Phototherapy Mask

Abstract

The present invention relates to an LED light therapy mask, the mask comprising a multi-layer structure formed from at least one flexible material that is operable to adopt a desired 3D shape profile to fit the contours of a person's face.

Description

[Technical field]

[0001] The present invention relates to phototherapy devices that can be configured to be worn and covered over a person's face, and in particular, but not exclusively, to medical and / or cosmetic radiation masks for delivering phototherapy to an individual's face. [Background technology]

[0002] Phototherapy, a "light-based treatment," is the application of low levels of light energy to stimulate or control biological processes and has proven therapeutic effects. The effective mechanism is a natural response similar to photosynthesis in plants through a process known as photobiomodulation. LED phototherapy (i.e., phototherapy using light-emitting diodes (LEDs) to deliver light) is well-proven to have regenerative and anti-inflammatory effects without causing trauma, and is safe and suitable for all skin types. The treatment involves exposing the skin to low levels of beneficial light energy from the visible and infrared portions of the light spectrum. Specific wavelengths interact with biological systems and activate key cellular receptors, thus triggering the transfer of light energy to cellular energy. Activated skin cells function better and regenerate faster, promoting youthful, healthy, and radiant skin. With the move to non-invasive treatments, LED phototherapy offers a progressive alternative to more aggressive procedures that carry a higher risk of adverse reactions, discomfort, and downtime. LED energy delivered via spectrally pure wavelengths stimulates the skin's own repair mechanisms, helping to correct problematic skin conditions and restore optimal skin function. LED phototherapy is now recognized as an essential tool for skin care practitioners and is well-proven to safely and effectively treat a wide range of inflammatory and problematic skin conditions, promote wound healing, and reduce signs of skin aging.

[0003] There are products on the market that provide light therapy to a user's face. These typically include a mask with an array of LEDs disposed or embedded on the inner surface of the mask, illuminating the skin of the user's face with light from the LEDs. Such masks typically curve to fit the overall shape of the face, but typically only curve or bend in one direction, i.e., along the midline of the face, and attach to the face like a shield. Exemplary light therapy masks are described in U.S. Patent Nos. 5,233,633; ... and 5,233,633.

[0004] Thus, existing designs often do not fit properly to the user's face, resulting in irregular or non-uniform exposure, especially including over-exposure or under-exposure in certain areas. Thus, there is a need for a phototherapy mask that overcomes these and other shortcomings. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2018 / 009270A1 Brochure [Patent Document 2] International Publication No. 2018 / 196310A1 Brochure [Patent Document 3] International Publication No. 2019 / 103301A1 Brochure [Patent Document 4] International Publication No. 2019 / 200686A1 Brochure [Patent Document 5] International Publication No. 2020 / 003231A1 Brochure [Patent Document 6] International Publication No. 2020 / 040435A1 Brochure [Patent Document 7] International Publication No. 2021 / 085886A1 Brochure [Patent Document 8] International Publication No. 2022 / 045850A1 Brochure Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present invention to provide a light therapy mask that closely fits the shape and contours of a person's face, thereby providing uniform light therapy to the facial skin. A further object is to provide a mask that is manipulable to create multiple curves or bends in the mask, both lengthwise and widthwise. Yet another object is to provide a light therapy system for efficient and effective light delivery to the skin, and to provide a light therapy device with increased longevity and operational efficiency compared to existing light therapy devices.

[0007] This objective is achieved by providing a mechanically flexible phototherapy mask with a multi-layer structure and suitable material composition. The mask provides mounting for an array of LEDs capable of emitting light at an inner mask surface that can be placed opposite and covering the skin of a person's face. The phototherapy device and system includes suitable electronic components that allow a user to select multiple treatment modes and activate and deactivate the LED chips according to the desired phototherapy session. In particular, the LEDs of the system include a multi-chip design in which the internal chips are thermally partitioned from each other to increase electronic and operational efficiency. [Means for solving the problem]

[0008] According to a first aspect of the present invention, there is provided a phototherapy mask configurable to be worn to cover a person's forehead, chin and cheeks, the mask comprising a flexible outer layer, a flexible inner layer positionable against the person's skin, a coupling arrangement physically coupling the outer layer and the inner layer to one another, an LED assembly having a plurality of LEDs and a flexible LED printed circuit board for mounting the LEDs, the LED assembly being mounted between and held in position by the inner layer and the outer layer, the mask being bendable to adopt a curved shape profile at least in a lengthwise direction between a forehead end and a chin end of the mask.

[0009] Reference herein to a "mechanically flexible phototherapy mask" encompasses a mask having individual mask layers that can be bent, curved, or folded out of a particular plane (e.g., a planar configuration) to adopt a curved profile. The material composition and physical structure of the mask allow the mask to be easily bent, shaped, and adjusted by the user's hands (thumb and fingers). Furthermore, each inner layer is preferably positioned intermediate the outer and inner layers, thereby having positional / motional freedom that allows each inner layer to slide over one another when the mask is bent to adopt a 3D shape profile.

