Pulse generator for trigeminal nerve stimulation

Abstract

This disclosure relates to a pulse generator device for trigeminal nerve stimulation. In one embodiment, the pulse generator device includes a processor configured to: generate pulses for delivery to an electrode assembly for a patient's treatment session, record data from the treatment session (where the data includes the impedance of the electrode assembly connected to the pulse generator and the current amplitude of the pulses), determine an average current amplitude from the data, determine an average treatment impedance from the data, determine the charge capacity of the battery of the pulse generator before starting a subsequent treatment session, and determine whether the charge capacity of the battery is sufficient to complete a subsequent treatment session for a specified duration by using the average current amplitude and the average treatment impedance. Additionally, the pulse generator device includes a display configured to display a screen including a graphical user interface (GUI).

Description

Technical Field

[0001] The present disclosure generally relates to external nerve stimulator devices and methods of using the same, and more particularly to external nerve stimulator devices configured to stimulate the superficial (cutaneous) sensory branches of the trigeminal nerve. Background Art

[0002] Current surgical treatment methods for certain medical conditions, such as epilepsy or other seizure-related conditions, may include stimulation of the nervous system by vagus nerve stimulation (VNS), which has been approved by the U.S. Food and Drug Administration (FDA). In this method, a stimulating electrode is surgically implanted to contact the vagus nerve as it passes through the neck. In addition to complications related to anesthesia, potential infections, costs, and other adverse events caused by VNS, many subjects receiving VNS treatment do not experience symptom relief, and there are no reliable predictors indicating that an implanted VNS device will result in good therapeutic efficacy.

[0003] Other methods of neuromodulation are the focus of ongoing research. For example, implantable methods are also being studied, including deep brain stimulation (DBS) of specific brain regions and intracranial stimulation of specific brain regions by devices that monitor brain activity and provide stimulation as needed. However, the risks of DBS include infection, bleeding, and damage to deep brain structures.

[0004] In certain clinical situations, electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have been used for neurological and psychiatric disorders. Traditionally, brain stimulation has become the primary treatment alternative to medication and psychotherapy, and ECT has been the mainstream brain stimulation method since the first half of the 20th century. However, ECT has risks of memory and other cognitive side effects, significant costs, and risks of anesthesia.

[0005] Many of the above methods are invasive and may have significant costs and side effects. In addition, despite multiple drug or surgical treatment trials, a significant percentage of patients are unable to recover from the disease or condition or achieve sufficient durable remission.

[0006] The information included in this background art section of the specification (including any references cited herein and any description or discussion thereof) is included only for technical reference purposes and should not be regarded as subject matter limiting the scope of the present invention. Summary of the Invention

[0007] One aspect of the subject matter of the present disclosure meets the above needs by providing a system and device configured to stimulate the trigeminal nerve in a minimally invasive manner and with reduced side effects compared to other neuromodulation methods.

[0008] The present disclosure relates to 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 supply coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller that executes instructions from the storage medium, and the microcontroller is configured to perform at least one of the following operations: generate electrical pulses having defined characteristics, record logs of usage and abnormal events, limit usage to a specific individual, interface with the electrode, provide signals indicating operating conditions and fault conditions to a designated individual, and provide a signal indicating the end of a treatment cycle to a designated individual. In some embodiments, the system may further include a power supply or a charging station. The power supply may be a battery, such as a rechargeable battery.

[0009] The present disclosure relates to a pulse generator for trigeminal nerve stimulation. In one embodiment, the generator includes a body having a front portion and a rear portion and includes at least one electrode channel. The pulse generator further includes a power source. The pulse generator further includes at least one microcontroller that executes instructions from a storage medium and is configured to perform at least one of the following operations: generate electrical pulses having defined characteristics, record logs of usage and abnormal events, limit usage to a specified individual, interface with the electrodes, provide signals indicating operating conditions and fault conditions to a specified individual, and provide a signal indicating the end of a treatment cycle to a specified individual. 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 entry port defined in the body. In one embodiment, the body is sized at approximately 115 millimeters (mm) (4.5 inches (in)) in height × 69 mm (2.7 in) in width × 27 mm (1.1 in) in depth and 145 grams (g) (5.1 ounces (oz)) in weight 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 rear portion of the body and configured to receive a battery. In one embodiment, the body is plastic, metal alloy, or composite material. In one aspect, the microcontroller limits the output current and the current is limited to be approximately less than 35 milliamperes (mA). In various embodiments, the current output has an upper limit of approximately 10 mA, 7 mA, or 5 mA. In some embodiments, the current output has a lower limit of approximately 2.5 mA. In some embodiments, the current output is fixed at approximately 5 mA. In one embodiment, the microcontroller is configured to deliver (or transmit) a true square wave charge balanced output signal or a non-rectangular output signal. In one aspect, the microcontroller generates electrical pulses having the following characteristics: a frequency of 1 - 300 Hertz (Hz), a pulse duration of 50 - 500 microseconds (μs), and a duty cycle of 1 - 100 percent (%). In one aspect, the electrode channel includes at least one groove configured to receive at least one protrusion located at an end of a wire of an electrode assembly to form a lock and key configuration. In one aspect, the electrode channel is keyed for a specific electrode assembly.

[0010] The present disclosure relates to a 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: generating electrical pulses having defined characteristics, logging usage and exception events, restricting usage to a specified individual, interfacing with a dedicated electrode, providing a signal indicating an operating condition and a fault condition to the specified individual, and providing a signal indicating the end of a treatment cycle to the specified individual. In one aspect, the operation of restricting usage to a specified individual includes 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 generating electrical pulses having defined characteristics is performed by a microcontroller, and the characteristics are a frequency of 1 - 300 Hz, a pulse duration of 50 - 500 μs, and a duty cycle of 1 - 100%. In one aspect, the operation of interfacing with the electrode is performed by at least one electrode channel defined in the pulse generator, the at least one electrode channel being keyed to the electrode.

[0011] The present disclosure relates to a computer-readable medium having computer-executable instructions for performing a process of stimulating a branch of the trigeminal nerve. In one embodiment, the instructions include causing a processor device to generate electrical pulses having defined characteristics, log usage and exception events, restrict usage to a specified individual, interface with a specified electrode, provide a signal indicating an operating condition and a fault condition to the specified individual, and provide a signal indicating the end of a treatment cycle to the specified individual.

[0012] In one or more embodiments, a method for trigeminal nerve stimulation includes: generating, by at least one processor of a pulse generator, pulses delivered to an electrode assembly for at least one treatment session of a patient, wherein the pulses have defined characteristics. The method further includes recording, by at least one processor of the pulse generator, data from at least one treatment session of the patient, wherein the data includes the impedance of the electrode assembly connected to the pulse generator during at least one treatment session and the current amplitude of the pulses generated during at least one treatment session. The method further includes determining, by at least one processor of the pulse generator, an average current amplitude by using data including the current amplitude for at least one of at least one treatment session. The method further includes determining, by at least one processor of the pulse generator, an average treatment impedance by using data including the impedance for at least one of at least one treatment session. Moreover, the method includes determining, by at least one processor of the pulse generator, the charge capacity of the battery of the pulse generator before starting a subsequent treatment session of the patient. Additionally, the method includes 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 a subsequent treatment session of the patient for a specified duration by using the average current amplitude and the average treatment impedance.

[0013] In one or more embodiments, the method further includes: when at least one processor of the pulse generator determines that the charge capacity of the battery is not sufficient to complete a subsequent treatment session of the patient for a specified duration, generating, by at least one processor of the pulse generator, an alert to the patient, the alert indicating that the charge capacity of the battery of the pulse generator is not sufficient to complete a subsequent treatment session for a specified duration. In at least one embodiment, the alert is a visual alert and / or an audible alert. In some embodiments, the visual alert includes text and / or an icon.

[0014] In one or more embodiments, the method further includes displaying, via a display of the pulse generator, a screen including a graphical user interface (GUI). In at least one embodiment, the screen includes average treatment data for at least one of at least one treatment session of the patient. In some embodiments, the screen includes a history of at least one treatment session of the patient. In one or more embodiments, the screen includes a history of the current amplitude of the pulses generated during at least one of at least one treatment session of the patient. In at least one embodiment, the screen includes a history of the impedance of the electrode assembly connected to the pulse generator during at least one of at least one treatment session of the patient.

[0015] In at least one embodiment, the method further includes measuring, by at least one processor of the pulse generator, an impedance of an electrode assembly connected to the pulse generator to generate a measured impedance. The method further includes 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 includes: when at least one processor of the pulse generator determines that the measured impedance is less than the base threshold impedance value, generating, by at least one processor of the pulse generator, an alert to the patient, the alert indicating that the measured impedance is below the base threshold impedance value.

[0016] In one or more embodiments, the method further includes measuring, by at least one processor of the pulse generator, an impedance of an electrode assembly connected to the pulse generator to generate a measured impedance. Additionally, the method includes determining, by at least one processor of the pulse generator, whether the measured impedance is greater than a maximum threshold impedance value. Further, the method includes: when at least one processor of the pulse generator determines that the measured impedance is greater than the maximum threshold impedance value, generating, by at least one processor of the pulse generator, an alert to the patient, the alert indicating that the measured impedance is above the maximum threshold impedance value.

[0017] In one or more embodiments, a pulse generator device for trigeminal nerve stimulation includes at least one processor configured to: generate pulses for delivery to an electrode assembly for at least one treatment session for a patient, wherein the pulses have defined characteristics; record data from at least one treatment session for the patient, wherein the data includes an impedance of the electrode assembly connected to the pulse generator during at least one treatment session and a current amplitude of the pulses generated during at least one treatment session; determine an average current amplitude by using data including the current amplitude for at least one of at least one treatment session; determine an average treatment impedance by using data including the impedance for at least one of at least one treatment session; determine a charge capacity of a battery of the pulse generator before starting a subsequent treatment session for the patient; determine, by using the average current amplitude and the average treatment impedance, whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent treatment session for the patient for a specified duration. Additionally, the pulse generator device includes a display configured to display a screen including a graphical user interface (GUI).

