Methods and devices for managing meibomian gland insufficiency

Abstract

The present invention provides a variety of methods and devices for management of meibomian gland lipid production and delivery deficiencies, including wearable fabrics configured with micro- and nano-scale electronic mechanism material matrices, or yarn composite fiber filaments made essentially of carbon nanotubes, graphene, spider silk, natural silk, denim, cotton, metal, or combinations thereof. Other methods and devices include management kits equipped with infrared and ultrasonic energy sources, intended for personalized treatment to improve overall health of the eyelids, while providing adjunctive relief for associated dry eye symptoms. Management kits can include wearable fabrics or eyewear frames equipped with infrared emitters and sensors, handheld imaging devices, and software containing usage frequency and information about improving eyelid hygiene, reviewed and periodically updated with user-specific information.

Description

[0001] This invention is a divisional application of the invention patent application filed on May 19, 2021, with application number 202180036329.1 and title "Method and apparatus for managing meibomian gland insufficiency".

[0002] Cross-references

[0003] This patent application requests the inclusion herein of: Australian Provisional Application Serial No. 2020 / 901615, filed on 20 May 2020, entitled “Wearable Fabric for Treating Meibomian Gland Defects”; another Australian Provisional Application Serial No. 2020 / 901616, filed on 20 May 2020, entitled “Kit for Meibomian Gland Defects”; and another Australian Provisional Application Serial No. 2020 / 901617, filed on 20 May 2020, entitled “Optical Device for Treating Meibomian Gland Defects”; all of the foregoing are incorporated herein by reference in their entirety. Technical Field

[0004] This disclosure relates to methods and apparatus for managing insufficient production and delivery of meibomian gland lipids by utilizing and / or applying thermal and mechanical energy to ocular appendages. Background Technology

[0005] Meibomian gland dysfunction is one of the most common causes of dry eye. Meibomian glands are located within the inner tarsal plate of the eyelid. Functionally, they are sebaceous glands responsible for supplying essential lipids (called meibomian glands) that help lubricate the surface of the eye. There are approximately 30 to 40 glands in the upper eyelid and 15 to 25 in the lower eyelid. The lipids they secrete coat the surface of the eye to prevent tear film evaporation.

[0006] Meibomian gland dysfunction can cause tears to evaporate more quickly, which can eventually lead to symptoms such as dry eyes, burning sensation, and / or eye irritation. Two common underlying causes of meibomian gland dysfunction are lipid coagulation or clogged pores in the glands, which prevent lipids from flowing to the surface of the eye.

[0007] Recommended clinical management includes warm compresses and eyelid massage, up to four times a day for 15 minutes each time, and the use of lubricants to improve dry eye-related symptoms.

[0008] Discussion of related technologies and requirements in this disclosure

[0009] US Patent Application US2019 / 015401 discloses a method for treating meibomian gland dysfunction using infrared and ultrasound energy. It utilizes an invasive pressure plate and a handheld device, requiring a physician to manage the treatment procedure.

[0010] The LipiFlow thermal pulsation system (integrated into the overall design), described in U.S. Patent 9314369B2, discloses another in-office medical device that applies sufficient heat to the eyelids to melt waxy deposits in the meibomian glands. Simultaneously, it applies pulsed pressure to the eyelids to open and completely release the glandular secretions. While the therapeutic effects using this integrated device are reliable, the procedure's drawbacks include its invasive nature and the need for strict physician supervision. Furthermore, the instrument costs for eye care physicians and the ongoing out-of-pocket expenses for end-users can be very high.

[0011] There is clearly a need to develop a method and apparatus to provide a non-invasive device that allows for self-management of procedures comfortably at home.

[0012] Furthermore, the ideal treatment management can be carried out with the eyes open and closed. Summary of the Invention

[0013] Carbon has various crystal structures, among which carbon nanotubes (1-D materials) and graphene (2-D materials) have previously been considered for use in micron and nanometer-scale electromechanical systems. Carbon nanotubes are nanoscale tubular molecules that are rolled up into a tubular shape.

[0014] Carbon nanotubes can be single-walled or multi-walled, depending on the manufacturing method. Their diameter ranges from tens to hundreds of nanometers. Their longitudinally hollow structure endows the material with unique mechanical, electrical, and chemical properties. These carbon nanotubes are typically conductive and possess mechanical strength and rigidity along their length. Carbon nanotubes also typically have a relatively high aspect ratio, or length-to-diameter ratio. These carbon nanotubes can be spun into fiber yarns by mechanically binding together a twisted assembly of individual tubes.

[0015] Graphene has a higher thermal conductivity than carbon nanotubes and its electrical resistance is lower than that of copper or silver. In some embodiments, 2D graphene sheets may be superior to 1D carbon nanotubes. Spider silk and silkworm silk are essentially composed of protein fibers made up of non-essential amino acids. The composition of non-essential amino acids present in silkworm silk determines their physical properties, such as elasticity, tensile strength, thermal and electrical conductivity, or electrical resistance. Due to these strong electromechanical properties, the use of carbon nanotubes or graphene sheets, spider silk or silkworm silk, or combinations thereof, as reinforcing materials in fabrics configured with composite materials would be advantageous in both structural and functional applications, and thus as disclosed herein for the management of meibomian gland dysfunction. Other advantages of this disclosure, such as replacing the need for relatively large, expensive, bulky, and energy-inefficient systems with a user-friendly, energy-efficient alternative with precise heating elements, making it relatively inexpensive, could eliminate physicians' fundamental reliance on performing surgery and managing meibomian gland dysfunction and other dry eye conditions, as evidenced in this disclosure.

[0016] Some embodiments of this disclosure relate to fundamentally noninvasive methods and / or apparatus for managing meibomian gland insufficiency, which at least partially utilize thermal energy to heat the eyelids, with the meibomian glands raising the eyelid temperature via heat conduction. In one specific embodiment of this disclosure, the envisioned wearable device is a fabric that can be placed side-by-side with the user's eyelids.

[0017] Some embodiments of this disclosure are configured by selecting a specific arrangement of nanofibers that provide thermal radiation most effectively absorbed by the tissue surrounding lipids or glands, thereby achieving a warming effect without significantly overheating other surrounding ocular appendages. In some embodiments, an integrated temperature sensor may be woven into the wearable fabric to provide feedback to maintain a preferred temperature range for applying heat to the eyelids.

[0018] In some embodiments, the wearable fabric may also be configured with multiple miniature ultrasonic transmitters that can be positioned near the eyelid margin to liquefy calcified or keratinized openings in the wearer's eyelids, either in continuous or intermittent mode, or in a pre-programmed mode, or by user-run trigger intervals.

[0019] In some embodiments, the wearable fabric may further be configured with closely fitting artificial muscles capable of applying contraction strokes that mimic the effect of an eyelid massage. For example, the use of crimped fibers may be an attractive candidate for this purpose because of their simple structure and ability to be actuated by thermal, electrical, or chemical stimulation. In one particular embodiment, carbon fibers may be coupled with a polydimethylsiloxane compound to generate artificial muscle movement and contraction strokes through the fibers. In one embodiment of this disclosure, the wearable fabric may be configured to allow a user to keep their eyes open to perform any routine visual tasks they would otherwise engage in on a normal day; this obviously requires a different structural configuration with a much smaller coverage area compared to a closed-eye condition. In another embodiment, the wearable fabric may also be configured with micromotors or piezoelectric activators.

[0020] In another embodiment of this disclosure, the wearable fabric can be configured such that the user may only use the wearable device with their eyes closed. In such embodiments specifically designed for closed-eye applications, it may be preferable to integrate sensors that detect closed eyelids and apply heat only when the eyelids are closed for an extended period. This provides the user with complete control over the treatment and also improves efficiency because more eyelid tissue is exposed to the treatment when the eyelids are closed. Other variations may be considered by those skilled in the art when applying the treatment overnight with eyes closed. In some embodiments of this disclosure, the fabric is configured with a matrix of electromechanical nanomaterials or nanofibers, which are substantially composed of nanoscale carbon nanotubes, or graphene plates, or graphene sheets, or spider silk fibers or natural silk fibers or other metal fibers, and these fiber bundles are further configured to be substantially aligned along at least one specific direction or axis of the wearer's or device user's eyelids.

[0021] In some embodiments, a micromotor or piezoelectric activator may be configured to provide vibration in a tangential direction to the wearer's eyelid; wherein the vibration of the at least one micromotor or piezoelectric activator generates a pressure wave from the origin of the meibomian gland to its opening, with a pressure range of 0.005 to 0.5 N / mm². 2 The frequency range is 0.5 to 3 Hz.

