Patent Description:
Currently available surgical treatment methods for certain medical disorders, such as epilepsy or other seizure related disorders, may include stimulation of the nervous system by vagus nerve stimulation (VNS), which has been approved by the United States (U. ) Food and Drug Administration (FDA). In this method, stimulating electrodes are surgically implanted in contact with the vagus nerve as it passes through the neck. In addition to complications related to anesthesia, potential for infection, cost, and other adverse events with VNS, many of the subjects who undergo VNS treatments do not achieve relief, and there is no reliable predictor of good outcomes from the implanted VNS device.

Other approaches to neuromodulation are the focus of on-going research. For example, implantable approaches are also being studied, including deep brain stimulation (DBS) of specific brain regions, and intracranial stimulation of the same via a device which monitors brain activity and delivers stimuli as needed. However, the risks of DBS include infection, hemorrhage, and injury to deep brain structures.

In some clinical situations, electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have been used for neurological and psychiatric conditions. Traditionally, brain stimulation has been a primary treatment alternative to medications and psychotherapy, and ECT has been the dominant brain stimulation approach since the first part of the 20th century. However, ECT carries risks of memory and other cognitive side effects, considerable cost, and risks of anesthesia.

Many of the above-described methods are invasive and may have considerable costs and side effects. Further, a substantial percentage of patients do not recover from or get adequate lasting relief for the condition or disorder despite multiple trials of pharmaceutical or surgical treatment.

The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the invention is to be bound.

<CIT> discloses a pulse generator device for trigeminal nerve stimulation.

One aspect of the subject matter of the present disclosure addresses the aforementioned needs by providing a system and device configured to stimulate the trigeminal nerve that is minimally invasive and has reduced side effects in comparison with other neuromodulation approaches.

Disclosed herein is a system for trigeminal nerve stimulation. In one embodiment, the system includes a storage medium, a pulse generator communicatively coupled to the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period. In some embodiments, the system may further include a power supply or charging station. The power source may be a battery, such as a rechargeable battery.

Disclosed herein is a pulse generator for trigeminal nerve stimulation. In one embodiment, the generator includes a body having a front and back portion and includes at least one electrode channel. The pulse generator also includes a power source. The pulse generator also includes at least one microcontroller executing instructions from a storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period. The pulse generator further includes a display configured to provide a graphical user interface and at least one user control feature configured to allow a user to control at least one operation of the pulse generator. The pulse generator may further include a power inlet port defined in the body. In one embodiment, the body has dimensions of approximately <NUM> millimeters (mm) (<NUM> inches (in)) Height x <NUM> (<NUM> in) Width x <NUM> (<NUM> in) Depth and a weight of <NUM> grams (g) (<NUM> ounces (oz. )) without a battery. In some embodiments, the power source may be a battery and the body may include at least one battery cavity defined in the back portion of the body that is configured to accept a battery. In one embodiment, the body is plastic, metal alloy or composite material. In one aspect, the microcontroller limits output current and the current is limited to approximately less than <NUM> Milliamps (mA). In various embodiments, the current output has an upper limit of approximately 10mA, 7mA or 5mA. In some embodiments, the current output has a lower limit of approximately <NUM>. In some embodiments, the current output is fixed at approximately 5mA. In one embodiment, the microcontroller is configured to deliver (or delivers) a true square-wave charge-balanced output signal or a non-rectangular output signal. In one aspect, the microcontroller produces electrical pulses having the following characteristics: frequency <NUM>- <NUM> Hertz (Hz), pulse duration <NUM>-<NUM> microseconds (µsec), duty cycle <NUM>-<NUM> percent (%). In one aspect, the electrode channel comprises at least one groove configured to accept at least one projection located at an end of a lead wire of the electrode assembly to form a lock and key configuration. In one aspect, the electrode channel is keyed for a specific electrode assembly.

Disclosed herein is a non-claimed method for operating a pulse generator having a processing device for stimulating at least one cutaneous trigeminal nerve branch using the pulse generator. In one embodiment, the method includes receiving instructions from a storage medium and performing at least one of the following operations: producing electrical pulses having defined characteristics, recording a log of use and anomalous events, restricting use to a specified individual, interfacing with specialized electrodes, providing a signal to the specified individual indicating operational conditions and trouble conditions, and providing a signal to the specified individual indicating an end of a treatment period. In one aspect, the operation of restricting use to a specified individual comprises requiring a patient user to provide a personal identification number (PIN) or a biometric ID to operate the pulse generator. In one aspect, the PIN is a five digit number and the biometric ID is a fingerprint. In one aspect, the operation of producing electrical pulses having defined characteristics is performed by a microcontroller and the characteristics are frequency <NUM>-<NUM>, pulse duration <NUM>-<NUM>µsec, duty cycle <NUM>-<NUM>%. In one aspect, the operation of interfacing with electrodes is performed by at least one electrode channel defined in the pulse generator that is keyed to the electrode.

Disclosed herein is a non-claimed computer-readable medium having computer-executable instructions for performing a process for stimulating a branch of a trigeminal nerve. In one embodiment, the instructions include causing a processor device to produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with specified electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.

In one or more non-claimed embodiments, a method for trigeminal nerve stimulation comprises producing, by at least one processor of a pulse generator, pulses delivered to an electrode assembly for at least one therapy session for a patient, where the pulses have defined characteristics. The method further comprises logging, by at least one processor of the pulse generator, data from at least one therapy session for the patient, where the data comprises impedance of the electrode assembly connected to the pulse generator during at least one therapy session and current amplitude of the pulses produced during at least one therapy session. The method further comprises determining, by at least one processor of the pulse generator, an average current amplitude by using the data comprising the current amplitude for at least one of at least one therapy session. The method also comprises determining, by at least one processor of the pulse generator, an average therapy impedance by using the data comprising the impedance for at least one of at least one therapy session. Also, the method comprises determining, by at least one processor of the pulse generator, a charge capacity of a battery of the pulse generator prior to beginning a subsequent therapy session for the patient. Further, the method comprises determining, by at least one processor of the pulse generator, whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance.

In one or more non-claimed embodiments, the method further comprises generating, by at least one processor of the pulse generator, an alert to the patient indicating that the charge capacity of the battery of the pulse generator is insufficient to complete the subsequent therapy session for the designated duration of time, when at least one processor of the pulse generator determines that the charge capacity of the battery is insufficient to complete the subsequent therapy session for the patient for the designated duration of time. In at least one embodiment, the alert is a visual alert and/or an audible alert. In some embodiments, the visual alert comprises text and/or an icon.

In one or more non-claimed embodiments, the method further comprises displaying, by a display of the pulse generator, a screen comprising a graphical user interface (GUI). In at least one embodiment, the screen comprises average therapy data for at least one of at least one therapy session for the patient. In some embodiments, the screen comprises a history at least one therapy session for the patient. In one or more embodiments, the screen comprises a history of the current amplitude of the pulses produced during at least one of at least one therapy session for the patient. In at least one embodiment, the screen comprises a history of the impedance of the electrode assembly connected to the pulse generator during at least one of at least one therapy session for the patient.

In at least one non-claimed embodiment, the method further comprises measuring, by at least one processor of the pulse generator, the impedance of the electrode assembly connected to the pulse generator to generate a measured impedance. The method further comprises determining, by at least one processor of the pulse generator, whether the measured impedance is less than a base threshold impedance value. Further, the method comprises generating, by at least one processor of the pulse generator, an alert to the patient indicating that the measured impedance is below the base threshold impedance value, when at least one processor of the pulse generator determines that the measured impedance is less than the base threshold impedance value.

In one or more non-claimed embodiments, the method further comprises measuring, by at least one processor of the pulse generator, the impedance of the electrode assembly connected to the pulse generator to generate a measured impedance. Also, the method comprises determining, by at least one processor of the pulse generator, whether the measured impedance is greater than a maximum threshold impedance value. In addition, the method comprises generating, by at least one processor of the pulse generator, an alert to the patient indicating that the measured impedance is above the maximum threshold impedance value, when at least one processor of the pulse generator determines that the measured impedance is greater than the maximum threshold impedance value.

In one or more embodiments, a pulse generator device for trigeminal nerve stimulation comprises at least one processor configured to: produce pulses delivered to an electrode assembly for at least one therapy session for a patient, where the pulses have defined characteristics; log data from at least one therapy session for the patient, where the data comprises impedance of the electrode assembly connected to the pulse generator during at least one therapy session and current amplitude of the pulses produced during at least one therapy session; determine an average current amplitude by using the data comprising the current amplitude for at least one of at least one therapy session; determine an average therapy impedance by using the data comprising the impedance for at least one of at least one therapy session; determine a charge capacity of a battery of the pulse generator prior to beginning a subsequent therapy session for the patient; and determine whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance. Further, the pulse generator device comprises a display configured to display a screen comprising a graphical user interface (GUI).

In at least one embodiment, at least one processor is further configured to generate an alert to the patient indicating that the charge capacity of the battery of the pulse generator is insufficient to complete the subsequent therapy session for the designated duration of time, when at least one processor determines that the charge capacity of the battery is insufficient to complete the subsequent therapy session for the patient for the designated duration of time. In some embodiments, the alert is a visual alert and/or an audible alert.

