US20070283973A1 - Apparatuses, Systems and Methods for Confirming Use of an Oral Appliance - Google Patents

Abstract

An oral appliance constructed with a housing that encloses a recorder and a transceiver. The oral appliance responds to commands received via the transceiver. When so directed, the oral appliance uses one or more sensors alone or in combination to record measurements at periodic intervals. When communicatively coupled to a suitably configured communication device, the oral appliance receives commands that direct the oral appliance to transmit an identifier, the recorded data, or both the identifier and the data. The transmitted data can be used to determine whether the user of the oral appliance has complied with a recommended usage schedule.

Description

BACKGROUND
• A number of oral appliances have been developed in association with various therapies related to the treatment of sleep apnea, snoring, bruxism, orthodontia, eating disorders and other medical and dental issues.
• Difficulty in breathing while sleeping often manifests itself as snoring or the more serious obstructive sleep apnea. Snoring is a condition affecting approximately forty percent (40%) of the adult population, while sleep apnea is believed to affect at least twenty (20) million people.
• In turn, bruxism consists of a static and/or dynamic contact between the dentition of the mandible and maxilla. Bruxism is commonly referred to as “tooth grinding,” which results in the physical destruction of tooth enamel directly leading to tooth decay as well as more serious problems. Bruxism affects nearly fifteen percent (15%) of the population and in advanced stages bruxism results in the abnormal and excessive grinding or clenching of teeth while an individual is asleep. Bruxism is medically classified as parasomnia or sleep disorder.
• In turn, temporomandibular joint syndrome (or dysfunction) (“TMJ”) is a disorder effecting the joint between the lower jaw and the skull. The temporomandibular joint lies between the temporal bone of the skull and the mandible of the jaw, and allows the jaw to open and close. The joint is formed by a condyle on the mandible, which hinges and glides in and out of the depression in the temporal bone.
• TMJ can be caused by bruxism, malocclusion, trauma, and arthritis. There is also an indication that a posterior or backward displacement of the condyle of the jaw significantly contributes to TMJ pain. TMJ has been associated with a wide variety of physical aliments, including migraine headaches. TMJ related headaches can become so severe as to cause nausea and blurred vision. Most people afflicted with TMJ suffer from a myofascial pain-dysfunction syndrome primarily as a muscle problem related to dental/skeletal relationships and tensional factors. The effects can range from mild to severe, including pain in the joint area that can extend to the shoulders, back, neck, and sinuses.
• U.S. Pat. No. 6,769,910 discloses a non-surgical oral appliance for improving breathing, and abating or completely alleviating snoring sounds, TMJ and bruxism while sleeping. In one embodiment the user is professionally fitted for the appliance such that the appliance positions the mandible in an open, protrusive, predetermined position such that the oral airway permits the enhanced passage of air.
• Oral appliances have been developed and prescribed in association with conditions in addition to the above-described oral, respiratory, dental and developmental disorders. According to the American Obesity Association (AOA), obesity is a disease that affects nearly one-third of the adult American population. The number of overweight and obese Americans has continued to increase since 1960—a trend that is not slowing down. Research conducted by the AOA indicates that 64.5 percent of adult Americans (about 127 million) are currently categorized as being overweight or obese. Each year, obesity causes at least 300,000 excess deaths in the United States alone, and healthcare costs of American adults with obesity amount to approximately $100 billion.
• Individuals with obesity are at risk of developing one or more serious medical conditions, which can cause poor health and premature death. For instance, research suggests that obesity is statistically linked to adverse medical conditions, such as diabetes, coronary heart disease, high blood pressure, osteoarthritis, hypertension, and cardiovascular disease to a name a few of the more severe conditions. The problems associated with obesity and other less severe weight issues are not limited to medical conditions. Obese and overweight people may also suffer from a number of other problems (e.g., lifestyle problems, psychological conditions, social problems, etc.).
