U.S. patent application number 10/632188 was filed with the patent office on 2005-02-03 for apparatus, system and method for treating dry eye conditions and promoting healthy eyes.
Invention is credited to Davison, Suzanne, Moto, Fernando, Paulson, Roy.
Application Number | 20050022823 10/632188 |
Document ID | / |
Family ID | 34104297 |
Filed Date | 2005-02-03 |
United States Patent
Application |
20050022823 |
Kind Code |
A1 |
Davison, Suzanne ; et
al. |
February 3, 2005 |
Apparatus, system and method for treating dry eye conditions and
promoting healthy eyes
Abstract
An apparatus and system, and methods for using such apparatus
and system, is provided for preserving the eye's natural and
artificial tears. The apparatus comprises two soft, pliable
eyecups, which each include and curved lens and contoured frame,
connected by a soft, pliable bridge. The lenses are maintained
within a pliable, and contoured frame that is designed and
constructed to encircle the orbital bone of the eye sockets,
creating a custom fit and effective seal over each eye. Attached to
each frame is a gasket that further seals the apparatus over the
eyes and provides additional comfort to the wearer. A contoured
strap, which is attached to each frame, maintains the position of
the apparatus on the wearer.
Inventors: |
Davison, Suzanne;
(Pleasanton, CA) ; Paulson, Roy; (Temecula,
CA) ; Moto, Fernando; (Moreno Valley, CA) |
Correspondence
Address: |
Steven B. Pokotilow, Esq.
Stroock & Stroock & Lavan LLP
180 Maiden Lane
New York
NY
10038
US
|
Family ID: |
34104297 |
Appl. No.: |
10/632188 |
Filed: |
July 30, 2003 |
Current U.S.
Class: |
128/858 |
Current CPC
Class: |
A61F 9/029 20130101 |
Class at
Publication: |
128/858 |
International
Class: |
A61F 009/00 |
Claims
What is claimed is:
1. An apparatus for treating dry eye conditions comprising: a pair
of soft, pliable, curved lenses, each of said lenses maintained
within a soft, pliable frame; a soft, pliable gasket on a back
portion of each of said frames, said gasket designed to
substantially encircle and contact the orbital bone of an eye
socket of the wearer; a bridge coupling said frames; and a
flexible, contoured strap having two end portions and a center
portion, wherein said two end portions are coupled to said frames
and said center portion is designed so as to maintain said
apparatus on a wearer; said apparatus adapted and constructed to
increase or maintain the humidity around the eyes of the wearer by
reducing the evaporation of natural or artificial tears, or added
moisture, and by increasing or maintaining the temperature around
the eyes of the wearer.
2. The apparatus of claim 1, further comprising a moisture pad
adapted to be maintained between said apparatus and the eyes of the
wearer, said moisture pad designed and constructed to aid in
increasing or maintaining the humidity around the eyes of the
wearer.
3. The apparatus of claim 2, wherein said moisture pad is formed of
an endothermic or exothermic material.
4. The apparatus of claim 2, wherein said moisture pad is formed of
a visco-elastic foam.
5. The apparatus of claim 1, wherein each of said lenses and said
frames are formed as unitary structures.
6. The apparatus of claim 1, wherein said lenses, said frames, and
said bridge are formed as a unitary structure.
7. The apparatus of claim 1, wherein said lenses and said frames
are each formed of flexible polyurethane.
8. The apparatus of claim 1, wherein said lenses are removable from
said frames.
9. The apparatus of claim 1, wherein said lenses are opaque.
10. The apparatus of claim 1, wherein said lenses are
translucent.
11. The apparatus of claim 1, wherein said lenses are colored.
12. The apparatus of claim 1, wherein said lenses comprise a
textured surface.
13. The apparatus of claim 1, wherein said gaskets are formed of
visco-elastic foam.
14. The apparatus of claim 1, wherein said gaskets are removable
from said frames.
15. The apparatus of claim 1, wherein said gaskets are formed of an
endothermic or exothermic material.
