Eyelid adhesive patch and method for eyelid closure

Abstract

An eyelid adhesive patch addresses the challenges of lagophthalmos and exposure keratopathy with a one-piece or multi-piece eyelid adhesive patch. In a one-piece eyelid adhesive patch, multiple adhesive layers adhere to different types of skin. In a two-piece eyelid adhesive patch, the two pieces are fastened together, e.g., hook and loop, adhesives, a button, etc. The eyelid adhesive patch provides a way for the eye to be opened and closed without removing the adhesive completely.

Description

Attorney Docket No. 105676-432984EYELID ADHESIVE PATCH AND METHOD FOR EYELID CLOSURECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 730,352, filed December 10, 2024, the contents of which are hereby incorporated by reference.BACKGROUND

[0002] Lagophthalmos, characterized by incomplete closure of one or both eyelids, is a common problem that impacts many people. It occurs in normal individuals and hospitalized patients who have been medically sedated and / or paralyzed (e.g., in the intensive care unit and operating room). Studies indicate that lagophthalmos has an incidence of 42% in the ICU population, over 50% in the asymptomatic general population, and 79% in the symptomatic dry eye patient population.

[0003] Lagophthalmos desiccates the cornea - the clear tissue in front of the eye’s pigmented iris - by exposing it to air. Abnormal drying-out of the cornea is a condition called exposure keratopathy (EK) and is further subdivided into short- and long-term subtypes. Short-term EK is associated with pain and foreign body sensation in the eye upon waking, excessive eye watering, and redness of the eye, but some individuals may be asymptomatic despite substantial corneal damage. Vision and comfort may be negatively impacted during the early hours of the day but progressively improve before recurring the next morning. Long-term exposure causes vision-threatening problems due to the breakdown of the cornea’s protective outermost layer, the corneal epithelium. Long-term EK can result in corneal abrasions, infections, scars, and even emergent corneal perforations. Left untreated, long-term EK can lead to permanent vision loss and can even require a corneal transplant.

[0004] Short-term EK is commonly seen as an exacerbating factor in patients with obstructive sleep apnea (OSA) who wear continuous positive airway pressure (CPAP) devices when they sleep. In these patients, air leakage from the CPAP mask can blow toward the eyes. Air leakage combined with lagophthalmos results in short-term EK, with many CPAP wearers waking in the morning with pain, foreign body sensation, redness, tearing, and irritation. There are various treatments to mitigate lagophthalmos in CPAPAttorney Docket No. 105676-432984wearers, including goggles, masks, and tape. Goggles and masks represent a significant burden to the user because of their size and high profile above the face, adding to the already burdensome size of many CPAP masks. Tape can be ineffective at keeping the eyelids fully closed and represent an impediment to nighttime waking (e.g., in individuals with urinary frequency) because the tape must be removed and re-stuck. Tape is also difficult to apply to one’s own eyes. Gels and ointments blur the vision.

[0005] Short-term EK is also commonly seen as an exacerbating factor in patients with Dry Eye Disease. Lagophthalmos aggravates underlying ocular surface inflammatory symptoms (i.e., pain, redness, foreign-body sensation) and increases the likelihood of corneal damage (i.e., scarring). There are various treatments to mitigate lagophthalmos in dry eye patients; however, methods such as tapes can be ineffective at keeping the eyelids fully closed at night and incompatible with nighttime waking (e.g., in individuals with urinary frequency). Gels and ointments blur the vision; goggles are uncomfortable; and, like tape, all the above fail to provide adequate relief.

[0006] Long-term EK is common in hospitalized patients who are sedated and / or paralyzed for one day or longer and whose eyecare is dependent on healthcare providers. Despite being 100% preventable, EK affects 21-56% of ICU patients. It is not standard in all hospitals to have an EK prevention protocol and in its absence, nurses understandably prioritize life-sustaining care over eye care. Where preventive measures are employed, tape or occlusive dressings are commonly used, which are even more inadequate in the inpatient setting than they are at home. Such dressings are also problematic because of the ICU’s protocol for pupil monitoring at least once per nursing shift, which requires repeated removal of adhesives that can damage the delicate eyelid skin and even cause corneal abrasions if improperly placed. Ophthalmic ointments, which are nearly ubiquitous in ICU protocols, make adhesive reapplication ineffective.

[0007] EK poses risks beyond the ICU setting. Lengthy surgeries under general anesthesia, especially where the patient lies prone (i.e., spine procedures) significantly increase the risk of short- and long-term EK. The incidence of corneal epithelial damage after surgery under general anesthesia is 10%. Other less common medical scenarios may put a patient at risk for EK. Lagophthalmos occurs in patients with a previous blepharoplasty, the most common invasive cosmetic facial surgery; thyroid eye disease, aAttorney Docket No. 105676-432984rare condition that affects 10 per 100,000 people; and facial palsy, stroke-associated facial paralysis that affects as many as 40,000 per year.

[0008] The widespread prevalence of lagophthalmos and EK across diverse disease states underscores the urgent need for effective and comfortable solutions. Innovations addressing complete eyelid closure in both ambulatory and inpatient settings are essential to safeguarding ocular health and mitigating the risks associated with these conditions.

[0009] Those skilled in the art label the area of the eyelid that is on the side of the nose as medial in location; the area of the eyelid that is on the side of the ear is labeled lateral in location. Mild lagophthalmos is associated with the medial area of the eyelids incompletely closing, but more severe lagophthalmos is associated with both the medial and lateral areas of the eyelids incompletely closing. Mild exposure keratopathy is more common than severe exposure keratopathy. Thus, the medial area of the eyelids is the most common location of incomplete eyelid closure and the medial area of the ocular surface is more common than the lateral surface to exhibit exposure keratopathy.

[0010] The surface geometry of the closed eyelid area is complex. It includes multiple regions with differing curvatures: the concave medial canthal region adjacent to the nasal bridge characterized by tight, multidirectional radii; the convex palpebral surface characterized by a larger radius of curvature; and the convex superior, inferior, and lateral orbital rim regions that transition continuously from the palpebral surface onto the facial bones. Together, these regions define a contiguous anatomical surface.

[0011] The eyelid area is covered by the thinnest skin on the human body, which is fragile and highly sensitive to traction and chemical irritation. It includes the medial and lateral canthi, eyelid margins, eyelashes, and eyebrow. The skin is prone to irritation from adhesives, which may cause contact dermatitis, and is susceptible to mechanical injury during adhesive removal. The hair is also prone to undesired epilation during adhesive removal.

[0012] Hydrogel adhesives have several properties that make them well-suited for application to the eyelid area. They can be high tack and highly compliant, allowing them to conform and adhere to the complex surface geometry of eyelid skin. At the same time, they can be gentle and removed atraumatically with minimal discomfort. Hydrogels can also be inert and therefore unlikely to cause irritation or noxious skin reactions. InAttorney Docket No. 105676-432984addition, they can be formulated to incorporate bioactive agents that provide physiological benefits during use. Adhesive hydrogels can be in high water content. Those skilled in the art express hydrogel water content as a percentage of the gel’s mass. High water content makes the adhesive hydrogel feel cool to the touch when applied to the skin. Wearers can perceive the coolness of the adhesive hydrogel as soothing. High water content also makes the adhesive hydrogel conductive to temperature. The tackiness of adhesive hydrogels can be measured by 90-degree peel tests after the adhesive has been adhered to stainless steel or bakelite plastic; tackiness can also be measured with PSTC-5, ASTM, or D6862 standard test methods. The gentleness of peeling adhesive hydrogels after it has been stuck to a surface can be measured by elongation of the gel at release, expressed in a percent value of the baseline thickness.

[0013] Those skilled in the art define hypoallergenic as less likely to cause irritation or allergic reaction. Those skilled in the art define translucency as visual difference of distinct images on each side of a material as measured by Contrast Ratio or Transparency Parameter. Those skilled in the art define transparency as the ability for light to pass through a material without appreciable scattering. Those skilled in the art define opacity as the inability of light to pass through a material. Those skilled in the art define Tack as the quick stickiness of a material which can be measured by methods such as the Rolling Ball Tack Test described in ASTM D3121 or indirectly as the 90* peel strength as described in ASTM D6862-11. Those skilled in the art define Pliability as the ease with which something bends without breaking, comparable to drapability and flexural stiffness as described in ISO 9073-9:2008(E), ASTM D1388-23, ASTM F3260-25. Those skilled in the art define Traumatically as causing injury to tissue and atraumatically as not causing injury to tissue.SUMMARY

[0014] An eyelid adhesive patch described below addresses the challenges of lagophthalmos and exposure keratopathy with a one-piece eyelid adhesive patch. In a one-piece eyelid adhesive patch, multiple adhesive layers adhere to different types of skin. In a two-piece eyelid adhesive patch, the two pieces are fastened together by some means, e.g., hook and loop, adhesives, a button, etc. The eyelid adhesive patch provides a means for the eye to be opened and closed without removing the adhesive completely.Attorney Docket No. 105676-432984The sensitive skin adhesive layers provide skin adhesion to the delicate skin of the eyelids, while the higher-tack adhesive layer adheres to less sensitive skin, such as the cheek skin.

[0015] The adhesive strength of the eyelid adhesive is tunable, allowing for multiple pieces to be designed with gentler adhesives for short-term closure (e g., in overnight use at home) that prioritize patient comfort and minimize skin irritation. In other embodiments, the eyelid adhesive would prioritize durability, lasting longer than an average ICU admission of 3-4 days.

[0016] For individuals with Dry Eye Disease and OSA who wear CPAP, the eyelid adhesive patch provides a means for easy eye opening during nocturnal hours without the need for adhesive removal. In the ICU, it provides a means for eye examinations and ointment administration without removing the adhesive.

[0017] In another embodiment, a one-piece eyelid adhesive patch may comprise a two- stage eyelid closure mechanism for use in operating rooms, which caters to patients who do not require repeated eyelid opening as well as nurse-anesthetists, who need to know that the eyelids are 100% closed every case.

[0018] An external eyelid adhesive patch must conform to the anatomical boundaries of the eyelid region to avoid patient discomfort and irritation. A single supporting member is positioned on the eyelid area with its medial boundary located medial to the medial canthus and generally ending before the nasal bridge. Its lateral boundary is located lateral to the medial canthus and generally ends before the lateral orbital rim. Its inferior boundary is located below the inferior eyelid margin and generally ends before the inferior orbital rim. Its superior boundary is located above the superior eyelid margin and generally ends before the superior orbital rim. Locating the member within these boundaries supports reliable adhesion and comfort during eyelid closure.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIGS. 1 A-G show a first embodiment of an eyelid adhesive patch.

[0020] FIGS. 2A-G show a second embodiment of an eyelid adhesive patch.

[0021] FIGS. 3A-H show a third embodiment of an eyelid adhesive patch.

[0022] FIGS. 4A-H show a fourth embodiment of an eyelid adhesive patch.Attorney Docket No. 105676-432984

[0023] FIGS. 5 A-H show a fifth embodiment of an eyelid adhesive patch.

[0024] FIGS. 6A-B illustrate a user interacting with the eyelid adhesive patch tactile indicators.

[0025] FIG. 7 illustrates a user applying the eyelid adhesive patch to the eyelid.

[0026] FIG. 8 illustrates two eyelid adhesive patches adhered to the eyelids of a user.

[0027] FIGS. 9A-B illustrates the eyelid adhesive patch opening and closing the eyelid.

[0028] FIG. 10 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a user.

[0029] FIG. 11 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a user.

[0030] FIGS. 12A-F shows a sixth embodiment of an eyelid adhesive patch.

[0031] FIGS. 13A-F shows a seventh embodiment of an eyelid adhesive patch.

[0032] FIGS. 14A-F shows an eighth embodiment of an eyelid adhesive patch.

[0033] FIG. 15 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient.

[0034] FIG. 16 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient.

[0035] FIGS. 17A-H shows a ninth embodiment of an eyelid adhesive patch.

[0036] FIG. 18 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient.

[0037] FIG. 19 illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.

[0038] FIG. 20 illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.

[0039] FIG. 21 illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.

[0040] FIGS. 22A-B illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.

[0041] FIGS. 23A-B illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.Attorney Docket No. 105676-432984

[0042] FIG. 24 illustrates another embodiment of an eyelid adhesive patch placed over the eye of a patient.

[0043] FIGS. 25A-G shows a tenth embodiment of an eyelid adhesive patch.

[0044] FIGS. 26A-B illustrates an embodiment of two eyelid adhesive patches on the same release liner.

[0045] FIGS. 27A-G shows an eleventh embodiment of an eyelid adhesive patch.

[0046] FIGS. 28A-G shows a twelfth embodiment of an eyelid adhesive patch.

[0047] FIGS. 29A-D illustrates the complex surface geometries of the eyelid area of a wearer, the underlying facial bony landmarks, the opening forces of the eyelid, and the closure forces exerted by an adhesive eyelid patch.

[0048] FIG. 30 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient.

[0049] FIG. 31 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient.

[0050] FIG. 32 illustrates another embodiment of two eyelid adhesive patches adhered to the eyelids of a patient with a CPAP mask.

[0051] FIG. 33 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0052] FIG. 34 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0053] FIG. 35 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient that is intubated.

[0054] FIG. 36 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0055] FIG. 37 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0056] FIG. 38 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0057] FIG. 39 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.Attorney Docket No. 105676-432984

[0058] FIG. 40 illustrates another embodiment of an eyelid adhesive patch adhered to the eyelid of a patient.

[0059] FIG. 41 is a flow chart illustrating one embodiment of a method of using various implementations of the eyelid adhesive patch.

[0060] FIG. 42 is a flow chart illustrating another embodiment of a method of using various implementations of the eyelid adhesive patch.

[0061] FIG. 43 is a flow chart illustrating one embodiment of a method of manufacturing various implementations of the eyelid adhesive patch.

[0062] FIG. 44 is a flow chart illustrating one embodiment of a method of manufacturing various implementations of the eyelid adhesive patch

[0063] FIG. 45 is a flow chart illustrating one embodiment of a method of manufacturing various implementations of the eyelid adhesive patch

[0064] FIGS. 46A-G shows a thirteenth embodiment of an eyelid adhesive patch.DETAILED DESCRIPTION OF THE DRAWINGS

[0065] Those skilled in the art will be familiar with key terms used to describe hydrogel adhesive properties. Water content refers to the proportion of the adhesive composed of water, which influences how cooling it feels to the touch. Tack describes the adhesive’s ability to stick to the skin upon light contact. Elongation reflects the stretchability of the material as it is peeled from the skin; higher elongation reduces shear forces on the skin and supports gentle removal. Hypoallergenic refers to the adhesive’s inert characteristics, indicating that it is unlikely to elicit irritation or other adverse reactions.

