WO2025104734A1 - Device and method for improving dry eye disease - Google Patents

Abstract

A method and device for improving dry eye disease. An applicator comprising: at least one heater such as radiofrequency (RF) energy configured to cause temperature modification of a surface of skin tissue; at least one muscle stimulator such as electric muscle stimulation Mu (EMS) energy configured to provide muscle stimulation to a muscle layer located below a skin tissue. Activating the RF to heat the skin tissue and the EMS according to respective activation patterns and placing the applicator in vicinity of the surface of the skin tissue of the inferior orbital rim. Heating the surface at least a portion of the skin tissue of the inferior orbital rim by the at least one heater; and stimulating at least a portion of the muscle layer located below the skin tissue of the inferior orbital rim from said muscle stimulator.

Description

DEVICE AND METHOD FOR IMPROVING DRY EYE DISEASE

RELATED APPLICATIONS

[0001] This application is related to US Provisional Application No. 63/599,054 filed November 15, 2023, entitled “Device and Method for Improving Dry Eye Disease” to which application priority is hereby claimed and the entire contents of which are herein incorporated by reference.

TECHNICAL FIELD

[0002] The present invention is in the medical field and relates specifically to ophthalmology, and more specifically relates to a device and a method for improving eye blinking in subjects suffering from dry eye disease.

BACKGROUND

[0003] Spontaneous eye blinking is an essential mechanism for maintaining the ocular surface moist. The relationship between the rate of blinking and Dry Eye Disease (DED) is well- established. It is observed that the patients with DED have a significantly higher blinking rate compared to healthy individuals, probably due to drying or irritation of the ocular surface caused by an unstable tear film.

[0004] Another blinking issue highly associated with DED patients may be incomplete or partial blinks, where the eyelids do not fully close, which can further contribute to tear evaporation and exacerbate symptoms of dryness, irritation, and redness.

SUMMARY

[0005] In accordance with a first aspect of the present invention, there is provided a device for improving eye disease and specifically dry eye disease. The device includes an electric pulse generator which is configured to provide electrical muscle stimulation (EMS) to the muscles in the underlying muscle layer of the skin tissue in vicinity of the eye. The device includes one or more energy transmitting elements to apply the EMS to at least a portion of the muscle layer underneath skin tissue of the inferior orbital rim that is the orbicularis oculi muscle. In some embodiments, the device may include a tissue heating source, specifically an electromagnetic (EM) source that emits electromagnetic (EM) energy, to heat a skin tissue of the inferior orbital rim and/or the surrounding skin tissue of the eye.

[0006] In some embodiments, one or more energy transmitting elements of the device are configured to apply the EMS and the heating EM energy to at least a portion of the skin tissue of the inferior orbital rim and the orbicularis oculi muscle. The combination of application of EMS to provide muscle stimulation and EM energy to heat the skin tissue, leads to the improvement in dry eye disease. In some exemplary embodiments, the electromagnetic (EM) wave utilized in the device is in the form of a radio frequency (RF). The choice of RF waves is deliberate due to their ability to penetrate the skin tissue without causing significant harm to the outer layers. This characteristic makes RF energy ideal for treatments that require targeted heating of specific tissues, such as the skin tissue of the inferior orbital rim and/or the orbicularis oculi muscle in the context of improving dry eye disease.

[0007] In one aspect of the current disclosure, there is a method for improving dry eye disease, the method comprising: providing an eye disease treatment device with an applicator comprising: at least one heater configured to cause temperature modification of a surface of the skin tissue, and at least one muscle stimulator configured to provide muscle stimulation to a muscle layer located below a skin tissue. The method further comprises, activating the at least one heater to heat the skin tissue and the muscle stimulator according to respective activation patterns; placing the applicator in vicinity of the surface of the skin tissue of the inferior orbital rim to heat the surface at least a portion of the skin tissue of the inferior orbital rim by the at least one heater; and stimulate at least a portion of the muscle layer located below the skin tissue of the inferior orbital rim from said muscle stimulator.

[0008] The method wherein the applicator further comprises one or more heads configured to contact the skin tissue, the one or more heads comprise one or more electrodes in electrical communication with the at least one heater and/or the at least one muscle stimulator, and wherein at least one electrode of the one or more electrodes is in electrical communication with the at least one heater and the at least one muscle stimulator. The method wherein said one or more electrodes comprise one or more multipolar electrode arrangements comprising at least one of the following: bi-polar electrodes; and at least three electrodes, with at least one electrode representing a first pole of a circuit and at least two electrodes representing an opposite pole of the circuit. The method, wherein the activation patterns of the at least one heater and the at least one muscle stimulator are user selectable and include one or more of the following: signal intensity, frequency, and duration.

