APPARATUS FOR TREATMENT OF SNORING AND SLEEP APNOEA

Abstract

A portable, battery powered apparatus (10) generates an electrical signal between electrodes (15a, 15b) to be applied to the skin of a patient for reduction or prevention of snoring or obstructive sleep apnoea. The signal comprises electrical stimulation at a frequency of 1-100 Hz and the signal comprises a stimulation free period of at least 0.5 seconds every 20 seconds, avoiding muscle fatigue when used for long periods, e.g. overnight.

Claims

1-33. (canceled)

34. A portable, battery powered apparatus that generates an electrical signal between electrodes to be applied to the skin of a patient for reduction or prevention of snoring or sleep apnoea, wherein the signal comprises electrical stimulation at a frequency of 1-100 Hz; and the signal comprises a stimulation free period of at least 0.5 seconds every 20 seconds.

35. The apparatus of claim 34, comprising: a pair of electrodes, and a power supply that generates an electrical signal between the electrodes to stimulate a patient's tongue muscle (genioglossus) when the electrodes are attached to the patient, wherein the signal is periodic and discontinuous so as to provide for continuous treatment without fatigue of a patient's tongue muscles such that the treatment fails to be effective.

36. The apparatus of claim 35, which provides for said continuous treatment over a period of 3 hours or more.

37. The apparatus of claim 34, wherein the signal is periodic and discontinuous in that it comprises a stimulation free period of at least 0.5 seconds every 10 seconds.

38. The apparatus of claim 34, wherein the signal is discontinuous in that it comprises a stimulation free period of at least 1 second every 10 seconds.

39. The apparatus of claim 34, wherein the signal has a frequency of 5-60 Hz.

40. The apparatus of claim 34, wherein the signal has a current of up to 20 mA.

41. The apparatus of claim 34, wherein the signal comprises pulses of duration up to 1 ms.

42. The apparatus of claim 34, comprising one or more controls for adjustment of one or more signal parameters by the patient, selected from the signal frequency, the signal current, the signal pulse width, the duration of the stimulation free period, and two or more or all such parameters.

43. The apparatus of claim 42, wherein the signal frequency can be adjusted by the patient between three or more frequencies.

44. The apparatus of claim 42, wherein the signal can be adjusted by the patient between three or more current settings.

45. The apparatus of claim 34, wherein the signal delivered by the power supply comprises two phases, a first phase during which its strength gradually increases and a second, later phase during which the signal remains essentially the same strength.

46. The apparatus of claim 45, wherein the duration of the first phase is from about 5 to about 30 minutes.

47. The apparatus of claim 45, wherein during the first phase the signal current or pulse width increases.

48. A method of treatment of snoring or sleep apnoea, comprising delivering via the skin of a patient a signal that stimulates the patient's tongue muscle, wherein the signal has a frequency of 1-100 Hz and is discontinuous in that it comprises a stimulation free period of at least 0.5 seconds every 20 seconds so as to provide for continuous treatment without fatigue of the patient's tongue muscle such that the treatment fails to be effective.

49. The method of claim 48, comprising delivering the signal of the treatment over a period of 3 hours or more.

50. The method of claim 48, wherein the signal has a frequency of 5-60 Hz.

51. The method of claim 48, wherein the signal has a current of up to 20 mA.

52. The method of claim 48, wherein the signal comprises a pulse of duration up to 1 ms.

53. The method of claim 48, wherein the signal is delivered using a portable, battery powered apparatus that generates an electrical signal between electrodes to be applied to the skin of a patient for reduction or prevention of snoring or sleep apnoea, wherein the signal comprises electrical stimulation at a frequency of 1-100 Hz; and the signal comprises a stimulation free period of at least 0.5 seconds every 20 seconds.

