US20130331768A1 - Eye treatment - Google Patents

Eye treatment Download PDF

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US20130331768A1
US20130331768A1 US13/992,768 US201113992768A US2013331768A1 US 20130331768 A1 US20130331768 A1 US 20130331768A1 US 201113992768 A US201113992768 A US 201113992768A US 2013331768 A1 US2013331768 A1 US 2013331768A1
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abrasive
eye
tissue
chafing
kit
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Louis D. Nichamin
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/14—Ectoparasiticides, e.g. scabicides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents

Definitions

  • the present invention pertains to methods and kits for treating and preventing eye and body conditions and for cleaning eye area tissue.
  • the invention also pertains to a composition of matter usable by the methods and kits.
  • Causes include seborrheic dermatitis (dandruff), the presence of a bacterial infection (commonly Staphylococcus ), a blocked oil gland in the eyelid, food, pollen or other allergies, and ocular rosacea.
  • Blepharitis is an inflammation, often chronic, of the eyelid.
  • Blepharitis is one of the most common eye disorders. Blepharitis can occur in two regions of the eye: at the lid margin on the outside front part of the eyelid where the eyelashes grow (referred to as “anterior blepharitis”) and at the inner eyelid where the moist part of the eyelid contacts the eye and the meibomian (oil) glands are located (referred to as “posterior blepharitis”).
  • Symptoms of blepharitis can include a red, itchy, irritated and/or swollen eyelid, crusting of the eyelid upon awakening, a sensation of a foreign body in the eye, a sensation of burning in the eye, sensitivity of the eye to light, and/or loss of eyelashes.
  • Ocular rosacea is a condition that affects the eyelids and ocular surface.
  • Ocular rosacea is a long term, inflammatory eye disease that can cause blepharitis and, less commonly, conjunctivitis (inflammation or infection of the conjunctiva that lines the eyelid and part of the eyeball).
  • conjunctivitis inflammation or infection of the conjunctiva that lines the eyelid and part of the eyeball.
  • the presence of ocular rosacea is commonly characterized by irritation, dryness, redness in the eyes, grittiness in the eyes, and/or blurry vision.
  • telangiectasias In more severe cases of ocular rosacea, lid margin and conjunctival telangiectasias (appearance of blood vessels near the surface), eyelid crusts, eyelid scales, corneal infiltrates, corneal ulcers, vascularization, and on occasion, sight-threatening disease occur.
  • Facial rosacea is a chronic skin condition involving abnormality in the sebaceous glands of the face and eyelids. Facial rosacea occurs on the forehead, cheeks, and nose and is divided into several subtypes, erythematotelangiectatic rosacea (characterized by redness, flushing, and telangiectasias, which is appearance of small blood vessels); papulopustular rosacea, (characterized by small bumps and pus filled lesions-including the presence of papules which are elevations of the skin without fluid) and pustules which are small, inflamed, pus filled, blister like lesions on the skin surface); and phymatous rosacea (characterized by thickened, bumpy skin).
  • Facial rosacea can affect anyone, but commonly starts in a person after about age 30, and preferentially affects individuals with light colored skin. Facial rosacea is widespread, with an estimated 10% of the American population exhibiting symptoms.
  • the arthropod Demodex is a tiny ectoparasitic mite that lives in or near skin, hair and eyelash follicles of mammals, including humans.
  • the two species D. folliculorum and D. brevis can co-exist in the face and eyelids, although D. brevis in particular tends to burrow into the eyelash sebaceous glands and the meibomian glands, where it lays eggs. Larvae hatch after about 4 days, and take another seven days to develop into adults. The lifespan of a mite is several weeks.
  • acne rosacea Although sometimes referred to as “acne rosacea” and confused with acne vulgaris (referred to commonly as “acne”) because both cause irritation to the face, facial rosacea and acne are different, and therefore the treatments recommended to manage them are also different.
  • Facial rosacea is distinguished from acne vulgaris by the presence of non-inflammatory comedones (follicles filled with sebum and sloughed off cells; commonly referred to as “whiteheads” and “blackheads”) with acne and their absence in facial rosacea.
  • acne and rosacea sometimes co-exist in skin, they often occur do not overlap and dermatologists recommend different protocols for treatment of rosacea and acne.
  • the goals with acne treatments are to reduce oil production, speed up skin turnover, control bacterial infection and reduce inflammation.
