US20070283973A1

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

Info

Publication number: US20070283973A1
Application number: US11/422,279
Authority: US
Inventors: William H. Longley
Original assignee: SCIENTIFIC INTAKE Ltd CO
Current assignee: SCIENTIFIC INTAKE Ltd CO
Priority date: 2006-06-05
Filing date: 2006-06-05
Publication date: 2007-12-13
Also published as: WO2007143624A2; CR10481A; WO2007143624A3; BRPI0712358A2; EP2023752A2; CA2654301A1; MX2008015491A

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 of FIG. 1.

FIG. 3 is a cross-sectional view of the oral appliance of FIG. 2 along lines 3-3.

FIG. 4 is a schematic diagram illustrating an embodiment of the oral appliance of FIG. 3.

FIG. 5 is a schematic diagram illustrating an embodiment of the housing of FIG. 4.

FIG. 6 is a schematic diagram illustrating an embodiment of storage locations within the memory of FIG. 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 to FIGS. 1-8. By way of example, FIG. 1 is a side view of the head 102 of a user that is using an oral appliance 100. As illustrated in the example embodiment, the oral appliance 100 comprises a palatal prosthetic that is shaped to closely contact the user's palate 104 (within the user's oral cavity). The oral appliance 100 is meant to be easily inserted, positioned and removed by a user of the oral appliance 100. As will be explained in greater detail below, oral appliance 100 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, the oral appliance 100 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 the oral appliance 100 and the user's palate.
The oral appliance 100 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 in FIG. 1 and briefly mentioned above, oral appliance 100 may be temporarily positioned within the oral cavity of patient 102 so that the oral appliance 100 is disposed under the patient's palate 104 and forms a palatal prosthetic.
Referring to FIGS. 2 & 3, the palatal prosthetic includes a portion 204 made from dental acrylic or other materials approved for such oral devices that extends below palate 104 to encapsulate a sensor or sensors, a recorder, a power source and a transceiver. As illustrated in FIG. 2, the palatal prosthetic is configured with extensions or contact surfaces. A first contact surface 205 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. A second contact surface 207 is arranged along the upper surface of the palatal prosthetic. The second contact surface 207 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, the second contact surface 207 is a quadrilateral with parallel sides adjacent to the front and rear of the palatal prosthetic. One or both of the first contact surface 205 and the second contact surface 207 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 the first contact surface 205 and second contact surface 207 can be constructed of flexible materials approved for use in an oral cavity.
As illustrated in the cross-sectional view of FIG. 3, the oral appliance 100 includes an upper surface 302 to be disposed under the patient's palate 104 when positioned in the oral cavity. In some embodiments, upper surface 302 (or portions thereof) may rest against the patient's palate 104. In other embodiments, upper surface 302 does not contact the patient's palate 104 but is securely and comfortably fixed under palate 104. The oral appliance 100 also includes a lower surface 304, which defines portion 204 that extends below palate 104 to define a prosthetic palate. Oral appliance 100 also comprises a dental attachment (e.g., dental wire 202—FIGS. 2 & 3), which may be used to securely fix the oral appliance 100 when it is positioned as desired within the oral cavity of user 102 as described above. It should be appreciated that the position, spatial orientation, etc. of dental wire 202 may be varied from that shown in FIGS. 2 & 3. Furthermore, additional dental attachments may be attached (e.g., integrally or otherwise) to dental wire 202. In alternative embodiments, dental wire 202 may be replaced with a more suitable dental attachment(s) based on a particular orthodontic configuration. Nonetheless, in the embodiment illustrated in FIGS. 2 & 3, dental wire 202 extends from the lateral sides of dental appliance 100.
FIG. 4 is a schematic diagram illustrating an embodiment of the oral appliance 100 of FIG. 3. As illustrated in the rear view of FIG. 4, the oral appliance 100 includes a housing 400 (shown with hidden lines) that forms an internal cavity 410 within the dental acrylic. As will be explained in greater detail below, housing 400 protects elements configured to periodically sense and record one or more environmental conditions surrounding the oral appliance 100 to identify to a reviewer of the recorded information the usage habits of the user 102 of oral device 100. In the embodiment illustrated in FIG. 4, housing 400 comprises a lower surface 402, an opposing upper surface 404, a right-side surface 406 and an opposing left-side surface 408. 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 a power source 520, a sensor 530 and a recorder 550 and transceiver 540 on an integrated circuit 510 within housing 400. In the illustrated embodiment, housing 400 entirely encompasses integrated circuit 510, power source 520, sensor 530, and antenna 560. In alternative embodiments (not shown), sensor 530 or other sensors such as sensor 580 may extend to or through a surface of housing 400 such that a portion of the sensor is exposed to the user's oral cavity.
As illustrated in FIG. 5, power source 520 is coupled and provides power to integrated circuit 510. Specifically, a positive terminal of power source 520 is electrically connected to a power input pin via conductor 512 and a negative terminal of power source 520 is electrically connected to a ground input pin via conductor 514.
