DEVICE FOR STIMULATING A NERVE OR A PART OF A NERVOUS SYSTEM AND A METHOD FOR CONTROLLING STIMULATION

Abstract

A device for stimulating a nerve of a living being comprises: a stimulation generating unit; a first pair of electrodes, a second pair of electrodes, and a third pair of electrodes configured to be arranged in a first, second, and third location, respectively, in relation to the nerve; wherein the stimulation generating unit is configured to generate a first waveform comprising a first frequency; a second waveform comprising a second frequency, and a third waveform comprising a third frequency to the first, second, and third pairs of electrodes, respectively; wherein the first and second frequencies define a beat frequency and the third frequency is related to the beat frequency by an integer number, wherein the stimulation generating unit is configured to output the first, second, and third waveforms for causing interferential stimulation in the nerve.

Claims

1. A device for stimulating a nerve or a part of a nervous system of a living being, said device comprising: a stimulation generating unit configured to generate stimulation signals for stimulating the nerve or the part of the nervous system; a first pair of electrodes configured to be arranged in a first location in relation to the nerve or the part of the nervous system; a second pair of electrodes configured to be arranged in a second location in relation to the nerve or the part of the nervous system; and a third pair of electrodes configured to be arranged in a third location in relation to the nerve or the part of the nervous system; wherein the stimulation generating unit is configured to generate a first waveform comprising a first frequency to the first pair of electrodes; a second waveform comprising a second frequency to the second pair of electrodes, and a third waveform comprising a third frequency to the third pair of electrodes; wherein the first frequency and the second frequency define a beat frequency corresponding to a difference between the first frequency and the second frequency and wherein the third frequency is related to the beat frequency by an integer number, wherein the stimulation generating unit is configured to output the first waveform, the second waveform, and the third waveform for causing interferential stimulation in the nerve or the part of the nervous system.

2. The device according to claim 1, wherein the device is configured to be at least partially implanted in the living being with the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes arranged at different locations in relation to the nerve or the part of the nervous system.

3. The device according to claim 2, wherein the device comprises a carrier configured to be arranged in relation to the nerve or the part of the nervous system, wherein the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes are mounted in or on the carrier.

4. The device according to claim 1, wherein the beat frequency is two times larger than the third frequency.

5. The device according to claim 1, further comprising a control unit configured to modulate the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively, and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively, for controlling the interferential stimulation of the nerve or the part of the nervous system.

6. The device according to claim 1, further comprising at least a fourth pair of electrodes configured to be arranged in a fourth location in relation to the nerve or the part of the nervous system, wherein the stimulation generating unit is configured to generate a fourth waveform comprising a fourth frequency to the fourth pair of electrodes, wherein the fourth frequency is related to the beat frequency by an integer number.

7. The device according to claim 6, wherein the stimulation generating unit is configured to be controlled to selectively output the third waveform to the third pair of electrodes or the fourth waveform to the fourth pair of electrodes for controlling the interferential stimulation in the nerve or the part of the nervous system.

8. The device according to claim 1, wherein the stimulation generating unit is configured to generate a first frequency and a second frequency, respectively, being in a range of 500 Hz-1 MHz, such as 50 kHz-1 MHz.

9. The device according to claim 1, wherein the stimulation generating unit is configured to generate the first frequency and the second frequency with a difference between the first frequency and the second frequency being in a range of 1 Hz-10 kHz, such as 1-5 kHz.

10. The device according to claim 1, wherein the stimulation generation unit is configured to generate the first waveform, the second waveform, and the third waveform with an amplitude of the third waveform being equal to or larger than an amplitude of the first waveform and an amplitude of the second waveform.

11. The device according to claim 1, wherein the first waveform, the second waveform, and the third waveform are sinusoidal signals.

12. The device according to claim 1, wherein the device comprises a feedback sensor configured to provide feedback on stimulation of the nerve or the part of the nervous system, wherein the stimulation generating unit is configured to be controlled in dependence of the feedback.

13. The device according to claim 12, wherein the feedback sensor is configured to monitor an effect of stimulation of the nerve or the part of the nervous system by monitoring a specific biomarker.

14. A method for controlling stimulation of a nerve or a part of a nervous system of a living being, said method comprising: providing a first control signal for controlling generation of a first waveform comprising a first frequency to a first pair of electrodes arranged in a first location in relation to the nerve or the part of the nervous system; providing a second control signal for controlling generation of a second waveform comprising a second frequency to a second pair of electrodes arranged in a second location in relation to the nerve or the part of the nervous system; and providing a third control signal for controlling generation of a third waveform comprising a third frequency to a third pair of electrodes arranged in a third location in relation to the nerve or the part of the nervous system; wherein the control signals control generation of the first waveform and the second waveform with a difference between the first frequency and the second frequency defining a beat frequency and control generation of the third frequency being related to the beat frequency by an integer number.

15. The method according to claim 14, further comprising modulating the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively, and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0108] The above, as well as additional objects, features and advantages of the present inventive concept, will be better understood through the following illustrative and non-limiting detailed description, with reference to the appended drawings. In the drawings like reference numerals will be used for like elements unless stated otherwise.

[0109] FIG. 1 is a schematic view illustrating interferential stimulation of a nerve.

[0110] FIG. 2 is a schematic view of a device according to an embodiment.

[0111] FIGS. 3a-3g are schematic views illustrating interferential signals in the nerve based on different arrangement of electrodes of the device and different waveforms output to the electrodes.

[0112] FIG. 4 is a schematic view of a system incorporating the device.