• Currently, there are a number of weight loss methods and devices for enabling people to attempt to manage their weight problems. The most prevalent methods include dieting, exercising, medications, body wrapping, surgical procedures, etc. Other weight management solutions involve mechanical devices and dental appliances. One such device is positioned in the mouth to stimulate salivation and swallowing, such as disclosed in U.S. Pat. Nos. 3,224,442 and 5,052,410.
• U.S. Pat. No. 5,924,422 discloses a removable, retainer-like device that is molded to fit the contours and configuration of the user's mouth. The upper surface of the retainer-like device is configured to fit the roof of the user's mouth, while the lower surface is configured to replicate the roof, or palate, of the user's mouth. The retainer-like device is adapted to be easily and quickly put into use, without any special training, by positioning it in the mouth with the upper surface against the palate, and pushing the retainer between the corresponding teeth. When worn, the device effectively lowers the roof of the user's mouth to reduce the overall volume of the oral cavity. The device is intended to be easily inserted and removed by the user.
• Regardless of the malady that a particular oral appliance is attempting to treat, the oral appliance, if it is to be effective, should be used in accordance with a prescribed usage schedule to attain the desired therapeutic benefits. Accordingly, the dental and medical professions, medical and dental insurers, parents and others interested in a user's compliance with a prescribed usage schedule for a respective device, recognize the paramount importance of developing systems and methods for ensuring a user's compliant use of an oral appliance.
SUMMARY
• Embodiments of an oral appliance that records and transfers information responsive to a user's usage of the oral appliance comprise a housing configured with a power source, a sensor, a recorder, and a transceiver. The recorder is powered by the power source and is configured to record a measurement responsive to the sensor. The transceiver is coupled to the recorder and is configured to communicate the measurement responsive to a command.
• An embodiment of a method for confirming compliant use of an oral appliance comprises the steps of providing an oral appliance to a user, the oral appliance configured to record one or more measurements indicative of placement of the oral appliance in an oral cavity, directing the oral appliance to transfer the measurements and analyzing the measurement.
• Other apparatuses, systems, methods, features and advantages will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. All such additional apparatuses, systems, methods, features and advantages are defined and protected by the accompanying claims.
BRIEF DESCRIPTION OF THE FIGS.
• The apparatuses, systems and methods for confirming use of an oral device can be better understood with reference to the following figures. The components within the figures are not necessarily to scale; emphasis instead is placed upon clearly illustrating the principles that support the apparatuses, systems and methods. Moreover, in the figures, like reference numbers designate corresponding parts throughout the different views.
• FIG. 1 is a side view of the head of a user that is using an oral appliance.
• FIG. 2 is a perspective view of an embodiment of the oral appliance ofFIG. 1.
• FIG. 3 is a cross-sectional view of the oral appliance ofFIG. 2 along lines3-3.
• FIG. 4 is a schematic diagram illustrating an embodiment of the oral appliance ofFIG. 3.
• FIG. 5 is a schematic diagram illustrating an embodiment of the housing ofFIG. 4.
• FIG. 6 is a schematic diagram illustrating an embodiment of storage locations within the memory ofFIG. 5.
• FIG. 7 is a flow diagram illustrating an embodiment of a method for confirming use of an oral appliance.
• FIG. 8 is a flow diagram illustrating an alternative embodiment of a method for confirming use of an oral appliance.
DETAILED DESCRIPTION
• An oral appliance is constructed with a housing or chamber that substantially encloses a sensor, a recorder, and a transceiver. The oral appliance responds to commands received via the transceiver. The oral appliance is reset or otherwise configured to periodically record a measurement or measurements for a desired length of time. The oral appliance is prescribed or otherwise provided to a user of the oral appliance. Preferably, before the desired length of time has expired, the user transfers recorded data to a communication device. This can be accomplished by returning the oral appliance to the provider of the device or providing the user with a suitably configured communication device that receives recorded data from the oral appliance and forwards the data to the provider to the provider of the device. When communicatively coupled to a suitably configured communication device, the oral appliance receives commands that direct the appliance to transmit the recorded measurements. The transmitted measurements can be used to determine whether the user of the oral appliance has complied with a recommended usage schedule.
