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.
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 10−7 moles 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
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.
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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.
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.