Oral muscle training device

Abstract

To provide a treatment system that is used when a user is awake and continuously reduces an irregular respiratory pattern during sleep.SOLUTION: A transmucosal neuromuscular electrical stimulation device comprises a mouthpiece (103), electrode means (133a) associated with the mouthpiece, and an electrical circuit component operably connected to the electrode means (133a). The mouthpiece comprises a pair of arms (131) coupled together at one end. The pair of arms branches from each other, comprises at least one flange (133) extended inwards from at least one arm, and has a shape cooperating with, similar to, or matching with a sublingual surface. The at least one flange comprises electrode means associated with the mouthpiece. At the time of being used, the electrode means applies electric stimulation to one or more tongue muscles through the sublingual surface via the electrode means to enhance resting muscle tension and / or sleep-time muscle tension.SELECTED DRAWING: Figure 10

Description

Technical Field

[0001] The present invention relates to oral muscle training, and more particularly to an oral muscle training device, a training method, a training system, and management software. More specifically, the present invention relates to, but is not limited to, the training of oral muscles for treating sleep disordered breathing.

Background Art

[0002] Snoring and sleep apnea are often considered to be part of a variety of disorders often referred to as sleep disordered breathing (SDB), and exhibit irregular sleep pattern symptoms during sleep. SDB is not only annoying but also results in health problems such as, for example, frequent awakenings during sleep, light sleep, stress on the heart, low blood oxygen concentration, headache, and fatigue.

[0003] The respiratory conduit between the back of the human nose and the mouth is a collapsible tube that reaches up to the larynx. Collapse or sagging of the respiratory conduit occurs at positive airway pressure and results in suffering from snoring and / or sleep apnea syndrome. On the other hand, it has been observed that such a thing does not occur at negative airway pressure.

[0004] As a result of efforts focusing on this phenomenon, several treatment methods have been developed. These treatment methods use a continuous positive airway pressure device to maintain the opening of the respiratory conduit or wear a mandibular advancement device to hold the jaw and tongue forward and expand the space at the back of the larynx.

[0005] These devices are uncomfortable and address only transient symptoms rather than the root cause. These devices must be used continuously while sleeping. As a result, it has been found that it is difficult for the user to sleep soundly, and compliance with the usage criteria is difficult. Therefore, a treatment that does not require constant use during sleep and addresses the root cause of the symptoms, as in the conventional devices described above, is desired.

[0006] Recent research has shown that implanting an electrical nerve stimulation device into the tongue and that the diaphragm is effective in treating obstructive sleep apnea. This involves invasive surgery of sensors and electrodes at the relevant sites of the nerves. The said device confirms episodes (manifestations of symptoms) of airway obstruction by using sensors, stimulates the nerves of the tongue to cause contractions, and alleviates airway disorders. Similar to a pacemaker, this also results in maintenance and management and other troublesome problems such as battery replacement, risks related to the electrical field, and problems related to external safety detection devices.

[0007] Furthermore, the stimulation occurs only during airway disorders during sleep and does not address the root cause.

Summary of the Invention

Problems to be Solved by the Invention

[0008] Therefore, a first object of the present invention is to provide a treatment system that is preferably used when awake and continuously reduces irregular breathing patterns during sleep.

[0009] A further object of the present invention is to provide a treatment system and device that are effective in at least one aspect compared to conventional systems and devices for treating SDB.

Means for Solving the Problems

[0010] Therefore, a first means for solving the problems is to provide an electrical stimulation device for training one or more oral muscles, for example, a transmucosal neuromuscular electrical stimulation device. This transmucosal neuromuscular electrical stimulation device includes a mouthpiece, electrode means connected to the mouthpiece, and an electrical circuit operably connected to the electrode means. When in use, the said device or electrical circuit applies electrical stimulation to one or more oral muscles, such as tongue muscles and / or palatal muscles, through the back layer of the mouth, for example, the oral mucosa, via the electrode means, for example, to increase muscle tension at rest and / or during sleep.

[0011] When a person is awake, the segments of the respiratory tract that are in a collapsed state are in an open state because the muscles that control this part are tense. When a person is asleep, the tension of this muscle is significantly relaxed. In the case of patients suffering from obstructive sleep apnea syndrome, the relaxation of the tension of this muscle is significantly large, small in snorers, and has been demonstrated to be significantly small in those who do not suffer from obstructive sleep apnea syndrome.

[0012] It has been demonstrated that an increase or tension in the activity of the pharyngeal muscles reduces the stretching and relaxation of the airway. The present invention is based on the finding that when using electrical stimulation, particularly electrical stimulation of the neuromuscular, to stimulate the tongue muscles and / or the palate and / or the sensory nerve fibers, the muscle strength and the recovery of the tension can be improved.

[0013] The device or the electrical circuit component of the present invention preferably has a structure for supplying a current, for example, a current such as a biphasic current or a biphasic impulse current, or an impulse current.

[0014] Another aspect of the present invention is to provide an electrical stimulation device for training one or more oral muscles, for example, a transmucosal neuromuscular electrical stimulation device, the device comprising a mouthpiece, electrode means connected to the mouthpiece, and electrical circuit components operably connected to the electrode means, and the device or the electrical circuit components having a structure for supplying a biphasic current, for example, a biphasic electrical impulse current, through the electrode means during use.

