Systems, devices, and methods for transcutaneous electrical stimulation

Abstract

Systems, devices, and methods are described herein that may be used to treat neurological conditions in a patient. A system for applying transcutaneous electrical stimulation to a patient may include an electrode configured to couple to a forehead of the patient. The electrode may include a substrate, a first conductor, a second conductor, and an insulator, and each of the first conductor, the second conductor, and the insulator are disposed on the substrate. The insulator may be positioned laterally between the first conductor and the second conductor. The first conductor and the second conductor may be configured to stimulate a trigeminal nerve of the patient. An electrode identification may be disposed on the substrate and across the first conductor and the second conductor. The housing may be configured to be releasably coupled to the electrode. The housing may include a signal generator configured to generate a set of pulses for the electrode.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 343,904, filed on May 19, 2022, the contents of which are hereby incorporated by reference in their entirety. Technical Field

[0003] The devices, systems and methods herein relate to non-invasive transcutaneous electrical stimulation that can be used for therapeutic applications including, but not limited to, treating migraine. Background Art

[0004] Migraine is a common neurobiological disorder characterized by recurrent headaches with hyperesthesias, which can significantly impair quality of life. Episodic migraine can be defined as a patient experiencing headaches one to fourteen days per month, with associated migraine symptoms (e.g., nausea, photophobia, phonophobia, etc.). Other symptoms, such as sleep disturbances, can also significantly reduce the patient's quality of life.

[0005] Conventional acute migraine treatments include pharmaceutical solutions such as analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and triptans. Similarly, pharmacological drugs are often used to treat conditions such as depression, anxiety, sleep, and the like. Conventional drugs are associated with several contraindications and moderate to severe side effects. For example, overdosage of acute migraine drugs may increase drug tolerance and even increase migraine frequency. Therefore, additional devices, systems, and methods for transcutaneous electrical stimulation may be desirable. Summary of the invention

[0006] Systems, devices and methods for acute non-invasive treatment of conditions (including but not limited to migraine) are described herein. Generally speaking, a system for applying transcutaneous electrical stimulation to a patient may include an electrode configured to be coupled to the patient's forehead. The electrode may include a substrate, a first conductor, a second conductor and an insulator, and each of the first conductor, the second conductor and the insulator is disposed on the substrate. The insulator may be positioned laterally between the first conductor and the second conductor. The first conductor and the second conductor may be configured to stimulate a patient's nerve, such as the trigeminal nerve. An electrode marker may be disposed on the substrate and across the first conductor and the second conductor. A housing may be configured to be releasably coupled to the electrode. The housing may include a signal generator configured to generate a group of pulses for the electrode.

[0007] In some variations, the electrode marker may include at least two openings, a first magnet coupled to a first adhesive conductor, and a second magnet coupled to a second adhesive conductor. The first magnet and the second magnet may extend through the corresponding openings of the electrode marker. In some of these variations, the housing may be configured to couple to the forehead of the patient using the electrode. In some of these variations, the housing may be configured to magnetically couple to the first magnet and the second magnet of the electrode. In some of these variations, the first magnet and the second magnet may be configured to receive the set of pulses generated by the signal generator. In some of these variations, the electrode marker may define a third opening, and the insulator may define a fourth opening of the insulator corresponding to the third opening. In some variations, the electrode marker may overlap with the first conductor and the second conductor. In some variations, the electrode marker may be disposed on the insulator. In some variations, the electrode marker may overlap with the insulator. In some variations, the electrode identifier may include a radio frequency identification (RFID) tag. In some variations, the insulator may separate the first conductor from the second conductor. In some variations, the electrode may include an adhesive conductor area of ​​the first adhesive conductor and the second adhesive conductor, the adhesive conductor area being between about 50% and about 80% of a substrate area of ​​the substrate.

[0008] In some variations, the first conductor may include a first lateral end opposite the insulator, and the second conductor may include a second lateral end opposite the insulator. In some of these variations, the first lateral end, the second lateral end, and the insulator may not overlap the first adhesive conductor and the second adhesive conductor. In some of these variations, the first lateral end and the second lateral end may include a lateral end area of ​​up to about 20% of the substrate area of ​​the substrate. In some of these variations, each of the first conductor and the second conductor may taper from the insulator to the corresponding lateral end.

[0009] In some variations, the signal generator may be configured to generate the set of pulses including a current between about 1 mA and about 35 mA. In some variations, the signal generator may be configured to generate the set of pulses including a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 17 mA, and a dead time between about 1 μs and about 10 μs. In some variations, the signal generator may be configured to generate the set of pulses including a duration between about 150 microseconds and about 450 microseconds, wherein the current increases by up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current increases by no more than about 50 microamperes in steps.

[0010] In some variations, the electrode can be configured to stimulate the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve. In some variations, the substrate can include a length between about 70 mm and about 120 mm. In some variations, the insulator can include a length between about 15 mm and about 50 mm and a width between about 5 mm and about 15 mm. In some variations, the first lateral end and the second lateral end can each include a height between about 5 mm and about 20 mm and a width between about 5 mm and about 10 mm.

[0011] In some variations, the system may further include a power source. The housing may be configured to separate the power source from the signal generator. In some of these variations, the signal generator may be separated from the power source by a predetermined distance. In some of these variations, the housing may include a set of protrusions configured to separate the power source from the signal generator. In some of these variations, the power source may include a battery. In some variations, the housing may include a power source coupled to the signal generator. The charger may be configured to wirelessly charge the power source.

[0012] Also described herein is a variation of an electrode configured to be coupled to the patient's forehead. The electrode may include a substrate, a first conductor, a second conductor, and an insulator, and each of the first conductor, the second conductor, and the insulator is disposed on the substrate. The insulator may be positioned laterally between the first conductor and the second conductor. The first conductor and the second conductor may be configured to stimulate the trigeminal nerve of the patient. An electrode marker may be disposed on the substrate and straddle the first conductor and the second conductor.

[0013] A variation of a device is also described herein, the device comprising: a signal generator configured to generate a set of pulses for percutaneously stimulating a trigeminal nerve of a patient; an identification reader configured to detect an electrode identification of an electrode releasably coupled to the device; and a processor and a memory coupled to the identification reader. The processor can be configured to detect the electrode identification using the identification reader, generate an authorization signal based on the detected identification, and stimulate the trigeminal nerve of the patient using the set of pulses based on the authorization signal.

[0014] In some variations, the processor may be configured to disable generation of the set of pulses when the electrode identification is not detected. In some variations, the processor may be configured to disable generation of the set of pulses when the authorization signal is one or more of unauthorized, expired, and used.

[0015] Also described herein is a method for treating a patient, the method comprising: coupling an electrode to the patient's forehead, the electrode comprising an electrode identifier for the electrode; coupling a housing of an electrical stimulation device to the electrode, the electrical stimulation device comprising a signal generator and an identifier reader; using the identifier reader of the electrical stimulation device to detect the electrode identifier; generating an authorization signal based on the detected identifier; and stimulating the patient's trigeminal nerve using a set of pulses generated by the signal generator based on the authorization signal.

[0016] In some variations, the stimulation can be configured to treat one or more of the following: migraine, tension, headache, cluster headache, migraine continua, semi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemiplegia, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, hypersomnia, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and cerebellar syndrome. In some variations, the method may also include releasing the device from the electrode. In some variations, the method may also include storing one or more of the following: treatment session time, selected therapeutic stimulation program, treatment session duration, maximum current amplitude in the treatment session, treatment session error, number of repetitions, total current delivered, total current delivered if maximum current amplitude is reached, battery charging time, battery charging duration, duration to reach full charge and battery charging error.

[0017] Also described herein is a method for applying transcutaneous electrical stimulation to a patient, the method comprising: selecting one or more stimulation parameters for the electrical stimulation; applying the electrical stimulation having the selected one or more stimulation parameters using an electrical stimulation system coupled to the patient; determining an amount of the electrical stimulation to be applied to the patient; and modifying at least one stimulation parameter based on the determined amount.

[0018] In some variations, determining the dosage may include calculating the charge delivered to the patient by the electrical stimulation system. In some variations, selecting the one or more stimulation parameters may include selecting one of a first treatment program having a first set of stimulation parameters and configured to preemptively treat a condition and a second treatment program having a second set of stimulation parameters and configured to acutely treat a condition.

[0019] In some variations, modifying the at least one stimulation parameter may be based on the determined usage, the modification comprising increasing the first treatment procedure session frequency and decreasing the second treatment procedure session frequency. In some variations, modifying the at least one stimulation parameter may be based on the determined usage, resulting in increasing the usage of the first treatment procedure. In some variations, the usage may be decreased within a predetermined time period after modifying the at least one stimulation parameter.

[0020] In some variations, a stimulation parameter of the one or more stimulation parameters may be adjusted while applying the electrical stimulation. In some variations, a third treatment program having a third set of stimulation parameters may be generated based on the adjusted stimulation parameters. In some variations, selecting the one or more stimulation parameters may include selecting the third treatment program. In some variations, a graphical user interface including the determined dosage may be generated.

[0021] In some variations, the one or more stimulation parameters may include one or more of the following: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, session time, session duration, maximum current amplitude in a session, and session frequency. In some variations, the electrical stimulation may include a frequency of the electrical stimulation, wherein the frequency is between about 10 Hz and about 300 Hz. In some variations, the electrical stimulation may include a current between about 1 mA and about 35 mA. In some variations, the electrical stimulation may include a pulse width between about 240 μs and about 260 μs. In some variations, the electrical stimulation may include a pulse amplitude of up to about 17 mA. In some variations, the electrical stimulation may include a dead time between about 1 μs and about 10 μs. In some variations, the electrical stimulation may comprise a duration of between about 150 microseconds and about 450 microseconds, wherein the current increases by a maximum of up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current increases in steps not to exceed about 50 microamperes.

[0022] In some variations, applying the electrical stimulation may include stimulating the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve. In some variations, the electrical stimulation system may include a signal generator releasably coupled to the electrode. Applying the electrical stimulation may include using the signal generator to generate a set of pulses for the electrode. In some variations, applying the electrical stimulation may treat one or more of the following: migraine, tension, headache, cluster headache, persistent migraine, semi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and cerebellar syndrome.

[0023] Also described herein is an electrical stimulation system comprising: an electrode configured to be coupled to a patient; a signal generator operably coupled to the electrode and configured to generate a set of pulses for transcutaneous electrical stimulation of the patient; and a processor and a memory coupled to the signal generator. The processor can be configured to receive one or more stimulation parameters, apply electrical stimulation having the received one or more stimulation parameters to a nerve of the patient using the electrode, determine an amount of the electrical stimulation applied to the nerve, and based on the determined amount, receive at least one modified stimulation parameter.

[0024] In some variations, determining the dosage may include calculating an electrical charge delivered to the nerve of the patient. In some variations, receiving the one or more stimulation parameters may include selecting one of a first treatment program having a first set of stimulation parameters and configured to preemptively treat a condition and a second treatment program having a second set of stimulation parameters and configured to acutely treat a condition.

[0025] In some variations, the processor may be configured to receive an increase in the frequency of sessions of the first therapeutic procedure and a decrease in the frequency of sessions of the second therapeutic procedure based on the determined usage. In some variations, the processor may be configured to receive an increase in the usage of the first therapeutic procedure. In some variations, the processor may be configured to receive a decrease in the usage of the first therapeutic procedure within a predetermined time period after modifying the at least one stimulation parameter.

[0026] In some variations, the processor may be configured to receive at least one modified stimulation parameter during one of the first therapy session and the second therapy session. In some variations, the processor may be configured to generate a third therapy program having a third set of stimulation parameters based on the received at least one modified stimulation parameter during one of the first therapy session and the second therapy session.

[0027] In some variations, the processor may be configured to receive a selection of the third treatment program. In some variations, the processor may be configured to generate a graphical user interface including the determined dosage.

[0028] In some variations, the electrical stimulation may include one or more of the following: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, treatment time, treatment duration, maximum current amplitude in a treatment, and treatment frequency. In some variations, the electrical stimulation may include a current between about 10 Hz and about 300 Hz. In some variations, the electrical stimulation may include a current between about 1 mA and about 35 mA. In some variations, the electrical stimulation may include a pulse width between about 240 μs and about 260 μs. In some variations, the electrical stimulation may include a pulse amplitude of up to about 17 mA. In some variations, the electrical stimulation may include a dead time between about 1 μs and about 10 μs. In some variations, the electrical stimulation may include a duration between about 150 microseconds and about 450 microseconds, wherein the maximum increase in current is up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current is increased stepwise by no more than about 50 microamperes. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a schematic block diagram of an illustrative variation of a transcutaneous electrical stimulation system.

[0030] FIG. 2A to FIG. 2C is a front view of an illustrative variation of a stimulation system coupled to a patient's forehead.

[0031] Figure 3A is a front perspective view of an illustrative variation of a transcutaneous electrical stimulation system. Figure 3B is a rear perspective view of an illustrative variation of a transcutaneous electrical stimulation system. Figure 3C is a front view of an illustrative variation of a transcutaneous electrical stimulation system. Figure 3D is a rear view of an illustrative variation of a transcutaneous electrical stimulation system. Figure 3E is a side view of an illustrative variation of a transcutaneous electrical stimulation system. Figure 3F is a top view of an illustrative variation of a transcutaneous electrical stimulation system.

[0032] Figure 4is an exploded view of an illustrative variation of a transcutaneous electrical stimulation system.

[0033] FIG. 5A to FIG. 5C is a schematic plan view of an exemplary variation of an electrode.

[0034] Fig. 6A is a schematic plan view of an exemplary variation of an electrode. Figure 6B yes Fig. 6A Schematic cross-sectional plan view of an exemplary variation of the electrode depicted in FIG. Figure 6C yes Figure 6B Schematic cross-sectional side view of an illustrative variation of the electrode depicted in FIG.

[0035] Figure 7 is a schematic plan view of an exemplary variation of an electrode.

[0036] Fig. 8A and Figure 8B is a schematic exploded perspective view of an exemplary variation of an electrode.

[0037] Fig. 9 is a rear exploded perspective view of an illustrative variation of a connector for a transcutaneous electrical stimulation system.

[0038] FIG. 10A to FIG. 10C is a schematic side view of an illustrative variation of a magnet for a transcutaneous electrical stimulation system.

[0039] Fig.11 is a schematic plan view of an illustrative variation of an RFID circuit for a transcutaneous electrical stimulation system.

[0040] Fig. 12A is a front perspective view of an illustrative variation of a switch for a transcutaneous electrical stimulation system. Fig. 12B is a side view of an illustrative variation of a switch for a transcutaneous electrical stimulation system. Fig. 12C is a rear view of an illustrative variation of a switch for a transcutaneous electrical stimulation system.

[0041] Fig.13A is a front perspective view of an illustrative variation of a rear housing of a transcutaneous electrical stimulation system. Fig. 13B is a front view of an illustrative variation of a rear housing of a transcutaneous electrical stimulation system.

[0042] Fig.14A is a front perspective view of an illustrative variation of a wireless charger. Fig. 14B is a front view of an exemplary variation of a wireless charger. Fig. 14C is a rear view of an exemplary variation of a wireless charger. Fig.14D is a side view of an exemplary variation of a wireless charger.

[0043] Fig.15A and Fig. 15Bis a graph of exemplary variations of pulse waveforms for transcutaneous electrical stimulation. Fig. 15C It is a graph showing the stimulus intensity changing over time.

[0044] Fig.16 A flow chart representation of an illustrative variation of electrode authorization is depicted.

[0045] FIG. 17A to FIG. 17G Depicted are illustrative variations of graphical user interfaces associated with transcutaneous electrical stimulation interfaces.

[0046] FIG. 18A to FIG. 18L Depicted are illustrative variations of graphical user interfaces related to transcutaneous electrical stimulation.

[0047] FIG. 19A to FIG. 19G Illustrative variations of graphical user interfaces related to patient data are depicted.

[0048] Fig. 20 A flowchart representation of an illustrative variation of applying neural stimulation is depicted. DETAILED DESCRIPTION

[0049] Systems, devices, and methods for non-invasive transcutaneous electrical stimulation, such as electrotherapy treatment for a condition, are described herein. For example, the systems, devices, and methods described herein can improve treatment efficacy, patient compliance, ease of use, and / or optimize dosage by, for example, providing ergonomic electrode configurations; providing electrode authorization to prevent patient error and / or unauthorized use; magnetically coupling durable housing components to disposable electrode components to facilitate electrode positioning and system setup; improving system performance based on component layout; determining neural stimulation dosage; modifying stimulation parameters for different treatment goals; and / or achieving an optimal dose (e.g., a minimum effective dose). For example, the optimal dose for some patients can be minimized or the minimum effective dose can be achieved.

[0050] The systems, devices and methods described herein can percutaneously stimulate one or more nerves of a patient. In some variations, the systems, devices and methods described herein can percutaneously stimulate the ophthalmic branch of the trigeminal nerve of a patient, thereby generating an analgesic effect to treat the patient. For example, a set of electrodes can be configured to deliver a set of pulses to electrically stimulate the nerve endings of the trigeminal nerve. The trigeminal nerve includes an ophthalmic branch, a maxillary branch and a mandibular branch. The trigeminal nerve on the forehead is divided into an inner frontal nerve (or supratrochlear nerve) and an outer frontal nerve (or supraorbital nerve). This set of pulses can be delivered percutaneously to the patient via supraorbital electrodes to stimulate (e.g., trigger action potentials) the afferent paths of the supratrochlearis / supratrochlear and supraorbital (supraorbitalis / supraorbital) nerves belonging to the upper branch of the trigeminal nerve (V1). The therapeutic effect of the treatment can last for at least 24 hours after treatment.

