Biofeedback enabled oral therapy device

Abstract

Devices, methods, software, and kits are provided for performing oral therapy with biofeedback to provide real-time data for clinicians to aid in designing a customized therapy plan and track patient compliance with a prescribed therapy regimen. The device provides mouthpieces, which are capable of providing both passive and active range of motion for the jaw. Inclusion of a distance sensor on the device allows measurement of mandible range of motion or maximal interincisal opening. The force, applied to the upper jaw and lower jaw during oral therapy, can be controlled by inserting springs into the device, which have different spring constants. The force on the jaw can further be adjusted by using spring offset inserts. In addition, the maximum range of motion for the jaw can be set using interchangeable top limit brackets or a top limit bracket comprising an adjustable range of motion limiter.

Description

BIOFEEDBACK ENABLED ORAL THERAPY DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims benefit under 35 U.S.C. § 119(e) of provisional application 63 / 647,501 , filed May 14, 2024, which application is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTION

[0002] Trismus, commonly referred to as lockjaw, is a condition associated with restricted opening of the mouth (less than 35 mm maximum interincisal opening) and sustained tetanic spasms of the muscles of mastication. The tetanic spasms may occur in various muscles, including the jaw openers (depressors) such as the pterygoid lateralis and digastric muscles and the jaw closers (elevators) such as the pterygoid medialis, temporalis, masseter muscles. Causes include radiation, surgery, trauma and temporomandibular joint (TMJ) disorders. Head and neck cancers are a leading cause of trismus particularly for patients having cancer in the oral cavity. Greater than 38% of patients having head and neck cancer develop trismus as a result of radiation therapy. 80-90% of patients, who receive radiation therapy to the pterygoid or masseter muscles, develop trismus. Trismus may also have traumatic, inflammatory, infectious, congenital, neoplasm, odontogenic, iatrogenic, neurogenic, or psychogenic (conversion disorder) etiologies. In some cases, trismus is serious enough to significantly impair quality of life, including causing difficulties with speech, eating, and the ability to perform dental hygiene procedures.

[0003] Current therapies for treatment of trismus aim to help patients re-integrate into society and improve health-related quality of life issues, for example, to allow sharing meals in public, improve speech and facial contour, and help with performing oral hygiene and care. Several devices currently exist for use in therapy to increase jaw opening such as the Dynasplint® Trismus System (Dynasplint Systems, Inc., Severna Park, MD), OraStretch® Press Rehab System (CranioMandibular Rehab, Inc., Denver, CO), TheraBite® Jaw Motion Rehab System (ATOS Medical, Inc., Jersey City, NJ), JawClamp (jawclamp.com / ), E-Z Flex II TMJ Exerciser (CranioMandibular Rehab, Inc., Denver, CO), Engstrom Jaw Device, and TheraPacer Jaw Mobilizer - Oral Interface™ (CranioMandibular Rehab, Inc., Denver, CO). Alternatively, treatment can be performed with stacked tongue depressors held between the teeth to increase mouth opening over time.

[0004] The current devices have many shortcomings. Current systems modulate force by altering hand grip strength with no easy way to control the intensity of treatment. Lacking biofeedback, the devices increase the risk of injury to the jaw. Progress over time is tracked by measuring jaw openingin the office or at home, but there is no easy way to track patient compliance. The devices require at least 9 mm of mouth opening (with bite pads) to use, which may not be achievable for some patients and may require patients to pre-stretch with their fingers before using a device. The pads or mouthpieces of devices may have poor adaptability to individual mouth topographies, especially for patients who have large gaps in their teeth. Many current devices are expensive, and without insurance coverage, the cost is a barrier to treatment for some patients.

[0005] Thus, there remains a need for a therapy device for treating trismus and other oral disorders that is relatively inexpensive, adaptable to individual patients, and that can provide biofeedback to track compliance and optimize the amount of pressure exerted for mouth opening to achieve maximal benefit without causing damage to the jaw.SUMMARY OF THE INVENTION

[0006] Devices, methods, software, and kits are provided for performing oral therapy with biofeedback to provide real-time data for clinicians to aid in designing a customized therapy plan and track patient compliance with a prescribed therapy regimen as well as aid patients in achieving their therapy goals and tracking their progress. The device provides mouthpieces, which are capable of providing both passive and active range of motion for the jaw. Inclusion of a distance sensor on the device allows measurement of mandible range of motion or maximal interincisal opening. The force, applied to the upper jaw and lower jaw during oral therapy, can be controlled by inserting springs into the device, which have different spring constants. The force on the jaw can further be adjusted by using spring offset inserts. In addition, the maximum range of motion for the jaw can be set using interchangeable top limit brackets or a top limit bracket comprising an adjustable range of motion limiter.

[0007] In one aspect, a device is provided, the device comprising: a main rod; a compressible element; an upper mouthpiece; a lower mouthpiece; a guide rod; a main body comprising: i) a complementary receiving location for the lower mouthpiece, wherein the lower mouthpiece fits inside the complementary receiving location for the lower mouthpiece and is reversibly attached to the main body at the receiving location for the lower mouthpiece; ii) a first complementary receiving location for the main rod, wherein the bottom of the main rod fits inside the complementary receiving location for the main rod to attach the bottom of the main rod to the main body; and iii) a complementary receiving location for the guide rod, wherein the bottom of the guide rod fits inside the complementary receiving location for the guide rod to attach the bottom of the guide rod to the main body; a top piece comprising: i) a complementary receiving location for the upper mouthpiece, wherein the uppermouthpiece fits inside the complementary receiving location and is reversibly attached to the main body at the receiving location for the upper mouthpiece; and ii) a second complementary receiving location for the main rod, wherein the main rod fits inside the second complementary receiving location for the main rod to adjustably attach the main rod to the top piece, wherein the top piece is at a position above the main body, wherein the top piece is moveable along the main rod vertically to allow the top piece to slide along the vertical length of the main rod, wherein the compressible element extends along the main rod from the top piece to the main body, wherein compression of the compressible element lowers the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject, wherein the upper mouthpiece and the lower mouthpiece are aligned to allow the subject to bite the upper mouthpiece with upper teeth and the lower mouthpiece with lower teeth, wherein expansion or compression of the compressible element determines positioning of the upper mouthpiece relative to the lower mouthpiece and amount of force exerted on the upper jaw and the lower jaw when the subject bites the upper mouthpiece and the lower mouthpiece, and wherein the subject can increase interincisal opening to allow the compressible element to expand while biting the upper mouthpiece and lower mouthpiece to establish a desired spacing between the upper mouthpiece and the lower mouthpiece; and iii) a complementary receiving location for the guide rod, wherein the guide rod fits inside the complementary receiving location for the guide rod to attach the guide rod to the top piece; a top limit bracket that sets a limit on range of motion of the top piece, wherein the top limit bracket comprises: i) a complementary receiving location for the main rod, wherein the top of the main rod fits inside the complementary receiving location for the main rod to attach the top limit bracket to the top of the main rod at a position above the top piece; and ii) a complementary receiving location for the guide rod, wherein the top of the guide rod fits inside the complementary receiving location for the guide rod to attach the top limit bracket to the top of the guide rod; and a fastener, wherein the fastener fastens the top limit bracket to the top of the main rod.

[0008] In certain embodiments, the compressible element comprises a spring comprising a coil, wherein the main rod is inserted into the coil.

[0009] In certain embodiments, the compressible element comprises a gas. In some embodiments, the gas is air.

[0010] In certain embodiments, the device further comprises a distance sensor for tracking motion of the top piece relative to the main body. In some embodiments, the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, whereindistance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body. In some embodiments, the first sensor component is a magnet that generates a magnetic field, and the second sensor component is a hall sensor, wherein the distance between the hall sensor and the magnet is measured based on detection of the magnetic field generated by the magnet. In other embodiments, the distance sensor comprises a linear potentiometer connected to a resistive track by a wiper or an internal slider carrier, wherein the linear potentiometer measures vertical displacement of the top piece along the main rod. In some embodiments, the resistive track is positioned along the main rod, and the linear potentiometer is positioned on the top piece.

[0011] In certain embodiments, the device further comprises a mouthpiece integrated force sensor.

[0012] In certain embodiments, the main rod is linear.

[0013] In certain embodiments, the main rod is curved. In some embodiments, the spring is an arc spring. In some embodiments, the guide rod is curved.

[0014] In certain embodiments, the top limit bracket comprises an adjustable range of motion limiter. In other embodiments, the top limit bracket can be exchanged for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.

[0015] In certain embodiments, the device further comprises a spring offset insert and a spring well, wherein the spring offset insert is positioned at the bottom of the spring well below the spring, wherein the spring offset insert increases compression of the spring when the top piece is lowered compared to when the spring offset insert is absent from the spring well, wherein the spring force exerted on the upper jaw and the lower jaw depends on the length of the spring offset insert and the spring constant of the spring.

[0016] In certain embodiments, the spring offset insert can be exchanged for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.

[0017] In certain embodiments, the spring can be exchanged for another spring having a different length, spring constant, or spring force.

[0018] In certain embodiments, the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

[0019] In certain embodiments, the upper mouthpiece and the lower mouthpiece are custom designed to fit mouth geometry of the subject.

[0020] In certain embodiments, the upper mouthpiece and the lower mouthpiece are custom designed to exercise a specific area of the mouth of the subject. In some embodiments, the upper mouthpiece and the lower mouthpiece engage all or some of the front teeth. In some embodiments, the upper mouthpiece and the lower mouthpiece further engage all or some of the molars.

[0021] In certain embodiments, the upper mouthpiece can be removed and exchanged for an upper mouthpiece of a different size or designed to exercise a different area of the mouth.

[0022] In certain embodiments, the lower mouthpiece can be removed and exchanged for a lower mouthpiece of a different size or designed to exercise a different area of the mouth.

[0023] In certain embodiments, the upper mouthpiece and the lower mouthpiece are available in different sizes to fit mouths of different sizes. In some embodiments, the upper mouthpiece and the lower mouthpiece are available in mouth sizes for an adult, adolescent, or child.

[0024] In certain embodiments, the main body is flared.

[0025] In certain embodiments, the spring comprises a metal. Exemplary metals include, without limitation, steel, bronze, or titanium.

[0026] In certain embodiments, the guide rod is positioned between the main rod and the upper and lower mouthpieces. In other embodiments, the guide rod is positioned between the main rod and the distance sensor.

[0027] In certain embodiments, the fastener is a screw, and the top of the main rod further comprises a nut insert, wherein the top limit bracket is attached to the top of the main rod by screwing the screw into the nut insert. In some embodiments, the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.

[0028] In certain embodiments, the complementary receiving location for the upper mouthpiece further comprises a nut insert, wherein a screw is used to attach the upper mouthpiece to the top piece by screwing the screw into the nut insert in the complementary receiving location for the upper mouthpiece. In some embodiments, the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.

[0029] In certain embodiments, the complementary receiving location for the lower mouthpiece further comprises a nut insert, wherein a screw is used to attach the lower mouthpiece to the main body by screwing the screw into the nut insert in the complementary receiving location for the lower mouthpiece. In some embodiments, the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.

[0030] In certain embodiments, the device further comprises an external data receiving device in communication with the distance sensor, wherein the external data receiving device stores data fromthe distance sensor. In some embodiments, the external data receiving device is connected to the distance sensor by a wire or wirelessly. In some embodiments, the distance sensor further comprises a first wireless communication unit, and the external data receiving device further comprises a second wireless communication unit in communication with the first wireless communication unit. In some embodiments, the first wireless communication unit utilizes a wireless communication protocol using an electromagnetic carrier wave or ultrasound to transfer data from the distance sensor to the external data receiving device using the second wireless communication unit. In some embodiments, the electromagnetic carrier wave is a radio wave, microwave, or an infrared carrier wave.

[0031] In certain embodiments, the external data receiving device further comprises a processor programmed to perform a computer-implemented method for monitoring oral therapy of the subject, the computer performing steps comprising: receiving data from the distance sensor of the device each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy, wherein the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, wherein distance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body; and displaying the distance between the first distance sensor component and the second distance sensor component that is measured by the distance sensor. In certain embodiments, the computer- implemented further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor. In certain embodiments, the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.

[0032] In certain embodiments, the device comprises a bio-compatible and dishwasher-safe or autoclavable resin or plastic. In some embodiments, the resin or plastic is compatible with three- dimensional (3D)-printing of the device. In some embodiments, the resin or plastic comprises a methacrylic acid ester. In some embodiments, the resin or plastic is a photoreactive resin or plastic.

[0033] In certain embodiments, the device comprises a metal. In some embodiments, the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

[0034] In certain embodiments, the device further comprises a measuring element on the main rod, wherein the measuring element can be used to measure distance between the upper mouthpiece and the lower mouthpiece. In some embodiments, the measuring element is an embossed ruler onan exterior surface of the main rod. In some embodiments, the measuring element is calibrated to zero at the position of the lower mouthpiece. In some embodiments, the measuring element measures the distance in millimeters.

[0035] In another aspect, a method of performing oral therapy using a device, described herein, is provided, the method comprising: lowering the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece sufficiently to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject; inserting the upper mouthpiece and the lower mouthpiece into the mouth of the subject, wherein upper teeth of the subject are located on a portion of the upper mouthpiece, and lower teeth of the subject are located on a portion of the lower mouthpiece when the subject bites the upper mouthpiece and the lower mouthpiece; and performing oral therapy exercises, wherein i) the subject opens the mouth wide enough to establish a desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a target mandible range of motion or interincisal opening for the subject, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during opening of the mouth, wherein the compressible element expands and exerts a force on the upper jaw and the lower jaw, ii) the subject holds the mouth open at the desired spacing between the upper mouthpiece and the lower mouthpiece for a selected period of time; and iii) the subject closes the mouth, wherein compression of the compressible element results in lowering of the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece.

[0036] In certain embodiments, the subject has an oral disorder that restricts jaw opening, weakens orofacial muscles, impairs biting or chewing, or any combination thereof. In some embodiments, the oral disorder is trismus.

[0037] In certain embodiments, the method further comprises removing the device from the subject’s mouth.

