System and method for management of secure cloud-based prescriptions and treatments for wearable medical devices

Abstract

A system and method for securely managing and administering wearable medical device treatments uses a cloud-connected digital platform. The system enables healthcare providers to prescribe personalized operational parameters for a patient's wearable medical device, which are securely uploaded to the cloud. A smartphone application is configured to access the cloud, download the prescribed treatment information, and transfer it to the wearable device via a Bluetooth connection. The application manages the purchase and usage of operational credits required for device activation, with credits stored securely in non-volatile memory and authenticated using digital signatures. The system enforces treatment time windows to ensure safe and controlled usage, preventing unauthorized follow-on treatments until a required time has elapsed. This approach enhances patient safety, improves treatment adherence, and facilitates remote monitoring and adjustment of therapy by healthcare providers.

Description

[0001] SYSTEM AND METHOD FOR MANAGEMENT OF SECURE CLOUDBASED PRESCRIPTIONS AND TREATMENTS FOR WEARABLE MEDICAL DEVICES

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to pending United States Provisional Application No. 63 / 651,790, filed on May 24, 2024, the contents of which are incorporated herein by reference. The application further claims priority to co-pending PCT applications PCT / US24 / 41736 and PCT / US24 / 41762, both of which were filed on August 9, 2024. The contents of both PCT applications are incorporated herein by reference.

[0004] STATEMENT RE: FEDERALLY SPONSORED RESEARCH / DEVELOPMENT

[0005] Not Applicable

[0006] BACKGROUND

[0007] 1. Technical Field

[0008] The present disclosure relates generally to treatment of dry Age-Related Macular Degeneration (AMD). The disclosure is more particularly directed to a system and method for treatment of dry AMD by ocular administration of microcurrent.

[0009] 2. Description of the Related Art

[0010] 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.

[0011] 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.

[0012] 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.

[0013] A 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.

[0014] The understanding and treatment of dry AMD has evolved significantly over time, beginning with the anatomical identification of the macula in the mid- 19th century. Although the specific disease of AMD was not recognized initially, Dr. Otto Haab, a Swiss ophthalmologist, provided one of the earliest descriptions of what he called “senile macular disease” in older adults in the late 19th century. By the 1920s, "Senile Macular Degeneration" became a more commonly used term, and a distinction was made between "wet" and "dry" forms of AMD, with dry AMD being more prevalent and less severe, characterized by drusen (yellow deposits under the retina) and changes in the retinal pigment epithelium.

[0015] The development of diagnostic tools such as fluorescein angiography from the 1960s to the 1980s allowed for better identification and differentiation of dry AMD from other retinal conditions, establishing drusen, geographic atrophy, and retinal pigment epithelium changes as hallmark features. The advent of optical coherence tomography (OCT) in the 1990s revolutionized the ability to visualize retinal layers in detail, enabling more precise and non-invasive monitoring of disease progression. Research into the pathophysiology of AMD during the 1990s and 2000s revealed that oxidative stress, inflammation, and lipid metabolism were key contributors to its development. Genetic studies highlighted the role of the complement system, with specific genes such as CFH (complement factor H) being implicated.

[0016] In 2005, the Age-Related Eye Disease Study (AREDS) demonstrated that a combination of antioxidants (vitamins C and E), zinc, and beta-carotene could slow AMD progression in certain patients, though this regimen was more effective for intermediate or advanced stages and did not cure the disease or restore lost vision. The 2008 AREDS2 study refined these findings by testing additional nutrients, such as lutein, zeaxanthin, and omega-3 fatty acids, and concluded that substituting betacarotene with lutein and zeaxanthin was safer and equally effective in reducing the risk of advanced AMD. Despite these advancements, no FDA-approved therapies specifically for treating dry AMD beyond the AREDS / AREDS2 supplements exist. The focus has largely remained on lifestyle modifications, such as smoking cessation, dietary adjustments, and regular monitoring.