[0015] By supplying a biphasic current, particularly a biphasic impulse current, the tongue and / or palate muscles that contribute to the stretching and relaxation of the airway are stimulated together with the sensory nerves, and the resting muscle tension and muscle tension can be increased during sleep.

[0016] The current is preferably a two-phase symmetric current, but additionally or alternatively, it may be a balanced or unbalanced two-phase asymmetric current. The device or electrical circuit component of the present invention is a structure that supplies a current with a frequency of 5 to 150 Hz through electrode means during use.

[0017] Another aspect of the present invention is to provide an electrical stimulation device for training one or more oral muscles, for example, a transmucosal neuromuscular electrical stimulation device. This device comprises a mouthpiece, electrode means associated with the mouthpiece, and an electrical circuit component operably connected to the electrode means, and the device or electrical circuit component is a structure that supplies a current with a frequency of 5 to 150 Hz through the electrode means during use.

[0018] The current includes a frequency of 5 to 150 Hz, for example 15 to 130 Hz, preferably a frequency of 20 to 120 Hz. Preferably, the current includes a frequency between 20 to 50 Hz and / or 50 to 120 Hz.

[0019] The device or electrical circuit component of the present invention may also be a structure that supplies two or more currents, for example, a first current and / or a second current. The second current may be different from the first current and / or changeable with the first current, or may be set independently of the first current. At least one of the first and / or second currents, for example both, is a two-phase current, and both are preferably symmetric currents, but may also be asymmetric and balanced or unbalanced currents. At least one of the first and / or second currents includes a frequency between 5 to 150 Hz, for example 10 to 140 Hz, for example 15 to 130 Hz, preferably between 20 to 120 Hz. One or more of the currents include a frequency between 20 to 50 Hz, and / or other currents may include a frequency between 50 to 120 Hz.

[0020] The inventor is convinced that a current including one or each of these frequency ranges is particularly suitable for the palatal and tongue muscles that contribute to the extension and relaxation of the airway.

[0021] When in use, the device or electrical circuit component of the present invention supplies at least one of the frequency ranges, or each current, through the inner membrane of the mouth, for example, the oral mucosa, to one or more oral muscles such as the palate and / or the tongue muscles, and has a structure that can enhance the normal tension of the resting muscles and / or the normal tension of the muscles during sleep. In an aspect of the present invention, the device of the present invention has a structure that applies a current, for example, a first current, to one or more palatal muscles when in use. Or, the device of the present invention has a structure that applies a current, for example, a second current, to one or more tongue muscles through the dorsal surface of the tongue when in use. Or, the device of the present invention has a structure that applies a current, for example, the first or second current, to one or more tongue muscles through the lower surface of the tongue when in use.

[0022] In an aspect of the present invention, the mouthpiece includes one or more arms and / or one or more accessories or flanges. The one or more accessories or flanges extend from the one or more arms and are adapted to contact, for example, one or more oral muscles. The at least one or more arms and / or one or more accessories or flanges are, for example, flat or planar with a major surface. Optionally, the mouthpiece includes a pair of arms, each of which includes one or more accessories or flanges. In an aspect of the present invention, the mouthpiece includes a pair of arms. The pair of arms extend at least partially parallel to each other and / or at an angle to each other and / or parallel to each other. For example, the mouthpiece includes a pair of arms that are joined at one end and branch from the other, for example, substantially in a V-shape or a U-shape or a horseshoe shape.

[0023] The one or more accessories or flanges extend inside the pair of arms, for example, from one arm towards the other arm. In an aspect of the present invention, each arm includes two or more accessories or flanges, for example, accessories or flanges extending from the free end of each arm and / or accessories or flanges extending from an intermediate portion of each arm.

[0024] At least one accessory or flange is curved, for example, in a flat curved shape or member and / or mouthpiece, or extends upward or downward from the surface of at least one arm. At least one accessory or flange may be shaped to cooperate with, or be similar to, or adapted to the surface of the tongue, for example, the dorsal tongue surface or the sublingual surface. In an aspect of the present invention, the mouthpiece comprises at least one accessory or flange shaped to cooperate with, or be similar to, or adapted to the dorsal tongue surface, and at least one accessory or flange shaped to cooperate with, or be similar to, or adapted to the sublingual surface. In an aspect of the present invention having a pair of arms, each arm comprises an accessory or flange shaped to cooperate with, or be similar to, or adapted to the dorsal tongue surface, and an accessory or flange shaped to cooperate with, or be similar to, or adapted to the sublingual surface.

[0025] At least one accessory or flange comprises one or more electrodes or an array of electrodes. At least one electrode or an array of electrodes is adjacent and / or connected and / or exposed on the surface of at least one accessory or flange, for example, the major surface. In an aspect of the present invention, at least one accessory or flange comprises an electrode connected to its major surface. The electrode connected to one of the major surfaces is separated and / or controlled independently of another or the other major surface. Additionally or alternatively, the electrode of one accessory or flange or the electrode coupled to one accessory or flange is separated and / or controlled independently of at least one other accessory or flange.

[0026] In an embodiment of the invention, the mouthpiece comprises a pair of arms joined together at one end, diverging from one another and substantially horseshoe shaped with one or more flanges extending inwardly from at least one of the arms, each of said flanges carrying electrode means. The mouthpiece comprises a pair of flanges extending inwardly from each arm, said flanges being configured to cooperate with a dorsal tongue surface. The mouthpiece comprises a pair of flanges extending inwardly from each arm, said flanges being configured to cooperate with a sublingual surface. Each of said pair of flanges may be configured to cooperate with a dorsal tongue surface extending from or adjacent a free end of the arm, and / or each of said pair of flanges may be configured to cooperate with a sublingual surface extending from an intermediate portion of said arm.

