Systems and methods for treatment of neuropathy

Abstract

Systems and methods for treatment of neuropathy are provided. In some examples, a method of prophylactic treatment for a disease state in a patient treatment is provided. The treatment can include (a) positioning an electromagnetic field generator adjacent to a cranial nerve; (b) directing an electromagnetic field from the electromagnetic field generator toward the cranial nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan. In some examples, a method of prophylactic treatment for a disease state in a patient treatment is provided. The treatment can include (a) positioning an electromagnetic field generator adjacent to a spinal nerve; (b) directing an electromagnetic field from the electromagnetic field generator toward the spinal nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

Description

SYSTEMS AND METHODS FOR TREATMENT OF NEUROPATHYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of U. S. Provisional Application No. 63 / 649,118, filed May 17, 2024, the contents of which are hereby incorporated in its entirety.FIELD OF USE

[0002] This disclosure is in the field of methods and devices that use an intense magnetic pulse to treat symptoms of a neurological disorder (e.g., pain, weakness, numbness, and / or tingling in one or more body parts) in one or more of cranial nerves and spinal nerves.RELATED DISCLOSURES

[0003] The following disclosures are incorporated herein by reference in their entirety: U.S. App. No. 10 / 327163, entitled “Means and methods for treating headaches,” filed on December 21, 2002 (issued as U.S. Patent No. 7,294,101); U.S. App. No. 11 / 305276, entitled “Magnetic pulsing system for inducing electric currents in a human body,” filed on December 19, 2005 (issued as U.S. Patent No. 8,262,556); U.S. App. No. 12 / 718163, entitled “Method and apparatus to record and analyze TMS treatments and results,” filed on May 5, 2010 (issued as U.S. Patent No. 9,492,680); U.S. App. No. 14 / 148932, entitled “Transcranial magnetic stimulation device for the treatment of migraine headaches,” filed January 7, 2014 (issued as U.S. Patent No. 9,561,384); U.S. App. No. 14 / 275927, entitled “Transcranial magnetic stimulation device for the treatment of migraine headaches,” filed May 13, 2014 (issued as U.S. Patent No. 9,526,912); U.S. App. No. 14 / 315994, entitled “Transcranial magnetic stimulation device with body proximity sensors for the treatment of migraine headaches,” filed June 26, 2014 (issued as U.S. Patent No. 9,968,798); and U.S. App. No. 15 / 347290, entitled “Transcranial magnetic stimulation device for the treatment of migraine headaches,” filed November 9, 2016 (issued as U.S. Patent No. 9,675,815).BACKGROUND OF THE INVENTION

[0004] One approach to the treatment of neuropathy is for the patient to take medication, either orally or through injection. Although medications can be at least partially effective in some instances, patients may still suffer neurological disorders when taking medication, such that the medication may be only partially effective. Also, at least some medications can potentially result in side effects for the patient and may lose effectiveness over time, such that migraine treatment with medication can be less than ideal in at least some instances.

[0005] Another approach may be to employ Transcranial Magnetic Stimulation (TMS), in which a device delivers a magnetic pulse that induces an electric current in the cortex of the human brain. This in turn may produce certain effects on the activity of brain neurons, such as perception of pain.

[0006] Although such systems can be effective in treating neurological disorders, this “top down” approach of helping the brain ignore pain signals may not be ideal to treat symptoms of neuropathy of nerves such as the cranial nerves and spinal nerves. Therefore, a need exists for improved methods of treatment for cranial nerve and / or spinal nerve neuropathy, such as using magnetic stimulation directly on the affected nerves.SUMMARY OF INVENTION

[0007] Systems and methods for treatment of neuropathy are provided. In some examples, a method of prophylactic treatment for a disease state in a patient treatment is provided. The treatment can include (a) positioning an electromagnetic field generator adjacent to a cranial nerve; (b) directing an electromagnetic field from the electromagnetic field generator toward the cranial nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

[0008] In some examples, the treatment plan is written into a patient specific module coupled to a processor that controls the electromagnetic field generator. In some examples, the patient specific module comprises a subscriber identity module (SIM). In some examples, the treatment consists of one treatment per day. In some examples, the treatment plan comprises a number of pulses to be delivered with each treatment. In some examples, the treatment plancomprises two pulses per treatment, and the treatment plan may comprise more than one treatment.

[0009] In some examples, the cranial nerve is a nerve selected from an olfactory nerve, an optic nerve, an oculomotor nerve, a trochlear nerve, a trigeminal nerve, an abducens nerve, a facial nerve, a vestibulocochlear nerve, a glossopharyngeal nerve, a vagus nerve, an accessory nerve, and a hypoglossal nerve. In some examples, the disease state may be any one or more of tinnitus, visual snow, a neurological disease, migraine treatment, migraine prevention, depression, bipolar disorder, anxiety, obsessive-compulsive disorder, attention deficit hyperactivity disorder, fibromyalgia, chronic pain, post-traumatic stress disorder, traumatic brain injury, addiction, smoking cessation, Parkinson’s disease, insomnia, phantom limb pain, complex regional pain syndrome (CRPS), trigeminal neuralgia, occipital neuralgia, temporomandibular joint disorder (TMJ), cervicogenic headache, whiplash disorder, bladder dysfunction (e.g., overactive bladder) and / or irritable bowel syndrome.