• The sensor is configured such that it is sensitive to one or more conditions associated with the user's oral cavity. For example, the sensor may be sensitive to a range of temperatures. Generally, the oral appliance will have the same temperature as its surrounding environment such as room temperature when it is not in the oral cavity and approximately ninety-eight degrees Fahrenheit when the appliance is positioned within the oral cavity. By periodically recording the measured temperature of the oral appliance it can be determined with a fairly high degree of certainty when the oral appliance was placed in the oral cavity. By way of further example, the sensor may be sensitive to other conditions expected in an oral cavity such as hydrogen ion concentration or pH, moisture or absolute humidity. Absolute humidity, expressed as grams of water vapor per volume of air, is a measure of the actual amount of water vapor or moisture in the air, regardless of the air's temperature.
• A temperature sensor can be entirely contained within a housing or cavity formed by a dental acrylic or other material approved for use in an oral cavity. For example, a TS20 temperature sensor is a high-precision complementary metal-oxide semiconductor (CMOS) temperature sensor that provides for high-accuracy low-power temperature monitoring. With a supply voltage of 2.4V to 6V, the aTS20 is accurate to ±3° C. over a temperature range of −40° C. to 125° C. and has a typical room temperature accuracy of ±0.5° C. Reducing the supply voltage to 2.4V does not change the negative and positive temperature extremes. In addition, the TS20 does not require external calibration. Calibration of each device is performed at the factory. The TS20 is available from Andigilog of Tempe, Ariz., U.S.A.
• A humidity sensor may have one or more surfaces exposed to the oral cavity with electrical and perhaps additional structural connectors contained and protected within a housing or cavity formed of dental acrylic or other material approved for use in an oral cavity. For example, a HIH-3602 series sensor provides a 0-100%, non-condensing, sensing solution in a TO-5 can package. The humidity sensor is a low-power device that operates from a supply voltage from 4.0V to 5.8V. The sensor is national institute of standards and technology (NIST) certified and is provided with a NIST sensor-specific printout. The HIH-3602 humidity sensors are available from Honeywell Sensing and Control of Minneapolis, Minn., U.S.A.
• The logarithmic pH scale is a measure of the number of moles of hydrogen ions (H⁺) per liter of solution. A pH sensor comprises measurement and reference electrodes. The measurement electrode generates the voltage used to measure a sample solution's pH. The reference electrode includes a barrier configured to screen or separate hydrogen ions from other ions in the solution. The reference and measurement electrodes generate a voltage directly proportional to the pH of the solution. At a pH of 7 (neutral), the electrodes will produce 0 volts between them. At a pH below 7 (acid) the electrodes will produce a voltage of one polarity, and at a pH above 7 (caustic) the electrodes will produce a voltage of the opposite polarity. The magnitude of the voltage will increase in proportion to the difference in logarithmic concentration from a neutral concentration of 10⁻⁷moles of hydrogen ions per liter. The applications of microelectronic fabrication techniques such as photolithography and thick- and thin-film metallization can be used to produce highly uniform and reproducible pH sensors that are relatively simple to calibrate and operate.
• The oral appliance can be configured with a combination of sensors that together provide data that can be analyzed to confirm compliant use of the oral appliance under various conditions. For example, the oral appliance can be configured with sensors responsive to concentrations of salt, sugars, fats, proteins, light and motion. Movement of the oral appliance consistent with chewing can be detected by an accelerometer. A concentration of salts, fats, proteins and/or sugars can be determined from a silicon-on-insulator based thin-film resistor. Such a sensor is described in “Silicon-On-Insulator Based Thin-Film Resistor for Chemical and Biological Sensor Applications,” Michael G. Nikolaides, et al., ChemPhysChem 2003, Vol. 4, pgs. 1104-1106, which is incorporated by reference in its entirety. Light can be detected by a charge-coupled device or other photosensors such as those provided in camera phones. Data received from an accelerometer can be correlated with one or more measurements of concentrations of salts, fats, proteins and/or sugars in the oral cavity and/or information from one or more photosensors to determine that a patient was eating while wearing the device. Furthermore, collected data can be analyzed to determine the quality of the patient's diet.