  • acne may be treated with application of acetone, alcohol, antibiotics, astringents, benzoyl peroxide, retinoids and salicylic acid, and/or ingestion of oral antibiotics, and, for women, ingestion of oral contraceptives. Techniques that cause exfoliation, such as chemical peels and microdermabrasion, may be used.
  • U.S. Patent Application Publication 2005/0037034 to Rhoades describes a composition for treating comedonal acne associated with acne vulgaris and inflammatory acne.
  • the composition contains an acne treatment agent together with abrasive particles in a base.
  • a method of using the agent is described.
  • the face is buffed or otherwise treated with the agent using, for example, a hand-held vibratory device.
  • the acne treatment agent can be, for example, benzoyl peroxide, salicylic acid, retinol, hydroxyl acid, or tea tree oil.
  • Facial rosacea patients are advised to avoid “trigger” factors.
  • Topical or oral antibiotics may be prescribed, although it is thought that these are effective due to their anti-inflammatory properties, rather than through their antibiotic properties.
  • Laser treatment may be used to reduce the appearance of blood vessels or other redness in the face.
  • Treatments of facial and ocular rosacea and blepharitis range from simple over-the-counter treatments to treatment from a dermatologist or ophthalmologist, depending on the severity and duration of the symptoms.
  • Over-the-counter treatments to relieve the symptoms of ocular rosacea and non-rosacea blepharitis include variations of basic washing and massaging routines.
  • the eyelids are cleaned and massaged one or more times a day.
  • First a warm, soft compress is applied to the eyelid for 5-10 minutes. This treatment is thought to loosen the lipids in the meibomian glands.
  • the eyelids are cleaned by gently sliding a cotton swab soaked with dilute baby shampoo across the lid margins.
  • the eyelids can be massaged using a finger or swab moving across the eyelid. While there is individual variation, these treatments may generally be performed over of the course of weeks to months to eliminate or reduce the symptoms of blepharitis. Symptoms of blepharitis tend to recur after this type of treatment and require an additional round or rounds of treatment or a different treatment.
  • ocular rosacea cases did not respond to the wash and massage treatments, other treatments have been tried.
  • Patients have been treated with medications to manage the inflammation (e.g., eye drops containing corticosteroids), topical or oral antibiotics (e.g., doxycycline, gentamicin, tetracycline, azithromycin) to eliminate bacterial infection, surgery, or chemicals to try to control Demodex infestation.
  • medications to manage the inflammation e.g., eye drops containing corticosteroids
  • topical or oral antibiotics e.g., doxycycline, gentamicin, tetracycline, azithromycin
  • U.S. Patent Application Publication 2007/0203462 to Soroudi and U.S. Patent Application Publication 2009/0137533 to Adkins describe eyelid treatment kits for improving eyelid hygiene and treating infection and inflammation using antibiotics to eliminate bacterial infection.
  • the kits are meant for treating infection (e.g., blepharitis, meibomitis, acute dacryocystitis, orbital or preseptal cellulitis), treating inflammation (e.g., hordeola, chalazia, or contact dermatitis), treating dry eyes, and/or as post-operative treatment.
  • the kit contains a low dose of an antibiotic (doxycline) and a non-irritating eyelid cleansing composition.
  • Soroudi describes an improved method and materials for use in order to apply heat to the peri-ocular region using a soft, non-abrasive, lint free material such as gauze.
  • the material may contain antibiotics and a cleaner that is gentle to the skin, such as baby shampoo. This material is applied to the eyelid in order to remove bacteria and decrease inflammation.
  • Demodex involves applying volatile liquids such as ether and alcohol to the eyelid to try to kill the mites.
  • volatile liquids such as ether and alcohol
  • toxicity concerns with use of these chemicals. Additionally, they were not effective at eliminating blepharitis.
  • compositions for the treatment of ophthalmic pathologies including ocular rosacea thought to be caused by infestation of Demodex , using the anti-parasitic agents avermectin and/or milbemycin.
  • the compositions can be applied directly to the eye, or can be solid forms deployed at the surface of the eye in the form of impregnated pads, snydets, and wipes.
  • Kaoukhov lists various additives that can be included in the compositions, including wetting agents, agents for improving flavor, preservatives, stabilizing agents, agents for regulating moisture, pH-regulating agents; buffers; agents for modifying osmotic pressure; emulsifying agents; agents for increasing viscosity; and antioxidants.