[0027] The present invention provides an electrical stimulation device for exercising one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation device. The electrical stimulation device comprises a mouthpiece, electrode means associated with the mouthpiece, and electrical circuitry operatively connected to the electrode means. The mouthpiece comprises a pair of arms joined together at one end and bifurcated from one another with one or more flanges extending inwardly from at least one of the arms. The or each flange includes at least a portion of the electrode means associated with the mouthpiece and is adapted to electrically stimulate one or more oral muscles. It is meant to be stimulating.

[0028] The present invention further provides a mouthpiece for providing electrical stimulation to one or more oral muscles, for example a transmucosal neuromuscular electrical stimulation, the mouthpiece comprising a pair of arms joined together at one end and bifurcated from one another with one or more flanges extending inwardly from at least one of the arms, the or each flange comprising electrode means associated with the mouthpiece for providing electrical stimulation to one or more oral muscles.

[0029] The mouthpiece includes a gripping base. This gripping base has an enlarged end portion, for example, an enlarged free end portion. The gripping base is integrally formed with, for example, the mouthpiece or the body, or one or more respective arms, and is connected or fixed to the mouthpiece or the body, or one or more or each arm, for example, by a neck portion.

[0030] The electrode means preferably has 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 part of the electrode means, for example, one or more electrodes, or each electrode, or all electrodes, is attached to or in contact with and on the mouthpiece, or is attached or integrated with the mouthpiece inside and / or at least partially. In an aspect of the present invention, the mouthpiece includes a shield or shielding means, for example, on one side of the electrode means, and suppresses or prevents an electrical stimulus or current flowing or supplied from or through the mouthpiece, or in the mouthpiece, or from one side of the mouthpiece. Materials suitable for the shield or shielding means are well known to those skilled in the art.

[0031] In an aspect of the present invention, the electrode means is structured or can be operated to selectively supply or apply an electrical stimulus, i.e., a current, to at least one of the electrode means, or from at least one of the electrode means, or from each of both side portions of the electrode means, or from both side portions of the electrode means, for example, by providing a shield means or a shield between, for example, a first set or series of electrode means of the electrode means, or electrodes, and a second set or series of electrode means of the electrode means, or electrodes.

[0032] In an aspect of the present invention, the mouthpiece can be inserted into the mouth by hand, for example, and can be held in an appropriate position. The mouthpiece has, for example, at least one flat and / or major surface, preferably at least partially flat and / or generally flat and / or paddle-shaped with two flat major surfaces. In an aspect of the present invention, the device of the present invention may include a handle. The mouthpiece is connected or mounted or attached to the handle, for example, firmly and / or removably, and can be inserted and / or held at one or more places or positions and / or orientations in the mouth during use, for example. In an aspect of the present invention, the mouthpiece does not require holding means for mounting or fixing the mouthpiece to the user's mouth or into the mouth or within the scope of the mouth.

[0033] In one aspect of the present invention, the mouthpiece is arranged such that the mouthpiece or the first side or the surface thereof is in contact with and / or adjacent to one or more palatal muscles, or may be in contact with and / or adjacent to one or more palatal muscles, above or over the mouth, for example. Additionally or alternatively, the palate and / or the mouthpiece, or the second side or the surface thereof, is in contact with or adjacent to one or more lingual muscles, for example the dorsal lingual surface, or may be in contact with or adjacent to one or more lingual muscles, for example the dorsal lingual surface. The mouthpiece may be provided with holding means for holding it in this manner. Further, the mounting means may be for mounting the mouthpiece below or under the mouth such that the mouthpiece or the first side or the surface thereof is in contact with or may be in contact with one or more lingual muscles, for example the sublingual surface, and / or the mouthpiece, or the first side or the surface thereof, is adjacent to or may be adjacent to one or more lingual muscles, for example the sublingual surface. In one aspect of the present invention, the device of the present invention comprises a first mouthpiece having holding means for holding the first mouthpiece above or over the mouth, and a second mouthpiece having holding means for holding the second mouthpiece below or under the mouth.

[0034] The device or handle of the present invention may comprise input means or an actuator. The input means or actuator comprises, for example, one or more input devices, buttons and / or switches, and / or dials that enable or activate or initiate, for example, the supply of electrical stimulation or current. The device or handle of the present invention may comprise a power source and / or a cable that can be connected to the power source. The device of the present invention comprises a main body. The main body comprises, incorporates, or provides a handle. Further, the device of the present invention includes or houses a power source. The power source comprises a rechargeable power source or one or more rechargeable batteries. The device of the present invention is adapted to recharge the power source by connecting the cable directly or operably, for example, inductively, to a charging station.

[0035] In one aspect of the present invention, the device of the present invention comprises adjustment means or a regulator, for example, frequency adjustment means or a regulator for adjusting the current or the frequency of the first and / or second current, for example, first and second current frequency adjustment means or a regulator for adjusting the frequency between one of the aforementioned frequency ranges, respectively. In one aspect of the present invention, the adjustment means or regulator is configured such that the adjustment means or regulator is stepwise and / or the user can select from two or more, for example, three, four, or five predetermined frequency settings. The device is adapted or structured to supply the first and second currents simultaneously (at an instantaneous time), and / or simultaneously (with temporal continuity), and / or simultaneously (in parallel). Further, the device of the present invention is capable of supplying the first and second currents in series, and / or in sequence, and / or continuously.