[0022] In some embodiments, the device may include a multilayer of nanofibers, which are essentially made of carbon nanotubes or graphene sheets or plates, and may be further configured to conform to the shape of the eyelids of an individual wearer. Various electromechanical configurations of nanofibers at multiple locations on the eyelids are contemplated in the present disclosure. The arrangement of nanofibers in the contemplated wearable device may further facilitate heating and mechanical vibration of the wearer's or user's eyelids in at least one specific direction or axis. This disclosure generally relates to methods and devices for managing insufficient meibomian gland lipid production and delivery, eyelid massage using thermal / infrared energy and / or by mechanical vibration, reinforced by the use of wearable fabrics made essentially of stretchable conductive composite yarns, such as nanofibers made of graphene, or carbon nanotubes, or silk, or spider silk, or metal nanowires or combinations thereof. Other suitable yarns are also contemplated.

[0023] One embodiment of this disclosure relates to the field of wearable fabrics made of nanofibers and composite materials. Specifically, the wearable fabric is configured such that bundles of nanofibers having a particular and controlled preferred orientation or arrangement are close to or in contact with the wearer's eyelids. This disclosure also relates to specific types of wearable fabrics configured with yarns comprising bundles of nanofibers exhibiting desired elastic modulus, tensile strength, thermal conductivity and / or electrical conductivity or resistivity.

[0024] Some other embodiments of this disclosure relate to a comprehensive management kit for meibomian gland insufficiency, which includes a convenient combination and personalized management solution for improving the overall health of the eyelids, ocular surface, or ocular appendages, and provides auxiliary relief for the wearer's symptoms of associated dry eye syndrome.

[0025] For example, one embodiment discloses a management kit including: (a) a glasses device for use in an open-eye state; (b) a wearable fabric for use in a closed-eye state; (c) a handheld imaging device for monitoring glandular health; and (d) a mobile application.

[0026] For example, the glasses device of the management kit may be configured with multiple infrared emitters of specific wavelengths to provide thermal energy and multiple infrared sensors to read the surface temperature of the eyelids. For example, the wearable fabric of the management kit may consist of numerous bundles of fibers made of composite yarns, which may be further configured with carbon nanotubes, graphene, spider silk, or natural silk. For example, the handheld imaging device of the management kit may include a multi-frequency self-focusing micromechanical ultrasound transducer and receiver for monitoring glandular health.

[0027] In some embodiments, the management kit further includes software containing dosage and supply information, as well as information on improving eyelid hygiene, which can be continuously checked and updated using periodic information obtained from the user profile. This disclosure relates to kits for managing insufficient meibomian gland lipid production and delivery in a wearer. This disclosure generally relates to personalized kits for maintaining eyelid hygiene and ocular surface health and improving any dry eye-related symptoms in a wearer.

[0028] This disclosure generally relates to kits, methods, and apparatus for managing defects in meibomian gland lipid production and transport, the kit including an eyeglass frame, a wearable fabric, and a portable imaging system. The eyeglass frame and wearable fabric are further configured with micro- or nano-electromechanical components that utilize infrared / thermal energy to massage the eyelids through mechanical vibrations facilitated by the eyeglass frame or wearable fabric, thereby improving the flow of lipids from the wearer's meibomian glands.

[0029] Certain embodiments of this disclosure relate to a fundamentally non-invasive method and / or apparatus for managing meibomian gland defects, which at least partially utilizes infrared light energy to increase the surface temperature of the eyelids, thereby increasing the surface temperature of the eyelids. The temperature of the meibomian glands is increased through the principle of heat conduction. In one specific embodiment of this disclosure, the contemplated ophthalmic device may be eyeglasses or wearable frames, while in another contemplated embodiment example of this disclosure, the ophthalmic device may be an eye mask or goggles, or may be configured near the eyelids or ocular appendages.

[0030] Some embodiments of the glasses or wearables disclosed herein are configured by selecting wavelengths that are most effectively absorbed by tissues surrounding lipids or glands, where a warming effect can be achieved substantially without overheating other tissues around the eye appendages. An integrated non-contact temperature sensor mounted on the glasses or wearable embodiments provides feedback to maintain a preferred temperature range. Several other operating modes are also considered.

[0031] The glasses or wearable frames may be fitted with rows of infrared light-emitting diodes (LEDs) that continuously or intermittently illuminate the upper or lower eyelids and eyelid margins at pre-programmed or user-triggered intervals. In one embodiment, it may be preferable to integrate sensors that detect eyelid closure, and apply heat only when the eyelids are closed for an extended period. This provides the user with complete control over the treatment and also improves efficiency because more eyelid tissue is exposed to treatment when the eyelids are closed.

[0032] Another variation of the disclosure may include a device that facilitates application during overnight eye closure to improve the efficacy of managing meibomian gland dysfunction. In such an embodiment, the user wears an infrared-emitting eye mask to receive prolonged heat treatment via an array of infrared energy sources configured within a wearable fabric mask device. Because the wearable fabric will be in contact with the eyelids, other forms of treatment can be integrated. For example, this might include the application of mechanical vibration or massage, ultrasonic cavitation of the pores, or photoacoustic imaging to control the condition.

[0033] Some embodiments disclose the use of separate infrared LED arrays, wherein the use of separate infrared source arrays can produce patterns of selectively illuminated regions. This configuration of the embodiments may be beneficial in stimulating lipid production and increasing mobility. Some of the contemplated disclosed embodiments use infrared light energy in the wavelength range of approximately 1.2 to 1.7 μm, aimed at maximizing therapeutic efficacy management, as these wavelength regions are known to be most efficiently absorbed by lipids.

[0034] This disclosure generally relates to methods and devices for treating dry eye syndrome, including infrared light and / or ultrasonic energy. One embodiment of this disclosure relates to an ophthalmic device that uses infrared light energy to manage insufficient production and delivery of meibomian gland lipids. Further development of methods and devices is needed to provide a non-invasive and / or manageable procedure that can be performed in the comfort of the end-user's home or without the need for assistance from a medical professional.

[0035] Another embodiment of this disclosure generally relates to the field of wearable fabrics made of nanofibers and composite materials. In particular, the wearable fabric is configured with nanofiber bundles in a preferred orientation or arrangement along the wearer's eyelids to a specific and controlled degree. This disclosure generally relates to types of wearable fabrics composed of yarns containing nanofiber bundles exhibiting desired elastic modulus, tensile strength, thermal conductivity, and / or electrical conductivity.

[0036] Some embodiments of this disclosure relate to a method and / or device for managing meibomian gland insufficiency, which uses infrared light to increase the temperature of the eyelids and / or ocular adnexa, thereby stimulating the flow of lipids secreted from the meibomian glands through thermal conduction.

[0037] Some other embodiments of this disclosure consider selecting wavelengths that are most effectively absorbed by lipids or glands and / or tissues surrounding the ocular appendages, so that the resulting heating effect can be achieved in the tissues surrounding the ocular appendages without overheating.

[0038] In some embodiments, an integrated non-contact temperature sensor is configured to provide feedback to maintain within the preferred temperature range for the individual end user.

[0039] Several other modes of operation are envisioned throughout the disclosure. In one specific embodiment, the ophthalmic device may be eyeglasses or a wearable frame, while in another embodiment, the ophthalmic device may be a wearable fabric or similar wearable device disposed near the eyelid. Attached Figure Description

[0040] Figure 1 The illustration shows a side view of the eye when it is open. The surface of the eye includes the black (pupil) and white (conjunctiva) parts located in the eyelids, the iris, the eyelids, and the meibomian glands. Figure 1 A front view structural diagram of a wearable fabric for eyelids disclosed in certain aspects of the present invention is further shown, the wearable fabric having nanofibers configured in both longitudinal and transverse directions for managing meibomian gland dysfunction.

[0041] Figure 2 A structural diagram of a wearable fabric having a mesh arrangement of nanofibers on the eyelid, according to certain aspects of this disclosure, is shown, which can be used to manage eyes suffering from meibomian gland dysfunction. Each wear session lasts approximately 5 to 20 minutes, and the device is powered by an external rechargeable battery.

[0042] Figure 3 A structural diagram showing a rear view of a pair of glasses or wearable devices that can be used to manage eyes with meibomian gland dysfunction according to certain aspects of this disclosure is illustrated.

[0043] Figure 4A structural diagram of a complete eyeglass or wearable device that can be used to manage eyes suffering from meibomian gland dysfunction, according to certain aspects of this disclosure, is shown.