  • wetting agents agents for improving flavor, preservatives, stabilizing agents, agents for regulating moisture, pH-regulating agents; buffers; agents for modifying osmotic pressure; emulsifying agents; agents for increasing viscosity; and antioxidants.
  • Tea tree oil was tested as a treatment for ocular rosacea.
  • Tea tree oil was originally obtained by steam distillation of the leaves of the Melaleuca family of trees, and especially from Melaleuca alternifolia , a tree native to Australia. Tea tree oil can be extracted from members of the Myrtaceae family, including Melaleuca alternifolia, Melaleuca linafolia, and Melaleuca dissitiflora . Tea tree oil contains terpenes (pinenes, terpinene, and cymene), cineole, and an alcohol terpinol. It was used as a traditional medicine to prevent and treat infections. It is thought to have antiseptic, antifungal, and antibacterial properties.
  • the recommended regimen of six strokes is repeated three times, with a 5-10 minute rest and stroke with a dry cotton tip to remove excess tea tree oil between repeats.
  • the protocol is performed weekly (e.g., for 3-9 weeks) at the clinic. In between clinic visits, the patient continues care at home, generally consisting of daily massages of the eyelids (e.g., for 3-5 minutes) with the fingers using diluted tea tree oil (e.g., 5%) in baby shampoo.
  • the treatment was tolerated by many patients; however others felt eyelid irritation and experienced eyelid spasms during the office tea tree oil treatment.
  • Microdermabrasion is a technique that mechanically ablates skin. It is used on the face, neck or arms to remove dead or damaged skin cells. It speeds the natural process of exfoliation by mechanically removing the uppermost layer of the epidermis. Microdermabrasion makes it easier for skin products to penetrate into the deeper layers of the skin. Epithelialization and collagen production are stimulated. It is used to counteract the effects of acne and photoaging and reduces acne scars, age spots, enlarged pores, fine lines, and the appearance of blemishes, other scars, stretch marks, undesired skin pigmentation, and wrinkles.
  • Microdermabrasion uses a device to spray fine microcrystals across the skin surface. This treatment causes superficial abrasion that removes a layer of stratum corneum of the skin. Microdermabrasion is currently contraindicated for an individual suffering from rosacea, seborrheic dermatitis, psoriasis, eczema, or vitiligo, and for any use close to the eye or on the eyelid.
  • the present invention relates to kits and methods for treating or preventing an eye or eye area condition or for cleansing eye area tissue.
  • the invention also relates to a composition of matter that can be used with the kits and methods.
  • One aspect of the invention provides a method of treating or preventing an eye condition in eye area tissue, such as e.g. anterior blepharitis, posterior blepharitis, Demodex induced blepharitis, conjunctivitis, dry eye, meibomitis, ocular Demodex infestation, and ocular rosacea.
  • the method includes the steps of administering an isoprenoidal essential oil to eye area tissue; chafing eye area tissue with an abrasive, and removing the abrasive.
  • the step of administering an isoprenoidal essential oil includes administering tea tree oil, such as e.g. at a concentration of about 0.5% (w/w) to about 4% (w/w) or at a concentration of about 5% (w/w) to about 50% (w/w).
  • the step of chafing eye area tissue may include chafing upper eyelid tissue, lower eyelid tissue, eyelid margin tissue, anterior eyelid margin tissue, posterior eyelid margin tissue, or eyelash follicle.
  • the step of chafing eye area tissue includes chafing with abrasive particles having a size such as, e.g. from about 1 ⁇ m to about 600 ⁇ m, from about 25 ⁇ m to less than 300 ⁇ m, or from about 300 ⁇ m to about 600 ⁇ m in a longest dimension.
  • the step of administering an isoprenoidal essential oil includes administering an abrasive at the same time.
  • the abrasive includes abrasive particles and the step of removing the abrasive includes removing the abrasive particles using a material, such as e.g. a moving gas at a pressure less than atmospheric pressure or an aqueous solution.
  • a material such as e.g. a moving gas at a pressure less than atmospheric pressure or an aqueous solution.
  • kits for treating an eye condition or cleansing an eye area tissue including an isoprenoidal essential oil for application to eye tissue, an abrasive for chafing eye area tissue, and an instruction for use for treating an eye condition or cleansing an eye area tissue.
