Electrical stimulation system and method including movable eyecup electrode platform assembly for positioning and fitting eyecup electrodes for the treatment of visual disease

Abstract

An electrical stimulation system for treating a visual disease is disclosed. In one example, the system includes a signal generator configured to generate a microcurrent waveform, and a headset. The headset includes an eyecup electrode coupled to the signal generator and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient. The headset also includes an eyecup electrode platform assembly including a platform configured to have the eyecup electrode coupled thereto. The eyecup electrode platform assembly is configured to move between a first and second position. The second position is a procedure position used during treatment when the headset is worn by the patient and the eyecup electrode is in contact with the skin surface. The first position allows the eyecup electrode to be distant from the skin surface. A method for manipulating the electrical stimulation system is also disclosed.

Description

PCT / US24 / 41736 09 August 2024 (09.08.2024)ELECTRICAL STIMULATION SYSTEM AND METHOD INCLUDING MOVABLE EYECUP ELECTRODE PLATFORM ASSEMBLY FOR POSITIONING ANDFITTING EYECUP ELECTRODES FOR THE TREATMENT OF VISUAL DISEASECROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 651,790, filed on May 24, 2024, which is hereby incorporated herein by reference in its entirety.FIELD

[0002] The present disclosure relates generally to electrical stimulation systems and methods, and more particularly to electrical stimulation systems and methods including a movable eyecup electrode platform assembly for configuring (e.g., positioning and fitting) eyecup electrodes for the treatment of age-related macular degeneration and other visual diseases.BACKGROUND

[0003] Electrical stimulation therapy has emerged as a viable treatment modality for numerous diseases and disorders of the human body. One method of providing electrical stimulation therapy is to deliver microcurrent, which is typically defined as current below 1 milliamp (peak), to tissue on or near the area of the body to be treated. For example, microcurrent in the range of 100 microamps to 1,000 microamps (peak) has been applied to skin of an eye region, generating pulses of low current (microamps) in specific waveform patterns and well-defined frequency ranges for the treatment of age-related macular degeneration and other visual diseases. While a variety of devices have been developed to provide microcurrent stimulation to skin of an eye region, there are a number of problems associated with these devices.

[0004] For example, some devices require a practitioner to physically hold the tip of an electrical contact probe against one or more target points on the skin of an eye region in order to apply the microcurrent stimulation. Attempting to hold a contact probe in the300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-2- delicate region of the eye for a typical treatment duration of 10 minutes or greater is difficult and very fatiguing. The physical body is not designed to hold devices in place for long durations of time. As a result, devices that rely on the practitioner's use of a contact probe are unstable due to the human fatigue factor. A related problem associated with the use of a contact probe is the potential risk to a patient. For example, if the practitioner loses his balance during a treatment session, the contact probe can be pressed too hard against the skin of the eye region causing discomfort or injury to the patient. Also, proper placement of the contact probe is entirely dependent on the skill of the practitioner performing the treatment. Inconsistent placement leads to differing results, causing ineffective treatments.

[0005] In order to address the human fatigue factor, devices have been developed in which one or more electrical contacts are held in position against the skin of an eye region of a patient. For example, some devices have a goggles-type design in which several electrical contacts are incorporated into the goggles and an elastic strap is placed around the patient's head. However, these devices may cause undue pressure to the skin of the eye region due to the elasticity of the strap and inaccurate adjustment levels. This increase in pressure can cause the electrical contacts to dig into the skin of the eye region resulting in discomfort to the patient.

[0006] Devices have also been developed in which one or more electrical contacts are incorporated into a type of eyeglass frame. However, the delivery of microcurrent stimulation using these devices is often not repeatable due to the fact that an eyeglass frame has large degrees of freedom and the placement of the electrical contacts on the skin of the eye region is inconsistent from one treatment session to the next. Hand held contact probes and goggles-type devices also suffer from this same repeatability problem.