[0066] Those skilled in the art will recognize that certain hydrogel adhesives exhibit both high compliance and high tack, which can make them difficult to handle without sticking to themselves. Such adhesives benefit from being bonded to a non-adhesive backing substrate, which provides shape stability while maintaining contour-conforming drapeability. The combination of the backing substrate and the skin-facing hydrogel adhesive is commonly referred to as an integral web. Backing materials can be selected for their degree of shape stability, stretchability, and contour-conforming pliability. They can also be chosen for their optical properties, including translucency or opacity, and for their ability to retain a plurality of microcapsules containing aromatic substances.Attorney Docket No. 105676-432984Additionally, backing substrates can be selected for their hypoallergenic properties, thickness, and tactile feel.

[0067] Those skilled in the art will recognize that the complex surface geometries of the eyelid area — particularly the concave medial canthal region adjacent to the nasal bridge, characterized by tight, multidirectional radii, and the convex superior, inferior, and lateral orbital rim regions — require an optimal combination of a hydrogel adhesive and a backing substrate. The hydrogel adhesive must provide sufficient tack to adhere effectively to these curved and irregular surfaces, as hydrogels with insufficient tack tend to spontaneously release from areas of complex curvature. The backing substrate must balance pliability and shape stability: substrates that are insufficiently pliable can pull the hydrogel off convex and concave surfaces, while substrates that lack adequate shape stability cannot exert a closure force sufficient to oppose the eyelid’s natural opening force. Together, a hydrogel adhesive with adequate tack and a backing substrate with appropriate pliability and shape stability enable durable adhesion and reliable eyelid closure.

[0068] Those skilled in the art will recognize that laminating a backing substrate and a hydrogel adhesive into an integral web comprising multiple layers is a process known as conversion. High-volume conversion of an eyelid adhesive patch can be accomplished using a roller system, which bonds the hydrogel adhesive to the backing substrate and cuts the final perimeter shape with a roller die cutter, although other methods may also be employed. Roller systems require that material relationships within the same layer run parallel to the direction of movement through the system. Accordingly, a linear separation between two areas of an adhesive layer must run parallel to the rolling direction, with one area positioned to the left of the separation and the other to the right. Similarly, two distinct adhesives within the same layer must be arranged relative to each other in a left-right orientation. A grabbable non-adhesive portion of the backing substrate is likewise positioned to the left or right of the adhesive within the same layer. These left-to-right relationships enable highly efficient roller die cutting without requiring precise registration of the cut relative to a specific position on the moving material.Attorney Docket No. 105676-432984

[0069] Those skilled in the art will recognize that an eyelid adhesive patch can be configured to transdermally deliver physiologically beneficial bioactive agents to eyelid tissues, including the skin, eyelashes, and meibomian glands. Such bioactive agents may include, for example, vitamins, retinoids, polysaccharides, peptides, growth factors, antioxidants, anti-inflammatory substances, botanical extracts, salts, acids, silicones, ceramides, metal ions, liposomes, nanoemulsions, nanoparticles, hydration-boosting agents, antibiotics, corticosteroids, calcineurin inhibitors, or combinations thereof.

[0070] Those skilled in the art will recognize that an eyelid adhesive patch can be configured to transmit olfactory stimuli to the wearer. This functionality can be achieved by including a layer containing a plurality of microcapsules with aromatic substances, such as essential oils, fragrance compounds, or combinations thereof.

[0071] Those skilled in the art will recognize that an eyelid adhesive patch can be configured to reduce light perception through the closed eyelid. Such a feature can be particularly beneficial in situations where ambient light is bright, such as during air travel, while the wearer desires to sleep.

[0072] The present disclosure is directed towards an eyelid adhesive patch. Those skilled in the art will recognize that the eyelid adhesive device could serve as an adhesive eyelid patch, an eyelid closure support device, an adhesive eyelid closure support device, an eyelid closure device, and / or similar terms.

[0073] In one aspect, the present disclosure is directed to an eyelid adhesive patch. FIGS 1A-1G illustrate a first embodiment of an eyelid adhesive patch 10. FIG. 1A illustrates a front view 10a of the first embodiment of an eyelid adhesive patch 10. A structural layer 2 may provide flexibility for the eyelid adhesive patch 10 to adhere to a curved surface of an eyelid 8 (shown in FIG. 7). “Flexibility” herein defined as elastic modulus ranging 0.03-0.50 GPa. The structural layer 2 may provide structure to maintain the shape of the eyelid adhesive patch 10 during and after the application of the eyelid adhesive patch 10 to the eyelid 8. “Structure” herein defined as thickness ranging 1-5mm, tensile strength ranging 5-40MPa, and elongation at break ranging 200-650%. Structural layer 2 may be Polyethylene, LDPE, LLDPE, ULDPE, Polypropylene, PVC or Ethylene Vinyl Acetate. Structural layer 2 may be Clear, translucent, hazy, opaque, black, colored. The eyelid adhesive patch 10 includes one or more tactile locators 11 comprised of a tactile locatorAttorney Docket No. 105676-432984layer 1 positioned on top of the structural layer 2. The tactile locators 11 may provide a tactile guide for a user to align a fingertip with their medial canthus 71 (shown in Fig. 7) adjacent to the nose, as shown in FIG. 8.

[0074] The eyelid adhesive patch 10 may comprise zero to ten tactile locators 11, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 10 may comprise zero, one, or more than one tactile locators 11. The eyelid adhesive patch 10 may include one or more touch points 51 comprised of a release liner layer 5. The touch points 51 may provide the user with non-adhesive points to handle and guide the eyelid adhesive patch 10 onto an appropriate location on the eyelid 8. The eyelid adhesive patch 10 may comprise zero to ten touch point 51, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 10 may comprise zero, one, or more than one touch point 51.

[0075] FIG. 1B illustrates a back side 10b of the eyelid adhesive patch 10. The back side 10b of the eyelid adhesive patch 10 may include the release liner layer 5 comprising a split 9 so as to divide the release liner layer 5 into two liner pieces 5a and 5b that can be removed separately from the eyelid adhesive patch 10. Separate removal of the liner pieces 5a and 5b in an appropriate order may facilitate handling of the eyelid adhesive patch 10, locating the eyelid adhesive patch 10 onto an appropriate landmark on the eyelid 8, and / or applicating the eyelid adhesive patch 10 to the skin. The eyelid adhesive patch 10 may comprise zero to ten splits 9, including any number or range comprised therein. In some embodiments, the release liner layer 5 may comprise zero, one, or more than one splits 9. The release liner layer 5 may be shaped to comprise touch points 51 as shown in FIG. 1A.

[0076] FIG. 1C illustrates a cross-sectional view of the layers 1, 2, 3, and 5 of the eyelid adhesive patch 10 through the middle, along an axis 101 shown in FIG. 1A. The release liner layer 5 may have split 9. A sensitive skin adhesive layer 3 may be attached to release liner layer 5. The structural layer 2 may be attached to sensitive skin adhesive layer 3. One or more tactile locators 11 may be attached to structural layer 2.

[0077] FIG. 1D illustrates a cross-sectional view of the layers 1, 2, 3, and 5 of the eyelid adhesive patch 10 through a tactile locator 11 along an axis 102 shown in FIG. 1A. In some embodiments, as illustrated, the release liner layer 5 may be substantially largerAttorney Docket No. 105676-432984than the other layers 1, 2, 3 since the release liner layer 5 may include one or more nonadhesive touch points 51.

[0078] FIG. 1E illustrates a cross-sectional view of the layers 2, 3, 4, and 5 of the eyelid adhesive patch 10 through the middle, along an axis 103 shown in FIG. 1 A. The lower one-third of the eyelid adhesive patch 10 may comprise a higher-tack adhesive layer 4. The higher-tack adhesive layer 4 may be positioned within the same layer as the sensitive skin adhesive layer 3, and may be adapted to adhere to non-sensitive skin such as the cheek. In some embodiments, it may be preferred that the higher-tack adhesive layer 4 does not stick to the eyelid 8 skin.

[0079] FIG. 1F illustrates a front view of the eyelid adhesive patch 10 after the release liner 5 is removed from the eyelid adhesive patch 10. In some embodiments, the nonadhesive touch points 51 may also be removed when the release liner 5 is removed from the eyelid adhesive patch 10.

[0080] FIG. 1G illustrates a back view 10b of one embodiment of eyelid adhesive patch 10 after the removal of the release liner 5. The lower one-third of the eyelid adhesive patch 10 may comprise the higher-tack adhesive layer 4. The higher-tack adhesive layer 4 may be positioned within the same layer as sensitive skin adhesive layer 3. In some embodiments, a cheek attachment portion 41 may comprise the higher-tack adhesive layer 4. In some embodiments, there may be a gap 7 without any adhesive between the sensitive skin adhesive layer 3 and the higher-tack adhesive layer 4. This gap may enable the user to feel tactile resistance when the sensitive skin adhesive layer 3 has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch 10 so as to not disrupt adhesion of the higher-tack adhesive layer 4 to the skin.

[0081] FIGS 2A-2G illustrate a second embodiment of an eyelid adhesive patch 20. FIG.2A illustrates a front view 20a of the second embodiment of an eyelid adhesive patch 20. The eyelid adhesive patch 20 may be comprised of the same layers as the eyelid adhesive patch 10 with an additional low-tac carrier layer 6. The low-tac carrier layer 6 may be positioned on top of the structural layer 2 and under tactile locators 12. The tactile locators 12 may be comprised of a tactile locator layer 1 and may provide a tactile guide for a user to align a fingertip with their medial canthus 71 (shown in FIG. 7) adjacent to the nose, as shown in FIG. 6B.Attorney Docket No. 105676-432984

[0082] The eyelid adhesive patch 20 may comprise zero to ten tactile locators 12, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 20 may comprise zero, one, or more than one tactile locators 12. The eyelid adhesive patch 20 may include one or more touch points 52 comprised of the low- tac carrier layer 6. The touch points 52 may provide the user non-adhesive points to handle and guide the eyelid adhesive patch 20 onto an appropriate location on the eyelid 8. The eyelid adhesive patch 20 may comprise zero to ten touch point 51, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 20 may comprise zero, one, or more than one touch point 52.

[0083] FIG. 2B illustrates a back view 20b of the eyelid adhesive patch 20. The back side 20b of the eyelid adhesive patch 20 may include the release liner layer 5 comprising zero, one, or more than one splits similar to the split 9 shown in FIG. 1B. The release liner layer 5 may comprise one or more touch points 52. In some embodiments, it may be advantageous to have at least two touch points 52 for a user or applicator to guide the eyelid adhesive patch 20 onto the eyelid 8 utilizing both hands.

[0084] FIG. 2C illustrates a cross-sectional view of the layers 1, 2, 3, 5, and 6 of the eyelid adhesive patch 20 through an axis 201 shown in FIG. 2A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The structural layer 2 may be attached to the sensitive skin adhesive layer 3. The low-tac carrier layer 6 may be attached to the structural layer 2. The low-tac carrier layer 6 may be larger than the other layers 1, 2, 3, and 5 to create an overlap that serves as the non-adhesive touch points 52 (shown in FIG. 2A). The one or more tactile locators 12 may comprise the top tactile locator layer 1 and attached to the low-tac carrier layer 6.

[0085] FIG. 2D illustrates a cross-sectional view of the layers 1, 2, 3, 5, and 6 of the eyelid adhesive patch 20 through a tactile locator 12 along an axis 202 shown in FIG. 2A. In some embodiments, as illustrated, the release liner layer 5 may be substantially larger than the other layers 1, 2, 3, and 6.

[0086] FIG. 2E illustrates a cross-sectional view of the layers 2, 3, 4, 5, and 6 of the eyelid adhesive patch 20 through the middle, along an axis 203 shown in FIG. 2A. The lower one-third of the eyelid adhesive patch 20 may comprise the higher-tac adhesiveAttorney Docket No. 105676-432984layer 4. The higher-tack adhesive layer 4 may be positioned within the same layer as the sensitive skin adhesive layer 3.

[0087] FIG. 2F illustrates a front view of the eyelid adhesive patch 20 after the release liner layer 5 is removed from the eyelid adhesive patch 20. In some embodiments, the low-tac carrier layer 6 may also be removed. The removal of the low-tac carrier layer 6 may also remove the tactile locators 12.

[0088] FIG. 2G illustrates a back view of the eyelid adhesive patch 20 after the removal of the release liner layer 5 and the low-tac carrier layer 6. As shown in FIG. 2G, a cheek attachment portion 42 may comprise the higher-tack adhesive layer 4. The sensitive skin adhesive layer 3 may adhere to the back of the structural layer 2 at a first adhesive side and a second adhesive side of the sensitive skin adhesive layer 3 may be configured to be placeable on the eyelid 8 of the user.

[0089] FIGS. 3A-3H illustrate a third embodiment of an eyelid adhesive patch 30. FIG.3A illustrates a front view 30a of a third embodiment of an eyelid adhesive patch 30. The eyelid adhesive patch 30 may be comprised of the same layers as the eyelid adhesive patch 20 and may include some additional layers. The low-tac carrier layer 6 may be positioned on top of a thicker structural layer 2b and under one or more tactile locators 13. The tactile locators 13 may be comprised of a tactile locator layer 1. The tactile locators 13 may provide a tactile guide for a user to align a fingertip with their medial canthus 71 (shown in FIG. 7) adjacent to the nose, as shown in FIG. 6B.

[0090] The eyelid adhesive patch 30 may comprise zero to ten tactile locators 13, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 30 may include zero, one, or more than one tactile locators 13. The eyelid adhesive patch 30 may include one or more touch points 53 comprised of the low-tac carrier layer 6. The one or more touch points 53 may provide the user with non-adhesive points 53 to handle and guide the eyelid adhesive patch 30 onto the eyelid 8. The eyelid adhesive patch 30 may comprise zero to ten touch point 53, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 30 may comprise zero, one, or more than one touch points 53.

[0091] FIG. 3B illustrates a back view of the eyelid adhesive patch 30. The back side 30b of the eyelid adhesive patch 30 may include the release liner layer 5 comprising zero,Attorney Docket No. 105676-432984one, or more than one splits similar to the split 9 shown in FIG. 1B. The release liner layer 5 may be configured to be of any shape that covers the layer on which the release liner layer 5 is positioned and / or adhered to. In some embodiments, the release liner layer 5 may be dimensioned larger than the eyelid adhesive patch 30 in order to maintain the structure of the release liner layer 5 without touching the rest of eyelid adhesive patch 30.