[0113] FIG. 5 is a flow chart of a method according to an embodiment.

DETAILED DESCRIPTION

[0114] Referring now to FIG. 1, interferential stimulation of a nerve 10 will be generally described.

[0115] As illustrated in FIG. 1, a first current source 12 is associated with a first pair of electrodes 14 and a second current source 32 is associated with a second pair of electrodes 34. The first pair of electrodes 14 is mounted in a first relation to an outer surface of the nerve 10 and the second pair of electrodes 34 is mounted in a second relation to the outer surface of the nerve 10.

[0116] The first current source 12 generates a first signal 16 with a first frequency X kHz and the second current source 32 generates a second signal 36 with a second frequency Y kHz. As illustrated in FIG. 1, the first signal provided to the first pair of electrodes 14 causes an electric field to be generated in a first portion 18 of the nerve 10 and the second signal 36 provided to the second pair of electrodes 34 causes an electric field to be generated in a second portion 38 of the nerve 1. The electric fields overlap in an overlapping portion 50, wherein the first signal 16 interferes with the second signal 36 to generate an interferential signal 52.

[0117] The interferential signal 52 has a frequency content including the first frequency and the second frequency. Further, the amplitude of the interferential signal 52 is modulated by a difference between the first frequency and the second frequency, X-Y, defining a beat frequency of the interferential signal 52.

[0118] The beat frequency may be much lower than the first and second frequencies. Further, the amplitude of the interferential signal 52 may be larger than individual amplitudes of the first signal 16 and the second signal 36, respectively, thanks to constructive interference of the signals.

[0119] Referring now to FIG. 2, a device 100 for stimulating a nerve 10 according to an embodiment is illustrated. Although interferential stimulation of a nerve 10 will be described hereinbelow, it should be realized that the interferential stimulation may alternatively be applied to another part of the nervous system, such as a part of the peripheral nervous system, e.g., to a ganglion. For simplicity and brevity, only stimulation of a nerve 10 will be described below.

[0120] The device 100 is configured to generate a third signal for modulating interference between a first signal and a second signal, as described above, such that the interferential signal within the nerve 10 may be accurately controlled for accurate selection of a location within the nerve 10 in which interferential stimulation is caused.

[0121] The device 100 comprises a stimulation generating unit 110, which may comprise separate stimulation generating modules, each dedicated to generating stimulation signals to a respective pair of electrodes. Alternatively, the stimulation generating unit 110 may be a single unit configured to generate and output the stimulation signals to the electrodes.

[0122] In FIG. 2, the device 100 is shown with the stimulation generating unit 110 comprising a first stimulation generating module 112, a second stimulation generating module 132 and a third stimulation generating module 142. The first stimulation generating module 112, the second stimulation generating module 132 and the third stimulation generating module 142 are separate from each other which may facilitate that the generation and output of stimulation signals from the stimulation generating modules 112, 132, 142 may be individually provided without crosstalk between the stimulation generating modules 112, 132, 142.

[0123] Each stimulation generating module may comprise a current generator for generating a current signal. The current generator may comprise an oscillator, which is configured to generate an alternating signal and an amplifier, which is configured to receive the alternating signal from the oscillator and output an amplified signal. The stimulation generating module may be controlled, e.g., for controlling a frequency of the alternating signal output by the oscillator or for controlling a gain of the amplifier. As realized by the person skilled in the art, the stimulation generating module may be implemented in numerous other ways for generating an alternating signal.

[0124] The first stimulation generating module 112 may comprise a first current generator, which may be connected to a first pair of electrodes 114. The first current generator may be configured to generate a first waveform and to output the first waveform to the first pair of electrodes 114. The first pair of electrodes 114 are arranged in a first location in relation to the nerve 10.

[0125] The second stimulation generating module 132 may comprise a second current generator, which may be connected to a second pair of electrodes 134. The second current generator may be configured to generate a second waveform and to output the second waveform to the second pair of electrodes 134. The second pair of electrodes 134 are arranged in a second location in relation to the nerve 10.

[0126] The third stimulation generating module 142 may comprise a third current generator, which may be connected to a third pair of electrodes 144. The third current generator may be configured to generate a third waveform and to output the third waveform to the third pair of electrodes 144. The third pair of electrodes 144 are arranged in a third location in relation to the nerve 10.

[0127] The first stimulation generating module 112 and the second stimulation generating module 132 are configured to generate and output the first waveform comprising a first frequency and the second waveform comprising a second frequency with a difference in the first and second frequencies such that the difference between the first frequency and the second frequency defines a beat frequency in interference within the nerve 10 of the first waveform and the second waveform.

[0128] The third stimulation generating module 142 is further configured to generate and output the third waveform comprising a third frequency that is related to the beat frequency by an integer number.

[0129] The third waveform modulates the beat frequency signal defined by interference of the first waveform and the second waveform such that an amplitude of the beat frequency signal is substantially increased. In particular, thanks to the third frequency being related to the beat frequency by an integer number, the third waveform may be matched to the beat frequency signal in order to amplify the beat frequency signal and to control stimulation of the nerve 10. A phase of the third waveform may be controlled in relation to a phase of the beat frequency signal such that constructive interference may be achieved in a desired location so as to cause interferential stimulation in the desired location of the nerve 10.