[0010] Preferably, the mask comprises cheek slits extending inwardly from each side of the mask towards the central longitudinal axis of the mask. Preferably, each slit is curved along its length corresponding to a width across the mask. Preferably, the width of each slit decreases in a direction from the periphery of the mask towards the central longitudinal axis. Preferably, the mask comprises a head strap attachment on each side. The head strap attachment preferably comprises a pair of apertures located above and below each cheek slit. The head straps may be introduced into the apertures such that when the head straps are placed under axial tension, the apertures are drawn together as the head straps are tightened. This configuration "closes" or "narrows" the width of the cheek slits to position and hold the mask securely on the person's face. Optionally, the head straps or at least a portion of the head straps are elasticated.

[0011] Preferably, the mask comprises a pair of eye openings. Preferably, the mask further comprises a mouth opening and / or a nose opening. Preferably, each cheek slit is located between the eye openings and the mouth opening along the length of the mask. Preferably, the mask further comprises an eye guard extending from or attachable to the eye openings. Preferably, the eye guard comprises a material different from the material of one or more layers of the mask.

[0012] Optionally, the connecting arrangement may comprise a number of male projections extending from one of the inner layer or the outer layer and a number of holes in the other of the outer layer or the inner layer, the projections being received in the holes to connect the inner layer and the outer layer. Optionally, the connecting arrangement is disposed at or toward the periphery of the mask, and / or the connecting arrangement is disposed exclusively at or toward the periphery of the mask. As will be appreciated, the connecting arrangement may include any means for connecting the outer layer and the inner layer to capture and / or encase the inner layer and provide a multi-layered composite unitary. Optionally, the connecting arrangement is an adhesive, chemical or thermal bond (such as thermal bonding) acting between the inner layer and the outer layer.

[0013] Preferably, the mask comprises an eye guard protruding from each respective eye opening in the inner layer, each eye guard comprising a material different from that of the inner and / or outer layers. Preferably, each eye guard is annular and defines a skirt at each eye opening.

[0014] Preferably, the mask further comprises a light-reflecting layer located intermediate the LED printed circuit board and the inner layer, the reflective layer comprising a plurality of openings extending in a direction in which the LEDs face the inner layer.

[0015] Preferably, the mask further comprises a light diffuser arrangement for diffusing light emitted from the LEDs and transmitted to the facial skin. Preferably, the diffuser arrangement comprises a plurality of light diffusers disposed proximate to each LED of the inner layer. Optionally, each light diffuser comprises a conical portion extending axially away from each LED of the inner layer. Preferably, each cylindrical portion comprises an open end for at least partially receiving an LED, such that the LED is disposed adjacent to an interior chamber defined by the conical portion of the light diffuser.

[0016] Optionally, the outer layer and / or the inner layer comprises a silicone material. Optionally, the flexible LED printed circuit board comprises at least one polymer substrate and a conductive layer having metal tracks coupled to or attached to the polymer substrate. Optionally, the reflective layer comprises a polymer material, a white material, or a reflective material.

[0017] Optionally, each LED is a multi-chip LED, with the chips of each LED configured to emit different wavelengths of light. Optionally, each LED is configured in a dual, triple or quad chip design. Preferably, each chip is thermally partitioned from each other via at least one physical partition. Such a configuration improves the thermal and operational efficiency of the mask, thereby preventing inactive chips from being heated by active chips. When the inactive chips are subsequently activated, they have improved electronic efficiency compared to the pre-heated chips. Preferably, the thermal portion of each chip is provided on or extends from a printed circuit board (PCB) layer.

[0018] Preferably, the device and system comprises an electronic controller electrically coupled to each LED, the controller configured to control the current supply to each LED to switch each chip of each LED between active and inactive modes. Preferably, the system further comprises input / output means including at least one processor, a user interface, a data storage library, an operating mode library or utility, an electronic diagnostic utility, a data storage device, a battery, an external power port, wired or wireless communication means for data transmission, and audio / visual input / output components. Preferably, the device further comprises a plurality of resistors mounted on the LED printed circuit board. The mask may comprise a resistor for each LED, each resistor being electronically addressed to a respective LED.

[0019] Preferably, the material composition of the mask is configured to allow the mask to bend from a generally planar shape profile to a contoured 3D shape profile that generally matches the contours of a human face.

[0020] According to a further aspect of the present invention, there is provided a method of preparing a phototherapy mask to be worn over a person's face, the method comprising providing a flexible multi-layer body having flexible outer and inner layers and an LED assembly mounted between the inner and outer layers, the multi-layer body being secured together via a connecting mechanism; and bending the multi-layer body to form a curved shape profile extending at least longitudinally between a forehead end and a chin end of the mask.

[0021] Preferably, the method includes bending the multi-layer body at the cheek slits such that bends extend laterally across the mask between inner termini of the cheek slits. Preferably, the method further includes forming a plurality of bends in the mask such that the mask adopts a curved profile extending lengthwise between the forehead and chin ends and widthwise between the sides of the mask.

