BACKGROUND

Field of the Invention

The present invention is directed to a holding case for an instrumented intra-oral appliance containing recorded data, which charges the intra-oral appliance while not in use and transmits recorded data to storage and/or for processing. The transferred data may be subjected to downloading, validation, storage, analysis, measuring, database fusion (with for example data from other devices), data output, and data recording. Output may be transferred to a cloud server, computer, processor, phone, or other hardware for review by a user.

In one aspect, the case includes a portion of the intra-oral appliance wearer's 3D dental geometry, which matches or mirrors the particular custom-shaped intra-oral appliance's geometry. In another aspect, the invention comprises an apparatus for performing an intra-oral appliance integrity check within the holding case. In a preferred embodiment of the present invention, the case includes a mechanism for transferring of data from the case and/or intra-oral appliance to a cloud server or other physical or virtual storage media where the data can be processed, reviewed, and/or analyzed by the appliance wearer and/or technical, research, medical, or other oversight personnel. In a related aspect, the data is transferred from the case and/or intra-oral appliance to a central data hub such as a computer, processor, phone, server, or storage unit, which then transmits the data to a cloud server or other storage medium where the data can be reviewed by the appliance wearer and/or, technical, research, medical, or other oversight personnel. In an aspect of this embodiment, the data may be processed or analyzed before or after it is reviewed.

In another embodiment, the case includes a UV light source within, near, or affixed to the holding case to completely or partially sterilize the intra-oral appliance.

In one embodiment, the case has a visual and/or graphical user interface such as a touchscreen, a series of LEDs or a single LED, a series of multicolor LEDs or single multicolor LED, and/or physical buttons or switches.

In another embodiment, a system of holding cases matched with instrumented intra-oral appliances containing recorded data, charges the intra-oral appliances while not in use and transmits recorded data from each individual appliance labeled by appliance or appliance user to a storage and/or processing device, such as an internal or remote storage and/or processing device, for review, processing, and/or analysis.

In yet another embodiment, the case includes a mechanism to identify its unique intra-oral appliance when in proximity to the case using a wireless protocol such as radio frequency identification (RFID), near field communication (NFC), Bluetooth low energy (BTLE), or other low energy communication protocol.

DESCRIPTION OF THE RELATED ART

All references disclosed herein are incorporated by reference.

U.S. Pat. No. 3,938,018 describes a device that charges a DC battery without physical connection between the charger and the battery.

U.S. Pat. No. 4,873,677 describes a device that includes inductive coils to charge a DC battery including a mechanical yoke in the charger case that aligns the inductive coils. In aspects, the current invention uses the wearer's anatomy as the alignment between the appliance and the charging case.

U.S. Patent Application Publication No. 2016/0250517 describes a system for monitoring a team sport activity including a plurality of training devices and a singular docking station to transfer data from the plurality of training devices to the singular docking station and charge the numerous training devices. The system teaches sending data within service broadcasting packets. The current invention embodies a unique, custom case for one specific intra-oral appliance that is associated with the case, whereby the case not only charges the matched appliance, but also, in some aspects, transmits data recorded on the appliance, sanitizes the device, etc. One case per appliance eliminates the need of the system administrator to handle individual devices which are exposed to and possibly covered in the wearer's bodily fluids, such as saliva or sweat. The addition of individual cases for each appliance reduces the risk of contamination of the wearer's device by third party handling, cross contamination by the handling of multiple devices, or contamination of the system administrator.

U.S. Pat. No. 8,092,251 describes an active packaging for electronic media device which provides power to the device while in packaging. The intent of the current invention is to charge the appliance for continued use and download the data from the appliance. These increase the functionality of the appliance by limiting the interaction with individual devices and increases the time between charges.

U.S. Patent Application Publication No. 2015/0097700 describes a plurality of athlete monitoring systems which connect to a plurality of docking stations for charging. However, the current invention stores data on the monitoring/measurement device, while the teachings of Application No. 2015/0097700 describe streaming data live to a base station. The invention described herein allows for both individual charging and data transmission from the plurality of appliances to a unique matched case.

