The apparatus of claim 1, further comprising an acoustic wave emitter coupled with the airflow measurement tube and configured to induce pressure waves within the airflow measurement tube.

12. The apparatus of claim 11, wherein the acoustic wave emitter is configured to induce sinusoidal pressure waves of a single frequency within the airflow measurement tube.

13. The apparatus of claim 11, wherein the acoustic wave emitter is configured to induce pressure waves with a composed pseudo-random waveform and pseudorandom frequencies within the airflow measurement tube.

14. The apparatus of claim 11, wherein the acoustic wave emitter is configured to induce a single custom waveform shape pressure wave of a single frequency within the airflow measurement tube.

15. A method of measuring an amount of at least one airflow or pressure through an airway of a subject, the method comprising:

positioning a mandible of the subject in a first position with a dental device; performing a first airway measurement of the airway of the subject with the mandible of the subject in the first position;

positioning the mandible of the subject in a second position with the dental device; performing a second airway measurement of the airway of the subject with the mandible of the subject in the second position; and

comparing the first airway measurement and the second airway measurement.

16. The method of claim 15, wherein positioning the mandible of the subject in the first position comprises positioning the mandible of the subject at a vertical distance from a maxilla of the subj ect.

17. The method of claim 15, wherein performing the first airway measurement and performing the second airway measurement comprise measuring a first airway impedance and a second airway impedance using a forced oscillation technique or an impulse oscillometry spirometer system.

18. The method of claim 15, wherein performing the first airway measurement and performing the second airway measurement comprise measuring a first airway impedance and a second airway impedance using an occlusion-type airway measurement technique.

19. The method of claim 15, wherein performing the first airway measurement and performing the second airway measurement comprise conducting each of the first airway measurement and the second airway measurement through nasal passages of the subject while the dental device is at least partially sealed to a portion of the subject.

20. The method of claim 15, wherein positioning the mandible of the subject in the first position comprises positioning the mandible of the subject at a vertical distance between front incisors and holding that position while an airway impedance measurement is conducted.

21. The method of claim 15, further comprising triggering the first airway measurement and the second airway measurement at a crossover from expiration to inspiration of the subject.

22. The method of claim 15, wherein performing the first airway measurement and performing the second airway measurement comprise performing and reporting the first airway measurement and the second airway measurement while the subject is asleep.

23. The method of claim 15, further comprising recording an oscillating waveform in a digital format and playing back the oscillating waveform on a codec circuit card through an amplifier.

24. The method of claim 15, wherein positioning the mandible of the subject comprises establishing at least one of a vertical position or an anterior/posterior position of the mandible of the subject to find a lower forced oscillation technique measurement.

25. The method of claim 24, wherein establishing the at least one of the vertical position or the anterior/posterior position of the mandible of the subject comprises using the lower forced oscillation technique measurement to find a suitable mandible position.

26. The method of claim 15, further comprising comparing known airway impedance with habitual breathing of the subject to enable screening for obstructive sleep apnea illness.