[0051] The system, apparatus and method can thus stimulate the ophthalmic branch of the patient's nerve, thereby generating an analgesic effect to treat the patient. For example, stimulation can treat one or more of the following: migraine, tension, headache, cluster headache, persistent migraine, semi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and cerebellar syndrome.

[0052] In some variations, with respect to treating migraines, a set of pulses having a relatively high frequency may be configured to induce a sedative effect on the nervous system to provide pain relief to the patient during a migraine. A set of pulses applied at predetermined intervals (e.g., over multiple sessions on different days) may be configured to stimulate the central nervous system to treat the patient's fronto-temporal cortex and reduce the frequency of migraines.

[0053] In some variations, systems, devices, and methods for electrotherapy treatment of a condition may provide a first treatment configured to preemptively treat the condition (e.g., a preventive treatment) and a second treatment configured to acutely treat the condition (e.g., an acute treatment). For example, the purpose of the first migraine treatment may be to reduce the frequency and / or shorten the duration of future migraines, while the purpose of the second migraine treatment may be to reduce the intensity and / or shorten the duration of a currently occurring migraine. The first migraine treatment may be provided when the patient is migraine-free (not currently experiencing a migraine), while the second migraine treatment may be provided when the patient is experiencing a migraine (e.g., upon experiencing the first symptoms of a migraine).

[0054] In general, the preferential and excessive use of acute neurostimulation (e.g., a second migraine treatment) over preventive neurostimulation (e.g., a first migraine treatment) may increase the risk of adverse reactions compared to selective preventive treatments that are generally better tolerated than acute neurostimulation. For example, the total energy delivered between courses of second migraine treatment may be higher than the total energy delivered between courses of first migraine treatment. Therefore, it may be beneficial to track stimulation parameters over time, determine the dose of electrical stimulation applied, and modify the stimulation parameters of the neurostimulation treatment program to optimize the therapy provided. For example, in some variations, optimization of therapy may include achieving the optimal dose (e.g., the minimum effective dose) required (the lowest concentration of therapy) in order to achieve the desired effect and minimize the risk of adverse reactions. In addition, due to individual anatomical differences and variability in central pain mechanisms, pain tolerance of neurostimulation may vary from patient to patient (especially when starting a neurostimulation treatment regimen). Due to the complex processes of adaptation, allodynia, and habituation, the perception of the intensity of neurostimulation may change over time. However, standard dosing metrics for neurostimulation are generally unknown, so that neurostimulation dosing determination is currently limited to oversimplified (e.g., incomplete) surrogates (e.g., duration of treatment, number of treatments), thereby limiting the optimization of neurostimulation treatments. Analyzing and modifying neurostimulation treatments based on dosing metrics can lead to optimized dosing (e.g., minimum effective dose) and improved patient outcomes.

[0055] In some variations, the patient may increase the frequency (e.g., number of treatment sessions per time period) and intensity (e.g., maximum pulse amplitude) of the first treatment over time to obtain greater preemptive treatment benefit. For example, as the number, duration, and / or intensity of the first treatment increases, the frequency and / or intensity of migraine headaches may decrease, thereby reducing the number of second treatments administered and thereby optimizing therapy by obtaining an optimal dose (e.g., a minimum effective dose).

[0056] I. Systems and Equipment

[0057] In general, a transcutaneous electrical stimulation system may include one or more of the components necessary to treat and optionally monitor a patient using the systems described herein. Figure 1A block diagram of an exemplary transcutaneous electrical stimulation system 10 is depicted in . The system 10 may include one or more of a wearable system 100 (e.g., a stimulator, an external neurostimulator, an electrotherapy device), a charger 150, a computing device 160, 162, and a database 180. In some variations, the wearable system 100 may be coupled to one or more of the computing devices 160, 162 and the database 180 via a network 170 (e.g., via a wired or wireless connection). The wearable system 100 may be configured to apply external neural stimulation, such as external trigeminal nerve stimulation (e-TNS), to treat a patient. For example, the wearable system 100 may be configured to treat a condition in a non-invasive manner. For example, the wearable system 100 may be configured to deliver a set of pulses to one or more of the supraorbital nerve and the supratrochlear nerve of the ophthalmic branch of the trigeminal nerve to generate an analgesic effect. In some variations, the wearable system 100 may be releasably coupled to the forehead of the patient to apply external neural stimulation to treat the condition.

[0058] FIG. 2A to FIG. 2C Corresponding wearable systems 200, 202, 204 having similar features and / or components to the wearable system 100 are depicted, which are releasably coupled to the forehead of the patient 250. In some variations, the electrodes of the system can be configured to be releasably coupled (e.g., adhered using, for example, an adhesive) to the forehead of the patient (such as in a supraorbital area where there is typically little hair) to facilitate self-supporting coupling and release of the electrodes to the forehead. For example, the electrodes can be coupled to a strip or band (e.g., an elastic strip or elastic loop, a headband) configured to be held in place on and / or around the patient's head. Each of the systems 200, 202, 204 can be self-supported on the forehead for at least as long as the treatment session (e.g., up to about 20 minutes, up to about 60 minutes, up to about 120 minutes). As described in more detail herein, the system can include a durable component (e.g., a housing) and a disposable component (e.g., an electrode), the durable component including a signal generator and a processor. The disposable component can be manually coupled to and decoupled from the patient (e.g., the supraorbital region of the forehead), and the durable component can be manually coupled to and decoupled from the disposable component (e.g., the electrodes) to releasably couple the system to the patient. In some variations, wearable system 200 corresponds to a variation without electrode identification, wearable system 202 corresponds to a variation including electrode identification, and wearable system 204 corresponds to a variation including electrode identification and configured to be controlled using an external device (e.g., a computing device, a smart phone) employing a GUI as described herein.

[0059] Return to reference Figure 1In some embodiments, the wearable system 100 may include one or more of an electrode 112, which may include an electrode identifier 114 and a connector 115, and a stimulation device 102, which may include a signal generator 116, an electrode identifier reader 118, an input device 120, an output device 122, a processor 124, a memory 126, a communication device 128, a power source 130, and a connector 132, each of which is described in more detail herein.

[0060] In some variations, the wearable system 100 may include durable components and disposable components. For example, the disposable components of the wearable system 100 may include electrodes 112. In some variations, the durable components of the wearable system 100 may include a stimulation device 102, which is configured to carry, encapsulate or otherwise contain one or more of a signal generator 116, an electrode identification reader 118, an input device 120, an output device 122, a processor 124, a memory 126, a communication device 128, a power supply 130, and a connector 132. The stimulation device 102 may be a reusable part of the wearable system 100, while the electrode 112 may be disposable and replaced after a predetermined number of uses and / or a predetermined time interval (e.g., single use, limited use). Therefore, the electrode 112 may be releasably coupled to the stimulation device 102. In some variations, the stimulation device 102 may be provided separately from the electrode 112. With proper maintenance (e.g., cleaning, charging), the durable components may provide long-term functionality. In some variations, the housing of the stimulation device may be formed by one or more techniques such as injection molding, machining, solvent bonding, interference / press fit assembly, ultrasonic welding, and additive manufacturing (e.g., 3D printing). One or more of the components of the wearable system 100 may be disposed on a printed circuit board (PCB).

[0061] In some variations, the electrode 112 can be configured to be releasably (e.g., reversibly) coupled, adhered, and / or attached to the patient's forehead for delivering transcutaneous electrical stimulation. For example, the electrode 112 can be releasably coupled to the stimulation device 102 via a connector 132 (e.g., a magnet), as described in more detail herein. In this way, the electrode 112 can be adhered (e.g., via an adhesive) to the patient's forehead, and the stimulation device 102 can be separately coupled to the electrode 112. In some variations, the electrode 112 may include an electrode identification 114. The electrode identification 114 may be configured to uniquely identify and / or authorize the electrode 112 as compatible and / or authorized for use as a component of the wearable system 100. This can increase patient safety and therapeutic efficacy by preventing the use of the wearable system 100 with unauthorized and / or expired electrodes. In some variations, the electrode identification 114 may include a radio frequency identification (RFID) tag. The electrode identification 114 may be detected by a corresponding electrode identification reader 118 disposed in the stimulation device 102 .

[0062] In some variations, the signal generator 116 may be configured to generate a set of electrical pulses based on a set of stimulation parameters, as described in more detail herein. In some variations, the input device 120 may be configured to generate an input signal (e.g., start / stop treatment) based on a patient input (e.g., a button press). In some variations, the output device 122 may be configured to output data associated with the use of the wearable system 100 (e.g., visual and / or auditory notifications). In some variations, the processor 124 and the memory 126 may be configured to control the wearable system 100. In some variations, the communication device 128 may be configured to communicate with one or more components of the system 10, such as a network 170, a computing device 160, 162 (e.g., a mobile phone, a tablet computer, a laptop computer, a desktop personal computer), and a database 180. The power supply 130 may be configured to provide energy to one or more components of the wearable system 100. For example, the power supply 130 may be a battery (e.g., rechargeable or non-rechargeable) or other energy source. In some variations, power source 130 may be coupled to and recharged by charger 150 via a wired and / or wireless connection.

[0063] In some variations, the wearable system 100 may include a signal generator 116 configured to generate a set of pulses for percutaneous stimulation of the patient's trigeminal nerve. As described above, the identification reader 118 may be configured to detect an electrode identifier 114 that is releasably coupled to an electrode 112 of the wearable system 100. The processor 124 and the memory 126 may be coupled to the identification reader 118. The processor 124 may be configured to detect the electrode identifier 114 using the identification reader 118, generate an authorization signal based on the detected identifier 114, and stimulate the patient 140 (e.g., the trigeminal nerve) using the set of pulses based on the authorization signal. In some variations, the processor may be configured to prohibit the generation of the set of pulses when the electrode identifier 114 is not detected. In some variations, the processor may be configured to prohibit the generation of the set of pulses when the authorization signal is one or more of unauthorized, expired, and used.

[0064] FIG. 3A to FIG. 3F are various external views (e.g., perspective, front, rear, side, top views) of a durable component (e.g., housing) of the transcutaneous electrical stimulation system 300. A first side (e.g., front) of the system 300 may include an input device 310 (e.g., button, switch) configured to receive input (e.g., instructions) from a patient to facilitate operation of the system 300. A second side (e.g., rear) of the system 300, opposite the first side, may include a connector 320 configured to couple to a corresponding connector of a disposable electrode (not shown for clarity). When coupled to the patient's forehead, the first side may face away from the patient and the second side may face toward the patient. In some variations, the connector 320 may be configured to couple the electrode ( FIG. 3A to FIG. 3F 300) is electrically connected to an internal signal generator of the system 300. Additionally or alternatively, the connector 320 can be configured to mechanically and / or magnetically couple the electrode to the system 300. For example, the connector 320 can include a snap and / or a set of magnets.

[0065] Figure 4400, the electronic circuit 460, the power supply 470, the spacer 490, and the electrode identification reader 480. Each of these components is described in more detail herein. From a first side of the system 400 (e.g., the switch cover 410, the front of the system 400) to a second side (e.g., the rear housing 440, the rear of the system 400), the switch 420, the electronic circuit 460, the power supply 470, the spacer 490, and the electrode identification reader 480 can be disposed successively within the front housing 430 and the rear housing 440. For clarity, the electronic circuit 460, the power supply 470, the spacer 490, and the electrode identification reader 480 are shown in FIG. Figure 4 4 is shown removed from the front housing 430 and the rear housing 440.

[0066] In some variations, the housing of the transcutaneous electrical stimulation system can have a length between about 50 mm and about 75 mm, a width between about 30 mm and about 60 mm, and a depth between about 10 mm and about 20 mm, including all ranges and subvalues ​​therebetween. In some variations, the housing of the system can be composed of one or more thermoplastic polymers, such as, for example, polycarbonate / acrylonitrile butadiene styrene (PC / ABS) and polycarbonate (PC).

[0067] A. Electrode

[0068] Generally speaking, the electrodes described herein can be configured to be releasably coupled to the forehead of a patient for delivering a set of pulses, such as biphasic electrical pulses. For example, the electrode can include an adhesive having two patient contact portions configured to adhere to the skin and two system contact portions configured to receive the set of pulses from a stimulation system (e.g., a signal generator).

[0069] FIG. 5A to FIG. 5C504. It is a schematic diagram of an exemplary variation of corresponding electrodes 500, 502, 504. Generally speaking, electrode 500 is narrower and longer than electrodes 502, 504 to accommodate lateral ends 530, 532 while maintaining a similar total area. Electrode 502 has a wider insulator 510 and a shallower taper than electrode 504. Electrode 500 may include an insulator 510 and a conductor 520, which includes a first conductor 522 and a second conductor 524. Insulator 510 separates first conductor 522 from second conductor 524. Each of first conductor 522 and second conductor 524 may taper from insulator 510 to corresponding lateral ends 530, 532 of electrode 500. The tapered configuration of electrodes 500, 502, 504 can ensure that only desired nerves are stimulated, and facilitates patient manipulation of electrodes. Electrodes 500, 502, 504 are depicted as having the same area (e.g., about 1600mm 2 ) conductor. In some variations, the first conductor 522 may include a first lateral end 530 opposite the insulator 510, and the second conductor 524 may include a second lateral end 532 opposite the insulator 510. In some variations, the first lateral end 530, the second lateral end 532, and the insulator 510 do not overlap with the first adhesive conductor 522 and the second adhesive conductor 524. In some variations, the first lateral end 530 and the second lateral end 532 may each include a lateral end area of ​​up to about 20% of the area of ​​the electrode 500. In some variations, the lateral ends 530, 532 may not have adhesive and are convenient for manipulation by a user (e.g., a patient). Although only electrode 500 explicitly depicts conductors 522, 524 having lateral ends 530, 532, any of the electrodes 502, 504 and those described herein may include lateral ends as described herein.

[0070] In some variations, the electrode may include a length between about 90 mm and about 120 mm and a height between about 25 mm and about 35 mm. In some variations, the conductor of the electrode includes a length between about 35 mm and about 60 mm and a height between about 25 mm and about 35 mm. In some variations, the insulator of the electrode may include a length between about 2 mm and about 15 mm.

[0071] FIG. 6A to FIG. 6CRespective schematic plan views 602, cross-sectional plan views 604, and cross-sectional side views 606 of variations of electrode 600 are illustrated, respectively. Electrode 600 may include multiple layers, including a substrate 610, a set of connectors 620 (e.g., two, three, four, or more), one or more connector substrates 630, and an insulator 640, a conductor 650, an adhesive conductor 660, and a release liner 670. In some variations, substrate 610 may include a metal surface 612 and / or a backing material. In some variations, the set of connectors 620 may include a set of plates, magnets, and / or fasteners. In some variations, connector substrate 630 may be made of a thermoplastic polymer, including, for example, polyvinyl chloride (PVC), polyethylene terephthalate (PET), nylon, urethane, polyethylene (PE), combinations thereof, and the like. In some variations, connector substrate 630 may include an electrode identifier, as described in more detail herein. In some variations, insulator 640 may include a nonwoven fabric. In some variations, adhesive conductor 660 may include a gel.

[0072] In some variations, a set of connectors 620 (e.g., metal plates) can be circular and can have a radius of about 4 mm and a thickness between about 0.4 mm and about 1 mm, including all ranges and subvalues ​​therebetween. In some variations, the set of connectors 620 can have a diameter (e.g., length, width) of about 8 mm. In some variations, the center-to-center distance between adjacent connectors of the set of connectors 620 can be about 13 mm, the width of the insulator 640 can be about 7 mm and the length of the insulator 640 can be about 43 mm, the width of the electrode 600 can be about 43 mm and the length of the electrode 600 can be about 94 mm. In some variations, the conductor 650 can include a diameter between about 1500 mm. 2 and about 1700mm 2 The area between.

[0073] Fig. 8A and Figure 8B 800, 852 are corresponding schematic exploded perspective views of exemplary variations of electrodes 800, 852. Fig. 8A As shown, electrode 800 may include a substrate 810 (e.g., a backing material), a first conductor 820, a second conductor 822, an insulator 830 (e.g., a non-woven fabric), a first connector 840, a second connector 842, a connector substrate 850, a first adhesive conductor 860, a second adhesive conductor 862, a release liner 870, and an electrode identifier 880. Figure 8B An electrode 852 is shown that is similar to electrode 800 but has a circular connector base 851. In some variations, such as Fig. 8AAs shown, multiple connectors 840, 842 can be provided on a single connector substrate 850, and Figure 8B Each connector 840, 842 is depicted disposed on a corresponding connector substrate 851. Connector substrate 850 may include a shape that overlaps a space (e.g., a space corresponding to an insulator) between first adhesive conductor 860 and second adhesive conductor 862. Connector substrate 850 may define an opening for grounding. In some variations, connector substrate 850 may include a shape that overlaps a portion of corresponding first adhesive conductor 860 and second adhesive conductor 862.

[0074] In some variations, the first connector 840 and the second connector 842 may include a cylindrical body. In other variations, the set of connectors 840, 842 may include other shapes (e.g., a rectangular body, a circle, a hemisphere). For another example, one or more of the connectors may include a curved shape (e.g., a C-shape).

[0075] In some variations, the first connector 840 and the second connector 842 can have the same configuration (e.g., size, shape). In some variations, the first connector 840 and the second connector 842 can have different configurations. In some variations, the connectors 840, 842 can have a thickness between about 0.4 mm and about 1.0 mm, including all ranges and subvalues ​​therebetween. In some variations, the connectors 840, 842 can be metal.

[0076] In some variations, the first conductor 820, the second conductor 822, and the insulator 830 can each be disposed on the substrate 810. The insulator 830 can be positioned laterally between the first conductor 820 and the second conductor 822. The first conductor 820 and the second conductor 822 can be configured to receive a set of pulses to stimulate a patient's nerve. The electrode marker 880 can be disposed on the substrate 810 and spans the first conductor 820 and the second conductor 822 and the insulator 830 (e.g., overlaps with them, is above them, intersects with them).

