WO2012064684A2

WO2012064684A2 - Compliance monitoring system for oral appliance wear

Info

Publication number: WO2012064684A2
Application number: PCT/US2011/059679
Authority: WO
Inventors: Kent Moore; Michael Williford
Original assignee: Kent Moore; Michael Williford
Priority date: 2010-11-10
Filing date: 2011-11-08
Publication date: 2012-05-18
Also published as: WO2012064684A3

Abstract

Embodiments of the present invention are related to a compliance monitoring system for oral appliance wear and associated apparatus and methods. In one embodiment, an oral appliance is provided. The oral appliance comprises at least one housing configured to releasably attach to at least a portion of the upper and/or lower teeth or jaw, the housing further comprising at least one pressure sensor associated with the housing and configured to measure one or more forces applied to the housing during use of the appliance and acquire data indicative of use of the appliance.

Description

COMPLIANCE MONITORING SYSTEM FOR ORAL APPLIANCE WEAR

FIELD

Embodiments of the present invention discussed herein are related to a compliance monitoring system for oral appliances. In particular, some embodiments of the present invention are related to oral appliances structured for mandibular

advancement. Such oral appliances have application in treatment of various sleep disorders, such as snoring and obstructive sleep apnea.

BACKGROUND

Many people have difficulty breathing properly, which can result in various sleep disorders. These sleep disorders may be common snoring or more serious conditions, like obstructive sleep apnea. It is generally thought that snoring or obstructive sleep apnea occurs when a person's tongue at least partially obstructs the airway. One treatment for keeping the tongue from obstructing a person's airway is with an oral appliance.

The purpose of an oral appliance utilized for treatment of obstructive sleep apnea is to expand the upper airway. This eliminates airway closure and improves or eliminates obstructive sleep apnea and associated symptoms. The primary mechanism by which this effect is obtained is by mandibular advancement. Mandibular advancement advances the tongue base and stretches the soft tissues of the upper airway. Secondary airway benefits include stiffening of the upper airway by diminishing soft tissue compliance and lowering the critical airway closing pressure, thereby improving, if not eliminating obstructive upper airway events. However, oral appliances only work as intended if properly worn. Thus, a need exists for doctors of patients with obstructive sleep apnea to be able to monitor patient compliance for wearing of oral appliances.

SUMMARY OF INVENTION

Embodiments of the present invention provide apparatus and associated methods for a compliance monitoring system for oral appliance wear. One exemplary embodiment is directed to an oral appliance. The oral appliance comprises at least one housing configured to releasably attach to at least a portion of the upper and/or lower teeth or jaw. The housing further comprises at least one pressure sensor associated with the housing and is configured to measure one or more forces applied to the housing during use of the appliance and acquire data indicative of use of the appliance. The housing may further comprise a transmitter configured to send the data. In other embodiments, the housing may further comprise a memory configured to store the data received from the pressure sensor. In another embodiment, the housing may further comprise a battery configured to power the pressure sensor, memory, and transmitter.

In other embodiments, the housing may further comprise a lingual portion configured to engage the inner surface of the teeth and a facial portion configured to engage the outer surface of the teeth. Additionally, the pressure sensor may be positioned adjacent to the facial portion. In some embodiments, the housing may comprise a flexible wash and an acrylic shell, and the pressure sensor may be positioned between the flexible wash and acrylic shell.

In another embodiment, where the housing is configured to couple to the upper teeth and/or jaw, the oral appliance comprises a second housing configured to releasably attach to at least a portion of the lower teeth or jaw. In some embodiments, the second housing may comprise at least one second pressure sensor associated with the second housing and configured to measure one or more forces applied to the second housing during use of the appliance and acquire data indicative of use of the appliance.

Additionally, the second housing may comprise a lingual portion configured to engage the inner surface of the lower teeth and a facial portion configured to engage the outer surface of the lower teeth, and the second pressure sensor is positioned adjacent to the lingual portion. In some embodiments, the second housing may comprise a second memory configured to store the data received from the second pressure sensor. In some embodiments, the second housing may comprise a second transmitter configured to communicate the data acquired by the second pressure sensor. Additionally, the second housing may further comprise a second battery configured to power the second pressure sensor, second memory, and second transmitter.