[0010] In some examples, a method of prophylactic treatment for a disease state in a patient treatment is provided. The treatment can include (a) positioning an electromagnetic field generator adjacent to a spinal nerve; (b) directing an electromagnetic field from the electromagnetic field generator toward the spinal nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

[0011] In some examples, the treatment plan is written into a patient specific module coupled to a processor that controls the electromagnetic field generator. In some examples, the patient specific module comprises a subscriber identity module (SIM). In some examples, the treatment includes one treatment per day. Alternatively, in some examples, the treatment includes two or more treatments per day. For example, the treatment may include two, three, four, five, six, seven, eight, nine, or ten or more treatments per day.

[0012] In some examples, the treatment plan comprises a number of pulses to be delivered with each treatment. In some examples, the treatment plan comprises two pulses per treatment. In some embodiments, the treatment plan includes a plurality of pulses. For example, the plurality of pulses is two, three, four, five, six, seven, eight, nine, or ten or more pulses per treatment.

[0013] In some examples, the spinal nerve is a nerve selected from nerves in cervical region, a thoracic region, a lumbar region, a sacral region, and a coccygeal region. In someexamples, the disease state may be any one or more of migraine, cluster headache, tension headache, tinnitus, intervertebral disc disease, fibromyalgia, allodynia, hyperalgesia, paresthesia, neuropathic pain, sciatica, peripheral neuropathy, genicular pain, epicondyle pain, postherpetic neuralgia, phantom limb pain, complex regional pain syndrome, occipital neuralgia, insomnia, depression, cervicogenic headache, whiplash-associated disorder, bladder dysfunction (e.g., overactive bladder) and / or irritable bowel syndrome.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a top view of a first example handheld treatment device that may be used in the methods of treatment described herein, according to an example of the present disclosure.

[0015] FIG. 2 is a cross section of the first example handheld treatment device at section “AA” of FIG. 1, according to an example of the present disclosure.

[0016] FIG. 3 is a front side view of the first example handheld treatment device, according to an example of the present disclosure.

[0017] FIG. 3A is a front side view of the first example handheld treatment device, according to an example of the present disclosure.

[0018] FIG. 4 is a partial back side view of the first example handheld treatment device, according to an example of the present disclosure.

[0019] FIG. 5 shows the user interface of a second example handheld treatment device, according to an example of the present disclosure.

[0020] FIG. 6A shows a schematic illustration of the components of the second example handheld treatment device, according to an example of the present disclosure.

[0021] FIG. 6B shows a computer program embodied on a tangible medium comprising instructions to permit and control treatment with one or more of the first example handled treatment device and the second handheld treatment device, according to an example of the present disclosure.

[0022] FIG. 7 shows a brain of a patient including the cranial nerves.

[0023] FIG. 8 shows a body of a patient including the spinal nerves.DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure encompasses a variety of embodiments, each tailored to enhance the treatment and management of neuropathy through the use of magnetic pulse therapy. These embodiments are unified by their innovative approach to delivering non-invasive, patientcentric care, leveraging advanced technology to provide personalized treatment options. Collectively, these embodiments represent a multifaceted solution aimed at improving the efficacy, accessibility, and user experience of magnetic pulse therapy for individuals suffering from neuropathy.

[0025] Referring now to FIG. 1, a first example handheld treatment device 10 that may be used in the methods of treatment described herein is shown. FIG. l is a top view of the handheld treatment device 10. The handheld treatment device 10 may have a left cylindrical portion 1 IL and a right cylindrical portion 11R around which portions the patient may hold the handheld treatment device 10. FIG. 2 is a cross section of the handheld treatment device 10 at section “AA” of FIG. 1. As seen in FIG. 2, within the left cylindrical portion 1 IL is the left capacitor 3 IL and within the right cylindrical portion 11R is the right capacitor 31R. The top view of the handheld treatment device 10 also shows the left fingers groove 13L, the right fingers groove 13R, the left thumb hole 12L and the right thumb hole 12R all of which may be shaped to provide a comfortable and secure means for the patient to hold the handheld treatment device 10 when she places it on her head for the treatment of a neurological disorder. The present disclosure includes the concept that there may be no thumb holes 12L and 12R so as to provide additional volume interior to the handheld treatment device 10 for the electronic components. In that case, the patient may place her thumb to the side of her fingers or around the body of the handheld treatment device 10.

[0026] FIG. 1 also shows an ON-OFF switch 15 in an ON-OFF switch recess 16. The ONOFF switch 15 is used to turn the handheld treatment device 10 on or off. When the ON-OFF switch 15 is pushed downward on its right side, it is in the ON position. When that occurs, an LED light 17 turns on to indicate that the handheld treatment device 10 has been turned on. It may be typical for the LED light 17 to have an amber or green color to indicate that the device is ready to charge its capacitors 3 IL and 31R. The ON-OFF switch 15 may be pushed down on its left side to turn the handheld treatment device 10 off. The ON-OFF switch recess 16 is provided to decrease the possibility that the ON-OFF switch 15 may be inadvertently turned to its ONstate. The recess placement of the ON-OFF switch 15 also disallows it being turned off when the ON state is desired.

[0027] As seen in FIG. 1, the top surface of the handheld treatment device 10 may also have a capacitor charge switch 23 to cause the battery (not shown) to begin the charging of the capacitors 3 IL and 31R. The capacitor charge switch 23 may be within the charge switch recess 24 so that it is under the top surface of handheld treatment device 10 to prevent the accidental pushing of the capacitor charge switch 23. By having both switches 15 and 23 on the top surface of the handheld treatment device 10 placed respectively within the recesses 16 and 24, accidental actuation of either of the switches 15 or 23 may be prevented. This may prevent the handheld treatment device 10 from being inadvertently turned on.