[0007] Thus, there is a need for an improved delivery system that overcomes one or more of the problems set forth above and can be used to deliver microcurrent stimulation to skin of an eye region for the treatment of age-related macular degeneration and other visual diseases.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-3-SUMMARY

[0008] An example of the present disclosure provides an electrical stimulation system for treating a visual disease. The system comprises a signal generator configured to generate a microcurrent waveform, and a headset. The headset comprises: an eyecup electrode coupled to the signal generator and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient; and an eyecup electrode platform assembly comprising a platform configured to have the eyecup electrode coupled thereto. The eyecup electrode platform assembly is configured to move between a first position and a second position. The second position is a procedure position used during treatment when the headset is worn by the patient and the eyecup electrode is in contact with the skin surface while the eyecup electrode is coupled to the platform. The first position allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform.

[0009] Another example provides a method for manipulating an electrical stimulation system for treating a visual disease. The method comprises providing a signal generator that generates a microcurrent waveform, and providing a headset. The headset comprises: an eyecup electrode coupled to the signal generator and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient; and an eyecup electrode platform assembly comprising a platform configured to have the eyecup electrode coupled thereto. The method also comprises moving the eyecup electrode platform assembly between a first position and a second position. The second position is a procedure position used during treatment when the headset is worn by the patient and the eyecup electrode is in contact with the skin surface while the eyecup electrode is coupled to the platform. The first position allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform.

[0010] These and other aspects of the present disclosure are described in the Detailed Description below and the accompanying drawings. Other aspects and features of examples will become apparent to those of ordinary skill in the art upon reviewing the following description of specific, examples in concert with the drawings. While features of the present disclosure may be discussed relative to certain examples and figures, all examples can300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-4- include one or more of the features discussed herein. Further, while one or more examples may be discussed as having certain advantageous features, one or more of such features may also be used with the various examples discussed herein. In similar fashion, while examples may be discussed below as device, system, or method examples, it is to be understood that such examples can be implemented in various devices, systems, and methods of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. For the purpose of illustration only, there is shown in the drawings certain examples. It is understood, however, that the inventive concepts disclosed herein are not limited to the precise arrangements and instrumentalities shown in the figures. The detailed description will refer to the following drawings in which like numerals, where present, refer to like items.

[0012] FIG. 1 A illustrates an exploded rear perspective view of an exemplary electrical stimulation system including adjustable eyecup electrodes and a movable eyecup electrode platform assembly for positioning and fitting the adjustable eyecup electrodes for the treatment of visual disease.

[0013] FIG. IB illustrates a non-exploded rear perspective view of the electrical stimulation system shown in FIG. 1 A.

[0014] FIG. 2A illustrates an exploded enlarged front perspective view of the movable eyecup electrode platform assembly and face module (of the headset) of the electrical stimulation system shown in FIG. 1 A.

[0015] FIG. 2B illustrates a non-exploded enlarged front perspective view of the movable eyecup electrode platform assembly and face module shown in FIG. 2A.

[0016] FIG. 3 A illustrates an exploded enlarged perspective view of the movable eyecup electrode platform assembly shown in FIG. 2A.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-5-

[0017] FIG. 3B illustrates a non-exploded enlarged perspective view of the movable eyecup electrode platform assembly shown in FIG. 3 A.

[0018] FIG. 4A illustrates an exploded enlarged perspective view of the movable eyecup electrode platform assembly shown in FIG. 3 A, without adjustment knobs.

[0019] FIG. 4B illustrates a non-exploded enlarged perspective view of the movable eyecup electrode platform assembly shown in FIG. 4A.

[0020] FIG. 5A illustrates an exploded enlarged perspective view of the adjustable eyecup electrodes and a portion of the eyecup electrode platform assembly (including a platform) of the electrical stimulation system shown in FIG. 1 A.

[0021] FIG. 5B illustrates a non-exploded enlarged perspective view of the portion of the eyecup electrode platform assembly (including the platform) shown in FIG. 5A.

[0022] FIG. 6A illustrates an enlarged perspective view of one of the adjustable eyecup electrodes of the electrical stimulation system shown in FIG. 1 A.

[0023] FIG. 6B illustrates an enlarged cross-sectional side view of the adjustable eyecup electrode shown in FIG. 6A.