[0038] In certain embodiments, the method further comprises repeating the oral therapy exercises a selected number of times.

[0039] In certain embodiments, the subject performs further oral therapy exercises, wherein the subject opens the mouth wide enough to establish a second desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a second target mandible range of motion or maximal interincisal opening for the subject, wherein the second desired spacing is greater than the first desired spacing, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during said opening of the subject’s mouth, wherein the spring expands and exerts aspring force on the upper jaw and the lower jaw, and wherein the subject holds the mouth open at the second desired spacing between the upper mouthpiece and the lower mouthpiece for a second selected period of time. In some embodiments, the method is repeated, wherein each time the subject opens the mouth wider to establish a desired spacing between the upper mouthpiece and the lower mouthpiece that is greater than the previous desired spacing. In some embodiments, the method is repeated until the desired spacing is at a maximum obtainable for the subject.

[0040] In certain embodiments, the thickness of the top limit bracket is selected based on the target mandible range of motion or maximal interincisal opening for the subject.

[0041] In certain embodiments, the method further comprises exchanging the spring offset insert for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.

[0042] In certain embodiments, the method further comprises exchanging the top limit bracket for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.

[0043] In certain embodiments, the method further comprises exchanging the spring for another spring having a different length or spring constant.

[0044] In certain embodiments, the method is repeated, each time exchanging the spring in the device for another spring having a greater spring force prior to performing the method until the maximum tolerable spring force is reached.

[0045] In certain embodiments, the method is repeated, each time exchanging the spring offset insert in the device for another spring offset insert having a greater length prior to performing the method until the maximum tolerable spring force is reached.

[0046] In certain embodiments, the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

[0047] In certain embodiments, the method is repeated at a frequency prescribed by a medical practitioner.

[0048] In another aspect, a kit comprising a device for performing oral therapy, as described herein, and instructions for performing oral therapy with the device are provided. In some embodiments, the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

[0049] In another aspect, a computer-implemented method for monitoring oral therapy of a subject is provided, the computer performing steps comprising: receiving data from the distance sensor ofthe device each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance measured by the distance sensor.

[0050] In certain embodiments, the computer-implemented further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.

[0051] In certain embodiments, the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying the amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.

[0052] In certain embodiments, the computer-implemented method further comprises using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.

[0053] In certain embodiments, the computer-implemented method further comprises using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.

[0054] In certain embodiments, the computer-implemented method further comprises determining frequency of use of the device by the subject in order to monitor compliance of the subject with a prescribed regimen for performing the oral therapy.

[0055] In certain embodiments, the computer-implemented method further comprises: calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.

[0056] In certain embodiments, the computer-implemented method further comprises: measuring the mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; and displaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.

[0057] In certain embodiments, the computer-implemented method further comprises displaying difference between a target mandible range of motion or target maximal interincisal opening for the subject and the measured mandible range of motion or maximal interincisal opening at a selected time point.

[0058] In certain embodiments, the computer-implemented method further comprises displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.

[0059] In certain embodiments, the computer-implemented method further comprises displaying difference between a target spring force and the spring force used at a selected time point.

[0060] In certain embodiments, the computer-implemented method further comprises displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.

[0061] In certain embodiments, the computer-implemented method further comprises displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw and a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.

[0062] In certain embodiments, the computer-implemented method further comprises: displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribed oral therapy regimen to the subject after the information is entered by the clinician.

[0063] In certain embodiments, the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises.

[0064] In certain embodiments, the clinician can edit the information to change the prescribed oral therapy regimen.

[0065] In certain embodiments, the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.

[0066] In certain embodiments, the computer-implemented method further comprises displaying the measured interincisal opening when the subject bites the upper and lower mouthpieces of the device, the length of time the subject keeps mouth open at a target interincisal opening, number of repetitions of the oral therapy exercises, total length of time the subject performs a prescribed oral therapy regimen, or any combination thereof.

[0067] In certain embodiments, the computer-implemented method further comprises displaying a timer that provides visual feedback on the amount of time the subject is keeping mouth open at a target interincisal opening and / or provides an audio alert when the subject has kept mouth open atthe target interincisal opening for a selected amount of time. In some embodiments, the timer further shows the length of time a subject has been performing a prescribed oral therapy regimen.

[0068] In certain embodiments, the computer-implemented method further comprises: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.

[0069] In certain embodiments, the computer-implemented method further comprises displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject. In some embodiments, the calendar further tracks when the oral therapy exercises are completed by the subject.

[0070] In certain embodiments, the computer-implemented method further comprises sending a notification reminding the subject to perform oral therapy exercises at a selected time. In some embodiments, the notification is an audio or visual push notification to a mobile device application or a desktop computer application. In some embodiments, the notification is an email, a text message, or an alarm providing an audio alert.

[0071] In certain embodiments, the computer-implemented method further comprises displaying a user interface presenting a questionnaire configured to receive input from the subject regarding selfreported results of using the oral therapy device.

[0072] In certain embodiments, the questionnaire comprises a Gothenberg Trismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.

[0073] In another aspect, a non-transitory computer-readable medium is provided, the non-transitory computer-readable medium comprising program instructions that, when executed by a processor in a computer, causes the processor to perform a computer-implemented described herein.

[0074] In another aspect, a kit comprising the non-transitory computer-readable medium, described herein, and instructions for performing oral therapy is provided.

[0075] In another aspect, a system is provided, the system comprising: a device for performing oral therapy, as described herein; a processor; a display component; and a data storage component. In certain embodiments, the processor is programmed to perform a computer-implemented method, described herein, for monitoring oral therapy of a subject using the device.BRIEF DESCRIPTION OF THE DRAWINGS

[0076] FIGS. 1A-1 B. Initial design of the device for oral therapy. FIG. 1A shows the device with the upper mouthpiece raised. FIG. 1 B shows the device with the upper mouthpiece lowered. The device easily disassembles and allows force to be controlled by inserting springs with different spring constants. The force at opening can further be adjusted by using spring offset inserts. The maximum range of motion can be set using interchangeable top limit brackets. The range of motion and other exercise data can be obtained through a hall effect sensor and magnet or a linear potentiometerbased system.

[0077] FIG. 2. Schematic of an exemplary device for oral therapy.

[0078] FIG. 3. Spring offset inserts. By sliding a spring offset insert into the spring well, the spring becomes further compressed at the closed position. This allows the initial force at opening to be gradually increased or reduced depending on progression of treatment. Through combining a small set of offset inserts and springs with a range of spring constants, it is possible to finely tune the force exerted. The same effect could be achieved by threading the base of the slider rod in the spring well and using a threaded nut offset or similar mechanical system.

[0079] FIGS. 4A-4B. Top limit brackets. FIG. 4A shows a top limit bracket that provides for a smaller range of motion compared to that shown in FIG. 4B. The top limit brackets limit the maximum range of motion and are easily interchangeable. The limit can be increased as the condition improves.

[0080] FIGS. 5A-5B. Interchangeable mouthpieces. FIG. 5A shows a larger mouthpiece, which can engage more teeth including the molars. FIG. 5B shows a more compact mouthpiece, which can engage the front teeth. The mouthpieces are easily interchangeable (e.g., remove hex screws). The mouthpieces may be custom-designed for patient-specific mouth geometry (e.g., derived from a scan etc.) or to exercise specific areas of the mouth.

[0081] FIGS. 6A-6B. Hall effect sensor-based motion tracking. FIG. 6A shows a side view of the device with the Hall effect sensor. FIG. 6B shows a top view of the device with the Hall effect sensor. The Hall effect sensor, embedded in the top piece, transduces the magnetic field produced by the magnet embedded in the main body into an electrical signal. Because spring constant (and length of any spring offset insert used) is known, the force being exerted at any point during exercise is easily calculated by the software. This provides an inexpensive sensing option that allows all electronics to be contained in the top piece.

[0082] FIG. 7. Hall effect motion tracking block diagram.

[0083] FIG. 8. Linear potentiometer-based motion tracking. Alternatively, an embedded linear potentiometer can be used to accomplish motion tracking.

[0084] FIG. 9. Schematic of device using linear potentiometer-based motion tracking.

[0085] FIG. 10. Embedded linear potentiometer block diagram.

[0086] FIGS. 11A-11 B. Alternate design variant of the device with curved path of travel that more closely mimics the natural movement of the jaw. FIG. 11 A shows the device with the upper mouthpiece lowered. FIG. 11 B shows the device with the upper mouthpiece raised. The version of the device allows force to be applied perpendicularly to the mandible and maxilla through the full range of motion of the jaw. All previously discussed components (interchangeable top limit brackets and spring offset inserts), as well as sensing modalities (hall effect sensing and embedded linear potentiometer) can also be used in this alternate design variant.

[0087] FIG. 12. Schematic of an exemplary device with the curved path design.

[0088] FIGS. 13A-13C. show strategy for use of a device for trismus therapy using biofeedback from a distance sensor to provide real-time data for clinicians to aid in customization of the device and the trismus therapy regimen. Custom software is used with the device to track frequency and intensity of trismus therapy, patient adherence to a prescribed therapy regimen, and improvement in trismus measurements over time. FIG. 13A shows an overview of the process of patient selection, customization of the device for performing trismus therapy, including choice of mouthpieces with the possibility of using custom mouthpieces adapted to individual mouth topographies, adjusting distance between the upper and lower mouthpieces, and adjusting the magnitude of spring force, customization of the trismus therapy plan, and patient evaluation of progress. FIG. 13B shows the process of customization of the trismus therapy plan using biofeedback to monitor maximal interincisal opening (MIO), spring force tolerance, frequency and intensity of trismus therapy, and compliance with a prescribed therapy plan. FIG. 13C shows device data biofeedback, which informs patients on their progress and aids clinical therapy decisions for clinicians.

[0089] FIG. 14. Schematic of an exemplary device with an adjustable range of motion limiter.

[0090] FIGS. 15A-15D. Images of a subject using a prototype device with software tracking number of repetitions and range of motion with visual feedback and a timer to monitor stretch time. FIG. 15A shows the subject using the device to perform oral exercises with his mouth closed at stretch time = 0. FIG. 15B shows the subject using the device to perform oral exercises with his mouth open. The software provides visual feedback, wherein the vertical height of a marker shows the degree of mouth opening and that mouth opening has reached a selected threshold (represented as a horizontal line). A timer shows that the subject has kept his mouth open for a stretch time = 1 .20 seconds. FIG. 15C shows the subject using the device to perform hand exercises with his hand closed at stretch time = 0. FIG. 15D shows the subject using the device to perform hand exercises with his hand open. Thesoftware provides visual feedback showing that hand opening has reached a selected threshold and the subject has kept his hand open for a stretch time = 1 .80 seconds.DETAILED DESCRIPTION OF THE INVENTION

[0091] Devices, methods, software, and kits are provided for performing oral therapy with biofeedback to provide real-time data for clinicians to aid in designing a customized therapy plan and track patient compliance with a prescribed therapy regimen and results of oral therapy with use of the device. The device provides adaptable and low-profile mouthpieces, which are capable of providing both passive and active range of motion for the jaw. Inclusion of a distance sensor on the device allows measurement of mandible range of motion or maximal interincisal opening. A computer-implemented method is also provided, which can be used with the device sensor to provide biofeedback, including tracking frequency and intensity of oral therapy, patient adherence to a prescribed therapy regimen, and improvement in trismus measurements over time.

[0092] Before the present devices, methods, software, and kits are described, it is to be understood that this invention is not limited to the particular devices, methods, software, and kits described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0093] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0094] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications arecited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[0095] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[0096] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a sensor" includes a plurality of such sensors and reference to "the device" includes reference to one or more devices and equivalents thereof, known to those skilled in the art, and so forth.

[0097] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.Definitions

[0098] The term "about," particularly in reference to a given quantity, is meant to encompass deviations of plus or minus five percent.

[0099] The term “compressible element” refers to a material or component that decreases in volume when a pressure or force is applied.

[0100] The term “oral disorder” refers to any disease or condition that restricts jaw opening, weakens orofacial muscles, and / or impairs biting or chewing. Oral disorders include, but are not limited to, trismus, a stroke, traumatic brain injury, infection (e.g., tetanus, an abscess, or dental infection), or facial burn causing orofacial muscle weakness or jaw restriction, temporomandibular joint arthritis, scleroderma, myositis, dystonia, oromandibular dystonia, Parkinson’s disease, multiple sclerosis, myotonic dystrophy, stiff person syndrome, post-surgical scarring causing jaw restriction, Botox toxicity, a temporomandibular joint disorder, fibrosis, spasm, bruxism, myofascial pain syndrome, micrognathia, spinal muscular atrophy, psychogenic trismus, wound healing in a facial area that causes soft tissue restriction for motion, trigeminal neuralgia, glossopharyngeal neuralgia, Moebius syndrome, myotonic dystrophy, juvenile idiopathic arthritis of the temporomandibular joint (TMJ),congenital TMJ ankylosis, Pierre Robin sequence, down syndrome, autism spectrum disorder, Rett syndrome, cerebral palsy, and muscular dystrophy (e.g., Duchenne muscular dystrophy, Becker muscular dystrophy).

[0101] The term “hand disorder” refers to any disease or condition that weakens hand muscles or grip strength. Hand disorders include, but are not limited to, carpal tunnel syndrome, cubital tunnel syndrome, tendinitis, peripheral neuropathy, arthritis (e.g., rheumatoid arthritis, osteoarthritis, psoriatic arthritis), gout, camptodactyly, Parkinson's disease, multiple sclerosis, and Guillain-Barre syndrome.

[0102] The terms “individual”, “subject”, “recipient”, and “patient” are used interchangeably herein and refer to any mammalian subject for whom diagnosis, treatment, or therapy is desired, particularly humans.

[0103] The term “user” as used herein refers to a person that uses a device disclosed herein for performing one or more steps of the presently disclosed methods for performing oral therapy. The user may be a patient undergoing oral therapy or a health care practitioner, such as the patient’s physician or a clinician assisting with the oral therapy.