[0028] When the capacitor charge switch 23 is pushed down to charge the capacitors 3 IL and 31R, a series of LED lights called the capacitor charging lights 20 may illuminate in sequence to indicate that the capacitors 3 IL and 31R are being charged. The optimum color for the capacitor charging lights 20 is probably amber which indicates that the patient may get ready for the (preferably) green LED capacitors charged light 21 to turn on which indicates that the capacitors 3 IL and 31 have been fully charged and are ready to be discharged into the spherical cap coil 22. The circular outline of the spherical cap coil 22 is shown by dotted lines in FIG. 1. The sequence of lighting the LED lights 20 may be on a timed basis or they may be triggered by the capacitors 3 IL and 31R reaching a specific and increasing voltage. An example of the time dependence of the lighting of the capacitor charging lights 20 may be if it may take 40 seconds to charge the capacitors 3 IL and 31R and if there were exactly ten capacitor charging lights 20, then each additional amber LED light 20 may come on at 4 second intervals until all ten of the capacitor charging lights 20 were turned on. When the last amber LED light 20 illuminates, (that LED light 20 next to the green LED light 21) then simultaneously the green capacitors charged light 21 may come on, or the capacitors charged light 21 may come on 4 seconds after the last amber LED light 20 comes on. In either case, when the green LED light 21 illuminates, that indicates that the capacitors 3 IL and 31R have been fully charged. It should be understood that each of the LED lights indicating that the capacitors 3 IL and 31R are being charged may be first flashing and then go on steady and then the next LED light may flash until it becomes steady. As few as one such LED to first flash then go on is conceived of as part of the present disclosure oras many as 10 LED lights to first flash then stay steady on is also conceived of for this disclosure.

[0029] Once the capacitors 3 IL and 31R are fully charged, they are ready to be discharged into the spherical cap coil 22 to create an intense magnetic pulse. As an additional indication to the patient that the capacitors 3 IL and 31R have been fully charged, a sound generator (not shown) within the handheld treatment device 10 may create a sound that may last from as short as 0.001 second to as long as 2 seconds as an additional indication to the patient that the capacitors 3 IL and 31R have been fully charged. An optimum sound may last approximately l±0.5 second and may have a pleasant single tone or it may be a musical type of sound.

[0030] In one embodiment, once fully charged the handheld treatment device may begin a countdown such as is seen on self-timers on cameras where the green LED 21 may flash slowly at first, then faster, then go solid on, then the pulse may be delivered. A soft tone or a clicking sound may by itself, or with the LED, utilize the same pattern of speeding up, then going steady just before the pulse is delivered. In this way, once the pattern begins, the patient may place the handheld treatment device in the appropriate location for treatment and wait until the pattern stops, the green LED 21 stays continuously on and the pulse is delivered.

[0031] FIGS. 1, 2, and 4 indicate the novel means that the handheld treatment device 10 may utilize for the patient to hold for the treatment of neuropathy. It should be understood that the handheld treatment device 10 may be used to apply a magnetic pulse to any part of the human body where the application of that magnetic pulse may be effective in the treatment of some medical problem.

[0032] FIG. 2 is a cross section of the handheld treatment device 10 at section “A-A” of FIG. 1 showing the left cylindrical portion 1 IL, the right cylindrical portion 11R, the left capacitor 3 IL, the right capacitor 31R, the left thumb hole 12L, the right thumb hole 12R, and an electronics and battery section 32. FIG. 4 is a partial side view shown from the back of the handheld treatment device 10. From these three figures (FIGS. 1, 2, and 4) it will be apparent to a person of ordinary skill in this art that this is a novel and efficient means for the patient to securely and comfortably hold the handheld treatment device. It should also be understood that the handheld treatment device 10 may be conveniently held without the need for thumb holes 12L and 12R.

[0033] From FIGS. 1 and 4 it is clear to see that as many as four of the patient's fingers (other than her thumb) of her left hand may be placed in the left fingers groove 13L and the right-hand fingers may be simultaneously placed in the right fingers groove 13R. At that same time, FIGS. 1 and 2 show that the patient's left thumb may be placed through the left thumbhole 12L, and her right thumb may be placed through the right thumbhole 12R. This novel and useful means for holding the handheld treatment device 10 allows the patient to place the handheld treatment device 10 securely onto her body wherever treatment with a strong magnetic pulse may ameliorate some health problem.

[0034] A switch may be used to trigger the discharge of the capacitors 3 IL and 31R into the spherical cap coil 22 to create an intense, short time duration, magnetic pulse. This handheld treatment device 10 may be designed to have the patient place the device on her body for the treatment of a neurological disorder at some reasonable time (greater than 2 seconds) after the capacitors charged light 21 is turned. A time period of about 7±1 seconds after the LED green light 21 comes on may be an optimum time period for the patient to comfortably place the handheld treatment device 10 onto her body. At that time, the electric current in the spherical cap coil 22 may produce the desired intense magnetic pulse. The maximum pulse intensity at the center of the spherical cap coil 22 may be greater than 0.2 Tesla and optimally the maximum pulse intensity may be 1.0±0.5 Tesla. The pulse rise time may be between approximately 100 and 300 milliseconds with an optimum time being 190±10 milliseconds.

