METHOD AND APPARATUS FOR TREATING DYSPHAGIA

Abstract

A mouthpiece (1) for the treatment of dysphagia, the mouthpiece (1) being shaped for receipt and retention within the mouth of a user, the mouthpiece (1) comprises at least one abutment surface for engaging at least one of the inside surface of a lip and/or the inside of a cheek and/or the palate of a user, the abutment surface comprising stimulation means for providing electrical stimulation to the inside surface of a lip and/or the inside of a cheek and/or the palate of a user, in use.

Claims

1. A mouthpiece for the treatment of dysphagia, the mouthpiece being shaped for receipt and retention within the mouth of a user and comprising at least one abutment surface for engaging at least one of the inside surface of a lip and/or the inside of a cheek and/or the palate of a user, the at least one abutment surface comprising a stimulator for providing electrical stimulation to the inside surface of a lip and/or the inside of a cheek and/or the palate of a user, in use.

2. The mouthpiece according to claim 1, wherein the stimulator comprises a first electrode set which is arranged or arrangeable to apply, in use, an electric current to the inside of the lip of the user and/or wherein the stimulator comprises a second electrode set which is arranged or arrangeable to apply, in use, an electric current to the inside of the cheek of the user and/or a further electrode set which is arranged to apply, in use, an electric current to the palate of the user.

3. The mouthpiece according to claim 2, comprising two or more of the first electrode set, second electrode set and further electrode set.

4. The mouthpiece according to claim 3, wherein the stimulator is arranged to provide electrical stimulation between electrodes of an electrode set and/or between electrode sets.

5. The mouthpiece according to claim 1, wherein the mouthpiece comprises plural abutment surfaces, each comprising a stimulator for providing electrical stimulation to the inside surface of a lip and/or the inside of a cheek and/or the palate of a user, in use.

6. The mouthpiece according to claim 1, comprising a lip-engaging member which comprises a first of said at least one abutment surface for engaging the inside of the lip.

7. The mouthpiece according to claim 6, wherein the lip-engaging member is configured to at least partially cover the inside of the lip of the user, in use and/or wherein the lip-engaging member is configured to at least partially cover the inside and the outside of the lip of the user, in use.

8. The mouthpiece according to claim 1, comprising at least one cheek engaging member.

9. The mouthpiece according to claim 8, wherein said at least one cheek engaging member, the or each of which comprises at least one of said at least one abutment surface for engaging the inside of the cheek.

10. The mouthpiece according to claim 1, comprising at least one palate-engaging member (14a, 14b), and preferably wherein said at least one palate-engaging member (14a, 14b) comprises at least one of said at least one abutment surface for engaging the palate.

11. The mouthpiece according to claim 1, comprising at least one tongue-engaging member, for engaging the tongue of the user, in use.

12. The mouthpiece according to claim 11, comprising plural tongue-engaging members.

13. The mouthpiece according to claim 12, wherein each tongue-engaging member comprises an electrode set arranged to provide electrical stimulation to the upper surface of the tongue and/or the lower surface of the tongue of the user.

14. The mouthpiece according to claim 1, further comprising a controller arranged to control said stimulator for providing electrical stimulation.

15. A dysphagia treatment apparatus comprising the mouthpiece (1) according to claim 1, and a controller, wherein said controller is external to but operatively connected or connectable to said mouthpiece.

16. A method of treating dysphagia, the method comprising applying electrical stimulation to one or more of the inner lip surface, the inner cheek surface and/or the palate of the user.

17. A method according to claim 16, further comprising inserting a mouthpiece into the mouth of a user, the mouthpiece having one or more of a lip engaging member comprising a first electrode set comprising an electrode and counter electrode, a cheek engaging member comprising a second electrode set comprising an electrode and counter electrode and a palate engaging member comprising a further electrode set comprising an electrode and counter electrode.

