Apparatus for use in delivering electrical stimulation

Abstract

An apparatus for use in delivering electrical stimulation to a trigeminal nerve of the mouth of a user, the apparatus comprising: a teeth engaging portion; at least one supporting member extending from the teeth engaging; and at least a first pair of electrodes comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are supported by the at least one supporting member; and wherein the at least one supporting member, when the teeth engaging portion is engaged with teeth of the user, is configured to bias each electrode of the first pair of electrodes to contact tissue of a palate of the mouth of the user to deliver the electrical stimulation to the trigeminal nerve.

Description

[0001] APPARATUS FOR USE IN DELIVERING ELECTRICAL STIMULATION

[0002] Field

[0003] The present disclosure relates to an apparatus for use in delivering electrical stimulation to a mouth of a user and, in particular, to a mouthpiece for use in delivering electrical stimulation to the trigeminal nerve. The present disclosure also relates to a system comprising the apparatus in combination with an electrical stimulator.

[0004] Background

[0005] Cranial nerves are paired structures defined as nerves that exit the brain and do not transit the spinal cord. They provide afferent (sensory) and efferent (motor) innervation to structures in the head and neck. They originate from neural processes associated with distinct brainstem nuclei and cortical structures. Cranial nerve, V (i.e. the trigeminal nerve), is functionally mixed with sensory and motor elements and is the largest of the cranial nerves. It carries motor innervation to the muscles of the tongue and sensory innervation from various areas in the head and neck.

[0006] The trigeminal nerve possesses three branches, VI (ophthalmic), V2 (maxillary) and V3 (mandibular). It has been demonstrated that the central nervous system can be influenced via some or all of the cranial nerves, including the trigeminal branches VI and V3 either within the skull or elsewhere on the nerve pathway (e.g. via the vagus nerve below the neck).

[0007] However, effectively stimulating the trigeminal nerve via branch V2 (maxillary) and V3 (mandibular) is a challenge.

[0008] Summary

[0009] According to a first aspect of the present disclosure there is provided an apparatus for use in delivering electrical stimulation to a mouth of a user, the apparatus comprising : a teeth engaging portion; at least one supporting member extending from the teeth engaging portion; and at least a first pair of electrodes comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are supported by the at least one supporting member; and wherein the at least one supporting member, when the teeth engaging portion is engaged with teeth of the user, is configured to bias each electrode of the first pair of electrodes to contact one of: tissue of a palate of the mouth of the user, or tissue of a gum of the mouth of the user for use in delivering the electrical stimulation.

[0010] The at least one supporting member may be elongate. In one or more examples, the at least one supporting member may have a terminal end and the first electrode and the second electrode may be supported at or towards the terminal end of the at least one supporting member.

[0011] In one or more examples, the teeth engaging portion is configured to contact the teeth of the user.

[0012] In one or more embodiments, the apparatus comprises at least two supporting members including at least a first supporting member and a second supporting member, each extending from the teeth engaging portion at a common lateral side of the teeth engaging portion, wherein the first supporting member is configured to support one of the first electrode and the second electrode and the second supporting member is configured to support the other of the first electrode and the second electrode.

[0013] In one or more embodiments, one of the first electrode and the second electrode is arranged anterior to the other when the apparatus is received in the mouth of the user.

[0014] In one or more embodiments, the or each supporting member is cantilevered.

[0015] In one or more embodiments, the or each supporting member comprises a first surface that faces said at least one of the tissue of the palate of the mouth of the user or the tissue of the gum of the mouth of the user, wherein: a) the first surface includes a socket defined by a raised wall configured to receive at least one electrode of the at least first pair of the electrodes; b) the first surface includes a recess configured to receive at least one electrode of the at least first pair of the electrodes; c) the first surface includes a recess configured to receive at least one electrode of the at least a first pair of the electrodes such that the at least one electrode is substantially flush with the first surface; d) at least one electrode of the at least first pair of the electrodes is printed onto the first surface; e) the first surface is configured to support at least one electrode of the at least first pair of electrodes such that at least part of the at least one electrode sits proud of the first surface; f) the at least one electrode of the at least first pair of electrodes is adhered to the first surface; and g) the at least one electrode of the at least first pair of electrodes is moulded onto the first surface.

[0016] In one or more embodiments, the apparatus includes a plurality of electrical conductors each configured to electrically connect to a respective one of the first pair of electrodes (and optionally any further electrodes) to provide for connection of the first electrode and the second electrode to an electrical stimulator for applying a potential difference across the at least first pair of electrodes. In one or more examples, the potential difference is a voltage difference between the electrodes of the at least first pair of electrodes which may be configured to change over time.

[0017] In one or more embodiments, the plurality of electrical conductors are printed on the at least one supporting member.

[0018] In one or more embodiments, the at least one supporting member includes an aperture configured to receive at least one electrical conductor of the plurality of electrical conductors routed at least partially or wholly through the at least one supporting member. The at least one electrical conductor may be connected to a rear face of the electrode. The at least one electrical conductor may comprise a wire. In other examples, at least one electrical conductor of the plurality of electrical conductors is routed at least partially over a surface of the at least one supporting member. Accordingly, an aperture may not be present.

[0019] In one or more embodiments, the apparatus includes a second pair of electrodes comprising a third electrode and a fourth electrode, and the at least one supporting member comprises a plurality of supporting members comprising at least one left-lateral-side supporting member and at least one right-lateral-side supporting member, each extending from the teeth engaging portion at a corresponding lateral side of the teeth engaging portion, wherein the at least one left-lateral-side supporting member is configured to support the first pair of electrodes and the right-lateral-side supporting member is configured to support the second pair of electrodes.

[0020] In one or more examples, the left-lateral-side supporting member branches at a point spaced from the teeth engaging portion into a first branch and a second branch, wherein the first branch and the second branch each support one of the first electrode and the second electrode. In one or more examples, the right-lateral-side supporting member branches at a point spaced from the teeth engaging portion into a first branch and a second branch, wherein the first branch and the second branch each support one of the third electrode and the fourth electrode.

[0021] In one or more other embodiments, the apparatus includes a second pair of electrodes comprising a third electrode and a fourth electrode, and the at least one supporting member comprises four supporting members comprising a first supporting member and a second supporting member each extending from the teeth engaging portion at (e.g. at spaced locations along) a first common lateral side of the teeth engaging portion, and a third supporting member and a fourth supporting member each extending from the teeth engaging portion at (e.g. at spaced locations along) a second common lateral side of the teeth engaging portion opposed the first common lateral side, wherein the third supporting member is configured to support one of the third electrode and the fourth electrode and the fourth supporting member is configured to support the other of the third electrode and the fourth electrode.