[0044] Figure 5 A top view of a kit for managing meibomian gland defects is shown, including a wearable eyeglass frame, wearable fabric, handheld ultrasound imager, and USB data transmitter as disclosed herein.

[0045] Figure 6 The capabilities of a handheld ultrasound imaging system were demonstrated, which transfers measured signals to a handheld device (such as a mobile phone or tablet).

[0046] Figure 7 The illustration shows a flowchart of a method for managing an eye suffering from meibomian gland insufficiency, as disclosed herein, according to certain aspects of this disclosure.

[0047] Figure 8 A flowchart is shown of a method guided by personalized user data according to certain aspects of this disclosure, as disclosed herein, which can be used to manage eyes suffering from meibomian gland insufficiency.

[0048] Figure 9 A front view of one embodiment of this disclosure is shown, with the wearer wearing it as a face mask.

[0049] Figure 10 The illustration shows someone wearing the item disclosed herein. Figure 9 The various components of one of the embodiments described herein. Detailed Implementation

[0050] The following description illustrates several embodiments that can share common features of this disclosure. It should be understood that one or more structural features of one embodiment may be combined with one or more functional features of other embodiments. Related terminology should not be used to interpret the scope or limitation of the claims.

[0051] Figure 1 The right half shows a side view of the ocular surface, highlighting the anterior part of the eye (101, cornea, iris, and pupil), eyelids and upper and lower meibomian glands 102 and 103; and the orifice / opening of the eyelid 104.

[0052] Figure 1 The left half (top) shows a front view of the currently disclosed wearable fabric, which has nanofiber arrays (105a and 105b, line stripes) arranged in the meibomian gland (vertical) direction. In this example, the nanofiber array of the wearable fabric comprises at least in part a stretchable conductive composite yarn material made of carbon nanotubes and graphene sheets.

[0053] In another variation of the disclosed embodiments, the nanofiber array of the wearable fabric may at least partially comprise natural silk, spider silk, or rayon. In another variation of the disclosed embodiments, the nanofiber array of the wearable fabric may at least partially comprise metal or metal alloy. In another variation of the disclosed embodiments, the nanofiber array of the wearable fabric may at least partially comprise cotton or denim, and an elastomer formed from polymers or copolymers of polyamides, polyesters, polyolefins, and mixtures thereof.

[0054] The wearable fabric may be equipped with an infrared emitter 108a, which is positioned near the upper and / or lower eyelids to provide additional heating to the eyelids. The wearable fabric is also equipped with a temperature sensor or detector 108b, positioned near the upper and / or lower eyelids. The temperature sensor or detector can be used to obtain feedback on the surface temperature of the eyelids. Furthermore, the electronic circuitry of the wearable fabric may be powered by an externally or internally placed battery, such as a 12V button cell battery. Additionally, the battery may be configured to be rechargeable via an expansion slot.

[0055] In addition to infrared emitters, infrared sensors, and ultrasonic transducers, wearable fabrics can also be equipped with micromotors or piezoelectric activators to provide vibrations in the tangential direction of the wearer's eyelids; wherein the vibration of at least one micromotor or piezoelectric activator generates a pressure wave from the origin of the meibomian gland to its opening, with a pressure range of 0.005 to 0.5 N / mm². 2 The frequency range is 0.5 to 3 Hz.

[0056] Figure 1 The left half (bottom) also shows a side view of another envisioned wearable fabric, which is configured with an array of nanofibers (106a and 106b, stripes) arranged in a direction perpendicular to the meibomian glands (horizontal), an infrared emitter 109a and an infrared sensor 109b configured near the edge of the eyelid.

[0057] also, Figure 1 The wearable fabric is also equipped with an ultrasound emitter 109c to promote the breaking up of calcified eyelid openings, which in turn helps increase the amount of lipids in the tarsal plate through the openings. The ultrasound emitter is positioned at the edge of the eyelid. The electronic circuitry of the wearable fabric can be powered by an externally or internally placed battery, such as a flexible, rechargeable lithium-ion battery.

[0058] Figure 2A side view of another envisioned wearable fabric is shown, configured with nanofiber arrays (201 and 202, cross-stripe patterns) arranged in two directions (horizontal and vertical) parallel and perpendicular to the meibomian glands. Furthermore, wires adjacent to the positive and negative terminals can be operated by an externally or internally placed battery 203. In some embodiments, the nanofibers may be doped with other elements, such as boron. It is conceivable... Figure 1 and Figure 2 Various other configurations are possible to simplify the present disclosure to make it operable. The device can be designed to be simple and inexpensive; on the other hand, more complex embodiments with similar functionality are also conceivable. For example, the power source can be configured as an extension of wearable fabric, or it can be obtained externally via a cable. In another example, the power source can be housed in a headgear to reduce load on the eyelids, eye sockets, or near the face.

[0059] In addition, temperature control can be achieved via a manual switch, or by configuring an electronic chip on the wearable fabric, which... Figure 2 The control is based on feedback provided by the readings obtained from the infrared sensor depicted. Various other configurations can also be considered. For more accurate temperature readings, it may be advantageous to temporarily disable the nanofibers before and during temperature measurement.

[0060] Figure 1 and Figure 2 The wearable fabric can be further configured with ultrasound transmitters near the lower and upper edges of the eyelids. An onboard rechargeable battery is envisioned to power the transmitters, sensors, and microchip computer. Data or information processed on the microcomputer 205 can be transmitted to a smart device 208 (mobile phone or tablet) via standard Bluetooth connectivity 207 or wireless functionality 206. The transmitted data or information may relate to, for example, the voltage settings of the wearable fabric, the current settings of the wearable fabric, the resistance settings of the nanofibers, the frequency settings of the ultrasound transmitters, the power settings of the ultrasound transmitters, the temperature readings of the infrared sensors, the blink detector, the device's battery status, the device's Wi-Fi status, the device's Bluetooth status, or querying the device's idle status. Further improvements to enhance efficiency can be considered by customizing the device using patient-specific parameters. For example, the shape and size of the eyelids can be obtained using state-of-the-art imaging systems such as time-of-flight sensors, 3D depth imaging, etc., which are commonly used for facial imaging. Using information from captured images, wearable fabrics or similar devices can be 3D printed to specific personalized parameters for individual users, further improving the efficacy and efficiency of managing meibomian gland dysfunction through a customized arrangement of the sensors and transmitters.

[0061] This disclosure relates to a method and apparatus for treating meibomian gland defects, which uses thermal energy to increase the temperature of the eyelid, thereby increasing the temperature of the meibomian gland, leading to the liquefaction of coagulated meibomian lipids. By selecting an appropriate arrangement of carbon nanotubes or graphene layers constituting the fiber bundles of the intended wearable fabric, the heating effect is modulated to be effectively absorbed by the lipids or surrounding tissues, achieving good heating without overheating other tissues. It should be learned from semiconductor physics that chemical doping (i.e., adding impurities to a semiconductor) can lead to a significant increase in free carrier concentration, thereby improving electrical and thermal conductivity.

[0062] In some embodiments, these carbon nanotubes exhibit higher electrical conductivity or lower resistivity than, for example, modern metallic wiring, even at the nanoscale. In some embodiments, carbon nanofibers or graphene sheets may be combined with certain impurities to slightly increase resistivity for precise heating of the element. For example, boron-doped single-walled carbon nanotubes may be used in the intended device.

[0063] In another embodiment, the combination of boron and nickel can be incorporated into one or more carbon electrodes. In other examples, the electrodes may also contain one or more catalysts, such as Fe, Co, or Ni and / or alloys thereof. In some embodiments, the conductive nanofibers may include at least one of carbon nanotubes, graphene, or metal wires.

[0064] In yet another preferred embodiment, the yarn in the fabric comprises at least one fiber selected from wool, cotton, nylon, synthetic fibers, or metals. Certain embodiments of this disclosure relate to managing meibomian gland dysfunction via wearable fabrics configured with carbon nanotubes, graphene sheets, spider silk, natural silk, or combinations thereof.

[0065] Some embodiments of composite carbon nanotube structures involve several carbon nanotubes disposed within a matrix composed of a metal or metal oxide, which can be used to fabricate wearable fabrics for the treatment of meibomian gland dysfunction. Composite carbon nanotube structures can also be used as thermal interface devices in encapsulated integrated circuit devices.

[0066] Some embodiments of this disclosure include wearable nanofabrics made of composite yarns; wherein the composite yarns are prepared using a method comprising: forming a metal layer with nanowires; anodizing the metal layer to form a porous metal oxide layer; and forming carbon nanotubes in the pores of the porous metal oxide layer.

