HK1237696B

HK1237696B - Oral muscle training

Info

Publication number: HK1237696B
Application number: HK17112035.3A
Authority: HK
Inventors: 安舒尔．萨马
Original assignee: 希格尼菲尔医疗科技有限公司
Priority date: 2014-12-03
Filing date: 2015-10-12
Publication date: 2022-05-27

Abstract

A trans mucosal neuromuscular electrical stimulation device (1) including a mouthpiece (3, 03), electrodes (32a, 33a, 132a, 133a) associated with the mouthpiece (3, 103). The device (1) and/or mouthpiece (3, 103) incorporates electrical circuitry operatively connecting to the electrodes (32a, 33a, 132a, 133a) to a power source and is configured to provide, in use, electrical stimulation to one or more palate and/or tongue muscles via the electrodes (32a, 33a, 132a, 133a) through the oral mucosa. The treatment regime, including the location of stimulation and the parameters used, is designed to increase resting muscle tone and/or muscle tone during sleep.

Description

Oral muscle training

The present invention relates generally to oral muscle training, and more particularly to oral muscle training devices, methods, systems, and control software. More particularly, but not exclusively, the present invention relates to training the muscles in the mouth for treating sleep-disordered breathing.

Snoring and sleep apnea are considered part of a spectrum of conditions commonly referred to as sleep-disordered breathing (SDB), whose symptoms are related to disturbed breathing patterns during sleep. SDB is not only annoying but can also lead to health problems such as frequent awakenings from sleep, light sleep, heart strain, low oxygen levels in the blood, headaches, and fatigue.

The respiratory passage between the back of the nose and the mouth to the level of the larynx is a collapsible tube. It has been observed that collapse of the respiratory passage occurs at positive airway pressure in individuals who snore and/or suffer from sleep apnea, while it occurs at negative airway pressure in individuals who do not snore and/or suffer from sleep apnea.

To address this, treatments have been developed that include using a continuous positive airway pressure device to keep the airway open, or wearing a mandibular advancement appliance to hold the jaw and tongue forward, thereby increasing the space at the back of the throat.

These devices can cause discomfort, only temporarily address symptoms rather than the underlying cause, and require continuous use during sleep. Consequently, users find it difficult to fall asleep, resulting in low compliance. It would be desirable to provide a treatment that does not require the constant use of such a device during sleep and that addresses the underlying cause of the disease.

Recent studies have shown that electrical nerve stimulators implanted in the tongue and diaphragm are effective in treating obstructive sleep apnea. This involves an invasive procedure to implant sensors and electrodes onto the nerves in these areas. The device uses sensors to identify obstructive episodes and stimulates the lingual nerve to cause contractions, thereby alleviating the obstructive event. As with pacemakers, this approach carries maintenance costs and other complications, such as battery replacement, risks associated with the electric field, and issues with external safety monitoring devices. Furthermore, stimulation occurs only during obstructive episodes during sleep; it does not address the underlying cause of the disease.

Thus, a first, non-exclusive object of the present invention is to provide a treatment system, preferably for use in the waking state, that provides a sustainable reduction in disordered breathing patterns during sleep. Another, more general object of the present invention is to provide a treatment system and apparatus that is more effective in at least one aspect than existing systems and apparatus for treating SDB.

Thus, a first aspect of the present invention provides an electrical stimulation device for training one or more oral muscles, for example, a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, an electrode arrangement and a circuit, the electrode arrangement being associated with the mouthpiece and the circuit being operably connected to the electrode arrangement, wherein the device or circuit is configured to provide electrical stimulation to one or more oral muscles (for example, the tongue and/or palate muscles) via the electrode arrangement through the inner membrane of the mouth (for example, the oral mucosa) during use, for example to increase resting muscle tone and/or muscle tone during sleep.

When a person is awake, the contractile section of the respiratory passageway is held open by the tone of the muscles that control this area. When a person is asleep, this muscle tone decreases significantly. Evidence has shown that this decrease in muscle tone is significantly increased in patients with obstructive sleep apnea, decreased in those who snore, and significantly reduced in individuals without these disorders.

Studies have shown that increasing pharyngeal muscle activity or tone reduces airway contractility, and the present invention is based on the recognition that electrical stimulation, particularly neuromuscular electrical stimulation, can be used to stimulate the tongue and/or palate muscles and/or sensory nerves to improve muscle strength and tone recovery.

The device or circuit is preferably configured to provide a current, eg, a current or a pulsed current (eg, a two-phase current or a pulsed current).

Another aspect of the present invention provides an electrical stimulation device for training one or more oral muscles, such as a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, an electrode arrangement and a circuit, the electrode arrangement being associated with the mouthpiece and the circuit being operably connected to the electrode arrangement, wherein the device or circuit is configured to provide a two-phase current, such as a two-phase electrical pulse current, via the electrode arrangement during use.

