U.S. patent application number 13/992768 was filed with the patent office on 2013-12-12 for eye treatment.
The applicant listed for this patent is Louis D. Nichamin. Invention is credited to Louis D. Nichamin.
Application Number | 20130331768 13/992768 |
Document ID | / |
Family ID | 46383836 |
Filed Date | 2013-12-12 |
United States Patent
Application |
20130331768 |
Kind Code |
A1 |
Nichamin; Louis D. |
December 12, 2013 |
EYE TREATMENT
Abstract
Methods and kits for treating or preventing an eye condition or
for cleaning an eye area tissue are provided. A method of the
invention includes administering an isoprenoidal essential oil to
eye area tissue, chafing eye area tissue with an abrasive, and
removing the abrasive. A kit according to the invention includes an
isoprenoidal essential oil, an abrasive for chafing eye area
tissue, and in instruction for use for treating an eye condition or
cleansing an eye area tissue. The invention also includes a
composition of matter comprising an isoprenoidal essential oil and
a plurality of abrasive particles in ophthamologically acceptable
base.
Inventors: |
Nichamin; Louis D.;
(Brookville, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Nichamin; Louis D. |
Brookville |
PA |
US |
|
|
Family ID: |
46383836 |
Appl. No.: |
13/992768 |
Filed: |
December 28, 2011 |
PCT Filed: |
December 28, 2011 |
PCT NO: |
PCT/US2011/067479 |
371 Date: |
August 26, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61428043 |
Dec 29, 2010 |
|
|
|
Current U.S.
Class: |
604/22 ;
424/769 |
Current CPC
Class: |
A61P 29/00 20180101;
A61P 27/02 20180101; A61K 9/0048 20130101; A61F 9/0008 20130101;
A61P 31/04 20180101; A61M 2037/0007 20130101; A61P 33/14 20180101;
A61K 36/61 20130101; A61K 36/82 20130101; A61P 27/04 20180101; A61F
9/00 20130101 |
Class at
Publication: |
604/22 ;
424/769 |
International
Class: |
A61F 9/00 20060101
A61F009/00; A61K 36/61 20060101 A61K036/61 |
Claims
1. A method of treating or preventing an eye condition in eye area
tissue comprising: administering an isoprenoidal essential oil to
eye area tissue; chafing eye area tissue with an abrasive; and
removing the abrasive.
2. The method of claim 1 wherein treating an eye condition
comprises treating a condition selected from the group consisting
of: anterior blepharitis, posterior blepharitis, Demodex induced
blepharitis, conjunctivitis, dry eye, meibomitis, ocular Demodex
infestation, and ocular rosacea.
3. The method of claim 1 wherein administering an isoprenoidal
essential oil to eye area tissue comprises administering tea tree
oil.
4. The method of claim 3 wherein the concentration of tea tree oil
is about 0.5% (w/w) to about 4% (w/w).
5. The method of claim 3 about the concentration of tea tree oil is
about 5% (w/w) to about 50% (w/w).
6. The method of claim 1 wherein chafing eye area tissue comprises
chafing a tissue selected from the group consisting of: upper
eyelid tissue, lower eyelid tissue, eyelid margin tissue, anterior
eyelid margin tissue, posterior eyelid margin tissue, and eyelash
follicle.
7. The method of claim 1 wherein chafing eye area tissue with an
abrasive comprises chafing with abrasive particles having a size
from about 1 .mu.m to about 600 .mu.m in a longest dimension.
8. The method of claim 7 wherein chafing eye area tissue comprises
chafing with abrasive particles having a size from about 25 .mu.m
to less than 300 .mu.m in a longest dimension.
9. The method of claim 7 wherein chafing eye area tissue comprises
chafing with abrasive particles having a size from 300 .mu.m to
about 600 .mu.m in a longest dimension.
10. The method of claim 1 wherein chafing the eye area comprises
performing a motion selected from the group consisting of rubbing
and vibrating.