[0104] The term “trismus” refers to a bilateral restriction in mouth opening with a maximal interincisal opening (MIO) of 35 mm or less. Trismus may be associated with reduced mandible mobility, sustained tetanic spasm of the muscles of mastication, and difficulty in opening the jaw. Patients with trismus may be further classified as having mild trismus (e.g. 20-35 mm interincisal opening), moderate trismus (e.g., 10-20 mm interincisal opening) or severe trismus (e.g., less than 10 mm interincisal opening). Trismus may be caused by radiation, surgery, trauma, or temporomandibular joint (TMJ) disorders. Intra-articular causes of trismus include, but are not limited to, internal derangement of TMJ / meniscus displacement, fractured mandibular condyle or intracapsular fracture, TMJ dislocation, traumatic synovitis, septic arthritis, osteoarthritis, inflammatory arthritis (e.g. rheumatoid or psoriatic), ankylosis, and osteophyte formation. Extra-articular causes of trismus include, but are not limited to, trauma not involving the mandibular condyle (e.g., a fracture of another part of the mandible, fractures of the middle third of the facial skeleton, fractures of the zygoma or zygomatic arch), post surgical edema, e.g., removal of impacted lower wisdom teeth, or other dentoalveolar surgery, recent prolonged dental treatment (e.g., root canal therapy), following administration of inferior alveolar nerve block with local anesthetic (medial pterygoid), hematoma of medial pterygoid, acute infections of the oral tissues, especially involving the buccal space or muscles of mastication, odontogenic infection, peritonsillar abscess, acute parotitis, e.g., mumps, pericoronitis, submasseteric abscess, tetanus, tetany, local malignancy, myofascialpain / temporomandibular joint dysfunction, radiation fibrosis, fibrosis from burns, submucous fibrosis, systemic sclerosis, myositis ossificans, coronoid hyperplasia, malignant hyperpyrexia, epidermolysis bullosa, drug associated dyskinesia, psychotic disturbances, and hysteria. In some cases, trismus is a complication of radiotherapy or chemotherapy for treatment of cancer and is a common complication of treatment of head and neck cancers.

[0105] The term “maximal interincisal opening” or “MIO” is the distance between the central incisors when the mouth is fully open.

[0106] The term “range of motion” or “ROM” refers to the maximum distance the mandible moves.

[0107] The terms "connected" or "coupled" are used in an operational sense and are not necessarily limited to a direct connection or coupling. For example, two devices or components may be coupled directly, or via one or more intermediary media or devices. As another example, devices may be coupled in such a way that information or data can be passed between them, while not sharing any physical connection with one another. In some cases, two devices or components may be connected by a wire or wirelessly to each other.Devices for Performing Oral Therapy

[0108] Devices are provided for performing oral therapy with biofeedback to provide real-time data for clinicians to aid in designing a customized therapy plan and track patient progress and compliance with a prescribed therapy regimen. The device provides mouthpieces, which are capable of providing both passive and active range of motion for the jaw. Inclusion of a distance sensor on the device allows measurement of mandible range of motion or maximal interincisal opening. The force, applied to the upper jaw and lower jaw during oral therapy, can be controlled by inserting springs into the device, which have different spring constants. The force on the jaw can further be adjusted by using spring offset inserts. In addition, the maximum range of motion for the jaw can be set using interchangeable top limit brackets or a top limit bracket comprising an adjustable range of motion limiter. Range of motion and other exercise data can be obtained through a hall effect sensor and magnet or linear potentiometer-based system.

[0109] In an exemplary embodiment, illustrated in FIGS. 1 A-1 B and FIG. 2, the device for performing oral therapy comprises: a main rod, a spring comprising a coil, wherein the main rod is inserted into the coil, an upper mouthpiece, a lower mouthpiece, a guide rod, a main body, a top piece, a top limit bracket, and a fastener. The main body comprises: i) a complementary receiving location for the lower mouthpiece, wherein the lower mouthpiece fits inside the complementary receiving location and is reversibly attached to the main body at the receiving location for the lower mouthpiece; ii) aspring well, wherein the bottom of the main rod fits inside the spring well to attach the bottom of the main rod to the main body; and iii) a complementary receiving location for the guide rod, wherein the bottom of the guide rod fits inside the complementary receiving location for the guide rod to attach the bottom of the guide rod to the main body. The top piece is at a position above the main body and comprises: a complementary receiving location for the upper mouthpiece, wherein the upper mouthpiece fits inside the complementary receiving location and is reversibly attached to the main body at the receiving location for the upper mouthpiece; and a complementary receiving location for the main rod, wherein the main rod fits inside the complementary receiving location for the main rod to adjustably attach the main rod to the top piece. The top piece is moveable along the main rod vertically to allow the top piece to slide along the vertical length of the main rod. The spring extends along the main rod from the top piece to the main body, wherein compression of the spring lowers the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject. The upper mouthpiece and the lower mouthpiece are aligned to allow the subject to bite the upper mouthpiece with upper teeth and the lower mouthpiece with lower teeth, wherein expansion or compression of the spring determines positioning of the upper mouthpiece relative to the lower mouthpiece and the amount of spring force exerted on the upper jaw and the lower jaw. The subject can increase interincisal opening, while biting the upper mouthpiece and lower mouthpiece, to cause the spring to expand until a desired spacing between the upper mouthpiece and the lower mouthpiece is established. The top piece also includes a complementary receiving location for the guide rod, wherein the guide rod fits inside the complementary receiving location to attach the guide rod to the top piece. The top limit bracket sets a limit on the range of motion of the top piece, and comprises: i) a complementary receiving location for the main rod, wherein the top of the main rod fits inside the complementary receiving location for the main rod to attach the top limit bracket to the top of the main rod at a position above the top piece; and ii) a complementary receiving location for the guide rod, wherein the top of the guide rod fits inside the complementary receiving location for the guide rod to attach the top limit bracket to the top of the guide rod. The top limit bracket can be exchanged for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece. Alternatively, the top limit bracket may comprise an adjustable range of motion limiter, as illustrated in FIG. 14. The device also includes a fastener that fastens the top limit bracket to the top of the main rod. In certain embodiments, the fastener is a screw, and the top of the main rod further comprises a nut insert, wherein the top limit bracket is attached to the top of the main rod by screwing the screw into the nutinsert. In some embodiments, the screw used to fasten the top limit bracket to the top of the main rod is a hexagonal screw, a thumb screw, or a flat head slotted screw.

[0110] The exemplary embodiment, illustrated in FIGS. 1 A-1 B and FIG. 2 shows a device in which the main rod is linear. However, in some embodiments, the main rod is curved as illustrated in FIGS. 11 A-11 B and FIG. 12. In embodiments, wherein the main rod is curved, the device may have a curved spring such as an arc spring, and the guide rod may also be curved.

[0111] In certain embodiments, the device further comprises a spring offset insert, wherein the spring offset insert is positioned at the bottom of the spring well below the spring, wherein the spring offset insert increases compression of the spring when the top piece is lowered compared to when the spring offset insert is absent from the spring well, wherein the spring force exerted on the upper jaw and the lower jaw depends on the length of the spring offset insert and the spring constant of the spring. The spring offset insert can be exchanged for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw. Alternatively or additionally, the spring can be exchanged for another spring having a different length or spring constant to change the spring force exerted on the upper jaw and the lower jaw. Spring force can be gradually increased or reduced in the device depending on progression of treatment. Combining a set of offset inserts of different lengths and springs with a range of spring constants, it is possible to finely tune the force exerted on the jaw of a patient during oral therapy. In certain embodiments, the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

[0112] In an alternative embodiment, the device comprises a compressible element comprising a gas instead of a spring. The compressible element may comprise any suitable compressible gas, but preferably the gas is non-toxic and non-flammable. In some embodiments, the compressible element comprises air, nitrogen, carbon dioxide, oxygen, neon, or argon. The compressible element extends along the main rod from the top piece to the main body, wherein compression of the gas lowers the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject. Expansion or compression of the gas determines positioning of the upper mouthpiece relative to the lower mouthpiece and the amount of force or pressure exerted on the upper jaw and the lower jaw when the subject bites the upper mouthpiece and the lower mouthpiece. The subject can increase interincisal opening to allow the compressibleelement to expand while biting the upper mouthpiece and lower mouthpiece to establish a desired spacing between the upper mouthpiece and the lower mouthpiece.

[0113] In certain embodiments, the device further comprises a distance sensor for tracking motion of the top piece relative to the main body. In some embodiments, the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, wherein distance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body. FIGS. 6 and 7 illustrate an exemplary embodiment in which the first sensor component is a magnet that generates a magnetic field, and the second sensor component is a hall sensor, wherein the distance between the hall sensor and the magnet is measured based on detection of the magnetic field generated by the magnet.

[0114] In another exemplary embodiment, shown in FIGS. 8 and 9, the device comprises a distance sensor comprising a linear potentiometer connected to a resistive track by a wiper or an internal slider carrier, wherein the linear potentiometer measures vertical displacement of the top piece along the main rod. In some embodiments, the resistive track is positioned along the main rod, and the linear potentiometer is positioned on the top piece.

[0115] In certain embodiments, a set of interchangeable mouthpieces may be used with the device. The complementary receiving location for the upper mouthpiece in the top piece may comprise a nut insert, wherein a screw is used to attach the upper mouthpiece to the top piece by screwing the screw into the nut insert. Likewise, the complementary receiving location for the lower mouthpiece in the main body may comprise a nut insert, wherein a screw is used to attach the lower mouthpiece to the main body by screwing the screw into the nut insert. Exemplary screws that may be used for attaching the mouthpieces include, without limitation, hexagonal screws, thumb screws, and flat head slotted screws. The screws can be unscrewed to remove the upper and lower mouthpieces from the device to exchange them for other mouthpieces.

[0116] The upper mouthpiece and the lower mouthpiece can be custom designed to fit the mouth geometry of a particular individual or custom designed to exercise a specific area of the mouth. For example, a mouthpiece may engage all or some of the front teeth and / or all or some of the molars. In certain embodiments, the upper mouthpiece and / or the lower mouthpiece can be removed and exchanged for an upper mouthpiece and / or lower mouthpiece of a different size or designed to exercise a different area of the mouth. In certain embodiments, the upper mouthpiece and the lower mouthpiece are available in different sizes to fit mouths of different sizes or geometries or subjects of different ages (e.g., adult, adolescent, or child).

[0117] In certain embodiments, the device further comprises an external data receiving device in communication with the distance sensor, wherein the external data receiving device stores data from the distance sensor. In some embodiments, the external data receiving device is connected to the distance sensor by a wire or wirelessly. In some embodiments, the distance sensor further comprises a first wireless communication unit, and the external data receiving device further comprises a second wireless communication unit in communication with the first wireless communication unit. In some embodiments, the first wireless communication unit utilizes a wireless communication protocol using an electromagnetic carrier wave or ultrasound to transfer data from the distance sensor to the external data receiving device using the second wireless communication unit. In some embodiments, the electromagnetic carrier wave is a radio wave (e.g., Bluetooth), microwave, or an infrared carrier wave. In certain embodiments, the external data receiving device further comprises a processor programmed to perform a computer-implemented method for monitoring oral therapy of the subject and providing biofeedback, as described further below.

[0118] In certain embodiments, the device for performing oral therapy is composed of a biocompatible resin or plastic. In some embodiments, the resin or plastic is compatible with three- dimensional (3 D)-printing of the device. For example, resins comprising a photoreactive methacrylic acid ester such as BioMed Clear from Formlabs (Somerville, MA) or other suitable resins can be used in 3D-printing of the device. Various 3D printing systems may be used in manufacturing the devices, including digital light processing (DLP), liquid crystal display (LCD), and stereolithography (SLA), selective laser sintering (SLS), and other laser-based 3D printing systems, among others. The devices can be produced relatively inexpensively in this manner (see Examples). Alternatively, the device may be composed of a metal such as, but not limited to stainless steel, carbon steel, titanium, a titanium alloy, or aluminum.Methods of Performing Therapy

[0119] The devices described herein can be used for treating any type of disorder that restricts jaw opening, weakens orofacial muscles, and / or impairs biting or chewing. Such disorders include, but are not limited to, trismus, stroke, traumatic brain injury, infection (e.g., tetanus, an abscess, or dental infection), or facial burn causing orofacial muscle weakness or jaw restriction, temporomandibular joint arthritis, scleroderma, myositis, dystonia, oromandibular dystonia, Parkinson’s disease, multiple sclerosis, myotonic dystrophy, stiff person syndrome, post-surgical scarring causing jaw restriction, Botox toxicity, a temporomandibular joint disorder, fibrosis, spasm, bruxism, myofascial pain syndrome, micrognathia, spinal muscular atrophy, psychogenic trismus, wound healing in a facialarea that causes soft tissue restriction for motion, trigeminal neuralgia, glossopharyngeal neuralgia, Moebius syndrome, myotonic dystrophy, juvenile idiopathic arthritis of the temporomandibular joint (TMJ), congenital TMJ ankylosis, Pierre Robin sequence, down syndrome, autism spectrum disorder, Rett syndrome, cerebral palsy, and muscular dystrophy (e.g., Duchenne muscular dystrophy, Becker muscular dystrophy).

[0120] Oral therapy may be performed with a device by lowering the top piece along the main rod vertically to decrease the spacing between the upper mouthpiece and the lower mouthpiece sufficiently to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject. The upper mouthpiece and the lower mouthpiece are inserted into the mouth of the subject such that upper teeth of the subject are located on a portion of the upper mouthpiece, and lower teeth of the subject are located on a portion of the lower mouthpiece when the subject bites the upper mouthpiece and the lower mouthpiece. During performance of oral therapy exercises with the device, the subject opens the mouth wide enough to establish a desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a target mandible range of motion or interincisal opening for the subject while continuing to bite the upper mouthpiece and the lower mouthpiece. During mouth opening, the compressible element (e.g., spring or gas) expands and exerts a force on the upper jaw and the lower jaw. The subject may hold the mouth open at a desired spacing between the upper mouthpiece and the lower mouthpiece for a selected period of time (i.e., stretch time) and then close the mouth and compress the compressible element to lower the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece.