In one or more embodiments, the display is a liquid crystal display (LCD) or an organic light-emitting diode (OLED) display. In at least one embodiment, the pulse generator device further comprises at least one button configured for programming the designated duration of time for the therapy session. In one or more embodiments, the pulse generator comprises dimensions such that the pulse generator fits within a hand of a user. In at least one embodiment, the current amplitude of the pulses produced has an upper limit of <NUM> mA.

In at least one embodiment, at least one processor is further configured to restrict use of the pulse generator by requiring a password for the patient. In one or more embodiments, the password for the patient is programmable.

A more extensive presentation of features, details, utilities, and advantages of the present invention is provided in the following written description of various embodiments of the invention, illustrated in the accompanying drawings, and defined in the appended claims.

The present disclosure, both as to its organization and manner of operation, may be understood by reference to the following description, taken in connection with the accompanying drawings, in which:.

The present disclosure relates to a device configured for stimulation of the sensory branches of the trigeminal nerve in the face and forehead (trigeminal nerve stimulation or TNS). More specifically, an external pulse generator or neurostimulator configured for stimulation of the sensory components of the ophthalmic nerve and its branches, the infraorbital nerve and its branches, and the mentalis nerves or its branches, and including the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and infratrochlear nerves is disclosed herein. The pulse generator may be used to treat various disorders, such as neurological disorders as disclosed in, for example, <CIT>, entitled Systems, Devices and Methods for the Treatment of Neurological Disorders and Conditions and psychiatric disorders as disclosed in, for example, <CIT> entitled Devices, Systems and Methods for Treatment of Neuropsychiatric Disorders.

In previous studies, a commercially available TENS unit, the EMS <NUM>, has been used. The TENS unit is designed to deliver currents up to <NUM> mA, well above the levels needed for external TNS. In clinical use for TNS for epilepsy, for example, the high currents would present a potential safety hazard to patients, both for dermal injury and the passage of current through the skull and injuring the brain parenchyma. The pulse generator or neurostimulator as disclosed herein is configured to limit the current delivered and includes a programmable microcontroller to implement the features disclosed herein, thereby reducing the potential for patient injury and optimizing ease of use (user friendliness).

The pulse generator as disclosed herein includes a programmable microcontroller which, in various embodiments, may implement some or all of the following features: produces electrical pulses of specific, programmable characteristics; records a log of use and anomalous events; restricts use to a specified individual; interfaces with various electrode designs, including both subcutaneous implantable electrode designs, such as those described in <CIT> and <CIT>, and cutaneous electrode designs, such as those described in <CIT> and <CIT>; signals the patient-user (or a physician or other care provider) about operational conditions and trouble conditions; signals the need for a physician reprogramming visit with weekly warning signals and suspending operations until reprogrammed at the specified date; and is rechargeable and is sealed to protect against, for example, liquid penetration into the internal structure of the pulse generator. In some embodiments, the pulse generator may signal a physician or other care provider over the internet or cell phone and the communication may be in real time. In some embodiments, the pulse generator can inform a physician or other care provider that the patient may be having a seizure (based on processing implanted or external EEG data, or other physiologic data such as autonomic nervous system indices (e.g. heart rate variability)) or that the patient has fallen (based on processing data from an accelerometer built into the pulse generator or implanted in the patient).

The unique anatomy of the trigeminal nerve, and its direct and indirect projections to key areas of the brainstem, thalamus and cortex involved with sensory processing, attention, and autonomic function, may allow the use of stimulation by a pulse generator as disclosed herein for a variety of neurological, psychiatric and other conditions in which stimulation may be desirable.

For a discussion related to the trigeminal nerve, reference is now made to <FIG>, which illustrate the location of several branches of the trigeminal nerve and the location of the major foramina for the superficial branches of the trigeminal nerve. The trigeminal nerve is the largest cranial nerve and has extensive connections with the brainstem and other brain structures. As it is the fifth of the twelve cranial nerves, it is also known interchangeably as CNV. The trigeminal nerve has three major sensory branches over the face, all of which are bilateral, and highly accessible. The supraorbital nerve, or ophthalmic nerve, is frequently referred to as the V<NUM> division. The infraorbital branch, or the maxillary nerve, is commonly referred to as the V<NUM> division. The superficial branch, or the mandibular nerve (also known as the mentalis branch), is referred to as the V<NUM> division. The supraorbital nerve supplies sensory information about pain, temperature, and light touch to the skin of the forehead, the upper eyelid, the anterior part of the nose, and the eye. The infraorbital branch supplies sensory information about pain, temperature, and light touch sensation to the lower eyelid, cheek, and upper lip. The mentalis branch supplies similar sensory modalities to the jaw, tongue, and lower lip.

As can be understood from <FIG>, these branches exit the skull through three foramina. The supraorbital nerve or ophthalmic nerve exits at foramen <NUM> (the supraorbital foramen or notch), approximately <NUM>-<NUM> from the nasal midline (in adults), and is located immediately above the orbital ridge that is near the eyebrow. The nasal nerve is a division of the ophthalmic nerve. The infraorbital branch or maxillary nerve exits at foramen <NUM> (the infraorbital foramen), approximately <NUM>-<NUM> from the nasal midline (in adults) and the mentalis nerve exits at foramen <NUM> (the mentalis foramen) approximately <NUM>-<NUM> from the nasal midline (in adults). Other sensory branches, including the zygomaticofacial, zygomaticoorbital, zygomaticotemporal, and auriculotemporal, arise from other foramina.

Fibers from the three major branches join together to form the trigeminal ganglion. From there, fibers ascend into the brainstem at the level of the pons to synapse with the main sensory nucleus of the pons, the mesencephalic nucleus of Cranial Nerve V, and the spinal nucleus and tract of V. Pain fibers descend in the spinal nucleus and tract of V, and then ascend to the ventral posterior medial nucleus (VPM) of the thalamus and then project to the cerebral cortex. Light touch sensory fibers are large myelinated fibers, which ascend to the ventral posterior lateral (VPL) nucleus of the thalamus. Afferent sensory fibers project from the trigeminal nuclei to the thalamus and the cerebral cortex.

The trigeminal nucleus has projections to the nucleus tractus solitarius (NTS), the locus ceruleus, the cerebral cortex, and the vagus nerve. The NTS receives afferents from the vagus nerve and trigeminal nerve. NTS integrates input from multiple sources, and projects to structures in the brainstem and forebrain, including the locus ceruleus.

The locus ceruleus is a paired nuclear structure in the dorsal pons, and is located just beneath the floor of the fourth ventricle. The locus coeruleus has extensive axonal projections to a broad number of brainstem, sub-cortical and cortical structures, and is an important part of the reticular activating system. The locus ceruleus is a core part of the brainstem noradrenergic pathway, and produces the neurotransmitter norepinephrine. Norepinephrine plays a key role in attention, alertness, blood pressure and heart rate regulation, anxiety and mood.

While not wishing to be bound by any particular theory, in certain embodiments, the connections between the trigeminal nerve, locus coeruleus, nucleus and tractus solitarius, thalamus, and cerebral cortex, may be relevant to a potential role of the trigeminal nerve in numerous disorders and conditions. Thus, cutaneous stimulation of the trigeminal nerve via a pulse generator as disclosed herein or a system that includes the pulse generator may be effective in the treatment of multiple disorders and conditions where treatment via trigeminal nerve stimulation is indicated.

Accordingly, stimulation of the superficial or cutaneous branches of the trigeminal nerve provides an avenue for non-invasive neuromodulation. Further, stimulation parameters can be tailored for the individual condition, such that the brainstem, thalamic, or cortical structures involved in the individual condition can be activated or inhibited depending on the pathophysiology of the condition being treated.

In one embodiment, as can be understood from <FIG>, a system <NUM> for stimulation of the trigeminal nerve or a branch thereof includes an electrode assembly <NUM>, a neurostimulator or pulse generator <NUM> and electrical cable or wire <NUM>. The electrode assembly <NUM> may be configured for the bilateral simultaneous and asynchronous stimulation of the ophthalmic nerves. In other embodiments, the electrode assembly may be configured for unilateral or bilateral stimulation of one or more branches of the trigeminal nerve as disclosed elsewhere herein. The electrode assembly <NUM> may include a pair of electrodes for placement on a region of the patient's face. It can be appreciated that a single electrode or multiple electrodes may be used. An electrode assembly that may be used with the present disclosure is also described in co-pending <CIT> and <CIT>. In one embodiment, the electrical cable or wire <NUM> is configured to provide a physical and electrical link between the generator <NUM> and the electrode assembly <NUM> via lead wires. In other embodiments, the generator <NUM> and the electrode assembly <NUM> communicate wirelessly (i.e. the wire <NUM> and lead wires are not used). In one embodiment, the generator <NUM> is portable and attached to the belt of the patient <NUM>. In other embodiments, the generator <NUM> is non-portable. In some embodiments, the system <NUM> may include a charging station.

