Oral muscle training

Abstract

The present application relates to oral muscle training. A device (1) for transmucosal neuromuscular electrical stimulation comprises a mouthpiece (3, 103), electrodes (32a, 33a, 132a, 133a) associated with the mouthpiece (3, 103). The device (1) and / or the mouthpiece (3, 103) comprises circuitry operably connecting the electrodes (32a, 33a, 132a, 133a) to a power source, and the device and / or mouthpiece is configured to provide, in use, electrical stimulation to one or more palatal and / or lingual muscles via the electrodes (32a, 33a, 132a, 133a) through the oral mucosa. A treatment regimen comprising the site of stimulation and parameters of use is designed to increase resting muscle tone and / or muscle tone during sleep.

Description

[0001] This application is a divisional of application number 2015800711152, filed on October 12, 2015, having the title "Oral Muscle Training".

[0002] The present invention relates generally to oral muscle training, and in particular to oral muscle training devices, methods, systems, and control software. More specifically, but not exclusively, the present invention relates to the training of muscles in the mouth for the treatment of sleep disordered breathing.

[0003] Snoring and sleep apnea are considered to be part of a sequence of disorders commonly referred to as sleep disordered breathing (SDB), the symptoms of which relate to patterns of breathing disturbance during sleep. SDB is not only annoying, but can also cause health problems, for example, frequent waking from sleep, light sleep, heart strain, low oxygen levels in the blood, headaches, and fatigue.

[0004] The respiratory passage between the back of the nose and the mouth of a human to the level of the larynx is a collapsible tube. It has been observed that collapse of the respiratory passage occurs at positive airway pressures in individuals who snore and / or have sleep apnoea syndrome, and at negative airway pressures in individuals who do not snore and / or have sleep apnoea syndrome.

[0005] To address this phenomenon, treatment methods have been developed which include the use of continuous positive airway pressure devices to keep the respiratory passage open, or wearing a mandibular advancement device to hold the jaw and tongue forward, thereby increasing the space at the back of the throat.

[0006] These devices can cause discomfort, only address the symptoms temporarily, rather than the underlying cause of the disease, and must be used continuously during sleep. As a result, users find it difficult to fall asleep, and therefore have low compliance. It would therefore be desirable to provide a treatment which does not require the frequent use of such devices during sleep and addresses the underlying cause of the disease.

[0007] Recent research has shown that implanting electrical nerve stimulators in the tongue and diaphragm can be effective in treating obstructive sleep apnoea. This involves an invasive surgery to implant sensors and electrodes onto nerves in these areas. The device uses the sensors to identify an obstruction episode and stimulates the hypoglossal nerve to cause a contraction to alleviate the obstructive event. Like a pacemaker, this approach results in maintenance costs and other complications, for example, battery replacement, risks associated with electrical fields, and problems associated with external safety detection devices. Furthermore, the stimulation only occurs during an obstructive episode during sleep; it does not address the underlying cause of the disease.

[0008] It is therefore a first, non-exclusive, object of the present invention to provide a treatment system, preferably for use in a wakeful state, which provides a sustainable reduction in the pattern of respiratory disturbances during sleep. It is a further, more general, object of the present invention to provide a treatment system and device which is more effective than existing systems and devices for treating SDB in at least one respect.

[0009] It is therefore a first aspect of the present invention to provide an electrical stimulation device for training one or more oral muscles, e.g. a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and an electrical circuit operatively connected to the electrode arrangement, wherein the device or the electrical circuit is configured to provide, in use, electrical stimulation to one or more oral muscles, e.g. tongue and / or palatal muscles, via the electrode arrangement through the inner lining of the mouth, e.g. the oral mucosa, for example to increase resting muscle tone and / or muscle tone during sleep.

[0010] When a person is awake, the collapsible section of the respiratory passageway remains open due to the tone of the muscles controlling this region. When a person is asleep, this muscle tone decreases significantly. Evidence has shown that this decrease in muscle tone is significantly increased in patients suffering from obstructive sleep apnoea, is reduced in those who snore, and is significantly reduced in individuals who do not suffer from these disorders.

[0011] Studies have shown that increasing pharyngeal muscle activity or tone reduces collapsibility of the airway, and the present invention is based on the recognition that electrical stimulation, in particular neuromuscular electrical stimulation, can be used to stimulate tongue and / or palatal muscles and / or sensory nerves to improve muscle strength and tone recovery.

[0012] The device or the electrical circuit is preferably configured to provide electrical current, e.g. electrical current or pulsed electrical current, e.g. biphasic electrical current or pulsed electrical current.

[0013] It is therefore a first aspect of the present invention to provide an electrical stimulation device for training one or more oral muscles, e.g. a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and an electrical circuit operatively connected to the electrode arrangement, wherein the device or the electrical circuit is configured to provide, in use, electrical stimulation to one or more oral muscles, e.g. tongue and / or palatal muscles, via the electrode arrangement through the inner lining of the mouth, e.g. the oral mucosa, for example to increase resting muscle tone and / or muscle tone during sleep.

[0014] By providing biphasic electrical current, in particular biphasic pulsed electrical current, tongue and / or palatal muscles and sensory nerves contributing to airway collapsibility can be stimulated to increase resting muscle tone and muscle tone during sleep.

[0015] The current is preferably a two-phase symmetric current, but it can additionally or alternatively be a two-phase non-symmetric current, which can be balanced or unbalanced. The device or circuit can be configured to provide, in use, a current via the electrode arrangement at a frequency between 5 Hz and 150 Hz.

[0016] Another aspect of the application provides a device for electrical stimulation of one or more muscles of the oral cavity, for example a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and a circuit operatively connected to the electrode arrangement, wherein the device or circuit is configured to provide, in use, a current via the electrode arrangement at a frequency between 5 Hz and 150 Hz.

[0017] The current can comprise a frequency between 10 Hz and 140 Hz, for example between 15 Hz and 130 Hz, preferably between 20 Hz and 120 Hz. Preferably, the current comprises a frequency between 20 Hz and 50 Hz and / or between 50 Hz and 120 Hz.