• Outputs from the above-described sensors can be analog current, voltage, or frequency; or digital conversions of the same. In some embodiments the measurements are recorded in five minute intervals from a start or reset time commanded via an external communication device. The measurements can be transferred periodically or in real-time and analyzed to determine usage patterns and overall compliance with a prescribed therapeutic schedule.
• Having generally described the apparatuses, systems and methods for confirming use of an oral appliance, various additional embodiments will be described with respect toFIGS. 1-8. By way of example,FIG. 1 is a side view of thehead102 of a user that is using anoral appliance100. As illustrated in the example embodiment, theoral appliance100 comprises a palatal prosthetic that is shaped to closely contact the user's palate104 (within the user's oral cavity). Theoral appliance100 is meant to be easily inserted, positioned and removed by a user of theoral appliance100. As will be explained in greater detail below,oral appliance100 comprises a housing or cavity (not shown) that isolates and protects the above-described sensor or sensors, as well as a recorder, a power source and a transceiver.
• In alternative embodiments, theoral appliance100 comprises a prosthetic housing that fits within the user's maxilla but does not contact the user's palate. In these alternative embodiments the housing is suspended in the oral cavity such that a gap is formed between the upper surface of theoral appliance100 and the user's palate.
• Theoral appliance100 includes an upper arch portion, a lower arch portion, or both upper and lower arch portions. An upper arch portion may take the general shape of the user's maxilla or fit within the confines of the user's maxilla and in some arrangements may surround one or more of the user's upper teeth. A lower arch portion may take the general shape of the user's mandible or fit within the confines of the user's mandible above the tongue and in some arrangements may surround one or more of the user's lower teeth. In alternative embodiments one or both (when both arch portions are present) of the arch portions may comprise a housing that contains an internal cavity for substantially encompassing the above-described sensors, as well as protecting a recorder, a power source and a transceiver.
• As best illustrated inFIG. 1 and briefly mentioned above,oral appliance100 may be temporarily positioned within the oral cavity ofpatient102 so that theoral appliance100 is disposed under the patient'spalate104 and forms a palatal prosthetic.
• Referring toFIGS. 2 & 3, the palatal prosthetic includes aportion204 made from dental acrylic or other materials approved for such oral devices that extends belowpalate104 to encapsulate a sensor or sensors, a recorder, a power source and a transceiver. As illustrated inFIG. 2, the palatal prosthetic is configured with extensions or contact surfaces. Afirst contact surface205 is arranged along the edges of the palatal prosthetic to limit any forces that the palatal prosthetic would apply to the user's maxilla and upper teeth. Asecond contact surface207 is arranged along the upper surface of the palatal prosthetic. Thesecond contact surface207 provides a comfortable fit and cushions any forces that may be applied to the user's palate while chewing food with the palatal prosthetic in place. In the illustrated embodiment, thesecond contact surface207 is a quadrilateral with parallel sides adjacent to the front and rear of the palatal prosthetic. One or both of thefirst contact surface205 and thesecond contact surface207 may be made from a plasticized methacrylate resin of the acrylic polymer chemical family. A methacrylate is a combination of ethyl acetate, ethanol and methyl ethyl ketone. In alternative embodiments, one or both of thefirst contact surface205 andsecond contact surface207 can be constructed of flexible materials approved for use in an oral cavity.
• As illustrated in the cross-sectional view ofFIG. 3, theoral appliance100 includes anupper surface302 to be disposed under the patient'spalate104 when positioned in the oral cavity. In some embodiments, upper surface302 (or portions thereof) may rest against the patient'spalate104. In other embodiments,upper surface302 does not contact the patient'spalate104 but is securely and comfortably fixed underpalate104. Theoral appliance100 also includes alower surface304, which definesportion204 that extends belowpalate104 to define a prosthetic palate.Oral appliance100 also comprises a dental attachment (e.g.,dental wire202—FIGS. 2 & 3), which may be used to securely fix theoral appliance100 when it is positioned as desired within the oral cavity ofuser102 as described above. It should be appreciated that the position, spatial orientation, etc. ofdental wire202 may be varied from that shown inFIGS. 2 & 3. Furthermore, additional dental attachments may be attached (e.g., integrally or otherwise) todental wire202. In alternative embodiments,dental wire202 may be replaced with a more suitable dental attachment(s) based on a particular orthodontic configuration. Nonetheless, in the embodiment illustrated inFIGS. 2 & 3,dental wire202 extends from the lateral sides ofdental appliance100.
