Oral electro-stimulator

Abstract

An intraoral device includes a splint, an array of electrodes, a controller, and a sensor. The splint is configured to fit mandibular teeth. The array of electrodes is coupled to the splint. The array is aligned on a medial plane and proximal to a distal portion of the splint. The controller is coupled to the array. The controller is coupled to a power supply. The sensor is coupled to the controller and coupled to the splint. The sensor is configured to provide a measure of moisture.

Description

[0001] ORAL ELECTRO-STIMULATOR

[0002] TECHNICAL FIELD

[0003] This document pertains generally, but not by way of limitation, to a medical device for treating xerostomia.

[0004] BACKGROUND

[0005] Xerostomia, known broadly as dry mouth, is the perception of oral dryness. In addition to discomfort, xerostomia can lead to several long-term medical complications within the oral cavity and gastrointestinal system. Treatment options are limited and are either not effective or not convenient for all people with xerostomia.

[0006] Often, xerostomia is driven by under-producing salivary glands but can also result from abnormal sensory and autonomic neural activity. Typical causes of xerostomia include medications (for example, anticholinergics, antidepressants, opioids, and benzodiazepines, antipsychotics), Sjogren’s syndrome, nerve damage, as well as radiation and chemotherapy of the neck and face. In many cases, xerostomia leads to further medical complications that can deteriorate oral, gastrointestinal, and mental health.

[0007] Sufficient saliva output is required for good oral health. Without enough saliva, proper digestion, speech, infection control, and teeth and gum health decline.

[0008] Xerostomia treatment options are rather limited.

[0009] US 11,969,593 refers to a system for the treatment of dry mouth using electrical stimulation of the salivary glands.

[0010] SUMMARY

[0011] An intraoral device includes a splint, an array of electrodes, a controller, and a sensor. The splint is configured to fit mandibular teeth. The array of electrodes is coupled to the splint. The array is aligned on a medial plane and proximal to a distal portion of the splint. The controller is coupled to the array. The controller is coupled to a power supply. The sensor is coupled to the controller and coupled to the splint. The sensor is configured to provide a measure of moisture. Saliva can be characterized as moisture.

[0012] The present inventors have recognized, among other things, that a problem to be solved can include xerostomia treatment. The present subject matter can help provide a solution to this problem, such as by providing an intraoral device having electrodes that provide stimulation in response to a sensed moisture measurement.

[0013] Although examples are described herein may reference to the lingual nerve, the techniques, methods, system and apparatus described herein are applicable to or can be modified to be applicable to all nerves that innervate the oral cavity including the lingual nerve, trigeminal nerve, maxillary nerve, mandibular nerve, buccal nerve, facial nerve, glossopharyngeal nerve and / or the vagus nerve.

[0014] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0015] This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0018] FIG. 1A illustrates a perspective view of a device according to one example.

[0019] FIG. IB illustrates a perspective view of a device according to one example.

[0020] FIG. 2 illustrates selected anatomy, according to one example. FIG. 3A illustrates a block diagram of a system according to one example.

[0021] FIG. 3B illustrates a view of a controller, according to one example.

[0022] FIG. 4 illustrates a flow chart of a method according to one example.

[0023] DETAILED DESCRIPTION

[0024] FIG. 1A illustrates a perspective view of device 100 A according to one example. The view shown depicts device 100 A from a perspective above and behind the lower arch of teeth.

[0025] Device 100 A includes splint 90 A configured to fit a lower arch of teeth. The lower arch of teeth, also known as mandibular teeth, are adjacent the lower gum line. In the example shown, affixed to splint 90A is controller 110A, power supply 130A, sensors 140B, and electrode array 120A. Electrode array 120A is affixed to one side of splint 90A, however, in other examples, a complementary electrode array is affixed to both sides of splint 90A. In addition, sensors 140B include two electrical conductors that cooperatively provide a measure of moisture.