[0121] In certain embodiments, the subject performs further oral therapy exercises, wherein the subject opens the mouth wide enough to establish a second desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a second target mandible range of motion or maximal interincisal opening for the subject, wherein the second desired spacing is greater than the first desired spacing, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during said opening of the subject’s mouth, wherein the compressible element (e.g., spring or gas) expands and exerts a force on the upper jaw and the lower jaw, and wherein the subject holds the mouth open at the second desired spacing between the upper mouthpiece and the lower mouthpiece for a second selected period of time. In some embodiments, the method is repeated, wherein each time the subject opens the mouth wider to establish a desired spacing between the upper mouthpiece and the lower mouthpiece that is greater than the previous desiredspacing. In some embodiments, the method is repeated until the desired spacing is at a maximum obtainable for the subject.

[0122] In certain embodiments, the thickness of the top limit bracket is selected based on a target mandible range of motion or maximal interincisal opening for the subject. In some embodiments, the method further comprises exchanging the top limit bracket for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece. In some embodiments, the top limit bracket comprises an adjustable range of motion limiter that is adjusted to change the limit on the range of motion of the top piece.

[0123] In certain embodiments, the method further comprises exchanging the spring offset insert for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw. In certain embodiments, the method is repeated, each time exchanging the spring offset insert in the device for another spring offset insert having a greater length prior to performing the method until the maximum tolerable spring force is reached. Alternatively or additionally, the spring in the device can be exchanged for another spring having a different length or spring constant to adjust the spring force exerted on the upper and lower jaw. In certain embodiments, the method is repeated, each time exchanging the spring in the device for another spring having a greater spring force prior to performing the method until the maximum tolerable spring force is reached. In certain embodiments, the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

[0124] The therapy exercise may be repeated a selected number of times followed by removal of the device from the subject’s mouth. In certain embodiments, a particular oral therapy regimen is performed with the device at a frequency prescribed by a medical practitioner.

[0125] Alternatively or additionally, the devices described herein can be used for performing hand therapy or measuring grip strength. The method comprises: (a) positioning fingers of the right hand on top of the right side of the top piece and positioning the thumb of the right hand underneath the right side of the main body; (b) positioning fingers of the left hand on top of the left side of the top piece and positioning the thumb of the left hand underneath the left side of the main body; (c) closing the right hand and the left hand to squeeze the top piece and the main body together, wherein compression of the compressible element (e.g., spring or gas) results in lowering of the top piece along the main rod vertically to decrease spacing between the top piece and the main body; (d) opening the right hand and the left hand, wherein expansion of the compressible element results in rising of the top piece along the main rod vertically to increase spacing between the top piece andthe main body; and (e) repeating (c) - (d). In some embodiments, the method further comprises using a force sensor on the device to measure grip strength of the subject.

[0126] In some embodiments, the device is used to treat a hand disorder. By “hand disorder” is meant any disease or condition that weakens hand muscles or grip strength. Such hand disorders include, but are not limited to, carpal tunnel syndrome, cubital tunnel syndrome, tendinitis, peripheral neuropathy, arthritis (e.g., rheumatoid arthritis, osteoarthritis, psoriatic arthritis), gout, camptodactyly, Parkinson's disease, multiple sclerosis, and Guillain-Barre syndrome. In some embodiments, the device is used to increase grip strength or strengthen muscles in the hand.System and Computer-implemented Methods

[0127] Systems and computer-implemented methods are also provided, which can be used with the device to provide biofeedback, including tracking frequency and intensity of oral therapy, patient adherence to a prescribed therapy regimen, and improvement in trismus measurements over time.

[0128] In some embodiments, a system is provided comprising a processor programmed for monitoring oral therapy of a subject using a device described herein. The processor can be programmed to perform steps of a computer-implemented method comprising: receiving data from a distance sensor of the device each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance measured by the distance sensor. In some embodiments, the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, wherein distance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body. In some embodiments, the first sensor component is a magnet that generates a magnetic field, and the second sensor component is a hall sensor, wherein the distance between the hall sensor and the magnet is measured based on detection of the magnetic field generated by the magnet. In other embodiments, the distance sensor comprises a linear potentiometer connected to a resistive track by a wiper or an internal slider carrier, wherein the linear potentiometer measures vertical displacement of the top piece along the main rod. In some embodiments, the resistive track is positioned along the main rod, and the linear potentiometer is positioned on the top piece.

[0129] In certain embodiments, the computer-implemented further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.

[0130] In certain embodiments, the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying the amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.

[0131] In certain embodiments, the computer-implemented method further comprises determining frequency of use of the device by the subject in order to monitor compliance of the subject with a prescribed regimen for performing the oral therapy.

[0132] In certain embodiments, the computer-implemented method further comprises calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.

[0133] In certain embodiments, the computer-implemented method further comprises measuring the mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; and displaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.

[0134] In certain embodiments, the computer-implemented method further comprises displaying the difference between a target mandible range of motion or target maximal interincisal opening for the subject and the measured mandible range of motion or maximal interincisal opening at a selected time point.

[0135] In certain embodiments, the computer-implemented method further comprises displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.

[0136] In certain embodiments, the computer-implemented method further comprises displaying the difference between a target spring force and the spring force used at a selected time point.

[0137] In certain embodiments, the computer-implemented method further comprises displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.

[0138] In certain embodiments, the computer-implemented method further comprises displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw and a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.

[0139] In certain embodiments, the computer-implemented method further comprises displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribedoral therapy regimen to the subject after the information is entered by the clinician. In some embodiments, the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises. In some embodiments, the clinician can edit the information to change the prescribed oral therapy regimen. In some embodiments, the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.

[0140] In certain embodiments, the computer-implemented method further comprises displaying the measured interincisal opening when the subject bites the upper and lower mouthpieces of the device, the length of time the subject keeps mouth open at a target interincisal opening, number of repetitions of the oral therapy exercises, total length of time the subject performs a prescribed oral therapy regimen, or any combination thereof.

[0141] In certain embodiments, the computer-implemented method further comprises displaying a timer that provides visual feedback on the amount of time the subject is keeping the mouth open at a target interincisal opening and / or provides an audio alert when the subject has kept the mouth open at the target interincisal opening for a selected amount of time. In some embodiments, the timer further shows the length of time a subject has been performing a prescribed oral therapy regimen.

[0142] In certain embodiments, the computer-implemented method further comprises: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.

[0143] In certain embodiments, the computer-implemented method further comprises displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject. In some embodiments, the calendar further tracks when the oral therapy exercises are completed by the subject.

[0144] In certain embodiments, the computer-implemented method further comprises sending a notification reminding the subject to perform oral therapy exercises at a selected time. In some embodiments, the notification is an audio or visual push notification to a mobile device application or a desktop computer application. In some embodiments, the notification is an email, a text message, or an alarm providing an audio alert.

[0145] In certain embodiments, the computer-implemented method further comprises displaying a user interface presenting a questionnaire configured to receive input from the subject regarding selfreported results of using the oral therapy device. In some embodiments, the questionnaire comprises a Gothenberg Trismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.

[0146] In certain embodiments, the computer-implemented method further comprises using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.

[0147] In certain embodiments, the computer-implemented method further comprises using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.

[0148] In certain embodiments, the computer-implemented method further comprises storing the data that is acquired for the subject in a database.

[0149] The methods can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware. The disclosed and other embodiments can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer readable medium for execution by, or to control the operation of, a data processing apparatus. The computer readable medium can be a machine-readable storage device, a machine- readable storage substrate, a memory device, a composition of matter effecting a machine-readable propagated signal, or any combination thereof.

[0150] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.

[0151] In a further aspect, the system for performing the computer-implemented method, as described, may include a processor, a storage component (i.e., memory), a display component, andother components typically present in general purpose computers. In some embodiments, the processor is provided by a computer or handheld device (e.g., a cell phone or tablet). The storage component stores information accessible by the processor, including instructions that may be executed by the processor and data that may be retrieved, manipulated or stored by the processor.

[0152] The storage component includes instructions. For example, the storage component includes instructions for monitoring oral therapy and providing biofeedback to a subject using a device, described herein, for oral therapy stored therein according to the methods described herein. The computer processor is coupled to the storage component and configured to execute the instructions stored in the storage component in order to receive the inputted distance sensor data and analyze the distance sensor data according to a computer-implemented method described herein.

[0153] In some embodiments, the computer processor and / or storage component are coupled to a distance sensor of the device for performing oral therapy through a wired or wireless connection. Wireless communication may be provided by electromagnetic (e.g., radiofrequency (such as Bluetooth), microwave, or infrared carrier wave) or ultrasound links to the device. In some embodiments, an external data receiving device is connected to the distance sensor by a wire or wirelessly. In some embodiments, the distance sensor further comprises a first wireless communication unit, and the external data receiving device further comprises a second wireless communication unit in communication with the first wireless communication unit. In some embodiments, the first wireless communication unit utilizes a wireless communication protocol using an electromagnetic carrier wave or ultrasound to transfer data from the distance sensor to the external data receiving device using the second wireless communication unit. In some embodiments, the electromagnetic carrier wave is a radio wave (e.g., a Bluetooth connection), microwave, or an infrared carrier wave.

[0154] The processor and / or memory may be operably connected to a display device, for example, via a wired, such as a Universal Serial Bus (USB) connection, or wireless connection, such as a Bluetooth connection. Any convenient display device, such as a liquid crystal display (LCD), lightemitting diode (LED) display, plasma (PDP) display, quantum dot (QLED) display or cathode ray tube display device may be used. The display component may display visual biofeedback to a subject using a device for oral therapy. For example, the display may display one or more of the following: interincisal opening when the subject bites the upper and lower mouthpieces of the device, the length of time the subject keeps mouth open at a target interincisal opening, number of repetitions of oral therapy exercises, and / or the total length of time the subject performs a prescribed oral therapy regimen. The display may further display a timer to provide visual feedback on the amount of timethe subject is keeping the mouth open at a target interincisal opening. Alternatively or additionally, an audio alert may be provided when the subject has kept the mouth open at a target interincisal opening for a selected amount of time. A displayed timer may also be used to show the length of time a subject has been performing a prescribed oral therapy regimen. The display may also display a pressure marker to provide visual biofeedback to the subject on the amount of pressure exerted on the lower jaw and upper jaw to allow the subject to see if the pressure is within an acceptable range. The display may further display guidance regarding whether the spring should be exchanged for a spring with a different spring constant or the spring offset insert should be exchanged for a spring offset with a different length to adjust the amount of spring force exerted on the jaw.

[0155] The storage component may be of any type capable of storing information accessible by the processor, such as a hard-drive, memory card, ROM, RAM, DVD, CD-ROM, USB Flash drive, write- capable, and read-only memories. The processor may be a general purpose processor, a graphics processor unit, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor can also include primarily analog components. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a graphics processor unit, a mainframe computer, a digital signal processor, a portable computing device, a personal organizer, a device controller, and a computational engine within an appliance, to name a few.

[0156] The steps of a method, process, or algorithm described in connection with the embodiments disclosed herein can be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module, engine, and associated databases can reside in memory resources such as in RAM memory, FRAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium, media, or physical computer storage known in the art. An exemplary storage medium can be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In thealternative, the storage medium can be integral to the processor. The processor and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal. In the alternative, the processor and the storage medium can reside as discrete components in a user terminal.

[0157] The instructions may be any set of instructions to be executed directly (such as machine code) or indirectly (such as scripts) by the processor. In that regard, the terms "instructions," "steps" and "programs" may be used interchangeably herein. The instructions may be stored in object code form for direct processing by the processor, or in any other computer language including scripts or collections of independent source code modules that are interpreted on demand or compiled in advance.

[0158] Data may be retrieved, stored or modified by the processor in accordance with the instructions. For instance, although the system is not limited by any particular data structure, the data may be stored in computer registers, in a relational database as a table having a plurality of different fields and records, XML documents, or flat files. The data may also be formatted in any computer-readable format such as, but not limited to, binary values, ASCII or Unicode. Moreover, the data may comprise any information sufficient to identify the relevant information, such as numbers, descriptive text, proprietary codes, pointers, references to data stored in other memories (including other network locations) or information which is used by a function to calculate the relevant data.

[0159] In certain embodiments, the processor and storage component may comprise multiple processors and storage components that may or may not be stored within the same physical housing. For example, some of the instructions and data may be stored on removable CD-ROM and others within a read-only computer chip. Some or all of the instructions and data may be stored in a location physically remote from, yet still accessible by, the processor. Similarly, the processor may comprise a collection of processors which may or may not operate in parallel.

[0160] In some embodiments, the method can be performed using a cloud computing system. In these embodiments, the distance sensor data, acquired for a subject during oral therapy, and the programming can be exported to a cloud computer, which runs the program, and returns an output to the user.Kits

[0161] Any of the devices for performing oral therapy or the software designed to be used with the device to provide biofeedback, as described herein, may be provided in a kit. The kit may also include packaging that includes a compartment, e.g., a sterile compartment, for holding the device. Thepackaging may be any suitable packaging for holding the device. Examples of packaging and methods of packaging are described in, e.g., U.S. Pat. Nos. 3,755,042, 4,482,053, 4,750,619; U.S. App. Pub. Nos. 20050268573, 20100133133, each of which are incorporated herein by reference.

