Eyeshade for treatment and / or prevention of periorbital edema, kit for treatment of periorbital edema and method of manufacturing eyeshade

Abstract

Eyeshades for treating and / or preventing periorbital edema, kits for treating periorbital edema, and methods of making an eyeshade are provided. The eyeshade includes: two side portions extending on both sides of a bridge portion; and a holding member for attaching the eyeshade to the face of the user; wherein each side portion comprises an orbital region and a sub-orbital region, the sub-orbital region comprising one or more protrusions extending away from the user-facing surface of the eye patch such that when the eye patch is attached to the user's face, pressure is applied to the corresponding sub-orbital region of the face; the eyeshade is basically matched with the outline of the face of the user; and compared with the rest part of the side part, the under-orbit area has higher rigidity.

Description

[0001] This application is a divisional application of an application with an application date of May 15, 2020 (entered the Chinese national stage on November 16, 2021), national application number 202080036478.3 (international application number PCT / SG2020 / 050285), and invention name “Eye Mask”. Technical Field

[0002] Generally, the present invention relates to eye patches for treating and / or preventing periorbital edema. Background Art

[0003] Periorbital puffiness under the eyes, colloquially known as "eye bags" in its milder form, is common with aging. The tissues surrounding the eyes, including some of the muscles that support the eyelids, tend to weaken, and the skin around the eyes can thin and may swell or sag. In addition, the suborbicularis oculi fat pad may increase in size, which, combined with the aforementioned weakening of the tissues, can cause the lower eyelids to appear swollen. Periorbital puffiness can also occur in other situations, such as after surgery.

[0004] Several treatments have been proposed for eye bags. Treatments range from home remedies, such as reducing salt intake and elevating the head while sleeping, to various creams, gels, and patches. However, these treatments have various drawbacks, such as high cost and / or poor effectiveness. Furthermore, all of these known treatments have not been found to be effective in preventing the occurrence or recurrence of eye bags.

[0005] Other possible treatments include the use of medications, such as furosemide, to reduce and prevent peripheral edema. However, such treatments are not suitable for universal use. Surgery to remove eye bags is also possible, but as with any surgery, there are inherent risks.

[0006] It would be desirable to overcome or alleviate at least one of the problems discussed above, or at least provide a useful alternative. Summary of the invention

[0007] Disclosed herein is an eye mask for treating and / or preventing periorbital edema, comprising:

[0008] two side portions extending from the bridge portion; and

[0009] a retaining member for attaching the eye mask to the face of a user;

[0010] Wherein each side portion includes an orbital region and a sub-orbital region configured to apply pressure to a corresponding sub-orbital region of the face when the eye mask is attached to the face of a user.

[0011] Also disclosed herein is a kit for treating periorbital edema, comprising a plurality of eye masks according to the preceding paragraphs, respective eye masks having respective infraorbital regions, the respective infraorbital regions of the respective eye masks being configured to progressively apply greater pressure to the corresponding infraorbital regions of the face.

[0012] Also disclosed herein is a method of making an eye mask for treating and / or preventing periorbital edema of a user, comprising:

[0013] Obtaining three-dimensional (3D) facial scan data of a user;

[0014] generating a hood design based on the 3D facial scan data, the hood design comprising two side portions extending from a bridge portion;

[0015] wherein each side portion includes an orbital region and a sub-orbital region configured to apply pressure to a corresponding sub-orbital region of a user's face when the eye mask is attached to the face;

[0016] manufacturing a cover body according to the cover design; and

[0017] A retaining member is provided at the mask body, the retaining member being used to attach the eye mask to the face of the user.

[0018] Also disclosed herein is a method of treating periorbital edema in a subject in need thereof, comprising applying at least one eye patch as disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Embodiments of the invention will now be described by way of non-limiting examples with reference to the accompanying drawings, in which:

[0020] Figure 1 is a front perspective view of an eye mask according to certain embodiments;

[0021] Figure 2 yes Figure 1 A front plan view of the eye mask;

[0022] Figure 3 is a right side perspective view of an eye mask according to certain embodiments;

[0023] Figure 4 It passes through Figure 2 A schematic cross-sectional view of line 4-4;

[0024] Figure 5 is a schematic cross-section through an alternative eye mask;

[0025] Figure 6 is a schematic cross-sectional view through another alternative eye mask;

[0026] Fig. 7A is a front perspective view of an eye mask according to certain embodiments;

[0027] Figure 7B yes Fig. 7A A rear view stereogram of an eye mask;

[0028] Fig. 8A is a front plan view of an eye mask according to certain embodiments;

[0029] Figure 8B yes Fig. 8A A left stereogram of the eye mask;

[0030] Figure 8C yes Fig. 8A Examples of inner lining pieces of eye masks;

[0031] Fig.8D yes Fig. 8A Examples of frame pieces of eye masks;

[0032] Fig. 9A is a front plan view of an eye mask according to another embodiment;

[0033] Fig. 9B yes Fig. 9A Right side view of the eye mask;

[0034] Fig. 9C yes Fig. 9A Rear view of the eye mask;

[0035] Fig.10 is a flow chart of a method of making an eye mask according to certain embodiments; and

[0036] Fig.11 is a schematic depiction of a kit of eye patches when used for the treatment of peri-orbital edema. DETAILED DESCRIPTION

[0037] Embodiments of the present invention generally relate to eye masks and kits for treating and / or preventing periorbital edema, to methods of making the same, and to methods of treatment using such eye masks and / or kits.

[0038] The eye mask has two side portions extending from a bridge portion. Each side portion includes an orbital region and a suborbital region, the suborbital region being configured to apply pressure to a corresponding suborbital region of the face when the eye mask is attached to the user's face. Thus, when the eye mask is in place, compression is applied to an area of ​​the face that is susceptible to edema. Advantageously, this directional compression effect has been found to reduce edema in individuals suffering from edema when the mask is worn during sleep. It has also been found to be effective in preventing the occurrence of edema. The beneficial effects of the present invention can be achieved in at least a single overnight use for preventing eye bags.