In one embodiment, the electrode assembly <NUM> is configured for bilateral stimulation of both the right and left supraorbital branches of the Trigeminal Nerve (V1) located above the eyebrows over the forehead. The electrode assembly may include both <NUM>-contact and <NUM>-contact electrodes. The contact areas from which the electrical stimulation will travel from the pulse generator to the patient will be placed on the forehead over the V1 branch of the trigeminal nerve bilaterally. The regions of contact are arranged such that the electrical current travels perpendicular to the two branches of the V1 branch between two conductive areas (<NUM> contact) or such that the current travels parallel to the two pathways of the V1 branch (<NUM> contact).

In one embodiment, the electrode assembly <NUM> may be configured to deliver a symmetric biphasic pulse. In other embodiments, the pulse waveform may be asymmetric and/or multiphasic.

The electrodes may be secured to the forehead by hypoallergenic biocompatible hydrogels, such as DermaFlow™ hydrogel (Axelgaard Manufacturing Co, Ltd, Fallbrook, CA, USA). Such gels have been specifically developed for use on the skin and forehead, to minimize skin irritation, and have undergone ISO skin sensitization and histocompatibility studies in animals.

The lead wires <NUM> carry the electrical impulse from the pulse generator to the conductive regions of contact thereby delivering the prescribed stimulation. In one aspect, the lead wires are <NUM>" lead wires that carry the electrical impulse from the pulse generator to the conductive regions of contact. The lead wires exit a single side of the pulse generator and will be bundled together. The lead wires terminate in a specialized plug that connects to the pulse generator's socket, and is configured to prevent a patient-user from connecting the electrodes to other, potentially-hazardous sources of current.

In some embodiments, and as can be understood with reference to <FIG>, the pulse generator <NUM> may also be used in conjunction with a physician docking/programming console. In other embodiments, the "programming" functions described herein may be performed directly via the user-interface described elsewhere herein. The programming docking console allows prescribing physicians to set parameters for the user/patient and to monitor the patient's use since last docking event (e.g. by uploading of logfiles). When a patient-user visits the prescribing physician, the pulse generator <NUM> can be programmed to administer the specific stimulation parameters prescribed by the physician by using the console, such as pulse frequency. These parameters may be set individually, or the physician may select from pre- established combinations (of, e.g., repetition frequency, pulse width, on-period/off-period). The docking/programming station may provide for selection of these parameters from menus or offer stepwise setting of parameters, within ranges and steps as allowed by the pulse generator <NUM>. At follow-up visits, the logfiles may be examined to ascertain actual patterns of device use, as this information may be useful in treatment planning. These data may be displayed as text, or may be presented graphically, for example, as a graph showing amounts of daily use. These data may be stored for the physician to incorporate into the medical record for an individual patient.

For a more detailed discussion of the pulse generator, reference is now made to <FIG>, which illustrate various views of one exemplary embodiment of the pulse generator, <FIG>, which is a block diagram depicting one embodiment of the pulse generator <NUM>, and <FIG>, which is a flow chart illustrating one embodiment of a method for operation of the pulse generator <NUM>.

As can be understood from <FIG>, and with reference to <FIG> and <FIG>, the pulse generator <NUM> comprises a sealed body or case <NUM> which encloses or houses the internal components, such as the microcontroller and battery discussed below, and other wiring and electronic components. The pulse generator may be manufactured by ITO Co. , Ltd, Japan. or other suitable manufacturer.

The sealed body <NUM> protects the internal components and prevents liquids, etc. from penetrating the body and damaging internal components. In one embodiment, the pulse generator <NUM> is housed in a rectangular hard plastic case <NUM> with dimensions of approximately <NUM> (<NUM>. 5in) H x <NUM> (<NUM>. 7in) W x <NUM> (<NUM>. 1in) D and a weight of 145gr (<NUM>. 1oz) without a battery. In other embodiments, the body or case may be made of a metallic alloy or a composite material. As shown in <FIG>, and others, the body <NUM> includes a front portion <NUM> and a back portion <NUM>. The front and back portion are sealingly engaged to prevent fluids, etc. from entering the body and interfering with the internal and electrical components housed within the body. As shown in <FIG> and <FIG>, the body <NUM> may include raised features <NUM> configured to provide a gripping surface by which a user, physician, etc. can open the pulse generator to, for example, replace a battery or other electrical component. As can be seen in <FIG> and others, the pulse generator <NUM> may also include user control features <NUM>, e.g. buttons, that allow the user to turn the power on and off or that provide a temporary lock. In some embodiments, the user control features <NUM> may be up and down arrow buttons that allow the patient-user to adjust the stimulus amplitude. In some embodiments, this is the only parameter which is user-adjustable (all others are controlled via the physician's programming).

As shown in <FIG>, <FIG>, and others, the pulse generator <NUM> may also include at least one specialized socket or channel <NUM> for connecting the lead wires of the electrodes. The channel <NUM> comprises grooves or openings <NUM> configured to accept an end of the lead wires of the electrode assembly. That is, the channel <NUM> is "keyed" for the end of the electrode or the electrode assembly. The end of the lead wire <NUM> includes corresponding projections 39a such that the projections 39a are received in the grooves <NUM> in a lock and key type configuration. This lock and key configuration prevent a patient-user from connecting the electrodes to other, potentially-hazardous sources of current and other incompatible electrode assemblies from being used with the pulse generator. In use, when a two-contact electrode is used, one channel <NUM> is utilized. When a four contact electrode is used, two channels <NUM> are utilized.

As can be seen in at least <FIG>, the pulse generator <NUM> may also include a power inlet port <NUM>. The power inlet port <NUM> is configured to accept a connector from a power supply source, such as a DC power supply. In use, the pulse generator is powered by a battery and/or the power supply source (not shown).

In some embodiments, the pulse generator <NUM> is powered by a rechargeable lithium-ion 9V battery that is received in a battery cavity <NUM> of the body <NUM>, as shown in at least <FIG>, <FIG> and <FIG>. In some embodiments, the generator <NUM> is powered by lithium-polymer batteries.

As can be understood from <FIG>, <FIG>, <FIG>, <FIG>, <FIG> and others, the pulse generator <NUM> also includes a display <NUM>, such as an LED or LCD screen, to display a graphical user interface (GUI). The display may also be controlled by a microcontroller <NUM> on a display PCB <NUM>. The display PCB <NUM> is coupled to the pulse generator microcontroller <NUM> on the microcontroller PCB <NUM> via a ribbon <NUM>. The display <NUM> may be manipulated by user control features <NUM> that allow the physician and patient to select specific graphical menus. The user control features <NUM> may be generated on the GUI or may be features of or integrated with the case <NUM>. The GUI may include a touch-screen interface, thereby allowing the user-patient to make a selection by touching it on the screen.

The GUI is used to control the electric stimulation parameters and, in some embodiments, may provide password protection. In one embodiment, two levels of password protection are provided. The first level of protection allows patients to change their stimulation parameters within a range that has been predetermined by qualified medical personnel, which may be limited to electrical current amplitude. The second level of password protection allows qualified medical personnel to limit the range of stimulation parameters available to the patient. In addition to these parameters, qualified medical personnel can select timed therapy regimens of <NUM> to <NUM> hours, as well as a continuous stimulation mode.

As can be understood from <FIG>, the pulse generator is coupled to a power source <NUM>. With reference to <FIG>, in one embodiment, the pulse generator <NUM> is operably coupled to a battery <NUM>. In other embodiments, the power source may be any suitable power source, such as a fuel cell, or etc. In some embodiments, the battery <NUM> is rechargeable using inductive coupling to the patient's home base station. In some embodiments, the rechargeable battery has a <NUM> year life. The battery <NUM> and/or the pulse generator <NUM> may be operably coupled to a (an additional) power supply or charging station <NUM>, such as the patient's home base station. The battery may be an internal lithium rechargeable battery. In one embodiment, the battery has a capacity up to <NUM> mA-hours to last a minimum of <NUM>-<NUM> hours between charges. In some embodiments, the pulse generator may also be used in conjunction with the patient recharging station. In one embodiment, the patient recharging station is a bedside stand and recharging facility for storing the device when not in use. The pulse generator <NUM> is also operably coupled to electrodes <NUM> (which may be a part of the electrode assembly <NUM>). In some embodiments, the pulse generator <NUM> may be coupled to the electrodes <NUM> via the wire <NUM> or the generator <NUM> and the electrodes <NUM> may be wirelessly coupled. In some embodiments, the electrodes <NUM> and the generator <NUM> may be a single unit, e.g. thegenerator <NUM> is connected directly to and positioned generally on the electrode. The electrode <NUM> may be replaced daily (or at another appropriate time) but the generator <NUM> is reusable. In other embodiments, the generator may be intended for a single-time use (non-reusable). The electrodes <NUM> may provide data to the pulse generator <NUM> and the generator <NUM> may, in turn, produce an output <NUM>, such as notification to the patient that an electrode has become disconnected or that an electrode needs to be repositioned. In some embodiments, the pulse generator <NUM> may further include a digital display of some or all parameters including output current and skin impedance. As indicated in <FIG>, the pulse generator <NUM> is in communication with a storage medium <NUM>. In some embodiments, the storage medium is integrated with the pulse generator. In some embodiments, the storage medium is a separate component of the system. The pulse generator <NUM> includes a microcontroller <NUM>, or other suitable processor, for receiving and executing instructions from a storage medium <NUM>, such as a non-volatile storage medium, magnetic storage medium, optical storage medium, flash memory, other computer readable medium, or suitable memory device. A processor, such as the microcontroller <NUM>, may control operation of the pulse generator <NUM>. The processor <NUM> may be any electronic device cable of processing, receiving and/or transmitting instructions. For example, the processor <NUM> may be a microprocessor, a microcomputer and the like. Various features to be implemented by the programmable microcontroller <NUM> of the pulse generator <NUM> are discussed in more detail with reference to <FIG>.