[0162] In addition to the above components, the subject kits may further include (in certain embodiments) instructions for using the device and software for performing oral therapy. These instructions may be present in the subject kits in a variety of forms, one or more of which may be present in the kit. One form in which these instructions may be present is as printed information on a suitable medium or substrate, e.g., a piece or pieces of paper on which the information is printed, in the packaging of the kit, in a package insert, and the like. Yet another form of these instructions is a computer readable medium, e.g., diskette, compact disk (CD), flash drive, and the like, on which the information has been recorded. Yet another form of these instructions that may be present is a website address which may be used via the internet to access the information at a removed site.Utility

[0163] The devices and software described herein are useful for performing oral therapy. The devices and software can be used for performing therapy for any condition that causes a bilateral restriction in mouth opening, weakens orofacial muscles, and / or impairs biting or chewing. Such disorders include, but are not limited to, trismus, stroke, traumatic brain injury, infection (e.g., tetanus, an abscess, or dental infection), or facial burn causing orofacial muscle weakness or jaw restriction, temporomandibular joint arthritis, scleroderma, myositis, dystonia, oromandibular dystonia, Parkinson’s disease, multiple sclerosis, myotonic dystrophy, stiff person syndrome, post-surgical scarring causing jaw restriction, Botox toxicity, a temporomandibular joint disorder, fibrosis, spasm, bruxism, myofascial pain syndrome, micrognathia, spinal muscular atrophy, psychogenic trismus, wound healing in a facial area that causes soft tissue restriction for motion, trigeminal neuralgia, glossopharyngeal neuralgia, Moebius syndrome, myotonic dystrophy, juvenile idiopathic arthritis of the temporomandibular joint (TMJ), congenital TMJ ankylosis, Pierre Robin sequence, down syndrome, autism spectrum disorder, Rett syndrome, cerebral palsy, and muscular dystrophy (e.g., Duchenne muscular dystrophy, Becker muscular dystrophy).

[0164] In particular, the devices and software are useful for performing therapy for trismus caused by radiation, surgery, trauma, or temporomandibular joint (TMJ) disorders. Intra-articular causes of trismus include, but are not limited to, internal derangement of TMJ / meniscus displacement, fractured mandibular condyle or intracapsular fracture, TMJ dislocation, traumatic synovitis, septic arthritis, osteoarthritis, inflammatory arthritis (e.g. rheumatoid or psoriatic), ankylosis, and osteophyteformation. Extra-articular causes of trismus include, but are not limited to, trauma not involving the mandibular condyle (e.g., a fracture of another part of the mandible, fractures of the middle third of the facial skeleton, fractures of the zygoma or zygomatic arch), post surgical edema, e.g., removal of impacted lower wisdom teeth, or other dentoalveolar surgery, recent prolonged dental treatment (e.g., root canal therapy), following administration of inferior alveolar nerve block with local anesthetic (medial pterygoid), hematoma of medial pterygoid, acute infections of the oral tissues, especially involving the buccal space or muscles of mastication, odontogenic infection, peritonsillar abscess, acute parotitis, e.g., mumps, pericoronitis, submasseteric abscess, tetanus, tetany, local malignancy, myofascial pain / temporomandibular joint dysfunction, radiation fibrosis, fibrosis from burns, submucous fibrosis, systemic sclerosis, myositis ossificans, coronoid hyperplasia, malignant hyperpyrexia, epidermolysis bullosa, drug associated dyskinesia, psychotic disturbances, and hysteria. In some cases, trismus is a complication of radiotherapy or chemotherapy for treatment of cancer and is a common complication of treatment of head and neck cancers.

[0165] Alternatively or additionally, the devices described herein can be used for performing hand therapy or measuring grip strength. In some embodiments, the device is used to increase grip strength or strengthen hand muscles. In some embodiments, the device is used to treat a hand disorder such as, but not limited to, carpal tunnel syndrome, cubital tunnel syndrome, tendinitis, peripheral neuropathy, arthritis (e.g., rheumatoid arthritis, osteoarthritis, psoriatic arthritis), gout, camptodactyly, Parkinson's disease, multiple sclerosis, or Guillain-Barre syndrome.Examples of Non-Limiting Aspects of the Disclosure

[0166] Aspects, including embodiments, of the present subject matter described above may be beneficial alone or in combination, with one or more other aspects or embodiments. Without limiting the foregoing description, certain non-limiting aspects of the disclosure numbered 1 -137 are provided below. As will be apparent to those of skill in the art upon reading this disclosure, each of the individually numbered aspects may be used or combined with any of the preceding or following individually numbered aspects. This is intended to provide support for all such combinations of aspects and is not limited to combinations of aspects explicitly provided below.1. A device comprising: a main rod; a compressible element; an upper mouthpiece;a lower mouthpiece; a guide rod; a main body comprising: i) a complementary receiving location for the lower mouthpiece, wherein the lower mouthpiece fits inside the complementary receiving location for the lower mouthpiece and is reversibly attached to the main body at the receiving location for the lower mouthpiece; ii) a first complementary receiving location for the main rod, wherein the bottom of the main rod fits inside the complementary receiving location for the main rod to attach the bottom of the main rod to the main body; and iii) a complementary receiving location for the guide rod, wherein the bottom of the guide rod fits inside the complementary receiving location for the guide rod to attach the bottom of the guide rod to the main body; a top piece comprising: i) a complementary receiving location for the upper mouthpiece, wherein the upper mouthpiece fits inside the complementary receiving location and is reversibly attached to the main body at the receiving location for the upper mouthpiece; and ii) a second complementary receiving location for the main rod, wherein the main rod fits inside the second complementary receiving location for the main rod to adjustably attach the main rod to the top piece, wherein the top piece is at a position above the main body, wherein the top piece is moveable along the main rod vertically to allow the top piece to slide along the vertical length of the main rod, wherein the compressible element extends along the main rod from the top piece to the main body, wherein compression of the compressible element lowers the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject, wherein the upper mouthpiece and the lower mouthpiece are aligned to allow the subject to bite the upper mouthpiece with upper teeth and the lower mouthpiece with lower teeth, wherein expansion or compression of the compressible element determines positioning of the upper mouthpiece relative to the lower mouthpiece and amount of force exerted on the upper jaw and the lower jaw when the subject bites the upper mouthpiece and the lower mouthpiece, and wherein the subject can increase interincisal opening to allowthe compressible element to expand while biting the upper mouthpiece and lower mouthpiece to establish a desired spacing between the upper mouthpiece and the lower mouthpiece; and iii) a complementary receiving location for the guide rod, wherein the guide rod fits inside the complementary receiving location for the guide rod to attach the guide rod to the top piece; a top limit bracket that sets a limit on range of motion of the top piece, wherein the top limit bracket comprises: i) a complementary receiving location for the main rod, wherein the top of the main rod fits inside the complementary receiving location for the main rod to attach the top limit bracket to the top of the main rod at a position above the top piece; and ii) a complementary receiving location for the guide rod, wherein the top of the guide rod fits inside the complementary receiving location for the guide rod to attach the top limit bracket to the top of the guide rod; and a fastener, wherein the fastener fastens the top limit bracket to the top of the main rod.2. The device of aspect 1 , wherein the compressible element comprises a spring comprising a coil, wherein the main rod is inserted into the coil.3. The device of aspect 2, wherein the spring can be exchanged for another spring having a different length, spring constant, or spring force.4. The device of aspect 3, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.5. The device of any one of aspects 2-4, further comprising a spring offset insert and a spring well, wherein the spring offset insert is positioned at the bottom of the spring well below the spring, wherein the spring offset insert increases compression of the spring when the top piece is lowered compared to when the spring offset insert is absent from the spring well, wherein the spring force exerted on the upper jaw and the lower jaw depends on the length of the spring offset insert and the spring constant of the spring.6. The device of aspect 5, wherein the spring offset insert can be exchanged for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.7. The device of any one of aspects 2-6, wherein the spring comprises a metal.8. The device of aspect 7, wherein the metal is steel, bronze, or titanium.9. The device of aspect 1 , wherein the compressible element comprises a gas, optionally wherein the gas is air.10. The device of any one of aspects 1 -9, further comprising a distance sensor for tracking motion of the top piece relative to the main body.11. The device of aspect 10, wherein the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, wherein distance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body.12. The device of aspect 11 , wherein the first sensor component is a magnet that generates a magnetic field, and wherein the second sensor component is a hall sensor, wherein the distance between the hall sensor and the magnet is measured based on detection of the magnetic field generated by the magnet.13. The device of aspect 10, wherein the distance sensor comprises a linear potentiometer connected to a resistive track by a wiper or an internal slider carrier, wherein the linear potentiometer measures vertical displacement of the top piece along the main rod.14. The device of aspect 13, wherein the resistive track is positioned along the main rod, and wherein the linear potentiometer is positioned on the top piece.15. The device of any one of aspects 10-14, further comprising an external data receiving device in communication with the distance sensor, wherein the external data receiving device stores data from the distance sensor.16. The device of aspect 15, wherein the external data receiving device is connected to the distance sensor by a wire or wirelessly.17. The device of aspect 16, wherein the distance sensor further comprises a first wireless communication unit, and wherein the external data receiving device further comprises a second wireless communication unit in communication with the first wireless communication unit.18. The device of aspect 17, wherein the first wireless communication unit utilizes a wireless communication protocol using an electromagnetic carrier wave or ultrasound to transfer data from the distance sensor to the external data receiving device using the second wireless communication unit.19. The device of aspect 18, wherein the electromagnetic carrier wave is a radio wave, microwave, or an infrared carrier wave.20. The device of any one of aspects 1-19, further comprising a mouthpiece integrated force sensor.21 . The device of any one of aspects 1 -20, wherein the main rod is linear.22. The device of any one of aspects 1 -20, wherein the main rod is curved.23. The device of aspect 22, wherein the compressible element is an arc spring.24. The device of aspect 22 or 23, wherein the guide rod is curved.25. The device of any one of aspects 1 -24, wherein the top limit bracket comprises an adjustable range of motion limiter, or wherein the top limit bracket can be exchanged for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.26. The device of any one of aspects 1 -25, wherein the upper mouthpiece and the lower mouthpiece are custom designed to fit mouth geometry of the subject.27. The device of any one of aspects 1 -26, wherein the upper mouthpiece and the lower mouthpiece are custom designed to exercise a specific area of the mouth of the subject.28. The device of aspect 27, wherein the upper mouthpiece and the lower mouthpiece engage all or some of the front teeth.29. The device of aspect 28, wherein the upper mouthpiece and the lower mouthpiece further engage all or some of the molars.30. The device of any one of aspects 1 -29, wherein the upper mouthpiece can be removed and exchanged for an upper mouthpiece of a different size or designed to exercise a different area of the mouth.31 . The device of any one of aspects 1 -30, wherein the lower mouthpiece can be removed and exchanged for a lower mouthpiece of a different size or designed to exercise a different area of the mouth.32. The device of any one of aspects 1 -31 , wherein the upper mouthpiece and the lower mouthpiece are available in different sizes to fit mouths of different sizes.33. The device of aspect 32, wherein the upper mouthpiece and the lower mouthpiece are available in mouth sizes for an adult, adolescent, or child.34. The device of any one of aspects 1 -33, wherein the main body is flared.35. The device of any one of aspects 1 -34, wherein the guide rod is positioned between the main rod and the upper and lower mouthpieces.36. The device of any one of aspects 1 -34, wherein the guide rod is positioned between the main rod and the distance sensor.37. The device of any one of aspects 1 -36, wherein the fastener is a screw, and wherein the top of the main rod further comprises a nut insert, wherein the top limit bracket is attached to the top of the main rod by screwing the screw into the nut insert.38. The device of aspect 37, wherein the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.39. The device of any one of aspects 1 -38, wherein the complementary receiving location for the upper mouthpiece further comprises a nut insert, wherein a screw is used to attach the upper mouthpiece to the top piece by screwing the screw into the nut insert in the complementary receiving location for the upper mouthpiece.40. The device of any one of aspects 1 -39, wherein the complementary receiving location for the lower mouthpiece further comprises a nut insert, wherein a screw is used to attach the lower mouthpiece to the main body by screwing the screw into the nut insert in the complementary receiving location for the lower mouthpiece.41 . The device of aspect 39 or 40, wherein the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.42. The device of any one of aspects 1 -41 , wherein the device comprises a biocompatible and dishwasher-safe or autoclavable resin or plastic.43. The device of aspect 42, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device.44. The device of aspect 42 or 43, wherein the resin or plastic comprises a methacrylic acid ester.45. The device of any one of aspects 42-44, wherein the resin or plastic is a photoreactive resin or plastic.46. The device of any one of aspects 1 -41 , wherein the device comprises a metal.47. The device of aspect 46, wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.48. The device of any one of aspects 1-47, further comprising a measuring element on the main rod, wherein the measuring element can be used to measure distance between the upper mouthpiece and the lower mouthpiece.49. The device of aspect 48, wherein the measuring element is an embossed ruler on an exterior surface of the main rod.50. The device of aspect 48 or 49 wherein the measuring element is calibrated to zero at the position of the lower mouthpiece.51 . The device of any one of aspects 48-50, wherein the measuring element measures the distance in millimeters.52. A method of performing oral therapy with the device of any one of aspects 1 -51 , the method comprising: lowering the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece sufficiently to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject; inserting the upper mouthpiece and the lower mouthpiece into the mouth of the subject, wherein upper teeth of the subject are located on a portion of the upper mouthpiece, and lower teeth of the subject are located on a portion of the lower mouthpiece when the subject bites the upper mouthpiece and the lower mouthpiece; and performing oral therapy exercises, wherein i) the subject opens the mouth wide enough to establish a desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a target mandible range of motion or interincisal opening for the subject, wherein the subject continuesto bite the upper mouthpiece and the lower mouthpiece during opening of the mouth, wherein the compressible element expands and exerts a force on the upper jaw and the lower jaw, ii) the subject holds the mouth open at the desired spacing between the upper mouthpiece and the lower mouthpiece for a selected period of time; and iii) the subject closes the mouth, wherein compression of the compressible element results in lowering of the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece.53. The method of aspect 52, wherein the subject has an oral disorder that restricts jaw opening, weakens orofacial muscles, impairs biting or chewing, or any combination thereof.54. The method of aspect 52, wherein the oral disorder is trismus.55. The method of any one of aspects 52-54, further comprising removing the device from the subject’s mouth.56. The method of any one of aspects 52-55, further comprising repeating said performing the oral therapy exercises a selected number of times.57. The method of any one of aspects 52-56, wherein the subject performs further oral therapy exercises, wherein the subject opens the mouth wide enough to establish a second desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a second target mandible range of motion or maximal interincisal opening for the subject, wherein the second desired spacing is greater than the first desired spacing, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during said opening of the subject’s mouth, wherein the spring expands and exerts a spring force on the upper jaw and the lower jaw, and wherein the subject holds the mouth open at the second desired spacing between the upper mouthpiece and the lower mouthpiece for a second selected period of time.58. The method of aspect 57, wherein the method is repeated, wherein each time the subject opens the mouth wider to establish a desired spacing between the upper mouthpiece and the lower mouthpiece that is greater than the previous desired spacing.59. The method of aspect 58, wherein the method is repeated until the desired spacing is at a maximum obtainable for the subject.60. The method of any one of aspects 52-59, wherein thickness of the top limit bracket is selected based on the target mandible range of motion or maximal interincisal opening for the subject.61 . The method of any one of aspects 52-60, further comprising exchanging the spring offset insert for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.62. The method of any one of aspects 52-61 , further comprising exchanging the top limit bracket for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.63. The method of any one of aspects 52-62, further comprising exchanging the spring for another spring having a different length or spring constant.64. The method of any one of aspects 52-63, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.65. The method of any one of aspects 52-64, wherein the method is repeated, each time exchanging the spring in the device for another spring having a greater spring force prior to performing the method until the maximum tolerable spring force is reached.66. The method of any one of aspects 52-65, wherein the method is repeated, each time exchanging the spring offset insert in the device for another spring offset insert having a greater length prior to performing the method until the maximum tolerable spring force is reached.67. The method of any one of aspects 52-66, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.68. The method of any one of aspects 52-67, wherein the method is repeated at a frequency prescribed by a medical practitioner.69. A kit comprising the device of any one of aspects 1 -51 and instructions for performing oral therapy with the device.70. The kit of aspect 69, wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.71. A computer-implemented method for monitoring oral therapy of a subject, the computer performing steps comprising: receiving data from the distance sensor of the device of any one of aspects 10-51 each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance measured by the distance sensor.72. The computer-implemented method of aspect 71 , wherein the computer-implemented method further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.73. The computer-implemented method of aspect 72, wherein the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.74. The computer-implemented method of any one of aspects 71 -73, further comprising determining frequency of use of the device by the subject.75. The computer-implemented method of any one of aspects 71-74, further comprising:calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.76. The computer-implemented method of any one of aspects 71-75, further comprising: measuring mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; and displaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.77. The computer-implemented method of aspect 76, further comprising displaying difference between a target mandible range of motion or target maximal interincisal opening for the subject and a measured mandible range of motion or maximal interincisal opening at a selected time point.78. The computer-implemented method of aspect 76 or 77, further comprising displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.79. The computer-implemented method of any one of aspects 71 -78, further comprising displaying difference between a target spring force and the spring force used at a selected time point.80. The computer-implemented method of any one of aspects 71 -79, further comprising displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.81 . The computer-implemented method of any one of aspects 71 -80, further comprising displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw; and further displaying a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.82. The computer-implemented method of any one of aspects 71-81 , further comprising:displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribed oral therapy regimen to the subject after the information is entered by the clinician.83. The computer-implemented method of aspect 82, wherein the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises.84. The computer-implemented method of aspect 82 or 83, wherein the clinician can edit the information to change the prescribed oral therapy regimen.85. The computer-implemented method of aspect 84, wherein the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.86. The computer-implemented method of any one of aspects 71 -85, further comprising displaying the measured interincisal opening when the subject bites the upper and lower mouthpieces of the device, length of time the subject holds the mouth open at the target interincisal opening, the number of repetitions of the oral therapy exercises, total length of time the subject performs the prescribed oral therapy regimen, or any combination thereof.87. The computer-implemented method of any one of aspects 71 -86, further comprising displaying a timer that provides visual feedback on the amount of time the subject holds mouth open at a target interincisal opening and / or provides an audio alert when the subject has held mouth open at the target interincisal opening for a selected amount of time.88. The computer-implemented method of aspect 87, wherein the timer further shows the total length of time the subject has been performing the prescribed oral therapy regimen.89. The computer-implemented method of any one of aspects 71-88, further comprising: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.90. The computer-implemented method of any one of aspects 71 -89, further comprising displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject.91 . The computer-implemented method of aspect 90, wherein the calendar further tracks when the oral therapy exercises are completed by the subject.92. The computer-implemented method of any one of aspects 71 -91 , further comprising sending a notification reminding the subject to perform oral therapy exercises at a selected time.93. The computer-implemented method of aspect 92 wherein the notification is an audio or visual push notification to a mobile device application or a desktop computer application.94. The computer-implemented method of aspect 92 or 93, wherein the notification is an email, a text message, or an alarm providing an audio alert.95. The computer-implemented method of any one of aspects 71 -94, further comprising displaying a user interface presenting a questionnaire configured to receive input from the subject regarding self-reported results of using the oral therapy device.96. The computer-implemented method of aspect 95, wherein the questionnaire comprises a Gothenberg Trismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.97. The computer-implemented method of any one of aspects 71 -96, further comprising using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.98. The computer-implemented method of any one of aspects 71 -97, further comprising using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.99. The computer-implemented method of any one of aspects 71 -98, wherein the distance sensor data and / or force sensor data are stored in a cloud data storage system.100. The computer-implemented method of aspect 99, wherein the cloud data storage system is a public cloud storage system or a private cloud storage system.101. A non-transitory computer-readable medium comprising program instructions that, when executed by a processor in a computer, causes the processor to perform the method of any one of aspects 71 -100.102. A kit comprising the non-transitory computer-readable medium of aspect 101 and instructions for performing oral therapy.103. A system comprising : the device of any one of aspects 1 -51 ; a processor; a display component; and a data storage component.104. The system of aspect 103, wherein the processor is programmed to perform a computer-implemented method for monitoring oral therapy of a subject using the device, the computer performing steps comprising: receiving data from the distance sensor of the device of any one of aspects 1 1 -51 each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance between the first distance sensor component and the second distance sensor component that is measured by the distance sensor.105. The system of aspect 104, wherein the computer-implemented method further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.106. The system of aspect 105, wherein the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.107. The system of any one of aspects 103-106, wherein the computer-implemented method further comprises determining frequency of use of the device by the subject.108. The system of any one of aspects 103-107, wherein the computer-implemented method further comprises: calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.109. The system of any one of aspects 103-108, wherein the computer-implemented method further comprises: measuring mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; and displaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.110. The system of aspect 109, wherein the computer-implemented method further comprises displaying difference between a target mandible range of motion or target maximal interincisal opening for the subject and the measured mandible range of motion or maximal interincisal opening at a selected time point.11 1. The system of aspect 109 or 110, wherein the computer-implemented method further comprises displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.112. The system of any one of aspects 103-111 , wherein the computer-implemented method further comprises displaying difference between a target spring force and the spring force used at a selected time point.113. The system of aspect 1 12, wherein the computer-implemented method further comprises displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.114. The system of any one of aspects 103-113, wherein the computer-implemented method further comprises displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw; and further displaying a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.115. The system of any one of aspects 103-114, wherein the computer-implemented method further comprises displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribed oral therapy regimen to the subject after the information is entered by the clinician.116. The system of aspect 115, wherein the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises.117. The system of aspect 116, wherein the clinician can edit the information to change the prescribed oral therapy regimen.118. The system of aspect 117, wherein the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.119. The system of any one of aspects 103-118, wherein the computer-implemented method further comprises displaying interincisal opening when the subject bites the upper and lower mouthpieces of the device, length of time the subject holds the mouth open at the target interincisal opening, the number of repetitions of the oral therapy exercises, total length of time the subject performs the prescribed oral therapy regimen, or any combination thereof.120. The system of any one of aspects 103-119, wherein the computer-implemented method further comprises displaying a timer that provides visual feedback on the amount of time the subject holds mouth open at a target interincisal opening and / or provides an audio alert when the subject has held mouth open at the target interincisal opening for a selected amount of time.121. The system of aspect 120, wherein the timer further shows the total length of time the subject has been performing the prescribed oral therapy regimen.122. The system of any one of aspects 103-121 , wherein the computer-implemented method further comprises: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.123. The system of any one of aspects 103-122, wherein the computer-implemented method further comprises displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject.124. The system of aspect 123, wherein the calendar further tracks when the oral therapy exercises are completed by the subject.125. The system of any one of aspects 103-124, wherein the computer-implemented method further comprises sending a notification reminding the subject to perform oral therapy exercises at a selected time.126. The system of aspect 125, wherein the notification is an audio or visual push notification to a mobile device application or a desktop computer application.127. The system of aspect 125 or 125, wherein the notification is an email, a text message, or an alarm providing an audio alert.128. The system of any one of aspects 103-127, wherein the computer-implemented method further comprises displaying a user interface presenting a questionnaire configured to receive input from the subject regarding self-reported results of using the oral therapy device.129. The system of aspect 128, wherein the questionnaire comprises a Gothenberg Trismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.130. The computer-implemented method of any one of aspects 103-129, further comprising using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.131. The computer-implemented method of any one of aspects 103-130, further comprising using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.132. The computer-implemented method of any one of aspects 103-131 , wherein the distance sensor data and / or force sensor data are stored in a cloud data storage system.133. The computer-implemented method of aspect 132, wherein the cloud data storage system is a public cloud storage system or a private cloud storage system.134. A method of performing hand therapy with the device of any one of aspects 1 -51 , the method comprising:(a) positioning fingers of right hand on top of right side of the top piece and positioning thumb of the right hand underneath right side of the main body;(b) positioning fingers of left hand on top of left side of the top piece and positioning thumb of the left hand underneath left side of the main body;(c) closing the right hand and the left hand to squeeze the top piece and the main body together, wherein compression of the compressible element results in lowering of the top piece along the main rod vertically to decrease spacing between the top piece and the main body;(d) opening the right hand and the left hand, wherein expansion of the compressible element results in rising of the top piece along the main rod vertically to increase spacing between the top piece and the main body; and(e) repeating (c) - (d).135. The method of aspect 134, wherein the subject has a hand disorder that weakens hand muscles or grip strength.136. The method of aspect 134, wherein the subject wants to perform the hand therapy to increase grip strength.137. The method of any one of aspects 134-136, further comprising using a force sensor on the device to measure grip strength of the subject or strengthen hand muscles.