[0035] Although it is understood that a 7 second time delay may be optimum, it should be understood that any time period between approximately 1 second and 60 seconds may be used as a time interval from the time that the LED light 21 goes on until the magnetic pulse is actuated to treat the patient. Any time period that is less than approximately 1 second may be too short a time interval for the patient to feel comfortable in getting the handheld treatment device 10 properly placed onto her body.

[0036] A design feature of the present disclosure is that a sound may be created by the handheld treatment device 10 at the same time that the magnetic pulse is delivered. This sound may last for a time period between 0.001 second and 2 seconds with an optimum time being approximately l±0.5 seconds. The importance of this sound is that it indicates to the patient that a magnetic pulse that is within the specified intensity limits for the handheld treatment device 10 has been delivered. In some examples, the sound may be at least one of an alert that indicates thecapacitors are charged and the device is ready to use and a sound that indicates that a discharge is occurring (e.g., a sonic pop). If either the amplitude or the pulse rise time of the magnetic pulse delivered by the spherical cap coil 22 is not within its specified limits, then no sound may be created and the patient may know to contact the manufacturer to obtain a new handheld treatment device 10. The detection of pulse amplitude and pulse rise time may be made by a small coil placed at or near the center of the spherical cap coil 22.

[0037] An additional feature of the present disclosure is to “pot” the coil 22 by encapsulating it in at least one of plastic, resin, or epoxy. This may reduce the noise produced by wire movement in the coil when it is energized to deliver a pulse. Potting the coil also prevents unwanted motion of the wires of the coil 22, resulting in improved longevity for the coil and other internal electrical components.

[0038] After the magnetic pulse is actuated, the device may remain in the ON condition but the LED lights 20 and 21 may go to an off condition. The patient can get another pulse by once again pressing the capacitor charge switch 24, the LED lights 20 may then illuminate sequentially approaching the green LED light 21. When the light 21 is illuminated, the timing circuit may start the time period to cause the magnetic pulse to occur. When the patient takes the last of a sequence of magnetic pulses, she may press down on the left side of the ON-OFF switch 15 to turn off all the circuits of the handheld treatment device 10. Alternatively, the device may turn off after a preset period of time.

[0039] FIG. 3 is a front surface view of the handheld treatment device 10, and FIG. 4 is a partial view of the back surface of the handheld treatment device 10. FIG. 3 shows a battery recharging light 18 that may indicate to the patient when the battery in the handheld treatment device 10 may need to be recharged. It may be typical for the battery in the handheld treatment device 10 to have a sufficient capacity to provide about twenty magnetic pulses. An optimum LED light 18 may be a light that flashes on and off at about a 0.5 second period when there is enough capacity left in the battery to provide between 5 and 8 magnetic pulses. The battery needs recharging LED light 18 may remain steadily on when there may be between 1 and 4 pulses remaining before the battery is completely discharged. That LED light 18 may remain on if there was no capacity left in the battery and the ON-OFF switch 15 was in the ON condition. It is also understood that the LED light 18 may emit a red colored light or any other colored light that may signify the need for the battery to be recharged. Recharging of the battery within thehandheld treatment device 10 may be accomplished by means of a separate recharging device (not shown) that includes an AC-to- DC convertor and wire with plug (not shown) as is typically used to recharge any portable device such as a cell phone or a tablet. Such a recharging device may have a plug that may fit into the battery recharge receptacle 19 that is shown in FIG. 3. It is also envisioned that a multi-segment LED battery indicator may be used instead to show the battery state as is done on digital cameras and cell phones.

[0040] In some examples, the handheld treatment device 10 may be modified or replaced to have one or more controls as shown in FIG. 3 A. This may simplify the handheld treatment device 10 by putting all the display and buttons together on a single surface and orienting them in such a way as to minimize the potentially damaging effects of the magnetic pulse.Specifically, the handheld device 120 may be a single power button 121 that may initiate a power on and charge cycle and after a pulse is delivered and may stay active for a specified period to allow initiation of a next pulse. If not activated, the handheld treatment device 120 may turn off completely to save battery. The handheld treatment device 120 may also include a battery charge indicator 123, a racetrack of LEDs 122 that light sequentially as the capacitors charge, and two pulse activation buttons 125L and 125R either or both of which may deliver the pulse and are designed to be pressed with the patient's fingers or thumbs as they hold the device against their body. In some examples, the handheld treatment device 120 may be operated based on prescriptions. A light or LED 128 with the Rx symbol is also on the front to ensure that the patient knows they have pulses remaining on their prescription. When the prescribed number of pulses have been depleted below a predetermined threshold, or when the prescription is within a pre-set period from expiration, the light 128 may flash or remain lit to notify the patient. The light 128 may be a red, green, or amber LED or it may be a single color that is solid on when pulses are available, off when not and flashes when near the limit.

[0041] A light or LED 128 with the RX symbol next to it is also on the front to ensure that the patient knows they have pulses left on their prescription. As the pulses near the limit, or when the prescription is within a pre-set period from expiration, the light 128 may flash to notify the patient. The light 128 may be a red / green LED or it may be a single color that is solid on when pulses are available, off when not and flashes when near the limit.

[0042] Other display icons that are on the front surface are the child lock display 127 that is activated by a hidden switch near the SIM card slot (not shown). A temperature icon 129 mayshow if conditions are too hot or too cold for use. An AC power indicator 124 may show when the device is charging and may flash during charging, turn solid when done. Finally, a call customer service icon 126 may provide a notification that the device has experienced an internal failure of hardware or software and may also prompt the patient to call when the prescription is running out or has run out.

