Dental retainer with pH sensor

Abstract

An oral insert includes at least one pH sensor in electronic communication with a power source and a data transceiver. The pH sensor is exposed to fluids in the patient's mouth and measures the pH of the fluids to determine fluid composition.

Claims

1. An apparatus for gathering pH data from a patient's mouth, comprising: an oral insert comprising a contoured region connected to a labial bow and a palate region connected to clasps for securing the oral insert; a plurality of flat pH sensors positioned in the palate region and the contoured region of the oral insert in respective positions configured to expose the flat pH sensors for measuring pH, wherein the respective positions correspond to respective biomarkers sensed in the respective positions; wherein the plurality of flat pH sensors are proximal pH sensors and distal pH sensors positioned on the oral insert in proximal and distal positions, and wherein the proximal positions are adjacent the clasps for securing the oral insert and distal positions are adjacent the labial bow; at least one data transmission device and at least one power device in respective positions in the palate region of the oral insert and separated from the distal pH sensors within the contoured region of the oral insert and further separated from proximal pH sensors within the palate region of the oral insert, wherein the separated data transmission device and separated power device are in electrical communication across the oral insert with all of the plurality of flat pH sensors and configured to transmit pH sensor data to a network; wherein proximal pH sensors provide respective pH sensor data corresponding to one respective biomarker related to gastroesophageal reflux disease (GERD) acid in the patient's saliva, and wherein the respective pH sensor data from the distal pH sensors corresponds to another respective biomarker for dietary acid exposures in the patient's mouth.

2. An apparatus according to claim 1, wherein said oral insert comprises a shape that fits against a roof of the patient's mouth.

3. An apparatus according to claim 1, wherein said oral insert comprises a Hawley retainer.

4. An apparatus according to claim 1, wherein said clasps comprise Adams clasps.

5. An apparatus according to claim 1, further comprising a receiver connected to a computer to retain the pH sensor data in computerized memory for analysis.

6. An apparatus according to claim 1, wherein said palate region and said contoured region are separable.

7. An apparatus according to claim 1, wherein said oral insert is removable from the mouth via manual manipulation.

8. An apparatus according to claim 1, wherein the flat pH sensors are so dimensioned as to fit within the patient's mouth.

9. The apparatus according to claim 1, further comprising mechanical fasteners attaching the pH sensors to the oral insert.

10. The apparatus according to claim 9, wherein the mechanical fasteners attach the pH sensors to the oral insert in a modular arrangement.

11. A system for recording pH levels in a patient's mouth for a period of time and diagnosing medical conditions, the system comprising: a processor in data communication with computerized memory storing computer implemented software configured with instructions to record pH readings of saliva in the patient's mouth; an oral insert comprising clasps and a labial bow, each for securing the oral insert in the patient's mouth; a plurality of pH sensors positioned on the oral insert in respective positions configured to expose the pH sensor to the saliva at a plurality of locations in the patient's mouth; wherein the plurality of pH sensors are proximal pH sensors and distal pH sensors positioned on the oral insert in proximal and distal positions, and wherein the proximal positions are adjacent the clasps for securing the oral insert and distal positions are adjacent the labial bow; at least one data transmission device and at least one power device positioned in the oral insert and separated from the pH sensors, wherein the separated data transmission device and separated power device are in electrical communication across the oral insert, via respectively separate circuits, with all of the plurality of flat pH sensors, and wherein the data transmission device is configured to transmit pH sensor data to a network; photographs documenting erosive lesions on certain teeth of the patient, said photographs being accessible for visual comparison to a scale showing a severity of dental erosion, wherein the comparison to the scale and the pH sensor data correlate acid exposure on the certain teeth; and suggested treatment data stored in the computerized memory and corresponding to levels of the severity of dental erosion on the scale.

12. The system according to claim 11, wherein the network is a wireless data communications network.

13. The system according to claim 11, wherein the oral insert comprises channels directing saliva from the patient's mouth to the pH sensor for determining the pH level.

14. The system according to claim 11, wherein the scale is a Keels-Coffield Severity Scale.

15. The system according to claim 11, wherein the comparison differentiates GERD acid exposures from dietary acid exposures in the mouth.