[0026] Splint 90A can include a rigid plastic or an elastic material fitted for a particular set of teeth. In one example, the electrical components are interconnected with electrical conductors embedded or surface mounted to selected portions of splint 90A.

[0027] FIG. IB illustrates a perspective view of device 100B according to one example. Device 100B includes splint 90B stylized as a rectangular arch structure. The example shown can represent an embodiment suited for a universal fit. In contrast, device 100A is configured for a custom fit.

[0028] Device 100B includes a pair of electrode arrays 120B disposed on opposing portions of distal region 50 of splint 90B. In addition, device 100B includes sensors 140A, also disposed on opposing portions of distal region 50.

[0029] Medial plane 40 and vertical axis 30 are shown for clarity.

[0030] In one example, a controller is affixed in the region of the lingual bar at the proximal region 60.

[0031] Electrode array 120B is disposed on opposing sides of medial plane 40 and configured to physically contact a buccal region of tissue. Array 120B can include an insulative substrate having conductive pads. The conductive pads can be exposed on an interior surface and can be raised proud or flush with the insulative substrate. Array 120B can be affixed to splint 90B by an adhesive bond or a mechanical fastener. In the example shown, array 120B extends below the gum line and has a bulbous rectangular form with an aspect ratio in which a vertical axis is parallel to that of axis 30.

[0032] Sensors 140A are disposed on opposing sides of medial plane 40 and configured to contact a buccal region of tissue. Sensors 140A can be affixed by an adhesive bond or a mechanical fastener. Sensors 140 A are configured and positioned to sense moisture collected in the lower jaw region, adjacent the mandibular teeth. A single sensor (such as sensor 140A) can be configured to operate independently and provide an output signal indicative of moisture detected at a sense surface. In one example, a pair of sensors 140A are configured to cooperatively provide a measure of moisture. In this example, the sensors are part of an electrical resistance measuring circuit.

[0033] Sensors 140A can include various types of moisture sensing devices. For example, a moisture sensor can include a ceramic sensor, a quartz crystal microbalance sensor, a polymer sensor, a tunable diode laser absorption spectroscopy sensor, or an electrode as part of a capacitance sensor or electrical resistance.

[0034] FIG. 2 illustrates selected anatomy, according to one example. In the figure, mandible 80 carries a plurality of mandibular teeth 70, some of which are labeled. Representative lingual nerve 210 is shown to generally follow the path beneath mandibular teeth 70 and in the region near the teeth, a portion of nerve 210 runs substantially horizontally.

[0035] FIG. 2 also depicts electrode array 120C in context with nerve 210. The planform of array 120C is tailored to generally intersect the path of nerve 210. Notably, some electrodes of array 120C align well with nerve 210 and other electrodes are distal relative to the site of nerve 210.

[0036] FIG. 3A illustrates a block diagram of system 100C according to one example. System 100C includes electrode array 120D, controller HOB, and sensor 140C. As shown, electrode array 120D, controller 110B, and sensor 140C are electrically interconnected. System 100C can include a power supply including a battery or other electric source. Electrode array 120D includes a plurality of electrodes arranged in an array, here shown as three columns (column Cl, C2, C3) and six rows (rows Rl, R2, R3, R4, R5, and R6) and some electrodes are labeled as electrode 122A, 122B, and 122C. In one example, each electrode is individually addressable based on selection by controller 110B. For example, for a first particular lingual nerve anatomy, stimulation can be optimized using electrodes at R2, C3 and at R4, Cl and for a second particular lingual nerve anatomy, stimulation can be optimized using electrodes at Rl, Cl and at R3, C2.

[0037] In the example shown, sensor 140C is illustrated as a single component having an output corresponding to a measure of moisture.

[0038] The moisture sensing capabilities of the intraoral device provide feedback for optimizing xerostomia treatment. The sensor can be configured to continuously monitor oral moisture levels and provide real-time data to the controller for adaptive stimulation protocols.