[0130] The first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144 may be configured to be arranged in relation to a cross-section of the nerve 10 perpendicular to a longitudinal direction of the nerve 10. The first pair of electrodes 114 may be configured to be arranged at an opposite side of a circumference of the nerve 10 to the second pair of electrodes 134. However, individual electrodes within a pair of electrodes 114, 134 may still be configured to be arranged with a distance in-between such that the current waveform received by the electrodes will propagate through nerve tissue between the electrodes. The electrodes of the third pair of electrodes 144 may be configured to be arranged at opposite sides of the circumference of the nerve 10 with each of the electrodes of the third pair of electrodes 144 being arranged between one of the electrodes of the first pair of electrodes 114 and one of the electrodes of the second pair of electrodes 134 along the circumference of the nerve 10.

[0131] Thus, the first pair of electrodes 114 may be associated with a first part of the circumference of the nerve 10 and the second pair of electrodes 134 may be associated with a second part of the circumference of the nerve 10. This implies that the portions of the cross-section of the nerve in which the first waveform and the second waveform, respectively, define electric fields are quite different so as to allow interferential stimulation deep within the nerve 10.

[0132] However, according to an alternative, the electrodes of the first pair of electrodes 114 may be configured to be alternatingly arranged with the electrodes of the second pair of electrodes 134 and the electrodes of the third pair of electrodes 144 around the circumference of the nerve 10. Different arrangements of the first pair of electrodes 114, the second pair of electrodes 134 and the third pair of electrodes 114 in relation to the nerve 10 may be used depending on a location within the nerve 10 at which stimulation is desired.

[0133] According to another alternative, the electrodes of the first pair of electrodes 114 may be displaced in relation to each other along a longitudinal direction of the nerve 10. The electrodes of the second pair of electrodes 134 may also be displaced in relation to each other along a longitudinal direction of the nerve 10. Also, the electrodes of the third pair of electrodes 144 may be displaced in relation to each other along a longitudinal direction of the nerve 10. The first pair of electrodes 114 may be displaced from the second pair of electrodes 134 and the third pair of electrodes 144 along the circumference of the nerve 10, but the electrodes of the first, second, and third pairs of electrodes 114, 134, 144 may be arranged at common positions in relation to the longitudinal direction of the nerve 10. This implies that an interferential signal 152 may be provided along the longitudinal direction of the nerve 10, which may be useful for stimulating the nerve 10. However, it may be more difficult to select a desired location within the cross-section of the nerve 10 when the electrodes of the pairs of electrodes 114, 134, 144 are displaced in the longitudinal direction of the nerve 10.

[0134] As illustrated in FIG. 2, the device 100 may comprise a carrier 170, such as in the form of a cuff, in which the first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144 are mounted. The cuff 170 may facilitate arrangement of the first, second, and third pairs of electrodes 114, 134, 144 in contact with a surface of the nerve 10.

[0135] The first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144 may be mounted in the cuff 170 with a fixed relation between the electrodes. This implies that the cuff 170 may provide a well-defined relation between the electrodes providing a simple manner of arranging all the electrodes with a desired relationship to each other and to the nerve 10.

[0136] The device 100 may further comprise a control unit 160. The control unit 160 may be configured to provide control signals to the stimulation generating unit by providing control signals to the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 for controlling generation of the first waveform, generation of the second waveform, and generation of the third waveform, respectively. The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other. The control unit 160 may thus ensure that a desired interferential signal is generated for providing desired interferential stimulation of the nerve 10.

[0137] The control unit 160 may be configured to provide control signals to the first current generator, to the second current generator, and to the third current generator, respectively, for controlling the generation of the first waveform, the generation of the second waveform, and the generation of the third waveform, respectively. The control signals to the first current generator, to the second current generator, and to the third current generator may modulate the first waveform, the second waveform, and the third waveform, respectively, for controlling the interferential stimulation provided by the device 100.

[0138] The control unit 160 may be configured to provide control signals for modulating the first frequency of the first waveform and/or the second frequency of the second waveform. This implies that the beat frequency may be changed. Thus, the control unit 160 may further be configured to provide control signals for modulating the third frequency of the third waveform such that the third frequency relates to the beat frequency by an integer number.

[0139] The control unit 160 may be configured to provide control signals for modulating an amplitude of the first waveform and/or an amplitude of the second waveform and/or an amplitude of the third waveform. This implies that a location within the nerve 10 having a maximum amplitude of the interferential signal may be moved. The location having maximum amplitude of the interferential signal is located closer to a pair of electrodes outputting a weaker signal than to a pair of electrodes outputting a stronger signal.

[0140] The control unit 160 may be configured to provide control signals for modulating a time instant for start of the first waveform and/or a time instant for start of the second waveform and/or a time instant for start of the third waveform. Thus, a phase relationship between the first waveform, the second waveform, and the third waveform may be controlled for controlling a waveform of the interferential signal.

[0141] The control unit 160 may comprise a stimulation controller which is configured to generate and transmit the control signals to the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142.

[0142] According to an embodiment, the stimulation controller may comprise a processing unit for executing an application program for controlling the generation and timing of control signals. The stimulation controller may further comprise a memory storing the application program and storing settings for controlling the generation and timing of control signals. The stimulation controller may be configured to receive new settings for altering the control by the stimulation controller. The stimulation controller may also or alternatively comprise several versions of settings to allow selection of different settings depending on a desired stimulation. The stimulation controller may further comprise a clock or may be configured to receive a clock signal as input for timing of control signals.

[0143] According to an alternative, the stimulation controller may comprise an application-specific integrated circuit (ASIC) for controlling the generation and timing of control signals.