Description

BRIEF SUMMARY OF THE FIGURES

(1) FIG. 1A is a PRIOR ART schematic diagram of a biomedical device used to implant sensors in the esophagus of a subject.

(2) FIG. 1B is a PRIOR ART schematic diagram of the sensor of FIG. 1A implanted in a patient's esophagus.

(3) FIG. 2 is a PRIOR ART side perspective view of a wireless modular sensor as shown in FIGS. 1A and 1B.

(4) FIG. 3 is a PRIOR ART schematic diagram of a sensor system collecting data from a sensor placed on an exterior of a mouth piece insert.

(5) FIG. 4 is a PRIOR ART schematic diagram of a sensor system collecting data from a sensor placed on a dental device implanted within teeth of a patient.

(6) FIG. 5 is a PRIOR ART schematic diagram of a sensor system collecting data from a sensor placed on an interior of a mouth piece insert.

(7) FIG. 6A is a top view of a PRIOR ART pH sensor formed as a series of flat layers.

(8) FIG. 6B is a side cross sectional view of a PRIOR ART pH sensor of FIG. 6A.

(9) FIG. 7A is a side perspective view of a PRIOR ART pH sensor formed as a series of flat layers via electroplating techniques.

(10) FIG. 7B is a side perspective view of the PRIOR ART pH sensor of FIG. 7A formed as a series of electroplated layers and subject to potassium chloride saturation processes.

(11) FIG. 8A is a top perspective view of a PRIOR ART pH sensor having a thin film construction in a substantially flat assembly.

(12) FIG. 8B is a top perspective view of the PRIOR ART pH sensor of FIG. 8A after further processing.

(13) FIG. 8C is a side cross section view of the PRIOR ART pH sensor of FIG. 8B assembled as thin film layers.

(14) FIG. 9 is a PRIOR ART schematic of one kind of gastroesophageal reflux monitoring system.

(15) FIG. 10 is a PRIOR ART schematic of one kind of power circuit possible to use in implementing the monitoring system of FIG. 9 with power induced by inductive links.

(16) FIG. 11 is a top perspective view of a PRIOR ART Hawley retainer used for orthodontics and retaining alignment of orthodontic corrective procedures.

(17) FIG. 12 is a top perspective view of an oral device such as a retainer having a pH sensor incorporated therein according to embodiments of this invention.

(18) FIG. 13 is a schematic representation of the effects of dental acid erosion as numerous levels of tooth loss.

DETAILED DESCRIPTION

(19) This disclosure incorporates an apparatus, a method, and a system of measuring pH of oral fluids, including saliva and/or gastric fluid and/or mixes thereof, present in the patient's mouth. The term “pH” is used herein according to its broadest commonly used meaning in science. The reference to pH is commonly applied on a numeric scale used to specify acidity or basicity of a solution. Most references place the numeric scale in a range of 0 to 14, with pure water being a neutral value of seven (7), acids being denoted less than seven (<7), and bases denoted greater than seven (>7). The pH of a body fluid can be used to diagnose medical and dental conditions, including but not limited to gastro-esophageal reflux disease, dental acid erosion in the mouth, and similar conditions by which gastric fluids from the stomach move up the esophagus and into the patient's mouth. The acids in the gastric fluids cause numerous harmful effects on the esophagus, the mouth, on the teeth, and related tissue. The pH sensor placed in a patient's mouth is also useful to determine incidents in which dietary habits or food intake changes the pH in the patient's mouth. One goal, therefore, is to identify and track pH trends in the patient's mouth with an oral insert having a pH sensor and then using that information for diagnosing and treating underlying medical conditions, dental effects, and sources of acid erosion in the mouth.