[0092] FIG. 3C illustrates a cross-sectional view of the layers 1, 2a, 2b, 3, 5, and 6 of the eyelid adhesive patch 30 through the middle, along an axis 301 shown in FIG. 3A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The very thin structural layer 2a may be attached to the sensitive skin adhesive layer 3. The thicker structural layer 2b may be attached to the very thin structural layer 2a. The low-tac carrier layer 6 may be attached to the structural layer 2. The one or more tactile locators 12 may comprise the top tactile locator layer 1 and attached to the low-tac carrier layer 6.

[0093] FIG. 3D illustrates a cross-sectional view of the layers 1, 2a, 2b, 3, 5, and 6 of the eyelid adhesive patch 30 through one tactile locator 13 along an axis 302 shown in FIG.3A. The release liner layer 5 may be substantially larger than the other layers 1, 2, 3, and 6.

[0094] FIG. 3E illustrates a cross-sectional view of the layers 2a, 2b, 3, 4a, 5, and 6 of the eyelid adhesive patch 30 through the middle, along an axis 303 shown in FIG. 3A. The lower one-third of the eyelid adhesive patch 30 may comprise the higher-tack adhesive layer 4. The higher-tack adhesive layer 4 may be positioned within the same layer as the sensitive skin adhesive layer 3.

[0095] FIG. 3F illustrates a front view of the eyelid adhesive patch 30 after the release liner layer 5 and low-tac carrier layer 6 are removed. The removal of low-tac carrier layer 6 may remove the tactile locators 13 in layer 1.

[0096] FIG. 3G illustrates a side view 30c of the eyelid adhesive patch 30 after the removal of the release liner layer 5 and the low-tac carrier layer 6 with layers 2a, 2b, 3, and 4a.

[0097] FIG. 3H illustrates a back view of the eyelid adhesive patch 30 after the removal of the release liner layer 5 and the low-tac carrier layer 6. As shown in FIG. 3H, a cheek attachment portion 43 may comprise a very thin higher-tack adhesive layer 4a. TheAttorney Docket No. 105676-432984sensitive skin adhesive layer 3 may adhere to the back of structural layer 2a of a first adhesive side. The sensitive skin adhesive layer 3 may comprise a second adhesive side configured to be placeable on the eyelid 8 of the user. There may be a gap 7 between the sensitive skin adhesive layer 3 and the very thin higher-tack adhesive layer 4a.

[0098] FIGS. 4A-4H illustrate a fourth embodiment of an eyelid adhesive patch 40. FIG.4A illustrates a front view 40a of the fourth embodiment of the eyelid adhesive patch 40. The eyelid adhesive patch 40 may be comprised of the same layers as the eyelid adhesive patch 20 and may include some additional layers. The eyelid adhesive patch 40 may include one or more tactile locators 14 comprised of the tactile locator layer 1. The one or more tactile locators 14 may provide a tactile guide for a user to align a fingertip with their lower medial canthus 71 (shown in FIG. 7) adjacent to the nose, as shown in FIG.6B. The one or more tactile locators 14 may provide a tactile guide for a user to align a fingertip with their lower medial canthus 72 (shown in FIG. 7).

[0099] The eyelid adhesive patch 40 may comprise zero to ten tactile locators 14, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 40 may include zero, one, or more than one tactile locator 14. The eyelid adhesive patch 40 may comprise one or more touch point 54 comprised of the sensitive skin adhesive layer 3. The one or more touch point 54 may provide the user with a nonadhesive point to handle and guide the eyelid adhesive patch 40 onto the eyelid 8. The eyelid adhesive patch 40 may comprise zero to ten touch point 54, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 40 may comprise zero, one, or more than one touch point 54. The touch point 54 is shown on a superior edge of eyelid adhesive patch 40 but may be placed along any edge that makes it easy for the applicator or the user to remove the eyelid adhesive patch 40.

[0100] FIG. 4B illustrates a back view 40b of the eyelid adhesive patch 40. The release liner layer 5 may comprise zero, one, or more than one splits similar to the split 9 shown in FIG. 1B. The release liner layer 5 may be any shape that covers the layer on which release liner layer 5 is positioned and / or adhered to.

[0101] FIG. 4C illustrates a cross-sectional view of the layers 2a, 2b, 3, and 5 of the eyelid adhesive patch 40 through the middle, along an axis 401 shown in FIG. 4A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The very thinAttorney Docket No. 105676-432984structural layer 2a may be attached to the sensitive skin adhesive layer 3. The thicker structural layer 2b may be attached to the very thin structural layer 2a. The one or more tactile locators 14 may comprise the top tactile locator layer 1 (not shown). There may be a gap 7 between the very thin higher-tack adhesive layer 4a and the sensitive skin adhesive layer 3.

[0102] FIG. 4D illustrates a cross-sectional view of the layers 1, 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 40 through one tactile locator 14, along an axis 402 shown in FIG. 4A. The release liner layer 5 may be dimensioned larger than the other layers, 1, 2, and 3.

[0103] FIG. 4E illustrates a cross-sectional view of the layers 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 40 through the middle, along an axis 403 shown in FIG. 4A. The lower one-third of the eyelid adhesive patch 40 may comprise the higher-tack adhesive layer 4. The higher-tack adhesive layer 4 may be positioned within the same layer as the sensitive skin adhesive layer 3. The thicker structural layer 2 may be dimensioned and contoured such that a peripheral portion thereof extends beyond the perimeters of layers 2a, 4a, and 5, thereby defining one or more outwardly projecting touch points 54 configured to provide a user touch point for handling and positioning of the device.

[0104] FIG. 4F illustrates a front view of the eyelid adhesive patch 40 after the removal of the release liner layer 5. FIG. 4G illustrates a side view of the eyelid adhesive patch 40 after the removal of the release liner layer 5. FIG. 4H illustrates a back view of the eyelid adhesive patch 40 after the removal of the release liner layer 5. The eyelid adhesive patch 40 may include a cheek attachment portion 44 that comprises the very thin higher-tack adhesive layer 4a. The sensitive skin adhesive layer 3 may adhere to the back of the very thin structural layer 2a on a first adhesive side. The sensitive skin adhesive layer 3 may include a second adhesive side configured to be placeable on the eyelid 8 of the user.

[0105] FIGS. 5A-5H illustrate a fifth embodiment of an eyelid adhesive patch 50. FIG.5A illustrates a front view 50a of the eyelid adhesive patch 50. The eyelid adhesive patch 50 may include one or more tactile locators 15 comprised of a tactile locator layer 1. The tactile locators may provide a tactile guide for a user to align their fingertip with their lower medial canthus 71 (shown in FIG. 7) adjacent to the nose, as shown in FIG. 6B.Attorney Docket No. 105676-432984The tactile locators may provide a tactile guide for a user to align their fingertip with their lower medial canthus 72 (shown in FIG. 7).

[0106] The eyelid adhesive patch 50 may comprise zero to ten tactile locators 15, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 50 may comprise zero, one, or more than one tactile locator 15. The eyelid adhesive patch 50 may comprise one or more touch point 55 comprised of the sensitive skin adhesive layer 3. The one or more touch point 55 may provide the user with a non-adhesive point to handle and guide the eyelid adhesive patch 50 onto the eyelid 8. The eyelid adhesive patch 50 may comprise zero to ten touch point 55, including any number or range comprised therein. In some embodiments, the eyelid adhesive patch 50 may comprise zero, one, or more than one touch point 55. The touch point 55 is shown on the superior edge of eyelid adhesive patch 50 but may be placed along any edge that makes it easy for the applicator or the user to remove the eyelid adhesive patch 50.

[0107] FIG. 5B illustrates a back view 50b of the eyelid adhesive patch 50. The release liner layer 5 may comprise zero, one, or more than one splits 9a. The release liner layer 5 may be of any shape that covers the layer on which it is positioned and / or adhered to.

[0108] FIG. 5C illustrates a cross-sectional view of the layers 2a, 2b, 3, and 5 of the eyelid adhesive patch 50 through the middle, along an axis 501 shown in FIG. 5A. The sensitive skin adhesive layer 3 may be attached to the release liner layer 5. The very thin structural layer 2a may be attached to the sensitive skin adhesive layer 3. The thicker structural layer 2b may be attached to the very thin structural layer 2a. The low-tac carrier layer 6 may be attached to the structural layer 2. The one or more tactile locators 12 may comprise the top tactile locator layer 1 and attached to the low-tac carrier layer 6. The one or more tactile locators 15 may comprise the top tactile locator layer 1 (not shown).

[0109] FIG. 5D illustrates a cross-sectional view of the layers 1, 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 50 through one tactile locator 15, along an axis 502 shown in FIG. 5A. The release liner layer 5 may be larger than the other layers 1, 2, and 3. FIG.5E illustrates a cross-sectional view of the layers 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 50 through the middle, along an axis 503 shown in FIG. 5A. The lower one-third of the eyelid adhesive patch 50 may comprise the higher-tack adhesive layer 4.Attorney Docket No. 105676-432984The higher-tack adhesive layer 4 may be positioned within the same layer as the sensitive skin adhesive layer 3. The sensitive skin adhesive layer 3 may be smaller than the other layers and / or may provide one or more non-adhesive touch point 55.

[0110] FIG. 5F illustrates a front side 50a of the eyelid adhesive patch 50 after the removal of the release liner layer 5. FIG. 5G illustrates a side view 50c of the eyelid adhesive patch 50 after the removal of the release liner layer 5. FIG. 5H illustrates a back view of the eyelid adhesive patch 50 after the removal of the release liner layer 5. The eyelid adhesive patch 50 may include a cheek attachment portion 45 that comprises the very thin higher-tack adhesive layer 4a. The sensitive skin adhesive layer 3 may adhere to the back of the very thin structural layer 2a on a first adhesive side. The sensitive skin adhesive layer 3 may include a second adhesive side configured to be placeable on the eyelid 8 of the user. There may be a gap 7 between the very thin higher-tack adhesive layer 4a and the sensitive skin adhesive layer 3.

[0111] FIGS. 6A-B illustrates a frontal view 60 of the eyelid adhesive patch 60 similar to the eyelid adhesive patch 10 shown in FIG. 1 before application. There are various methods for applying any of the eyelid adhesive patch 10, 20, 30, 40, 50, 60. For example, as illustrated in FIGS. 6A-B, the user may self-apply the eyelid adhesive patch 60. The user may remove a single layer. For example, the user may remove the release liner layer 5. In some embodiments of the method, the user may additionally or alternatively remove the low-tac carrier layer 6 (not shown in the eyelid adhesive patch 60). The user may then use one or more tactile locators 16 to align the eyelid adhesive patch 60 correctly by placing the one or more tactile locators 16 along the medial canthus 71 (shown in FIG. 7) and / or medial canthus 72 (shown in FIG. 7). The eyelid adhesive patch 60 may include one or more non-adhesive touch points 56 for the user to hold on to eyelid adhesive patch 60 without touching an adhesive layer (not shown).

[0112] If the eyelid adhesive patch 60 utilizes a split as shown previously on the release liner layer 5, one portion of the release liner layer 5 may be removed first, and a first portion of the exposed adhesive layer under that removed portion of the release liner layer 5 may be applied to the user first. Then, another portion of the release liner layer 5 may be removed, and a second portion of the exposed adhesive layer may be applied to the user next. In some embodiments, the method of the applying the eyelid adhesiveAttorney Docket No. 105676-432984patch 10, 20, 30, 40, 50, 60 may include apply more than one portion of the exposed adhesive layer depending on the number of splits in the eyelid adhesive patch 10, 20, 30, 40, 50, 60. In some embodiments, more than one portion of the exposed adhesive layer may be applied simultaneously. In some embodiments, each portion of the exposed adhesive layer may be applied sequentially. In some embodiments, some portions of the exposed adhesive layer may be applied sequentially, and some portions of the exposed adhesive layer may be applied simultaneously.

[0113] FIG. 7 illustrates an eyelid adhesive patch 60 or 70 being self-applied by the user.After the removal of the medial half of the release liner layer 5 (not shown), the user may align the medial touch point 56a (FIG. 6B) with the medial canthus 71 and adhering the medial half 61a (FIG. 6A) of the eyelid adhesive patch 60 or 70 to the periorbital cheek and eyelid 8. The lateral half 61b (FIG. 6A) of the eyelid adhesive patch 60 or 70 may then be removed from the backside (not shown) of the eyelid adhesive patch 60 or 70. The placement of the non-adhesive touch point 16 (FIG. 6A) may guide the user on how to apply eyelid adhesive patch 60 or 70. As shown in FIG. 7, the non-adhesive touch point(s) 56a / 56b may be positioned under the middle finger of the user. In other embodiments the non-adhesive touch points may be on the superior edge 62a, the inferior edge 62b, or the medial edge 62c (all shown in FIG. 6B) of the eyelid adhesive 60 or 70.

[0114] As shown in FIG. 8, eyelid adhesive patches 80a and 80b may be adhered to the cheek and / or the eyelid of the user. One or more tactile indicators 18a, 18b may be aligned to the canthus on both the medial and lateral sides of the eyelid 8 to guide the user or another applicator. The user or applicator may use the one or more tactile indicators 18a, 18b to orient and / or apply eyelid adhesive patches 80a and 80b.

[0115] Referring to FIGS. 9A-9B, an eyelid adhesive patch 90a may be adhered to the cheek 8b and / or the eyelid 8 of the user and may be configured to keep the eyelid closed. The eyelid adhesive patch 90b may be adhered to the cheek 8b while the user pulls back part of the eyelid adhesive patch 90b to open the eye. The eyelid adhesive patch 90a may be peeled back whenever the user needs to see out of one or both eyes. The eyelid adhesive patch 90b may be re-adhered to further reclose the eye 8a. A tactile locator (not shown) may or may not be applied to a non-adhesive touch point to guide the user to the non-adhesive touch point while both eyes are closed so that the user may open one orAttorney Docket No. 105676-432984both eyes. The non-adhesive touch point (not shown) may be made of any other material that distinguishes the non-adhesive touch point from the rest of the eyelid adhesive patch 90a, 90b. The difference in material may guide the user to the non-adhesive touch point.