[0018] In at least one embodiment, the at least one processor is further configured to generate an alert to the patient when the at least one processor determines that the charge capacity of the battery is not sufficient to complete the subsequent treatment session for the patient for a specified duration, the alert indicating that the charge capacity of the battery of the pulse generator is not sufficient to complete the subsequent treatment session for the specified duration. In some embodiments, the alert is a visual alert and / or an audible alert.

[0019] 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 includes at least one button configured to program a specified duration of a treatment session. In one or more embodiments, the pulse generator is sized such that it fits in a user's hand. In at least one embodiment, the current amplitude of the generated pulses has an upper limit of 8.0 mA.

[0020] In at least one embodiment, at least one processor is further configured to restrict the use of the pulse generator by requiring a patient password. In one or more embodiments, the patient password is programmable.

[0021] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. In the following written description of various embodiments of the invention, which is illustrated in the accompanying drawings and defined in the appended claims, a more extensive presentation of the features, details, utilities, and advantages of the invention is provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The manner in which the invention is organized and operated can be understood by reference to the following description taken in conjunction with the accompanying drawings.

[0023] Figure 1A and 1B shows the positions of several branches (nerves) of the trigeminal nerve and the positions of the major foramina of the superficial branches of the trigeminal nerve.

[0024] Figure 2A depicts an example of a subject wearing an electrode assembly and a pulse generator in accordance with aspects of the present disclosure;

[0025] Figure 2B depicts an example of a subject wearing an electrode assembly and a pulse generator in another embodiment in accordance with aspects of the present disclosure;

[0026] Figure 3A is a front perspective view of another embodiment of a pulse generator in accordance with aspects of the present disclosure;

[0027] Figure 3B is Figure 3A a front elevational plan view of the pulse generator;

[0028] Figure 3C is Figure 3A a left side view of the pulse generator;

[0029] Figure 3D isFigure 3A Right side view of the pulse generator;

[0030] Figure 3E-1 is Figure 3A Top perspective view of the pulse generator;

[0031] Figure 3E-2 is Figure 3A Top plan view of the pulse generator;

[0032] Figure 3F-1 and Figure 3F-2 depict Figure 3A Top plan view of the front and rear inner sides of the housing of the pulse generator;

[0033] Figure 3G is Figure 3A Top view of the rear inner side of the housing of the pulse generator, showing some electrical components and a display;

[0034] Figure 3H is Figure 3G The pulse generator, showing the electrical components below the display;

[0035] Figure 3I-3J shows Figure 3H An enlarged view of the electrical components shown in;

[0036] Figure 3K is Figure 3I-3J Rear plan view of the electrical components shown;

[0037] Figure 3L is Figure 3H Rear plan view of the display and associated electrical components;

[0038] Figure 4 Block diagram of the system of FIG. 3;

[0039] Figure 5 Flowchart showing an embodiment of the method of operating the pulse generator;

[0040] Figures 6 to 26 Relates to another embodiment of the disclosed pulse generator;

[0041] Figure 6 Front perspective view of two of the disclosed pulse generators;

[0042] Figure 7 is Figure 6 Another front perspective view of two of the pulse generators;

[0043] Figure 8 is Figure 6 Front perspective view of one of the pulse generators and Figure 6Rear perspective view of another pulse generator;

[0044] Figure 9 is Figure 6 Front perspective view of one pulse generator and Figure 6 Rear perspective view of another pulse generator;

[0045] Figure 10 is a perspective view of the pulse generator shown connected to the electrode assembly 1060; Figure 6 of;

[0046] Figure 11A depicts a user holding Figure 6 the pulse generator;

[0047] Figure 11B depicts a user programming Figure 6 the pulse generator;

[0048] Figure 12 is a diagram of the pulse generator shown connected to a computing device; Figure 6 of;

[0049] Figure 13 is Figure 6 Top plan view of the pulse generator;

[0050] Figure 14 is Figure 6 Bottom plan view of the pulse generator;

[0051] Figure 15 is Figure 6 Front plan view of the pulse generator adjacent to a scale;

[0052] Figure 16 is Figure 6 Left side view of the pulse generator adjacent to a scale;

[0053] Figures 17-24 shows a plurality of exemplary screens that can be displayed on the display of Figure 6 the pulse generator for a user to obtain treatment data of a patient's record;

[0054] Figure 17 is a graphical user interface (GUI) screen for accessing a patient's treatment data log, in which average treatment data selection is selected;

[0055] Figure 18 is a GUI screen that shows exemplary average treatment data of a patient;

[0056] Figure 19 is a GUI screen for accessing a patient's treatment data log, in which "treatment session data selection" is selected;

[0057] Figure 20 is a GUI screen that shows an exemplary historical list of treatment sessions for a patient, where "Treatment Session 2: January 2, 2020" is selected;

[0058] Figure 21 is a GUI screen that shows exemplary treatment data for Treatment Session 2 of the patient on January 2, 2020, where "Treatment Amplitude Selection" is selected;

[0059] Figure 22 is a GUI screen that shows an exemplary historical list of treatment amplitudes during Treatment Session 2 of the patient on January 2, 2020;

[0060] Figure 23 is a GUI screen that shows exemplary treatment data for Treatment Session 2 of the patient on January 2, 2020, where "Treatment Impedance Selection" is selected;

[0061] Figure 24 is a GUI screen that shows an exemplary historical list of treatment impedances during Treatment Session 2 of the patient on January 2, 2020;

[0062] Figure 25 is a flowchart showing a method for determining whether the impedance of the system is out of range; and

[0063] Figure 26 is a flowchart showing a method for determining Figure 6 whether the battery capacity of the pulse generator is sufficient to complete a treatment session within a specified duration. Detailed Description

[0064] The present disclosure relates to devices configured to stimulate the sensory branches of the trigeminal nerve in the face and forehead (trigeminal nerve stimulation or TNS). More specifically, disclosed herein is an external pulse generator or nerve stimulator configured to stimulate the sensory components of the ophthalmic nerve and its branches, the infraorbital nerve and its branches, and the mental nerve or its branches, including the supraorbital nerve, the supratrochlear nerve, the infraorbital nerve, the auriculotemporal nerve, the zygomaticotemporal nerve, the zygomatico-orbital nerve, the zygomaticofacial nerve, the nasal nerve, and the infratrochlear nerve. The pulse generator can be used to treat a variety of conditions, such as neurological conditions (as disclosed, for example, in U.S. Patent Application No. 12 / 898,675, entitled "Systems, Devices and Methods for the Treatment of Neurological Disorders and Conditions") and psychiatric conditions (as disclosed, for example, in U.S. Patent Application No. 12 / 898,686, entitled "Devices, Systems and Methods for Treatment of Neuropsychiatric Disorders"), the entire contents of the above patent applications being incorporated herein by reference.

[0065] In previous studies, the commercially available TENS unit EMS 7500 has been used. The TENS unit is designed to deliver currents up to 100 mA, far higher than the levels required for external TNS. For example, when TNS is used clinically for epilepsy treatment, the high current can pose potential safety hazards to the patient, whether skin damage or current flowing through the skull and damaging the brain parenchyma. The pulse generator or nerve stimulator disclosed herein is configured to limit the delivered current and includes a programmable microcontroller to implement the features disclosed herein, thereby reducing the likelihood of patient injury and optimizing the convenience of use (user-friendliness).

[0066] The pulse generators disclosed herein include a programmable microcontroller which, in various embodiments, may implement some or all of the following features: generating electrical pulses having specific programmable characteristics; recording logs of usage and abnormal events; restricting usage to specified individuals; interfacing with various electrode designs including subcutaneously implantable electrode designs (such as those described in U.S. Patent Application Nos. 12 / 898,685 and 12 / 898,696, both of which are incorporated herein by reference) and skin electrode designs (such as those described in U.S. Application Nos. 12 / 898,675 and 12 / 898,686); sending signals to a patient user (or physician or other caregiver) regarding operating conditions and fault conditions; sending a signal with a weekly warning that the physician needs reprogramming access and pausing operation until reprogramming on a specified date; and the programmable microcontroller is rechargeable and sealed to prevent, for example, liquids from penetrating into the internal structure of the pulse generator. In some embodiments, the pulse generator may signal a physician or other caregiver via the Internet or a cell phone, and the communication may be real-time. In some embodiments, the pulse generator may notify a physician or other caregiver that the patient may be having a seizure (based on processing implanted or external EEG data or other physiological data such as an autonomic nervous system index (such as 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).

[0067] The unique anatomy of the trigeminal nerve, as well as its direct and indirect projections to key brainstem, thalamic, and cortical regions involved in sensory processing, attention, and autonomic function, may permit the use of a pulse generator for stimulation, as disclosed herein for various neurological, psychiatric, and other disorders that may require stimulation.

[0068] For a discussion of the trigeminal nerve, reference is now made to Figures 1A-1B , Figures 1A-1B which shows the locations of several branches of the trigeminal nerve and the locations of the major foramina of 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. Since it is the fifth of the twelve cranial nerves, it may also be referred to interchangeably as CN V. The trigeminal nerve has three main sensory branches in the face, all of which are bilateral and easily accessible. The supraorbital nerve or ophthalmic nerve is commonly referred to as the V1 division. The infraorbital branch or maxillary nerve is commonly referred to as the V2 division. The superficial branch or mandibular nerve (also known as the mental branch) is called the V3 division. The supraorbital nerve provides sensory information regarding pain, temperature, and light touch to the skin of the forehead, upper eyelid, front of the nose, and eye. The infraorbital branch provides sensory information regarding pain, temperature, and light touch to the lower eyelid, cheek, and upper lip. The mental branch provides a similar sensory modality to the chin, tongue, and lower lip.