[0144] The first stimulation generating module 112 and the second stimulation generating module 132 may be configured to generate the first waveform and the second waveform, respectively, having a first frequency and a second frequency, respectively, in a range of 500 Hz-1 MHz, such as 50 kHz-1 MHz.

[0145] The first stimulation generating module 112 and the second stimulation generating module 132 may further be configured to generate the first waveform and the second waveform with a difference in frequency in a range of 1 Hz-10 kHz, such as 1-5 kHz. Thus, the beat frequency of the interferential signal may be in the range of 1 Hz-10 kHz, such as 1-5 kHz.

[0146] The first frequency and the second frequency generated by the first stimulation generating module 112 and the second stimulation generating module 132 may thus be sufficiently high so as not to affect the nerve 10, such as being higher than 500 Hz or higher than 50 kHz. The difference between the first frequency and the second frequency, i.e., the beat frequency, may be set so as to be adapted to provide proper stimulation of the nerve 10.

[0147] The third stimulation generating module 142 may be configured to generate the third waveform comprising a third frequency which is related to the beat frequency by an integer number.

[0148] According to an embodiment, the beat frequency may be two times larger than the third frequency. The beat frequency being two times larger than the third frequency may be particularly advantageous in forming a desired interferential signal in the nerve 10.

[0149] However, it should be realized that the third frequency may be related to the beat frequency by an integer number in other ways. For instance, the third frequency may be equal to the beat frequency, or the third frequency may be two, three or four times larger than the beat frequency. This may still allow the third waveform to modulate the interference between the first and second waveforms so as to form an interferential signal that may efficiently cause stimulation in the nerve 10.

[0150] Thus, according to embodiments, the third frequency of the third waveform may be in the range of 0.5 Hz-20 kHz, such as 500 Hz-10 kHz.

[0151] The signal the first waveform, the signal of the second waveform, and the signal of the third waveform may be sinusoidal signals. This implies that no net charges are delivered to the living being by the first waveform, the second waveform, and the third waveform, respectively. Hence, accumulation of net charges in the living being is avoided, which may otherwise negatively affect the living being.

[0152] The stimulation controller may be configured to control the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 to control the device 100 to provide stimulation of the nerve 10 according to a stimulation paradigm. The stimulation controller may thus store settings of the stimulation paradigm and may be configured to control the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generation module 142 to generate and output the first waveform, the second waveform, and the third waveform for providing the desired stimulation paradigm to the nerve 10.

[0153] The device 100 may comprise a feedback sensor 180. The feedback sensor 180 is configured to measure a property related to the stimulation of the nerve 10. The feedback sensor 180 may provide measurement data to the control unit 160, which may use the measurement data in order to control the stimulation generating unit 110 in dependence of the measurement data.

[0154] The feedback sensor 180 may be configured to sense a voltage amplitude at the first pair of electrodes 114, at the second pair of electrodes 134, and at the third pair of electrodes 144, respectively, using the same electrodes used for providing the first, second, and third waveforms or using additional electrodes in vicinity of first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144, respectively.

[0155] The control unit 160 may analyze the measurement data, such as the sensed voltage amplitudes. The control unit 160 may store desired values of the voltage amplitudes to be used in the stimulation of the nerve 10 such that the control unit 160 may control the stimulation generating modules 112, 132, 142 in dependence of the sensed voltage amplitudes such that the desired values are reached. The stored desired values may represent calibration values corresponding to the device 100 providing stimulation of a desired location in the nerve 10.

[0156] The control unit 160 may alternatively determine a location in the nerve 10 being stimulated based on the sensed voltage amplitudes in order to control the stimulation generating modules 112, 132, 142 such that a desired location is stimulated.

[0157] The feedback sensor 180 may alternatively be configured to measure a property related to an effect of the stimulation of the nerve 10. Thus, the feedback sensor 180 may be arranged to measure a property in a separate location from the location where stimulation of the nerve 10 takes place. The feedback sensor 180 may be thus be arranged in a separate housing, which may for instance be implanted in the body of the living being or may be worn on the body of the living being depending on the property to be measured. The feedback sensor 180 may then communicate with the control unit 160 through wired or wireless communication.

[0158] The feedback sensor 180 may be configured to monitor a specific biomarker in order to monitor an effect of the stimulation of the nerve 10.

[0159] According to an embodiment, the feedback sensor 180 is configured to monitor a heart rate and/or a breathing rate as a specific biomarker. According to another embodiment, the feedback sensor 180 is configured to monitor mechanical effects caused by the stimulation, such as muscle activity or intestine mobility as a specific biomarker. According to yet another embodiment, the feedback sensor 180 is configured to monitor an inflammatory biomarker as a specific biomarker.

[0160] The control unit 160 may be configured to analyze the feedback from the feedback sensor 180 in order to determine whether the desired effect of the stimulation of the nerve 10 is achieved. Such analysis may provide an indication whether a correct location in the nerve 10 is stimulated.

[0161] For instance, the vagus nerve provides signals to many different parts of the body. The analysis of the feedback from the feedback sensor 180 may reveal whether stimulation by the device 100 provides stimulation of a correct location in the vagus nerve such that the desired part of the body is affected. Hence, the feedback may be used for monitoring that the correct location in the vagus nerve is stimulated, such that the device 100 is controlled to selectively stimulate a portion of the vagus nerve for providing the desired effect of the stimulation.

[0162] Referring now to FIGS. 3a-3g, interferential signals achieved in the nerve 10 are discussed. It should be realized that the interferential signals are based on simulations and may not correspond exactly to interferential signals in an actual nerve 10. However, the interferential signals in FIGS. 3a-3g illustrate how stimulation in the nerve 10 may be controlled.

