Smart wearable device to treat meibomian gland deficiencies

Abstract

A method and apparatus that enhances the capabilities of a smart wearable device for managing meibomian gland dysfunction. This disclosure incorporates pressure sensing mechanisms, self-adjusting eye cups, interchangeable face covers, a dedicated frequency range for improved vibration features, and consideration for spatial and / or temporal temperature gradients for meibum heating efficiency. The disclosed method and apparatus may be a wearable device further configured to adjust to various face shapes and provide improved comfort for the user. The disclosed pressure sensing mechanisms aim to monitor and control the pressure applied to the eye during device use, mitigating potential transient and long-term corneal moulding. The disclosure also contemplates a variety of vibration frequencies, presenting a more dynamic and efficacious treatment for meibomian gland dysfunction. The spatial and / or temporal temperature gradient feature allows for more versatile heating options aimed at improving the efficiency of the management of meibomian gland dysfunction. This disclosure represents an advancement in the management of meibomian gland dysfunction, offering a more tailored and effective approach to managing the underlying eye condition.

Description

SMART WEARABLE DEVICE TO TREAT MEIBOMIAN GLAND DEFICIENCIESCROSS-REFERENCE

[0001] This patent application claims priority to the Australian Provisional Application serial no. 2024 / 900825, filed on March 27, 2024, entitled “SMART WEARABLE DEVICE TO TREAT MEIBOMIAN GLAND DEFICIENCIES”; which is herein incorporated by reference in their entirety.FIELD OF THE INVENTION

[0002] The disclosure generally pertains to the advancement of methods and apparatus for managing deficiencies of meibomian gland dysfunction. This includes thermal energy and / or lid-massaging through mechanical vibrations facilitated using a smart wearable device. The device is enhanced with pressure-sensing mechanisms to monitor and / or control the pressure applied to the eye during use, mitigating the potential for transient and long-term corneal moulding. This disclosure further extends to the field of wearable devices designed with enhanced capabilities for treating meibomian gland dysfunction. The device comprises self-adjusting eye cups and interchangeable face cushion covers, accommodating users with various face shapes and improving comfort during use. The device also boasts an expanded vibration frequency range, offering a more dynamic and efficacious treatment or management for meibomian gland dysfunction. The disclosure also relates to smart wearable devices that incorporate temporal temperature gradient features for more efficient and versatile heating options. This feature, possibly used in conjunction with the spatial gradient proposed in the previous invention, allows for more effective management of the condition. These enhancements serve to improve the overall user experience and effectiveness of the treatment or management. In summary, this disclosure represents an advancement in the treatment or management of meibomian gland dysfunction, offering a more effective approach to managing the condition using smart wearable devices with enhanced capabilities.BACKGROUND

[0003] The present invention pertains to the condition of Meibomian Gland Dysfunction (MGD), a prevalent cause of dry eye disorders. The meibomian glands, located within the inner tarsal plate of the eyelids, are sebaceous glands that play a pivotal role in ocular health by producing a lipid substance, referred to as meibum, which provides lubrication to the surface of the eye. The human eye typically houses an estimated 30 to 40 meibomian glands on the upper eyelids and about 15 to 25 on the lower eyelids. These glands distribute the essential meibum across the ocular surface to prevent rapid evaporation of the tear film, thereby maintaining ocular surface homeostasis. Any dysfunction of these glands disrupts the tear film's stability, leading to increased evaporation rates. Such conditions may ultimately result in symptoms commonly associated with dry eyes, such as ocular discomfort, a burning sensation, and / or irritation. Dysfunctions of meibomian glands can primarily be attributed to two fundamental issues: the solidification of the meibum within the glands or the obstruction of the ducts that facilitate the flow of meibum onto the eye's surface. The prevailing clinical management of MGD involves the application of warm compresses and lid massage for 15-minute sessions up to four times daily. In addition, the use of lubricants is often recommended as an adjunctive measure to alleviate dry eye- associated symptoms.DISCUSSION OF RELATED ART

[0004] The present disclosure refers to the US patent application US2019 / 015401 A1 by Van Valen et al., which is integrated in its entirety. This patent details a method that employs infra-red and ultra-sound energy to alleviate meibomian gland dysfunction. However, the referenced procedure utilizes pressure plates and handheld devices, which may introduce a degree of invasiveness and potentially necessitate the intervention of a medical professional. Reference is also made to the LipiFlow thermal pulsation system by Tear Sciences Inc., and its accompanying US patent 9314369B2, which is incorporated in full. This patent reveals a specialized medical device that applies heat to the eyelids to dissolve waxy deposits in the meibomian glands while simultaneously exerting pulsed pressure to open and thoroughly evacuate the contents of the glands.

[0005] Although the efficacy of such comprehensive devices is not disputed, the procedure is invasive and mandates supervision from a medical professional. Furthermore, the cost of the instrument for eye-care practitioners and potential ongoing out-of-pocket expenses for the end-user may become prohibitively high. Therefore, there exists a need for further advancements in the development of a method and apparatus that provides a non-invasive device, permitting administration of the procedure at the convenience of the end-user's home or without substantial assistance from a medical professional. Further benefits of the present disclosure will become apparent, such as the replacement of relatively large, expensive, cumbersome, and energy-inefficient systems with advanced alternatives that are user- friendly and energy-efficient. The enhanced smart wearable device incorporates pressure-sensing mechanisms, self-adjusting eye cups, interchangeable face cushion covers, and a dedicated frequency range for improved vibration features. It also considers temporal temperature gradients for efficiency. This device is designed to adjust to various face shapes, thereby providing improved comfort for the user. The disclosed pressure sensing mechanisms aim to monitor and control the pressure applied to the eye during device use, mitigating potential transient and long-term corneal moulding. The disclosure also contemplates a variety of vibration frequencies, presenting a more dynamic and efficacious treatment or management for meibomian gland dysfunction. The integration of these advancements may significantly reduce the need for substantial aid from a medical practitioner to conduct the procedure and manage meibomian gland dysfunction and other dry eye conditions, ultimately making the treatment or management more accessible and cost-effective.SUMMARY OF THE INVENTION

[0006] Certain embodiments of this disclosure involve an improved method and device for managing meibomian gland deficiencies. In addition to utilising thermal energy to warm the upper and lower eyelids and increasing the temperature of the meibomian glands through principles of thermal conduction, the enhancements in this disclosure contemplate the incorporation of pressure-sensing mechanisms, self-adjusting eye cups, interchangeable face cushion covers, temporal temperature gradients, and a dedicated frequency range of vibration features for improved efficiency.

[0007] In one embodiment of the disclosure, the wearable device is designed to fit comfortably and adjust to various face shapes, providing improved user comfort.

[0008] In another embodiment of the disclosure, the wearable device is configured by selecting a specific arrangement of the heating elements that offer thermal radiation that is efficiently absorbed by the lipids or the tissue surrounding the glands, while the disclosed pressure sensing mechanisms are aimed to monitor and / or control the pressure applied on the eye during device use, mitigating any potential transient and long-term inadvertent corneal moulding.

[0009] In certain other embodiments, an integrated temperature sensor may be woven into the eyecup to provide feedback to maintain the preferred temperature range of heat application on the eyelids.

[0010] Certain embodiments of the disclosure contemplate a variety of vibration frequencies, presenting a more dynamic and efficacious treatment or management for meibomian gland dysfunction. For example, in one embodiment, the wearable device may be configured with compact artificial muscles capable of applying contractile strokes mimicking the effects of lid massaging. The integration of these advancements may significantly reduce the need for substantial aid from a medical professional to conduct the procedure and manage meibomian gland dysfunction.

[0011] Certain embodiments of the disclosure contemplate a variety of oscillatory, vibratory, or periodic motions causing a more dynamic and efficacious treatment or management for meibomian gland dysfunction utilising kinetic energy generated by oscillatory, vibratory, or periodic motions.

[0012] A key characteristic of the present disclosure relates to the pressure sensing feature, which is aimed to ensure that the device does not exert excessive pressure on the eye while also being able to detect when the ideal pressure range has been reached. This feature may be realised using a pressure sensor that is combined with a spring, foam, bellow, or a similar compressible material.

[0013] Such a combination allows for the device to apply appropriate pressure to the eye, enhancing its overall effectiveness and user comfort. In some examples, the integration of this pressure-sensing mechanism provides a significant advantage in terms of safety and comfort.

[0014] In an additional embodiment, and for technical precision, the net force exerted by the device is further quantified using a spring rate and displacement sensor. This measured force, distinct from the pressure (force per unit area) that varies with the contact geometry on the eyelid, offers a more accurate assessment of the load applied by the eyecup, thereby supporting the safe and effective operation of the device.

[0015] In some embodiments, by continuously monitoring the pressure exerted on the eye, the device can prevent potential damage or discomfort that might be caused by excessive pressure on the wearer’s eye. This monitoring ability not only ensures the safe operation of the device but also contributes to a more pleasant user experience. Moreover, because pressure is defined as force per unit area and the area of contact on the eyelid may vary, it is beneficial to quantify the net force applied using a spring rate and displacement sensor. This technical measurement of net force provides a consistent assessment of the load applied by the eyecup, thereby reinforcing the device’s safety and effectiveness even when the contact area changes in users.

[0016] In certain embodiments, the pressure sensor can provide feedback to the device's control system. This feedback enables the device to self-adjust its pressure, ensuring that it remains within the preferred range. This self-regulation feature is particularly beneficial as it reduces the need for user intervention, making the device more user-friendly and convenient to use. Moreover, recognizing that pressure is defined as force per unit area and that the contact area may vary, some embodiments incorporate a net force measurement using a spring rate and displacement sensor. This approach precise control over the load applied by the eyecup, thereby enhancing overall performance and safety.

[0017] In some other embodiments, the pressure (if contact area is known) or the force sensor, combined with a compressible and / or elastic material, also makes the device adaptable to various face shapes and sizes. This adaptability ensures that the device can effectively deliver the treatment, regardless of individual differences in eye morphology. This feature also enhances the device's versatility, making it suitable for a wide range of users. Furthermore, the pressure sensing feature also improves the efficiency of the treatment. In some embodiments, the pressure sensing feature may only provide auditory feedback to the user triggering manual adjustment of the head strap to reduce the pressure on the eyelids.

[0018] In other embodiments, by ensuring that the device maintains the optimal pressure on the eyelid, it facilitates a more effective transfer of heat energy and kinetic energy or motion transfer. This efficient transfer enables more effective treatment of meibomian gland dysfunction, further enhancing the device's usefulness.

[0019] One other contemplated feature of the disclosure involves the use of an air pump in combination with a soft bellow to apply adjustable pressures on the eye enabling the device to accommodate a wider range of pressure preferences enhancing adaptability and user comfort. For example, the use of an air pump allows for precise control over the pressure applied, ensuring that the device can provide effective treatment without causing discomfort.

[0020] For example, the pressure applied by the air pump may be fed into a feedback loop which can inform the user to adjust the device as needed. Such a feedback mechanism ensures that the pressure remains within the optimal range, further enhancing the safety and effectiveness of the device. Depending on the implementation, this feature can be used to either prevent excessive force on the eyelid or ensure sufficient contact between the eyecup and the eyelid for efficient heat transfer.

[0021] In other embodiments, two variations of this feature may be implemented. In a basic version, the device would only signal when there is excessive force on the eyelid, helping to prevent potential damage to the eye. In some embodiments, a more advanced implementation would also signal when the eyecup is not making sufficient contact with the eyelid, ensuring optimal heat transfer to the meibomian glands. Such an advanced version would provide a more comprehensive feedback mechanism, further enhancing the device's usability and effectiveness.

[0022] In some embodiments, the pressure-sensing (if the contact area can be determined) or the force sensing or the load-sensing feature of the device could be designed in various ways, including digital devices like a membrane switch or analogue devices like pressure-sensitive carbon films. These devices can provide accurate measurements of the pressure applied, ensuring that the device operates within the optimal pressure range. The accuracy of these devices also contributes to the overall safety and effectiveness of the device.

[0023] In some embodiments, piezo electrical crystals are another suitable option for the pressure-sensing, force-sensing or load-sensing device. These crystals are known for their sensitivity and accuracy, making them an excellent choice for this application.

[0024] Regardless of the specific implementation, the pressure sensing, the forcesensing or the load-sensing feature is a critical aspect of this disclosure, ensuring that the device can provide effective and safe treatment for meibomian gland dysfunction.

[0025] The disclosure contemplates another method for acquiring an eye pressure- related, force-related or load-related signal by harnessing the capacitive property of two opposing metal plates. Such an approach may involve the use of two metal-coated plates situated at the anterior and posterior sides of the foam that holds the eye cups. These plates are connected to a high-frequency voltage source, creating a capacitive circuit.

[0026] As the separation between the two plates changes, so does the impedance of the capacitive circuit. This change in impedance, in conjunction with the spring rate of the foam, allows for the determination of the compression force exerted on the eye. This method may provide a more precise and more reliable measure of the pressure, force or load applied, contributing to the device's overall safety and efficacy.

[0027] A significant advantage of such a method is that it provides a non-invasive means of measuring the pressure, force or load applied on the eye. By using the existing foam and metal-coated plates, the device can determine the pressure, force or load without needing to directly contact the eye. Such a non-invasive approach may further enhance the comfort and safety of the device, making it a more appealing option for users.

[0028] In some embodiments, to ensure user safety and compliance with electromagnetic interference requirements, the device may include appropriate electrical shielding to protect the user from potential electrical hazards and prevent the device from interfering with other electronic devices in the vicinity. Such a feature not only enhances the device's safety but also its usability, as it allows the device to be used in various settings without causing electromagnetic interference.

[0029] In some embodiments, such a capacitive method of pressure, force or load measurement, in combination with the other features of the device, provides a comprehensive solution for managing meibomian gland dysfunction. By ensuring accurate pressure, force or load application and providing effective heat and vibration treatment, the device offers a more comfortable, safe, and effective alternative to traditional treatment methods and devices.

[0030] In some embodiments of the disclosure, an alternative method for obtaining an eye pressure-related, force-related or load-related signal may involve the use of an induction-based sensor system. Such a system would be implemented between the anterior and posterior plates on either side of the foam wherein one of these plates would have a spiral-shaped coil connected to a high-frequency voltage source, generating an electromagnetic field like the induction sensors that are commonly found in traffic light systems.

[0031] For example, a metal plate on the opposing side of the foam interacts with this field and changes the impedance of the excitation circuit, depending on the separation of the two plates. Measuring the change in this impedance provides feedback on the force with which the foam is compressed. Such an induction-based system provides an effective method for monitoring and / or controlling the pressure, force or load applied by the device.

[0032] One of the key benefits of such a method involving an induction-based sensor system is its high sensitivity and accuracy. For example, the use of an induction-based sensor system may allow for precise measurements of the pressure, force or load applied, ensuring that the device operates within the optimal range. This precision enhances the safety and efficacy of the device, contributing to a more effective and comfortable treatment experience for the user.

[0033] Although such a system may be precise, appropriate electrical shielding may be necessary to ensure user safety and to comply with electromagnetic interference requirements. Wherein the contemplated shielding not only protects the user from potential electrical hazards but also prevents interference with other electronic devices. This measure enhances the device's safety and usability, allowing it to be used in various settings without causing disruptions.

[0034] The induction-based sensor system, in conjunction with the other features of the device, provides a comprehensive and effective solution for managing meibomian gland dysfunction. By ensuring accurate pressure application and providing effective heat and vibration treatments, the device offers a more comfortable, safe, and effective alternative to traditional treatment methods.

[0035] In some embodiments, the disclosure contemplates an intrinsically safer method that uses electrically conductive foam sandwiched between the two metal- coated plates. Wherein such a method provides a safety advantage as it reduces the risk of electrical hazards. For example, as the foam is compressed, its conductivity increases and the change in conductivity, which can be easily measured, serves as an indicator of the applied compression force, providing real-time feedback to users.

[0036] For example, suitable foams for such an application are commercially available and typically contain carbon particles or silver fibres. These materials are known for their stable resistance, which is unaffected by temperature and humidity. Their stability ensures accurate and reliable measurements, enhancing the device's overall performance and safety.

[0037] In some other embodiments, to further increase the accuracy of the pressure, force or load measurements, the relationship between resistance and force can be determined for individual eye cups post-assembly. This process may involve measuring the resistance of the foam under varying levels of compression to establish a resistance-force curve. This curve can then be used to interpret the resistance measurements during device use, improving the accuracy of the pressure, force or load readings.

[0038] In such examples, a dedicated test rig may be used to facilitate this procedure. Wherein, the test rig would apply varying levels of force to the eye cup and measure the resulting resistance, enabling the establishment of the resistance-force curve. The use of a test rig not only increases the accuracy of the measurements but also standardizes the process, ensuring consistent results. The use of electrically conductive foam, in combination with the other features of the device, provides a comprehensive and effective solution for managing meibomian gland dysfunction.

[0039] By ensuring accurate pressure (when the area of contact can be determined), force or load application and providing effective heat and vibration treatments, the device offers a safer, more comfortable, and more effective alternative to traditional treatment methods. These innovative features underscore the potential of the device as a cutting-edge tool in the management of this common condition.

[0040] Another alternative method contemplated by the invention for ensuring appropriate pressure, force or load on the eyelid involves a thin pin that is attached to a plate with a ball joint directly under the geometric centre of the heating patch behind the eye cup. As the cup contacts the eyelid and the foam compresses, the pin slides freely through a central hole in the base plate. A section of the pin is coated with an electrically conductive material, and two sets of electrical contacts detect the position of the pin. When the ring touches the first set of contacts, this indicates that the foam is compressed sufficiently to ensure good contact between the cup and the eyelid. If more pressure, force or load is applied, the pin is pushed further inwards until the conductive ring closes the circuit of the maximum force contacts, triggering a warning signal. The flexible ball joint allows for some tip, tilt, and lateral movement of the eye cup without affecting the functionality of the pressure, force or load sensing. Using a similar configuration, the contacts and conductive ring can be modified to obtain an analogue signal of the cup position. This would utilize technology commonly used in linear potentiometers, such as two wipers and a carbon coating along the pin. These methods offer the advantage of having no friction that could interfere with the detected signal. Besides providing feedback on potentially harmful excessive pressure, force or load on the eyelid, the measured load can also indicate if there is insufficient contact between the eyelid and the cup to ensure adequate heat transfer. These methods are designed to be relatively insensitive to bending, twisting, or shear forces that may be introduced as the cup touches and conforms to the eyelid. The use of a conductive pin, in combination with the other features of the device, offers a comprehensive solution for managing meibomian gland dysfunction. By ensuring accurate pressure, force or load application and providing effective heat and vibration treatments, the device offers a safer, more comfortable, and more effective alternative to traditional treatment methods. These innovative features highlight the potential of the device as a cutting-edge tool in the management of this common condition.

[0041] To ensure the device's adaptability to a variety of face shapes, a set of features has been considered. These consider variables such as pupil distance, the positioning of the eyes (whether deep-set or forward sitting) and varying facial curvatures. The use of a compressible component allows for self-alignment of the device to the position of the eyes, accommodating different pupil distances and eye positions.

[0042] For further adjustments to accommodate deep-set or forward-sitting eyes and different facial curvatures, removable magnetic cushion covers are proposed. These cushion covers, which allow the device to rest comfortably on the forehead, can be composed of various foam thicknesses and densities and can be swapped out as required.

[0043] This feature enhances the device's adaptability and user comfort. The removable magnetic cover is designed to be disinfected and / or washable and made of anti-microbial fabric, medical-grade silicone, or similar materials to meet biocompatibility and hygiene requirements. This design consideration not only enhances user comfort but also ensures the device's long-term usability and hygiene.