• FIG. 4 is a schematic diagram illustrating an embodiment of theoral appliance100 ofFIG. 3. As illustrated in the rear view ofFIG. 4, theoral appliance100 includes a housing400 (shown with hidden lines) that forms an internal cavity410 within the dental acrylic. As will be explained in greater detail below,housing400 protects elements configured to periodically sense and record one or more environmental conditions surrounding theoral appliance100 to identify to a reviewer of the recorded information the usage habits of theuser102 oforal device100. In the embodiment illustrated inFIG. 4,housing400 comprises a lower surface402, an opposing upper surface404, a right-side surface406 and an opposing left-side surface408. It should be understood that alternative arrangements are possible including those where the dental acrylic conformally coats portions of one or more sensors and entirely coats the power source, recorder and transceiver.
• FIG. 5 is a schematic diagram illustrating the arrangement of apower source520, asensor530 and arecorder550 andtransceiver540 on anintegrated circuit510 withinhousing400. In the illustrated embodiment,housing400 entirely encompasses integratedcircuit510,power source520,sensor530, andantenna560. In alternative embodiments (not shown),sensor530 or other sensors such assensor580 may extend to or through a surface ofhousing400 such that a portion of the sensor is exposed to the user's oral cavity.
• As illustrated inFIG. 5,power source520 is coupled and provides power tointegrated circuit510. Specifically, a positive terminal ofpower source520 is electrically connected to a power input pin viaconductor512 and a negative terminal ofpower source520 is electrically connected to a ground input pin viaconductor514.
• Integrated circuit510 includesrecorder550 andtransceiver540.Sensor530 is coupled torecorder550 vialink518.Sensor580 is coupled torecorder550 vialink524 and link526.Sensor580 encloses saliva andother liquids581, which translate throughmembrane585 from the user's oral cavity.Link524 is coupled tomeasurement electrode582.Link526 is coupled toreference electrode584.Transceiver540 is coupled torecorder550 vialink557.Transceiver540 is coupled toantenna560 vialink516.Transceiver540 is also coupled toconnector570 vialink522. In the illustrated embodiment,connector570 is protected from the user's oral cavity viacover575. Cover575 is arranged so that it can be removed when a technician desires tocommunicatively couple transceiver540 via a wired connection to external communication devices and replaced whenoral appliance100 is returned to the user.Sensor530 is responsive to temperature, motion or both.Sensor580 is responsive to humidity, pH, and concentrations of salts, fats, proteins and carbohydrates including glucose, sucrose, and fructose present in beverages and food in the patient's oral cavity. It should be understood that alternative arrangements of sensor580 (not shown) may be devised toplace sensor580 such that it can detect the presence of food and beverages in the patient's oral cavity. In these alternative arrangements,controller552 can be configured to record measurements fromsensor580 when movement of the oral appliance consistent with chewing is detected.
• Recorder550 includescontroller552,memory554 andtimer555.Controller552 is coupled tomemory554 viabus553.Controller552 is further coupled totimer556 vialink555.
• Transceiver540 includes encoder/decoder542 and modulator/demodulator544. Encoder/decoder542 is coupled to modulator/demodulator544 viabus543.
• In operation, a radio-frequency signal containing one or more commands from a suitably configured communication device is received viaantenna560 and a tuner (not shown). The received signal is forwarded to modulator/demodulator544 vialink516. When theoral appliance100 is coupled via a wired connection to a communication device (not shown), commands can be forwarded to modulator/demodulator544 viaconnector570 and link522. Modulator/demodulator544 detects and separates information from the received signal. The information is forwarded to encoder/decoder542 viabus543. Encoder/decoder542 converts the received information to a format compatible withcontroller552.Controller552 responds in accordance with the one or more received