Another embodiment is directed to a storage container for storing an oral appliance, comprising a receiver configured to receive data indicative of use of the oral appliance from a transmitter associated with the oral appliance, a memory configured to store the data received from the transmitter, and a second transmitter for communicating the data. The storage container may further comprise a power source and/or an inductive charger configured to charge a battery associated with the oral appliance using the power source.

Other embodiments of the present invention include a method for monitoring compliance of oral appliance wear. The method comprises acquiring data from at least one pressure sensor associated with the oral appliance while being worn by a patient and communicating the data to a data acquisition system. The method may further comprise communicating the data from the data acquisition device to a network.

In yet another embodiment of the present invention, a system for monitoring compliance of an oral appliance is provided. The system comprises an oral appliance comprising at least one housing configured to releasably attach to at least a portion of the upper and/or lower teeth or jaw. The housing comprises at least one pressure sensor associated with the housing and configured to measure one or more forces applied to the housing during use of the appliance and acquire data indicative of use of the oral appliance. The system further comprises a data acquisition device configured to receive data indicative of use of the oral appliance from the oral appliance.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

FIG. 1 is a perspective view of an oral appliance structured for mandibular advancement, in accordance with some embodiments discussed herein;

FIG. 2 is a partial side view of the anterior teeth and associated force vectors, in accordance with some embodiments discussed herein;

FIG. 3 is a cross-sectional view of an oral appliance engaged with the anterior teeth, in accordance with some embodiments discussed herein;

FIG. 4 is a front view of a person's maxillary teeth including microdot pressure sensors positioned thereon, in accordance with some embodiments discussed herein;

FIG. 5 is a partial cross-sectional view of a fin and coupling adjustment

mechanism associated with an oral appliance for mandibular advancement, in

accordance with some embodiments discussed herein;

FIG. 6 is a diagram of a compliance monitoring system, in accordance with some embodiments discussed herein; and

FIG. 7 is a flow chart of a method for monitoring compliance with oral appliance wear, in accordance with some embodiments discussed herein. DETAILED DESCRIPTION

The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the inventions are shown. Indeed, these inventions may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal

requirements. Like numbers refer to like elements throughout FIG. 1 shows an oral appliance 10 configured for mandibular advancement that may be used in accordance with embodiments of a compliance monitoring system as described herein. Such devices can be effective in helping to overcome and treat sleep disorders; such as difficulty sleeping, snoring, and obstructive sleep apnea. The oral appliance 10, shown in FIG. 1 , is configured to be positioned within a user's mouth and removably attached to a user's upper jaw/teeth and lower jaw/teeth. The oral appliance 10 may be defined to receive a user's teeth and/or jaw so as to fit comfortably inside the user's mouth. In the depicted embodiment, the oral appliance 10 comprises an adjustment assembly 15 which allows for positional adjustment of a user's lower jaw relative to the user's upper jaw. The positional adjustment creates a larger airway for a user to breathe through, which typically aids in treating the user's sleep disorder, although such an adjustment assembly may not be necessary for some appliances. Additionally, the oral appliance 10 may be designed to remain in a user's mouth overnight and also be adjusted while remaining inside the user's mouth or adjusted after taking outside of the user's mouth. Furthermore, the adjustment assembly 15 may be used for various oral appliances for mandibular advancement such as for intraoral distraction devices, as well as between any two anatomical members (e.g., upper and lower jaws) allowing for positional adjustment therebetween.

FIG. 1 shows an oral appliance 10 which has an anterior portion 12 that corresponds to the anterior or front of a user's jaw and a posterior portion 16 spaced away from the anterior portion that corresponds to the posterior or rear of a user's jaw. In the depicted embodiment, the oral appliance 10 includes an upper housing 20 and a lower housing 30 and may utilize an adjustment assembly with advancement blocks and flanges for mandibular advancement. Example types of oral appliances that could be employed are described in U.S. Patent No. 6,604,527 and PCT Application No.

PCT/US2011/03671 , which are hereby incorporated by reference in their entireties.