[0024] FIG. 6C illustrates an enlarged plan view of the adjustable eyecup electrode shown in FIG. 6A.DETAILED DESCRIPTION

[0025] Examples of an electrical stimulation system 100 are illustrated and described in this disclosure that are innovative in design and technology, lightweight for ease of use and patient comfort, and simple to operate in the hands of trained personnel or even the patient. This microcurrent electro-therapy is a cutting-edge and non-invasive way to treat the dry version of Aged-Related Macular Degeneration (AMD). Examples of this technology are clinically proven to reverse the effects of Dry AMD, restore vision, drastically improve the patient’s quality of life, and reduce healthcare costs.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-6-

[0026] AMD is the leading cause of legal blindness for more than 2 million Canadians over the age of 50. There is no cure for AMD, and existing pharmaceutical and laser treatments have proven only marginally effective in slowing the disease’s progression. Today, AMD is the leading cause of severe vision loss in North America. Moreover, its prevalence is expected to double over the next 20 years as baby boomers continue to age.

[0027] More specifically, AMD is responsible for 8.7% of all blindness worldwide and is the most common cause of blindness in developed countries. Its prevalence increases with age and is therefore magnified by population ageing. Dry or atrophic AMD accounts for 85% of cases and is characterized by retinal pigmented epithelium dysfunction, and is a risk factor for, or even a precursor state of wet AMD, characterized by choroidal neovascularization. Geographic atrophy with loss of the retinal pigmented epithelium is accompanied by atrophy of adjacent photoreceptors and is a late stage of AMD. Dry AMD is debilitating with loss of ability to read, recognize faces, see signs while driving, producing greater life stress, lower activity levels, greater risk of depression, functional disability and also an associated increased risk of cognitive impairment. Risk factors for dry AMD include smoking, increasing age, higher serum cholesterol levels, and obesity. While treatment with vascular endothelial growth factor (VEGF) inhibitors is effective in wet AMD, presently there are no approved treatments for dry AMD.

[0028] AMD causes damage to the macula, the central part of the retina responsible for seeing details. There are two types of AMD: dry or atrophic; and wet or neo-vascular. Virtually all AMD begins in the dry form and according to the Canadian Ophthalmological Society, nine of ten people with AMD suffer from dry AMD.

[0029] The likelihood of an individual developing AMD is primarily determined by genetic predisposition, ethnicity, and health. If you are Caucasian, and your parents, grandparents or siblings have had AMD, you are at a substantially increased risk of developing the disease. Many studies have asserted that those with a history of smoking are also susceptible.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-7-

[0030] As mentioned above, there is no known cure. Macular degeneration treatments approved for use in the U.S. focus only on slowing the progression of the disease and, in some cases, consist of placing pharmaceutical injections directly on the retina.

[0031] Treatments with examples of this electrical stimulation system 100 are not invasive and do not involve drugs. The microcurrent therapy employed by these examples of electrical stimulation system 100 are comparable to a modern-day TENS device in terms of being harmless to a patient.

[0032] More specifically, microcurrent provides electrical stimulation to nerve fibers through cutaneous electrodes, using lower current than transcutaneous electrical nerve stimulation (TENS). Microcurrent is best known for skin healing with reduction of inflammation, improved local blood circulation, and improved mitochondrial function, and has even recently been adapted for direct cardiac application to improve reduced ejection fraction heart failure. Wound healing is improved by microcurrent energy through alterations in cell metabolism, changes in extracellular matrix and pro-inflammatory signals. Animal studies of transpalpebral electrical stimulation demonstrated a positive signal, preventing photoreceptor loss and improving retinal function, as well as stimulating Muller cells toward neuroregeneration and repair. A study of human volunteers found a microcurrent effect on ganglion cells that was polarity-dependent. In twenty-eight patients with planned vitrectomy, thirteen received microcurrent pre-operatively. In treatment patients, positive effects were demonstrated on retinal cell function and survival, and reduced proinflammatory cytokines (IL-6, IL-8), and reduced bioactive lipid mediator expression (lysophosphatidylcholine), compared to 15 patients who did not receive microcurrent. An early study demonstrated that transpalpebral microstimulation could be safely administered to patients with dry AMD, treating 25 eyes in seventeen patients receiving two to ten weekly treatments, finding improvement in visual acuity in 52% of eyes.