<FIG> is a flow chart illustrating one embodiment of a method <NUM> for operating a pulse generator in accordance with the present disclosure. The method <NUM> may be performed by the microcontroller <NUM>, or other suitable processor executing instructions from a computer readable medium. It should be appreciated that the operations of the method <NUM> may be performed in the order illustrated, in another suitable order and/or one or more operations may be performed simultaneously. Moreover, in some embodiments, the method <NUM> may include more orfewer operations than those illustrated.

In operation <NUM>, the pulse generator may be turned on or otherwise activated. As part of this operation, the identity of the intended recipient of the treatment may be verified. That is, use of the pulse generator may be restricted to a specific individual patient for which TNS treatment has been prescribed, and may not be used by other unauthorized individuals. In some embodiments, a multi-digit personal code (PIN) that may be chosen by the patient and set by the physician. In some embodiments, the PIN may be a <NUM> digit code. The patient enters the PIN before treatment will begin. If there are more than a predetermined number of incorrect guesses (e.g. <NUM>) of the PIN, the generator ceases to be operational (e.g. "locks up") for <NUM> hour (or other appropriate time) and logs the event. In some embodiments, only one treatment session per day is permitted. In other embodiments, a biometric identification system (e.g. a thumbprint) may be used instead of a PIN. The PIN or biometric ID prevent sharing of devices and may reduce the risk of clinically inappropriate use by other individuals.

In operation <NUM>, an electrode check is made. The electrode check may be performed at the start of the session and may monitor the electrode assembly for operational anomalies. In one embodiment, the pulse generator may include a "handshake" with a chip or circuit on or associated with the electrode, which downloads a serial number, and detects the model of electrode (e.g. a single pair of contacts or separate R/L pairs of contacts). In the operation, the pulse generator checks to determine if it is connected to the electrodes, the electrodes are properly positioned and the like. In some embodiments, the pulse generator may further deliver stimulation signals to the electrode contacts within an electrode assembly in this operation and may set the "used" bit on the electrode assembly at the end of treatment to enforce single use. This ensures that the gel on the contacts is uncontaminated, as damaged gel could produce current flow irregularities ("hot spots") leading to skin injury from excessive local current flow. If the electrode check is ok (e.g. the electrodes are connected, properly positioned and the like), then the method may proceed to operation <NUM>-pulse generation.

If the electrode check is not ok, then the method proceeds to operation <NUM>. For example, if impedance suddenly becomes high, then a signal will be sent to indicate that the electrodes have become disconnected ("infinite" impedance). If impedance is low or excessively low, then the user is prompted to relocate the electrodes (e.g. there is a need to reposition the electrode to ensure skin safety). In some embodiments, the signal may also be sent or alternatively sent to a physician or other care provider and/or a designated family member. The pulse generator may signal such trouble conditions. Treatment may be terminated or the patient may adjust the electrodes as indicated and restart treatment (e.g. turning the pulse generator off and then back on or the pulse generator may perform another electrode check).

The method <NUM> may next proceed to operation <NUM>. A pulse may be generated in this operation. The pulse characteristics may include: (<NUM>) controlled-current rectangular pulses, to one or two channels, with one or more of the following characteristics: (a) maximum deliverable current of <NUM> mA/channel (or as defined elsewhere in this disclosure), (b) physician may set upper and lower bounds for each patient, ranging from <NUM> to <NUM> mA (e.g. default settings of 1mA lower bound, 20mA upper bound), (c) user-adjustment of actual current delivery within that range to allow setting for comfort, (d) provision for a single bipolar channel, with user ability to swap polarity (e.g. shift from "right side = positive/left side = negative" to the opposite) and (e) provision for a pair of bipolar channels with user ability to swap polarity (e.g. right and left channels are separate pairs, each with a lower and upper electrode contact, and options are "upper pos. / lower neg. " and "lower pos. / upper neg. " arrangements); (<NUM>) pulse width (duration) from <NUM> to <NUM>, which may be set by physician (e.g. default <NUM>); (<NUM>) repetition rate frequency ranging from <NUM> to <NUM>, which may be set by physician; (<NUM>) duty cycle adjustable by physician, setting the seconds on and seconds off periods, each variable from <NUM> to <NUM> in, for example, <NUM> steps (e.g. default <NUM> on / <NUM> off); and (<NUM>) session length of <NUM> to <NUM> hours (e.g. default <NUM> hours). Various embodiments may permit adjustment or programming of any or all of the foregoing. In some embodiments, the operation includes <NUM>-channels, and operates at the following parameters: frequency <NUM>-<NUM>, pulse duration <NUM>-<NUM>, duty cycle <NUM>-<NUM>%. The two channels may be configured to provide either synchronous or asynchronous stimulation. In some embodiments, the pulse generated in this operation may be transmitted across two separate channels or multiple unique pulses may be generated and carried across a separate channel. In some embodiments, the pulse wave form may be shaped through programmable settings for pulse duration, frequency, and duty cycle and the like. These programmable settings may be adjusted only by a physician or other authorized caregiver in certain embodiments. Generally, reprogramming of operational parameters discussed herein may be restricted to parties supplying an appropriate password or other credential, such as a biometric indicator. This feature may prevent patients from using the generator at settings contrary to medical prescription or outside of FDA labeling.

As can be understood from the previous section, the programmable microcontroller <NUM> limits output current. That is, the patient-adjustable current is limited to approximately less than <NUM> mA to maximize tolerance, minimize current and charge density, and minimize any potential for current penetration through the skull. The controller <NUM> may deliver true square-wave charge-balanced output. This may be advantageous because existing commercial TENS units have asymmetric output, resulting in irregular stimulation, and risk for formation of hotspots, which may contribute to skin irritation or injury. In some embodiments, asymmetric waveforms may be employed, provided the specific signals are safe.

The microcontroller may be set to a range of outputs. In one embodiment, the range may be set to approximately between <NUM>. 5mA and approximately 7mA. In one embodiment, the microcontroller limits the output current to approximately <NUM> mA, and the patient may adjust the current within a range below 7mA. In another embodiment, the microcontroller can limit the output current to a narrow range (e.g. to ensure safety and compliance) of between approximately <NUM> mA to approximately <NUM> mA using an external electrode two or four contact electrode. In this way, the patient is prevented from delivering current at too high or too low of an output. In still another embodiment, the output current may be limited to an exact current, e.g. <NUM> mA, up to a maximum of a fixed current of <NUM> mA, depending on the size, resistance, or impedance of the electrode. In another embodiment, the output current is limited to a range not to exceed <NUM> mA, <NUM> mA, or <NUM> mA. Without wishing to be limited by any particular theory, it is believed that higher currents, depending on the size and impedance of the electrode, may cause pain, discomfort and/or skin irritation for the patient.

The method <NUM> may further include an operation <NUM> in which the activity of the pulse generator is logged. The logging of use operation <NUM> may include: (<NUM>) recording data for each session, such as: (a) session start date-and-time; (b) session stop date-and-time (actual time treatment was ended), (c) user-adjustable setting (e.g. actual current delivered), and (d) session-specific data (e.g. max & min impedance, electrode & configuration). The operation <NUM> may also include: logging operational anomalies (e.g. electrode disconnects, low impedances, lock-outs for attempts at unauthorized use, etc.), transferring data to the physician's programming console and may include the capacity to store <NUM> months of treatment data. In other embodiments, less than <NUM> months or greater than <NUM> months of data may be stored. A patient's compliance (adherence) and usage is monitored via, e.g., logfiles. Such monitoring may be used to help monitor use patterns in assessing a patient's response to treatment (e.g., a poor clinical response may be linked to using the device less often than prescribed).

In some embodiments, the pulse generator may also signal operational parameters to the patient. This may be part of the logging of use operation <NUM> or may be part of a differentor a separate operation. For example, a signal may be sent if the user is locked out for PIN guessing, a signal may indicate the minutes until the generator is unlocked. In another example, a signal may be sent if the need for physician follow-up reprogramming is coming up and the signal indicates how many more days of treatment remain before a "refill" date is reached. The pulse generator may also display current time and date in the time zone where programmed, display time left in current session (hr:min) and/or display time needed in charger (hr:min) to be ready for the next session.