Oral appliances, such as the oral appliance 10 shown in FIG. 1 , have been designed for use in various patient clinical scenarios. Such applian^'ces have been described for use in patients who are edentulous though the discussion herein will focus only on the use of oral appliances in the dentate patient. However, it is understood that embodiments of the present invention can be utilized with many other types of oral appliances. Some oral appliances may be one piece, but currently the most commonly used designs are typically fabricated as two piece appliances (i.e., both upper and lower trays), which adapt to the maxillary and mandibular arches, respectively. These oral appliances interdigitate, or interlock (i.e., using coupling and fin advancement

mechanism), so that primary force vectors can be applied to the teeth. As the teeth are anchored to the jaw via individual periodontal ligaments, forces applied to the mandibular teeth result in mandibular advancement at the level of the temporomandibular joint.

When an oral appliance is placed into the oral cavity it is retained by the maxillary and mandibular teeth. Various methods of retention have been utilized in the past (e.g., ball and post metal clasps), however, currently the most widely used vehicle to gain retention is the use of thermoplastic material that is applied during the initial processing of the appliance to the undercuts around the teeth. This material is flexible, and permits the device to be placed and removed, albeit with some effort. Typically, this flexible material is placed during the initial fabrication and processing of the device as a veneer or flexible wash adjacent to the teeth, overlaid with a more durable and harder acrylic shell.

Advancement mechanisms (e.g., advancement screws) are then affixed to the hard acrylic shell in order to allow titration or forward movement of the mandible. The amount or degree of forward movement or posturing of the mandible will vary from patient to patient.

With reference to FIG. 2, in order to advance the mandible, the oral appliance places a distalizing force F₁ to the lingual or inner surface 32 of the mandibular or lower anterior teeth 34. This is the primary force vector that is applied to the mandibular dentition with use of the appliance. An opposing force vector F₂ of equal magnitude is also generated to the facial or outer surfaces 36 of the maxillary or upper anterior teeth 38.

The primary force vectors F^ and F₂ are universal and mandatory forces that are applied to the teeth in all dentate patients that utilize oral appliances. These forces are reliably applied to each patient that uses these devices when the appliance is inserted into the oral cavity and as such, comprise an extremely consistent signal for evaluation of use of the device. For this reason, monitoring of these force vector F-, and F₂ can be utilized as a reliable mechanism for monitoring compliance with recommending wearing of the oral appliance by determining when an oral appliance is being used.

In one example embodiment of the present invention, with reference to FIG. 3, one or more pressure sensors 70 could be placed in strategic locations within the upper and/or lower housings 20, 30 of an oral appliance. These strategic locations could benefit from the universal and mandatory force vectors F-i and F₂ that are applied during mandibular advancement. The pressure sensors 70, such as microdot pressure sensors, could measure when these force vectors are applied to the teeth, indicating that the oral appliances are being worn. In some embodiments, the pressure sensors 70 can be configured to measure force units and convert the measurements to pressure units based on surface area covered by the sensors. Alternatively or additionally, the pressure sensors 70 may be configured to measure force and/or pressure directly. In the depicted embodiment, the pressure sensors 70 can be applied between the flexible veneer 23 and the hard acrylic shell 27 of the upper and lower housings 20, 30. For example, the pressure sensors 70 could be positioned proximate to the anterior portion 12 of the housing. These sensors are then strategically placed so as to interact with the surfaces of teeth which receive the primary force vectors Fi and F₂, namely, the facial surfaces of the upper anterior teeth, and the lingual surfaces of the lower anterior teeth, as previously discussed with respect to FIG. 2.

In some embodiments, other useful components for a compliance monitoring system (e.g., a memory device, a transmitter, and a battery) may be positioned within the acrylic shell of the upper and lower housings 20, 30 so as to provide protection to the patient while still allowing those components to work as intended (e.g., the pressure sensors can still effectively gather pressure sensor data).