16. The apparatus of claim 1, wherein said gaskets are at least
partially covered with a fabric.
17. The apparatus of claim 1, wherein said center portion of said
strap is wider than said two end portions of said strap.
18. The apparatus of claim 17, wherein said strap is formed of a
four-way stretch polyester blend.
19. An apparatus for treating dry eye conditions comprising: a pair
of soft, pliable, curved eyecups, each of said eyecups designed and
constructed to substantially encircle and contact the orbital bones
of the eye sockets of the wearer, while minimizing tissue pressure
and occlusion of the blood and lymphatic vessels in the orbital
area, so as to comfortably increase or maintain the humidity around
the eyes of the wearer by reducing the evaporation of natural or
artificial tears, or added moisture, and by increasing or
maintaining the temperature around the eyes of the wearer.
20. The apparatus of claim 19, further comprising a visco-elastic
gasket positioned on each of said eyecups.
21. The apparatus of claim 19, further comprising a moisture pad
adapted to be maintained between said eyecups and the eyes of the
wearer, said moisture pad designed and constructed to aid in
increasing or maintaining the humidity around the eyes of the
wearer.
22. An apparatus for treating dry eye conditions comprising: a pair
of soft, pliable, curved eyecups, each of said eyecups designed and
constructed to substantially encircle and contact the orbital bones
of an eye socket of the wearer; a thin, soft elastic strap having
two end portions attached to said eyecups and designed so as to
maintain the apparatus on the wearer; and wherein said eyecups and
strap each are formed of specific flexible materials such that said
apparatus can be adjusted in the as worn position so that the
dynamic tension between the eyecups and the strap provide a comfort
level associated with a maximum 50% IFD of said eyecups while the
humidity proximate the eye sockets of the wearer.
23. The apparatus of claim 22, further comprising a pair of
visco-elastic gaskets positioned on said eyecups, wherein said
gaskets provide an effective seal around the eye sockets of the
wearer.
24. An apparatus for treating dry eye conditions comprising: a pair
of soft, pliable, curved lenses, each of said lenses maintained
within a soft, pliable frame; a soft, pliable gasket on a back
portion of each of said frames, said gasket designed to
substantially encircle and contact the orbital bones of an eye
socket of the wearer; a bridge coupling said frames; said apparatus
adapted and constructed to increase or maintain the humidity around
the eyes of the wearer by reducing the evaporation of natural or
artificial tears, or added moisture and by increasing or
maintaining the temperature around the eyes of the wearer.
25. A method for treating dry eye conditions comprising: providing
an apparatus formed of soft, pliable materials and designed and
constructed to substantially encircle and contact the orbital bones
of an eye socket of the wearer, and placing said apparatus on a
sufferer of dry eye conditions for an effective amount of time.
26. The method according to claim 25, further comprising adding a
moisture solution to said apparatus.
27. The method according to claim 25, further comprising providing
a moisture pad adapted and constructed to be insertable between
said apparatus and the eye sockets of the wearer.
28. The method according to claim 27, further comprising
moistening, heating or cooling said moisture pad.
29. The method according to claim 27, further comprising adding a
medicinal solution to said moisture pad.
30. A method for administering medicine via dermal absorption
comprising: providing medicine with skin absorption properties to
an apparatus adapted to be worn by a wearer proximate the eyes of
the wearer; placing said apparatus with said medicine proximate the
eyes of the wearer such that said medicine can be administered
proximate the eyes of the wearer.
31. The method of claim 30, wherein said apparatus comprises a
gasket and wherein said medicine is administered via said gasket.
Description
FIELD OF THE INVENTION
[0001] This invention relates generally to an apparatus, system and
method for treating dry and irritated eye conditions. Particularly,
this invention relates to an apparatus constructed and adapted to
help control, maintain, and/or increase the temperature and
humidity around the eye to aid in limiting evaporation of natural
and/or artificial tears, which aids in thickening of the lipid
layer, thereby improving the overall health of the eye. This
invention also relates to an apparatus, system and method that
provides for controlled application of medicine to the eyes.