[0044] The disclosure also improves upon the heating and vibration technologies of existing devices. A curved eye cup, designed, at least in part, based on the National Institute for Occupational Safety and Health (NIOSH) anthropometric database of head forms, has been contemplated to better fit different eye shapes. The heating element may be placed flat behind the eyecup or curved inside the eyecup surface, with the latter option making direct contact with the eyelid for more efficient heat transfer.

[0045] Additionally, the implementation of a dynamic thermal gradient on the eyelid can encourage a smoother flow of liquefied meibum from the glands. This feature enhances the effectiveness of the device in treating meibomian gland dysfunction. To further improve the device's effectiveness, the invention proposes an increased oscillatory and vibration frequency range, from 0.5 to 300Hz.

[0046] This wider range allows for more precise control over the vibration treatment, enhancing its therapeutic effects. These innovative features highlight the potential of the device as a comprehensive and effective tool for managing meibomian gland dysfunction.

[0047] In certain embodiments, the device is equipped with a user-programmable electronic controller that allows for customisation of the device parameters, including duration, temperature, massage intensity, and other treatment variables. This level of customisation enables the device to adapt to the unique needs of each user, enhancing its effectiveness and user satisfaction. In some embodiments, the electronic controller provides a user-friendly interface for managing the device's settings, facilitating users to easily adjust the device to their comfort and treatment needs. For example, if a user prefers a longer duration of treatment, higher temperature, or more intense massage than recommended by the eye practitioner, the electronic controller facilitates easy adjustments to these settings. In some embodiments, to further enhance the usability of the device, it is designed to be operated by a light-weight battery offering the desirable trait of portability to use the device in various settings, for example, at home, at work, or on the go, wherein the users can easily bring the device with them for regular treatment sessions. The portability feature also makes it easier for users to adhere to their treatment regimen, enhancing the device's overall effectiveness.

[0048] In some embodiments, the lightweight battery mentioned here may take the form of a lithium polymer (LiPo) battery. LiPo batteries are known for their compactness, energy density, and relatively low weight. These characteristics align perfectly with the device’s intended purpose, ensuring that users can seamlessly integrate it into their daily routines. In some embodiments, the devices incorporating the lightweight battery shall comply with appropriate electrical safety requirements to further enhance the safety of the device. In other embodiments, the lightweight battery mentioned here may take the form of a lithium-ion, lithium-cobalt-oxide, lithium-lron- Phosphate or similar. In some other embodiments, by eliminating the need for a direct electrical connection during active operation, the device reduces the risk of electrical hazards. This safety feature, combined with the device's other safety measures, ensures that users can use the device with peace of mind. In certain embodiments, the user-programmable electronic controller and battery-powered design, combined with the device's other features, provide a comprehensive and user-friendly solution for managing meibomian gland dysfunction. In other embodiments, by allowing for customisation, portability, and safety, a more comfortable, convenient, and to an extent more effective alternative to traditional treatment methods and devices is contemplated in this disclosure.

[0049] Certain embodiments of the disclosure contemplate the integration of an optical distance sensor configured to measure displacement of the eyecup relative to a reference position. Such a configuration allows for the displacement to be convertible into an eyelid-contact force using a known spring or foam rate. This implementation provides an alternative mechanism for the force-sensing or pressure-sensing arrangement, offering a different technical approach to achieving similar safety and efficacy outcomes. In certain embodiments, the eyecups, or a pair of eye cups, are designed with skin-contacting surfaces featuring ridges or grooves that are specifically sized and arranged to aid in directing liquefied meibum toward the eyelid margin during vibration. These surface features may be oriented perpendicular or diagonal to the vibration direction, ranging from 0.5 mm to 2 mm in thickness and height. Such design elements enhance the therapeutic effect by facilitating the expression of meibum from the glands to the ocular surface, thereby improving the overall effectiveness of the treatment. Certain embodiments of the disclosure contemplate vibration amplitudes optimized between 0.2 mm and 1.0 mm peak-to-peak, with vibration frequencies optimized in different ranges for specific therapeutic effects. For instance, lower frequencies of 5 to 15 Hz may facilitate gentle stimulation, while higher frequencies of 20 to 50 Hz may promote more effective gland expression. In some implementations, the vibration arrangement may utilize mobile phone-type actuators operating within a 50-300 Hz range with peak amplitude between 0.05 mm and 0.5 mm, to enhance localized stimulation while preventing excessive displacement.

[0050] In certain embodiments, the controller implements sophisticated vibration models, such as a damped vibration model according to the equation A(t) = Amax * exp(-Bt) * cos(2irft), where Amax is peak amplitude, f is vibration frequency, t is time, and B is a damping coefficient ranging between 0.1 s’1and 5 s’1. This approach reflects natural attenuation of vibration intensity over time, providing a more physiologically appropriate stimulation pattern. In other implementations, the controller may implement vibration profiles that follow frequency modulation and amplitude modulation according to the equation A(t) = Amax * sin(2rrf*t + phi), wherein Amax is the peak amplitude, f is the frequency of oscillation, phi is the phase shift, and t is the time, with dynamic adjustments to these parameters based on real-time sensor inputs.

[0051] Certain embodiments contemplate the use of multiple actuators per eyecup, each independently controllable to create directional vibration patterns that guide meibum flow toward the eyelid margin. This multi-actuator arrangement allows formore sophisticated and targeted therapy, potentially improving treatment outcomes by enhancing the directional flow of meibum toward the eyelid margin.

[0052] In certain embodiments, the controller is programmed to implement asynchronous vibration management between the left and right eyes, with one eyelid receiving vibration while the other experiences heat treatment only, followed by a reverse treatment sequence. Additionally, the controller may be programmed to deliver different vibration intensities to left and right eyes based on differences in comfort sensitivity or severity of meibomian gland dysfunction between the eyes.

[0053] This asymmetric approach acknowledges the potential for differing conditions between the eyes and allows for tailored treatment for each eye within the same session. Certain embodiments of the disclosure contemplate a comprehensive treatment protocol designed to improve key clinical metrics, including Ocular Surface Disease Index (OSDI), Meibomian Gland Score (MGS), and Tear Breakup Time (TBUT) measurements after repeated use. In some implementations, the controller may be configured to operate the device in a twice-daily treatment protocol for a period of at least six weeks to provide statistically significant improvements in meibomian gland function and tear film stability. These protocol-driven approaches are designed to maximize therapeutic efficacy while maintaining convenience for home-based treatment.

[0054] In certain embodiments, the thermal energy delivery assembly is configured to achieve therapeutic heating of the eyelid within 3 minutes of activation and reach equilibrium temperature within approximately 10 minutes of activation. The controller may be programmed to maintain a desired eyelid temperature range, wherein the eyelid surface temperature is between 38°C and 42.5°C during operation based on feedback from the temperature sensor. This rapid heating capability, combined with precise temperature control, ensures effective thermal therapy while minimizing session duration, thereby enhancing user compliance.

[0055] Certain embodiments of the disclosure contemplate the incorporation of machine learning algorithms configured to identify optimal thermal and vibration treatment parameters specific to the user based on usage patterns, feedback, and measured physiological responses. This adaptive approach allows the device to continuously refine its treatment delivery, potentially improving outcomes over time through increasingly personalized therapy protocols.

[0056] In certain embodiments, the controller is programmed to implement a phased treatment protocol comprising a warm-up phase lasting 2 to 4 minutes, a therapeutic phase lasting 8 to 12 minutes, and a cool-down phase lasting 1 to 2 minutes, with specific vibration patterns assigned to each phase. This structured approach to treatment delivery ensures a comprehensive therapeutic experience while maintaining user comfort throughout the session. Certain embodiments contemplate a compliance monitoring system that records treatment adherence metrics and provides reminders and incentives to maintain the prescribed treatment regimen. The controller may be configured to generate treatment efficacy reports correlating symptom improvements with treatment adherence, thereby providing valuable feedback to both users and healthcare providers regarding the relationship between treatment consistency and outcomes. In certain embodiments, the controller is configured to detect if the device is properly positioned on the user's face before initiating or continuing thermal therapy, based on signals from at least one of: contact sensors, proximity sensors, or temperature differential measurements. This safety feature prevents inadvertent operation of the device when not properly positioned, thereby enhancing user safety and ensuring effective treatment delivery.BRIEF DESCRIPTION OF THE FIGURES

[0057] FIGURE 1 is a schematic representation of the pressure-sensing, force-sensing or load-sensing feature of the disclosure. It depicts the combination of a pressure sensor, and a compressible material designed within the eyecup to measure and adjust the pressure, force or load on the eye in one embodiment of the device disclosed herein.

[0058] FIGURE 2 is a schematic representation of an alternative pressure-sensing, force-sensing or load-sensing feature of the disclosure. It showcases an inductionbased sensor system implemented between anterior and posterior plates on either side of the foam within the eyecup in one embodiment of the device disclosed herein.

[0059] FIGURE 3 is a schematic representation of an alternative, intrinsically safer, pressure-sensing, force-sensing or load-sensing feature of the disclosure. It demonstrates the use of electrically conductive foam placed between two metal- coated plates in one embodiment of the device disclosed herein.

[0060] FIGURE 4 is a schematic representation of an alternative feature to ensure adequate pressure, force or load is applied on the eyelids via the eyecup of one embodiment of the device disclosed herein.

[0061] FIGURE 5 is a schematic representation of an alternative feature to ensure appropriate levels of pressure, force or load are applied on the eyelids via the eyecup of one embodiment of the device disclosed herein.

[0062] FIGURE 6 is a schematic representation of an alternative feature to ensure measured levels of pressure, force or load are applied on the eyelids via the eyecup of one embodiment of the device disclosed herein.

[0063] FIGURE 7 illustrates the front, side, and isometric views of the eyecup of one embodiment of the device disclosed herein.

[0064] FIGURE 8 illustrates another block diagram that focuses on the interaction of the microcontroller with the other components of the device disclosed herein.

[0065] FIGURE 9 is a block diagram that presents the electronic components of the device disclosed herein.

[0066] FIGURE 10 illustrates an isometric view, in two different perspectives of one embodiment of the device disclosed herein.

[0067] FIGURE 10A illustrates another view of the disclosed embodiment highlighting the head strap (101 1 , a strap to secure the body on the user’s head).

[0068] FIGURE 10B illustrates another view of the disclosed embodiment highlighting the head strap (1022, a strap to secure the body on the user’s head) and the main body of the device (1021 , a main body configured to be worn over a user’s eyes).

[0069] FIGURE 1 1 illustrates a front and back view of one embodiment of the device disclosed herein.

[0070] FIGURE 12 illustrates an exploded view of the key features of one embodiment of the device disclosed herein.

[0071] FIGURE 12-A illustrates another exploded view of the key features of another embodiment of the device disclosed herein.

[0072] FIGURE 12-B illustrates another exploded view of the key features of another embodiment of the device disclosed herein.

[0073] FIGURE 13 illustrates the assembly view of one embodiment of the body of the device disclosed herein with and without a magnetic cushion attached.

[0074] FIGURE 14 illustrates the detached magnetic cushion of one embodiment of the device disclosed herein in a magnified view, wherein the alignment grooves of the main housing are in line with the slots for the magnets within the cushion to facilitate seamless attachment of the magnetic cushion to the body of the device.

[0075] FIGURE 15 is another illustration of the detached magnetic cushion of another embodiment of the device disclosed herein in a magnified view, wherein the alignment groves of the main housing are assembled in line with the slots for the magnets within the cushion to facilitate seamless attachment of the magnetic cushion to the body of the device.

[0076] FIGURE 16 illustrates a detailed exploded view of all the features of one embodiment of the device disclosed herein.

[0077] FIGURE 17 illustrates a detailed view of the heating element (coil) assembled under the eyecup of one embodiment of the device disclosed herein. The heating elements herein constitute thermal energy delivery assembly in this embodiment.

[0078] FIGURE 18 illustrates a back view of one embodiment of the device disclosed herein, wherein some electronics are fitted into the housing of the device.

[0079] FIGURE 19 illustrates a bottom view of one embodiment of the device disclosed herein, wherein the fitted vibration components (solenoid) are featured within the housing of the device.

[0080] FIGURE 20 illustrates an alternative arrangement for generating oscillatory motion, building upon the design presented in Figure 4.

[0081] FIGURE 21 is a schematic representation of an embodiment of an eyecup pressure, force, or load regulation system, incorporating a spiral compression spring for controlled movement and optical distance sensing for force measurement.

[0082] FIGURE 22 illustrates a calibration diagram used to establish a correlation between the measured optical distance and the force applied to the eyecup.

[0083] FIGURE 23 illustrates the placement of a vibration actuator at the back of the eyecup, enabling controlled vibratory stimulation for enhanced user comfort and therapeutic efficacy.

[0084] FIGURE 24 presents a series of screenshots from the Meiboleyes App, a companion application designed to provide users with a self-tracking interface for managing their usage of the Meiboleyes device.

[0085] FIGURE 25 presents the thermal response of a custom-built model eye subjected to controlled heating by the prototype device.

[0086] Figure 26 illustrates the thermal response of the device in both controlled and in vivo environments.DETAILED DESCRIPTION

[0087] The following description is provided in relation to several embodiments that may share common characteristics of the disclosure. It is to be understood that one or more structural characteristics of one embodiment may be combined with one or more functional characteristics of other embodiments. The relevant subject headings should not be used in construing the scope of the claims or the claim limitations. The pressure sensing (when the contact area may be determined), force-sensing or load-sensing feature of this disclosure is aimed at preventing the device from over-exerting pressure, force or load on the eye and sensing when the desired pressure, force or load range has been achieved. For example, such a feature may be implemented through a pressure, force or load sensor combined with spring, foam, bellow, or similarly compressible and / or elastic material, to allow for the device to push up to the eye.

[0088] In some other embodiments, an air pump may also be used for adjustable pressures, force or load on the eye. In any of the contemplated pressure sensing, force-sensing or load-sensing methods, the amount of pressure, force or load measured is inputted into a feedback loop to indicate to the user to adjust the device as required. For example, this feature can be implemented in two variations. One would be considered a basic version, wherein the implemented method would only indicate an excessive force on the eyelid to prevent the user from damaging the eye.

[0089] In another example, a more advanced implementation would also indicate that the eyecup does touch the eyelid sufficiently to ensure good heat transfer to the meibomian glands while ensuring the touch does not cause excessive eye pressure, force or load. For example, the force or pressure sensing device may be digital like a membrane switch or provide an analogue output signal like pressure-sensitive carbon films. In other examples, Piezo electrical crystals would also be suitable for the implementation of such a method. In some embodiments, the pressure sensing, forcesensing or load-sensing mechanisms may only provide auditory feedback to the user triggering manual adjustment of the head strap to reduce the pressure on the eyelids.

[0090] Figure 1 illustrates a unique feedback loop system for user adjustments, wherein a capacitive method utilises two opposing metal plates to obtain an eye pressure-related, force-sensing or load-sensing signal considered within the eyecup of one of the embodiments of the device disclosed herein.

[0091] For example, using the existing foam (102) that holds the eye cups (104) and the heater (105), two metal-coated plates at the anterior (101 ) and posterior (103) sides of the foam are connected to a high-frequency voltage source (106); wherein the impedance of this capacitive circuit is expected to change with the separation of the two plates; wherein together with the spring rate of the foam, the compression force can be determined. In this example, appropriate electrical shielding may be added to ensure user safety and compliance with electromagnetic interference requirements. Such a contemplated configuration allows for real-time monitoring and adjustment of the pressure exerted on the eye, thereby ensuring optimal user comfort and treatment effectiveness.

[0092] Alternatively, in another embodiment of the disclosure, an induction-based sensor system is implemented between the anterior (201 ) and posterior plates (203) on either side of the foam bearing the eyecup (204) configured with a heating element (205); wherein a spiral-shaped coil (203a) on one of the plates is connected to a high- frequency voltage source (206) to generate an electromagnetic field, similar to the induction sensors on traffic lights. The metal plate at the opposing side of the foam interacts with the field and changes the impedance of the excitation circuit, depending on the separation of the two plates. Measuring the change in impedance provides feedback on the force with which the foam is compressed, as illustrated in Figure 2. Again, in such a method, appropriate electrical shielding is added to ensure user safety and compliance with electromagnetic interference requirements. In this example, a novel pressure-sensing induction-based sensor system is implemented which allows the device to function within the optimal pressure range, thereby enhancing the safety and efficacy of the device.

[0093] Figure 3 illustrates a safer, alternative pressure-sensing, force-sensing or loadsensing feature of the device disclosed herein. In one embodiment of the disclosure, an intrinsically safer method may be contemplated which uses electrically conductive foam (302) bearing the eyecup (304) configured with a heating element (305), configured between the two metal-coated plates (anterior, 301 & posterior, 302).

[0094] In this example, as the foam (305) is compressed, the conductivity will increase, providing an easily measurable parameter indicative of the applied compression force. In other embodiments, suitable foams may be procured from commercially available which usually contain carbon particles or silver fibres. In this method, resistance is claimed to be relatively unaffected by temperature and humidity. To further increase accuracy in such a method of operation, the resistance vs force relationship can be ascertained for individual eye cup post assembly; wherein a dedicated test rig may facilitate this procedure.

[0095] In various embodiments of the disclosure where a pressure-sensing, forcesensing or load-sensing feature, the person skilled in the art may be able to differentiate between force and pressure. While these terms seem to be used interchangeably, they have distinct meanings.

[0096] Force represents the push or pull action exerted on an object and it results in changes to an object’s motion or direction. For example, in the case of our embodiments, when we compress the electrically conductive foam (302) within our device, the force applied to the foam causes it to change its conductivity. This change serves as an easily measurable parameter indicative of the applied compression force, which is a vector quantity, meaning it has both direction and magnitude.

[0097] On the other hand, pressure refers to the physical force applied per unit area of a surface which quantifies how force is distributed over a specific region. In our case, pressure acts on the eyecup’s surface. As the foam compresses, the pressure increases due to the same force being distributed over a smaller area, wherein the pressure is a scalar quantity, meaning it lacks direction. Therefore, while we discuss “pressure” on the eyelid, we are essentially referring to the force applied to a specific area. Given the relatively constant area of the eyecup touching the eyelid, force and pressure may be directly correlated, hence sometimes these terms are used interchangeably, nevertheless, the implicit difference between pressure and force is expected to be understood well for a person skilled in the art.

[0098] In another embodiment of the disclosure, as illustrated in Figure 4, an alternative method to ensure adequate pressure, force or load on the eyelid may involve a thin pin that is attached to a plate with a ball joint directly under the geometric centre of the heating patch (401 ) behind the eye cup (404); wherein the pin (406) slides freely through a central hole in the base plate as the cup makes contact with the eyelid and the foam (402) compresses. In this example, one section of the pin may be coated with an electrically conductive material (407) and further two sets of electrical contacts (403) are configured to facilitate the detection of the position of the pin.

[0099] In this example, if the ring touches the first set of contacts, the foam is compressed sufficiently to ensure good contact between the cup and the eyelid, obtained via a signal from minimum force contacts (410). In the instance, where additional pressure is applied, the pin shall be pushed further inwards until the conductive ring (408) closes the safety circuit of the maximum force contacts (409), triggering a warning signal. The flexible ball (405) joint allows for some tip-tilt and lateral movement of the eye cup without affecting the functionality of the force-sensing feature.

[0100] Using a similar configuration, in another embodiment, the contacts and conductive ring can be modified to obtain an analogue signal of the cup position as required. This configuration of the embodiment would utilise technology commonly used in linear potentiometers, i.e. two wipers and a carbon coating along the pin.

[0101] In some embodiments of the disclosure, the advantage of methods become explicit is that friction may not significantly interfere with the detected signal. Besides providing feedback on potentially harmful excessive pressure on the eyelid, the measured load can also be used to indicate if there is insufficient contact between the eyelid and the cup to ensure adequate heat transfer. In some other configurations, these contemplated methods should also be relatively insensitive to bending, twisting or shear force that may be introduced as the cup touches and conforms to the eyelid.