[0116] Referring to FIG. 10, an eyelid adhesive patch 100 is positioned on the eyelids of a user. One or more tactile indicators 110a and 110b may be used to guide the user or applicator how to place the eyelid adhesive patch 100 onto the eyelid. The tactile indicator 110b may align with the medial canthus 71 (shown in FIG. 6B) of the eyelid 8 while tactile indicator 110a aligns with the bottom most point 8d of eyelid adhesive patch 100. The illustrated embodiment includes one non-adhesive touch point 510 that the user or applicator may use to apply the eyelid adhesive patch 100 without touching the adhesive backing (not shown).

[0117] Referring to FIG. 11, an eyelid adhesive patch 110 is positioned on the eyelids 8 of a user. One or more tactile indicators 111a and 111b may be used to guide the user or applicator when positioning the eyelid adhesive patch 110 onto the eyelid. The tactile indicator 111a may align with the medial canthus 72 (shown in FIG. 6B) while tactile indicator 111b may align with the bottom most point 8d of the eyelid adhesive patch 110. The illustrated embodiment includes one non-adhesive touch point 511 that the user or applicator may use to apply the eyelid adhesive patch 110 without touching the adhesive backing (not shown).

[0118] FIGS. 12A-12F illustrate a sixth embodiment of an eyelid adhesive patch 120.FIG. 12A illustrates a front view 120a of eyelid adhesive patch 120. The eyelid adhesive patch 120 may include three non-adhesive touch points 512 to allow a user or applicator to handle and apply the eyelid adhesive patch 120 without touching an adhesive backing (e.g., the skin adhesive layer 3). A visual indicator 9b (e.g., a dashed line 9b) may be positioned on a front side 120a to allow a user or an applicator to align the eyelid adhesive patch 120 along the canthus of a patient.

[0119] FIG. 12B illustrates a cross-sectional view of eyelid adhesive patch 120 through the top non-adhesive touch points 512 along an axis 1201 shown in FIG. 12A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The structural layer 2 may be attached to the sensitive skin adhesive layer 3.Attorney Docket No. 105676-432984

[0120] FIG. 12C illustrates a cross-sectional view of eyelid adhesive patch 120 through the middle, along an axis 1202 shown in FIG. 12A.

[0121] FIG. 12D illustrates a back view 120b of eyelid adhesive patch 120. A split 9c may divide the release liner layer 5 into a first portion 5c and a second portion 5d. One of the first and second portions 5c and 5d may be peeled off first and adhered to the eyelid skin of a user. The other potion may be peeled off next, which is then adhered to the cheek. In one embodiment, the portion located at the top end (e.g., closer to the top of the eyelid) may be peeled first.

[0122] FIG. 12E illustrates a cross-sectional view of eyelid adhesive patch 120 through the middle along an axis 1202 shown in FIG. 12A when the release liner layer 5 has been removed. There may be a gap 7 in the skin adhesive layer 3 to prevent adhesive sticking directly to the canthus, thereby preventing adhesive accidentally adhering to the eye.

[0123] FIG. 12F illustrates a back view 120b of eyelid adhesive patch 120 after the removal of release liner layer 5, with gap 7 in the skin adhesive layer 3.

[0124] FIGS. 13A-13F illustrate a seventh embodiment of an eyelid adhesive patch 130.FIG. 13A illustrates a front view 130a of eyelid adhesive patch 130. The eyelid adhesive patch 130 may include four non-adhesive touch points 513 to allow a user or applicator to handle and apply the eyelid adhesive patch 130 without touching an adhesive backing (e.g., the skin adhesive layer 3). A visual indicator 9b (e.g., a dashed line 9b) may be positioned on a front side 130a to allow a user or an applicator to align the eyelid adhesive patch 130 along the canthus of a patient. The eyelid adhesive patch 130 may include a second structural layer 2c comprising a cinching flap 9d that is shorter in the vertical meridian of the eyelid adhesive patch 130 and is illustrated with one of the touch points 513 that protrudes from the bottom aspect of the layer. If the user or applicator chooses to further tighten the closure of the eyelids after application of the upper and lower skin adhesive 5e and 5f to the eyelid and periorbital skin, the cinching flap 9d can be used. Cinching flap 9d, comprised of the second structural layer 2c, may be grasped by the touch point 513 to peel the lower portion of the cinching flap 9d off of the front surface 130a of the primary flap 9e of a structural layer 2d. Then cinching flap 9d can be pulled further downward toward the bottom edge of the primary flap 9e, where it can be re-adhered to the front surface of the primary flap 9e. In so doing, relocation of theAttorney Docket No. 105676-432984bottom portion of the cinching flap 9d onto the bottom edge of the primary flap 9e pulls the upper eyelid downward toward the lower eyelid to “cinch” the eyelids closed more tightly than was achieved with application of the primary flap skin adhesives.

[0125] FIG. 13B illustrates a cross-sectional view of eyelid adhesive patch 130 through the top non-adhesive touch points 513 along an axis line 1301 shown in FIG. 13A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The first structural layer 2d may be attached to the sensitive skin adhesive layer 3. The cinching adhesive layer 3a may be attached to the first structural layer 2d. The second structural layer 2c may be attached to the cinching adhesive layer 3a. The skin adhesive layer 3 may be shorter than layers 2d and 5 to allow the non-adhesive touch points 514 to protrude out from the eyelid adhesive patch 140.

[0126] FIG. 13C illustrates a cross-sectional view of eyelid adhesive patch 130 through the middle, along an axis 1302 shown in FIG. 13A.

[0127] FIG. 13D illustrates a back view of eyelid adhesive patch 130. The eyelid adhesive patch 130 may include a split 9b that divides the release liner layer 5 into a first portion 5c and a second portion 5d. One of the first and second portions 5c and 5d may be peeled off first and adhered to the eyelid skin of a user. The other potion may be peeled off next, which is then adhered to the cheek. In one embodiment, the portion located at the top end (e.g., closer to the top of the eyelid) may be peeled first.

[0128] FIG. 13E illustrates a cross-sectional view of eyelid adhesive patch 130 through the middle, along an axis 1302 shown in FIG. 13A when the release liner layer 5 has been removed.

[0129] If the user or the applicator wishes to further tighten the closure of the eyelids after application of the upper and lower skin adhesive to the eyelid and periorbital skin, they can perform the following steps:a. The cinching flap 9d of layer 2c can be grasped by touch point 513 to peel the lower portion of the cinching flap 9d off of the front surface of the primary flap 9e of structural layer 2d.b. Then the cinching flap 9d can be pulled further downward toward the bottom edge of the primary flap 9e, where it can be re-adhered to the front surface of the primary flap 9e. In so doing, relocation of the bottom portion of the cinching flapAttorney Docket No. 105676-4329849d onto the bottom edge of primary flap 9e pulls the upper eyelid downward toward the lower eyelid to “cinch” the eyelids closed more tightly than was achieved with application of the primary flap skin adhesives. There may be a gap 7b in the skin adhesive layer 3 a of the cinching flap 9d to provide a tactile detente when opening this cinching flap 9d to cinch the eyelids more tightly together. c. The user or the applicator peels the lower portion of the cinching flap 9d from the front surface of the primary flap until resistance from peeling the lower adhesive stops due to the gap 7b in adhesive layer 3 a to prevent peeling of the upper adhesive of the cinching flap 9d from the front surface of the primary flap 9e. There is also a gap in the skin adhesive layer 3 to provide a tactile detente when opening the patch to examine the eye.d. The user or applicator peels the primary flap 9e from the lower eyelid periorbital skin until resistance from peeling the lower adhesive stops due to the gap 7a in adhesive layer 3 to prevent peeling of the upper adhesive from the upper eyelid.

[0130] FIG. 13F illustrates a back view of eyelid adhesive patch 130 after the removal of the release liner layer 5, with gap 7b in the skin adhesive layer 3.

[0131] FIGS. 14A-14F illustrate a eight embodiment of an eyelid adhesive patch 140.FIG. 14A illustrates a front view 140a of eyelid adhesive patch 140. The eyelid adhesive patch 140 may include four non-adhesive touch points 514 to allow a user or applicator a handle and apply the eyelid adhesive patch 140 without touching an adhesive backing (e.g., the skin adhesive layer 3). A visual indicator 9b (e.g., a dashed line 9b) may be positioned on a front side 140a to allow a user or an applicator to align the eyelid adhesive patch 140 along the canthus of a patient. A second structural layer 2c comprising a cinching flap 9f that is shorter in the vertical meridian of the eyelid adhesive patch 140 is illustrated with touch point 514 that protrudes from a bottom aspect of the layer. The cinching flap 9f in FIG. 14A is similar to the cinching flap 9d in FIG.13A, except the cinching flap 9f in FIG. 14A passes through a beltloop 6a that is cut into a primary flap 9e comprised of structural layer 2d. If the applicator wishes to further tighten the closure of the eyelids after application of the upper and lower skin adhesive to the eyelid and periorbital skin, the cinching flap 9f comprised of structural layer 2c may be grasped by the touch point 513 to peel the lower portion of the cinching flap 9f off ofAttorney Docket No. 105676-432984the front surface of the primary flap 9e comprised of structural layer 2d then pulled further downward toward the bottom edge of the primary flap 9e, where it can be readhered to the front surface of the primary flap 9e. In so doing, relocation of the bottom portion of the cinching flap onto the bottom edge of the primary flap pulls the upper eyelid downward toward the lower eyelid to “cinch” the eyelids closed more tightly than was achieved with application of the primary flap skin adhesives.

[0132] FIG. 14B illustrates a cross-sectional view of eyelid adhesive patch 140 through the top non-adhesive touch points 514 along an axis 1401 shown in FIG. 14A. The sensitive skin adhesive layer 3, may be attached to the release liner layer 5. The first structural layer 2d may be attached to the sensitive skin adhesive layer 3. The cinching adhesive layer 3a may be attached to the first structural layer 2d. The second structural layer 2c may be attached to the cinching adhesive layer 3a. The skin adhesive layer 3 may be shorter than layers 2d and 5 to allow the non-adhesive touch points 514 to protrude out from the eyelid adhesive patch 140.

[0133] FIG. 14C illustrates a cross-sectional view of eyelid adhesive patch 140 through the middle, along an axis 1402 shown in FIG. 14A.

[0134] FIG. 14D illustrates a back view of eyelid adhesive patch 140. The eyelid adhesive patch 140 may include a split 9c that divides the release liner layer 5 into a first portion 5c and a second portion 5d.

[0135] One of the first and second portions 5c and 5d may be peeled off first and adhered to the eyelid 8 skin of a user. The other potion may be peeled off next, which is then adhered to the cheek.

[0136] FIG. 14D illustrates a cross-sectional view of eyelid adhesive patch 140 through the middle, along an axis1402 shown in FIG. 14A when the release liner layer 5 has been removed.

[0137] There may be gap 7b in the skin adhesive layer 3 to prevent adhesive sticking directly to the canthus, thereby preventing adhesive accidentally adhering to the eye.

[0138] If a user or an applicator wishes to further tighten the closure of the eyelids after application of the upper and lower skin adhesive to the eyelid and periorbital skin, they can perform the following steps:Attorney Docket No. 105676-432984a. The cinching flap 9f of layer 2c can be grasped by touch point 514 to peel the lower portion of the cinching flap 9f off of the front surface of the primary flap of structural layer 2d then pulled through beltloop 6a further downward toward the bottom edge of the primary flap 9e, where it can be re-adhered to the front surface of the primary flap. In so doing, relocation of the bottom portion of the cinching flap onto the bottom edge of primary flap 9e pulls the upper eyelid downward toward the lower eyelid to “cinch” the eyelids closed more tightly than was achieved with application of the primary flap skin adhesives. There is a gap 7a in the adhesive layer 3a of the cinching flap 9f to provide a tactile detente when opening this flap to cinch the eyelids more tightly together.b. The user or applicator peels the lower portion of the cinching flap 9f from the front surface of the primary flap 9e until resistance from peeling the lower adhesive stops due to the gap 7a in adhesive layer 3 a to prevent peeling of the upper adhesive of the cinching flap 9f from the front surface of the primary flap 9e. There is also a gap 7b in the skin adhesive layer 3 to provide a tactile detente when opening the patch to examine the eye.c. The user or applicator peels the primary flap 9e from the lower eyelid periorbital skin until resistance from peeling the lower adhesive stops due to the gap 7b in adhesive layer 3 so as to prevent peeling of the upper adhesive from the upper eyelid.

[0139] FIG. 14F illustrates a back view 140b of eyelid adhesive patch 140 after the removal of release liner layer 5, with gap 7b in the skin adhesive layer 3.

[0140] FIG. 15 illustrates an eyelid adhesive patch 150 positioned on the eyelids 8 of a patient 1000.

[0141] FIG. 16 illustrates an eyelid adhesive patch 160 positioned on the eyelids 8 of an intubated and sedated patient 1001.

[0142] FIGS. 17A-17H illustrate a ninth embodiment of an eyelid adhesive patch 170.FIG. 17A illustrates a front view 170a of the eyelid adhesive patch 170. The eyelid adhesive patch 170 may include one or more tactile locators 117 comprised of a tactile locator layer 1. The one or more tactile locators 117 may provide a tactile guide for a user to align their fingertip with their lower medial canthus 71 adjacent to the nose, asAttorney Docket No. 105676-432984shown in FIG. 6B. The tactile locators may provide a tactile guide for a user to align their fingertip with their The eyelid adhesive patch 170 may comprise zero, one, or more than one tactile locator 117.

[0143] FIG. 17B illustrates a back view 170b of the eyelid adhesive patch 170.

[0144] FIG. 17C illustrates a cross-sectional view of the layers 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 170 through the middle, along an axis 1701 shown in FIG. 17A. The sensitive skin adhesive layer 3 may be attached to the release liner layer 5, which may also be on the same layer of the very thin higher-tac adhesive layers 4a. The very thin structural layer 2a may be attached to the sensitive skin adhesive layer 3 and very thin higher-tack adhesive layer 4a. The thicker structural layer 2b may be attached to the very thin structural layer 2a.

[0145] FIG. 17D illustrates a cross-sectional view of the layers 1, 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 170 along an axis 1702 shown in FIG. 17A.

[0146] FIG. 17E illustrates a cross-sectional view of the layers 2a, 2b, 3, 4a, and 5 of the eyelid adhesive patch 170 through the middle, along an axis 1703 shown in FIG. 17A.

[0147] FIG. 17F illustrates a front view 170a of the eyelid adhesive patch 170 after the removal of the release liner layer 5.

[0148] FIG. 17G illustrates a side view of the eyelid adhesive patch 170 after the removal of the release liner layer 5.

[0149] FIG. 17H illustrates a back view 170b of the eyelid adhesive patch 170 after the removal of the release liner layer 5.