18. A method according to claim 16, further comprising inserting a mouthpiece into the mouth of a user, the mouthpiece having two or more of a lip engaging member comprising a first electrode set comprising an electrode and counter electrode, a cheek engaging member comprising a second electrode set comprising an electrode and counter electrode and a palate engaging member comprising a further electrode set comprising an electrode and counter electrode.

19. A method according to claim 17, comprising applying electrical stimulation between the electrode and counter electrode of an electrode set.

20. A method according to claim 18, comprising applying electrical stimulation between the electrode of a first electrode set and counter electrode of a second or further electrode set.

Description

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[0075] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings in which:

[0076] FIG. 1 shows a schematic diagram of a mouthpiece according to an embodiment of the invention;

[0077] FIG. 2 shows a schematic side view of a controller for use with the mouthpiece of FIG. 1;

[0078] FIG. 3 shows a schematic side view of a charging station for use with the mouthpiece shown in FIG. 2 and/or the controller shown in FIG. 2;

[0079] FIG. 4 shows a schematic perspective view of a mouthpiece according to an embodiment of the invention;

[0080] FIG. 5 shows a schematic perspective view of the mouthpiece shown in FIG. 4; and

[0081] FIG. 6 shows a schematic cross-sectional side view of the mouthpiece shown in FIG. 4 received within the mouth of a user.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0082] Referring now to FIG. 1, there is shown a mouthpiece 1 according to an embodiment of the invention. The mouthpiece 1 comprises a lip member 2, cheek-engaging members 3, a first tongue-engaging member 4 and a second tongue-engaging member 5, in this embodiment.

[0083] The mouthpiece 1 (e.g., some or all component parts thereof) may be at least partially formed from a medically acceptable plastic material, for example silicone rubber. At least some of the mouthpiece 1 may be formed from a conductive plastic material, e.g., conductive silicone.

[0084] The lip member 2 comprises an internal lip-engaging member 2a and an external lip engaging member 2b. In this embodiment, the internal lip-engaging member 2a and the external lip engaging member 2b are formed integrally. However, in embodiments, they may be separate, joined or joinable together. Additionally, or alternatively, the external lip engaging member 2b may not be provided. The lip member 2 (e.g., the internal lip-engaging member 2a) comprises an abutment surface for engaging the inside surface of a lip of a user, in use. The internal lip-engaging member 2a comprises a first electrode set or electrodes 20 (shown as dotted circles in FIG. 1). The first electrodes 20 are operable, in use, to electrically stimulate the inside of a lip of a user via the abutment surface, i.e. the electrodes 20 may comprise a first electrode and a first counter electrode such that the lip is stimulated by passage of electrical stimulation therebetween. The lip member 2 (e.g., the internal lip-engaging member 2a) is configured (e.g., sized and/or shaped) to fit a lip of a user, in use. In embodiments, at least a portion of the lip member 2 may be formed of a deformable and/or resilient material. The lip member 2 may be configured to at least partially fit onto, over and/or around a lip of a user (e.g., to at least partially cover a lip of a user).

[0085] The cheek-engaging members 3 comprise a first cheek-engaging member 3a and a second cheek-engaging member 3b. Each of the first and second cheek-engaging members 3a, 3b comprise an abutment surface 3b1 for engaging the inside of a cheek of a user, in use. Each of the first and second cheek-engaging members 3a, 3b comprise a second electrode set or electrodes 30. The second electrodes 30 are operable, in use, to electrically stimulate the inside of a cheek of a user via the abutment surfaces 3b1. Thus, a first cheek engaging member 3a may comprise a second electrode 30 and a second counter electrode 30 such that the cheek may be stimulated by passage of electrical stimulation therebetween. The second cheek engaging member 3b may be similarly arranged. The first and second cheek-engaging members 3a, 3b are configured (e.g., sized and/or shaped) to fit against opposed inside cheeks of a user, in use. The first and second cheek-engaging members 3a, 3b may be or comprise ‘pads’. For example, the first and second cheek-engaging members 3a, 3b may comprise first and/or second major surfaces. The first or second major surface may comprise the abutment surface 3b1. The first and second cheek-engaging members 3a, 3b may be at least partially polygonal in shape. The first and second cheek engaging members 3a, 3b may be located, positioned and/or arranged to positively engage the inner surface of the wearer's cheeks.

