US-12622640-B2 - Oral data collecting device for diagnosis or prognosis

US12622640B2US 12622640 B2US12622640 B2US 12622640B2US-12622640-B2

Abstract

An apparatus that monitors information associated with an oral cavity is provided, the apparatus comprising: a three-dimensional oral appliance; a data collection device having at least one sensor and/or hydrogel like material configured to sense the information associated with the oral cavity; an interface device cooperatively coupled to the data collection device, the interface device configured to transfer the information from the sensor device to a receiving device external to the oral cavity or the entire device is analyzed.

Inventors

Peter John Zegarelli

Assignees

Emanate Biomedical, Inc.

Dates

Publication Date: 20260512
Application Date: 20220506

Claims (10)

1 . A non-transitory computer-readable medium comprising instructions that, when executed by a processing device, perform operations comprising: monitoring biological characteristics associated with an oral cavity from a data collection device of a three-dimensional oral appliance; the data collection device having at least one sensor disposed in a cargo area adjacent to the teeth and contacting the soft tissue of the oral cavity such that the data collection device is configured to sense the biological characteristics comprising oxygen content and/or carbon dioxide content associated with the oral cavity; and an interface device cooperatively coupled to the data collection device, the interface device configured to transfer information of the biological characteristics from the sensor device to a receiving device external to the oral cavity or the data collection device itself is configured to be removed and sent for analysis.
2 . A non-transitory computer-readable medium of claim 1 , wherein the information of the biological characteristics further comprises at least one of pH, temperature, pressure, and bacterial content.
3 . A non-transitory computer-readable medium of claim 1 , wherein the operations further comprise monitoring, using the data collection device, at least one of continuously and periodically.
4 . A non-transitory computer-readable medium of claim 1 , wherein the operations further comprise transferring, using the interface device, the information external to the oral appliance wirelessly.
5 . A non-transitory computer-readable medium of claim 1 , wherein the operations further comprise: processing, using the processing device, the information associated with the oral cavity; and transferring, using the processing device, the processed information to the interface device.
6 . An oral appliance for collecting biological information about at least a portion of teeth and/or soft tissue areas inside an oral cavity, the oral appliance comprising an interior surface having a sampling medium disposed in or on at least a portion of and/or all of the interior surface of the oral appliance, the interior surface being formed to fit contours of at least the portion of the teeth and/or soft tissue areas inside the oral cavity and being configured for holding the sampling medium in contact with at least the portion of the teeth and/or soft tissue areas inside the oral cavity, the sampling medium configured to collect biological tissue from the oral cavity and be removed from the interior surface of the oral appliance, wherein the sampling medium is removable from the oral appliance, and the sampling medium is disposed in a cargo area adjacent to the teeth and the sampling medium is configured to contact the soft tissue of the oral cavity.
7 . An oral appliance according to claim 6 , wherein the sampling medium comprises a hydrogel, and the device itself is then analyzed.
8 . An oral appliance according to claim 6 , wherein the sampling medium is disposed at a discrete location in the oral appliance and is configured to wick biological tissue from the oral cavity, which is disposed adjacent to the sampling medium.
9 . An oral appliance according to claim 6 , wherein the sampling medium is further configured to collect biological fluids, exudates or cells.
10 . An oral appliance according to claim 6 , wherein the oral appliance does not move teeth.

Description

BACKGROUND Oral appliances that allow drug delivery to the oral cavity have been developed that have a reservoir to hold liquid medicaments or a cargo area that have a foam disposed in the cargo area for delivery of the drug to the oral cavity. These oral appliances are available in universal sizes to generically fit adults or are custom made for a precise fit to the teeth and gums of the individual patient. Oral appliances that are provided in universal sizes often do not adequately match the patient's actual oral cavity characteristics. This can lead to poor contact in areas where such oral appliances are adapted to deliver the drug. Custom made oral appliances present a better fit to the patient's oral cavity since they are fabricated to match the actual oral cavity in which they are employed. Based on the above, new oral appliances are needed that improve measurement of the biological activity occurring in the oral cavity, for example, saliva activity, pressure, oxygen content, temperature, pH, bacteriologic/viral/cellular assays, gingival/periodontal fluids and exudates or other bodily fluids or exudates such as phlegm or sputum or other parameters in order to more accurately treat diseases on an individual basis. Such oral appliances may be easily manufactured and, in some embodiments, based on the patient's actual oral cavity architecture so that they are easy and comfortable for the patient to wear, or the oral appliance can be a universal fit appliance for the person to wear. SUMMARY New oral appliances are provided that apply sensors to an oral cavity in a three dimensional manner. In various embodiments an oral appliance is provided for sensing various biological characteristics including temperature, pH, O2, and CO2, content in saliva or sulcular assays or other conditions in the mouth. The oral appliance contains an interior surface having a sensor array disposed in or on at least a portion of and/or the entire interior surface of the oral appliance. In some embodiments, the oral appliance can be a universal oral appliance to fit most users. In some embodiments, the oral appliance is a custom fit oral appliance where the interior surface of the oral cavity is formed to fit contours of at least the portion of the teeth and/or soft tissue areas inside the oral cavity and is configured for supporting and holding the sensor array in contact with at least the portion of the teeth and/or soft tissue areas inside the oral cavity to assay the environment. In various embodiments, the oral appliance is monolithic or a single piece and the interior surface is individually custom fit and formed to fit contours of the teeth and/or soft tissue areas inside the oral cavity of a specific person and no other. Unlike prior art oral appliances, an embodiment of the oral appliance of the present application has differing types of sensor arrays as part of the appliance. In certain embodiments, the oral appliance comprises several variations configured to assay various substances. In some embodiments, the sensors can be at discrete positions on the exterior surface of the oral appliance, and/or on the interior surface of the oral appliance to sense the biological environment within the oral cavity and transmit the data to a remote computer of the user, and/or health care provider to monitor, diagnose or prognose the condition of the wearer's oral cavity over a continuous period of time (e.g., minutes, hours, 24 hours, 48 hours, 1 week). In certain embodiments, the material of the oral appliance is a polymer gel, a hydrogel, a brush polymer or a combination thereof, or of some sponge like character or tampon material. In some embodiments, the hydrogel comprises, consists essentially of or consists of an amount from about 10% to about 90% by weight, from about 20% to about 80% by weight, from about 30% to about 70% by weight, from about 40% to about 60% by weight of the oral appliance. The material employed serves to absorb cells, chemical secretions, and other biomaterials. Once the oral appliance has been used for a period of time to allow sampling of cells, chemical secretions, and other biomaterials, the user removes the appliance and it is then analyzed. In some embodiments, the oral appliance is optionally constructed from a digital data set representing at least a portion of or all of the teeth and/or soft tissue areas inside the oral cavity. This permits precise placement of sensors at positions of interest. In some embodiments, there is an oral appliance for assaying chemical properties or environmental conditions at a portion of teeth and/or soft tissue areas inside an oral cavity, the oral appliance comprising an interior surface having a sensor array disposed in or on at least a portion of and/or all of the interior surface of the oral appliance, the interior surface being formed to fit contours of at least the portion of the teeth and/or soft tissue areas inside the oral cavity and being configured for ho