In another embodiment, as shown in FIG. 4, multiple pressure sensors 70 can be positioned across the teeth 1 1 to maximize the ability to monitor when the oral appliance is being worn. In some embodiments, the pressure sensors 70 may be positioned within the housing of the oral appliance such that each of the sensors correspond to one or more teeth 1 1. Other embodiments, as shown in FIG. 5, may utilize pressure sensors 70 directly with the articulating or interfacing surfaces of the upper and lower housings, such as a fin-coupling or flange advancement mechanism for an oral appliance configured for mandibular advancement. For example, the housings may include respective flanges that are configured engage one another when being worn (see e.g., FIG. 1 ), and at least one pressure sensor may be associated with either or both of the flanges for acquiring data as the flanges engage or otherwise interact with one another. In the depicted embodiment, one or more pressure sensors 70 may be positioned on the fin 26 or advancement block 29 to monitor when the advancement block 29 engages or otherwise interacts with the flange or fin 26, thereby indicating when the oral appliance is being properly utilized. Such an embodiment could be used in addition to or as an alternative to positioning of the pressure sensors 70 as shown in FIG. 3.

FIG. 6 shows an exemplary embodiment of a compliance monitoring system 50 for oral appliance wear. In the depicted embodiment, the compliance monitoring system 50 comprises an upper housing 20 and lower housing 30 of an oral appliance 10 and a storage container 40. The system 50 may be in communication with a network 60.

The upper housing 20 may comprise at least one pressure sensor 70, a memory device 72, a power source 74, and a transmitter 76. In the depicted embodiment, the lower housing 30 may also comprise at least one pressure sensor 70', a memory device 72', a power source 74', and a transmitter 76'.

The pressure sensors 70, 70' of the upper and lower housings 20, 30 may be configured to measure the forces applied to a patient's teeth while the oral appliance trays or housings are being used. The memory device 72, 72', such as a memory chip or other storage device, is configured to store data and send data to the transmitter 76, 76'. The transmitter 76, 76', such as a small radiofrequency transmitter, is configured to send the data from the memory device 72, 72' to the storage container 40. The pressure sensors 70, 70', memory devices 72, 72', and transmitters 76, 76' are located within the upper and lower housings 20 and 30 receive power from the power source 74, 74', which in some embodiments may comprise a small battery designed to undergo inductive charging for replenishing lost power.

In some embodiments, the upper and lower housings may also comprise a clock 79, 79', which can be in communication with the pressure sensors 70, 70' and memory device 72, 72'. The clock 79, 79' may be configured to provide time, duration, and/or date data to the memory device while the pressure sensors are providing pressure sensor data such that pressure sensor data is linked to a corresponding time, date, and/or duration.

In other embodiments, the memory device 72, 72' is configured to erase the pressure sensor data stored in the memory device 72, 72' upon successful transmission of the data to the storage container 40, thereby allowing continued use of the memory device 72, 72' for compliance monitoring. In other embodiments, the upper and lower housings 20, 30 may also comprise a receiver that is configured to receive instructions from the storage container 40 and relay the instructions to the memory device 72, 72'. In such an embodiment, the instructions could comprise erasing the pressure sensor data in the memory device 72, 72' or the instructions could comprise beginning transmission of the pressure sensor data. Thus, in some embodiments, the memory device 72, 72' may be configured as a processor to perform the functions as indicated herein.

In some embodiments, the transmitter 76, 76' may be configured as a radio frequency identification ("RFID") tag. Generally, the RFID tag comprises a tag that includes an integrated circuit (IC) chip microprocessor and a resonant circuit formed by a coiled antenna and a capacitor. The RFID tag could be passive, active, read only, and/or read/write. In a passive RFID system, a device, such as a reader, generates a magnetic field at a predetermined frequency. When an RFID tag, which usually can be categorized as being either read-only or read/write, is exposed to the magnetic field, a small electric current is induced in the device's resonant circuit. This circuit provides power to the tag, which then modulates the magnetic field in order to transmit information that is pre- programmed on the tag back to the reader at a predetermined frequency. The reader then receives, demodulates, and decodes the signal transmission, and sends the data on to a data acquisition system for further processing. Thus, if the RFID tag and/or pressure sensor 70 are passive, no external electric power, such as the power source 74 is required.