[0163] In FIG. 3a, a first waveform is provided into the nerve 10 by the first pair of electrodes 114 and a second waveform is provided by the second pair of electrodes 134, wherein the first pair of electrodes 114 and the second pair of electrodes 134 are arranged at different locations in relation to a circumference of the nerve 10 as illustrated in FIG. 3a.

[0164] The first waveform is a sinusoidal signal having a first frequency of 1 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 1.01 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation.

[0165] In FIG. 3a, the interferential signal between the first waveform and the second waveform at a location 20 in the nerve 10 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is illustrated. Attenuation of each of the first waveform and the second waveform between the location 20 and the first pair of electrodes 114 and the second pair of electrodes 134, respectively, is 0.5. As shown in FIG. 3a, the interferential signal exhibits a beat frequency of 10 Hz varying between a maximum interference and a minimum interference wherein the first and second waveforms cancel each other.

[0166] In FIG. 3b, in addition to the first and second waveforms illustrated in FIG. 3a, a third waveform is provided into the nerve 10 by the third pair of electrodes 144. The third pair of electrodes 144 are arranged at a different location in relation to a circumference of the nerve 10 compared to the first pair of electrodes 114 and the second pair of electrodes 134. The electrodes of the third pair of electrodes 144 are arranged on opposite sides of the nerve 10 and each of the electrodes 144 are arranged between an electrode of the first pair of electrodes 114 and an electrode of the second pair of electrodes 134 along the circumference of the nerve 10 as illustrated in FIG. 3b.

[0167] The third waveform is a sinusoidal signal having a third frequency of 5 Hz and an amplitude of 2 mV. Thus, the beat frequency is two times larger than the third frequency. The third waveform is provided with a 90 phase offset in relation to the first and second waveforms.

[0168] In FIG. 3b, the interferential signal between the first waveform, the second waveform, and the third waveform at the location 20 in the nerve 10 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is illustrated. Attenuation of the third waveform between the location 20 and the third pair of electrodes 144 is 0.5.

[0169] As shown in FIG. 3b, the third waveform modulates the interference between the first waveform and the second waveform such that an amplitude of the interferential signal is substantially increased. In addition, the interferential signal is formed with a similar signal shape as a typical monophasic or biphasic current stimulation which is realized in existing implants.

[0170] FIGS. 3c and 3d illustrate similar stimulation effects as illustrated in FIGS. 3a and 3b. However, in FIGS. 3c and 3d, stimulation in a different location of the nerve 10 is illustrated using different stimulation parameter settings.

[0171] In FIG. 3c, a first waveform is provided into the nerve 10 by the first pair of electrodes 114 and a second waveform is provided by the second pair of electrodes 134, wherein the first pair of electrodes 114 and the second pair of electrodes 134 are arranged at different locations in relation to a circumference of the nerve 10 as illustrated in FIG. 3c, the locations of the first and second pair of electrodes 114, 134 being the same as illustrated in FIG. 3a.

[0172] The first waveform is a sinusoidal signal having a first frequency of 1 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 1.01 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation.

[0173] In FIG. 3c, the interferential signal between the first waveform and the second waveform at a location 22 in the nerve 10 arranged closer to the first pair of electrodes 114 than the second pair of electrodes 134 is illustrated. Attenuation of the first waveform between the location 22 and the first pair of electrodes 114 is 0.5, whereas attenuation of the second waveform between the location 22 and the second pair of electrodes 134 is 0.25. As shown in FIG. 3c, the interferential signal exhibits a beat frequency of 10 Hz varying between a maximum interference and a minimum interference wherein the first and second waveforms do not fully cancel each other out at minimum interference.

[0174] In FIG. 3d, in addition to the first and second waveforms illustrated in FIG. 3c, a third waveform is provided into the nerve 10 by the third pair of electrodes 144. The third pair of electrodes 144 are arranged at a different location in relation to a circumference of the nerve 10 compared to the first pair of electrodes 114 and the second pair of electrodes 134, in the same manner as illustrated in FIG. 3b.

[0175] The third waveform is a sinusoidal signal having a third frequency of 5 Hz and an amplitude of 1.5 mV. Thus, the beat frequency is two times larger than the third frequency. The third waveform is provided with a 90 phase offset in relation to the first and second waveforms.

[0176] In FIG. 3d, the interferential signal between the first waveform, the second waveform, and the third waveform at the location 22 in the nerve 10 closer to the first pair of electrodes 114 than the second pair of electrodes 134 is illustrated. Attenuation of the third waveform between the location 22 and the third pair of electrodes 144 is 0.5.

[0177] As shown in FIG. 3d, the third waveform modulates the interference between the first waveform and the second waveform such that an amplitude of the interferential signal is substantially increased. Thus, as illustrated in FIGS. 3b and 3d, a location in the nerve 10 being stimulated may be controlled such that the stimulation may be steered to different locations in the nerve 10. It should be noted that the stimulation illustrated in FIG. 3d has a lower amplitude than the stimulation illustrated in FIG. 3b and also a gradient of the interferential signal in-between positive and negative halves of a cycle is smaller for the interferential signal illustrated in FIG. 3d than the interferential signal in FIG. 3b. This implies that there is a lower probability of activating nerve fibers at location 22 using the stimulation indicated in FIG. 3d compared to location 20 using the stimulation indicated in FIG. 3b.