[0017] Emerging treatments like complement inhibitors, such as pegcetacoplan (tradename EMPAVELI - indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults to reduce hemolysis and improve hemoglobin levels), have shown promise in slowing the progression of geographic atrophy in clinical trials. However, these treatments are not yet approved in countries such as the United States and Canada, where the standard approaches continue to emphasize AREDS / AREDS2 supplements and lifestyle changes.

[0018] Microcurrent therapy, also known as microcurrent stimulation (MCS) or microcurrent electrical stimulation (MES), is another treatment that has been explored for dry AMD. This therapy involves applying low-intensity electrical currents to specific areas around the eyes to improve cellular function and promote retinal health. It is believed that microcurrent may stimulate the mitochondria within retinal cells, enhancing energy production, reducing oxidative stress, and potentially slowing AMD progression.

[0019] Studies and case reports have suggested that microcurrent therapy can help stabilize or even improve vision in some patients by promoting the removal of drusen, reducing inflammation, or improving blood circulation in the retina and choroid. Drusen are formed from accumulation of waste materials and lipids (fatty proteins) between the retina and a layer called Bruch's membrane, which is just beneath the retinal pigment epithelium (RPE). These waste materials consist of cellular debris and byproducts that naturally occur from the metabolic processes of the retinal cells. Over time, the eye's ability to clear this waste diminishes, especially with aging or due to genetic factors, leading to the buildup of drusen. Factors such as oxidative stress, inflammation, and impaired clearance of cellular waste in the retina are believed to contribute to their formation.

[0020] Microcurrent therapy is available in Canada through certain specialized eye clinics or holistic health centers, although it is not considered a standard treatment and is not widely accessible. The therapy is typically administered by an ophthalmologist or trained healthcare provider using small electrodes placed around the eyes or on specific acupuncture points near the eyes. Microcurrent therapy represents a non- invasive adjunctive approach to managing dry AMD.

[0021] Microcurrent treatments for conditions like dry AMD are typically applied in sessions that last about 15 to 45 minutes each. The frequency of these sessions can vary depending on the specific treatment protocol and the patient's response, but they are often administered two to three times per week initially.

[0022] Microcurrent treatments for conditions like dry AMD typically use very low- intensity electrical currents, usually in the range of 10 to 500 microamperes (pA). This level of current is much lower than what is used in conventional electrical stimulation therapies and is designed to be gentle enough not to cause discomfort or muscle contraction. The exact current level used can vary depending on the specific device, the treatment protocol, and the patient's individual needs. Most microcurrent devices allow for adjustments within this range to tailor the treatment to the patient’s tolerance and therapeutic response. The goal is to apply a current level that stimulates cellular repair and regeneration without causing any adverse effects.

[0023] For microcurrent treatments like those used for dry AMD, the voltage range is typically very low, usually between 1 to 20 volts (V). The voltage is kept low to ensure that the current remains at the microampere level (10 to 500 pA), which is gentle enough to avoid discomfort or any significant risk to the patient while still delivering therapeutic effects. A specific voltage applied can vary depending on the device and the treatment protocol, but it is controlled to provide just enough electrical potential to drive the desired microcurrent through the tissues without causing pain or adverse effects.

[0024] After an initial period, which could range from several weeks to a few months, the frequency may be reduced to once a week or once every few weeks for maintenance. The overall duration of treatment can vary widely, with patients undergoing microcurrent therapy indefinitely, depending on individual conditions and observed benefits.

[0025] BRIEF SUMMARY

[0026] In accordance with an example embodiment of the present disclosure, a system and method for management of secure, cloud-based prescriptions and treatments for wearable medical devices includes receiving digitally signed treatment data, previously uploaded into a cloud server by a patient’s healthcare provider, into a digital device, such as a smartphone. Received treatment information is time stamped and stored in non-volatile memory. A user purchases device use credits to use for treatment sessions with the treatment device through the cloud server. The user initiates a treatment session via their smartphone which, in turn, transfers treatment information to configure a wearable medical device for a treatment session. The device use credits are debited and a number of available treatments decremented in connection with an applied treatment.

[0027] In accordance with a further example embodiment, the patient’s healthcare provider can renew or update a patient’s prescription in the cloud server.