By providing biphasic current, particularly biphasic electrical pulse current, the tongue and/or palate muscles and sensory nerves that contribute to airway contractility can be stimulated to increase resting muscle tone and muscle tone during sleep.

The current is preferably a two-phase symmetrical current, but it may additionally or alternatively be a two-phase asymmetrical current which may be balanced or unbalanced.The apparatus or circuit may be configured to provide, in use, a current having a frequency of between 5 Hz and 150 Hz via the electrode arrangement.

Another aspect of the invention provides a device for electrical stimulation of training one or more oral muscles, such as a device for transmucosal neuromuscular electrical stimulation, the device comprising a mouthpiece, an electrode arrangement and a circuit, the electrode arrangement being associated with the mouthpiece and the circuit being operably connected to the electrode arrangement, wherein the device or circuit is configured to provide an electric current having a frequency between 5 Hz and 150 Hz via the electrode arrangement during use.

The electric current may 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 electric current comprises a frequency between 20 Hz and 50 Hz and/or between 50 Hz and 120 Hz.

The device or circuit can be configured to provide two or more currents, for example, a first current and/or a second current, the second current being different from the first current and/or being configurable or settable independently of the first current. At least one of the first current and/or the second current, for example both, can include two-phase currents, each current preferably being symmetrical, but can be asymmetrical, and balanced or unbalanced. At least one of the first current and/or the second current can include 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 include a frequency between 20 Hz and 50 Hz, and/or the other current can include a frequency between 50 Hz and 120 Hz.

The present inventors believe that applying current in one or each of these two frequency ranges is particularly suitable for targeting the palatine and tongue muscles that contribute to the contractility of the airway.

The device or circuit can be configured to provide, or at least one or each, an electrical current to one or more oral muscles (e.g., palatal muscles and/or tongue muscles) during use, for example, through the 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, during use, an electrical current, e.g., a first current, to one or more palatal muscles. Additionally or alternatively, the device can be configured to provide, during use, an electrical current, e.g., a second current, to one or more tongue muscles via the dorsal surface of the tongue. Additionally or alternatively, the device can be configured to provide, during use, an electrical current, e.g., a first current or a second current, to one or more tongue muscles via the underside of the tongue.

In an embodiment, the mouthpiece may include one or more arms and/or one or more appendages or flanges that may extend from the one or more arms, for example, for contacting one or more oral muscles. At least one arm and/or at least one appendage or flange may be flat or planar, for example, having a major surface. Alternatively, the mouthpiece may include a pair of arms, each of which may include one or more appendages or flanges. In some embodiments, the mouthpiece includes a pair of arms that may extend at least partially alongside each other, and/or extend at an angle relative to each other, and/or extend parallel to each other. For example, the mouthpiece may include a pair of arms that are joined together at one end and diverge from each other at the other end, for example, in a generally V-shaped or U-shaped or horseshoe-shaped shape.

One or more appendages or flanges may extend within a pair of arms, e.g., from one arm toward the other arm. In some embodiments, each arm includes at least one appendage or flange, e.g., extending toward and/or toward each other. In embodiments, each arm includes 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 a mid-portion of each arm.

At least one appendage or flange may be curved, e.g., a flat, curved shape or member, and/or extend upward or downward, or beyond the plane of the mouthpiece or at least one of its arms. At least one appendage or flange may be shaped to fit or approach or accommodate a surface of the tongue, e.g., the dorsal surface of the tongue or the sublingual surface of the tongue. In an embodiment, the mouthpiece includes at least one appendage or flange shaped to fit or approach or accommodate a dorsal surface of the tongue, and at least one appendage or flange shaped to fit or approach or accommodate a sublingual surface of the tongue. In an embodiment having a pair of arms, each arm may include an appendage or flange shaped to fit or approach or accommodate a dorsal surface of the tongue, and an appendage or flange shaped to fit or approach or accommodate a sublingual surface of the tongue.

At least one of the appendages or flanges may include one or more electrodes or a sequence thereof. At least one electrode or sequence of electrodes may 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 an embodiment, at least one of the appendages or flanges includes an electrode associated with each of its major surfaces. The electrode associated with one of the major surfaces may be isolated from the other electrode or its other major surface and/or controllably independent of the other electrode or its other major surface. Additionally or alternatively, an electrode of or associated with one appendage or flange may be isolated from and/or controllably independent of at least one other appendage or flange.

In an embodiment, the mouthpiece may include a pair of arms joined together at one end and diverging from each other to provide a generally horseshoe shape having one or more flanges extending inwardly from at least one arm, the flange or each flange comprising an electrode arrangement. The mouthpiece may include a pair of flanges, each extending inwardly from a respective arm, the flanges being shaped to accommodate a dorsum surface of the tongue. The mouthpiece may include a pair of flanges, each extending inwardly from a respective arm, the flanges being shaped to accommodate a lingual surface under the tongue. Each of the pair of flanges may be shaped to accommodate a dorsum surface of the tongue, extending from or adjacent to the free end of the arm, and/or each of the pair of flanges may be shaped to accommodate a lingual surface under the tongue, extending from a mid-portion of the arm.