[0067] In some embodiments, the envisioned thermal interface and method comprise an array of carbon nanotubes arranged substantially perpendicular to the meibomian glands on the upper or lower eyelid. In other embodiments, the anticipated thermal interface and method comprise an array of carbon nanotubes arranged substantially parallel to the meibomian glands on the upper or lower eyelid; wherein the thermal interface further comprises a plurality of structures for thermal contact with different structures within the wearable fabric; a plurality of substantially aligned carbon nanotubes projecting substantially perpendicularly from a plurality of surface structures are configured to improve thermal contact with the remaining plurality of structures to enhance the thermal efficiency of the wearable fabric, thereby better managing potential meibomian gland dysfunction in the wearer.

[0068] In some other embodiments, certain frequencies of the ultrasound transmitter are configured such that the energy beam is focused onto the edge and / or portion of the eyelid, such as the meibomian glands and / or ocular adnexa. In some embodiments, an integrated temperature sensor provides feedback to maintain within a preferred temperature range. A variety of other operating modes are also envisioned.

[0069] In some embodiments, ultrasonic energy can be used to help liquefy or emulsify blocked openings, or calcification within the eyelid margin. For example, an additional ultrasonic energy source can be used to manage keratinization of eyelid margin pores (openings); wherein the ultrasonic energy can be configured to have a resonant frequency between 50 kHz and 1 MHz, between 1 MHz and 1.5 MHz, or between 50 kHz and 2 MHz.

[0070] In some other embodiments, an additional ultrasonic energy source may be used to control the calcification of the openings at the eyelid margin; wherein the ultrasonic energy may be configured with a resonant frequency of at least 50 kHz, at least 75 kHz, at least 100 kHz, at least 150 kHz, at least 300 kHz, at least 500 kHz, at least 750 kHz, at least 1 MHz, at least 1.5 MHz, or at least 2 MHz.

[0071] Among the various exemplary embodiments presented in this disclosure, the size, strength, and arrangement of ultrasonic energy emitters, as well as other physical and functional characteristics of wearable devices, are envisioned.

[0072] In some embodiments, to improve lipid flow through the meibomian glands, at least one, three, or six ultrasound energy emitters may be arranged side-by-side with the margins of the upper and / or lower eyelids.

[0073] In some other embodiments, the number of ultrasound energy emitters may be between 1 and 3, or 2 and 4, or 2 and 5, or 1 and 6, in order to improve the flow of lipid secretion in the tarsal plate.

[0074] In some embodiments, the number, size, and arrangement of energy sources configured within the wearable fabric device can make at least 1 mm2 At least 8mm 2 At least 20mm 2 At least 40mm 2 At least 60mm 2 At least 100mm 2 At least 150mm 2 Or at least 200mm 2 The surface area of ​​the eyelids is managed or treated.

[0075] In some embodiments, the quantity, size, and arrangement of wearable fabric can help control the surface area of ​​the eyelid to 0.5 mm. 2 up to 1mm 2 1mm 2 up to 8mm 2 8mm 2 Up to 20mm 2 20 mm 2 up to 40 mm 2 40 mm 2 up to 60mm 2 60mm 2 Up to 100mm 2 100 mm 2 Up to 150mm 2 or 150mm 2 Up to 200mm 2 between

[0076] Figure 3 The diagram shows a rear view of a proposed eyeglass frame or wearable device, configured with a source array (white-filled features) and detectors (dark-shaped features), arranged inwards in the direction of the upper and / or lower eyelids. The white-filled features depict infrared light sources configured on the upper edge 301 and lower edge 302 of the proposed eyeglass frame or wearable device. The dark-filled features depict infrared temperature sensors on the lower edges 303, 304 and upper edges 305, 306 of the proposed eyeglass frame.

[0077] It can be imagined Figure 3 Various other configurations are possible to simplify the present disclosure into operability. The device can be designed to be simple and inexpensive; on the other hand, more complex embodiments with similar functionality can be considered. For example, the power supply for the glasses or wearable device can be configured within the glasses, or the power can be obtained externally via a wire. Furthermore, temperature control can be performed via a manual switch or by an electronic chip configured on the glasses or wearable frame, providing feedback based on readings obtained via an infrared sensor. Various other configurations are also conceivable. To obtain more accurate temperature readings, it may be advantageous to temporarily disable the infrared emitter before and during temperature measurement.

[0078] Figure 4 Another version of the smart eyeglasses frame envisioned in this disclosure is shown. Figure 4 A complete view of a smart eyeglass frame or wearable device is shown, with infrared sources (white-filled features) configured on the lower edges 401 and upper edges 403 of the eyeglasses or wearable device; and infrared sensors (402 and 404, black-filled features) located on the lower edge of the eyeglasses or wearable device. Figure 4 The glasses or wearable device are further configured with ultrasound sources on the lower 405 and upper 406 edges. To conduct ultrasound energy to the eyelid surface, particularly focusing on blocked or calcified openings, a matching liquid bag can be provided. For example, the liquid bag can be a biocompatible gel, gel bag, water bag, or any other liquid that helps conduct and guide ultrasound energy to the blocked opening. An onboard rechargeable battery 407 powers the transmitter, sensor, and microcomputer 408. Data or information processed on the microcomputer can be stored on-board and / or transmitted to a smart device (411, phone, or tablet) communication chip via standard Bluetooth connectivity 410 or wireless functionality 409 or near-field transmission. The transmitted data or information can relate to, for example, the intensity setting of the infrared transmitter, the power setting of the infrared transmitter, the frequency setting of the ultrasound transmitter, the power setting of the ultrasound transmitter, the temperature reading of the infrared sensor, the blink detector, the device's battery status, the device's Wi-Fi status, the device's Bluetooth status, or querying the device's idle status.

[0079] In some embodiments, the size of the infrared emitting region that can be configured on the upper and / or lower edges of the glasses or wearable device disclosed herein can be approximately 0.2 mm. 2 up to 0.4mm 2 0.3mm 2 up to 0.6 mm 2 Between, 0.4 mm 2 up to 0.8mm 2 Between, 0.8 mm 2 and up to 1 mm 2 Between, or 0.2 mm 2 Up to 1 mm 2 between.

[0080] In some embodiments, the size of the infrared emitting region that can be configured on the upper and / or lower edges of the glasses or wearable device disclosed herein may be at least 0.2 mm. 2 0.3 mm 2 0.4 mm 2 0.5 mm 2 0.6 mm 2 0.7 mm 20.8mm 2 0.9 mm 2 or 1 mm 2 .

[0081] In some embodiments, to improve the flow of meibomian gland lipids through the meibomian glands, at least 3, 6, 9, 12, or 15 infrared energy sources may be configured on the upper and / or lower edges of the glasses or wearable device.

[0082] In some other implementations, the number of infrared energy sources may be between 3 and 6, or 6 and 9, or 9 and 12, or 3 and 12, or 3 and 15, in order to improve the flow of meibomian gland secretions.

[0083] In some embodiments, the wearable eyeglass frame of the present invention includes an infrared emitter disposed on the back of the eyeglass frame facing the upper or lower eyelid, which is coupled to at least one micro-optical element to improve transmission and thermal efficiency to the wearer's eyelid; wherein the micro-optical element is configured to generate a patch defining an application area.

[0084] In some other embodiments that utilize wearable fabrics or smart eyeglass frames or wearable frames to improve the flow of meibomian secretions, the surface temperature of the upper or lower eyelid may be at least 40°C, 41°C, 42°C, 43°C, 44°C, 45°C, or 46°C.

[0085] In some other embodiments that utilize wearable fabrics or smart eyeglass frames or wearable frames to improve the flow of meibomian gland secretions, the surface temperature of the upper or lower eyelid can be between 40°C and 41°C, 41°C and 42°C, 42°C and 43°C, 43°C and 44°C, 44°C and 45°C, 41°C and 45°C, 43°C and 46°C, 40°C and 43°C, or 40°C and 46°C.

[0086] In some other embodiments that utilize wearable fabrics or smart eyeglass frames or wearable frames to improve the flow of meibomian gland secretions, the contemplated infrared energy source may operate in the wavelength range of 1 μm to 1.2 μm, 1.2 μm to 1.6 μm, 1.2 μm to 1.8 μm, or 1 μm to 2 μm.