[0022] In one or more examples, the first electrode is a first positive electrode, the second electrode is a first negative electrode. In one or more examples, the third electrode is a second positive electrode and the fourth electrode is a second negative electrode.

[0023] In one or more embodiments, the teeth engaging portion comprises a channel which is shaped to follow a curvature of a dental arch of the upper or lower jaw of the user, and is configured to receive and, optionally, grip the teeth of the user when in use. Thus, the teeth engaging portion may have the form of a mouthguard.

[0024] In one or more embodiments, the teeth engaging portion comprises: a plate configured to be disposed between an upper set of teeth and a lower set of teeth of the user, wherein the plate is configured to at least partially follow a curvature of a dental arch of the upper or lower jaw of the user; and wherein the teeth engaging portion is configured to be held in place by a biting force exerted on the plate by the teeth of the user.

[0025] In one or more examples, the plate is a substantially flat plate configured to follow the shape of the dental arch of the mouth of the user and configured to be secured by a biting force exerted on the flat plate by the user.

[0026] In one or more examples, the teeth engaging potion is an arcuate strip configured to engage with an inwardly facing surface of the upper set of teeth and provide an outward force against the upper set of teeth of the user when in use such that the teeth engaging portion is securely held in the mouth of the user and the or each supporting member extends therefrom in an upward direction so as to position an electrode at one of the tissue of the palate or the tissue of the gum of the mouth of the user when in use.

[0027] In one or more examples, the or each supporting member is configured to substantially follow the shape of the palatal arch of the mouth of the user. The or each supporting member may be of a flexible material and / or includes one or more flexible hinges. In one or examples, when the teeth engaging portion is engaged with the teeth, the at least one supporting member flexes from a default position to press each electrode of the first pair of electrodes to contact the one of: tissue of the palate of the mouth of the user, or tissue of the gum of the mouth of the user.

[0028] In one or more embodiments, the at least first pair of electrodes and the at least one supporting member are configured for providing electrical stimulation of a nerve in the mouth of the user via one of: the palate within the mouth of the user; an outwardly facing surface of an upper gum within the mouth of the user; an inwardly facing surface of an upper gum within the mouth of the user; an outwardly facing surface of a lower gum within the mouth of the user; and an inwardly facing surface of a lower gum within the mouth of the user.

[0029] In one or more embodiments, each electrode of the at least first pair of electrodes is formed of one of: a dental amalgam material, a metallic material; and a conductive plate, which may be domed or flat or other shape.

[0030] In one or more embodiments, each electrode of the at least first pair of electrodes is configured to provide the electrical stimulation to one of: an ophthalmic branch of a trigeminal nerve of the user, a maxillary branch of a trigeminal nerve of the user, and a mandibular branch of a trigeminal nerve of the user.

[0031] In one or more examples, the at least first pair of electrodes and at least one supporting member are configured for providing electrical stimulation to a branch of the trigeminal nerve of the user.

[0032] In one or more embodiments, the apparatus comprises an intra-oral electrode array apparatus.

[0033] In one or more embodiments, the apparatus includes at least a first part of an electrical coupling, wherein the electrical coupling is electrically connected to the at least first pair of electrodes to enable the apparatus to be connected to an electrical stimulator for applying a voltage and / or current to the at least first pair of electrodes.

[0034] Thus, the apparatus may includes a first part of an electrical coupling, wherein the first part of the electrical coupling is configured to be coupled to a second, corresponding part of the electrical coupling configured to provide an electrical signal for delivering the electrical stimulation to the mouth of the user.

[0035] In one or more examples, the first part of the electrical coupling comprises a common electrical coupling to provide for connection of an electrical stimulator to the at least first pair of electrodes (and, optionally, any further pairs of electrodes) via the plurality of electrical conductors. In one or more examples, the common electrical coupling is physically connected to the teeth engaging portion. In other examples, the common electrical coupling is physically connected to the at least one supporting member. In other examples, the common electrical coupling is provided at the end of one or more wires, which may comprise the plurality of electrical conductors, wherein the one or more wires extend from the apparatus and are configured to extend outside the mouth of the user and provide an electrical connection to the electrodes of the apparatus. In one or more examples, a complementary second part of the electrical coupling of the electrical stimulator is configured to couple to the common electrical coupling of the apparatus. The first part of the electrical coupling and the complementary second part of the electrical coupling may be embodied as a plug and socket.

[0036] In one or more embodiments, providing electrical stimulation comprises providing a voltage and / or a current to the mouth of the user.

[0037] According to a second aspect of the present disclosure there is provided a system comprising the apparatus of the first aspect in combination with an electrical stimulator, wherein the electrical stimulator is configured to produce an electrical signal for providing the electrical stimulation via the at least first pair of electrodes.

[0038] In one or more examples, the electrical stimulator comprises circuitry for applying a voltage and / or current or a pattern of voltages or currents across / between the at least first pair of electrodes (e.g. and any further electrodes) for delivering the electrical stimulation.

[0039] In one or more examples, the electrical stimulator is integral with the apparatus and is configured to be received in the mouth of the user together with the apparatus. In one or more examples, the electrical stimulator is integrated in or supported by the teeth engaging portion. In other examples, the electrical stimulator is separate from the teeth engaging portion. The electrical stimulator may be configured to be positioned outside the mouth.

[0040] In one or more examples, the electrical stimulator comprises a signal generator and a controller which defines one or more of the magnitude, timing, frequency, pattern of voltages and / or currents for generation by the signal generator that provide said electrical stimulation. The controller may be communicatively coupled to the signal generator, such as by a wired or wireless connection.

[0041] In one or more examples, the controller is integrated with the signal generator of the electrical stimulator. In other examples, the signal generator and the controller are separate, and the controller is configured to control the signal generator by a wired or wireless coupling. Thus, communication circuitry may be provided with the signal generator and with the controller. Thus, the controller may be provided by a smartphone or other electronic device to control the signals generated by the signal generator for providing the electrical stimulation. The controller may be reprogrammable such that the signals generated by the signal generator can be defined, updated or controlled live.

[0042] In one or more examples, the electrical stimulator is configured to provide signals to the at least first pair of electrodes by an inductive coupling to cause the at least first pair of electrodes to deliver the electrical stimulation. Thus, in one or more examples, the electrical stimulator may include a first coil and the first electrode may include a second coil and the second electrode may include a third coil to provide the inductive coupling. Thus, the electrical stimulator is configured to induce a current and / or voltage in the electrodes which in turn provides the electrical stimulation. Thus, the electrical stimulator may be provided remote, such as outside the mouth, and induce the current and / or voltage through the cheek and / or lips and / or head of the user.

[0043] In one or more examples, the electrical stimulator includes a battery or other power source, which may be integrated in or supported by the teeth engaging portion. The battery may or may not be rechargeable. In other examples the electrical stimulator is configured to be coupled to a separate power supply such as a battery.