[0022] According to a further aspect of the present invention, there is provided a method of irradiating human facial skin, the method including providing a flexible multi-layer body having flexible outer and inner layers and an LED assembly attached between the inner and outer layers, the flexible multi-layer body having a contoured 3D shape profile; powering the LEDs using at least one battery; selecting a treatment mode from a plurality of treatment modes via a user interface; determining via a controller whether there is sufficient power remaining in the battery to power the LEDs to provide the treatment mode with a predetermined LED power demand delivered for a predetermined time; and outputting a notification by the controller to a user to activate the LEDs to provide the treatment mode or not activate the selected treatment mode based on the determined power of the battery.

[0023] According to a further aspect of the present invention, there is provided a method of illuminating human facial skin, the method comprising providing a flexible multi-layer body having flexible outer and inner layers and an LED assembly mounted between the inner and outer layers, the flexible multi-layer body having a contoured 3D shape profile; emitting light from the LEDs; and passing the light emitted from the LEDs through at least one optical diffuser positioned proximate, opposite and / or adjacent to each LED in the inner layer to diffuse the light as it is transmitted to the skin.

[0024] According to a further aspect of the present invention, there is provided a light therapy mask configurable to be worn to cover at least a portion of a person's forehead, chin and cheeks, the mask comprising a flexible multi-layer construction defining inner and outer surfaces to be positioned on opposite sides of the person's face, an LED assembly having a plurality of LEDs and a flexible LED printed circuit board for mounting the LEDs, the LED assembly being mounted between and held in position by the inner and outer layers, the mask being bendable to adopt a curved shape profile at least in a lengthwise direction between a forehead end and a chin end of the mask. According to a further aspect of the present invention, there is provided a light therapy method using the light therapy mask described herein.

[0025] According to a further aspect of the present invention, there is provided a phototherapy mask comprising a flexible body defining an inner surface and an outer surface opposite a person's face, and an LED assembly having a plurality of LEDs and a flexible LED printed circuit board for mounting the LEDs, the LED assembly being attached to the body, wherein the body and LED assembly are capable of bending or flexing in at least one of a length and width direction of the mask.

[0026] Specific embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 is a front view of an LED light therapy mask having a flexible configuration to adopt a curved 3D shape profile, according to certain embodiments of the present invention. [Diagram 2] FIG. 2 is a rear perspective view of the mask of FIG. 1 with layers removed for illustrative purposes. [Diagram 3] FIG. 2 is a further front perspective view of the mask of FIG. 1 machined into a 3D shaped profile having curvature in both the length and width directions. [Figure 4] FIG. 4 is a side perspective view of the mask of FIG. 3. [Diagram 5] FIG. 5 is a top view of the mask of FIG. [Figure 6] FIG. 6 is a rear perspective view of the mask of FIG. 5 in a generally planar, uncurved configuration. [Figure 7] FIG. 7 is a side view of the mask of FIG. 6 having a generally planar configuration. [Figure 8] FIG. 8 is a rear perspective view of an eye guard that can be attached to the mask of FIGS. 1 to 7. [Figure 9] FIG. 9 is a front perspective view of the eye guard of FIG. 8. [Figure 10] FIG. 10 is a rear perspective view of the mask of FIG. 6 with the eye guards of FIGS. 8 and 9 in place over the eye openings. [Figure 11] FIG. 11 is a rear view of the mask of FIG. 10 provided with a head strap for securing the mask to a person's head. [Figure 12] FIG. 12 is a further rear view of the mask of FIG. 11 with the inner layer removed for illustrative purposes. [Figure 13] FIG. 13 is a rear view of the LED PCB layer of the mask of FIG. [Figure 14] FIG. 13 is a rear perspective view of the mask of FIG. 12 machined into a 3D curved shaped profile. [Figure 15] 2 is a cross-sectional view of the layers of the mask of FIG. 1, taken toward a peripheral region of the mask. [Figure 16] 2 is a further cross-sectional view of the layers of the mask of FIG. 1, taken toward a central region of the mask. [Figure 17]FIG. 2 is a schematic diagram of various electronic components of the present invention that are relevant to the operation of the mask described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] The present invention relates to a method and system (particularly a mask) for delivering LED light therapy to a user's face. An embodiment of the method is a non-invasive treatment that delivers clinically proven therapeutic light energy for rejuvenating and corrective effects. Specific wavelengths are absorbed by the skin to stimulate cell renewal and collagen production, resolving problematic skin conditions such as acne and redness, and promoting skin healing. It is a safe and painless treatment with no downtime. Users can expect immediate improvements in skin tone, hydration, and brightness, while the beneficial light simultaneously stimulates deeper cellular processes for longer-lasting results. For sensitive skin conditions, the method of the present invention can provide relief without redness or irritation. Light therapy can be used to treat acne, psoriasis, sensitive skin, musculoskeletal pain, and other skin conditions, and can also be used for wound healing. Additional cosmetic treatments include skin rejuvenation, reduction of pigmentation and redness, etc.