Another aspect of the invention provides a device for electrical stimulation of training one or more oral muscles, for example, a device for transmucosal neuromuscular electrical stimulation, the device comprising a mouthpiece, an electrode arrangement and a circuit, the electrode arrangement being associated with the mouthpiece, the circuit being operably connected to the electrode arrangement, wherein the mouthpiece comprises a pair of arms which are joined together at one end and diverge from each other at the other end, one or more flanges extending inwardly from at least one arm, the flange or each flange comprising at least a portion of the electrode arrangement associated therewith for providing electrical stimulation to one or more oral muscles.

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

The mouthpiece may comprise a clamping base which may comprise an enlarged end, for example an enlarged free end, which free end may be connected or fixed to the mouthpiece or its body or one or more arms or each arm thereof (for example, formed integrally with the mouthpiece, or its body or one or more arms or each arm thereof), for example by a constricted portion.

The electrode arrangement preferably comprises at least one anode and at least one cathode, for example, two or more anodes and/or two or more cathodes, for example, a plurality of anodes and a plurality of cathodes. At least a portion of the electrode arrangement, for example, one or more electrodes or each electrode or all electrodes may be mounted to or on or within the mouthpiece and/or at least partially housed or contained within the mouthpiece. In some embodiments, the mouthpiece comprises, for example, a shielding member or shielding means on one side of the electrode arrangement, for example to inhibit or prevent electrical stimulation or current from being applied or provided by, or provided at or from, a side of the mouthpiece. Suitable materials for the shielding member or shielding means will be apparent to those skilled in the art.

In an embodiment, the electrode arrangement is configured or operable to, for example, selectively provide or apply electrical stimulation or current on at least one side or each side or both sides, for example, by means of a shielding arrangement or shielding member between an electrode arrangement or electrodes comprising a first group or first sequence and a second group or second sequence of electrode arrangements or electrodes. In some embodiments, the first current is provided or applied at a first side (e.g., a primary side) of the mouthpiece, or from a first side (e.g., a primary side) of the mouthpiece, and/or by a first group or first sequence of electrode arrangements or electrodes. Additionally or alternatively, the second current is provided or applied at a second side (e.g., a primary side) of the mouthpiece, or from a second side (e.g., a primary side) of the mouthpiece, and/or by a second group or second sequence of electrode arrangements or electrodes. In other embodiments, the first current and the second current may be provided or applied from at least one side or each side or both sides.

The mouthpiece can be inserted into the mouth and held in place, for example manually. The mouthpiece can be at least partially flat and/or substantially flat and/or paddle-shaped, for example, having at least one flat and/or major surface, preferably two flat major surfaces. In some embodiments, the device can include a handle to which the mouthpiece can, for example, be rigidly and/or releasably connected or mounted or attached, for example so that the mouthpiece can be inserted and/or held in one or more locations or positions and/or orientations in the mouth during use. In some embodiments, the mouthpiece does not have any mounting means for mounting or securing it to the user's mouth or in the user's mouth or in the user's mouth.

In an embodiment, the mouthpiece may include a mounting arrangement. The mounting arrangement may be used to mount the mouthpiece to an upper portion of the mouth, for example 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 top 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, for example, the dorsal surface of the tongue. Additionally or alternatively, the mounting arrangement may be used to mount the mouthpiece to a lower portion of the mouth, for example 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, for example, the tongue surface under the tongue. In an embodiment, the apparatus comprises a first mouthpiece having a mounting arrangement for mounting it to the upper portion of the mouth, and a second mouthpiece for mounting it to the lower portion of the mouth.

The device or handle may include an input device or activator, which may include one or more input devices, buttons and/or push buttons and/or switches and/or dials, etc., for example, to enable or activate or start electrical stimulation or electric current. The device or handle may include a power supply and/or a cable connectable to the power supply. In some embodiments, the device includes a main body, the main body includes or contains or provides a handle, and/or the device includes or accommodates a power supply, which may include a rechargeable power supply or one or more rechargeable batteries, and/or it may include a cable or be operably connected (e.g., inductively) to a charging station that includes or contains a cable, for example, to enable the power supply to be recharged. The device may include a charging station.

In some embodiments, the device includes a regulating device or regulator (e.g., a frequency regulating device or regulator) for regulating the frequency of the current or the frequency of the first current and/or the second current, for example, a corresponding first current and second current frequency regulating device or regulator for regulating the frequency of the current, for example, between one of the above-mentioned ranges. In an embodiment, the regulating device or regulator is a step-type 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 current and the second current simultaneously and/or concurrently and/or in parallel. Additionally or alternatively, the device can be operable or configured to provide the first current and the second current in series and/or sequentially and/or continuously.