[0044] In general, the electrical stimulator may comprise: a signal generator for providing the electric signal, a power source for powering the signal generator, and an output coupled to the signal generator and configured to provide the electrical signal to the at least first pair of electrodes for providing the electrical stimulation to the mouth of the user.

[0045] In one or more embodiments, the electrical stimulator is external to the apparatus, and wherein the output of the electrical stimulator is electrically coupled to the at least first pair of electrodes by one of a wired connection or a wireless connection.

[0046] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that other embodiments, beyond the particular embodiments described, are possible as well. All modifications, equivalents, and alternative embodiments falling within the spirit and scope of the appended claims are covered as well.

[0047] The above discussion is not intended to represent every example embodiment or every implementation within the scope of the current or future Claim sets. The figures and Detailed Description that follow also exemplify various example embodiments. Various example embodiments may be more completely understood in consideration of the following Detailed Description in connection with the accompanying Drawings.

[0048] Brief Description of the Drawings

[0049] One or more embodiments will now be described by way of example only with reference to the accompanying drawings in which:

[0050] Figures 1A, IB, 1C and ID show various views of an apparatus according to an example embodiment for providing electrical stimulation to a palate of a mouth of a user;

[0051] Figure 2 shows a cross section of an example embodiment of an apparatus of the present invention;

[0052] Figure 3 shows a further embodiment of the apparatus which engages with the teeth to secure the apparatus;

[0053] Figures 4A and 4B show a cross section and a plan view of an example embodiment wherein the teeth engaging portion is configured to engage with the inner surface of the upper dental arch;

[0054] Figure 5 shows an example embodiment of an apparatus for providing electrical stimulation to a gum of the mouth of the user;

[0055] Figures 6A, 6B, 6C, and 6D show four example configurations of the supporting member(s); and

[0056] Figures 7A, 7B, 7C, 7D, and 7E shows a number of different example configurations for the system comprising the apparatus and an electrical stimulator.

[0057] Detailed Description

[0058] The present disclosure relates to an apparatus for use in delivering electrical stimulation to a mouth of a user. The electrical stimulation of the trigeminal nerve through the mouth of the user has been found to provide an effective way to achieve neuromodulation and / or improve brain function in certain circumstances. Thus, in one or more examples, we provide an apparatus to effectively provide the electrical stimulation.

[0059] The electrical stimulation that is provided can be used to provide neuromodulation in the user. Neuromodulation is the process of changing the activity of the brain through the stimulation of nerves, in particular cranial nerves, using electrical stimulation. Electrical stimulation of these nerves can modulate abnormal neural pathway behaviours caused by disease or traumatic processes / experiences.

[0060] Neuromodulation can achieve a neuroplastic response which is the ability of the brain to form and reorganize synaptic connections, especially in response to learning or experience or following injury or disease processes. In some examples, neuromodulation can lead to improved recovery times after experiencing physical trauma. In other examples the neuroplastic response can improve other processes such as improving vascular activity in the event of acute medical conditions.

[0061] Neuromodulation to achieve a neuroplastic response can be undertaken in both the peripheral nervous and central nervous system affecting both somatic and autonomic systems.

[0062] Apparatus overview

[0063] Figures 1A to ID show examples of an apparatus 100 to be placed in the mouth of a user. In some examples, the apparatus 100 may be referred to as a mouthpiece or intra-oral oral electrode array apparatus. For ease of understanding, the figures are generally presented with the features of the apparatus 100 in solid lines and anatomical features of the user shown using dashed lines. We will describe the embodiment of Figures 1A to ID, which appears similar to a mouthguard, and then describe numerous variations that may be implemented to the component parts of the apparatus 100. As will be described with reference to other figures, the apparatus 100 can take many different forms and is not limited to the form of a mouthguard.

[0064] In general, the apparatus 100 comprises a teeth engaging portion 102 and at least one supporting member 121-124, wherein the at least one supporting member supports at least a pair of electrodes 112, 114 and positions them against the palate or gum. In the present example, four supporting members 121, 122, 123, 124 are shown. The supporting members 121, 122, 123, 124 extend from the teeth engaging portion 102 and are formed integrally therewith. In other examples, they may be permanently or removably attached or secured to the teeth engaging portion 102. The supporting members 121-124 are attached to the teeth engaging portion 102 at one end and therefore cantilevered. The supporting members 121-124 are each generally elongate arms and have a terminal end 106 opposite the point that extends from the teeth engaging portion 102. In some other examples, the supporting members 121-124 may not have a terminal end and, instead, may form a continuous arch that follows the shape of the palatal arch of the mouth of the user. In such an example, the supporting member(s) 121-124 may be integral with or secured or attached to the teeth engaging portion 102 at opposite sides of the teeth engaging portion 102 or comprise a plate that extends up from the teeth engaging portion 102 and is configured to lie, at least partially, against the palate.

[0065] The apparatus 100 includes at least a first pair of electrodes 110 which comprise a first electrode 112 and a second electrode 114. This embodiment also includes a second pair of electrodes 128 such that each of the four supporting members supports one of the electrodes. The first electrode 112 and the second electrode 114 are supported at or towards the terminal end 106 of the supporting members 121, 122 spaced from the teeth engaging portion 102.

[0066] The supporting members 121-124 are configured to extend such that the pairs of electrodes 110, 128 are positioned to effectively apply the electrical stimulation to stimulate the trigeminal nerve. Thus, the supporting members 121-124 project or extend from the teeth engaging portion 102 in a direction such that they are positioned adjacent or on either the palate of the mouth of the user or adjacent or on the gum of the mouth of the user when in use. The electrodes may contact the roof of the mouth adjacent the hard palate, the soft palate or the boundary between the hard and soft palate. Accordingly, the supporting members 121-124 may have different lengths and shapes.

[0067] In the embodiment of Figures 1A-1D, the supporting members 121-124 position the respective pairs of electrodes 110, 128 against the palate. However, in other examples, the at least one supporting member 104 may position the electrodes against an inwardly facing surface of the gum (i.e. the surface of the gum behind the teeth 108). In another example, shown in Figure 5, the at least one supporting member 504 may be directed towards the outwardly facing surface of the gum (i.e. in front of the teeth 108).

[0068] Figures 1A and IB show the apparatus 100 with the first electrode 112 and the second electrode 114 supported by the two supporting members 121, 122 respectively. Likewise, a third electrode 130 and a fourth electrode 132 of the second pair of electrodes 128 are supported by the two supporting members 123, 124. In this example, the supporting members extend from spaced locations along the teeth engaging portion 102 and may be separate by a gap 125 on each side of the teeth engaging portion 102. However, in other examples, the two supporting members 121, 122 may project from the teeth engaging portion at a common point and branch to form the arms of the two supporting members 121, 122. The two supporting members 123, 124 may have the same form, or a different form.