(20) As described herein, these acids can be detected by a pH sensor placed within a patient's body in a position that tracks the change of pH in a given body fluid, including but not limited to saliva in the mouth. The term “saliva” as used herein is given its broadest plain meaning with the understanding that any patient's mouth will include saliva and mixes of food, drink, saliva and gastric fluids in various proportions throughout the day and night. The term “saliva” as used herein is not limited to any particular chemical composition of solution but generally refers to the body fluid detectable in a patient's mouth at any given time. It is notable that the term “saliva” as used herein is a general term referring to and including general body fluids, food/drink, and other aqueous solutions in the mouth that have mixed with pure saliva emitted from salivary glands. Saliva pH falling into lower ranges (e.g., less than or equal to a pH of approximately six (6)) indicates an acidity that can be corrosive of the teeth, gingiva, and the mouth in general. Numerous studies exist that identify saliva mixture pH levels considered unhealthy, and this disclosure is not limited to any one pH level or range of pH levels. The overall apparatus, system, and method disclosed herein track pH in a way that the changes of saliva pH are monitored for health purposes, whether in a diagnostic or treatment setting.

(21) In one embodiment, an apparatus according to this disclosure includes an orally inserted device that may be referred to as a “retainer” or “mouth piece” or “mouth guard” in general terms to denote an overall shape. The oral device as used herein typically conforms to at least a portion of the shape of a patient's mouth. Without limiting the invention to any one embodiment, this disclosure includes oral inserts that conform to at least one of a roof of a patient's mouth, a patient's gingiva, a patient's teeth, or any location on which the oral inserts can temporarily affix during use. In one embodiment, the oral insert is manually inserted and removable by the patient similar to other known mouth guards. The oral insert preferably stays in place by fitting against at least a portion of the mouth, often the roof of the mouth, and may include Adams clasps and a labial bow that allow the patient's teeth to assist in holding the oral insert in place. As shown in the prior art FIG. 11, a standard Hawley retainer accommodates such a fit by being molded into a shape that conforms to the curvature and contours of a patient's palate, and teeth. The Hawley retainer of FIG. 11 is also shown with reinforced hardware (1110) in the shape of Adams clasps and a labial bow that engage the patient's teeth to hold the retainer more securely against the roof of the mouth. The Adams clasps (1110) and the labial bow (1112) provide a three prong retention system that fixes the Hawley retainer to the patient's mouth until manually removed. The prior art Hawley retainer (1100) is discussed herein only as an example of a kind of mouthpiece that may exhibit a shape and fit that accommodates other embodiments of this disclosure but is in no way limiting of the invention.

(22) FIG. 12 is one example of a mouth piece, referred in some embodiments as an oral insert, that can be used to measure pH in a patient's mouth, particularly in regard to the pH of the patient's saliva. Again, one goal is to monitor pH of saliva (including mixtures of saliva, gastric fluids, food and drink) as present in the mouth at any given time, record pH readings over a sample period, and process those recordings with computerized data processing equipment for diagnostic and treatment purposes. The diagnostic and treatment purposes of the device shown in FIG. 12 may include, but are not limited to, detecting and monitoring acid reflux disease, dental acid erosion of the teeth, and sources of the acids including gastric acids as well as food and drink intake. The device may be helpful in confirming the fact that dental acid erosion has been and is occurring in a patient's mouth (even in instances when the patient is unaware) and further providing evidence of the source of that erosion, whether by acid reflux or dietary factors.

(23) The device as shown in FIG. 12 may add value to many other areas of a patient's medical and dental care. For example, with saliva having a pH less than 5.0, permanent loss of enamel and tooth structure can result. The pH levels may increase a patient's susceptibility to oral cancers, and the pH monitor could be used in assisting with sleep apnea concerns. This disclosure is supplemented by the information of FIG. 13, which is a well-recognized set of standards used to evaluate, categorize, and document the severity of dental erosion due to dental acid erosion. This set of standards, referred to in the art as the Keels-Coffield Severity Scale, has been developed by the named inventor in this matter. The Keels-Coffield Severity Scale is particularly useful in diagnosing and treating gastroesophageal reflux disease (GERD) but is not limited to any one area.