[0009] In another aspect of the disclosure, the method, further comprises: providing a control unit; activating by the control unit the at least one heater and the muscle stimulator in one or more of the following activation patterns: alternating heating and stimulating, sequentially, intermittently, and simultaneously. The method also further comprises controlling and varying, by the control unit, parameters of the at least one heater and the at least one muscle stimulator, wherein the parameter include one or more of the following: signal intensity, frequency, and duration. The method wherein the at least one heater is an electromagnetic (EM) source that provides the EM energy in the form of radiofrequency (RF) and the at least one muscle stimulator is an electric pulse generator that provides electric muscle stimulation (EMS). The method wherein the skin is heated, and the muscles stimulated for a predetermined time.

[0010] In yet another aspect of the disclosure, the method further comprising: providing an imaging unit coupled to the control unit; detecting, by the imaging unit and the control unit, at least one of, (i) a pattern of eye blinking, and (ii) a pattern of the eyelid closure. Then varying the use of the EMS and/or the RF based on the detecting, by the imaging unit and the control unit, at least one of, (i) the pattern of eye blinking, and (ii) the pattern of the eyelid closure. The method further comprising varying, by the control unit, at least one parameter of the EMS and/or the RF, wherein the at least one parameter is one of varying one or both the EMS and/or RF for: intensity; treatment duration; frequency; pulse duration; and power/amplitude. The muscle layer stimulated is the orbicularis oculi muscle.

[0011] In one aspect of the disclosure, there is a device for improving dry eye disease, the device comprising: an applicator comprising: at least one heater configured to cause temperature modification of a surface of the skin tissue, and at least one muscle stimulator configured to provide muscle stimulation to a muscle layer located below a skin tissue. The device wherein the applicator when placed in the vicinity of the surface of the skin tissue of the inferior orbital rim is configured to activate the at least one heater to heat the skin tissue and the muscle stimulator according to respective activation patterns; heat the surface at least a portion of the skin tissue of the inferior orbital rim by the at least one heater; stimulate at least a portion of the muscle layer located below the skin tissue of the inferior orbital rim from the at least one muscle stimulator. [0012] The device wherein the applicator further includes one or more heads configured to be placed in contact with the skin tissue of the inferior orbital rim, the one or more heads serving as contacts to deliver energy from the at least one muscle stimulator and heat from the at least one heater, respectively. The device wherein the at least one heater is an electromagnetic (EM) source that provides the EM energy in the form of radiofrequency (RF) and the at least one muscle stimulator is an electric pulse generator that provides electric muscle stimulation (EMS).

[0013] In a final aspect of the disclosure, the device wherein the EMS is a non-static electric current and the applicator includes one or more temperature sensors configured to sense and monitor the temperature on the skin tissue. The device further comprises a control unit and an imaging unit, and the control unit is coupled with the imaging unit and are configured to detect at least one of a pattern of; eye blinking, or eyelid closure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The novel features and characteristics of the disclosure are set forth in the appended claims. The disclosure itself, however, as well as a preferred mode of use, further objectives, and advantages thereof, will best be understood by reference to the following detailed description of an illustrative embodiment when read in conjunction with the accompanying figures. One or more embodiments are now described, by way of example only, with reference to the accompanying figures.

[0015] FIG. 1 illustrates a schematic view of a device used for improving eye conditions, in accordance with an exemplary embodiment of the present invention.

[0016] FIGs. 2A-H illustrates views of an applicator of the device used for improving eye conditions, in accordance with an exemplary embodiment of the present invention.

[0017] FIGs. 3A and 3B illustrates application of a treatment method according to an exemplary embodiment of the present invention.

[0018] FIGs. 4A-J illustrates views of a console with the device used for improving eye conditions, in accordance with an exemplary embodiment of the present invention.

[0019] The figures depict embodiments of the inventions for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the disclosure described herein. DETAILED DESCRIPTION

[0020] The foregoing has broadly outlined the features and technical advantages of the present disclosure in order that the detailed description that follows may be better understood. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

[0021} In some embodiments, the current disclosure has a device that uses both a muscle stimulator and a heater to improve eye conditions such as but not limited to dry eye disease (DED). In some embodiments, the muscle stimulator is an electric pulse generator to provide electrical muscle stimulation (EMS) and the heater is an EM wave source to provide radiofrequency (RF) energy for heating to the target tissue.