[0033] In other words, an electro-therapeutic electrical stimulation system 100 in accordance with examples of this technology employs very small doses of electrical energy (microcurrent) to: slow the progression in early-stage AMD, and revitalize macular structures & significantly restore vision in advanced AMD. Treatment is painless and takes only minutes. Extensive studies have demonstrated the treatment to be completely safe. The300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-8- electrical stimulation system 100 in accordance with example of this technology can be portable (along with a carrying case), and be battery operated or rechargeable (e.g., with 30 treatments per charge). It can have convenient, easily accessible device controls, low-weight (e.g., 0.45 kg), and easy to clean and maintain.

[0034] Microcurrent therapy that utilize wavelengths and microcurrent waveforms applied to injured tissue increases the total current in the diseased region and restores natural responses and characteristics for cells and tissue to regain and maintain their viability.Retinal cells that were considered dead are not dead, but are in a toxic dormant state and are revived with microcurrent therapy. Current science has shown that when microcurrent therapy is applied, damaged retinal blood vessels become more absorptive and adenosine triphosphate (ATP) product! on / rel ease occurs, promoting enhanced vision in patients with macular degeneration (AMD). Examples of this technology utilize a regimen of microcurrent therapy applied at wavelengths and microcurrent waveforms that stimulate retinal blood flow and electrical cellular response to achieve maximal visual acuity improvement.

[0035] In an example treatment, each procedure takes approximately 32 minutes, and includes a 40-cycle treatment of microcurrent stimulation applied to four sites around the eyes (upper left lid, lower left lid, upper right lid and lower right lid) for 40 seconds at each location, simultaneously.

[0036] With each trial subject, significant restored vision can be achieved with the first approximately 30-minute treatment. For example, a patient can expect to go from 20 / 200 vision to 20 / 40 vision in 3 weeks using the electrical stimulation system 100 in accordance with examples of this technology.

[0037] The electrical stimulation system 100 in accordance with examples of this technology can have one-time or multiple-time eyecup electrode adjustment. Conductive gel can be provided on skin around the eyes and / or on eyecup electrodes 60(1) and 60(2), and to the headset's conductive face pads 20. The electrical stimulation system 100 in accordance with examples of this technology is placed on a patient's head. When ready for treatment, the patient presses a start button to begin a preset treatment.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-9-

[0038] The electrical stimulation system 100 in accordance with an example of this technology includes wearable headset 50 and an AC-powered operated signal generator 90 that provides a pulsed microcurrent waveform output with a default varying frequency pattern from 1 - 50 Hz and a settable current level between 50 - 200 pA. This signal is fed to the headset 50 comprising two independent eyecup electrodes 60(1) and 60(2), which deliver current to the eye (with the eyelid closed). In an example, the current completes a circuit through the conductive face pads 20 (using, for example, conductive fibers or mesh embedded in the face pads 20) which are in electrical contact with the patient’s face and / or forehead, while the headset 50 is worn by the patient. Compression of the face pads 20 to the face / forehead is accomplished by, for example, elastic straps 51 of the headset 50. This configuration ensures that the electrical contacts of the face pads 20 are held tightly against the face / forehead. Other configurations for completing the current path are possible such as by doing so in an eye-to-eye manner, e.g., by not using the face pads 20 as an electrical conduit. Signal parameters, timing, and auditory feedback control operations are controlled by a microprocessor (not shown) housed in a control unit (also not shown) which itself may be housed in the face module 52 (of the headset 50) or an other part of the headset 50.Although the signal generator 90 is shown in FIG., 1 A as being separate from the headset 50, it may alternatively be incorporated into any part of headset 50 including within or attached to the face module 52. An optional face module cover 53 may be raised or lowered from the face module 52 and may provide access to the components (e.g., the control unit if housed in the face module 52, and eyecup electrodes 60(1) and 60(2)) within the face module 52.