[0087] In some other embodiments that utilize wearable fabrics or smart eyeglass frames or wearable frames to improve the flow of meibomian gland secretions, the envisioned infrared light energy can operate at wavelengths above at least 1 μm, 1.1 μm, 1.2 μm, 1.3 μm, 1.4 μm, 1.5 μm, 1.6 μm, 1.7 μm or 1.8 μm.

[0088] In some embodiments, the number, size, and arrangement of infrared energy sources mounted on smart eyeglasses frames or wearable frames can provide at least 1 mm 2 4 mm 2 8 mm 2 12 mm 2 16 mm 2 20 mm 2 30 mm 2 40 mm 2 60 mm 2 or 80 mm 2 The surface area of ​​the eyelids.

[0089] In some embodiments, the number, size, and arrangement of infrared energy sources mounted on eyeglasses or wearable frames can provide 1 mm 2 Up to 8 mm 2 8 mm 2 Up to 20 mm 2 20 mm 2 Up to 40 mm 2 30 mm 2 Up to 60 mm 2 40 mm 2 Up to 70 mm 2 50 mm 2 Up to 80 mm 2 or 20 mm 2 Up to 80 mm 2 Between eyelid treatment management area

[0090] In some embodiments of this disclosure, the envisioned glasses or wearable frames may be configured with multiple rows of infrared light sources that continuously or intermittently illuminate the eyelids and eyelid margins at pre-programmed or user-triggered intervals.

[0091] In one embodiment of certain examples, it may be necessary or preferred to integrate a sensor that can detect closed eyelids, which can adjust the applied heating energy based on the open or closed state of the eyelids.

[0092] For example, the intensity and duration of the infrared light source pulses can be automatically adjusted based on whether the eyes are open or closed. For instance, with the eyes closed, the pulse intensity and duration can be programmed to be significantly greater than the expected intensity and duration with the eyes open. Such programming capabilities provide users with complete control over their treatment and also improve efficiency because more eyelid tissue is exposed to treatment when the eyelids are closed, rather than when they are open.

[0093] In yet another exemplary embodiment, a different variant can be envisioned for overnight use on a closed eye; where ultrasonic energy can be used to manage cavitation of the blocked pores. By using a single array of infrared LEDs, patterns of selectively illuminated areas can be created. This may be beneficial for stimulating lipid production and increasing fluidity.

[0094] The most effective therapeutic results can be obtained by using infrared light with wavelengths between 1.2 and 1.7 μm. These are the regions where lipids absorb energy most efficiently.

[0095] In some other contemplated variations of this disclosure, not every user is an eyeglass wearer, in which case the contemplated device of this disclosure may be a wearable frame without lenses or with flat lenses or sunglasses, as listed herein.

[0096] Information regarding the functional and structural aspects of the content disclosed herein should be interpreted solely as a representative basis for guiding those skilled in the art in using the disclosure and variations of embodiments. This disclosure is not limited to any particular construction described and illustrated herein, but should be constructed in accordance with all modifications that may fall within the scope of the appended claims. Although the embodiments shown and described are intended to be practical and preferred, it will be apparent to those skilled in the art that different specific designs and / or methods may be used, and can be employed without departing from the spirit and scope of this disclosure. The description of this disclosure refers to one or more embodiments, some of which are illustrated by the accompanying drawings. The embodiments or drawings are provided in an illustrative manner and should not be construed as limiting the scope of this disclosure.

[0097] Some embodiments of this disclosure relate to the management of meibomian gland dysfunction via eyeglass frames or wearable devices configured such that a wavelength of an infrared light source is matched with certain frequencies of additional ultrasonic energy, such that the energy beam is focused onto the eyelid and / or a portion of the eyelid, such as the meibomian gland and / or ocular appendages. In yet another embodiment of this disclosure, other forms of energy, such as continuous or pulsed energy with relatively high peak energy, may also be used for meibomian gland treatment. The size, intensity, and arrangement of the energy source, as well as other physical and functional characteristics of the eyeglasses or wearable devices, can be considered in the various exemplary embodiments presented in this disclosure.

[0098] In addition to the discomfort caused by meibomian gland dysfunction, blocked meibomian glands can lead to other eye infections, including styes, chalazion, or blepharitis. Diagnosis and treatment of dry eye involve several factors, including tear production, tear film quality, eyelid hygiene, natural bacteria, and even diet. This disclosure also envisions multifaceted approaches to managing meibomian gland defects through the conception of personalized kits, as disclosed herein. Therefore, this disclosure provides convenient combinations and personalized treatments for improving overall eyelid hygiene and improving meibomian gland defects.

[0099] The advent of current technologies has made it possible to miniaturize complex optical, electrical, electronic, or mechanical systems into portable, handheld, and relatively economical devices capable of performing the same complex tasks as those of the previous decade. This disclosure includes a kit for managing meibomian gland dysfunction comprising a diagnostic, non-invasive pocket imaging system for the user. Other advantages of this disclosure, such as user-friendly, energy-efficient, precise heating elements, and relative inexpensiveness, and the potential to eliminate the fundamental need for physician-assisted surgery and management of meibomian gland dysfunction and dry eye, will become apparent.

[0100] Figure 5 A kit for managing meibomian gland insufficiency is demonstrated, comprising: a wearable frame configured with at least one transmitter and a sensor; a wearable fabric comprising a bundle of composite yarns of electromechanical materials; and a handheld portable ultrasound device comprising at least one ultrasound transmitter and a sensor for imaging the wearer's meibomian glands. As disclosed herein, the kit 500 for managing meibomian gland deficiency includes an eyeglass frame 501, a wearable fabric 502, a handheld ultrasound device 503, and a USB data transmitter 504. The functions of the eyeglass frame and the wearable fabric are as follows... Figures 1 to 4 As shown.

[0101] Figure 6 The handheld ultrasound imaging system 603 is demonstrated to function on the wearer's upper eyelids 601 and lower eyelids 602, relaying the measured signals to a handheld device (605, such as a mobile phone or tablet) via a Bluetooth or Wi-Fi module. Data collected from the user can be sent and stored in the cloud 606.

[0102] Figure 7The illustration shows a flowchart of a method for managing the eyes according to certain aspects of this disclosure, as disclosed herein. In some embodiments of the kit, a time-of-flight sensor or a 3D depth camera can be used to image the shape, size, and other features of a user's eyelids to allow 3D reconstruction of the eyelid and facial contours. Furthermore, the imaging information about the eyelid and facial contours can be used as input to a conventional or specialized 3D printer to obtain eyeglasses or wearable frames, which can be further configured to include anticipated infrared sensors and emitters to manage meibomian gland defects, as disclosed herein. In yet another embodiment of the kit, the imaging information about the eyelid and facial contours can be used as input to a conventional or specialized 3D printer to obtain a wearable face mask.

[0103] Figure 8 Further improvements to the intended public disclosure are provided, where individual user parameters can be used to customize the device to improve efficiency. Figure 8 A flowchart of a method for managing the eyes, guided by personalized user data according to certain aspects of this disclosure, is further illustrated herein. In one embodiment of the kit disclosed herein, data describing meibomian gland characteristics, such as the shape, size, area, volume, or expressibility of the meibomian glands (i.e., the ability of the meibomian glands to release meibum when pressure is applied), can be collected as a function of time.

[0104] In some embodiments of the kit, the collected information summarizing the characteristics of the meibomian glands can be displayed on a handheld device, such as a tablet or telephone. In one embodiment, a substantially non-invasive method and / or device, such as glasses or a wearable frame, is selected from the kit that at least partially uses infrared energy to heat the eyelids, thereby increasing the temperature of the meibomian glands based on the principle of heat conduction. For example, a substantially non-invasive method and / or device may be selected from the kit. For example, a wearable fabric that at least partially uses thermal energy to heat the eyelids, thereby increasing the temperature of the meibomian glands based on the principle of heat conduction, may also be referred to as Joule heating.

[0105] In some embodiments of this disclosure, the wearable fabric of the kit is intended to be configured with a specific arrangement of fibers that provide thermal radiation, which is most effectively absorbed by tissue surrounding lipids or glands, achieving a warming effect without significantly overheating other tissues around the eye appendages. In some embodiments of the kit, an integrated non-contact temperature sensor may be configured onto the eyeglass frame. A variety of other modes of operation will be conceived by those skilled in the art.

[0106] In some embodiments of the kit, an integrated temperature sensor may be woven into the wearable fabric to provide feedback to maintain a preferred temperature range for the heating application. In some embodiments of the kit, the wearable fabric may also be configured with an additional array of micro-ultrasound transmitters, which may be positioned near the edges of the upper and / or lower eyelids to operate in continuous or intermittent modes or in a pre-programmed mode, or to liquefy calcified or keratinized openings in the wearer's eyelids at user-triggered intervals.