[0069] As can be seen from Figure 1A and Figure 1B As can be understood, these branches exit the skull through three foramina. The supraorbital nerve or ophthalmic nerve exits through the 1st foramen (supraorbital foramen or notch), approximately 2.1 - 2.6 cm from the nasal midline (in adults), and lies above the orbit near the eyebrow. The nasal nerve is a division of the ophthalmic nerve. The infraorbital branch or maxillary nerve exits at the 2nd foramen (infraorbital foramen), approximately 2.4 - 3.0 cm from the nasal midline (in adults), while the mental nerve exits at the 3rd foramen (mental foramen), approximately 2.0 - 2.3 cm from the nasal midline (in adults). Other sensory branches include zygomaticofacial, zygomaticotemporal, and auriculotemporal from other foramina.

[0070] The fibers of the three main branches combine to form the trigeminal ganglion. From there, the fibers ascend to the brainstem at the pons level, synapsing with the main sensory nucleus of the pons, the mesencephalic nucleus of cranial nerve V, and the nuclei and tract V of the spinal cord. Pain fibers descend in the spinal nucleus and tract V and then ascend to the ventral posteromedial nucleus (VPM) of the thalamus and then project to the cerebral cortex. Light touch sensory fibers are large myelinated fibers that ascend to the ventral posterolateral (VPL) nucleus of the thalamus. Afferent sensory fibers project from the trigeminal nucleus to the thalamus and cerebral cortex.

[0071] The trigeminal nucleus has projections to the nucleus of the solitary tract (NTS), locus coeruleus, cerebral cortex, and vagus nerve. The NTS receives afferents from the vagus nerve and trigeminal nerve. The NTS receives input from multiple sources and projects to structures in the brainstem and forebrain, including the locus coeruleus.

[0072] The locus coeruleus is a paired nuclear structure in the dorsal pons and lies immediately beneath the floor of the fourth ventricle. The locus coeruleus has extensive axonal projections to a wide range of brainstem, subcortical, and cortical structures and is an important part of the reticular activating system. The locus coeruleus 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.

[0073] Although not bound by any particular theory, in certain embodiments, the connections between the trigeminal nerve, locus coeruleus, solitary nucleus and tract, thalamus, and cerebral cortex may be relevant to the potential role of the trigeminal nerve in many diseases and disorders. Thus, cutaneous stimulation of the trigeminal nerve via a pulse generator as disclosed herein or a system including a pulse generator may be effective in the treatment of a variety of diseases and disorders indicated for treatment by trigeminal nerve stimulation.

[0074] Thus, stimulating the superficial or cutaneous branches of the trigeminal nerve provides a means for non-invasive neuromodulation. Additionally, stimulation parameters can be customized for an individual condition, such that brainstem, thalamic, or cortical structures involved in the individual condition can be activated or inhibited according to the pathophysiology of the condition being treated.

[0075] In one embodiment, as can be appreciated from Figures 2A to 2B a system 100 for stimulating the trigeminal nerve or its branches includes an electrode assembly 10, a nerve stimulator or pulse generator 15, and a cable or wire 20. The electrode assembly 10 can be configured for bilateral simultaneous and asynchronous stimulation of the ophthalmic nerve. In other embodiments, the electrode assembly can be configured for unilateral or bilateral stimulation of one or more branches of the trigeminal nerve, as disclosed elsewhere herein. The electrode assembly 10 can include a pair of electrodes for placement on a patient's facial region. It can be appreciated that a single electrode or multiple electrodes can be used. Electrode assemblies that can be used in conjunction with the present disclosure are also described in co-pending U.S. Application Nos. 12 / 898,675 and 12 / 898,686, both of which are incorporated herein by reference. In one embodiment, the cable or wire 20 is configured to provide a physical and electrical connection between the generator 15 and the electrode assembly 10 via leads. In other embodiments, the generator 15 and the electrode assembly 10 communicate wirelessly (i.e., without using the wire 20 and leads). In one embodiment, the generator 15 is portable and attached to a belt of the patient 5. In other embodiments, the generator 15 is non-portable. In some embodiments, the system 100 can include a charging station.

[0076] In one embodiment, the electrode assembly 10 is configured for bilateral stimulation of the left and right supraorbital branches of the trigeminal nerve (V1) located above the eyebrows on the forehead. The electrode assembly can include 2-contact and 4-contact electrodes. Electrical stimulation will propagate from the pulse generator to the contact areas of the patient that will be placed on the forehead, on the bilateral trigeminal V1 branches. The contact areas are arranged such that the current propagates perpendicular to the two branches (2 contacts) of the V1 branch between the two conductive areas, or such that the current propagates parallel to the two paths of the V1 branch (4 contacts).

[0077] In one embodiment, the electrode assembly 10 can be configured to deliver symmetric biphasic pulses. In other embodiments, the pulse waveform can be asymmetric and / or polyphasic.

[0078] The electrodes can be through a hypoallergenic biocompatible hydrogel, such as DermaFlow TMA hydrogel (Axelgaard Manufacturing Co, Ltd, Fallbrook, CA, USA) is fixed to the forehead. Such gels have been specifically developed for the skin and forehead to minimize skin irritation and have been subject to ISO skin sensitization and histocompatibility studies in animals.

[0079] Wire 40 transmits electrical pulses from the pulse generator to the contacting conductive area, thereby delivering a prescribed stimulation. In one aspect, the wire is a 13.5-inch wire that transmits electrical pulses from the pulse generator to the contacting conductive area. The wire extends from one side of the pulse generator and is bundled together. The wire terminates in a dedicated plug that connects to a socket of the pulse generator and is configured to prevent a patient user from connecting the electrode to other potentially dangerous current sources.

[0080] In some embodiments, and as referenced Figure 4 As can be appreciated, the pulse generator 15 can also be used in combination with a physician docking / programming console. In other embodiments, the "programming" functions described herein can be performed directly via the user interface described elsewhere herein. The programming docking console allows a prescribing physician to set parameters for the user / patient and monitor the usage of the patient since the last docking event (e.g., by uploading a log file). When the patient user visits the prescribing physician, the pulse generator 15 can be programmed to manage specific stimulation parameters prescribed by the physician, such as the pulse frequency, by using the console. These parameters can be set individually, or the physician can select from pre-established combinations (e.g., repetition frequency, pulse width, on / off cycle). The docking / programming station can select these parameters from a menu or provide step-by-step parameter settings within the range and step size allowed by the pulse generator 15. At subsequent visits, the log file can be examined to determine the actual pattern of device usage, as this information may be useful for the treatment plan. This data can be displayed as text or graphically, e.g., a chart showing daily usage. This data can be stored for the physician to incorporate into the individual patient's medical record.

[0081] For a more detailed discussion of the pulse generator, reference is now made to Figures 3A-3L 、 Figure 4 and Figure 5 , Figures 3A-3L which show various views of an exemplary embodiment of the pulse generator, Figure 4 is a block diagram showing an embodiment of the pulse generator 15, while Figure 5 is a flowchart showing an embodiment of the method of operation of the pulse generator 15.

[0082] As can be seen from Figures 3A to 3L and with reference to Figure 4 andFigure 5 It is understood that the pulse generator 15 includes a sealed body or housing 25 that seals or houses internal components (such as the microcontroller and battery discussed below) as well as other wiring and electrical components. The pulse generator may be manufactured by ITO Co., Ltd. in Japan or other suitable manufacturers.

[0083] The sealed body 25 protects the internal components and prevents liquids, etc. from penetrating into the body and damaging the internal components. In one embodiment, the pulse generator 15 is housed in a rectangular hard plastic housing 25 that measures approximately 115 mm (4.5 inches) H × 69 mm (2.7 inches) W × 27 mm (1.1 inches) D and weighs 145 g (5.1 ounces) without the battery. In other embodiments, the body or housing may be made of a metal alloy or composite material. As Figure 3C shown, etc., the body 25 includes a front portion 26 and a rear portion 27. The front and rear portions are sealed together to prevent fluids, etc. from entering the body and interfering with the internal components and electrical components housed within the body. As Figure 3D and 3F-1 shown, the body 25 may include a raised feature 28 that is configured to provide a gripping surface by which a user, physician, etc. can open the pulse generator to, for example, replace the battery or other electrical components. As can be seen from Figures 3A-3B and other figures, the pulse generator 15 may also include user control features 30, such as buttons, that allow the user to turn the power on and off or provide a temporary lock. In some embodiments, the user control feature 30 may be up and down arrow buttons that allow a patient user to adjust the stimulation amplitude. In some embodiments, this is the only parameter that is user adjustable (all other parameters are controlled by the physician's programming).

[0084] As Figure 3E-1 、 3E-2 、3I - 3K, etc. shown, the pulse generator 15 may also include at least one dedicated socket or channel 35 for connecting the leads of the electrodes. The channel 35 includes a groove or opening 39 that is configured to receive the end of the lead of the electrode assembly. That is, the channel 39 is "keyed" for the end of the electrode or electrode assembly. The end of the lead 12 includes a corresponding protrusion 39a such that the protrusion 39a is received in the groove 39 in a lock and key type configuration. This lock and key configuration prevents a patient user from connecting the electrode to other potentially dangerous current sources and from using other incompatible electrode assemblies with the pulse generator. In use, when using a two - contact electrode, one channel 35 is utilized. When using a four - contact electrode, two channels 35 are utilized.

[0085] At least in Figure 3E-1 and 3E-2As can be seen, the pulse generator 15 may further include a power input port 36. The power input port 36 is configured to receive a connector from a power source such as a DC power supply. In use, the pulse generator is powered by a battery and / or a power source (not shown).

[0086] In some embodiments, the pulse generator 15 is powered by a rechargeable lithium-ion 9V battery that is housed in a battery cavity 29 of the body 25, as shown in at least Figure 3F-2 、 3G and 3I. In some embodiments, the generator 15 is powered by a lithium polymer battery.