The current or at least one of the first current and/or the second current (e.g., both) may comprise a pulsed current. The pulse duration of each pulsed current may be between 50 μs and 1000 μs, for example, between 100 μs and 900 μs, for example, between 150 μs and 800 μs, preferably between 200 μs and 700 μs. Preferably, for example, an additional regulating device or regulator (e.g., a pulse duration regulating device or regulator) of the device is provided for regulating the pulse duration within one of the above ranges.

The electrical stimulation or current or the first current and/or the second current may comprise an intensity or current amplitude that is preferably selected or selectable to provide maximum contraction of the muscle being treated. By way of example, the intensity or amplitude may 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. Additional adjustment means or regulators may be provided, for example, intensity or amplitude adjustment means or regulators for adjusting the intensity or amplitude, for example, 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.

In some embodiments, the device is configured or programmed to provide electrical stimulation or current or the first current and/or the second current for a predetermined time period, which can include between 1 minute and 1 hour, for example, between 5 minutes and 30 minutes, preferably, between 10 minutes and 20 minutes. Additional adjustment means or regulators can be provided, for example, treatment duration adjustment means or regulators for adjusting the treatment duration, for example, from 0 to 10 hours, or from 0 to 5 hours, or from 0 to 1 hour, or from 0 to 30 minutes.

The device may include a control device that may be programmed or programmable to control one or more characteristics of the electrical stimulation or current, for example according to a predetermined treatment regimen. The control device may include a control system and/or a controller and/or may include or be at least partially included in an electrical circuit. The control device may include at least a portion of a regulating device or regulator, such as one or more of a frequency and/or pulse duration and/or intensity and/or amplitude and/or treatment duration regulating device or regulator.

In some embodiments, the input device can be used to configure or operatively control and/or adjust one or more characteristics of the electrical stimulation or current or the first current and/or the second current, such as frequency and/or pulse duration and/or intensity and/or amplitude and/or duration of treatment. Additionally or alternatively, the device or input device can include 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 handheld device) that can operatively program and/or control and/or adjust one or more of the above-mentioned characteristics.

The device or control means or regulating means may be configured or programmed to control the electrical stimulation or the electrical current or one or more characteristics of the first current and/or the second current, for example, in a predetermined manner and/or according to a predetermined treatment regimen. The device or control means may be operable or programmable to create and/or change a predetermined treatment regimen, for example, via a device to which the electrical stimulation device is connected, for example, via an input means.

Another aspect of the invention provides a computer program element comprising computer-readable program code means for causing a processor to execute the program to implement a method or treatment regimen comprising providing electrical stimulation to one or more oral muscles (e.g., palatine muscles and/or tongue muscles) through the lining of the mouth (e.g., oral mucosa), for example to increase resting muscle tone and/or muscle tone during sleep.

Another aspect of the invention provides a method or treatment regimen for training one or more oral muscles, such as by transmucosal neuromuscular electrical stimulation, the method comprising providing or applying electrical stimulation to one or more oral muscles (e.g., palatal muscles and/or tongue muscles) through the lining of the mouth (e.g., oral mucosa), for example to increase resting muscle tone and/or muscle tone during sleep.

For the avoidance of doubt, any feature described herein is equally applicable to any aspect of the present invention.

The method or treatment regimen can include, for example, providing or applying a current, such as an electrical current or a pulsed current, such as a biphasic current or a pulsed current, to one or more oral muscles.

Another aspect of the present invention provides a method or treatment regimen for training one or more oral muscles, for example by transmucosal neuromuscular electrical stimulation, the method comprising providing or applying a biphasic current (e.g., a biphasic electrical pulse current) to one or more oral muscles (e.g., palatal muscles and/or tongue muscles) through the inner membrane of the mouth (e.g., oral mucosa), for example via an electrode device.

The method or treatment regimen may include providing or applying a first current and/or a second current, which may be different from the first current. At least one (e.g., both) of the current or the first current and/or the second current may include an alternating current. At least one or each current may include 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 includes a frequency between 20 Hz and 50 Hz, and/or the second current includes a frequency between 50 Hz and 120 Hz.

In embodiments, the two-phase current or the phases of the first and second currents may be applied simultaneously and/or concurrently. In some embodiments, the two-phase current or the phases of the first and second currents may be applied in series and/or sequentially and/or continuously.

The current or at least one of the first current and/or the second current (e.g., both) may include pulsed currents. The pulse duration of each pulsed current may be between 50 μs and 1000 μs, e.g., between 100 μs and 900 μs, e.g., between 150 μs and 800 μs, preferably, between 200 μs and 700 μs.

The electrical stimulation or current or the first current and/or the second current may comprise an intensity or current amplitude that is preferably selected or selectable to provide maximum contraction of the muscle being treated. By way of example, the intensity or amplitude may comprise approximately 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.