11. The method of claim 1 wherein administering an isoprenoidal
essential oil further comprises administering an abrasive at the
same time.
12. The method of claim 1 wherein the abrasive comprises abrasive
particles and removing the abrasive comprises removing the abrasive
particles using a material selected from the group consisting of a
moving gas at a pressure less than atmospheric pressure and an
aqueous solution.
13. A kit for treating an eye condition or cleansing an eye area
tissue, the kit comprising: 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.
14. The kit of claim 13 wherein the abrasive comprises abrasive
particles.
15. The kit of claim 14 wherein the abrasive particles comprises
particles having a size from about 25 .mu.m to less than 300 .mu.m
in a longest dimension.
16. The kit of claim 14 wherein the abrasive particles comprises
particles having a size from about 25 .mu.m to less than 300 .mu.m
in a longest dimension.
17. The kit of claim 14 wherein the abrasive particles comprises
particles having a size from 300 .mu.m to about 600 .mu.m in a
longest dimension.
18. The kit of claim 14 wherein the isoprenoidal essential oil and
the abrasive particles form a mixture.
19. The kit of claim 13 wherein the isoprenoidal essential oil
comprises tea tree oil at a concentration of between about 0.5%
(w/w) and about 50% (w/w).
20. The kit of claim 19 wherein the concentration of the tea tree
oil is between about 5% and about 50%.
21. The kit of claim 20 wherein the concentration of the tea tree
oil is between about 0.5% to about 4%.
22. The kit of claim 13 further comprising an applicator for
applying the isoprenoidal essential oil to an eye tissue wherein
the applicator comprises the abrasive.
23. A composition of matter comprising: about 0.5% to about 4%
isoprenoidal essential oil in an ophthalmologically acceptable
base; and a plurality of abrasive particles.
24. The composition of claim 23 wherein the isoprenoidal essential
oil comprises tea tree oil.
Description
CROSS REFERENCE TO RELATED APPLICATIONS?
[0001] This application claims the benefit under 35 U.S.C. 119 of
U.S. Provisional Patent Application No. 61/428,043, filed Dec. 29,
2010, titled "Eye Treatment". This application is herein
incorporated by reference in its entirety.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD
[0003] 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.
BACKGROUND
[0004] Problems in and around the eyelid can be caused by various
diseases or conditions. 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.
[0005] Eyelid problems can result in blepharitis, which 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.
[0006] 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). The presence of ocular
rosacea is commonly characterized by irritation, dryness, redness
in the eyes, grittiness in the eyes, and/or blurry vision. 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.
[0007] By some estimates, appearance of ocular rosacea correlates
with the presence of facial rosacea about 50% of the time. 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).
[0008] 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.
[0009] The exact cause(s) of facial and/or ocular rosacea are not
known. Cold or windy weather, genetic factors, hot baths, infection
with the bacteria Helicobacter pylori (commonly associated with the
presence of stomach ulcers), side effects of certain medications,
ingestion of hot or spicy foods or drinks, stress, sun exposure,
and the presence of Demodex folliculorum or Demodex brevis on the
skin of the face and/or eyelid have been proposed as possible
causes or triggers for rosacea.
[0010] 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. Some data suggest that Demodex mites may
harbor the bacterium Bacillus oleronius. One mechanism that has
been hypothesized to explain how the presence of Demodex might
correlate with rosacea is that the human immune system responds to
proteins produced by B. oleronius, resulting in inflammation (see
e.g., Li et al., "Correlation between ocular Demodex infestation
and serum immunoreactivity to Bacillus proteins in patients with
facial rosacea", Ophthalmology 2010;117:870-877 and references
therein).
[0011] 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.
[0012] Acne is the most common skin condition in the United States.
While it can occur at any age, it most commonly affects teenagers
and young adults. 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.
[0013] Although 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. In addition to
cleansing the skin, 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.
[0014] The effects of acne may be reduced but not eliminated by
applying a sufficient amount of tea tree oil. Enshaieh et al.