[0077] In some variations, the electrode identifier 880 may include a set of openings 882 (e.g., at least two openings), and the substrate 810 may include a corresponding set of openings 812. The first connector 840 may be coupled to the first adhesive conductor 860, and the second connector 842 may be coupled to the second adhesive conductor 862. The first connector 840 and the second connector 842 may be configured to align with and extend through the corresponding openings 882 of the electrode identifier 880 and the corresponding openings 812 of the substrate 810. The electrode identifier openings 882 may also align with and may overlap with the substrate openings 812.

[0078] In this manner, the first connector 840 and the second connector 842 may be configured to receive a set of pulses generated by a signal generator (e.g., signal generator 116). The set of openings 882 may include a third opening 883, and the insulator 830 may define a fourth opening 832 corresponding to (e.g., overlapping) the third opening 883 of the insulator for grounding.

[0079] like Fig. 8A and Figure 8B As shown, the electrode identifier 880 can overlap with the first conductor 820 and the second conductor 822 in the lateral direction of the electrodes 800 and 852, and can be located between the substrate 810 and the first conductor 820 and the second conductor 822 in the thickness direction of the electrodes 800 and 852 (e.g., from the front of the shell to the rear of the shell). In addition, the electrode identifier 880 can be disposed on the insulator 830 and overlap with the insulator. In some variations, the electrode identifier 880 may include a radio frequency identification (RFID) tag. Although depicted as an RFID tag, the electrode identifier can be any of the electrode identifiers described herein, such as, for example, a QR code, a barcode, text, a sign, a memory, etc. This configuration can minimize interference caused by the RFID tag without reducing electrode performance and / or substantially increasing the size of the electrode.

[0080] The dimensions described herein allow the electrodes to deliver a set of pulses to the patient's nerves. In some variations, the magnets as described herein can be formed of any biocompatible conductive metal and / or alloy, including but not limited to tungsten, silver, platinum, platinum-iridium, nickel-titanium alloys, copper-zinc-aluminum-nickel alloys, and copper-aluminum-nickel alloys, combinations thereof, and the like.

[0081] a. Electrode identification

[0082] Generally speaking, electrodes as described herein may include electrode identifications that can be detected by an electrode identification reader and used to determine the suitability of electrodes for use with a stimulation system. For example, when an electrode has been identified as credible and has been appropriately configured (e.g., appropriately coupled to a stimulation system) based on the detected electrode identification, a set of pulses may be generated and delivered to the electrode to stimulate the patient's nerves. Conversely, when an electrode has not yet been detected and / or has been identified as an unauthorized, expired, and / or overused electrode, the generation of the set of pulses may be prohibited and / or a notification (e.g., audio and / or visual warning) may be output. This may prevent damage to the patient and / or reduce the likelihood of suboptimal treatment due to degradation of electrode performance.

[0083] In some variations, an electrode configured to be coupled to a patient's forehead may include a substrate, a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate the patient's trigeminal nerve. An electrode marker may be disposed on the substrate and across the first conductor and the second conductor.

[0084] In some variations, the electrode may include an electrode identifier, such as a radio frequency identification (RFID) tag, a QR code, a barcode, text, a sign, a memory, and the like. For example, the electrode identifier may be printed on a surface (e.g., a surface of a substrate, a surface of a conductor), adhered to a surface by an adhesive, a combination thereof, and the like. In some variations, the electrode identifier may be configured to electronically store data, such as a unique identifier of the electrode. The electrode identifier may be used to track the electrode and / or may be used to authorize the electrode. In some variations, the electrode identifier may be configured to wirelessly transmit data (e.g., authorization information, usage information) to an identification reader of a transcutaneous electrical stimulation system. For example, in variations in which the electrode identifier may include an RFID tag, the RFID tag may include data such as a unique identifier and a password for the electrode.

[0085] Steering Figure 7 , which depicts a schematic plan view of an illustrative variation of an electrode 700, the electrode comprising a first conductor 710, a second conductor 712, an insulator 720, and an electrode marker 740. The electrode marker 740 can be disposed on (e.g., coupled to) the first conductor 710, the second conductor 712, and the insulator 720 and positioned to laterally span (e.g., overlap) the first conductor, the second conductor, and the insulator. In some variations, the electrode marker 740 can include a length of about 30 mm and a width of about 16 mm. In some variations, the electrode marker 740 can be centered along one or more of the vertical axis and the horizontal axis of the electrode.

[0086] The electrode identifier 740 may include openings 740, 742 configured to receive corresponding connectors (e.g., magnets) that may extend (e.g., protrude) through the openings 740, 742 of the electrode identifier 740 to couple to the system housing and / or components (durable components) contained therein. This configuration may reduce the size and / or weight of the electrode without reducing electrode performance, which may improve the ergonomics of attaching the electrode to the patient's body (e.g., forehead). The alignment of the electrode identifier 740 with each of the conductors 710, 712, the insulator 720, and the magnet may facilitate a compact electrode and may reduce power requirements for reading the electrode identifier 740.

[0087] b. Connectors

[0088] Generally speaking, a stimulation system (e.g., wearable system 100) can include a connector (e.g., connector 132) configured to releasably couple a housing of the system (and / or components contained in the housing) to an electrode. The connector can be configured to mechanically and / or magnetically couple the electrode to the system. In this manner, the electrode can be used as a disposable component with a predetermined number of uses, while the housing of the stimulation system and components contained in the housing can be durable components that can be reused as desired.

[0089] Fig. 9 9 is a rear exploded perspective view of an exemplary variation of a connector of a transcutaneous electrical stimulation system 900. In some variations, the connector may include a connector body 910 and a set of magnets 920, which are configured to be magnetically coupled to a corresponding connector (e.g., connector 620) on an electrode. The magnet 910 may be coupled to one or more leads (not shown), which may be coupled to a signal generator configured to generate a set of pulses. The magnet 910 may be configured to partially extend into a corresponding opening 930 of the connector body 910. In some variations, the connector body 910 may include a set of recessed portions configured to receive corresponding magnets on an electrode. In some variations, the connector body 910 may protrude from the housing of the system 900. The connector body 910 may include a rounded surface to prevent damage. In some variations, the connector may be centered above one or more of the horizontal axis and the vertical axis of the system 900. In some variations, the set of magnets 920 may be circular or any of the shapes discussed herein.

[0090] In some variations, the diameter or width of each of the openings 930 may be between about 3 mm and about 5 mm. In some variations, the center-to-center distance between the outermost openings 930 may be between about 10 mm and about 15 mm.

[0091] In some variations, magnet 920 can be coupled to one or more conductive wires (e.g., leads) configured to connect the electrode to one or more components of a durable component, including a signal generator, a processor, etc. In some variations, each magnet can be coupled to a corresponding insulated lead formed by any conductive metal and / or biocompatible conductive metal and / or alloy (including but not limited to copper, silver, platinum, platinum-iridium, combinations thereof, etc.). One or more portions of the lead can be flexible or semi-flexible, one or more portions can be rigid or semi-rigid, and / or one or more portions of the lead can be transformed between a flexible configuration and a rigid configuration. The leads described herein can be made of any material or combination of materials. For example, the lead can be insulated using one or more polymers (e.g., silicone, polyvinyl chloride, latex, polyurethane, polyethylene, PTFE, nylon).

[0092] In some variations, the magnets of the connector may be coupled to a substrate such as an electronic circuit (eg, electronic circuit 460) such that the magnets may protrude through an opening in the system housing and couple to electrodes while being secured to the substrate. FIG. 10A to FIG. 10C 1 is a schematic side view of an illustrative variation of a magnet 1020 coupled to an electronic circuit 1010 of a transcutaneous electrical stimulation system 1002, 1004, 1006. In some variations, a fastener 1030 can be configured to hold the magnet 1020 to the electronic circuit 1010 to maintain the coupling between the magnet 1020 and the electronic circuit 1010, such as FIG. 10A to FIG. 10C As shown in Fig. 10A In the embodiment, the fastener 1030 can be configured to apply a pushing force to the electronic circuit 460. For example, the fastener 1030 can include a spring configured to hold the fastener 1030 to the surface of the electronic circuit 460. Fig. 10C In the embodiment of the present invention, the spring fastener 1030 can be coupled between the magnet 1020 and the electronic circuit 1010.

[0093] Additionally or alternatively, the electronic circuit (e.g., a flexible printed circuit board (PCB)) may include a set of recessed portions, each recessed portion being sized to receive and retain a corresponding magnet. In some variations, the magnets may be coupled (e.g., using an adhesive) to a rigid surface of a PCB (e.g., a rigid-flex-rigid PCB).

[0094] B.Signal Generator

[0095] In general, the signal generator of any of the systems, devices and methods described herein can be configured to generate a set of pulses for percutaneous stimulation of a patient's nerves. In some variations, the signal generator can include a high voltage generator and a current pulse generator. The high voltage generator can be configured to convert power (e.g., up to 100V) from a power source (e.g., a battery) into a high voltage signal that can be input to the current pulse generator. The current pulse generator can be configured to convert the high voltage signal into a set of pulses for a therapeutic stimulation program with a predetermined set of parameters (e.g., duration, intensity), as described in more detail herein. In some variations, the current pulse generator can include at least two transistors.

[0096] In some embodiments, the signal generator can be configured to generate a set of pulses based on a set of parameters including one or more of pulse frequency, pulse width, pulse period, pulse amplitude, ramp-up time, stabilization time, ramp-down time, treatment duration, phase charge, rise time, stagnation period, and overshoot.

[0097] In some variations, the phase charge may be up to about 5 μC. In some variations, the rise time of the pulse may be up to about 5 μs at about 50% of the maximum value.

[0098] In some variations, the signal generator may be configured to generate the set of pulses comprising a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 17 mA, and a dead time between about 1 μs and about 10 μs.

[0099] In some variations, the signal generator may be configured to generate different sets of pulses (e.g., pulses with different parameters, therapeutic stimulation programs) based on one or more of a treatment indication and / or a treatment type (e.g., acute treatment, preventive treatment). For example, a set of pulses configured to treat an acute migraine may include a pulse frequency of about 100 Hz, a pulse width of about 250 μs, a pulse period of about 500 μs, a maximum pulse amplitude of about 16 mA, a ramp-up time of about 14 minutes, a stabilization time of about 46 minutes, a ramp-down time of about 45 seconds, and a treatment duration of about 60 minutes.

[0100] In some variations, a set of pulses configured to prevent migraine may include a pulse frequency of about 60 Hz, a pulse width of about 250 μs, a pulse period of about 500 μs, a maximum pulse amplitude of about 16 mA, a ramp-up time of about 14 minutes, a stabilization time of about 6 minutes, a ramp-down time of about 45 seconds, and a treatment duration of about 20 minutes.

[0101] In some variations, the signal generator may increase the pulse amplitude incrementally, which may, for example, help reduce side effects. For example, a therapeutic stimulation program may include the following sequence: increasing the pulse amplitude from 0 mA to a first amplitude for a first duration; maintaining the first amplitude for a second duration; increasing the pulse amplitude from the first amplitude to the second amplitude at a first rate; maintaining the second amplitude for a third duration; decreasing the pulse amplitude from the second amplitude to the third amplitude at a second rate; maintaining the third amplitude for a fourth duration; decreasing the pulse amplitude from the third amplitude to the fourth amplitude at a third rate; maintaining the fourth amplitude for a fifth duration; decreasing from the fourth amplitude to the fifth amplitude at a fourth rate; maintaining the sixth duration; decreasing from the fifth amplitude to the sixth amplitude at a fifth rate; maintaining the sixth duration at the sixth amplitude; decreasing from the sixth amplitude to the seventh amplitude at a sixth rate; maintaining the eighth duration at the seventh amplitude; decreasing from the seventh amplitude to the eighth amplitude for a ninth duration.

[0102] In some variations, the signal generator may increase the pulse amplitude incrementally, which may, for example, help reduce side effects. For example, a therapeutic stimulation program may include the following sequence: increase the pulse amplitude from 0 mA to about 1.5 mA in about 10 ms; maintain at about 1.5 mA for about 250 ms; increase the pulse amplitude from about 1.5 mA to about 25 mA by steps of about 0.5 mA every 30 ms; maintain at about 25 mA for about 1 second; decrease the pulse amplitude from about 25 mA to about 20 mA in about 50 ms; maintain at about 20 mA for about 1 second; decrease the pulse amplitude from about 25 mA to about 20 mA in about 50 ms; maintain at about 20 mA for about 1 second; decrease the pulse amplitude from about 25 mA to about 25 mA in about 50 ms The pulse amplitude is reduced from about 20mA to about 15mA; maintained at about 15mA for about 1 second; reduced from about 15mA to about 10mA in about 50ms; maintained at about 10mA for about 1 second; reduced from about 10mA to about 5mA in about 50ms; maintained at 5mA for about 1 second; reduced from about 5mA to about 1.5mA in about 50ms; maintained at about 1.5mA for about 1 second; reduced from about 1.5mA to 0mA in about 50ms.

[0103] In some variations, the signal generator may increase the pulse amplitude incrementally, which may, for example, help reduce side effects. For example, a therapeutic stimulation program may include the following sequence: increasing the pulse amplitude from 0 mA to about 0.32 mA in about 10 ms; maintaining at about 0.32 mA for about 250 ms; increasing the pulse amplitude from about 0.32 mA to about 25 mA by steps of about 0.5 mA every 30 ms; maintaining at about 25 mA for about 1 second; decreasing the pulse amplitude from about 25 mA to about 20 mA in about 50 ms; maintaining at about 20 mA for about 1 second; maintaining at about 20 mA for about 50 ms Reduce the pulse amplitude from about 20mA to about 15mA; hold at about 15mA for about 1 second; reduce from about 15mA to about 10mA within about 50ms; hold at about 10mA for about 1 second; reduce the pulse amplitude from about 10mA to about 5mA within about 50ms; hold at 5mA for about 1 second; reduce from about 5mA to about 1.5mA within about 50ms; hold at about 1.5mA for about 1 second; reduce from about 1.5mA to 0mA within about 50ms.

[0104] C. Electrode identification reader

[0105] Generally speaking, an electrode identification reader (eg, an RFID reader) may be configured to communicate with the electrode identification to receive data corresponding to the electrode. For example, the electrode identification reader may be configured to receive one or more of electrode data, usage data, and authorization data.

[0106] In some variations, the electrode identification and electrode identification reader can be placed within a predetermined proximity of each other (e.g., a disposable electrode coupled to a durable system housing) to facilitate communication and / or data transfer. For example, the coupling between the stimulation system and the electrode can be determined based on a measured load. If a predetermined load (e.g., an electrode) is detected, then the electrode can be authorized using the electrode identification reader and the electrode identification. In some variations, the electrode identification reader can include one or more of an RFID reader, a barcode reader, an optical character reader, etc. For example, Fig.11 is a schematic plan view of an exemplary variation of an RFID circuit 1100 for a transcutaneous electrical stimulation system. In some variations, as Figure 4 As shown, the electrode identification reader 480 can be disposed between the rear housing 440 and the power supply 470. That is, the electrode identification reader 480 is disposed as close as possible to the rear housing 440 in order to increase sensitivity and reduce power consumption of electrodes coupled to the system 400. In some variations, the electrode identification reader can include an antenna configured to generate a magnetic field at a predetermined frequency (e.g., approximately 13 MHz).

[0107] Additionally or alternatively, the electrode identification reader may include an optical sensor (eg, CCD, camera) configured to generate an image of the electrode identification (eg, QR code).

[0108] D. Input devices

[0109] Generally speaking, the input device of the transcutaneous electrical stimulation system can be used as a control interface for the patient. In some variations, the system may include one or more input devices. For example, the wearable system 100 may include an input device 120 (e.g., a button switch) configured to control the wearable system 100. Additionally or alternatively, the computing device 160 may include a corresponding input device (e.g., a touch screen interface) configured to control the wearable system 100. In some variations, the input device 120 may be configured to receive input to control one or more of the signal generator 116, the output device 122, the communication device 128, etc. For example, the patient's actuation of the input device 120 (e.g., switches 310, 410, 420, 1200) may be processed by the processor 124 and the memory 126 to output a control signal to the signal generator 116.

[0110] Some variations of the input device may include at least one switch configured to generate a control signal. In some variations, the input device may encompass at least about 50% of a first side (e.g., front) of the system housing, thereby providing a larger surface area for contact. For example, Figure 3A and Figure 3C A switch 310 is depicted covering at least about 50% of the surface area of ​​a first side of the system 300. In some variations, the switch can be configured to cover at least about 60%, at least about 70%, at least about 80%, at least about 90%, including all ranges and subvalues ​​therebetween. When the system is coupled to the patient's forehead, the patient cannot see the input device, so that a larger contact area can facilitate non-visual operation of the system. In some variations, the switch 310 may include a single button. In some variations, the switch may include multiple buttons (e.g., actuators) located at different portions of the housing. For example, one or more portions of the switch 310 (e.g., an upper portion, a lower portion, a first lateral portion, a second lateral portion) may correspond to corresponding buttons configured for a corresponding set of functions.