[0087] As can be understood from Figure 3G 、 3H 、3I, 3K, 3L, etc., the pulse generator 15 further includes a display 40, such as an LED or LCD screen, to display a graphical user interface (GUI). The display may also be controlled by a microcontroller 126 on a display PCB 128. The display PCB 128 is connected to a pulse generator microcontroller 125 on a microcontroller PCB 129 via a ribbon 127. The display 40 may be manipulated by a user control feature 30 that allows a physician and a patient to select specific graphical menus. The user control feature 30 may be generated on the GUI or may be a feature of or integrated with the housing 25. The GUI may include a touchscreen interface, thereby allowing the user patient to make selections by touching on the screen.

[0088] The GUI is used to control the electrical 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 the patient to change their stimulation parameters within a range that has been pre-determined by a qualified medical personnel, and the stimulation parameters may be limited to the current amplitude. The second level of password protection allows a qualified medical personnel to limit the range of stimulation parameters available to the patient. In addition to these parameters, a qualified medical personnel may also select a timed treatment regimen of 1 to 16 hours as well as a continuous stimulation mode.

[0089] As can be understood from Figure 4 it can be understood that the pulse generator is connected to a power source 100. Referring to Figures 3A-3L, in one embodiment, the pulse generator 15 is operably coupled to the battery 100. In other embodiments, the power source can be any suitable power source, such as a fuel cell, etc. In some embodiments, the battery 100 is inductively rechargeable using a home base station connected to the patient. In some embodiments, the rechargeable battery has a 5-year lifespan. The battery 100 and / or the pulse generator 25 can be operably coupled to an (additional) power supply or charging station 115, such as the patient's home base station. The battery can be an internal lithium rechargeable battery. In one embodiment, the battery has a capacity of up to 1000 mA-hours to last at least 36 - 48 hours between charges. In some embodiments, the pulse generator can also be used in combination with a patient recharge station. In one embodiment, the patient recharge station is a bedside table and recharge facility for storing the device when not in use. The pulse generator 15 is also operably coupled to the electrode 105 (which can be part of the electrode assembly 10). In some embodiments, the pulse generator 15 can be coupled to the electrode 105 via the wire 20 or the generator 15, and the electrode 105 can be wirelessly coupled. In some embodiments, the electrode 105 and the generator 15 can be a single unit, for example, the generator 15 is directly connected to the electrode and is generally located on the electrode. The electrode 105 can be replaced daily (or at another suitable time), but the generator 15 is reusable. In other embodiments, the generator can be designed for single use (non-reusable). The electrode 105 can provide data to the pulse generator 15, and the generator 15 can in turn generate an output 120, such as notifying the patient that the electrode has become disconnected or that the electrode needs to be repositioned. In some embodiments, the pulse generator 15 can further include a digital display of some or all parameters, including output current and skin impedance. As Figure 4 shown, the pulse generator 15 communicates with the storage medium 110. 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 15 includes a microcontroller 125 or other suitable processor for receiving and executing instructions from the storage medium 110, such as a non-volatile storage medium, magnetic storage medium, optical storage medium, flash memory, other computer-readable media, or a suitable memory device. A processor such as the microcontroller 125 can control the operation of the pulse generator 15. The processor 125 can be any electronic device cable that processes, receives, and / or transmits instructions. For example, the processor 125 can be a microprocessor, a microcomputer, etc. Referring Figure 5 to a more detailed discussion of the various features implemented by the programmable microcontroller 125 of the pulse generator 15.

[0090] Figure 5FIG. 0 is a flowchart showing an embodiment of a method 200 for operating a pulse generator according to the present disclosure. The method 200 may be executed by a microcontroller 125 or other suitable processor executing instructions from a computer-readable medium. It should be understood that the operations of the method 200 may be executed in the order shown, in another suitable order, and / or one or more operations may be executed simultaneously. Additionally, in some embodiments, the method 200 may include more or fewer operations than those shown.

[0091] In operation 205, 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, the use of the pulse generator may be limited to a specific individual patient for whom TNS treatment has been performed, and other unauthorized individuals may not be able to use it. In some embodiments, a multi-digit personal identification number (PIN) may be selected by the patient and set by the physician. In some embodiments, the PIN may be a 5-digit code. The patient will enter the PIN before starting the treatment. If the number of incorrect guesses of the PIN exceeds a predetermined number (e.g., 5), the generator stops operating (e.g., "locks") for 1 hour (or other appropriate time) and records the event. In some embodiments, only one treatment session is allowed per day. In other embodiments, a biometric system (e.g., fingerprint) may be used instead of the PIN. The PIN or biometric ID prevents device sharing and can reduce the risk of improper clinical use by other individuals.

[0092] In operation 210, an electrode check is performed. The electrode check may be performed at the start of the treatment session and may monitor for operational abnormalities of the electrode assembly. In one embodiment, the pulse generator may include a "handshake" that has a chip or circuit on the electrode or has a chip or circuit associated with the electrode that downloads a serial number and detects the model of the electrode (e.g., a single pair of contacts or separate R / L contact pairs). In operation, the pulse generator checks to determine if it is connected to the electrode, if the electrode is properly positioned, etc. In some embodiments, in this operation, the pulse generator may further deliver a stimulation signal to the electrode contacts within the electrode assembly and may set a "used" bit on the electrode assembly at the end of the treatment to enforce single use. This ensures that the gel on the contacts is not contaminated, as damaged gel can produce irregular currents ("hot spots"), resulting in excessive local current and skin injury. If the electrode check is okay (e.g., the electrode is connected, properly placed, etc.), the method may proceed to operation 215, pulse generation.

[0093] If the electrode check fails, the method proceeds to operation 212. For example, if the impedance suddenly becomes high, a signal will be sent indicating that the electrode is disconnected ("infinite" impedance). If the impedance is low or too low, the user will be prompted to reposition the electrode (e.g., repositioning of the electrode is required to ensure skin safety). In some embodiments, the signal may also be sent or alternatively sent to a physician or other caregiver and / or designated family member. The pulse generator may signal such a fault condition. Treatment may be terminated, or the patient may adjust the electrodes as instructed and restart treatment (e.g., turn the pulse generator off and then on again, or the pulse generator may perform another electrode check).

[0094] Method 200 may then proceed to operation 215. In this operation, pulses can be generated. Pulse characteristics can include: (1) controlled current rectangular pulses of one or two channels having one or more of the following characteristics: (a) a maximum deliverable current of 30 mA per channel (or the current defined elsewhere in this disclosure), (b) the physician can set upper and lower limits for each patient, ranging from 0.3 to 30 mA (e.g., default settings of 1 mA lower limit and 20 mA upper limit), (c) the user adjusts the actual current output within this range to allow for comfort settings, (d) provides a single bipolar channel with the ability for the user to switch polarities (e.g., from "right = positive / left = negative" to the opposite), and (e) provides a pair of bipolar channels with the ability for the user to switch polarities (e.g., the right and left channels are separate pairs, each channel having upper and lower electrode contacts, and the options are "upper positive / lower negative" and "lower positive / upper negative" arrangements); (2) a pulse width (duration) of 10 to 3000 μs, which can be set by the physician (e.g., default of 250 μs); (3) a repetition frequency that can be set by the physician, with a frequency range of 10 to 300 Hz; (4) a duty cycle that can be adjusted by the physician, setting the on and off periods in seconds, with each variable ranging from 5 s to 60 s, e.g., in 5 s steps (e.g., default of 30 s on / 30 s off); (5) a treatment duration of 1 to 23 hours (e.g., default of 8 hours). Various embodiments may allow for adjustment or programming of any or all of the foregoing. In some embodiments, this operation includes 2 channels and operates with the following parameters: frequency 1 - 300 Hz, pulse duration 50 - 500 μs, duty cycle 1 - 100%. These two channels can be configured to provide synchronous or asynchronous stimulation. In some embodiments, the pulses generated in this operation can be transmitted on two separate channels, or multiple unique pulses can be generated and carried on separate channels. In some embodiments, the pulse waveform can be shaped through programmable settings for pulse duration, frequency, and duty cycle, etc. In certain embodiments, these programmable settings can only be adjusted by the physician or other authorized caregivers. Generally, reprogramming of the operation parameters discussed herein may be limited to parties providing an appropriate password or other credentials (e.g., biometric indicators). This feature may prevent patients from using the generator in settings contrary to medical prescriptions or outside of the FDA label.

[0095] As can be understood from the foregoing, the programmable microcontroller 125 limits the output current. That is, the patient-adjustable current is limited to be approximately less than 35 mA to maximize tolerance, minimize current and charge density, and minimize any possibility of current penetration through the skull. The controller 125 can deliver a truly square-wave charge-balanced output. This can be advantageous because existing commercial TENS devices have an asymmetric output, resulting in irregular stimulation and a risk of forming hot spots, which can irritate or damage the skin. In some embodiments, if a particular signal is safe, an asymmetric waveform can be employed.

[0096] The microcontroller can be set to an output range. In one embodiment, the range can be set to be approximately between 2.5 mA and approximately 7 mA. In one embodiment, the microcontroller limits the output current to approximately 7 mA, and the patient can adjust the current within the range below 7 mA. In another embodiment, the microcontroller can limit the output current to a narrow range between approximately 2.5 mA and approximately 5 mA using an external electrode two-contact or four-contact electrode (e.g., to ensure safety and compliance). In this way, the patient is prevented from delivering current at too high or too low an output. In yet another embodiment, the output current can be limited to an exact current, e.g., 5 mA, with a maximum fixed current of 7 mA, depending on the size, resistance, or impedance of the electrode. In another embodiment, the output current is limited to a range not exceeding 10 mA, 7 mA, or 5 mA. Without wishing to be bound by any particular theory, it is believed that higher currents, depending on the size and impedance of the electrode, may cause patient pain, discomfort, and / or skin irritation.