[0022] In general, EMS is a therapeutic technique that involves applying electrical currents to muscles to induce involuntary muscle contractions. EMS is used in physical therapy and fitness settings to enhance muscle strength, increase muscle endurance, and facilitate muscle recovery. Typically, during EMS, electrodes are placed on the skin over the target muscles, and controlled electrical pulses are delivered through these electrodes to stimulate the motor neurons responsible for muscle contractions. These electrical impulses mimic the natural signals sent by the central nervous system during physical activity to activate muscles. EMS, in general, encompasses various techniques, including DMSt (dynamic muscle stimulation), which can be specifically tailored to address different treatment goals and muscle responses. DMSt is often preferred for enhancing various aspects of underlying muscle fibers, such as strength, endurance, volume, toning, and intramuscular blood flow. By linking EMS to DMSt, healthcare professionals and fitness experts can leverage the benefits of dynamic muscle stimulation to achieve optimal results in muscle activation and overall physical performance. Whether used for rehabilitation or performance enhancement, DMSt offers a versatile and effective means of improving muscle function and facilitating muscle-related therapies.

[0023] Heating the skin tissue may employ radio frequency (RF). In general, RF refers to a form of electromagnetic wave that may be emitted and absorbed by charged particles. It typically falls within the range of 3 kHz to 300 GHz, which is commonly known as the radio wave spectrum. RF energy may be transferred to the skin tissue through several mechanisms, including the interaction with pre-existing electric dipoles, polarization of atoms and molecules, and displacement of conduction electrons and ions. These interactions may result in vibrations within the tissue, leading to the generation of heat. In some embodiments, skin tissue of the inferior orbital rim is heated by RF.

[0024] The use of RF heating may enhance blood circulation to impaired muscles, which may contribute to improved functionality. RF heating may promote eye health by positively impacting the meibomian glands. The meibomian glands are located in the eyelids and responsible for producing and secreting a special oil known as meibum. This oil forms a vital component of the tear film, which helps maintain the ocular surface's lubrication and protection. However, in some cases, dysfunction or blockage of the meibomian glands can lead to a condition called meibomian gland dysfunction (MGD), contributing to dry eye symptoms. By assisting in the secretion of meibum and improving tear film stability, RF heating can contribute to maintaining ocular surface health and support a more comfortable and healthier eye environment.

[0025] In patients with Dry Eye Disease (DED), the frequency of blinking may increase as a compensatory mechanism due to the eyes drying out. The lack of sufficient tear production in DED can lead to dryness and discomfort in the eyes, prompting the body to respond by increasing the frequency of blinking to spread the limited tear film over the ocular surface and alleviate dryness. Further, Lagophthalmos, a condition where the eyes are unable to fully close, can also contribute to DED. The inability to completely close the eyelids leaves the eyes exposed, leading to inadequate tear coverage and reduced tear retention. Consequently, this exposure may cause the eyes to dry out quickly, exacerbating the symptoms of DED.

[0026] By improving eye blinking and promoting proper eye closure, therapeutic approaches may help restore tear film balance, alleviate dryness, and enhance overall eye comfort. A combination of DMSt and RF heating may address the specific needs. By utilizing DMSt, the muscles responsible for blinking and/or eye closure may be effectively strengthened, potentially leading to improved muscle function, and enhancing the quality of blinking and eye closure. In particular, focusing on strengthening the lower muscles may aid in achieving better closure of the eyelids, potentially reducing the risk of dryness associated with inadequate eye protection. The combination of DMSt and RF heating offers a multifaceted approach that may address the challenges faced by patients with Lagophthalmos, aiming to improve their overall eye health and comfort.

[0027] FIG. 1 depicts a schematic view of a non-limiting example of a device (100) for improving eye conditions, in accordance with the present invention.

[0028] In some exemplary embodiments of the present invention, the device (100) includes an electric pulse generator (120) that generates non-static electric current or transcutaneous current, which is configured effectively stimulates the expansion and contraction of the muscles or trigger repetitive muscle contractions. In some embodiments, the device (100) includes an EM wave source (130) responsible for emitting an EM wave energy to facilitate the heating of the user's skin. The EM waves may be specifically in the form of radiofrequency (RF).

[0029] FIG. 2 depicts a schematic view of a non-limiting example of a specialized energy transmitting element (150) that may be part of the device (100). These energy transmitting elements (150) are designed to target the skin tissue of interest, precisely where the therapeutic effects are desired. The energy transmitting elements may be configured as hand-held devices or applicator (hereinafter applicator). In some embodiments, the applicator may include the elements of the device (100) in the hand-held device or applicator. In some embodiments, the applicator (150) is connected to a base treatment unit or console, as illustrated in FIGs. 4A to 4J, having additional elements of device (100) through a cord (175). In some embodiments, the base treatment unit or console is configured to adjust the height of the console, as seen in FIG. 4C, wherein the console is adjusted higher for convenience of the user.