[0018] The device or circuit can be configured to provide two or more currents, for example a first current and / or a second current, which can be different from and / or independently configurable or settable from the first current. At least one of the first current and / or the second current, for example both, can comprise a two-phase current, each current preferably being symmetric, but can be asymmetric, and balanced or unbalanced. At least one of the first current and / or the second current can comprise a frequency between 5 Hz and 150 Hz, for example between 10 Hz and 140 Hz, for example between 15 Hz and 130 Hz, preferably between 20 Hz and 120 Hz. In some embodiments, one of the currents can comprise a frequency between 20 Hz and 50 Hz and / or the other current can comprise a frequency between 50 Hz and 120 Hz.

[0019] The inventors believe that applying a current in one or each of these two frequency ranges is particularly suitable for targeting the palatal and tongue muscles which contribute to the contractility of the airway.

[0020] The device or circuitry can be configured to provide, in use, electrical current or at least one or each electrical current to one or more oral muscles (e.g. palatal muscles and / or lingual muscles), for example via the inner lining of the mouth (e.g. oral mucosa), to increase resting muscle tone and / or muscle tone during sleep. In some embodiments, the device is configured to provide, in use, electrical current, e.g. a first electrical current, to one or more palatal muscles. Additionally or alternatively, the device can be configured to provide, in use, electrical current, e.g. a second electrical current, to one or more lingual muscles via the dorsal surface of the tongue. Additionally or alternatively, the device can be configured to provide, in use, electrical current, e.g. the first electrical current or the second electrical current, to one or more lingual muscles via the underside of the tongue.

[0021] In embodiments, the mouthpiece can comprise one or more arms and / or one or more appendages or flanges, which can extend from the one or more arms, e.g. for contacting one or more oral muscles. At least one arm and / or at least one appendage or flange can be flat or planar, e.g. have a major surface. Optionally, the mouthpiece can comprise a pair of arms, each arm can comprise one or more appendages or flanges. In some embodiments, the mouthpiece comprises a pair of arms, which can extend at least partially alongside each other and / or at an angle relative to each other and / or parallel to each other. For example, the mouthpiece can comprise a pair of arms, which join together at one end and diverge from each other at the other end, e.g. generally V-shaped or U-shaped or horseshoe-shaped.

[0022] The one or more appendages or flanges can extend internally of the pair of arms, e.g. from one arm to the other arm. In some embodiments, each arm comprises at least one appendage or flange, e.g. opposite and / or towards each other. In embodiments, each arm comprises two or more appendages or flanges, e.g. an appendage or flange extending from a free end of each arm and / or an appendage or flange extending from an intermediate portion of each arm.

[0023] The at least one appendage or flange can be curved, e.g. a flat curved shape or member, and / or extend upwards or downwards, or beyond the plane of the mouthpiece or at least one arm thereof. The at least one appendage or flange can be shaped to fit or approximate or accommodate the tongue surface, e.g. the dorsal tongue surface or the sublingual tongue surface. In embodiments, the mouthpiece comprises at least one appendage or flange shaped to fit or approximate or accommodate the dorsal tongue surface and at least one appendage or flange shaped to fit or approximate or accommodate the sublingual tongue surface. In embodiments having a pair of arms, each arm can comprise an appendage or flange shaped to fit or approximate or accommodate the dorsal tongue surface and an appendage or flange shaped to fit or approximate or accommodate the sublingual tongue surface.

[0024] At least one of the appendages or flanges can include one or more electrodes or sequences thereof. The at least one electrode or sequence of electrodes can be adjacent to and / or associated with and / or exposed at a surface (e.g., a major surface) of the at least one appendage or flange. In embodiments, at least one of the appendages or flanges includes an electrode associated with each of its major surfaces. An electrode associated with one of the major surfaces can be isolated from another electrode or another major surface thereof, and / or controllably independent of another electrode or another major surface thereof. Additionally or alternatively, an electrode of or associated with one appendage or flange can be isolated from and / or controllably independent of at least one other appendage or flange.

[0025] In embodiments, the mouthpiece can include a pair of arms joined together at one end and diverging from one another to provide a generally horseshoe shape with one or more flanges extending inwardly from at least one of the arms, the or each flange including an electrode arrangement. The mouthpiece can include a pair of flanges each extending inwardly from a respective arm, the flanges shaped to accommodate a dorsum linguae surface. The mouthpiece can include a pair of flanges each extending inwardly from a respective arm, the flanges shaped to accommodate a sublingual tongue surface. Each of the pair of flanges can be shaped to accommodate a dorsum linguae surface, extending from or adjacent a free end of the arm, and / or each of the pair of flanges can be shaped to accommodate a sublingual tongue surface, extending from a middle portion of the arm.

[0026] Another aspect of the present invention provides an apparatus for electrical stimulation of one or more oral muscles, e.g., transmucosal neuromuscular electrical stimulation, the apparatus comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and an electrical circuit operably connected to the electrode arrangement, wherein the mouthpiece includes a pair of arms joined together at one end and diverging from one another at another end, one or more flanges extending inwardly from at least one of the arms, the or each flange including at least a portion of the electrode arrangement associated therewith for providing electrical stimulation to the one or more oral muscles.

[0027] Yet another aspect of the present invention provides an electrical stimulation mouthpiece for training one or more oral muscles, e.g., a transmucosal neuromuscular electrical stimulation mouthpiece, the mouthpiece comprising a pair of arms joined together at one end and diverging from one another, one or more flanges extending inwardly from at least one of the arms, wherein the or each flange includes an electrode arrangement associated therewith for providing electrical stimulation to the one or more oral muscles.

[0028] The mouthpiece can comprise a clamping base, which can comprise an enlarged end, e.g. an enlarged free end, which can be connected or fixed to the mouthpiece or its body or one or more arms or each arm thereof, e.g. integrally formed therewith, e.g. by a constricted portion.