[0097] Method 200 can further include operation 220, wherein an activity log of the pulse generator is recorded. Using the log of operation 220 can include: (1) recording data for each session, such as: (a) the session start date and time; (b) the session stop date and time (actual time the treatment ends), (c) user-adjustable settings (e.g., the actual delivered current), and (d) session-specific data (e.g., maximum and minimum impedance, electrodes, and configuration). Operation 220 can further include: recording operation anomalies (e.g., electrode disconnect, low impedance, lockout for unauthorized use attempts, etc.), transmitting the data to the physician's programming console, and operation 220 can include the capacity to store six months of treatment data. In other embodiments, less than six months or more than six months of data can be stored. Monitoring the patient's compliance behavior (adherence) and usage through, for example, a log file. Such monitoring can be used to help monitor usage patterns to evaluate the patient's response to treatment (e.g., poor clinical responses may be related to using the device fewer times than prescribed).

[0098] In some embodiments, the pulse generator may also signal the patient about the operating parameters. This can be part of the record 220 of the operation, or can be part of a different or separate operation. For example, if the user is locked out for PIN guessing, a signal can be sent that can indicate the number of minutes until the generator is unlocked. In another example, if a need for subsequent reprogramming of the physician is upcoming, a signal can be sent and the signal indicates how many days of treatment remain before reaching the "refill" date. The pulse generator can also display the current time and date in the programmed time zone, display the time remaining (hours: minutes) in the current treatment session, and / or display the time (hours: minutes) required for the charger to prepare for the next treatment session.

[0099] Method 200 may further include operation 225, in which the end of an authorized treatment cycle is signaled. In one embodiment, several weeks (e.g., default of 3 weeks) before the end of a treatment cycle (e.g., default of 3 months), operation 230 notifies the user that the treatment cycle is about to end and that a follow-up visit to the prescribing physician for a clinical evaluation and a need to schedule reprogramming is required. In one embodiment, the notification is made at the start of the treatment session. In the following weeks, the patient is notified of the remaining one week to schedule an appointment. In the last week, the remaining days are counted down daily. In the last treatment of the authorized period, the user will be notified that this is the last treatment.

[0100] In operation 230, the treatment is terminated. Use of the generator can be paused (e.g., the user is locked out) until reprogrammed by a physician or the physician programming console, or use of the generator can be terminated.

[0101] Figures 6 to 26 Another embodiment related to the disclosed pulse generator. In particular, Figure 6 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 repeat units, and the "a" and "b" in the reference numerals in these figures are only used to indicate a particular one of the two pulse generators 610a, 610b as shown. Additionally, it should be noted that the pulse generators 610a, 610b may each additionally include Figures 2A to 4 at least some of the features and / or functions of the pulse generator 15.

[0102] In Figure 6Among them, the pulse generators 610a, 610b are shown as respectively including a display 625. In one or more embodiments, the display 625 can 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 as each including a housing 615, which can be a hard shell housing (e.g., made of plastic).

[0103] In addition, the pulse generators 610a, 610b are shown as each including a port 620 on their respective bottom sides. In one or more embodiments, the port 620 is a universal serial bus (USB) port. During the operation of the pulse generators 610a, 610b, one end of a cable (e.g., reference Figure 12 1230) (e.g., a USB cable) is connected to the port 620, and the other end of the cable (e.g., Figure 12 1230) is connected to a computing device (e.g., Figure 12 1200).

[0104] In addition, in Figure 6 the pulse generators 610a, 610b are shown as respectively including a plurality of buttons 630, 635, 640. Specifically, the button 630 is an up arrow button, the button 640 is a down arrow button, and the button 635 is a lock and set key button. During the operation of the pulse generators 610a, 610b, a user (e.g., a patient, a caregiver (e.g., a parent) and / or a healthcare professional (e.g., a physician)) presses the buttons 630, 640 to scroll up and down respectively through the text, letters, numbers, characters, icons, and / or screens displayed on the displays 625 of the pulse generators 610a, 610b. In addition, during the operation of the pulse generators 610a, 610b, the user presses the buttons 630, 640 to adjust the current amplitude (up and down) of the pulses generated by the pulse generators 610a, 610b. And, the user (e.g., a patient, a caregiver, and / or a healthcare professional) presses the button 635 to select a highlighted entry (e.g., text, letter, number, character, or icon) displayed on the screen of the display 625. In addition, the user can press the button 635 to lock and unlock the buttons 630, 635, 640 so that they are inactive during a treatment session. It should be noted that the buttons 630, 635, 640 can be locked (e.g., via the button 635) so that they are inactive during a treatment session, so that the patient does not inadvertently (e.g., during sleep) press any of the buttons 630, 635, 640 during the treatment session.

[0105] In Figure 6In it, displays 625 of each of the pulse generators 610a, 610b are shown to display different screens. Specifically, the display 625 of the pulse generator 610a is shown to display a login screen, which a user (e.g., a patient, a caregiver, and / or a healthcare professional) uses to log in to the pulse generator 610a to perform a treatment session. On the login screen, a plurality of icons are displayed. These icons include an unlock icon 650, a high impedance signal icon 660, and a battery capacity icon 645a. When displayed on the display 625, the unlock icon 650 indicates that the buttons 630, 635, 640 of the pulse generator 610a are unlocked (i.e., not locked) and are active and available for the user. When displayed on the display 625, the high impedance signal icon 660 indicates that the system is exhibiting high impedance (e.g., an impedance greater than a maximum impedance threshold). For details on determining the high impedance of the system, see Figure 25 the discussion. The battery capacity icon 645a shows the amount of battery charge remaining in the battery of the pulse generator 610a. Specifically, in Figure 6 it, the battery capacity icon 645a shows that the battery has approximately fifty percent (50%) of the charge remaining. In one or more embodiments, the pulse generator 610a is capable of measuring the remaining battery capacity with an accuracy of plus or minus (+ / -) five (5)%. It should be noted that in one or more embodiments, when the battery capacity drops below a predetermined low battery capacity threshold (e.g., 10% of the battery capacity), and / or when an error (e.g., high impedance) is detected, the pulse generator 610a will switch to a low power mode (e.g., to conserve battery capacity).

[0106] Also shown on the display of the pulse generator 610a is the patient's password (or personal identification number (PIN)) for input by the user (e.g., a patient, a caregiver, or a healthcare professional) into the pulse generator 610. Specifically, in this figure, the patient's password (or PIN) includes four digits and starts with "820". The password (or PIN) for the patient can be generated by the pulse generator 610a for the patient (e.g., by using a random number generator), or the user (e.g., a patient, a caregiver, or a healthcare professional) can program it (e.g., select and customize it).

[0107] It should be noted that in one or more embodiments, the password for the patient can include (and can be customized by the user to include) more or fewer than four digits, as Figure 6 shown. In one or more embodiments, the patient's password can be programmed to include only digits, only letters (possibly case-sensitive), only characters, only icons or digits, or a combination of letters, characters, and / or icons.

[0108] In one or more embodiments, after a user has logged in the pulse generator 610a for a patient, after a specific period of user inactivity (e.g., 5 minutes) has elapsed, the pulse generator 610a will automatically lock the buttons of the device.

[0109] In Figure 6 , the display screen of the pulse generator 610b is shown to display a treatment session screen, which is used by a user (e.g., a patient, a caregiver, and / or a healthcare professional) to program the parameters of a patient treatment session. On the treatment session screen, a plurality of icons are displayed. These icons include a lock icon 655, a solid connection symbol icon 665, and a battery capacity icon 645b. When displayed on the display 625, the lock icon 655 indicates that the buttons 630, 635, 640 are unlocked and active for use by the user. When displayed on the display 625, the solid connection symbol icon 665 indicates that the system is fully electrically connected for a treatment session (e.g., the impedance of the system is between a maximum impedance threshold and a base impedance threshold). The battery capacity icon 645b shows the amount of battery charge remaining in the battery of the pulse generator 610b. In particular, in Figure 6 , the battery capacity icon 645b shows that the battery has approximately seventy-five percent (75%) of its charge remaining. In one or more embodiments, the pulse generator 610b is capable of measuring the remaining battery capacity with an accuracy of + / - 5%. It should be noted that in one or more embodiments, when the battery capacity drops below a predetermined low battery capacity threshold (e.g., 10% of the battery capacity), the pulse generator 610b will switch to a low power mode (e.g., to conserve battery capacity). In some embodiments, when the battery capacity is below the low battery capacity threshold, the pulse generator 610b will prevent the user from initiating a treatment session for the patient.

[0110] The treatment session duration is also shown on the treatment session screen on the display 625 of the pulse generator 610b. In particular, in Figure 6 , the treatment session screen on the display 625 of the pulse generator 610b shows that the treatment session duration 675 has been set by a user (e.g., a patient or a healthcare provider) to 8.0 hours. Additionally, on the treatment session screen on the display 625 of the pulse generator 610b, the treatment progress (remaining time) 680 is shown as fifteen (15) minutes.

[0111] Additionally, in one or more embodiments, the treatment session screen on the display 625 of the 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 Figure 10In addition, in one or more embodiments, a treatment session screen on the display 625 of the pulse generator 610b may show a treatment completion indicator (not shown), which indicates that the treatment session has been completed.

[0112] Additionally, it should be noted that in one or more embodiments, for ease of user programming, the treatment session screen on the display 625 of the pulse generator 610b may show a plurality of pre-programmed timed treatment programs (i.e., treatment session programs for which a treatment duration has been selected), from which the user can select to choose a treatment session for the patient.