[0178] As illustrated by the examples in FIGS. 3b and 3d, the stimulation generation unit 110 may be configured to generate the first waveform, the second waveform, and the third waveform with an amplitude of the third waveform being equal to or larger than an amplitude of the first waveform and an amplitude of the second waveform. This may imply that the third waveform may efficiently modulate the interference between the first waveform and the second waveform for forming a sufficiently strong interferential signal for stimulating the nerve 10.

[0179] In FIG. 3e, in addition to the first and second waveforms illustrated in FIG. 3a, a third waveform is provided into the nerve 10 by the third pair of electrodes 144 and a fourth waveform is provided into the nerve 10 by a fourth pair of electrodes 146. The third pair of electrodes 144 are arranged at a different location in relation to the circumference of the nerve 10 compared to the first pair of electrodes 114 and the second pair of electrodes 134, in the same manner as illustrated in FIG. 3b. The fourth pair of electrodes 146 are arranged at yet a different location in relation to the circumference of the nerve 10 compared to the first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144. The electrodes of the fourth pair of electrodes 146 are arranged on opposite sides of the nerve 10 and one of the electrodes of the fourth pair of electrodes 146 is arranged between the electrodes of the first pair of electrodes 114 and the other of the electrodes of the fourth pair of electrodes 146 is arranged between the electrodes of the second pair of electrodes 134 along the circumference of the nerve 10 as illustrated in FIG. 3e. Thus, as illustrated in FIG. 3e, the device 100 may comprise a fourth pair of electrodes 146. The stimulation generating unit 110 may be configured to generate a fourth waveform comprising a fourth frequency to the fourth pair of electrodes 146. The stimulation generating unit 110 may comprise an additional stimulation generating module for separately providing the fourth waveform to the fourth pair of electrodes 146.

[0180] As illustrated in FIG. 3e, additional electrodes may thus be used for further controlling the location within the nerve 10 being stimulated. This further facilitates maximizing the interferential signal in a location in the nerve 10 which does not correspond to a location in which interference between the first waveform and the second waveform is strongest.

[0181] In FIG. 3e, an interferential signal is illustrated based on interference between the first waveform, the second waveform, the third waveform, and the fourth waveform. Here, the first waveform is a sinusoidal signal having a first frequency of 1 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 1.01 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation.

[0182] The third waveform in FIG. 3e is a sinusoidal signal having a third frequency of 1 kHz and an amplitude of 0.5 mV. The third waveform is provided with a 180 phase offset in relation to the first and second waveforms. Thus, in this case, the third frequency of the third waveform is equal to the first frequency of the first waveform.

[0183] The fourth waveform is a sinusoidal signal having a fourth frequency of 5 Hz and an amplitude of 1 mV. Thus, the beat frequency is two times larger than the fourth frequency. The fourth waveform is provided with a 90 phase offset in relation to the first and second waveforms.

[0184] In FIG. 3e, the interferential signal between the first waveform, the second waveform, the third waveform, and the fourth waveform at a location 24 in the nerve arranged closer to the first pair of electrodes 114 along a direction of a line between the electrodes of the fourth pair of electrodes 146 is illustrated. Attenuation of the first waveform between the location 24 and the first pair of electrodes 114 is attenuation of the second waveform between the location 24 and the second pair of electrodes 134 is 0.25, attenuation of the third waveform between the location 24 and the third pair of electrodes 144 is 0.5 and attenuation of the fourth waveform between the location 24 and the fourth pair of electrodes 146 is 0.5.

[0185] As shown in FIG. 3e, the fourth waveform modulates interference between the first waveform, the second waveform, and the third waveform such that an amplitude of the interferential signal is substantially increased. In addition, the interferential signal is formed with a similar signal shape as a typical monophasic or biphasic current stimulation which is realized in existing implants.

[0186] In FIG. 3e, the third waveform has a frequency equal to the first frequency. It should however be realized that both the third waveform and the fourth waveform may be provided to be related to the beat frequency by an integer number.

[0187] Also, the stimulation generating unit 110 may be configured to be controlled to selectively output the third waveform to the third pair of electrodes 11 or the fourth waveform to the fourth pair of electrodes 146 for controlling the interferential stimulation in the nerve 10. Thus, a location in the nerve 10 being stimulated may be controlled by selection of which electrodes to be used for outputting waveforms for forming the interferential signal in the nerve 10.

[0188] In FIG. 3f, an interferential signal formed by the first waveform, the second waveform, and the third waveform is illustrated, wherein the first pair of electrodes 114, the second pair of electrodes 134 and the third pair of electrodes 144 arranged in the same manner as illustrated in FIG. 3b is used and wherein the interferential signal at the location 20 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is again illustrated.

[0189] In FIG. 3f, the first waveform, the second waveform and the third waveform have different characteristics in a first time interval and a second time interval.

[0190] In the first time interval, the first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 11 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation of 90 at start of the first time interval. The first and the second waveform thus define a beat frequency of 1 kHz. The third waveform is a sinusoidal signal having a third frequency of 500 Hz and an amplitude of 2 mV. Thus, the beat frequency is two times larger than the third frequency. The third waveform is provided with a common phase relation to the first and second waveforms. The first time interval has a duration corresponding to a single period of the beat frequency.

[0191] In the second time interval, the first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 10.2 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation of at start of the first time interval. The first and the second waveform thus define a beat frequency of 200 Hz. The third waveform is a sinusoidal signal having a third frequency of 100 Hz and an amplitude of 2 mV. Thus, the beat frequency is two times larger than the third frequency. The third waveform is provided with a common phase relation to the first and second waveforms. The second time interval has a duration corresponding to a single period of the beat frequency during the second time interval.