[0102] In another embodiment of the disclosure, as illustrated in Figure 5, an alternative method to ensure adequate pressure, force or load on the eyelid may involve a thin pin that is attached to a plate with a ball joint directly under the geometric centre of the heating patch (501 ) behind the eye cup (504); wherein the pin (506) slides freely through a central hole in the base plate as the cup makes contact with the eyelid and the spring (502) compresses. In this example, one section of the pin may be coated with an electrically conductive material (507) and further two sets of electrical contacts (503) are configured to facilitate the detection of the position of the pin. In this example, if the ring touches the first set of contacts, the spring is compressed sufficiently to ensure good contact between the cup and the eyelid, obtained via a signal from minimum force contacts (510). In the instance, where additional pressure is applied, the pin shall be pushed further inwards until the conductive ring (508) closes the safety circuit of the maximum force contacts (509), triggering a warning signal.

[0103] The flexible ball (505) joint allows for some tip-tilt and lateral movement of the eye cup without affecting the functionality of the force-sensing feature. The configuration described in Figure 5 showcases a compressible component with multiple degrees of freedom, facilitated by a spring, enabling self-alignment of the device. The feature of Figure 5 discloses another method of delivering a comfortable and effective treatment experience for the user.

[0104] In another embodiment of the disclosure, as illustrated in Figure 6, an alternative method to ensure adequate pressure, force or load on the eyelid may involve a thin pin that is attached to a plate with a ball joint directly under the geometric centre of the heating patch (601 ) behind the eye cup (604); wherein the pin (606) slides freely through a central hole in the base plate as the cup makes contact with the eyelid and the bellow (602) compresses. In this example, one section of the pin may be coated with an electrically conductive material (607) and further two sets of electrical contacts (603) are configured to facilitate the detection of the position of the pin. In this example,

[0105] if the ring touches the first set of contacts, the spring is compressed sufficiently to ensure good contact between the cup and the eyelid, obtained via a signal from minimum force contacts (610). In the instance, where additional pressure, force or load is applied, the pin shall be pushed further inwards until the conductive ring (608) closes the safety circuit of the maximum force contacts (609), triggering a warning signal. The flexible ball (605) joint allows for some tip-tilt and lateral movement of the eye cup without affecting the functionality of the force-sensing feature.

[0106] The configuration described in Figure 6 showcases a compressible component with multiple degrees of freedom, facilitated by a bellow, enabling selfalignment of the device. The feature of Figure 6 discloses another method of delivering a comfortable and effective treatment experience for the user. The compressible component is the only difference between embodiments described in Figures 4, 5 and 6, which take the form of a foam, spring and bellow. In other embodiments of the disclosure, to ensure the device can fit a variety of face shapes including variables such as pupil distance, deep-set or forward sitting eyes, and facial curvatures, several features may be implemented. For example, to adjust for pupil distance and deep-set or forward sitting eyes, the compressible component used may be configured to incorporate numerous degrees of freedom and will enable the device to self-align to the position of the eyes. In other embodiments, for further adjustments to deep-set or forward sitting eyes and different facial curvatures, removable magnetic cushion covers that enable the device to rest on the forehead may be configured with various foam thicknesses and / or densities which can be swapped out as required.

[0107] In another variant of the disclosure, the removable magnetic cover may be configured to be washable and composed of anti-microbial fabric, medical-grade silicone or similar materials to facilitate biocompatibility and hygiene requirements. In other embodiments of the disclosure, to ensure more efficient heat transfer, a curved eye cup, shown in Figure 7, has been configured based on the National Institute for Occupational Safety and Health (NIOSH) anthropometric database of head forms, to fit different eye shapes. In some embodiments, the heating element may be placed flat behind the eyecup or curved inside the eyecup surface, with the latter option being directly in contact with the eyelid. Additionally, a dynamic thermal gradient applied on the eyelid can encourage a smoother flow of liquefied meibum from the glands. In some embodiments, the vibration, or oscillatory frequency range may range from 0.5 to 300Hz to further encourage a smoother flow of liquefied meibum from the glands. For further adjustments, in some embodiments, removable magnetic cushion covers of diverse thicknesses and densities may be considered.

[0108] Figure 7 details the front (701 ), side (702), and isometric (703) views of the eyecup, a key component of one of the embodiments disclosed herein. The designing of the eyecup of the embodiment of the present disclosure contemplated anthropometric data is configured to fit various eye shapes comfortably and effectively. In some embodiments, the eyecup may be designed to accommodate a range of eye shapes including but not limited to oval, round, almond, and hooded eyes. In other embodiments, the eyecup may be tailored to fit sizes ranging from small to large, with depths varying from shallow to deep. Additionally, geometric parameters such as curvature, width, and height may be optimised to ensure a secure and ergonomic fit for a diverse range of prospective users of the device disclosed herein.

[0109] Figure 8 is a detailed functional block diagram illustrating the electronic components and architecture of the device. The diagram depicts the interconnections between the various functional elements, sensors, indicators, power management systems, and communication interfaces. The mobile device (801 ) serves as the primary user interface for remote control and monitoring capabilities. It communicates wirelessly with the main microcontroller unit (MCU) through an integral wireless communication system (802). Element 803 represents the wireless communication interface to the MCU, enabling bidirectional data transfer between the mobile device(801 ) and the system's central processing unit. Non-volatile memory (804) is incorporated to store configuration parameters and serial number information, ensuring device identification and operational settings are preserved even during power loss events. Serial FLASH memory (805) provides storage capacity for data logging and event recording, maintaining a chronological record of the device's operations and encountered conditions for later analysis and troubleshooting. A temperature sensor (806) is included among the recommended auxiliary functions, providing ambient temperature measurements that inform system operation and environmental monitoring capabilities. The real-time clock (807) maintains accurate timekeeping for the system, enabling time-stamped operations, scheduled functions, and precise logging of events. This component may be optionally included based on specific application requirements. A watchdog / brownout protection circuit (808) monitors system voltage and operation, providing a failsafe mechanism to reset the MCU in case of voltage fluctuations or processing errors, thus enhancing system reliability when not provided internally by the MCU. A battery fuel gauge (809) continuously monitors the state of charge of the power source, providing critical information about remaining operational time and battery health. The USB Type-C connector (810) serves as the primary physical interface for external connections, enabling both power delivery for battery charging and data communication with external devices.

[0110] Further, Figure 8, there is a battery charger circuit (81 1 ) manages the power conversion and charging protocols, ensuring safe and efficient charging of the internal battery from the USB power source. The rechargeable lithium-ion battery (812) functions as the primary power source for the device, providing portable operation without requiring continuous external power. A protection circuit (813) safeguards the battery and system components against potential electrical hazards including overcharging, over-discharging, short circuits, and excessive current draw. The boost DC / DC converter (814) elevates the battery voltage to the required level for system operation, as specifically noted to satisfy electronic component voltage range requirements. The supply regulation converter (815) provides stable, regulated power to all system components, filtering voltage fluctuations and ensuring consistent operation across varying load conditions. A power rail voltage sensor (816) monitors the system's power distribution network, enabling the MCU to detect and respond tovoltage anomalies or power distribution issues. The UART (Universal Asynchronous Receiver-Transmitter) interface (817) provides serial communication capabilities primarily intended for debugging and development purposes, facilitating firmware updates and system diagnostics. A buzzer component (818) generates audible alerts and notifications, providing acoustic feedback to users regarding system status, warnings, or operation confirmation. The loudspeaker (819) delivers audio output with greater fidelity than the buzzer and is included as an optional component for applications requiring enhanced audio capabilities. Push buttons (820) provide direct user input capabilities, enabling manual control and interaction with the device's functions without requiring the mobile device interface.[0011 1 ] Further, Figure 8, there are LED indicators (821 ) provide visual feedback regarding system status, operation modes, and alerts through illuminated signals that can be readily observed by users. A color display (822) is included as an optional component to provide enhanced visual feedback and user interface capabilities beyond simple indicator lights, enabling more complex information presentation. A 7- segment LED display (823) offers numerical and basic alphanumeric output capabilities, providing direct visual feedback of system parameters, and is included as an optional component based on application requirements. A vibration actuator (824) generates haptic feedback, providing tactile notifications to users that can be perceived in environments where visual or auditory alerts might be ineffective or inappropriate. Pressure sensors (825) monitor applied force or pressure conditions, providing data that can inform system operations based on physical interactions or environmental conditions. The RTC (Real-Time Clock) crystal (826) provides precise timing reference for the optional real-time clock module, ensuring accurate timekeeping independent of the main system clock. A heat patch with integrated temperature sensor (827) enables both thermal monitoring and controlled heating capabilities, providing temperature regulation functionality for applications requiring thermal management. The MCU (803, Microcontroller Unit) forms the central processing core of the system, coordinating all peripheral components, processing sensor inputs, controlling outputs, managing communications, and executing the primary control software. As indicated in the diagram, the software class compliance would be at least with IEC 62304 Class B standards. The diagram, Figure 8, illustrates the signal and data flow between interconnected components through directionalarrows, demonstrating the functional relationships and communication pathways that enable the integrated operation of the device. Power distribution is similarly depicted, showing the routing of electrical power from the USB input, through the battery charging and power management systems, to the various active components requiring electrical supply, in at least one preferred embodiment of the current disclosure.

[0112] Figure 9 illustrates a detailed functional block diagram that primarily focuses on the interaction of the Bluetooth Low Energy Microcontroller Unit (MCU) with other components of the device. The diagram depicts the power management system, user interface elements, sensor integration, control mechanisms, memory components, and communication pathways that collectively enable the device's operation. The charging interlock (901 ) provides a safety mechanism that monitors and controls the charging process, ensuring that device operation and charging functions interact appropriately without compromising system integrity or user safety. The USB Battery Charger (903) manages power input from external sources via connection point (902), converting standard USB power to appropriate charging parameters for the lithium-ion battery. This component implements charging protocols and protection mechanisms to ensure safe and efficient battery charging. Input connection (904) represents the power and communication interface between the USB charger and the lithium-ion battery, facilitating both power transfer for charging and status information exchange. The Battery Monitoring system (905) continuously assesses the lithium-ion battery's state of charge, health, temperature, and discharge characteristics. This component provides critical battery status information to the MCU for power management decisions and user notifications. The Watchdog circuit (906) serves as a system integrity monitor, automatically resetting the MCU in case of software malfunction or processing errors. This failsafe mechanism ensures the device can recover from unexpected operational anomalies without requiring manual intervention. User Push Buttons (907) provide the physical interface for direct user interaction with the device, enabling manual control inputs such as power on / off, mode selection, intensity adjustments, and function activation without requiring the companion mobile application. The Pressure Sensing Board (908) is included as an optional component that measures applied force or pressure, providing tactile interaction data to the MCU. This sensor enables the device to respond to physical contact or positioning against the body.

[0113] The Real Time Clock (909) maintains accurate timekeeping independent of the main system clock, enabling time-stamped operations, scheduled functions, therapy timing, and precise logging of events even during low-power states. The Programming and Debugging Interface (910) provides direct access to the MCU for firmware updates, system diagnostics, and development activities. This interface allows technical personnel to maintain, troubleshoot, and enhance device functionality throughout its lifecycle.

[0114] Further, Figure 9 includes the ELIIS4 EEPROM (91 1 ) provides nonvolatile memory storage for device configuration settings, calibration parameters, and operational preferences, ensuring these critical values are preserved even when power is completely removed from the system. Memory connection point (912) represents the communication interface between the MCU and the EEPROM storage, through which configuration data and operating parameters are read and written. The NOR Flash memory (913) provides higher-capacity non-volatile storage for program code, user profiles, operational logs, and usage history. This memory component stores the device's firmware and maintains records of device usage for analysis and optimization. The Buzzer (914) generates audible feedback signals to alert the user of system status, operation completion, warnings, or other notifications that require attention when visual indicators might not be noticed.

[0115] The Vibration Motor (915) produces haptic feedback through mechanical oscillation, providing tactile notifications to the user and delivering therapeutic vibration stimulation as part of the device's treatment capabilities. These parts form the vibration arrangement contemplated in the disclosed device herein. The Vibration Motor Control (916) regulates the vibration motor's operation, controlling parameters such as intensity, frequency, pattern, and duration based on therapy requirements and user settings. The Heater Board with Temperature Sensor (917) integrates thermal elements with feedback mechanisms, enabling precise temperature control for therapeutic heating applications while monitoring actual temperature to ensure safety and efficacy. The Heater Control module (918) manages power delivery to the heating elements based on temperature feedback, user settings, and safety parameters, implementing control algorithms to maintain stable and accurate thermal output.

[0116] The Display (919) provides visual information to the user regarding system status, operational modes, treatment progress, battery level, and other parameters relevant to device operation and therapy delivery. User LED Indicators (920) provide simple visual feedback through illuminated signals, indicating power status, charging state, active modes, connectivity status, and alert conditions through different colours and blinking patterns.

[0117] Further, Figure 9 includes the Display Power management (921 ) controls energy delivery to the display component, optimizing power consumption by activating the display only when needed and regulating operating voltage for efficiency. Power connection point (922) represents the distribution pathway from the voltage regulation system to the power monitoring system, enabling comprehensive oversight of system power distribution. The Board Power management (923) supplies regulated electrical power to the main circuit board components, ensuring stable voltage levels and current availability for reliable system operation. The Heater Safety Watchdog (924) provides an independent monitoring system specifically for the heating elements, implementing hardware-level safety cutoffs to prevent overheating regardless of MCU status or software condition. The Heater Power management (925) delivers controlled electrical energy to the heating elements, implementing both digital and analogue regulation to achieve precise thermal output while maintaining energy efficiency. The central Bluetooth Low Energy MCU functions as the system's computational core, processing inputs from sensors, managing power distribution, controlling therapeutic outputs, maintaining timing, storing and retrieving data, implementing safety protocols, and enabling wireless communication with external devices such as smartphones and tablets. Through the MCU's Bluetooth connectivity, the device transmits critical operational data to companion smart devices, including voltage settings, current parameters, heating element resistance values, vibration actuator frequency settings, power levels of infrared emitters or receivers, temperature readings from the infrared and contact sensors, battery status information, wireless connectivity status, and device operational state. The bidirectional arrows throughout the diagram indicate signal and data flow between components, illustrating how the MCU coordinates all device functions while maintaining feedback loops for safety and efficacy.

[0118] Power distribution pathways are similarly depicted, showing how electrical energy is routed from the battery through regulation systems to various active components according to their specific requirements. The integrated temperature sensing systems provide continuous feedback to the MCU, enabling the maintenance of user-defined therapeutic temperature ranges through closed-loop control algorithms that adjust power delivery to the heating elements in real-time, ensuring both comfort and safety during operation, in at least one preferred embodiment of the current disclosure.

[0119] Figure 10 provides an isometric view of the device from two different perspectives 1001 and 1002; wherein 1003 depicts the pair of eye cups. This illustration gives a comprehensive overview of the device's design and highlights the thoughtful integration of its various components. In some other embodiments, the logo appearing on the front view (1002) might be of smaller size, bigger size or absent. Figure 10-A provides another isometric view of the device from another perspective; wherein 101 1 depicts the head strap of the device. This illustration gives another overview of the device's design and highlights the thoughtful integration of its head strap (a strap to secure the body on the user’s head). Figure 10-B provides another isometric view of the device from another perspective; wherein 1022 depicts the head strap of the device and wherein 1021 depicts the main body of the device disclosed herein. This illustration gives another overview of the device's design and highlights the thoughtful integration of its head strap (a strap to secure the body on the user’s head).

[0120] Figure 11 showcases the back (1 101 ) and front (1102) views of one of the embodiments of the device disclosed herein. In some other embodiments, the logo appearing on the front view (1 102) might be of smaller size, bigger size or absent. In some embodiments, the device may include a user interface wherein the user interface includes a digital display; wherein the digital display is a touchscreen.

[0121] Figure 12 presents an exploded view of the device's key features. This detailed illustration allows for a deeper understanding of the device's construction and the interaction of its various components, which showcases the compressible foam (1202), coil heater (1203), eyecup (1204), and the device body (1201 ), of one embodiment of the device disclosure herein.

[0122] Figure 12-A provides an exploded view of one embodiment of the disclosed device, illustrating how each component is arranged and interacts within the overall assembly. As shown, the device body encompasses multiple internal and external elements designed to provide both structural integrity and functional support. A front cover (2) and a rear cover (6) form the primary enclosure, protecting the internal circuitry and mechanical components. Within this enclosure, a battery (1 ) supplies power to a main PCB (15), an optical sensor PCB (17), a push buttons PCB (18), and a heating PCB (19), each of which is secured by dedicated fixtures or mounting points. A compressible foam element (3) is positioned to provide cushioning and comfort against the user’s face or eye region, while an eyecup (5) is contoured to fit around the orbital area, ensuring a snug yet comfortable seal. To deliver targeted heat therapy or warming functionality, a coil heater (19) is arranged in thermal communication with the eyecup (5) and / or foam (3). The heating PCB (19) regulates power to the coil heater (19), enabling precise temperature control.

[0123] A cushion (3) may be further secured via a cushion adapter (14) to enhance the ergonomic interface with the user’s face, which may come in small, medium and large sizes, in one embodiment. Additional components facilitate the device’s interactive features and secure assembly. Fixtures for a heart PCB (4) and fixtures for QLED (8) (or other display / illumination modules) ensure that specialized electronics or sensors remain firmly in place. A webbing (7) may be integrated or attached around the exterior to help adjust and stabilize the device on the user’s head. User input is handled by a switch button (9), a spring button (10), and push buttons pin(s) (1 1 ), which collectively interface with the push buttons PCB (15) to register commands such as power on / off or mode selection. In this embodiment, each of the listed elements works in tandem to provide a comfortable fit, reliable performance, and straightforward user interaction. The exploded view of Figure 12-A highlights how the battery (1 ), electronics (15, 16, 17 & 18), heater (19), eyecup (5), foam (3), and covers (2, 6) interrelate, thereby offering a clear understanding of the construction and assembly sequence of the device. By illustrating each part in spatial relation, Figure 12-A reveals how heat, power, and sensor functionalities are seamlessly integrated within the overall design.

[0124] Figure 12-B provides an exploded view of another embodiment of the disclosed device, highlighting each component’s placement and role within the overall assembly. A battery (1 ) serves as the primary power source, delivering electrical energy to various subsystems and circuit boards. The front cover (2) and rear cover (6) collectively form the principal enclosure, providing structural support and protection for the internal electronics. A cushion (3), which may be formed of foam or similar compressible material, is positioned to ensure comfort and a secure seal against the user’s face or surrounding area. To accommodate specific functional modules, fixtures for a heart PCB (4) are integrated to hold a dedicated circuit board in place, while fixtures for QLED (8) secure one or more QLED or display modules. An eye cup (5) is contoured to align with the user’s orbital region, facilitating proper positioning and user comfort. A lens (9) is situated so as to deliver optical clarity or shielding, depending on the intended function (e.g., vision enhancement, sensor protection, or light filtering). The device is fastened around the user’s head or face with webbing (7), which may be adjustable to accommodate various head sizes. A switch button (10) provides a user interface for turning the device on / off or cycling through operational modes. Beneath or adjacent to the switch button (10), a spring base (11 ) allows for tactile feedback or spring-biased movement, improving user interaction. One or more push buttons (12) can be used to trigger additional functions, with each push button typically anchored via pins (13) that ensure reliable pivot or alignment within the covers. To account for anatomical differences among users, a cushion adapter (14) (offered in small, medium, or large variants) is included to support or mount the cushion (3). This adapter helps maintain a consistent fit and seal around the user’s facial contours. Collectively, the exploded view in FIG. 13 illustrates how each of these elements — battery (1 ), covers (2, 6), cushion (3), fixtures (4, 8), eye cup (5), webbing (7), lens (9), switch button (10), spring base (1 1 ), push buttons (12), pins (13), and cushion adapter (14), cooperates within a cohesive design to provide comfort, functionality, and ease of use.