Description

[0043] The invention is now described in specific embodiments in the following examples and with reference to the accompanying drawings in which:

[0044] FIG. 1 shows a schematic circuit diagram of the power supply and electronics to generate the stimulation signal of the apparatus of the invention;

[0045] FIG. 2 shows a schematic view from underneath of an apparatus of the invention;

[0046] FIG. 3 shows a schematic view from above of the apparatus of FIG. 2;

[0047] FIG. 4 shows a schematic view from below and to the side of the housing of the apparatus of FIG. 2;

[0048] FIG. 5 shows a schematic view from below and to the side of the apparatus of FIG. 2;

[0049] FIG. 6 shows a schematic view from below of the housing; and

[0050] FIG. 7 shows a schematic view from above of the housing, illustrating housing elements that in the assembled device are directly connected to the body.

[0051] Referring to FIG. 1, apparatus of the invention incorporates circuitry as schematically set out, designed to generate the stimulation signal described in the embodiments set out in detail below.

[0052] The battery charge controller is incorporated into a recharging cradle and can be plugged into the mains and receives the housing of the anti-snoring device to recharge its inbuilt rechargeable battery.

[0053] The unit incorporates a microcontroller that takes input from the switches allowing the user to change the settings mentioned earlier. The microcontroller generates the signals using the signal generator and controls other components. Memory provides the ability to store data for subsequent transfer to an external device for data analysis.

[0054] The filter circuit and the charge pump generate required waveforms which are then passed through a driver to control the power. The unit also has a protection circuit that monitors the output for enhanced safety.

[0055] Referring to FIGS. 2-7, the anti-snoring device shown generally as 10 has a V-shaped body 12 attached in its assembled form to housing 14 that holds the rechargeable battery and the printed circuit board incorporating the signal control circuitry illustrated schematically in FIG. 1.

[0056] On the body 12, electrodes 15a,b are located respectively on the two arms of the V, connected via connecting conductors (internal to the body, hence not shown) to body contact pads on the lower surface of the body (hence obscured by the housing in the figures). These pads correspond with and make contact within the assembled device to housing contact pads 18a,b on the housing 14. Hence, signal output from the housing driven by the circuitry and the battery is transmitted from contact pads 18a,b on the housing via contact pads on the body and the internal conductors in the body to the electrodes 15a,b for delivery to the patient.

[0057] Miscellaneous contact pads 19a,b,c,d on the housing 14 are for connection to the battery recharging cradle (via pads 19a,d) and for optional connection to an external computer interface for interrogation of data stored on the housing memory unit (via pads 19b,c). Other charging options, such as inductive charging can also be used.

[0058] On the top surface of housing 14 are control buttons 20, 21. An on/off button 20 enables the patient to turn the device on and then off. The button further has in prototype A (see below) three positions for selection of different signal frequencies. In prototype B (again see below) there is no selection of signal frequency by the patient and this button has just an on/off function. Second control button 21 is provided on the right hand side as shown in FIG. 6 and has positions for control of current, with three positions available to the user in prototype A and seven in prototype B (see details below).

[0059] In use, a patient removes the detachable unit 22 from the charging unit cradle (not shown) and inserts it into the housing 14. Note that while some figures show separated components of the device, in use the device is a single unit as shown in fully assembled form in FIG. 5. For storage between uses the contact surfaces of electrode pads 15a,b are covered with removable, adhesive covers. The patient removes these by peeling them off, exposing tacky contact areas on the electrode pads. The connection between these pads and the patient can be maintained in day-to-day use by application of additional contact gel or by exchange of the adhesive covers.

[0060] The device is attached to respective left and right-hand sides of the underneath of the jaw and secured in place, optionally using adhesive tape or hydrogel adhesive if needed, with the pads sticking to and making electrical contact with either side of the jaw or just below.