[0029] The electrode arrangement preferably comprises at least one anode and at least one cathode, e.g. two or more anodes and / or two or more cathodes, e.g. a plurality of anodes and a plurality of cathodes. At least a portion of the electrode arrangement, e.g. one or more electrodes or each electrode or all electrodes, can be mounted to the mouthpiece or mounted on or in the mouthpiece and / or at least partially housed or contained within the mouthpiece. In some embodiments, the mouthpiece comprises a shield or shielding arrangement, e.g. on one side of the electrode arrangement, e.g. for inhibiting or preventing electrical stimulation or current being applied or provided by or from one side of the mouthpiece. Suitable materials for the shield or shielding arrangement will be apparent to the skilled person.

[0030] In embodiments, the electrode arrangement is configured or operable to selectively provide or apply electrical stimulation or current, e.g. at or from at least one or each or both sides, e.g. by comprising a first set or sequence of electrode arrangements or electrodes and a shield or shielding arrangement between a second set or sequence of electrode arrangements or electrodes. In some embodiments, a first current is provided or applied at or from a first side (e.g. a primary side) of the mouthpiece and / or by a first set or sequence of electrode arrangements or electrodes. Additionally or alternatively, a second current is provided or applied at or from a second side (e.g. a primary side) of the mouthpiece and / or by a second set or sequence of electrode arrangements or electrodes. In other embodiments, a first current and a second current can be provided or applied from at least one or each or both sides.

[0031] The mouthpiece can be inserted into and held in place in the mouth, e.g. manually. The mouthpiece can be at least partially flat and / or substantially flat and / or paddle-shaped, e.g. having at least one flat and / or major surface, preferably two flat major surfaces. In some embodiments, the device can comprise a handle to which the mouthpiece can be rigidly and / or releasably connected or mounted or attached, e.g. to enable the mouthpiece to be inserted and / or held in one or more sites or locations and / or orientations in the mouth in use. In some embodiments, the mouthpiece does not have any mounting means for mounting or securing it to or in the mouth of a user.

[0032] In embodiments, the mouthpiece can comprise a mounting device. The mounting device can be used to mount the mouthpiece to an upper portion of the mouth, e.g. such that the mouthpiece or a first side or surface thereof contacts or can contact and / or is adjacent to one or more palatal muscles and or the roof of the mouth, and / or the mouthpiece or a second side or surface of the mouthpiece contacts or can contact and / or is adjacent to one or more tongue muscles, e.g. the dorsal tongue surface. Additionally or alternatively, the mounting device can be used to mount the mouthpiece to a lower portion of the mouth, e.g. such that the mouthpiece or a first side or surface thereof contacts or can contact and / or is adjacent to one or more tongue muscles, e.g. the sublingual tongue surface. In embodiments, the device comprises a first mouthpiece having a mounting device for mounting it to an upper portion of the mouth and a second mouthpiece for mounting it to a lower portion of the mouth.

[0033] The device or handle can comprise an input device or activator, which can comprise one or more input devices, buttons and / or push buttons and / or switches and / or dials etc., e.g. for enabling or activating or initiating the electrical stimulation or current. The device or handle can comprise a power source and / or a cable connectable to a power source. In some embodiments, the device comprises a main body comprising or including or providing the handle, and / or the device comprises or houses a power source, which can comprise a rechargeable power source or one or more rechargeable batteries, and / or which can comprise a cable or be operatively (e.g. inductively) connectable to a charging station comprising or including a cable, e.g. to enable the power source to be recharged. The device can comprise a charging station.

[0034] In some embodiments, the device comprises a regulating device or regulator for regulating the frequency of the electrical current or the frequency of the first and / or second electrical current, e.g. respective first and second electrical current frequency regulating devices or regulators, e.g. within one of the ranges described above. In embodiments, the regulating device or regulator is a step-wise regulating device or regulator and / or is configured to enable a user to select from one of two or more (e.g. three, four or five) predetermined frequency settings. The device can be operable or configured to provide the first and second electrical currents simultaneously and / or concurrently and / or in parallel. Additionally or alternatively, the device can be operable or configured to provide the first and second electrical currents in series and / or sequentially and / or consecutively.

[0035] At least one (e.g., both) of the electrical stimulation or current or first current and / or second current can comprise a pulsed current. The pulse duration of each pulsed current can be between 50 ps and 1000 ps, e.g., between 100 ps and 900 ps, e.g., between 150 ps and 800 ps, preferably between 200 ps and 700 ps. Preferably, a further adjustment means or adjuster (e.g., pulse duration adjustment means or adjuster) of the device is provided, e.g., in one of the above ranges, for adjusting the pulse duration.

[0036] The electrical stimulation or current or first current and / or second current can comprise an intensity or current amplitude, which is preferably selected or selectable to provide a maximum contraction of the muscle being treated. By way of example, the intensity or amplitude can comprise about 10 mA, e.g., between 1 mA and 100 mA, e.g., between 5 mA and 50 mA, e.g., between 5 mA and 15 mA or between 7 mA and 25 mA, e.g., between 8 mA and 12 mA. A further adjustment means or adjuster, e.g., intensity or amplitude adjustment means or adjuster, can be provided for adjusting the intensity or amplitude, e.g., from 0 to 500 mA, or from 0 to 250 mA, or from 0 to 200 mA, or from 0 to 150 mA, or from 0 to 100 mA.

[0037] In some embodiments, the device is configured or programmed to provide the electrical stimulation or current or first current and / or second current for a predetermined period of time, which can comprise between 1 minute and 1 hour, e.g., between 5 minutes and 30 minutes, preferably between 10 minutes and 20 minutes. A further adjustment means or adjuster, e.g., treatment duration adjustment means or adjuster, can be provided for adjusting the treatment duration, e.g., from 0 to 10 hours, or from 0 to 5 hours, or from 0 to 1 hour, or from 0 to 30 minutes.

[0038] The device can comprise a control means, which can be programmed or programmable to control one or more features of the electrical stimulation or current, e.g., in accordance with a predetermined treatment regimen. The control means can comprise a control system and / or a controller and / or can comprise or be at least partially comprised in the circuitry. The control means can comprise at least a portion of the adjustment means or adjusters, e.g., one or more of the frequency and / or pulse duration and / or intensity and / or amplitude and / or treatment duration adjustment means or adjusters.