[0192] In FIG. 3f, the interferential signal between the first waveform, the second waveform, and the third waveform at the location 20 in the nerve 10 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is illustrated. Attenuation of each of the first waveform, the second waveform and the third waveform between the location 20 and the first pair of electrodes 114, the location 20 and the second pair of electrodes 134 and the location 20 and the third pair of electrodes 144, respectively, is 0.5.

[0193] As illustrated in FIG. 3f, the interferential signal may be controlled to mimic traditional charge balanced stimulation. This enables steering stimulation predominantly to a particular location in the nerve 10. The phase of the first waveform, second waveform and third waveform ensure that the interferential signal is positive in the first time interval and negative in the second time interval.

[0194] In FIG. 3g, an interferential signal formed by the first waveform, the second waveform, and the third waveform is illustrated, wherein the first pair of electrodes 114, the second pair of electrodes 134 and the third pair of electrodes 144 arranged in the same manner as illustrated in FIG. 3b is used and wherein the interferential signal at the location 20 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is again illustrated.

[0195] The first waveform is a sinusoidal signal having a first frequency of 1 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 1.01 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation.

[0196] The third waveform is a sinusoidal signal having a third frequency of 10 Hz and an amplitude of 2 mV. Thus, the beat frequency is now equal to the third frequency. The third waveform is provided with a 90 phase offset in relation to the first and second waveforms.

[0197] In FIG. 3g, the interferential signal between the first waveform, the second waveform, and the third waveform at the location 20 in the nerve 10 centrally between the first pair of electrodes 114 and the second pair of electrodes 134 is illustrated. Attenuation of each of the first waveform, the second waveform and the third waveform between the location 20 and the first pair of electrodes 114, the location 20 and the second pair of electrodes 134 and the location 20 and the third pair of electrodes 144, respectively, is 0.5.

[0198] As shown in FIG. 3g, the third waveform modulates the interference between the first waveform and the second waveform such that an amplitude of the interferential signal is substantially increased. The interferential signal has a different signal shape than illustrated in FIG. 3b. However, the interferential signal in FIG. 3g illustrates that a different relation between the third frequency and the beat frequency may be used while still allowing control of stimulation of the nerve. It should also be realized that other relations between the third frequency and the beat frequency could be used, such as the third frequency being two or three times larger than the beat frequency.

[0199] Although the interferential signals in FIGS. 3a-3g have been illustrated based on continuous signals of the first waveform, the second waveform and the third waveform, it should be realized that the first waveform, the second waveform and the third waveform may be intermittent signals. Thus, each of the waveforms may comprise a sequence of pulses having a varying signal within each of the pulses with the signal varying at the frequency of the waveform. Thus, stimulation may be provided to the nerve 10 at a time instance when pulses of the waveforms are output, whereas no signal is output by the electrodes between the pulses.

[0200] Thanks to the stimulation generating unit 110 being configured to provide intermittent current waveforms, the stimulation of the nerve 10 may be provided in an energy-efficient manner only outputting signals when stimulation is actually to take place. This implies that the device 100 is suitable for being implanted (for which energy saving is particularly important in order to ensure long lifetime of the implanted device or avoid frequent charging of the implanted device). The device 100 may further be used with stimulation paradigms that include a nerve 10 being stimulated in very long sessions (such as up to 30 minutes) comprising sequences of pulses being provided in plural periods separated by off time when no stimulation is provided. Thus, the stimulation generating unit 110 may be configured not to output signal during an entire session but rather to only output signals during the stimulation pulses within the session.

[0201] Referring now to FIG. 4, the device 100 may be incorporated in a system 190 of separate physical units.

[0202] The device 100 may be configured to be implanted in the living being, such as a human being. The first pair of electrodes 114 and the second pair of electrodes 134 are preferably configured to be in contact with the nerve 10 for providing accurate control of signals transmitted into the nerve 10 and avoiding attenuation of signals from the first pair of electrodes 114 and the second pair of electrodes 134 before reaching the nerve 10. The third pair of electrodes 144 and any additional pairs of electrodes, such as the fourth pair of electrodes 146, may also be configured to be in contact with the nerve 10.

[0203] The first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 are preferably also implanted in the living being. This implies that wires connecting the first stimulation generating module 112 to the first pair of electrodes 114, wires connecting the second stimulation generating module 132 to the second pair of electrodes 134, and wires connecting the third stimulation generating module 142 to the third pair of electrodes 144 may be short so as to provide good quality of signals provided to the first pair of electrodes 114, the second pair of electrodes 134, and the third pair of electrodes 144.

[0204] The control unit 160 is preferably also implanted in the living being. The control unit 160 may preferably transfer control signals to the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 through wired communication, e.g., for accurately controlling timing of control signals. Thus, the control unit 160 may be implanted in the living being to avoid wires extending from an implant to a unit external to the body of the living being.

[0205] The control unit 160 and the stimulation generating unit 110 may be arranged within a common housing, which may be positioned close to the nerve 10 when the device 100 is implanted. The housing may provide an encasing of circuitry of the device 100 so as to protect the circuitry and to provide an appropriate outer surface for implantation in the living being.