[0039] In one embodiment, the moisture detection system operates by measuring electrical resistance between two conductors positioned in the oral cavity. As moisture levels change, the electrical resistance between the conductors varies proportionally, providing a quantifiable measure of oral dryness. The sensor can include a pair of electrical conductors that cooperatively provide a measure of moisture, where decreased resistance indicates higher moisture content and increased resistance indicates lower moisture content.

[0040] Splint 90A can include a rigid plastic material that is custom-fitted for a particular set of teeth, providing precise anatomical alignment and secure positioning. The rigid plastic construction provides stable electrode positioning and consistent electrical contact with target tissues.

[0041] Alternatively, the splint can comprise an elastic material configured for universal fit, as shown in device 100B which includes splint 90B stylized as a rectangular arch structure suited for universal fit applications. The elastic material option provides flexibility for patients who require adjustable fitting or who may experience changes in oral anatomy over time.

[0042] The sensor can be positioned strategically within the distal region of the splint to optimize moisture detection in areas where saliva naturally collects. In the embodiment shown in FIG. IB, sensors 140A are disposed on opposing sides of medial plane 40 and configured to contact a buccal region of tissue, allowing for comprehensive moisture monitoring across the lower jaw region.

[0043] Alternative moisture sensing technologies can be employed depending on the specific application requirements. The sensor can include various types of moisture sensing devices such as a ceramic sensor, a quartz crystal microbalance sensor, a polymer sensor, a tunable diode laser absorption spectroscopy sensor, or an electrode as part of a capacitance sensor or electrical resistance measurement circuit.

[0044] The electrode selection system provides personalized stimulation based on individual anatomical variations and real-time moisture feedback. The controller is configured to systematically evaluate multiple electrodes within the array to determine optimal stimulation locations for each patient.

[0045] In one embodiment, sensors 140B include two electrical conductors that cooperatively provide a measure of moisture, as shown in FIG. 1A. The electrical conductors are positioned to create a measurable resistance path through the oral environment, where the presence of saliva and other oral fluids affects the electrical resistance between the conductors. The power supply comprises a miniature battery that can be integrated into the splint structure, as shown with power supply 130A in FIG. 1A. The controller positioning in the lingual region of the splint, proximal to the electrode array, provides efficient signal transmission while maintaining a compact device profile.

[0046] The electrical resistance measurement system operates on the principle that moisture content directly correlates with conductivity. As moisture levels increase in the oral cavity, the electrical resistance between the paired conductors decreases proportionally, providing a quantifiable indication of oral hydration status. This resistance-based measurement approach offers advantages in terms of simplicity, reliability, and real-time monitoring capabilities.

[0047] The array of electrodes is positioned to contact a buccal region of tissue below the gum line, as illustrated in the embodiments where array 120B extends below the gum line and has a bulbous rectangular form. This positioning provides effective stimulation of the lingual nerve pathways that control salivary gland function. The electrodes are configured to physically contact the buccal region of tissue, with array 120B including an insulative substrate having conductive pads that can be exposed on an interior surface and can be raised proud or flush with the insulative substrate. This design provides reliable electrical contact while maintaining patient comfort during extended wear periods.

[0048] The sensor positioning in the distal region of the splint, adjacent to the electrode array, as shown with sensors 140 A disposed on opposing portions of distal region 50, provides optimal moisture detection in areas where therapeutic stimulation is delivered. This integrated positioning approach provides coordinated operation between sensing and stimulation functions while maintaining device compactness and patient comfort.

[0049] As shown in FIG. 3A, electrode array 120D includes a plurality of electrodes arranged in an array with three columns (Cl, C2, C3) and six rows (Rl, R2, R3, R4, R5, R6), where each electrode is individually addressable based on selection by controller HOB. This configuration allows for precise targeting of the lingual nerve based on individual anatomical variations.