[0069] Figure 1C shows a cross sectional view along line A-A in figure 1A. It will be appreciated that the cross-sectional shape of the electrode 114 is only illustrative and the actual electrode shape can vary and may be generally conformal to the mouth of the user. Thus, a face of each electrode 110, 128 may be flat, domed or have a more complex shape.

[0070] The teeth engaging portion 102, in the present example, comprises a channel 118 to receive the upper set of teeth 108. The channel may at least partly grip the teeth 108 to hold the apparatus in place. In the present example, the teeth engaging portion 102 includes a further channel 119 for receiving the lower set of teeth. However, in other examples, the further channel 119 may be absent.

[0071] Figure ID shows the apparatus 100 with the first electrode 112, the second electrode 114, the third electrode 130 and the fourth electrode 132 removed from their respective supporting members 121-124. The at least one supporting member 102 includes a section 116, which may take the form of a recess and / or cup, for receiving one of the first electrode 112 and the second electrode 114. The various sections 116 for receiving the first to fourth electrodes 112, 114, 140, 132 will be described in more detail later.

[0072] Thus, in summary, the present example comprises two supporting members 121, 122 on a first lateral side 126 wherein each supporting member 121, 122 supports a respective electrode of the first pair of electrodes. Further, the present example comprises two further supporting members 123, 124 on a second lateral side, opposite the first lateral side, wherein each of the further supporting members supports a respective third electrode 130 and a fourth electrode 132 of a second pair of electrodes 128. The third and fourth electrodes can mirror the configuration of the first and second electrodes 112 and 114 as described above (albeit configured to be positioned on the opposing common lateral side of the mouth of the user when in use).

[0073] Further, in more general terms, the plurality of supporting members 121-124 comprise at least one left-lateral-side supporting member 121, 122 and at least one right-lateral- side supporting member 123, 124 each extending from the teeth engaging portion 102 at a corresponding lateral side of the teeth engaging portion 102. It will be appreciated that having independent supporting members for each electrode can make it easier for the supporting members 104 to conform to the shape of a palatal arch of the mouth 202 when in use and can enable a more reliable and consistent electrical contact to be maintained when in use.

[0074] In the examples shown herein the arrangements of the pairs of electrodes are, generally, laterally symmetrical. However, it will be appreciated that in some examples the electrodes on the left and right lateral side of the apparatus 100 may not be symmetrically arranged. Likewise, the supporting members may or may not be symmetrically arranged. In some examples, the electrodes on the left lateral side may be arranged differently to the electrodes on the right lateral side. In some other examples, the apparatus may only have electrodes on one of the left or right lateral side of the apparatus 100.

[0075] Figure 2 illustrates a simplified cross section of a further embodiment when received in the mouth 202 of the user.

[0076] In the example of figure 2, the teeth engaging portion 102 and the supporting members 122, 124 are arranged to bias each electrode of the first pair of electrodes 110 to contact a surface on the inside of the mouth 202 of the user to allow enable electrical conduction for providing electrical stimulation to nerves within the mouth of the user (the electrical stimulation is shown schematically as 204). It will be appreciated that the biasing force may be generated by deforming of the at least one supporting member from its default, rest position when the apparatus 100 is inserted into the mouth of the user and the teeth engaging portion 102 engages the teeth 108.

[0077] It will be appreciated that the one or more supporting members may extend so as to position the at least first pair of electrodes 110 for effective electrical stimulation 204 of the trigeminal nerve in the mouth 202. However, more generally, the at least one supporting member 121-124 may position the at least first pair of electrodes 110 and any further electrodes such that they are located proximal to one or more of an ophthalmic branch of the trigeminal nerve, a maxillary branch of the trigeminal nerve and a mandibular branch of the trigeminal nerve. In other examples other portions or different branches of the trigeminal nerve may also be stimulated by an appropriate arrangement of the supporting members 121-124 and the at least first pair and second pair of electrodes 110, 128. In some examples the first pair and / or second pair of electrodes 110 may be arranged to stimulate the dental nerves, lingual nerves or other nerves in the mouth.

[0078] We will now describe different example embodiments for the main structures of the apparatus 100. The main structures that will be described include the teeth engaging portion 102, the arrangement of the pairs of electrodes and the structure of the one or more supporting members 121-124.

[0079] An electrical stimulator which is configured to provide the electric signal to the electrodes will also be described including how the stimulator can be coupled to the electrodes.

[0080] It will be appreciated that the examples described herein represent only some of the possible combinations of the apparatus and the system. It will be appreciated that other combinations are also within the scope of the present disclosure as will be apparent to a skilled person. For reasons of brevity, all possible combinations of the relevant parts are not explicitly disclosed but are intended to be covered by this disclosure.

[0081] Teeth engaging portion

[0082] Figures 1 to 5 show different embodiments of the teeth engaging portion 102.

[0083] In figures 1 and 2 and 5 the teeth engaging portion 102 includes a channel 118 which grips the teeth 108 and may be held in place by a friction fit over the surface of the teeth 108. However, in other examples, the channel 118 of the teeth engaging portion 102 does not provide a friction fit and instead, the teeth engaging portion 102 may be configured to make contact with the teeth and be secured during use using one or both of a biting force generated by the user and by the use of oral prosthesis adhesive (such as "Fixodent"®).

[0084] The channel 118, as shown in the embodiment of Figure 1A-1D, may follow the complete dental arch 120 of the mouth of the user or may only partially follow the dental arch (not shown). The channel 118 may be provided in continuous or discontinuous sections.

[0085] Figure 3 shows a further embodiment in which the teeth engaging portion 102 comprises a plate 302. In this example, the plate 302 does not grip the teeth 108 and requires a biting force to hold the teeth engaging portion 302 in place. In such an example, the electrodes, supported by the supporting members 304, may be pushed against the palate 206 of the mouth when the user bites on the plate 302, which in turn may urge the supporting members 304 away from their default, rest position and cause them to hold the electrodes 110 against the palate 206. In some examples, the plate 302 may be a substantially flat plate that is configured to be disposed between the upper set of teeth 212 and the lower set of teeth 214. The plate 302 may be configured to follow the curvature of the dental arch 120 of the upper jaw and / or the lower jaw of the user. This arrangement allows the user to secure the apparatus 300 in position by biting down on the plate 302. This can allow for a much simpler arrangement which may be more comfortable for the user as it requires less material and can be made smaller. In some examples, the plate 302 may be formed of several smaller portions or tabs that extend between the jaws. Thus, the tabs may not cover the entire dental arch 120. In such an example (not shown) the plate or tabs of the apparatus 300 may be secured in position by being clamped by the rear teeth of the user. Provision of tabs or a plate that extends between the rear teeth and does not extend between the front teeth may be more comfortable for the user.