[0039] Figure 1 and Figure 2 An example of an eye mask 10 according to some embodiments is shown. The eye mask 10 includes a mask body, which includes a bridge portion 12, a first side portion 14 and a second side portion 16, which extend from the bridge portion 12 and are located on both sides of the bridge portion 12. The first side portion 14 may include an aperture 13 near its end, and the second side portion 16 may include an aperture 15 near its end. The apertures 13, 15 can be used to attach a retaining member, such as a strap or a tie (not shown), which is used to fix the eye mask 10 to the user's face. Alternatively, the strap can be attached to the side portions 14, 16 in other ways, such as by staples, adhesives or heat seals. The strap is preferably elastic and adjustable to accommodate different head shapes while maintaining a compression effect. Advantageously, the elastic strap achieves a good compression effect while still ensuring comfort.

[0040] Figure 1 and Figure 2 The side portions 14, 16 in the embodiment of the present invention may be integral with the bridge portion 12 so that the cover 10 is formed as a single piece. However, it will be understood that the side portions 14, 16 may alternatively be rigidly coupled to the bridge portion 12.

[0041] The first side portion 14 includes an orbital region 18 and a sub-orbital region 24 (below the orbital region 18), the orbital region 18 being adapted to cover the right eyeball of the user, the sub-orbital region being configured to apply pressure to a corresponding sub-orbital region of the face when the eye mask 10 is attached to the face of the user. Similarly, the second side portion 16 includes an orbital region 20 and a sub-orbital region 26, the orbital region 20 being adapted to cover the left eyeball of the user, the sub-orbital region 26 being configured to apply pressure to a corresponding sub-orbital region of the face (also referred to herein as an eye bag region) when the eye mask 10 is attached to the face of the user.

[0042] The side portions 14, 16 can have a thinner cross-section than the bridge portion 12. In this regard, the orbital regions 18, 20 can have a thinner cross-section than the bridge portion 12. In at least some embodiments, the orbital region and the sub-orbital region can have different thicknesses. For example, the orbital regions 18, 20 of the side portions 14, 16 can have a thinner cross-section than the sub-orbital regions 24, 26. By forming these portions of the eye mask to have a thinner cross-section, they can be made to have a lower rigidity. This is more advantageous because it reduces the pressure on the subject's eyes and, therefore, provides greater comfort to the user.

[0043] In some embodiments, the suborbital area is made thicker than the orbital area. This increases rigidity below the eye area for better compression.

[0044] The retaining member can be adjustable to change the pressure applied by the suborbital region 24, 26 of the eye mask 10. For example, the retaining member can be a strap having a first portion and a second portion fixed to each other by a fastener such as a hook-and-loop fastener, wherein the first portion carries a hook (or loop) and is attached to one side portion 14 of the eye mask 10, and the second portion carries a loop (or hook) and is attached to the other side portion 16. For example, the components of the hook-and-loop fastener can all be carried on one portion, which passes through the other portion and returns to itself to form a loop. In some embodiments, the strap can be formed as a single component having a hook portion on one surface and a loop portion on the opposite surface, wherein the strap is connected to the first side portion 14 and passes through a portion of the second side portion 16 (e.g., through the orifice 15) and is looped back to itself so that the hook portion engages with the loop portion. The hook portion and the loop portion can extend along most or the entire length of the strap to achieve greater adjustability.

[0045] The retaining member is appropriately sized to provide sufficient tension to hold the eye mask in place. In some embodiments, the tension in the retaining member may be adjustable, such as by one or more straps as described above. The retaining member holds the eye mask in place, such as during restless sleep, without discomfort when the user lies on his or her side.

[0046] The suborbital regions 24 and 26 of the eye mask 10 are constructed according to the user's facial shape. For example, the user's facial shape can be determined by three-dimensional (3D) scanning, such as by using the Face Camera Pro of Bellus 3D, Inc. The 3D scan can be performed at the end of the day, when the periorbital area tends to be less swollen. The 3D facial scan data can be analyzed to determine the outer limits of the eyeball, and then a mask design that substantially matches the contours of the user's face is generated, particularly in the suborbital area, so that when the mask 10 is worn and held in place at the suborbital area in a manner that contacts the corresponding suborbital area of ​​the user's face, the suborbital areas 24, 26 apply gentle pressure in the area where swelling tends to occur. Therefore, wearing the mask 10 overnight produces a compression effect that tends to reduce periorbital swelling.

[0047] like Figure 4 As shown in the schematic cross-sectional view of , the eye mask 10 may have an inner (ie, face-contacting) surface 30 having a relatively flat profile in the suborbital region 24. In this version, the eye mask 10 may be particularly suitable for preventing eye bags.

[0048] In such Figure 5In some embodiments shown, the eye mask 10 can be configured to treat existing eye bags. A facial scan of the user can be obtained to determine contours in the infraorbital area. The eye mask 10 can be manufactured to have an infraorbital shape that accommodates the determined contours but is designed to apply pressure to the eye bags. Figure 5 , the infraorbital region 44 is concave or recessed outwardly (i.e., in a direction away from the user's face) to include one or more raised protrusions corresponding to existing eye bags. The raised protrusions at the infraorbital region 44 allow pressure to be applied to the corresponding infraorbital region of the face when the user suffers from periorbital swelling, such as in the morning, after surgery, or due to an underlying medical condition. The raised shape accommodates pre-existing eye bags, wherein the inner surface of the infraorbital region 44 contacts the eye bags so as to apply gentle compression to the eye bags when the eye mask is attached to the user's face. Once the size of the eye bags is reduced, a mask with smaller raised protrusions (i.e., flatter) can be used, and ultimately a mask without protrusions (such as a mask with a flatter shape) can be used. Figure 4 as shown) to achieve a smooth extension of the existing cheek line to the eye area. Fig.11 An example of a series of such masks for gradually flattening eye bags is shown in FIG. 1 and described in more detail below.

[0049] By gradually flattening the protrusion, an additional directional compression effect can be achieved in the suborbital area without requiring the user to compress the mask. Thus, the compression effect can be enhanced without increasing the user's discomfort. The recessed or concave suborbital area 44 can have a depth of between about 3 mm and 20 mm relative to the suborbital area 24, so that different degrees of compression can be applied, with less depth producing greater compression.

