System and method for neuron remodeling waveform

Abstract

A system and method for applying electromagnetic signals to neurons to trigger nerve repair and generation includes generating a low frequency square wave and applying it to the patient to locate a desired nerve and generate a high frequency signal in the range of 50KHz to 500 KHz to the nerve while varying frequency and amplitude to trigger nerve repair and generation.

Description

SYSTEM AND METHOD FOR NEURON REMODELING WAVEFORMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 564,743 filed March 13, 2024 entitled SYSTEM AND METHOD FOR NEURON REMODELING WAVEFORM, the entire content of which is hereby incorporated by reference herein.Field of the Disclosure

[0002] The present disclosure relates to treatment of patients suffering from peripheral sensory motor neuropathy and includes generating and applying a low frequency electrical signal to a nerve for the purpose of nerve location of a nerve to be treated followed by application of a high frequency signal to aid in nerve repair.Related Art

[0003] One of the most prevalent forms of sensory neuropathy is diabetic peripheral neuropathy (DPN) which affects almost 1% of the world population. DPN is often accompanied by symptoms such as pain, foot ulcers and limb amputations. DPN is often reported as nerve damage and enhanced by poor glucose control and may present through a variety of subtypes, such as small-fiber or large-fiber neuropathy, autonomic neuropathy, or radiculopathy.

[0004] One example of motor neuropathy is known as Bell’s Palsy which is generally a consequence of a viral assault on the facial nerves resulting in paralysis of the facial nerves.

[0005] All neuropathic conditions are, at some point, likely to become refractory regarding their response to known pharmaceuticals and other forms of treatment such as neuromodulation, exercise, massage etc. At this point, such pathologies are known to become intractable and the only treatment options become symptomatic based and typically include anti -convulsive therapies, anti-depressants and / or opiates.

[0006] Neuromodulation options may include transcutaneous electrical nerve stimulation (TENS) or surgically invasive therapies such as spinal cord stimulation (SCS). These therapies use electric signals to inhibit or otherwise suppress pain impulses from reaching the brain via the central nervous system such that these therapies are also symptom based. Such neuromodulation electrical nerve stimulation devices involve the use of low frequency electrical signals, typically in the range of 1 Hz to 10 kHz. In general, higher frequency electrical signals, in the 50 kHz to 500 kHz range (including Radio Frequency signals within this range) are only used for ablation of tissue and are not suitable for treatment of neuropathic conditions.

[0007] It would be advantageous to provide for treatment of neuropathy that addresses more than just symptoms and pain management.SUMMARY

[0008] It is an object of the present disclosure to provide a method and system for generating and applying a low frequency electrical signal to a nerve to be treated followed by application of a high frequency signal to aid in nerve repair.

[0009] A system for applying electromagnetic radiation in accordance with an embodiment of the present disclosure includes: a stimulator device configured to generate electromagnetic waves of a desired wavelength and frequency; a probe operable connected to the stimulator device and configured to direct the electromagnetic waves to a user’s body; a feedback electrode in contact with the user’ s body, the feedback electrode operable to provide feedback information associated with a user’s body’s response to the electromagnetic radiation; and a controller operably connected to the feedback electrode and receiving feedback information and operably connected to the stimulator device to provide control signals to the stimulator device wherein the electromagnetic radiation is generated based on the control signals, wherein the stimulator device and probe provide a low frequency electromagnetic wave to a portion of a user’s body to stimulate at least one nerve, and following the low frequency electromagnetic wave, provide a high frequency electromagnetic wave to stimulate neural growth

[0010] In embodiments, the low frequency electromagnetic wave is a square wave.

[0011] In embodiments, the low frequency electromagnetic wave has a frequency in a range of 1Hz to 10kHz.

[0012] In embodiments, the square wave has a duration of between 0.1 and 0.3 ms.

[0013] In embodiments, the high frequency electromagnetic wave includes a series of pulses.

[0014] In embodiments, the series of pulses includes a series of amplitude varying pulses.

[0015] In embodiments, the series of pulses comprise an exponentially decaying sinusoidal waveform.

[0016] In embodiments, the high frequency electromagnetic wave has a frequency in a range of 50 kHz to 500 kHz.

[0017] In embodiments, the probe includes at least one electrode providing transcutaneous transmission of the low voltage electromagnetic wave and the high frequency electromagnetic wave.