[0150] FIG. 18 illustrates an alternate embodiment of eyelid adhesive patch 180 positioned on the eyelids 8 of a patient 1002 using a CPAP machine.

[0151] FIG. 19 illustrates an alternate embodiment of eyelid adhesive patch 190 positioned on the eyelids 8 of an intubated neonate 1003 in the neonatal intensive care unit (NICU).

[0152] FIG. 20 illustrates an alternate embodiment of eyelid adhesive patch 200 positioned on the eyelids 8 of an intubated child 1004 in the pediatric intensive care unit (PICU).Attorney Docket No. 105676-432984

[0153] FIG. 21 illustrates an alternate embodiment of eyelid adhesive patch 210 positioned on the eyelids 8 of a patient 1005 undergoing a dental procedure with in-office anesthesia

[0154] FIG. 22A illustrates incomplete eyelid closure of a patient 1006 with lagophthalmos in one eye due to Bell’s Palsy.

[0155] FIG. 22B illustrates an alternate embodiment of eyelid adhesive patch 220 positioned on the eyelids 8 of the patient 1006 shown in FIG. 22A.

[0156] FIG. 23A illustrates the incomplete eye closure of a patient with lagophthalmos in both eyes (right worse than left) due to Thyroid Eye Disease.

[0157] FIG. 23B illustrates an alternate embodiment of eyelid adhesive patch 230 positioned on the eyelids 8 of the patient 1006 shown in FIG. 23 A.

[0158] FIG. 24 illustrates an alternate embodiment of eyelid adhesive patch 240 positioned on the eyelids 8 on a dog 1007 receiving general anesthesia in a clinic.

[0159] FIGS. 25A-G illustrate a tenth embodiment of an eyelid adhesive patch 250. FIG.25A illustrates a front view of the 250a embodiment of an eyelid adhesive patch 250. A conforming backing layer 1 may provide enough flexibility for the eyelid adhesive patch 250 to adhere to a curved surface of an eyelid 8. The conforming backing layer 1 may provide enough structure to maintain the shape of the eyelid adhesive patch 250 during and after the application of the eyelid adhesive patch 250 to the eyelid 8.

[0160] FIG. 25B illustrates a back side 250b of the eyelid adhesive patch 250 with the release liner of layer 4. The back side 250b of the eyelid adhesive patch 250 may include the release liner layer 5. The release liner layer 5 may be contoured to define one or more non-adhesive touch points 525 that facilitate grasping and peeling the liner from the eyelid adhesive patch 250, and may be sized larger than layers 1, 2, and 3 to accommodate these touch points.

[0161] FIG. 25C illustrates a cross-sectional view of the layers 1, 2, 3, 4 of the eyelid adhesive patch 250 through the middle, along an axis 2501 shown in FIG. 25A. The release liner layer 5 may be a removable bottom layer that protects the adhesive during storage and is removed at the time of application of the patch to a wearer. A bonding layer 2 may be a top structural layer. A sensitive skin adhesive layer 3 may be a skin-Attorney Docket No. 105676-432984facing layer. A very thin structural layer 2 may be what bonds layers 3 and 1 together in a laminated integral web.

[0162] The backing layer 1 may be comprised of Polyethylene, LDPE, LLDPE, ULDPE, Polypropylene, Polyurethane, PVC, or Ethylene Vinyl Acetate. The backing layer 1 may have variable transparency and color, including clear, translucent, hazy, opaque, black, and colored. The backing layer 1 may have thickness ranging from 1mm to 5mm, including any range comprised therein. The backing layer 1 may have a nominal thickness of about 3mm. The backing layer 1 may have an elastic modulus ranging from about 0.03- GPa to about 0.5 GPa, including any range comprised therein. The backing layer 1 may have a tensile strength ranging from about 5MPa to about 40 MPa, including any range comprised therein. The backing layer 1 may have an elongation at break from about ranging 200% to about 650% including any range comprised therein.

[0163] The backing layer 1 may be further coated in a plurality of microcapsules containing aromatic substances including essential oils, aromatic compounds, or combinations thereof.

[0164] The sensitive skin adhesive layer 3 may be comprised of an adhesive hydrogel with the following properties. The sensitive skin adhesive layer 3 may have a water content of about 10% to about 95%, including any range comprised therein. The sensitive skin adhesive layer 3 may have an optimal water content of about 30% to about 50%. The sensitive skin adhesive layer 3 may have a thickness of about 0.25mm to about 1.25 mm, including any range comprised therein. The sensitive skin adhesive layer 3 may have an optimal thickness of about 0.5 mm to about 1.0 mm. The sensitive skin adhesive layer 3 may have a transparency of clear, translucent, or colored. The sensitive skin adhesive layer 3 may have an adhesion of about 40 g / cm to about 500 g / cm, including any range comprised therein and measured by 90-degree peel from stainless steel. The sensitive skin adhesive layer 3 may be comprised of silicone gel. In some embodiments, the sensitive skin adhesive layer 3 may further be impregnated with one or a combination of a bioactive physiologically beneficial transdermal agent that elutes from the hydrogel, an active pharmaceutical ingredients including but not limited to antibiotics, corticosteroid, calcineurin inhibitors, antiparasitic, or combinations thereof, and vitamins, retinoids, polysaccharides, peptides, growth factors, antioxidants, antiAttorney Docket No. 105676-432984inflammatory substances, extracts, salts, acids, silicones, ceramides, metal ions, botanicals, liposomes, nanoemulsions, nanoparticles, hydration-boosters, or combinations thereof. The sensitive skin adhesive layer 3 may be hypoallergenic, free from acrylates, and / or contain acrylates.

[0165] FIG. 25D illustrates a cross-sectional view of the layers 1, 2, 3, 4 of the eyelid adhesive patch CC with the release liner of layer 4 along an axis 2503 shown in FIG. 25A.

[0166] FIG. 25E illustrates a front side 250a of the eyelid adhesive patch 250 without the release liner of layer 4 shown in FIG. 25 A.

[0167] FIG. 25F illustrates a cross-sectional view of the layers 1, 2, and 3 of the eyelid adhesive patch 250 without the release liner of layer 4 through the middle, along an axis 2503 shown in FIG. 25A.

[0168] FIG. 25G illustrates a back side 250b of the eyelid adhesive patch 250 without the release liner of layer 4 shown in FIG. 25B. The sensitive skin hydrogel adhesive layer 3 may provide enough adhesive tack to adhere to the complex surface geometries of the eyelid area. The sensitive skin hydrogel adhesive layer 3 may provide enough water content to feel cool to the touch. The skin hydrogel adhesive layer 3 may provide enough elongation to reduce shear forces on the skin and support gentle removal. The skin-facing adhesive layer 3 may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions.

[0169] FIG. 26A-B illustrates a front view 260c and cross-sectional view 260d of the embodiment of an eyelid adhesive patch wherein multiple eyelid adhesive patches 260a and 260b are on a single release liner 4. The additional layers 1, 2, and 3 are separate between eyelid adhesive patches 260a and 260b as shown in FIG. 26B. The release liner layer 5 can be shaped or dimensioned to support multiple eyelid adhesive patches 260a and 260b on a single liner, enabling two or more patches to be provided together. The release liner layer 5 may be contoured to define one or more areas that serve as touch points, facilitating grasping and peeling of the liner from the eyelid adhesive patch 260a and 260b.

[0170] FIGS. 27A-G illustrate an eleventh embodiment of an eyelid adhesive patch 270.FIG. 27A illustrates a front view of the 270a embodiment of an eyelid adhesive patchAttorney Docket No. 105676-432984270. A conforming backing layer 1 may provide enough flexibility for the eyelid adhesive patch 270 to adhere to a curved surface of an eyelid 8. The conforming backing layer 1 may provide enough structure to maintain the shape of the eyelid adhesive patch 270 during and after the application of the eyelid adhesive patch 270 to the eyelid 8.

[0171] FIG. 27B illustrates a back side 270b of the eyelid adhesive patch 270 with the release liner layer 5. The back side 270b of the eyelid adhesive patch 270 may include the release liner layer 5. The release liner layer 5 may be contoured to define one or more non-adhesive touch points 527 that facilitate grasping and peeling the liner from the eyelid adhesive patch 270, and may be sized larger than layers 1, 2, and 3 to accommodate these touch points.

[0172] FIG. 27C illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 270 through the middle, along an axis 2701 shown in FIG. 27A. Sensitive skin hydrogel adhesive layer 3 may be attached to the release liner 4. Very thin adhesive structural layer 2 may be attached to the sensitive skin hydrogel adhesive layer 3. The conforming backing layer 1 may be attached to the very thin adhesive structural layer 2.

[0173] FIG. 27D illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 270 with the release liner layer 5 along an axis 2703 shown in FIG. 27A. The sensitive skin hydrogel adhesive layer 3 may include a discontinuity as illustrated along an axis 2702 that defines a first adhesive area 3a, a second adhesive area 3b, and an intervening space or gap 7 of layer 1 without adhesive. The release liner layer 5 covers areas 3a, 3b, and intervening space 7.

[0174] FIG. 27E illustrates a front side 270a of the eyelid adhesive patch 270 without the release liner of layer 4 shown in FIG. 27A.

[0175] FIG. 27F illustrates a cross-sectional view of the layers 1, 2, and 3 of the eyelid adhesive patch 270 without the release liner of layer 4 through the middle, along an axis 103 shown in FIG. 27A. The sensitive skin hydrogel adhesive layer 3 may include a discontinuity as illustrated along an axis 102 that defines a first adhesive area 3a, a second adhesive area 3b, and an intervening space or gap 7 of layer 1 without adhesive. This gap 7 may enable the user to feel tactile resistance when the first adhesive area 3a has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch 270 so as to not disrupt adhesion of layer 3b to the skin.Attorney Docket No. 105676-432984

[0176] FIG. 27G illustrates a back side 270b of the eyelid adhesive patch 270 without the release liner layer 5 shown in FIG. 27B. The sensitive skin hydrogel adhesive layer 3 may provide enough adhesive tack to adhere to the complex surface geometries of the eyelid area. The sensitive skin hydrogel adhesive layer 3 may provide enough water content to feel cool to the touch. The sensitive skin hydrogel adhesive layer 3 may provide enough elongation to reduce shear forces on the skin and support gentle removal. The sensitive skin hydrogel adhesive layer 3 may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions. The sensitive skin hydrogel adhesive layer 3 may include a discontinuity as illustrated along an axis 2702 that defines a first adhesive area 3a, a second adhesive area 3b, and an intervening space or gap 7 of layer 1 without adhesive.

[0177] FIGS. 28A-G illustrate a twelfth embodiment of an eyelid adhesive patch 280.FIG. 28A illustrates a front view of the 280a embodiment of an eyelid adhesive patch 280. A conforming backing layer 1 may provide enough flexibility for the eyelid adhesive patch 280 to adhere to a curved surface of an eyelid 8. The structural layer 1 may provide enough structure to maintain the shape of the eyelid adhesive patch 280 during and after the application of the eyelid adhesive patch 280 to the eyelid 8.

[0178] FIG. 28B illustrates a back side 280b of the eyelid adhesive patch 280 with the release liner layer 5. The back side 280b of the eyelid adhesive patch 280 may include the release liner layer 5. The release liner layer 5 may be contoured to define one or more non-adhesive touch points 528 that facilitate grasping and peeling the liner from the eyelid adhesive patch 280, and may be sized larger than layers 1, 2, and 3 to accommodate these touch points.

[0179] FIG. 28C illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 280 through the middle, along an axis 2801 shown in FIG. 28A. Sensitive skin hydrogel adhesive layer 3 may be attached to the release liner 4. Very thin adhesive structural layer 2 may be attached to the sensitive skin hydrogel adhesive layer 3. The conforming backing layer 1 may be attached to the very thin adhesive structural layer 2.

[0180] FIG. 28D illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 280 with the release liner layer 5 along an axis 2803 shown in FIG. 28A. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogelAttorney Docket No. 105676-432984adhesive layer 4d may include a discontinuity between them as illustrated along an axis 102 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, and an intervening space or gap 7 of layer 1 without adhesive. The release liner of layer 4 covers areas 3, 8, and intervening space or gap 7.

[0181] FIG. 28E illustrates a front side 280a of the eyelid adhesive patch 280 without the release liner of layer 4 shown in FIG. 28A.

[0182] FIG. 28F illustrates a cross-sectional view of the layers 1, 2, and 3 of the eyelid adhesive patch 280 without the release liner of layer 4 through the middle, along an axis 2803 shown in FIG. 28A. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogel adhesive layer 4d may include a discontinuity between them as illustrated along an axis 2802 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, and an intervening space or gap 7 of layer 1 without adhesive. This gap 7 may enable the user to feel tactile resistance when the first adhesive layer 3 has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch 280 so as to not disrupt adhesion of layer 8 to the skin.

[0183] FIG. 28G illustrates a back side 280b of the eyelid adhesive patch 280 without the release liner layer 5 shown in FIG. 28B. The sensitive skin hydrogel adhesive layer 3 may provide adhesive tack to adhere to the complex surface geometries of the eyelid area. The sensitive skin hydrogel adhesive layer 3 may provide water content to feel cool to the touch. The sensitive skin hydrogel adhesive layer 3 may provide elongation to reduce shear forces on the skin and support gentle removal. The sensitive skin hydrogel adhesive layer 3 may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogel adhesive layer 4d may include a discontinuity between them as illustrated along an axis 2802 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, and an intervening space or gap 7 of layer 1 without adhesive. This gap 7 may enable the user to feel tactile resistance when the first adhesive layer 3 has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch 280 so as to not disrupt adhesion of layer 4d to the skin. The skinfacing adhesive layer 4d may provide tack that resists peeling from the skin during repeated cycles of unsticking and re-sticking layer 3 to the skin. The skin-facing adhesiveAttorney Docket No. 105676-432984layer 4d may provide water content to feel cool to the touch. The skin-facing adhesive layer 4d may provide elongation to reduce shear forces on the skin and supports gentle removal. The skin-facing adhesive layer 4d may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions.