[0050] In certain embodiments, each suborbital region 24, 26 of the eye mask includes an elongated compression region, such as a substantially crescent-shaped region. The elongated compression region provides a larger contact surface area and thus provides more consistent pressure during use.

[0051] The bridge portion 12 is shaped so that it substantially conforms to the contour of the nose area of ​​the subject. The bridge portion 12 may cover a majority of the nose area or at least a portion of the nose area. For example, the b-ridge portion may be a nose clip. The bridge portion 12 may be more rigid than the side portions 14, 16. This helps to enhance the compression effect on the suborbital area when the user wears the mask 10. For example, the bridge portion 12 may be made of a material that is more rigid than the side portions 14 and 16. Alternatively, the bridge portion 12 may be made of the same material as the side portions 14, 16, but may have a greater thickness than the side portions 14, 16. In the case where the mask 10 is formed by 3D printing, this may be achieved by, for example, printing an additional layer of material in the bridge portion 12.

[0052] Alternatively, the bridging portion may be thickened so that it can provide structural balance and support.The bridging portion may have a thickness of about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 1 mm to about 6 mm, or about 1 mm to about 4 mm.

[0053] The bridge portion 12 can also provide a compressive force acting on both sides of the dorsum of the nose area. This provides another advantage of keeping the eye mask in place during use. For this reason, when manufacturing the eye mask, the bridge portion can be made slightly narrower than the nose area of ​​the subject.

[0054] The eye mask 10 (as well as other embodiments of eye masks described below) may be used in a variety of applications.

[0055] In one application, the eye mask 10 can be used as a "preventative" mask for a user who suffers from early morning eye swelling. The preventative mask has a shape that conforms to the normal facial shape of the user during the day to produce a directional compression effect to prevent fluid from penetrating into the subcutaneous tissue at night. For example, the purpose of the preventative mask is to maintain the facial shape consistent with the facial shape determined from an initial facial scan of the user that corresponds to the user's "normal" facial shape.

[0056] In another application, a user with existing (usually hereditary) eye bags may be provided with a "therapeutic" mask or set of masks. The first mask is targeted for compression based on the initial shape of the eye bag, and subsequent masks may gently increase pressure by providing successively less prominent (flatter) infraorbital areas, gradually and progressively reducing swelling. Fig.11 An example of a kit comprising a therapeutic mask is schematically described in . The first mask 10.1 of a series of n masks has convex protrusions in the suborbital areas 24.1 and 26.1. The subsequent mask 10.2 has convex protrusions in the suborbital areas 24.2 and 26.2 that are flatter than those of the mask 10.1. Finally, the nth mask 10.n has no convex protrusions in the suborbital areas 24.n and 26.n. Fig.11 As described, n=3, but a lesser or greater number of masks may be used as part of a treatment kit. The total number of masks in the set of masks generally depends on the size of the existing eye bags.

[0057] The eye mask 10 (or any other eye mask disclosed herein) can be configured to treat periorbital edema by being shaped in the infraorbital region to produce directional pressure in a generally upward direction (e.g., from below the infraorbital region toward the infraorbital region or the orbital region), or straight (horizontally), or inward from the edge of the eye bag (toward the nose), or a combination of two or more of these.

[0058] Now go to Figure 3, shows an alternative embodiment of the eye mask 100. Figure 1 and Figure 2 implementation method, Figure 3 The side portions 114, 116 in the housing 100 are integral with the bridge portion 112 so that the housing 100 is formed as a single piece. However, it will be understood that at least a portion of the side portions 114, 116 may alternatively be rigidly coupled to the bridge portion 112 by appropriate fastening means.

[0059] The first side portion 114 includes an orbital region 118 adapted to cover the right eyeball of the user and a suborbital region 124 configured to apply pressure to a corresponding suborbital region of the face when the eye mask 100 is attached to the user's face. The second side portion 116 includes Figure 3 The infraorbital region of the second side portion 116 is configured to apply pressure to the corresponding infraorbital region (also referred to herein as the eye bag region) of the face when the eye mask 100 is attached to the face of the user.

[0060] The eye mask 100 may include at least one through hole 102 (in this case, a plurality of through holes 102, 104, 106) to help with breathability and thereby improve the wearer's comfort level. The eye mask 100 has a bridge portion 112 from which a first side portion 114 and a second side portion 116 extend. The first side portion 114 may include an aperture 113 near its end, and the second side portion 116 may include an aperture 115 near its end. The apertures 113, 115 may be used to attach a retaining member, such as a strap or tie (not shown), for securing the eye mask 100 to the user's face. Alternatively, the strap may be attached to the side portions 114, 116 in other ways, such as by staples, adhesives, or heat seals.

[0061] The through holes 102 improve air permeability around the eye area and allow oxygenation of the retina.

[0062] The through hole 102 may have a diameter of about 0.5 mm to about 10 mm. In some embodiments, the through hole 102 has a diameter of about 0.5 mm to about 2 mm. The through hole may extend to the end of the eye mask. In some embodiments, portions of the first side portion 114 and / or the second side portion 116 may be formed as a mesh or micro-mesh to achieve better breathability.

[0063] Through holes can be arranged in an array. An array of through holes 102 is formed in the first side portion 114. Similarly, an array of through holes 106 is formed in the second side portion 116. An array of through holes 104 is also formed in the bridging portion 112. Forming an array of through holes in each part of the cover 100 increases the breathability and reduces the weight of the cover 100, thereby further contributing to the comfort of the user. The spacing between the through holes in the array can be adjusted to maintain the firmness of the eye mask. It has been found that keeping the spacing within a certain range can further facilitate the formation of an eye mask that is not easily damaged. For example, the interval can be from about 3mm to about 15mm, about 3mm to about 12mm, about 3mm to about 10mm, about 3mm to about 8mm, or about 3mm to about 6mm. However, it will be understood that the hole can be formed only in one of the cover parts 112, 114, 116, for example, or only in the side parts 114, 116, especially, for example, in the orbital area 118.