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

In some embodiments, the method or treatment regimen may include providing or applying an electrical stimulation or an electrical current or a first current and/or a second current to a first muscle or muscle group and/or the upper or dorsal surface of the tongue for a first predetermined period of time. The first muscle or muscle group may include one or more palatine and/or tongue muscles, for example, one or more intrinsic surface muscles, the uvula palatini, the levator veli palatini, and the palatopharyngeus.

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

Additionally or alternatively, the method or treatment regimen comprises performing one or more of the above steps at predetermined intervals, which may include between once a day and ten times a day or any number therebetween, for example, twice a day. Additionally or alternatively, the method or treatment regimen comprises performing one or more of the above steps during a predetermined treatment period, which may include between one week and twelve weeks, for example, between two weeks and ten weeks, for example, between five axes and eight weeks, for example, six weeks.

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

In some embodiments, the method or treatment regimen includes a first treatment period, e.g., during which electrical stimulation or current or the first and/or second current is provided or applied, e.g., 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), e.g., during which one or more characteristics of the electrical stimulation or current or the first and/or second current are adjusted or altered, e.g., relative to the first period, e.g., 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 a second regimen, e.g., different from the first regimen.

In an exemplary embodiment, the method or treatment regimen comprises providing or applying electrical stimulation to one or more oral muscles for 10 to 20 minutes twice daily for six weeks, e.g., to establish resting muscle tone and/or muscle tone during sleep. Additionally or alternatively, the method or treatment regimen comprises providing or applying electrical stimulation to one or more oral muscles for 10 to 20 minutes once daily on an ongoing basis, e.g., to establish resting muscle tone and/or muscle tone during sleep.

Another aspect of the present invention provides a method or treatment regimen for training one or more oral muscles, such as by sensory stimulation, comprising providing or applying vibration stimulation to one or more oral muscles (e.g., palatal muscles and/or tongue muscles). The method may also include any one or more features of the above-described method.

Another aspect of the present invention provides a computer program element comprising computer readable program code means for causing a processor to execute a program to implement the above method or treatment regimen. Yet another aspect of the present invention provides a computer program element embodied on a computer readable medium.

Yet another aspect of the present invention provides a computer-readable medium having stored thereon a program, wherein the program is arranged to cause a computer to execute the program to implement the above-described method or treatment regimen.

Yet another aspect of the invention provides a control device or a control system or a controller comprising the above-mentioned computer program element or computer-readable medium, or for controlling a treatment regimen to train one or more oral muscles, for example by transmucosal neuromuscular electrical stimulation, for example for controlling the above-mentioned method.

Within the scope of the present application, it is expressly contemplated that the various aspects, embodiments, examples and alternatives set forth in the preceding paragraphs, claims and/or the following description or drawings, and in particular in the individual features thereof, may be employed independently or in any combination. Features described in conjunction with one aspect or embodiment of the invention are applicable to all aspects or embodiments, unless such features are incompatible.

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

FIG1 is a perspective view of an electro-stimulation device according to an embodiment of the present invention;

FIG2 is a perspective view of the main body of the device of FIG1;

FIG3 is a perspective view of the mouthpiece of the device of FIG1 ;

FIG4 is a perspective view of a charging station for the device of FIG1 ;

FIG5 is a schematic diagram of a human mouth showing the palatoglossus muscles and the surface of the tongue;

FIG6 is a schematic diagram showing the extrinsic tongue muscles of a human tongue;

FIG7 is a schematic diagram showing the intrinsic tongue muscles of a human tongue;

FIG8 is another schematic diagram of a human mouth showing the muscles of the palate;

FIG9 is a schematic diagram showing additional muscles of the palate;

Figure 10 is a top view of a mouthpiece of an electro-stimulation device according to a second embodiment of the present invention; and

FIG. 11 is a side view of the mouthpiece of FIG. 10 .

Referring now to Figures 1 to 4, there is shown an electro-stimulation device 1 comprising a main body 2, a mouthpiece 3, and a charging station 4. The main body 2 acts as a handle and is generally cylindrical in this embodiment and comprises a first upper end 20 having a male connector 21 with protrusions 22 on each side thereof to provide a bayonet-type fit and an electrical socket 23 for receiving an electrical connector (not shown) of the mouthpiece 3. The main body 2 also 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.

The main body 2 also includes a battery (not shown) and circuitry including an inverter for converting the battery's direct current into two separate symmetrical two-phase currents. A first dial 24 is operable to adjust the current amplitude of the first two-phase current from 0 to 100 mA. A second dial 25 is operable to adjust the current amplitude of the second two-phase current from 0 to 100 mA. A 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. A 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.