[0113] Figure 7 is Figure 6 Another front perspective view of the two pulse generators 610a, 610b. In this figure, the pulse generator 610b is upside down, thus showing the top side of the pulse generator 610b. The top side of the pulse generator 610b is shown to include a socket 710. During operation of the pulse generator 610b, one end of a wire (e.g., reference Figure 10 of 1010) is connected to the socket 710. The wire (e.g., reference Figure 10 of 1010) is split into two wires having two remaining ends. The two remaining ends of the wire (e.g., reference Figure 10 of 1010) are connected to respective first leads (e.g., reference Figure 10 ) of an electrode assembly (e.g., reference Figure 10 of 1040) (e.g., positive lead) and a second lead (e.g., reference Figure 10 of 1050) (e.g., negative lead), and the electrode assembly further includes an electrode pad (e.g., reference Figure 10 of 1060).

[0114] Additionally, the left side of the pulse generator 610b is shown to include a power switch 720. The power switch 720 can be switched to the "on" position to turn on the pulse generator 610b, and switched to the "off" position to turn off the pulse generator. In this figure, the power switch 720 is shown as a slide switch. However, in one or more embodiments, various different types of switches other than slide switches can be used for the power switch 720, including but not limited to pushbutton switches or toggle switches.

[0115] In one or more embodiments, when the power switch 720 is switched to the "off" position, the pulse generator 610b is in the off mode. In the off mode, the pulse generator 610b does not provide treatment, no diagnostics are obtained through the pulse generator 610b, and the pulse generator 610b cannot communicate with a computing device (e.g., Figure 12Communication with the 1200). Additionally, in the off mode, the battery of the pulse generator 610b does not supply any power to the electronic devices of the pulse generator 610b.

[0116] In one or more embodiments, when the power switch 720 is switched to the "on" position, the pulse generator 610b can operate in a low-power mode. When the pulse generator 610b operates in the low-power mode, the pulse generator 610b does not provide any treatment, the pulse generator 610b does not obtain a diagnosis, and the pulse generator 610b cannot communicate with a computing device (e.g., Figure 12 the 1200). In this mode, the battery of the pulse generator 610 supplies power to the electronic devices of the pulse generator 610b.

[0117] Figure 8 is Figure 6 A front perspective view of one pulse generator 610a and Figure 6 A rear perspective view of another pulse generator 610b. In this figure, the bottom sides of each pulse generator 610a, 610b are shown to include ports 620a, 620b (e.g., USB ports). During operation, one end of a cable (e.g., refer to Figure 12 the 1230) (e.g., a USB cable) is connected to each of the ports 620a, 620b, and the other end of the cable (e.g., refer to Figure 12 the 1230) is connected to a computing device (e.g., refer to Figure 12 the 1200).

[0118] Also in this figure, the back side of the pulse generator 610b is shown as a circular shape. When the user holds the pulse generator 610b in the user's hand (e.g., see Figure 11A and 11B ), the circular shape of the back side of the pulse generator 610b makes the user (e.g., a patient or a healthcare provider) feel comfortable. In this way, the shape of the pulse generator 610b is designed ergonomically so that the user can easily and comfortably operate the pulse generator 610b with only one hand. Additionally, several protrusions are shown on the back side of the pulse generator 610b. When the pulse generator 610b is placed on a surface (e.g., a tabletop), the protrusions on the back side of the pulse generator 610b make the pulse generator 610b stable (e.g., does not roll). It should be noted that in one or more embodiments, as Figure 9 shown by the pulse generator 610b, the back side of the pulse generator 610b can be manufactured to have more or fewer than two protrusions. Additionally, as Figure 9 shown, the protrusions can be formed to have different sizes and / or shapes compared to the protrusions of the pulse generator 610b.

[0119] Figure 9 is Figure 6 a front perspective view of one pulse generator 610a of Figure 6 and a rear perspective view of another pulse generator 610b of Figure 10 In this figure, the top sides 610a, 610b of each pulse generator are shown to include sockets 710a, 710b. During operation, wires (e.g., see

[0120] Figure 10 is a perspective view of the pulse generator 610 of Figure 6 shown connected to an electrode assembly. In this figure, the wire cable 1010 is shown connected to the socket 710 of the pulse generator 610. The wire 1010 is split into two wires having two remaining ends. The two remaining ends of the wire 1010 are respectively connected to the first lead (e.g., positive lead) 1040 and the second lead (e.g., negative lead) 1050 of the electrode assembly. The electrode assembly includes a first lead 1040, a second lead 1050, and an electrode pad 1060, and the electrode pad includes a plurality of electrodes. During operation, the electrode pad 1060 is connected to the patient's head (e.g., referring to the article 10 connected to the Figure 2B forehead of patient 5), and the electrodes of the electrode pad 1060 deliver pulses to the patient.

[0121] Figure 11A depicts a user (e.g., patient, caregiver, or healthcare provider) 1110 holding Figure 6 the pulse generator 610. As shown in this figure, the pulse generator 610 is ergonomically designed (e.g., designed in terms of size and shape) for single-handed use by the user 1110, and enables the pulse generator 610 to fit comfortably in the hand of the user 1110 for use. In one or more embodiments, the pulse generator 610 can be designed to have a volume between two (2) cubic inches (in 3 ) and five (5) cubic inches (in 3 ). In some embodiments, the pulse generator 610 can be designed to have a volume of approximately 3.7 cubic inches (in 3 ).

[0122] Figure 11B depicts a user (e.g., patient or healthcare provider) 1110 programming Figure 6 the pulse generator 610. In this figure, it is shown that the user 1110 presses the button 635 of the pulse generator 610.

[0123] As described above, the pulse generator 610 includes a plurality of buttons, which are the up arrow button 630 (see Figure 6)), the down arrow button 640 (see Figure 6 ), and the lock and set key button 635. The up arrow button 630 (see Figure 6 ) and the down arrow button 640 (see Figure 6 ) allow the user 1110 to scroll up and down respectively through the text, letters, numbers, characters, icons, and / or on the display 625 of the pulse generator 610 (refer to Figure 6 ). In addition, the user can press the buttons 630, 640 to adjust the current amplitude of the pulses generated by the pulse generator 610 (upward and downward respectively). Also, the lock and set key button 635 allows the user 1110 to select the highlighted item (e.g., text, letter, number, character, or icon) displayed on the screen of the display 625 of the pulse generator 610.

[0124] During the operation of the pulse generator 610, before starting a treatment session for a patient, the user 1110 can use (i.e., press) the up arrow button 630 (refer to Figure 6 ), the down arrow button 640 (see Figure 6 ), and / or the lock and set key button 635 to input the patient's password (or PIN) (see Figure 6 of 670) into the pulse generator 610 to log in to the patient's pulse generator. After the user 1110 has logged in to the patient's pulse generator 610, the user 1110 can input the duration of the patient's treatment session. The user can use (i.e., press) the up arrow button 630 (see Figure 6 ), the down arrow button 640 (see Figure 6 ), and / or the lock and set key button 635 to specify the duration of the treatment session.

[0125] Once the treatment session has started, the user 1110 can use (i.e., press) the up arrow button 630 (refer to Figure 6 ), the down arrow button 640 (refer to Figure 6 ), and / or the lock and set key button 635 to select a comfortable current amplitude level of the pulses for the patient. For example, the user 1110 can select a comfortable current amplitude level of 5.2 mA at the start of the treatment session.

[0126] It should be noted that in one or more embodiments, pressing the up arrow button 630 (refer to Figure 6 ) and / or the down arrow button 640 (refer to Figure 6)The current amplitude level of the pulse can be adjusted in specific step sizes (i.e., each time the buttons 630, 640 are pressed, the current amplitude will change by 0.1 mA). In one or more embodiments, the step size for adjusting the current amplitude level can be 0.1 mA, and the current amplitude level can be adjusted within the range of 0 mA to 8 mA. In one or more embodiments, the step size for adjustment can be greater than or less than 0.1 mA and / or the adjustment range can vary within the range of 0 mA to 8 mA.

[0127] After a period of time has passed since the start of the treatment session, the patient may decide that the initial current amplitude level setting (e.g., 5.2 mA) is insufficient (e.g., no longer provides any sensation to the patient) or intolerable. Therefore, the patient may decide to increase or decrease the current amplitude level to a higher or lower level of the pulse. Then, the user 1110 (e.g., the patient or a healthcare provider) can again use (i.e., press) the up arrow button 630 (see Figure 6 ), the down arrow button 640 (see Figure 6 ), and / or the lock and set key button 635 to select a new comfortable current amplitude level of the pulse for the patient.

[0128] During the duration of the treatment session, the pulse generator 610 will record (e.g., refer to Figure 5 's 220) the history of at least some data from the treatment session. In one or more embodiments, during the duration of the treatment session, the pulse generator 610 will record the history of the treatment current amplitude (e.g., refer to Figure 22 's screen 2200), and record the history of the treatment impedance (e.g., refer to Figure 24 's screen 2400). Additionally, in one or more embodiments, the pulse generator 610 will record the duration of the treatment session 675 (e.g., 8.0 hours), the average treatment current amplitude of the treatment session, and / or the average treatment impedance of the treatment session. In one or more embodiments, the pulse generator 610 includes an internal real-time clock (RTC) that is used to timestamp all the recorded data.

[0129] In one or more embodiments, all the data collected and recorded by the pulse generator 610 during the duration of the treatment session will be stored within the pulse generator 610. The user (e.g., the patient or a healthcare provider) can access the recorded data of the patient in the pulse generator 610 by logging into the pulse generator 610 using the patient's password (or PIN) 610.

[0130] Figure 12 is shown connected to the computing device 1200 Figure 6Diagram of the pulse generator 610. In this diagram, the pulse generator 610 is connected to the computing device 1200 via a cable 1230. One end of the cable (e.g., a USB cable) 1230 is connected to the port 620 (e.g., a USB port) of the pulse generator 610. And the other end of the cable 1230 is connected to the port (e.g., a USB port) of the computing device 1200. In this diagram, the computing device 1200 is described as a laptop computer including a display 1210. However, in other embodiments, the computing device 1200 can be various different types of computing devices other than a laptop computer, including (but not limited to) desktop computers, servers, smartphones, and tablet devices.