[0107] In another embodiment of the kit disclosed herein, the wearable fabric may be configured to allow users to keep their eyes open to perform any routine visual tasks they would normally engage in on a normal day; while in another embodiment of the kit disclosed herein, the wearable fabric may be configured to allow users to use the wearable device only under near-vision conditions. In embodiments of the kit specifically designed for applications during eyelid closure, sensors for detecting eyelid closure are preferably integrated, and heat is applied only when the eyelid is closed for an extended period. This provides the user with complete control over the treatment and also improves efficiency because more eyelid tissue is exposed to treatment during eyelid closure.

[0108] Those skilled in the art may consider other variations of the treatment when the eyes are closed overnight.

[0109] In some embodiments of the kit disclosed herein, the fabric is configured with a matrix of electromechanical materials or fibers, which are substantially composed of carbon nanotubes or graphene plates or sheets or spider silk fibers or natural silk fibers or other metal fibers, and these fiber bundles are further configured to be substantially aligned along at least one particular direction or axis along the eyelids of the wearer or user of the device.

[0110] In some embodiments of the kit, the device may include a multilayer of nanofibers, substantially made of carbon nanotubes and / or graphene sheets or plates, which may be further configured to conform to the shape of an individual wearer's eyelids. Various electromechanical configurations of the nanofibers at multiple locations on the eyelids are contemplated in the currently disclosed kit. The arrangement of the nanofibers in the envisioned wearable device may further facilitate heating and mechanical vibration in at least one specific direction or axis of the wearer's or user's eyelids.

[0111] Various other configurations of the kit can be envisioned to put this disclosure into practice. The kit's device can be designed to be simple and inexpensive, while more complex embodiments are also conceivable. For example, the power source can be configured as an extension of the wearable fabric of the kit, or it can be obtained externally via a cable. The wearable fabric of the kit can be further configured with ultrasonic transmitters near the lower and upper edges of the eyelids. An onboard rechargeable battery is envisioned to power the transmitters, sensors, and microchip computer. Data or information processed on the microcomputer can be transmitted to smart devices using standard Bluetooth connectivity or wireless functionality.

[0112] Claims Example Set A – Wearable Fabrics

[0113] A wearable fabric device configured to be positioned alongside the wearer's eyelids for managing meibomian gland dysfunction in the wearer;

[0114] The wearable fabric device includes a substantially stretchable conductive composite yarn material comprising one or more of the following: carbon nanotubes, graphene sheets, natural silk, spider silk or rayon, metal or alloy, cotton or denim, and elasticity from polymers or copolymers of polyamide, polyester, polyolefin and mixtures thereof.

[0115] The wearable fabric device also includes one or more of the following components: an infrared transmitter, an infrared sensor, an ultrasonic transmitter, a micro motor, a microcomputer, a Bluetooth module, a near-field communication chip, a Wi-Fi module, and a rechargeable battery power supply.

[0116] The wearable fabric device in use applies heat energy from the outside to the wearer's upper and / or lower eyelids; causing the application of heat energy to liquefy the lipids (meibum) in the wearer's meibomian glands;

[0117] The wearable fabric device in use applies mechanical energy from the outside to the wearer's upper or lower eyelids, causing the directional force generated by the mechanical energy to act on the obstruction within the meibomian gland at its opening;

[0118] In this method, the wearable fabric device applies concentrated ultrasonic energy near the opening of the wearer's upper or lower eyelid; this application of ultrasonic energy promotes the emulsification of hardened meibomian fat at the opening of the wearer's upper or lower eyelid; and

[0119] Among them, the wearable fabric device in use provides closed-loop feedback and active control mechanisms to use a mobile application to fine-tune the thermal and mechanical energy applied to the wearer's eyelids.

[0120] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the fabric is configured to take into account wearer-specific information about the eyelids, face, or eye socket.

[0121] One or more of the aforementioned examples of wearable fabric devices in set A, wherein the number of infrared emitters arranged side by side with the eyelid edge is between 2 and 6, between 2 and 8, between 3 and 9, or between 4 and 10.

[0122] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the at least one infrared emitter has a wavelength of at least 950 nm, at least 1050 nm, at least 1150 nm, at least 1300 nm, at least 1500 nm, or at least 1700 nm.

[0123] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the area on which heat is applied to the wearer's upper or lower eyelid is at least 3 mm. 2 .

[0124] Wearable fabric devices of one or more of the foregoing examples in group A, wherein the area on which heat is applied to the wearer's upper or lower eyelid is between 3 and 9 mm. 2 3 to 12 mm 2 or 3 to 18mm 2 between.

[0125] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the surface temperature on the upper or lower eyelid is at least 40°C, at least 40.5°C, at least 41°C, at least 41.5°C, at least 42°C, at least 42.5°C, at least 43°C, or at least 43.5°C.

[0126] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the surface temperature on the upper or lower eyelid is between 40°C and 43.5°C, between 41°C and 42.5°C, between 41.5°C and 43°C, between 41.5°C and 44.5°C, or between 41.5°C and 46.5°C.

[0127] One or more of the aforementioned examples of wearable fabric devices in set A, wherein heat is continuously and uniformly applied to the upper or lower eyelid for 10 to 60 minutes.

[0128] One or more of the aforementioned examples of wearable fabric devices in set A, wherein heat energy is applied discontinuously to the upper or lower eyelid in a pulsating mode for a period of 10 to 60 minutes, such that the pulsating operation mode generates a temperature gradient at the eyelid position.

[0129] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the applied thermal energy has a frequency between 10 and 30 Hz for continuous heating.

[0130] One or more of the aforementioned examples of wearable fabric devices in set A, wherein the applied thermal energy has a frequency between 0.5 and 5 Hz for pulse heating.

[0131] One or more of the aforementioned examples of wearable fabric devices in set A, wherein heat is applied across the upper or lower eyelid in a gradient manner, such that the temperature at which heat is applied to the meibomian gland opening is at least 2°C higher than the temperature applied to the top of the meibomian gland, such that the applied temperature gradient facilitates the smooth flow of liquefied meibomian fat from the gland to the opening of the wearer's eyelid.

[0132] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the at least one micromotor is configured to provide vibration in the tangential direction of the wearer's eyelid.

[0133] Wearable fabric devices of one or more of the foregoing examples in group A, wherein the vibration of the at least one micromotor generates a pressure wave from the origin of the meibomian gland to its opening, with a pressure range of 0.005 to 0.5 N / mm. 2 The frequency range is 0.5 to 3 Hz.

[0134] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the at least one micromotor is configured to provide rotational force distribution in the tangential direction of the wearer's eyelid.

[0135] Wearable fabric devices of one or more of the foregoing examples in set A, wherein at least one ultrasound transmitter is configured to be side-by-side with the edge of the upper eyelid and at least one ultrasound transmitter is configured to be side-by-side with the edge of the lower eyelid.

[0136] One or more of the aforementioned examples of wearable fabric devices in set A, wherein the number of ultrasound emitters configured to be arranged alongside the eyelid margin is between 2 and 6, between 2 and 8, or between 3 and 9.

[0137] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the frequency of the at least one ultrasonic transmitter is at least 100 kHz, at least 200 kHz, at least 300 kHz, at least 400 kHz, or at least 500 kHz.

[0138] Wearable fabric devices of one or more of the foregoing examples in set A, wherein the frequency range of the at least one ultrasonic transmitter is between 100 kHz and 500 kHz, 200 kHz and 500 kHz, or 100 kHz and 300 kHz.

[0139] One or more of the aforementioned examples of wearable fabric devices in set A, wherein the fabric is held in place by an elastic headpiece against the upper or lower eyelid; wherein the elastic headpiece is equipped with a rechargeable battery for powering the device at the back of the head.

[0140] A method for managing meibomian gland dysfunction in a wearer, the method comprising an executable mobile application comprising: (a) a wearable device communication module configured to communicate with a wearable device, according to an example of claim A; (b) a data processing module for processing data received by the wearable device; and (c) a user interface module for providing a user interface for collecting user-specific data for storage in a user database and prompting the user for suggestions on modifying treatment management or better treating the user's meibomian gland dysfunction.

[0141] A method for managing meibomian gland dysfunction in a wearer, utilizing wearer- or user-specific data, includes multiple thresholds that can be set or modified by the wearer or user via a user interface module of a mobile application.