  • the abrasive includes abrasive particles having a size such as, e.g. from about 1 ⁇ m to about 600 ⁇ m, from about 25 ⁇ m to less than 300 ⁇ m, or from about 300 ⁇ m to about 600 ⁇ m in a longest dimension.
  • the isoprenoidal essential oil and the abrasive particles form a mixture.
  • the isoprenoidal essential oil includes tea tree oil, such as e.g. at a concentration of between about 0.5% (w/w) and about 50% (w/w), about 5% (w/w) and about 50% (w/w) or about 0.5% to about 4% (w/w).
  • the kit further includes an applicator for applying the isoprenoidal essential oil to an eye tissue and the applicator includes the abrasive.
  • composition of matter including about 0.5% to about 4% isoprenoidal essential oil, such as e.g. tea tree oil, in an ophthalmologically acceptable base and a plurality of abrasive particles.
  • isoprenoidal essential oil such as e.g. tea tree oil
  • FIG. 1 shows a method of eye treatment using an abrasive according to one aspect of the invention.
  • FIG. 2 shows a perspective view of an eyelid margin and a posterior eyelid margin treatment with an abrasive and isoprenoidal essential oil.
  • FIG. 3 shows hand-held applicator dispensing mixture of an abrasive and an isoprenoidal essential oil to an eye area tissue and chafing eye area tissue with the abrasive.
  • FIG. 4 shows application of an abrasive composition to an eyelid using a pressurized liquid.
  • FIG. 5 shows an abrasive being removed from eye area tissue using a vacuum source.
  • FIG. 6 shows a kit for eye treatment or eye cleansing according to one aspect of the invention.
  • a composition of matter according to the disclosure is a novel combination of a microdermabrasive along with a therapeutically effective amount of an isoprenoidal essential oil.
  • the composition may be useful for treatment or prevention of a peri-ocular eye, eyelid, and/or surface ocular condition, disorder, disease, and/or syndrome, and any combination of these conditions, disorders, diseases, and/or syndromes including but not limited to blepharitis (anterior and posterior), Demodex -induced blepharitis, ocular Demodex , dry eye (dry eye syndrome), meibomitis, meibomian gland dysfunction, pre- and post-operative applications, and ocular rosacea.
  • the composition may be in ophthalmically acceptable base or may be another base.
  • the composition may be applied to the eyelid, eye margin, and/or area near the eyelid, eyebrow area, or to other areas of the face, or to the neck or body.
  • kits and methods for treating and preventing a peri-ocular eye, eyelid, and/or surface ocular condition, disorder, and/or disease, and/or combinations of these conditions, disorders, diseases and/or syndromes including but not limited to blepharitis (anterior and posterior), Demodex -induced blepharitis, ocular Demodex , dry eye (dry eye syndrome), conjunctivitis, blepharoconjunctivitis, meibomitis, meibomian gland dysfunction, pre- and post-operative applications, and/or ocular rosacea.
  • the kits, methods, and compositions may also be used to cleanse an eye area that does not have a disease or condition, such as for regular (e.g.
  • compositions, kits, and methods may remove body oils or other secretions, detritus, dirt, skin cells, or may remove a substance applied to the eye area such as a cosmetic or cosmetic-related product, including but not limited to adhesive, concealer, eye base, eyeliner, eye shadow, mascara.
  • Use of the compositions, kits, and methods described herein may prevent or solve problems related to the eye that may be an area different than the treatment area, such as eye dryness, grittiness, redness associated with contact lens wear, complications or issues related to ophthalmologic or surgical interventions including laser surgery (such as (LASIK, LASEK, PRK).
  • FIG. 1 shows a method of eye treatment using an abrasive according to one aspect of the invention.
  • Eye area tissue 2 is being treated in this example.
  • a finger or device may be used to pull the eyelid at least partially away from the eyeball area to prevent cleaning or treatment material from contacting the eyeball or other sensitive eye areas.
  • Hand-held wand 12 has been used to apply a composition 18 of an abrasive material and isoprenoidal essential oil (e.g. tea tree oil) to lower eyelid margin 4 and lower eyelid 10 .
  • Upper eyelid 8 and upper eyelid margin 6 have not been treated.
  • Hand 14 is holding and rubbing wand 4 through mixture 18 to chafe, abrade, and cleanse lower eyelid margin 4 , including chafing eyelashes 16 .
  • the abrasive is removed.