[0064] FFF and SLS printers can be used to include vent holes 102, 104, 106 in cover 100 by simply omitting printing material in the corresponding hole locations. Alternatively, when printing with an FFF printer, the holes can be printed using a secondary soluble material (e.g., PVA, etc.), which is then removed by washing in water.

[0065] In certain embodiments, the orbital regions 18, 20, 118, and / or 120 may be offset to improve user comfort. Figure 6 As shown, the eye socket region 18 can be adjusted so that it protrudes outward, i.e., further away from the inner (face-contacting) surface 40 of the eye mask 10. In one example, the 3D facial scan data can be adjusted so that the eye socket region 18 is offset by a range between about 5 mm and about 7 mm and therefore does not contact the eye socket region of the user's face when the mask 10 is worn, thereby allowing freer eye movement during REM sleep and improving user comfort. Figure 6 An exemplary adjusted orbital region 58 is shown in FIG. 5 , wherein the initial orbital region 18 is shown in dashed outline.

[0066] The side portions of the eye mask can be made of a flexible polymer material. Such a material can have a lower stiffness or a lower Shore A hardness than the material used in the bridge portion. For example, the flexible polymer material can be selected from the group consisting of thermoplastic polyurethane (TPU), polylactic acid (PLA), thermoplastic elastomer (TPE), plasticized copolyamide TPE (PCTPE), nylon, acrylonitrile butadiene styrene (ABS) and any combination of two or more thereof. For example, Agilus 30, a polymer jet photopolymer with excellent tear resistance and capable of withstanding repeated bending and flexing, can be used.

[0067] The side portions 14, 16, 114, 116 may have a bending strength of about 10 MPa to about 50 MPa. Alternatively, the material of the side portions 14, 16, 114, 116 may be characterized by Shore hardness. Embodiments may have a Shore A hardness in the range of about 10A to 100A.

[0068] For 3D printing using a fused filament fabrication (FFF) printer, the shield can be printed using flexible filaments (e.g., TPU, Recreus Filaflex, MatterHacker Soft PLA, NinjaTek SemiFlex, Polymakr Polyflex, FormFuturaFlexiFil TPC, taulman3D PCTPE, etc.). For 3D printing using a selective laser sintering (SLS) printer, powders of flexible materials (e.g., TPU, TPE, etc.) can be used.

[0069] 3D printers such as the Stratasys Objet500 Connex3 3D ​​can be used for advanced 3D printing processes. Other non-limiting examples are the Stratasys J750 liquid resin-based 3D printer for printing Vero+Tango material blends, and filament-based 3D printers such as the BCN3D Sigma and Prusa i3 for printing nylon and TPU materials.

[0070] In some embodiments, as described above, the bridging portion 12 or 112 can be formed of a material that is more rigid than the material of the side portions 14, 16 (or 114, 116). For example, the bridging portion 12 can be made of a material selected from the group consisting of: polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), nylon, and polycarbonate. The bridging portion 12 can have a bending strength of about 50 MPa to about 100 MPa. Alternatively, the material of the bridging portion 12 can be characterized by its Shore hardness. For example, the bridging portion 12 can have a Shore A hardness ranging from about 50A to 100A.

[0071] Now refer to Fig. 7A and Figure 7B , another embodiment of an eye mask 200 is shown. Side portions, generally indicated at 202 and 204, extend from a bridge portion 206. Side portion 202 includes an upper flexible portion 203 and a lower rigid portion 213. Similarly, side portion 204 includes an upper flexible portion 205 and a lower rigid portion 215. The lower rigid portions 213 and 215 are part of a frame structure 208, which includes a bridge portion 206 located intermediate the lower rigid portions 213, 215.

[0072] The eye mask 200 has at least one elongated aperture 218 at each side thereof for receiving a retaining member, such as a strap, for securing the eye mask 200 to the user's head.

[0073] exist Fig. 7A and Figure 7B In the example of FIG. 1 , the flexible upper portions 203 and 205 cover the eye socket area of ​​the user when in use, while the rigid lower portions 213 and 215 on both sides of the bridge portion 206 include corresponding sub-orbital areas 224 and 226, which are rigid and configured to apply pressure to the corresponding sub-orbital areas of the face when the eye mask is attached to the face of the user. Fig. 7A and Figure 7B The eye socket areas indicated at 203a and 205a are less rigid than the frame element 208.

[0074] for Figures 1 to 3 In embodiments, the suborbital regions 224, 226 may be outwardly concave or recessed to include one or more convex projections, such as Figure 5 The infraorbital region 44 is shown with a raised protrusion. As with other embodiments disclosed herein, the protrusions of different depths at the infraorbital regions 224, 226 allow for different pressures to be applied to the corresponding infraorbital regions of the face when the eye mask is attached to the face of the user.

[0075] In some embodiments, the upper portions 203, 205 are formed of a different material than the lower portions 213, 215 of the frame element 208. The upper portions 203, 205 can be formed using a material having a lower rigidity and / or a lower Shore A hardness than the frame element 208. Advantageously, this provides greater comfort to the user because, for example, it provides greater freedom of eye movement during, for example, REM sleep. The higher rigidity of the bridge portion 206 of the frame element 208 allows the eye mask 200 to remain in place during sleep by, for example, resting against the dorsum region of the user's nasal area.

[0076] The upper portions 203, 205 can be formed with a thinner cross-section than the bridge portion 206. The upper portions 203, 205 can, for example, have a thickness of about 0.2 mm to about 5 mm, about 0.2 mm to about 4 mm, about 0.2 mm to about 2 mm, or about 0.4 mm to about 1 mm. This is more advantageous because it reduces pressure on the subject's eyes and, therefore, provides greater comfort to the user. In addition, the thinner, softer material also prevents or substantially reduces skin indentations along the edge of the eye mask 200.

[0077] In combination with the bridge portion 206, the lower portions 213, 215 provide the eye mask with a structural frame "exoskeleton" that provides balance, limits movement at the bridge of the nose, and increases compression under the eyes. In addition, because the upper portions 203, 205 can be made of a less rigid (and potentially softer) material, it is expected that the user will feel more comfortable. This is due to greater flexibility around the eyeball while maintaining lower and upper eye area compression.