(24) The chart summarizing the Keels-Coffield Severity Scale is attached as FIG. 13 and shows four levels of severity for dental acid erosion, respectively numbered as Level Zero (no erosion of the teeth present), Level 1 (mild erosion), Level Two (moderate erosion), and Level Three (severe erosion). Table 1 below summarizes the identification of severity at each level and certain possible treatment considerations for a hypothetical patient. The oral pH sensor disclosed herein could be used in conjunction with the Keels-Coffield Severity Scale to diagnose and treat gastroesophageal reflux disease, diet problems, and habitual triggers that eventually lead to severe dental acid erosion. None of these proposed uses of the system, device, and method of the present application should be considered limiting of the concepts of this disclosure in any way.

(25) TABLE-US-00001 TABLE 1 Treatment Options as Determined by the Keels-Coffield Clinical Severity Scale of Dental Erosion. Level 0 No Suggested Treatments NO EROSION Level 1 If the child confirms a positive history of GERD symptoms, refer to his/her MILD pediatrician or a GI specialist for testing and management. If there is no dental sensitivity, routine fluoride application and sealants may be adequate. If dental sensitivity occurs. protect the teeth with occlusal composite resin build-ups. Monitor and document the erosive lesions with photographs and/or casts (as tolerated by the child). Level 2 Same recommendations as for MILD erosions, however, teeth with MODERATE MODERATE erosions will require occlusal composite resin build-ups or SSC's to protect against further loss of tooth structure. Level 3 Same recommendations for MILD and MODERATE erosions, however, teeth SEVERE with SEVERE erosions may require pulp therapy or extraction (if non- restorable).

(26) An overall oral insert (1218) of FIG. 12 is one example of a device that may be temporarily positioned in the patient's mouth to measure pH of saliva therein. In FIG. 12, the oral insert (1218) may include a contoured region (1220A) that tracks the shape and fit of a patient's teeth and gingiva and a palate region that tracks the shape and fit of the roof of the patient's mouth. The contoured region (1220A) and the palate region (1220B) may be formed as one solitary piece via known processes such as but not limited to 3-D printing, molding and casting of plastics, polymers, resins, and the like. Numerous polymeric or even metal alloys are within the scope of this disclosure and no single material or method of manufacturing is limiting of the apparatuses, systems, or methods disclosed herein. In other embodiments, the contoured region and the palate region may be manufactured separately and even be made of different kinds of materials that are suitable for the relative positions and functions of the respective regions (1220A, 1220B) of the oral insert. In one non-limiting embodiment, the contoured region and the palate region may be permanently attached to each other, but in other circumstances, this disclosure encompasses a modular assembly allowing for the contoured region (1220A) and the palate region (1220B) to be separable at the option of the user and/or medical/dental provider. A separable arrangement of the contoured portion (1220A) and the palate portion (1220B) may be useful in manufacturing techniques, sensor placement, and for providing housings for other equipment placed within the mouth guard, or oral insert (1218), such as the battery (1210) and the transceiver (1215) shown in FIG. 12.

(27) The oral insert (1218) depicted in FIG. 12 includes numerous sensors configured to sense and measure biomarkers in the mouth and saliva. In one embodiment, the sensors (1225A-1225G) are strategically placed and include at least one sensor (1225E, e.g.,) but typically a plurality of sensors (1225A-1225G) as shown in FIG. 12. In one embodiment, the sensor placement is determined according to the patient's anatomy, space availability on or within the oral insert, and/or a medical/dental provider's professional judgment regarding sensor positions likely to lead to the most accurate readings of a biomarker available in a given situation. For example, and without limiting this disclosure, in one embodiment, the sensors (1225A-1225G) include pH sensors that fit within the oral insert (1218) in preferred positions for measuring pH of a patient's saliva and transmitting the readings to a computerized component, such as but not limited to a transceiver (1215) that further transmits the pH data to a computer via a network as described below.