[0039] In some embodiments, the input device can be for or configured or operable to control and / or adjust one or more of the characteristics of the electrical stimulation or current or first current and / or second current, e.g. frequency and / or pulse duration and / or intensity and / or amplitude and / or treatment duration. Additionally or alternatively, the device or input device can comprise an interface or connection means such as a connector or socket for connecting the device or control device to another device (e.g. a personal computer or hand-held device) which can be operable to program and / or control and / or adjust one or more of the above-mentioned characteristics.

[0040] The device or control device or adjustment device can be configured or programmed to control one or more of the characteristics of the electrical stimulation or current or first current and / or second current, e.g. in a predetermined manner and / or according to a predetermined treatment regime. The device or control device can be operable or programmable to create and / or change the predetermined treatment regime, e.g. by a device to which the electrical stimulation device is connected, e.g. via the input device.

[0041] Another aspect of the application provides a computer program element comprising computer readable program code means for causing a processor to execute a program to implement a method or treatment regime comprising providing electrical stimulation to one or more oral cavity muscles (e.g. palatal and / or lingual muscles) via a lining of the mouth (e.g. oral cavity mucosa), e.g. to increase resting muscle tone and / or muscle tone during sleep.

[0042] Another aspect of the application provides a method or treatment regime, e.g. for training one or more oral cavity muscles by transmucosal neuromuscular electrical stimulation, the method comprising providing or applying electrical stimulation to one or more oral cavity muscles (e.g. palatal and / or lingual muscles) via a lining of the mouth (e.g. oral cavity mucosa), e.g. to increase resting muscle tone and / or muscle tone during sleep.

[0043] For the avoidance of doubt, any of the features described herein are equally applicable to any aspect of the application.

[0044] The method or treatment regime can comprise providing or applying electrical current, e.g. electrical current or pulsed electrical current, e.g. biphasic electrical current or pulsed electrical current, to the one or more oral cavity muscles.

[0045] Another aspect of the application provides a method or treatment regime, e.g. for training one or more oral cavity muscles by transmucosal neuromuscular electrical stimulation, the method comprising providing or applying biphasic electrical current (e.g. biphasic pulsed electrical current) to one or more oral cavity muscles (e.g. palatal and / or lingual muscles) via a lining of the mouth (e.g. oral cavity mucosa), e.g. via an electrode arrangement.

[0046] The method or treatment regimen can comprise providing or applying a first current and / or a second current, which can be different from the first current. At least one (e.g., both) of the current or the first current and / or the second current can comprise an alternating current. The at least one or each current can comprise a frequency between 5 Hz and 150 Hz, for example, between 10 Hz and 140 Hz, for example, between 15 Hz and 130 Hz, preferably, between 20 Hz and 120 Hz, more preferably, between 20 Hz and 50 Hz and / or between 50 Hz and 120 Hz. In some embodiments, the first current comprises a frequency between 20 Hz and 50 Hz, and / or the second current comprises a frequency between 50 Hz and 120 Hz.

[0047] In embodiments, the two-phase current or the phases of the first current and the second current can be applied simultaneously and / or concurrently. In some embodiments, the two-phase current or the phases of the first current and the second current can be applied in series and / or in sequence and / or consecutively.

[0048] At least one (e.g., both) of the current or the first current and / or the second current can comprise a pulsed current. A pulse duration of each pulsed current can be between 50 ps and 1000 ps, for example, between 100 ps and 900 ps, for example, between 150 ps and 800 ps, preferably, between 200 ps and 700 ps.

[0049] The electrical stimulation or current or the first current and / or the second current can comprise an intensity or current amplitude, which is preferably selected or selectable to provide a maximum contraction of the muscle being treated. By way of example, the intensity or amplitude can comprise about 10 mA, for example, between 1 mA and 100 mA, for example, between 5 mA and 50 mA, for example, between 5 mA and 15 mA or between 7 mA and 25 mA, for example, between 8 mA and 12 mA.

[0050] The method or treatment regimen can comprise providing or applying the electrical stimulation or current or the first current and / or the second current for a predetermined period of time, which can comprise between 1 minute and 1 hour, for example, between 5 minutes and 30 minutes, preferably, between 10 minutes and 20 minutes.

[0051] In some embodiments, the method or treatment regimen can comprise providing or applying the electrical stimulation or current or the first current and / or the second current to the first muscle or muscle group and / or to an upper or dorsal surface of the tongue for a first predetermined period of time. The first muscle or muscle group can comprise one or more palatal muscles and / or tongue muscles, for example, one or more intrinsic surface muscles, a uvular muscle, a levator veli palatini muscle, and a palatopharyngeal muscle.

[0052] Alternatively or concurrently, the method or treatment may include providing or applying electrical stimulation or current, or a first current and / or a second current, to a second muscle or muscle group and / or the underside of the tongue (e.g., sublingual region) for a second predetermined time period. The second muscle or muscle group may include one or more palatal muscles and / or tongue muscles, and one or more of the second muscle or muscle group may be different from the first muscle or muscle group (e.g., the genioglossus muscle). By way of example, the first predetermined time period may include between five and thirty minutes, for example, five minutes, ten minutes, fifteen minutes, twenty minutes, or thirty minutes, and / or the second predetermined time period may include between five and thirty minutes, for example, five minutes, ten minutes, fifteen minutes, twenty minutes, or thirty minutes.

[0053] Alternatively or alternatively, the method or treatment regimen includes performing one or more of the above steps at predetermined intervals, which may include once a day and ten times a day or any number therebetween, such as twice a day. Alternatively or alternatively, the method or treatment regimen includes performing one or more of the above steps during a predetermined treatment period, which may include between one and twelve weeks, such as between two and ten weeks, such as between five and eight weeks, such as six weeks.