[0078] In some embodiments, the orbital regions 203a, 205a are carried on a liner attached to the frame element. For example, the liner 210 can be attached to the frame element 208. Figure 7B As shown in a rear view of the embodiment of the present invention, wherein the variation in shading indicates areas of different rigidity, the liner 210 may have a first portion 210a and a second portion 210b, wherein the first portion 210a carries the orbital regions 203a, 205a and the second portion 210b is attached to the frame element 208. The second portion 210b of the liner 210 contacts the sub-orbital regions 224, 226 of the eye-contacting portions 202 and 204. The corresponding portions 224' and 226' of the liner in the second portion 210b are aligned with the sub-orbital regions 224 and 226. Similarly, a portion of the liner 206' is aligned with the bridge portion 206.

[0079] The suborbital region 224, 226 may extend substantially to the end of the eye mask. The extension of the suborbital region 224 or 226 may extend to a position near the orifice 218. Fig. 7A The mid-infraorbital region is shown extending to a position below the orifice 218, but alternatively, the extension may be located above the orifice 218 or above and below the orifice 218. Advantageously, this provides additional strength to the eye mask so that it is less susceptible to breakage or tearing. Additionally, the extensions of the infraorbital regions 224, 226 may be looped around the orifice 218. This strengthens the orifice 218 so that it does not tear when subjected to the tension of the retaining members securing the eye mask 200 to the user's head.

[0080] FIG. 8A to FIG. 8DAnother embodiment of the eye mask is shown. The eye mask 300 may include an inner lining 310 and an outer frame 308. The inner lining 310 is assembled with the outer frame 308 to form the eye mask 300. The eye mask 300 has a first side portion 302 and a second side portion 304, each of which extends from a bridge portion 306. The frame 308 has a first suborbital region 324 associated with the first side portion 302 and a second suborbital region 326 associated with the second side portion 304 at its lower portion. The first suborbital region 324 and the second suborbital region 326 are configured to apply pressure to the corresponding suborbital region of the face when the eye mask 300 is attached to the face of the user. For example, this can be achieved by means of a protruding protrusion on the opposite (user-facing) surface of the mask 300 in the suborbital regions 324, 326. The eye mask 300 also has orbital regions 303, 305 above the suborbital regions 324, 326.

[0081] The inner liner can be made of a flexible polymer material, as discussed above with respect to other embodiments. The inner liner can also be a smooth and soft material. The inner liner can also be a non-porous and non-leaching material, which is conducive to functionalization with cosmetics and / or active ingredients.

[0082] The eye mask 300 also includes an aperture 318 for attaching a retaining member (not shown) for securing the eye mask 300 to the face of a user.

[0083] The inner lining 310 can be made of a less rigid (or softer) material than the outer frame 308 and substantially covers the orbital region, the suborbital region, and the nasal region of the user's face. The outer frame 308 can be made of a more rigid (or harder) material and substantially covers the nasal region of the user's face. The outer frame 308 can also extend to the end of the eye mask 300 so that it forms a frame (or perimeter) around at least the orbital regions 303 and 305. For example, as Figure 8C and Fig.8D As shown, the frame 308 can have cut-out portions 333 and 335 so that when the inner liner 310 is coupled to the frame 308, the orbital regions 303 and 305 (respectively) remain exposed.

[0084] In some embodiments, the inner liner 310 may have a plurality of apertures 315 to improve the breathability of the mask 300. For example, the apertures 315 may be arranged in an array and may be arranged at least in the orbital regions 303 and 305.

[0085] The inner lining 310 can be combined with the outer frame 308 to form the eye mask 300. To this end, the bridge portion 306 includes a layered structure of the inner lining 310 and portions of the outer frame 308. The orbital regions 303, 305 of the side portions 302, 304 are carried on the inner lining 310, while the suborbital regions 324, 326 of the side portions 302, 304 include a layered structure of portions of the inner lining 310 and portions of the outer frame 308. In use, the inner lining 310 is positioned to contact the user's face. This is advantageous because the inner lining (softer, smoother material) provides comfort for nighttime use.

[0086] The layered construction of the inner lining 310 and outer frame 308 at the infra-orbital regions 324, 326 of the eye mask 300, and the layered construction of the inner lining 310 only at the orbital regions 303, 305 of the eye mask 300 are advantageous because the inner lining 310 can be made smooth (and breathable if the orifice 315 is included) for greater comfort, while the stiffer exoskeleton 308 provides support, structural balance, and compression over the infra-orbital regions 324, 326.

[0087] In addition to being made of a material with relatively low rigidity, the inner lining 310 may also have a thickness of about 0.1 mm to about 10 mm, or about 0.2 mm to about 8 mm, about 0.2 mm to about 6 mm, about 0.2 mm to about 4 mm, or about 0.2 mm to about 2 mm. In some embodiments, the inner lining 310 has a thickness of about 0.5 mm.

[0088] The outer frame 308 may have a thickness of about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 1 mm to about 6 mm, about 1 mm to about 4 mm, about 1 mm to about 2 mm. In some embodiments, the outer frame 308 has a thickness of about 1 mm.

[0089] The inner lining 310 may extend beyond the boundaries of the outer frame 308, such as Fig. 8A and Figure 8B As shown. The inner lining 310 can extend, for example, from about 0.2 mm to about 10 mm, from about 0.5 mm to about 8 mm, from about 0.5 mm to about 5 mm, or from about 1 mm to about 5 mm. This can help minimize skin indentations when the user wears the eye mask 300 at night.

[0090] 9A to 9CAnother embodiment of an eye mask 400 is shown. In this embodiment, a rigid lower portion 408 spans across the bridge portion 406 and the side portions 402, 404. The bridge portion 406 and the lower portions of the side portions 402, 404 are thickened to enhance the compression effect. The upper portion of the eye mask 400 includes a mesh covering the eye socket areas 403, 405 of the side portions 402, 404 to improve breathability and at the same time provide rigidity to make the eye mask 400 more durable. Similar to other embodiments disclosed herein, the eye socket areas 403, 405 of the side portions 402, 404 (mesh areas) and the bridge portion 406 (thickened areas) can be printed with different materials and / or different hardnesses.