[0086] The first tongue-engaging member 4 comprises an abutment surface for engaging the upper surface of the tongue of a user, in use. The first tongue-engaging member 4 comprises a third electrode set or electrodes 40. The third electrodes 40 are operable, in use, to electrically stimulate the upper surface of the tongue of a user. Thus, a first tongue engaging member 4 may comprise a third electrode 40 and a second counter electrode 40 such that the upper surface of the tongue may be stimulated by passage of electrical stimulation therebetween. The second tongue-engaging member 5 comprises an abutment surface for engaging the lower surface of the tongue of a user, in use. The second tongue-engaging member 5 comprises fourth electrodes 50. The fourth electrodes 50 are operable, in use, to electrically stimulate the lower surface of the tongue of a user. The second tongue engaging member 5 may comprise a third electrode 50 and a second counter electrode 50 such that the lower surface of the tongue may be stimulated by passage of electrical stimulation therebetween.

[0087] The first and second tongue-engaging members 4, 5 are joined together at one of their ends. The first and second tongue-engaging members 4, 5 diverge along their lengths. A space is defined between the first and second tongue-engaging members 4, 5. The first and second tongue-engaging members 4, 5 are configured so that the space therebetween is for receipt of part of the tongue of a user.

[0088] The mouthpiece 1 may also contains batteries (not shown) and electrical circuitry (not shown). The electrical circuitry may include inverters for converting the direct current of the batteries into currents, for example biphasic currents. The electrical circuitry is connected via wires W to the first, second, third and fourth electrodes 20, 30, 40, 50, in this embodiment.

[0089] The mouthpiece 1 may comprise an on/off button (not shown). The mouthpiece 1 may comprise controls (not shown) for operating one or more function thereof. For example, the controls may be used by an operator of the mouthpiece 1 to control the duration, frequency, intensity and/or location of electrical stimulation (e.g., to one/some or each of the electrodes).

[0090] In use, the mouthpiece 1 is inserted into the mouth of a user. For example, the first and second cheek-engaging members 3a, 3b are fitted against and/or otherwise attached to the inside of the cheeks of the user, e.g., so that the abutment surfaces 3b1 thereof are engaged with the inside of the cheeks of the user. The lip member 2 is fitted over a lip of the user, for example such that the abutment surface of the internal lip-engaging member 2a of the lip member 2 engages the inside of the lip of the user. The first and second tongue-engaging members 4, 5 are inserted into the mouth of the user so that the tongue of the user is located between the first and second tongue-engaging members 4, 5. In particular, the first tongue-engaging member 4 is positioned such that the abutment surface thereof engages the upper surface of the tongue of the user. The second tongue-engaging member 5 is positioned such that the abutment surface thereof engages the lower surface of the tongue of the user.

[0091] The mouthpiece 1 is then turned on (for example via the on/off button). The mouthpiece 1 is then activated to cause electrical stimulation of the inside of the cheek and/or the inside of the lip of the user. Additionally, the mouthpiece 1 may be activated to cause electrical stimulation of the upper and/or lower surface of the tongue of the user.

[0092] Two biphasic currents may be applied, each of which is configured with a first set of parameters including intensity, frequency and pulse duration. The parameters may be selected to provide maximal contraction of the muscles of the lip and cheek in the user. The treatment may be carried out for a period of about 60 minutes, for example 10, 20, 30, 40 or 50 minutes.

[0093] The intensity, frequency and pulse duration may then be adjusted. The two stimulation signals, e.g., biphasic currents may then be applied through the third and/or fourth electrodes 40, 50 to, respectively, the upper or lower surface of the tongue. The second set of parameters may be selected to provide maximal contraction of the user's genioglossus muscle (for example). The treatment may be carried out for a period of about 20 minutes. In embodiments, different sets of parameters may be used for the two biphasic currents supplied to one, some or each of the first, second, third and fourth electrodes 20, 30, 40, 50.