[0039] The microcurrent generation in examples of this disclosure may employ the types described in U.S. Patent Nos. 10,456,579 (issued to Salazar), 11,007,367 (issued to O'Clock), or 11,896,827 (issued to O'Clock) which are herein incorporated by reference. Other aspects of the electrical stimulation system 100 (or microcurrent device), including methods therefor, disclosed in these patents may be employed in any of the examples of this disclosure and which are also all herein incorporated by reference.

[0040] With reference to FIGS. 1 A-5B, an example of the electrical stimulation system 100 for treating a medical condition, such as a visual disease is illustrated. The electrical stimulation system 100 comprises a signal generator 90 configured to generate a microcurrent waveform, and a headset 50. The headset 50 comprises at least one of two300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-10- eyecup electrodes 60(1) and 60(2) and an eyecup electrode platform assembly 10. The electrical stimulation system 100 may have other types and / or numbers of other systems, devices, components or other elements in other configurations.

[0041] The eyecup electrode platform assembly 10 comprises a platform 11 that enables each of the eyecup electrodes 60(1) and 60(2) to be movably and removably coupled (via, for example, a magnet 4) to, for example, a planar surface 12 of the platform 11 of the eyecup electrode platform assembly 10. The platform 11 may alternatively have a non-planar surface (not shown). In any of the examples described herein, each of the eyecup electrodes 60(1) and 60(2) are each capable of movement, including in two orthogonal directions, along the planar surface 12 of the platform 11 via the magnet 4 which resides at least partly within a recess 63 of a mounting post 62 of each of the electrodes 60(1) and 60(2), as shown in FIGS. 6A-6C with respect to one example eyecup electrode 60 selected from the two eyecup electrodes 60(1) and 60(2). This configuration allows a user (i.e., the patient, or other person such as a helper / assistant) of the electrical stimulation system 100 to easily and quickly adjust the positioning of each of the eyecup electrodes 60(1) and 60(2) with respect to the eyecup electrode platform assembly 10. In one example, the adjustment may include a helper / assistant reorienting the eyecup electrode platform assembly 10 (e.g., by way of an adjustment knob 17 or other adjustment mechanism) so that the platform 11 faces the helper / assistant, while the headset 50 is worn by the patient. In another example, the adjustment may include the patient reorienting the eyecup electrode platform assembly 10 (e.g., by way of the adjustment knob 17 or other adjustment mechanism) so that the platform 11 faces the patient, while the headset 50 is not worn by the patient.

[0042] Each of the eyecup electrodes 60(1) and 60(2) is coupled to the signal generator 90 and configured to contact and deliver the microcurrent waveform to the skin surface (such as eyelids) within an eye region of a patient. In any of the examples described herein, each of the eyecup electrodes 60(1) and 60(2) may be, for example, the same or similar example eyecup electrode 60 illustrated in FIGS. 6A-6C and may comprise: the mounting post 62; an upper contact pad 66a; an upper extension arm 64a coupled between the mounting post 62 and the upper contact pad 66a; a lower contact pad 66b; and a lower extension arm 64b coupled between the mounting post 62 and the lower contact pad 66b. The upper and lower contact pads 66a, 66b are configured to make the contact with the skin300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-11- surface, wherein the delivery of the microcurrent waveform to the skin surface is through the upper and lower contact pads 66a, 66b. Other types of eyecup electrodes 60(1) and 60(2) may alternatively be employed, either with or without the use of a magnet 4.

[0043] In any of the examples described herein, the mounting post 62 may comprise the recess 63, where the magnet 4 at least partly resides within the recess 63 or completely within the recess 63, although other configurations may be utilized. Additionally, in any of the examples described herein, the recess 63 and the magnet 4 may also both be cylindrical with a diameter of the magnet 4 being smaller than a diameter of the recess 63. Further, in any of the examples described herein, the magnet 4 may also be coupled to a sidewall of the recess 63 via adhesive via friction-fit, or in other manners.