[0030] In some exemplary embodiments of the present invention, the applicator (150) may have one or more heads (160) that make optimal contact with the skin tissue of interest, e.g. tissue of the lower orbital rim. In some embodiments, the energy transmitting element (160) are on a distal end of the applicator and the applicator is configured to receive a plurality of alternative disposable heads (160). In some embodiments, the number of heads (160) on the applicator may vary based on the size, for example, the transmitting element or applicator (150) may only have one head or may have six heads. In some embodiments, the one or more heads can be made of stainless steel. In some embodiments, the one or more heads are electrodes (160). In some embodiments, the applicator includes one or more temperature sensors (not shown). In some embodiments, these one or more temperature sensors are configured to sense and monitor temperature of the skin tissue, thereby giving feedback that enables control of the applied EMS and/or RF energy.

[0031] In some embodiments, some of the electrodes (160) deliver RF energy and some deliver electrical pulses or current as EMS (130). Alternatively, the same electrodes may deliver RF energy and electrical current intermittently. Thus, RF energy and EMS may be delivered by the same applicator (150). In some embodiments, electrical pulses form the electrical muscle stimulation (EMS) signal is applied independent of the RF signal 130. When RF energy is applied, electrodes may be bipolar electrodes, which may consist of at least one pair of two active contacts located together, and wherein, the pair are one electrode of one polarity and the second electrode of a second and opposite polarity.

[0032] In some embodiments, and when applying RF energy, the electrodes may be monopolar electrodes, which may involve a single active contact paired with a larger return electrode. In some embodiments, the electrodes polarity may alternate during use of the device. In some embodiments, there are at least two applicators (150) of device (100), one for providing RF energy and a second for providing the EMS. In some embodiments, there are at least two applicators (150) of the device (100), both with at least the ability to provide EMS.

[0033] In some embodiments the applicator is a frame (not shown) with the heads (160) on a probe within the frame. The heads may be configured to move inside the frame. In some embodiments, the frame is a C-shaped frame. In some embodiments, the C-shape of the treatment area 210 would be the shape of the frame and a control unit (110), which may be part of the device (100) adjusts the speed at which the probe moves within the frame.

[0034] In some exemplary embodiments, microelectrodes may be used to precisely target delicate areas around the eyes, while macroelectrodes may be employed for broader muscle stimulation. The choice of electrodes may be tailored to individual patients' needs and the treatment objectives, allowing for personalized and effective therapy. The use of or selection of electrodes may facilitate the precise and targeted application of EMS and RF energy, maximizing the therapeutic impact on eye condition improvement and providing a comprehensive approach to managing Dry Eye Disease. [0035] In some embodiments, the EM generator (120) provides low current DC pulse signals to cause the muscles to expand and contract. In some of the exemplary embodiments of the present invention, DMSt may be implemented by various approaches. For instance, in an implementation, DMSt may involve the manual movement of the electrodes across the targeted region of the skin, carefully adjusting their positions to optimize the stimulation process. In another example, DMSt may be achieved by skillfully modifying the amount of electric pulse passing through each of the electrodes. By controlling the intensity and duration of the electrical impulses, the device may deliver varying degrees of muscle stimulation, catering to individual needs and treatment objectives. In yet another example, DMSt may be achieved by selectively turning on and off a plurality of electrodes.

[0036] In some embodiments, the device may include a control unit (110) that serves as a central component for overseeing and managing the device’s operations. The control unit (110) may be implemented as either a general-purpose computer or a dedicated circuit, depending on the specific design requirements. In this disclosure, “control unit” (in the singular) is understood to mean one or more control units or controllers or processors that may be hosted on a single computer or whether the features and functions of the control unit are distributed over a plurality of networked computers. In some embodiments, the control unit (110) further comprises a central processing unit (CPU), a memory and associated user interfaces including but not limited to, display or an input which may include a keyboard and/or mouse (not shown).

[0037] The inclusion of a CPU may enable the control unit (110) to execute complex algorithms and process data in real-time, enabling precise control over the parameters of muscle stimulation and RF energy application. Additionally, the memory component, which can be located either in the cloud or internally within the device, may store relevant data, including user preferences, treatment history, safety protocols etc. This capability ensures continuity and efficiency during multiple sessions, as the device can retrieve and apply previous treatment settings and tailor the therapy based on individual user needs and responses.