USB port 28 is configured to enable device 1 to be connected to a personal computer (not shown) to independently program one or more characteristics of the first two-phase current and the second two-phase current. In this embodiment, the frequency of the first two-phase current is set to a value between 20 Hz and 50 Hz, the second two-phase current is set to a value between 50 Hz and 120 Hz, and the pulse duration of each two-phase current is set to a value between 200 μs and 700 μs. The personal computer (not shown) may also include control software operable to override dials 24, 25, 26, and 27. The software can be programmed to apply two-phase currents having predetermined characteristics that are independent of each other, such as amplitude, frequency, and pulse duration, and a predetermined time period. It is further contemplated that device 1 may include a memory storing such predetermined characteristics, which can be modified by connecting a personal computer (not shown) to device 1 via USB port 28. In such embodiments, the dials may be omitted or configured to adjust the aforementioned characteristics from their preprogrammed values. In some embodiments, it is contemplated that more or fewer functions may be provided via manual dials, buttons, etc.

The mouthpiece 3 comprises a cylindrical base 30 and a substantially flat paddle-shaped contact portion 31, which is integrally formed with the upper end of the base 30 and has a first main surface and a second main surface 32, 33. The base 30 comprises a socket (not shown) at its lower end 34, having an electrical connector (not shown) for being accommodated in the electrical socket 23 of the main body 2. The mouthpiece 3 also comprises an electrical circuit (not shown) that supplies a corresponding sequence of electrodes 32a, 33a below each main surface 32, 33. The electrode sequences 32a, 33a are electrically isolated from each other by a shielding material. The electrical circuit (not shown) of the mouthpiece 3 is operably connected to the electrical circuit (not shown) of the main body 2 in use, so that the first sequence of electrodes 32a transmits a first two-phase current and the second sequence of electrodes 33a transmits a second two-phase current.

In this embodiment, the mouthpiece 3 is provided as a component separate from the main body 2 and is configured so that it can be easily cleaned between sessions. However, in alternative embodiments, the mouthpiece 3 may be formed integrally with the main body 2. In yet other embodiments, the mouthpiece 3 may include mounting means for mounting it to the upper and/or lower portion of the user's mouth in a manner similar to a retainer. In such an embodiment, the device 1 may include a pair of mouthpieces 3, each mouthpiece 3 including 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 may include two sequences of electrodes 32a, 33a to contact the roof of the user's mouth and stimulate one or more palatal muscles on one side, and to contact the dorsal surface of the tongue on its other side and stimulate one or more tongue muscles. The second mouthpiece 3 may include a single sequence of electrodes 32a to stimulate the sublingual muscles. Each mouthpiece 3 may include a power source and wireless communication means such as a Bluetooth communication means for communicating with a personal computer (not shown), for example.

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 source. The protrusion 41 in this embodiment comprises an inductive coupler, and the station 4 comprises an electrical circuit connected to the mains cable 42 for supplying power to the inductive coupler for inductively charging a battery (not shown) in the main body 2.

Turning now to Figures 5 to 9, various tongue and palatal muscles are illustrated. The features of the mouth shown in Figures 5 to 7 more clearly illustrate the tongue muscles, wherein the pharyngeal palatine arch 51, palatine tonsils 52, palatoglossus 53, buccinator 54, circumflex papilla 55, fungiform papilla 56, dorsal surface of the tongue 57, styloglossus 58, hyoglossus 59, mandible 60, genioglossus 61, longitudinal, transverse, and vertical intrinsic muscles 62, 63, 64, and geniohyoid muscle 65 are illustrated.

It has been determined that the tone of the genioglossus muscle 61 has the greatest impact on tongue contractility, 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. The tone of the intrinsic surface muscles, such as the longitudinal and transverse intrinsic muscles 62, 63, also helps to reduce airway contractility.

The features of the mouth shown in Figures 8 and 9 more clearly illustrate the palatal muscles, wherein the dental arch 66, premaxilla 67, incisive foramen 68, palatine process 69, palatine bone 70, posterior nasal spine 71, palatine foramen 72, uncinate process 73, tensor veli palatini muscle (tensor veli palatini muscle) 74, levator veli palatini muscle 75, tensor veli palatini muscle (tensor veli palatini muscle) 76, uvula palatini muscle 77 and palatopharyngeus muscle 78 are shown.

To varying degrees, the constrictor and dilator muscles of the palate also contribute to snoring and sleep apnea. The goal of treatment is to dilate the throat, so electrical stimulation is targeted at the midline dilator palatine muscles, such as the uvula palatini 77, levator veli palatini 75, and palatopharyngeus 78.

In use, the mouthpiece 3 is applied to the dorsal surface of the tongue 57 and the aforementioned palatal muscles, and two biphasic currents are applied, each configured with a first set of parameters including intensity, frequency, and pulse duration. These biphasic currents propagate through the lining of the mouth, the oral mucosa, to stimulate the intrinsic surface muscles 62, 63, the uvula palatini 77, the levator veli palatini 75, and the palatopharyngeus 78. The parameters are selected to provide the user with maximum contraction of these muscles, and the treatment is performed for 20 minutes.