[0044] The eyecup electrode platform assembly 10 is configured to move between a first position (see FIGS. 2A and 2B) and a second position (see FIGS. 1 A, IB, 3A and 3B). The second position is a procedure position used during treatment when the headset 50 is worn by the patient and each of the eyecup electrodes 60(1) and 60(2) is in contact with the skin surface while each of the eyecup electrodes 60(1) and 60(2) is coupled to the platform 11. The first position allows each of the eyecup electrodes 60(1) and 60(2) to be distant from the skin surface while each of the eyecup electrodes 60(1) and 60(2) is coupled to the platform. In any of the examples described herein, the first position is a calibration position used when the headset 50 is worn, or not worn, by the patient and allows for positioning or repositioning of each of the eyecup electrodes 60(1) and 60(2) on the platform 11 by a user (i.e., the patient, or other person such as a helper / assistant).

[0045] In any of the examples described herein, the eyecup electrode platform assembly 10 may further comprise an adjustment knob 17 or other adjustment mechanism. Actuation of the adjustment knob 17 (or other adjustment mechanism) by a user (i.e., the patient, or other person such as a helper / assistant) while the headset is worn or not worn by the patient may result in movement of the eyecup electrode platform assembly 10 between a first position and a second position to allow for, for example, easy access to the platform 11 by the user for positioning and fitting one or more of the eyecup electrodes 60(1) and 60(2) on the platform 11 while the eyecup electrode platform assembly 10 is in the first position. Additionally, in any of the examples described herein, actuation of the adjustment knob 17300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-12-(or other adjustment mechanism) by the user may result in movement of the eyecup electrode platform assembly 10 between the second position and a third position. The third position may be a headset-removal position used when the headset is ready to be removed from the patient and allows each of the eyecup electrodes 60(1) and 60(2) to be distant from the skin surface while each of the eyecup electrodes 60(1) and 60(2) are coupled to the platform. Further, in any of the examples described herein, the third position may be between the first position and the second position, or the third position may be identical to the first position.

[0046] Another example provides a method for manipulating an electrical stimulation system 100 for treating a visual disease. The method comprises providing a signal generator 90 that generates a microcurrent waveform, and providing a headset 50. The headset 50 comprises at least one of two eyecup electrodes 60(1) and 60(2) and an eyecup electrode platform assembly 10. Each of the eyecup electrodes 60(1) and 60(2) is coupled to the signal generator 90 and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient. The eyecup electrode platform assembly 10 comprises platform 11 configured to have each of the eyecup electrodes 60(1) and 60(2) coupled to the platform 11 (via, for example, a planar surface 12 of the platform 11) in, for example, a movable and removable manner through use of, for example, magnet 4 (as described more fully above) or other mechanism. The method also comprises moving the eyecup electrode platform assembly 10 between a first position (see FIGS. 2 A and 2B) and a second position (see FIGS. 1 A, IB, 3A and 3B). The second position is a procedure position used during treatment when the headset 50 is worn by the patient and each of the eyecup electrodes 60(1) and 60(2) is in contact with the skin surface while each of the eyecup electrodes 60(1) and 60(2) is coupled to the platform 11. The first position allows each of the eyecup electrodes 60(1) and 60(2) to be distant from the skin surface while each of the eyecup electrodes 60(1) and 60(2) is coupled to the platform. In any of the examples described herein, the first position is a calibration position used when the headset 50 is worn, or not worn, by the patient. In either scenario, the method may also comprise positioning or repositioning of each of the eyecup electrodes 60(1) and 60(2) on the platform 11 (via, for example, using magnet 4) while the eyecup electrode platform assembly 10 is in the calibration position.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-13-