[0036] The current, or at least one of the first and / or second currents, for example both, includes pulsed current. The pulse duration of each pulsed current is preferably between 50 μs and 1000 μs, for example between 100 μs and 900 μs, more preferably between 150 μs and 800 μs, particularly between 200 μs and 700 μs. The said or another adjustment means or regulator, for example, the pulse duration adjustment means or regulator of the device of the present invention, is preferably adapted to adjust the pulse duration to one of the aforementioned ranges, for example.

[0037] The electrical stimulation or current, or the first and / or second currents, includes intensity or current amplitude. The intensity or current amplitude is preferably selected to provide the maximum contraction of the muscle to be treated. By way of example, the said intensity or amplitude is about 10 mA, for example between 5 and 50 mA, between 1 and 100 mA, between 5 and 15 mA, or between 7 and 25 mA, or between 8 and 12 mA. The said or another adjustment means or regulator, for example, the intensity or amplitude adjustment means or regulator, is adapted to adjust the intensity or amplitude to a range of, for example, 0 to 500 mA, or 0 to 250 mA, or 0 to 200 mA, or 0 to 150 mA, or 0 to 100 mA.

[0038] In one aspect of the present invention, the device is structured or programmed to supply the electrical stimulation or current or the first and / or second currents for a predetermined time, for example between 1 minute and 1 hour, for example between 5 minutes and 30 minutes, preferably between 10 minutes and 20 minutes. The said or another adjustment means or regulator, for example, the treatment time adjustment means or regulator, is adapted to adjust the treatment time to a range of, for example, 0 to 10 hours, or 0 to 5 hours, or 0 to 1 hour, or 0 to 30 minutes.

[0039] The device of the present invention may be provided with control means. The control means is programmed or can be programmed, for example, to control one or more characteristics of the electrical stimulation or current or plurality of currents according to a predetermined treatment regimen. The control stage comprises a control system and / or a controller and / or is at least partially included in an electrical circuit. The control means may include at least a part of the adjustment means or regulator, and may include, for example, one or more frequencies, and / or pulse duration, and / or intensity, and / or amplitude, and / or treatment duration adjustment means or regulator.

[0040] In one aspect of the present invention, the input means has a structure capable of controlling and / or adjusting an electrical stimulation or current, or one or more characteristics of the first and / or second current, such as frequency, and / or pulse duration, and / or intensity, and / or amplitude, and / or treatment duration, or can operate in such a manner. Further, the device or input means may be provided with an interface or connection means such as a connector or receptacle for connecting the device, or a personal computer capable of programming and / or controlling and / or adjusting one or more of the aforementioned characteristics, or control means for controlling another device such as a portable device.

[0041] The device or control means, or adjustment means, has a structure capable of controlling one or more characteristics of an electrical stimulation or current, or the first and / or second current, according to a predetermined method and / or a predetermined treatment regimen, or is programmed to be so. The device or control means is operative or programmed such that, for example, an electrical stimulation device can construct and / or modify a predetermined treatment by a device connected, for example, via the input means.

[0042] The present invention provides a computer program element comprising program code means suitable for inputting into a computer for causing a processor to apply electrical stimulation through the inner membrane of the mouth, such as the oral mucosa, to one or more oral muscles, such as the palate and / or tongue muscles, for example, during sleep, to increase the tone of resting muscles, or to execute a treatment regimen.

[0043] Furthermore, the present invention provides a method or treatment regimen for training one or more oral muscles, for example, by transmucosal neuromuscular electrical stimulation. This method includes applying electrical stimulation through the inner membrane of the mouth, such as the oral mucosa, to one or more oral muscles, such as the palate and / or tongue muscles, for example, during sleep, to increase the tone of resting muscles.

[0044] For the sake of avoiding doubt, all features of the invention described in the specification, claims, drawings and abstract apply to all aspects of the invention.

[0045] The method or treatment regimen of the present invention includes supplying or applying an electric current, such as a biphasic current or an impulse current such as a biphasic impulse current, to one or more oral muscles.

[0046] Furthermore, the present invention provides a method or treatment regimen for training one or more oral muscles, for example, by transmucosal neuromuscular electrical stimulation. This method includes supplying or applying a biphasic current, for example, a biphasic impulse current, through electrode means through the inner membrane of the mouth, such as the oral mucosa, to one or more oral muscles, such as the palate and / or tongue muscles.

[0047] The method or regimen of the present invention involves supplying or applying a first current and / or a second current that is different from the first current. The current or at least one of the first current and / or the second current, for example, both currents, includes an alternating current. The current or at least one of each current is between 5 and 150 Hz, for example, between 10 and 140 Hz, for example, between 15 and 130 Hz, preferably between 20 and 120 Hz, more preferably between 20 and 50 Hz, and / or between 50 and 120 Hz. In some embodiments, the first current includes a frequency between 20 and 50 Hz, and / or the second current includes a frequency between 50 and 120 Hz.

[0048] In an embodiment of the present invention, the phases of the two-phase current, or the first and second currents, are applied simultaneously and / or in parallel. In a plurality of embodiments, the phases of the two-phase current, or the first and second currents, are supplied in series, and / or sequentially, and / or continuously.