[0018] In embodiments, the probe includes a transcutaneous needle configured to pass through the user’s skin to provide percutaneous transmission of the low frequency electromagnetic wave and the high frequency electromagnetic wave.

[0019] In embodiments, a frequency of the low frequency electromagnetic wave is varied based on the feedback information to target a desired nerve.

[0020] In embodiments, a frequency of the high frequency electromagnetic wave is varied based on the feedback information to improve nerve repair.

[0021] In embodiments, the feedback electrode is positioned on the user’s body and operable to provide the feedback information indicative of the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave to the controller.

[0022] In embodiments, the feedback electrode includes an EEG electrode operable to provide EEG information indicative of the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave.

[0023] In embodiments, the feedback electrode comprises an EMG electrode or an AMG electrode operable to provide EMG information or AMG information, respectively, indicative of the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave.

[0024] A method of applying electromagnetic waves to a nerve in a user’s body in accordance with an embodiment of the present disclosure includes: generating a low frequency electromagnetic wave; providing the low frequency electromagnetic wave to a probe configured for contact with the user’s body, applying the low frequency electromagnetic wave to the user’s body via the probe; generating a high frequency electromagnetic wave; providing the high frequency electromagnetic wave to the probe; applying the high frequency electromagnetic wave to the user’s body via the probe; receiving, using a feedback electrode connected to the user’s body, feedback information associated with the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency electromagnetic waver; providing control signals to the stimulator device from a controller, wherein the control signals are based on at least the feedback information to target the nerve.

[0025] In embodiments, the low frequency electromagnetic wave has a frequency in a range of 1Hz to 10kHz.

[0026] In embodiments, the high frequency electromagnetic wave has a frequency in a range of 50 kHz to 500 kHz.

[0027] In embodiments, the method includes generating the control signals to include low frequency control signals associated with generating the low frequency electromagnetic wave and high frequency control signals associate with generating the high frequency electromagnetic wave based on the feedback information.

[0028] In embodiments, a respective low frequency of the low frequency electromagnetic wave and a respective high frequency of the high frequency electromagnetic wave is varied based on the feedback information.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The above and related objects, features and advantages of the present disclosure will be more fully understood by reference to the following, detailed description of the preferred, albeit illustrative, embodiments of the present invention when taken in conjunction with the accompanying figures, wherein:

[0030] FIG. 1 is an exemplary illustration of a low frequency wave followed by high frequency pulse waves used to aid in nerve repair in accordance with an embodiment of the present disclosure; and

[0031] FIG. 2 illustrates an exemplary device suitable for providing the waveform of FIG. 1.DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0032] Applicant has determined that high frequency electromagnetic fields in the 50KHz to 500KHz range (including Radio Frequencies within this range) applied in nonablative applications, such as pulsed high frequency signals, trigger certain effects on neuropathic nerves including neuron ultrastructural modifications that may modify, disable, or reset neuron function. In embodiments, application of these electromagnetic signals may repair damaged nerves.

[0033] C Fos is a protein that is an immunoreactive marker of gene expression. Following application of pulsed high frequency treatment and up to 7 days thereafter, C Fos may be upregulated for up to 7 days which indicates gene expression changes within neurons in the affected nerves.

[0034] Activating Transmission Factor (ATF-3) is also expressed, indicating a promotion of neurite growth up to 14 days after the application of pulsed high frequency treatment.

[0035] In particular, pulsed high frequency treatment targets small fiber neurons (A-delta and C-fibers) and provides microstructural changes in the cell body, not its processes. Pulsed high frequency treatment may thus be viewed as a neuro-remodelling technique, rather than merely as a method of modulating neural conduction i.e. neuromodulation.

[0036] Such results are unexpected as the mathematical limitations of current neural propagation models do not allow for prediction of these positive effects of pulsed high frequency treatment in the 50kHz and 500KHz range.

[0037] Conventionally, the propagation of nerve impulses triggered by electromagnetic simulation is modelled by two distinct, but complementary mathematical models: the cable equation and the Hodgkin-Huxley equations. The cable equation is based on the insight that a nerve, in many ways, resembles a transmission line. The mathematics of such transmission lines, commonly referred to as the telegrapher’s equations, were developed in 1853 by William Thomson and later refined into the present form by Oliver Heaviside. Indeed, this theoretical advance is what allowed for the transatlantic telegraph cable to provide efficient communication between Europe and North America.