[0094] The application of electrical stimulation, e.g., biphasic currents, according to the parameters described above stimulate the skeletal muscles of the user's mouth. It is also believed that the application of stimulation, such as biphasic current, to these skeletal muscles creates a further, sensory function, such as a vibratory sensation. Whilst not wishing to be bound by any theory, it is believed that this electrical and vibratory stimulation of the nerves provides feed back to the brain which further enhances the mitigation of dysphagia. Specifically, it is believed that the effectiveness of this treatment is enhanced by multisensory integration within the nervous system.

[0095] By way of example, a treatment regime could involve a six week induction period during which each of the aforementioned muscle groups are stimulated for a period of 10 to 20 minutes, twice daily. The treatment regime, which is designed to mitigate dysphagia, could then be followed by an ongoing maintenance regime involving 60 minute sessions once per day.

[0096] Whilst the electrical stimulation may be ‘intra’ an electrode set, say between the first electrode 20 and first counter electrode 20, it may also be inter electrode sets, for example between the first electrode 20 and the second counter electrode 30, or between the first electrode 20 and the third counter electrode 40, or between the third electrode 40 and the first 20 or second 30 counter electrode 40. In all cases, the applied stimulation is between the mouthpiece 1 electrodes and requires no further electrodes mounted outside of the mouth of the user.

[0097] In embodiments, the mouthpiece 1 may be at least partially controlled by a controller 6 (for example, as shown in FIG. 2). The controller 6 comprises electrical circuitry (not shown) and batteries (not shown) to power the electrical circuitry, in this embodiment.

[0098] The controller 6 is substantially cylindrical in this embodiment and includes a first, upper end 60 with a male connector 61 having a projection 62 on each of its side to provide a bayonet fitting and an electrical socket 63 for receiving an electrical connector (not shown) of the mouthpiece 1. On its front surface, the controller 6 also includes an ON/OFF button 6a, four dials 64, 65, 66, 67, a USB port 68 and a second, lower end 69. In embodiments, the controller 6 may have any suitable shape, and need not be cylindrical.

[0099] The mouthpiece 1 may be configured to connect to the controller 6, in this embodiment. For example, the mouthpiece 1 may comprise a socket or receptacle (not shown) for connection of the controller 6. The socket may be provided on or in the lip member 2, the first tongue-engaging member 4 and/or the second tongue-engaging member 5. In embodiments, however, the mouthpiece 1 may be configured to be controlled remotely (e.g., wirelessly for example using a Bluetooth® connection). In these embodiments, the mouthpiece 1 may not be physically connected or connectable to the controller 6.

[0100] The first dial 64 is operable to adjust the current amplitude of, say, a first biphasic current from, say, 0 to 100 mA. The second dial 65 is operable to adjust the current amplitude of, say, a second biphasic current from, say, 0 to 100 mA. The third dial 66 is operable to adjust the duration of the period during which the first biphasic current is supplied from, say, 1 to 30 minutes. The fourth dial 67 is operable to adjust the duration of the period during which the second biphasic current is supplied from, say, 1 to 30 minutes.

[0101] The USB port 68 is configured to enable the controller 6 to be charged and/or connected to a personal computer (not shown) or other further electronic device, for example to program one or more characteristics of the first and second biphasic currents independently (and/or to upload or download data to and from the controller). In embodiments, the mouthpiece 1 may comprise a connection (e.g., a USB port or other type of port), for example for programming the first and second biphasic currents and/or for uploading or downloading of data to and from the mouthpiece.