[0111] In some variations, the input device of the transcutaneous electrical stimulation system may include a switch cover 410 and a switch 420, such as Figure 4 As shown. The switch cover 410 may include a non-deformable material, such as the same or similar material as the system housing, and the switch 420 may include an elastically deformable material so that the switch 420 functions as a button. Similarly, FIG. 12A to FIG. 12C12 are respective front perspective, side, and rear views of a switch 1200 of a transcutaneous electrical stimulation system. In some variations, the switch 420, 1200 may include a deformable material (e.g., rubber, silicone) configured for repeated tactile actuation by a patient. In some variations, the switch 410, 1200 may include a set of protrusions 1210 facing a first side of the housing. In some variations, adjacent protrusions 1210 may be spaced approximately 5 mm apart. The set of protrusions 1210 may be configured to face and / or contact a switch cover (in FIGS. 12 to 13 ). Fig. 12C 4. The switch 410, 1200 may include a recess 1220 on a second side of the housing opposite the first side of the housing. One or more components of the system (e.g., a processor, a memory of the electronic circuit 460) may be disposed within the recess 1220. For example, the recess 1220 may have a length of about 12 mm and a width of about 10 mm.

[0112] Additionally or alternatively, in a variation of an input device that includes at least one switch, the switch may include, for example, at least one of: a button (e.g., a hard key, a soft key), a touch surface, a keyboard, an analog stick (e.g., a joystick), a directional pad, a mouse, a trackball, a dial, a step switch, a rocker switch, a pointer device (e.g., a stylus), a motion sensor, an image sensor, and a microphone. The motion sensor may receive a signal from an optical sensor and classify a patient gesture as a control signal. The microphone may be configured to receive audio and recognize speech (e.g., a verbal command) as a control signal. In a variation of a system that includes multiple input devices, different input devices may generate different types of signals. For example, some input devices (e.g., buttons on a stimulation system) may be configured to generate control signals to start / stop treatment, while other input devices (e.g., a touch screen of a computing device) may be configured to generate control signals to modify stimulation parameters (e.g., time, intensity).

[0113] In a variation of an input device that includes one or more buttons, button presses of different durations can perform different functions. For example, a longer button press can correspond to selecting a preventive treatment stimulation program. In contrast, a button press of a shorter duration can, for example, correspond to selecting an acute treatment stimulation program. As another example, a first button (e.g., located at the top portion of a switch) can correspond to a first group of functions including selecting a stimulation treatment program (e.g., acute treatment, preventive treatment), a second button (e.g., located at the bottom portion of a switch) can correspond to a second group of functions including changing one or more of the intensity (e.g., amplitude) and duration of the treatment, and a third button (e.g., located at a lateral portion of a switch) can correspond to a third group of functions including connecting the stimulation system to a mobile application (e.g., a mobile application running on a mobile phone) of a computing device.

[0114] E. Output device

[0115] Generally speaking, the output device 130 of the transcutaneous electrical stimulation wearable system 100 and / or the computing device 160, 162 can be configured to output data corresponding to the transcutaneous electrical stimulation system, and can include one or more of a display device (e.g., a set of LEDs), an audio device (e.g., a buzzer), and a tactile device. In some variations, the output device may include a display device that includes at least one of a light emitting diode (LED), a liquid crystal display (LCD), an electroluminescent display (ELD), a plasma display panel (PDP), a thin film transistor (TFT), an organic light emitting diode (OLED), an electronic paper / electronic ink display, a laser display, and / or a holographic display.

[0116] In some variations, the display device 130 may include one or more LEDs (e.g., one, two, three, four, or more) and may include a tricolor LED (e.g., red, green, blue). In some variations, the output device 130 may be configured to indicate, for example, the status of the device. For example, the output device 130 may be configured to indicate one or more of a treatment program (e.g., acute treatment, preventive treatment), a sleep state, a standby state, a battery charge state (e.g., low, charged, charging, voltage value), a computing device connection state, and an electrode authorization state. In some variations, the display device 130 may include one or more portions of the switch cover 410 and the switch 420 having a transparent portion and / or a translucent portion, the one or more portions having a transparent portion and / or a translucent portion configured to output light generated by the set of LEDs. In other words, the display device 130 may include a transparent and / or translucent portion of the switch cover 410 and / or the switch 420.

[0117] In some variations, the output device 130 may include an optical waveguide (e.g., a light pipe, a distribution light guide, etc.). One or more optical waveguides may receive light from a light source (e.g., an illumination source) using a predetermined combination of light output parameters (e.g., wavelength, frequency, intensity, mode, duration). In some variations, the optical waveguide may be integrally formed with one or more parts of the housing (e.g., a switch cover) of the device. An optical waveguide may refer to a physical structure that guides electromagnetic waves such as visible spectrum waves to passively propagate and distribute received electromagnetic waves. Non-limiting examples of optical waveguides include optical fibers, rectangular waveguides, light pipes, light pipes, combinations thereof, and the like. For example, a light pipe may include a hollow structure with a reflective lining or a transparent solid configured to propagate light by total internal reflection. The optical waveguides described herein may be made of any suitable material or combination of materials. For example, in some variations, the optical waveguide may be made of optical grade polycarbonate. In some variations, the housing as described herein may be co-injection molded to form the optical waveguide. In other variations, the optical waveguide may be formed separately and coupled to the housing. In some variations, an optical waveguide described herein may include one or more portions configured to emit light. For example, at least one of the portions may include one or more shapes. For example, the optical waveguide may follow an edge of a housing and / or form the shape of a logo. In some variations, an optical waveguide described herein may include a surface profile including, for example, a multi-faceted surface configured to increase visibility from a predetermined vantage point.

[0118] The light patterns described herein may, for example, include one or more of flashes, light and dark, isoluminous and isoluminous, etc., and / or any suitable light / dark pattern of light. For example, flashes may correspond to rhythmic light, wherein the total duration of light in each cycle is shorter than the total duration of darkness, and wherein the flashes of light have equal durations. Light and dark may correspond to rhythmic light, wherein the duration of light in each cycle is longer than the total duration of darkness. Isoluminous and isoluminous may correspond to light with dark and light cycles of equal length. Light pulse patterns may include one or more colors (e.g., different color outputs per pulse), light intensity, and frequency.

[0119] In some variations, the transcutaneous electrical stimulation system may additionally or alternatively include output devices, such as audio devices and / or tactile devices. For example, the audio device may audibly output patient data, stimulation data (e.g., treatment procedures), error data, system data (e.g., power status), authorization data (e.g., electrode authorization), alarms, and / or notifications (e.g., treatment starts, treatment ends). For example, when the power supply is insufficient or when an unauthorized electrode is coupled to the signal generator of the device, the audio device may output an audible alarm. In some variations, the audio device may include at least one of the following: a speaker, a piezoelectric audio device, a magnetostrictive speaker, and / or a digital speaker. In some variations, the patient can communicate with other users using an audio device (e.g., a microphone) and a communication channel. For example, a user can form an audio communication channel (e.g., a cellular call, a VoIP call) with a health care provider or another person.

[0120] In some variations, the audio device of output device 130 and / or computing device 160, 162 may be configured to indicate the state of the device. For example, the audio device (and any of the output devices described herein) may be configured to indicate power state (e.g., on), treatment program (e.g., acute treatment, preventive treatment), current amplitude (e.g., steady state amplitude, maximum current reached, manually increased current), sleep state, standby state, battery charge state (e.g., low, charged, charging, voltage value), computing device connection state, patient connection state (e.g., electrodes coupled to the patient's forehead), and electrode authorization state.

[0121] In some variations, a haptic device may be incorporated into the transcutaneous electrical stimulation system and / or computing device 160, 162 to provide additional sensory output (e.g., force feedback) to the patient. For example, the haptic device may generate a tactile response (e.g., a vibration) to confirm a user input to an input device (e.g., a button) or to communicate an operating state (e.g., a first vibration pattern corresponding to a first operating state, a second vibration pattern corresponding to a second operating state).

[0122] F. Housing

[0123] Generally speaking, the housing of a transcutaneous electrical stimulation system can be configured to encapsulate a set of durable components in a compact and lightweight form factor that can be held to a patient's skin surface (e.g., forehead) while the patient is receiving treatment. In addition, the housing of the system can be configured to arrange components disposed therein to improve the performance of the system. Figure 4 As described above, the electronic circuit 460, the power supply 470, the spacer 490 and the electrode identification reader 480 may be arranged successively in the housing. Fig.13A and Fig. 13Bare respective front perspective and front views of a rear housing of a transcutaneous electrical stimulation system configured to secure components of the stimulation system in position relative to one another.

[0124] In some variations, the housing of the stimulation device can be configured to separate the power source from the signal generator (e.g., maintain a predetermined distance between the electronic circuit and the power source). For example, a set of protrusions 1330 and a set of fasteners 1340 (e.g., hooks) of the rear housing can be configured to couple to the electronic circuit (e.g., including the signal generator) so that the electronic circuit is held in place within the housing 1300 of the system. For example, the set of protrusions 1330 and the set of fasteners 1340 can be configured to couple (e.g., attach) to the electronic circuit so that the electronic circuit 460 is separated from the power source 470. The spacing formed by the protrusions 1330 and the fasteners 1340 can accommodate heat and dimensional changes in the power source 470 (e.g., due to battery expansion), thereby improving system performance and extending the life of the system. The set of fasteners 1340 (e.g., hooks, clamps) can also be configured to couple (e.g., attach) the electronic circuit 460 (e.g., the edge of the electronic circuit) to the housing 1300. In some variations, the distance between the fasteners (e.g., upper fastener, lower fastener) can be between about 25 mm and about 35 mm. In some variations, the protrusion 1330 can include a height between about 5 mm and about 10 mm, including all ranges and sub-values ​​therebetween. In some variations, the fastener 1340 can include a height between about 5 mm and about 10 mm, including all ranges and sub-values ​​therebetween. In some variations, the protrusion 1330 can include a first height, and the fastener 1340 can include a second height greater than the first height. For example, the first height can be about 7 mm and the second height can be about 9 mm. In some variations, the protrusion 1330 and the fastener 1340 can be arranged along the opposite lateral ends of the housing. In some variations, the electronic circuit (e.g., electronic circuit 460) can be separated from the power supply (e.g., power supply 470) by up to about 2.0 mm and up to about 1.0 mm, including all ranges and sub-values ​​therebetween.

[0125] In some variations, the set of protrusions 1330 can be configured to couple to a first side of an electronic circuit (e.g., a signal generator), and the set of fasteners 1340 can be configured to couple to a second side of the electronic circuit opposite to the first side. In some variations, the set of protrusions 1330 can be configured to separate the electronic circuit (e.g., a signal generator) from the connector 1310 by a second predetermined distance. For example, the electronic circuit can be separated from the housing by up to about 10 mm, up to about 7 mm, up to about 5 mm, including all ranges and sub-values ​​therebetween. In some variations, the height of the set of protrusions 1330 can be less than the height of the set of fasteners 1340. In some variations, the set of protrusions 1330 and the set of fasteners 1340 can be located on opposite ends of the housing (e.g., top and bottom, left and right) so that the set of protrusions 1330 and the set of fasteners 1340 do not contact the power supply. Fig.13A and Fig. 13B A set of four protrusions 1330 is shown, but the set of protrusions 1330 may include any number of protrusions, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more. Similarly, Fig.13A and Fig. 13B A set of two fasteners 1340 is illustrated, but the set of fasteners 1340 may include any number of fasteners, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more. In some variations, the set of protrusions 1330 may be configured to contact the electronic circuit and / or protrude through corresponding openings in the electronic circuit to hold the electronic circuit in place relative to the housing.

[0126] G. Processor

[0127] like Figure 1 As depicted, the transcutaneous electrical stimulation wearable system 100 may include a processor 124 and a machine-readable memory 126 (e.g., collectively referred to as a controller) in communication with one or more computing devices 160, 162. The processor 124 may be connected to the computing devices 160, 162 via a wired or wireless communication channel. The processor 124 may be configured to control one or more components of the wearable system 100, such as a signal generator 116, an electrode identification reader 118, and a communication device 128. The processor 124 may be implemented consistent with many general-purpose or special-purpose computing systems or configurations. Various exemplary computing systems, environments, and / or configurations suitable for use with the systems and devices disclosed herein may include, but are not limited to, software or other components within or embodied on a personal computing device, a network device, a server or server computing device (such as a routing / connection component), a portable (e.g., handheld) or laptop device, a multi-processor system, a microprocessor-based system, and a distributed computing network.

[0128] The processor 124 may incorporate data received from the memory 126, patient input, and computing devices 160, 162 to control the system 10, 100. The memory 126 may also store instructions to cause the processor 124 to execute modules, processes, and / or functions associated with the system 100 and / or computing devices 160, 162. The processor 124 may be any suitable processing device configured to run and / or execute a set of instructions or codes, and may include one or more microcontrollers, data processors, image processors, graphics processing units, physical processing units, digital signal processors, and / or central processing units. The processor 124 may be, for example, a general purpose processor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), which is configured to execute application processes and / or other modules, processes, and / or functions associated with the system and / or a network associated therewith. For example, the processor 124 may be a dual-core microcontroller. The underlying device technology can be provided in various component types, such as metal oxide semiconductor field effect transistor (MOSFET) technology like complementary metal oxide semiconductor (CMOS), bipolar technology like emitter coupled logic (ECL), polymer technology (e.g., silicon conjugated polymer and metal conjugated polymer-metal structures), hybrid analog and digital, combinations thereof, etc.

[0129] H. Memory

[0130] Some variations of the memory 126 described herein involve a computer storage product having a non-transitory computer-readable medium (also referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not itself include a transient propagating signal (e.g., a propagating electromagnetic wave that carries information on a transmission medium such as air or a cable). The medium and computer code (also referred to as code or algorithm) may be designed and constructed for one or more specific purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media, such as hard disks, floppy disks, and magnetic tapes; optical storage media, such as compact disks / digital video disks (CD / DVD), compact disk-read only memories (CD-ROMs), and holographic devices; magneto-optical storage media, such as optical disks; solid-state storage devices, such as solid-state drives (SSDs) and solid-state hybrid drives (SSHDs); carrier signal processing modules; and hardware devices that are specifically configured to store and execute program code, such as application specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memories (ROMs), and random access memory (RAM) devices. Other variations described herein relate to computer program products that may include, for example, instructions and / or computer code disclosed herein.

[0131] The systems, devices, and / or methods described herein may be implemented by software (implemented on hardware), hardware, or a combination thereof. Software modules (implemented on hardware) may be expressed in a variety of software languages ​​(e.g., computer code), including C, C++, , Python, Ruby, and / or other object-oriented, procedural or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions (e.g., generated by a compiler), code for generating network services, and files containing high-level instructions that are executed by a computer using an interpreter. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0132] In some embodiments, a set of parameters can be stored in memory 126 and / or transmitted to computing device 160, the set of parameters including: treatment session time (e.g., treatment session timestamp or time when treatment session started), selected treatment stimulation program, treatment session duration (e.g., number of minutes in treatment session), maximum current amplitude in treatment session, treatment session errors, number of repetitions, total current delivered, total current delivered if maximum current amplitude is reached, a set of pulse parameters, battery charge time (e.g., timestamp), battery charge duration, duration to full charge, and battery charging errors.

[0133] I. Communication equipment

[0134] In some variations, the transcutaneous electrical stimulation system 100 described herein can communicate with a network and a computer system through a communication device 128. In some variations, the transcutaneous electrical stimulation wearable system 100 can communicate with other devices (e.g., computing devices) via one or more wired and / or wireless networks. A wireless network may refer to any type of digital network that is not connected by any type of cable. Examples of wireless communications in a wireless network include, but are not limited to, Bluetooth, cellular, radio, satellite, and microwave communications. However, a wireless network can be connected to a wired network to connect to the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are typically carried by copper twisted pair, coaxial cable, and / or fiber optic cable. There are many different types of wired networks, including wide area networks (WANs), metropolitan area networks (MANs), local area networks (LANs), Internet (IANs), campus networks (CANs), global area networks (GANs) (such as the Internet), and virtual private networks (VPNs). In the following, a network refers to any combination of wireless, wired, public, and private data networks that are typically interconnected by the Internet to provide a unified networking and information access system.

[0135] In some variations, communications using the communication device 128 may be encrypted. The communication device 128 may be used to transmit any of the data stored in the memory 126 (eg, a set of parameters described herein).

[0136] Cellular communications can encompass technologies such as GSM, PCS, CDMA or GPRS, W-CDMA, EDGE or CDMA2000, LTE, WiMAX, and 5G network standards. Some wireless network deployments combine networks from multiple cellular networks or use a mix of cellular, Wi-Fi, and satellite communications. In some variations, the network interface 116 may include a radio frequency receiver, a transmitter, and / or an optical (e.g., infrared) receiver and transmitter. The communication device 128 may communicate with one or more components of the system 10, 100 by wire and / or wirelessly.

[0137] J. Power Supply

[0138] Generally speaking, the transcutaneous electrical stimulation system described herein can receive power from an internal power source (e.g., a lithium battery, a disposable battery) and can be recharged using an external power source (e.g., a wireless charger, a wall socket). The transcutaneous electrical stimulation system can receive power via a wired connection and / or a wireless connection (e.g., induction, RF coupling, etc.). The transcutaneous electrical stimulation system may include one or more power algorithms that are configured to conserve energy and increase the life of the transcutaneous electrical stimulation system.

[0139] K. Charger

[0140] Generally speaking, a charger may be configured to provide power and / or recharge a power source of a transcutaneous electrical stimulation system. FIG. 14A to FIG. 14D 1400 are the corresponding front perspective view, front view, rear view and side view of the charger 1400. FIG. 14A to FIG. 14D As shown, the charger 1400 can have a generally disc-like shape. In some variations, the charger 1400 can be configured to receive and hold the stimulation system. For example, the charger 1400 can include one or more recesses and / or protrusions to receive a rear portion of the stimulation system. In some variations, the charger 1400 can be electrically coupled to a power source for the stimulation system. In some variations, a system such as system 300 can be disposed on a surface of the charger 1400 to wirelessly transfer energy to the system 300 via inductive coupling (e.g., electromagnetic coupling). In some variations, the charger can include a USB-C cable.