[0029] LED energy delivered via spectrally pure wavelengths stimulates the skin's own repair mechanisms, helping to correct problematic skin conditions and restore optimal skin function. Successful treatment with LED phototherapy is determined by delivering clinically proven wavelengths at optimized intensities to maximize the light / chromophore interactions that allow these specific cellular responses to occur. Chromophores are targeted compounds within the skin that have unique light absorption properties. If the wavelength does not match the targeted chromophore, there will be no absorption, no reaction, and no results. Also, if the light power delivered is too low, the desired response may not occur.

[0030] The disclosed method and system embodiments are configurable to deliver the industry-leading and most clinically proven wavelengths for LED light therapy: blue 415nm, red 633nm, and near infrared 830nm. The invention can also be configured to operate to emit other wavelengths as needed. Each wavelength of light is absorbed by a different targeted chromophore, stimulating specific skin enhancing processes and resulting in proven therapeutic benefits. The disclosed method and system allows these beneficial wavelengths to be delivered in single or multi-wavelength modes via multiple protocol (or mode) options, providing a tailored and adaptable treatment approach. Multi-wavelength treatment targets a variety of indications in one session to maximize skin improvement benefits.

[0031] Blue Light 415nm (up to 1mm penetration): Primary mechanism: Antibacterial. Blemish-fighting blue light destroys acne-causing bacteria and helps prevent breakouts. Blue light is absorbed by acne bacteria, triggering a natural photochemical reaction that releases singlet oxygen. Singlet oxygen has powerful antibacterial properties and helps eliminate blemishes while being gentle on the skin. It also helps balance oil production and improve skin clarity. Applied with a combination of red and near infrared light, this treatment is highly effective against acne and is excellent as a post-treatment to help minimize breakouts and reduce redness.

[0032] Red light 633nm (2-3mm penetration): Primary mechanism: Rejuvenation and cell renewal. Rejuvenating red light promotes cell renewal and repair, stimulating collagen and elastin synthesis for smoother, firmer skin. Red light is absorbed by the mitochondria of cells and stimulates the synthesis of adenosine triphosphate (ATP), the energy essential for cell function. By supercharging our cells, a cascade of beneficial biological reactions is triggered, resulting in a variety of skin-enhancing effects. Activated skin cells function better and can regenerate up to 200% faster. Red light is absorbed powerfully by fibroblasts, increasing collagen and elastin synthesis and enhancing hydration levels. Improved blood flow increases tissue oxygenation and promotes repair, while stimulation of the lymphatic system promotes detoxification. Red light instantly improves skin tone, hydration and vitality, while beneficial light simultaneously stimulates cellular processes resulting in long-term benefits to skin appearance and health.

[0033] Near Infrared Light (NIR) 830nm (5-10mm penetration): Primary mechanism: Wound healing effect. Near Infrared light is absorbed in the deepest layers of the skin and acts synergistically with red light to provide optimal rejuvenation effects. Exposure to 830nm NIR light increases blood circulation, providing vital oxygen and nutrients to help regulate inflammation, promote wound healing, calm inflammation, and reduce redness. NIR light brings strength and integrity to compromised, environmentally damaged, and sensitive skin conditions. It is also clinically effective in treating hyperpigmentation.

[0034] The present device, system and method embodiments may include single, twin, triple or other multi-chip LEDs to provide the target wavelengths required to enable treatment of one or more conditions such as acne, psoriasis, wound healing and musculoskeletal pain. Indications for use include, but are not limited to, the following conditions; skin rejuvenation; facial complexion; dry skin; pigmentation: photodamage; pigmentation; acne: mild to moderate; acne: moderate to severe; redness: vascular; redness: skin tone; sensitive skin; skin: problem conditions; psoriasis; wound healing; pain. LED light therapy works by delivering a consistent amount of light across the user's target area. Due to the inverse square law, the amount of light power varies based on the distance the LEDs are placed from the user's target area (skin). Because existing masks are worn on the user's face as a shield, the LEDs on the lower half of the face and across the forehead are placed farther away from the target area than the LEDs around the cheeks and nose. As a result, the user receives different levels of light power across the target area, which ultimately leads to inconsistent treatment due to the difference in light power delivered.

[0035] The present invention includes embodiments having a 2D-3D flexible design that allows the user to manipulate the mask into a 3D shape with multiple curvatures. This allows the operator or user to mold the mask to be evenly positioned across the face, so that the array of LEDs distributed on the inner surface of the mask is positioned at a substantially uniform separation distance from the skin across all areas of the face. This allows the device to provide a more uniform and consistent treatment through the light output provided by the LEDs. To improve fit, the elastic feature of the head strap allows the mask to fit and remain in place across the face, opposite the skin, ensuring consistent light delivery over the treatment period.