Integrated circuit 510 includes recorder 550 and transceiver 540. Sensor 530 is coupled to recorder 550 via link 518. Sensor 580 is coupled to recorder 550 via link 524 and link 526. Sensor 580 encloses saliva and other liquids 581, which translate through membrane 585 from the user's oral cavity. Link 524 is coupled to measurement electrode 582. Link 526 is coupled to reference electrode 584. Transceiver 540 is coupled to recorder 550 via link 557. Transceiver 540 is coupled to antenna 560 via link 516. Transceiver 540 is also coupled to connector 570 via link 522. In the illustrated embodiment, connector 570 is protected from the user's oral cavity via cover 575. Cover 575 is arranged so that it can be removed when a technician desires to communicatively couple transceiver 540 via a wired connection to external communication devices and replaced when oral appliance 100 is returned to the user. Sensor 530 is responsive to temperature, motion or both. Sensor 580 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 sensor 580 (not shown) may be devised to place sensor 580 such that it can detect the presence of food and beverages in the patient's oral cavity. In these alternative arrangements, controller 552 can be configured to record measurements from sensor 580 when movement of the oral appliance consistent with chewing is detected.
Recorder 550 includes controller 552, memory 554 and timer 555. Controller 552 is coupled to memory 554 via bus 553. Controller 552 is further coupled to timer 556 via link 555.
Transceiver 540 includes encoder/decoder 542 and modulator/demodulator 544. Encoder/decoder 542 is coupled to modulator/demodulator 544 via bus 543.
In operation, a radio-frequency signal containing one or more commands from a suitably configured communication device is received via antenna 560 and a tuner (not shown). The received signal is forwarded to modulator/demodulator 544 via link 516. When the oral appliance 100 is coupled via a wired connection to a communication device (not shown), commands can be forwarded to modulator/demodulator 544 via connector 570 and link 522. Modulator/demodulator 544 detects and separates information from the received signal. The information is forwarded to encoder/decoder 542 via bus 543. Encoder/decoder 542 converts the received information to a format compatible with controller 552. Controller 552 responds in accordance with the one or more received commands. For example, an identifier set command includes a unique identifier that can be stored in memory 554, 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 instructs controller 552 to read and communicate each of the recorded measurements, a clear command directs controller 552 to remove recorded measurements from memory 554. A suitably configured communication device may send multiple commands when oral appliance 100 is within range (in a wireless data transfer mode) or directly coupled via connector 570 and link 522 (in a wired data transfer mode). It should be understood that antenna 560 and connector 570 as well as link 516 and link 522 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, controller 552 in accordance with periodic signals received via link 555 from timer 556 latches a current or a voltage provided by sensor 530.
In some embodiments, controller 552 is configured with an analog to digital converter, which generates a digital representation of the analog output from sensor 530. In these embodiments controller 552 simply forwards the latched and digitized measurement into the next available location within memory 554. In other embodiments, memory 554 is configured with calibration information, which is used to convert the recorded measurement to a scale. When the sensor 530 in these other embodiments is responsive to temperature, the scale may be degrees Fahrenheit or degrees Celsius. When the sensor 530 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). Sensor 580 as described above may produce relative voltages, the polarity and magnitude of which are indicative of the pH of the fluid 581. Regardless of the nature of sensor 530 and/or sensor 580, converted measurements are stored in the next available location within memory 554.
Memory 554 includes adequate storage locations to store measurements for an extended session. When the user 102 of oral appliance 100 fails to place the oral appliance 100 within signal range of a suitably configured communication device and controller 552 has forwarded a measurement to each available memory location within memory 554, subsequent measurements will be forwarded to and will overwrite measurement information in the same sequence as previous measurements were stored in memory 554. It should be understood that when oral appliance 100 is within range of a communication device measurements can be sent in near real-time from the oral appliance 100 to the communication device.
FIG. 6 is a schematic diagram illustrating an embodiment of storage locations within the memory 554 of FIG. 5. As shown in FIG. 6, memory 554 includes identifier store 610, start time store 620, interval store 630, and measurement store 640. As previously described, identifier store 610 is a designated memory location for a unique identifier for oral appliance 100. Start time store 620 is a designated memory location for a start time. Interval store 640 is a designated memory location for an interval or duration of time that controller 552 will wait between recording and storing an environmental parameter as determined by sensor 530. As further indicated in FIG. 6, measurement store 640 includes many designated memory locations, such as location 641, location 642, location 643 through to location 644 in a leftmost column of locations, through to location 645, the last location in a rightmost column of measurement store 640. It should be understood that each of the individual measurement locations could be arranged in other sequences separate and distinct from the sequence shown in FIG. 6.