[0038] The adaptation of Thomson’s model was accomplished largely by Hodgkin and Rushton and named the cable equation. The main difference between the two models is that the cable equation is limited to a transmission line where inductance is neglected. This was done under the assumption that the high-frequency domain would never have to be addressed when considering the human nervous system.

[0039] There is, however, a large inductive component to nerve physiology, which was proposed by Cole in 1941 to be caused by piezoelectric properties of the nerve membrane. In the low-frequency domain, much of the inductive effect of the nerve can be neglected. With the advent of electromagnetic stimulation in the high frequency domain, i.e. RF as a therapeutic modality, however, it is necessary to take into account the opposition to changes in current which is indicated by the presence of inductance.

[0040] The Hodgkin-Huxley equations are complementary to the cable equation. In order to mathematically model nerves, the nerves may be considered to consist of separate compartments, each of which may be represented by a circuit element corresponding to asection of cable. Since a signal cannot propagate effectively down the entire length of an axon, the impulse must be amplified periodically. Such amplification may be provided through the mechanism of ion channels, many of which are activated through changes in voltage between the interior and exterior of the nerve membrane. A change in the potential difference will cause the channels to open, allowing positively charged ions such as sodium, potassium, and calcium to enter the axoplasm (and in some cases negative chloride ions). This results in a further change of potential difference, effectively creating an electrical signal which can propagate along the axon as described by the cable equation in the low-frequency case. This impulse may be termed as action potential. The nature of this transmission will have a substantial effect on the voltage-gated ion channels, and therefore it is vital that the correct mathematical model be used in each domain of applicability.

[0041] When higher frequencies are utilized, however, the minimum time requirement for stimulation at sufficient intensity for an action potential to be obtained (known as chronaxie) is generally not achieved, as this typically is on the order of 100-500 ps. Thus, the Hodgkin-Huxley model does not apply in a frequency domain of more than a few kilohertz. In general, under these models, the highest frequency that evokes an action potential is about lOKHz and typically uses a pulse width of at least 100 us. After the potential is evoked, the nerve typically requires a refraction period of about 10ms, but may be up to 50 ms, which corresponds to a minimum frequency of about 100 Hz. Thus, conventional models are generally only useful at these lower frequencies and do not and cannot predict the benefits provided by the high frequency waveforms discussed herein.

[0042] Letting R denote intracellular resistance, C the capacitance of the nerve membrane and G the shunt conductance of the same, the cable equation describes the change in transmembrane voltage V over the length of the axon (denoted by x) as a function of time by: V dV„ , = RC +RGV. dx2dtFurther, including the inductance L of the nerve yields the telegrapher’s equations, which may be combined into the following expression for the transmembrane voltage: V V dV

[0043] In both cases, the axonal current may be derived from the expression for V. Although the expressions may look very similar, the effect on axonal current is pronounced in the high-frequency domain. The axonal current stresses the mitochondria in a neuron which causes a metabolic cascade and results in gene expression changes that result in microstructural changes that repair the neuron.

[0044] Solutions for the axonal current were obtained by solving for the cable and telegrapher’s equations with the boundary conditions supplied by a current injected intracellularly as an exponentially decaying sinusoidal waveform. Current was evaluated at distances from 10 pm from the source to a distance of 5 cm over a period of half a second.

[0045] It is clear from the results that inductance plays a role in increasing the amplitude of the signal propagated in the neuron and contributes to nerve repair. This increase is however not enough to fully explain transmission efficacy. Inductance due to the nerve membrane increases with incident frequency, which would contribute to improved transmission. To obtain a complete picture though, other components of the nerve also need to be taken into account. Microtubules, which are polymers that form part of the cytoskeleton and occur throughout the axon, massively increase the conductance of solutions at frequencies of 50-500 kHz.. Although it is not necessary to explicitly model these as circuit elements, their effect may be implicitly incorporated into the telegrapher’s equations by rendering the value of R as a decreasing function of frequency. The capacitance of the cell membrane is also inversely proportional to frequency, which plays a major role in allowing efficient signal transfer.