  • the abrasive may be removed by any means, including rinsing with a liquid, treatment with vacuum, and/or wiping (e.g. with a cloth, material, towel, or towelette).
  • an eye area tissue Prior to treatment with an abrasive, an eye area tissue may be prepared, such as by washing or rinsing (e.g. with warm water).
  • Prior eye treatments avoided the use of harsh or abrasive materials near the eye for fear of damaging or irritating the sensitive eye.
  • Abrasive materials in particular, have been avoided for use near the eye.
  • the novel use in the invention of an abrasive or microabrasive near eye tissue, in combination with an isoprenoidal essential oil, according to one aspect of the disclosure, may allow a lower level of isoprenoidal essential oil to be effective.
  • the use of a lower concentration of oil, in combination with an abrasive or microdermabrasive may be more effective, safer and less irritating for a patient than is use of a higher amount of oil without an abrasive.
  • the treatments may be sufficiently safe to be self-applied by the patient without requiring treatment in a medical setting (e.g., a clinic or physician's office) such as after an initial visit with a physician or other health care provider.
  • a medical setting e.g., a clinic or physician's office
  • the material may be sufficiently safe to be available over-the-counter and the method used by a patient or individual without requiring a doctor or clinic visit.
  • An option for convenient and inexpensive self-treatment is desirable in any case and may be particularly advantageous for patients who have chronic and/or long-term conditions, and for patients for whom conditions recur after an initially successful treatment regimen. Eye conditions and symptoms may recur in an individual due to a new exposure to a causative agent.
  • Gao et al. Cornea, Vol. 26, No.
  • compositions, methods, and kits according to the disclosure may be used at home or in a salon or other personal care setting, and may be applied by the individual, a helper, or a facial aesthetic specialist.
  • the treatment acts to remove skin, a layer of skin, skin debris, micro-organisms, eyelashes, oils, and/or other related or unrelated substances.
  • the abrasive particles are thought to work by mechanically agitating the eye area tissue, eyelid, eyelash, and follicle to improve penetration or access of the oil.
  • the treatment may work to agitate or move unwanted material such as Demodex eggs, larva or mites and remove them from the eyelash follicle or other part of the eye or eyelid, or to make them accessible to the oil.
  • the dermabrasive may also eliminate organisms by direct killing or damage.
  • FIG. 2 shows a perspective view of an eyelid margin and a posterior eyelid margin treatment with an abrasive and isoprenoidal essential oil.
  • Meibomian glands 56 are blocked, for example by secretions or dirt.
  • Head 52 of wand 50 is chafing posterior eyelid margin 38 on lower eyelid 30 with mixture or composition 57 of abrasive and isoprenoidal essential oil.
  • the treatment is cleaning blocked meibomian glands surface 56 resulting in unblocked or opened meibomian glands 42 and allowing fluid, debris, oils, sebum or micro-biologic material to escape from meibomian glands 48 , shown in a cross sectional area of the eyelid in this drawing.
  • Chafing may also or instead be performed along anterior eyelid margin 36 , shown on the other side of grey line 40 from the posterior margin, to clean margin surface and eyelash 44 . Chafing may also be performed on lower eyelid skin 32 . Conjunctiva 34 is free from treatment. Rubbing, chafing, or otherwise agitating posterior eyelid margin, anterior eyelid margin, eyelid skin, and/or other eye area tissue may move eyelash follicle 46 or may move other structures at or below the surface. This agitation along with the chafing may improve or allow flow of body oil, sebum or micro-biologic material out of tissue and may allow penetration of cleansing media or oil, such as isoprenoidal essential oil, into tissues.
  • cleansing media or oil such as isoprenoidal essential oil
  • the abrasive may include any abrasive particle, powder, or crystal including but not limited to one or more of the following: aluminum oxide (e.g., alumina, aluminum trioxide, corundum powder), barium sulfate, boron nitride, calcium carbonate, cellulose acetate, ceramic, diamond, diatomaceous earth, emerald, ethylene/acric acid copolymer, fibers, garnet, glass, kaolin, lauroyl lysine, lava, magnesium oxide, mica, modified starch, nylon, other metals, other polymers, other silicon dioxides or silicon containing materials, polyethylene, polymethyl methacrylate polypropylene, polystyrene, polytetrafluoroethylene (PTFE), pumice, ruby, sand, sapphire, seashells, sericite, silica, silicon dioxide, silicon carbide, sodium bicarbonate, sodium chloride crystals, starch, silk, talc, topaz, ze
  • An abrasive particle according to the disclosure may be any shape and have any number of sides.