[0125] Figure 13 provides a detailed assembly view of the main housing or main body of the device, demonstrating its versatile design by showcasing it in two different states - one with an attached magnetic cushion (1301 ) and one without a magnetic cushion (1302). In this embodiment, the attached magnetic cushion exemplifies how the device can be enhanced with additional components to increase its functionality or improve its user experience.

[0126] In this embodiment, the magnetic cushion (1301 ) is designed to be easily attached and detached, providing users with the flexibility to modify the device as per their requirements or preferences.

[0127] Figures 14 and 15 provide an enhanced view of the detached magnetic cushion from two different perspectives for different embodiments of the devices disclosed herein. These figures demonstrate the placement and design of the alignment grooves and magnet slots, which facilitate a seamless attachment of the magnetic cushion to the main body of the device.

[0128] Figure 14 depicts the cushion in a detached state, highlighting the grooves specifically designed for alignment with the main housing or main body of the device. The grooves (1403) highlighted in detail A of 1401 (scaled 3:1 ) are key to ensuring the correct positioning of the cushion on the device. In this embodiment, precision in this alignment is critical for the device's correct functioning and user comfort. In addition, the figures also illustrate the slots for the magnets within the cushion. These slots are shown in a transparent view, 1402, revealing the magnets' placement within the cushion. In this embodiment, the magnets' role is to secure the cushion to the main body of the device magnetically, providing a strong yet easily detachable connection.

[0129] Figure 15 illustrates how the cushion (1501 & 1502) magnetically attaches and aligns itself to the main housing (1503). The magnetic cushion's design and the main housing's corresponding alignment grooves allow for a seamless fit, facilitating a smooth and secure attachment process.

[0130] Overall, Figures 14 and 15 offer an in-depth understanding of the magnetic cushion's design and its interaction with the main body of the device, highlighting the thoughtfulness behind the device's design for easy assembly and disassembly of at least one embodiment of the devices disclosed herein.

[0131] Figure 15 elucidates how the cushion magnetically (1501 , 1502, 1503 & 1504) attaches itself and aligns with the magnets on the main housing (1505, 1506, 1507, 1508) of the device. This seamless fit is facilitated by the magnetic cushion's design and the corresponding alignment grooves in the main housing, ensuring a smooth and secure attachment process.

[0132] The figure provides a transparent view of the cushion and the device without the cushion, both in front view with 4 magnetic slots (1501 -1504 and 1505 - 1508 respectively). A key feature is the tongue, highlighted in detail A at scale 3:1 (1509), which slots into the groove highlighted in detail B at scale 3:1 (1510). In this example, the magnetic slots hold a magnet each, four in total), which magnetically attach to the cover, having an identical set of magnets glued on the other side, behind the cover. Overall, Figures 14 and 15 offer an understanding of the construct of the magnetic cushion's design and its interaction with the main body of the device, providing the device's thoughtful design for effortless assembly and disassembly in at least one embodiment of the devices disclosed herein.

[0133] Figure 16 showcases a detailed exploded view of all the features of the device in accordance with a standard engineering format for a Bill of Materials (BOM). This comprehensive illustration of one embodiment of the disclosure allows for a clear understanding of at least one permutation and combination of the choice of intended device designs and arrangements of components disclosed herein. In this example, the placement of magnets can be found in components, or parts, 7 and 3 in Figure 16. In this example, each of these parts houses four magnets, located at the most left and right corners of the slot, wherein these magnets are configured to enable the component, or part 8, the cushion, which is adhered to component or part 7, to be magnetically attached to part 3, which allows for easy assembly and secure attachment of the cushion to the device. The cushion, component, or part 8, may be wrapped in different materials depending on the desired comfort and functionality.

[0134] For example, some options for this part or component include fabric or silicon, both providing their unique benefits to the device's overall user experience as disclosed herein. Figure 16 further details other components of the device, including the housing shell (1 ), button (2), snap-fit cover (3), eyecup foam (4), heater (5), eyecup (6), and magnetic base plate (7); wherein each of these parts plays a significant role in the device’s function and user interaction, as disclosed herein. For example, the housing shell (1 ) serves as the protective outer covering of the device, while the button (2) allows for user input to control the device’s functions. The snap-fit (3) cover provides easy access to the internal components for maintenance or replacement. The eyecup foam (4) for counter pressure on the eyelids and heater (5) are the elements, working in tandem with the eyecup to provide heat to the user. The magnetic base (7) plate provides a secure and stable base for the device, ensuring it remains in place during use. Overall, Figure 16 provides a comprehensive view of the device's assembly for at least one potential embodiment of the device disclosed herein.

[0135] Figure 17 presents a detailed view of the heating element (1701 ), which constitutes the thermal energy delivery assembly in this embodiment, assembled within the eyecup of the device. The heating element, placed directly behind or inside the eyecup, is vital to the device’s function of providing efficient heat transfer. In this embodiment, the heating element (1701 ) is assembled and situated within the eyecup of the device. In other embodiments, the heating element may be positioned either directly behind, on the top, or within the eyecup, to facilitate efficient heat transfer, which is vital for the optimal operation of the devices disclosed herein. In this embodiment, the design includes a conductive coil made of copper, 1701 , and a sensor, 1702, that is placed in the central area of the design; wherein the conductive coil is specially designed to work in tandem with the eyecup with specific resistance properties to ensure an even and desirable temperature distribution across the surface of the eyecup. In other embodiments, different coil designs with different lengths, widths, spirality or resistance may be contemplated, to provide consistent heating, making the device effective and reliable for its intended purpose. In this embodiment, the feedback sensor's central position allows it to accurately monitor and control the heating element, ensuring the desired temperature is consistently achieved and maintained on the eyecup surface. Furthermore, the coil can also be constructed using different materials.

[0136] While copper is used in this embodiment, other metals such as aluminium, silver, gold, or nickel could be utilized for their respective conductivity properties. Beyond metallic conductors, the coil could also be formed using carbon ink, graphene, or other composite materials. These alternative materials provide flexibility in design and can offer improved performance characteristics in certain scenarios. The feedback sensor's central position allows it to accurately monitor and control the heating element, ensuring the desired temperature is consistently achieved and maintained on the eyecup surface.

[0137] Figure 18 provides a back view of the device, focusing on the assembly of the electronic components into the housing of one of the embodiments of the device disclosed herein. Figure 18 elucidates the back view of the device, highlighting the integral Real Time Clock (RTC, 1801 ) for accurately recording the date and time of treatment sessions. In this embodiment, the device also houses a MicroSD card holder (1802) to store treatment session information and sensor data. In this embodiment, powering the device is a Lithium Polymer (LiPo) battery, 1803, ensuring uninterrupted operation of the wearable device. In addition, in this embodiment, the device is equipped with various connectors designated to interface with heaters, pressure sensors, and vibration actuators (1804).

[0138] In this embodiment, an integrated switch allows for toggling the device's operation and adjusting user treatment settings (1805). In this embodiment, the device's microcontroller and electronic circuits (1806) are designed to control several functionalities, including but not limited to buzzer and LED indicators, heaters, pressure sensors, and vibration actuators. This illustration of one embodiment of the disclosure showcases the device's ability to maintain a sleek, user-friendly design while efficiently housing its components. However, it should be understood that the configuration and arrangement as shown and described herein is one possible embodiment of the device and is presented for illustrative purposes. Variations in the configuration, including alternative arrangements of the electronic components, or the addition or omission of certain components, are possible without deviating from the spirit and scope of the disclosure. Such variations considered by a person of skill in the art are intended to be included within the scope of this disclosure.

[0139] Figure 19 offers a bottom view of the device disclosed herein, highlighting where the vibration components are housed within one embodiment of the device. These components are crucial to the device's function of providing effective vibration treatments, a key feature in managing meibomian gland dysfunction. In this embodiment, the device is specifically designed to accommodate variations in pupillary distances and head curvatures, a feature achieved through the incorporation of a ball joint (1901 ).

[0140] In this example, this ball joint serves as an adjustable interface, allowing for customisation and thus enhancing user comfort and device efficacy. Additionally, this embodiment of the device also includes an eye cup (1902), strategically positioned to ensure direct contact with the user's upper and / or lower eyelids. In this example, the design feature serves a two-fold purpose - firstly, to secure the device in place during operation, and secondly, to channel the vibrations produced by the device directly to the user's upper and / or lower eyelids.

[0141] In this example, the vibration is generated by a solenoid electromagnetic actuator (1903), carefully calibrated to provide tangential vibrations, a specificity that allows for the vibrations to be applied directly and efficiently to the user's upper and / or lower eyelid.

[0142] The solenoid (1903) actuator's precise and targeted functionality further enhances the device's overall performance in terms of providing a consistent and effective vibrational stimulus to the user's upper and / or lower eyelid. This is a representative embodiment of the disclosure that represents a smart wearable device, specifically designed for pupillary and curvature adaptability, eyelid contact and focused vibrational stimulus, all of which are key elements to efficient and effective function.

[0143] Figure 20 showcases an alternative arrangement for generating oscillatory motion, building upon the design presented in Figure 4. The oscillatory motion in this layout is produced by eccentrically spinning a pin, which is driven by a motor and disc, generating a circular oscillatory pattern. A lateral view of one eye of the vibrational prototype device, including a motor actuator, is depicted.

[0144] The design elements include foam or spring (2001 ), an eyecup (2002), a heating patch (2003), a plate with ball joint, a pin (2005, refer to Figure 4 for details) capable of free vertical movement, a base plate with opening for pin pivot, an eccentrically spinning disc (2007) connected to the motor shaft and the motor itself (2008).

[0145] In certain other embodiments, the heating elements within the eyecups of the disclosed devices may be configured to provide a surface temperature of the upper and / or lower eyelids that may be at least 39°C, 40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C. In certain other embodiments, the heating elements within the eyecups of the disclosed devices may be configured to provide a surface temperature of the upper or lower eyelids may be between 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 43°C, 40°C to 43°C, or 40°C to 46°C.

[0146] Additionally, in some embodiments, as an intrinsic safety feature, a thermal safety circuit breaker may be incorporated within the heating elements of the eyecups of the disclosed devices; wherein this safety circuit breaker would act as a safeguard, preventing excessive temperatures that could potentially harm the user.

[0147] Figure 21 is a schematic representation of an embodiment of an eyecup pressure, force, or load regulation system, incorporating a spiral compression spring for controlled movement and optical distance sensing for force measurement. The eyecup (2105) is supported by a spring mechanism that enables lateral movement and angular alignment to conform to the user's eyelid. An optical distance sensor (2107) is positioned to measure the displacement of the eyecup as it makes contact with the eyelid, ensuring an accurate force determination based on the known spring rate. The system transmits the measured force data to a CPU for digitization and processing, enabling real-time monitoring and feedback. The preferred spring rate ranges from 0.09 N / mm to 0.12 N / mm, and the spring may be wound in a circular or oval shape. Threshold values for excessive or insufficient force can be established, allowing user feedback to ensure optimal pressure application. In one embodiment, the disclosed system incorporates an eyecup mounting mechanism configured to ensure consistent and controlled contact pressure on the eyelid during operation.

[0148] The eyecup is mechanically supported by a spiral compression spring, which enables lateral freedom of movement as well as angular adaptability to conform to variations in eyelid curvature. The spring applies a defined restorative force, thereby ensuring proper seating and contact stability without excessive pressure that could cause discomfort or impede functionality.

[0149] The system further integrates an optical distance sensor, positioned to measure the compression displacement of the eyecup relative to a reference position. By utilizing a known spring rate, the system effectively converts displacement data into force readings, providing a continuous and real-time analogue force measurement. Unlike conventional force-sensing approaches that may be affected by tilt or lateral movement, this configuration remains substantially insensitive to such variations, thereby enhancing the reliability and accuracy of force estimation.

[0150] The force values obtained from the optical sensing system are processed and digitized via a CPU, which allows for dynamic force monitoring. Threshold values for minimum and maximum acceptable forces can be preconfigured, enabling automated feedback mechanisms to notify the user when corrective action is required. Such feedback may be visual, auditory, or haptic, ensuring ease of use and enhanced operability.

[0151] The spring mechanism is designed with an optimal spring rate ranging between 0.09 N / mm and 0.12 N / mm, balancing compliance and stability. The spring geometry may be selected based on application-specific requirements, with both circular and oval winding configurations available to accommodate different mounting orientations and space constraints.

[0152] By integrating mechanical compliance via a spring-loaded eyecup and non-contact optical force measurement, the disclosed system enables precise, repeatable, and user-adaptive force regulation. This configuration is particularly advantageous in wearable ophthalmic applications, where maintaining a consistent yet comfortable force on the eyelid is critical for effective operation.

[0153] Figure 22 illustrates a calibration diagram used to establish a correlation between the measured optical distance and the force applied to the eyecup. The calibration process involves recording displacement values from the optical sensor while a known force is applied to the eyecup.

[0154] A resulting force vs. displacement curve is generated, enabling precise force estimation based on measured displacement values. The calibration data is used to ensure accurate and repeatable force readings, facilitating real-time monitoring and feedback mechanisms in an operational environment.

[0155] In one embodiment, the disclosed optical force sensing system is subject to a calibration process that establishes a direct correlation between the measured optical displacement and the force applied to the eyecup. This calibration process is essential for ensuring the accuracy and reliability of the system in dynamically determining applied forces during operation.

[0156] The calibration methodology involves applying a known force to the eyecup while simultaneously measuring the corresponding optical displacement using a distance sensor.

[0157] The resulting force-displacement relationship is characterized through an empirical calibration curve, which serves as a reference for real-time force determination. The system utilizes this calibration data to convert measured displacement values into force readings, ensuring a high degree of precision and repeatability.

[0158] A key advantage of this optical sensing approach is its insensitivity to lateral and tilt movements of the eyecup. Unlike traditional force measurement methods that rely on direct mechanical contact or strain-based sensors, the disclosed approach enables non-contact, high-resolution force estimation with minimal interference from angular misalignment or external mechanical disturbances.

[0159] The calibration data is stored within the CPU processing unit, allowing for dynamic adjustments and recalibrations based on environmental conditions or system wear over time. Additionally, the calibration framework supports the implementation of threshold-based force control, where upper and lower force limits can be predefined to ensure user safety and device efficacy.

[0160] By integrating real-time optical force sensing with a robust calibration procedure, the disclosed system offers an efficient, non-intrusive, and highly accurate method for ensuring precise force application in ophthalmic and other sensitive applications.

[0161] Figure 23 illustrates the placement of a vibration actuator at the back of the eyecup, enabling controlled vibratory stimulation for enhanced user comfort and therapeutic efficacy. The actuator (2304) may be implemented as a rotating disc motor, an eccentric shaft motor, or a linear actuator, with the generated vibration following a circular or linear pattern in any chosen direction. The system allows for both continuous and intermittent operation, with the latter providing advantages in terms of user comfort and battery efficiency. A connection (2305) to a driver and control circuit is included, enabling fine-tuned adjustments of frequency and amplitude. The preferred operational range includes frequencies below 50 Hz and vibration amplitudes of less than 1 mm (peak-to-peak). Gradual ramping up and down of vibration amplitude and frequency is incorporated to enhance user comfort during intermittent operation.

[0162] In one embodiment, the disclosed system incorporates a vibration actuator positioned at the back of the eyecup, facilitating controlled vibratory stimulation of the eyelid. The actuator (2304) may be implemented as a rotating disc motor, an eccentric shaft motor, or a linear actuator, depending on the desired mode of vibration. The generated vibrations may follow a circular or linear trajectory, with directional control allowing adaptation to specific therapeutic needs.

[0163] The system supports continuous or intermittent operation, with the latter offering improved user comfort and extended battery life. Intermittent vibration provides gradual modulation of stimulation, reducing potential discomfort associated with abrupt changes in vibratory intensity. The system is designed to enable fine-tuned adjustments of both frequency and amplitude, allowing customization based on individual user requirements. The preferred operational parameters include frequencies below 50 Hz and vibration amplitudes of less than 1 mm peak-to-peak, ensuring both efficacy and comfort.

[0164] To further enhance usability, the system incorporates gradual ramping of vibration intensity and frequency during activation and deactivation. This controlled transition prevents sudden mechanical stimulation, minimizing potential discomfort and optimizing therapeutic benefits. The actuator is electrically connected to a driver and control circuit (2305), allowing for automated or user-controlled adjustments based on predefined therapy protocols.

[0165] The disclosed vibration mechanism provides a versatile and adaptive approach to eyelid stimulation, enabling effective therapeutic application while maintaining user comfort. The modular actuator selection, combined with programmable control parameters, ensures a customizable and user-centric solution for ophthalmic applications.

[0166] The vibration actuator illustrated in Figure 23 can be driven to achieve different motion profiles to provide tailored stimulation patterns; wherein the system leverages a set of predefined vibration motion profiles, each purposed to elicit a distinct functional effect in aiding the delivery, restoration and / or maintenance of healthy ocular function. For example, these motion profiles may be generated by, or stored in a controller module, and the various profiles and patterns of profiles may include profiles which mimic familiar common auditory phenomena such as bumps, ticks, clicks, buzzes, hums, pulsations, and also transition profiles which are profiles which over some non-zero time transition from one frequency of vibration to another and / or one intensity of vibration to another.

[0167] In other examples a transition profile may be immediately followed by at least one identical or different transition profile such that the frequency of vibration and / or intensity of vibration continuously transitions between two or more than two frequencies and / or intensities for at least one cycle. Profiles may be composite, comprising of at least two other profiles with each profile after the first either following the preceding profile immediately or following after some predefined time has elapsed. Composite profiles may be wholly predefined, partially predefined or constructed on the fly. Where composite profiles are not fully predefined, the non-predefined aspects may be controlled in response to a user input, biometric or other sensor, computed algorithm result, or randomly.

[0168] In another embodiment, the vibration actuator can be programmed to generate a variety of motion profiles such as bumps, ticks, clicks, pulsations, and transitions, each modifiable in terms of frequency, duration, and intensity. Such programmability allows for a customized therapy. The actuator may be configured to cycle through multiple motion profiles or composite profiles, enabling periodic changes in stimulation to minimize discomfort and / or maximize therapeutic benefit.

[0169] In an alternative embodiment, the actuator controller may be controlled via an external interface, such as a computer or mobile device, using a communication protocol that enables real-time adjustment of vibration parameters. The external control interface may provide an interactive selection menu where users can choose from predefined motion or composite motion profiles or customize new sequences. The connection may be established using wired or wireless means, including but not limited to USB, Bluetooth, or proprietary protocols.

[0170] The vibration control system of Figure 23 may be designed to accommodate different operational modes, including delivery of a single motion profile or composite profile, periodic delivery of a motion profile or composite motion profile, and continuous delivery of a motion profile, composite motion profile, or collection of identical or different single motion profiles or composite profiles. The system may also integrate a real-time monitoring function that adjusts the delivered profile or profiles based on user input, user feedback, biometric or other sensor inputs, timer, time of day clock, calendar, computed algorithm result, or any combination of these. This adaptive control ensures optimized therapeutic efficacy, user comfort, or balance between therapeutic efficacy and user comfort. In one implementation, the system features a diagnostic and calibration mode, allowing for precise adjustment of actuator performance. This mode enables automated tuning of vibration intensity, frequency, ensuring consistent and reproducible stimulation, and minimized system power consumption, across different device configurations, and compensating for manufacturing tolerances and / or inaccuracies. Additionally, safety mechanisms may be integrated to prevent overstimulation, including predefined limits on vibration intensity and automated shutdown procedures in case of prolonged exposure. Safety systems may use inputs from accelerometer sensors, timers, mechanical, optical or magnetic sensors and / or switches to determine when vibration motion profiles or composites are adjusted in their frequency, intensity, duty cycle, count, and / or adjustment of rest period duration between motion profiles or composites, or cessation of motion altogether. The disclosed system is highly modular, enabling compatibility with various actuator types and control architectures. The actuator's driver circuit may be configured to support different power modes, optimizing energy consumption based on real-time usage conditions.