[0102] In this embodiment, the frequency of the first biphasic current is set at a value between 2.0 and 50 Hz, the second biphasic current is set at a value between 5.0 and 120 Hz and the pulse duration of each biphasic current is set at a value between 200 and 700 μs. The personal computer (not shown) may also incorporate control software operable to override or program the dials 64, 65, 66, 67. The software may be programmed to apply biphasic currents having predetermined characteristics independent from one another, such as amplitudes, frequencies and pulse durations and for a predetermined period of time. It is further envisaged that the mouthpiece 1 and/or the controller 6 could incorporate a memory on which is stored such predetermined characteristics, which may be modified by connecting a personal computer (not shown) or other further electronic device to the mouthpiece 1 or the controller 6 (e.g., via the USB port 28 or a USB port). In such embodiments, the dials may be omitted or configured to adjust the aforementioned characteristics from their pre-programmed values. In some embodiments, it is envisaged that more or less functionality is provided by manual dials, buttons and the like.

[0103] In embodiments, the above-described control may be accomplished and/or provided in or by the mouthpiece 1, alone. For example, the electrical circuitry of the mouthpiece 1 may be configured to carry out one, some or each function of control as described above (e.g., regarding the control of biphasic current delivery).

[0104] Referring now to FIG. 3, there is shown a charging station 7 for charging the controller 6 and/or the mouthpiece 1. The charging station 7 has a cylindrical base 70 with a cylindrical projection 71 and an electrical cable 72 for connecting the charging station 7 to a source of mains electricity. The projection 71 in this embodiment incorporates an inductive coupling and the charging station 7 includes electrical circuitry connected to the electrical mains cable 72 for supplying electricity to the inductive coupling to inductively charge the batteries (not shown) in the mouthpiece 1 and/or the controller 6. The mouthpiece 1 may comprise a receptacle (not shown), for example in the lower end 69. The receptacle of the mouthpiece 1 may be configured to cooperate with the projection 71 of the charging station 7. When connected together the charging station 7 may be operable to charge the batteries in the controller 6 and/or in the mouthpiece 1.

[0105] Referring now to FIGS. 4 and 5, there is shown a mouthpiece 11 comprising first and second members 14, 15 according to an embodiment of the invention. Although not shown, it will be appreciated by one skilled in the art that the mouthpiece 11 comprises a lip-engaging member and cheek-engaging members as described herein (e.g., as shown in FIG. 1). In embodiments, however, the mouthpiece 11 may be provided absent a lip-engaging member and/or cheek-engaging members as described herein.

[0106] The mouthpiece 11 (e.g., some or all component parts thereof) may be at least partially formed from a body or medically-acceptable plastic material, for example silicone rubber, and at least some of the mouthpiece may be formed from a body or medically-acceptable conductive plastic material e.g., conductive silicone.

[0107] The mouthpiece 11 also comprises a controller 16, in this embodiment. The controller 16 may have or comprise electric circuitry and/or a power source (not shown). The controller 16 may comprise a connection for connecting to a source of power, for example a USB connection or the like. The controller 16 may be configured to control operation of the mouthpiece, for example in a manner similar to that described with respect to the mouthpiece 1 shown in FIG. 1. The controller 16 may comprise an on/off button. The controller 16 may comprise an input mechanism (such as one or more button or dial or the like) for controlling or altering the electrical stimulation (e.g., one or more parameter such as duration, frequency, amplitude or the like).

[0108] The first member 14 is joined to the second member 15 at a joining end thereof. The first member 14 has a ‘forked’ configuration. The first member 14 comprises first and second arms 14a, 14b. A first end of each of the first and second arms 14a, 14b extend from a common base portion 14c. A second end of each of the first and second arms 14a, 14b is opposed to the first end of each, respective arm 14a, 14b. At or adjacent the second end of each arm 14a, 14b an electrode 140 is provided. The electrodes 140 are arranged to provide electrical stimulation, in use, to the roof of the mouth (palate) of a user and/or to the inside of the throat of the user. The first member 14 is at least partially curved along its length, e.g., from the second ends of the arms 14a, 14b to the base portion 14c. The first member 14 comprises an abutment surface for engaging with the roof of the mouth and/or the inside of the throat of the user, in use. In this embodiment, each of the arms 14a, 14b comprise an abutment surface for engaging with the roof of the mouth and/or the inside of the throat of a user, in use.