[0046] Due to effects of increasing inductance and decreasing capacitance of the cell membrane, as well as decreasing resistance in the axoplasm, one might conclude that signal propagation will only improve with higher frequencies. However, physiologicalcomponents render this infeasible. For example, the skin acts as a high-pass filter due to its dielectric properties, which operate to filter frequencies in the range of 50 - 500 kHz. Additionally, the bilipid membrane, extracellular fluid and axoplasm of the nerve itself act as a low-pass filter, preventing high-frequency signals from effectively penetrating. These physical structures effectively provide a band-pass filter which will attenuate the efficacy of transcutaneous signals much lower or significantly higher than 100 kHz . Critically, the optimal value for the decrease of axonal resistance due to microtubular effects has been measured in the range of 100 kHz, however, in embodiments, the frequency may be varied since different frequencies may have a different effect on the nerve. In embodiments, a range of frequencies from 50 KHz to 500 KHz is best suited to not only overcome the filtering effects of extracellular structures, but also take advantage of the frequencydependent properties of the nerve itself which may vary.

[0047] In view of the above, the present disclosure relates to a method and system of treating neuropathic nerves using electromagnetic signals to modify, disable or reset neurons.

[0048] In embodiments, the system and method of the present disclosure will provide a square wave at a relatively low frequency of about 1Hz - 10kHz that may be used for nerve location. In embodiments, 2 Hz may be used as this frequency creates response that are easy to observe. In embodiments, the low frequency electromagnetic wave triggers a response in the nerve, or a muscle associated with the nerve that maybe used to confirm that the correct nerve is being targeted. Thereafter, a second, high frequency signal may be generated and applied to the nerve to stimulate change in the neurons. In embodiments, the high frequency signal may be a series of pulses that are provided in the 50KHz to 500 KHz range. In embodiments, the high frequency pulses may vary in amplitude i.e. either on the front or decaying side or both such that the pulses cover a wide range of amplitudes, typically 0 to 100 milliamps. In embodiments, physiological differences between patients may result in variations in where to apply the electromagnetic signals, which may be applied either transcutaneous or percutaneous, as well as the most effective amplitude to stimulate mitochondria of the neuron to trigger change. In embodiments, feedback information, such as EEG information may provide confirmation that the treatment is effective at reducing pain, for example. Such pain reduction feedback information may beused to confirm that stimulation is being targeted properly. In embodiments, feedback information such as EMG and AMG information may provide confirmation that a desired nerve is being stimulated. In embodiments, the physiological differences may develop over a period of time such that feedback information may not immediately reflect such changes. In embodiments, such feedback information may be recorded in order to identify changes that occur over longer periods of time and to provide information regarding effective frequencies and amplitudes.

[0049] In embodiments, the high frequency electromagnetic pulses may vary in frequency to address physiological differences between patients which result in different propagation pathways in the user’s cells. In embodiments, a series of high frequency pulses may be provided with each series provided at a different frequency within the high frequency range of 50kHz to 500 kHz. In embodiments, as noted above, high frequency signals in the 100 kHz range may be most effective.

[0050] In embodiments, gene expression changes may be triggered within specific current windows which may be relatively low, for example, 50 nanoamps. In embodiments, the current window may be smaller, for example, in the picoamp range. In embodiments, the current windows may vary in amplitude based on the types of cell. Further, physiological differences between patients may result in different changes. For example, in some experiments, red blood cells may be dedifferentiated into normoblasts or stem cells, depending on specific current windows applied to the cells. Different current windows may be applied to different types of cells and may trigger different types of gene expression triggers at different frequencies in the high frequency range. In embodiments, different frequencies or amplitudes may be used to target difference cells or cells in different patients. In embodiments, as noted above, feedback information may be received and saved and analysed to determine preferred frequencies and amplitudes to stimulate neural change and growth.

[0051] In embodiments, the system and method may generate a low frequency (between 1Hz - 10kHz) square wave S (see FIG. 1) that may be used for nerve location or targeting. Subsequently, a series of high frequency pulses Pl, P2, P3, for example, in the high frequency range of 50 kHz to 500 kHz may be provided. As noted above, multiple seriesof pulses may be provided at different frequencies and amplitudes following application of the square wave S. The separate square wave S may be applied for nerve location and subsequent high frequency, including radio frequency pulses, which may be provided as a battery of high frequency pulses that are followed by a second square wave which may be used to confirm nerve location. That is, in embodiments, in FIG. 1, for example, another square S wave may follow the pulse P3. In embodiments, the second square wave S may have the same frequency and amplitude as the first square wave S. In embodiments, the frequency and amplitude may be modified compared to the first square wave S. In embodiments, the second square wave may be used to confirm positioning of the probe 10.