[0141] II. Methods

[0142] Also described herein is a method for non-invasive transcutaneous electrical stimulation using the devices and systems described herein. Generally speaking, the methods described herein include coupling electrodes to the skin surface (e.g., forehead) of the patient, and coupling the housing of the electrical stimulation system to the electrodes. In some variations, the electrodes may be coupled to the housing of the electrical stimulation system before being coupled to the skin surface, and in other variations, the electrodes may be coupled to the skin surface, after which the housing of the electrical stimulation system may be coupled to the electrodes, while the electrodes remain coupled to the skin surface (i.e., in situ). In some variations, one or more of the stimulation system and / or computing device may provide instructions on how to couple electrodes and / or couple electrodes to the patient and / or how to use the system (e.g., select and start a treatment course). The electrode may include an electrode identifier for the electrode, and the electrical stimulation system may include a signal generator and an identifier reader. The electrode identifier may be detected using an identifier reader of the electrical stimulation system. An authorization signal may be generated based on the detected identifier, and a group of pulses generated by the signal generator based on the authorization signal may be used to stimulate the patient's nerve (e.g., trigeminal nerve). In some variations, the method may further include removing the electrode from the electrode release system and / or from the skin surface, which may occur simultaneously or sequentially.

[0143] A. Apply electrical stimulation

[0144] Fig.15A and Fig. 15B is a graph of exemplary variations of pulse waveforms for transcutaneous electrical stimulation. For example, Fig.15A and Fig. 15B A set of biphasic bipolar pulses (eg, stimulation signals) having an excitation phase followed sequentially by a compensation phase is illustrated. Fig. 15B The diagram shows the pulse amplitude, pulse width, dead time and pulse period of a set of biphasic bipolar pulses.

[0145] In some variations, a set of pulses may include one or more of the following: a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 16 mA, a difference between the excitation phase and the compensation phase of ±1.5 mA at 16 mA, a dead time between about 1 μs and about 9 μs, an overshoot of about 8 mA at 16 mA within about 1 μs maximum.

[0146] In some variations, an acute treatment session as described herein may include a set of pulses that may include a frequency of about 100 Hz, a pulse width of about 250 μs, a pulse duration of about 500 μs, an amplitude that increases at a linear rate of about 0.5 mA / 29 seconds (e.g., increasing the amplitude from about 1.5 mA to about 16 mA over about 14 minutes), followed by a steady amplitude of about 16 mA for about 46 minutes, for a total treatment time of about 60 minutes. In some variations, the amplitude at the end of treatment may decrease linearly from about 16 mA to about 1.5 mA over about 45 seconds, and then to 0 mA.

[0147] In some variations, a course of prophylactic treatment may include a set of pulses comprising a frequency of about 60 Hz, a pulse width of about 250 μs, a pulse duration of about 500 μs, an amplitude increasing at a linear rate of about 0.5 mA / 29 seconds (e.g., from about 0.32 mA or 1.5 mA to about 16 mA in about 14 minutes), followed by a steady amplitude of about 16 mA for about 6 minutes, for a total treatment time of about 20 minutes. In some variations, the amplitude at the end of treatment may decrease linearly from about 16 mA to about 1.5 mA in about 45 seconds, and then to 0 mA.

[0148] Additionally or alternatively, the input device 120 and / or computing device 160, 162 can be actuated (e.g., by the patient) to manually increase the amplitude (e.g., intensity). For example, each button press can correspond to an increase of approximately 0.5 mA per second. When operating a mobile application on a mobile phone, the patient can select to change the amplitude on the GUI. In some variations, a group of pulses (e.g., acute treatment procedure, preventive treatment procedure). For example, Fig. 15Cis a graph of stimulation intensity (e.g., amplitude mA) over time for a preventive treatment course. The dashed line corresponds to a preventive treatment course as described herein, and the solid line at about the 8th minute and 10 mA corresponds to the patient manually controlling to maintain intensity. At about the 13th minute, the patient manually increases the amplitude to about 12 mA until the treatment course ends at about the 20th minute, after which a ramp-down of about 45 seconds occurs. It should be understood that manual commands can be entered by the patient at any point between treatment courses to modify stimulation parameters (e.g., amplitude, duration, etc.).

[0149] It should be understood that when the power source is activated (e.g., power-on state), the stimulation system can undergo a startup sequence. In some variations, stimulation system activation can include one or more of the following: determining the power level of the power source (e.g., battery), and measuring a predetermined load (e.g., connection of an electrode to the patient's forehead). In some variations, if the predetermined load is measured, then unless a command is received to select a different treatment course (e.g., such as a button press on input device 120), a predetermined treatment course (e.g., an acute treatment course, a preventive treatment course) can be automatically initiated. If the predetermined load is not measured, the system can transition to a standby state.

[0150] In some variations, the memory of the system may be configured to store one or more of: session time (e.g., start time, timestamp), selected therapeutic stimulation program, session duration, maximum current amplitude in a session, session errors, number of repetitions, total current delivered, total current delivered if maximum current amplitude is reached, battery charge time, battery charge duration, duration to full charge, and battery charge errors. In some variations, data stored in the memory may be encrypted (e.g., AES128).

[0151] In some variations, a graphical user interface (GUI) may be configured for operating a transcutaneous electrical stimulation system and / or treating a patient. FIG. 17A to FIG. 1 7M depicts an illustrative variation of a graphical user interface associated with a transcutaneous electrical stimulation interface, as will be described in more detail herein.

[0152] B. Electrode Authorization

[0153] Treating a patient using a transcutaneous electrical stimulation system as described herein may include authorizing the electrodes prior to generating electrical stimulation pulses. Generally, the method may include detecting an electrode identification using an identification reader, generating an authorization signal based on the detected identification, and stimulating the patient's trigeminal nerve using the set of pulses based on the authorization signal. For example, Fig.16A flowchart representation of a method for authorizing an electrode 1600 using any of the systems and devices described herein is depicted. The method 1600 may include coupling an electrode to a patient's forehead. For example, the electrode 112 may include an electrode identification 114 for the electrode 112. The housing of the electrical stimulation system may be coupled to the electrode 1604. For example, the wearable system 100 may include a signal generator 116 and an identification reader 118 (e.g., an electrode identification reader). Optionally, the stimulation system may be connected to a computing device so that the computing device may be configured to control (e.g., operate) the stimulation system. For example, one or more of a Bluetooth and Wi-Fi connection may be established between a mobile application of the computing device and the stimulation system so that the patient controls the stimulation system using the computing device. In some variations, a treatment program 1606 may be selected. For example, the wearable system 100 may be activated with a default treatment program (e.g., acute treatment, preventive treatment). In some variations, the electrode identification may be detected using an identification reader of the electrical stimulation system. For example, the electrode identification (e.g., a unique value, code assigned to the electrode) and / or the password of the electrode identification 114 can be detected by the identification reader 118 of the wearable system 100. The identification reader 118 can determine whether the detected identification and / or password matches the authorized identification and password 1610. If not, the generation of a set of pulses can be prohibited 1612. That is, when the authorized electrode identification is not detected, the generation of the set of pulses is prohibited.

[0154] If the detected identification and password match the authorized identification and password, an authorization signal 1614 is generated based on the detected identification. The determination of whether to generate the set of pulses can be based on the generated authorization signal 1616. For example, when the authorization signal is one or more of unauthorized, expired, and overused, the generation of the set of pulses 1612 is prohibited. For example, each electrode can be associated with a predetermined validity period and a predetermined number of uses (e.g., 5 treatment sessions, 10 treatment sessions, 20 treatment sessions). Otherwise, a set of pulses 1618 is allowed to be generated due to the authorization signal indicating the valid electrode. The set of pulses 1620 can be used to stimulate the patient. For example, a set of pulses generated by a signal generator based on an authorization signal indicating permission to use the detected electrode can be used to stimulate the patient's trigeminal nerve. In some variations, the system can be released from the electrode 1622. For example, when the treatment session has ended, the stimulation device 102 of the wearable system 100 can be removed from the electrode 112 and / or the electrode 112 can be removed from the patient's skin surface (e.g., forehead).

[0155] C. Graphical User Interface

[0156] In some variations, the stimulation systems described herein may be operated by one or more of an input device on the system itself (e.g., button 310) and a mobile application executed on a computing device 160, 162 (e.g., mobile phone, laptop, desktop PC) that communicates with the stimulation system. This may facilitate improved ergonomics, control, and monitoring of treatment sessions. In some variations, the mobile application may include a set of GUIs, as described in more detail herein. Fig.17A 1700 includes a menu interface. For example, GUI 1700 may be a home page. GUI 1700 may include one or more of the following: a log condition icon 1702 (e.g., migraine), a log treatment icon 1704, a stimulation system icon 1706, a treatment status 1708, and a system power indicator 1709 (e.g., system battery status). A user may select one or more of log condition icon 1702, log treatment icon 1704, and stimulation system icon 1706 to access additional functionality. For example, selection of log condition icon 1702 may transition from menu interface 1700 to GUI 1730 (e.g., Fig.17D ), selection of the record treatment icon 1704 may transition from the menu interface 1700 to the GUI 1720 (e.g., Fig. 17C ), and selection of the stimulation system icon 1706 may transition from the menu interface to the GUI 1710 (e.g., Fig. 17B ). In some variations, the stimulation system icon 1706 may include a graphical representation of the elapsed treatment time. For example, in some variations, the stimulation system icon 1706 may indicate the amount of elapsed treatment time as a ring that fills (e.g., extends along its circumference) over time, a series of icons (e.g., bars) that appear progressively, a line that increases in length, combinations thereof, etc. In some variations, different colors may be used to indicate different parts of the treatment process. For example, yellow, green, and red may be used to indicate the corresponding ramp-up, steady-state, and ramp-down current intensity states of a treatment session.

[0157] Fig. 17B is a variation of GUI 1710 that includes a treatment interface. For example, GUI 1700 can display data corresponding to an ongoing stimulation therapy session. GUI 1710 can include one or more of: a timer 1712 (e.g., indicating the amount of time that has passed and / or the time remaining in the treatment session), a graph 1714 corresponding to intensity (e.g., current delivered) over time, a treatment state 1716 (e.g., acute treatment session, preventive treatment session), and a system power indicator 1718 (e.g., a percentage of battery life remaining).

[0158] Fig. 17Cis a variation of a GUI 1720 that includes a recorded treatment interface. For example, the GUI 1720 may include a calendar 1722 containing information related to one or more planned treatment sessions, recorded treatment sessions, and / or recorded conditions. The GUI 1720 may include one or more of a timer 1712 (e.g., indicating the amount of time that has passed and / or the time remaining in a treatment session), a graph 1714 corresponding to intensity (e.g., delivered current) over time, a treatment status 1716, and a system power indicator 1718. The GUI 1720 may also include one or more of a condition summary 1724 (e.g., migraine) and a treatment summary 1725. The condition summary 1724 may include a set of recorded condition data including, but not limited to, date, duration, intensity, and a patient-entered description. The treatment summary 1726 may include electrical stimulation data including one or more of the following: treatment session time, selected treatment stimulation program, treatment session duration, maximum current amplitude in the treatment session, treatment session errors, number of repetitions (e.g., number of treatments), total current delivered, and total current delivered if maximum current amplitude is reached. Additionally or alternatively, a system summary may be displayed and include one or more of the following: battery charge time, battery charge duration, duration to full charge, and battery charge errors. Treatment sessions initiated by the electrical stimulation systems described herein may be automatically recorded to a record treatment interface and viewed at a later time.

[0159] Fig.17D is a variation of the GUI 1730 that includes a record symptom interface. For example, the GUI 1730 may display a set of selectable location icons 1732 corresponding to the location of pain on the patient's head. Additionally or alternatively, the patient may enter one or more of the following: perceived symptom intensity (e.g., from 1 to 10), trigger conditions (e.g., food, stress, smell), one or more symptoms (e.g., throbbing headache, body pain, visual distortion), one or more medications taken (e.g., prescription medications, over-the-counter medications such as NSAIDs), non-drug treatments (e.g., electrical stimulation sessions), effectiveness of any of the aforementioned medications and / or treatments (e.g., from 1 to 5, able / inability to continue activities). In some variations, the patient may further enter a description of the symptom as one or more of text (e.g., a log), audio (e.g., a voice recording), and / or images (e.g., pictures, videos, selfies). The data entered into the record symptom interface may be tracked over time for patient monitoring.

[0160] In some variations, one or more notifications may be displayed on a computing device 160 of a user 140 of the system. For example, a scheduled reminder for a preventive treatment may be output on one or more of the computing device 160 and the wearable system 100 at a predetermined interval (e.g., every day at 9:00 a.m. for a 20-minute treatment).

[0161] FIG. 17E to FIG. 17G is a variation of GUIs 1740, 1742, 1744 that include condition trends and treatment trends. For example, GUI 1740 may display a set of condition trends, such as patient input trigger conditions, symptoms, locations, intensity, and calculated trends, such as condition and / or treatment frequency (e.g., each day of the week, each part of the day). GUI 1742 may display one or more of the following: treatment effectiveness, treatment procedures (e.g., acute, preventive), and condition trends over time (e.g., migraine frequency, migraine intensity, average duration of migraine). GUI 1744 may display one or more treatment trends over time (e.g., acute treatment, preventive treatment, electrical stimulation system treatment). It should be understood that the data displayed in any of the GUIs may be transmitted (e.g., exported) as a separate report for one or more of a patient, family member, caregiver, health care professional, etc. In some variations, the data displayed in any of the GUIs disclosed herein may be displayed in real time to an authorized user (e.g., patient, family member, caregiver, health care professional). For example, a healthcare professional may be granted access to view GUIs and / or reports corresponding to treatment trends, condition trends, and the like.

[0162] Although described above with respect to the treatment of migraine, it should be understood that GUIs 1700 to 1744 with corresponding features may be used with respect to the treatment of any of the disorders or conditions described herein. For example, the GUI may include a sleep log icon, where the patient may enter their own sleep data (e.g., a description of sleep, rest, pre-sleep activities), or an anxiety log, where the patient may enter anxiety triggers, anxiety intensity, anxiety frequency, duration, anxiety symptoms, etc. Similarly, the GUI may include one or more icons related to patient data, including one or more of the following: heart rate, oxygen saturation, blood pressure, menstrual cycle, sleep, nutrition, hydration, medications consumed, activity level, geographic location, weather, air pressure, temperature, humidity, pollen count, air quality, pollution level, demographic data, etc. The patient data may be received from a measurement device configured to measure, receive and / or analyze one or more characteristics of the user. Non-limiting examples of measurement devices include wearable activity devices (e.g., pedometers or other activity trackers, smart jewelry, smart watches, smart rings), hydration trackers, blood pressure monitors, heart rate monitors, ultrasonic sensors, cholesterol monitors, scales, geo-location devices (e.g., GPS, GLONASS), smart phones, refrigerators, PCs, implantable diagnostic devices, ingestible diagnostic devices, and other diagnostic devices. Furthermore, while in some embodiments the measurement device may be a wearable device as described above, it should be understood that in other embodiments the measurement device may be configured as a non-wearable device. One example of a non-wearable measurement device for measuring one or more sleep parameters is an implantable device or external monitor, such as a bedside monitor or a home virtual assistant (e.g., similar to or Google HomeTM devices), set-top box services (e.g., similar to Apple ), or other smart appliances, such as clocks, radios, etc. In some variations, the system described herein may include multiple measurement devices, one or more of which may be wearable devices, and one or more of which may be configured as non-wearable devices.

[0163] Fig.18Ais a variation of GUI 1800 that includes a menu interface. For example, GUI 1800 can be a home page. GUI 1800 can include one or more of the following: an acute treatment icon 1820, a preventive treatment icon 1822, a stimulation system icon 1824, a record condition icon 1826, an opinion icon 1828, a stimulation system connection status 1812, and a system power indicator 1813 (e.g., system battery status). A user can select one or more of the acute treatment icon 1820, the preventive treatment icon 1822, and the stimulation system icon 1824 to access additional functionality. For example, selection of the acute treatment icon 1820 can initiate and / or start a timer to track, record, and / or control an acute treatment using a stimulation device (e.g., device 102, 200, 202, 204, 300, 400), and transition from GUI 1800 to GUI 1801 (e.g., Fig.18B ). Selection of the preventive therapy icon 1822 may initiate and / or start a timer to track, record, and / or control preventive therapy using the stimulation device. Selection of the stimulation system icon 1824 may transition from the GUI 1800 to the GUI 1802 (e.g., Fig.18C ). GUI 1802 may include a preventive treatment icon 1830 for initiating a preventive treatment using a stimulation device, and an acute treatment icon 1832 for initiating an acute treatment using a stimulation device. Any of the icons described herein may include one or more of alphanumeric characters, pictures, graphical elements, and the like (including combinations thereof). Additionally or alternatively, the icons may be the same size or may have variable sizes, and the size and prominence of the icons on the GUI may change depending on the user's selection. For example, in some variations, the selected icon (in Fig.18A In the example, the acute treatment icon 1820) can be larger than the other icons.

[0164] Selection of the record condition icon 1826 in the GUI 1800, 1801 may transition from the GUI 1800, 1801 to the GUI 1720 (e.g., Fig. 17C ). Selection of the opinion icon 1828 may transition from the GUIs 1800, 1801 to one or more of the GUIs 1740, 1742, 1744 (e.g., FIG. 17E to FIG. 17G ).