[0167] It will be apparent to one of ordinary skill in the art that various changes and modifications can be made without departing from the spirit or scope of the invention.EXPERIMENTAL

[0168] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the present invention, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g. amounts, temperature, etc.) but someexperimental errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, molecular weight is weight average molecular weight, temperature is in degrees Centigrade, and pressure is at or near atmospheric.

[0169] All publications and patent applications cited in this specification are herein incorporated by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0170] The present invention has been described in terms of particular embodiments found or proposed by the present inventor to comprise preferred modes for the practice of the invention. It will be appreciated by those of skill in the art that, in light of the present disclosure, numerous modifications and changes can be made in the particular embodiments exemplified without departing from the intended scope of the invention. All such modifications are intended to be included within the scope of the appended claims.Example 1Therapy Device for Treating Oral Disorders

[0171] An ideal therapy device would be dynamic with the ability to intensify or de-intensify therapy, have an active and passive range of motion for jaw therapy, be able to track real-time compliance and increase overall therapy compliance (application-based), track progress over time, measure force required for biofeedback, adapt to various mouth topographies, and have an ergonomic design with adaptability for patients of all ages, including the adult, elderly, adolescent, and pediatric population. In addition, a device would optimally be portable with a pleasing aesthetic, inexpensive, durable, and easily cleaned. Ideally, a device would also have broad applicability across all jaw disorders.

[0172] Here, we describe development of a therapy device designed to achieve these goals. The device is compact with adaptable and low-profile mouthpieces, which can provide both passive and active range of motion for the jaw. Biofeedback is provided for therapy by using distance and / or force sensors on the mouthpiece along with software designed to provide visual and / or audio biofeedback to the subject. The device can be produced relatively inexpensively with a 3-D printer.

[0173] FIGS. 1A-1 B and FIG. 2 show an initial version of the device. The device easily disassembles and allows force to be controlled by inserting springs with different spring constants. The force on the jaw at opening can further be adjusted by using spring offset inserts. The maximum range of motion can be set using interchangeable top limit brackets. The range of motion and other exercisedata can be obtained through a hall effect sensor and a magnet or a linear potentiometer-based system.

[0174] As shown in FIG. 3, spring offsets can be inserted into the spring well to further compress the spring at the closed position. This allows the initial force at opening of the jaw to be gradually increased or reduced depending on progression of treatment. Through combining a small set of offset inserts and springs with a range of spring constants, it is possible to finely tune the force exerted. The same effect can be achieved by threading the base of the slider rod in the spring well and using a threaded nut offset or similar mechanical system.

[0175] The top limit brackets, shown in FIGS. 4A-4B, limit the maximum range of motion and are easily interchangeable. The limit can be increased as the condition of a patient improves.

[0176] Interchangeable mouthpieces may be used with the device, which can be custom-designed for patient-specific mouth geometry (e.g., derived from a scan etc.) or to exercise specific areas of the mouth. FIGS. 5A-5B show exemplary mouthpieces of different types. FIG. 5A shows a larger mouthpiece, which can engage more teeth including the molars. FIG. 5B shows a more compact mouthpiece, which can engage the front teeth. The mouthpieces are easily added or removed from the device by using a screw (e.g., hex screw), which can be tightened to attach a mouthpiece or loosened to remove a mouthpiece from the device.

[0177] A Hall effect sensor can be used for motion tracking, as shown in FIGS. 6A-6B and FIG. 7. The Hall effect sensor, embedded in the top piece, transduces the magnetic field produced by a magnet embedded in the main body into an electrical signal. Because spring constant (and length of any spring offset insert used) is known, the force being exerted at any point during exercise is easily calculated by software. This provides an inexpensive sensing option that allows all electronics to be contained in the top piece. Alternatively, an embedded linear potentiometer can be used to accomplish motion tracking, as shown in FIGS. 8 and 9.

[0178] FIGS. 11A-11 B and FIG. 12 show another version of the device having a curved path of travel that more closely mimics the natural movement of the jaw. This version of the device allows force to be applied perpendicularly to the mandible and maxilla through the full range of motion of the jaw. All previously discussed components (interchangeable top limit brackets and spring offset inserts), as well as sensing modalities (hall effect sensing and embedded linear potentiometer) can also be used in this alternate design.