[0049] The current, or at least one of the first and / or second currents, for example, both, includes an impulse current. The duration of the impulse current or each impulse current is preferably between 50 and 1000 μs, for example, between 100 and 900 μs, for example, between 150 and 800 μs.

[0050] The electrical stimulation or current, or the first and / or second currents, may include an intensity or current amplitude, and the intensity or current amplitude is preferably selected or is selected to generate the maximum contraction of the muscle to be treated. By way of example, the intensity or current amplitude is between about 10 mA, for example, between 1 and 100 mA, for example, between 5 and 50 mA, for example, between 5 and 15 mA, or between 7 and 25 mA, for example, between 8 and 12 mA.

[0051] The method or treatment regimen supplies or applies the electrical stimulation or current, or the first and / or second currents, for a predetermined time, that is, between 1 minute and 1 hour, for example, between 5 and 30 minutes, preferably between 10 and 20 minutes.

[0052] The method or treatment regimen according to the present invention includes supplying or applying electrical stimulation or current, or first and / or second currents, for a predetermined time to a first muscle or muscle group and / or the upper or back surface of the tongue. The first muscle or muscle group includes one or more palatal and / or lingual muscles, such as one or more intrinsic superficial muscles, palatoglossus muscles, levator veli palatini muscles, and pharyngopalatine muscles.

[0053] Furthermore, the method or treatment regimen of the present invention includes supplying or applying electrical stimulation or current or first and / or second currents for a second predetermined time to a second muscle or muscle group and / or the underside of the tongue, such as under the tongue. The second muscle or muscle group includes one or more palatal and / or lingual muscles, one or more of which are different from the first muscle or muscle group, such as the genioglossus muscle. For example, the first predetermined time is 5 to 30 minutes, such as 5 minutes or 10 minutes or 15 minutes or 20 minutes or 30 minutes, and the second predetermined time is 5 to 30 minutes, such as 5 minutes or 10 minutes or 15 minutes or 20 minutes or 30 minutes.

[0054] Furthermore, the method or treatment regimen of the present invention includes performing one or more of the aforementioned steps at a predetermined interval, such as between 1 and 10 times per day, or any number of times therebetween, such as 2 times per day. Furthermore, the method or treatment regimen of the present invention includes performing one or more of the aforementioned steps over a predetermined treatment period, that is, between 1 and 20 weeks, such as between 2 and 10 weeks, such as between 5 and 8 weeks, such as between 5 and 6 weeks.

[0055] The method or treatment regimen of the present invention includes adjusting one or more characteristics of the electrical stimulation or current or first and / or second currents, such as frequency and / or pulse duration, and / or intensity, and / or amplitude, and / or treatment duration. This adjustment can be performed using input means such as one or more push buttons and / or dials, or the like, or via a receptacle by a connector or device such as a personal computer or portable device.

[0056] In the present invention, the method or treatment regimen includes, for example, a first period for treatment, during which, for example, electrical stimulation or current, or the first and / or second currents are supplied or applied to, for example, enhance the tone of resting muscles in a beneficial sense and / or the muscle tone during sleep in a beneficial sense. In an aspect of the present invention, the method or treatment regimen includes, for example, a second period for maintenance, during which, for example, one or more characteristics of the electrical stimulation or current, or the first and / or second currents are adjusted or changed, for example, with respect to the first treatment period, to maintain the resting muscle tone and / or the muscle tone during sleep. The first period may include a first regimen, and / or the second period may include a second regimen different from the first regimen.

[0057] In an exemplary aspect, the method or treatment regimen includes supplying or applying electrical stimulation to one or more oral muscles twice a day for 10 to 20 minutes for 6 weeks to, for example, provide muscle tone during resting muscle tone and / or sleep. Additionally, the method or treatment regimen includes continuously supplying or applying electrical stimulation to one or more oral muscles once a day for 10 to 20 minutes to, for example, maintain the resting muscle tone and / or the muscle tone during sleep.

[0058] According to another aspect of the present invention, there is provided a method or treatment regimen for training one or more oral muscles, for example, by sensory stimulation. This method includes supplying or applying vibratory stimulation to one or more oral muscles, such as the palate and / or tongue muscles. Further, this method includes one or more characteristics of the methods described above.

[0059] The present invention also provides a computer program element including computer-readable program code means for causing a processor to perform the procedures of the methods or treatment regimens described above. Further, the present invention provides a computer program element embodied in a computer-readable medium.

[0060] Furthermore, the present invention provides a computer-readable medium having a program stored in a computer and adapted to cause the computer to perform the procedures for executing the method or treatment regimen described above.

[0061] Furthermore, the present invention provides a control means, control system or controller for controlling the above-described computer program elements or computer-readable medium, or a treatment regimen for training one or more oral muscles, such as trans-mucosal neuromuscular stimulation, for example the method described above.

[0062] The various objects, aspects, embodiments and variations of the present invention described in the specification, drawings, claims, abstract, etc. should be understood independently or in combination. The plurality of features described with respect to one aspect of the present invention apply to all aspects unless otherwise specified.