[0028] In accordance with a further example embodiment, treatments are made available during preset time windows which can be set by the patient’s healthcare provider.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] These and other features and advantages of the various embodiments disclosed herein will be better understood with respect to the following description and drawings, in which:

[0031] Figure 1 illustrates a system diagram for a system for management of secure cloud-based prescriptions and treatments for wearable medical devices; Figures 2A and 2B illustrate an example embodiment of a MCS treatment system;

[0032] Figure 3 illustrates a flowchart of an example embodiment of a system for management of secure cloud-based prescriptions and treatments for wearable medical devices;

[0033] Figure 4A and Figure 4B illustrate an example embodiment of a sequence of digital device display screens displayed on a smartphone during an operation such as that described in the flowchart of Figure 3.

[0034] DETAILED DESCRIPTION

[0035] The detailed description set forth below in connection with the appended drawings is intended as a description of certain embodiments of a system and method for management of secure, cloud-based prescriptions and treatments for wearable medical devices, and is not intended to represent the only forms that may be developed or utilized. The description sets forth the various structure and / or functions in connection with the illustrated embodiments, but it is to be understood, however, that the same or equivalent structure and / or functions may be accomplished by different embodiments that are also intended to be encompassed within the scope of the present disclosure. It is further understood that the use of relational terms such as first and second, and the like are used solely to distinguish one entity from another without necessarily requiring or implying any actual such relationship or order between such entities.

[0036] As noted above, current dry AMD microcurrent treatment, such as that applied in Canada, require on-site professional application. The time and expense associated with going to a professional office for microcurrent treatment can be significant. Patients typically need to commit to frequent sessions, often starting with two to three sessions per week, each lasting about 15 to 45 minutes. This regular scheduling can require considerable time fortravel, waiting, and the treatment itself, which may disrupt daily routines, work schedules, and personal commitments.

[0037] Costs can also add up quickly, as microcurrent therapy is often considered an alternative or experimental treatment not yet covered by public or private insurance plans. This means patients may often pay out-of-pocket for each session, with costs ranging from $50 to $200 or more per session depending on the clinic, practitioner, and location.

[0038] Commuting costs can add another layer of expense to microcurrent therapy, especially since treatments often require frequent visits to a professional office. These costs will vary depending on the patient’s location, the distance to the clinic, and their mode of transportation. For patients who drive, expenses can include fuel, parking fees, and vehicle wear and tear. In urban areas, parking near medical offices or clinics can be particularly costly or challenging to find. For those relying on public transportation, costs will depend on local transit fares, which can accumulate over numerous trips. Additionally, patients living in rural or remote areas may need to travel long distances to access a specialized clinic, leading to significantly higher commuting costs and travel time.

[0039] Beyond the direct financial costs, commuting can also involve the personal cost of time, stress from traffic or navigating public transit, and physical discomfort, especially for older patients or those with mobility issues. All these factors can make regular commuting to a clinic for microcurrent therapy both a financial and logistical burden.

[0040] Over several weeks or months, the cumulative expense can become quite substantial, especially considering that multiple sessions are usually needed to achieve potential benefits. The necessity for ongoing or maintenance treatments can further increase the financial burden, making microcurrent therapy a time-consuming and expensive option for many patients.

[0041] Example embodiments herein provide a system where a patient is fitted for a take-home ocular current applicator that includes features designed to provide the benefits of professionally administered treatments, safety features for patient application, and ongoing professional monitoring and prescription adjustment. While these features are advantageously used for dry AMD treatments, it is to be understood that they are suitably applied to any medical or wearable device applied to a user.

[0042] Example embodiments described herein include a headset configured to deliver a microcurrent waveform to a skin surface within an eye region of a patient. The headset comprises eyecup electrodes configured to contact the skin surface. The microcurrent waveform is delivered to the skin surface through the eyecup electrode. The headset also includes an eyecup electrode platform assembly and a magnet. The eyecup electrode is movably and removably coupled to the eyecup electrode platform assembly via the magnet. This configuration allows a user of the headset to easily and quickly adjust the positioning of the eyecup electrode with respect to the eyecup electrode platform assembly. The headset is originally configured for the head and eye dimensions of an individual user by a healthcare professional. The healthcare professional also prescribes MCS treatment (duration, current level, etc.) for the patient which is sent to the Cloud. The patient can then take the headset home.