[0091] An inner liner (not shown) may be further laminated onto the inner (user-facing) surface of the eye mask 400. In addition to increasing the user's comfort level, the inner liner also provides a surface for the application of cosmetics and / or active ingredients that may help reduce periorbital puffiness.

[0092] In certain embodiments, additional therapeutic components may be applied to the inner surface 30, 40 of the eye mask 10 in the infraorbital region (24, 26, 44) of the eye mask 10 (and similarly for other eye masks 100, 200, 300, 400 disclosed herein). For example, an active agent in the form of a coating or lining or impregnated in a coating or lining may be applied in the infraorbital region. Example active agents are moisturizers, cooling agents, anti-aging agents, and antioxidants. Combinations of any two or more thereof may also be used.

[0093] The eye masks 10, 100, 200, 300, 400 can be included as part of a kit for treating periorbital edema. For example, a plurality of such eye masks can be provided, with respective eye masks having respective suborbital regions configured to apply progressively greater pressure to the corresponding suborbital regions of the face. In one example, the eye masks in the kit have suborbital regions with projections that gradually become shallower in depth.

[0094] Certain embodiments relate to a method of manufacturing an eye mask for treating and / or preventing swelling around the user's eye sockets. The exemplary embodiment is discussed with reference to the eye mask 10, but it will be understood that the method can also be applied to manufacture any other embodiment including the eye mask 100, 200, 300 or 400.

[0095] For example, Fig.10As shown, method 700 may include step 710 of obtaining three-dimensional (3D) facial scan data of a user. The scan may be generated by an off-the-shelf device such as the Face Camera Pro from Bellus 3D, Inc. Other types of facial scanners such as handheld scanners may also be used.

[0096] Next, method 700 may include a step 720 of analyzing the facial scan data to determine the boundaries of the orbicularis oculi muscle. Analyzing step 720 may also include determining the boundaries of the eye bag area (infraorbital region) on the user's face.

[0097] Optionally, method 700 may include step 730 of adjusting the 3D facial scan data in the infra-orbital region, as will be explained in more detail below. Once the 3D facial scan data is obtained (and optionally, adjusted), the method proceeds to step 740, where a mask design is generated (e.g., in a 3D printable format such as an STL file). The mask design includes two side portions extending from a bridge portion. Each side portion includes an orbital region and an infra-orbital region that is configured to apply pressure to a corresponding infra-orbital region of the user's face when the eye mask is attached to the face. Described above and in Figure 1 Exemplary hood designs are depicted in Figures 9 through 9.

[0098] Next, in step 750, the mask body is manufactured according to the mask design, for example by 3D printing. In some embodiments, the mask body is manufactured by filament manufacturing, selective laser sintering, or stereolithography. In other embodiments, the eye mask is manufactured in two parts. The inner lining and the outer frame can be manufactured separately and combined using an appropriate adhesive or bonding method. For example, the two parts can be thermally bonded. Advantageously, this allows the two parts to be made of different materials. For example, the inner lining can be printed with a thermoplastic filament with a lower melting point, so that a smooth final surface can be directly obtained for improving comfort and hygiene. In contrast, since the outer frame does not contact the user's face, fine polishing is not required, and the rough 3D printed product can be further processed by, for example, sanding.

[0099] Finally, at step 760, a retaining member is provided at the mask body for attaching the eye mask to the user's face. For example, the eye mask may be attached to the user's face by, for example, stapling, gluing, heat sealing, or passing through a hole in a side portion of the mask body (e.g., Figure 1 and Figure 3 Attach a retainer such as a tie or belt to the cover body.

[0100] As mentioned above, the 3D facial scan data may be modified before the mask design is generated. This may be done in a number of ways.

[0101] For example, the 3D facial scan data may be modified to include one or more raised protrusions (facing outwardly toward the user) in each infra-orbital area of ​​the eye mask.

[0102] In one example, where a mask or set of masks is used to treat existing eye bags, a new 3D face scan dataset can be created to represent the preferred eye contour without existing eye bags, i.e. the individual face contour without the bulge caused by excess fluid. This dataset represents the desired end shape and contour (mask data Z = preferred face contour).

[0103] In some embodiments, method 700 can be used to produce a set of masks for treating periorbital edema. For example, the 3D facial scan data can be incrementally changed to create mask designs with gradually lower indentations at the suborbital regions 24, 26, wherein each corresponding mask design is used to print a corresponding mask. The group of mask designs can be slowly and incrementally moved from the initial facial scan data to a final data set Z representing a preferred facial contour. For example, for small eye bags, a group of 4 masks (mask data sets A, B, C, Z) can be created. For larger, more noticeable eye bags, more masks may be needed so that the compression effect is kept within reasonable limits to allow the skin time to adapt. In this case, a group of 10 mask contours can be created to obtain a mask data set Z from the initial data set.

[0104] In another example, the shape of the protrusion of the existing eye bags can be determined from the facial scan data and then inverted and transformed into a matching shape using CAD, thereby producing a mask design that will cause a compression effect when the subject wears the mask. To gradually modify the compression effect over time, an adjustable strap (such as a hook and loop strap) can be used to hold the mask on the user's head, where the user can adjust the tightness of the adjustable strap over time to gradually increase the compression effect and push the infraorbital area toward the desired facial contour.

[0105] In another example, the 3D facial scan data may be modified such that the bridge portion of the hood design is thicker than the side portions.

[0106] In another example, the 3D facial scan data may be modified to include one or more apertures in the mask design so that when the mask design is printed, one or more through holes are formed in the eye mask. An array of such holes may be included in the mask design.

[0107] In some embodiments, an active agent may be applied to the infraorbital region of the eye mask before or after the retainer is attached to the mask body. For example, the active agent may be included in a coating or lining. The active agent may be selected from the group consisting of a moisturizer, a cooling agent, an anti-aging agent, an antioxidant, and combinations thereof.