[0165] In some variations, selection of the acute treatment icon 1820 may activate and / or start a timer to track and / or record the acute treatment using the stimulation device and transition the GUI 1800 to the GUI 1801. The GUI 1801 may include an acute treatment icon 1821 including a timer and a treatment state 1814 indicating that the acute treatment using the stimulation device is active. Additionally or alternatively, the stimulation system icon 1825 may include a graphical representation of the elapsed treatment time or the remaining treatment time (e.g., a ring-based timer). Furthermore, while depicted with respect to the stimulation system icon 1825, it should be understood that the acute treatment icon 1821 and / or the preventive treatment icon 1822 (when the preventive treatment is activated and / or timed) may include a graphical representation of the elapsed treatment time or the remaining treatment time (e.g., a ring-based timer).

[0166] Fig.18D and FIG. 18G to FIG. 18J A variation of the graphical user interface that includes a preventive treatment interface. Fig.18D is a variation of GUI 1803 that includes a preventive treatment interface. For example, GUI 1803 can display data corresponding to a preventive stimulation treatment course in progress (e.g., in real time). GUI 1803 can include one or more of the following: a timer 1840 (e.g., indicating the amount of time that has passed and / or the remaining time in the treatment course), a graph 1842 corresponding to the intensity (e.g., the current delivered) over time, a stop treatment icon 1844, an increase intensity icon 1846, a treatment status 1815 (e.g., preventive treatment course), and a system power indicator 1813 (e.g., a percentage of battery life remaining). The intensity level of the stimulation treatment can correspond to the pulse amplitude of the treatment stimulation program generated by the stimulation device and delivered to the patient. For example, a treatment stimulation program (e.g., a preventive treatment program) can include a predetermined minimum pulse amplitude (e.g., 0 mA) and a predetermined maximum pulse amplitude (e.g., about 16 mA). Graph 1842 may depict delivered pulse amplitudes between a minimum pulse amplitude (e.g., 0 mA) and a maximum pulse amplitude on a predetermined scale (e.g., minimum - 0%, low - 25%, medium - 50%, high - 75%, maximum - 100%) over time (e.g., minutes). For some patients, presenting intensity levels as a function of current may be unfamiliar and confusing, so that a relative description of treatment intensity (e.g., low, medium, high) may be more understandable and useful.

[0167] In some variations, the patient may select stop therapy icon 1844 to disable further stimulation during the therapy session (e.g., stop the therapy session) and / or stop tracking and / or recording the therapy session. For example, selection of stop therapy icon 1844 may disable preventive therapy or acute therapy using a stimulation device (e.g., device 102, 200, 204, 300, 400), and / or may stop tracking and / or recording preventive therapy or acute therapy, and may transition the displayed GUI to GUI 1804 (e.g., Fig.18E ). The patient may confirm the end of the treatment session via GUI 1804. In some variations, GUI 1804 may be displayed on another GUI (e.g., a preventive treatment interface, an acute treatment interface).

[0168] In some variations, the goal of the preventive stimulation therapy can be to gradually acclimate the patient to higher intensity treatments over time (e.g., over multiple treatment sessions) in order to prevent or reduce the likelihood of migraines. Acclimatization is generally a patient-specific process. For example, a patient may initially find preventive treatment intensities above a low level (e.g., 25% of the maximum intensity level) uncomfortable or intolerable for more than a few minutes. However, the patient may acclimate to the low intensity levels over multiple treatment sessions, such that the patient is able to tolerate higher intensity levels after the acclimatization period.

[0169] In some variations, a patient may modify a predetermined set of pulses delivered during a stimulation therapy session to improve their treatment outcome (e.g., reduce the frequency and intensity of migraine headaches). For example, a patient may modify a predetermined set of pulses, including modifying one or more of the following: pulse amplitude, ramp-up time, stabilization time, ramp-down time, and session duration. In some variations, a preventive stimulation therapy session may include a predetermined set of pulses configured to prevent migraine headaches. As a non-limiting example of preventive stimulation parameters, a predetermined set of pulses may include a pulse frequency of about 60 Hz, a pulse width of about 250 μs, a pulse period of about 500 μs, a maximum pulse amplitude of about 16 mA, a ramp-up time of about 14 minutes, a stabilization time of about 6 minutes, a ramp-down time of about 45 seconds, and a session duration of about 20 minutes. In GUI 1803, a patient may select an increase intensity icon 1846 to increase the rate at which the intensity (e.g., pulse amplitude) increases. Increasing the intensity rate may shorten the ramp-up time of a therapy session and achieve a longer stabilization time without modifying the session duration. Additionally or alternatively, the patient may select a decrease intensity icon (not shown) to decrease the rate at which the intensity increases. This may be useful when the patient desires a longer ramp-up time (where the intensity increases more slowly, i.e., at a lower rate).

[0170] Figure 18Gis a variation of GUI 1806 that includes a preventive treatment interface in which the delivered pulse amplitude has been linearly increased from 0% to about 80% of the maximum pulse amplitude. In GUI 1806, the patient can select maintain intensity icon 1848 to maintain the current pulse amplitude (e.g., 80% of the maximum pulse amplitude). This can be useful when the patient determines that further intensity (e.g., pulse amplitude) increases are undesirable or would be difficult to tolerate (e.g., uncomfortable, painful). Fig.18H and Fig.18I 1807, 1808, including a preventive treatment interface, wherein the intensity has been maintained (e.g., at 80% of the maximum pulse amplitude) for a stabilization time. In some variations, the patient may select the increase intensity icon 1846 during the stabilization time to increase the maximum pulse amplitude for the preventive treatment session. Additionally or alternatively, the patient may select the decrease intensity icon (not shown) if a lower pulse amplitude is desired. Fig.18J is a variation of GUI 1809 that includes a preventive treatment interface for a complete preventive treatment course. A graph 1842 of GUI 1809 depicts a step-like increase in intensity over time in alternating ramp-up periods (increasing intensity) and steady-state periods (constant intensity) and ramp-down periods (reducing intensity). In some variations, one or more of an audio notification and a tactile notification may be output during a treatment course (e.g., when intensity changes, when a ramp-up period starts and / or stops, when a ramp-down period starts and / or stops, when a steady-state period starts and / or stops) and / or when a treatment course is completed. In some variations, selection of the stop treatment icon 1844 and the increase intensity icon 1846 may be disabled when a treatment course is completed.

[0171] In some variations, completion of a treatment session may transition the displayed GUI (e.g., GUI 1809) to GUI 1805 (e.g., Fig.18F ). The patient may confirm the start of another treatment session via GUI 1805. In some variations, GUI 1805 may be displayed on (overlaid on) another GUI (eg, GUI 1809).

[0172] Figure 18K and Figure 18L is a variation of a graphical user interface that includes an acute therapy interface. In some variations, a goal of the acute stimulation therapy is to shorten one or more of the duration and intensity of an acute (eg, ongoing) migraine headache. Figure 18Kis a variation of GUI 1810 that includes an acute treatment interface. For example, GUI 1810 can display data corresponding to an ongoing (e.g., real-time) acute stimulation therapy session. GUI 1810 can include one or more of: a timer 1840 (e.g., indicating the amount of time that has passed and / or the time remaining in the therapy session), a graph 1842 corresponding to intensity (e.g., delivered current) over time, a stop therapy icon 1844, a maintain intensity icon 1848, a therapy status 1814 (e.g., an acute therapy session), and a system power indicator 1813 (e.g., a percentage of battery life remaining). In some variations, the patient can select the stop therapy icon 1844 to disable further stimulation during the therapy session (e.g., to stop the therapy session).

[0173] In some variations, a patient may modify a predetermined set of pulses delivered during an acute stimulation therapy session to improve their treatment outcome (e.g., reduce the duration of a migraine). GUI 1810 depicts a graph 1842 in which the delivered pulse amplitude has been linearly increased from 0% to approximately 82% of the maximum pulse amplitude. In GUI 1803, the patient may select maintain intensity icon 1848 to maintain the current pulse amplitude (e.g., 82% of the maximum pulse amplitude), where, for example, 82% of the maximum pulse amplitude is sufficient to reduce migraine symptoms.

[0174] Figure 18L 18 is a variation of GUI 1811 that includes a preventive treatment interface in which the intensity has been maintained (e.g., at 82% of the maximum pulse amplitude) for a stabilization time. In some variations, if the patient desires additional stimulation, the patient may select the increase intensity icon 1846 during the stabilization time to increase the maximum pulse amplitude for the acute treatment session. Additionally or alternatively, if a lower pulse amplitude is desired, the patient may select the decrease intensity icon (not shown).

[0175] FIG. 19A to FIG. 19GIllustrative variations of graphical user interfaces 1900, 1902, 1904, 1906 that include condition trends and treatment trends are depicted. For example, GUI 1900 may include a "Problem" column containing condition trends (e.g., "8.0 migraine days per month"), a "Solution" column containing treatment statistics, and a "Results" column containing treatment trends (e.g., "22 attack-free days!"). GUI 1902 may display one or more condition trends over time (e.g., migraine triggers, migraine symptoms, migraine location, migraine frequency, migraine intensity). GUI 1904 may display one or more treatment trends over time (e.g., acute treatment, preventive treatment, electrical stimulation system treatment, medication, no treatment). GUI 1906, 1908 may display a set of condition trends and treatment trends over time (e.g., migraine frequency, migraine intensity, migraine duration, treatment frequency, treatment effectiveness). GUIs 1900, 1902, 1904, 1906 may be accessed by one or more of the patient and authorized users (e.g., family members, caregivers, health care professionals). GUIs 1910, 1912 may display a set of condition and treatment data including amount, date, start time, duration, maximum intensity, location, symptoms, acute treatment, efficacy, and user notes.

[0176] D. Determination of dosage

[0177] Treating a patient using a transcutaneous electrical stimulation system (e.g., a system described herein) can include determining a dosage, and modifying a treatment program (e.g., stimulation parameters) based on the determined dosage. Determining the dosage of neurostimulation over time to modify the stimulation parameters can facilitate optimizing treatment of the condition by, for example, facilitating providing the patient with the lowest effective dose of neurostimulation, thereby improving treatment outcomes and minimizing the risk of adverse effects of the treatment. Neurostimulation includes applying electrical stimulation having multiple stimulation parameters, including, but not limited to, frequency, current (e.g., pulse amplitude), pulse width, etc. However, these parameters do not provide dosages like conventional physical medication dosages (e.g., 20 mg taken twice a day, 10 mL of oral medication taken with each meal). Therefore, using intuitive metrics to determine the dosage of neurostimulation for a patient can facilitate understanding and modification of neurostimulation therapy, and can help optimize neurostimulation therapy for a particular patient, including, for example, reducing the total dosage of neurostimulation over time.

[0178] For example, Table 1 depicts a general outline of neurostimulation therapy for an exemplary patient:

[0179] Table 1 :

[0180] Preventive treatment procedures Acute treatment procedures Number of treatments / month 15 5 Average treatment intensity 10mA 6mA Average treatment duration (minutes) 10:54 54:12

[0181] Based on the data in Table 1, a patient may not be able to determine whether the dosage they receive from the preventive treatment program and the acute treatment program is appropriate, or how it can be modified for improvement. For example, based on Table 1 alone, even if it is determined which treatment program provides a higher dosage between the preventive treatment program and the acute treatment program, it may not be obvious to the patient and / or health care provider. Although the acute treatment program provides a lower number of treatments and a lower average treatment intensity relative to the preventive treatment program, the average treatment duration of the acute treatment program is five times higher than that of the preventive treatment program. The average treatment duration corresponds to the duration of the treatment course, but generally includes time when energy is not delivered (e.g., dead time between pulses). The methods described herein provide a baseline measure (e.g., a metric) for determining and modifying the neurostimulation dosage for neurostimulation therapy.

[0182] In some variations, the dosage of electrical stimulation for neurostimulation therapy can be determined by calculating the charge delivered to an anatomical target (such as, for example, a patient's nerve, such as the trigeminal nerve). For example, the charge can be calculated based on stimulation parameters of the electrical stimulation, which include one or more of the following: frequency, current, pulse width, pulse amplitude (e.g., stimulation intensity), dead time (e.g., time without energy delivery), pulse duration, and treatment duration. The dosage can be calculated based on the energy delivered to the patient over time (e.g., amplitude and stimulation duration, excluding the period between pulses in which energy is not delivered). For example, the total duration of a preventive treatment program can be about 20 minutes, but the stimulation duration of the preventive treatment program in which energy is actually delivered (e.g., the time period in which energy is not delivered (such as between pulse widths) excluding the duration of the treatment) can be about 50 seconds within the 20-minute treatment program. Similarly, the total duration of an acute treatment program can be about 60 minutes, but the stimulation duration of the acute treatment program can be about 90 seconds within the 60-minute treatment program. The amplitude of the stimulation can be varied (e.g., ramped up, steady, ramped down) over the duration of the stimulation, as in e.g. Fig.18J As shown in GUI 1809.

[0183] In some variations, the amount of electrical stimulation may be calculated in terms of charge (e.g., coulombs C, centicoulombs cC) as the sum of the current amplitudes multiplied by the corresponding duration over which the current is delivered. In some variations, a prophylactic treatment program may include doses of up to about 40 cC per treatment course, between about 5 cC and about 25 cC per treatment course, between about 10 cC and about 35 cC per treatment course, and between about 15 cC and about 25 cC per treatment course, including all values ​​and subranges therebetween.

[0184] In some variations, an acute treatment program may include doses of up to about 200 cC per treatment course, between about 10 cC and about 150 cC per treatment course, between about 20 cC and about 140 cC per treatment course, between about 30 cC and about 100 cC per treatment course, and between about 100 cC and about 200 cC per treatment course, including all values ​​and subranges therebetween.

[0185] Table 2 depicts a summary of neurostimulation treatment over time, including the corresponding neurostimulation dosage:

[0186] Table 2

[0187] Preventive treatment procedures Acute treatment procedures Number of treatments / month 15 25 Average treatment intensity 10mA 6mA Average treatment duration (minutes) 10:54 54:12 Average dose / treatment 4.9cC 46cC Average dose / month 73.9cC 1,150cC

[0188] Table 2 includes the same data as Table 1, but additionally, the dosage data includes an average dose per treatment and an average dose per month, which is calculated based on the stimulation parameters of the electrical stimulation provided during the corresponding preventive treatment program and the acute treatment program. For example, based on Table 2, the average dose per treatment of the acute treatment program (e.g., 46 cC) is more than nine times the average dose per treatment of the preventive treatment program (e.g., 4.9 cC). The average monthly dose ratio between the acute treatment program and the preventive treatment program is even higher, at about 15.6 (e.g., 1150 cC / 73.9 cC). This difference in the total dose delivered between the acute treatment program and the preventive treatment program may be primarily due to the higher number of acute treatments performed relative to the preventive treatment.

[0189] Based on the additional context and opinion provided by these determined dosages, one or more modifications may be made to the patient's neurostimulation treatment program to improve treatment outcomes. For example, based on the dosages calculated in Table 2, the patient and / or health care provider may determine that the total dosage applied via the acute treatment program (e.g., 1150 cC per month) presents an undesirable level of risk for adverse reactions, and the neurostimulation treatment program (e.g., one or more stimulation parameters) may be modified to increase one or more of the frequency of treatment sessions, duration of treatment, intensity of treatment, and number of preventive treatment courses. In some variations, one or more of the preventive treatment program course frequency and dosage may be increased based on the determined dosage, and the acute treatment program course frequency may be reduced, as described in detail with respect to Table 3. In this way, the total dosage administered to the patient may be reduced over a subsequent predetermined time period. For example, after performing the modified treatment, the summary of the neurostimulation is reflected in Table 3.

[0190] Table 3

[0191] Preventive treatment procedures Acute treatment procedures Number of treatments / month 28 7 Average treatment intensity 10mA 6mA Average treatment duration (minutes) 19:54 45:12 Average dose / treatment 13cC 38cC Average dose / month 364cC 266cC

[0192] Between Table 2 and Table 3, the number of preventive treatment courses increased from 15 to 28, while the number of acute treatment courses decreased from 25 to 7, because the need for acute migraine treatment naturally decreased due to the effectiveness of the modified treatment program. That is, when patients participate in more preventive treatment courses with longer treatment durations, the frequency of the need for acute treatment courses can be naturally reduced. Although the average dose per treatment and the average dose per month of the preventive treatment program increase from Table 2 to Table 3, the average dose per treatment and the average dose per month of the acute treatment program decrease, so that the total monthly dose delivered between the treatment programs in Table 2 and Table 3 is reduced by almost half from 1223.9cC to 630cC. Therefore, determining the dosage of electrical stimulation applied to an anatomical target (in this example, the trigeminal nerve) can promote stimulation parameter modification to achieve a lower / minimum effective dose and reduce the occurrence of symptoms of the disease (in this example, migraine). The dosage determination described herein can be used for any anatomical target and any disease treated with electrical stimulation.

[0193] In some variations, modifying stimulation parameters to improve treatment outcomes can also include generating additional treatment programs based on, for example, patient and / or health care professional input. For example, a patient can determine from Table 2 that the frequency and duration of preventive treatment program sessions should be increased in order to reduce the frequency of migraine headaches and corresponding acute neurostimulation treatments. In particular, the patient can determine that the average dose per treatment of approximately 4.9 cC should be gradually increased by increasing the average treatment duration by 10 minutes and 54 seconds. Before or during a preventive treatment session, the patient can modify the treatment duration to a predetermined amount (e.g., 15 minutes) to generate a third (e.g., customized, user-defined) treatment program. The third treatment program can enable a user to set their own intensity pathway and function as a customized preventive treatment program or a customized acute treatment program.

[0194] In particular, with reference to GUIs 1803, 1806, 1807, 1808, 1810, 1811, the maintain intensity icon 1848 can be selected to increase the stimulation parameters (e.g., treatment duration) of a predetermined treatment program to generate a new (e.g., patient-defined) treatment program, which can then be reapplied for future treatments and can be further modified as needed. Modifiable treatment programs can encourage patient compliance with neurostimulation treatments and can improve patient outcomes. It should be understood that a user can generate any number of modified treatment programs (e.g., a third treatment program, a fourth treatment program, a fifth treatment program, a sixth treatment program, etc.).