commands. For example, an identifier set command includes a unique identifier that can be stored inmemory554, a start time reset command includes information responsive to a time or a time and date, an interval set command includes information that defines a time interval between measurements, a transmit command instructscontroller552 to read and communicate each of the recorded measurements, a clear command directscontroller552 to remove recorded measurements frommemory554. A suitably configured communication device may send multiple commands whenoral appliance100 is within range (in a wireless data transfer mode) or directly coupled viaconnector570 and link522 (in a wired data transfer mode). It should be understood thatantenna560 andconnector570 as well aslink516 and link522 could be replaced by an infrared transmitter (e.g., a diode) and infrared sensitive device to communicate with an external communication device wirelessly.
• During a session, which is defined as the time between a start time reset command and a transmit command,controller552 in accordance with periodic signals received vialink555 fromtimer556 latches a current or a voltage provided bysensor530.
• In some embodiments,controller552 is configured with an analog to digital converter, which generates a digital representation of the analog output fromsensor530. In theseembodiments controller552 simply forwards the latched and digitized measurement into the next available location withinmemory554. In other embodiments,memory554 is configured with calibration information, which is used to convert the recorded measurement to a scale. When thesensor530 in these other embodiments is responsive to temperature, the scale may be degrees Fahrenheit or degrees Celsius. When thesensor530 in these other embodiments is responsive to humidity, the scale may be a percentage from 0% (an environment devoid of water vapor) to 100% (an environment completely saturated with water vapor).Sensor580 as described above may produce relative voltages, the polarity and magnitude of which are indicative of the pH of thefluid581. Regardless of the nature ofsensor530 and/orsensor580, converted measurements are stored in the next available location withinmemory554.
• Memory554 includes adequate storage locations to store measurements for an extended session. When theuser102 oforal appliance100 fails to place theoral appliance100 within signal range of a suitably configured communication device andcontroller552 has forwarded a measurement to each available memory location withinmemory554, subsequent measurements will be forwarded to and will overwrite measurement information in the same sequence as previous measurements were stored inmemory554. It should be understood that whenoral appliance100 is within range of a communication device measurements can be sent in near real-time from theoral appliance100 to the communication device.
• FIG. 6 is a schematic diagram illustrating an embodiment of storage locations within thememory554 ofFIG. 5. As shown inFIG. 6,memory554 includesidentifier store610, starttime store620,interval store630, andmeasurement store640. As previously described,identifier store610 is a designated memory location for a unique identifier fororal appliance100. Starttime store620 is a designated memory location for a start time.Interval store640 is a designated memory location for an interval or duration of time thatcontroller552 will wait between recording and storing an environmental parameter as determined bysensor530. As further indicated inFIG. 6,measurement store640 includes many designated memory locations, such aslocation641,location642,location643 through tolocation644 in a leftmost column of locations, through tolocation645, the last location in a rightmost column ofmeasurement store640. It should be understood that each of the individual measurement locations could be arranged in other sequences separate and distinct from the sequence shown inFIG. 6.
• FIG. 7 is a flow diagram illustrating an embodiment of amethod700 for confirming use of anoral appliance100. In this regard, the functions associated withblocks720 and730 represent respective specified steps or functions that can be embodied in software and/or a combination of hardware and firmware. When embodied in software and/or hardware/firmware, blocks720 and730 represent modules, segments, or portions of code, which comprise one or more executable instructions for implementing the specified function(s).Method700 begins withblock710 where anoral appliance100 is provided to auser102. As described above, the providedoral appliance100 is configured to record a measurement or measurements indicative of placement in the oral cavity ofuser102. In preferred embodiments,oral appliance100 is directed to periodically record one or more specified measurements over a select length of time that does not exceed the capacity of a memory device to save the measurements. Thereafter, as indicated inblock720, theoral appliance100 is directed to transfer the measurement or measurements. As shown inblock730, the received information is analyzed to see if it confirms the user's usage (i.e., placement) of theoral appliance100 in the oral cavity.