[0050] The electrode selection process can be optimized for different lingual nerve anatomies. For example, for a first particular lingual nerve anatomy, stimulation can be optimized using electrodes at R2, C3 and at R4, Cl, while for a second particular lingual nerve anatomy, stimulation can be optimized using electrodes at Rl, Cl and at R3, C2.

[0051] The controller HOB includes processor 160 configured to execute instructions for selecting a particular electrode or pair of electrodes based on sensor feedback and stored algorithms. The controller HOB can receive sensor data from sensor 140C and execute an algorithm to select a stimulus protocol, including selected electrodes, timing selections, and stimulation signal characteristics such as duration, duty cycle, amplitude, frequency, phase, and other parameters.

[0052] Memory 170 is configured to store data including archived data as to stimulation and response, and instructions for executing electrode selection algorithms. This allows the system to learn and adapt to individual patient responses over time, optimizing treatment effectiveness. The electrode selection method includes systematically testing multiple electrodes while monitoring moisture response, storing optimal electrode configurations in memory, and implementing maintenance routines that utilize the stored optimal parameters for ongoing treatment. This adaptive approach provides that stimulation remains effective as patient conditions change over time.

[0053] As illustrated in FIG. 3 A, electrode array 120D includes a plurality of electrodes arranged in an array with three columns (Cl, C2, C3) and six rows (Rl, R2, R3, R4, R5, R6), totaling at least eighteen individual electrodes. Each electrode, including electrodes 122A, 122B, and 122C, is individually addressable based on selection by controller HOB.

[0054] The individual addressability of each electrode allows for precise customization of stimulation patterns. The controller 110B is configured to systematically activate specific electrodes or combinations of electrodes to optimize therapeutic effectiveness for each patient’s unique anatomical configuration. This selective activation capability enables the system to adapt to variations in lingual nerve positioning and tissue response characteristics.

[0055] Signal generator 150 can include a pulse generator configured to provide an output signal to electrode array 120D, where the output signal can include an AC signal or a modulated DC signal. This flexibility in signal types allows for optimization of stimulation parameters based on individual patient response and therapeutic requirements.

[0056] The pulse generation capability of the controller HOB enables precise control over stimulation timing, duration, and intensity. The pulsed electrical signal characteristics can be adjusted to provide optimal nerve stimulation while minimizing patient discomfort and maximizing therapeutic effectiveness.

[0057] FIG. 3B illustrates a block diagram view of controller HOC, according to one example. Controller 110C can be viewed as a functional arrangement of elements characterized as signal generator 150, power supply 130B, processor 160, and memory 170.

[0058] Signal generator 150 can include a pulse generator configured to provide an output signal to electrode array 120D, for example. The output signal can include an AC signal or a modulated DC signal. Power supply 130B can include a miniature battery or other power source. Supply BOB can provide power for elements of the system as described herein.

[0059] Processor 160 can include an analog or digital processor configured to provide a stimulation signal to selected electrodes of electrode array BOD. In one example, processor 160 executes instructions stored in memory to facilitate selection of electrodes of the array for stimulation. In addition, processor 160 can be configured to receive sensor data from sensor 140C, for example, and execute an algorithm to select a stimulus protocol. The stimulus protocol can include selected electrodes, timing selections, stimulation signal characteristics (such as duration, duty cycle, amplitude, frequency, phase, and other parameters).

[0060] The processor 160 is configured to execute an algorithm to select a stimulus protocol, including selected electrodes, timing selections, and stimulation signal characteristics such as duration, duty cycle, amplitude, frequency, phase, and other parameters. This algorithmic approach allows the system to systematically evaluate electrode performance and optimize stimulation patterns for individual anatomical variations.

[0061] Processor 160 can be configured to receive sensor data from sensor 140C (FIG. 3A) and execute algorithms for selecting particular electrodes or pairs of electrodes based on real-time feedback and stored optimization data. The algorithm can account for individual lingual nerve anatomy variations, ensuring that stimulation is delivered to the most effective electrode locations for each patient.