[0038] In some exemplary embodiments, the primary function of the control unit (110) is to regulate various essential parameters, ensuring precise and controlled muscle stimulation and RF energy application. Specifically, the control unit (110) may determine the duration, intensity, frequency, and other relevant aspects of the electric pulses in the electrical current used for muscle stimulation. Additionally, the control unit (110) may govern the RF energy used for heating the adipose layer, thereby ensuring optimal and safe application. In some exemplary embodiments of the present invention, the input/ output devices are user-friendly interface (not shown) for providing an intuitive and interactive interface for users or healthcare professionals. This interface may include a display screen, buttons, touch panels, or other intuitive input methods. Using the input/output device interface, users can conveniently adjust settings and monitor the device's performance during the treatment process. The display screen may offer real-time feedback, displaying treatment progress, session duration, or relevant data, empowering users to actively engage in the treatment and make informed decisions.

[0039] In some exemplary embodiments, the control unit (110) controls the electric pulse generator for EMS and the electromagnetic (EM) source for RF to turn on and off either simultaneously, independently, alternately, periodic, or any combination thereof. This allows for a dynamic and precise control over each modality of muscle stimulation heat application skin tissue. This control may also allow for tailored treatment strategies based on the specific needs of each patient. In some embodiments, the control unit can synchronize the application of EMS and RF energy, precisely coordinating the on and off cycles. In some exemplary embodiments, the control unit can customize and fine-tune the treatment by modifying the various parameters of the EMS and/or various parameters of the RF energy, such as intensity of energy, treatment duration, frequency, pulse duration, and power/amplitude. In some exemplary embodiments, the control unit is configured to apply the EMS and/or RF energy to the skin tissue of the inferior orbital rim and/or the orbicularis oculi muscle for a predetermined time.

[0040] In some embodiments, the control unit may vary the parameters of RF energy, for example, allow for the RF energy to be delivered at specific intervals, providing controlled bursts of energy to heat the skin tissue without causing excessive discomfort or damage. Similarly, the parameters of EMS or DMSt may be varied to deliver muscle stimulation in a controlled manner, based on the patient's tolerance and response. The control unit may allow for the gradual increase or decrease of EMS intensity, ensuring that the muscles are stimulated effectively without causing discomfort or strain.

[0041] In some exemplary embodiments of the present invention, the device may include an imaging unit (180) to detect the quality of blinking by detecting a pattern of the eye blinking. Currently, the diagnosis of dry eye is often conducted manually by physicians who may assess the tightness of the lower eyelid by gently pulling it. Alternatively, sophisticated image analysis techniques may be employed, wherein the imaging unit (180) may measure the minimum distance between the upper and lower eyelids during blinking. In healthy individuals, this distance should ideally be zero, indicating a complete closure of the eyes during blinking. However, a measurement of 3 to 4 mm may indicate an underlying issue, such as lagophthalmos, possibly causing or worsening dry eye disease.

[0042] In individuals with normal eye function, the frequency of blinking typically ranges from 10 to 12 times per minute. However, patients with dry eye conditions may exhibit a higher blinking frequency, which may range from 20 to 30 times per minute. By utilizing the imaging unit (180), the device may accurately measure the blinking frequency and may promptly detect any deviations from the normal range, potentially aiding in the early identification and treating of dry eye conditions.

[0043] Additionally, the control unit may control and vary the parameters of the EMS and/or RF energy based on the detected pattern of the eye blinking or closure. In some exemplary embodiments of the present invention, the imaging unit may detect irregular blinking patterns or signs of discomfort before the treatment process begins. This dynamic adjustment based on eye images allows for a tailored and responsive treatment, optimizing the therapeutic benefits for improving eye condition and addressing the individual needs of the patient. In some exemplary embodiments, the control unit is coupled with an imaging unit.

[0044] In some exemplary embodiments of the present invention, the output from the imaging unit (180) may be utilized to dynamically adjust the parameters by the control unit (110) in a controlled manner. The parameters of the EMS and/or RF energy may include, for example, intensity, frequency, treatment duration, pulse duration and power/amplitude. For instance, if the imaging unit (180) detects a higher blinking frequency than the normal range, which may be indicative of dry eye conditions, the control unit (110) may alter the parameters of the electrical muscle stimulation and RF energy application accordingly. For example, the control unit (110) may increase the intensity or frequency of electrical muscle stimulation to target specific muscle groups and improve eye blinking in a controlled and gradual manner. In some embodiments, the imaging unit (180) continuously provides real-time feedback on the patient's blinking patterns during the treatment sessions, allowing the control unit (110) to make precise and controlled adjustments. If the imaging unit identifies any irregularities or discomfort in the pre-treatment videos, the control unit may adapt and fine-tune the EMS and RF energy parameters to effectively target specific muscle groups.