[0036] Referring to FIG. 1, the LED light therapy mask 10 includes an outward or outer surface 11 having a perimeter defined by a first longitudinal edge (or end) 18 positionable on a person's forehead, a second longitudinal edge (or end) 19 positionable on a person's chin region, and two lateral edges (or sides) 20 extending longitudinally between the ends 18 and 19. A plurality of strap apertures 12 extend through the mask 10 at each longitudinal side 20 toward the periphery of the mask. The mask 10 further includes a pair of eye openings 14, a nose slit 15, and a mouth opening 16. A nose guard 27 extends between the eye openings 14 in the region of the slits 15 toward the mouth opening 16 to cover a majority of the person's nose when the mask 10 is placed on the face. The mask 10 is symmetrical about a longitudinal axis 29, except for an electronic connection 17 (e.g., a micro USB port) provided at or toward the mask chin end 19. A pair of slits extend widthwise across the mask 10 from each side 20. Each slit 13 is positioned so as to be located approximately at the lower end of the nose slit 15 region in the lengthwise direction between the eye openings 14 and the mouth opening 16. Thus, the slits 13 correspond approximately to the cheeks of a person wearing the mask 10.

[0037] The material composition of the mask 10 is designed to be flexible and easily bent, curved and shaped by the operator's hands and fingers so that the mask can conform to a 3D configuration corresponding to the generally curved shape profile of a person's face. Such curvature includes a first bend or curve (28) that extends generally in the length direction and a second bend or curve 21 that extends widthwise across the mask. The cheek slits 13 facilitate the user bending the mask 10 in that the curve 21 extends between the innermost lengthwise ends 13a of the slits 13. Figures 3-5 further illustrate how the mask 10 can be curved in both the length direction and the width direction. In particular, the bend or curve 28 extends lengthwise, i.e., in the same direction as the longitudinal axis 29 of the mask 10. With particular reference to Figure 3, the curve 28 extends generally in the z-direction while the curve 21 extends generally in the x-direction. Thus, the mask 10 is bent in the z-direction via the first and second bends 28, 21. Additionally, due to the material composition of the mask 10, the nose guard 27 is also adjustable and can be bent or hinged to open and close the slit 15 via a pivot about a nose bridge 27a that extends laterally between the eye holes 14. FIG. 4 shows how the forehead end 18 and chin end 19 are bent backwards (z-direction) away from the front-most portion of the mask 10 (corresponding to the nose guard 27) via the widthwise bends 21. Similarly, FIG. 5 shows how the side 20 is bent backwards (z-direction) from the nose guard 27 via the lengthwise bends 28. FIGS. 6 and 7 show the flexible material composition of the mask 10 that can be manipulated between a 2D nearly flat or planar shape profile and a 3D fully contoured shape profile. Thus, the present mask 10 is fully adjustable to include multiple bends, folds and angular orientations as desired. Such an arrangement is provided firstly by the material composition of the mask and secondly by the multi-layer structure shown and described with reference to FIGS.

[0038] Referring to FIG. 16, the mask 10 includes an inner layer 40 having an inwardly facing surface 45 intended to be placed opposite a person's skin. The mask 10 also includes an outer layer 58 that faces outwardly and has an outwardly facing or exterior surface 11. The inner layer 40 is provided with a plurality of projections, bosses or lugs 49 at or toward the periphery of the mask 10. A plurality of corresponding holes 24 are provided in the outer layer 58 to receive respective end regions 59 of the lugs 49. Such a configuration provides an interlocking arrangement that physically attaches the outer layer 40 and the inner layer 58 together. The lug ends 59 and holes 24 may be configured with suitable friction fit components (e.g., bayonets, deformable lugs, detents, washers, etc.) to provide a click-lock type interlocking arrangement for secure assembly of the multi-layer structure. The mask 10 further includes a plurality of inner layers including, among others, a light reflective layer 47 and an LED printed circuit board (PCB) layer 48. Each layer 47, 48 is provided with a plurality of respective apertures to allow the lugs 49 of the inner layer 40 to mate with the outer layer 58. However, the relative size of the apertures in the layers 47, 48 provide such layers with some positional freedom when sandwiched between the outer layer 40 and the inner layer 58. This allows the inner layers 47, 48 to slide over each other and beyond to have positional freedom relative to the outer layer 40 and the inner layer 58 as the mask 10 is curved in both the length and width directions to adopt the curved shape profile of Figures 2-5.

[0039] 15 , inner layer 40 also includes an inner surface 46 opposite inner surface 23 of reflective layer 47. PCB layer 48 includes an inner surface 51 opposite inner surface 50 of reflective layer 47. LED PCB layer further includes an inner surface 56 opposite inner surface 57 of outer layer 58.

[0040] 16, the inner layer 40 is shaped to provide a unique light delivery system that allows for a wide distribution of light near the skin. Rather than outcouple and direct the light to a focal area, the unique design feature of this optic reflects and refracts a portion of the light inside the optic, thereby irradiating (distributing) the light over a wide area and avoiding the creation of dark spots where the light is at the surface of the skin and oversaturating the cells. In particular, the inner layer 40 is provided with a plurality of diffusers 61 that protrude from the inner surface 46 towards the outer layer 58. Each diffuser 61 includes a generally frustoconical shape and defines an interior void or region 60 that is surrounded by a conical wall of the diffuser 61 that extends between an inner end 62 (at layer 40) and an outer end 63 (at / near PCB layer 48). The outer end 63 of the annular diffuser is open to be positioned and extend around the LED 22 mounted on the PCB layer 48. Thus, each LED 22 is disposed adjacent a reduced diameter end of a conical diffuser 61. According to a preferred embodiment, each LED 22 protrudes at least partially into the cavity 60 through a respective open end of each diffuser 61.