[0054] The method or treatment may include adjusting one or more characteristics of electrical stimulation or current, or a first current and / or a second current, such as frequency and / or pulse duration and / or intensity and / or amplitude and / or treatment duration. Adjustment may be made via a device (e.g., a personal computer or handheld device) using input devices (e.g., one or more buttons and / or dials, etc.) or via an interface or connection device (e.g., a connector or socket).

[0055] In some embodiments, the method or treatment regimen includes a first treatment period, such as a period during which electrical stimulation or current, or a first current and / or a second current, is provided or applied, for example to establish resting muscle tone and / or muscle tone during sleep. The method or treatment regimen may also include a second period (e.g., a maintenance period), such as a period during which one or more characteristics of the electrical stimulation or current, or the first current and / or the second current, are adjusted or altered, for example, relative to the first period, to maintain resting muscle tone and / or muscle tone during sleep. The first period may include a first regimen, and / or the second period may include, for example, a second regimen different from the first regimen.

[0056] In an example embodiment, the method or treatment regime comprises providing or applying electrical stimulation to the one or more oral muscles for 10 to 20 minutes, twice a day, for six weeks, for example to establish resting muscle tone and / or muscle tone during sleep. Additionally or alternatively, the method or treatment regime comprises providing or applying electrical stimulation to the one or more oral muscles for 10 to 20 minutes, once a day on a continuous basis, for example to establish resting muscle tone and / or muscle tone during sleep.

[0057] Another aspect of the application provides a method or treatment regime of training one or more oral muscles, for example by sensory stimulation, the method comprising providing or applying vibratory stimulation to the one or more oral muscles, for example palatal and / or lingual muscles. The method can further comprise any one or more features of the above described methods.

[0058] A further aspect of the application provides a computer program element comprising computer readable program code means for causing a processor to execute a program to implement the above described methods or treatment regimes. A still further aspect of the application provides a computer program element embodied on a computer readable medium.

[0059] A still further aspect of the application provides a computer readable medium having stored thereon a program, wherein the program is arranged to cause a computer to execute a program to implement the above described methods or treatment regimes.

[0060] A still further aspect of the application provides a control device or control system or controller comprising the above described computer program element or computer readable medium, or for controlling a treatment regime to train one or more oral muscles, for example by transmucosal neuromuscular electrical stimulation, for example for controlling the above described methods.

[0061] The present application relates to, but is not limited to, the following aspects:

[0062] 1) A device for transmucosal neuromuscular electrical stimulation comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and an electrical circuit operatively connected to the electrode arrangement, wherein the device is configured to provide electrical stimulation to one or more palatal and / or lingual muscles via the electrode arrangement through the oral mucosa in use to increase resting muscle tone and / or muscle tone during sleep.

[0063] 2) The device according to 1), wherein the electrical stimulation comprises biphasic pulsed current at a frequency of between 5 Hz and 150 Hz.

[0064] 3). The device according to 2), wherein the biphasic pulsed current comprises a frequency between 20 Hz and 120 Hz.

[0065] 4). The device according to 2) or 3), wherein the biphasic pulsed current comprises a frequency between 20 Hz and 50 Hz.

[0066] 5). The device according to 2) or 3), wherein the biphasic pulsed current comprises a frequency between 50 Hz and 120 Hz.

[0067] 6). The device according to any one of 2) to 5), wherein the biphasic pulsed current comprises an amplitude between 1 mA and 100 mA.

[0068] 7). The device according to any one of 2) to 6), wherein the biphasic pulsed current comprises an amplitude between 5 mA and 15 mA.

[0069] 8). The device according to any one of 2) to 7), wherein the biphasic pulsed current comprises a pulse duration between 200 ps and 700 ps.

[0070] 9). The device according to any one of 2) to 8), further comprising adjustment means for adjusting one or more of the frequency, the amplitude, the pulse duration and the treatment duration of the biphasic pulsed current.

[0071] 10). The device according to any one of 1 ) to 9), further comprising control means programmed or programmable to control one or more features of the electrical stimulation or the biphasic current according to a predetermined treatment protocol.

[0072] 11 ). The device according to any one of 1 ) to 10), wherein the electrode means comprise a first sequence of electrodes associated with a first side of the mouthpiece and a second sequence of electrodes associated with a second side of the mouthpiece.

[0073] 12). The device according to 11 ), wherein the first sequence of electrodes is operable to provide a first current and the second sequence of electrodes is operable to provide a second current.

[0074] 13). The device according to any one of 1 ) to 12), further comprising a handle, the mouthpiece being mounted to the handle to enable the mouthpiece to be inserted and / or held in one or more sites or positions and / or orientations within a mouth in use.

[0075] 14). The device according to any one of 1 ) to 13), wherein the mouthpiece has no mounting means for securing it to a user's mouth.

[0076] 15). The device according to any one of 1) - 12), wherein the mouthpiece comprises mounting means for mounting the mouthpiece to the mouth.

[0077] 16). The device according to any one of 1) - 15), wherein the mouthpiece comprises a pair of arms which join together at one end and diverge from each other to provide a generally horseshoe shape with one or more flanges extending inwardly from at least one arm, the or each flange comprising electrode means.

[0078] 17). The device according to 16), wherein the mouthpiece comprises a pair of flanges, each flange extending inwardly from a respective arm, the flanges being shaped to accommodate a dorsum linguae surface.

[0079] 18). The device according to 16) or 17), wherein the mouthpiece comprises a pair of flanges, each flange extending inwardly from a respective arm, the flanges being shaped to accommodate a sublingual surface.

[0080] 19). The device according to 18) when dependent on 17), wherein each of the pair of flanges shaped to accommodate a dorsum linguae surface extends from or adjacent the free end of the arm, and each of the pair of flanges shaped to accommodate a sublingual surface extends from a mid-portion of the arm.

[0081] 20). A computer program element comprising computer readable program code means for causing a processor to execute a program to implement a method or treatment regime, the method or treatment regime comprising providing electrical stimulation to one or more palatal and / or lingual muscles through oral mucosa to increase resting muscle tone and / or muscle tone during sleep.

[0082] 21). A method of training one or more oral muscles by transmucosal neuromuscular electrical stimulation, the method comprising applying electrical stimulation to one or more palatal and / or lingual muscles through oral mucosa to increase resting muscle tone and / or muscle tone during sleep.