[0045] In combination with this diagnostic capability, the device's imaging unit (180) may be employed as a valuable tool to monitor the success of the treatment. After undergoing a therapeutic session using the device, the imaging unit (180) may be utilized to assess the effectiveness of the treatment. By comparing the post-treatment blinking patterns and eyelid distance measurements with the initial ones, the device may provide insights into the treatment's efficacy. This diagnostic step may be essential in determining whether further treatment sessions are required to achieve the desired results. If the imaging unit (180) reveals persistent deviations from the normal blinking patterns or eyelid distance, it may signal the need for additional treatment sessions to ensure optimal improvement.

[0046] In some exemplary embodiments of the invention, the device (100) may be equipped with an activation switch (170) designed to control the on and off functionality of the device. This activation switch (170) may serve as a user-friendly interface for controlling the device, allowing users to start or stop the treatment process conveniently. The activation switch (170) may be independently controlled by the users, providing them with the flexibility to initiate the treatment at their preferred time and pace. In some exemplary embodiments of the present invention, the activation switch (170) may be automatically activated, perhaps by a pre-set timer or in response to specific treatment parameters. This automatic activation may streamline the treatment process, making it more seamless and consistent for users. The activation switch (170) may be positioned at a place easily accessible to the user, ensuring effortless operation during the treatment process. For instance, the activation switch may be integrated into the design of one or more energy transmitting elements. Alternatively, the activation switch may be positioned on the control unit, providing users with centralized control over the device's functionalities.

[0047] In some exemplary embodiments of the present invention, the control unit may include a footswitch (not shown). This footswitch is a user-friendly and provides hands-free input device that enables convenient and efficient operation of the device during the treatment process. The footswitch may activate or deactivate the device, for example, the RF energy and EMS application. [0048] In some exemplary embodiments of the present invention, the device (100) may be powered by a power source (140), which may include either an internal power source like a rechargeable battery, offering portability, or an external power source. The internal power source allows the device to operate independently of any external power supply, providing the advantage of convenience in various settings, even when not near a power outlet. This portability enhances flexibility in treatment, enabling users to use it while on the go or in situations where access to a power outlet may be limited or unavailable. Alternatively, in other exemplary embodiments, the device (100) may be powered by an external power source through a standard household power outlet using a power cable. This option ensures a continuous power supply, making it suitable for extended treatment sessions or clinical settings where portability may be less of a concern.

[0049] In some exemplary embodiments of the present invention, the use of needle electrodes and surface electrodes may also be considered, depending on the specific treatment requirements. This needle electrodes may be an additional applicator in the device (100).

[0050] In some exemplary embodiments of the present invention, a device with embodiments as discussed above may be used in a method to treat patients with Dry Eye Disease (DED) and/or treating patients with Lagophthalmos eye disease.

[0051] In some embodiments, there is a method to treat patients with eye disease by providing one or more energy transmitting elements or apparatus 150 to apply energy to at least a portion of the skin tissue of an inferior orbital rim and/or the orbicularis oculi muscle, wherein the combination of application of muscle stimulation and/or heat the skin tissue of the inferior orbital rim leads to the improvement in eye blinking. In some embodiments, EMS is the muscle stimulation modality and RF energy is the heating modality. In some exemplary embodiments of the present invention, the method may involve the integration of dynamic Muscle Stimulation (DMSt) as the EMS. In some embodiments, the lower section of the orbicularis oculi muscle is treated with DMSt in the area 210 around an eye 105 of FIG. 3A. That is, the applicator is moved by the user over the entire surface of area 210. In some embodiments, orbicularis oculi muscle is treated with muscle stimulation of EMS or DMSt including in the area 215 around the eye 105 as seen in FIG. 3B above the eye. In some embodiments, the entire orbicularis oculi muscle is treated with muscle stimulation of EMS or DMSt including above the eye.

[0052] In some exemplary embodiments, the RF energy, or similar heating energy, heats the skin tissue of the inferior orbital rim within a specific temperature range of, for example, 40 - 42 °C, or 41 °C +/- 5 °C. Maintaining the treatment within this controlled heating range may provide an effective and targeted approach, optimizing the therapeutic benefits while ensuring the safety and comfort of the patient. In some embodiments, the temperature range is carefully chosen to provide one or more of the following in the skin in vicinity of the eye: stimulate collagen production, promote tissue tightening, and activate rejuvenation processes, all contributing to the improvement of eye blinking and addressing Dry Eye Disease.