The method <NUM> may further include an operation <NUM> in which the end of the authorized treatment period is signaled. In one embodiment, several weeks (e.g. default is <NUM> weeks) prior to the end of the treatment period (e.g. default is <NUM> months), the operation <NUM> notifies the user that the treatment period is nearing its end and that a follow up visit with the prescribing doctor for clinical assessment and reprogramming needs to be scheduled. In one embodiment, notification is made at the start of the session. In subsequent weeks, the patient is notified that one less week remains to schedule the visit. In the final week, a daily count-down of days remaining is provided. At the final treatment in the authorized period, the user is notified that this is the last treatment.

In operation <NUM>, the treatment is terminated. Use of the generator may be suspended (e.g. user is locked out) until reprogrammed by a physician or physician programming console or use of the generator may be terminated.

<FIG> are directed to another embodiment of the disclosed pulse generator. In particular, <FIG> is a front perspective view of two of the disclosed pulse generators 610a, 610b. It should be noted that the pulse generators 610a, 610b are exact duplicate units, and that the "a" and "b" in the reference numerals in these figures are simply used to indicate the specific pulse generator of the two pulse generators 610a, 610b shown in the figures. In addition, it should be noted that the pulse generators 610a, 610b may each additionally comprise at least some of the features and/or functionality of the pulse generator <NUM> of <FIG>.

In <FIG>, the pulse generators 610a, 610b are shown to each include a display <NUM>. In one or more embodiments, the display <NUM> may be a liquid crystal display (LCD) or an organic light-emitting diode (OLED) display. Also in this figure, the pulse generators 610a, 610b are shown to each include a housing <NUM>, which may be a hard-shell housing (e.g., manufactured from plastic).

In addition, the pulse generators 610a, 610b are shown to each include, on their respective bottom side, a port <NUM>. In one or more embodiments, the port <NUM> is a universal serial bus (USB) port. During operation of the pulse generators 610a, 610b, an end of a cable (e.g., refer to <NUM> of <FIG>) (e.g., a USB cable) is connected to the port <NUM>, and the other end of the cable (e.g., refer to <NUM> of <FIG>) is connected to a computing device (e.g., refer to <NUM> of <FIG>).

Additionally, in <FIG>, the pulse generators 610a, 610b are shown to each include a plurality of buttons <NUM>, <NUM>, <NUM>. Specifically, button <NUM> is an up-arrow button, button <NUM> is a down-arrow button, and button <NUM> is a lock and set key button. During operation of the pulse generators 610a, 610b, buttons <NUM>, <NUM> are depressed by a user (e.g., a patient, a care giver (such as a parent), and/or a health care professional (such as a physician)) to scroll up and down, respectively, through text, letters, numbers, characters, icons, and/or screens displayed on the display <NUM> of the pulse generators 610a, 610b. In addition, during operation of the pulse generators 610a, 610b, buttons <NUM>, <NUM> are depressed by a user to adjust a current amplitude (up and down) of the pulses generated by the pulse generators 610a, 610b. And, button <NUM> is depressed by a user (e.g., a patient, a care giver, and/or a health care professional) to select a hi-lighted item (e.g., text, letter, number, character, or icon) displayed on a screen of the display <NUM>. In addition, button <NUM> may be depressed by a user to lock and unlock the buttons <NUM>, <NUM>, <NUM> so that they are inactive during a therapy session. It should be noted that the buttons <NUM>, <NUM>, <NUM> may be locked (e.g., via button <NUM>) such that they are inactive during a therapy session so that the patient may not inadvertently (e.g., during sleep) press any of the buttons <NUM>, <NUM>, <NUM> during the therapy session.

In <FIG>, the displays <NUM> of each of the pulse generators 610a, 610b is shown to display a different screen. In particular, the display <NUM> of pulse generator 610a is shown to display a login screen, which is used by a user (e.g., a patient, a care giver, and/or a health care professional) to log into the pulse generator 610a to perform a therapy session. On the login screen, a plurality of icons are shown. These icons include an unlocked icon <NUM>, a high impedance signal icon <NUM>, and a battery capacity icon 645a. The unlocked icon <NUM>, when displayed on the display <NUM>, indicates that the buttons <NUM>, <NUM>, <NUM> of pulse generator 610a are unlocked (i.e. not locked) and are active and available for use by the user. The high impedance signal icon <NUM>, when displayed on the display <NUM>, indicates that the system is exhibiting a high impedance (e.g., an impedance greater than a maximum impedance threshold). Refer to the discussion of <FIG> for details regarding the determination of a high impedance of the system. The battery capacity icon 645a shows the amount of battery charge remaining in the battery of the pulse generator 610a. In particular, in <FIG> the battery capacity icon 645a is showing that the battery has approximately fifty (<NUM>) percent (%) of charge remaining. In one or more embodiments, the pulse generator 610a is able to measure the remaining battery capacity to an accuracy of plus or minus (+/-) five (<NUM>) %. It should be noted that in one or more embodiments, the pulse generator 610a will switch to a Low Power Mode (e.g., conserving battery capacity) when the battery capacity falls below a predetermined low battery capacity threshold value (e.g., <NUM> % battery capacity), and/or when an error (e.g., a high impedance) is detected.

Also shown on the display of pulse generator 610a is a password (or a personal identification number (PIN)) for the patient being entered into the pulse generator <NUM> by the user (e.g., the patient, a care giver, or a health care professional). Specifically, in this figure, the password (or PIN) for the patient comprises four numbers, beginning with "<NUM>". The password (or PIN) for the patient may be generated (e.g., by using a random number generator) by the pulse generator 610a for the patient, or may be programmable (e.g., chosen by and customizable) by the user (e.g., the patient, a care giver, or a health care professional) for the patient.

It should be noted that, in one or more embodiments, the password for the patient may comprise (and may be customizable by the user to comprise) more or less than four digits, as is shown in <FIG>. And, in one or more embodiments, the password for the patient may be programmable to comprise only numbers, only letters (which may be case sensitive), only characters, only icons, or a combination of numbers, letters, characters, and/or icons.

In one or more embodiments, after the user has logged into the pulse generator 610a for the patient, the pulse generator 610a will automatically lock the buttons of the device after a specific duration of time (e.g., <NUM> minutes) of user inactivity has lapsed.

In <FIG>, the display of pulse generator 610b is shown to display a therapy session screen, which is used by a user (e.g., a patient, a care giver, and/or a health care professional) to program the parameters for a therapy session for the patient. On the therapy session screen, a plurality of icons are shown. These icons include a locked icon <NUM>, a solid connection symbol icon <NUM>, and a battery capacity icon 645b. The locked icon <NUM>, when displayed on the display <NUM>, indicates that the buttons <NUM>, <NUM>, <NUM> are unlocked and are active for use by the user. The solid connection symbol icon <NUM>, when displayed on the display <NUM>, indicates that the system is adequately electrically connected (e.g., the impedance of the system lies between a maximum impedance threshold and a base impedance threshold) for a therapy session. The battery capacity icon 645b shows the amount of battery charge remaining in the battery of the pulse generator 610b. In particular, in <FIG> the battery capacity icon 645b is showing that the battery has approximately seventy-five (<NUM>) % of charge remaining. In one or more embodiments, the pulse generator 610b is able to measure the remaining battery capacity to an accuracy of +/- <NUM> %. It should be noted that in one or more embodiments, the pulse generator 610b will switch to a Low Power Mode (e.g., conserving battery capacity) when the battery capacity falls below a predetermined low battery capacity threshold value (e.g., <NUM> % battery capacity). In some embodiments, the pulse generator 610b will prevent the user from initiating a therapy session for a patient when the battery capacity is below a low battery capacity threshold value.

Also on the therapy session screen on the display <NUM> of pulse generator 610b, the therapy session duration is shown. In particular, in <FIG>, the therapy session screen on the display <NUM> of pulse generator 610b shows that the therapy session duration <NUM> is set by the user (e.g., a patient or health care provider) to be <NUM> hours. Additionally, on the therapy session screen on the display <NUM> of pulse generator 610b, the therapy progress (time remaining) <NUM> is shown to be fifteen (<NUM>) minutes.

In addition, in one or more embodiments, the therapy session screen on the display <NUM> of pulse generator 610b may show an impedance indicator (not shown), which indicates the impedance of the electrodes on the electrode assembly (e.g. refer to <NUM> of <FIG>). Also, in one or more embodiments, the therapy session screen on the display <NUM> of pulse generator 610b may show a therapy completion indicator (not shown), which indicates that the therapy session has completed.

Additionally, it should be noted that in one or more embodiments, the therapy session screen on the display <NUM> of pulse generator 610b may show, for ease of programming by the user, a plurality of preprogrammed timed-therapy programs (i.e. therapy session programs that already have a therapy duration chosen), which the user may choose from to select to use for the therapy session for the patient.