[0142] Wearable fabric devices as executed by one or more of the preceding claims of set A, wherein the executable mobile application is used to change the properties of applying thermal or mechanical energy to the upper or lower eyelids of the wearer.

[0143] A method for managing meibomian gland dysfunction in a wearer, the method comprising the steps of: (a) receiving data from a wearable device according to any one of the examples of claims in set A; (b) processing the received data in a data processing unit via a mobile application; (c) comparing at least one set of processed data with at least one standard or baseline measurement associated with normative data of meibomian gland dysfunction; and (d) generating or altering thermal or mechanical energy as part of personalized treatment using the wearable device.

[0144] Claims Example Set B – Glasses-based Device for MGD

[0145] An eyeglass frame for managing meibomian gland dysfunction in wearers;

[0146] The eyeglass frame includes one or more of the following components: an infrared emitter, an infrared sensor, an ultrasonic transducer, a microcomputer, a Bluetooth module, a near-field communication chip, a Wi-Fi module, and a rechargeable battery power source;

[0147] The eyeglass frame directs heat energy to the surface of the wearer's upper and / or lower eyelids, causing at least some of the lipids (meibum) in the wearer's meibomian glands to liquefy when the eyes are open and closed.

[0148] The eyeglass frames in use provide closed-loop feedback and active control mechanisms to fine-tune the heat applied to the wearer's eyelid surface using a mobile application.

[0149] The eyeglass frames of one or more of the aforementioned examples in set B, wherein the shape of the eyeglass frames is configured to take into account wearer-specific information regarding the eyelids, face, or eye socket.

[0150] One or more of the aforementioned examples of eyeglass frames in set B, wherein the number of infrared emitters disposed on the back of the eyeglass frame is between 2 and 8, between 4 and 12, or between 2 and 16; wherein the arrangement of the back of the eyeglass frame causes them to direct heat energy toward the wearer's eyelids.

[0151] One or more of the aforementioned examples of eyeglass frames in set B, wherein each infrared emitter disposed on the back of the eyeglass frame is also coupled to at least one micro-optical element to improve the heat transfer and efficiency of the eyelids of the eyeglass wearer. The micro-optical element is configured to generate a patch defining an application area.

[0152] Eyeglass frames of one or more of the foregoing examples in set B, wherein the wavelength of the infrared emitter has at least 950 nm, at least 1050 nm, at least 1150 nm, at least 1300 nm, at least 1500 nm, or at least 1700 nm.

[0153] The eyeglass frames of one or more of the foregoing examples in set B, wherein the area on which heat is applied to the wearer's upper or lower eyelid is at least 3 mm. 2 .

[0154] The eyeglass frames of one or more of the aforementioned examples in set B, wherein the area on which heat is applied to the wearer's upper or lower eyelid is between 3 and 6 mm. 2 3 to 12 mm 2 , or 3 and up to 18 mm 2 between.

[0155] The eyeglass frames of one or more of the foregoing examples in set B, wherein the surface temperature on the upper or lower eyelid is at least 40°C, at least 40.5°C, at least 41°C, at least 41.5°C, at least 42°C, at least 42.5°C, at least 43°C, or at least 43.5°C.

[0156] The eyeglass frames of one or more of the foregoing examples in set B, wherein the surface temperature on the upper or lower eyelid is between 40°C and 43.5°C, between 41°C and 42.5°C, between 41.5°C and 43°C, between 41.5°C and 44.5°C, or between 41.5°C and 46.5°C.

[0157] The eyeglass frames of one or more of the aforementioned examples in set B, wherein the number of infrared light sources is at least three in the upper edge of the eyeglasses and at least three in the lower edge of the eyeglasses.

[0158] The eyeglass frames of one or more of the aforementioned examples in set B, wherein the number of ultrasound transmitters configured to be parallel to the eyelid margin is between 2 and 6, between 2 and 8, or between 3 and 9.

[0159] The eyeglass frames of one or more of the aforementioned examples in set B, wherein each ultrasonic transmitter has a frequency of at least 100 kHz, at least 200 kHz, at least 300 kHz, at least 400 kHz, or at least 500 kHz.

[0160] The eyeglass frames of one or more of the aforementioned examples in set B, wherein each of the ultrasonic transmitters has a frequency range of 100 kHz to 500 kHz, 200 kHz to 500 kHz, or 100 kHz to 300 kHz.

[0161] One or more of the aforementioned examples of eyeglass frames in set B, wherein each ultrasonic transmitter is used in conjunction with a fluid-filled silicone bag adjacent to the ultrasonic source of the eyeglass frame and the closed eyelid to facilitate the transfer of ultrasonic energy to a target location on the eyelid.

[0162] The eyeglass frames of one or more of the aforementioned examples in set B, wherein heat is continuously and uniformly applied to the upper or lower eyelid for 10 to 60 minutes.

[0163] The eyeglass frames of one or more of the aforementioned examples in set B, wherein thermal energy is applied discontinuously to the upper or lower eyelid in a pulsating mode for 10 to 60 minutes, such that the pulsed operation mode generates a positional gradient of eyelid temperature; wherein the applied thermal energy pulses have a frequency between 0.1 Hz and 30 Hz.

[0164] A method for managing meibomian gland dysfunction in a wearer, the method comprising an executable mobile application comprising: (a) a wearable device communication module arranged to communicate with glasses, according to an example of claim B; (b) a data processing module for processing data received by the glasses; and (c) a user interface module for providing a user interface for collecting user-specific data for storage in a user database and prompting the user for suggestions on modifying the management or better treatment of the user's meibomian gland dysfunction.

[0165] A method for managing meibomian gland dysfunction in a wearer, utilizing wearer- or user-specific data, including multiple thresholds that can be set or modified by the wearer or user via a user interface module of a mobile application.

[0166] Wearable eyeglass frames of one or more of the foregoing examples in set B, wherein a mobile application can be executed to change the properties of the heat energy applied to the wearer's upper or lower eyelids.

[0167] A method for managing meibomian gland dysfunction in a wearer, the method comprising the steps of: (a) receiving data from glasses according to any one of the examples of claims in set B; (b) processing the received data in a data processing unit via a mobile application; (c) comparing at least one set of processed data with at least one standard or baseline measurement associated with normative data of meibomian gland dysfunction; and (d) generating or altering thermal or mechanical energy as part of personalized treatment using a wearable device.

[0168] Claims Example Set C – Kit for Treating Meibomian Gland Dysfunction

[0169] A kit for managing meibomian gland defects in wearers includes: a wearable fabric, an eyeglass frame, a handheld portable ultrasound imaging device, and a mobile application; wherein the wearable fabric or eyeglass frame is configured to take into account specific measurements of at least one user;

[0170] The wearable fabric of the kit includes a basically stretchable conductive composite yarn material, comprising one or more of the following: carbon nanotubes, graphene sheets, natural silk, spider silk, rayon, pure metal, metal alloy, cotton, denim, or an elastomer formed from polymers or copolymers of polyamide, polyester, polyolefin and mixtures thereof.

[0171] The wearable fabric of the kit also includes one or more of the following components: multiple infrared emitters, multiple infrared thermometers, multiple ultrasonic transducers, multiple micro motors, a microcomputer, a Bluetooth module, a near-field communication chip, a Wi-Fi module, and a rechargeable battery power supply.

[0172] Among them, multiple infrared emitters of the wearable fabric provide the desired level of heat energy during use to be applied from the outside to the wearer's eyelids, causing the lipids (melanin) in the wearer's meibomian glands to liquefy when the eyes are closed.

[0173] The wearable fabric contains multiple micromotors that provide the desired level of mechanical energy or vibrational force during use, applied externally to the wearer's eyelids to generate a modulated directional force to expel coagulated meibomian glands through the openings of the wearer's meibomian glands;

[0174] Among them, multiple ultrasonic transducers in the wearable fabric apply ultrasonic energy in a purposeful manner, focusing or directing it toward the opening of the wearer's eyelids, in order to promote the emulsification of lipids at the opening of the wearer's eyelids.

[0175] The wearable fabric of the kit in use provides closed-loop feedback to the wearer and offers an active control mechanism to fine-tune the heat and mechanical force applied to the wearer's eyelids using a mobile application.

[0176] The eyeglasses frame of the kit includes one or more of the following components: multiple infrared emitters, multiple infrared sensors, multiple ultrasonic transducers, a microcomputer, a Bluetooth module, a near-field communication chip, a Wi-Fi module, and a rechargeable battery power supply.