  • An abrasive particle may be overall diamond (triangle) shaped, elliptical, marquise shaped, octagonal, oval, pear shaped, rectangular, round, squared, or may be combinations or variations (e.g. a rounded square) of these shapes.
  • An abrasive particle may have one surface or may have more than one surface (e.g. sides or faces).
  • An abrasive particle may have 2, 3, 4, 5, 6-10, 11 to 20, 21 to 30, up to 40, up to 50, up to 60, or more than 60 sides.
  • a surface of an abrasive particle may be substantially smooth, regular, textured or irregular.
  • An abrasive particle may have one or more sharp edges or points.
  • An abrasive particle may be sized from about 1 to about 600 microns (1 ⁇ m to 600 ⁇ m) across a longest dimension.
  • Abrasive particles in a group may all be similarly shaped to one another or may be differently shaped from one another. Abrasive particles in a group may all be about the same size, or may range in size. A group of particles may be larger than a minimum or may be smaller than a maximum. A group of abrasive particle may include particles from about 1 to about 15 microns across, about 15 microns to about 25 microns, about 25 microns to about 100 microns, about 100 to about 300 microns, or about 300 to about 600 microns. In one example, a group of abrasive particles may include particles from greater than about 25 microns to less than about 300 microns across. Differently sized and differently shaped particles may be chosen for different reasons.
  • a particle with a rough surface may be applied using a wand or towelette, while a substantially round particle may be propelled towards the surface under pressure.
  • An abrasive may include a group of separate particles, or may include a substrate with an abrasive surface or may be any combination or variation.
  • a substrate may have a plurality of abrasive particles connected with (attached to) it to provide an abrasive surface, or it may be a material having a rough textured surface.
  • a rough textured surface may have a pore size on its surface from about 1 to about 15 microns across, about 15 microns to about 25 microns, about 25 microns to about 100 microns, about 100 to about 300 microns, or about 300 to about 600 microns.
  • the amount and composition of the abrasive in the compound is chosen so as to have the desired effect while minimizing unnecessary abrasion, damage or irritation to the eye region or sensitive peri-ocular region.
  • the product and method of this disclosure may be used in conjunction with chemical exfoliation, chemical peel, crystal free dermabrasion and/or laser resurfacing.
  • One or more isoprenoidal essential oil may be included in the composition along with an abrasive.
  • the list of essential oils includes but is not limited to those described in U.S. Patent Application Publication 2009/0214676 to Gao et al., which is incorporated herein by reference.
  • 1,4-cineole, 1,8-cineole, (4R)-limonene 1,2-epoxide, 3-isopropoxyphthalide, 3-propoxyphthalide, 6-terpinolene, 7-methyl-3-methylideneocta-1,6-diene (myrcene), acetaldehyde, alpha-pinene, alpha-terpinene, alpha-terpineol, alpha-thugene, caraway oil, cardinene, (+)-carvone, (+)-cis-limonene 1,2 epoxide, cuminic aldehyde, d-carvone, dill seed oil, dill weed oil, dipentene, dipentene (+/ ⁇ ) limonene, eucalyptol, furfurol, gamma-terpinene, 1-carvone, (+)-ledene, (+)-limonene, (R)-( ⁇ )carvone, (R)-
  • the concentration of the oil(s) in the formulation may be any safe and effective amount. Higher concentrations may be more effective but may be administered by a health care professional to ensure safety.
  • the oil may be added to the composition at concentrations from less than about 1% (w/w) and up to about 50% (w/w). About 50% to about 60%, about 70%, about 80%, about 90% or about 95-99% oil may be added to the composition.
  • the oil may be added at about 0.5%, about 1%, about 2%, about 3%, about 4% or about 5% to the composition.
  • an over-the-counter formulation may contain oil(s) at a concentration of about 0.5% to about 4% (e.g. about 0.5% to 4.5%).
  • a formulation e.g.
  • tea tree oil available by prescription, from a physician or for use in a physician's office may contain from about 5% up to about 50% or more oil.
  • a formulation may contain from about 5% up to about 10%, about 20%, about 30%, about 40%, or about 50%. Any changes to tree oil composition and manufacture as covered by ISO standard 4730, including updates to the standard, are included.