<FIG> is another front perspective view of the two pulse generators 610a, 610b of <FIG>. In this figure, pulse generator 610b is turned upside down such that the top side of the pulse generator 610b is shown. The top side of the pulse generator 610b is shown to comprise a receptacle <NUM>. During operation of the pulse generator 610b, an end of a lead wire (e.g., refer to <NUM> of <FIG>) is connected to the receptacle <NUM>. The lead wire (e.g., refer to <NUM> of <FIG>) splits into two wires having two remaining ends. The two remaining ends of the lead wire (e.g., refer to <NUM> of <FIG>) are connected to a first lead (e.g., refer to <NUM> of <FIG>) (e.g., a positive lead) and a second lead (e.g., refer to <NUM> of <FIG>) (e.g., a negative lead), respectively, of an electrode assembly (e.g., refer to <FIG>), which also comprises an electrode pad (e.g., refer to <NUM> of <FIG>).

In addition, the left side of pulse generator 610b is shown to include a power switch <NUM>. The power switch <NUM> may be switched to the "on" position to turn the pulse generator 610b on, and switched to the "off" position to turn the pulse generator off. In this figure, the power switch <NUM> is shown to be a slide switch. However, in one or more embodiments, various different types of switches other than a slide switch may be employed for the power switch <NUM> including, but not limited to, a button switch or a toggle switch.

In one or more embodiments, when power switch <NUM> is switched to the "off" position, the pulse generator 610b is in an Off Mode. In the Off Mode, no therapy is delivered by the pulse generator 610b, no diagnostics are obtained by the pulse generator 610b, and the pulse generator 610b is unable to communicate with a computing device (e.g., <NUM> of <FIG>). In addition, in the Off Mode, the battery of the pulse generator 610b does not provide any power to the electronics of the pulse generator 610b.

In one or more embodiments, when the power switch <NUM> is switched to the "on" position, the pulse generator 610b may be operating in a Low Power Mode. When the pulse generator 610b is operating in a Low Power Mode, no therapy is delivered by the pulse generator 610b, no diagnostics are obtained by the pulse generator 610b, and the pulse generator 610b is unable to communicate with a computing device (e.g., <NUM> of <FIG>). In this mode, the battery of the pulse generator <NUM> provides power to the electronics of the pulse generator 610b.

<FIG> is a front perspective view of one pulse generator 610a of <FIG>, and a back perspective view of the other pulse generator 610b of <FIG>. In this figure, the bottom side of each of the pulse generators 610a, 610b is shown to comprise a port 620a, 620b (e.g., a USB port). During operation, an end of a cable (e.g., refer to <NUM> of <FIG>) (e.g., a USB cable) is connected to each of the ports 620a, 620b, and the other end of each of the cables (e.g., refer to <NUM> of <FIG>) is connected to a computing device (e.g., refer to <NUM> of <FIG>).

Also in this figure, the back side of pulse generator 610b is shown to be rounded in shape. The rounded shape of the back side of the pulse generator 610b allows for comfort to the user (e.g., a patient or a health care provider), when the user is holding the pulse generator 610b in the user's hand (e.g., refer to <FIG> and <FIG>). As such, the shape of the pulse generator 610b is ergonomically designed such that the pulse generator 610b is easy and comfortable to operate by a user using only a single hand. Additionally, the back side of the pulse generator 610b is shown to comprise a couple of protrusions. The protrusions on the back side of the pulse generator 610b allow for the pulse generator 610b to be stable (e.g., not roll) when the pulse generator 610b is placed on a surface (e.g., a tabletop). It should be noted that in one or more embodiments, the back side of the pulse generator 610b may be manufactured to have more or less than the two protrusions as is shown in the pulse generator 610b in <FIG>. In addition, the protrusions may be formed to be of different sizes and/or shapes than as the protrusions of the pulse generator 610b as is shown in <FIG>.

<FIG> is a front perspective view of one pulse generator 610a of <FIG>, and a back perspective view of the other pulse generator 610b of <FIG>. In this figure, the top side of each of the pulse generators 610a, 610b is shown to comprise a receptacle 710a, 710b. During operation, a lead wire (e.g., refer to <NUM> of <FIG>) is connected to each of the receptacles 710a, 710b.

<FIG> is a perspective view showing a pulse generator <NUM> of <FIG> connected to an electrode assembly. In this figure, a lead wire cable <NUM> is shown to be connected to the receptacle <NUM> of the pulse generator <NUM>. The lead wire <NUM> splits into two wires having two remaining ends. The two remaining ends of the lead wire <NUM> are connected to a first lead (e.g., a positive lead) <NUM> and a second lead (e.g., a negative lead) <NUM>, respectively, of an electrode assembly. The electrode assembly comprises the first lead <NUM>, the second lead <NUM>, and an electrode pad <NUM>, which comprises a plurality of electrodes. During operation, the electrode pad <NUM> is connected to the head of a patient (e.g., refer to item <NUM> connected to the forehead of patient <NUM> of <FIG>), and the electrodes of the electrode pad <NUM> deliver pulses to the patient.

<FIG> depicts a user (e.g., a patient, a care giver, or health care provider) <NUM> holding a pulse generator <NUM> of <FIG>. As shown in this figure, the pulse generator <NUM> is ergonomically designed (e.g., designed in size and shape) for single-handed use by a user <NUM>, and such that the pulse generator <NUM> fits comfortably in a hand of a user <NUM> for use. In one or more embodiments, the pulse generator <NUM> may be designed to have a volume between two (<NUM>) inches cubed (in<NUM>) and five (<NUM>) in<NUM>. In, some embodiments, the pulse generator <NUM> may be designed to have a volume of approximately <NUM> in<NUM>.

<FIG> depicts a user (e.g., a patient or health care provider) <NUM> programming a pulse generator <NUM> of <FIG>. In this figure, the user <NUM> is shown to be depressing the button <NUM> of the pulse generator <NUM>.

As previously mentioned above, the pulse generator <NUM> comprises a plurality of buttons, which are an up-arrow button <NUM> (refer to <FIG>), a down-arrow button <NUM> (refer to <FIG>), and a lock and set key button <NUM>. The up-arrow button <NUM> (refer to <FIG>) and down- arrow button <NUM> (refer to <FIG>) allow for the user <NUM> to scroll up and down, respectively, through text, letters, numbers, characters, icons, and/or screens displayed on the display <NUM> (refer to <FIG>) of the pulse generator <NUM>. In addition, buttons <NUM>, <NUM> may be depressed by a user to adjust a current amplitude (up and down, respectively) of the pulses generated by the pulse generator <NUM>. And, the lock and set key button <NUM> allows for the user <NUM> to select a hi-lighted item (e.g., text, letter, number, character, or icon) displayed on a screen of the display <NUM> of the pulse generator <NUM>.

During operation of the pulse generator <NUM>, prior to initiating a therapy session for a patient, the user <NUM> may use (i.e. depress) the up-arrow button <NUM> (refer to <FIG>), the down-arrow button <NUM> (refer to <FIG>), and/or lock and set key the button <NUM> to enter the patient's password (or PIN) (refer to <NUM> of <FIG>) into the pulse generator <NUM> to log into the pulse generator for the patient. After the user <NUM> has logged into the pulse generator <NUM> for
the patient, the user <NUM> can input the duration for the therapy session for the patient. The user may use (i.e. depress) the up-arrow button <NUM> (refer to <FIG>), the down-arrow button <NUM> (refer to <FIG>), and/or the lock and set key button <NUM> to specify the duration for the therapy session.

Once the therapy session begins, the user <NUM> may use (i.e. depress) the up-arrow button <NUM> (refer to <FIG>), the down-arrow button <NUM> (refer to <FIG>), and/or the lock and set key button <NUM> to select a comfortable current amplitude level for the pulses for the patient. For example, the user <NUM> may select a comfortable current amplitude level of <NUM> mA at the beginning of the therapy session.

It should be noted that, in one or more embodiments, the depressing of the up-arrow button <NUM> (refer to <FIG>) and/or the down-arrow button <NUM> (refer to <FIG>) may adjust the current amplitude level of the pulses by a specific step size (i.e. each depressing of the buttons <NUM>, <NUM> will change the current amplitude by <NUM> mA). In one or more embodiments, the step size for adjusting the current amplitude level may be <NUM> mA, and the current amplitude level may be adjusted in a range from <NUM> mA to <NUM> mA. In one or more embodiments, the step size for adjustment may be greater than or less than <NUM> mA and/or the range of adjustment may vary from the range of <NUM> mA to <NUM> mA.

After some time has passed since the beginning of the therapy session, the patient may decide that the initial current amplitude level setting (e.g., of <NUM> mA) is insufficient (e.g., no longer provides any sensation to the patient) or is intolerable and, as such, the patient may decide to increase or decrease the current amplitude level to a higher level or lower level for the pulses. The user <NUM> (e.g., the patient or heath care provider) may then again use (i.e. depress) the up-arrow button <NUM> (refer to <FIG>), the down-arrow button <NUM> (refer to <FIG>), and/or the lock and set key button <NUM> to select a new comfortable current amplitude level for the pulses for the patient.