[0041] According to a preferred embodiment, the inner layer 40 comprises medical grade silicone. Preferably, the outer layer 58 is also formed from medical grade silicone and is the same or similar to the inner layer 40. Such materials can include existing common silicone materials for medical applications. As will be appreciated, such silicones can be manufactured by addition curing or condensation curing techniques to achieve the required density and physical and mechanical properties, including, among others, softness, bending strength, etc. The reflective layer 47 can comprise a polymeric material (polyalkylene, polypropylene, polyethylene, etc.) or a metallic material such as aluminum, and is reflective and light-impermeable to reflect any light from the LEDs 22 back towards the skin (located beneath the inner layer 40). The reflective layer 47 can comprise, for example, a white PTFE sheet and can have a window 65 configured to allow the LEDs 22 to protrude. The PCB layer 48 can comprise a multi-layer structure having a polymeric substrate supporting a plurality of metal tracks. The PCB layer 48 can further comprise additional polymeric layers that sandwich or at least partially encapsulate the conductive tracks within one or more electrically insulating polymeric layers. Optionally, the polymer substrate and / or layers may include polyimide, polyalkylenes such as polypropylene, polyethylene, etc. Such construction provides the desired flexibility of the PCB layer 48.

[0042] According to a preferred embodiment, each LED 22 comprises a first chip 22a and a second chip 22b having different emission wavelengths. For example, the chip 22a may be configured to emit red light and the chip 22b may be configured to emit infrared light. As will be appreciated, the mask 10 may be provided with LEDs 22 having any configuration and multiple chips 22a, 22b that emit different wavelengths of light within a desired region of the electromagnetic spectrum suitable for medical and cosmetic phototherapy. For example, each LED 22 may include a dual chip configuration or may include three, four or more chips each providing at least two different wavelengths of light. The LEDs 22 are substantially uniformly distributed on the PCB layer 48 as shown in FIG. 2 with the inner layer 40 removed for illustrative purposes. Thus, when activated, each LED 22 and the particular one of the activated chips 22a, 22b is configured to emit light substantially over the entire or at least a majority of the inner surface 45. The emitted light is cast on the skin as diffuse illumination through the diffuser 61, particularly avoiding a reduction in the surface area where the light is concentrated, which may be harmful to the skin (as a highly concentrated irradiation zone). The present configuration, particularly the multi-layer structure including the diffuser 61, provides a nearly uniform light glow of the desired intensity on an area of ​​human skin. This twin LED design comprises two internal LED portions or areas that are thermally separated by a thermal partition 64. This promotes better heat dissipation from the chips, improving light efficiency. Previous LED masks typically use 5050 LEDs in a 6-pin configuration. All three chips are mounted inside the same LED well, so that when two or more chips are operated simultaneously, the heat generated is dissipated across the surface area of ​​the LEDs / LEDs mounted on the PCB board. This results in light loss due to increased operating temperatures and heat dissipation to inactive adjacent chips. By thermally partitioning / isolating the LED chips 22a, 22b via the partitions 64, the mask positionally and thermally isolates the chips from each other, improving the light efficiency of the product. Improved thermal stability results in more light output per LED and improved lifetime performance.

[0043] 6, 8, 9 and 10, the mask 10 is provided with a pair of eye guards 25. The guards 25 include different materials and / or compositions than the layers 40, 47, 48 and 58. The inner layer 40 is optically transparent, while the eye guards 25 are constructed of an optically impermeable material. Each guard 25 has a generally annular shape profile. In particular, each guard 25 includes a first annular longitudinal end 30 having a size and shape profile disposed and extending around a respective eye opening 14. Each eye opening 14 includes an annular groove 14a (optionally having a lip, shoulder or stepped annular region) to allow the eye guards 25 to be clipped onto a mating contact at the respective eye opening 14. Each guard 25 further includes an annular collar 31 disposed adjacent the first end 30 and an annular skirt 32 extending from the collar 31, the skirt 32 terminating at a second end 33 of the annular guard. The end 33 is radially enlarged relative to the first end 30 and is provided with a generally elliptical profile in the circumferential direction to conform to the contours and general shape of the human eye socket. Thus, when the guard 25 is secured in place over the eye opening 14, the annular end 33 fits tightly against the skin of each eye socket, completely partitioning it spatially and isolating each eye from the irradiation emitted by the LED 22. The eye shield 25 protects the eye from off-angle light distribution. Medical devices are subject to rigorous photonic testing for both the user and the practitioner, if applicable. Typically, such devices carry risk classifications for both blue and near infrared light. Due to the close proximity of the mask, the light is considered a higher risk classification and requires protective eyewear. The eye shield 25 is designed to conform to various facial profiles and fit comfortably around the eyes in the eye socket, following the principles of swimming goggles. The material composition is dense, reducing and preferably completely blocking overall light exposure to the eyes when in use. Preferably, the material of the guard 25 is light-opaque to completely block the irradiating light. Preferably, the material of the guard 25 is at least partially flexible to provide a compression fit in the eye socket.