[0083] 22). The method according to 21), comprising applying the electrical stimulation to an upper or dorsal surface of the tongue for a first predetermined period to stimulate a first muscle or muscle group, and applying the electrical stimulation to an underside of the tongue for a second predetermined period to stimulate a second muscle or muscle group.

[0084] 23). The method according to 22), wherein the first muscle or muscle group comprises one or more of intrinsic surface muscles, palatine uvula muscles, levator veli palatini muscles and palatopharyngeal muscles, and the second muscle or muscle group comprises genioglossus muscles.

[0085] 24) The method according to any one of 21)-23) includes a first treatment period and a second maintenance period, wherein the electrical stimulation is applied to one or more palatal muscles and / or tongue muscles according to a first scheme during the first treatment period, and the electrical stimulation is applied to one or more palatal muscles and / or tongue muscles according to a second scheme different from the first scheme during the second maintenance period.

[0086] Within the scope of this application, it is readily contemplated that aspects, embodiments, examples, and alternatives set forth in the foregoing paragraphs, claims, and / or the following description or drawings, and particularly in their various features, may be employed independently or in any combination. Features described in connection with one aspect or embodiment of the invention apply to all aspects or embodiments, unless such features are incompatible. Attached Figure Description

[0087] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0088] Figure 1 This is a perspective view of an electrical stimulation device according to an embodiment of the present invention;

[0089] Figure 2 yes Figure 1 A perspective view of the main body of the device;

[0090] Figure 3 yes Figure 1 A perspective view of the nozzle of the device;

[0091] Figure 4 yes Figure 1 A perspective view of the charging station for the equipment;

[0092] Figure 5 This is a schematic diagram of a human mouth, showing the palatoglossus muscle and the surface of the tongue;

[0093] Figure 6 This is a schematic diagram showing the external muscles of the human tongue;

[0094] Figure 7 This is a schematic diagram showing the internal muscles of the human tongue;

[0095] Figure 8 This is another schematic diagram of a human mouth, showing the muscles of the palate;

[0096] Figure 9 This is a schematic diagram showing the other muscles of the palate;

[0097] Figure 10 This is a top view of the mouthpiece of an electrical stimulation device according to a second embodiment of the present invention; and

[0098] Figure 11 is Figure 10 a side view of the mouthpiece.

[0099] Reference is now made to Figures 1 to 4 , showing an electrical stimulation device 1 comprising a main body 2, a mouthpiece 3 and a charging station 4. The main body 2 serves as a handle, is generally cylindrical in this embodiment, and comprises a first upper end 20 having a male connector 21 with a protrusion 22 on each side thereof to provide a bayonet fitting, and an electrical socket 23 for receiving an electrical connector (not shown) of the mouthpiece 3. The main body 2 further comprises on its front surface an on / off button 2a, four dials 24, 25, 26, 27, a USB port 28 and a second lower end 29 having a socket (not shown) for receiving a protrusion 41 of the charging station 4.

[0100] The main body 2 further comprises a battery (not shown) and an electrical circuit comprising an inverter for converting the direct current of the battery into two separate symmetrical two-phase currents. The first dial 24 is operable to adjust the current amplitude of the first two-phase current from 0 to 100 mA. The second dial 25 is operable to adjust the current amplitude of the second two-phase current from 0 to 100 mA. The third dial 26 is operable to adjust the duration of the time period during which the first two-phase current is supplied from 1 minute to 30 minutes. The fourth dial 27 is operable to adjust the duration of the time period during which the second two-phase current is supplied from 1 minute to 30 minutes.

[0101] The USB port 28 is configured to enable the device 1 to be connected to a personal computer (not shown) to independently program one or more features of the first and second two-phase currents. In the present embodiment, the frequency of the first two-phase current is set at a value between 20 Hz and 50 Hz, the second two-phase current is set at a value between 50 Hz and 120 Hz, and the pulse duration of each two-phase current is set to a value between 200 μβ and 700 μβ. The personal computer (not shown) can also comprise control software operable to override the dials 24, 25, 26, 27. The software can be programmed to apply two-phase currents having predetermined characteristics independent of one another, such as amplitude, frequency and pulse duration, and predetermined time periods. It is further envisaged that the device 1 can contain a memory having such predetermined characteristics stored therein, which can be modified by connecting the personal computer (not shown) to the device 1 via the USB port 28. In such embodiments, the dials can be omitted or configured to adjust the above-mentioned characteristics from their pre-programmed values. In some embodiments, it is envisaged that more or less functionality is provided by manual dials, buttons, etc.

[0102] The mouthpiece 3 comprises a cylindrical base 30 and a generally flat paddle-shaped contact portion 31 formed integrally with the upper end of the base 30 and having first and second major surfaces 32, 33. The base 30 comprises a socket (not shown) at its lower end 34 for receiving an electrical connector (not shown) housed within the electrical socket 23 of the main body 2. The mouthpiece 3 also comprises an electrical circuit (not shown) which feeds a respective sequence of electrodes 32a, 33a under each of the major surfaces 32, 33. The sequences of electrodes 32a, 33a are electrically isolated from one another by a shielding material. The electrical circuit (not shown) of the mouthpiece 3 is operatively connected to the electrical circuit (not shown) of the main body 2 in use, such that the first sequence of electrodes 32a carries the first two-phase current and the second sequence of electrodes 33a carries the second two-phase current.

[0103] In the present embodiment, the mouthpiece 3 is provided as a separate component from the main body 2 and is configured so that it can be easily cleaned between sessions. However, in alternative embodiments, the mouthpiece 3 can be integrally formed with the main body 2. In yet further embodiments, the mouthpiece 3 can comprise mounting means for mounting it to the upper and / or lower portion of the user's mouth in a similar manner to the holder. In such embodiments, the apparatus 1 can comprise a pair of mouthpieces 3, each comprising mounting means, wherein the first mouthpiece 3 is adapted to be mounted to the upper portion of the user's mouth and the second mouthpiece 3 is adapted to be mounted to the lower portion of the user's mouth. The first mouthpiece 3 can comprise two sequences of electrodes 32a, 33a to contact the top of the user's mouth and stimulate one or more palatal muscles on one side and contact the dorsal surface of the tongue and stimulate one or more tongue muscles on the other side. The second mouthpiece 3 can comprise a single sequence of electrodes 32a to stimulate the hypoglossal muscle. Each mouthpiece 3 can comprise a power source and a wireless communication device, such as a Bluetooth communication device, for example, in communication with a personal computer (not shown).