Advantages of the Invention

[0063] The trans-mucosal neuromuscular electrical stimulation device provided by the present invention, which applies electrical stimulation to one or more oral muscles, such as the tongue muscle and / or the palatal muscle, for training, includes a mouthpiece, electrode means associated with the mouthpiece, and electrical circuit components operably connected to the electrode means. During use, through the electrode means, it can enhance the resting muscle tension and / or the muscle tension during sleep through the inner layer of the mouth, such as the oral mucosa. It does not require constant use during sleep as in the prior art, does not cause discomfort to the user, and provides a treatment technique that can address the root cause of sleep apnea rather than being a transient treatment method.

Brief Description of the Drawings

[0064]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Mode for Carrying Out the Invention

[0065] FIGS. 1 to 4 show an electrical stimulation device 1 including a main body 2, a mouthpiece 3, and a charging station 4. The main body 2 functions as a handle and, in this aspect, is generally cylindrical and has a first upper end portion 20. The first upper end portion 20 is provided with a male connector 21. The male connector 21 has protrusions 22 on its respective sides, forming a bayonet-type stopper. Further, the male connector 21 is provided with an electrical socket 23 for receiving an electrical connector (not shown) of the mouthpiece 3. The main body 2 has an ON / OFF button 2a, four dials 24, 25, 26, and 27, a USB port 28, and a lower end portion 29 on its front surface. The lower end portion 29 is provided with a receptacle (not shown) for receiving a protrusion 41 of the charging station 4.

[0066] The main body 2 houses a battery (not shown) and electrical circuit components. The electrical circuit components include an inverter that converts the direct current of the battery into two separate symmetrical two-phase currents. The first dial 24 can be operated to adjust the current amplitude of the first two-phase current from 0 to 100 mA. The second dial 25 can be operated to adjust the current amplitude of the second two-phase current from 0 to 100 mA. The third dial 26 can be operated to adjust the supply time so that the first two-phase current is supplied for 1 to 30 minutes. The fourth dial 27 can be operated to adjust the supply time so that the second two-phase current is supplied for 1 to 30 minutes.

[0067] The USB port 28 is structured to connect the device 1 to a personal computer (not shown) so that one or more characteristics of the first two-phase current and the second two-phase current can be programmed separately. In this aspect, the frequency of the first two-phase current is set to a value between 20 and 50 Hz, the frequency of the second two-phase current is set to a value between 50 and 120 Hz, and the pulse duration of each two-phase current is set to a value between 200 and 700 μs. The personal computer (not shown) may be equipped with control software that can be operated to override the dials 24, 25, 26, and 27. The control software may be programmed to supply two-phase currents having different predetermined characteristics for a predetermined time. The different predetermined characteristics are, for example, amplitude, frequency, and pulse duration. Further, the device 1 can incorporate a memory in which the predetermined characteristics are stored. The memory can be modulated by connecting a personal computer (not shown) to the device 1 via the USB port 28. In this aspect, the dials can be omitted or the structure can be such that the above-described characteristics are adjusted based on pre-programmed values. In some aspects, more or less, the program functions are provided by manual dials, buttons, etc.

[0068] The mouthpiece 3 includes a cylindrical base 30 and a substantially flat paddle-shaped contact portion 31. The paddle-shaped contact portion 31 is integrally formed with the upper end portion of the base 30 and has first and second major surfaces 32, 33. The base 30 is provided at its lower end portion 34 with a receptacle (not shown) for receiving an electrical connector (not shown) inside the electrical socket 23 of the main body 2. The mouthpiece 3 also includes electrical circuit components that provide a series of electrodes 32a, 33a respectively directly below each of the major surfaces 32, 33. The electrodes 32a, 33a are electrically isolated from each other by a shielding member. The electrical circuit components (not shown) of the mouthpiece 3 are electrically connected to the electrical circuit components (not shown) of the main body 2 during use, such that the first row of electrodes 32a supplies a first two-phase current and the second row of electrodes 33a supplies a second two-phase current.

[0069] In this aspect, the mouthpiece 3 is provided as a component isolated from the main body 2 and has a structure that allows for easy maintenance during the usage period. However, in another aspect, the mouthpiece 3 is integrally formed with the main body 3. Further, in another aspect, the mouthpiece 3 can incorporate mounting means for mounting the mouthpiece 3 above and / or below the user's mouth in the same manner as for a retainer. In such an aspect, the device 1 includes a pair of mouthpieces 3 incorporating the mounting means, with the first mouthpiece 3 being mounted above the user's mouth and the second mouthpiece 3 being mounted below the user's mouth. The first mouthpiece 3 can incorporate two rows of electrodes 32a, 33a to contact the user's palate, stimulate one or more palatal muscles on one side, and contact the back of the tongue to stimulate one or more lingual muscles on the other side. The second mouthpiece 3 can incorporate one row of electrodes 32a to stimulate the sublingual muscles. The said or each mouthpiece 3 can incorporate a wireless communication means such as Bluetooth (registered trademark) communication means that communicates with a power source and, for example, a personal computer (not shown).

[0070] The charging station 4 is provided with a cylindrical base 40. The cylindrical base 40 is provided with a cylindrical protrusion 41 and an electric cable 42 that connects the charging station 4 to the main current power source. The protrusion 41 in this embodiment incorporates electromagnetic coupling, and the charging station 4 is provided with electrical circuit components connected to the main electrical cable 42, supplies electricity to the electromagnetic coupling, and electromagnetic induction charges a battery (not shown) in the main body 2.