[0043] The patient's prescription can include a set number of treatments. Then, as with drug prescription refills, the patient should revisit their professional for possible modification and renewal of their prescription. To use the headset, the patient purchases credits from the cloud using their digital device, such as their smartphone. Their smartphone is Bluetooth paired with their headset, which downloads their prescription information from the cloud, configures the headset, and initiates treatment according to the prescription provided the patient has prescription uses remaining and sufficient prepaid credits. The patient can purchase more credits if needed.

[0044] This system allows for greater convenience and flexibility since patients can perform treatments at home rather than frequently commuting to a professional office, saving time, travel expenses, and minimizing disruptions to daily routines. The system also ensures personalized care; the headset is custom-fitted to the individual by a healthcare professional, who prescribes specific treatment parameters, allowing for tailored therapy that can be easily adjusted based on progress or changes in the patient's condition.

[0045] By utilizing a cloud-based platform for managing prescriptions, the system provides enhanced monitoring and control, enabling healthcare professionals to track adherence, treatment outcomes, and make timely adjustments. The use of credits and Bluetooth connectivity with a smartphone for configuring treatments offers real-time feedback and ease of use while ensuring that treatments are administered correctly according to the prescribed settings.

[0046] Moreover, the ability to purchase credits as needed gives patients flexibility in managing their treatment costs, potentially making the therapy more accessible and affordable over time. This system also reduces the burden on healthcare facilities by minimizing in-office treatment sessions, thus allowing professionals to focus on more critical aspects of patient care.

[0047] Example embodiments herein include a digital device app equipped with an electronic timekeeper that manages treatment credits through a cloud-assisted platform. This system uses a credit transfer method where the app keeps a separate count of the total credits granted and the total credits consumed, stored in non-volatile memory on the device. This setup allows for secure transfer of usage credits from the cloud to the device.

[0048] To prevent fraudulent activity, unauthorized duplication or "replay" of data packets, the credit transfer system employs a digitally signed packet that includes a timestamp. The digital signature ensures that each packet is unique and confirms its authenticity. The timestamp records when the credit transfer is authorized, and the device is programmed to reject any attempts to use another credit packet within a defined time window. The system ensures that credits cannot be transferred more than once per time window, maintaining secure and accurate treatment control and usage tracking.

[0049] The digital signing process is managed by the cloud and the device, as the app or any intermediate network components are not considered trustworthy. This means the cloud generates a digitally signed packet with a timestamp that is then verified by the device. This approach assures that only legitimate and authorized credit transfers occur, as any packet that does not match the digital signature or falls outside the valid time frame is automatically rejected. By handling digital signing directly between the cloud and the device, the system maintains a high level of security, ensuring that credits are accurately allocated and that all transactions are protected against unauthorized duplication or misuse.

[0050] Example embodiments herein are detailed in connection with ocular MCS treatment. It is to be appreciated that they are usable with any suitable wearable medical device. Wearable medical devices such as transcranial magnetic stimulation (TMS) devices, home-based dialysis machines, portable defibrillators, and smart compression therapy devices could benefit from a cloud-connected system. In this system, healthcare providers can upload operational prescriptions, like treatment duration, intensity, and frequency, directly to the cloud. Patients would then use their smartphones to download the prescribed treatment parameters, manage device operation credits, and relay the instructions to their wearable devices. The system ensures that treatments are spaced out appropriately by enforcing time intervals between sessions, preventing overuse and enhancing patient safety. Devices like neuromuscular electrical stimulation units, wearable laser therapy, biofeedback devices, and CPAP machines could all leverage this system to provide personalized, controlled, and effective treatments at home while maintaining close connection with healthcare providers through the cloud.