[0047] In any of the examples described herein, the eyecup electrode platform assembly 10 may further comprise an adjustment knob 17 or other adjustment mechanism. With this configuration, the method may also comprise actuating the adjustment knob 17 (or other adjustment mechanism) by a user (i.e., the patient, or other person such as a helper / assistant) while the headset is worn or not worn by the patient to cause the movement of the eyecup electrode platform assembly 10 between the first position and the second position. This would allow for, for example, easy access to the platform 11 by the user for positioning and fitting one or more of the eyecup electrodes 60(1) and 60(2) on the platform 11 while the eyecup electrode platform assembly 10 is in the first position. Additionally, in any of the examples described herein, the method may further comprise: moving the eyecup electrode platform assembly 10 (via, for example, actuating the adjustment knob 17 or other adjustment mechanism by the user) between the second position and a third position, wherein the third position is a headset-removal position used when the headset 50 is ready to be removed from the patient and allows each of the eyecup electrodes 60(1) and 60(2) to be distant from the skin surface while each of the eyecup electrodes 60(1) and 60(2) is coupled to the platform; and removing the headset 50 from the patient while the eyecup electrode platform assembly 10 is in the headset-removal position. Further, in any of the examples described herein, the third position may be between the first position and the second position, or the third position may be identical to the first position.Example procedures

[0048] One or more eyecup electrodes 60(1) and 60(2) are coupled to platform 11 (via, for example, planar surface 12) of the eyecup electrode platform assembly 10, which is accessible from a front opening of the face module 52 (i.e., of the headset 50) when the face module cover 53 is raised or removed from the face module 52. In this step, the eyecup electrode platform assembly 10 is in the first, or calibration, position. This step can be done while the headset 50 is on or off the patient.

[0049] The face module 52 (or the entire headset 50) is then mounted to the patient (if not already on the patient) and the adjustment knobs 17 are actuated by turning the adjustment knobs 17 in a first rotation direction thereby rotating the platform 11 (with the one or more eyecup electrodes 60(1) and 60(2) coupled thereto) towards the skin surface within300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-14- an eye region of a patient, so that the one or more eyecup electrodes 60(1) and 60(2) come in contact with the skin surface. This results in the eyecup electrode platform assembly 10 being in the second, or procedure, position. The one or more eyecup electrodes 60(1) and 60(2) should ideally touch skin surface regions below the eye brow and below the eye socket, but not on the eyeball. The face module cover 53 can subsequently be lowered and the procedure may begin by, for example, pressing a Run / Pause button or other mechanism to administer treatment or therapy.

[0050] To reposition the one or more eyecup electrodes 60(1) and 60(2), the face module cover 53 may be raised or removed (if not already done), and the platform 11 (with the one or more eyecup electrodes 60(1) and 60(2) coupled thereto), may be extended outwardly from the skin surface (if the headset is worn by the patient) by turning the adjustment knobs 17 in a second rotation direction opposite the first rotation direction. This actuation of the adjustment knobs 17 results in the eyecup electrode platform assembly 10 being returned to the first, or calibration, position. Repositioning of the one or more eyecup electrodes 60(1) and 60(2) on the platform 11 may begin at this stage. The headset 50 may alternatively not be worn by the patient during this step.

[0051] After the one or more eyecup electrodes 60(1) and 60(2) are repositioned, the face module 52 (or the entire headset 50) may be placed back on the patient’s head (if not already on). The adjustment knobs 17 are turned once again in a first rotation direction would move the eyecup electrode platform assembly 10 back into the second, or procedure, position (such that the one or more eyecup electrodes 60(1) and 60(2) come in contact with the skin surface) where the procedure may begin, as described above.

[0052] Once the treatment is completed, the one or more eyecup electrodes 60(1) and 60(2) can be disengaged from the skin surface by turning the adjustment knobs 17 in the second rotation direction. This moves the eyecup electrode platform assembly 10 to the first position or a third position (i.e., between the first and second position) where the platform 11 (with the one or more eyecup electrodes 60(1) and 60(2) coupled thereto) is distant from the skin surface. The headset 50 can then be easily and safely removed from the patient.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-15-

[0053] Having thus described the basic concept of the technology, it will be rather apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and scope of the technology. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the scope of the present invention.300076993v2

Claims

PCT / US24 / 41736 09 August 2024 (09.08.2024)-16-CLAIMSWhat is claimed is:

1. An electrical stimulation system for treating a visual disease, the system comprising: a signal generator configured to generate a microcurrent waveform; and a headset comprising: an eyecup electrode coupled to the signal generator and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient; and an eyecup electrode platform assembly comprising a platform configured to have the eyecup electrode coupled thereto; wherein the eyecup electrode platform assembly is configured to move between a first position and a second position, wherein the second position is a procedure position used during treatment when the headset is worn by the patient and the eyecup electrode is in contact with the skin surface while the eyecup electrode is coupled to the platform, and wherein the first position allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform.