(Indian J. Dermatol Venereol Leprol. 2007, January-February:
73(1):22-25) describe the difficulties of obtaining an acne
treatment medicine that has an effect and is tolerated by patients.
Enshaieh et al. report use of 5% tea tree oil to treat mild to
moderate acne vulgaris and found that 5% tea tree oil was 3.55
times more effective in improving total acne lesions and 5.75 times
more effective in reducing acne severity as measured by the Acne
Severity Index (ASI). Bassett et al. (Med J Aus), 1990, Oct. 15,
153(8):455-8 examined the effectiveness of 5% tea tree oil in
reducing the number of inflamed and non-inflamed lesions in
patients with acne. Application of 5% tea tree oil for twenty
minutes two times a day for 45 minutes to patients suffering from
acne reduced the number of lesions. The tea tree oil acted more
slowly than the acne treatment (benzoyl peroxide) to which it was
compared. Of note, even using frequent (e.g. twice daily) and
relatively long application times over the course of many weeks, 5%
tea tree oil treatment was of limited efficacy in treating
acne.
[0015] 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.
[0016] Increasingly aggressive acne treatment modalities may be
used, as shown by the use of oral medications such as isotretinoin,
which has significant side effects on the entire body for
individuals whose acne cannot be managed by other methods. Simple,
effective and safe acne treatments are still lacking.
[0017] These acne treatments tend to be harsh, and harsh treatments
have traditionally been thought to worsen the symptoms of rosacea.
In particular, because skin affected with facial rosacea is easily
irritated, the American Academy of Dermatologists (AAD) recommends
gentle face washing for patients. The skin should not be rubbed or
scrubbed. Even use of a bath puff or washcloth is discouraged as it
can be irritating. Use of alcohol, astringents, clove oil,
eucalyptus oil, exfoliants, fragrance, peppermint, salicylic acid,
toners, and witch hazel has typically been discouraged.
[0018] 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.
[0019] 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.
[0020] Over-the-counter treatments to relieve the symptoms of
ocular rosacea and non-rosacea blepharitis include variations of
basic washing and massaging routines. In one typical protocol, 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.
Next, the eyelids are cleaned by gently sliding a cotton swab
soaked with dilute baby shampoo across the lid margins. Next, 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.
[0021] In ocular rosacea cases (and in non-rosacea blepharitis
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.
[0022] 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.
[0023] Other treatments for Demodex involve applying volatile
liquids such as ether and alcohol to the eyelid to try to kill the
mites. However, there are toxicity concerns with use of these
chemicals. Additionally, they were not effective at eliminating
blepharitis.
[0024] Other treatments for blepharitis associated with a Demodex
infestation involve spreading an ointment containing 1% mercury
oxide or 2% metronidazole gel or Pilocarpine at the base of the
eyelashes. The purpose is to entrap mites as they emerge from the
follicle at night.
[0025] Kaoukhov et al., U.S. Patent Application Publication
2009/0093421, describes 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. The efficacy of this as a topical
application is unknown and possible side effects due to the use of
avermectin and milbemycin are a concern.
[0026] More recently, 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.
[0027] Work from Schaffer C G Tseng (Gao et al., "In vitro and in
vivo killing of Demodex by tea tree oil", British J of
Ophthalmology (2005) 89:1468-1473; Gao et al., Cornea "Clinical
treatment of ocular demodecosis by lid scrub with tea tree oil
(February 2007): Vol. 26(2); Gao et al. U.S. Patent Application
Publication 2009/0214676; Gao et al. U.S. Patent Application
Publication 2009/0061025; Li et al. "Correlation between ocular
Demodex infestation and serum immunoreactivity to Bacillus proteins
in patients with facial rosacea", Ophthalmology 2010;117:870-877)
describe reagents, tests, and treatment for patients harboring
ocular Demodex. The authors found that application of tea tree oil,
caraway oil, and dill weed oil in vitro would kill Demodex. The
treatment uses a high concentration of tea tree oil (e.g., 50%) in
baby shampoo. The protocol involves cleaning the eyelids and
eyelashes with a composition at the doctor's office using a cotton
tip wetted in baby shampoo containing 50% tea tree oil. 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. Although the combined treatments rid the
eyelids of mites in a majority of the cases, the treatments are
inconvenient and costly, requiring weekly visits to the doctor or
clinic, as well as additional daily treatments for up to three
months. Of particular note, several patients whose symptoms had
improved were not entirely rid of the Demodex infestations and
continued to have symptoms, albeit reduced, of redness, itching,
foreign body sensation, dryness, blurry vision, pain, burning
sensation and grittiness even after weeks of intensive
treatments.