[0051] Figure 1 illustrates a system diagram 100 for a system for management of secure cloud-based prescriptions and treatments for wearable medical devices. Included is a wearable medical device 104, illustrated as an MCS treatment headset that includes a wireless data connection, such as connection via Bluetooth 106. The system includes a data device, such as a smartphone or tablet. In the illustrated example embodiment, the data device is comprised of smartphone 108. Smartphone 108 includes functionality provided by hardware block diagram 108’ . Included is a network interface 112, suitably comprised of one or more of any suitable wireless or wired data connection, such as cellular or WiFi. Also included is a user interface including a display and user input, suitably comprised of touchscreen 116. Also included is memory, suitably comprised of non-volatile memory 120 and volatile memory 124. Also included is one or more CPUs, such as CPU 128. A wireless data interface, illustrated as Bluetooth interface 132, provides data communication with headset 104.

[0052] Smartphone 108 is in data communication with network cloud 136 via network interface 112. The network cloud is comprised of any suitable wired or wireless data connection, and is suitably comprised of a local area network (LAN), a wide area network (WAN) which may comprise the internet, or any suitable combination thereof.

[0053] Also in data communication with network cloud 136 is cloud server 140 and financial institution 144. Cloud server 140 works with financial institution 144 for digital exchange of currency 148 associated with purchase of prescription treatment credits for headset 104. Purchased, digitally signed credits 152 are communicated to smartphone 108 where they are time stamped and relayed to headset 104 as digitally signed / time stamped credits 152’. Such digitally signed credits are suitably stored in non-volatile memory of a digital device to remain available persistently. Also illustrated is a withheld or rejected credit 156 which is associated with a treatment attempted outside a prescribed treatment window, such as a treatment that has not achieved a preset time threshold from a prior treatment.

[0054] Figures 2A and 2B illustrate an example embodiment of a MCS treatment system 200, illustrated as a wearable headset. Treatments with examples of this electrical stimulation system 200 are not invasive and do not involve drugs. The microcurrent therapy employed by these examples of electrical stimulation system 200 are comparable to a modern-day TENS device in terms of being harmless to a patient.

[0055] 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.

[0056] In other words, an electro-therapeutic electrical stimulation system 200 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. The electrical stimulation system 200 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.

[0057] 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) production / release 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.

[0058] 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.

[0059] 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 200 in accordance with examples of this technology.

[0060] The electrical stimulation system 200 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 214(1) and 214(2), and to the headset's conductive face pads 216. The electrical stimulation system 200 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.

[0061] The electrical stimulation system 200 in accordance with an example of this technology includes wearable headset 204 and an AC-powered operated signal generator 224 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 204 comprising two independent eyecup electrodes 214(1) and 214(2), which deliver current to the eye (with the eyelid closed). In an example, the current completes a circuit through the conductive face pads 216 (using, for example, conductive fibers or mesh embedded in the face pads 216) which are in electrical contact with the patient’s face and / or forehead, while the headset 204 is worn by the patient. Compression of the face pads 216 to the face / forehead is accomplished by, for example, elastic straps 208 of the headset 204. This configuration ensures that the electrical contacts of the face pads 216 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 216 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 212 (of the headset 204) or another part of the headset 204. Although the signal generator 224 is shown in FIG. 2A as being separate from the headset 204, it may alternatively be incorporated into any part of headset 204 including within or attached to the face module 212. An optional face module cover 220 may be raised or lowered from the face module 212 and may provide access to the components (e.g., the control unit if housed in the face module 212, and eyecup electrodes 214(1) and 214(2)) within the face module 212.

[0062] Each of the eyecup electrodes 214(1) and 214(2) is coupled to the signal generator 224 and configured to contact and deliver the microcurrent waveform to the skin surface (such as eyelids) within an eye region of a patient. In examples described herein, the first position is a calibration position used when the headset 204 is worn, or not worn, by the patient and allows for positioning or repositioning of each of the eyecup electrodes 214(1) and 214(2) on the platform 228 by a user (i.e., the patient, or other person such as a helper / assistant). Eyecup electrode platform assembly 226 comprises a platform 228 that enables each of the eyecup electrodes 214(1) and 214(2) to be movably and removably coupled (via, for example, a magnet).

[0063] 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 200 (or microcurrent device), including methods therefore, disclosed in these patents may be employed in any of the examples of this disclosure and which are also all herein incorporated by reference.