During the duration of the therapy session, the pulse generator <NUM> will log (e.g., refer to <NUM> of <FIG>) a history of at least some of the data from the therapy session. In one or more embodiments, during the duration of the therapy session, the pulse generator <NUM> will log a history of the therapy current amplitudes (e.g., refer to screen <NUM> of <FIG>), and log a history of the therapy impedances (e.g., refer to screen <NUM> of <FIG>). In addition, in one or more embodiments, the pulse generator <NUM> will log the duration of the therapy session <NUM> (e.g., <NUM> hours), the average therapy current amplitude for the therapy session, and/or the average therapy impedance for the therapy session. In one or more embodiments, the pulse generator <NUM> comprises an internal Real Time Clock (RTC), which is used to timestamp all of the logged data.

In one or more embodiments, all of the data collected and logged by the pulse generator <NUM> during the duration of the therapy session will be stored within the pulse generator <NUM>. A user (e.g., the patient or a health care provider) may access the logged data for a patient in the pulse generator <NUM> by logging into the pulse generator <NUM> by using the password (or PIN) <NUM> for the patient.

<FIG> is a diagram showing a pulse generator <NUM> of <FIG> connected to a computing device <NUM>. In this figure, the pulse generator <NUM> is connected to the computing device <NUM> via a cable <NUM>. In particular, an end of the cable (e.g., a USB cable) <NUM> is connected to a port (e.g., a USB port) <NUM> of the pulse generator <NUM>. And, another end of the cable <NUM> is connected to a port (e.g., a USB port) of the computing device <NUM>. In this figure, the computing device <NUM> is depicted to be a laptop computer comprising a display <NUM>. However, in other embodiments, the computing device <NUM> may be various different types of computing devices other than a laptop computer including, but not limited to, a desktop computer, a server, a smart phone, and a tablet device.

In one or more embodiments, during operation, the computing device <NUM> may deliver power to the pulse generator <NUM> via the cable <NUM> to charge the battery of the pulse generator <NUM>. In one or more embodiments, the battery shall charge from twenty-five (<NUM>) % capacity to full charge within a period of four (<NUM>) hours. In some embodiments, the pulse generator <NUM> may comprise a light emitting diode (LED) (not shown) to indicate to the user that battery charging is occurring.

In addition, in one or more embodiments, a user may download logged therapy data for a patient from the pulse generator <NUM> to the computing device <NUM> via the cable (e.g., a USB cable) <NUM>. In some embodiments, the pulse generator <NUM> will enable connection with the computing device <NUM> for the data transfer via the USB connectivity. In at least one embodiment, the pulse generator <NUM> will communicate (which includes the transmission of the logged data) with the computing device <NUM> by using USB protocol.

In some embodiments, the user may run an application (e.g., a data downloading application) (e.g., a personal computer (PC) application) on the computing device <NUM> to download logged data for a patient from the pulse generator <NUM> to the computing device <NUM>.

In at least one embodiment, the therapy session parameters (e.g., frequency, pulse width, hold time, rest time, and/or ramp time) for the pulse generator <NUM> may be programmed by a health care provider using the computing device <NUM> (e.g., by means of an application running on the computing device <NUM>).

In one or more embodiments, the pulse generator <NUM> comprises security means (e.g., password protection, password lock out, firewalls, and/or data encryption) for preventing cybersecurity attacks from other devices. In addition, in some embodiments, the pulse generator <NUM> utilizes data encryption to protect patient privacy and data.

<FIG> is a top plan view of a pulse generator <NUM> of <FIG>. In this figure, the top side of the pulse generator <NUM> is shown to comprise a receptacle <NUM>.

<FIG> is a bottom plan view of a pulse generator <NUM> of <FIG>. In this figure, the bottom side of the pulse generator <NUM> is shown to comprise a port <NUM>.

<FIG> is a front plan view of a pulse generator <NUM> of <FIG> next to rulers. In this figure, the pulse generator <NUM> is shown to have an approximate height of <NUM> inches, and an approximate width of <NUM> inches. It should be noted that in other embodiments, the pulse generator <NUM> may be manufactured to be of various different height and/or width dimensions than as shown in <FIG>.

<FIG> is a left side view of a pulse generator <NUM> of <FIG> next to rulers. In this figure, the pulse generator <NUM> is shown to have an approximate depth of <NUM> inches. It should be noted that in other embodiments, the pulse generator <NUM> may be manufactured to be of various different depths than as shown in <FIG>.

<FIG> show a plurality of exemplary screens that may be displayed on the display <NUM> of the pulse generator <NUM> of <FIG> to be used by a heath care provider to obtain logged therapy data for a patient. It should be noted that the screens shown in <FIG> are merely example screens that may be employed by the disclosed system, and that the disclosed system may employ various different versions of these exemplary screens and/or may employ more or less screens than as disclosed herein.

Also, it should be noted that, in one or more embodiments, the screens of <FIG> may be displayed on the display <NUM> (e.g., refer to <FIG>) of a computing device <NUM> (e.g., refer to <FIG>) to be used by a health care provider to obtain (download) logged therapy data for a patient. In some embodiments, the heath care provider may download the screens of the <FIG> via a portable document format (PDF) file.

<FIG> is a graphical user interface (GUI) screen <NUM> to access a therapy data log for a patient, where the "Average Therapy Data" selection is selected. In this figure, screen <NUM> displays two selections for the user to select. In particular, in this figure, the "Average Therapy Data" selection is shown to have been selected by the user. After the "Average Therapy Data" selection is selected by the user, the display <NUM> will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing exemplary average therapy data for a patient. In this figure, screen <NUM> shows the average therapy data for a patient. In particular, the average therapy data includes the average therapy amplitude, the average therapy impedance, and the average therapy duration. In one or more embodiments, the average therapy data is the average of the data logged for all of the previous therapy sessions for a patient. In some embodiments, a user may specify which of all of the pervious therapy sessions for the patient that the average therapy data may be calculated (i.e. data from only a select number of therapy sessions for the patient will be used for the calculation of the average therapy data).

In one or more embodiments, the screen <NUM> comprises a "Back" button, which when selected, will cause the display <NUM> to display the previous screen (e.g., the Therapy Data Log screen). After the user selects the "Back" button the display will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> to access a therapy data log for a patient, where the "Therapy Sessions Data" selection is selected. In this figure, screen <NUM> displays two selections for the user to select. In particular, in this figure, the "Therapy Session Data" selection is shown to have been selected by the user. After the "Therapy Sessions Data" selection is selected by the user, the display <NUM> will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing an exemplary historical listing of therapy sessions for a patient, where Therapy Session <NUM>: Jan <NUM>, <NUM>, is selected. In this figure, screen <NUM> shows a listing of all of the past therapy sessions for the patient. In particular, in this figure, the "Session <NUM>: Jan <NUM>, <NUM>" selection is shown to have been selected by the user. After the "Session <NUM>: Jan <NUM>, <NUM>" selection is selected by the user, the display <NUM> will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing exemplary therapy data for Therapy Session <NUM>, on January <NUM>, <NUM>, for a patient, where the "Therapy Amplitudes" selection is selected. In this figure, screen <NUM> shows the therapy session duration, the therapy session start time, the therapy session stop time, the average therapy amplitude, and the average therapy impedance. In addition, the screen <NUM> shows two selections for the user to select. In particular, the screen <NUM> shows that the user has selected the "Therapy Amplitudes" selection. After the "Therapy Amplitudes" selection is selected by the user, the display <NUM> will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing exemplary historical listing of the therapy amplitudes during Therapy Session <NUM>, on January <NUM>, <NUM>, for a patient. In this figure, screen <NUM> shows a listing of all of the therapy amplitudes (which include time stamps) for the patient for this particular therapy session.

In one or more embodiments, the screen <NUM> comprises a "Back" button, which when selected, will cause the display <NUM> to display the previous screen (e.g., the Session <NUM>: Jan <NUM>, <NUM> screen). After the user selects the "Back" button the display will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing exemplary therapy data for Therapy Session <NUM>, on January <NUM>, <NUM>, for a patient, where the "Therapy Impedances" selection is selected. In this figure, the screen <NUM> shows two selections for the user to select. In particular, the screen <NUM> shows that the user has selected the "Therapy Impedances" selection. After the "Therapy Impedances" selection is selected by the user, the display <NUM> will display screen <NUM> (refer to <FIG>).

<FIG> is a GUI screen <NUM> showing exemplary historical listing of the therapy impedances during Therapy Session <NUM>, on January <NUM>, <NUM>, for a patient. In this figure, screen <NUM> shows a listing of all of the therapy impedances (which include time stamps) for the patient for this particular therapy session.

<FIG> is a flow chart showing the method for determining whether the impedance of the system (which comprises the pulse generator connected to the electrode assembly) is out of range. At the start <NUM> of the method, at the beginning of the therapy session, at least one processor (e.g., microprocessor <NUM>) of the pulse generator <NUM> measures the impedance of the system, which comprises the pulse generator connected to the electrode assembly <NUM>. Then, at least one processor (e.g., microprocessor <NUM>) of the pulse generator <NUM> determines whether the measured impedance is less than a base threshold value (e.g., <NUM>Ω), which would indicate a likely short circuit <NUM>. If at least one processor of the pulse generator <NUM> determines that the impedance is less than the base threshold value, the pulse generator will discontinue therapy and/or will alert (e.g., by a visual (textual (e.g., ERR) or icon alert and/or an audible alert) the patient that the impedance is below the base threshold value <NUM>.