[0061] The patient then turns on the device to a setting established from previous use. When being used for the first time, the patient turns on the device and then titrates its stimulation signal output to one suitable to that particular patient. In practice, the patient increases or decreases the signal current and increases or decreases the signal frequency (if control is available) to the point at which the stimulation is bearable and not so great as to prevent the patient falling asleep. One approach is to increase the current and/or frequency to the point at which the signal is not bearable by the patient and then turn it down to the point at which it is just bearable and will not prevent the patient falling asleep. Another approach is to turn the user variable elements to their minimum settings and then increase them one by one to the point at which the stimulation signal is just noticeable. For different patients, differing approaches to identifying a signal that is effective overnight and does not prevent restful sleep are taken. Once the apparatus is turned on and a particular setting chosen, the signal parameters are thus set. Over a period of approximately 20 minutes the voltage across the electrodes (giving the signal current) ramps up, i.e. gradually increases, from zero to the end voltage value. This allows for the patient to fall asleep before the signal has reached full strength, the level at which it will remain throughout sleep.

[0062] Between uses, the detachable unit is removed and can be recharged in the cradle. Simple assessment of the success of the device can be determined by whether the patient sleeps restfully without snoring. More complicated analysis can be carried out by downloading stored usage data from the housing via interface pads 19b,c and analysis e.g. by medically trained personnel.

[0063] The device settings for two developed prototypes are set out below. As will be appreciated, other devices are envisaged with alternative signal and device parameters and with alternative options for the user variable elements, as described more generally in the description above.

[0064] Specific details of 2 prototype devices that have been developed, with signal parameters and other internal features are as follows:

TABLE-US-00001 Model Prototype A Prototype B Duty cycle 50% 30% Time period for duty cycle 10 s 20 s Pulse width 250 μs 300 μs Current limit to the 1-20 mA 1-20 mA electrode pads Signal frequency 20-40 Hz 30 Hz Signal waveform sinusoidal square wave Internal memory RAM for internal log of usage data Maximum voltage at the pads 80 v (+40/−40) 80 v (+40/−40) On/Off button On housing Power supply Internal rechargeable battery User variable elements Signal frequency Current variable variable in 3 steps: in 7 steps: 2 mA, 20 Hz, 30 Hz, 40 Hz; 4 mA, 6 mA, current variable in 3 8 mA, 10 mA, steps: 3 mA, 6 mA, 12 mA, 14 mA 9 mA
A separate battery charge unit is provided for connection to mains supply while not in use. Full charging takes 3-6 hours following typical overnight use.

[0065] Test of Anti-Snoring Device

[0066] A further prototype device of the invention was used in overnight trials to compare its effect on stimulated vs. control, non-stimulated patients.

[0067] The prototype was set up to deliver a pulse width of approximately 250 microseconds with a voltage adapted to deliver a signal current of about 4-8 mA, with frequency 30 +/−2 Hz and duty cycle of 50%, with a substantially sinusoidal signal. A single prototype device was used for all patients.

[0068] Comparison between stimulated and non-stimulated patients indicated no severe adverse events in any patients as a result of use of the prototype.

[0069] Anti-Snoring Device with 6 Pre-Set Signals

[0070] A further prototype device of the invention was constructed with buttons allowing the user to turn the device on/off, by pressing a combination of both button 1 and button 2, and to cycle through 6 pre-set signals, by pressing button 1 to cycle up the settings and button 2 to cycle down the settings.

[0071] The signals were as follows:

TABLE-US-00002 Parameter Setting 1 Setting 2 Setting 3 Setting 4 Setting 5 Setting 6 Target current  1.5 mA  3 mA  4.5 mA  6 mA  10 mA  15 mA Pulse width 250 μs 250 μs 275 μs 300 μs 325 μs 350 μs Frequency  30 Hz  30 Hz  30 Hz  30 Hz  30 Hz  30 Hz
After a set period of time, suitably around 1 minute, the buttons disable, ensuring that the settings cannot be adjusted accidentally during normal sleep. The requirement to press two buttons to switch the device on/off, opposed to just one, also prevents the user from disabling the device during normal sleep.

[0072] Accordingly, the present invention provides apparatus and a method for treatment of snoring and/or sleep apnoea.