[0064] Figure 3 illustrates flowchart 300 of an example embodiment of a system for management of secure cloud-based prescriptions and treatments for wearable medical devices. The process commences at block 304 and proceeds to block 308 where a patient visits with a healthcare provider, such as an ophthalmologist or optometrist where they receive a diagnosis and prescription at block 316. A headset is customized for the patient at block 320, such as adjusting fit to conform to the patient’s physical face and eye characteristics. The provider determines a MCS treatment regimen and uploads an associated prescription to a cloud service at block 324. An example MCS treatment prescription may include device parameter configuration settings such as provided in the table below.

[0065] The patient creates an account with the cloud service at block 328, suitably creating a username and password, adding payment information and identifying their healthcare provider. The patient can then login to their account at block 332 where their information, such as prescriber information, treatments remaining, treatment dosing, and the like, is shown on a display of their digital device, such as their smartphone, at block 336. A patent is given the option to purchase treatment credits at lock 340. If they choose to do so, the patent enters payment information, such as a credit or debit card, bank account, or a stored payment option, at block 344. The cloud service clears payment with a financial institution at block 348, and the system proceeds to block 352 where their smartphone is paired with their treatment headset.

[0066] If the patient does not choose to purchase credits at block 340, the system proceeds directly to block 352. A patient elects whether to initiate a treatment at block 356. If they do not choose treatment, they may logout at block 360 and the process ends at block 364. If the patent does not logout, the system returns to block 336.

[0067] If the patient selects treatment at block 356, a test is made at block 368 to determine if the patient has treatments available, such as treatments remaining from their prescriber. If no treatments remain, the system returns to block 336. If treatment is available, their smartphone receives a digitally signed treatment token from the cloud service server at block 372. Their smartphone timestamps the received token at block 376, and a test is made at block 380 as to whether the patient is currently in an open treatment time window. If not, the system proceeds to block 384 where a corresponding error message is displayed before the process returns to block 336. If the patient is within an open treatment window, the treatment is completed and the patient’s account is debited at block 388. The process then returns to block 336.

[0068] Steps 392 in the flowchart of Figure 4 are suitably accomplished with a user’s digital device, such as their smartphone or tablet, and implemented in accordance with an installed App.

[0069] Figures 4A and 4B illustrate an example embodiment of a sequence of screens 400A / 400B displayed on a patient’s smartphone during an operation such as that described in the flowchart of Figure 3. Referring initially to Figure 4A. Welcome screen 404 includes a selectable option indicia 408 for a patient’s initial sign-up and selectable option indicia 412 to login to an established account. If the sign-up option is selected, screen 416 is shown where patient information, suitably accompanied by a saved payment option, is obtained and their account is created.

[0070] When the patient chooses to login to their existing account by selecting indicia 412 on screen 404, screen 420 is generated to secure their login information. Once login is successful, screen 424 is displayed, showing selectable indicia 428 to obtain more treatments and selectable indicia 432 to initiate a connection to their treatment device. When the patient selects indicia 428 to secure additional treatments, referring to Figure 4B, screen 436 is displayed showing selectable indicia 440 to purchase a specified number of treatment credits and selectable indicia 444 to subscribe to additional credits. Next, an order confirmation is displayed at screen 448. The user can then check out and complete their purchase by selecting selectable indicia 452. Payment processing is shown on screen 456 and purchase confirmation is shown on screen 460.

[0071] If the patient selects indicia 432 of Figure 4A to connect to their device, screen 464 is shown where connection is initiated, such as by a Bluetooth pairing between the smartphone and the headset. The system commences pairing is commenced when the selectable indicia 468 is selected by the patient. Screen 472 is then shown during the pairing process. Screen 476 is then displayed confirming a successful pairing, suitably providing prescription information to the headset. Treatment can then be completed by suitable headset controls.

[0072] Example embodiments herein can be achieved on any suitable data device and operating system. Example pseudocode for an application, such as electronic device App, such as a smartphone or tablet, to manage an MCS treatment follows:

[0073] 1. Initialize the Application:

[0074] - Initialize non-volatile memory to store treatment credits and data.

