ORAL MUSCLE TRAINING

Abstract

A device (100) for training oral muscle tone, the device (100) includes a mouthpiece (103) having a first and second arm (131) diverging away from one another and each carrying at least one electrode means (132a, 132b, 133a, 133b), at least one of the at least one electrode means protruding proud of adjacent portions of the arms (131), electrical circuitry operatively connected to the electrode means (132a, 132b, 133a, 133b), at least one of the at least one electrode means comprising an electrically conductive polymeric or plastics material.

Claims

1. A retainer-less device for training oral muscle tone, the device comprising a mouthpiece having a first and second arm diverging away from one another and each carrying at least one electrode, at least one of the at least one electrode protruding proud of adjacent portions of the arms, electrical circuitry operatively connected to said at least one electrode, said at least one electrode comprising an electrically conductive polymeric material.

2. A device according to claim 1, wherein each of said first and second arms have a longitudinal axis and comprise a flange extending as a continuation of the longitudinal axis from a free end of the arm, each flange carrying said at least one electrode.

3. The device according to claim 1, wherein the electric circuitry is formed from electrically conductive polymeric material.

4. A device for training oral muscle tone, the device comprising a mouthpiece having joined first and second arm diverging away from one another, each of said first and second arms having a longitudinal axis and having a flange extending as a continuation of the longitudinal axis from a free end of the arm, each flange carrying an at least one electrode, said at least one electrode protruding proud of adjacent portions of the flange, electrical circuitry operatively connected to the electrode, said at least one electrode comprising an electrically conductive polymeric material.

5. The device according to claim 4, wherein the electric circuitry is formed from electrically conductive plastics material or an electrically conductive polymeric material

6. The device according to claim 4, wherein each of said first and second arms comprises two flanges extending therefrom, each of the flanges comprising a body portion and an electrode protruding proud of the surrounding area of each of the body portions.

7. The device according to claim 6, wherein the electrode of each flange is arranged, in use, to be located or locatable either side of a midline of the face of the user.

8. The device according to claim 4, wherein at least one of the flanges is shaped to cooperate with or approximate or accommodate a dorsal tongue surface.

9. The device according to claim 6, wherein at least one of said flanges is shaped to cooperate with or approximate or accommodate a sublingual tongue surface.

10. The device according to claim 4, wherein the mouthpiece is at least in part formed from a non-electrically conductive polymeric material, for example a silicone polymeric material.

11. The device according to claim 10, wherein the non-electrically conductive polymeric material comprises a silicone rubber.

12. The device according to claim 10, wherein the non-electrically conductive polymeric material at least partially surrounds the at least one electrode and electrical circuitry.

13. The device according to claim 4, wherein the electrically conductive polymeric material comprises an electrically conductive silicone plastics material, for example an electrically conductive silicone rubber.

14. The device according to claim 4, wherein the electrically conductive polymeric material comprises electrically conductive particles embedded within a polymeric matrix.

15. The device according to claim 4, comprising a controller arranged to energise the at least one electrode.

16. The device according to claim 15, wherein the controller is programmed or programmable to control one or more features of the electrical stimulation according to a predetermined treatment regime.

17. A method of forming a device for training one or more oral muscles, the method comprising forming one or more electrodes from an electrically conductive plastics material and providing said one or more electrodes on at least one arm of a pair of arms such that said one or more electrodes protrude beyond the adjacent surface of the arm.

18. A method according to claim 17, comprising forming electrical circuitry from an electrically conductive plastics material or electrically conductive polymeric material.

19. A method according to claim 18, comprising integrally forming electrical circuitry and said one or more electrode from an electrically conductive plastics material or electrically conductive polymeric material.

20. A method according to claim 19, comprising at least partially encapsulating said one or more electrode and/or said electrical circuitry within a non-electrically conductive plastics material or no-electrically conductive polymeric material.

Description

[0072] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings in which:

[0073] FIGS. 1A, 1B and 1C are respectively perspective, plan and side elevation views of an apparatus according to an embodiment of the invention;

[0074] FIG. 2 is a schematic of a human mouth showing the palatoglossus and surface of the tongue;

[0075] FIG. 3 is a; a schematic illustrating the extrinsic tongue muscles of a human tongue;

[0076] FIG. 4 is a schematic illustrating the intrinsic tongue muscles of a human tongue;

[0077] FIG. 5 is another schematic of a human mouth showing the muscles of the palate; and

[0078] FIG. 6 is a schematic illustrating further muscles of the palate.