[0206] However, in other embodiments, the third pair of electrodes 144 may be arranged externally to the living being, such as being arranged to provide the third waveform through the skin of the living being into the nerve 10. Thus, the device 100 may be partially implanted with the first stimulation generating module 112 and the second stimulation generating module 132 as well as the first pair of electrodes 114 and the second pair of electrodes 134 being implanted while the third stimulation generating module 142 and the third pair of electrodes 144 are arranged externally to the body of the living being.

[0207] The control unit 160 may be arranged in a common housing with the first and second stimulation generating modules 112, 132 or in a common housing with the third stimulation generating module 142. Alternatively, the control unit 160 may be distributed in plural modules that are commonly arranged with the first and second stimulation generating modules 112, 132 and with the third stimulation generating module 142, respectively. The plural modules may then communicate with each other for synchronizing control of the stimulation generating modules.

[0208] Hence, the device 100 may be distributed in a plurality of separate physical units forming a system.

[0209] The system 190 comprises an implant, which may incorporate the entire device 100 as described above, including the third stimulation generating module 142, the third pair of electrodes 144, and the control unit 160. The implanted device 100 may further comprise a communication unit 162, which may be configured to communicate with an external device 192 of the system 190 through wireless communication.

[0210] The implanted device 100 may thus for instance receive control signals from the external device 192 for changing parameters of the stimulation, such as parameters defining the stimulation paradigm, such as to control a location within the nerve 10 to be stimulated or a frequency, an amplitude, or a duration of a stimulation to be provided. The communication unit 162 may be provided within the control unit 160 or may be separately provided for providing wireless communication to the external device 192.

[0211] The external device 192 may be provided as a wearable for allowing use of short-range communication between the implanted device 100 and the external device 192. The external device 192 may be configured to be worn on the skin close to the implanted device 100. However, the external device 192 may alternatively be configured to be worn in any other suitable manner, such as the external device 192 being in form of a smartwatch provided with functionality for communicating with the implanted device 100. Alternatively, the external device 192 may be adapted to be arranged close to the living being, even if not being necessarily worn, such as the external device 192 being in form of a mobile phone provided with functionality for communicating with the implanted device 100.

[0212] The external device 192 may function as an intermediate device for allowing the implanted device 100 to receive and transmit information to a remote device 194. Thus, the external device 192 may enable communication between the implanted device 100 and a remote device 194 arranged anywhere, e.g., by means of communication between the external device 192 and the remote device 194 through a telecommunication or computer network, such as the Internet.

[0213] The external device 192 and/or the remote device 194 may provide information to the implanted device 100 for configuring the implanted device 100 such as for controlling parameters of the stimulation.

[0214] The implanted device 100 may further be configured to transmit information to the external device 192 and/or the remote device 194 regarding stimulations performed, which may be used as input for controlling future stimulations.

[0215] The external device 192 and the implanted device 100 may further be configured to provide wireless charging of the implanted device 100. Thus, the implanted device 100 may be wirelessly charged so as to increase lifetime of the implanted device 100.

[0216] However, in other embodiments, as discussed above, the control unit 160 and/or the third stimulation generating module 144 and the third pair of electrodes 144 may be arranged externally to the living being, such as being configured to be worn on the skin close to the implanted device 100.

[0217] In such case, the control unit 160 arranged in a housing externally to the living being may be configured communicate with the remote device 194 without any intermediate external device 192 being involved in the communication.

[0218] The device 100 may further be configured with additional functionality in a housing (incorporating the control unit 160 and/or the third stimulation generating module 142 and the third pair of electrodes 144) arranged externally to the living being. For instance, the parts of the device 100 being implanted may be wirelessly charged from a charging unit in the housing arranged externally to the living being.

[0219] Referring now to FIG. 5, a method for controlling stimulation of a nerve 10 or a part of the nervous system will be described.

[0220] The method comprises providing 202 a first control signal for controlling generation of a first waveform comprising a first frequency to a first pair of electrodes 114 arranged in a first location in relation to the nerve 10 or a part of the nervous system.

[0221] The method further comprises providing 204 a second control signal for controlling generation of a second waveform comprising a second frequency to a second pair of electrodes 134 arranged in a second location in relation to the nerve or the part of the nervous system.

[0222] The method further comprises providing 206 a third control signal for controlling generation of a third waveform comprising a third frequency to a third pair of electrodes 134 arranged in a third location in relation to the nerve 10 or the part of the nervous system.

[0223] The first control signal may be provided to a first stimulation generating module 112, the second control signal may be provided to a second stimulation generating module 132 and the third control signal may be provided to a third stimulation generating module 142. Thus, the control signals may be provided for allowing individual generation of the first waveform, the second waveform, and the third waveform, respectively, which may facilitate avoiding crosstalk between the stimulation generating modules in generation of the waveforms.

[0224] The control signals control generation of the first waveform and the second waveform with a difference between the first frequency and the second frequency defining a beat frequency and control generation of the third frequency being related to the beat frequency by an integer number.

[0225] Thus, the control signals may be provided for controlling generation of waveforms such that the third waveform may modulate interference between the first and second waveforms in the nerve 10 or part of the nervous system for allowing accurate selection of a location in the nerve 10 or the part of the nervous system in which interferential stimulation will occur.

[0226] The method may further comprise modulating the first waveform, the second waveform, and the third waveform by modulating the first frequency, the second frequency, and the third frequency, respectively, by modulating an amplitude of the first waveform, the second waveform, and the third waveform, respectively, and/or by modulating a time instant for start of the first waveform, the second waveform, and the third waveform, respectively.

[0227] In the above the inventive concept has mainly been described with reference to a limited number of examples. However, as is readily appreciated by a person skilled in the art, other examples than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.