[0043] FIG. 4 is a partial view of the back of the handheld treatment device 10. As described above, FIG. 4 shows the left finger groove 13L and part of the right finger groove 13R. It is into these grooves that the patient may place 3 to 4 fingers (but not the thumb) to securely hold the handheld treatment device 10 when it is placed onto the patient's body. In some examples, the handheld treatment device 10 can include an LED 31 to indicate that a prescription refill is needed. The LED 31 may flash with a time period of approximately 0.5 seconds when there are only approximately 17 to 30 pulses still available before the doctor must provide a refill prescription or only 14 to 8 days remaining until the end of the time period during which time the handheld treatment device 10 may remain operable. The LED 31 may remain steadily on when there are 16 or fewer pulses remaining before the handheld treatment device 10 becomes inoperable or there are only 7 or fewer days left until the handheld treatment device 10 becomes inoperable. With these warnings, the patient can be alerted that she must contact her doctor to receive a refill prescription.

[0044] The prescription refill port 33 is used by the patient to accommodate a refill of her prescription for magnetic pulses, which refill prescription may come from her physician or any other person legally authorized to write a prescription. Unlike other refill prescriptions written on a piece of paper that a patient may typically receive from a doctor to obtain an additional dose of pills, the refill prescription for the handheld treatment device 10 may be delivered electronically or by means of radio frequency (RF) communication or by means of a SIM card that is placed into the handheld treatment device 10 through the port 33. The SIM card can also be used to provide a unique serial number for each patient. In that case, each and every handheld treatment device 10 may be identified with its unique serial number being provided by the SIM card.

[0045] In some examples, a refill prescription for each patient may increase the number of pulses as prescribed by the patient's doctor and may also extend the time period during which the device may remain in a condition where it can be turned to its ON state and can be used to deliver a magnetic pulse. As an example, if a patient experiences four episodes of pain eachmonth and uses ten magnetic pulses to treat each episode, then she may use forty pulses per month and 240 pulses in a six-month period. For such a patient, a physician might prescribe 250 pulses over a six month period with the handheld treatment device 10 and thereafter remaining in an off condition, or preventing any further pulses from being emitted, if either the 251stpulse is requested, or the 6-month time period has elapsed. Before either of those events occurs, the LED light 33 may start flashing and later turn steadily on as a warning to the patient to promptly obtain a refill prescription from her doctor. It may be desirable for the LED light 31 to have a color that is different from the colors chosen for the LED lights 17, 20 and 21. It may be desirable for the LED lights 18 and 31 to have the same color, as each may indicate to the patient that some action must be taken.

[0046] The handheld treatment device 10 may be sealed and waterproof. The handheld treatment device 10 may be constructed of a sturdy material enabling the handheld treatment device 10 to maintain the waterproof seal even when dropped.

[0047] Referring now to FIG. 5, a second example handheld treatment device 500 that may be used in the methods of treatment described herein is shown. Similar to the handheld treatment device 10, the handheld treatment device 500 may generate a magnetic field to treat the patient. Instead of having multiple buttons, switches, and light indicators, the handheld treatment device 500 may include a patient interface 520. The patient interface 520 may include a display 522 and at least one button 524. The display 522 may be a touch screen display. The at least one button 524 may include a plurality of buttons. The display 522 is operable to show one or more of whether the handheld treatment device 500 is powered on or off, the current state of charge of a battery of the device 500, whether the battery needs to be recharged, the remaining number of magnetic pulses the device 500 is able to generate on the current state of charge, a current temperature of the device 500, an overheating warning, patient prescription information, prescription refill alert, current error or fault codes associated with the device 500, child lock status of the device 500, customer service contact information, and / or gauge of current capacitor charging state.

[0048] FIG. 5 shows the handheld treatment device 500 and the patient interface 520. The display 520 may include instructions for the patient, such as for example “Press the + button to begin treatment.” The display 520 may show menus for the patient to select a treatment or to enter patient data, for example data to measure a plurality of subjective patient sensations.Although the display 520 shown may include a curved surface with a centrally located display, many configurations of the handheld treatment device 10 can be used. For example, the surface with the display may be flat, and the other surfaces curved. Alternatively, or in combination, the treatment device may include a substantially rectangular geometry with many flat surfaces and comers with right angles.

[0049] FIG. 6A shows a schematic illustration of the components of one or more of the handheld treatment devices described herein.. Any one of the handheld treatment devices described herein 10 may include a processor 612, which may be one or more processors, for example a distributed processor system. The processor 612 may include a tangible medium such as a memory 612M. The memory may include volatile memory such as random access memory (“RAM”) and non-volatile memory such as flash RAM. The memory 612M of processor 612 may include a configuration file, or “config.” file, that may include parameters for the system to operate and deliver treatment to the patient, for example calibration and control voltage parameters. The processor 612 may be coupled to a plurality of additional components of the treatment device. The processor 612 may include at least one processor, for example a single processor with instructions for treatment, and may include an additional processor, for example a display processor coupled to a touch screen display to control the acquisition of data from the patient.