[0184] FIG. 29A illustrates the complex anatomic surface of a closed left eye of a wearer 2999 in FIG. 29D. Those skilled in the art label the horizontal cross-section of a computed tomographic radiograph (i.e. CT scan) of a wearer’s 2999 face as in FIG. 29A an axial view. Those skilled in the art label the vertical cross-section of a CT scan of a wearer’s 2999 face as in FIG. 29B a sagittal view. Those skilled in the art label the en face cross-section of the wearer’s 2999 face as in FIG. 29C a coronal view. Those skilled in the art label the anatomic landmark 2901 the medial canthus 71, the anatomic landmark 2902 the medial canthus 72, anatomic landmark 2903 the superior orbital rim, anatomic landmark 2904 the inferior orbital rim, anatomic landmark 2905 the nasal bridge, anatomic landmarks 2906 and 2907 the palpebral surface comprising upper palpebral surface 2906 and lower palpebral surface 2907, anatomic landmark 2996 the facial bones of the cheek, and anatomic landmark 2997 the facial bones of the temple. Those skilled in the art label the skin of the palpebral surfaces 2906 and 2907 the thinnest skin on the human body that is both fragile and sensitive to traction and noxious substrates, inclusive of the medial and lateral canthi, eyelid margins, eyelashes, and eyebrow. As in FIG. 29A, 29B, and 29D those skilled in the art label direction S superior, direction I inferior, direction M medial, direction L lateral. Those skilled in the art refer to the anatomic landmarks of the right and left eye as the same landmarks of each eye.

[0185] Reference rectangle 2988 of FIG. 29D. illustrates that the eyelid area whereupon an adhesive eye patch can be placed on a closed left eye 2998 of wearer 2999, defines medial, lateral, superior, and inferior boundaries that are respectively disposed medial to the medial canthus 72 and extending to or terminating short of the nasal bridge, lateral to the medial canthus 72 and extending to or terminating short of the lateral orbital rim, inferior to the inferior eyelid margin and extending to or terminating short of the inferior orbital rim, and superior to the superior eyelid margin and extending to or terminating short of the superior orbital rim.Attorney Docket No. 105676-432984

[0186] As illustrated in FIG. 29A, the closed left eye of a wearer comprises a surface visualized in horizontal cross-section at reference line 2982 in axial view of FIG. 29A, the surface comprising the concave surface of the medial canthal skin adjacent the nasal bridge having tight, multidirectional radii of curvature, the convex palpebral surface having a larger radius of curvature, and the convex surfaces of the lateral orbital rims that transition continuously from the palpebral surface onto the facial bones, all of said surfaces together defining a contiguous anatomical surface region

[0187] As illustrated in FIG. 29B, the closed left eye of a wearer comprises a surface visualized in vertical cross-section at reference line 2981 in sagittal view of FIG. 29B, the surface comprising the concave surface of the medial canthal skin adjacent the nasal bridge having tight, multidirectional radii of curvature, the convex palpebral surface having a larger radius of curvature, and the convex surfaces of the superior and inferior orbital rims that transition continuously from the palpebral surface onto the facial bones, all of said surfaces together defining a contiguous anatomical surface region

[0188] As illustrated in the sagittal view of FIG. 29B, arrow 2959 illustrates an opening force exerted by the eyelid opening muscles on the upper eyelid. As illustrated in the sagittal view of FIG. 29B, arrow 2960 illustrates an opening force exerted by the eyelid opening. Muscles on the lower eyelid. Arrows 2961 and 2962 illustrate the closure force exerted by an eyelid patch adhered to the eyelid area when method 900 blocks 901-902 is used to apply the eyelid patch, wherein the closure forces on the upper and lower eyelids are equal and opposite each other and in opposite directions and greater magnitude from the opening forces of the upper and lower eyelids, respectively. Arrows 2963 and 2964 illustrate the closure force exerted by an eyelid patch adhered to the eyelid area, when method 900 blocks 901-905 or method 1000 blocks 1001-1005 are used to apply the eyelid patch, wherein the closure forces on the upper eyelid is increased by adhering the eyelid patch to the upper eyelid but not the lower eyelid, pulling the eyelid patch in the inferior direction to exert downward traction on the upper eyelid toward the lower eyelid, and sticking the remainder of the eyelid patch to the lower eyelid

[0189] As shown in FIG. 30, eyelid adhesive patch 300a and 300b may be contoured into a circular shape to adhere to the eyelid area of the user. The patch may be opaque or transparent.Attorney Docket No. 105676-432984

[0190] As shown in FIG. 31, eyelid adhesive patch 31 Oa and 31 Ob may be contoured into a circular shape to adhere to the eyelid area of the user. The patch may be opaque or black to block light transmission.

[0191] As shown in FIG. 32, eyelid adhesive patch 320a and 320b may be dimensioned into a small circular shape to adhere to the eyelid area of the user and to avoid overlap with a CPAP mask. Those skilled in the art label the area of the eyelid that is on the side of the nose as medial in location; the area of the eyelid that is on the side of the ear is labeled lateral in location. The patch may be opaque or transparent.

[0192] As shown in FIG. 33, eyelid adhesive patch 330 may be contoured into a tall rectangular shape to adhere to the eyelid area of the user.

[0193] As shown in FIG. 34, eyelid adhesive patch 340 may be contoured into a narrow rectangular shape to adhere to the eyelid area of the user.

[0194] As shown in FIG. 35, eyelid adhesive patch 350 may be contoured into a cross shape to adhere to the eyelid area of the user.

[0195] As shown in FIG. 36, eyelid adhesive patch 360 may be contoured into a circular shape with one or more triangular wedges cut out at the nasal and temporal canthal areas to conform to and adhere to the eyelid area of the user.

[0196] As shown in FIG. 37, eyelid adhesive patch 370 may contoured into a tall rectangular shape as illustrated not to scale with one or more triangular wedges cut out at the nasal and temporal canthal areas to conform to and adhere to the eyelid area of the user.

[0197] As shown in FIG. 38, eyelid adhesive patch 380 may contoured into a narrow rectangular shape as illustrated not to scale with one or more triangular wedges cut out at the nasal and temporal canthal areas to conform to and adhere to the eyelid area of the user.

[0198] As shown in FIG. 39, eyelid adhesive patch 390 may contoured into an oval shape as illustrated not to scale with one or more triangular wedges cut out at the nasal and temporal canthal areas to conform to and adhere to the eyelid area of the user.

[0199] As shown in FIG. 40, eyelid adhesive patch 400 may be contoured into a cross shape as illustrated not to scale with one or more triangular wedges cut out at the nasal and temporal canthal areas to conform to and adhere to the eyelid area of the user.Attorney Docket No. 105676-432984

[0200] FIGS. 15, 16, 18-24, and 30-40 are merely depictions of the different types of application uses an embodiment of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, and 400 may have in various settings. FIG. 16 illustrates patch 50 in an endotracheal intubation inpatient setting. FIG. 18 illustrates patch 50 in a smaller-sized embodiment than illustrated in FIG.16; FIG. 18 illustrates patch 50 in a continuous positive airway pressure (CPAP) nasal mask home setting. FIGS. 19-20 illustrate patch 50 in a smaller-sized embodiment than illustrated in FIG. 16; FIGS. 19-20 illustrate patch 50 in a neonatal intensive care endotracheal intubation inpatient setting (FIG. 19) and a pediatric intensive care endotracheal intubation inpatient setting (FIG. 20). FIG. 20 illustrates patch 50 in a vertically oriented hinge embodiment rather than diagonally oriented as in FIG. 16; FIG.20 illustrates patch 50 in a dentistry nitrous oxide nasal hood outpatient setting. FIGS. 22A and 22B illustrate patch 50 in a unilateral Bell’s palsy outpatient setting for addressing lagophthalmos. FIGS. 23A and 23B illustrate patch 50 in a bilateral thyroid eye disease outpatient setting for addressing lagophthalmos. FIGS. 23 A, 23B, 24A, and 24B represent two of many clinical outpatient settings in ophthalmology practice requiring openable-closable, removable, patient-applied eyelid closure with patch 50, including other settings involving corneal pathology such as neurotrophia, microbial keratitis, punctate keratopathy, and persistent epithelial defects, all of which can be primary pathologies without lagophthalmos or secondary pathologies that result from lagophthalmos. FIG. 24 illustrates patch 50 in a fur-applied embodiment rather than the skin-applied embodiment of FIG. 16; FIG 24 illustrates a veterinary endotracheal intubation inpatient setting.

[0201] In a preferred embodiment, the release liner layer 5 is horizontally split into top and bottom release liner pieces. Horizontal splitting of the release liner layer 5 enables reproducible application of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 when standing at the head of the bed, as is customary for anesthesiologists and nurse anesthetists. The eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170,Attorney Docket No. 105676-432984180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 is applied by removing the upper half of the release liner layer 5 and applying the exposed skin adhesive to the upper eyelid, then removing the lower half of the release liner layer 5, grabbing the non-adhesive touch point 11 on the lower half of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 to pull the upper eyelid into contact with the lower eyelid margin and then simultaneously sticking the lower half of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 to the periorbital and cheek skin. Another preferred method for applying the adhesive patch is to apply the bottom half of the adhesive after removal of the release liner layer 5 to the periorbital and cheek skin, remove the upper half of the release liner layer 5, then grab the non-adhesive touch point 11 on the upper half of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 to pull the lower eyelid into contact with the upper eyelid margin and then simultaneously sticking the upper adhesive to the upper eyelid skin.

[0202] Regarding the various layers, the tactile locator layer 1 may be formed from a material that is tactilely distinguishable from the other material layers. In settings where the user is the patient wearing the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400, the tactile locator layer 1 is added for the user to align the eyelid adhesive with the canthus or some other anatomical feature of the face in order to apply the patch correctly without direct visualization of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400, as would be the case for a user whose eye is closed during application of the patch.Attorney Docket No. 105676-432984

[0203] The structural layer 2 may be comprised of any material rigid enough to maintain the shape of the eyelid adhesive patch 10 without folding on itself, and any material flexible enough to adhere to the curved surface of the eyelid. The structural layer 2 has a sensitive skin adhesive layer 3 on the back to adhere to the skin of the eyelid. The adhesive on the structural layer 2 may comprise any acrylic, silicone, hydrogel and / or combination thereof. This may apply to very thin structural layer 2a, thicker structural layer 2b, or cinching flap 9f comprised of structural layer 2c.

[0204] The sensitive skin adhesive layer 3 may be comprised of any adhesive that can be easily removed from the skin without tearing, pulling, or otherwise irritating the skin. The adhesive may comprise any acrylic, silicone, hydrogel and / or combination thereof. This may apply to cinching flap-to-primary flap adhesive layer 3 a. The adhesive, if a hydrogel or other appropriate material, may serve a dual function as a skin adhesive and a direct- contact therapeutic agent delivery depot. Certain embodiments may deliver therapeutic agents such as aloe, hyaluronic acid, retinol, anti-inflammatory compounds, moisturizing compounds, and dermatologically rejuvenating compounds.

[0205] The higher-tack adhesive layer 4 or very thin higher-tack adhesive layer 4a may be comprised of any adhesive that can be easily removed but adheres more strongly than the sensitive skin adhesive layer 3. The higher-tack adhesive layer 4 is intended to be used on less delicate skin or to adhere to any of the other layers. This may apply to very thin higher tach adhesive layer 4a.

[0206] The release liner layer 5 may be comprised of any material that is easy to handle and remove off the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400. The release liner layer 5 may or may not contain an adhesive. The release liner layer 5 may or may not retain itself on the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 through friction.

[0207] The low-tac carrier layer 6 may be comprised of any material that can be easily removed - similarly to release liner layer 5. The low-tac carrier layer 6 and / or the belt loop in the primary flap layer 6a (shown in FIGS. 14A-F) may be comprised of anyAttorney Docket No. 105676-432984material with tack that is lower than the tack that bonds the other layers together into an integral web.

[0208] The eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may comprise any shape suitable for adhering to the eyelid and surrounding area. In one embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be procured as a pair wherein one patch is meant for the right eye and the other patch is meant for the left eye. In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be procured as a pair wherein one patch can be applied to both eyes and is not specific to one eye or another. Different sizes of the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be used in various scenarios. For example, a smaller eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be used in pediatric and veterinary applications. Larger eyelid adhesive patches 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be used for adults of varying sizes.

[0209] The eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be of appropriate dimensions to enable the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 to fit within the medial aspect of the eyelid, wherein its surface and edges are protected below the highest points of the brow and nasal bridge. When it is of the appropriate dimensions, the eyelid adhesive patch 10,Attorney Docket No. 105676-43298420, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may avoid direct contact with a cushioned surface when sleeping, such as a pillow, and is less disturbed by head movements during sleep.

[0210] In one embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may comprise one, two, or three pieces adhered to the skin separately. The eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 pieces may fasten together by any means - for example, an adhesive, hook and loop, a button, etc.

[0211] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may have zero, one, or more than one non-adhesive touch points for the user to align the patch to the eye without touching the adhesive backing and di storting / disturbing the adhesion. In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 release liner layer 5 may be split into multiple sections so that the multiple sections may be peeled off from the eyelid adhesive separately from each other.

[0212] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may comprise more than one layer.

[0213] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may comprise zero, one, or more than one tactile locators to provide a tangibly different material for the user to use as a guide for locating and applying the patch correctly onto the eye.Attorney Docket No. 105676-432984

[0214] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may or may not be transparent.

[0215] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may or may not comprise lubricants or similar compounds.

[0216] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be one piece with multiple layers or one piece with one layer.

[0217] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may be two or more pieces with one or more layers each.

[0218] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may include some means for tightening wherein multiple edges of the patch are tightened together to better secure the eye closed.

[0219] In another embodiment, the eyelid adhesive patch 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 may include some means for tightening wherein multiple pieces of the patch are tightened together to better secure the eye closed.

[0220] FIGS. 41-42 are flow charts illustrating various methods of using various implementations of the eyelid adhesive patch. These specific methods represent various aspects of the same method 900, and as such, each step of the individually listed methods may be introduced into other methods. Similarly, any listed step in any particular method may be omitted, as each step is intended to be illustrative and not limiting. Finally, theAttorney Docket No. 105676-432984order of each method is also illustrative, meaning the order of steps in each method may be changed while remaining within the scope of the overall method 900.

[0221] FIG. 41 illustrates one implementation of the method 900 of using an eyelid adhesive patch. The method 900, according to one implementation, begins at block 901 with removing a temporary covering layer from a skin-facing adhesive layer.

[0222] The method 900, according to one implementation, continues at block 902 with adhering the skin-facing adhesive layer onto the upper and lower eyelid area of a closed eye of a wearer.

[0223] The method 900, according to one implementation, continues at block 903 with step 903 a releasing the lower portion of the skin-facing adhesive layer from the lower eyelid area or step 903b releasing the upper portion of the skin-facing adhesive layer from the upper eyelid area.

[0224] The method 900, according to one implementation, continues at block 904 with step 904a exerting a tractional force on the upper eyelid area using the device wherein the traction is directed toward the lower eyelid or step 904b exerting a tractional force on the lower eyelid area using the device wherein the traction is directed toward the upper eyelid.