An active RFID system operates in much the same way, but in an active system the RFID tag includes its own battery, allowing the tag to transmit data and information, such as at the touch of a button. Read only RFID tags have a permanent memory that may not be modified, while read/write RFID tags are capable of having updated information written to the RFID tag. However, in some instances, the RFID tag and/or pressure sensor 70 may be active and require an external power source, such as the power source 74.

In the depicted embodiment, the storage container 40 may comprise a power source 84, receiver 87, memory device 82, clock 89, inductive charger 83, and transmitter 86. The power source 84 can be any power source that provides power to the

components of the storage container 40, including portable and non-portable power sources. The receiver 87 is configured to receive data from at least one transmitter 76, 76' of the upper or lower housings 20, 30 of the oral appliance. The memory device 82 is configured to store the pressure sensor data received by the receiver 87. The clock 89 is configured to provide time, duration, and/or date data to the memory device 82 that corresponds to and is stored with the pressure sensor data received by the receiver 87. The inductive charger 83 is configured to replenish the power source 74, 74' of the upper and lower housings 20, 30 when the upper and lower housings 20, 30 are placed inside the storage container 40. The transmitter 86 is configured to communicate the stored pressure sensor data to a network 60 or other device, which is configured to receive the data and in some embodiments, create reports comprising the data. In other

embodiments, the storage container may only comprise a receiver, a memory device, and a transmitter.

In some embodiments, a data acquisition system, such as the storage container, may wirelessly communicate with the oral appliance 10. In particular, the data acquisition system may be capable of both interrogating the oral appliance 10 to cause the pressure sensors 70 to acquire pressure sensor data and wirelessly transferring/receiving data to/from the pressure sensors 70 via the transmitter 76, 76'. As such, no wiring is necessary to initiate interrogation and/or communication between the oral appliance 10 and the data acquisition system.

In other embodiments, the data acquisition system could communicate with the transmitter 76, 76' proximate to the oral appliance 10 (e.g., a hand-held reader/writer) or distant from the oral appliance 10 (e.g., at a central data processing station). The data acquisition system may typically include a processor or similar computing device operating under the control of software so that data acquired from the transmitter 76, 76' of the oral appliance 10 may be analyzed. The processor could be embodied by a computer such as a desktop, laptop, tablet computer, or portable processing device capable of processing the data generated by the oral appliance 10. For example, the data acquisition system could be a hand-held reader/writer that a doctor or technician could use to scan the transmitter 76, 76' and download data acquired by the oral appliance 10. Similarly, the data acquisition system could create a database to store the data acquired by the oral appliance 10 in response to the data collected by the data acquisition system.

In other embodiments, data acquisition may occur through wired communication. For example, the oral appliance 10 may include an input port configured for connection to a data acquisition system that could download the pressure sensor data directly.

Additionally or alternatively, the storage container may be configured for transfer of data via wired connection, such as being configured with an input port.

In other various embodiments, the compliance monitoring system may comprise a single housing including one or more associated pressure sensors. The single housing may also include a transmitter for continuous transmission of the sensor data. In other embodiments, the housing may comprise a memory in communication with the pressure sensor, wherein the pressure sensor data could be stored on the memory and directly downloaded without the use of a transmitter. The single housing could also be used with a storage container with various components as described herein. In some

embodiments, as described above, a doctor could scan the oral appliance and/or storage container during a patient visit to upload the stored compliance data. As such, various combinations of the components of an oral appliance described herein may be used for embodiments of a compliance monitoring system.

FIG. 7 shows a flow chart of one embodiment of a method for monitoring compliance of oral appliance wear 100 utilizing some embodiments of the compliance monitoring system 50, as described with respect to FIG. 6.

While the oral appliance 10 is being worn at 110, one or more pressure sensors of the oral appliance monitors forces on the housings and the memory device receives the pressure sensor data from the pressure sensor at 112. The pressure sensor data is then stored in the memory device of the oral appliance at 113.