[0050] In one example, the processor 612 may be coupled to a patient specific module (hereinafter “PSM”), for example a known subscriber identity module (hereinafter “SIM”). The PSM may also include a known smart card with patient treatment information. For example, a SIM 524 may include a smart card configured to control at least some aspects of the patient treatment, for example the number of pulses available for the patient over a specific time period. The SIM 524 may include additional treatment parameters such as the maximum number of pulses per unit time that the patient can deliver. The SIM card 524 may also include instructions for a treatment plan, for example treatment commands. The processor 612 may be configured to reduce the number of treatments available for patient Pl that are stored on the SIM 614 in response to delivery of a treatment to the patient. The processor 612 may include instructions to treat the patient in response to parameters stored on the SIM 524, for example the number of treatments. The SIM 524 may include a card that is inserted into the treatment device. The SIM 524 may include a number keyed to the treatment device. For example, the handheld treatmentdevices described herein may include a serial number written to non-volatile memory and SIM 524 may be keyed to the serial number.

[0051] The treatment parameters written to the SIM 524 may include a treatment plan. The treatment plan may include a maximum number of treatments over a set period of time, for example no more than one treatment per hour. The treatment plan may also include a minimum number of treatments over the period of time, for example no less than one treatment per day. The treatment plan stored on the SIM 524 may also include instructions for prophylactic treatments, for example one treatment per day. In some examples, the treatment includes two or more treatments per day. For example, the treatment may include two, three, four, five, six, seven, eight, nine, or ten or more treatments per day. In some examples, the treatment plan comprises a number of pulses to be delivered with each treatment. In some examples, the treatment plan comprises two pulses per treatment. In some embodiments, the treatment plan includes a plurality of pulses. For example, the plurality of pulses is two, three, four, five, six, seven, eight, nine, or ten or more pulses per treatment. The handheld treatment devices described herein may be programmed to alert the patient for treatment. The treatment plan may also include a number of pulses to be delivered with each treatment, for example two pulses per treatment. One of ordinary skill in the art, for example a treating physician, may determine an optimal treatment plan for a patient based on empirical studies with an empirical number of patients, for example studies comprising meta data from about 100 patients treated by additional physicians.

[0052] The processor 612 may be coupled to the patient interface 520. The patient interface 520 may include many known interface components, for example known displays, touch screens, buttons and buzzers. An input device of interface 520 may include the touch screen 522. The input device may include many known input devices such as pointing devices, keyboards, and touch screens 522. The patient interface 522 may include a treat button 524 for the patient to initiate treatment. However, the treat button may provide additional input, for example for the patient to enter data. The patient interface 520 may include an alarm, for example a buzzer 626, configured to alert the patient. The buzzer 626 may alert the patient when it is time for the patient to enter additional information into a patient journal. The buzzer 626 may also alert the patient that it is time for a treatment with the magnetic field. In some examples, the buzzer 626 emits a chime or a tone to alert the patient that that it is time for atreatment. In some examples, the buzzer 626 plays a pre-recorded voice prompt to alert the patient that that it is time for a treatment.

[0053] The processor 612 may be coupled to circuitry 618 to treat the patient with the magnetic field. Circuitry 618 may include a coil 618C to generate the magnetic field to treat the patient. Circuitry 618 may include a control voltage 618A, a capacitor 618B, one coil 618C, a heat sensor 618D and a pickup sensor 618E. The coil 618C can be coupled to a capacitor 618B. The capacitor 618B can be charged and the stored charge can be released to treat the patient. Capacitor may include a plurality of capacitors to store sufficient charge. The control voltage 618A can be used to set the voltage of the capacitor and charge the capacitor to the set voltage, for example with a voltage controller. Pick up sensor 618E can measure the magnetic field, for example the peak magnetic field, when capacitor 618B discharges through coil 618C. The circuitry 618 may include switches coupled to processor 612 to control the circuitry 618, for example the charging and discharging of capacitor 618B. A heat sensor 618D can measure a current temperature or change in temperature of the capacitor 618D.

[0054] Processor 612 can be coupled to communication circuitry 616. The communication circuitry 616 may include a USB port on treatment device. The communication circuitry 616 may include wireless communication circuitry configured to communicate with a wireless communication protocol, for example a Bluetooth™ protocol or Wi-Fi or Cellular. The communication circuitry 616 can upload patient data to a remote server where the patient data can be stored for review by a physician. The communication circuitry 616 can also download treatment related parameters, for example parameters for the configuration file. The treatment related parameters of the configuration file may be stored on the SIM 614.

[0055] The patient specific module may include a processor, for example a processor of a smart card, such that the tangible medium of the smart card and the processor of the smart card include the at least one processor of the treatment device. The instructions for treatment can be embodied in tangible medium of the at least one processor, in which a computer program comprising instructions for patient treatment is embodied on the tangible medium. The tangible medium may be a remote tangible medium (e.g., a cloud storage space). Data may be uploaded to the remote tangible medium via the communication circuitry 616 over a network. The processor 612 may delete locally stored data once the data is uploaded to the cloud storage space.

[0056] FIG. 6B shows a computer program 612PG embodied on tangible medium 612M comprising instructions to permit and control treatment of the patient with the at least one processor of FIGS. 5 and 6A. Computer program 612PG may include an input routine 612MI, and output routine 612MO and a run routine 612MR. In some examples, input routine 612MR may include an input module operatively coupled to a source of data, for example at least one of the treatment and patient data of the smart card or the subjective input data of the patient interface. Run routine 612MR may include, for example, a security module, a treatment module, and a subjective data module to collect the subjective data from the patient. The security module may include instructions configured to process the patient specific identifier and the device identifier and encryption codes of the smart card. The treatment module may include instructions configured to determine the treatment parameters to the treatment circuitry in response the patient treatment parameters from the patient specific module and the configuration file. The subjective data module can be configured to ask questions of the patient as described above. Each of the security module, the treatment module and the subjective data module can be operatively coupled to the output module 612MO to output relevant information to the user and physician as appropriate. For example, the security module can indicate when the patient specific module is read correctly when inserted into the receptacle. The treatment module can output treatment parameters to the circuitry for treatment, and the subjective data module can output data to another computer such that the subjective data can be sent to the treating physician.