[0225] The method 900, according to one implementation, continues at block 905 step 905a adhering the released portion of the skin-facing adhesive layer onto the upper eyelid area of a closed eye or step 905b adhering the released portion of the skin-facing adhesive layer onto the lower eyelid area of a closed eye.

[0226] FIG. 42 illustrates one implementation of the method 1000 of using an eyelid adhesive patch. The method 1000, according to one implementation, begins at block 1001 with removing a temporary covering layer from a skin-facing adhesive layer.

[0227] The method 1000, according to one implementation, continues at block 1002 with adhering the skin-facing adhesive layer onto the upper and lower eyelid area of a closed eye of a wearer.

[0228] The method 1000, according to one implementation, continues at block 1003 with step 1003a releasing the first adhesive area from the upper eyelid area until a détente is felt at the non-adhesive hinge, thereby preserving adhesion of the second adhesive area to the lower eyelid area or step 1003b releasing the first adhesive area from the lower eyelidAttorney Docket No. 105676-432984area until a détente is felt at the non-adhesive hinge, thereby preserving adhesion of the second adhesive area to the upper eyelid

[0229] The method 1000, according to one implementation, continues at block 1004 with step 1004a exerting a tractional force on the upper eyelid area using the device wherein the traction is directed toward the lower eyelid or step 1004b exerting a tractional force on the lower eyelid area using the device wherein the traction is directed toward the upper eyelid.

[0230] The method 1000, according to one implementation, continues at block 1005 step 1005a adhering the first adhesive area of the skin-facing adhesive layer onto the upper eyelid area of a closed eye or step 1005b adhering the first adhesive area of the skinfacing adhesive layer onto the lower eyelid area of a closed eye.

[0231] FIGS. 43-45 are flow charts illustrating various methods of manufacturing various implementations of the eyelid adhesive patch. These specific methods represent various aspects of the same method 1100, and as such, each step of the individually listed methods may be introduced into other methods. Similarly, any listed step in any particular method may be omitted, as each step is intended to be illustrative and not limiting. Finally, the order of each method is also illustrative, meaning the order of steps in each method may be changed while remaining within the scope of the overall method 1100.

[0232] The method 1100, according to one implementation, begins at block 1101 with providing a surface-conforming, shape-stable substrate material and a hydrogel skin adhesive.

[0233] The method 1100, according to one implementation, continues at block 1102 with joining the hydrogel skin adhesive to a first surface of the substrate material over a first area thereof to form an integral web.

[0234] The method 1100, according to one implementation, continues at block 1103 with cutting the integral web to form a final periphery of the eyelid adhesive patch, the final periphery being shaped to provide a graspable non-adhesive tab and enable the device to adhere to a closed external eyelid skin area of a wearer.Attorney Docket No. 105676-432984

[0235] The method 1200, according to one implementation, begins at block 1201 with impregnating a hydrogel skin adhesive with one or more bioactive physiologically beneficial transdermal agents.

[0236] The method 1200, according to one implementation, continues at block 1202 with providing a surface-conforming, shape-stable substrate material and a hydrogel skin adhesive impregnated with bioactive physiologically beneficial transdermal agents.

[0237] The method 1200, according to one implementation, continues at block 1203 with joining the hydrogel skin adhesive to a first surface of the substrate material over a first area thereof to form an integral web.

[0238] The method 1200, according to one implementation, continues at block 1204 with cutting the integral web to form a final periphery of the eyelid adhesive patch, the final periphery being shaped to provide a graspable non-adhesive tab and enable the device to adhere to a closed external eyelid skin area of a wearer.

[0239] The method 1300, according to one implementation, begins at block 1301 with impregnating a hydrogel skin adhesive with one or more bioactive physiologically beneficial transdermal agents.

[0240] The method 1300, according to one implementation, continues at block 1302 with providing a surface-conforming, shape-stable substrate material and a hydrogel skin adhesive impregnated with bioactive physiologically beneficial transdermal agents.

[0241] The method 1300, according to one implementation, continues at block 1303 with joining the hydrogel skin adhesive to a first surface of the substrate material over a first area thereof to form an integral web.

[0242] The method 1300, according to one implementation, continues at block 1304 with cutting the integral web to form a final periphery of the eyelid adhesive patch, the final periphery being shaped to provide a graspable non-adhesive tab and enable the device to adhere to a closed external eyelid skin area of a wearer.

[0243] The method 1300, according to one implementation, continues at block 1305 with coating the substrate with a layer which includes a plurality of microcapsules containing an aromatic substance.

[0244] 46A-G illustrate a thirteenth embodiment of an eyelid adhesive patch 460. 46A illustrates a front view of the 460a embodiment of an eyelid adhesive patch 460. AAttorney Docket No. 105676-432984conforming backing layer 1 may provide enough flexibility for the eyelid adhesive patch 460 to adhere to a curved surface of an eyelid 8. The structural layer 1 may provide enough structure to maintain the shape of the eyelid adhesive patch 460 during and after the application of the eyelid adhesive patch 460 to the eyelid 8. 46B illustrates a back side 460b of the eyelid adhesive patch 460 with the release liner layer 4. The back side 460b of the eyelid adhesive patch 460 may include the release liner layer 4. The release liner layer 4 may be contoured to define one or more non-adhesive touch points 5. 46C that facilitate grasping and peeling the liner from the eyelid adhesive patch 460, and may be sized larger than layers 1, 2, and 3 to accommodate these touch points. 46C illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 460 through the middle, along an axis 4601 shown in FIG. 46A. Sensitive skin hydrogel adhesive layer 3 may be attached to the release liner 4. Very thin adhesive structural layer 2 may be attached to the sensitive skin hydrogel adhesive layer 3. The conforming backing layer 1 may be attached to the very thin adhesive structural layer 2.

[0245] 46D illustrates a cross-sectional view of the layers 1, 2, 3, and 4 of the eyelid adhesive patch 460 with the release liner layer 4 along an axis 4603 shown in FIG. 46A. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogel adhesive layer 4d may include a discontinuity between them as illustrated along an axis 4603 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, a third adhesive area 4e comprised of a higher tack adhesive, an intervening space or gap 7 of layer 1 without adhesive, and an intervening space or gap 8 of layer 1 without adhesive. The release liner of layer 4 covers areas 3, 4d, 4e, and intervening space or gaps 7 and 8.

[0246] 46E illustrates a front side 460a of the eyelid adhesive patch 460 without the release liner of layer 4 shown in FIG. 46A46F illustrates a cross-sectional view of the layers 1, 2, and 3 of the eyelid adhesive patch 460 without the release liner of layer 4 through the middle, along an axis 4603 shown in FIG. 46A. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogel adhesive layers 4d and 4e may include a discontinuity between them as illustrated along an axis 4603 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, a third adhesive area 4e comprised of a higher tack adhesive, and intervening spaces or gaps 7Attorney Docket No. 105676-432984and 8 of layer 1 without adhesive. These gaps 7 and 8 may enable the user to feel tactile resistance when the first adhesive layer 3 has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch 460 so as to not disrupt adhesion of layer 4d or 4e to the skin. 46G illustrates a back side 460b of the eyelid adhesive patch 460 without the release liner layer 5 shown in FIG. 46B. The sensitive skin hydrogel adhesive layer 3 may provide adhesive tack to adhere to the complex surface geometries of the eyelid area. The sensitive skin hydrogel adhesive layer 3 may provide water content to feel cool to the touch. The sensitive skin hydrogel adhesive layer 3 may provide elongation to reduce shear forces on the skin and support gentle removal. The sensitive skin hydrogel adhesive layer 3 may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions. The sensitive skin hydrogel adhesive layer 3 and high-tack sensitive skin hydrogel adhesive layers 4d and 4e may include a discontinuity between them as illustrated along an axis 4603 that defines a first adhesive area 3, a second adhesive area 4d comprised of a higher tack adhesive, a third adhesive area 4e comprised of a higher tack adhesive, and intervening spaces or gaps 7 and 8 of layer 1 without adhesive. These gaps 7 and 8 may enable the user to feel tactile resistance when the first adhesive layer 3 has been completely peeled off the eyelid 8, signaling the user to stop peeling the eyelid adhesive patch so as to not disrupt adhesion of layer 8 to the skin. The skin-facing adhesive layers 4d and 4e may provide tack that resists peeling from the skin during repeated cycles of unsticking and re-sticking layer 3 to the skin in tandem with either layer 4d or 4e, wherein preservation of adhesion of 4d would result from peeling areas 4e and 3 from the skin, and wherein preservation of adhesion of 4e would result from peeling areas 4d and 3 from the skin. The skin-facing adhesive layers 4d and 4e may provide enough water content to feel cool to the touch. The skin-facing adhesive layers 4d and 4e may provide enough elongation to reduce shear forces on the skin and supports gentle removal. The skin-facing adhesive layer 4d and 4e may be hypoallergenic rendering it unlikely to trigger irritation or other adverse reactions.

[0247] The eyelid adhesive patch is placed upon a closed eyelid of a wearer’s eyelid region, the region characterized by complex surface geometries covered by the thinnest skin on the human body that is both fragile and sensitive to traction and noxious substrates, inclusive of the medial and lateral canthi, eyelid margins, eyelashes, andAttorney Docket No. 105676-432984eyebrow, the eyelid adhesive patch includes a medial boundary disposed medial to a medial canthus of the eyelid region and extending to or terminating short of a nasal bridge of the eyelid region, a lateral boundary disposed lateral to a lateral canthus of the eyelid region and extending to or terminating short of a lateral orbital rim of the eyelid region, an inferior boundary disposed inferior to an inferior eyelid margin of the eyelid region and extending to or terminating short of an inferior orbital rim of the eyelid region, and a superior boundary disposed superior to a superior eyelid margin of the eyelid region and extending to or terminating short of a superior orbital rim of the eyelid region.

[0248] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, a further aspect is included from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms a further aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0249] Although the disclosure has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the disclosed apparatus, systems and methods.