FIG. 7 is a flow diagram illustrating an embodiment of a method 700 for confirming use of an oral appliance 100. In this regard, the functions associated with blocks 720 and 730 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, blocks 720 and 730 represent modules, segments, or portions of code, which comprise one or more executable instructions for implementing the specified function(s). Method 700 begins with block 710 where an oral appliance 100 is provided to a user 102. As described above, the provided oral appliance 100 is configured to record a measurement or measurements indicative of placement in the oral cavity of user 102. In preferred embodiments, oral appliance 100 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 in block 720, the oral appliance 100 is directed to transfer the measurement or measurements. As shown in block 730, the received information is analyzed to see if it confirms the user's usage (i.e., placement) of the oral appliance 100 in the oral cavity.
FIG. 8 is a flow diagram illustrating an alternative embodiment of a method 800 for confirming use of an oral appliance 100. 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 of method 800 can be embodied on a computer-readable medium.
Alternative method 800 begins with block 810 where a communication device is used to communicate with and configure oral appliance 100. In block 820, the configured oral appliance 100 is provided to a user. The user may be instructed at this or some other time to begin a scheduled or prescribed therapy by positioning oral appliance 100 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 the oral appliance 100 is configured to limit the volume of the oral cavity, as a weight loss aid, the oral appliance 100 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 of oral appliance 100 may require the user to show use through a significant portion of each day. When this is the case, the oral appliance 100 may be configured to measure and record one or more environmental parameters in intervals shorter than 5 minutes.
When the user 102 is in possession and is presumably using the oral appliance 100 in accordance with the prescribed or desired schedule, the oral appliance 100 is measuring and recording at least one environmental parameter every few minutes. The query of block 830 and wait block 835 are repeated until as indicated in query block 830, oral appliance 100 is communicatively coupled to a suitably configured communication device. When this is the case, as indicated by the flow control arrow labeled, “YES,” exiting block 830, method 800 continues with optional block 840, where the communication device communicates a command to the oral appliance 100 to transfer an identifier. The identifier associated with the oral appliance 100 may be an alphanumeric string unique to the particular oral appliance 100 presently in close proximity to the communication device. In alternative embodiments, the identifier may be a number or consist entirely of letters.
In block 850, the communication device directs the oral appliance 100 to transfer one or more measurements indicative of the user's use of the oral appliance 100 since it was first presented to the user and/or since the one or more measurements were transferred from the oral appliance 100. In block 860, 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,” exiting block 860, a wait function or step is performed as indicated in block 865. Thereafter, processing continues with the query of block 860 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,” exiting block 860, the communication device directs the oral appliance 100 to erase the stored measurements (in block 870). In block 880, 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 the oral appliance 100 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

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 of claim 1, wherein the sensor is sensitive to temperature.

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

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

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

6. The oral appliance of claim 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 of claim 1, wherein the sensor is sensitive to light.

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

9. The oral appliance of claim 8, further comprising:

a timer.

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

11. The oral appliance of claim 1, further comprising:

a controller.

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

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

14. The oral appliance of claim 1, further comprising:

a memory for storing the measurement at periodic intervals.

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

16. The oral appliance of claim 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 of claim 17, wherein the measurement comprises a temperature reading.

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

20. The method of claim 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 of claim 17, wherein directing the oral appliance to transfer the measurement comprises communicatively coupling the oral appliance to a communication device.

22. The method of claim 21, further comprising:

transmitting a command to the oral appliance.

23. The method of claim 21, further comprising:

providing the communication device to a medical professional.

24. The method of claim 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 of claim 17, wherein analyzing the measurement comprises communicating information to a computing device.

26. The method of claim 17, further comprising:

directing the oral appliance to transfer an identifier.

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

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

29. The method of claim 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 of claim 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 of claim 31, wherein the orthodontic appliance comprises a retainer.

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

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

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

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

37. The oral system of claim 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 of claim 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.