[0052] In embodiments, one or more feedback electrodes 14 may be positioned on the user’s skin to receive feedback from the square wave S used for nerve location. In embodiments, the feedback electrodes 14 may be or include EEG electrodes or EMG / AMG electrodes providing closed loop feedback indicating a relative location of the nerve relative to the source of the square wave S. In embodiments, multiple feedback electrodes 14 may be provided. As noted above, the square wave S may be applied via a transcutaneous probe 10 (see FIG. 2). In embodiments, the transcutaneous probe 10 may be similar to that disclosed in U.S. Patent No. 8,275,461, the entire content of which is incorporated by reference herein. In embodiments, the square wave S may be provided via a percutaneous needle or probe 10, which may be similar to that disclosed in co-pending U.S. Patent Application Serial No. 18 / 386,731 filed November 3, 2023 entitled ELECTRONIC REGIONAL ANESTHESIA AND PAIN MANAGEMENT SYSTEM AND METHOD, the entire content of which is incorporated by reference herein. In embodiments, the transcutaneous probe, or percutaneous needle 10 may be electrically connected to a stimulator device 12, similar to that described in U.S. Patent No. U.S. Patent No. 8,275,461.

[0053] In embodiments, the percutaneous needle 10 may include one or more conducting portions positioned at a distal end thereof to allow for providing a variable and shaped electric field which may be used to better target a nerve. Such a needle is described in copending U.S. Patent Application Serial No. 18 / 386,731.

[0054] In embodiments, as noted above, system 100 (see FIG. 2) may use one or more feedback electrodes 14 to detect a response from the targeted nerve and / or muscles associated therewith in the user’s body in order to determine a position of the probe or needle 10 relative to the nerve. In embodiments, the probe or needle 10 may be used to apply the low frequency square wave S followed by the high frequency pulses discussed above. As noted above, the feedback electrodes 14 may use electromyography (EMG) and / or acceleromyograph (AMG) to provide feedback information associated with the muscle associated with the target nerve. In embodiments, the transcutaneous probe, or percutaneous needle 10 may be electrically connected to the stimulator device 12. Alternately the feedback electrode 14 may be an EEG electrode and provide information regarding pain associates the target nerve.

[0055] FIG. 1 illustrates an exemplary square wave S that precedes a series of high frequency pulses Pl, P2, P3 that may be generated by the stimulator device 12, for example. As can be seen in FIG. 1, in embodiments, the square wave S may have a duration of between 0.1 and 0.3 ms. In embodiments, the square wave may induce a current between 0 and 30 mA. In embodiments, a first high frequency pulse Pl may be exponentially decaying sinusoidal waveform and may have a period of 0.1 to 1 ms. In embodiments, the pulse Pl may be any amplitude varying waveform. In embodiments, a second pulse P2 may be an increasing sinusoidal waveform. In embodiments, the high frequency pulse P3 may include both an increasing sinusoidal waveform and varying sinusoidal waveform. As noted above, the varying amplitude of the pulses is preferable to account for differences in physiology between patients. In embodiments, the frequency of the pulses Pl, P2, P3 may also vary. In embodiments, as noted above, frequency may be varied to account for different biological characteristics of patients.

[0056] In embodiments, in operation, the system 100 may include the stimulator 12 configured to provide the square wave S followed by the high frequency pulse or pulses Pl, P2, P3. As noted above, the square wave S and the high frequency pulses Pl, P2, P3 may be provided to a nerve via a transcutaneous probe 10, or percutaneous needle 10, which may be operatively connected to the stimulator 12. In embodiments, a controller 22 may be provided to send control signals to the stimulator 12 to generate the square wave S and the pulses Pa, P2, P3 at desired frequencies and amplitudes. In embodiments, thestimulator 12 generates the square wave S first to stimulate a target nerve to be treated. In embodiments, the controller 22 may provide control signals to the stimulator 12 to provide any of the pulses Pl, P2, P3. In embodiments, the pulses Pl, P2, P3 may be provided in sequence. In embodiments, the pulses Pl, P2 or P3 may be repeated. In embodiments, the pulses Pl, P2 and P3 may be provided in any sequence. In embodiments, the additional or fewer pulse may be generated. In embodiments, the pulses Pl, P2, P3 may have different frequencies within the high frequency range of 50KHz to 500KHz. In embodiments, the pulses Pl, P2, P3 may have different amplitudes. In embodiments, a second square wave signal may be generated following the pulses to better locate the target nerve. In embodiments, the square wave may be repeated to allow for continuous monitoring of the nerve, that is to ensure that the target nerve is being treated throughout the process. In embodiments, the square wave may be repeated at a frequency of between 1 and 10 Hz.