(28) For embodiments in which the sensors are pH sensors (1225A-1225G), one embodiment allows for pH sensors to be scaled and constructed in a way that allows for comfortable placement in a patient's mouth (e.g., the flat, layered pH sensors discussed above could be one non-limiting option). At least one of these pH sensors is in contact with the patient's saliva during a sampling period to gather pH data about the saliva. The positions of the sensors (1225A-1225G) may be adjusted as necessary, and in one embodiment, the sensors may be placed on the mouth guard by the care provider after the mouth guard or oral insert has been manufactured. In this regard, the sensors may be attached to a previously manufactured oral insert device with adhesives that withstand the oral environment or even with mechanical fasteners (e.g., a pin mechanism attached to the back of the sensor that punctures the oral insert device and sticks the sensor into the body of the oral insert device). These kinds of arrangements allow for modular sensor placement by a medical/dental practitioner after considering the patient's anatomy and limitations of a mouth guard built for a particular patient.

(29) In the example of FIG. 12, the oral insert device (1218) includes a proximal end (1280) relative to the patient's esophagus and a distal end (1290) relative to the patient's esophagus. The sensors (1225A-1225G) include pH sensors placed along the proximal end (1280) of the oral insert device (1218), as this position is closest to the sources of gastric fluids and stomach acids that may be subject to reflux into a patient's mouth. The pH sensors (1225D, 1225F) placed along the proximal end of the oral insert device are likely, therefore, to be an early indicator of saliva having the highest acidity and lowest pH readings if gastro-esophageal reflux disease is an issue for the patient. Other sensors may be placed strategically as well, and practitioners have numerous options for designing sensor placement. All of the sensors are exposed to the patient's saliva for reading and recording pH values in a system as described herein.

(30) In one embodiment, the sensors (1225) are connected to a computerized network at least partially housed within the mouth guard/oral insert (1218). The computerized network according to the disclosure set forth herein includes at least a power source (1210), such as a battery positioned in a portion of the oral insert and a transmitting component (1215) such as a transceiver that is powered by the power source to transmit the data to another component in the network. In one non-limiting embodiment, the transceiver (1215) is a wireless transceiver that transmits the gathered pH data along a wireless transmission network to a computer such as a server or even a local personal computer. The computer includes a processor and associated memory to calculate more detailed analyses for the pH data gathered over time.

(31) The oral insert (1218) according to the disclosure herein is configured to use on patients that may not be able to express symptoms to a care giver or may be experiencing symptoms during sleep. Taking the sleep state as an example, in one embodiment, at least one section (1285) of the oral insert is adapted to direct saliva from the mouth across at least one sensor. In this regard, the oral insert may incorporate channels (1230) or at least contours in the construction of the device so that saliva is more likely to reach key sensor positions for analysis. Accordingly, the sensors may be positioned in wells that are slightly recessed to pool saliva onto the sensor. With this construction, the oral device may effectively measure pH of saliva in a patient's mouth when the patient's head is turned one way or another during sleep. Instead of saliva flowing along an inner side of a patient's cheeks and then swallowed, the channels (1230) may direct the saliva to a sensor of interest. The channels (1230) described herein are not limited to any particular shape or configuration. The channels may be simple troughs, enclosed tunnels through the palate section (1220B), or simple inclines and contours that promote saliva delivery to the sensor.

(32) The device of FIG. 12 is illustrated with data/electrical signal connectors (1255) that are suitable for data transmission to other computerized components in a system having components connected over a data transmission network. In the embodiment shown, the sensors (1225), a power source (1210), and a transceiver (1215) are the only components housed in the oral insert (1218) itself. This arrangement would therefore include capabilities to transmit data from the device in use in a patient's mouth to an outside computer receiver/transceiver for analysis by an associated processor implementing computer instructions of stored software designed for pH considerations. The embodiments of this disclosure, however, may include additional or fewer components of the system so long as the sensor data can be analyzed by a medical/dental professional, preferably in an automated and computerized setting. For example, as processing capabilities reside on more devices with smaller footprints, additional processing power may be implemented directly on or within the body of the oral insert (1218). Power options may also be varied and remain with the concepts disclosed herein.

(33) Although the present disclosure has been described in detail with reference to particular arrangements and configurations, these example configurations and arrangements may be changed significantly without departing from the scope of the present disclosure. For example, although the present disclosure has been described with reference to particular communication exchanges involving certain network access and protocols, network device 102 may be applicable in other exchanges or routing protocols. Moreover, although network device 102 has been illustrated with reference to particular elements and operations that facilitate the communication process, these elements, and operations may be replaced by any suitable architecture or process that achieves the intended functionality of network device 102.