[0057] The handheld treatment devices described herein may be applicable to all nerves and may use magnetic stimulation to treat the nerves. Magnetic stimulation may be able to affect peripheral nerves (i.e., nerves close to the surface of the body) and also nerves that are deep in the tissue of the patient which may not otherwise be accessible for treatment with pharmaceuticals or other devices that are not implanted, such as transcutaneous electrical nerve stimulation (TENS). For example, magnetic stimulation may be able to affect nerves that transmit pain signals in the elbow, knee, or shoulder. As an additional example, magnetic stimulation may be able to affect the nerves deep in the tissue which may include the cervical spine or sciatic nerve or nerves associated with the lumbosacral plexus. By way of yet afurther examples, magnetic stimulation may be able to affect nerves that are associated with and / or triggered by one or more of trigeminal neuralgia, temporomandibular joint disorder (TMI), postherpetic neuralgia, phantom limb pain, complex regional pain syndrome (CRPS), occcipitalneuralgia, depression, anxiety disorders, post-traumatic stress disorder (PTSD), insomnia, cervicogenic headache, whiplash-associated disorders, irritable bowel syndrome (IBS), bladder dysfunction (e.g., overactive bladder). The mechanism of action of the magnetic stimulation may inhibit calcium influx into neurons which may reduce the neurotransmitter release across the synapse. For example, the glutamate release may be reduced across the synapse. As magnetic stimulation may affect nerves generally, stronger pulses administered less frequently and weaker pulses administered more frequently may produce a similar effect. In some examples, treating the cortex along with the cranial nerves and / or the spinal nerves may improve treatment.

[0058] It should be noted that a migraine may be caused by ascending signals originating from the shoulders or neck of the patient (e.g., ascending signals indicating anxiety based on tensed shoulder and neck muscles may produce symptoms of a migraine). In the treatment and / or prevention of migraines, the handheld treatment devices described herein may be applied one or more of the cortex, cranial nerves, and spinal nerves (as described below) to improve the treatment outcome.

[0059] Example treatment methods are described below

[0060] Treatment of Cranial Nerves

[0061] The handheld treatment devices described herein may be configured and applied to a patient to treat cranial nerves. FIG. 7 shows a brain 740 of a patient. A brain stem 750 inside the brain 740 has a plurality of cranial nerves 760 extending from the brain stem 750. The plurality of cranial nerves 760 may include twelve pairs of nerves. The plurality of cranial nerves 760 may include an olfactory nerve 710, an optic nerve 712, an oculomotor nerve 714, a trochlear nerve 716, a trigeminal nerve 718, an abducens nerve 720, a facial nerve 722, a vestibulocochlear nerve 724, a glossopharyngeal nerve 726, a vagus nerve 728, an accessory nerve 730, and a hypoglossal nerve 732. Each of the nerves are adapted to relay information between the brain 740 and certain parts of the body.

[0062] The disease states that may be treated by applying a pulse to the cranial nerves may include tinnitus, visual snow, a neurological disease, migraine, depression, bipolar disorder, anxiety, obsessive-compulsive disorder, attention deficit hyperactivity disorder, fibromyalgia, chronic pain, post-traumatic stress disorder, traumatic brain injury, addiction, smoking cessation, Parkinson’s disease, insomnia, phantom limb pain, complex regional pain syndrome (CRPS), trigeminal neuralgia, occipital neuralgia, temporomandibular joint disorder (TMJ), cervicogenicheadache, whiplash disorder, bladder dysfunction (e.g., overactive bladder) and / or irritable bowel syndrome.

[0063] Treatment of Spinal Nerves

[0064] The handheld treatment devices described herein may be configured and applied to a patient to treat spinal nerves. The spinal nerves may include branches of nerves that innervate muscles of the head, neck, and back. FIG. 8 shows a body 840 of a patient. A spinal cord 850 of the body 840 may have a plurality of spinal nerves 860 extending from the spinal cord 850. The plurality of spinal nerves 860 may include thirty-one pairs of spinal nerves 860 divided into a plurality of regions. The plurality of spinal nerves 860 may include a cervical region 810, a thoracic region 812, a lumbar region 814, a sacral region 816, and a coccygeal region 818. The cervical region 810 may include eight pairs of the plurality of spinal nerves 860. The thoracic region 812 may include twelve pairs of the plurality of spinal nerves 860. The lumbar region 814 may include five pairs of the plurality of spinal nerves 860. The sacral region 816 may include five pairs of the plurality of spinal nerves 860. The coccygeal region 818 may include one pair of the plurality of spinal nerves 860. The plurality of spinal nerves 860 are adapted to transmit sensory, motor, and autonomic impulses between the spinal cord 850 and the rest of the body 840.