[0057] In embodiments, the feedback electrodes 14 may be positioned on the user’s skin and may be used to provided stimulation information based on a reaction of the target nerve, and / or a reaction of a muscle associated with the target nerve. In embodiments, the feedback sensors 14 (EMG / AMG) may provide feedback information indicating the intensity of muscle activation to the controller 22 due to the evoked potential triggered by the stimulator 12 and probe 10 applying the square wave S, for example.

[0058] In embodiments, the feedback information indicative of stimulation may be used to establish a position of the probe or needle relative to the target nerve. In embodiments, the amplitude or frequency of the pulses Pl, P2, P3 may be varied depending on the position of the probe or needle 10. In embodiments, the probe or needle 10 may be repositioned based on the feedback information. In embodiments, the feedback information may be provided to the controller 22 and the controller may provide appropriate control signals to the stimulator 12 to vary frequency and / or amplitude of the low frequency electromagnetic wave (square wave S) or the high frequency electromagnetic wave (pulses Pl, P2, P3). In embodiments, the control signals may be preset and may not be based on feedback information. In embodiments, the controller 22 may include one or more input elements configured to allow a user to provide control information that may be used to provide the control signals. In embodiments, the controlinformation may be stored on a memory in the controller and may be changed or deleted based on user input. In embodiments, the control information may be provided to the controller 22 via a wired or wireless connection to a computing device which may be a computer, laptop computer, server, smartphone, or other mobile electronic device, to name a few. In embodiments the control information may include or be based on prior feedback information such that the control signals may be provided based on the feedback information . In embodiment, the stimulator 12 and controller 22 may be integrated into each other.

[0059] In embodiments, feedback electrodes 14 may use a combination of AMG and EMG, which is useful as they measure different signals and compensate for their respective shortcomings. For example, AMG is prone to movement artifacts and struggles to pick up very small myographic signals, while EMG is subject to artifacts relating to electrostatic discharge as well as electromagnetic interference but immune to movement artifacts and is able to pick up very small myographic signals.

[0060] In embodiments, the feedback electrodes 14 may provide EEG information and changes in the nociceptive pain index (NOC) from a baseline bNOC may be quantified or otherwise processed by the controller 22 and incremental adjustments to the square wave S and / or the pulses Pl, P2, P3 may be made.

[0061] In embodiments, the stimulator 12 may be disconnected from the probe 10 and switched out for another unit in the case of a malfunction and / or when the battery is depleted.

[0062] In embodiments, the stimulator 12 may be used to stimulate the target nerve to re-train the neural connection and / or the neural structure to repair damage. In embodiments, control of the stimulator 12 may be automated and controlled by the controller 22.

[0063] In embodiments, a method of applying an electromagnetic wave to a nerve in a user’s body may begin at step S300 (See FIG. 3) with generating a low frequency electromagnetic wave. In embodiments, this low frequency electromagnetic wave may be the square wave S discussed above. In step S302 the low frequency electromagnetic waveis provided to a probe, such as probe 10 or needle 10 discussed above, which contacts the user’s body. At step S304, the low frequency electromagnetic wave may be applied to the user’s body via the probe. In embodiments, steps S302 and S304 may be combined. At step S306, a high frequency electromagnetic wave is generated. The high frequency electromagnetic wave may be the high frequency pulses Pl, P2, P3 discussed above. At step S308, the high frequency electromagnetic wave may be provided to the probe. At step S400, the high frequency electromagnetic wave may be applied to the user’s body using the probe, which may be the probe 10 or needle 10 discussed above. In embodiments, steps S308 and S400 may be combined. In embodiments, at step S402, feedback information associated with the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency electromagnetic waver may be provided using feedback electrode 14, for example, connected to the user’s body. In embodiments, feedback information may be received both after step S304 and after step S308. In embodiments, at step S404, control signals may be provided, by the controller 22, for example, to the stimulator 12, for example, regarding generation of the low frequency and high frequency electromagnetic waves based on the feedback information.