  • the tea tree oil may be obtained by steam distillation from a Melaleuca tree, or may be obtained from a manufactured source containing terpinen-4-ol. Any form or variation of tea tree oil may be added.
  • the oil and microabrasive may be combined into any form, including but not limited to colloid, cream, gel, emulsion, liquid, ointment, lotion, paste, semi-liquid, solution, and solid.
  • constituents may be added, either singularly or in combination, including but not limited to acne treatment agent, alcohol, animal extract, anti-oxidant agent, anti-parasitic agent, antiseptic agent, anti-bacterial agent, ash, astringent, balm, binder, bleaching agents, collagen stimulating agent, colorants, desquamation additives, drying agent, EDTA, emollient, flower or flower extract, free radical scavenger, fruit or fruit extract, hair growth regulators, herbs or herb extract, honey, humectant, hydration agent, lubricant, lubricity agent, moisturizer, numbing agent, nuts or nut extract, oil, other anti-microbial agents, other cleaner, other essential oils, other microcidal agents, other plant extract, peel agents, peptides, pH buffering agent, protein, shampoo, skin conditioner, soap, sunscreen, toner, tree or tree extract, unguent, vegetable extract, viscosity control agent, vitamin, vitamin analog (e.g., allantion, Aloe vera
  • FIG. 3 shows hand-held device 74 dispensing mixture 78 of an abrasive and an isoprenoidal essential oil from applicator 80 to eye area tissue 70 including eyelid margin tissue and eyelid tissue.
  • the device is being used by an individual 76 to chafe eyelid margin tissue 72 with the mixture.
  • the applicator may rotate, rub, vibrate, or otherwise move to aid in the chafing process.
  • the individual's finger 82 holds eyelid margin 72 away from the eyeball to prevent the mixture and applicator from contacting the eyeball.
  • a composition or material for use may be dispensed in any way (e.g., from an applicator/device/wand, a bottle, a jar, a package (e.g. an individual package), a pump (pump bottle), a tube, or a tub.
  • the material may be dispensed to any appropriate material, such as an applicator/device/wand, a finger, an individual wipe, or a towelette.
  • a material may be dispensed directly to a tissue, such as an eye area tissue, from a dispenser.
  • the invention includes methods of topically administering a composition containing an oil and abrasive to eye area tissue including to an eyelid and eye margin.
  • FIG. 4 shows a physician, technician or aesthetician chafing an abrasive 102 and isoprenoidal essential oil 104 on upper eyelid 92 using pressurized liquid 106 .
  • a mixture containing the oil and microdermabrasive is propelled onto eyelid 92 , eyelash 94 , or other eye area tissue 90 using applicator 96 as held by a physician or aesthetician 98 .
  • Head 100 of applicator 96 may be any shape or size to allow application and/or cause chafing. For example, a smaller head may be used for eye area tissue around the eyelashes and a relatively larger head may be used over the bulk of the eye lid or eye area (or other face, neck, or body) tissue.
  • the composition may be propelled in any way, such as using a compressed gas or compressed liquid.
  • the composition may be a liquid or may be in the form of an aerosol.
  • the composition may be under pressure before application or may be pressurized during application. A vacuum may be used to draw the mixture across the eyelid.
  • Any device may be used, such as those described in US 2002/0169461 to Simon et al. or US 2004/0092959 to Bernaz.
  • Excess, used, or otherwise unwanted abrasive may be removed by any means, such as using a towel, a wand, or a wipe.
  • a device may be used to remove excess, used, or otherwise unwanted abrasive mixture, such as by using liquid or vacuum.
  • FIG. 5 shows vacuum source 114 connected with vacuum tubing or conduit 116 removing used abrasive mixture 120 from eyelid 112 .
  • a low pressure source may be used to remove abrasive and/or tea tree oil from any part of the body, including from eye area tissue 110 .
  • essential oil is applied to the eyelid and/or surrounding area using a device, and chafing may be performed with an abrasive pad.
  • a high pressure water may be abrasive.
  • Isoprenoid oil may be added to a high pressure water stream using any device, such as described in US 2009/0138026 to Wu.
  • the compound containing the oil and microdermabrasive may be massaged into the eyelid. Massage may be performed using the fingers.
  • the composition may be applied to the eyelid and/or eyelash using part of the body, such as a knuckle or finger, or a material (e.g., a pad, sponge, brush, sponge, or swab containing an applicator such as cotton, polyester, rayon, or other material).