2. The system of claim 1, wherein the platform is further configured to have the eyecup electrode movably and removably coupled thereto.

3. The system of claim 2, wherein the first position is a calibration position used when the headset is worn by the patient and allows for positioning or repositioning of the eyecup electrode on the platform.

4. The system of claim 2, wherein the first position is a calibration position used when the headset is not worn by the patient and allows for positioning or repositioning of the eyecup electrode on the platform.

5. The system of claim 1, wherein the eyecup electrode platform assembly further comprises an adjustment knob, and wherein the movement of the eyecup electrode platform300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-17- assembly between the first position and the second position is actuated by the adjustment knob.

6. The system of claim 1, wherein the eyecup electrode platform assembly is further configured to move between the second position and a third position, and wherein the third position is a headset-removal position used when the headset is ready to be removed from the patient and allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform.

7. The system of claim 6, wherein the eyecup electrode platform assembly further comprises an adjustment knob, and wherein the movement of the eyecup electrode platform assembly between the second position and the third position is actuated by the adjustment knob.

8. The system of claim 7, wherein the third position is between the first position and the second position.

9. The system of claim 7, wherein the third position is identical to the first position.

10. The system of claim 2, wherein the platform comprises a planar surface, and wherein the platform is further configured to have the eyecup electrode movably and removably coupled to the planar surface.

11. A method for manipulating an electrical stimulation system for treating a visual disease, the method comprising: providing a signal generator that generates a microcurrent waveform; providing a headset comprising: an eyecup electrode coupled to the signal generator and configured to contact and deliver the microcurrent waveform to a skin surface within an eye region of a patient; and an eyecup electrode platform assembly comprising a platform configured to have the eyecup electrode coupled thereto; and300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-18- moving the eyecup electrode platform assembly between a first position and a second position, wherein the second position is a procedure position used during treatment when the headset is worn by the patient and the eyecup electrode is in contact with the skin surface while the eyecup electrode is coupled to the platform, and wherein the first position allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform.

12. The method of claim 11, wherein the platform is further configured to have the eyecup electrode movably and removably coupled thereto.

13. The method of claim 12, wherein the first position is a calibration position used when the headset is worn by the patient, and wherein the method further comprises positioning or repositioning the eyecup electrode on the platform while the eyecup electrode platform assembly is in the calibration position.

14. The method of claim 12, wherein the first position is a calibration position used when the headset is not worn by the patient, and wherein the method further comprises positioning or repositioning the eyecup electrode on the platform while the eyecup electrode platform assembly is in the calibration position.

15. The method of claim 11, wherein the eyecup electrode platform assembly further comprises an adjustment knob, and wherein the method further comprises actuating the adjustment knob to cause the movement of the eyecup electrode platform assembly between the first position and the second position.

16. The method of claim 11, wherein the method further comprises: moving the eyecup electrode platform assembly between the second position and a third position, wherein the third position is a headset-removal position used when the headset is ready to be removed from the patient and allows the eyecup electrode to be distant from the skin surface while the eyecup electrode is coupled to the platform; and removing the headset from the patient while the eyecup electrode platform assembly is in the headset-removal position.300076993v2PCT / US24 / 41736 09 August 2024 (09.08.2024)-19-17. The method of claim 16, wherein the eyecup electrode platform assembly further comprises an adjustment knob, and wherein the method further comprises actuating the adjustment knob to cause the movement of the eyecup electrode platform assembly between the second position and the third position.

18. The method of claim 17, wherein the third position is between the first position and the second position.

19. The method of claim 17, wherein the third position is identical to the first position.

20. The method of claim 12, wherein the platform comprises a planar surface, and wherein the platform is further configured to have the eyecup electrode movably and removably coupled to the planar surface.300076993v2

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