[0171] In battery-operated implementations, power management algorithms may be employed to extend operational lifespan while maintaining consistent or optimized performance. In another embodiment, the actuator mechanism may also include feedback components such as accelerometers or pressure sensors to ensure precise control of vibratory output. These sensors provide real-time data that can be used to adjust the drive signal to the actuator dynamically. In another example, the disclosed embodiments of Figure 23 may provide a comprehensive framework for implementing controlled vibratory stimulation; wherein the combination of actuator programmability, adaptive control, and modularity ensures broad applicability across different use cases, including therapeutic treatment, management of dry eye, management of tired eyes, relaxation enhancement, and potentially, sensory rehabilitation.

[0172] In one example, the mathematical formulation governing the vibration control involves frequency modulation and amplitude modulation, where the vibration frequency and amplitude can be expressed as: A(t) = Amax * sin (2*rrTt + phi), wherein ‘Amax’ is the peak amplitude, T is the frequency of oscillation, ‘phi’ is the phase shift and ‘t’ is the time; and wherein the system dynamically adjusts and based on real-time sensor inputs. To ensure a balance between user comfort and the effective clearance of gland channels and orifices, the preferred range of vibration amplitudes lies between 0.2 mm and 1 .0 mm (peak-to-peak). The frequency range is optimized between 5 Hz and 50 Hz, with lower frequencies (5-15 Hz) facilitating gentle stimulation for relaxation and higher frequencies (20-50 Hz) promoting effective gland expression and oil release onto the ocular surface. This selection ensures that the mechanical stimulation remains within tolerable limits while maximizing the therapeutic impact of the vibration therapy. In other embodiments, the frequency range may be extended up to 75 Hz, 100 Hz, 125 Hz and up to 150 Hz, further promoting effective gland expression and oil release onto the ocular surface. This selection ensures that the mechanical stimulation remains within tolerable limits while maximizing the therapeutic impact of the vibration therapy. In another embodiment, vibration actuators similar to those use in mobile phones may be used, and the operational parameters may need to be adjusted accordingly. For example, the mobile phone actuators typically operate within the 50-300 Hz range, producing lower displacement but higher frequency mechanical stimulation.

[0173] Using these to model this the desired behaviour for our application, the amplitude and frequency function can be adapted as: A(t) = Amax * cos (2*π *f*t), wherein ‘Amax’ is the peak amplitude, f is the frequency of oscillation and ‘t’ is the time; wherein the ‘Amax’ for mobile actuators typically falls between 0.05 mm and 0.5 mm, and the f frequency is optimized between 50 Hz and 300 Hz. Lower amplitudes with higher frequencies enhance localized stimulation while preventing excessive displacement that could cause discomfort; wherein this model may offer effective gland stimulation while leveraging the high-frequency capabilities of mobile vibration motors. In another embodiment, vibration actuators similar to those found in mobile phones may be used, and the operational parameters may need to be adjusted accordingly. For example, the mobile phone actuators typically operate within the 50- 300 Hz range, producing lower displacement but higher frequency mechanical stimulation. Utilising these to model the desire behaviour for our application, a more sophisticated approach may be employed by incorporating damping and system resonance characteristics: A(t) = Amax * exp(-B*t) * cos (2*π *f*t); where ‘ B’ represents the damping coefficient that accounts for material and user contact absorption, ensuring controlled energy dissipation; and wherein ‘Amax’ is the peak amplitude, f is the frequency of oscillation. In our preferred embodiments, ‘B’ may typically range between 0.1 s-1 and 5 s-1 , with lower values preserving vibration intensity for longer durations and higher values ensuring rapid attenuation to prevent overstimulation. In this equation, ‘B’ is the rate at which the amplitude decays over time. Since, t (time) has units of seconds (s), ‘B’ has inverse time, such that B*t remains dimensionless. The peak amplitude ‘Amax’ for mobile actuators should be within 0.05 mm to 0.8 mm, ensuring gentle yet effective stimulation. Such a model may reflect the natural attenuation of vibration intensity over time, stimulating the desired response from meibomian gland and improving user comfort.

[0174] In another embodiment, the programmatic implementation follows an event-driven model, where vibration motion profiles are queued and executed sequentially based on predefined schedules. For example, the function controlling the actuator may be structured as follows: where each motion profile or composite profile consists of a profile identifier, an intensity value, a duration of execution, and an interprofile delay; wherein, the scheduler cycles through these profiles and updates the actuator position accordingly.

[0175] Certain implementations may use vibration and motion drive controllers or modules which are commonly used to a provide haptic feedback effect and other user interface effects in mobile phones, tablet or other electronic devices. Said controllers and modules are used to deliver motion profiles or composite profiles which may be wholly or partially pre-configured, or wholly or partially customizable in the haptic controller. The delivered motion profiles, components of composite profiles, or composite profiles in these implementations comprise of drive signals resembling those commonly purposed in providing haptic effects and may include clicks, doubleclicks, triple-clicks, ticks, hums, buzzes, bumps, transitions, or alerts.

[0176] While in some cases, the left and right eye vibration may be synchronised and identical, it may be advantageous in terms of patient comfort, efficacy, and / or battery conservation to apply different patterns of eyelid massaging vibration at any particular point in time on the left and right eye. For example, one eyelid may be vibrated for a certain period, while the other experiences heat treatment only, followed by the reverse order; or vibration intensity in one eye may ramp up, while the other ramps down. In certain embodiments, there device may be programmed to deliver a more intense treatment, or otherwise different vibrational motion profile or composite profile in one eye than is delivered to the other eye, because of different comfort sensitivities or differences in the severity of meibomian gland dysfunction or other condition between left and right eyes. Different left and right eye motion profiles, composite profiles, or heat profiles may be applied to optimise therapy, comfort, or power consumption efficiency where there is or is not a difference in left and right eye sensitivity or disease. Figure 24 presents a series of screenshots from the Meiboleyes App, a companion application designed to provide users with a self-tracking interface for managing their usage of the Meiboleyes device. The application enables users to schedule treatments, monitor compliance, track usage statistics, and access relevant device and condition-related information. The app solely functions as a data receiver and does not transmit any commands or modifications to the Meiboleyes device beyond standard Bluetooth communication for retrieving information. The scheduling functionality within the app is entirely user- driven and serves as a reminder system rather than an automated treatment enabler. Figure 24 presents a series of screenshots from the Meiboleyes App, a companion application designed to manage usage of the Meiboleyes device. In one embodiment,the app functions as a self-tracking interface that enables users to schedule treatments, monitor compliance, track usage statistics, and access relevant device and condition-related information via standard Bluetooth communication without transmitting commands or modifications to the device. In alternative embodiments, the app may support two-way communication and be configured to require its use for device operation. Additionally, the app may differentiate between user roles: for example, providing standard patients with self-tracking and reminder functionalities while offering restricted menu items exclusively to eye care practitioners (ECPs) to set treatment parameters or extract specific statistical results in accordance with regulatory requirements.

[0177] Moreover, further embodiments may include the capability to push firmware updates to the device, thereby enhancing its operational flexibility and ensuring that all necessary functions are contemplated. In one embodiment, the disclosed Meiboleyes App serves as an optional companion interface for users using the Meiboleyes device. The app facilitates self-monitoring, compliance tracking, and treatment scheduling, providing users with an intuitive method to oversee their therapy regimen. The app solely functions as a receiver of device status and statistical data, ensuring that it does not interfere with the physical operation of the Meiboleyes device.

[0178] In one embodiment, the Home Page serves as the central dashboard, displaying the current status of the Meiboleyes device alongside an overview of scheduled treatments and historical usage statistics. Users can opt-in for push notifications to receive alerts regarding upcoming treatments. The real-time connection with the device allows for instant updates on device status, including battery level, operational readiness, and last recorded treatment session. In one embodiment, the Statistics Page enables users to track their own adherence to the treatment schedule. The page utilizes data logs retrieved from the Meiboleyes device to determine: The total number of completed sessions; The frequency of missed sessions; The historical compliance rate over a defined period; A graphical representation of adherence trends; By integrating statistical visualization, users can self-evaluate their treatment consistency and make informed decisions regarding their adherence to the prescribed regimen. In one embodiment, the schedule treatments page may allow users to schedule, edit, or delete treatments through a built-incalendar interface. While treatments can be freely scheduled at the user’s discretion, the app does not impose restrictions or enforce treatment execution. Instead, the scheduling system functions as a customizable reminder mechanism, ensuring users receive timely notifications about planned sessions. The user may view a weekly schedule of their planned treatments; add, modify, or remove individual treatment slots; or configure recurring reminders for long-term compliance. In one embodiment, when adding a new treatment session, users can set: the date and time for the session; the number of reminders to be sent before the scheduled session; the notification format (push notification, vibration alert, etc.); this feature enhances user selfregulation and improves treatment adherence through reminder customization based on individual needs.

[0179] The information page may provide users with educational content about Meibomian Gland Dysfunction (MGD) and the importance of consistent treatment. It may also serves as a device guide, offering information on: proper device handling and maintenance; recommended cleaning procedures; and frequently asked questions on treatment best practices. The settings page may further allow users to adjust app-specific preferences, such as: theme customization for user-friendly display options; notification settings to enable / disable alerts; data retention preferences (e.g., defining how long treatment history is stored). The settings adjusted within the app may not allow the user to modify the device’s physical parameters or operation. The app may solely function as a passive tracking and scheduling interface for enhanced user engagement.

[0180] In another embodiment, the integration of the Meiboleyes App into the treatment regimen may enhance the user experience through improved compliance tracking: wherein the users may independently assess their adherence to therapy, enabling better outcomes: The app may serve as a flexible notification system, reducing the likelihood of missed sessions. The data-driven Insights for selfmanagement via statistics and visualization tools may empower users to make informed decisions about their therapy. The app may maintain a non-invasive role, ensuring that the device’s core functionality remains independent while offering convenient tracking tools.

[0181] The present disclosure relates to a medical device for the application of controlled thermal energy to the periocular region, specifically targeting the eyelid and associated structures. The device is configured to deliver a therapeutic level of heat in a manner that is optimized for the treatment of Meibomian Gland Dysfunction (MGD) and related ophthalmic conditions. In an effort to validate the efficacy of the device, a series of experimental studies were conducted utilizing both a laboratory-based model eye system and in vivo human testing protocols.

[0182] Figure 25 represents the thermal response of a custom-built model eye subjected to controlled heating by the prototype device. The model eye was utilized to characterize the time required to reach both the therapeutic threshold and equilibrium temperature. The thermal response curves illustrate the stability and consistency of heat delivery, ensuring device reliability under simulated conditions.

[0183] The data confirms that the device achieves therapeutic heating within 3 minutes and reaches equilibrium temperature around 10 minutes, with a maximum recorded model eye temperature of 48°C. Due to the absence of biological thermal regulation (e.g., blood flow), the observed equilibrium temperature is expected to be lower in human subjects. Figure 26 illustrates the thermal response of the device in both controlled and in vivo environments. Thermal imaging sequences detail the progressive heating effects, highlighting localized temperature increases and heat distribution during application. The sequence of images provides empirical validation of the device’s ability to elevate and maintain surface temperatures within the therapeutic range necessary for the treatment of Meibomian Gland Dysfunction (MGD). The final panel confirms in vivo efficacy, where eyelid surface temperatures reach 42.1 °C, demonstrating the device's suitability for ocular therapy in real-world conditions. Figure 26 illustrates the thermal distribution recorded via infrared imaging during various phases of device operation, demonstrating the temperature modulation over different conditions. The figure consists of four panels, each highlighting distinct thermal conditions associated with the prototype's use.

[0184] Figure 26, panel 2601 represents ambient temperature reading of 25.0°C on the carrier of the device, as indicated by marker 2602. The thermal camera captures the pre-activation state of the device, where the surrounding area remains at baseline temperature. The marked regions (2603) indicate focal heating zonesreaching 49.1 °C, illustrating localized heating. Figure 26, panel 261 1 represents status following activation, the device elevates the temperature within the treatment zone. Marker 2612 highlights an overall temperature of 47.2°C, while marker 2613 demonstrates a localized temperature rise to 49.9°C, indicative of consistent heating across the ocular surface. Figure 26, panel 2621 represents the stage where the device sustains thermal distribution, showing a temperature reading of 45.7°C at 2622, with peripheral areas experiencing heat retention at 49.3°C. This suggests effective heat transfer to the underlying tissue, mimicking conditions observed during treatment. Finally, Panel 2631 represents in vivo ocular surface thermal measurements, wherein 2632 highlights a measured eyelid surface temperature of 42.1 °C, with the surrounding ocular region registering 41 ,9°C. This demonstrates the device’s ability to achieve target therapeutic temperature levels for Meibomian Gland Dysfunction (MGD) treatment.Laboratory testing on a model eye

[0185] A custom-built model eye was utilized to assess the thermal behaviour of the prototype device in a controlled environment. The model eye mimicked the thermal properties of the human eyelid, absent the influence of vascular heat dissipation. The study demonstrated that upon application of the device, the target therapeutic temperature was achieved within approximately three minutes, with equilibrium stabilization occurring at approximately ten minutes. The experimental data indicated that in a static, non-vascularized system, the temperature equilibrium reached approximately 48°C. However, due to thermoregulatory effects in live tissue, the effective equilibrium temperature in a human subject is expected to be lower. Figure 25 illustrates the measured temperature profiles over time, evidencing the device’s capability to rapidly attain and sustain a therapeutic heat range.Initial clinical testing and thermal response on human eyes

[0186] A subsequent phase of testing was conducted in vivo, wherein the prototype device was applied directly to the eyelids of human subjects. The thermal response was recorded using infrared thermal imaging techniques, demonstrating that the device was capable of achieving an internal temperature of 49°C.

[0187] The external eyelid surface was measured to stabilize at approximately 42°C, aligning with the established therapeutic range necessary for effective heatbased management of MGD. Figure 26 presents the thermal camera images capturing the progressive heating effect, with temperature distributions measured at multiple time points. This data substantiates the device’s ability to deliver controlled and sustained heat within clinically relevant parameters.Pilot testing (10-min) short-term thermal exposure

[0188] To further assess the efficacy of the device under practical application conditions, a pilot study was conducted wherein the device was applied to the eyelids of five human subjects for a duration of ten minutes. Baseline and postmanagement session temperature measurements were obtained, confirming a consistent increase in eyelid temperature to an average of 41.1 ± 0.5°C. The following table summarizes the pre- and post-session temperature data for individual subjects:

[0189] These results in the above table confirm that the device effectively raises and maintains eyelid temperature within the desired therapeutic range. A subsequent evaluation was conducted on a cohort of eleven subjects, wherein the device was applied for an extended duration of fifteen minutes.

[0190] Post-session measurements were recorded for both the right and left eyelids, capturing peak thermal response before the natural cooling process commenced upon device removal. The maximum recorded temperatures are presented in the following dataset:

[0191] This data in the above table validates the device’s ability to maintain effective thermal therapy parameters across a range of individual anatomical variations. A comprehensive clinical pilot study was conducted to assess the long-term impact of twice-daily use of the device over a six-week period. Ten participants were enrolled in the study, with primary outcome measures including the Ocular Surface Disease Index (OSDI), Meibomian Gland Score (MGS), and Tear Breakup Time (TBUT). Following the completion of the trial, statistically significant improvements were observed in multiple key clinical parameters, as outlined in the table below:

[0192] The observed reductions in OSDI scores demonstrate a clinically meaningful improvement in ocular surface discomfort and dry eye symptoms. Additionally, increases in MGS and TBUT indicate enhanced Meibomian gland function and tear film stability. The statistical significance of these findings supports the therapeutic efficacy of the device in real-world applications.

[0193] The experimental and clinical data presented herein substantiate the effectiveness of the disclosed device in delivering controlled therapeutic heat to the periocular region. The results demonstrate the ability of the device to achieve and maintain target temperatures within established therapeutic thresholds, thereby facilitating the effective management of Meibomian Gland Dysfunction and associated ocular surface disorders. These findings provide a robust basis for the device’s clinical application and regulatory positioning, supporting its integration as a novel therapeutic intervention in ophthalmic care.

[0194] The collective experimental data — including bench-top model eye testing (Figure 25), in vivo thermal imaging (Figure 26), in-house pilot tests with varied exposure durations, and a pilot clinical trial involving human subjects — demonstrate the robust performance, safety, and clinical utility of the device. The embodiments described herein are intended to cover all modifications and equivalents within the scope of the appended claims, thereby ensuring broad protection of the inventive concept.

[0195] In certain embodiments, the device can maintain a preferred range of temperature on the upper or lower eyelids. This feature, enabled by an integrated temperature sensor, facilitates the improvement of meibomian secretion flow, further enhancing the device's effectiveness in treating meibomian gland dysfunction. In certain embodiments, the pair of eyecups of the wearable device may be configured to treat a surface area encompassing at least 100 mm2, 150 mm2, 200 mm2, 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2or 700 mm2surface area of the eyelids. In other embodiments, the device is designed to manage a specific surface area of the eyelids. The number, size, and arrangement of the device's components allow for the management of this surface area, ensuring that the device can effectively deliver the management regardless of individual variations in eye morphology.

[0196] In some versions, one or two pneumatic or electromagnetic actuators are designed to generate a vibration in the axial or tangential direction of the wearer's eyelids. The vibrations produced by at least one electromagnetic actuator create a pressure wave from the start to the outlet of the meibomian glands. The vibration's amplitude and frequency can be independently regulated in the electromagnetic actuators, allowing for treatment or management with any combination of pressure and frequency between 0.005 to 0.5 N / mm2and 0.5 to 300 Hz, respectively. To enhance the effectiveness of meibum expression, the skin-touching surface of the eye cup element can be modified with ridges and grooves. These ridges and grooves, which can be perpendicular or diagonal to the vibration direction, can range from 0.5 mm to 2 mm in thickness and height. The device, as described in the above embodiments, also integrates wireless functionalities, such as Bluetooth or Wi-Fi, that enable the transmission of data or information to a smart device, phone, or tablet. This information can pertain to various settings and operational statuses of the wearable device, enhancing user convenience and control over the treatment or management process. While the embodiments and figures provide a detailed overview of the device, its design, and functionalities, it is pertinent to note that the invention may incorporate modifications and variations. The information presented herein should be seen as a teaching aid for those skilled in the art to employ the invention and variations of the embodiments disclosed herein. The construction of the invention is not restricted to the embodiments described and illustrated here. It is open to modifications that fall within the scope of the appended claims.

[0197] Departures from the specific designs and methods described herein may be apparent to those skilled in the art and may be used without departing from the spirit and scope of the invention. While the invention is described with reference to one or more embodiments, which are illustrated by accompanying figures, these embodiments or figures are provided by way of explanation and are not to be construed as limiting to the scope of the disclosure.

[0198] The described embodiments, along with the various permutations and combinations of the features disclosed, form the basis of the invention. These features are not limited to the specific combinations described and can be combined in any way that falls within the scope of the invention.

[0199] Each feature disclosed in this specification may be replaced by alternative features serving the same, equivalent, or similar purpose unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features. The invention is not to be restricted in form nor limited in scope except by the claims appended hereto. The described embodiments, therefore, are to be considered in all respects as illustrative and not restrictive.