[0179] FIG. 14 shows a schematic of an exemplary device with a top limit bracket comprising an adjustable range of motion limiter.Example 2Software for Use with the Device to Provide Visual and Audio Biofeedback

[0180] The software is designed to provide visual and / or audio biofeedback to the subject. Visual biofeedback may be provided through a display of one or more of the following: interincisal opening when the subject bites the upper and lower mouthpieces of the device, the length of time the subject keeps mouth open at a target interincisal opening, number of repetitions of oral therapy exercises, and the total length of time the subject performs a prescribed oral therapy regimen. A timer may be displayed to gives visual feedback on the amount of time the subject is keeping the mouth open at a target interincisal opening or provide an audio alert when the subject has kept the mouth open at a target interincisal opening for a selected amount of time. A timer may also be used to show the length of time a subject has been performing a prescribed therapy regimen. A pressure marker may be displayed to provide visual biofeedback to the subject on the amount of pressure exerted on the lower jaw and upper jaw to allow the subject to see if the pressure is within an acceptable range.

[0181] The software is designed to be simple and user friendly with easy navigation and a simple layout requiring minimal button pushing. Some aspects may be automated. For example, a set of repetitions may be automated versus having to push start to begin the next repetition.Certain features of the software application may be used without the device. For example, the software may display a menu that allows a clinician to enter prescribed exercises, including the number of repetitions, bite hold times at a target interincisal opening and / or target spring force, and sets of therapy exercises. The clinician may be able to reenter the menu to adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of therapy exercises, or the prescribed frequency of performing the set of therapy exercises, or any combination thereof, as needed. The software may further display a prescribed therapy regimen to the patient.

[0182] Patients may be provided with the ability to track their own data over time. Clinicians may also have the ability to access certain information on patient therapy exercise data.

[0183] The software may also provide information about trismus and other oral disorders and instructions for performing therapy with the device. Videos may be provided that demonstrate how to perform oral therapy exercises with the device and how to navigate the software application. A calendar may be included to track how often exercises are completed, including the number of sessions per day.

[0184] In addition, the software may send notifications to a patient that encourage the patient to do exercises throughout the day. The application may provide the ability to set notification preferences such as how often to be reminded to perform oral therapy exercises, and how notifications are sent, such as by audio or visual push notifications to a mobile device, email or text messages, setting an alarm to provide an audio alert at a selected time for performing therapy exercises, etc.

[0185] The software may also provide a self-reporting tool to be filled out by the patient. This selfreporting tool may include patient-reported outcome measures (PROMs), a Gothenberg Trismus questionnaire, or other self-reporting tool covering, for example, jaw related problems, difficulties with eating and oral hygiene, psychological concerns, and other medical concerns, as well as observed changes resulting from using the device.Example 3Application Using Artificial Intelligence (Al)

[0186] The application guides the clinician and patient through initial trismus assessment of the patient, including assessments of the jaw, facial symmetry, and movement of the jaw when opening, closing, and lateralization. The application includes a module that shows a patient how to use and calibrate the device, which is interactive. The application assesses severity of trismus and tolerance of therapy tasks, synthesizes results, and generates therapy recommendations on tasks and intensity. The application tracks data including how the patient is using the device, jaw measurements, and frequency of use of the device by the patient. The application further synthesizes the data to discover trends and make recommendations to a clinician or patient on how to adjust therapy.

[0187] Al is used by the application to take into account patient reports of effort with therapy tasks and any discomfort or psycho-social circumstances (e.g., I feel tired today, why couldn’t I do this?) to adjust a task or recommend returning the device to the provider. Al is also used to help the patient in decision making on whether to return the device to the provider or expand their medical team based on performance and reports of pain or lack of progress. The application provides a virtual therapy coach to increase motivation and compliance with therapy and use of the device. The virtual therapy coach may provide suggested educational material and learning modules based on patient reported concerns. In addition, the application may include the ability to establish parental controls for the use of the Al. The application may use Al to report trends in mouth opening, muscle strength, and use of device in an easy to view manner.

[0188] The application allows for visual, auditory and sensory biofeedback while a person is doing a task with the device. This allows for correction or adjustment of a task based on performance. Image recognition is used to analyze facial and jaw movements as well as contour and shadowing of the face. This allows movement to be analyzed with specific exercises to give feedback on form to make sure users are doing exercises correctly and consistently. The application provides an interface to the user that may present exercises like games that are appropriate for adults and children and reward users with badges for reaching set goals. Kid friendly education materials and modules are also included. In addition, the application is compatible with smart phones and tablets and has the ability to provide reminders pushed to multiple devices.

Claims

What is claimed is:

1. A device comprising: a main rod; a compressible element; an upper mouthpiece; a lower mouthpiece; a guide rod; a main body comprising: i) a complementary receiving location for the lower mouthpiece, wherein the lower mouthpiece fits inside the complementary receiving location for the lower mouthpiece and is reversibly attached to the main body at the receiving location for the lower mouthpiece; ii) a first complementary receiving location for the main rod, wherein the bottom of the main rod fits inside the complementary receiving location for the main rod to attach the bottom of the main rod to the main body; and ill) a complementary receiving location for the guide rod, wherein the bottom of the guide rod fits inside the complementary receiving location for the guide rod to attach the bottom of the guide rod to the main body; a top piece comprising: i) a complementary receiving location for the upper mouthpiece, wherein the upper mouthpiece fits inside the complementary receiving location and is reversibly attached to the main body at the receiving location for the upper mouthpiece; and ii) a second complementary receiving location for the main rod, wherein the main rod fits inside the second complementary receiving location for the main rod to adjustably attach the main rod to the top piece, wherein the top piece is at a position above the main body, wherein the top piece is moveable along the main rod vertically to allow the top piece to slide along the vertical length of the main rod, wherein the compressible element extends along the main rod from the top piece to the main body, wherein compression of the compressible element lowers the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject, wherein the upper mouthpiece andthe lower mouthpiece are aligned to allow the subject to bite the upper mouthpiece with upper teeth and the lower mouthpiece with lower teeth, wherein expansion or compression of the compressible element determines positioning of the upper mouthpiece relative to the lower mouthpiece and amount of force exerted on the upper jaw and the lower jaw when the subject bites the upper mouthpiece and the lower mouthpiece, and wherein the subject can increase interincisal opening to allow the compressible element to expand while biting the upper mouthpiece and lower mouthpiece to establish a desired spacing between the upper mouthpiece and the lower mouthpiece; and iii) a complementary receiving location for the guide rod, wherein the guide rod fits inside the complementary receiving location for the guide rod to attach the guide rod to the top piece; a top limit bracket that sets a limit on range of motion of the top piece, wherein the top limit bracket comprises: i) a complementary receiving location for the main rod, wherein the top of the main rod fits inside the complementary receiving location for the main rod to attach the top limit bracket to the top of the main rod at a position above the top piece; and ii) a complementary receiving location for the guide rod, wherein the top of the guide rod fits inside the complementary receiving location for the guide rod to attach the top limit bracket to the top of the guide rod; and a fastener, wherein the fastener fastens the top limit bracket to the top of the main rod.

2. The device of claim 1 , wherein the compressible element comprises a spring comprising a coil, wherein the main rod is inserted into the coil.

3. The device of claim 2, wherein the spring can be exchanged for another spring having a different length, spring constant, or spring force.

4. The device of claim 3, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

5. The device of any one of claims 2-4, further comprising a spring offset insert and a spring well, wherein the spring offset insert is positioned at the bottom of the spring well below the spring, wherein the spring offset insert increases compression of the spring when the top piece is lowered compared to when the spring offset insert is absent from the spring well, wherein the spring force exerted on the upper jaw and the lower jaw depends on the length of the spring offset insert and the spring constant of the spring.

6. The device of claim 5, wherein the spring offset insert can be exchanged for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.

7. The device of any one of claims 2-6, wherein the spring comprises a metal.

8. The device of claim 7, wherein the metal is steel, bronze, or titanium.

9. The device of claim 1 , wherein the compressible element comprises a gas, optionally wherein the gas is air.

10. The device of any one of claims 1 -9, further comprising a distance sensor for tracking motion of the top piece relative to the main body.

11. The device of claim 10, wherein the distance sensor comprises a first sensor component on the main body and a second sensor component on the top piece, wherein distance between the first distance sensor component and the second distance sensor component is measured to track motion of the top piece relative to the main body.

12. The device of claim 11 , wherein the first sensor component is a magnet that generates a magnetic field, and wherein the second sensor component is a hall sensor, wherein the distance between the hall sensor and the magnet is measured based on detection of the magnetic field generated by the magnet.

13. The device of claim 10, wherein the distance sensor comprises a linear potentiometer connected to a resistive track by a wiper or an internal slider carrier, wherein the linear potentiometer measures vertical displacement of the top piece along the main rod.

14. The device of claim 13, wherein the resistive track is positioned along the main rod, and wherein the linear potentiometer is positioned on the top piece.

15. The device of any one of claims 10-14, further comprising an external data receiving device in communication with the distance sensor, wherein the external data receiving device stores data from the distance sensor.

16. The device of claim 15, wherein the external data receiving device is connected to the distance sensor by a wire or wirelessly.

17. The device of claim 16, wherein the distance sensor further comprises a first wireless communication unit, and wherein the external data receiving device further comprises a second wireless communication unit in communication with the first wireless communication unit.

18. The device of claim 17, wherein the first wireless communication unit utilizes a wireless communication protocol using an electromagnetic carrier wave or ultrasound to transfer data from the distance sensor to the external data receiving device using the second wireless communication unit.

19. The device of claim 18, wherein the electromagnetic carrier wave is a radio wave, microwave, or an infrared carrier wave.

20. The device of any one of claims 1 -19, further comprising a mouthpiece integrated force sensor.21 . The device of any one of claims 1 -20, wherein the main rod is linear.

22. The device of any one of claims 1 -20, wherein the main rod is curved.

23. The device of claim 22, wherein the compressible element is an arc spring.

24. The device of claim 22 or 23, wherein the guide rod is curved.

25. The device of any one of claims 1-24, wherein the top limit bracket comprises an adjustable range of motion limiter, or wherein the top limit bracket can be exchanged for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.

26. The device of any one of claims 1 -25, wherein the upper mouthpiece and the lower mouthpiece are custom designed to fit mouth geometry of the subject.

27. The device of any one of claims 1 -26, wherein the upper mouthpiece and the lower mouthpiece are custom designed to exercise a specific area of the mouth of the subject.

28. The device of claim 27, wherein the upper mouthpiece and the lower mouthpiece engage all or some of the front teeth.

29. The device of claim 28, wherein the upper mouthpiece and the lower mouthpiece further engage all or some of the molars.

30. The device of any one of claims 1 -29, wherein the upper mouthpiece can be removed and exchanged for an upper mouthpiece of a different size or designed to exercise a different area of the mouth.31 . The device of any one of claims 1 -30, wherein the lower mouthpiece can be removed and exchanged for a lower mouthpiece of a different size or designed to exercise a different area of the mouth.

32. The device of any one of claims 1 -31 , wherein the upper mouthpiece and the lower mouthpiece are available in different sizes to fit mouths of different sizes.

33. The device of claim 32, wherein the upper mouthpiece and the lower mouthpiece are available in mouth sizes for an adult, adolescent, or child.

34. The device of any one of claims 1 -33, wherein the main body is flared.

35. The device of any one of claims 1 -34, wherein the guide rod is positioned between the main rod and the upper and lower mouthpieces.

36. The device of any one of claims 1 -34, wherein the guide rod is positioned between the main rod and the distance sensor.

37. The device of any one of claims 1-36, wherein the fastener is a screw, and wherein the top of the main rod further comprises a nut insert, wherein the top limit bracket is attached to the top of the main rod by screwing the screw into the nut insert.

38. The device of claim 37, wherein the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.

39. The device of any one of claims 1-38, wherein the complementary receiving location for the upper mouthpiece further comprises a nut insert, wherein a screw is used to attach the upper mouthpiece to the top piece by screwing the screw into the nut insert in the complementary receiving location for the upper mouthpiece.

40. The device of any one of claims 1-39, wherein the complementary receiving location for the lower mouthpiece further comprises a nut insert, wherein a screw is used to attach the lower mouthpiece to the main body by screwing the screw into the nut insert in the complementary receiving location for the lower mouthpiece.41 . The device of claim 39 or 40, wherein the screw is a hexagonal screw, a thumb screw, or a flat head slotted screw.

42. The device of any one of claims 1 -41 , wherein the device comprises a bio-compatible and dishwasher-safe or autoclavable resin or plastic.

43. The device of claim 42, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device.

44. The device of claim 42 or 43, wherein the resin or plastic comprises a methacrylic acid ester.

45. The device of any one of claims 42-44, wherein the resin or plastic is a photoreactive resin or plastic.

46. The device of any one of claims 1 -41 , wherein the device comprises a metal.

47. The device of claim 46, wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

48. The device of any one of claims 1 -47, further comprising a measuring element on the main rod, wherein the measuring element can be used to measure distance between the upper mouthpiece and the lower mouthpiece.

49. The device of claim 48, wherein the measuring element is an embossed ruler on an exterior surface of the main rod.

50. The device of claim 48 or 49 wherein the measuring element is calibrated to zero at the position of the lower mouthpiece.51 . The device of any one of claims 48-50, wherein the measuring element measures the distance in millimeters.

52. A method of performing oral therapy with the device of any one of claims 1 -51 , the method comprising: lowering the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece sufficiently to allow insertion of the upper mouthpiece and the lower mouthpiece into the mouth of a subject;inserting the upper mouthpiece and the lower mouthpiece into the mouth of the subject, wherein upper teeth of the subject are located on a portion of the upper mouthpiece, and lower teeth of the subject are located on a portion of the lower mouthpiece when the subject bites the upper mouthpiece and the lower mouthpiece; and performing oral therapy exercises, wherein i) the subject opens the mouth wide enough to establish a desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a target mandible range of motion or interincisal opening for the subject, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during opening of the mouth, wherein the compressible element expands and exerts a force on the upper jaw and the lower jaw, ii) the subject holds the mouth open at the desired spacing between the upper mouthpiece and the lower mouthpiece for a selected period of time; and iii) the subject closes the mouth, wherein compression of the compressible element results in lowering of the position of the top piece along the main rod vertically to decrease spacing between the upper mouthpiece and the lower mouthpiece.