[0071] Figures 5 to 9 show various lingual muscles and palatal muscles. The characteristics of the mouth shown in Figures 5 to 7 clearly show the lingual muscles. That is, the pharyngopalatine arch 51, palatine tonsil 52, glossopalatine muscle 53, buccal muscle 54, circumvallate papilla 55, fungiform papilla 56, dorsal surface of the tongue 57, styloglossus muscle 58, hyoglossus muscle 59, mandible 60, genioglossus muscle 61, longitudinal, transverse, and vertical intrinsic muscles 62, 63, 64, and geniohyoid muscle 65 are shown.

[0072] The genioglossus muscle 61 is the largest extrinsic tongue muscle and is involved in the forward extension of the tongue and the expansion of the opening degree of the airway of the larynx. Therefore, it is established that the tension of the genioglossus muscle 61 affects the extension and compressibility of the tongue. It is involved in the reduction of the extensibility and compressibility of the inner surface muscles such as the longitudinal and transverse intrinsic muscles 62 and 63.

[0073] The characteristics of the mouth shown in Figures 8 and 9 clearly show the palatal muscles. That is, the dental arch 66, premaxilla 67, mental foramen 68, palatal process of the maxilla 69, palatine bone 70, posterior nasal spine 71, palatal foramen 72, hamular bone 73, tensor veli palatini muscle 74, levator veli palatini muscle 75, palatopharyngeus muscle 76, palatoglossus muscle 77, and pharyngopalatine muscle 78 are shown.

[0074] Even with some differences, the constrictor and dilator muscles of the palate are also involved in snoring and sleep apnea. The purpose of treatment is to expand the larynx and direct electrical stimulation to the palatal dilator muscles on the midline such as the palatoglossus muscle 77, levator veli palatini muscle 75, and pharyngopalatine muscle 78.

[0075] During use, the mouthpiece 3 is applied to the dorsal surface of the tongue 57 and the above-described palatal muscles, and a biphasic current is applied. The biphasic currents are each composed of a first parameter set including intensity, frequency, and pulse duration. These biphasic currents are transmitted through the back of the mouth and the oral mucosa, stimulating the intrinsic muscles 62, 63, the uvular muscle 77, the levator veli palatini muscle 75, and the pharyngopalatine muscle 78. The parameters are selected to give the maximum contraction of these muscles to the user, and the treatment is carried out for 20 seconds.

[0076] Next, the intensity, frequency, and pulse duration are adjusted, and the mouthpiece 3 is applied to the lower side of the tongue. A biphasic current having a second parameter set is applied transmucosally to stimulate the genioglossus muscle 61. The second parameter set is selected to give the maximum contraction of the user's genioglossus muscle 61, and the treatment is carried out for 20 seconds.

[0077] By applying a biphasic current according to the above-described parameters, the above-described skeletal muscles are stimulated. It is considered that by applying the biphasic current to the above-described skeletal muscles, a sensory function such as a vibration sensation is caused. Although not preferring to be bound by any theory, it is considered that by electrically and vibrationally stimulating the nerves, feedback is given to the brain, and further, the degree of improvement of muscle tension is enhanced. In particular, the effect of this treatment is considered to be enhanced by multisensory integration within the nervous system.

[0078] Illustrated as an example, this treatment regimen includes a 6-week induction period. During this induction period, the above-described groups of muscles are each stimulated 2 times a day for 10 to 20 minutes. This treatment regimen is designed to tense the muscles, and further, continuous maintenance is carried out, including sessions of 20 to 20 minutes once a day.

[0079] Figures 10 and 11 show a mouthpiece 103 according to a second aspect similar to the first aspect. In Figures 10 and 11, the same elements are denoted by reference numerals with the prefix 1. The mouthpiece 103 according to this aspect includes a gripping base 130 and a pair of curved arms 131 that are integrally formed with one end of the base and are horseshoe-shaped. Each of the arms has first and second contact flanges 132 and 133, and an electrode (not shown) is embedded in the first and second contact flanges 132 and 133.

[0080] The first contact flange 132 extends inward from one free end of each arm 131 toward each other, and also extends upward to form a curved shape so as to receive the dorsal tongue surface 57 of the tongue of a patient (not shown). The second contact flange 133 extends inward from the middle portion of each arm 131 toward each other, and also extends downward to form a curved shape so as to receive the sublingual tongue surface.

[0081] The base 130 has an enlarged end portion 134 that is coupled to the arm 131 by a neck portion 135. The end face of the enlarged end portion 134 is provided with an electrical connector 136 and is adapted to be connected to a power source (not shown). The connector 136 includes a USB, a micro USB, or other suitable type of wired connector. In other aspects, the connector is replaced with wireless connection means. In some aspects, the mouthpiece incorporates a power source such as a battery.

[0082] Similar to the first aspect, the mouthpiece 103 includes electrical circuit components (not shown) that provide respective columns of electrodes 132a, 133a on the surfaces of each flange 132, 133, i.e., on the upper and lower surfaces of each flange 132, 133 respectively. Each column of these electrodes 132a, 133a is electrically isolated from each other by a shielding material and is adapted to stimulate all the surrounding muscles simultaneously or in any required order. The electrodes 132a, 133a cooperate with and are coupled to the outer surfaces of the flanges 132, 133 to form a substantially contacting surface. In this aspect, the mouthpiece 103 is made of a silicon-grade or biocompatible-grade plastic material. In this aspect, the electrodes 132a, 133a are preferably made of gold, or copper, or a composite material, or an alloy with an exposed surface.