[0200] The information with respect to functional and structural aspects of the disclosure should be construed merely as a representative basis for teaching a person skilled in the art to employ the invention and variations of those embodiments. This disclosure is not restricted to any construction described and illustrated here but should be constructed to cohere with all modifications that may fall within the scope of the appended claims. Although shown and described are what are believed to be practical and preferred embodiments, it is apparent that departures from specific designs and / or methods described will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the invention. The disclosure is described with reference to one or more embodiments, some of which are illustrated by accompanying figures. The embodiments or figures are provided by way of explanation and are not to be construed as limiting to the scope of the disclosure.

[0201] CLAIM EXAMPLES

[0202] A smart wearable device for treating Meibomian Gland Dysfunction (MGD), at least comprising: a thermal energy source for providing heat treatment or management to the eyelids; a mechanical vibrator for providing vibrational treatment or management to the eyelids; a pressure sensor for monitoring and / or controlling the pressure applied to the eye; self-adjusting pair of eyecups, for adapting to different eye shapes; interchangeable face cushion covers for improving user comfort; a user interface for customising or programming personalised treatment or management settings; and a power management system for energy-efficient operation, wherein the device is configured for home use without professional assistance.

[0203] The smart wearable device of one or more claims of claim examples, wherein the thermal energy source is adjustable to provide a range of heat treatment or management, therapies or management, wherein the range of heat treatment, therapy or management includes at least three different temperature settings, wherein the range of heat treatment, therapy or management include at least two different treatment, therapy or management durations; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper and / or lower eyelids at least 39°C,40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper or lower eyelids between 39°C to 41 °C, 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 42°C, 40°C to 43°C, or 40°C to 46°C; wherein the eyecups are configured to treat a surface area encompassing at least 100 mm2, 150 mm2, or 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2, or 700 mm2, of the eyelids; wherein the mechanical vibrator is adjustable to provide a range of vibrational treatment, therapy or management; wherein the range of vibrational treatment, therapy or management includes at least three different frequency settings; wherein the pressure sensor is adjustable to provide a range of pressure settings; wherein the range of pressure settings includes at least three different pressure levels; wherein the self-adjusting eye cups are made of a flexible material; wherein the flexible material is biocompatible silicone; wherein the interchangeable face cushion covers are available in a variety of sizes; wherein the variety of sizes at least includes small, medium, and large sizes; wherein the userinterface includes a digital display; wherein the digital display is a touchscreen; wherein the power management system includes a rechargeable battery; wherein the rechargeable battery is a lithium-ion battery; wherein the device further comprises a carrying case for storing and transporting the device; wherein the carrying case includes a charging port for charging the device; wherein the device further comprises a user manual for instructing a user on how to use the device; wherein the user manual is provided in both print and digital formats; wherein the device is configured to automatically shut off after a predetermined period of use; wherein the device is designed to manage a specific surface area of the eyelids, and the number, size, and arrangement of the device’s components allow for effective treatment delivery regardless of individual variations in eye morphology.

[0204] A smart wearable device for treating Meibomian Gland Dysfunction (MGD), at least comprising: a thermal energy source adjustable to provide a range of heat treatments, therapies or management; a mechanical vibrator adjustable to provide a range of vibrational treatments, therapies or management; a pressure sensor adjustable to provide a range of pressure settings; self-adjusting eyecups made of a flexible material for adapting to different eye shapes; interchangeable face cushion covers available in a variety of sizes for user comfort; a user interface including a digital display for programming personalised treatment settings; a power management system including a rechargeable lithium-ion battery for energy-efficient operation; and a carrying case with a charging port for storing, transporting, and charging the device, wherein the device is configured for home use without professional assistance and is configured to automatically shut off after a predetermined period of use.

[0205] The smart wearable device of one or more claims of claim examples, wherein the range of heat treatments, therapies or management includes at least three different temperature settings; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper and / or lower eyelids at least 39°C,40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper or lower eyelids between 39°C to 41 °C, 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 42°C, 40°C to 43°C, or40°C to 46°C; wherein the eyecups are configured to treat a surface area encompassing at least 100 mm2, 150 mm2, or 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2, or 700 mm2, of the eyelids; wherein the range of vibrational treatments, therapies or management includes at least three different frequency settings; wherein the range of pressure settings includes at least three different pressure levels; wherein the digital display is a touchscreen; wherein the flexible material of the self-adjusting eye cups is silicone; wherein the variety of sizes of the interchangeable face cushion covers includes small, medium, and large; wherein the device further comprising a user manual for instructing a user on how to use the device; wherein the user manual is provided in both print and digital formats; wherein the predetermined period of use after which the device automatically shuts off is programmable by the user; wherein the device is configured to provide a visual and / or auditory alert when the predetermined period of use has elapsed; wherein the device is configured to provide a visual and / or auditory alert when the battery level is low; wherein the device is configured to provide a visual and / or auditory alert when the pressure applied to the eye exceeds a predetermined threshold; wherein the device is configured to provide a visual and / or auditory alert when the temperature of the thermal energy source exceeds a predetermined threshold; wherein the device is configured to provide a visual and / or auditory alert when the frequency of the mechanical vibrator exceeds a predetermined threshold; wherein the device is configured to provide feedback to the user regarding the effectiveness of the treatment; wherein the feedback includes information about the duration of the treatment, the temperature of the thermal energy source, the frequency of the mechanical vibrator, and / or the pressure applied to the eye; wherein the device is configured to store data about the treatment sessions, including the duration of each session, the temperature of the thermal energy source during each session, the frequency of the mechanical vibrator during each session, and / or the pressure applied to the eye during each session; wherein the stored data can be accessed by the user and / or a healthcare provider; wherein the device is configured to wirelessly communicate with a smartphone, tablet, computer, and / or other device to allow the user and / or a healthcare provider to monitor the treatment sessions, adjust the settings of the device, and / or access the stored data; wherein the device is designed to manage a specific surface area of the eyelids, and the number, size, and arrangement of the device’s components allow for effective treatment delivery regardless of individual variations in eye morphology.

[0206] A smart wearable device for treating Meibomian Gland Dysfunction (MGD), comprising at least, self-adjusting eye cups, interchangeable face cushion covers, pressure sensing mechanisms, thermal energy delivery system, mechanical vibration module, and control unit for adjusting treatment parameters, designed for home use, non-invasive alternative to traditional MGD management.

[0207] The smart wearable device of one or more claims of claim examples; wherein the self-adjusting eye cups adapt to the user’s eye shape; wherein the device further comprises a user interface for customising treatments, therapies or management settings; wherein the interchangeable face cushion covers are available in different materials for user comfort; wherein the pressure sensing mechanisms ensure optimal pressure during treatment; wherein the thermal energy delivery system utilise temporal temperature gradients; wherein the thermal energy delivery system utilise spatial temperature gradients; wherein the thermal energy delivery system utilise spatio-temporal temperature gradients; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper and / or lower eyelids at least 39°C,40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper or lower eyelids between 39°C to 41 °C, 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 42°C, 40°C to 43°C, or 40°C to 46°C; wherein the eyecups are configured to treat a surface area encompassing at least 100 mm2, 150 mm2, or 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2, or 700 mm2, of the eyelids; wherein the mechanical vibration module offers a range of vibration frequencies; wherein the control unit allows users to adjust treatment parameters; wherein the device provides real-time feedback on treatment progress; wherein the non-invasive alternative reduces reliance on medical professionals; wherein the smart wearable device of enhances user compliance with consistent home use; wherein the device is suitable for both acute and chronic MGD cases; wherein the thermal energy delivery system promotes meibum secretion; wherein the mechanical vibration module improves meibum flow; wherein the device minimises discomfort during treatment; wherein the pressure sensing mechanisms prevent excessive pressure on the eye; wherein the smart wearable device facilitates self-management of MGD symptoms; wherein the device is adaptable for various eye shapes and sizes; wherein the user interface includes a digital display; wherein thedigital display is a touchscreen; wherein the user interface displays treatments, therapies or management duration and intensity; wherein the interchangeable face cushion covers allow customisation based on user preferences; wherein the device is designed to manage a specific surface area of the eyelids, and the number, size, and arrangement of the device’s components allow for effective treatment, therapy or management delivery regardless of individual variations in eye morphology.

[0208] The smart wearable device of one or more claims of claim examples, wherein the housing accommodates vibration components essential for providing vibrational treatments, therapies or management, said housing comprising: an adjustable ball joint interface allowing customization to fit various pupillary distances and head curvatures, thereby enhancing user comfort and device efficacy; an eye cup positioned to make direct contact with the user’s eyelids, ensuring the device remains securely in place during operation and effectively channels vibrations to the eyelids; and a solenoid electromagnetic actuator calibrated to generate tangential vibrations, providing precise and targeted vibrational stimulus to the user’s eyelids for consistent and effective treatment.

[0209] The smart wearable device of one or more claims of claim examples, wherein the heating element is assembled within the eyecup to facilitate efficient heat transfer, said heating element comprising: a conductive coil made of copper, specially designed to work in tandem with the eyecup, ensuring an even and desirable temperature distribution across the surface of the eyecup; a sensor placed in the central area of the design, allowing accurate monitoring and control of the heating element; In other embodiments, different coil designs with varying lengths, widths, spirality, or resistance may be contemplated to provide consistent heating, ensuring the device’s effectiveness and reliability. The coil can also be constructed using alternative materials such as aluminium, silver, gold, or nickel, each chosen for their respective conductivity properties. Beyond metallic conductors, the coil could be formed using carbon ink, graphene, or other composite materials, offering flexibility in design and potential performance improvements.

[0210] The smart wearable device of one or more claims of claim examples, wherein a method and apparatus to ensure adequate pressure on the eyelid involves that is attached to a plate with a ball joint directly under the geometric centre of theheating patch behind the eye cup; wherein the thin pin slides freely through a central hole in a base plate as the cup contacts the eyelid and a spring compress; wherein the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin; and wherein the apparatus is configured such that when the ring touches the first set of contacts, the spring compresses sufficiently to ensure good contact between the cup and the eyelid, and signals minimum force contacts; and when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; and wherein the flexible ball joint allows for the tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force-sensing feature; and wherein the method and apparatus provides a compressible component with multiple degrees of freedom, enabling self-alignment of the device and delivering a comfortable and effective treatment experience for the user.[0021 1 ] The smart wearable device of one or more claims of claim examples, wherein the housing incorporates a magnetic cushion designed for seamless attachment and alignment with magnets on the main housing. The magnetic cushion features: alignment grooves corresponding to the magnets in the main housing, ensuring a smooth and secure attachment process; a tongue that slots into a groove, facilitating precise alignment; magnetic slots that hold individual magnets, allowing magnetic attachment to the cover; wherein an identical set of magnets glued on the other side of the cover, ensuring a secure fit.

[0212] The smart wearable device of one or more claims of claim, wherein the housing incorporates a comprehensive arrangement of components, including a protective housing shell serving as the outer covering; a user input button for controlling device functions; a snap-fit cover allowing easy access to internal components; eyecup foam providing counter pressure on the eyelids; a heater working in tandem with the eyecup to provide heat; an eyecup ensuring direct contact with the user’s eyelids; a magnetic base plate offering a secure and stable base to house the magnets for the cushion; a magnetically attachable cushion wrapped in materials like fabric or silicon for user comfort and functionality.

[0213] The smart wearable device of one or more claims of claim examples, wherein a method and apparatus to ensure adequate pressure on the eyelid involves that is attached to a plate with a ball joint directly under the geometric centre of the heating patch behind the eye cup; wherein the pin slides freely through a central hole in the base plate as the cup contacts the eyelid, and the foam compresses; wherein one section of the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin such that when the ring touches the first set of contacts, then the foam is compressed sufficiently to ensure good contact between the cup and the eyelid, and signals minimum force contacts; and when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; wherein the apparatus further comprises a flexible ball joint allowing for tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force sensing feature.

[0214] The smart wearable device of one or more claims of claim examples, wherein a method and apparatus involves a closed feedback loop offering individual user adjustments to enhance user experience, wherein a capacitive apparatus utilising two opposing metal plates is configured in the device to obtain an eye pressure-related signal considered within the eyecups conjoined with the foam that holds the eye cups and the heater; wherein two metal-coated plates configured at the anterior and posterior sides of the foam are connected to a high-frequency voltage source; wherein the impedance of this capacitive circuit is expected to change with the separation of the two plates; wherein together with the spring rate of the foam, the compression force can be determined; wherein appropriate electrical shielding is added to ensure user safety and compliance with electromagnetic interference requirements; wherein the method and apparatus allows for real-time monitoring and adjustment of the pressure exerted on the eye, thereby ensuring optimal user comfort and treatment effectiveness.

[0215] The smart wearable device of one or more claims of claim examples, wherein the housing incorporates electronic components essential for providing efficient treatment, said housing comprising: an integral Real Time Clock (RTC, 1801 ) accurately recording treatment session date and time; a MicroSD card holder (1802)storing treatment session information and sensor data; a Lithium Polymer (LiPo) battery (1803) ensuring uninterrupted device operation; various connectors (1804) designated for interfacing with heaters, pressure sensors, and vibration actuators; an integrated switch (1805) allowing toggling of device operation and user treatment settings; a microcontroller and electronic circuits (1806) controlling functionalities including buzzer and light-emitting-diodes (LED) indicators, heaters, pressure sensors, and vibration actuators.

[0216] The smart wearable device of one or more claims of claim examples, wherein an apparatus to ensure adequate pressure on the eyelid involves an induction-based sensor system implemented between the anterior and posterior plates on either side of the foam bearing the eyecup is configured with a heating element; wherein the apparatus incorporates a spiral-shaped coil on one of the plates is connected to a high-frequency voltage source to generate an electromagnetic field and a metal plate at the opposing side of the foam is configured to interact with the field; wherein changes in the impedance of the excitation circuit based on the separation of the two plates provides the measurement of the change in impedance facilitating quantitative feedback on the force with which the foam is compressed, ensuring optimal pressure on the eyelid; wherein appropriate electrical shielding is added to ensure user safety and compliance with electromagnetic interference requirements; wherein the pressure sensing induction-based sensor system enhances the safety and efficacy of the device by functioning within the optimal pressure range.

[0217] The smart wearable device of one or more claims of claim examples, wherein an apparatus to ensure adequate pressure on the eyelid at least involves electrically conductive foam below the eyecup configured with a heating element; wherein the apparatus incorporates two metal-coated plates positioned on either side of the electrically conductive foam and configured such that when the electrically conductive foam is compressed, its conductivity increases, providing a measurable parameter indicative of the applied compression force on the eyelid; wherein the electrically conductive foam contains carbon particles or silver fibers; wherein the resistance of the electrically conductive foam remains relatively unaffected by temperature and humidity; and wherein the resistance-force relationship can bepredetermined for individual eye cup assembly using a dedicated test rig and programmed into the device to enhance accuracy.

[0218] The smart wearable device of one or more claims of claim examples, wherein the arrangement for generating vibration utilises an eccentrically spinning pin driven by a motor and disc to create a circular vibration pattern; wherein the design elements include foam or spring, eye cup, heating patch, a ball joint, a pin capable of free vertical movement, an eccentrically spinning disc connected to the motor shaft, and the motor itself.

[0219] The smart wearable device of one or more claims of claim examples, wherein one or two pneumatic or electromagnetic actuators generate vibrations in the axial or tangential direction of the wearer’s eyelids; wherein the vibrations produced by at least one electromagnetic actuator create a pressure wave from the start to the outlet of the meibomian glands; wherein the electromagnetic actuators facilitate independent regulation of vibration amplitude and frequency; wherein the device enables treatment with any combination of pressure and frequency between 0.005 N / mm2to 0.5 N / mm2and 0.5 Hz to 300 Hz, respectively; wherein the skin-touching surface of the eye cup element is modified with ridges and grooves to enhance the effectiveness of meibum expression; wherein the ridges and grooves can be configured perpendicular or diagonal to the vibration direction and range from 0.5 mm to 2 mm in thickness and height.

[0220] A smart wearable device for treating Meibomian Gland Dysfunction (MGD), comprising: a thermal energy source for providing heat treatment to the eyelids; a mechanical vibrator for providing vibrational treatment to the eyelids; a pressure sensor for monitoring and / or controlling the pressure applied to the eye; self- adjusting eyecups for adapting to different eye shapes; interchangeable face cushion covers for improving user comfort; a user interface for programming personalised treatment settings; and a power management system for energy-efficient operation, wherein the device is configured for home use without professional assistance.

[0221] The smart wearable device of one or more claims of claim examples, wherein the thermal energy source is adjustable to provide a range of heat treatments; wherein the range of heat treatment includes at least three different temperaturesettings; wherein the range of heat treatment includes at least two different treatment durations; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper and / or lower eyelids at least 39°C,40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C; wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper or lower eyelids between 39°C to 41 °C, 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 42°C, 40°C to 43°C, or 40°C to 46°C; wherein the eyecups are configured to treat a surface area encompassing at least 100 mm2, 150 mm2, or 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2, or 700 mm2, of the eyelids; wherein the mechanical vibrator is adjustable to provide a range of vibrational treatment; wherein the range of vibrational treatment includes at least three different frequency settings; wherein the pressure sensor is adjustable to provide a range of pressure settings; wherein the range of pressure settings includes at least three different pressure levels; wherein the self-adjusting eye cups are made of a flexible material; wherein the flexible material is biocompatible silicone; wherein the interchangeable face cushion covers are available in a variety of sizes; wherein the variety of sizes at least includes small, medium, and large sizes; wherein the user interface includes a digital display; wherein the digital display is a touchscreen; wherein the power management system includes a rechargeable battery; wherein the rechargeable battery is a lithium-ion battery; wherein the device further comprises a carrying case for storing and transporting the device; wherein the arrangement for generating vibration utilises an eccentrically spinning pin driven by a motor and disc to create a circular vibration pattern; wherein the design elements include foam or spring, eye cup, heating patch, a ball joint, a pin capable of free vertical movement, an eccentrically spinning disc connected to the motor shaft, and the motor itself; wherein one or two pneumatic or electromagnetic actuators generate vibrations in the axial or tangential direction of the wearer’s eyelids; wherein the vibrations produced by at least one electromagnetic actuator create a pressure wave from the start to the outlet of the meibomian glands; wherein the electromagnetic actuators facilitate independent regulation of vibration amplitude and frequency; wherein the device enables treatment with any combination of pressure and frequency between 0.005 N / mm2to 0.5 N / mm2and 0.5 Hz to 300 Hz, respectively; wherein the skin-touching surface of the eye cup element is modified with ridges and grooves to enhance the effectiveness of meibum expression; wherein the ridges and grooves can be configured perpendicular to thevibration direction; wherein the ridges and grooves can be configured diagonal to the vibration direction; wherein the ridges and grooves range from 0.5 mm to 2 mm in thickness and height; wherein the housing incorporates electronic components essential for providing efficient treatment; wherein the housing comprises an integral Real Time Clock (RTC) accurately recording treatment session date and time; wherein the housing comprises a MicroSD card holder storing treatment session information and sensor data; wherein the housing comprises a Lithium Polymer (LiPo) battery ensuring uninterrupted device operation; wherein the housing comprises various connectors designated for interfacing with heaters, pressure sensors, and vibration actuators; wherein the housing comprises an integrated switch allowing toggling of device operation and user treatment settings; wherein the housing comprises a microcontroller and electronic circuits controlling functionalities including buzzer and light-emitting-diodes (LED) indicators, heaters, pressure sensors, and vibration actuators; wherein an apparatus to ensure adequate pressure on the eyelid involves an induction-based sensor system implemented between the anterior and posterior plates on either side of the foam bearing the eyecup is configured with a heating element; wherein the apparatus incorporates a spiral-shaped coil on one of the plates is connected to a high-frequency voltage source to generate an electromagnetic field and a metal plate at the opposing side of the foam is configured to interact with the field; wherein changes the impedance of the excitation circuit based on the separation of the two plates provides the measurement of the change in impedance facilitating quantitative feedback on the force with which the foam is compressed, ensuring optimal pressure on the eyelid; wherein the housing incorporates a comprehensive arrangement of components; wherein the components include a protective housing shell serving as the outer covering; wherein the components include a user input button for controlling device functions; wherein the components include a snap-fit cover allowing easy access to internal components; wherein the components include eyecup foam providing counter pressure on the eyelids; wherein the components include a heater working in tandem with the eyecup to provide heat; wherein the components include an eyecup ensuring direct contact with the user’s eyelids; wherein the components include a magnetic base plate offering a secure and stable base to house magnets for the cushion covers; wherein the components include a magnetically attachable cushion wrapped in materials like fabric or silicon for user comfort and functionality; wherein a method and apparatus to ensure adequatepressure on the eyelid involves a thin pin flexibly attached at the center of the heating patch behind the eye cup; wherein the pin slides freely through a central hole in the base plate as the cup contacts the eyelid, and the foam compresses; wherein one section of the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin; wherein when the ring touches the first set of contacts, then the foam is compressed sufficiently to ensure good contact between the cup and the eyelid, and signals minimum force contacts; wherein when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; wherein the apparatus further comprises a flexible ball joint allowing for tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force sensing feature; wherein a method and apparatus to ensure adequate pressure on the eyelid involves a thin pin flexibly attached at the centre of the heating patch behind the eye cup; wherein the thin pin slides freely through a central hole in a base plate as the cup contacts the eyelid and a spring compresses; wherein the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin; wherein the apparatus is configured such that when the ring touches the first set of contacts, the spring compresses sufficiently to ensure good contact between the cup and the eyelid, and signals minimum force contacts; wherein when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; wherein the flexible ball joint allows for the tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force-sensing feature; wherein the method and apparatus provides a compressible component with multiple degrees of freedom, enabling self-alignment of the device and delivering a comfortable and effective treatment experience for the user; wherein the housing incorporates a magnetic cushion designed for seamless attachment and alignment with magnets on the main housing; wherein the magnetic cushion features alignment grooves corresponding to the magnets in the main housing, ensuring a smooth and secure attachment process; wherein the magnetic cushion features a tongue that slots into a groove, facilitating precise alignment; wherein the magnetic cushion features magnetic slots that hold individual magnets, allowing magnetic attachment to the cover; wherein an identical set of magnets is glued on the other side of the cover, ensuring a secure fit; The smart wearable device of claim 1 , wherein the housing accommodatesvibration components essential for providing vibrational treatments, therapies or management; wherein the housing comprises an adjustable ball joint interface allowing customization to fit various pupillary distances and head curvatures, thereby enhancing user comfort and device efficacy; wherein the housing comprises an eye cup positioned to make direct contact with the user’s eyelids, ensuring the device remains securely in place during operation and effectively channels vibrations to the eyelids; wherein the housing comprises a solenoid electromagnetic actuator calibrated to generate tangential vibrations; wherein the solenoid electromagnetic actuator provides precise and targeted vibrational stimulus to the user’s eyelids for consistent and effective treatment.