[0062] Memory 170 is configured to store data including archived data as to stimulation and response, and instructions for executing an algorithm. This storage capability allows the system to maintain records of effective stimulation parameters and electrode configurations for each patient.

[0063] The controller can include memory functionality that stores data corresponding to selected electrodes of the array, enabling the system to recall and implement previously successful treatment protocols. This memory-based approach provides consistent treatment delivery and allows for progressive optimization of therapeutic outcomes. FIG. 4 illustrates a flow chart of method 400 according to one example. Method 400 represents an operation during which a device is fitted to a user and deployed to detect moisture and provide stimulation of a lingual nerve.

[0064] At 410, method 400 includes receiving a measure of moisture. An electrical resistance can be a proxy for the measure of moisture. In other examples, a relative moisture or an absolute moisture measurement is provided.

[0065] At 420, method 400 includes selecting an electrode for delivering an electrical stimulation. The electrode can include any one of a plurality of electrodes coupled to the splint and can be measured with reference to a selected reference electrode or signal. In one example, selecting an electrode includes selecting a pair of electrodes configured to provide a stimulation. A controller, such as controller 110B or HOC, can be configured to execute instructions for selecting a particular electrode or pair of electrodes.

[0066] At 430, method 400 includes stimulating the selected electrode based on an algorithm. The stimulation can include selecting one or more parameters for providing a signal to the tissue using the electrode selected from the electrode array.

[0067] At 440, method 400 includes determining if untested electrodes remain. If the determination is affirmative, then method 400 follows path 445 returning to 410 receiving a measure of moisture. If the determination is negative, then method 400 proceeds to execute a maintenance routine. In a maintenance routine, the selected stimulation parameters, and selected electrodes, are stored in a memory accessible to the controller for future use.

[0068] Claims Related Examples

[0069] The disclosure herein includes but is not limited to the following illustrative examples. The various examples described below can be combined in any combination. Elements thereof can be combined in any combination. The elements thereof are optional unless otherwise indicated.

[0070] Various examples have been described. These and other examples are within the scope of the following claims.

[0071] Example 1 is an intraoral device comprising: a splint configured to fit mandibular teeth; an array of electrodes coupled to the splint, the array aligned on a medial plane and proximal to a distal portion of the splint; a controller coupled to the array, the controller coupled to a power supply; and a sensor coupled to the controller and coupled to the splint, the sensor configured to provide a measure of moisture.

[0072] In Example 2, the subject matter of Example 1 includes, wherein the splint is inelastic.

[0073] In Example 3, the subject matter of Examples 1-2 includes, wherein the array is aligned on a vertical axis.

[0074] In Example 4, the subject matter of Examples 1-3 includes, wherein the array includes a plurality of pairs of electrodes.

[0075] In Example 5, the subject matter of Examples 1-4 includes, wherein the controller is configured to provide a pulse.

[0076] In Example 6, the subject matter of Examples 1-5 includes, wherein the controller is configured to provide stimulation at a signal level based on the measure of moisture.

[0077] In Example 7, the subject matter of Example 6 includes, wherein the controller is configured to execute instructions to select an electrode of the array.

[0078] In Example 8, the subject matter of Examples 1-7 includes, wherein the controller is configured to select an electrode of the array in response to the measure of moisture.

[0079] In Example 9, the subject matter of Examples 1-8 includes, wherein the controller includes a memory and wherein the memory is configured to store data corresponding to a selected electrode of the array.

[0080] In Example 10, the subject matter of Examples 1-9 includes, wherein the controller is affixed to a lingual region of the splint.

[0081] In Example 11, the subject matter of Examples 1-10 includes, wherein the measure of moisture is indicated by electrical resistance.

[0082] In Example 12, the subject matter of Examples 1-11 includes, wherein the sensor comprises a pair of electrical conductors configured to measure electrical resistance as an indicator of moisture.