[0053] In some embodiments, and when there are at least two applicators (150) of the device (100), with at least the ability to provide EMS, the muscle is stimulated from two positions that may be opposite sides, simultaneously. This may cause the muscle fibers to be stimulated at lower stimulation strength. By way of specific example, instead of stimulating at X in one spot on the muscle, stimulate at X/2 on opposite sides of the muscle. This may improve tolerance for the patient.

[0054] In some exemplary embodiments, the method includes turning on and off the electric pulse generator for EMS and the electromagnetic (EM) source for RF either simultaneously, independently, alternately, periodic, or any combination thereof. This allows for a dynamic and precise control over each modality of muscle stimulation heat application skin tissue. This may also allow for tailored treatment strategies based on the specific needs of each patient. In some embodiments, the method synchronizes the application of EMS and RF energy, precisely coordinating the on and off cycles.

[0055] In some exemplary embodiments, the method customizes and fine-tune the treatment by modifying the various parameters of the EMS and/or various parameters of the RF energy, such as intensity of energy, treatment duration, frequency, pulse duration, and power/amplitude. In some exemplary embodiments, the method applies the EMS and/or RF energy to the skin tissue of the inferior orbital rim and/or the orbicularis oculi muscle for a predetermined time.

[0056] In some specific examples, the method includes the applicator being applied in a repetitive and slow back and forth C-shape motion 210, from the zygomatic-frontal suture, along the orbital rim and up to the anterior lacrimal crest. The infra-orbital nerve, lateral to the nostrils, was avoided. The orbicularis oculi muscle is affected. In some embodiments, there is a week interval between treatments.

[0057] In some exemplary embodiments of the present invention, the method may include observing the eye blinking before, during or after treatment by an imaging unit. The imaging unit may be coupled to the control unit. In some embodiments, the imaging unit and the control unit work in tandem to enhance the method's effectiveness and provide valuable insights into eye blinking patterns. In some embodiments, the imaging unit provides valuable visual feedback and assessment of the eye’s condition pre- and post-treatment. In some embodiments, the imaging unit employs advanced imaging technologies, such as high-resolution cameras or infrared sensors.

SPECIFIC EXAMPLES

[0058] In specific but non-limiting examples, the options of treatment may be set to DMSt duration= 5 min; power = 50-65%; frequency = 1.56-3.13 Hz; and pulse duration = 180-240 sec, with the RF energy adjusted so as to reach a skin temperature of 40 - 41 degrees C. In another non-limiting specific example, the options of treatment may be set to DMSt duration = 5 min; power = 50-65%; frequency = 1.56-3.13 Hz; and pulse duration = 100-240 sec, with the RF energy adjusted to as to reach a skin temperature of 40 - 41 degrees C. In some embodiments, the method includes heating the skin tissue for 2 minutes per eye and then both heating. Then stimulating with EMS with heating simultaneously for 5 minutes per eye.

[0059] In some non-limiting specific embodiments, the frequency of the RF is between 0.5MHz to 2MHz. In some embodiments, the EMS signal with pulses of DC current between+/- 500ma. In some embodiments, the RF power is up to and including 50 Watts. In some embodiments, the EMS pulse duration is about 20-400 micro-seconds (usee) or about 150-200 usee. In some embodiments the signal frequency of the EMS pulse is about 1 to 12.5 Hz or about 3 Hz. In some embodiments, the intensity of the EMS pulse is about 200 Vpp (Voltage peek to peek). In some embodiments, an EMS pulse of about 20 to 400 micro-seconds is provided and EMS energy is applied 20% of the time and RF energy is applied for 80% of the time. In some embodiments, an EMS pulse of 100 micro-seconds is provide during an interval of 2 milli second after which a RF energy is applied, for a duration of 8 milli-seconds. In some embodiments, this sequence is reversed, and the example sequences are applied repetitively. Optionally, other duration may be used, for example the duration of EMS pulse may be longer than the duration of RF energy or vice versa.

[0060] It should be appreciated that the above-described methods and apparatus may be varied in many ways, including omitting or adding steps, changing the order of steps and the type of devices used. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every embodiment of the invention. Further combinations of the above features are also considered to be within the scope of some embodiments of the invention. [0061] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.