SUMMARY

The present invention is a holding case for an instrumented intra-oral appliance containing recorded data. The holding case downloads data for transfer to, in one embodiment, a central data location and charges the instrumented intra-oral appliance, among other things. The holding case may also include 3D dental geometry of the wearer to receive the appliance and can perform additional tasks such as a device integrity check, sterilization, and provide a visual user interface for the user. The invention includes the implementation of a single holding case or a group of holding cases as part of a system of cases to monitor a specific population.

In a preferred embodiment, the present invention is a holding case for an instrumented intra-oral appliance containing recorded data. The holding case transfers data bilaterally with the appliance allowing for the data from the appliance to be processed, analyzed, validated, compiled, and/or stored on the case or in another location, and data, input, information, instructions, or commands can be sent to the case to modify the operation of the appliance. The case may also include a processor to process information from the appliance. The case may also include a storage medium to store information from the appliance. The case may also include an antenna to send information from the appliance, before or after processing, to a remote electronic device, such as a server, computer, processor, phone, or television, by way of example.

In another embodiment, the case may comprise the apparatus for holding the intra-oral appliance, electronics for charging the electronic intra-oral appliance, electronics for downloading and/or transferring data, and in some aspects custom dentition. The electronics may be glued, potted, snap-fitted, adhered, taped, press-fitted, or otherwise attached to the case. The custom dentition may be 3D-printed, thermoformed, pressure formed, injection molded or otherwise manufactured. The custom dentition may be glued, snap-fitted, pressure fitted, adhered, sonic welded, or otherwise attached to the case and/or electronics.

In one aspect, the holding case includes 3D dental geometry of the wearer to receive the appliance. This would facilitate the accurate placement of inductive coils and radio antennae for charging and data transfer. Accurate receipt of the appliance, as defined by a field detect in the inductive coil of the case, may also initiate reading of data, transfer of data, charging, integrity checks, or other functions performed by the case.

The holding case, in some aspects, performs additional tasks, such as device and data integrity checks. These tasks are performed using sensors on or in the appliance, and/or unique sensors within, in, or on the holding case, or using a processor within, near, or on the appliance that, in aspects, may have superior computing power to that contained within the appliance, or may be the same processor. Alternatively, a processor in, on, or near the holding container/case may be used.

In another aspect, a device integrity check includes the measurement of frequency data measured by sensors in the appliance when the appliance is inserted into the case. The action of inserting the device into the case, in aspects, initiates data recording on the appliance, which also initiates the appliance or the appliance case performing an integrity check on the data. In other cases, a user may manually control when data is sent or received, or integrity checks performed.

A device integrity check may include sensors in the appliance case to measure interaction between the appliance and the 3D dental geometry in the case including, but not limited to, surface area, force, pressure, or strain. Changes in surface contact would indicate the appliance has been mechanically deformed.

In one aspect of this invention, the case comprises a UV light source within the holding case that sterilizes the intra-oral appliance. The UV light source is designed to irradiate most or all surfaces of the appliance for sufficient duration to sterilize the appliance and is timed to occur before, during or after transmission of data.

The holding case, in certain aspects, includes a visual user interface. The visual user interface provides the user information regarding the appliance including that the correct appliance is in proximity to the case, that the appliance needs to be serviced or replaced, that the appliance is not properly placed in the case, or the status of its data download, the status of the charge, that data should be reviewed by the user on another device, that the user should contact technical, research, medical, or other oversight personnel, and other functions relating to the appliance, the user, and/or data on the appliance. The visual user interface may be provided on a separate device such as a tablet, smartphone, computer, server, or other electronics display.

In another embodiment, the visual user interface provides a third party such as a parent, coach, practitioner, or technical, research, medical, or other oversight personnel, information regarding the case and/or the appliance, including if it needs to be serviced or replaced, the status of its data download, the status of the charge, the amount of time the appliance has been in use, if the device memory is full, that data should be reviewed on another device, etc. Such visual user interface provided to a third party may also act as an alert of the state of the user or the appliance, for example a visual indicator may be provided to communicate a traumatic head impact event experienced by the person wearing the appliance.