[0131] In one or more embodiments, during operation, the computing device 1200 can supply power to the pulse generator 610 via the cable 1230 to charge the battery of the pulse generator 610. In one or more embodiments, the battery should be fully charged from 25% capacity within four (4) hours. In some embodiments, the pulse generator 610 may include a light-emitting diode (LED) (not shown) to indicate to the user that the battery is charging.

[0132] In addition, in one or more embodiments, the user can download treatment data of a patient's record from the pulse generator 610 to the computing device 1200 via a cable (e.g., a USB cable) 1230. In some embodiments, the pulse generator 610 will enable connection to the computing device 1200 via a USB connection for data transfer. In at least one embodiment, the pulse generator 610 will communicate with the computing device 1200 (including the transmission of recorded data) by using the USB protocol.

[0133] In some embodiments, the user can run an application (e.g., a data download application) (e.g., a personal computer (PC) application) on the computing device 1200 to download the patient's record data from the pulse generator 610 to the computing device 1200.

[0134] In at least one embodiment, a healthcare provider can use the computing device 1200 (e.g., by means of an application running on the computing device 1200) to program treatment session parameters (e.g., frequency, pulse width, hold time, rest time, and / or ramp time) for the pulse generator 610.

[0135] In one or more embodiments, the pulse generator 610 includes security means (e.g., password protection, password lock, firewall, and / or data encryption) to prevent cybersecurity attacks from other devices. In addition, in some embodiments, the pulse generator 610 utilizes data encryption to protect patient privacy and data.

[0136] Figure 13 is Figure 6 A top plan view of the pulse generator 610. In this figure, the top side of the pulse generator 610 is shown as including the socket 710.

[0137] Figure 14 is Figure 6 A bottom plan view of the pulse generator 610. In this figure, the bottom side of the pulse generator 610 is shown as including the port 620.

[0138] Figure 15 is Figure 6 A front plan view of the pulse generator 610 near the scale. In this figure, the pulse generator 610 is shown as having a height of approximately 3.5 inches and a width of approximately 1.5 inches. It should be noted that in other embodiments, the pulse generator 610 may be manufactured to have different height and / or width dimensions than Figure 15 shown.

[0139] Figure 16 is Figure 6 A left side view of the pulse generator 610 near the scale. In this figure, the pulse generator 610 is shown as having a depth of approximately 0.75 inches. It should be noted that in other embodiments, the pulse generator 610 may be manufactured to have a different depth than Figure 16 shown.

[0140] Figures 17-24 Shows a plurality of exemplary screens that can be displayed on the display 625 of the pulse generator 610 in Figure 6 for a healthcare provider to obtain recorded treatment data of a patient. It should be noted that Figures 17-24 the screens shown are merely exemplary screens that can be employed by the disclosed system, and the disclosed system may employ various different versions of these exemplary screens and / or may employ more or fewer screens than those disclosed herein.

[0141] Additionally, it should be noted that in one or more embodiments, Figures 17 to 24 the screens of Figure 12 can be displayed on the display 1210 of the computing device 1200 (e.g., refer to Figure 12 ) for a healthcare provider to use to obtain (download) the recorded treatment data of a patient. In some embodiments, the healthcare provider may download the Figures 17 to 24 screens in a Portable Document Format (PDF) file.

[0142] Figure 17It is a graphical user interface (GUI) screen 1700 for accessing a patient's treatment data log, where the "Average Treatment Data" option is selected. In this figure, screen 1700 displays two options for the user to choose from. In particular, in this figure, it is shown that the "Average Treatment Data" option has been selected by the user. After the user selects the "Average Treatment Data" option, the display 625 will display screen 1800 (refer to Figure 18 ).

[0143] Figure 18 It is GUI screen 1800, which shows exemplary average treatment data of a patient. In this figure, screen 1800 shows the average treatment data of the patient. In particular, the average treatment data includes average treatment amplitude, average treatment impedance, and average treatment duration. In one or more embodiments, the average treatment data is the average of the data recorded for all previous treatment sessions of the patient. In some embodiments, the user can specify which of all the previous treatment sessions of the patient can be used to calculate the average treatment data (i.e., calculate the average treatment data using only the data from the selected number of treatment sessions of the patient).

[0144] In one or more embodiments, screen 1800 includes a "Return" button, which, when selected, will cause the display 625 to display the previous screen (e.g., the treatment data log screen). After the user selects the "Return" button, the display will display screen 1900 (refer to Figure 19 ).

[0145] Figure 19 It is GUI screen 1900 for accessing a patient's treatment data log, where the "Treatment Session Data" option is selected. In this figure, screen 1900 displays two options for the user to choose from. In particular, in this figure, the "Treatment Session Data" option is shown as having been selected by the user. After the user selects the "Treatment Session Data" option, the display 625 will display screen 2000 (refer to Figure 20 ).

[0146] Figure 20 It is GUI screen 2000, which shows an exemplary historical list of treatment sessions for a patient, where treatment session 2: January 2, 2020 is selected. In this figure, screen 2000 shows a list of all past treatment sessions of the patient. In particular, in this figure, it is shown that the option "Session 2: January 2, 2020" has been selected by the user. After the user selects the option "Session 2: January 2, 2020", the display 625 will display screen 2100 (refer to Figure 21 ).

[0147] Figure 21It is the GUI screen 2100, which shows exemplary treatment data for treatment session 2 of the patient on January 2, 2020, where the "treatment amplitude" option is selected. In this figure, the screen 2100 shows the treatment session duration, the treatment session start time, the treatment session stop time, the average treatment amplitude, and the average treatment impedance. Additionally, the screen 2100 shows two options for the user to select. In particular, the screen 2100 shows that the user has selected the "treatment amplitude" option. After the user selects the "treatment amplitude" option, the display 625 will display the screen 2200 (refer to Figure 22 ).

[0148] Figure 22 It is the GUI screen 2200, which shows an exemplary historical list of the treatment amplitude of the patient during treatment session 2 on January 2, 2020. In this figure, the screen 2200 shows a list of all treatment amplitudes (including timestamps) of the patient for this specific treatment session.

[0149] In one or more embodiments, the screen 2200 includes a "Return" button, which when selected will cause the display 625 to display the previous screen (e.g., the screen for session 2: January 2, 2020). After the user selects the "Return" button, the display will display the screen 2300 (refer to Figure 23 ).

[0150] Figure 23 It is the GUI screen 2300, which shows exemplary treatment data for treatment session 2 of the patient on January 2, 2020, where the "treatment impedance" option is selected. In this figure, the screen 2300 shows two options for the user to select. In particular, the screen 2100 shows that the user has selected the "treatment impedance" option. After the user selects the "treatment impedance" option, the display 625 will display the screen 2400 (refer to Figure 24 ).

[0151] Figure 24 It is the GUI screen 2400, which shows an exemplary historical list of the treatment impedance of the patient during treatment session 2 on January 2, 2020. In this figure, the screen 2300 shows a list of all treatment impedances (including timestamps) of the patient for this specific treatment session.

[0152] Figure 25is a flowchart showing a method for determining whether the impedance of a system, which includes a pulse generator connected to an electrode assembly, is out of range. At the start 2500 of the method, at the start of a treatment session, at least one processor (e.g., microprocessor 125) of the pulse generator 610 measures the impedance of the system, which includes the pulse generator connected to the electrode assembly 2510. Then, at least one processor (e.g., microprocessor 125) of the pulse generator 610 determines whether the measured impedance is less than a base threshold (e.g., 200 Ω), which would indicate that a short circuit may have occurred 2520. If at least one processor of the pulse generator 610 determines that the impedance is less than the base threshold, the pulse generator will stop the treatment and / or issue the following alert to the patient (e.g., via visual (text (e.g., ERR) or icon alert and / or audible alert): impedance below base threshold 2530.

[0153] However, if at least one processor of the pulse generator 610 determines that the impedance is not less than the base threshold, then at least one processor of the pulse generator 610 will determine whether the measured impedance is greater than a maximum threshold value (e.g., 15,000 Ω), which would indicate a possible open circuit 2540. If at least one processor of the pulse generator 610 determines that the impedance is greater than the maximum threshold, the pulse generator will abort the treatment and / or issue the following alert to the patient (e.g., via visual (text or icon (e.g., high impedance signal icon 660 (see Figure 6 )) alert and / or audible alert): impedance above maximum threshold 2550.

[0154] However, if at least one processor of the pulse generator 610 determines that the impedance is not greater than the maximum threshold, the method returns to step 2510. Then, the method will continue for the duration of the treatment.

[0155] Note that in one or more embodiments, whenever an error is detected (e.g., impedance below base threshold or impedance exceeding maximum threshold), the pulse generator 610 will switch to a low power mode (e.g., to conserve battery capacity).

[0156] Figure 26 is a flowchart showing a method for determining Figure 6A method for determining whether the battery capacity of the pulse generator 610 is sufficient to complete a treatment session within a specified duration. At the start 2600 of the method, at least one processor (e.g., microprocessor 125) of the pulse generator 610 determines (reads) the current battery capacity (e.g., 80% capacity) 2610. Then, at least one processor of the pulse generator 610 determines (reads) the duration of the treatment session (e.g., 8.0 hours) 2620. Then, at least one processor of the pulse generator 610 determines the average current amplitude of the patient's past treatment sessions (by looking at the patient's recorded data) 2630. Then, at least one processor of the pulse generator 610 determines the average treatment impedance of the patient's past treatment sessions (by looking at the patient's recorded data) 2640.

[0157] Then, at least one processor of the pulse generator 610 determines whether the battery capacity (e.g., 80% capacity) is sufficient to complete the treatment session within the specified duration (e.g., 8.0 hours) of the patient by using the average current amplitude and the average treatment impedance 2660.