[0075] 2. Patient Login Function:

[0076] - Prompt the patient to enter login credentials.

[0077] - Authenticate the patient's credentials with the cloud server.

[0078] - If authentication is successful:

[0079] - Retrieve and display the patient's current credit balance.

[0080] - Retrieve the treatment prescription from the cloud server.

[0081] - If authentication fails:

[0082] - Display an error message and prompt the patient to try again.

[0083] 3. Credit Purchase Function:

[0084] - Display available credit packages for purchase.

[0085] - Allow the patient to select a credit package and confirm the purchase. - Send the purchase request, including patient ID and selected package details, to the cloud server.

[0086] - Receive the purchased credits from the cloud server.

[0087] - Receive the purchased credits, to digitally signed, from the cloud server.

[0088] - Apply timestamp to digitally signed credits received from the cloud server.

[0089] - Store the purchased credits securely in non-volatile memory.

[0090] - Update and display the patient’s current credit balance.

[0091] 4. Check for Sufficient Credits:

[0092] - Retrieve the available credits from non-volatile memory.

[0093] - Retrieve the number of credits required for the treatment from the prescription.

[0094] - If the available credits are greater than or equal to the required credits:

[0095] - Return "True" (sufficient credits available).

[0096] - Otherwise:

[0097] - Display a message indicating insufficient credits and prompt for a purchase.

[0098] - Return "False" (insufficient credits).

[0099] 5. Check for Valid Treatment Time Window:

[0100] - Retrieve the timestamp of the last treatment from non-volatile memory.

[0101] - Retrieve the current system time.

[0102] - If the difference between the current time and the last treatment time is less than the minimum allowed interval:

[0103] - Return "False" (treatment within restricted time window).

[0104] - Otherwise:

[0105] - Return "True" (treatment allowed).

[0106] 6. Initiate Bluetooth Pairing:

[0107] - If there is a valid treatment prescription in the cloud, the user requests treatment, and Check for Sufficient Credits is "True":

[0108] - Initiate Bluetooth pairing with the treatment headset.

[0109] - If Bluetooth pairing is successful:

[0110] - Proceed to the next step.

[0111] - If Bluetooth pairing fails:

[0112] - Display an error message and halt the process.

[0113] 7. Initiate Treatment Function: - If Check for Valid Treatment Time Window is "True":

[0114] - Send the treatment prescription to the headset via Bluetooth.

[0115] - Enable the headset to start the treatment.

[0116] - Deduct the required number of credits from the stored credit balance.

[0117] - Store the updated credit balance and the timestamp of the treatment in nonvolatile memory.

[0118] - Display a message indicating that the treatment has been successfully initiated.

[0119] - Otherwise:

[0120] - Display a message indicating that treatment initiation has failed due to a timing restriction.

[0121] 8. Suspend Treatment Function:

[0122] - If the treatment is attempted within a restricted time window:

[0123] - Display a message indicating that the treatment cannot be initiated at this time.

[0124] - Send a signal to the headset to suspend treatment.

[0125] 9. Main Application Loop:

[0126] - Call the "Patient Login Function".

[0127] - While the app is running:

[0128] - If the patient selects to purchase credits:

[0129] - Call the "Credit Purchase Function".

[0130] - If the patient requests to start treatment:

[0131] - Call "Check for Sufficient Credits".

[0132] - Call "Check for Valid Treatment Time Window".

[0133] - If both checks are "True":

[0134] - Call "Initiate Bluetooth Pairing".

[0135] - Call "Initiate Treatment Function".

[0136] - Continuously monitor for treatment timing violations:

[0137] - Call "Suspend Treatment Function".

[0138] The particulars shown herein are by way of example only for purposes of illustrative discussion, and are not presented in the cause of providing what is believed to be most useful and readily understood description of the principles and conceptual aspects of the various embodiments of the present disclosure. In this regard, no attempt is made to show any more detail than is necessary for a fundamental understanding of the different features of the various embodiments, the description taken with the drawings making apparent to those skilled in the art how these may be implemented in practice.