[0222] An eyecup mounting system comprising: an eyecup configured to contact an eyelid; a spiral compression spring coupled to the eyecup, allowing lateral and angular movement; and an optical distance sensor configured to measure compression displacement of the eyecup relative to a reference position; wherein the optical distance sensor measures displacement and converts said measurement into force data using a known spring rate; wherein the spring rate is within the range of 0.09 N / mm to 0.12 N / mm; wherein the system further comprising a CPU configured to process the optical sensor data, determine real-time force values, and provide feedback to the user based on predefined force thresholds; wherein the spring is wound in a circular or oval shape to accommodate different mounting configurations.

[0223] A force measurement system for an eyecup, comprising: an optical distance sensor configured to measure displacement of the eyecup relative to a reference position; a calibration module storing a force-displacement correlation dataset derived from controlled calibration measurements; and a CPU processing unit configured to convert measured displacement data into real-time force values based on the calibration dataset; wherein the force-displacement calibration curve is generated by applying a known force to the eyecup and recording corresponding optical displacement values; wherein the optical distance sensor is configured to provide continuous, real-time force measurement with high resolution and minimal sensitivity to lateral or angular movement of the eyecup; wherein the CPU processing unit dynamically adjusts force conversion parameters based on environmental conditions, sensor drift, or recalibration cycles; wherein the system further comprisinga threshold detection system configured to alert the user if applied force exceeds a predefined maximum or falls below a predefined minimum.

[0224] A vibration-enabled eyecup system, comprising: an eyecup configured to contact an eyelid; a vibration actuator (2304) attached to the back of the eyecup, configured to generate circular or linear vibration; and a control circuit (2305) configured to modulate the frequency and amplitude of the vibration actuator based on user preferences or predefined therapy protocols; wherein the vibration actuator is selected from a rotating disc motor, an eccentric shaft motor, or a linear actuator; wherein the operational frequency of the vibration is below 50 Hz, and the peak-to- peak amplitude is less than 1 mm; wherein the vibration mode can be continuous or intermittent, with the latter enabling battery conservation and enhanced user comfort; wherein the control circuit is configured to gradually ramp up and down the amplitude and frequency of vibration to improve user comfort during activation and deactivation.

[0225] A mobile application for tracking usage of an ophthalmic treatment device, comprising: a device status module configured to display the current operational state of the treatment device; a treatment scheduling module allowing the user to create, modify, and delete treatment reminders based on a built-in calendar interface; a statistics module configured to retrieve historical treatment data from the device and provide visual analytics on user compliance; an educational module providing treatment guidance, device maintenance instructions, and condition-related information; wherein the treatment scheduling module provides user-configurable reminders without modifying the operational parameters of the device; wherein the statistics module retrieves device-generated session completion data and identifies missed or incomplete sessions; wherein the device status module displays battery level, last recorded session, and operational readiness of the management device; wherein the educational module includes instructions for device care, common troubleshooting steps, and recommendations for optimized usage.CLAIM SET A

[0226] A smart wearable device comprising: a thermal energy source adjustable to provide a range of heat treatments; a mechanical vibrator adjustable to provide a range of vibrational treatments; a pressure sensor adjustable to provide a range of pressure settings; self-adjusting eyecups made of a flexible material;interchangeable face covers available in a variety of sizes; a user interface including a digital display; a power management system including a rechargeable battery; a carrying case for storing and transporting the device.

[0227] The smart wearable device of one or more above claims, wherein the range of heat treatment includes at least three different temperature settings.

[0228] The smart wearable device of one or more above claims, wherein the range of heat treatment includes at least two different treatment durations.

[0229] The smart wearable device of any preceding claim, wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper and / or lower eyelids at least 39°C, 40°C, 41 °C, 42°C, 43°C, 44°C, 45°C, or 46°C. The smart wearable device of any preceding claim, wherein the heating elements within the eyecups are configured to provide a surface temperature of the upper or lower eyelids between 40°C to 41 °C, 41 °C to 42°C, 42°C to 43°C, 43°C to 44°C, 44°C to 45°C, 41 °C to 45°C, 43°C to 46°C, 39°C to 42°C, 40°C to 43°C, or 40°C to 46°C.

[0230] The smart wearable device of any preceding claim, wherein the eyecups are configured to treat a surface area encompassing at least 100 mm2, 150 mm2, or 200 mm2of the eyelids.

[0231] The smart wearable device of any preceding claim, wherein the arrangement for generating vibration utilises an eccentrically spinning pin driven by a motor and disc to create a circular oscillatory pattern; wherein one or two pneumatic or electromagnetic actuators generate vibrations in the axial or tangential direction of the wearer’s eyelids; wherein the vibrations produced by at least one electromagnetic actuator create a pressure wave from the start to the outlet of the meibomian glands; wherein the electromagnetic actuators facilitate independent regulation of vibration amplitude and frequency; wherein the device enables treatment with any combination of pressure and frequency between 0.005 N / mm2to 0.5 N / mm2and 0.5 Hz to 300 Hz, respectively.

[0232] The smart wearable device of any preceding claim, wherein the skintouching surface of the eye cup element is modified with ridges and grooves to enhance the effectiveness of meibum expression; wherein the ridges and grooves can be configured perpendicular to the vibration direction; wherein the ridges and grooves can be configured diagonally to the vibration direction; wherein the ridges and grooves range from 0.5 mm to 2 mm in thickness and height.

[0233] The smart wearable device of any preceding claim, wherein the housing incorporates electronic components essential for providing efficient treatment; wherein the housing comprises an integral Real Time Clock (RTC) accurately recording treatment session date and time; wherein the housing comprises a local memory storage option for storing treatment session information and sensor data; wherein the housing comprises a Lithium Polymer (LiPo) battery ensuring uninterrupted device operation; wherein the housing comprises various connectors designated for interfacing with heaters, temperature sensors, pressure sensors, and vibration actuators; wherein the housing comprises one or more integrated switches allowing toggling of device operation and user treatment settings; wherein the housing comprises a microcontroller and electronic circuits controlling functionalities including buzzer and light-emitting-diodes (LED) indicators, heaters, temperature sensors, pressure sensors, and vibration actuators.

[0234] The smart wearable device of any preceding claim, wherein an apparatus to ensure adequate pressure on the eyelid involves an induction-based sensor system implemented between the anterior and posterior plates on either side of the foam bearing the eyecup is configured with a heating element; wherein the apparatus incorporates a spiral-shaped coil on one of the plates is connected to a high-frequency voltage source to generate an electromagnetic field and a metal plate at the opposing side of the foam is configured to interact with the field; wherein changes in the impedance of the excitation circuit based on the separation of the two plates provides the measurement of the change in impedance facilitating quantitative feedback on the force with which the foam is compressed, ensuring optimal pressure on the eyelid.

[0235] The smart wearable device of any preceding claim, wherein the housing incorporates a comprehensive arrangement of components; wherein the components include a protective housing shell serving as the outer covering; wherein the components include one or more user input buttons for controlling device functions; wherein the components include a snap-fit cover allowing easy access to internal components; wherein the components include eyecup foam providing counter pressure on the eyelids; wherein the components include a heater working in tandem with the eyecup to provide heat; wherein the components include an eyecup ensuring direct contact with the user’s eyelids; wherein the components include a magnetic base plate offering a secure and stable base for the device; wherein the componentsinclude a magnetically attachable cushion wrapped in materials like fabric or silicon for user comfort and functionality.

[0236] The smart wearable device of any preceding claim, wherein a method and apparatus to ensure adequate pressure on the eyelid involves a thin pin flexibly attached at the centre of the heating patch behind the eye cup; wherein the pin slides freely through a central hole in the base plate as the cup contacts the eyelid, and the foam compresses; wherein one section of the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin; wherein when the ring touches the first set of contacts, then the foam is compressed sufficiently to ensure good contact between the cup and the eyelid and signals minimum force contacts; wherein when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; wherein the apparatus further comprises a flexible ball joint allowing for tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force sensing feature.

[0237] The smart wearable device of any preceding claim, wherein a method and apparatus to ensure adequate pressure on the eyelid involves a thin pin flexibly attached at the centre of the heating patch behind the eye cup; wherein the thin pin slides freely through a central hole in a base plate as the cup contacts the eyelid and a spring compresses wherein the pin is coated with an electrically conductive material, and two sets of electrical contacts are configured to detect the position of the pin; wherein the apparatus is configured such that when the ring touches the first set of contacts, the spring compresses sufficiently to ensure good contact between the cup and the eyelid, and signals minimum force contacts; wherein when additional pressure is applied, the pin is pushed further inwards until the conductive ring closes the circuit of maximum force contacts, triggering a warning signal; wherein the flexible ball joint allows for the tip, tilt, and lateral movement of the eye cup without affecting the functionality of the force-sensing feature; wherein the method and apparatus provides a compressible component with multiple degrees of freedom, enabling self-alignment of the device and delivering a comfortable and effective treatment experience for the user.

[0238] The smart wearable device of any preceding claim, wherein the housing incorporates a magnetic cushion designed for seamless attachment and alignment with magnets on the main housing; wherein the magnetic cushion features alignmentgrooves corresponding to the magnets in the main housing, ensuring a smooth and secure attachment process; wherein the magnetic cushion features a tongue that slots into a groove, facilitating precise alignment; wherein the magnetic cushion features magnetic slots that hold individual magnets, allowing magnetic attachment to the cover; wherein an identical set of magnets is glued on the other side of the cover, ensuring a secure fit.

[0239] The smart wearable device of any preceding claim, wherein the housing accommodates vibration components essential for providing vibrational treatments, therapies, or management; wherein the housing comprises an electromagnetic actuator calibrated to generate tangential vibrations; wherein the electromagnetic actuator provides precise and targeted vibrational stimulus to the user’s eyelids for consistent and effective treatment; wherein the housing comprises an adjustable ball joint interface allowing customisation to fit various pupillary distances and head curvatures, thereby enhancing user comfort and device efficacy; wherein the housing comprises an eye cup positioned to make direct contact with the user’s eyelids, ensuring the device remains securely in place during operation and effectively channels vibrations to the eyelids.

[0240] The smart wearable device of any preceding claim, wherein the range of vibrational treatment includes at least three different frequency settings.

[0241] The smart wearable device of any preceding claim, wherein the range of pressure settings includes at least three different pressure levels.

[0242] The smart wearable device of any preceding claim, wherein the flexible material is biocompatible silicone.

[0243] The smart wearable device of any preceding claim, wherein the variety of sizes at least includes small, medium, and large sizes.

[0244] The smart wearable device of any preceding claim, wherein the digital display is a touchscreen.

[0245] The smart wearable device of any preceding claim, wherein the digital display is not a touchscreen with preset buttons for temperature and treatment duration.

[0246] The smart wearable device of any preceding claim, wherein the rechargeable battery is a lithium-ion battery.

[0247] The smart wearable device of any preceding claim, wherein the local storage option is a MicroSD card.

[0248] The smart wearable device of any preceding claim, wherein the electromagnetic actuator is solenoid.Claim Set B

[0249] A wearable device for home-based treatment or management of meibomian gland dysfunction, comprising: (i) a main body configured to be worn over a user’s eyes; (ii) a strap to secure the body on the user’s head; (iii) a pair of eyecups, each eyecup having a skin-contacting surface (Figure 16, part 6, for example) contoured for contacting an upper or lower eyelid, said eyecups being mounted so as to self-align to variations in the user’s face shape; (iv) a thermal energy delivery assembly disposed at or behind each eyecup (Figure 17, 1701 , for example), configured to provide heating to the contacted eyelid at a temperature sufficient to liquefy meibum and facilitate meibomian gland expression; (v) a vibration arrangement associated with each eyecup or the main body, configured to impart oscillatory or vibratory motion onto the eyelid to further facilitate meibum outflow; (vi) a force- or pressure-sensing arrangement (for example, it could be, it could be an electrically conductive foam or an optical distance sensor) configured to measure compressive load exerted by each eyecup on the wearer’s eyelid, so as to monitor and / or limit excessive force; (vii) at least one user-adjustable cushion component (for example Figure 12-B, part 3) or face-seal component, (for example Figure 12-A, part 3) arranged between the main body and the user’s face to accommodate variations in pupillary distance, eyelid protrusion, and facial curvature, and (viii) a controller in communication with the thermal energy delivery assembly (for example, parts 15 in Figure 12-A), the vibration arrangement, and the force- or pressure-sensing arrangement, said controller being programmed to: (1 ) receive user-selectable parameters including target temperature and vibration settings, (2) regulate operation of the thermal energy delivery assembly to maintain a desired eyelid temperature range, (3) adjust or limit the vibration arrangement and eyecup contact force based on signals from the force- or pressure-sensing arrangement, and (4) optionally log usage data or provide alerts, wherein the device is configured to be operated repeatedly by a wearer without professional assistance, and further wherein the combination of controlled heating, vibration, and force measurement is operable to promote expression of meibomian glands in a non-invasive manner.

[0250] The wearable device of any preceding claim, wherein the force-sensing or pressure-sensing arrangement comprises electrically conductive foam compressed between two metal-coated plates, whereby changes in the foam’s electrical properties correlate to the compressive load on the eyelid.

[0251] The wearable device of any preceding claim, wherein the force-sensing or pressure-sensing arrangement comprises an optical distance sensor configured to measure displacement of the eyecup relative to a reference position, the displacement being convertible into an eyelid-contact force using a known spring or foam rate.

[0252] The wearable device of any preceding claim, wherein each eyecup is mounted via a flexible bellow or spring permitting at least one of tip, tilt, or lateral translation, thereby allowing self-alignment to the wearer’s eye contour.

[0253] The wearable device of any preceding claim, wherein the vibration arrangement comprises at least an electromagnetic, or solenoid actuator, per eyecup, each independently controllable to create directional vibration patterns that guide meibum flow toward the eyelid margin; wherein the vibratory movement in a range of about 0.5 Hz to 300 Hz, optionally including intermittent or pulsed modes of operation.

[0254] The wearable device of any preceding claim, wherein each eyecup’s skin-contacting surface is formed with ridges or grooves sized and arranged to aid in directing liquefied meibum toward the eyelid margin during vibration. The wearable device of any preceding claim, further comprising one or more interchangeable face cushion covers of varying thicknesses and materials, each releasably attachable to the main body or eyecups by at least one of magnets or snap-fit features, to accommodate different face shapes and to enhance hygiene.

[0255] The wearable device of any preceding claim, wherein the thermal energy delivery assembly includes a temperature sensor for feedback control, maintaining a desired eyelid temperature range between about 38°C and 42.5°C during operation.

[0256] The wearable device of any preceding claim, further comprising a rechargeable battery housed in the main body and a power management subsystem configured to deliver current selectively to the thermal energy delivery assembly and vibration arrangement.

[0257] The wearable device of any preceding claim, wherein the controller is operable to record usage data including temperature profiles, vibration duration, and force metrics, and optionally to store the data on an onboard memory or a removable storage device.

[0258] The wearable device of any preceding claim, wherein the controller is configured for wireless data communication via at least one of Bluetooth or Wi-Fi, thereby enabling a companion software application to retrieve session logs and display compliance statistics or reminders.

[0259] The wearable device of any preceding claim, further comprising a user interface selected from: a built-in digital display screen, one or more LED indicators with push-button controls, or a mobile-device application, to allow the user to adjust temperature, vibration intensity, and session duration.

[0260] The wearable device of any preceding claim, wherein the force- or pressure-sensing arrangement triggers a warning or alert upon detecting a load exceeding a predetermined threshold, thereby reducing a risk of excessive pressure on the cornea.

[0261] The wearable device of any preceding claim, wherein the controller is programmed to automatically discontinue or limit heating and / or vibration if the force- or pressure-sensing arrangement indicates that the contact load exceeds a safe limit for longer than a specified duration.

[0262] The wearable device of any preceding claim, wherein each eyecup includes an embedded heating element shaped to conform with the cup’s curvature, said heating element comprising at least one of a wire coil, carbon-ink trace, or printed circuit heater.

[0263] The wearable device of any preceding claim, wherein the user- adjustable cushion or face-seal component is configured with anti-microbial or washable materials, optionally medical-grade silicone or fabric, for improved hygiene and reusability.

[0264] The wearable device of any preceding claim, further comprising a safety circuit (803 communication with 806, 827) including a thermal fuse or thermal switch that interrupts power to the thermal energy delivery assembly if an over-temperature condition is detected.

[0265] The wearable device of any preceding claim, wherein the vibration arrangement is configured such that one eyecup can vibrate independently of the other, allowing differential treatment settings for each eye in the same session.

[0266] The wearable device of any preceding claim, wherein the controller can implement a temporal temperature gradient in which the heating assembly cycles through at least two different temperature setpoints over a single treatment session to enhance meibum outflow.