The invention comprises the implementation of a single holding case or a group of holding cases which are part of a system to record and transmit data related to a specific population. An implementation of a group of holding cases as a system, in one aspect, also includes a central hub that charges the holding cases or stores, analyzes, or processes information. The charging of the cases could be accomplished either wired or wirelessly.

In one embodiment, firmware updates for cases or appliances are transferred from the central hub, a server, or a computer to the cases and/or appliances, or a singular case and/or appliance. This file transfer can be performed over the air via wireless protocol, through an inductive coil used for charging and transferring data, through a direct wired connection, or any other means.

Such firmware updates may be for the appliances, in which case the firmware would be transferred from the central hub, a computer, or a server directly to the appliances, or through the case as connected to the appliance. This file transfer can be performed over the air via wireless protocol, through an inductive coil used for charging and transferring data, through a direct wired connection, or any other means.

In another aspect, data from an appliance or a plurality of appliances are reviewed on a local central storage device. The local storage device may include, but is not limited to, a phone, tablet, computer or other electronic device with a user display.

In yet another aspect of this invention, the data from an appliance or a plurality of appliances are reviewed remotely after data has been sent to a cloud server location, another computer, a phone, or other remote electronic device. The data can be reviewed as a whole, or a subset of data can be reviewed that is selected manually, randomly, based on specific criteria, or based on data integrity evaluations conducted by the appliance, the appliance case, the central data hub, computer software, or cloud-based software.

In one embodiment, the only data observed from an appliance or a plurality of appliances locally is their charge and download status to protect the data privacy of the appliance's wearer from the local system administrator.

In one embodiment of the present invention, a case for an electronic intra-oral appliance is provided that charges the intra-oral appliance, and downloads and/or transfers data from the intra-oral appliance. Charging may be accomplished by wired or wireless means of providing electricity to the case and/or the intra-oral appliance coupled to the case.

In another embodiment of the present invention, the case transfers data to a computer, smartphone, tablet computer, processor, a server, or the cloud for storage and analysis. Such analysis may include, but is not limited to, human performance data or health metrics, blood oxygen level, heart rate, head kinematics (e.g., experienced during impact events, with an emphasis on avoiding recording false positives), etc.

In another embodiment, data transferred from the intra-oral appliance and the results of the analysis are sent for review by a user, such as on a computer, television, smartphone, tablet, or other hardware. The analysis of the data may occur on a processor, a computer, a smartphone, a tablet, or any other software located on hardware, a server, on the cloud, or otherwise. The data may be transmitted to a central repository either wirelessly or by wired communication/connection. In other embodiments, the analysis and output may be performed by electronics and/or processor(s) located on, in, or near the case. Data may also be stored on a storage device on, in, or near the case.

In another embodiment, the data analysis feedback to a user may comprise biostatistics, indication of possible traumatic event, injury, or condition, possible diagnoses of a traumatic event, injury, or condition, along with possible treatment of such event, injury, or condition, including whether to consult with a physician.

In another embodiment, the data analysis feedback to technical, research, medical, or other oversight personnel may comprise biostatistics, indication of possible traumatic event, injury, or condition, possible diagnoses of a traumatic event, injury, or condition, along with possible treatment of such event, injury, or condition, including whether to consult with a physician.

In another embodiment, the data analysis feedback to technical, research, medical or other oversight personnel may comprise biostatistics, indication of elevated risk of possible traumatic event, injury, or condition, or possible prescriptive treatments or alterations in training to mitigate the elevated risk of possible traumatic event, injury, or condition.

In another embodiment, the case and associated software/firmware may perform electronics, structural, data, and other integrity checks on the intra-oral appliance. Feedback is provided to a user if, for example, the electronics, structure, data, or other component of the intra-oral appliance and/or recording system has been compromised. In the case of a group of cases as part of a system, feedback is provided to the system administrator.

In another embodiment, the results of electronics, structural, and data integrity checks are sent to research, technical, medical, or other oversight personnel. If the device requires replacement or service, notification is sent for a replacement appliance to be manufactured or shipped to replace the damaged or compromised device.