However, if at least one processor of the pulse generator <NUM> determines that the impedance is not less than the base threshold value, at least one processor of the pulse generator <NUM> will then determine whether the measured impedance is greater than a maximum threshold value (e.g., <NUM>,<NUM>Ω), which would indicate a likely open circuit <NUM>. If at least one processor of the pulse generator <NUM> determines that the impedance is greater than the maximum threshold value, the pulse generator will discontinue therapy and/or will alert (e.g., by a visual (textual or icon (e.g., the high impedance signal icon <NUM> (refer to <FIG>)) alert and/or an audible alert) the patient that the impedance is above the maximum threshold value <NUM>.

However, if at least one processor of the pulse generator <NUM> determines that the impedance is not greater than the maximum threshold value, the method proceeds back to step <NUM>. Then, the method will continue for the duration of the therapy.

It should be noted that in one or more embodiments, the pulse generator <NUM> will switch to the Low Power Mode (e.g., conserving battery capacity) any time an error (e.g., the impedance is below a base threshold or the impedance is above a maximum threshold) is detected.

<FIG> is a flow chart showing the method for determining whether the battery capacity of a pulse generator <NUM> of <FIG> is sufficient to complete a therapy session for a designated duration. At the start <NUM> of the method, at least one processor (e.g., microprocessor <NUM>) of the pulse generator <NUM> determines (reads) the current battery capacity (e.g., <NUM> % capacity) <NUM>. At least one processor of the pulse generator <NUM> then determines (reads) the duration for the therapy session (e.g., <NUM> hours) <NUM>. Then, at least one processor of the pulse generator <NUM> determines (by reviewing logged data for the patient) the average current amplitude of past therapy sessions for the patient <NUM>. At least one processor of the pulse generator <NUM> then determines (by reviewing logged data for the patient) the average therapy impedance of past therapy sessions for the patient <NUM>.

Then, at least one processor of the pulse generator <NUM> determines whether the battery capacity (e.g., <NUM> % capacity) is sufficient to complete a therapy session for the designation duration (e.g., <NUM> hours) for the patient by using the average current amplitude and the average therapy impedance <NUM>.

At least one processor of the pulse generator <NUM> then determines whether the battery capacity is sufficient for the duration of the therapy session <NUM>. If at least one processor of the pulse generator <NUM> determines that the battery capacity is not sufficient for the duration of the therapy session, at least one processor of the pulse generator <NUM> will alert (e.g., by a visual (textual or icon) alert and/or an audible alert) the patient that the battery capacity is insufficient to complete the therapy session for the duration <NUM>. In one or more embodiments, Then, if at least one processor of the pulse generator <NUM> determines that the battery capacity is not sufficient for the duration of the therapy session, at least one processor of the pulse generator <NUM> will prevent the user from initiating a therapy session at that time. Then, the method ends <NUM>.

However, if at least one processor of the pulse generator <NUM> determines that the battery capacity is sufficient for the duration of the therapy session, then the method ends <NUM>.

In use, in one embodiment, the electrode assembly <NUM>, <NUM> is positioned over the forehead of the patient <NUM>. In some embodiments, the electrode assembly <NUM>, <NUM> may include an insulative connection region which helps to line up the assembly <NUM>, <NUM> with the midline of the nose of the patient <NUM>. In some embodiments, the electrode assembly <NUM>, <NUM> is placed over the supraorbital foramina, located over the orbital ridge approximately <NUM>-<NUM> lateral to nasal midline. In one embodiment, the electrode assembly <NUM>, <NUM> is then connected to a pulse generator <NUM>, <NUM> via the electrical cable <NUM>, <NUM>. In other embodiments, the electrode assembly <NUM>, <NUM> is connected to the pulse generator <NUM>, <NUM> via a wireless connection. In some embodiments, the electrode assembly may be a subcutaneous or percutaneous implantable electrode assembly. In the "percutaneous" form, the electrodes are inserted through the skin but the pulse generator <NUM>, <NUM> remains external; there may be a lead wire which exits through the skin, or the electrode may be entirely within the skin tissue and they are coupled to a non-implanted pulse generator <NUM>, <NUM> through, e.g., inductive coupling. The pulse generator <NUM>, <NUM> then provides stimulation according to methods as described herein.

As indicated above, the pulse generator <NUM>, <NUM> disclosed herein may be used to treat a disorder or condition in a patient using trigeminal nerve stimulation (TNS). Broadly speaking, the method of treatment includes positioning external electrodes over or near at least one of the foramina or branches of the trigeminal nerve (<FIG>), and stimulating the electrodes using a stimulator or pulse generator <NUM>, <NUM> as disclosed herein for a fixed time at specified operational parameters. In one embodiment, the external electrodes are positioned over the foramina of the supraorbital or ophthalmic nerves (<FIG>, Foramen <NUM>). In alternative embodiments, the electrode assembly <NUM>, <NUM> can be positioned over the foramina of the maxillary nerves (<FIG>, Foramen <NUM>) or the mandibular nerves (<FIG>, Foramen <NUM>). In yet other embodiments, the stimulation can be unilaterally applied to one foramen of the trigeminal nerves. In other embodiments, electrodes may be positioned at a region of the patient's face (on the right and/or left side) corresponding with the supratrochlear nerve, infratrochlear nerve, zygomaticotemporal, zygomaticofacial, zygomaticoorbital, mentalis, nasal and/or auriculotemporal nerves and/or their respective foramina. In other embodiments, subcutaneous implantable electrodes may be used with the pulse generator <NUM>, <NUM> as disclosed herein. At least one processor (e.g., programmable microcontroller <NUM> of <FIG>) of the pulse generator <NUM>, <NUM> may be programmed to operate at one or more of the following parameters.

In various embodiments, the stimulation is delivered at a specific pulse width or range of pulse widths (or pulse duration). The stimulation can be set to deliver pulse widths in the range greater than and/or less than one or more of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, up to <NUM>. Those of skill in the art will recognized that one or more of the above times can be used as a border of a range of pulse widths.

In some embodiments, the stimulation amplitude is delivered as a voltage or current controlled stimulation. In other embodiments it can be delivered as a capacitive discharge. In various embodiments, the current amplitude can be in any range within a lower limit of about <NUM>µA and an upper limit of about <NUM> mA - <NUM> mA, depending on the surface area of the electrodes, inter-electrode distance, the branch(es) stimulated, and the modeling data as described above. In various embodiments, the amplitude can be in a range greater than and/or less than one or more of <NUM> microamps (µA), <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM>µA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA and <NUM> mA. In some embodiments, the current amplitudes are less than <NUM> mA, or less than <NUM> mA, depending on the size, impedance, resistance, or configuration of the electrode(s). In some embodiments, the current amplitude is between about <NUM>. 5mA and about <NUM> mA. Those of skill in the art will recognize that one or more of the above amplitudes can be used as a border of a range of amplitudes.

In various embodiments, the stimulation can be delivered at one or more frequencies, or within a range of frequencies. The stimulation can be set to be delivered at frequencies less than, and/or greater than one or more of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In various embodiments, the stimulation can be set to be delivered at frequencies greater than, and/or less than, one or more of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, up to <NUM>. Those of skill in the art will recognize that one or more of the above frequencies can be used as a border of a range of frequencies.

In various embodiments, the stimulation is delivered at a specific duty cycle or range of duty cycles. The stimulation can be set to be delivered at a duty cycle in the range greater than and/or less than one or more of <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%,
<NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, or <NUM>%. In some embodiments, to ensure preservation of the nerve, a duty cycle of <NUM>% to <NUM>% may be preferable. In some embodiments, duty cycles up to <NUM>% may be useful in particular circumstances. Those of skill in the art will recognize that one or more of the above percentages can be used as a border of a range of duty cycles.

All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. The exemplary drawings are for purposes of illustration only and the dimensions, positions, order, and relative sizes reflected in the drawings attached hereto may vary.

Where non-claimed methods described above indicate certain events occurring in certain order, those of ordinary skill ir the art having the benefit of this disclosure would recognize that the ordering may be modified and that such modifications are in accordance with the variations of the present disclosure. Additionally, parts of methods may be performed concurrently in a parallel process when possible, as well as performed sequentially. In addition, more steps or less steps of the methods may be performed.

Claim 1:
A pulse generator device for trigeminal nerve stimulation, the pulse generator device comprising:
at least one processor configured to:
produce pulses delivered to a cutaneous electrode assembly for at least one therapy session for a patient, wherein the pulses have defined characteristics,
log data from the at least one therapy session for the patient, wherein the data comprises impedance of the cutaneous electrode assembly connected to the pulse generator during the at least one therapy session and current amplitude of the pulses produced during the at least one therapy session,
determine an average current amplitude by using the data comprising the current amplitude for at least one of the at least one therapy session,
determine an average therapy impedance by using the data comprising the impedance for at least one of the at least one therapy session,
determine a charge capacity of a battery of the pulse generator prior to beginning a subsequent therapy session for the patient, and
determine whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance; and
a display configured to display a screen comprising a graphical user interface (GUI).