Once the oral appliance is removed from the patient's mouth and placed in the storage container 40 for storage at 120, the transmitter of the oral appliance sends the captured pressure sensor data to the storage container at 122. The storage container receives the pressure sensor data at 123 and stores the pressure sensor data at 124. In some embodiments, the storage container may comprise a clock that sends time, duration, and/or date data with the pressure sensor data to be stored in the memory device as well. At 125, the storage container may send a signal to the oral appliance to erase the pressure sensor data stored in the oral appliance memory device. In response to receiving the signal, the oral appliance erases the memory device at 126. Additionally, at 127, the storage container can send power to the oral appliance, which charges the power supply of the oral appliance at 128.

With the pressure sensor data stored in the storage container, the storage container may transmit or upload that data periodically to an external network at 130. The external network can receive the data at 132 and in some embodiments, can create a report of the data at 134. Uploading of the data can be performed, for example, via the internet or other communication system to a secure server which can place the data into a report format which can be downloaded by those interested in the data.

Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included herein. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. An oral appliance, comprising:

at least one housing configured to releasably attach to at least a portion of the upper and/or lower teeth or jaw, the housing comprising:

at least one pressure sensor associated with the housing and configured to measure one or more forces applied to the housing during use of the appliance and acquire data indicative of use of the oral appliance.

2. The oral appliance of claim 1, wherein the housing further comprises a lingual portion configured to engage the inner surface of the teeth and a facial portion configured to engage the outer surface of the teeth, and wherein the pressure sensor is positioned adjacent to the facial portion.

3. The oral appliance of claim 1 , wherein the housing further comprises a first memory configured to store the data received from the pressure sensor.

4. The oral appliance of claim 3, wherein the housing further comprises a first transmitter configured to communicate the data acquired by the pressure sensor.

5. The oral appliance of claim 4, wherein the housing further comprises a first battery configured to power the pressure sensor, memory, and transmitter.

6. The oral appliance of claim 1 , wherein the housing is configured to releasably attach to at least a portion of the upper teeth or jaw.

7. The oral appliance of claim 6, further comprising a second housing configured to releasably attach to at least a portion of the lower teeth or jaw.

8. The oral appliance of claim 7, wherein the second housing further comprises at least one second pressure sensor associated with the second housing and configured to measure one or more forces applied to the second housing during use of the appliance and acquire data indicative of use of the appliance.

9. The oral appliance of claim 8, wherein the second housing further comprises a lingual portion configured to engage the inner surface of the lower teeth and a facial portion configured to engage the outer surface of the lower teeth, and wherein the second pressure sensor is positioned adjacent to the lingual portion.

10. The oral appliance of claim 8, wherein the second housing further comprises a second memory configured to store the data received from the second pressure sensor.

11. The oral appliance of claim 10, wherein the second housing further comprises a second transmitter configured to communicate the data acquired by the second pressure sensor.

12. The oral appliance of claim 11 , wherein the second housing further comprises a second battery configured to power the second pressure sensor, second memory, and second transmitter.

13. The oral appliance of claim 1 , wherein the housing further comprises a flexible wash and an acrylic shell, and wherein the pressure sensor is positioned between the flexible wash and acrylic shell.

14. The oral appliance of claim 7, wherein each of the housings further comprises a flange configured to engage one another for mandibular advancement, and wherein the at least one pressure sensor is associated with one or both of the flanges and configured to measure one or more forces resulting from engagement therebetween.

15. A storage container for storing an oral appliance, comprising:

a receiver configured to receive data indicative of use of the oral appliance from a first transmitter associated with the oral appliance;

a memory configured to store the data received from the first transmitter;

and a second transmitter for communicating the data.

16. The storage container of claim 15 further comprising a power source.

17. The storage container of claim 15 further comprising an inductive charger configured to charge a battery associated with the oral appliance using the power source.

18. A method for monitoring compliance of oral appliance wear, comprising:

acquiring data from at least one pressure sensor associated with an oral appliance while being worn by a patient, the data being indicative of use of the appliance; and

communicating the data to a data acquisition device.

19. A system for monitoring compliance of an oral appliance:

an oral appliance, comprising:

at least one pressure sensor associated with the housing and configured to measure one or more forces applied to the housing during use of the appliance and acquire data indicative of use of the oral appliance; and

a data acquisition device configured to receive data indicative of use of the oral appliance from the oral appliance.