The intensity, frequency, and pulse duration are then adjusted, and the mouthpiece 3 is applied to the underside of the tongue. Two biphasic currents having a second set of parameters are now 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 user's genioglossus muscle 61, and the treatment is performed for 20 minutes.

The skeletal muscles are stimulated by applying a biphasic current according to the aforementioned parameters. It is also believed that applying this biphasic current to these skeletal muscles produces further sensory functions, such as a vibration sensation. While not wishing to be bound by any theory, it is believed that this electrical and vibration stimulation of the nerves provides feedback to the brain, which further enhances the improvement in muscle tone. Specifically, it is believed that the effects of this treatment are enhanced through multisensory integration within the nervous system.

By way of example, a treatment regimen may include a six-week induction period during which each of the aforementioned muscle groups is stimulated for 10 to 20 minutes twice daily. A treatment regimen designed to build muscle tone may be followed by an ongoing maintenance regimen comprising daily 10 to 20 minute sessions.

Referring now to Figures 10 and 11, a mouthpiece 103 according to a second embodiment similar to the first embodiment is shown, wherein like references describe like 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 first and second contact flanges 132, 133 in which electrodes (not shown) are embedded.

The first contact flanges 132 extend inwardly and upwardly from the free ends of the respective ones of the arms 131 toward each other to form a curved shape for receiving the dorsal surface 57 of the patient's tongue (not shown). The second contact flanges 133 extend inwardly and downwardly from the middle portions of the respective ones of the arms 131 toward each other to form a curved shape for receiving the sublingual tongue surface.

The base 130 includes an enlarged end 134 that is coupled to the arm 131 via a constricted portion 135. The end surface of the enlarged end 134 includes an electrical connector 136 for connecting 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. In some embodiments, the mouthpiece includes a power source such as a battery.

Similar to the first embodiment, the mouthpiece 103 also includes circuitry (not shown) that supplies a corresponding 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 their associated flanges 132, 133 cooperate to form generally contiguous surfaces. In this embodiment, the mouthpiece 103 is formed of a silicon grade or biocompatible grade plastic material. The electrodes 132a, 133a in this embodiment are preferably formed of gold or copper or a composite material or any such alloy having an exposed surface.

In use, the mouthpiece 103 is placed in the patient's mouth and the patient's tongue is received within the mouthpiece 103 so that the dorsal surface 57 of the tongue contacts the first contact flange 132 and the lingual surface under the tongue contacts the second contact flange 133. It will be understood by those skilled in the art that the first flange 132 will contact the posterior portion of the dorsal surface 57 of the tongue and the second flange 133 will contact the anterior portion of the lingual surface under the tongue. When the patient's mouth is closed, the flanges 132, 133 can also contact and stimulate adjacent muscles on the other side of the tongue, for example, the palatal muscles. The muscles are stimulated in a similar manner to the device 1 according to the first embodiment, but this mouthpiece 103 enables muscles to be stimulated on both sides of the tongue simultaneously. It will be understood that with this design, muscles based in and around the tongue, including muscles in the hard palate area and the soft palate area, can be stimulated.

It will be appreciated by those skilled in the art that several variations to the above-described embodiment are envisaged without departing from the scope of the invention. For example, the mouthpiece 3 may take any suitable form, but is preferably designed so that the electrical stimulation can be applied to the appropriate muscles as described above. The dials 24, 25, 26, 27 may be replaced by other similar adjustment means, or even omitted as described above. The mouthpiece 3 and the main body 2 may be provided as an integral unit, and the charging station 4 may be omitted, for example the main body 2 may comprise a main cable 42 or require only disposable batteries or some other power source. Similarly, the USB port 28 may be omitted or replaced by some other connection means, which may be a wireless connection means. It will also be appreciated by those skilled in the art that any number of combinations of the aforementioned features and/or those shown in the accompanying drawings provide significant advantages over the prior art and are therefore within the scope of the invention described herein.

Oral muscle training

FIG2 is a perspective view of the main body of the device of FIG1;

FIG3 is a perspective view of the mouthpiece of the device of FIG1 ;

FIG4 is a perspective view of a charging station for the device of FIG1 ;

FIG9 is a schematic diagram showing additional muscles of the palate;

FIG. 11 is a side view of the mouthpiece of FIG. 10 .

FIG2 is a perspective view of the main body of the device of FIG1;

FIG3 is a perspective view of the mouthpiece of the device of FIG1 ;

FIG4 is a perspective view of a charging station for the device of FIG1 ;

FIG9 is a schematic diagram showing additional muscles of the palate;

FIG. 11 is a side view of the mouthpiece of FIG. 10 .

FIG2 is a perspective view of the main body of the device of FIG1;

FIG3 is a perspective view of the mouthpiece of the device of FIG1 ;

FIG4 is a perspective view of a charging station for the device of FIG1 ;

FIG9 is a schematic diagram showing additional muscles of the palate;

FIG. 11 is a side view of the mouthpiece of FIG. 10 .