[0177] Among them, multiple infrared emitters in the eyeglass frame concentrate heat energy onto the surface of the wearer's eyelids, so that the lipids (melanin) in the meibomian glands of the wearer when the eyes are open;

[0178] Among them, the eyeglass frames of the kit in use provide closed-loop feedback and active control mechanisms to fine-tune the heat applied to the wearer's eyelid surface using a mobile application;

[0179] The handheld portable ultrasound imaging device includes an ultrasound transducer probe and an ultrasound receiver for monitoring the health of the wearer's meibomian glands, and it utilizes the principle of multi-frequency self-focusing ultrasound imaging.

[0180] The kit of one or more of the preceding claims of the set C, wherein the plurality of infrared emitters disposed within the wearable fabric or eyeglass frame is at least 3, 6, 9 or 12, and the plurality of sensors disposed within the wearable fabric or eyeglass frame is at least 2, 3 or 4.

[0181] A kit of one or more of the preceding claims of Set C, wherein the wavelengths of the plurality of infrared emitters disposed within a wearable fabric or eyeglass frame have at least 1 μm, 1.1 μm, 1.2 μm, 1.3 μm, 1.4 μm, 1.5 μm or 1.6 μm.

[0182] The kit of one or more of the preceding claims of Set C, wherein the frequency of the at least one ultrasonic transducer on the wearable frame or eyeglass frame is at least 100 kHz, at least 200 kHz, at least 300 kHz, at least 400 kHz, or at least 500 kHz.

[0183] The kit of one or more of the preceding claims of the set C, wherein the frequency of the at least one ultrasonic transmitter on the wearable frame or eyeglass frame is between 100 kHz and 500 kHz, 200 kHz and 500 kHz, or 100 kHz and 300 kHz.

[0184] The kit of one or more of the preceding claims of Set C, wherein the plurality of ultrasonic transducers of the wearable fabric are intentionally configured to be side by side with the edge of the upper or lower eyelid.

[0185] The kit of one or more of the preceding claims of the set C, wherein the fabric is held in place close to the upper or lower eyelid using an elastic headgear; wherein the elastic headgear is equipped with a rechargeable battery for powering the device at the back of the head.

[0186] The kit of one or more of the preceding claims of set C, wherein the handheld portable ultrasound device is wireless.

[0187] The kit of one or more of the preceding claims of Set C, wherein the handheld portable ultrasound device is used to provide feedback on the ongoing management of the wearer's meibomian gland defects.

[0188] The kit of one or more of the preceding claims of Set C, wherein the handheld portable ultrasound device is used to provide feedback on the ongoing management of the wearer's meibomian gland defects.

[0189] The kit of one or more of the preceding claims of Set C, wherein heat energy from the wearable fabric is continuously and uniformly applied to the upper or lower eyelid for 10 to 60 minutes.

[0190] A suite of one or more of the preceding claims of Set C, wherein the thermal energy is applied discontinuously to the upper or lower eyelid in a pulsating mode for a period of 10 to 60 minutes, such that the amplitude and frequency of the thermal energy in a pulsed operating mode create a positional gradient of eyelid temperature; wherein the applied thermal energy pulses have a frequency between 0.1 and 30 Hz.

[0191] A kit of one or more of the preceding claims of set C, wherein the heat energy is applied in a gradient manner across the upper or lower eyelid, such that the heat energy applied to the top of the meibomian gland is at least 2°C higher than the heat energy applied to the meibomian gland opening, such that the applied temperature gradient facilitates the smooth flow of liquefied meibomian fat from the gland to the opening of the wearer's eyelid.

[0192] The kit according to one or more of the preceding claims of group C, wherein the at least one micromotor is configured to provide vibration in a tangential direction to the wearer's eyelid; wherein the vibration of the at least one micromotor generates a pressure wave from the origin of the meibomian gland to its opening, the pressure ranging from 0.005 to 0.5 N / mm. 2 The frequency range is 0.5 to 3 Hz.

[0193] The kit of one or more of the preceding claims of the set C, wherein the at least one micromotor is configured to provide a rotational force in the tangential direction of the wearer's eyelid.

[0194] The suite of one or more of the preceding claims in set C, wherein feedback for the ongoing management of a user’s meibomian gland defect may include data on the following characteristics of the meibomian gland: size, shape, texture, area, volume, or expressibility of the gland.

Claims

1. A wearable device for managing meibomian gland dysfunction in a wearer, the device being configured to be worn in close contact with the wearer's eyelids, the device comprising: A pair of material components for the wearer's left and right eyes, each material component being configured to contact the upper and lower eyelids of the wearer's left and right eyes; Each material component includes one or more of the following: carbon nanotubes, graphene plates or graphene sheets, natural silk, spider silk or rayon, cotton yarn, denim, metal, metal nanowires or alloys, or an elastic material formed from polymers or copolymers of polyamide, polyester, polyolefin and mixtures thereof. At least one heat delivery component is configured to deliver heat within each of the material components to provide sufficient temperature to the contacting eyelid to liquefy the meibomian glands and promote meibomian gland secretion. At least one vibration device, within each of the material components, is configured to transmit mechanical energy to apply a massage to the eyelids to further promote the outflow of meibomian fat, the vibration device comprising at least one micromotor or piezoelectric activator; A closed-loop feedback and active control mechanism is configured to fine-tune the heat energy applied to the wearer's eyelids by the device. A microcomputer, communicating with the heat transfer assembly and the vibration device, has a data processing module programmed to: Receive user data, including target temperature and vibration settings; and Fine-tune the heat delivery assembly to maintain the desired eyelid temperature range; The device is configured to be repeatedly operated by the wearer at home without the assistance of an ophthalmologist. The device is configured to take into account specific information about the wearer's eyelids, face, or eye sockets.

2. The wearable device according to claim 1, wherein, The at least one micromotor or piezoelectric activator is configured to provide vibration to the wearer's eyelids; wherein the vibration generates a pressure wave from the origin of the meibomian gland to the orifice, with a pressure range of 0.005 to 0.5 N / mm². 2 .

3. The wearable device according to claim 2, wherein, The direction of vibration is consistent with the tangential direction of the eyelid.

4. The wearable device according to claim 1, wherein, The arrangement of the material components of the wearable device facilitates the transfer of mechanical energy to at least one specific direction or axis of the wearer's eyelids.

5. The wearable device according to claim 1, wherein, The heat energy is applied to the upper or lower eyelid for a duration of 10 to 60 minutes.

6. The wearable device according to claim 1, wherein, The heat energy is continuously and evenly applied to the upper or lower eyelid.

7. The wearable device according to claim 1, wherein, The heat energy is applied discontinuously to the upper or lower eyelid in a pulsed pattern, such that the amplitude and frequency of the pulsed pattern create a positional temperature gradient in the eyelid.

8. The wearable device according to claim 1, wherein, The heat energy is applied continuously, or pulsed heating is performed at a frequency of 0.5 to 5 Hz.

9. The wearable device according to claim 1, wherein, The heat energy is applied discontinuously to the upper or lower eyelid in a pulsed pattern; wherein the applied heat energy pulse has an amplitude of at least 2°C, and wherein the frequency of the applied heat energy pulse is between 0.5 and 5 Hz.

10. The wearable device according to claim 9, wherein, The heat energy is applied in a gradient manner to the upper or lower eyelid, such that the applied temperature gradient promotes a smoother flow of liquefied oil from the glands to the eyelid openings, resulting in improved stimulation or flow.

11. The wearable device according to claim 1, wherein, When the device is in use, the surface temperature of the upper or lower eyelid is maintained between 40°C and 46.5°C.

12. The wearable device according to claim 1, wherein, The surface temperature of the upper or lower eyelid is at least 40°C.

13. The wearable device according to claim 1, wherein, The area on which the heat energy is applied to the wearer's upper or lower eyelid is at least 20 mm². 2 .

14. The wearable device according to claim 1, wherein, The number, size, and arrangement of the energy sources configured within the wearable device ensure that at least 20mm 2 The surface area of ​​the eyelids is managed or treated.

15. The wearable device according to claim 1, wherein, The microcomputer collects user-specific data and provides prompts and suggestions to the wearer.

16. The wearable device according to claim 1, wherein, A combination of controlled heating, vibration, closed-loop feedback, or active control mechanisms can promote meibomian gland secretion in a largely non-invasive manner.

17. The wearable device according to claim 1, wherein, Multiple micromotors provide the necessary mechanical energy, vibration, or directional force to the outside of the wearer's eyelids to expel blockages located within the meibomian glands through the openings of the meibomian glands.

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