[0158] Then, at least one processor of the pulse generator 610 determines whether the battery capacity is sufficient for the duration of the treatment session 2670. If at least one processor of the pulse generator 610 determines that the battery capacity is not sufficient for the duration of the treatment session, then at least one processor of the pulse generator 610 will issue an alert to the patient (e.g., via a visual (text or icon) alert and / or an audible warning) that the battery capacity is not sufficient to complete the treatment session within the duration 2680. Then, in one or more embodiments, if at least one processor of the pulse generator 610 determines that the battery capacity is insufficient during the duration of the treatment session, then at least one processor of the pulse generator 610 will prevent the user from starting the treatment session from that point on. Then, the method ends 2690.

[0159] However, if at least one processor of the pulse generator 610 determines that the battery capacity is sufficient for the duration of the treatment session, then the method ends 2690.

[0160] In use, in one embodiment, electrode assemblies 10, 1060 are positioned on the forehead of patient 5. In some embodiments, electrode assemblies 10, 1060 may include insulating connection regions that assist in aligning assemblies 10, 1060 with the midline of patient 5's nose. As shown, electrode assemblies 10, 1060 are placed above the supraorbital foramina, above the supraorbital ridges that are laterally about 2.1 - 2.6 cm from the midline of the nose. In one embodiment, electrode assemblies 10, 1060 are then connected to pulse generators 15, 610 via cables 20, 1010. In other embodiments, electrode assemblies 10, 1060 are connected to pulse generators 15, 610 via a wireless connection. In some embodiments, the electrode assemblies may be subcutaneous or percutaneous implantable electrode assemblies. In the "percutaneous" form, the electrodes are inserted through the skin, but pulse generators 15, 610 remain external; however, there may be wires passing through the skin, or the electrodes may be entirely within the skin tissue and they are coupled to a non-implanted pulse generator 15, 610, for example, by inductive coupling. Then, pulse generators 15, 610 provide stimulation according to the methods described herein.

[0161] As described above, the pulse generators 15, 610 disclosed herein can be used to treat diseases or disorders of a patient using trigeminal nerve stimulation (TNS). Broadly speaking, the treatment method includes placing external electrodes above or near at least one of the foramina or branches of the trigeminal nerve ( Figures 1A-1B ), and stimulating the electrodes with a stimulator or pulse generator 15, 610 for a fixed period of time under specified operating parameters, as disclosed herein. In one embodiment, the external electrodes are located above the foramen of the supraorbital or ophthalmic nerve ( Figure 1A , foramen 1). In alternative embodiments, electrode assemblies 10, 1060 may be positioned above the foramen of the maxillary nerve ( Figure 1A , foramen 2) or above the foramen of the mandibular nerve ( Figure 1B , foramen 3). In other embodiments, stimulation may be applied unilaterally to one foramen of the trigeminal nerve. In other embodiments, the electrodes may be positioned in a region (on the right and / or left side) of the patient's face that corresponds to the supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomatico-orbital nerve, mentalis nerve, nasal and / or auriculotemporal nerve and / or their respective foramina. In other embodiments, subcutaneous implantable electrodes may be used with the pulse generators 15, 610 disclosed herein. At least one processor of pulse generators 15, 610 (e.g., Figure 4 's programmable microcontroller 125) may be programmed to operate with one or more of the following parameters.

[0162] In various embodiments, stimulation is delivered with a specific pulse width or range of pulse widths (or pulse duration). The stimulation can be set to deliver pulse widths in a range greater than and / or less than one or more of 50 μs, 60 μs, 70 μs, 80 μs, 90 μs, 100 μs, 125 μs, 150 μs, 175 μs, 200 μs, 225 μs, 250 μs, up to 500 μs. Those skilled in the art will recognize that one or more of the above times can be used as the boundaries of a pulse width range.

[0163] In some embodiments, the stimulation amplitude is delivered as 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 between a lower limit of about 300 μA and an upper limit of about 30 mA - 35 mA, depending on the surface area of the electrodes, the inter-electrode distance, the branching of the stimulation, 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 50 microamps (μA), 75 μA, 100 μA, 125 μA, 150 μA, 175 μA, 200 μA, 225 μA, 250 μA, 275 μA, 300 μA, 325 μA, 350 μA, 375 μA, 400 μA, 425 μA, 450 μA, 475 μA, 500 μA, 525 μA, 550 μA, 575 μA, 600 μA, 625 μA, 650 μA, 675 μA, 700 μA, 725 μA, 850 μA, 875 μA, 900 μA, 925 μA, 950 μA, 975 μA, 1 mA, 2 mA, 3 mA, 4 mA, 5 mA, 6 mA, 7 mA, 8 mA, 9 mA, 10 mA, 11 mA, 12 mA, 13 mA, 14 mA, 15 mA, 16 mA, 17 mA, 18 mA, 19 mA, and 20 mA. In some embodiments, the current amplitude is less than 7 mA or less than 6 mA, depending on the size, impedance, resistance, or configuration of the electrodes. In some embodiments, the current amplitude is between about 2.5 mA and about 5 mA. Those skilled in the art will recognize that one or more of the above amplitudes can be used as the boundaries of an amplitude range.

[0164] In various embodiments, stimuli can be delivered at one or more frequencies or within a frequency range. The stimuli can be set to be delivered at a frequency less than and / or greater than one or more of 50 Hz, 45 Hz, 40 Hz, 35 Hz, 30 Hz, 25 Hz, 20 Hz, 15 Hz, or 10 Hz. In various embodiments, the stimuli can be set to be delivered at a frequency greater than and / or less than one or more of 20 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, 70 Hz, 80 Hz, 90 Hz, 100 Hz, 120 Hz, 125 Hz, 150 Hz, up to 300 Hz. Those skilled in the art will recognize that one or more of the above frequencies can be used as the boundaries of a frequency range.

[0165] In various embodiments, stimuli are delivered at a specific duty cycle or within a duty cycle range. The stimuli can be set to be delivered at a duty cycle within a range greater than and / or less than one or more of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%. In some embodiments, a duty cycle of 10% to 50% may be preferred to ensure preservation of the nerve. In certain embodiments, a duty cycle of up to 100% may be useful in specific situations. Those skilled in the art will recognize that one or more of the above percentages can be used as the boundaries of a duty cycle range.

[0166] All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are for identification purposes only to assist the reader in understanding the present invention and do not impose limitations, particularly with respect to the position, orientation, or use of the present invention. Unless otherwise specified, connection references (e.g., attach, couple, connect, and engage) will be construed broadly and may include intermediate members between assemblies of elements and relative movement between elements. Thus, a connection reference does not necessarily infer that two elements are directly connected and in a fixed relationship to each other. Exemplary figures are for illustrative purposes only, and the dimensions, positions, sequences, and relative dimensions reflected in the accompanying figures may vary.

[0167] In cases where the above methods indicate that certain events occur in a certain order, those of ordinary skill in the art who benefit from the present disclosure will recognize that the order can be modified and such modifications are consistent with variations of the present disclosure. Additionally, if possible, portions of the method can be performed simultaneously in parallel processes or sequentially. Additionally, more or fewer steps of the method can be performed.

[0168] Accordingly, the embodiments are intended to illustrate alternatives, modifications, and equivalents that may fall within the scope of the claims.

[0169] The foregoing specification and examples provide a complete description of the structure and use of exemplary embodiments of the invention. Although the various embodiments of the invention have been described above to a certain degree of particularity or with reference to one or more separate embodiments, those skilled in the art can make various changes to the disclosed embodiments without departing from the spirit or scope of the invention. Accordingly, other embodiments are contemplated. It is intended that all matter contained in the foregoing description and shown in the accompanying drawings be interpreted as illustrative only of particular embodiments and not as limiting. Changes in detail or structure may be made without departing from the basic elements of the invention as defined in the appended claims.

Claims

1. A pulse generator device for trigeminal nerve stimulation, the pulse generator device comprising: At least one processor configured to: Generate pulses delivered to an electrode assembly for at least one treatment session of a patient, wherein the pulses have defined characteristics, the defined characteristics being a frequency of 1 - 300 Hz, a pulse duration of 50 - 500 μs, and a duty cycle of 1 - 100%; Record data of at least one treatment session of the patient, wherein the data includes the impedance of the electrode assembly connected to the pulse generator during the at least one treatment session and the current amplitude of the pulses generated during the at least one treatment session; Determine an average current amplitude by using data including the current amplitude for at least one of the at least one treatment session; Determine an average treatment impedance by using data including the impedance for at least one of the at least one treatment session; Before starting a subsequent treatment session of the patient, determine the charge capacity of the battery of the pulse generator, and Determine whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent treatment session of the patient for a specified duration by using the average current amplitude and the average treatment impedance; and A display configured to display a screen including a graphical user interface GUI.

2. The pulse generator device according to claim 1, wherein, The at least one processor is further configured to generate an alert to the patient when the at least one processor determines that the charge capacity of the battery is not sufficient to complete the subsequent treatment session of the patient for a specified duration, the alert indicating that the charge capacity of the battery of the pulse generator is not sufficient to complete the subsequent treatment session for the specified duration.

3. The pulse generator device according to claim 2, wherein: The alert is at least one of a visual alert or an audible alert.

4. The pulse generator device according to claim 3, wherein The display is one of a liquid crystal display LCD or an organic light emitting diode OLED display.

5. The pulse generator device according to claim 1, wherein The pulse generator device further includes: at least one button configured to program a specified duration.

6. The pulse generator device according to claim 1, wherein, The pulse generator is sized such that the pulse generator fits in a user's hand.

7. The pulse generator device according to claim 1, wherein, The current amplitude of the generated pulses has an upper limit of 8.0 mA.

8. The pulse generator device according to claim 1, wherein, The at least one processor is further configured to restrict the use of the pulse generator by requiring a patient password.

9. The pulse generator device according to claim 8, wherein, The patient password is programmable.

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