[0195] In some variations, a customized (e.g., third) treatment program may be selected from a GUI similar to GUI 1802, but with a third option for the third treatment program. For example, the patient may subsequently select the third treatment program having a first predetermined treatment duration (e.g., 15 minutes) until the patient further modifies the treatment program (e.g., increases the treatment duration to 20 minutes). For example, when the patient becomes comfortable (e.g., accustomed) to the duration of the preventive treatment session of the first predetermined treatment duration (e.g., 15 minutes), the patient may generate a fourth treatment program having a second predetermined treatment duration (e.g., 20 minutes). Similarly, the patient may determine that an acute treatment program session with a higher dose and lower duration may be more effective in providing acute migraine relief, and may generate a fifth treatment program reflecting such modifications.

[0196] A method of applying a neural stimulation therapy may include selecting a neural stimulation therapy program having a set of stimulation parameters, applying electrical stimulation using electrodes coupled to a patient, determining an amount of neural stimulation to be applied to the patient, and modifying at least one stimulation parameter based on the determined amount. For example, Fig. 20 Depicted is a flow chart representation generally describing a method of applying transcutaneous electrical stimulation using any of the systems and devices described herein to a patient 2000. The method 2000 may include coupling an electrode to a forehead of a patient 2002. For example, the electrode 204 may be coupled to the patient 250 (e.g., the patient's forehead).

[0197] In some variations, a set of stimulation parameters may be selected for stimulating an anatomical target (e.g., a nerve such as the trigeminal nerve) of patient 2004. The set of stimulation parameters may correspond to a treatment program, such as a preventive treatment program having a first set of stimulation parameters configured to preemptively treat a condition, an acute treatment program having a second set of stimulation parameters configured to acutely treat a condition, or another (e.g., customized, modified) treatment program. For example, a first treatment program (e.g., a preventive treatment program) may be configured to preemptively treat a condition (e.g., a migraine), a second treatment program (e.g., an acute treatment program) may be configured to acutely treat a condition, and a third treatment program (e.g., a user-defined intensity pathway) may be customized by a user. As described in more detail herein, the third treatment program may correspond to a set of stimulation parameters selected by a user (e.g., a customized preventive treatment program, a customized acute treatment program). In some variations, the set of stimulation parameters may be selected using a GUI such as that shown in GUIs 1700 , 1710 , 1800 , 1801 , 1802 , 1803 , 1805 , 1806 , 1807 , 1808 , 1809 , 1810 , 1811 .

[0198] In some variations, the stimulation parameters may be one or more of the following: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, session time, session duration, maximum current amplitude during a session, and session frequency. For example, in some variations, the frequency may be between about 10 Hz and about 300 Hz, the current may be between about 1 mA and about 35 mA, the pulse width may be between about 240 μs and about 260 μs, the pulse amplitude may be up to about 17 mA, the dead time may be between about 1 μs and about 10 μs, the duration may be between about 150 microseconds and about 450 microseconds, and the maximum increase in current may be up to about 20 mA at a rate less than or equal to about 40 microamperes per second and the step-wise increase in current may not exceed about 50 microamperes.

[0199] In some variations, an electrode coupled to a patient may be used to apply electrical stimulation 2006 with selected stimulation parameters. For example, in some variations in which the electrode is coupled to the patient's forehead, applying electrical stimulation may include stimulating the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve. A signal generator may be used to generate a set of pulses for the electrodes to apply electrical stimulation. The electrical stimulation may be configured to treat one or more of the following: migraine, tension, headache, cluster headache, migraine continua, hemi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, hypersomnia, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke, and cerebellar syndrome. As described herein, one or more stimulation parameters may be modified while applying electrical stimulation (e.g., between treatment sessions). For example, the patient may provide input to the GUI to increase the stimulation duration or maximum current amplitude.

[0200] In some variations, a dosage of electrical stimulation applied to the trigeminal nerve may be determined 2008. For example, the dosage determination may include calculating the charge delivered to the patient's trigeminal nerve. For example, the delivered charge may be determined by calculating the current (e.g., pulse amplitude) multiplied by the duration (e.g., pulse width) over the duration of the treatment session. In some variations, the determined dosage may be output 2010. For example, a graphical user interface including the determined dosage may be generated and displayed on a computing device.

[0201] In some variations, at least one stimulation parameter may be modified based on the determined dosage 2012. For example, a first treatment procedure session frequency and / or dosage may be increased based on the determined dosage, and / or a second treatment procedure session frequency may be decreased. In some variations, applying electrical stimulation may include modifying at least one stimulation parameter during one of the first treatment session and the second treatment session to generate a third treatment program having a third set of stimulation parameters. For example, the third treatment program may enable a user to set their own intensity pathway and function as a customized preventive treatment program or a customized acute treatment program.

[0202] Optionally, a determination can be made whether to initiate another treatment session 2014. If so, the process can return to step 2002, where selecting stimulation parameters 2004 can include selecting a third treatment program having a third set of stimulation parameters. As described herein, as a result of modifying at least one stimulation parameter, the dosage can be reduced during a subsequent time period.

[0203] Exemplary embodiments

[0204] Embodiment A1. A system for applying transcutaneous electrical stimulation to a patient, the system comprising:

[0205] an electrode configured to be coupled to a forehead of the patient, the electrode comprising:

[0206] substrate;

[0207] a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate the trigeminal nerve of the patient; and

[0208] an electrode marker disposed on the substrate and spanning the first conductor and the second conductor; and

[0209] A housing is configured to be releasably coupled to the electrode, the housing including a signal generator configured to generate a set of pulses for the electrode.

[0210] Embodiment A2. A system according to embodiment A1, wherein the electrode identifier includes at least two openings, and a first magnet coupled to the first adhesive conductor and a second magnet coupled to the second adhesive conductor, wherein the first magnet and the second magnet extend through the corresponding openings of the electrode identifier.

[0211] Embodiment A3. A system according to embodiment A2, wherein the shell is configured to couple to the forehead of the patient using the electrode.

[0212] Embodiment A4. A system according to embodiment A2, wherein the housing is configured to magnetically couple to the first magnet and the second magnet of the electrode.

[0213] Embodiment A5. A system according to embodiment A2, wherein the first magnet and the second magnet are configured to receive the set of pulses generated by the signal generator.

[0214] Embodiment A6. A system according to embodiment A2, wherein the electrode marker defines a third opening, and the insulator defines a fourth opening of the insulator corresponding to the third opening.

[0215] Embodiment A7. A system according to embodiment A1, wherein the electrode marker overlaps with the first conductor and the second conductor.

[0216] Embodiment A8. A system according to embodiment A1, wherein the electrode identifier is disposed on the insulator.

[0217] Embodiment A9. A system according to embodiment A1, wherein the electrode marker overlaps with the insulator.

[0218] Embodiment A10. A system according to embodiment A1, wherein the electrode identifier comprises a radio frequency identification (RFID) tag.

[0219] Embodiment A11. A system according to Embodiment A1, wherein the insulator separates the first conductor from the second conductor.

[0220] Embodiment A12. A system according to Embodiment A1, wherein the electrode includes an adhesive conductor area of ​​the first adhesive conductor and the second adhesive conductor, and the adhesive conductor area is between about 50% and about 80% of the substrate area of ​​the substrate.

[0221] Embodiment A13. A system according to embodiment A1, wherein the first conductor includes a first lateral end opposite the insulator, and the second conductor includes a second lateral end opposite the insulator.

[0222] Embodiment A14. A system according to Embodiment A13, wherein the first lateral end, the second lateral end, and the insulator do not overlap with the first adhesive conductor and the second adhesive conductor.

[0223] Embodiment A15. A system according to embodiment A13, wherein the first lateral end and the second lateral end comprise a lateral end area of ​​up to about 20% of the substrate area of ​​the substrate.

[0224] Embodiment A16. A system according to Embodiment A13, wherein each of the first conductor and the second conductor tapers from the insulator to the corresponding lateral end.

[0225] Embodiment A17. A system according to Embodiment A1, wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a current between about 1 mA and about 35 mA.

[0226] Embodiment A18. A system according to embodiment A1, wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 17 mA, and a dead time between about 1 μs and about 10 μs.

[0227] Embodiment A19. A system according to embodiment A1, wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a duration between about 150 microseconds and about 450 microseconds, wherein the maximum increase in current is up to about 20 mA at a rate of less than or equal to about 40 microamperes per second, and wherein the step-wise increase in current does not exceed about 50 microamperes.

[0228] Embodiment A20. A system according to embodiment A1, wherein the electrode is configured to stimulate the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve.

[0229] Embodiment A21. A system according to Embodiment A1, wherein the substrate comprises a length between about 70 mm and about 120 mm.

[0230] Embodiment A22. A system according to embodiment A1, wherein the insulator comprises a length between about 15 mm and about 50 mm and a width between about 5 mm and about 15 mm.

[0231] Embodiment A23. A system according to embodiment A13, wherein the first lateral end and the second lateral end each comprise a height between about 5 mm and about 20 mm and a width between about 5 mm and about 10 mm.

[0232] Embodiment A24. A system according to embodiment A1, the system also includes a power supply, wherein the housing is configured to separate the power supply from the signal generator.

[0233] Embodiment A25. A system according to embodiment A24, wherein the signal generator is separated from the power supply by a predetermined distance.

[0234] Embodiment A26. A system according to embodiment A24, wherein the housing includes a set of protrusions, and the set of protrusions are configured to separate the power supply from the signal generator.

[0235] Embodiment A27. A system according to embodiment A24, wherein the power source includes a battery.

[0236] Embodiment A28. A system according to Embodiment A1, wherein the housing includes a power source coupled to the signal generator, and the housing further includes a charger configured to wirelessly charge the power source.

[0237] Embodiment B1. An electrode configured to be coupled to a forehead of a patient, the electrode comprising:

[0238] substrate;

[0239] a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate the trigeminal nerve of the patient; and

[0240] An electrode marker is disposed on the substrate and straddles the first conductor and the second conductor.

[0241] Embodiment C1. A system comprising:

[0242] a signal generator configured to generate a set of pulses for transcutaneously stimulating a trigeminal nerve of a patient;

[0243] an identification reader configured to detect an electrode identification of an electrode releasably coupled to the system; and

[0244] A processor and a memory, the processor and the memory are coupled to the identification reader, the processor being configured to:

[0245] Using the identification reader to detect the electrode identification;

[0246] generating an authorization signal based on the detected identification; and

[0247] The trigeminal nerve of the patient is stimulated using the set of pulses based on the authorization signal.

[0248] Embodiment C2. The system of embodiment C1, wherein the processor is configured to:

[0249] When the electrode identifier is not detected, generation of the set of pulses is prohibited.

[0250] Embodiment C3. A system according to embodiment C1, wherein the processor is configured to:

[0251] When the authorization signal is one or more of unauthorized, expired, and overused, generation of the set of pulses is prohibited.

[0252] Embodiment D1. A method of treating a patient, the method comprising:

[0253] coupling an electrode to the patient's forehead, the electrode including an electrode identifier for the electrode;

[0254] coupling a housing of an electrical stimulation system to the electrode, the electrical stimulation system comprising a signal generator and an identification reader;

[0255] Using the identification reader of the electrical stimulation system to detect the electrode identification;

[0256] generating an authorization signal based on the detected identification; and

[0257] The patient's trigeminal nerve is stimulated using a set of pulses generated by the signal generator based on the authorization signal.

[0258] Embodiment D2. A method according to embodiment D1, wherein the stimulation is configured to treat one or more of the following: migraine, tension, headache, cluster headache, persistent migraine, semi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorder, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and cerebellar syndrome.

[0259] Embodiment D3. A method according to embodiment D1, which also includes releasing the system from the electrode.

[0260] Embodiment D4. A method according to embodiment D1, further comprising storing one or more of the following: treatment time, selected therapeutic stimulation program, treatment duration, maximum current amplitude during a treatment, treatment errors, number of repetitions, total current delivered, total current delivered if maximum current amplitude is reached, battery charging time, battery charging duration, duration to reach full charge, and battery charging errors.

[0261] Embodiment E1. A system for applying transcutaneous electrical stimulation to a patient, the system comprising:

[0262] an electrode configured to be coupled to a forehead of the patient, the electrode comprising:

[0263] substrate;

[0264] a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate the trigeminal nerve of the patient; and

[0265] A housing is configured to allow size variation of the power supply by isolating the power supply from the signal generator.

[0266] Embodiment E2. The system of Embodiment E1, wherein the housing is configured to releasably couple to the electrode, the housing comprising:

[0267] a signal generator configured to generate a set of pulses for the electrode;

[0268] a power supply coupled to the signal generator;

[0269] A set of protrusions is configured to separate the power source from the signal generator by a first predetermined distance.

[0270] Embodiment E3. A system according to embodiment E1, wherein the set of protrusions includes a set of fasteners.

[0271] Embodiment E4. A system according to embodiment E3, wherein the set of protrusions is configured to couple to a first side of the signal generator, and the set of fasteners is configured to couple to a second side of the signal generator opposite the first side.

[0272] Embodiment E5. A system according to embodiment E3, wherein the set of fasteners includes a first fastener and a second fastener, and the first fastener and the second fastener are separated by a distance between about 25 mm and about 35 mm.

[0273] Embodiment E6. A system according to embodiment El, wherein the power supply is configured to increase in size within the housing when generating the set of pulses.

[0274] Embodiment E7. A system according to embodiment E1, wherein the power source includes a battery.

[0275] Embodiment E8. A system according to Embodiment E1, wherein the set of protrusions is configured to attach the signal generator to the housing.

[0276] Embodiment E9. The system of Embodiment E1, wherein the housing includes a connector configured to releasably couple to the electrode, and the set of protrusions is configured to separate the signal generator from the connector by a second predetermined distance.

[0277] Embodiment E10. The system of Embodiment E1 further comprising a charger configured to wirelessly charge the power source.

[0278] Embodiment E11. A system according to embodiment E1, the system also includes an electrode marker disposed on the substrate.

[0279] Embodiment F1. A method for applying transcutaneous electrical stimulation to a patient, the method comprising:

[0280] selecting one or more stimulation parameters for the electrical stimulation;

[0281] applying the electrical stimulation having the selected one or more stimulation parameters using an electrical stimulation system coupled to the patient;

[0282] determining an amount of the electrical stimulation applied to the patient; and modifying at least one stimulation parameter based on the determined amount.

[0283] Embodiment F2. A method according to embodiment F1, wherein determining the dosage comprises calculating the charge delivered to the patient by the electrical stimulation system.

[0284] Embodiment F3. A method according to embodiment F1, wherein selecting the one or more stimulation parameters includes selecting one of a first treatment program and a second treatment program, the first treatment program having a first set of stimulation parameters and configured for preemptive treatment of the condition, and the second treatment program having a second set of stimulation parameters and configured for acute treatment of the condition.

[0285] Embodiment F4. A method according to Embodiment F3, wherein modifying the at least one stimulation parameter based on the determined dosage comprises increasing the frequency of the first treatment procedure sessions and decreasing the frequency of the second treatment procedure sessions.

[0286] Embodiment F5. A method according to Embodiment F3, wherein modifying the at least one stimulation parameter based on the determined dosage results in increasing the dosage of the first treatment procedure.

[0287] Embodiment F6. The method of embodiment F4, further comprising reducing the dosage within a predetermined time period after modifying the at least one stimulation parameter.

[0288] Embodiment F7. A method according to embodiment F3, wherein a stimulation parameter of the one or more stimulation parameters is adjusted while applying the electrical stimulation.

[0289] Embodiment F8. The method of embodiment F7, further comprising generating a third treatment program having a third set of stimulation parameters based on the adjusted stimulation parameters.

[0290] Embodiment F9. A method according to embodiment F8, wherein selecting the one or more stimulation parameters includes selecting the third treatment program.

[0291] Embodiment F10. The method of Embodiment F1, further comprising generating a graphical user interface including the determined usage amounts.

[0292] Embodiment F11. A method according to embodiment F1, wherein the one or more stimulation parameters include one or more of the following: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, treatment time, treatment duration, maximum current amplitude in a treatment and treatment frequency.

[0293] Embodiment F12. A method according to embodiment F1, wherein the electrical stimulation comprises a frequency of the electrical stimulation, wherein the frequency is between about 10 Hz and about 300 Hz.

[0294] Embodiment F13. The method of Embodiment F1, wherein the electrical stimulation comprises a current between about 1 mA and about 35 mA.

[0295] Embodiment F14. The method of Embodiment F1, wherein the electrical stimulation comprises a pulse width between about 240 μs and about 260 μs.

[0296] Embodiment F15. A method according to embodiment F1, wherein the electrical stimulation comprises a pulse amplitude of up to about 17 mA.

[0297] Embodiment F16. The method of Embodiment F1, wherein the electrical stimulation comprises a dead time between about 1 μs and about 10 μs.

[0298] Embodiment F17. A method according to embodiment F1, wherein the electrical stimulation comprises a duration between about 150 microseconds and about 450 microseconds, wherein the maximum increase in current is up to about 20 mA at a rate of less than or equal to about 40 microamperes per second, and wherein the current increases stepwise by no more than about 50 microamperes.

[0299] Embodiment F18. A method according to Embodiment F1, wherein applying the electrical stimulation comprises stimulating the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve.

[0300] Embodiment F19. A method according to embodiment F1, wherein the electrical stimulation system includes a signal generator releasably coupled to the electrode, and wherein applying the electrical stimulation includes using the signal generator to generate a set of pulses for the electrode.