[0083] When in use, the mouthpiece 103 is placed in the patient's mouth, the patient's tongue is received in the mouthpiece 103, the dorsal tongue surface 57 is brought into contact with the first contact flange 132, and the sublingual tongue surface is brought into contact with the second contact flange 133. It is believed that those skilled in the art can understand that the first contact flange 132 contacts the rear part of the dorsal tongue surface 57 and the second contact flange 133 contacts the front part of the sublingual tongue surface. When the patient closes the mouth, the flanges 132, 133 can also contact and stimulate the adjacent muscles on the other side of the tongue, such as the palatal muscles. The muscles are stimulated in a manner similar to the method of the device 1 according to the first aspect, but the mouthpiece 103 can stimulate both sides of the tongue simultaneously. It is believed that it can be understood that with this structure, it is possible to stimulate the muscles of the tongue and the muscles around the tongue, including the muscles in the hard palate and the velum palatinum.

[0084] Those skilled in the art would understand that several modifications can be considered in the above-described embodiments without departing from the scope of the claims. For example, the mouthpiece 3 can have any shape as long as it is structured to be able to apply electrical stimulation to the appropriate muscles described above. The dials 24, 25, 26, and 27 can be replaced with other similar adjustment means or, as described above, can be omitted. The mouthpiece 3 and the main body 2 are provided as an integrated unit. The charging station 4 can be omitted. For example, the main body 2 can also incorporate the main cable 42, or simply disposable batteries or other power sources can be used. Similarly, the USB port 28 can be omitted or replaced with another connection means, such as a wireless connection means. Furthermore, those skilled in the art would understand that the features superior to the prior art described in the specification, claims, and drawings can be combined in any manner.

Industrial Applicability

[0085] The apnea therapy device for sleep of the present invention applies electrical stimulation to one or more oral muscles, such as the tongue muscle and / or the palatal muscle, and trains them, including a mouthpiece, electrode means associated with the mouthpiece, and electrical circuit components operably connected to the electrode means. During use, through the electrode means, via the inner layer of the mouth, such as the oral mucosa, it can enhance the resting muscle tension and / or the muscle tension during sleep. Unlike the prior art, it does not require constant use during sleep, does not cause discomfort to the user, and is not a transient treatment method, but a treatment technology that addresses the root cause of sleep apnea syndrome. Therefore, it has applicability in the related medical field and the surrounding medical industry.

Explanation of Reference Numerals

[0086] 1 Electrical stimulation device 2 Main body 2a ON / OFF button 3 Mouthpiece 4 Charging station 20 First upper end 21 Male connector 22 projections 23 electrical socket 24 first dial 25 second dial 26 third dial 27 fourth dial 28 USB port 29 lower end 30 cylindrical base 31 contact part 32 first major surface 32a electrode 33 second major surface 33a, electrode 34 lower end 40 cylindrical base 41 cylindrical projection 42 electrical cable 51 pharyngeal velar arch 52 palatine tonsil 53 glossopalatine muscle 54 buccinator muscle 55 vallate papilla 56 fungiform papilla 57 dorsal surface of tongue 58 styloglossus muscle 59 hyoglossus muscle 60 mandible 61 genioglossus muscle 62 longitudinal intrinsic muscle 63 transverse intrinsic muscle 64 vertical intrinsic muscle 65 geniohyoid muscle 66 dental arch 67 premaxilla 68 mental foramen 69 palatal process of maxilla 70 palatine bone 71 posterior nasal spine 72 palatine foramen 73 hamular bone 74 tensor veli palatini muscle 75 levator veli palatini muscle 76 tensor tympani muscle 77 palatopharyngeal muscle 78 pharyngopalatine muscle 103 mouthpiece 130 gripping base 131 Arm 132 First Contact Flange 133 Second Contact Flange 135 Neck Portion 134 Enlarged End Portion 136 Electrical Connector 132a Electrode 133a Electrode

Claims

1. A transmucosal neuromuscular electrical stimulation device comprising a mouthpiece, electrode means associated with said mouthpiece, and electrical circuit components operably connected to said electrode means, said mouthpiece comprising a pair of arms joined together at one end to a gripping base, said pair of arms being branched from each other and comprising a first flange and a second flange extending inwardly from each arm, said first flange extending inwardly from or adjacent to each free end of said pair of arms and being shaped to cooperate with, or be similar or adapted to, the dorsal tongue surface, said second flange being provided at an intermediate portion of said arm and being shaped to cooperate with, or be similar or adapted to, the sublingual tongue surface, as said electrode means, said first flange includes a first electrode and said second flange includes a second electrode, said gripping base has an enlarged end portion coupled to said pair of arms, and an end face of said enlarged end portion comprises an electrical connector, When in use of said transmucosal neuromuscular electrical stimulation device, applying said electrical stimulation via said electrode means to one or more tongue muscles through said dorsal tongue surface and said sublingual tongue surface of a user to enhance resting muscle tone and / or sleep-time muscle tone. A transmucosal neuromuscular electrical stimulation device characterized thereby.

2. The transmucosal neuromuscular electrical stimulation device according to claim 1, wherein said first electrode and said second electrode each comprise a column of electrodes, and said columns of electrodes are electrically isolated from each other by a shielding material.

3. The transmucosal neuromuscular electrical stimulation device according to claim 2, wherein said columns of electrodes of said first electrode and said second electrode are configured to stimulate the muscles of the tongue simultaneously or in a required order.

Images