[0079] Referring now to FIGS. 1A to 1C there is shown apparatus 100 according to the invention comprising a mouthpiece 103 which includes a gripping base 130 of substantially uniform width with depending portion 134 arranged to extend over a user's bottom lip. The apparatus 100 also includes a pair of curved arms 131 formed integrally with one end of the base 130 to form a horseshoe shape. Each of the arms 131 has first and second flanges 132, 133 within which are provided electrodes (132a, b; 133a, b). The electrodes (132a, b; 133a, b) protrude proud of the adjacent portions of the associated flanges 132, 133 to facilitate good connection with the facing portion of the user's tongue, i.e. maximise the contact area and/or contact pressure between the electrodes (132a, b; 133a, b) and the user's tongue. The electrodes (132a, b; 133a, b) protrude proud of the respective flange 132, 133 formed from the material of the mouthpiece so as to be the first point of contact between the apparatus 100 and the inside of a user's mouth.

[0080] Each of the first flanges 132 and second flanges 133 are planar and have a respective electrode (132a, b; 133a, b) protruding proud from a first major surface thereof. The first flanges 132 extend inwardly toward one another from the free end of a respective one of the arms 131 and substantially on the same plane as the respective arm 131. In use the flanges 132 engage the dorsal surface 57 of the tongue. The second flanges 133 extend inwardly toward one another from an intermediate part of a respective one of the arms 131 and downwardly for accommodating the sublingual tongue surface. As looked at in a perspective view (FIG. 1A), the electrodes 132a, 132b on the first flanges 132 will face downwardly whereas those electrodes 133a, 133b on the second contact flanges 133 will face generally upwardly. In this way, with the user's tongue located between the first 132 and second 133 flanges the electrodes 132a, 132b; 133a, 133b will apply an electrical field to both the dorsal and sublingual surfaces of a user's tongue and will specifically target the genioglossus muscle.

[0081] The mouthpiece 103 also includes electrical circuitry 140 feeding the respective electrodes (132a, b; 133a, b). Each of these electrodes (132a, b; 133a, b) is electrically isolated from the others by a shielding material, thereby enabling all surrounding muscles to be stimulated simultaneously or in any sequence required. In the present embodiment, the shielding material is the material of the mouthpiece 130 and the shield provided by the shielding material is described by the body of the mouthpiece 130.

[0082] As shown, the electrical circuitry 140 is shown in schematic form.

[0083] In this embodiment, the mouthpiece 103, and therefore shielding material, is formed of a food grade or a biocompatible grade plastic material, for example made from silicone plastics material. The electrodes 132a, b; 133a, b and electrical circuitry 140 are formed of an electrically conductive silicone plastics material in this embodiment. The electrically conductive silicone plastics material is formed from electrically conductive particles embedded within a silicone matrix. In the present embodiment, the electrically conductive granules are silver coated copper granules. These provide electrical conductivity in addition to antibacterial properties.

[0084] The electrodes 132a, 132b; 133a, 133b are partially surrounded by the material of the mouthpiece 130 such that a contact surface of each of the electrodes 132a, 132b; 133a, 133b is left exposed. The electrical circuitry 140 is completely encased by the material of the mouthpiece.

[0085] Each electrode 132a, 132b; 133a, 133b is in the form of a single pad in this embodiment as it provides a large surface area. With a mouthpiece 103 in which the dimensions are A=15-18 mm, B=50-55 mm, C=25-28 mm, D=18-21 mm, the electrodes will typically protrude by 0.5-5 mm from the surrounding, adjacent surface of the flange.

[0086] The electrical circuitry 140 is connected to a printed circuit board (PCB) 141.

[0087] The terminal portion of the depending portion 134 includes an electrical connector or interface 135 for connection with a control and/or power unit (not shown) which is arranged to provide the power to the electrodes (132a, b; 133a, b) of the mouthpiece 103. The connector 135 may comprise a USB, microUSB, USB-C, FireWire, Thuderbolt or any other suitable type of wired connector. The electrical connector or interface 135 is operably connected to the PCBA 141.

[0088] In other embodiments, the connector 135 is replaced with a wireless connection means. The wireless connection means may be provided on the PCBA 141 or may be separate therefrom.

[0089] In some embodiments, the mouthpiece 103 incorporates a power source, such as a battery. If so, the batter will be operably connected to the PCBA 141.

[0090] In use, the mouthpiece 103 is placed in a patient's mouth such that the teach bear on the upper and lower surfaces of the arms 131 and the tongue of the patient is received within the mouthpiece 103 such that the dorsal tongue surface 57 is in contact with the electrodes 132a, b and the sublingual tongue surface is in contact with the electrodes 133a, b. It will be appreciated by those skilled in the art that the electrodes 132a, b will contact a rearward or posterior portion of the dorsal tongue surface 57 and the electrodes 133a, b will contact a frontward or anterior portion of the sublingual tongue surface. With the patient's mouth closed, the flanges 132, 133 are also able to stimulate adjacent muscles on the other side of the tongue, for example the palate muscles. The mouthpiece 103 enables the muscles to be stimulated on both sides of the tongue simultaneously. It will be appreciated that with this design, the muscles based in and around the tongue may be stimulated, including those in hard and soft palate areas.