[0108] Embodiments are also directed to a method of treating a subject in need of treatment for periorbital edema, comprising administering an eye mask disclosed herein. For example, in some embodiments, the method can be used to treat a patient suffering from periorbital edema following eye or other facial surgery. To this end, a single eye mask or a kit of eye masks, each configured to provide a different amount of infraorbital compression, as disclosed herein, can be provided as part of a treatment regimen.

[0109] In one example of a treatment plan for a post-operative patient, a scan of the patient's face is obtained before surgery. Method 700 of FIG. 7 can then be performed post-operatively to generate a series of masks in which the scan data in the infraorbital region is incrementally adjusted from the initial infraorbital shape toward the initial infraorbital shape obtained from the pre-operative scan. The first mask is attached post-operatively and remains in place for 3 to 14 days to prevent or reduce swelling throughout the day and night. In some embodiments, the mask data can be modified to allow and accommodate the thickness of bandages, gauze, sutures, etc. in specific areas while still maintaining the desired compression effect.

[0110] Embodiments are also directed to an eye mask disclosed herein for treating periorbital edema.

[0111] Periorbital swelling or periorbital edema is the term for swelling around the eyeball. Periorbital edema can occur in just one eye, or it can occur in both eyes at the same time. One cause of periorbital edema is inflammation that causes fluid to build up around the eye. Some common causes of periorbital edema include mononucleosis (a viral eye infection), irregular sleep patterns, a high-salt diet, high alcohol intake, smoking, allergies, skin conditions, aging, crying, thyroid disease, periorbital cellulitis (a skin condition caused by infection and inflammation of the eyelids and skin around the eye), Chagas disease, nephrotic syndrome, trichinosis, tear gland dysfunction, superior vena cava obstruction, conjunctivitis, and eye trauma. Eyelid surgery, chemical burns, sunburn of the eyelids, sinusitis, eyelid skin infections such as impetigo and erysipelas, blepharitis, inflammatory bowel disease, chalazion, ocular herpes, and Graves' disease may also cause periorbital swelling.

[0112] Descriptions of some exemplary embodiments of the present disclosure are contained in one or more of the following numbered statements:

[0113] Statement 1. An eye patch for treating and / or preventing periorbital edema comprising:

[0114] two side portions extending on either side of the bridge portion; and

[0115] a retaining member for attaching the eye mask to a user's face;

[0116] Each side portion includes an orbital region and a suborbital region, wherein the orbital region is suitable for covering the eyeballs of the user, and the suborbital region is configured to apply pressure to the corresponding suborbital region of the face when the eye mask is attached to the face of the user.

[0117] Statement 2. The eye mask of Statement 1, wherein each suborbital region of the eye mask comprises one or more protrusions extending away from a user-facing surface of the eye mask.

[0118] Statement 3. An eye mask according to Statement 1 or Statement 2, wherein each infraorbital region of the eye mask includes an elongated compression area.

[0119] Statement 4. The eye mask of Statement 3 wherein said elongated compression region is crescent-shaped.

[0120] Statement 5. The eye mask of any one of Statements 2 to 4, wherein the one or more protrusions each have a depth in a range between about 1 mm and 10 mm.

[0121] Statement 6. An eye mask according to any one of Statements 1 to 5, comprising a frame element comprising said bridge portion and said infraorbital region of said side portions.

[0122] Statement 7. The eye mask of Statement 6, wherein the orbital region of the side portion is less rigid than the frame element.

[0123] Statement 8. An eye mask according to Statement 6 or Statement 7, wherein the orbital region is carried on a liner attached to the frame element.

[0124] Statement 9. The eye mask of Statement 8, wherein said lining extends at least partially beyond an edge of said frame element.

[0125] Statement 10. The eye mask of any one of Statements 1 to 9, wherein the side portions are made of a flexible polymer material.

[0126] Statement 11. An eye mask according to statement 10, wherein the flexible polymer material can be selected from the group consisting of: thermoplastic polyurethane (TPU), polylactic acid (PLA), thermoplastic elastomer (TPE), plasticized copolyamide TPE (PCTPE), nylon and combinations of any two or more thereof.

[0127] Statement 12. The eye mask of any one of Statements 1 to 11, wherein said side portion has a Shore A durometer in the range from about 10A to 100A.

[0128] Statement 13. An eye mask according to any one of Statements 1 to 12, wherein the side portions are rigidly coupled to the bridge portion or are integral with the bridge portion.

[0129] Statement 14. The eye mask of any one of Statements 1 to 13, wherein the bridge portion is more rigid than the side portions.

[0130] Statement 15. The eye mask of Statement 14, wherein said bridge portion is made of a material selected from the group consisting of: polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), nylon, and polycarbonate.

[0131] Statement 16. The eye mask of Statement 14 or Statement 15, wherein said bridge portion has a Shore A hardness in the range of from about 50A to about 100A.

[0132] Statement 17. The eye mask of Statement 14, wherein said bridge portion is made of the same material as said side portions and has a greater thickness than said side portions.

[0133] Statement 18. The eye mask of any one of Statements 1 to 17, comprising at least one through hole.

[0134] Statement 19. The eye mask of Statement 18, comprising an array of through holes.

[0135] Statement 20. The eye mask of Statement 19, comprising an array of through holes in each eye socket region.

[0136] Statement 21. The eye mask of any one of Statements 1 to 20, wherein said retaining member comprises a strap.

[0137] Statement 22. The eye mask of Statement 21, wherein said strap is adjustable to vary the pressure applied by said infraorbital region of said eye mask.

[0138] Statement 23. The eye mask of any one of Statements 1 to 22, comprising an active agent applied to the infraorbital region of the eye mask, the active agent selected from the group consisting of moisturizers, cooling agents, anti-aging agents, antioxidants, and combinations of any two thereof.

[0139] Statement 24. A kit for treating periorbital edema, comprising a plurality of eye masks according to any one of Statements 1 to 23, respective eye masks having respective infraorbital regions, the respective infraorbital regions of the respective eye masks being configured to apply progressively greater pressure to the corresponding infraorbital regions of the face.