[0301] Embodiment F20. A method according to embodiment F1, wherein the electrical stimulation is applied to treat one or more of the following: migraine, tension, headache, cluster headache, persistent migraine, semi-unilateral neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke and cerebellar syndrome.

[0302] Embodiment G1. An electrical stimulation system, comprising:

[0303] an electrode configured to be coupled to a patient;

[0304] a signal generator operably coupled to the electrode and configured to generate a set of pulses for transcutaneous electrical stimulation of the patient; and

[0305] A processor and a memory, the processor and the memory are coupled to the signal generator, the processor being configured to:

[0306] receiving one or more stimulation parameters;

[0307] applying the electrical stimulation having the received one or more stimulation parameters to a nerve of the patient using the electrode;

[0308] determining an amount of the electrical stimulation to apply to the nerve; and

[0309] Based on the determined dosage, at least one modified stimulation parameter is received.

[0310] Embodiment G2. A system according to embodiment G1, wherein determining the dosage includes calculating the charge delivered to the nerve of the patient.

[0311] Embodiment G3. A system according to embodiment G1, wherein receiving the one or more stimulation parameters includes selecting one of a first treatment program and a second treatment program, the first treatment program having a first set of stimulation parameters and configured for preemptive treatment of the condition, and the second treatment program having a second set of stimulation parameters and configured for acute treatment of the condition.

[0312] Embodiment G4. A system according to Embodiment G3, wherein the processor is configured to receive an increase in the frequency of treatment sessions of the first treatment procedure and a decrease in the frequency of treatment sessions of the second treatment procedure based on the determined usage.

[0313] Embodiment G5. A system according to embodiment G3, wherein the processor is configured to receive an increase in the dosage of the first treatment procedure.

[0314] Embodiment G6. A system according to embodiment G4, wherein the processor is configured to receive a reduction in the dosage of the first treatment program within a predetermined time period after modifying the at least one stimulation parameter.

[0315] Embodiment G7. A system according to Embodiment G3, wherein the processor is configured to receive at least one modified stimulation parameter during one of the first treatment session and the second treatment session.

[0316] Embodiment G8. A system according to embodiment G7, wherein the processor is configured to generate a third treatment program having a third set of stimulation parameters based on at least one modified stimulation parameter received during one of the first treatment session and the second treatment session.

[0317] Embodiment G9. A system according to embodiment G8, wherein the processor is configured to receive a selection of the third treatment program.

[0318] Embodiment G10. A system according to embodiment G1, wherein the processor is configured to generate a graphical user interface including the determined usage.

[0319] Embodiment G11. A system according to embodiment G1, wherein the electrical stimulation includes one or more of the following: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, treatment time, treatment duration, maximum current amplitude in a treatment and treatment frequency.

[0320] Embodiment G12. A system according to embodiment G1, wherein the electrical stimulation comprises a frequency between about 10 Hz and about 300 Hz.

[0321] Embodiment G13. A system according to embodiment G1, wherein the electrical stimulation comprises a current between about 1 mA and about 35 mA.

[0322] Embodiment G14. A system according to embodiment G1, wherein the electrical stimulation comprises a pulse width between about 240 μs and about 260 μs.

[0323] Embodiment G15. A system according to embodiment G1, wherein the electrical stimulation comprises a pulse amplitude of up to about 17 mA.

[0324] Embodiment G16. A system according to embodiment G1, wherein the electrical stimulation includes a dead time between about 1 μs and about 10 μs.

[0325] Embodiment G17. A system according to embodiment G1, wherein the electrical stimulation comprises a duration between about 150 microseconds and about 450 microseconds, wherein the maximum increase in current is up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the step-wise increase in current does not exceed about 50 microamperes.

[0326] Although the aforementioned variations have been described in more detail by way of illustration and example for the purpose of clarity and understanding, it will be apparent that certain changes and modifications may be practiced, and these changes and modifications are intended to fall within the scope of the appended claims. In addition, it should be understood that the components and features of the systems and devices described herein may be used in any combination. The description of certain elements or features of a particular drawing is not intended to be restrictive, nor should it be interpreted as implying that the element cannot be used in combination with any other described element. For all variations described herein, the steps of the method may not be performed in order. Some steps are optional, so that each step of the method may not be performed.

Claims

1. A system for applying transcutaneous electrical stimulation to a patient, the system comprising: an electrode configured to be coupled to a forehead of the patient, the electrode comprising: substrate; a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate a trigeminal nerve of the patient; and an electrode marker disposed on the substrate and spanning the first conductor and the second conductor; and A housing is configured to be releasably coupled to the electrode, the housing including a signal generator configured to generate a set of pulses for the electrode.

2. The system of claim 1 , wherein the electrode marker comprises at least two openings, and a first magnet coupled to a first adhesive conductor and a second magnet coupled to a second adhesive conductor, wherein the first magnet and the second magnet extend through corresponding openings of the electrode marker.

3. The system of claim 2, wherein the housing is configured to couple to the forehead of the patient using the electrodes. 4 . The system of claim 2 , wherein the housing is configured to magnetically couple to the first magnet and the second magnet of the electrode. 5 . The system of claim 2 , wherein the first magnet and the second magnet are configured to receive the set of pulses generated by the signal generator.

6. The system of claim 2, wherein the electrode marker defines a third opening, and the insulator defines a fourth opening of the insulator corresponding to the third opening.

7. The system of claim 1, wherein the electrode marker overlaps the first conductor and the second conductor. The system according to claim 1 , wherein the electrode marker is disposed on the insulator.

9. The system of claim 1, wherein the electrode marker overlaps the insulator.

10. The system of claim 1, wherein the electrode identifier comprises a radio frequency identification (RFID) tag.

11. The system of claim 1, wherein the insulator separates the first conductor from the second conductor.

12. The system of claim 1, wherein the electrode comprises an adhesive conductor area of ​​the first adhesive conductor and the second adhesive conductor, the adhesive conductor area being between about 50% and about 80% of a substrate area of ​​the substrate.

13. The system of claim 1, wherein the first conductor includes a first lateral end opposite the insulator and the second conductor includes a second lateral end opposite the insulator.

14. The system of claim 13, wherein the first lateral end, the second lateral end, and the insulator do not overlap the first and second adhesive conductors.

15. The system of claim 13, wherein the first lateral end portion and the second lateral end portion comprise a lateral end area of ​​up to about 20% of a substrate area of ​​the substrate.

16. The system of claim 13, wherein each of the first conductor and the second conductor tapers from the insulator to the respective lateral end.

17. The system of claim 1, wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a current between about 1 mA and about 35 mA.

18. The system of claim 1, wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a pulse width between about 240 μs and about 260 μs, a pulse amplitude up to about 17 mA, and a dead time between about 1 μs and about 10 μs.

19. The system of claim 1 , wherein the signal generator is configured to generate the set of pulses, the set of pulses comprising a duration between about 150 microseconds and about 450 microseconds, wherein the current increases by a maximum of up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current increases in steps by no more than about 50 microamperes.

20. The system of claim 1, wherein the electrode is configured to stimulate an afferent pathway of the supratrochlear nerve and an afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve.

21. The system of claim 1, wherein the substrate comprises a length between about 70 mm and about 120 mm.

22. The system of claim 1, wherein the insulator comprises a length between about 15 mm and about 50 mm and a width between about 5 mm and about 15 mm.

23. The system of claim 13, wherein the first lateral end and the second lateral end each comprise a height between about 5 mm and about 20 mm and a width between about 5 mm and about 10 mm.

24. The system of claim 1, further comprising a power source, wherein the housing is configured to isolate the power source from the signal generator.

25. The system of claim 24, wherein the signal generator is separated from the power source by a predetermined distance.

26. The system of claim 24, wherein the housing includes a set of protrusions configured to separate the power source from the signal generator.

27. The system of claim 1, further comprising a power source comprising a battery.

28. An electrode configured to be coupled to a forehead of a patient, the electrode comprising: substrate; a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate a trigeminal nerve of the patient; and An electrode marker is disposed on the substrate and straddles the first conductor and the second conductor.

29. A system, comprising: a signal generator configured to generate a set of pulses for transcutaneously stimulating a trigeminal nerve of a patient; an identification reader configured to detect an electrode identification of an electrode releasably coupled to the system; as well as a processor and a memory, the processor and the memory being coupled to the identification reader, the processor being configured to: Using the identification reader to detect the electrode identification; generating an authorization signal based on the detected identification; as well as The trigeminal nerve of the patient is stimulated using the set of pulses based on the authorization signal.

30. The system of claim 29, wherein the processor is configured to: When the electrode identifier is not detected, generation of the set of pulses is prohibited.

31. The system of claim 29, wherein the processor is configured to: When the authorization signal is one or more of unauthorized, expired, and overused, generation of the set of pulses is prohibited.

32. A method of treating a patient, the method comprising: coupling an electrode to a forehead of the patient, the electrode comprising an electrode identification for the electrode; coupling a housing of an electrical stimulation system to the electrode, the electrical stimulation system comprising a signal generator and an identification reader; detecting the electrode identification using the identification reader of the electrical stimulation system; generating an authorization signal based on the detected identification; as well as The patient's trigeminal nerve is stimulated using a set of pulses generated by the signal generator based on the authorization signal.

33. The method of claim 32, wherein the stimulation is configured to treat one or more of: migraine, tension, headache, cluster headache, migraine continua, hemispheric neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke, and cerebellar syndrome.

34. The method of claim 32, further comprising releasing the system from the electrode.

35. The method of claim 32, further comprising storing one or more of: treatment session time, selected therapeutic stimulation program, treatment session duration, maximum current amplitude during a treatment session, treatment session errors, number of repetitions, total current delivered, total current delivered if maximum current amplitude is reached, battery charging time, battery charging duration, duration to reach full charge, and battery charging errors.

36. A system for applying transcutaneous electrical stimulation to a patient, the system comprising: an electrode configured to be coupled to a forehead of the patient, the electrode comprising: substrate; a first conductor, a second conductor, and an insulator, each of the first conductor, the second conductor, and the insulator being disposed on the substrate, the insulator being positioned laterally between the first conductor and the second conductor, the first conductor and the second conductor being configured to stimulate a trigeminal nerve of the patient; and A housing is configured to allow the power supply to be sized differently by isolating the power supply from the signal generator.

37. The system of claim 36, wherein the housing is configured to releasably couple to the electrode, the housing comprising: a signal generator configured to generate a set of pulses for the electrodes; a power supply coupled to the signal generator; A set of protrusions is configured to separate the power source from the signal generator by a first predetermined distance.

38. The system of claim 36, wherein the set of protrusions comprises a set of fasteners.

39. The system of claim 36, wherein the set of protrusions is configured to couple to a first side of the signal generator and the set of fasteners is configured to couple to a second side of the signal generator opposite the first side.

40. The system of claim 36, wherein the set of fasteners includes a first fastener and a second fastener, the first fastener and the second fastener being separated by a distance between about 25 mm and about 35 mm.

41. The system of claim 36, wherein the power supply is configured to increase in size within the housing when generating the set of pulses.

42. The system of claim 36, wherein the power source comprises a battery.

43. The system of claim 36, wherein the set of protrusions is configured to attach the signal generator to the housing.

44. The system of claim 36, wherein the housing includes a connector configured to releasably couple to the electrode, the set of protrusions configured to separate the signal generator from the connector by a second predetermined distance.

45. The system of claim 36, further comprising a charger configured to wirelessly charge the power source.

46. ​​The system of claim 36, further comprising electrode markers disposed on the substrate.

47. A method for applying transcutaneous electrical stimulation to a patient, the method comprising: selecting one or more stimulation parameters for said electrical stimulation; applying the electrical stimulation having the selected one or more stimulation parameters using an electrical stimulation system coupled to the patient; determining an amount of the electrical stimulation to apply to the patient; as well as Based on the determined dosage, at least one stimulation parameter is modified.

48. The method of claim 47, wherein determining the dosage comprises calculating an electrical charge delivered to the patient by the electrical stimulation system.

49. The method of claim 47, wherein selecting the one or more stimulation parameters comprises selecting one of a first treatment program having a first set of stimulation parameters and configured for preemptive treatment of the condition and a second treatment program having a second set of stimulation parameters and configured for acute treatment of the condition.

50. The method of claim 49, wherein modifying the at least one stimulation parameter based on the determined dosage comprises increasing a first treatment procedure session frequency and decreasing a second treatment procedure session frequency.

51. The method of claim 49, wherein modifying the at least one stimulation parameter based on the determined dosage results in increasing the dosage of the first treatment procedure.

52. The method of claim 50, further comprising reducing the dosage within a predetermined time period after modifying the at least one stimulation parameter.

53. The method of claim 49, wherein a stimulation parameter of the one or more stimulation parameters is adjusted while applying the electrical stimulation.

54. The method of claim 53, further comprising generating a third therapy program having a third set of stimulation parameters based on the adjusted stimulation parameters.

55. The method of claim 54, wherein selecting the one or more stimulation parameters comprises selecting the third treatment program.

56. The method of claim 47, further comprising generating a graphical user interface including the determined usage.

57. The method of claim 47, wherein the one or more stimulation parameters comprise one or more of: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, session time, session duration, maximum current amplitude in a session, and session frequency.

58. The method of claim 47, wherein the electrical stimulation comprises a frequency of the electrical stimulation, wherein the frequency is between about 10 Hz and about 300 Hz.

59. The method of claim 47, wherein the electrical stimulation comprises a current between about 1 mA and about 35 mA.

60. The method of claim 47, wherein the electrical stimulation comprises a pulse width between about 240 μs and about 260 μs.

61. The method of claim 47, wherein the electrical stimulation comprises a pulse amplitude of up to about 17 mA.

62. The method of claim 47, wherein the electrical stimulation includes a dead time between about 1 μs and about 10 μs.

63. The method of claim 47, wherein the electrical stimulation comprises a duration between about 150 microseconds and about 450 microseconds, wherein the current increases by a maximum of up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current increases in steps by no more than about 50 microamperes.

64. The method of claim 47, wherein applying the electrical stimulation comprises stimulating the afferent pathway of the supratrochlear nerve and the afferent pathway of the supraorbital nerve of the ophthalmic branch of the trigeminal nerve.

65. The method of claim 47, wherein the electrical stimulation system comprises a signal generator releasably coupled to an electrode, and wherein applying the electrical stimulation comprises generating a set of pulses for the electrode using the signal generator.

66. The method of claim 47, wherein the electrical stimulation is applied to treat one or more of: migraine, tension, headache, cluster headache, migraine continua, hemispheric neuralgia-like non-conjunctival tear (SUCNT), chronic paroxysmal hemicrania, trigeminal neuralgia, facial nerve disorder, autism, depression, cyclothymia, coma, anxiety, tremor, aphasia, insomnia, sleep disorders, narcolepsy, epilepsy, attention deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, multiple sclerosis, stroke, and cerebellar syndrome.

67. An electrical stimulation system, comprising: an electrode configured to be coupled to a patient; a signal generator operably coupled to the electrode and configured to generate a set of pulses for transcutaneous electrical stimulation of the patient; as well as A processor and a memory, the processor and the memory are coupled to the signal generator, the processor being configured to: receiving one or more stimulation parameters; applying the electrical stimulation having the received one or more stimulation parameters to a nerve of the patient using the electrodes; determining an amount of said electrical stimulation to apply to said nerve; as well as Based on the determined dosage, at least one modified stimulation parameter is received.

68. The system of claim 67, wherein determining the dosage comprises calculating an electrical charge delivered to the nerve of the patient.

69. A system according to claim 67, wherein receiving the one or more stimulation parameters includes selecting one of a first treatment program and a second treatment program, wherein the first treatment program has a first set of stimulation parameters and is configured for preemptive treatment of the condition, and the second treatment program has a second set of stimulation parameters and is configured for acute treatment of the condition.

70. The system of claim 69, wherein the processor is configured to receive an increase in the frequency of the first therapeutic procedure sessions and a decrease in the frequency of the second therapeutic procedure sessions based on the determined usage.

71. The system of claim 69, wherein the processor is configured to receive an increase in the dosage of the first treatment procedure.

72. The system of claim 70, wherein the processor is configured to receive a reduction in the dosage of the first therapeutic program within a predetermined time period after modifying the at least one stimulation parameter.

73. The system of claim 69, wherein the processor is configured to receive at least one modified stimulation parameter during one of the first therapy session and the second therapy session.

74. The system of claim 73, wherein the processor is configured to generate a third treatment program having a third set of stimulation parameters based on the received at least one modified stimulation parameter during one of the first treatment session and the second treatment session.

75. The system of claim 74, wherein the processor is configured to receive a selection of the third treatment procedure.

76. The system of claim 67, wherein the processor is configured to generate a graphical user interface including the determined usage.

77. The system of claim 67, wherein the electrical stimulation comprises one or more of: frequency, current, pulse width, pulse amplitude, dead time, pulse duration, session time, session duration, maximum current amplitude in a session, and session frequency.

78. The system of claim 67, wherein the electrical stimulation comprises a frequency between about 10 Hz and about 300 Hz.

79. The system of claim 67, wherein the electrical stimulation comprises a current between about 1 mA and about 35 mA.

80. The system of claim 67, wherein the electrical stimulation comprises a pulse width between about 240 μs and about 260 μs.

81. The system of claim 67, wherein the electrical stimulation comprises a pulse amplitude of up to about 17 mA.

82. The system of claim 67, wherein the electrical stimulation comprises a dead time between about 1 μs and about 10 μs.

83. The system of claim 67, wherein the electrical stimulation comprises a duration between about 150 microseconds and about 450 microseconds, wherein the maximum increase in current is up to about 20 mA at a rate less than or equal to about 40 microamperes per second, and wherein the current is increased stepwise by no more than about 50 microamperes.

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