Claims

WHAT IS CLAIMED IS:

1. A system for management of secure cloud-based prescriptions and treatments for wearable medical devices comprising: a user input including a user input and a display; a processor and associated memory, the memory including volatile memory and non-volatile memory; a network interface configured for data communication with an associated cloud server; and a wireless data interface configured for data communication with a programmable, wearable medical treatment device; the processor configured to receive digitally signed treatment data from the cloud server via the network interface, store the received treatment data in the non-volatile memory, apply a time-stamp to the received treatment data, receive a user treatment request via the user input, establish data communication with the medical treatment device via the wireless data interface responsive to the received user treatment request, and apply the time-stamped treatment data to the medical treatment device via the wireless data interface.

2. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 1 wherein the received treatment data includes device use credit data configured to enable use of the medical treatment device.

3. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 2 wherein the received treatment data further includes prescription data configured to set operational parameters of the wearable medical device.

4. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 3 wherein the processor further configured to:determine whether a treatment request exists within a treatment time window; and preclude use of the medical treatment device when the request is determined to be outside of the time window.

5. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 2 wherein the processor is further configured to: receive, from an associated user, payment information associated with purchase of treatment sessions; and communicate received payment information to the cloud server; wherein the use credit data is received responsive to the communicated payment information.

6. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 5 wherein the processor is further configured to preclude transfer of the treatment data outside of a pre-established treatment time window.

7. The system for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 3 wherein the operational parameters include one or more of eye selection, session duration, stimulation current level, stimulation current frequency or treatment duty cycle.

8. A method for management of secure cloud-based prescriptions and treatments for wearable medical devices comprising: receiving digitally signed treatment data into a digital device from a cloud server via a network interface; storing the received treatment data in non-volatile memory of the digital device, applying a time-stamp to the received treatment data; receiving a user treatment request via a user input of the digital device; establishing data communication with a medical treatment device via a wireless data interface responsive to the received user treatment request, and applying the time-stamped treatment data to the medical treatment device via the wireless data interface.

9. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 8 wherein the received treatment data includes device use credit data configured to enable use of the medical treatment device.

10. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 9 wherein the received treatment data further includes prescription data configured to set operational parameters of the wearable medical device.

11. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 10 further comprising: determining whether a treatment request exists within a treatment time window; and precluding use of the medical treatment device when the request is determined to be outside of the time window.

12. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 9 further comprising: receiving, from an associated user, payment information associated with purchase of treatment sessions; and communicating received payment information to the cloud server; wherein the use credit data is received responsive to the communicated payment information.

13. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 12 further comprising precluding transfer of the treatment data outside of a pre-established treatment time window.

14. The method for management of secure cloud-based prescriptions and treatments for wearable medical devices of claim 10 wherein the operational parameters include one or more of eye selection, session duration, stimulation current level, stimulation current frequency or treatment duty cycle.

15. A non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices, the method comprising: receiving digitally signed treatment data into a digital device from a cloud server via a network interface;storing the received treatment data in non-volatile memory of the digital device, applying a time-stamp to the received treatment data; receiving a user treatment request via a user input of the digital device; establishing data communication with a medical treatment device via a wireless data interface responsive to the received user treatment request, and applying the time-stamped treatment data to the medical treatment device via the wireless data interface.

16. The non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices of claim 15 wherein the received treatment data includes device use credit data configured to enable use of the medical treatment device.

17. The non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices of claim 16 wherein the received treatment data further includes prescription data configured to set operational parameters of the wearable medical device.

18. The non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices of claim 16 wherein the method includes: determining whether a treatment request exists within a treatment time window; and precluding use of the medical treatment device when the request is determined to be outside of the time window.

19. The non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices of claim 16 wherein the method includes: receiving, from an associated user, payment information associated with purchase of treatment sessions; andcommunicating received payment information to the cloud server; wherein the use credit data is received responsive to the communicated payment information.

20. The non-transitory computer readable storage medium storing a program for causing a computer to execute a control method for secure cloud-based prescriptions and treatments for wearable medical devices of claim 19 wherein the method includes precluding transfer of the treatment data outside of a pre-established treatment time window.

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