• FIG. 8 is a flow diagram illustrating an alternative embodiment of amethod800 for confirming use of anoral appliance100. In this regard, each block represents a specified step or function. When embodied in software and/or hardware/firmware, each block represents a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified function(s).
• Operational software programs that may be used by a communication device, as well as operational software programs that may be used in conjunction with a computer communicatively coupled to the communication device, which comprise an ordered listing of executable instructions for implementing logical functions, can be embodied in any computer-readable medium for use by or in connection with an instruction execution system, apparatus, or device, such as a computer-based system, processor-containing system, or other system that can fetch the instructions from the instruction execution system, apparatus, or device and execute the instructions. Consequently, portions ofmethod800 can be embodied on a computer-readable medium.
• Alternative method800 begins withblock810 where a communication device is used to communicate with and configureoral appliance100. Inblock820, the configuredoral appliance100 is provided to a user. The user may be instructed at this or some other time to begin a scheduled or prescribed therapy by positioningoral appliance100 in the user's oral cavity for a desired amount of time. In some embodiments, this prescribed or desired use may comprise a length of time for use of the device within each 24-hour period from receipt of the device until a future appointment. When theoral appliance100 is configured to limit the volume of the oral cavity, as a weight loss aid, theoral appliance100 may only need to be present during meal times to be effective. However, a physician or other party interested in the user's compliant use oforal appliance100 may require the user to show use through a significant portion of each day. When this is the case, theoral appliance100 may be configured to measure and record one or more environmental parameters in intervals shorter than 5 minutes.
• When theuser102 is in possession and is presumably using theoral appliance100 in accordance with the prescribed or desired schedule, theoral appliance100 is measuring and recording at least one environmental parameter every few minutes. The query ofblock830 and waitblock835 are repeated until as indicated inquery block830,oral appliance100 is communicatively coupled to a suitably configured communication device. When this is the case, as indicated by the flow control arrow labeled, “YES,” exitingblock830,method800 continues withoptional block840, where the communication device communicates a command to theoral appliance100 to transfer an identifier. The identifier associated with theoral appliance100 may be an alphanumeric string unique to the particularoral appliance100 presently in close proximity to the communication device. In alternative embodiments, the identifier may be a number or consist entirely of letters.
• Inblock850, the communication device directs theoral appliance100 to transfer one or more measurements indicative of the user's use of theoral appliance100 since it was first presented to the user and/or since the one or more measurements were transferred from theoral appliance100. Inblock860, a query is performed to determine if the data transfer is complete. When the data transfer has not been completed, as indicated by the flow control arrow labeled, “NO,” exitingblock860, a wait function or step is performed as indicated inblock865. Thereafter, processing continues with the query ofblock860 until it is the case that the data transfer is complete. Once the data transfer is complete as indicated by the flow control arrow labeled, “YES,” exitingblock860, the communication device directs theoral appliance100 to erase the stored measurements (in block870). Inblock880, the communication device or a computing device communicatively coupled to the communication device analyzes the one or more measurements to determine if the user's use of theoral appliance100 is in accordance with one or more prescribed therapy schedules.
• While various embodiments of the apparatuses, systems and methods for confirming use of an oral appliance have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of the accompanying claims. Accordingly, the apparatuses, systems and methods for confirming use of an oral appliance are not to be restricted beyond the attached claims and their equivalents.