[0065] The disease states that may be treated by applying a pulse to the cranial nerves may include migraine, cluster headache, tension headache, tinnitus, intervertebral disc disease, fibromyalgia, allodynia, hyperalgesia, paresthesia, neuropathic pain, sciatica, peripheral neuropathy, genicular pain, epicondyle pain, postherpetic neuralgia, phantom limb pain, complex regional pain syndrome, occipital neuralgia, insomnia, depression, cervicogenic headache, whiplash-associated disorder, bladder dysfunction (e.g., overactive bladder) and / or irritable bowel syndrome. In an example of a tension headache, the tension headache may be caused by ascending signals originating from the shoulders or neck of the patient. For example, ascending signals indicating tensed shoulder and neck muscles may produce symptoms of a tension headache. Applying any of the handheld treatment devices described herein to the spinal nerves may provide relief from the tension headache symptoms. Treating the cortex along with the spinal nerves may improve the treatment outcome.

[0066] While the foregoing disclosure has been described in some detail for purposes of clarity and understanding, it will be clear to one skilled in the art from a reading of thisdisclosure that various changes in form and detail can be made without departing from the true scope of the disclosure. The above examples are provided to illustrate the object of this disclosure, but not to limit its scope; other variants of the disclosure will be readily apparent to those of ordinary skill in the art and are encompassed by the claims of the disclosure. The scope of the disclosure should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents.

[0067] Various other modifications, adaptations and alternative designs are of course possible in light of the teachings as presented herein. Therefore, it should be understood that, while still remaining within the scope and meaning of the appended claims, the object of this disclosure could be practiced in a manner other than that which is specifically described herein.

Claims

CLAIMS1. A method of prophylactic treatment for a disease state in a patient, the treatment comprising:(a) positioning an electromagnetic field generator adjacent to a cranial nerve;(b) directing an electromagnetic field from the electromagnetic field generator toward the cranial nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

2. The method of claim 1, wherein the treatment plan is written into a patient specific module coupled to a processor that controls the electromagnetic field generator.

3. The method of claim 1, wherein the patient specific module comprises a subscriber identity module (SIM).

4. The method of claim 1, wherein the treatment consists of one treatment per day.

5. The method of claim 1, wherein the treatment plan comprises a number of pulses to be delivered with each treatment.

6. The method of claim 1, wherein the treatment plan comprises two pulses per treatment and the treatment plan may comprise more than one treatment.

7. The method of claim 1, wherein the cranial nerve is a nerve selected from an olfactory nerve, an optic nerve, an oculomotor nerve, a trochlear nerve, a trigeminal nerve, an abducensnerve, a facial nerve, a vestibulocochlear nerve, a glossopharyngeal nerve, a vagus nerve, an accessory nerve, and a hypoglossal nerve.

8. The method of claim 1, wherein the disease state is selected from tinnitus, visual snow, a neurological disease, migraine treatment, migraine prevention, depression, bipolar disorder, anxiety, obsessive-compulsive disorder, attention deficit hyperactivity disorder, fibromyalgia, chronic pain, post-traumatic stress disorder, traumatic brain injury, addiction, smoking cessation, Parkinson’s disease, insomnia, phantom limb pain, complex regional pain syndrome, trigeminal neuralgia, occipital neuralgia, temporomandibular joint disorder, cervicogenic headache, whiplash disorder, bladder dysfunction, or irritable bowel syndrome.

9. A method of prophylactic treatment for a disease state in a patient, the treatment comprising:(a) positioning an electromagnetic field generator adjacent to a spinal nerve;(b) directing an electromagnetic field from the electromagnetic field generator toward the spinal nerve; and repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

10. The method of claim 9, wherein the treatment plan is written into a patient specific module coupled to a processor that controls the electromagnetic field generator.

11. The method of claim 9, wherein the patient specific module comprises a subscriber identity module (SIM).

12. The method of claim 9, wherein the treatment consists of one treatment per day.

13. The method of claim 9, wherein the treatment plan comprises a number of pulses to be delivered with each treatment14. The method of claim 9, wherein the treatment plan comprises two pulses per treatment and the treatment plan may comprise more than one treatment.

15. The method of claim 9, wherein the spinal nerve is a nerve selected from nerves in cervical region, a thoracic region, a lumbar region, a sacral region, and a coccygeal region.

16. The method of claim 9, wherein the disease state is selected from migraine, cluster headache, tension headache, tinnitus, intervertebral disc disease, fibromyalgia, allodynia, hyperalgesia, paresthesia, neuropathic pain, sciatica, peripheral neuropathy, genicular pain, epicondyle pain, postherpetic neuralgia, phantom limb pain, complex regional pain syndrome, occipital neuralgia, insomnia, depression, cervicogenic headache, whiplash-associated disorder, bladder dysfunction, or irritable bowel syndrome.

17. A method prophylactic treatment for a disease state in a patient, the treatment comprising:(a) positioning an electromagnetic treatment device adjacent to a cranial nerve or a spinal nerve;(b) directing an electromagnetic field from the electromagnetic field generator toward the cranial nerve or the spinal nerve, wherein the directing of the electromagnetic field includes discharging electrical energy stored in a capacitor of the electromagnetic treatment device to a spherical cap coil of the electromagnetic treatment device.

18. The method of claim 17, further comprising repeating the treatment of steps (a) and (b) no less than one treatment per day according to a treatment plan.

19. The method of claim 17, further comprising charging the capacitor, prior to the directing of the electromagnetic field, with a battery of the electromagnetic treatment device.

20. The method of claim 17, wherein the directing of the electromagnetic field includes generating a magnetic pulse with a pulse intensity of 1.0±0.5 Tesla.

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