[0091] In order to train the muscles of the mouth, a control unit (not shown) is programmed (or a pre-programmed program is selected) and the mouthpiece 103 and electrodes (132a, b; 133a, b) are connected to the control unit (not shown). Once the program has started, the control unit (not shown) will energise the electrodes according to the required or desired actuation profile to apply the electrical signal to the muscles.

[0092] Beneficially, the electrodes (132a, b; 133a, b) will apply an electrical signal to the muscles of the tongue, namely one or more of the mylohyoid, geniohyoid and anterior belly of digastric muscles whilst those of the mouthpiece 103 will apply an electrical signal to the genioglossus muscle and the body of the tongue.

[0093] The control unit (not shown) may comprise batteries (not shown) and logic and control circuitry (not shown) to control the application of electric currents to the various electrodes.

[0094] Turning now to FIGS. 2 to 6, there is shown various tongue and palate muscles. Features of the mouth shown in FIGS. 2 to 4 illustrate more clearly the tongue muscles, wherein there is shown the pharyngopalatine arch 51, palatine tonsil 52, palatoglossus 53, buccinator 54, valate papillae 55, fungiform papillae 56, dorsal tongue surface 57, styloglossus 58, hyoglossus 59, mandible bone 60, genioglossus 61, longitudinal, transverse and vertical intrinsic muscles 62, 63, 64 and geniohyoid 65.

[0095] It is well established that the tone of the genioglossus muscle 61 most affects the collapsibility of the tongue as it is the biggest of the extrinsic muscle and responsible for pulling the tongue forward and increasing the airway opening in the throat. The tone of intrinsic surface muscles, such as the longitudinal and transverse intrinsic muscles 62, 63, also contribute to the reduction of the collapsibility of the airway.

[0096] Features of the mouth shown in FIGS. 5 and 6 illustrate more clearly the palate muscles, wherein there is shown the dental arch 66, premaxilla 67, incisive foramen 68, palatine process of maxilla 69, palatine bone 70, posterior nasal spine 71, palatine foramen 72, hamulus 73, tensor palatini muscle 74, levator veli palatini muscle 75, tensor veli palatini muscle 76, uvular muscle 77 and palatopharyngeus muscle 78.

[0097] To a varying degree, the constrictor and dilator muscles of the palate also contribute to snoring and sleep apnoea. The aim of the treatment is to dilate the throat, hence electrical stimulation is directed at the dilatory palate muscles in the midline, such as the uvular muscle 77, the levator veli palatini muscle 75 and the palatopharyngeus muscle 78.

[0098] We have now found that the muscles of the floor of the mouth, and specifically one or more of mylohyoid, geniohyoid and anterior belly of digastric muscles also have an effect on the incidence of sleep apnoea, snoring and SDB in general. We have fund that lateral application of an electrical current across the chin is able to strengthen the muscles of the floor of the mouth which has a surprising and positive effect on muscle tone and helps to further reduce the incidence of SBDs. Indeed, we have found that toning the mylohyoid, and geniohyoid muscles improves the position of the hyoid and hypopharyngeal airway, thereby significantly reducing the incidence of OSA, snoring and SDB in general.

[0099] Because of the use of flexible polymeric or plastics materials, the mouthpiece 103 is capable of conforming to the mouth shape of plural users. Further, the use of flexible non-conductive polymeric or plastics materials for the arms ensures said flexibility. By using electrically conductive polymeric or plastics material for at least most of the electric circuitry 140, the flexure of the arms 131 in use will not lead to damage of the electrical circuitry 140. Further, the first flanges 132 and second flanges 133 on which the respective electrodes (132a, b; 133a, b) are located are also able to flex from their equilibrium position, thereby providing a resilient urging against the tongue of the wearer during use. The use of compatible materials for the mouthpiece arms 131 and electrodes 132a, b; 133a, b and circuitry 140 ensures that there is no delamination during use, or the material stress does not build up or become established at the interface therebetween.

[0100] It will be appreciated by those skilled in the art that several variations to the aforementioned embodiments are envisaged without departing from the scope of the invention. For example, although it is shown that flanges 132, 133 have a respective electrode (132a, b; 133a, b) protruding proud of a single major surface thereof, this need not be the case. It is envisaged that one or more of the flanges 132, 133 may have a respective electrode protruding proud from both major surfaces thereof, i.e. to increase the area of a user's mouth in contact with the electrodes (132a, b; 133a, b).

[0101] Further, although it is noted that the electrodes (132a, b; 133a, b) of the mouthpiece 103 are shown as single pads this need not be the case. Instead, they could be multiple pads or contact points.

[0102] Although the electrically conductive silicone plastic is described as having silver coated copper granules, it is envisaged that any metal, for example gold, silver or copper or composite material or any other suitable conductive material may be embedded within the silicone matrix. In embodiments, the electrically conductive silicone plastics material may be as described above but with electrically conductive fibres instead of granules. Further, the silicone polymeric or plastics material may be replaced in whole or part by other polymeric or plastics materials.

[0103] 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 appended drawings provide clear advantages over the prior art and are therefore within the scope of the invention described herein.