Claims (38)

1. An oral appliance, comprising:

a housing configured for placement within an oral cavity, the housing comprising:

a power source;

a sensor;

a recorder powered by the power source, coupled to the sensor and configured to record a measurement responsive to the sensor; and

a transceiver coupled to the recorder and configured to communicate the measurement responsive to a command.

2. The oral appliance ofclaim 1, wherein the sensor is sensitive to temperature.

3. The oral appliance ofclaim 1, wherein the sensor is sensitive to humidity.

4. The oral appliance ofclaim 1, wherein the sensor is sensitive to motion.

5. The oral appliance ofclaim 1, wherein the sensor is sensitive to a concentration of sodium chloride.

6. The oral appliance ofclaim 1, wherein the sensor is sensitive to a concentration of a carbohydrate selected from the group consisting of glucose, fructose and sucrose.

7. The oral appliance ofclaim 1, wherein the sensor is sensitive to light.

8. The oral appliance ofclaim 1, wherein the recorder and the transceiver are implemented on an integrated circuit.

9. The oral appliance ofclaim 8, further comprising:

a timer.

10. The oral appliance ofclaim 9, wherein the transceiver receives a timer command from a communication device.

11. The oral appliance ofclaim 1, further comprising:

a controller.

12. The oral appliance ofclaim 11, wherein the controller directs the transceiver to transmit an identifier responsive to a command received by the transceiver.

13. The oral appliance ofclaim 12, wherein the command directs the controller to perform one of a start, pause or terminate operation.

14. The oral appliance ofclaim 1, further comprising:

a memory for storing the measurement at periodic intervals.

15. The oral appliance ofclaim 14, wherein the memory stores a start time.

16. The oral appliance ofclaim 14, wherein the memory is erased responsive to an erase command received by the transceiver.

17. A method for confirming compliant use of an oral appliance, the method comprising:

providing an oral appliance to a user, the oral appliance configured to record a measurement indicative of placement of the oral appliance in an oral cavity;

directing the oral appliance to transfer the measurement; and

analyzing the measurement.

18. The method ofclaim 17, wherein the measurement comprises a temperature reading.

19. The method ofclaim 17, wherein the measurement comprises a humidity reading.

20. The method ofclaim 17, wherein directing the oral appliance to transfer the measurement comprises confirming the successful transfer of the measurement to the communication device and directing the oral appliance to erase the measurement.

21. The method ofclaim 17, wherein directing the oral appliance to transfer the measurement comprises communicatively coupling the oral appliance to a communication device.

22. The method ofclaim 21, further comprising:

transmitting a command to the oral appliance.

23. The method ofclaim 21, further comprising:

providing the communication device to a medical professional.

24. The method ofclaim 17, wherein directing the oral appliance to transfer the measurement comprises confirming the successful transfer of the measurement to the communication device and directing the oral appliance to erase the measurement.

25. The method ofclaim 17, wherein analyzing the measurement comprises communicating information to a computing device.

26. The method ofclaim 17, further comprising:

directing the oral appliance to transfer an identifier.

27. The method ofclaim 17, wherein the measurement is responsive to the concentration of hydrogen ions.

28. The method ofclaim 17, wherein the measurement is responsive to a concentration of sodium chloride.

29. The method ofclaim 17, wherein the measurement is responsive to a concentration of a carbohydrate selected from the group consisting of glucose, fructose and sucrose.

30. The method ofclaim 17, wherein the measurement is responsive to light.

31. An oral system for determining compliant use over time by a patient, comprising:

an orthodontic appliance;

a sensor integrated with the orthodontic appliance and able to detect a condition in the patient's oral cavity; and

a transceiver integrated within the orthodontic appliance and responsive to a command originating from a communication device.

32. The oral system ofclaim 31, wherein the orthodontic appliance comprises a retainer.

33. The oral system ofclaim 31, wherein the sensor is sensitive to temperature.

34. The oral system ofclaim 31, wherein the sensor is sensitive to humidity.

35. The oral system ofclaim 31, wherein the sensor is sensitive to pressure.

36. The oral system ofclaim 31, wherein the sensor is sensitive to a concentration of hydrogen ions.

37. The oral system ofclaim 31, further comprising:

a recorder coupled to the sensor and the transceiver, the recorder configured to periodically store at least one measurement received from the sensor.

38. The oral system ofclaim 37, wherein the recorder transfers stored measurements from two or more sensors with different sensitivities, the stored measurements recorded proximal in time to one another.

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