[0044] 11 and 12, the mask 10 is provided with a head strap 35 for securing the mask 10 to a person's head. According to a preferred embodiment, the strap 35 is split into two portions, each secured to a respective side via a strap aperture 12. In particular, the longitudinal portions of the strap at a first end are provided with hook-and-loop fasteners 36, 39, respectively, while the second end is provided with a pair of brace straps 37 and a cross strap 38, providing a generally triangular attachment area from which the longitudinal strap area extends. As mentioned, the split cheek design includes slits 13 in the cheek area. The cross straps 38 are elasticated between an upper fastening point and a lower fastening point, automatically closing the cheek slits 13. The hook-and-loop fasteners can then be secured to the back of the person's head, as shown in FIG. 14, to hold the mask on the person's face.

[0045] 13, PCB layer 48 further includes a plurality of resistors 44 associated with each of LEDs 22 configured to control current flow to LEDs 22. Each resistor 44 forms part of the electronic structure of the mask to provide the desired function and control of illumination according to a given treatment requirement and mode. PCB layer 48 also includes corresponding eye, nose and mouth openings 41, 42 and 43, along with cheek slits 48a that correspond to the general shape and configuration of mask 10, as shown in FIGS. 1-6.

[0046] With reference to FIG. 17, the present invention provides an LED-based phototherapy mask and illumination system having an electronic architecture 66 for activation and control of illumination emitted from the LEDs 22. In particular, the electronic architecture 66 may be provided in the mask 10 local to the multiple layers 40, 47, 28, 58. Alternatively or additionally, selected components are preferably housed in a suitable controller located remotely from the mask 10 and attachable via suitable electrical connections 34 to the electronic couplings 17 of the mask 10 attached to the PCB layer 48. The electronic controller comprises a central processing unit (CPU) 67 (usually one of multiple processors) and a user interface 68. The interface 68 may include a screen (such as a touch screen), buttons, dials, etc. suitable for controlling the activation and power output of the LEDs. A control module 69 is provided with suitable software, controllers, components and functions to implement different operating modes having predetermined LED operation times / durations and power output levels. The system also includes at least one library 70 (optionally a data reference library, a user data library or other data collection), selectable operating modes (implemented as software), a diagnostic utility 72 (implemented as software), a data storage utility 73, a battery 75, and optionally an external power port 74 for connecting to an external power source. The mode utility 71 includes a number of pre-set and / or configurable operating modes for the LEDs 22. Such modes include control of the illumination duration and output of the LEDs. Optionally, the first mode 71a can consist of a pre-set light therapy treatment time of 20 minutes, where the LED output gradually increases from a starting point to a maximum value and then decreases towards an end point. Illustratively, the second mode 71b can include a stepped time interval-based treatment, where the LEDs are powered for a pre-set time, subsequently deactivated, and then reactivated for a further time interval.A diagnostic utility 72 may be implemented to run continuously, powering the LEDs to monitor electronic performance and function, and providing notification of any operational errors or problems via interface 68. Electronic architecture 66 may further include additional electronic components providing wired or wireless communication over a local network, cloud storage, or the Internet. The system may also include sensors including, for example, light sensors, temperature sensors, proximity sensors, pressure sensors, voltmeters, ammeters, and / or timers. It will be understood that the various electronic components of architecture 66 shown in FIG. 17, including LEDs 22, are interconnected and operate according to conventional systems. Optionally, mask 10 may be electronically coupled to the remainder of electronic architecture 66 of FIG. 17 via wireless communication. Optionally, a battery 75 may be provided locally to mask 10 and wirelessly controlled to activate or deactivate LEDs 22 according to mode utility 71 as controlled by controller 69. In operation, once the mask has been adjusted to the desired 3D shape profile and the mask secured in place on the face, the user / operator can select a mode (e.g., 71a) from the mode utility 71 via the interface 68 and / or control device 69 for a given phototherapy session.

[0047] Although specific embodiments of the present invention have been illustrated and described, it should be understood that the above description is not intended to limit the present invention to these embodiments. It will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the present invention. Accordingly, it is intended that the present invention cover alternatives, modifications, and equivalents that may be included within the spirit and scope of the present invention as defined by the claims.

Claims

1. A phototherapy mask that can be worn and configured to cover a person's forehead, chin, and cheeks, A flexible outer layer, A flexible inner layer that can be positioned to face human skin, A connecting mechanism that physically connects the outer layer and the inner layer, An LED assembly having a plurality of LEDs and a flexible LED printed circuit board for mounting the LEDs, wherein the LED assembly is mounted between the inner layer and the outer layer and is positionally held by the inner layer and the outer layer, Equipped with, The mask is flexible such that it adopts a curved shape profile at least in the longitudinal direction between the forehead and chin ends of the mask.