[0086] In another embodiment, as shown in figures 4A and 4B, the teeth engaging portion 102 comprises an arcuate strip 402 (i.e. an arched strip of material) that can be inserted into the mouth and positioned against the inner surface of the dental arch 120 of the upper set of teeth 212. The arcuate strip 402 is shaped to engage with the dental arch 120.

[0087] The arcuate strip 402 is configured to provide an outward, retaining force against the inwardly facing side surface of the upper teeth for retaining the apparatus 400 in the mouth 202 of the user. In some examples, the arcuate strip 402 may include outwardly facing protrusions 406, 408. These protrusions may be configured to engage with interdental gaps (i.e. gaps between teeth). These protrusions may function as anchor points to hold the apparatus 400 in place when in use. These protrusions may be further configured to prevent the arcuate strip 402 from sliding back into the mouth of the user. The apparatus 400 may include an anchor tab 404. The anchor tab 404 extends from the teeth engaging portion to lie against the outwardly facing surface of the upper teeth. This may facilitate insertion and removal of the apparatus 400. The anchor tab 404 may clip to the front teeth to prevent the apparatus 400 from becoming dislodged during use. The retaining force generated by the arcuate strip 402 may be generated by resiliently deforming the arcuate strip from an initial shape and placing it behind the dental arch 120 in the mouth of the user. The arcuate strip 402 can be formed of a resilient material that produces the outward retaining force when the arcuate strip 402 is deformed for placement in the mouth. The retaining force urges the arcuate strip 402 against the rear surface of the upper set of teeth 212 and thus can hold the teeth engaging portion 402 in position without requiring any additional force or any additional adhesive. In such an embodiment, the apparatus 400 is less bulky and may be more comfortable and less disruptive to other tasks.

[0088] Figure 5 shows a further embodiment in which the teeth engaging portion 502 comprises a single channel 508 (the channel may have a structure similar to the channel 118 described with relation to figures 1 and 2). Thus, in this example, the teeth engaging portion 502 has a single channel to receive the upper teeth rather than a first channel for the upper teeth and a second, further channel for the lower teeth as in the previous examples.

[0089] In the example of figure 5, the at least one supporting member 504 is configured to position an electrode of the at least first pair of electrodes 110 to contact the tissue of the upper gum 208 of the mouth of the user. The supporting member 504 extends along the outer side of the upper set of teeth 212 of the user and is configured to position at least one electrode of the first pair of electrodes 110 at the upper gum 208 of the mouth of the user when in use. The other electrode of the pair may be position and a spaced location at the upper gum 208 or at the inner gum. It will be appreciated that the supporting member 504 can instead of, or in addition to extending in an upward direction, extend towards the lower gum 210 of the mouth of the user for providing electrical stimulation 506 to the tissue of the lower gum 208.

[0090] In an example (not shown) the teeth engaging portion includes a single channel to receive the lower teeth and the supporting member(s) extend to place the electrode for electrical stimulation of the tissue of the lower gum 210 of the mouth of the user. In some examples the at least one supporting member 104 may include a combination of both upward and downward extending supporting members 104 at separate locations around the teeth engaging portion 102.

[0091] Although not shown in figure 5, the apparatus 500 may be further configured to alternatively or additionally have a second pair of electrodes positioned on the opposite lateral side of the apparatus 500 for stimulating the nerve on the opposing lateral side of the mouth of the user, such as the gum at the other side of the mouth or the palate.

[0092] In the embodiments disclosed herein, the teeth engaging portion 102 comprises a portion of the apparatus 100-500 configured to at least contact the teeth 108 of the user in order to hold the apparatus 100-500 in place during use. The teeth engaging portion 102 may be made of dental resin or other suitable material such as a biocompatible polymer. The material for the teeth engaging portion may be selected to provide for a resilient deformation of the teeth engaging portion 102 and or the supporting members. In some examples the supporting members 104, 504 may be formed as an extension of the teeth engaging portion 105, 502 and in other examples the supporting members 104, 504 may be separate components that are attached or otherwise secured to the teeth engaging portion 102, such as by way of a removable connection.

[0093] Supporting members

[0094] The supporting member(s) may be configured to bias the electrodes against the mouth. In some examples, they may serve a further function of engaging the mouth to hold the apparatus 100 in the mouth.

[0095] The apparatus 100 may have at least two, at least three or at least four or more supporting members. These supporting members may be flexible or rigid and may be hinged. Thus, a hinge may provide a level of resilience to an otherwise rigid supporting member. Each supporting member may support a single or multiple electrodes. The number of electrodes can vary to tailor the level and location of electrical stimulation 204, 506 required.

[0096] In some examples, the or each supporting member may be rigid for a portion of its length extending from the teeth engaging portion 102 and may be elastically deformable along the remainder of its length towards and including the location where the electrodes of the first pair (and second pair, if present) of electrodes 110 are supported. In some examples, the proportion of the or each supporting member 104 that may be rigid may comprise 10%, 20%, 50% or up to 75% of the total length of the or each supporting member. In such examples these elastically deformable sections may enable consistent and compliant contact with the tissue of the palate 206 or the tissue of the gum 208, 210. It has already been described that Figures 1A to ID show an embodiment having four supporting members 121-124, however, with reference to those figures we will describe an embodiment where only two supporting members are provided. Thus, in some examples, the apparatus 100 may comprise two supporting members on one lateral side comprising the first supporting member 121 and the second supporting member 122. In such an embodiment, each of the first and second supporting members extend from the teeth engaging portion 102 at a first common lateral side 126 of the teeth engaging portion 102. The first common lateral side refers to one of the left or right halves of the mouth 202 of the user. In this case, the first common lateral side 126 will relate to the left side from the point of view of the user. In the embodiment of Figures 1A to ID each supporting member supports a single electrode.

[0097] We will now describe the interface between the electrodes and the supporting member(s) firstly with reference to Figure 2. The, or each, supporting member 104, 130 comprises a first surface 216 that faces at least one of the tissue of the palate 206 or the tissue of the upper or lower gum.

[0098] The first surface 216 includes a recess to receive the electrode 110. In the example of figure 2, the electrode is partially received within the recess and projects proud of the first surface 216, although it may be flush with the first surface 216 in other embodiments.

[0099] As shown in figure ID, the first surface 216 can include a socket 116. The socket may be defined by a raised wall 132 (or cavity in other examples). The socket 116 may be configured to receive at least one electrode of the at least first pair of the electrodes 110. The raised wall 132 may alternatively be configured to provide a cavity or socket into which dental amalgam or other mouldable conductive material may be placed to provide each electrode of the first pair of electrodes 110. This may be advantageous as the electrode may be selected or the material moulded to provide the desired electrode type / shape.