Claims

CLAIMS:

1. A method for improving dry eye disease, the method comprising: providing an eye disease treatment device with an applicator comprising: at least one heater configured to cause temperature modification of a surface of the skin tissue, and at least one muscle stimulator configured to provide muscle stimulation to a muscle layer located below a skin tissue; and activating the at least one heater to heat the skin tissue and the muscle stimulator according to respective activation patterns; placing the applicator in vicinity of the surface of the skin tissue of the inferior orbital rim; heating the surface at least a portion of the skin tissue of the inferior orbital rim by the at least one heater; and stimulating at least a portion of the muscle layer located below the skin tissue of the inferior orbital rim from said muscle stimulator.

2. The method according to claim 1, wherein the applicator further comprises one or more heads configured to contact the skin tissue, the one or more heads comprise one or more electrodes in electrical communication with the at least one heater and/or the at least one muscle stimulator.

3. The method according to claim 2, wherein at least one electrode of the one or more electrodes is in electrical communication with the at least one heater and the at least one muscle stimulator.

4. The method according to claim 2, wherein said one or more electrodes comprise one or more multipolar electrode arrangements comprising at least one of the following: bi-polar electrodes; and at least three electrodes, with at least one electrode representing a first pole of a circuit and at least two electrodes representing an opposite pole of the circuit.

5. The method according to claim 1, wherein said activation patterns of the at least one heater and the at least one muscle stimulator are user selectable and include one or more of the following: signal intensity, frequency, and duration.

6. The method according to claim 1, wherein the method further comprises: providing a control unit; activating by the control unit the at least one heater and the muscle stimulator in one or more of the following activation patterns: alternating heating and stimulating, sequentially, intermittently, and simultaneously.

7. The method of claim 6, that further comprises controlling and varying, by the control unit, parameters of the at least one heater and the at least one muscle stimulator, wherein the parameter include one or more of the following: signal intensity, frequency, and duration.

8. The method of claim 1, wherein the at least one heater is an electromagnetic (EM) source that provides the EM energy in the form of radiofrequency (RF) and the at least one muscle stimulator is an electric pulse generator that provides electric muscle stimulation (EMS).

9. The method of claim 1, wherein the skin is heated, and the muscles stimulated for a predetermined time.

10. The method of claim 6, further comprising: providing an imaging unit coupled to the control unit; detecting, by the imaging unit and the control unit, at least one of,

(i) a pattern of eye blinking, and

(ii) a pattern of the eyelid closure.

11. The method of claim 8, further comprising: providing an imaging unit coupled to the control unit; detecting, by the imaging unit and the control unit, at least one of,

(i) a pattern of eye blinking, and

(ii) a pattern of the eyelid closure; varying the use of the EMS and/or the RF based on the detecting, by the imaging unit and the control unit, at least one of,

(i) the pattern of eye blinking, and

(ii) the pattern of the eyelid closure.

12. The method of claim 8, further comprising: providing a control unit; varying, by the control unit, at least one parameter of the EMS and/or the RF, wherein the at least one parameter is one of varying one or both the EMS and/or RF for: intensity; treatment duration; frequency; pulse duration; and power/amplitude.

13. The method of claim 1, wherein the muscle layer is an orbicularis oculi muscle.

14. A device for improving dry eye disease, the device comprising: an applicator comprising: at least one heater configured to cause temperature modification of a surface of the skin tissue, and at least one muscle stimulator configured to provide muscle stimulation to a muscle layer located below a skin tissue, wherein the applicator when placed in the vicinity of the surface of the skin tissue of the inferior orbital rim is configured to activate the at least one heater to heat the skin tissue and the muscle stimulator according to respective activation patterns; heat the surface at least a portion of the skin tissue of the inferior orbital rim by the at least one heater; stimulate at least a portion of the muscle layer located below the skin tissue of the inferior orbital rim from the at least one muscle stimulator.

15. The device of claim 14, wherein the applicator further includes one or more heads configured to be placed in contact with the skin tissue of the inferior orbital rim, the one or more heads serving as contacts to deliver energy from the at least one muscle stimulator and heat from the at least one heater, respectively.

16. The device of claim 14, wherein the at least one heater is an electromagnetic (EM) source that provides the EM energy in the form of radiofrequency (RF) and the at least one muscle stimulator is an electric pulse generator that provides electric muscle stimulation (EMS).

17. The device of claim 16, wherein the EMS is a non-static electric current.

18. The device of claim 14, wherein the applicator includes one or more temperature sensors configured to sense and monitor the temperature on the skin tissue.

19. The device of claim 14, wherein the device further comprises a control unit and an imaging unit.

20. The device of claim 19, wherein the control unit is coupled with the imaging unit and are configured to detect at least one of a pattern of; eye blinking, or eyelid closure.