[0083] In Example 13, the subject matter of Examples 1-12 includes, wherein the array of electrodes comprises at least six electrodes arranged in multiple rows and columns. In Example 14, the subject matter of Example 13 includes, wherein the controller is configured to individually address each electrode in the array.

[0084] In Example 15, the subject matter of Examples 1-14 includes, wherein the splint comprises a rigid plastic material custom-fitted to a particular set of mandibular teeth.

[0085] In Example 16, the subject matter of Examples 1-15 includes, wherein the splint comprises an elastic material configured for universal fit.

[0086] In Example 17, the subject matter of Examples 1-16 includes, wherein the array of electrodes is positioned to contact a buccal region of tissue below a gum line.

[0087] In Example 18, the subject matter of Examples 1-17 includes, wherein the controller comprises a signal generator configured to provide a pulsed electrical signal.

[0088] In Example 19, the subject matter of Examples 1-18 includes, wherein the controller is configured to execute an algorithm for optimizing electrode selection based on individual lingual nerve anatomy.

[0089] In Example 20, the subject matter of Examples 1-19 includes, wherein the sensor is positioned in a distal region of the splint adjacent to the array.

[0090] In Example 21, the subject matter of Examples 1-20 includes, wherein the power supply comprises a miniature battery integrated into the splint.

[0091] In Example 22, the subject matter of Examples 1-21 includes, wherein the controller is positioned in a lingual region of the splint proximal to the array.

[0092] Example 23 is a method for treating xerostomia comprising: positioning an intraoral device having a splint configured to fit mandibular teeth in a mouth of a patient; sensing moisture levels in an oral cavity using a sensor coupled to the splint; selecting at least one electrode from an array of electrodes coupled to the splint based on the sensing the moisture levels; and delivering electrical stimulation through the at least one electrode to stimulate salivary gland function.

[0093] In Example 24, the subject matter of Example 23 includes, storing data corresponding to optimal electrode selection and stimulation parameters in a memory. In Example 25, the subject matter of Examples 23-24 includes, wherein selecting the at least one electrode comprises testing multiple electrodes sequentially and determining optimal stimulation locations.

[0094] In Example 26, the subject matter of Examples 23-25 includes, wherein the electrical stimulation is delivered at signal parameters including duration, duty cycle, amplitude, frequency, and phase selected based on the moisture levels as sensed.

[0095] Example 27 is a system for treating dry mouth comprising: an intraoral splint configured to conform to a lower dental arch; a plurality' of electrodes disposed on the intraoral splint and positioned to contact buccal tissue; a moisture detection circuit configured to measure oral moisture levels; a control circuit configured to automatically adjust stimulation parameters based on the oral moisture levels as measured; and a power source configured to provide electrical energy to one or more of the plurality of electrodes.

[0096] In Example 28, the subject matter of Example 27 includes, wherein the plurality of electrodes are arranged in a rectangular array with electrodes positioned on opposing sides of a medial plane.

[0097] In Example 29, the subject matter of Examples 27-28 includes, wherein the moisture detection circuit comprises a ceramic sensor, quartz crystal microbalance sensor, polymer sensor, or tunable diode laser absorption spectroscopy sensor.

[0098] In Example 30, the subject matter of Examples 27-29 includes, wherein the control circuit comprises a processor configured to execute instructions for selecting stimulation protocols based on archived stimulation and response data.

[0099] Example 31 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-30.

[0100] Various Notes

[0101] The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.’" Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0102] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0103] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0104] Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0105] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non- transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0106] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:

1. An intraoral device comprising: a splint configured to fit mandibular teeth; an array of electrodes coupled to the splint, the array aligned on a medial plane and proximal to a distal portion of the splint; a controller coupled to the array, the controller coupled to a power supply; and a sensor coupled to the controller and coupled to the splint, the sensor configured to provide a measure of moisture.