[0028] 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.
[0029] 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.
SUMMARY OF THE DISCLOSURE
[0030] 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. In some embodiments, 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. In some embodiments, 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).
[0031] In some embodiments, 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.
[0032] In some embodiments, the step of chafing eye area tissue
includes chafing with abrasive particles having a size such as,
e.g. from about 1 .mu.m to about 600 .mu.m, from about 25 .mu.m to
less than 300 .mu.m, or from about 300 .mu.m to about 600 .mu.m in
a longest dimension.
[0033] In some embodiments, the step of administering an
isoprenoidal essential oil includes administering an abrasive at
the same time.
[0034] In some embodiments, 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.
[0035] Another aspect of the invention provides a kit for treating
an eye condition or cleansing an eye area tissue, the kit 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.
[0036] In some embodiments, the abrasive includes abrasive
particles having a size such as, e.g. from about 1 .mu.m to about
600 .mu.m, from about 25 .mu.m to less than 300 .mu.m, or from
about 300 .mu.m to about 600 .mu.m in a longest dimension.
[0037] In some embodiments, the isoprenoidal essential oil and the
abrasive particles form a mixture.
[0038] In some embodiments, 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).
[0039] In some embodiments, the kit further includes an applicator
for applying the isoprenoidal essential oil to an eye tissue and
the applicator includes the abrasive.
[0040] Yet another aspect of the invention provides a 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] The novel features of the invention are set forth with
particularity in the claims that follow. A better understanding of
the features and advantages of the present invention will be
obtained by reference to the following detailed description that
sets forth illustrative embodiments, in which the principles of the
invention are utilized, and the accompanying drawings of which:
[0042] FIG. 1 shows a method of eye treatment using an abrasive
according to one aspect of the invention.
[0043] FIG. 2 shows a perspective view of an eyelid margin and a
posterior eyelid margin treatment with an abrasive and isoprenoidal
essential oil.
[0044] 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.
[0045] FIG. 4 shows application of an abrasive composition to an
eyelid using a pressurized liquid.
[0046] FIG. 5 shows an abrasive being removed from eye area tissue
using a vacuum source.
[0047] FIG. 6 shows a kit for eye treatment or eye cleansing
according to one aspect of the invention.
DETAILED DESCRIPTION
[0048] 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.
[0049] 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.
[0050] The invention further comprises 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. daily, weekly, monthly),
occasional, or one-time cleansing. The 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).
[0051] In various embodiments, the microdermabrasive and oil may be
applied to the eyelid and/or eye area tissue together, or they may
be applied separately. 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. After chafing, 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). Prior to
treatment with an abrasive, an eye area tissue may be prepared,
such as by washing or rinsing (e.g. with warm water).
[0052] 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. In some cases, 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. In some cases 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. For example, Gao et al. (Cornea, Vol. 26, No. 2, February
2007:136-143) recommends that a patient being treated for Demodex
discard make-up and weekly wash their bedding and pillowcases in
hot water to prevent re-exposure to Demodex. These steps may not be
sufficient and may be inconvenient. The 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.
[0053] While not limiting the method of action of the treatment, it
is thought that 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.
[0054] 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.
Inflammation, irritation, redness and other symptoms and problems
may be reduced. 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.
[0055] 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, zeolite, or polymer particles. In one
embodiment, Kiehl's Epidermal re-texturizing micro-dermabrasion
formulation may be used.