[0104] The charging station 4 has a cylindrical base 40 with a cylindrical protrusion 41 and an electrical cable 42 for connecting the charging station 4 to a mains power supply. The protrusion 41 in this embodiment comprises an inductive coupling and the station 4 comprises an electrical circuit connected to the mains cable 42 for supplying power to the inductive coupling for inductively charging a battery (not shown) in the main body 2.

[0105] Turning now to Figures 5 to 9 various tongue and palatal muscles are shown. Figures 5 to 7 The features of the mouth shown more clearly illustrate the tongue muscles, wherein the palatoglossal arch 51, the palatine tonsil 52, the palatoglossal muscle 53, the buccinator muscle 54, the contour papilla 55, the fungiform papilla 56, the dorsal surface of the tongue 57, the styloglossal muscle 58, the hyoglossal muscle 59, the mandible 60, the genioglossal muscle 61, the longitudinal, transverse and vertical intrinsic muscles 62, 63, 64 and the geniohyoid muscle 65 are shown.

[0106] It has been determined that the genioglossus muscle 61 has the greatest effect on the contractility of the tongue, as it is the largest of the extrinsic muscles and is responsible for pulling the tongue forward and increasing the airway opening in the larynx. Intrinsic surface muscle tone, such as the longitudinal and transverse intrinsic muscles 62, 63 also contribute to reducing the contractility of the airway.

[0107] Figure 8 and Figure 9 The features of the mouth shown illustrate the palatal muscles more clearly, where the dental arch 66, premaxilla 67, incisive foramen 68, palatine process 69, palatine bone 70, posterior nasal spine 71, palatine foramen 72, hamular process 73, levator veli palatini muscle 74, tensor veli palatini muscle 75, tensor veli palatini muscle 76, palatine muscle 77, and palatopharyngeal muscle 78 are shown.

[0108] The constrictor and dilator muscles of the palate also contribute to snoring and sleep apnea to varying degrees. The goal of treatment is to dilate the throat, so the electrical stimulation targets the dilator muscles of the palate, such as the palatine muscle 77, tensor veli palatini muscle 75, and palatopharyngeal muscle 78, which are centered on the midline.

[0109] In use, the mouthpiece 3 is applied to the dorsal surface 57 of the tongue and the palatal muscles described above, and two biphasic currents are applied, each biphasic current configured with a first set of parameters including intensity, frequency, and pulse duration. These biphasic currents are propagated through the lining of the mouth, the oral mucosa, to stimulate the intrinsic surface muscles 62, 63, palatine muscle 77, tensor veli palatini muscle 75, and palatopharyngeal muscle 78. The parameters are selected to provide maximum contraction of these muscles of the user, and a 20 minute treatment is performed.

[0110] The intensity, frequency, and pulse duration are then adjusted, and the mouthpiece 3 is applied to the underside of the tongue. Two biphasic currents, now with a second set of parameters, are applied and delivered across the mucosa to stimulate the genioglossus muscle 61. The second set of parameters is selected to provide maximum contraction of the genioglossus muscle 61 of the user, and a 20 minute treatment is performed.

[0111] The biphasic current is applied according to the parameters described above to stimulate the skeletal muscles described above. It is also believed that the application of this biphasic current to these skeletal muscles produces further sensory functions, such as a vibratory sensation. While not wishing to be bound by any theory, it is believed that this electrical and vibratory stimulation of the nerves provides feedback to the brain, which further enhances the improvement in muscle tone. In particular, it is believed that the effects of this treatment are enhanced by multisensory integration within the nervous system.

[0112] By way of example, the treatment regimen can include a six-week induction period during which each of the above muscle groups is stimulated for 10 to 20 minutes, twice per day. The treatment regimen designed to build muscle tone can be followed by a sustained maintenance regimen including a 10 to 20 minute period per day.

[0113] Reference is now made to Figure 10 and Figure 11 , showing a mouthpiece 103 according to a second embodiment similar to the first embodiment, where like references describe similar features with the prefix 1. The mouthpiece 103 according to this embodiment includes a clamping base 130 and a pair of curved arms 131 integrally formed with one end of the base 130 to form a horseshoe shape. Each arm has a first and second contact flange 132, 133 in which electrodes (not shown) are embedded.

[0114] The first contact flange 132 extends inwardly and upwardly from the free end of the respective one of the arms 131 towards each other to form a curved shape for accommodating the dorsum of the tongue surface 57 of the patient's tongue (not shown). The second contact flange 133 extends inwardly and downwardly from the middle portion of the respective one of the arms 131 towards each other to form a curved shape for accommodating the sublingual tongue surface.

[0115] The base 130 includes an enlarged end portion 134 which is joined to the arms 131 by a constricted portion 135. The end surface of the enlarged end portion 134 includes an electrical connector 136 for connection to a power source (not shown). The connector 136 can include a USB, micro-USB or any other suitable type of wired connector. In other embodiments, the connector is replaced by a wireless connection means. In some embodiments, the mouthpiece includes a power source such as a battery.

[0116] Similar to the first embodiment, the mouthpiece 103 also includes an electrical circuit (not shown) which supplies a respective sequence of electrodes 132a, 133a at each surface of each flange 132, 133 (i.e. each of the upper and lower surfaces of each flange 132, 133). Each of these electrode sequences 132a, 133a is electrically isolated from the other electrode sequences by a shielding material, thereby enabling all surrounding muscles to be stimulated simultaneously or in any desired order. The electrodes 132a, 133a and the outer surfaces of the flanges 132, 133 with which they are associated cooperate to form a substantially contiguous surface. In this embodiment, the mouthpiece 103 is formed from a silicon grade or biocompatible grade plastic material. The electrodes 132a, 133a in this embodiment are preferably formed from gold or copper or a composite material or any such alloy with an exposed surface.