(34) Numerous other changes, substitutions, variations, alterations, and modifications may be ascertained to one skilled in the art and it is intended that the present disclosure encompass all such changes, substitutions, variations, alterations, and modifications as falling within the scope of the appended claims.

(35) Note that in this Specification, references to various features (e.g., elements, structures, modules, components, steps, operations, characteristics, etc.) included in “one embodiment”, “example embodiment”, “an embodiment”, “another embodiment”, “some embodiments”, “various embodiments”, “other embodiments”, “alternative embodiment”, and the like are intended to mean that any such features are included in one or more embodiments of the present disclosure, but may or may not necessarily be combined in the same embodiments. Note also that an ‘application’ as used herein this Specification, can be inclusive of an executable file comprising instructions that can be understood and processed on a computer, and may further include library modules loaded during execution, object files, system files, hardware logic, software logic, or any other executable modules.

(36) In example implementations, at least some portions of the activities may be implemented in software provisioned on networking device 102. In some embodiments, one or more of these features may be implemented in hardware, provided external to these elements, or consolidated in any appropriate manner to achieve the intended functionality. The various network elements may include software (or reciprocating software) that can coordinate in order to achieve the operations as outlined herein. In still other embodiments, these elements may include any suitable algorithms, hardware, software, components, modules, interfaces, or objects that facilitate the operations thereof.

(37) Furthermore, the network elements of FIG. 1 (e.g., network devices 102) described and shown herein (and/or their associated structures) may also include suitable interfaces for receiving, transmitting, and/or otherwise communicating data or information in a network environment. Additionally, some of the processors and memory elements associated with the various nodes may be removed, or otherwise consolidated such that single processor and a single memory element are responsible for certain activities. In a general sense, the arrangements depicted in the Figures may be more logical in their representations, whereas a physical architecture may include various permutations, combinations, and/or hybrids of these elements. It is imperative to note that countless possible design configurations can be used to achieve the operational objectives outlined here. Accordingly, the associated infrastructure has a myriad of substitute arrangements, design choices, device possibilities, hardware configurations, software implementations, equipment options, etc.

(38) In some of example embodiments, one or more memory elements (e.g., memory 116) can store data used for the operations described herein. This includes the memory being able to store instructions (e.g., software, logic, code, etc.) in non-transitory media, such that the instructions are executed to carry out the activities described in this Specification. A processor can execute any type of instructions associated with the data to achieve the operations detailed herein in this Specification. In one example, processors (e.g., processor 114) could transform an element or an article (e.g., data) from one state or thing to another state or thing. In another example, the activities outlined herein may be implemented with fixed logic or programmable logic (e.g., software/computer instructions executed by a processor) and the elements identified herein could be some type of a programmable processor, programmable digital logic (e.g., a field programmable gate array (FPGA), an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM)), an ASIC that includes digital logic, software, code, electronic instructions, flash memory, optical disks, CD-ROMs, DVD ROMs, magnetic or optical cards, other types of machine-readable mediums suitable for storing electronic instructions, or any suitable combination thereof.

(39) These devices may further keep information in any suitable type of non-transitory storage medium (e.g., random access memory (RAM), read only memory (ROM), field programmable gate array (FPGA), erasable programmable read only memory (EPROM), electrically erasable programmable ROM (EEPROM), etc.), software, hardware, or in any other suitable component, device, element, or object where appropriate and based on particular needs. Any of the memory items discussed herein should be construed as being encompassed within the broad term ‘memory element.’ Similarly, any of the potential processing elements, modules, and machines described in this Specification should be construed as being encompassed within the broad term ‘processor.’

(40) The list of network destinations can be mapped to physical network ports, virtual ports, or logical ports of the router, switches, or other network devices and, thus, the different sequences can be traversed from these physical network ports, virtual ports, or logical ports.

(41) These and other embodiments supported by the disclosure herein are set forth in the claims that follow this detailed description.