[0056] 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.
[0057] An abrasive particle may be sized from about 1 to about 600
microns (1 .mu.m to 600 .mu.m) across a longest dimension.
[0058] 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. Different sizes and shapes may be
chosen for different eye area conditions, different skin types or
sensitivities, and/or different methods of application. 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.
[0059] 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.
[0060] 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.
[0061] The product and method of this disclosure may be used in
conjunction with chemical exfoliation, chemical peel, crystal free
dermabrasion and/or laser resurfacing.
[0062] 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)-(+)-limonene, myrcene, para-cimene,
(S)-(+)-carvone hydrate, Tea tree oil (Oil of Melaleuca),
terpinen-4-ol, and/or variations and/or pharmaceutically accepted
salts thereof may be added. 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. For example, 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%). In another
example, a formulation (e.g. 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. In another example, 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.
[0063] 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.
[0064] Other 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, alpha hydroxy
acids, alphanoic acid, Amazonian White Clay, benzoyl and other
peroxides, carotenoids, ceramide, coenzyme Q10, collagen, copper,
copper peptide, cortisone, elastin, glycerin, glycolic acid, green
tea extract, hyaluronic acid, hydrolipids, hydroquinone, hydroxyl
acid, ivermectin, lactic acid, lanolin, magnesium, mineral oil,
niacin, non-silicone oil (hydrocarbon oil, esters, ethers),
oatmeal, panthenol, phospholipids, polyethylene glycol (PEG) or
modified PEG, retinoids, retinol, retinyl propionate, salicylic
acid, sea algaenates, Shea butter, silicone oil, sodium chloride,
sodium hyaluronate, triclosan, urea, Vitamin B, Vitamin C
(ascorbate), Vitamin E (tocopherol), water, willow herb, willow
weed, witch hazel, zinc oxide.
[0065] A composition according to the disclosure may be applied as
shown in FIG. 3. 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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.
[0070] Any device may be used, such as those described in US
2002/0169461 to Simon et al. or US 2004/0092959 to Bernaz.
[0071] 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.
[0072] In another embodiment, essential oil is applied to the
eyelid and/or surrounding area using a device, and chafing may be
performed with an abrasive pad.
[0073] In another embodiment, 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.
[0074] The compound containing the oil and microdermabrasive may be
massaged into the eyelid. Massage may be performed using the
fingers.
[0075] In other embodiments, 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). In another embodiment, the composition may be applied
using a microdermabrasion device.
[0076] In one embodiment, 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.
[0077] In another embodiment, the compound may be coated on the
eyelid in a manner similar to the manner in which eye liner makeup
or mascara is applied.
[0078] In another embodiment, the compound may be applied by
squeezing a therapeutic amount of material out of a squeezable tube
or bottle.
[0079] Any of these methods of applying the compound may be
combined with any other method.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] For example, 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 sterile package, or may not be sterile or not
be in a sterile package.
[0084] 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.
[0085] 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.
[0086] Alternatively, 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.
[0087] As for additional details pertinent to the present
invention, materials and manufacturing techniques may be employed
as within the level of those with skill in the relevant art. The
same may hold true with respect to method-based aspects of the
invention in terms of additional acts commonly or logically
employed. Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Likewise, reference to a singular item,
includes the possibility that there are plural of the same items
present. More specifically, as used herein and in the appended
claims, the singular forms "a," "and," "said," and "the" include
plural referents unless the context clearly dictates otherwise. It
is further noted that the claims may be drafted to exclude any
optional element. As such, this statement is intended to serve as
antecedent basis for use of such exclusive terminology as "solely,"
"only" and the like in connection with the recitation of claim
elements, or use of a "negative" limitation. Unless defined
otherwise herein, all technical and scientific terms used herein
have the same meaning as commonly understood by one of ordinary
skill in the art to which this invention belongs. The breadth of
the present invention is not to be limited by the subject
specification, but rather only by the plain meaning of the claim
terms employed.
* * * * *