[0140] Statement 25. A method of making an eye mask for treating and / or preventing periorbital edema in a user, comprising:

[0141] Obtaining three-dimensional (3D) facial scan data of the user;

[0142] generating a hood design based on the 3D facial scan data, the hood design comprising two side portions extending on either side of a bridge portion;

[0143] wherein each side portion includes an orbital region and a sub-orbital region, the orbital region being adapted to cover an eyeball of the user, the sub-orbital region being configured to apply pressure to a corresponding sub-orbital region of the face of the user when the eye mask is attached to the face;

[0144] Designing and manufacturing a cover body according to the cover; and

[0145] A retaining member is provided at the mask body, the retaining member being used to attach the eye mask to the face of the user.

[0146] Statement 26. The method of statement 25, wherein the cover body is made by 3D printing.

[0147] Statement 27. The method of Statement 26, wherein said cover body is fabricated by fuse fabrication, selective laser sintering, or stereolithography.

[0148] Statement 28. The method of any one of Statements 25 to 27, comprising modifying the 3D facial scan data to include one or more protrusions in each infraorbital region of the eye mask.

[0149] Statement 29. The method of Statement 28, wherein the one or more protrusions each have a depth in a range between about 1 mm and about 10 mm.

[0150] Statement 30. The method of any one of Statements 25 to 29, wherein said bridge member is more rigid than said side portions.

[0151] Statement 31. The method of Statement 30, wherein the bridge portion is formed with a greater thickness than the side portions.

[0152] Statement 32. The method of Statements 25 to 31, comprising forming at least one through hole in said eye mask.

[0153] Statement 33. The method of Statement 32, comprising forming an array of through holes in said eye mask.

[0154] Statement 34. The method according to any one of Statements 25 to 33, comprising applying to said infraorbital region of said eye mask an active agent selected from the group consisting of: a moisturizer, a cooling agent, an anti-aging agent, an antioxidant, and a combination of any two thereof.

[0155] Statement 35. An eye mask according to any one of Statements 1 to 23 or a kit according to Statement 24 for use in treating periorbital edema.

[0156] Statement 36. A method of treating periorbital edema in a subject in need of such treatment, comprising applying one or more eye patches according to any one of Statements 1-23.

[0157] It will be understood that numerous further modifications and permutations of various aspects of the described embodiments may be made. Accordingly, the described aspects are intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.

[0158] Throughout this specification and the appended claims, unless the context requires otherwise, the word "comprise" and variations thereof will be understood to imply the inclusion of stated integers or steps or groups of integers or steps but not the exclusion of any other integers or steps or groups of integers or steps.

[0159] Reference in this specification to any previous publication (or information derived therefrom) or any known matter is not and should not be taken as an acknowledgement or approval or any form of indication that the previous publication (or information derived therefrom) or known matter forms part of the common general knowledge in the field of endeavor to which this specification relates.

Claims

1. An eye mask for treating and / or preventing periorbital edema, comprising: two side portions extending on either side of the bridge portion; as well as a retaining member for attaching the eye mask to a user's face; wherein each side portion includes an orbital region and a sub-orbital region, the sub-orbital region including one or more projections extending away from a user-facing surface of the eye mask so as to apply pressure to a corresponding sub-orbital region of the face when the eye mask is attached to the face of the user; wherein the eye mask substantially matches the contour of the user's face; and Therein, the suborbital region has a higher rigidity than the rest of the lateral portion.

2. The eye mask according to claim 1, wherein: Each infraorbital region of the eye mask includes an elongated compression area.

3. The eye mask according to claim 2, wherein: The elongated compression zone is crescent-shaped.

4. The eye mask of claim 1, comprising a frame member including the bridge portion and the infraorbital region of the side portions.

5. The eye mask according to claim 4, wherein: The orbital region of the side portion is less rigid than the frame element.

6. The eye mask according to claim 5, wherein: The orbital region is carried on a liner attached to the frame element.

7. The eye mask according to claim 6, wherein: The lining extends at least partially beyond an edge of the frame element.

8. The eye mask according to claim 1, wherein: The side portions are made of a flexible polymer material.

9. The eye mask according to claim 8, wherein: The flexible polymer material is selected from the group consisting of thermoplastic polyurethane (TPU), polylactic acid (PLA), thermoplastic elastomer (TPE), plasticized copolyamide TPE (PCTPE), nylon, and combinations of any two or more thereof.

10. The eye mask according to claim 1, wherein: The side portion has a Shore A hardness in the range of approximately 10A to 100A.

11. The eye mask according to claim 1, wherein: The bridge portion is more rigid than the side portions.

12. The eye mask according to claim 11, wherein The bridge portion is made of a material selected from the group consisting of polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), nylon, and polycarbonate.

13. The eye mask according to claim 11, wherein: The bridge portion is made of the same material as the side portions and has a greater thickness than the side portions.

14. The eye mask of claim 1, comprising an array of through holes.

15. An eye mask as claimed in claim 14, comprising an array of through holes in each eye socket region.

16. The eye mask of claim 1, comprising an active agent applied to the infraorbital region of the eye mask, the active agent selected from the group consisting of moisturizers, cooling agents, anti-aging agents, antioxidants, and combinations of any two thereof.

17. A kit for treating periorbital edema, comprising a plurality of eye masks according to claim 1, respective eye masks having respective infraorbital regions, the respective infraorbital regions of the respective eye masks being configured to apply progressively greater pressure to the corresponding infraorbital regions of the face.

18. A method of manufacturing an eye mask for treating and / or preventing periorbital edema of a user, the method comprising: Obtaining three-dimensional (3D) facial scan data of the user; generating a mask design based on the 3D facial scan data, the mask design being consistent with claim 1; Designing and manufacturing a cover body according to the cover; and A retaining member is provided at the mask body, the retaining member being used to attach the eye mask to the face of the user.

19. The method according to claim 18, wherein: The cover body is produced by 3D printing.

20. The method according to claim 18, wherein: The cover body is made by fuse fabrication, selective laser sintering or stereolithography.

Images