[0109] The second member 15 comprises first and second arms 15a, 15b (as shown in FIG. 5). Each of the arms 15a, 15b extend (e.g., at a first end) from the base portion 14c of the first member 14. In this way, the first and second members 14, 15 are joined together at one of their ends. The second, opposed, end of the arms 15a, 15b of the second tongue-engaging member 15 each comprise an electrode 150. The electrodes 150 are arranged to provide electrical stimulation to the sublingual surface of a user's tongue, in use. The second member 15 comprises an abutment surface for engaging with the sublingual surface of the tongue of a user, in use. In this embodiment, each of the arms 15a, 15b comprise an abutment surface for engaging with the sublingual surface of the tongue of a user, in use.

[0110] The second member 15 (e.g., the arms 15a, 15b thereof) extend from the first member 14 at an angle β therefrom. In embodiments, the angle β may be between about 30° and 90°, say between about 35°, 45°, 50°, 55°, 60° and 65°, 70°, 75°, 80°, 85° and 90°.

[0111] The second member 15 (e.g., the arms 15a, 15b) is relatively shorter than is the first member 14, in embodiments.

[0112] The mouthpiece 11 comprises a gripping portion 17, in this embodiment. The gripping portion 17 extends from the join between the first and second members 14, 15, in this embodiment. The gripping portion 17 is sized and shaped to be gripped between the front teeth of a user, in use. The gripping portion 17 comprises a projection, e.g., from the first member 14 (say from the joining end thereof). The projection is at least partially curved along its length. In embodiments, the curve of the projection is configured to receive the front teeth (e.g., at least some thereof) of the user, when the mouthpiece is in use.

[0113] The controller 16 extends from or is joined to the gripping portion 17, in this embodiment.

[0114] Referring now to FIG. 6, the mouthpiece 11 shown in FIGS. 4 and 5 is shown inserted into the mouth of a user. As can be seen, the second member 15 engages underneath the tongue T of the user. In this way the abutment surfaces of the second member 15 engages the sublingual surface of the user's tongue. The first member 14 extends over the upper (dorsal) surface of the user's tongue T. The abutment surfaces of the first member 14 engage with the roof of the mouth of the user and/or the inside of the throat of the user. The gripping portion 17 is held between the front upper teeth UTE and front lower teeth LTE of the user.

[0115] In use, the mouthpiece 11 is activated to provide electrical stimulation via the controller 16 in a similar manner to that described above with respect to the mouthpiece 1. The difference with mouthpiece 11 is that electrical stimulation is applied to the sublingual surface of the tongue and the roof of the mouth and/or the inside of the throat of the user. In embodiments, however, the mouthpiece 11 may be configured to additionally provide electrical stimulation to the upper (dorsal) surface of the tongue of the user. For example, the first member 14 may comprise third electrodes for providing electrical stimulation to the upper (dorsal) surface of the tongue of the user. Where this is the case, the first member 14 may be configured to engage, in use, the upper (dorsal) surface of the user's tongue.

[0116] 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.

[0117] For example, the mouthpiece 1 may take any suitable form, but is designed to enable the electrical stimulation to be applied to the appropriate muscles as described above. Additionally, or alternatively, the dials 64, 65, 66, 67 may be replaced with other similar adjustment means or even omitted as explained above. Additionally, or alternatively, any suitable number of dials or controls may be provided (and this need not be four, but could instead be 1, 2, 3, 5, 6 or more). Additionally, or alternatively, the mouthpiece 1 and controller 6 may be provided as an integral unit. Additionally, or alternatively, the charging station 4 may be omitted, for example the controller 6 may comprise a mains cable or connection for charging such as a USB socket or the like or may use single use (primary) batteries or some other power source. Similarly, the USB port 68 may be omitted or replaced with some other connection means, which may be a wireless connection means. Additionally, or alternatively, one or both of the tongue-engaging members 4, 5 may be omitted from the mouthpiece 1 or lip and/or cheek engaging members may be added to the mouthpiece 11 for electrically stimulating the lip and/or cheek.

[0118] 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.