[0100] In yet another embodiment, the at least one electrode of the at least first pair of electrodes 110 (and optionally any other electrodes) can be printed onto the first surface 216. This may allow for bespoke electrode shapes to be used for applying targeted electrical stimulation to the mouth of the user. The printing may comprise photoresist etching or the deposition of conductive ink. Other examples include the at least one electrode of the at least first pair of electrodes being adhered to the first surface 216 or otherwise secured. Further, one or more of the electrodes may be moulded, such as over-moulded in a two-shot process, onto the first surface 216. Accordingly, an electrically conductive polymer or other electrode material may be used.

[0101] With reference to Figure ID, the or each supporting member 104, 130 may include an aperture 134 through or partially through the thickness of the supporting member 104, 130. The aperture 134 may be configured to receive an electrical conductor, such as a wire, for electrically coupling at least one electrode of the first pair of electrodes 110 to a supply of the electrical signal for delivering the electrical stimulation 204, 506. In some examples, the electrical conductor may be formed wholly or partly within the supporting member 104. In another example the electrical conductor may not be routed through the at least one supporting member 104 and may comprise a cable that is directly connected to each electrode of the first pair of electrodes 110 and is separate from the supporting members 104, 130.

[0102] Figures 6A- 6D show a number of different arrangements for the supporting members The electrodes are shown at the first common lateral side 126 of the teeth engaging portion 102. It will be appreciated that the electrodes 112, 114 may alternatively or additionally be provided at the second common lateral side. Figures 6A-6D only show the electrodes on one side for simplicity. The illustrations highlight the main differences but the geometries of the supporting members 602-608 are not limited to the specific geometries shown.

[0103] Figure 6A is an example in which a single supporting member 602 extends from the teeth engaging portion 102. Both electrodes of the first pair of electrodes 110 are supported on the single supporting member 602. The supporting member 602 is joined to the teeth engaging portion 102 along a width dimension of the supporting member 602. The supporting member, along a length dimension, extends away from the teeth engaging portion 102 to position the electrodes 112, 114 against the palate. The width dimension is greater than the length dimension for the supporting member 602. The supporting member 602 has the form of a wide tab or plate-like structure rather than an arm as shown in earlier examples. The supporting member 602 may be at least partially flexible as described above to ensure a reliable contact with the palate 206 of the mouth of the user. In another example (not shown) the supporting member 602 may extend from an outer edge of the teeth engaging portion 102 and extend to a position which can support the first pair of electrodes 110 at the gum (upper 208 or lower 210) of the mouth of the user. Figure 6B shows an example in which the supporting members 604 comprise a first supporting member 621 and a second supporting member 622 which each independently extend from the teeth engaging portion 106 and respectively support the first electrode 112 and the second electrodes 114 of the first pair of electrodes 110. In this example, the first supporting member 621 is longer than the second supporting member, whereas in the example of Figure 1A-1D, the supporting members were substantially the same length. Further, in this example, the electrodes sit proud at the end of the supporting member without a raised wall 132.

[0104] Figure 6C shows an example in which a single supporting member 606 supports two electrodes. The supporting member 606 initially extends from the teeth engaging portion 106. A width of the supporting member 606 at the teeth engaging portion 106 substantially corresponds to the width of the separation between the first and second electrode of the first pair of electrodes 110. The supporting member 606 includes a groove 610 that partially divides it into two separate extensions from the initial common portion to independently support each electrode 112, 114 of the first pair of electrodes 110.

[0105] Figure 6D shows an example in which the supporting member 608 extends from a narrower section of the teeth engaging portion 102. In this example, the initial width of the supporting member 608 is less than the separation between the first electrode and the second electrode and is narrower than the width of the supporting member 606 shown in figure 6C. In this example embodiment, the supporting member 608 branches to provide a first branch 612 to support the first electrode 112 and a second branch 614 to support the second electrode. The common base allows for twisting of the supporting member 608, while the first and second branches allow for independent conformance to the palate and biasing of the electrodes towards the palate.

[0106] In another example embodiment (not shown), the or each supporting member may form an arch between the first common lateral side 126 and the second opposite common lateral side of the mouth of the user. In such an embodiment, the electrodes may be positioned on the arched supporting member to contact the tissue of the mouth of the user at suitable points along the palatal arch 206 to apply the required electrical stimulation 204, 506 to the nerves in the palate 206 of the mouth. In the embodiment where the supporting member 104 is an arch, a single supporting member may support the first pair of electrodes 110 and the second pair of electrodes 128, if present. Alternatively, separate arches may be provided or a combination of arches and arms. Electrodes

[0107] The first pair of electrodes and, if present, the second pair of electrodes 110, 128 may be formed from one of a dental amalgam material; a metallic material; and a conductive plate. The electrodes may comprise an otherwise conductive material, such as a graphene-based material or a conductive polymer. The electrodes may be shaped so as to have a domed or substantially flat profile. Depending on the shape of the palate or gum to be contacted, this can allow for improved contact at the surface of the tissue of the mouth. Improved contact may result in reduced electrical contact resistance.

[0108] In the examples described herein, the electrical stimulation 204, 506 is provided to the mouth 202 of the user via pairs of electrodes 110, 128. The first electrode 112 may be a first positive electrode and the second electrode 114 may be a first negative electrode. If present, the third electrode may be a second positive electrode and the fourth electrode may be a second negative electrode. However, it will be appreciated that in some examples, the polarity of each electrode in the first pair of electrodes 110 or the second pair of electrodes 128 do not need to be of different sign. Thus, in some examples the electrodes provide a potential difference but the pair of electrodes 110, 128 are of the same polarity.

[0109] In some examples the voltage difference may be less than 10 V, 20 V or 30 V, although other voltages are within the scope of the disclosure. For example, greater voltages may be used.

[0110] In the present examples, the electrical stimulation is provided by applying a potential difference between the electrodes which are positioned, by the supporting members, at different points along the length of the nerve to be stimulated. In general, the trigeminal nerve in the palate extends from the back of the mouth to the front. Thus, in general, the first electrode 112 or the second electrode 114 is arranged anterior to the other when the apparatus is received in the mouth 202 of the user as shown in figures 1A and IB. In other examples, the electrodes may be positioned such that the potential difference is provided between left and right branches of the nerve to be stimulated. Thus, a first electrode (and associated supporting member) of the pair may be configured contact the tissue adjacent a left branch of the trigeminal nerve in the palate, while the second electrode (and associated supporting member) of the pair may be configured to contact the tissue adjacent a right branch of the trigeminal nerve in the palate. Likewise, the apparatus may be configured to apply the potential difference across the nerves in the left and right gums.