53. The method of claim 52, wherein the subject has an oral disorder that restricts jaw opening, weakens orofacial muscles, impairs biting or chewing, or any combination thereof.

54. The method of claim 52, wherein the oral disorder is trismus.

55. The method of any one of claims 52-54, further comprising removing the device from the subject’s mouth.

56. The method of any one of claims 52-55, further comprising repeating said performing the oral therapy exercises a selected number of times.

57. The method of any one of claims 52-56, wherein the subject performs further oral therapy exercises, wherein the subject opens the mouth wide enough to establish a second desired spacing between the upper mouthpiece and the lower mouthpiece to achieve a second target mandible range of motion or maximal interincisal opening for the subject, wherein the second desired spacing is greater than the first desired spacing, wherein the subject continues to bite the upper mouthpiece and the lower mouthpiece during said opening of the subject’s mouth, wherein the spring expands and exerts a spring force on the upper jaw and the lower jaw, and wherein the subject holdsthe mouth open at the second desired spacing between the upper mouthpiece and the lower mouthpiece for a second selected period of time.

58. The method of claim 57, wherein the method is repeated, wherein each time the subject opens the mouth wider to establish a desired spacing between the upper mouthpiece and the lower mouthpiece that is greater than the previous desired spacing.

59. The method of claim 58, wherein the method is repeated until the desired spacing is at a maximum obtainable for the subject.

60. The method of any one of claims 52-59, wherein thickness of the top limit bracket is selected based on the target mandible range of motion or maximal interincisal opening for the subject.61 . The method of any one of claims 52-60, further comprising exchanging the spring offset insert for another spring offset insert having a different length to change the spring force exerted on the upper jaw and the lower jaw.

62. The method of any one of claims 52-61 , further comprising exchanging the top limit bracket for another top limit bracket having a different thickness to change the limit on the range of motion of the top piece.

63. The method of any one of claims 52-62, further comprising exchanging the spring for another spring having a different length or spring constant.

64. The method of any one of claims 52-63, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

65. The method of any one of claims 52-64, wherein the method is repeated, each time exchanging the spring in the device for another spring having a greater spring force prior to performing the method until the maximum tolerable spring force is reached.

66. The method of any one of claims 52-65, wherein the method is repeated, each time exchanging the spring offset insert in the device for another spring offset insert having a greater length prior to performing the method until the maximum tolerable spring force is reached.

67. The method of any one of claims 52-66, wherein the spring force is selected to exert the maximum tolerable spring force on the upper jaw and the lower jaw without causing jaw fracture when the subject bites the upper mouthpiece and the lower mouthpiece.

68. The method of any one of claims 52-67, wherein the method is repeated at a frequency prescribed by a medical practitioner.

69. A kit comprising the device of any one of claims 1 -51 and instructions for performing oral therapy with the device.

70. The kit of claim 69, wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

71. A computer-implemented method for monitoring oral therapy of a subject, the computer performing steps comprising: receiving data from the distance sensor of the device of any one of claims 10-51 each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance measured by the distance sensor.

72. The computer-implemented method of claim 71 , wherein the computer-implemented method further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.

73. The computer-implemented method of claim 72, wherein the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; anddisplaying amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.

74. The computer-implemented method of any one of claims 71 -73, further comprising determining frequency of use of the device by the subject.

75. The computer-implemented method of any one of claims 71 -74, further comprising: calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.

76. The computer-implemented method of any one of claims 71 -75, further comprising: measuring mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; and displaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.

77. The computer-implemented method of claim 76, further comprising displaying difference between a target mandible range of motion or target maximal interincisal opening for the subject and a measured mandible range of motion or maximal interincisal opening at a selected time point.

78. The computer-implemented method of claim 76 or 77, further comprising displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.

79. The computer-implemented method of any one of claims 71 -78, further comprising displaying difference between a target spring force and the spring force used at a selected time point.

80. The computer-implemented method of any one of claims 71 -79, further comprising displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.

81. The computer-implemented method of any one of claims 71 -80, further comprising displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw; and further displaying a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.

82. The computer-implemented method of any one of claims 71 -81 , further comprising: displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribed oral therapy regimen to the subject after the information is entered by the clinician.

83. The computer-implemented method of claim 82, wherein the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises.

84. The computer-implemented method of claim 82 or 83, wherein the clinician can edit the information to change the prescribed oral therapy regimen.

85. The computer-implemented method of claim 84, wherein the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.

86. The computer-implemented method of any one of claims 71 -85, further comprising displaying the measured interincisal opening when the subject bites the upper and lower mouthpieces of the device, length of time the subject holds the mouth open at the target interincisal opening, the number of repetitions of the oral therapy exercises, total length of time the subject performs the prescribed oral therapy regimen, or any combination thereof.

87. The computer-implemented method of any one of claims 71 -86, further comprising displaying a timer that provides visual feedback on the amount of time the subject holds mouth open at a target interincisal opening and / or provides an audio alert when the subject has held mouth open at the target interincisal opening for a selected amount of time.

88. The computer-implemented method of claim 87, wherein the timer further shows the total length of time the subject has been performing the prescribed oral therapy regimen.

89. The computer-implemented method of any one of claims 71 -88, further comprising: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.

90. The computer-implemented method of any one of claims 71 -89, further comprising displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject.91 . The computer-implemented method of claim 90, wherein the calendar further tracks when the oral therapy exercises are completed by the subject.

92. The computer-implemented method of any one of claims 71 -91 , further comprising sending a notification reminding the subject to perform oral therapy exercises at a selected time.

93. The computer-implemented method of claim 92 wherein the notification is an audio or visual push notification to a mobile device application or a desktop computer application.

94. The computer-implemented method of claim 92 or 93, wherein the notification is an email, a text message, or an alarm providing an audio alert.

95. The computer-implemented method of any one of claims 71 -94, further comprising displaying a user interface presenting a questionnaire configured to receive input from the subject regarding self-reported results of using the oral therapy device.

96. The computer-implemented method of claim 95, wherein the questionnaire comprises a Gothenberg Trismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.

97. The computer-implemented method of any one of claims 71 -96, further comprising using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.

98. The computer-implemented method of any one of claims 71 -97, further comprising using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.

99. The computer-implemented method of any one of claims 71 -98, wherein the distance sensor data and / or force sensor data are stored in a cloud data storage system.

100. The computer-implemented method of claim 99, wherein the cloud data storage system is a public cloud storage system or a private cloud storage system.

101. A non-transitory computer-readable medium comprising program instructions that, when executed by a processor in a computer, causes the processor to perform the method of any one of claims 71-100.

102. A kit comprising the non-transitory computer-readable medium of claim 101 and instructions for performing oral therapy.

103. A system comprising : the device of any one of claims 1 -51 ; a processor; a display component; and a data storage component.

104. The system of claim 103, wherein the processor is programmed to perform a computer-implemented method for monitoring oral therapy of a subject using the device, the computer performing steps comprising: receiving data from the distance sensor of the device of any one of claims 1 1 -51 each time the subject bites the upper mouthpiece with the upper teeth and the lower mouthpiece with the lower teeth during use of the device to perform the oral therapy; and displaying the distance between the first distance sensor component and the second distance sensor component that is measured by the distance sensor.

105. The system of claim 104, wherein the computer-implemented method further comprises displaying a marker, wherein vertical height of the marker represents degree of mouth opening of the subject based on the distance measured by the distance sensor.

106. The system of claim 105, wherein the computer-implemented method further comprises: displaying a horizontal line representing a selected target goal value for the degree of mouth opening; and displaying amount of time the subject maintains the degree of mouth opening at or above the selected target goal value.

107. The system of any one of claims 103-106, wherein the computer-implemented method further comprises determining frequency of use of the device by the subject.

108. The system of any one of claims 103-107, wherein the computer-implemented method further comprises: calculating the spring force exerted on the upper jaw and the lower jaw based on the length of the spring offset insert and the spring constant of the spring in the device; and displaying the spring force exerted on the upper jaw and the lower jaw.

109. The system of any one of claims 103-108, wherein the computer-implemented method further comprises: measuring mandible range of motion or maximal interincisal opening at a first selected time point and a second selected time point; anddisplaying difference between the measured mandible range of motion or maximal interincisal opening at the first selected time point and the second selected time point.

110. The system of claim 109, wherein the computer-implemented method further comprises displaying difference between a target mandible range of motion or target maximal interincisal opening for the subject and the measured mandible range of motion or maximal interincisal opening at a selected time point.11 1. The system of claim 109 or 110, wherein the computer-implemented method further comprises displaying a graph of the mandible range of motion or maximal interincisal opening measured at a plurality of timepoints on different days versus time.

112. The system of any one of claims 103-111 , wherein the computer-implemented method further comprises displaying difference between a target spring force and the spring force used at a selected time point.

113. The system of claim 112, wherein the computer-implemented method further comprises displaying a graph of the spring force measured at a plurality of timepoints on different days versus time.

114. The system of any one of claims 103-113, wherein the computer-implemented method further comprises displaying a marker representing the spring force to provide visual biofeedback to the subject on the amount of spring force exerted on the lower jaw and upper jaw; and further displaying a target range for the spring force to allow the subject to see if the marker representing the spring force is within the target range.

115. The system of any one of claims 103-114, wherein the computer-implemented method further comprises displaying a user interface configured to receive input from a clinician regarding information about a prescribed oral therapy regimen to be performed with the device by the subject; and displaying the prescribed oral therapy regimen to the subject after the information is entered by the clinician.

116. The system of claim 1 15, wherein the information about the prescribed oral therapy regimen comprises a description of a set of oral therapy exercises with bite hold times at a target interincisal opening and a target spring force, a prescribed number of repetitions of the set of oral therapy exercises, and a prescribed frequency of performing the set of oral therapy exercises.

117. The system of claim 1 16, wherein the clinician can edit the information to change the prescribed oral therapy regimen.

118. The system of claim 117, wherein the clinician can adjust the bite hold times, the target interincisal opening, the target spring force, the prescribed number of repetitions of the set of oral therapy exercises, or the prescribed frequency of performing the set of oral therapy exercises, or any combination thereof.

119. The system of any one of claims 103-118, wherein the computer-implemented method further comprises displaying interincisal opening when the subject bites the upper and lower mouthpieces of the device, length of time the subject holds the mouth open at the target interincisal opening, the number of repetitions of the oral therapy exercises, total length of time the subject performs the prescribed oral therapy regimen, or any combination thereof.

120. The system of any one of claims 103-119, wherein the computer-implemented method further comprises displaying a timer that provides visual feedback on the amount of time the subject holds mouth open at a target interincisal opening and / or provides an audio alert when the subject has held mouth open at the target interincisal opening for a selected amount of time.

121. The system of claim 120, wherein the timer further shows the total length of time the subject has been performing the prescribed oral therapy regimen.

122. The system of any one of claims 103-121 , wherein the computer-implemented method further comprises: displaying a user interface configured to receive input from the subject to allow selection of a video, wherein the video demonstrates how to perform oral therapy exercises with the device; and playing the video on a display viewable by the subject.

123. The system of any one of claims 103-122, wherein the computer-implemented method further comprises displaying a user interface presenting a calendar configured to receive input from the subject or a clinician regarding when oral therapy exercises are scheduled for the subject.

124. The system of claim 123, wherein the calendar further tracks when the oral therapy exercises are completed by the subject.

125. The system of any one of claims 103-124, wherein the computer-implemented method further comprises sending a notification reminding the subject to perform oral therapy exercises at a selected time.

126. The system of claim 125, wherein the notification is an audio or visual push notification to a mobile device application or a desktop computer application.

127. The system of claim 125 or 125, wherein the notification is an email, a text message, or an alarm providing an audio alert.

128. The system of any one of claims 103-127, wherein the computer-implemented method further comprises displaying a user interface presenting a questionnaire configured to receive input from the subject regarding self-reported results of using the oral therapy device.

129. The system of claim 128, wherein the questionnaire comprises a Gothenberg T rismus questionnaire, patient-reported outcome measures (PROMs), or questions about jaw related problems, difficulties with eating and / or performing oral hygiene, psychological concerns, and / or other medical concerns.

130. The computer-implemented method of any one of claims 103-129, further comprising using artificial intelligence to suggest educational material and learning modules based on concerns reported by the subject.

131. The computer-implemented method of any one of claims 103-130, further comprising using artificial intelligence to analyze changes in mouth opening and oral muscle strength of the subject and make recommendations to a clinician or the subject on how to adjust the oral therapy.

132. The computer-implemented method of any one of claims 103-131 , wherein the distance sensor data and / or force sensor data are stored in a cloud data storage system.

133. The computer-implemented method of claim 132, wherein the cloud data storage system is a public cloud storage system or a private cloud storage system.

134. A method of performing hand therapy with the device of any one of claims 1 -51 , the method comprising:(a) positioning fingers of right hand on top of right side of the top piece and positioning thumb of the right hand underneath right side of the main body;(b) positioning fingers of left hand on top of left side of the top piece and positioning thumb of the left hand underneath left side of the main body;(c) closing the right hand and the left hand to squeeze the top piece and the main body together, wherein compression of the compressible element results in lowering of the top piece along the main rod vertically to decrease spacing between the top piece and the main body;(d) opening the right hand and the left hand, wherein expansion of the compressible element results in rising of the top piece along the main rod vertically to increase spacing between the top piece and the main body; and(e) repeating (c) - (d).

135. The method of claim 134, wherein the subject has a hand disorder that weakens hand muscles or grip strength.

136. The method of claim 134, wherein the subject wants to perform the hand therapy to increase grip strength.

137. The method of any one of claims 134-136, further comprising using a force sensor on the device to measure grip strength of the subject or strengthen hand muscles.

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