[0064] As noted above, the frequency and / or amplitude of the low frequency electromagnetic waveform and the high frequency electromagnetic waveform may be changed using control signals provided by the controller 22, for example, based on the feedback information. Since different types of neurons and neurons in different people’s bodies may react to different frequencies and amplitudes, use of the feedback information to change frequency and amplitude may be advantageous.

[0065] Although the present invention is described and shown in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. Thus, various embodiments and variations are shown and described herein, and it is preferred, therefore, that the present invention be limited not by the specific disclosure herein.

Claims

WHAT IS CLAIMED IS:

1. A system for applying electromagnetic radiation comprises: a stimulator device configured to generate electromagnetic waves of a desired wavelength and frequency; a probe operable connected to the stimulator device and configured to direct the electromagnetic waves to a user’s body; a feedback electrode in contact with the user’s body, the feedback electrode operable to provide feedback information associated with a user’s body’s response to the electromagnetic radiation; and a controller operably connected to the feedback electrode and receiving feedback information and operably connected to the stimulator device to provide control signals to the stimulator device wherein the electromagnetic radiation is generated based on the control signals, wherein the stimulator device and probe provide a low frequency electromagnetic wave to a portion of a user’s body to stimulate at least one nerve, and following the low frequency electromagnetic wave, provide a high frequency electromagnetic wave to stimulate neural growth.

2. The system of claim 1, wherein the low frequency electromagnetic wave is a square wave.

3. The system of claim 2, wherein the low frequency electromagnetic wave has a frequency in a range of 1Hz to 10kHz.

4. The system of claim 2, where the square wave has a duration of between 0.1 and 0.3 ms.

5. The system of claim 1, wherein the high frequency electromagnetic wave includes a series of pulses.

6. The system of claim 5, wherein the series of pulses includes a series of amplitude varying pulses.

7. The system of claim 5, wherein the series of pulses comprise an exponentially decaying sinusoidal waveform.

8. The system of claim 1, wherein the high frequency electromagnetic wave has a frequency in a range of 50 kHz to 500 kHz.

9. The system of claim 1, wherein the probe includes at least one electrode providing transcutaneous transmission of the low frequency electromagnetic wave and the high frequency electromagnetic wave.

10. The system of claim 1, wherein the probe is a transcutaneous needles configured to pass through the user’s skin to provide percutaneous transmission of the low frequency electromagnetic wave and the high frequency electromagnetic wave.

11. The system of claim 1, where a frequency of the low frequency electromagnetic wave is varied based on the feedback information to target a desired nerve.

12. The system of claim 1, where a frequency of the high frequency electromagnetic wave is varied based on the feedback information to improve nerve repair.

13. The system of claim 1, wherein the feedback electrode is positioned on the user’s body and operable to provide the feedback information indicative of the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave to the controller.

14. The system of claim 1, wherein the feedback electrode comprises an EEG electrode operable to provide EEG information indicative of the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave.

15. The system of claim 1, wherein the feedback electrode comprises and EMG electrode or an AMG electrode operable to provide EEG information indicative ofthe user’s body’s reaction to the low frequency electromagnetic wave and the high frequency magnetic wave.

16. A method of applying electromagnetic waves to a nerve in a user’s body comprising: generating a low frequency electromagnetic wave; providing the low frequency electromagnetic wave to a probe; providing the low frequency electromagnetic wave to the user’s body via the probe; generating a high frequency electromagnetic wave; providing the high frequency electromagnetic wave to the probe; providing the high frequency electromagnetic wave to the user’s body via the probe; providing feedback information associated with the user’s body’s reaction to the low frequency electromagnetic wave and the high frequency electromagnetic waver; and providing control signals based on at least the feedback information to control generating the low frequency electromagnetic wave and the high frequency electromagnetic wave.

17. The method of claim 16, wherein the low frequency electromagnetic wave has a frequency in a range of 1Hz to 10kHz.

18. The method of claim 16, wherein the high frequency electromagnetic wave has a frequency in a range of 50 kHz to 500 kHz.

19. The method of claim 16, further comprising generating the control signals prior to providing the control signals to control generation of the low frequency electromagnetic wave and the high frequency electromagnetic wave.

20. The method of claim 19, wherein a respective low frequency of the low frequency electromagnetic wave and a respective high frequency of the high frequency electromagnetic wave is varied based on the feedback information.