[0111] In examples where two pairs of electrodes are provided, the two pairs may be configured to stimulate the same side of the palate or gum or different sides of the palate or gum. In another example, the first pair of electrodes 110 may be in contact with the palate 206 of the mouth of the user and the second pair of electrodes 128 may be in contact with the tissue of the upper gum 208 or the tissue of the lower gum 210 of the mouth 202 of the user. In such an embodiment the first pair of electrodes 110 may be on the same or a different lateral side 126 of the mouth of the user as the second pair of electrodes 128.

[0112] Electrode connection and providing electrical signals

[0113] It will be appreciated that the electrical stimulation provided to the nerves of the mouth of the user via the electrodes involves providing a voltage and / or a current to the mouth of the user via the pairs of electrodes 110, 128.

[0114] In order to provide the necessary electrical stimulation to the nerves in the mouth of the user, the apparatus is configured to receive a suitable electrical signal (e.g. voltage or current) for application to the tissue of the palate 116, upper gum 208, or the lower gum 210. To allow for routing of the electrical signals to the electrodes, the apparatus may include electrical conductors that couple to each of the electrodes of the first pair of electrodes and, if present, the second pair of electrodes.

[0115] Figures 7A to 7E show, schematically, arrangements of the apparatus 700 indicating how the electrodes (schematically shown as dots at the end of the electrical conductors 702) may be connected to receive the required electrical signal.

[0116] The apparatus 700 may be coupled to an electrical stimulator 704 which generates electrical signals to be applied via the electrodes for providing the electrical stimulation of the nerves. The plurality of electrical conductors 702 enable the respective electrodes to be connected to the electrical stimulator 704. The electrical stimulator 704 may be configured to apply an electric potential difference across the at least first pair of electrodes 110 and / or the second pair of electrodes 128. In other examples, the electrical stimulator may be configured to provide a predetermined current between the electrodes of the first pair of electrodes 110 and / or the second pair of electrodes 128. The electrical stimulator 704 may be configured to provide a DC signal and in other examples may be configured to provide a waveform comprising a time varying voltage or time varying current to the first pair of electrodes and / or the second pair of electrodes. In some examples, the first pair of electrodes 110 may be configured to receive the same or a different electrical signal to the second pair of electrodes 128.

[0117] In some examples, the plurality of electrical conductors 708 may be printed on the surface of the at least one supporting member 104. In such an example the conductors may be analogous to printed circuit board tracks either embedded within or on the front surface 216 or the rear surface 218 of the supporting members and / or teeth engaging portion 102. The printing may comprise photoresist etching or the deposition of conductive ink.

[0118] In some examples, the electrical stimulator and / or power source are integrated with or physically coupled to the apparatus. The electrical stimulator 704 may be formed within or coupled to the teeth engaging portion 102 (see figure 7A, 7B and 7C). Alternatively, the electrical stimulator 704 may be provided remote from the apparatus or teeth engaging portion (see figures 7D and 7E). In some examples, the electrical stimulator 704 comprises one or more coils for inductively coupling with one or more complementary coils of the electrodes. Thus, each electrode may be connected to a coil to form an electrode / coil assembly. In such an example, the electrical stimulation is provided by an inductive coupling between the electrical stimulator and the electrode / coil assemblies. The coils can be tuned to enable induction of voltages / currents in the different electrode / coil assemblies independently of one another.

[0119] The electrical stimulator 704 typically comprises a power source 706. The power source may comprise a battery, which may be rechargeable. The power source 706 may be located within or coupled to the teeth engaging portion 106, whereas in other examples the electrical stimulator 704 may be coupled to a separate power source, such as a battery, that is electrically coupled to the stimulator 704 by way of a further electrical conductor 710. In another example the electrical stimulator 704 may be inductively coupled 712 to the separate power source 706 to provide power to the stimulator 704 that is within the apparatus 700.

[0120] In some examples, the electrical stimulator 704 and the power source 706 may be external to the apparatus (see figure 7D). In such an example the stimulator and the power supply may form a single unit that can be coupled to the apparatus 700. In general, the apparatus 100-700 may be provided separately from the stimulator and / or power source. The apparatus 100-600 may be a disposable part, whereas the stimulator 704 and / or power source 706 can be reusable.

[0121] Thus, an electrical coupling 714 may be provided for connecting the electrical stimulator to the electrodes; the power source to the electrical stimulator; or a combined electrical stimulator and power source to the electrodes. Accordingly, the apparatus 700 can include at least a first part of the electrical coupling 714. The first part of the electrical coupling 714 may be a trailing plug or a socket at the end of a wire configured to receive a corresponding socket or plug. The trailing wire may allow for the electrical coupling to be made outside the mouth. In some examples, the plug or socket may be a part of or fixed to the apparatus 100-600, such as to the teeth engaging portion. The electrical coupling may be made inside the mouth. In some examples, the first part of the electrical coupling is configured to be coupled to a second, corresponding part of the electrical coupling which is part of the electrical stimulator or power source.

[0122] In some examples, the electrical coupling 714 may provide an electrical connection to both the first pair of electrodes 112 and the second pair of electrodes 214 or a plurality of electrical couplings 714 may be provided.

[0123] In general, electrical conductors, such as wires, 702 will connect from the stimulator 704 to the electrodes and may be attached to, embedded in or routed through the apparatus 100-600 (e.g. teeth engaging portion and / or supporting members). The stimulator may be configured to be part of the apparatus or located outside the mouth when in use.

[0124] The electrical conductor(s) 702 may be formed of single or multi strand copper, steel or other conductive material and coated in insulating or other protective material as required.

[0125] Further details of the electrical stimulator 704 will be provided below.

[0126] Stimulator and control device

[0127] In general, the electrical stimulator 714 comprise a signal generator for generating the electric signal to be applied to the electrodes or pairs of electrodes, and a power source or coupling for connecting to the power source for powering the signal generator. The signal generator may be formed of electrical circuitry configured to generate voltage and / or current signals (e.g. DC) or waveforms (e.g. AC). A controller may provide control signals to the signal generator to control the form of the voltage and / or current signals or waveforms. In other examples, the electrical stimulator may be preprogrammed with the signals / waveform it is expected to generate and a controller is unnecessary.

[0128] The signal generator may be preprogrammed with and / or the controller may define, via control signals to the signal generator, one or more of the magnitude, timing, frequency, pattern of voltages and / or currents for generation by the signal generator that provide said electrical stimulation.