Claims

1. A transmucosal neuromuscular electrical stimulation device, comprising a mouthpiece, an electrode assembly, and circuitry, the electrode assembly being associated with the mouthpiece and the circuitry being operatively connected to the electrode assembly, characterized in that the mouthpiece includes a pair of arms and at least one flange, the pair of arms being joined at one end and diverging from each other, the at least one flange extending inwardly from the at least one arm, the at least one flange being shaped to engage, approach, or adapt to a dorsolateral surface of the tongue, the at least one flange including the associated electrode assembly for providing electrical stimulation, in use, via the dorsolateral surface of the tongue to one or more palatine muscles and/or tongue muscles via the electrode assembly, to increase resting muscle tone and/or muscle tone during sleep.

2. The device according to claim 1, wherein the electrical stimulation comprises a two-phase electrical pulse current with a frequency between 5 Hz and 150 Hz.

3. The device according to claim 2, wherein the two-phase electrical pulse current includes a frequency between 20 Hz and 120 Hz.

4. The device according to claim 2 or claim 3, wherein the two-phase electrical pulse current includes a frequency between 20 Hz and 50 Hz.

5. The device according to claim 2 or claim 3, wherein the two-phase electrical pulse current includes a frequency between 50 Hz and 120 Hz.

6. The device according to claim 2, wherein the two-phase electrical pulse current includes an amplitude between 1mA and 100mA.

7. The device according to claim 6, wherein the two-phase electrical pulse current includes an amplitude between 5mA and 15mA.

8. The device according to claim 2, wherein the two-phase electrical pulse current includes a pulse duration between 200 μs and 700 μs.

9. The device according to claim 1 further includes an adjustment device for adjusting one or more of the frequency, amplitude, pulse duration, and/or treatment duration of the two-phase electrical pulse current.

10. The device of claim 2, further comprising a control device, the control device being programmed or programmable to control one or more features of the electrical stimulation or the biphasic electrical pulse current according to a predetermined treatment protocol.

11. The device of claim 1, wherein the electrode arrangement comprises 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.

12. The device of claim 11, wherein the first sequence electrode is operable to provide a first current, and the second sequence electrode is operable to provide a second current.

13. The device of claim 1, further comprising a handle, wherein the mouthpiece is mounted to the handle such that the mouthpiece can be inserted into and/or retained in one or more portions or positions and/or orientations within the mouth during use.

14. The device of claim 1, wherein the mouthpiece does not have a mounting device for securing it to the user's mouth.

15. The device of claim 1, wherein the mouthpiece includes a mounting means for mounting the mouthpiece to a mouth.

16. The device of claim 1, wherein the pair of arms are joined together at one end and spaced apart from each other to provide a generally horseshoe shape.

17. The device of claim 16, wherein the mouthpiece includes a first pair of flanges, each of the first pair of flanges extending inwardly from a respective arm, the first pair of flanges being shaped to adapt to the dorsal surface of the tongue.

18. The device of claim 16, wherein the mouthpiece includes a second pair of flanges, each of the second pair of flanges extending inwardly from a corresponding arm, the second pair of flanges being shaped to adapt to the surface of the tongue under the tongue.

19. The device of claim 17, wherein the mouthpiece includes a second pair of flanges, each of the second pair of flanges extending inwardly from a corresponding arm, the second pair of flanges being shaped to adapt to the surface of the tongue under the tongue.

20. The device of claim 19, wherein each of the first pair of flanges shaped to adapt to the dorsal surface of the tongue extends from or adjacent to the free end of the arm, and each of the second pair of flanges shaped to adapt to the sublingual surface of the tongue extends from the middle portion of the arm.

21. The device of claim 20, wherein the first pair of flanges is associated with a first sequence of electrodes of the electrode device, and the second pair of flanges is associated with a second sequence of electrodes of the electrode device.

22. A system for training one or more oral muscles by transmucosal neuromuscular electrical stimulation, comprising the device according to any one of claims 1-21.

23. The system of claim 22, wherein the system applies the electrical stimulation to the upper or dorsal surface of the tongue for a first predetermined time period to stimulate a first muscle or muscle group, and applies the electrical stimulation to the lower surface of the tongue for a second predetermined time period to stimulate a second muscle or muscle group.

24. The system of claim 23, wherein the first muscle or muscle group comprises one or more of the internal surface muscles, the uvula, the levator veli palatine, and the palatopharyngeal muscles, and the second muscle or muscle group comprises the genioglossus muscle.

25. The system according to any one of claims 22 to 24, wherein, during a first treatment period, the system applies the electrical stimulation to the one or more palatal muscles and/or tongue muscles according to a first scheme, and during a second maintenance period, the system applies the electrical stimulation to the one or more palatal muscles and/or tongue muscles according to a second scheme different from the first scheme.