2. The device of claim 1 wherein the splint is inelastic.

3. The device of any one of claims 1-2 wherein the array is aligned on a vertical axis.

4. The device of any one of claims 1-3 wherein the array includes a plurality of pairs of electrodes.

5. The device of any one of claims 1-4 wherein the controller is configured to provide a pulse.

6. The device of any one of claims 1-5 wherein the controller is configured to provide stimulation at a signal level based on the measure of moisture.

7. The device of claim 6 wherein the controller is configured to execute instructions to select an electrode of the array.

8. The device of any one of claims 1-7 wherein the controller is configured to select an electrode of the array in response to the measure of moisture.

9. The device of any one of claims 1-8 wherein the controller includes a memory and wherein the memory is configured to store data corresponding to a selected electrode of the array.

10. The device of any one of claims 1-9 wherein the controller is affixed to a lingual region of the splint.

11. The device of any one of claims 1-10 wherein the measure of moisture is indicated by electrical resistance.

12. The device of any one of claims 1-11 wherein the sensor comprises a pair of electrical conductors configured to measure electrical resistance as an indicator of moisture.

13. The device of any one of claims 1-12 wherein the array of electrodes comprises at least six electrodes arranged in multiple rows and columns.

14. The device of claim 13 wherein the controller is configured to individually address each of the at least six electrodes in the array.

15. The device of any one of claims 1-14 wherein the splint comprises a rigid plastic material custom-fitted to a particular set of mandibular teeth.

16. The device of any one of claims 1-15 wherein the splint comprises an elastic material configured for universal fit.

17. The device of any one of claims 1-16 wherein the array of electrodes is positioned to contact a buccal region of tissue below a gum line.

18. The device of any one of claims 1-17 wherein the controller comprises a signal generator configured to provide a pulsed electrical signal.

19. The device of any one of claims 1-18 wherein the controller is configured to execute an algorithm for optimizing electrode selection based on individual lingual nerve anatomy.

20. The device of any one of claims 1-19, wherein the sensor is positioned in a distal region of the splint adjacent to the array.

21. The device of any one of claims 1-20 wherein the power supply comprises a miniature battery integrated into the splint.

22. The device of any one of claims 1-21 wherein the controller is positioned in a lingual region of the splint proximal to the array.

23. A method for treating xerostomia comprising: positioning an intraoral device having a splint configured to fit mandibular teeth in a mouth of a patient; sensing moisture levels in an oral cavity using a sensor coupled to the splint; selecting at least one electrode from an array of electrodes coupled to the splint based on the sensing the moisture levels; and delivering electrical stimulation through the at least one electrode to stimulate salivary gland function.

24. The method of claim 23 further comprising storing data corresponding to optimal electrode selection and stimulation parameters in a memory.

25. The method of any one of claims 23-24 wherein selecting the at least one electrode comprises testing multiple electrodes sequentially and determining optimal stimulation locations.

26. The method of any one of claims 23-25 wherein the electrical stimulation is delivered at signal parameters including duration, duty cycle, amplitude, frequency, and phase selected based on the moisture levels as sensed.

27. A system for treating dry mouth comprising: an intraoral splint configured to conform to a lower dental arch;a plurality of electrodes disposed on the intraoral splint and positioned to contact buccal tissue; a moisture detection circuit configured to measure oral moisture levels; a control circuit configured to automatically adjust stimulation parameters based on the oral moisture levels as measured; and a power source configured to provide electrical energy to one or more of the plurality of electrodes.

28. The system of claim 27, wherein the plurality of electrodes are arranged in a rectangular array with electrodes positioned on opposing sides of a medial plane.

29. The system of any one of claims 27-28 wherein the moisture detection circuit comprises a ceramic sensor, quartz crystal micro-balance sensor, polymer sensor, or tunable diode laser absorption spectroscopy sensor.

30. The system of any one of claims 27-29 wherein the control circuit comprises a processor configured to execute instructions for selecting stimulation protocols based on archived stimulation and response data.

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