[0129] In one or more examples, the controller is integrated with the signal generator of the electrical stimulator. In other examples, the signal generator and the controller are separate, and the controller is configured to control the signal generator by a wired or wireless coupling. Thus, complementary parts of communication circuitry may be provided with the signal generator and with the controller. Thus, the controller may be provided by a smartphone or other mobile electronic device to control the signal generator for providing the electrical stimulation. An app (which may be downloaded to and / or updatable on) on the smartphone or other electronic device may control the signal generator and / or program the signal generator with instructions for generating the electrical stimulation. The controller, however it may be embodied, may be reprogrammable such that the signals generated by the signal generator can be defined, updated or controlled live. This is advantages as it enables the operation of the signal generator in terms of voltage levels and / or waveforms to be actively controlled or programmed easily.

[0130] In some examples, the voltage signals or waveforms may have a voltage in the range of 10-30V. The signal generator may be configured to provide an output current in the range of 0.1 to 8mA. The signal generator may be configured to deliver multiple prescribed waveforms with varying pulse width(s), varying amplitude(s) and varying frequency(ies).

[0131] It will be appreciated that any components said to be coupled may be coupled or connected either directly or indirectly. In the case of indirect coupling, additional components may be located between the two components that are said to be coupled. In this specification, example embodiments have been presented in terms of a selected set of details. However, a person of ordinary skill in the art would understand that many other example embodiments may be practiced which include a different selected set of these details. It is intended that the following claims cover all possible example embodiments.

Claims

CLAIMS1. An apparatus for use in delivering electrical stimulation to a trigeminal nerve of a mouth of a user, the apparatus comprising: a teeth engaging portion; at least one supporting member extending from the teeth engaging portion; and at least a first pair of electrodes comprising a first electrode and a second electrode, wherein the first electrode and the second electrode are supported by the at least one supporting member; and wherein the at least one supporting member, when the teeth engaging portion is engaged with teeth of the user, is configured to bias each electrode of the first pair of electrodes to contact tissue of a palate of the mouth of the user to deliver the electrical stimulation to the trigeminal nerve.

2. The apparatus of claim 1, wherein the apparatus comprises at least two supporting members including at least a first supporting member and a second supporting member, each extending from the teeth engaging portion at a common lateral side of the teeth engaging portion, wherein the first supporting member is configured to support one of the first electrode and the second electrode and the second supporting member is configured to support the other of the first electrode and the second electrode.

3. The apparatus of claim 1 or claim 2, wherein one of the first electrode and the second electrode is arranged anterior to the other when the apparatus is received in the mouth of the user.

4. The apparatus of any preceding claim, wherein the or each supporting member comprises a first surface that faces said at least one of the tissue of the palate of the mouth of the user, wherein: a) the first surface includes a socket defined by a raised wall configured to receive at least one electrode of the at least first pair of the electrodes; b) the first surface includes a recess configured to receive at least one electrode of the at least first pair of the electrodes; c) the first surface includes a recess configured to receive at least one electrode of the at least a first pair of the electrodes such that the at least one electrode is substantially flush with the first surface;d) at least one electrode of the at least first pair of the electrodes is printed onto the first surface; e) the first surface is configured to support at least one electrode of the at least first pair of electrodes such that at least part of the at least one electrode sits proud of the first surface; f) the at least one electrode of the at least first pair of electrodes is adhered to the first surface; and g) the at least one electrode of the at least first pair of electrodes is moulded onto the first surface.

5. The apparatus of any preceding claim, including a plurality of electrical conductors each configured to electrically connect to a respective one of the first pair of electrodes to provide for connection of the first electrode and the second electrode to an electrical stimulator for applying a potential difference across the at least first pair of electrodes.

6. The apparatus of claim 5, wherein the plurality of electrical conductors are printed on the at least one supporting member.

7. The apparatus of claim 5, wherein a) the at least one supporting member includes an aperture configured to receive at least one electrical conductor of the plurality of electrical conductors routed at least partially through the at least one supporting member; or b) the plurality of electrical conductors are at least partially routed over the surface of the at least one supporting member or teeth engaging portion.

8. The apparatus of any preceding claim, wherein the apparatus includes a second pair of electrodes comprising a third electrode and a fourth electrode, and the at least one supporting member comprises a plurality of supporting members comprising at least one left-lateral-side supporting member and at least one right-lateral-side supporting member, each extending from the teeth engaging portion at a corresponding lateral side of the teeth engaging portion, wherein the at least one left-lateral-side supporting member is configured to support the first pair of electrodes and the right-lateral-side supporting member is configured to support the second pair of electrodes.

9. The apparatus of any one of claims 1 to 7, wherein the apparatus includesa second pair of electrodes comprising a third electrode and a fourth electrode, and the at least one supporting member comprises four supporting members comprising a first supporting member and a second supporting member each extending from the teeth engaging portion at a first common lateral side of the teeth engaging portion, and a third supporting member and a fourth supporting member each extending from the teeth engaging portion at a second common lateral side of the teeth engaging portion opposed the first common lateral side, wherein the third supporting member is configured to support one of the third electrode and the fourth electrode and the fourth supporting member is configured to support the other of the third electrode and the fourth electrode.

10. The apparatus of claims 1 to 9, wherein the teeth engaging portion comprises a channel shaped to receive the teeth and follow a curvature of a dental arch of the upper and / or lower jaw of the user, and is optionally configured to grip the teeth of the user when in use.

11. The apparatus of claims 1 to 9, wherein the teeth engaging portion comprises: a plate configured to be disposed between an upper set of teeth and a lower set of teeth of the user, wherein the plate is configured to at least partially follow a curvature of a dental arch of the upper or lower jaw of the user; and wherein the teeth engaging portion is configured to be held in place by a biting force exerted on the plate by the teeth of the user.

12. The apparatus of any preceding claim including at least a first part of an electrical coupling, wherein the electrical coupling is electrically connected to the at least first pair of electrodes to enable the apparatus to be connected to an electrical stimulator for applying a voltage and / or current to the at least first pair of electrodes.

13. The apparatus of any preceding claim, wherein providing electrical stimulation comprises providing a voltage and / or a current to the trigeminal nerve of the mouth of the user.

14. A system comprising the apparatus of any preceding claim in combination with an electrical stimulator, wherein the electrical stimulator is configured to produce an electrical signal for providing the electrical stimulation via the at least first pair of electrodes.

15. The system of claim 14, wherein the electrical stimulator comprises: a signal generator for generating the electric signal, a power source for powering the signal generator, and an output configured provide the electrical signal to the at least first pair of electrodes for providing the electrical stimulation to the trigeminal nerve of the mouth of the user.

16. The system of claim 15, wherein the electrical stimulator is configured to communicatively couple to a controller which defines one or more of the magnitude, timing, frequency, pattern of voltages and / or currents for generation by the signal generator.

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