  • a material e.g., a pad, sponge, brush, sponge, or swab containing an applicator such as cotton, polyester, rayon, or other material.
  • the composition may be applied using a microdermabrasion device.
  • the composition is dispensed from a tube and applied to the eye margin using a finger.
  • the eyelid may be pulled away from the eye to prevent the composition from contacting the eyeball.
  • the composition may be carefully massaged into the eye margin, with care taken to avoid contact with the eyeball and other sensitive eye tissue.
  • the compound may be coated on the eyelid in a manner similar to the manner in which eye liner makeup or mascara is applied.
  • the compound may be applied by squeezing a therapeutic amount of material out of a squeezable tube or bottle.
  • the amount of composition applied and the method of applying it may be chosen so as to have the desired effect while minimizing unnecessary abrasion, damage or irritation to the eye region.
  • a kit for treating or preventing a peri-ocular eye, eyelid, and/or surface ocular condition, disorder, disease, and/or syndrome, and any combination of these conditions, disorders, diseases, and/or syndromes including but not limited to blepharitis (anterior and posterior), Demodex -induced blepharitis, ocular Demodex , dry eye (dry eye syndrome), meibomitis, meibomian gland dysfunction, pre- and post-operative applications, and rosacea or for cleaning eye area tissue may include one or more of any of the items listed in the disclosure. Additional items may also be included.
  • FIG. 6 shows kit 140 .
  • the kit has applicator 142 in sterile package 144 .
  • Tube 148 contains a mixture of an isoprenoidal essential oil and abrasive in an ophthalmologically acceptable base for application to eye area tissue.
  • An ophthalmologically acceptable base is a material that can be placed into a mammalian eye without causing any substantial harm or damage to the eye.
  • Towellete 146 for cleaning or removing abrasive and any instruction for use 150 are included.
  • a kit may have all of these items or may have some of these items or may instead have other items described herein.
  • the kit may include the following or combinations of the following: a container comprising microdermabrasive combined with an isoprenoid essential oil such as tea tree oil, a container comprising an isoprenoid essential oil such as tea tree oil, a container comprising a microdermabrasive, a dispenser configured to dispense isoprenoid oil, a microdermabrasive, or a combination of the isoprenoid oil and microdermabrasive, one or more containers comprising a lubricant, a cleansing agent, a shampoo, an anesthetic agent, a topical antiseptic, a topical antibiotic, an oral antibiotic or other oral supplement, a microdermabrasive device, an applicator (e.g., pad or swab), a set of directions for how to use the kit or scrub, and/or one or more disposable towels.
  • An isoprenoidal essential oils and abrasives may be included in the kit. Any item in a kit may be sterile, may be in a
  • a kit may include an instruction for use, such as an instruction for chafing eye area tissue, for example by using an abrasive applicator, using an abrasive device, or adding an abrasive material and adding an isoprenoidal essential oil.
  • An instruction for use may include an instruction for mixing an abrasive and oil (and other materials) to produce a mixture or composition for treating peri-ocular eye and eyelid conditions, disorders and/or disease, including but not limited to blepharitis (anterior and posterior), Demodex -induced blepharitis, ocular Demodex , dry eye, meibomitis, pre- and post-operative applications, and rosacea.
  • the directions may describe cleansing eye area tissue, including cleansing an eyelid, eye margin, and eyelash follicle with any of the materials and using any of the methods described herein.
  • a kit may be configured for use by an individual (such as for use at home or for use elsewhere (e.g. it may be portable) or it may be configured for use in a doctor's office, clinic, hospital or salon.
  • the oil and microabrasive components may be stored separately, and applied separately to the eyelid.
  • An abrasive may be used to apply an oil and chafe an eye tissue.
  • An applicator may comprise an abrasive, such as an abrasive surface or an abrasive end that may be used to chafe or abrade eye tissue. They may be applied at the same time on the eye area tissue or eyelid, mixed together, and the eyelid scrubbed. Alternatively, either one may be applied, the eyelid scrubbed and optionally rinsed, and then the other component may be applied. The eyelid may be scrubbed. The process may be repeated.

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US20160235585A1 (en) 2016-08-18
JP5952302B2 (ja) 2016-07-13
JP2014501281A (ja) 2014-01-20
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US20180000640A1 (en) 2018-01-04
JP2016155877A (ja) 2016-09-01

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