[0117] In use, the mouthpiece 103 is placed in the mouth of the patient and the patient's tongue is received within the mouthpiece 103 such that the dorsal tongue surface 57 is in contact with the first contact flange 132 and the sublingual tongue surface is in contact with the second contact flange 133. It will be appreciated by those skilled in the art that the first flange 132 will contact the posterior portion of the dorsal tongue surface 57 and the second flange 133 will contact the anterior portion of the sublingual tongue surface. When the patient's mouth is closed, the flanges 132, 133 are also able to contact and stimulate adjacent muscles on the other side of the tongue, for example the palatine muscles. The muscles are stimulated in a similar manner to the device 1 according to the first embodiment, but this mouthpiece 103 enables the muscles to be stimulated on both sides of the tongue at the same time. It will be appreciated that with this design, muscles based in and around the tongue can be stimulated, including muscles in the region of the hard palate and the soft palate.

[0118] It will be appreciated by those skilled in the art that several variations to the above described embodiments are envisaged without departing from the scope of the present application. For example, the mouthpiece 3 can take any suitable form, but is preferably designed such that electrical stimulation can be applied to the appropriate muscles as described above. The dials 24, 25, 26, 27 can be replaced with other similar adjustment means, or even omitted as described above. The mouthpiece 3 and main body 2 can be provided as a unitary unit, and the charging station 4 can be omitted, for example the main body 2 can include the main cable 42 or only require a disposable battery or some other power source. Similarly, the USB port 28 can be omitted or replaced with some other connection means which can be a wireless connection means. It will also be appreciated by those skilled in the art that any number of combinations of the foregoing features and / or those shown in the drawings provide a clear advantage over the prior art and are therefore within the scope of the present application as described herein.

Claims

1. A device for transmucosal neuromuscular electrical stimulation comprising a mouthpiece, an electrode arrangement associated with the mouthpiece, and an electrical circuit operatively connected to the electrode arrangement, characterized in that, The mouthpiece includes a pair of arms joined together at one end and diverging from one another, and at least one flange extending inwardly from at least one arm, the at least one flange shaped to fit or approximate or accommodate the sublingual tongue surface, the at least one flange including the electrode arrangement associated therewith for providing, in use, electrical stimulation to one or more palatal and / or tongue muscles via the sublingual tongue surface via the electrode arrangement to increase resting muscle tone and / or muscle tone during sleep.

2. The apparatus of claim 1, wherein, The at least one flange has a flat or planar major surface for contacting the sublingual tongue surface.

3. The apparatus of any of the preceding claims, wherein, The at least one flange extends downwardly and / or beyond a plane of the mouthpiece.

4. The apparatus of claim 1, further comprising a second flange extending inwardly from at least one arm.

5. The apparatus of claim 4, wherein, The second flange is shaped to fit or approximate or accommodate the sublingual tongue surface.

6. The apparatus of claim 4, wherein, The second flange is shaped to fit or approximate or accommodate the dorsal tongue surface.

7. The apparatus of claim 6, wherein, The second flange shaped to fit or accommodate the dorsal tongue surface extends from or adjacent a free end of the arm.

8. The apparatus of any one of claims 4-7, wherein, The at least one flange includes a first flange including at least one electrode or sequence thereof, and the second flange includes at least one electrode or sequence thereof.

9. The apparatus of claim 8, wherein, The at least one electrode or sequence thereof of the first flange is controllably independent of the at least one electrode or sequence thereof of the second flange.

10. The apparatus of claim 8, wherein, The at least one electrode or sequence thereof of the first flange is associated with a first side of the mouthpiece, and the at least one electrode or sequence thereof of the second flange is associated with a second side of the mouthpiece.

11. The apparatus of claim 8, wherein, A first current is provided or applied at or from the at least one electrode or sequence thereof of the first flange, and a second current is provided or applied at or from the at least one electrode or sequence thereof of the second flange.

12. The apparatus of claim 1, wherein, The at least one flange shaped to fit or approximate or accommodate the sublingual tongue surface extends from a middle portion of the arm.

13. The apparatus of claim 1, wherein, The electrical stimulation includes biphasic electrical pulse current at a frequency between 5 Hz and 150 Hz.

14. The apparatus of claim 13, wherein, The biphasic electrical pulse current includes an amplitude between 1 mA and 100 mA.

15. A system for training one or more oral muscles by transmucosal neuromuscular electrical stimulation, comprising the apparatus of any one of claims 1-14.

16. The system of claim 15, wherein, The system applies electrical stimulation via the sublingual tongue surface via the mouthpiece to one or more palatal and / or tongue muscles to increase resting muscle tone and / or muscle tone during sleep.

17. The system of claim 15, wherein, In a first treatment period, the system applies electrical stimulation to establish resting muscle tone and / or muscle tone during sleep, and in a second maintenance period, the system adjusts or varies the electrical stimulation relative to the first treatment period to maintain resting muscle tone and / or muscle tone during sleep.

18. The system of claim 15, wherein, The system adjusts or varies a frequency and / or pulse duration and / or intensity and / or amplitude of the electrical stimulation.

19. A system for training one or more oral cavity muscles by transmucosal neuromuscular electrical stimulation, wherein, The system applies the electrical stimulation to the sublingual surface of the tongue via a mouthpiece, the system applies the electrical stimulation from a first side of the tongue to a second side of the tongue to increase resting muscle tone and / or muscle tone during sleep.

20. The system of claim 19, wherein, The system applies the electrical stimulation from the sublingual surface of the tongue to the dorsal surface of the tongue.

21. The system of claim 20, wherein, The system applies the electrical stimulation substantially horizontally across the sublingual surface of the tongue from a first side to a second side of the tongue to increase resting muscle tone and / or muscle tone during sleep.

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