[0267] The wearable device of any preceding claim, wherein the vibration arrangement is adapted for gradual ramping of vibration frequency or amplitude at the beginning and end of a session, so as to reduce abrupt stimuli and enhance wearer comfort.

[0268] The wearable device of any preceding claim, wherein the controller is programmed to deliver transition profiles which, over a non-zero time, transition from one frequency of vibration to another frequency of vibration and / or from one intensity of vibration to another intensity of vibration.

[0269] The wearable device of any preceding claim, wherein the vibration arrangement is configured to generate vibration motion profiles selectable from a set of predefined profiles including at least two of: bumps, ticks, clicks, buzzes, hums, transitions and pulsations, each profile configured to elicit a distinct functional effect in aiding the delivery, restoration and / or maintenance of healthy ocular function.

[0270] The wearable device of any preceding claim, wherein the controller is configured to deliver composite vibration profiles comprising at least two other profiles, with each profile after the first either following the preceding profile immediately or following after a predefined time period has elapsed.

[0271] The wearable device of any preceding claim, wherein the controller is configured to deliver composite vibration profiles that are partially predefined, with non-predefined aspects controlled in response to at least one of: a user input, a biometric sensor input, another sensor input, a computed algorithm result, or a random selection.

[0272] The wearable device of any preceding claim, further comprising an external control interface accessible via a computer or mobile device, using a communication protocol that enables real-time adjustment of vibration parameters through an interactive selection menu where users can choose from predefined profiles or customize new sequences.

[0273] The wearable device of any preceding claim, wherein the controller is programmed to accommodate different operational modes, including delivery of a single motion profile, periodic delivery of a motion profile, continuous delivery of a motion profile, or delivery of a collection of different motion profiles.

[0274] The wearable device of any preceding claim, further comprising a realtime monitoring function that adjusts vibration profiles based on at least one of: user input, user feedback, biometric sensor inputs, timer inputs, time of day, calendar events, or computed algorithm results.

[0275] The wearable device of any preceding claim, further comprising a diagnostic and calibration mode allowing for automated tuning of vibration intensity and frequency to ensure consistent stimulation and minimize system power consumption across different device configurations, compensating for manufacturing tolerances and inaccuracies.

[0276] The wearable device of any preceding claim, further comprising safety mechanisms that use inputs from at least one of: accelerometer sensors, timers, mechanical sensors, optical sensors, magnetic sensors, or switches to determine when vibration motion profiles are adjusted in frequency, intensity, duty cycle, count, or when to adjust rest period duration between motion profiles or cease motion altogether.

[0277] The wearable device of any preceding claim, wherein the vibration amplitude is optimized between 0.2 mm and 1 .0 mm peak-to-peak, and the vibration frequency is optimized between 5 Hz and 50 Hz, with lower frequencies of 5 to 15 Hz facilitating gentle stimulation and higher frequencies of 20 to 50 Hz promoting effective gland expression.

[0278] The wearable device of any preceding claim, wherein the vibration arrangement is configured to operate at extended frequency ranges up to 150 Hz for promoting enhanced gland expression and oil release onto the ocular surface.

[0279] The wearable device of any preceding claim, wherein the vibration arrangement utilizes mobile phone-type actuators operating within a 50-300 Hz range with peak amplitude between 0.05 mm and 0.5 mm, to enhance localized stimulation while preventing excessive displacement.

[0280] The wearable device of any preceding claim, wherein the controller implements a damped vibration model according to the equation A(t) = Amax * exp(- Bt) * cos(2iTft), where Amax is peak amplitude, f is vibration frequency, t is time, and B is a damping coefficient ranging between 0.1 s’1and 5 s’1, to reflect natural attenuation of vibration intensity over time.

[0281] The wearable device of any preceding claim, wherein the controller is programmed to apply asynchronous vibration management sessions to left and right eyes, with one eyelid receiving vibration while the other experiences heat treatment only, followed by a reverse treatment sequence.

[0282] The wearable device of any preceding claim, wherein the controller is programmed to deliver different vibration intensities to left and right eyes based on differences in comfort sensitivity or severity of meibomian gland dysfunction between the eyes.

[0283] The wearable device of any preceding claim, further comprising a companion software application configured to provide users with a self-tracking interface for managing device usage, scheduling management sessions, monitoring compliance, tracking usage statistics, and accessing device and condition-related information.

[0284] The wearable device of any preceding claim, wherein the companion software application differentiates between user roles, providing standard patients with self-tracking and reminder functionalities while offering restricted menu items exclusively to eye care practitioners for setting management session parameters or extracting specific statistical results in accordance with regulatory requirements.

[0285] The wearable device of any preceding claim, wherein the programmatic implementation of vibration control follows an event-driven model, where vibration motion profiles are queued and executed sequentially based on predefined schedules, with each motion profile consisting of a profile identifier, an intensity value, a duration of execution, and an inter-profile delay.

[0286] The wearable device of any preceding claim, wherein the vibration arrangement is configured to simultaneously apply different patterns of vibration to left and right eyes for optimizing management therapy, comfort, or power consumption efficiency regardless of whether there are differences in left and right eye sensitivity or disease condition.

[0287] The wearable device of any preceding claim, wherein the controller is configured to implement vibration profiles that follow frequency modulation and amplitude modulation according to the equation A(t) = Amax * sin(2rrf*t + phi), wherein Amax is the peak amplitude, f is the frequency of oscillation, phi is the phase shift, and t is the time, and wherein the system dynamically adjusts these parameters based on real-time sensor inputs.

[0288] The wearable device of any preceding claim, wherein the vibration arrangement comprises multiple actuators per eyecup, each independently controllable to create directional vibration patterns that guide meibum flow toward the eyelid margin.

[0289] The wearable device of any preceding claim, wherein the controller is programmed to coordinate thermal gradient application with specific vibration profiles to optimize meibum liquefaction and expression in a single synchronized treatment sequence.

[0290] The wearable device of any preceding claim, wherein the thermal energy delivery assembly is configured to achieve therapeutic heating of the eyelid within 3 minutes of activation and reach equilibrium temperature within approximately 10 minutes of activation.

[0291] The wearable device of any preceding claim, wherein the controller is programmed to maintain the eyelid surface temperature between 38°C and 42.5°C during operation based on feedback from the temperature sensor.

[0292] The wearable device of any preceding claim, wherein each eyecup is configured to treat a surface area encompassing at least 100 mm2, 150 mm2, 200 mm2, 300 mm2, 400 mm2, 500 mm2, 600 mm2, or 700 mm2of the eyelid.

[0293] The wearable device of any preceding claim, wherein the vibration arrangement is configured to generate a pressure wave from the start to the outlet of the meibomian glands, with a pressure between 0.005 to 0.5 N / mm2and a frequency between 0.5 to 300 Hz.

[0294] The wearable device of any preceding claim, wherein each eyecup's skin-contacting surface is formed with ridges or grooves perpendicular or diagonal to the vibration direction, ranging from 0.5 mm to 2 mm in thickness and height, to aid in directing liquefied meibum toward the eyelid margin during vibration.

[0295] The wearable device of any preceding claim, wherein the controller is programmed to implement a treatment protocol configured to improve at least one of: Ocular Surface Disease Index (OSDI), Meibomian Gland Score (MGS), and Tear Breakup Time (TBUT) measurements after repeated use.

[0296] The wearable device of any preceding claim, wherein the controller is configured to operate the device in a twice-daily treatment protocol for a period of at least six weeks to provide statistically significant improvements in Meibomian gland function and tear film stability.

[0297] The wearable device of any preceding claim, wherein the thermal energy delivery assembly includes at least one of an infrared heating element, a resistive heating element, or a heating pad capable of delivering localized heating to theperiocular region with temperature variations of no more than ±1.0°C across the treated area.

[0298] The wearable device of any preceding claim, wherein the controller is programmed to modulate the heating profile during a treatment session to simulate a therapeutic thermal profile comprising a rapid warm-up phase reaching at least 38°C within 3 minutes, a therapeutic maintenance phase between 38°C and 42.5°C for at least 5 minutes, and an optional gradual cool-down phase.

[0299] The wearable device of any preceding claim, further comprising at least one infrared thermal sensor configured to measure the actual temperature of the eyelid surface during treatment, wherein the controller is programmed to adjust the thermal energy delivery in real-time based on the measured temperature to maintain therapeutic efficacy.

[0300] The wearable device of any preceding claim, wherein the controller is programmed to store thermal response profiles specific to individual users, based on previous treatment sessions, and to adjust subsequent heating parameters to optimize therapeutic efficacy while maintaining user comfort.

[0301] The wearable device of any preceding claim, further comprising a wireless data transmission capability configured to transmit treatment session data including duration, achieved temperature ranges, and vibration patterns to an electronic health record system or clinical database for remote monitoring by healthcare providers.

[0302] The wearable device of any preceding claim, wherein the controller implements a progressive therapeutic regimen that automatically adjusts temperature and vibration parameters over successive treatment sessions based on recorded user tolerance and treatment efficacy indicators.

[0303] The wearable device of any preceding claim, wherein the controller is programmed to detect variations in thermal response between sessions and to adjust heating parameters to compensate for ambient temperature, battery charge level, and device positioning variations.

[0304] The wearable device of any preceding claim, wherein the thermal energy delivery assembly is capable of generating and maintaining a medial-to-lateral or lateral-to-medial thermal gradient across the eyelid to promote directional meibum flow.

[0305] The wearable device of any preceding claim, wherein the controller includes a machine learning algorithm configured to identify optimal thermal and vibration treatment parameters specific to the user based on usage patterns, feedback, and measured physiological responses.

[0306] The wearable device of any preceding claim, wherein the controller is programmed to implement a phased treatment protocol comprising a warm-up phase lasting 2 to 4 minutes, a therapeutic phase lasting 8 to 12 minutes, and a cool-down phase lasting 1 to 2 minutes, with specific vibration patterns assigned to each phase.

[0307] The wearable device of any preceding claim, further comprising a compliance monitoring system that records treatment adherence metrics and provides reminders and incentives to maintain the prescribed treatment regimen, wherein the controller is configured to generate treatment efficacy reports correlating symptom improvements with treatment adherence.

[0308] The wearable device of any preceding claim, wherein the therapeutic thermal profile is configured to raise eyelid temperature from a baseline of approximately 32 to 35°C to a therapeutic range of 38 to 42.5°C, and wherein the controller monitors the rate of temperature change to ensure safe and effective heating.

[0309] The wearable device of any preceding claim, wherein the controller is configured to detect if the device is properly positioned on the user's face before initiating or continuing thermal therapy, based on signals from at least one of: contact sensors, proximity sensors, or temperature differential measurements.

[0310] A method of treating or managing meibomian gland dysfunction using the wearable device of any preceding claim, comprising the steps of: (a) positioning the device on a user’s face such that each eyecup aligns with an eyelid of the user; (b) activating the thermal energy delivery assembly to heat the eyelid to a targettherapeutic temperature between approximately 38°C and 42.5°C; (c) concurrently or sequentially activating the vibration arrangement to apply oscillatory or vibratory stimulation onto the eyelid, thereby facilitating expression of liquefied meibum toward the eyelid margin; (d) continuously monitoring the eyelid-contact force using the force- or pressure-sensing arrangement, adjusting or limiting said force to prevent excessive pressure on the eyelid or cornea; and (e) repeating the heating and vibration steps according to a predefined therapeutic regimen, optionally adjusted based on user feedback or physiological response data collected during prior sessions, thereby improving meibomian gland function and ocular surface health in a non-invasive manner.

Claims

AMENDED CLAIMS received by the International Bureau on 14 August 2025 (14.08.2025)CLAIMS1. A wearable device for home-based treatment or management of meibomian gland dysfunction, comprising:(i) a main body configured to be worn over a user’s eyes or eyelids;(ii) a strap to secure the body on the user’s head;(iii) a pair of eyecups, each eyecup having a skin-contacting surface contoured for contacting an upper and / or lower eyelid, said eyecups being mounted so as to self-align to variations in the user’s eye shape and face shape;(iv) a thermal energy delivery assembly disposed at or behind each eyecup, configured to cycle through at least two different temperature setpoints over a treatment session to enhance meibum outflow;(v) a vibration arrangement associated with each eyecup, independently controllable to apply different vibratory stimulations to each eye, and adapted to ramp frequency or amplitude at the start and end of a session;(vi) a force-sensing arrangement comprising one or more of:(a) a pair of metal-coated plates with interposed electrically conductive foam configured to vary conductivity upon compression;(b) a capacitive sensing system comprising metal-coated plates arranged to detect impedance changes due to foam compression;(c) an induction-based sensor system including a coil and a metal plate arranged to vary inductive impedance with foam compression;(d) an optical distance sensor configured to detect displacement of an eyecup relative to a reference position and compute contact force using known spring or foam constants;(e) a mechanical pin-based arrangement with electrical contacts to detect positional changes correlating to contact force or pressure;AMENDED SHEET (ARTICLE 19)wherein the sensing arrangement is configured to detect, control, or provide feedback on pressure or force applied to the eyelid; the arrangement being non-invasive, adaptable to varying face geometries; and(vii) a controller in communication with the thermal energy delivery assembly, the vibration arrangement, and the force- or pressure-sensing arrangement, said controller being programmed to:(1 ) receive user-selectable parameters including target temperature and vibration settings,(2) regulate operation of the thermal energy delivery assembly to maintain a desired eyelid temperature range,(3) adjust or limit the vibration arrangement and eyecup contact force based on signals from the force- or pressure-sensing arrangement, and(4) optionally log usage data or provide alerts, wherein the device is configured to be operated repeatedly by a wearer without professional assistance, and further wherein the combination of controlled heating, vibration, and force measurement is operable to promote expression of meibomian glands in a non-invasive manner.

2. The wearable device of claim 1 , wherein the force-sensing or pressure-sensing arrangement comprises electrically conductive foam compressed between two metal-coated plates, whereby changes in the foam’s electrical properties correlate to the compressive load on the eyelid.

3. The wearable device of claim 1 , wherein the force-sensing or pressure-sensing arrangement comprises an optical distance sensor configured to measure displacement of the eyecup relative to a reference position, the displacement being convertible into an eyelid-contact force using a known spring or foam rate.

4. The wearable device of any one of claims 1 to 3, wherein each eyecup is mounted via a flexible bellow or spring permitting at least one of tip, tilt, or lateral translation, thereby allowing self-alignment to the wearer’s eye contour.AMENDED SHEET (ARTICLE 19)5. The wearable device of any one of claims 1 to 4, wherein the vibration arrangement comprises an electromagnetic actuator that generates vibratory movement in a range of about 0.5 Hz to 300 Hz, optionally including intermittent or pulsed modes of operation.

6. The wearable device of any one of claims 1 to 5, wherein each eyecup’s skincontacting surface is formed with ridges or grooves sized and arranged to aid in directing liquefied meibum toward the eyelid margin during vibration.

7. The wearable device of any one of claims 1 to 6, further comprising one or more interchangeable face cushion covers of varying thicknesses and materials, each releasably attachable to the main body or eyecups by at least one of magnets or snap-fit features, to accommodate different face shapes and to enhance hygiene.

8. The wearable device of any one of claims 1 to 7, wherein the thermal energy delivery assembly includes a temperature sensor for feedback control, maintaining an eyelid surface temperature between about 38°C and 46°C during operation.

9. The wearable device of any one of claims 1 to 8, further comprising a rechargeable battery housed in the main body and a power-management subsystem configured to deliver current selectively to the thermal energy delivery assembly and vibration arrangement.

10. The wearable device of any one of claims 1 to 9, wherein the controller is operable to record usage data including temperature profiles, vibration duration, and force metrics, and optionally to store the data on an onboard memory or a removable storage device.

11. The wearable device of any one of claims 1 to 10, wherein the controller is configured for wireless data communication via at least one of Bluetooth or WiFi, thereby enabling a companion software application to retrieve session logs and display compliance statistics or reminders.AMENDED SHEET (ARTICLE 19)12. The wearable device of any one of claims 1 to 11 , further comprising a user interface selected from: a built-in display screen, one or more LED indicators with push-button controls, or a mobile-device application, to allow the user to adjust temperature, vibration intensity, and session duration.

13. The wearable device of any one of claims 1 to 12, wherein the force- or pressure-sensing arrangement triggers a warning or alert upon detecting a load exceeding a predetermined threshold, thereby reducing a risk of excessive pressure on the cornea.

14. The wearable device of any one of claims 1 to 13, wherein the controller is programmed to automatically discontinue or limit heating and / or vibration if the force- or pressure-sensing arrangement indicates that the contact load exceeds a safe limit for longer than a specified duration.

15. The wearable device of any one of claims 1 to 14, wherein each eyecup includes an embedded heating element shaped to conform with the cup’s curvature, said heating element comprising at least one of a wire coil, carbon- ink trace, or printed circuit heater.

16. The wearable device of any one of claims 1 to 15, wherein the user-adjustable cushion or face-seal component is configured with antimicrobial or washable materials, optionally medical-grade silicone or fabric, for improved hygiene and reusability.

17. The wearable device of any one of claims 1 to 16, further comprising a safety circuit including a thermal fuse or thermal switch that interrupts power to the thermal energy delivery assembly if an over-temperature condition is detected.

18. The wearable device of any one of claims 1 to 17, wherein the vibration arrangement is configured such that one eyecup can vibrate independently of the other, allowing differential treatment settings for each eye in the same session.

19. The wearable device of any one of claims 1 to 18, wherein the controller can implement a temporal temperature gradient in which the heating assemblyAMENDED SHEET (ARTICLE 19)cycles through at least two different temperature setpoints over a single treatment session to enhance meibum outflow.

20. The wearable device of any one of claims 1 to 19, wherein the vibration arrangement is adapted for gradual ramping of vibration frequency or amplitude at the beginning and end of a session, so as to reduce abrupt stimuli and enhance wearer comfort.

21. The wearable device of any one of claims 1 to 20, wherein the controller is programmed to modulate the heating profile during a treatment session to simulate a therapeutic thermal profile comprising a rapid warm-up phase reaching at least 38°C within 3 minutes, a therapeutic maintenance phase between 38°C and 42.5°C for at least 5 minutes, and an optional gradual cooldown phase.

22. The wearable device of any one of claims 1 to 21 , wherein the controller is programmed to implement a phased treatment protocol comprising a warm-up phase lasting 2 to 4 minutes, a therapeutic phase lasting 8 to 12 minutes, and a cool-down phase lasting 1 to 2 minutes, with specific vibration patterns assigned to each phase.

23. The wearable device of any one of claims 1 to 22, wherein the controller is programmed to deliver transition profiles which, over a non-zero time, transition from one frequency of vibration to another frequency of vibration and / or from one intensity of vibration to another intensity of vibration.

24. The wearable device of any one of claims 1 to 23, wherein the controller is programmed to apply asynchronous vibration management sessions to left and right eyes, with one eyelid receiving vibration while the other experiences heat treatment only, followed by a reverse treatment sequence.

25. The wearable device of any one of claims 1 to 24, wherein the controller is programmed to deliver different vibration intensities to left and right eyes based on differences in comfort sensitivity or severity of meibomian gland dysfunction between the eyes.AMENDED SHEET (ARTICLE 19)26. The wearable device of any one of claims 1 to 25, wherein the vibration arrangement is configured to generate vibration motion profiles selectable from a set of predefined profiles including at least two of: bumps, ticks, clicks, buzzes, hums, transitions and pulsations, each profile configured to elicit a distinct functional effect in aiding the delivery, restoration and / or maintenance of healthy ocular function.

27. The wearable device of any one of claims 1 to 26, wherein the device comprises at least one interchangeable and user-adjustable cushion or face-seal component, releasably attachable via magnets or snap-fits.AMENDED SHEET (ARTICLE 19)

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