2. The mask according to claim 1, further comprising cheek slits extending inward from each side of the mask toward the longitudinal central axis of the mask.

3. The mask according to claim 2, wherein each slit is curved along its length corresponding to the width direction across the mask.

4. The mask according to claim 2, wherein the width of each slit decreases in the direction toward the longitudinal central axis from the periphery of the mask.

5. The mask according to claim 1, comprising a pair of eye openings.

6. The mask according to claim 5, comprising a mouth opening and / or a nose opening.

7. The mask according to claim 2 or 5, wherein each cheek slit is located between the eye opening and the mouth opening in the longitudinal direction of the mask.

8. The mask according to claim 1, wherein the connecting mechanism comprises a plurality of male projections extending from one of the inner layer or the outer layer, and a plurality of holes provided in the other of the outer layer or the inner layer, the projections being received into the holes so that the inner layer and the outer layer can be connected.

9. The mask according to claim 8, wherein the coupling mechanism is arranged around or toward the mask, and / or the coupling mechanism is exclusively arranged around or toward the mask.

10. The mask according to claim 5, further comprising an eye guard protruding from each of the eye openings of the inner layer, wherein each eye guard is made of a material different from the material of the inner layer and / or outer layer.

11. The mask according to claim 10, wherein each eye guard is annular and defines a skirt over each eye opening.

12. The mask according to claim 1, further comprising a light-reflecting layer located between the LED printed circuit board and the inner layer, wherein the reflective layer has a plurality of openings extending in the direction toward the inner layer toward the LED.

13. The mask according to claim 1, further comprising a plurality of light diffusers arranged in close proximity to each LED in the inner layer.

14. The mask according to claim 13, wherein each light diffuser has a conical portion that extends axially away from each LED in the inner layer.

15. The mask according to claim 1, wherein the outer layer and / or the inner layer comprises a silicon material.

16. The mask according to claim 1, wherein the flexible LED printed circuit board comprises at least one polymer substrate and a conductive layer having metal tracks connected to or attached to the polymer substrate.

17. The mask according to claim 12, wherein the reflective layer comprises a polymer material, a white material, or a reflective material.

18. The mask according to claim 1, wherein each LED is a multi-chip LED, and the chip of each LED is configured to emit light of a different wavelength.

19. The mask according to claim 18, further comprising a thermal partition for thermally separating the chips at each LED.

20. The mask according to claim 19, further comprising an electronic controller electrically connected to each LED, wherein the controller is configured to control the current supply to each LED and switch each chip of each LED between an active mode and an inactive mode.

21. The mask according to claim 1, wherein the material composition of the mask is configured to allow the mask to be bent from a substantially planar shape profile to a 3D shape profile that substantially matches the contour of a human face.

22. The mask according to claim 1, further comprising a plurality of resistors attached to the LED printed circuit board.

23. A method for preparing a phototherapy mask that is worn and covers a person's face, To provide a flexible multilayer having a flexible outer layer and an inner layer, and an LED assembly attached between the inner layer and the outer layer, wherein the multilayer is fixed to each other via a connecting mechanism, The multilayer body is bent to form a curved profile that extends at least in the longitudinal direction between the forehead and chin ends of the mask, Methods that include...

24. The method according to claim 23, wherein the mask is provided with cheek slits extending inward from each side of the mask toward the longitudinal central axis of the mask.

25. The method according to claim 24, comprising bending the multilayer at the position of the slits such that a bent portion extends laterally across the mask between each inner end of the cheek slits.

26. The method according to claim 23, comprising forming a plurality of bends in the mask such that the mask adopts a curved shape profile that extends longitudinally between the forehead and chin and in widthwise between the sides of the mask.

27. A method of irradiating the skin of a person's face, To provide a flexible multilayer having a flexible outer layer and an inner layer, and an LED assembly mounted between the inner layer and the outer layer, wherein the flexible multilayer has a 3D shape profile that conforms to the contour, Power is supplied to the LED using at least one battery, The user interface allows for the selection of a treatment mode from multiple treatment modes, The controller determines whether there is enough power remaining in the battery to power the LEDs in order to supply the treatment mode, which involves a predetermined LED power demand that is supplied over a predetermined period of time, The controller activates the LED to supply the treatment mode, or, based on the determined power of the battery, outputs a notification to the user that the selected treatment mode will not be activated. Methods that include...

28. A method of irradiating the skin of a person's face, To provide a flexible multilayer having a flexible outer layer and an inner layer, and an LED assembly mounted between the inner layer and the outer layer, wherein the flexible multilayer has a 3D shape profile that conforms to the contour, The LED emits light, The light emitted from the LEDs is passed through at least one light diffuser positioned in close proximity to, opposite to, and / or adjacent to each LED in the inner layer, thereby diffusing the light when it is transmitted to the skin. Methods that include...

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