[0250] The following numbered embodiments are contemplated and are non-limiting: A hydrogel adhesive eyelid closure support device comprising a single, multi-layered member configured for placement upon a closed eyelid of a wearer’s eyelid region, the region characterized by complex surface geometries covered by the thinnest skin on the human body that is both fragile and sensitive to traction and noxious substrates, inclusive of the medial and lateral canthi, eyelid margins, eyelashes, and eyebrow, the multi-layered single member includingAttorney Docket No. 105676-432984a medial boundary disposed medial to a medial canthus of the eyelid region and extending to or terminating short of a nasal bridge of the eyelid region,a lateral boundary disposed lateral to a lateral canthus of the eyelid region and extending to or terminating short of a lateral orbital rim of the eyelid region,an inferior boundary disposed inferior to an inferior eyelid margin of the eyelid region and extending to or terminating short of an inferior orbital rim of the eyelid region, and a superior boundary disposed superior to a superior eyelid margin of the eyelid region and extending to or terminating short of a superior orbital rim of the eyelid region,a first surface and a second surface, wherein a hydrogel skin-facing adhesive layer is disposed on the first surface, a flexible non-adhesive backing layer is disposed on the second surface, the non-adhesive backing layer including one or more contiguous appendages disposed along a peripheral edge region thereof, a double-sided adhesive or bonding layer is interposed between the first and second surfaces to laminate the hydrogel skin-facing adhesive layer and the non-adhesive backing layer together to form a laminated layer, and a removable covering layer is disposed on the skin-facing adhesive layer,wherein, the multi-layered member is configured to apply a closure force to the eyelid region such that the closure force is configured to prevent opening of an eyelid in the eyelid region and simultaneously configured to peel from the eyelid without stimulating pain receptors from skin traction.2. The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the non-adhesive backing layer is pliable, non-irritating during prolonged contact with the skin, and conforming to the complex surface geometries of the eyelid region.3. The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the hydrogel skin-facing adhesive layer is pliable, tacky, nonirritating during prolonged contact with the skin, conforming to the complex surface geometries of the eyelid region, and gentle when peeled from the eyelid region skin.4. The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein excluding any appendages, the device comprises a circular, oval, rectangular, symmetric or asymmetric shape.Attorney Docket No. 105676-432984The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the device further comprises one or more wedge cutouts formed in the peripheral edge region.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the skin-facing adhesive layer comprises a hypoallergenic and odorless adhesive.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the skin-facing adhesive layer is configured to have thickness, elongation, and elasticity characteristics selected to provide gentle release from the skin, such that the skin-facing adhesive layer can be peeled from the skin atraumatically and without pain.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the skin-facing adhesive layer has thickness and water content characteristics selected to provide a tactile sensation of coolness and soothingness.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the laminated layer is transparent.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the laminated layer is translucent.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the non-adhesive backing layer is opaque and light-blocking. The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the device is used for CPAP, dry eye, exposure keratopathy outpatient, sleep aid, anesthesia, or palsy outpatient.The eyelid closure support device of clause 1, any other suitable clause, or any combination of suitable clauses, wherein an orientation indicator is disposed on the backing layer, the indicator being both tactile and visual to facilitate alignment with eyelid anatomical landmarks during self-application by the wearer, and being provided in a singular or multiple form to correspond to right-sided and left-sided application.An adhesive device comprisinga skin-facing adhesive layer,a backing layer,Attorney Docket No. 105676-432984a double-sided adhesive or bonding layer that laminates the skin-facing adhesive layer to the backing layer, andan intervening linear space disposed between a first adhesive area and a second adhesive area of the skin-facing adhesive layer,wherein within the intervening linear space the skin-facing adhesive layer and the doublesided adhesive or bonding layer are absent so as to render the backing layer continuous across the intervening linear space and thereby define a line of discontinuity in the skinfacing adhesive layer that divides the skin-facing adhesive layer into the first adhesive area and the second adhesive area,wherein the backing layer comprises pliability sufficient to permit bending of the adhesive device along the line of discontinuity.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the adhesive device is a multi-layer laminated single member.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the line of discontinuity is configured to be operable as a hinge that permits the adhesive device to fold upon itself such that the backing layer is able to contact itself when the first adhesive area is non-adherent to a surface of the wearer.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the line of discontinuity is configured to provide a tactile detente corresponding to resistance encountered during peeling of the first adhesive area from the surface so as to signal a user to cease a peeling force when the first adhesive area has been fully released and thereby preserve adhesion of the second adhesive area.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the device is configured to be applied to a continuous or a discontinuous surface and exert a closure force, release the closure force when the first adhesive area is non-adherent to the continuous surface or the discontinuous surface and re-exert the closure force when the first adhesive area is re-adherent to the continuous surface or the discontinuous surface, and alternatively cover the continuous surface or the discontinuous surface when the first adhesive area is adherent to the continuous surface or the discontinuous surface and expose the continuous surface or the discontinuous surface when the first adhesive area is non-adherent to the surface.Attorney Docket No. 105676-432984The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the skin-facing adhesive layer comprises a first adhesive disposed in the first adhesive area and a second adhesive disposed in the second adhesive area, the first adhesive and the second adhesive being distinct from one another, and wherein the second adhesive is configured to have tackiness that anchors the first adhesive area when the first adhesive area is non-adherent to a surface of the wearer.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the backing layer further comprises a backing-facing adhesive configured to retain the device in an open position when the device is folded upon itself at the hinge.The adhesive device of clause 14, any other suitable clause, or any combination of suitable clauses, wherein the line of discontinuity further comprises a border of an area of skin-facing material interposed between the first adhesive area and the second adhesive area, the skinfacing material configured to deliver therapeutic benefit to a tissue in contact.A method for applying a single-member adhesive eyelid closure support device:(i) removing a temporary covering layer from a skin-facing adhesive layer of the device; (ii) placing the skin-facing adhesive layer on upper and lower eyelid regions;The method of clause 22, any other suitable clause, or any combination of suitable clauses, further comprising:(iii) releasing a lower portion of the skin-facing adhesive layer from the lower eyelid region or releasing an upper portion of the skin-facing adhesive from the upper eyelid region.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device has a hinge as in embodiment 14 wherein releasing the lower portion of the skin-facing adhesive layer further includes peeling of the first adhesive area from a surface of the wearer up to the hinge point thereby preserving adhesion of the second adhesive area to a surface of the wearer.The method of clause 22, any other suitable clause, or any combination of suitable clauses, further comprising:((iv) exerting a tractional force on the upper or lower eyelid region using the device; and (v) re-applying the released upper or lower portion of the skin-facing adhesive layer to a location on the upper or lower eyelid region positioned farther from the eyelid margin.Attorney Docket No. 105676-432984The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein opening of the eyelids is prevented by the closure force applied by the adhesive eyelid closure support device without eyelid traction.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein opening of the eyelids is prevented by the closure force applied by the adhesive eyelid closure support device with eyelid traction.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer has exposure keratopathy or symptoms related to nocturnal, paralytic, cicatricial, or mechanical lagophthalmos.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device closes the eyelid of the wearer who has exposure keratopathy or symptoms related to lagophthalmos.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer has exposure keratopathy or symptoms related to the eyelid and ocular surface effects of wearing a CPAP mask.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device closes the eyelid of the wearer who has exposure keratopathy or symptoms related to the eyelid and ocular surface effects of wearing a CPAP mask.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer is a patient under anesthesia at risk for exposure keratopathy or symptoms related to medically induced paralytic lagophthalmos.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device closes the eyelid of a patient under anesthesia with or without airway support at risk for exposure keratopathy or symptoms related to medically induced paralytic lagophthalmos.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer is a patient sedated and / or obtunded in a critical -care unit with or without airway support who is at risk for exposure keratopathy or symptoms related to medically induced paralytic lagophthalmos.Attorney Docket No. 105676-432984The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device closes the eyelid of a patient sedated and / or obtunded in a critical-care unit with or without airway support who is at risk for exposure keratopathy or symptoms related to medically induced paralytic lagophthalmos. The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the peeling of a hinged eyelid support device enables a healthcare provider to open an eyelid of a patient sedated and / or obtunded in a critical-care or anesthesia setting to examine the pupil and the ocular surface and to administer therapeutic agents without removing the eyelid closure support device.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the reapplying of a hinged eyelid support device enables a healthcare provider to reclose the eyelid of a patient sedated and / or obtunded in a critical-care or anesthesia setting without requiring a replacement eyelid closure support device.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein partially unsticking and adhering the unstuck area of the adhesive eyelid closure support device while exerting a tractional force on the eyelids enables adjustment of eyelid closure tightness by the wearer or a healthcare provider.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the adhesive eyelid closure support device includes one or more bioactive agents configured to provide a physiologically beneficial transdermal effect to at least one of the eyelid skin, eyelashes, or meibomian glands of the wearer.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer is a patient with a non-healing corneal infection or corneal defect.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the single member closes the eyelid of a patient with a non-healing corneal infection or corneal defect in lieu of a surgical eyelid closure procedure.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein partially unsticking and adhering the unstuck area of the adhesive eyelid closure support device enables administration of therapeutic agents to the ocular surface without fully removing the eyelid closure support device and without requiring a replacement eyelid closure support device.Attorney Docket No. 105676-432984The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein the wearer desires reduction in light perception through the closed eyelid of the wearer in a well-lit environment such as during travel.A method of manufacturing an eyelid closure support device, comprising:(i) providing a surface-conforming, shape-stable substrate material and a hydrogel skin adhesive;(ii) joining the hydrogel skin adhesive to a first surface of the substrate material over a first area thereof to form an integral web comprising:a laminated adhesive area, anda non-adhesive area parallel to the adhesive area consisting of the substrate material alone; (iii) cutting the integral web to form a final periphery of the eyelid closure support device, the final periphery being shaped to:provide a graspable non-adhesive tab, andenable the device, when adhered to a closed external eyelid skin area of a wearer, to exert a closure force on the eyelids.The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said joining step comprises:a first laminated adhesive area,a second laminated adhesive area parallel to the first, wherein the second area comprises the same or distinct adhesive as the first,an intervening linear space disposed between and parallel to the first and second adhesive areas, wherein the space consists of the substrate material alone, anda non-adhesive area parallel to the adhesive area consisting of the substrate material alone. The method of clause 44, any other suitable clause, or any combination of suitable clauses, further comprisingimpregnating said hydrogel skin adhesive with one or more bioactive physiologically beneficial transdermal agents;The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said agents comprises vitamins, retinoids, polysaccharides, peptides, growth factors, antioxidants, anti-inflammatory substances, extracts, salts, acids, silicones, ceramides, metalAttorney Docket No. 105676-432984ions, botanicals, liposomes, nanoemulsions, nanoparticles, hydration-boosters, antibiotics, antiparasitics, corticosteroid, calcineurin inhibitors, or combinations thereof.The method of clause 44, any other suitable clause, or any combination of suitable clauses,, further comprisingcoating said substrate with a layer which includes a plurality of microcapsules containing an aromatic substance.The method of clause 44, any other suitable clause, or any combination of suitable clauses,, wherein said aromatic substance comprises essential oils, aromatic compounds, or combinations thereof.The method of clause 22, any other suitable clause, or any combination of suitable clauses, wherein said cutting step (iii) comprises roller die-cutting to form a final periphery of the eyelid closure support device.The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said joining step (ii) comprises combining said substrate and said hydrogel adhesive by adhesive bonding, crosslinking, mechanical bonding, ultrasonic bonding, laser welding, pressure, or a combination thereof.The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said joining step (ii) comprises adhesively joining said substrate material and said hydrogel as they are fed into an overlapping position in a die or roller.The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said coating step comprises a rolling step.The method of clause 44, any other suitable clause, or any combination of suitable clauses, wherein said cutting step (iii) comprises flat-bed die cutting, CAD knife bed cutting, or laser cutting flat-bed die cutting.

Claims

Attorney Docket No. 105676-432984CLAIMS1. A hydrogel adhesive eyelid closure support device comprising:a single, multi-layered member configured for placement upon a closed eyelid of a wearer’s eyelid region, the eyelid region characterized by complex surface geometries covered by the thinnest skin on the human body, the multi-layered single member including:a medial boundary,a lateral boundary,a superior boundary, andan inferior boundary,a first surface and a second surface, wherein a hydrogel skin-facing adhesive layer is disposed on the first surface, and wherein the hydrogel skin-facing adhesive layer is configured to be positioned on a wearer’s skin of the wearer’s eyelid region,a flexible non-adhesive backing layer is disposed on the second surface, the flexible nonadhesive backing layer including one or more contiguous appendages disposed along a peripheral edge region thereof,a double-sided adhesive or bonding layer is interposed between the first and second surfaces to laminate the hydrogel skin-facing adhesive layer and the non-adhesive backing layer together to form a laminated layer, anda removable covering layer is disposed on the skin-facing adhesive layer,wherein, the single, multi-layered member is configured to apply a closure force to the eyelid region such that the closure force is configured to prevent opening of the closed eyelid in the eyelid region and simultaneously configured to peel from the closed eyelid without stimulating pain receptors from skin traction.

2. The eyelid closure support device of claim 1, wherein the non-adhesive backing layer is pliable and non-irritating during prolonged contact with the skin of the eyelid region, and conforming to the complex surface geometries of the eyelid region.Attorney Docket No. 105676-4329843. The eyelid closure support device from claims 1-2, wherein the hydrogel skinfacing adhesive layer is pliable, tacky, and non-irritating during prolonged contact with the skin of the eyelid region, conforming to the complex surface geometries of the eyelid region, and gentle when peeled from the skin of the eyelid region.

4. The eyelid closure support device of claims 1-3, wherein the hydrogel skin-facing adhesive layer is configured to have thickness, elongation, and elasticity characteristics selected to provide gentle release from the skin of the eyelid region, such that the skin-facing adhesive layer can be peeled from the skin of the eyelid region atraumatically and without pain5. The eyelid closure support device of claims 1-4, wherein the hydrogel skin-facing adhesive layer has thickness and water content characteristics selected to provide a tactile sensation of coolness and soothingness.

6. The eyelid closure support device of claims 1-5, wherein the laminated layer is translucent.

7. An adhesive device comprisinga skin-facing adhesive layer,a backing layer,a double-sided adhesive or bonding layer that laminates the skin-facing adhesive layer to the backing layer, andan intervening linear space disposed between a first adhesive area and a second adhesive area of the skin-facing adhesive layer,wherein within the intervening linear space the skin-facing adhesive layer and the double-sided adhesive or bonding layer are absent so as to render the backing layer continuous across the intervening linear space and thereby define a line of discontinuity in the skin-facing adhesive layer that divides the skin-facing adhesive layer into the first adhesive area and the second adhesive area,wherein the backing layer comprises pliability sufficient to permit bending of the adhesive device along the line of discontinuity.Attorney Docket No. 105676-4329848. The adhesive device of claim 7, wherein the adhesive device is a multi-layer laminated single member.

9. The adhesive device of claims 7-8, wherein the line of discontinuity is configured to be operable as a hinge that permits the adhesive device to fold upon itself such that the backing layer is able to contact itself when the first adhesive area is non-adherent to a surface of the wearer.

10. The adhesive device of claims 7-9, wherein the line of discontinuity is configured to provide a tactile detente corresponding to resistance encountered during peeling of the first adhesive area from the surface of the wearer so as to signal a wearer to cease a peeling force when the first adhesive area has been fully released and thereby preserve adhesion of the second adhesive area.

11. The adhesive device of claims 7-10, wherein the device is configured to be applied to a continuous or a discontinuous surface and exert a closure force, release the closure force when the first adhesive area is non-adherent to the continuous surface or the discontinuous surface and re-exert the closure force when the first adhesive area is re-adherent to the continuous surface or the discontinuous surface, and alternatively cover the continuous surface or the discontinuous surface when the first adhesive area is adherent to the continuous surface or the discontinuous surface and expose the continuous surface or the discontinuous surface when the first adhesive area is non-adherent to the continuous or discontinuous surface.

12. The adhesive device of claims 7-11, wherein the skin-facing adhesive layer comprises a first adhesive disposed in the first adhesive area and a second adhesive disposed in the second adhesive area, the first adhesive and the second adhesive being distinct from one another, and wherein the second adhesive is configured to have tackiness that anchors the first adhesive area when the first adhesive area is non-adherent to the surface of the wearer.Attorney Docket No. 105676-43298413. A method for applying a single-member adhesive eyelid closure support device: (i) removing a temporary covering layer from a skin-facing adhesive layer;(ii) placing the skin-facing adhesive layer on upper and lower eyelid regions;14. The method of claim 13 further comprising:(iii) releasing a lower portion of the skin-facing adhesive layer from the lower eyelid region or releasing an upper portion of the skin-facing adhesive from the upper eyelid region.

15. The method of claims 13-14, wherein the single-member adhesive eyelid closure support device has a hinge as in claim 7 wherein releasing the lower portion of the skin-facing adhesive layer further includes peeling of the first adhesive area from a surface of the wearer up to the hinge point thereby preserving adhesion of the second adhesive area to the surface of the wearer.

16. The method of claims 13-15 further comprising:(iv) exerting a tractional force on the upper or lower eyelid region using the single-member adhesive eyelid closure support device; and(v) re-applying the released upper or lower portion of the skin-facing adhesive layer to a location on the upper or lower eyelid region positioned farther from an eyelid margin.

17. The method of claims 13-16, wherein the single-member adhesive eyelid closure support device closes an eyelid of the wearer who has exposure keratopathy or symptoms related to lagophthalmos.

18. The method of claims 13-16, wherein the single-member adhesive eyelid closure support device closes the eyelid of the wearer who has exposure keratopathy or symptoms related to the eyelid and ocular surface effects of wearing a CPAP mask.

19. The method of claims 13-16, wherein the peeling of the single-member adhesive eyelid closure support device enables a healthcare provider to open an eyelid of a patient sedated and / or obtunded in a critical-care or anesthesia setting to examine the pupil and the ocular surface andAttorney Docket No. 105676-432984to administer therapeutic agents without removing the single-member adhesive eyelid closure support device and to reclose the eyelid of the patient without requiring a replacement singlemember adhesive eyelid closure support device.

20. The method of claims 13-16, wherein partially unsticking and adhering the unstuck area of the single-member adhesive eyelid closure support device while exerting a tractional force on the eyelid enables adjustment of eyelid closure tightness by the wearer or a healthcare provider.

21. The method of claims 13-21, wherein the single-member adhesive eyelid closure support device includes one or more bioactive agents configured to provide a physiologically beneficial transdermal effect to at least one of the eyelid skin, eyelashes, or meibomian glands of the wearer.

22. The method of claims 13-16, wherein partially unsticking and adhering the unstuck area of the single-member adhesive eyelid closure support device enables administration of therapeutic agents to corneal infections and non-healing corneal defects without fully removing the single-member adhesive eyelid closure support device and without requiring a replacement single-member adhesive eyelid closure support device.

23. The method of claims 13-16, wherein the single-member adhesive eyelid closure support device reduces light transmission to the closed eyelid of the wearer.

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