BACKGROUND OF THE INVENTION
[0002] Approximately 60 million Americans suffer from dry eye
conditions alone. Of these, approximately 10 million Americans have
been diagnosed with severe dry eye conditions, e.g., Dry Eye
Syndrome or Chronic Dry Eye Disease (CDED), both clinically known
as keratoconjuctivitis sicca. CDED is a condition that results from
inflammation of the eye, as well as inflammation of the
tear-producing glands. This inflammation decreases the eyes'
ability to produce natural tears, which help protect the eyes from
irritation and keep them moisturized and lubricated. People who
suffer from CDED often experience constant pain from eye
irritation, including a sandy or gritty sensation that, if
untreated, can lead to scarring or ulceration of the cornea, which
can lead to a partial or total loss of vision.
[0003] Most cases of CDED result from normal aging of the eye;
however, CDED or dry, irritated, tired eyes can occur at any age.
It is estimated that nearly 75% of people over the age of 65 will
experience CDED conditions. CDED occurs in both men and women;
however, it is most common in women who are post-menopausal or
pregnant. Approximately 4 million Americans, of which approximately
90% are women, have CDED as a consequence of Sjogren's syndrome,
which is a chronic, slowly progressive autoimmune disease
characterized by dryness of the eyes and mouth and recurrent
salivary enlargement. Other diseases, such as rheumatoid arthritis,
lupus, scleroderma, and thyroid disease, can also cause CDED. In
addition, health, environmental, and lifestyle conditions can also
cause CDED. For example, people suffering from allergies
(approximately 50 million people) and people who wear contact
lenses (approximately 38 million Americans), have a greater risk of
developing CDED. Other circumstances that significantly dry,
irritate, and fatigue the eye include: computer use; low humidity
environments, such as flying in an airplane, in which the relative
humidity is typically between 5% to 15%; certain medications; eye
surgery; and certain medical conditions, such as bletharitis
(inflammation of the eyelids).
[0004] Some early signs of CDED include: 1) an occasional burning
sensation in the eyes when a person is in an area of low humidity
or high pollution; 2) a persistent and painful gritty sensation in
the eyes; 3) an inability to cry under emotional stress; 4)
decreased tolerance of contact lenses; and 5) in extreme cases,
unusual sensitivity to light, severe eye pain, or diminished
vision. In the early stages of the disorder, these symptoms may
come and go, but become more persistent as the condition worsens.
For most CDED cases, patients experience a greater discomfort as
the day progresses.
[0005] Over 25,000 people a day turn 50 years old in the U.S.
alone. It is estimated that by 2010, over 140,000,000 Americans
will be over the age of 50. As mentioned above, if dry eye
conditions are left untreated a person may develop CDED and,
eventually, a loss of vision. Thus, with a significant portion of
the population aging, the incidence of dry eyes will increase
significantly, as will the risk of developing CDED.
[0006] The hydration process of eyes and, in particular, the
corneal epithelium, includes tear production, evaporation, and
outflow loss. Indeed, studies suggest that dry eye conditions are
associated with an increased evaporation of tears from the ocular
surface. Further, increased humidity around the eye significantly
reduces, if not stops, the evaporation of tears and can restore and
thicken the lipid layer. See William D. Mathers, M. D., et al.,
Tear Flow and Evaporation in Patients with and without Dry Eye,
Ophthalmology, Vol. 103, no. 4 (April 1996), pp. 664-669; William
D. Mathers, M. D., Ocular Evaporation in Meibomian Gland
Dysfunction and Dry Eye, Ophthalmology, Vol. 100, no. 3 (March
1993), pp. 347-351; Donald R. Korb, O. D., et al., Effect of
Periocular Humidity on the Tear Film Lipid Layer, Cornea, Vol. 15,
no. 2 (1996), pp. 129-134.
[0007] Presently there is no cure for CDED; however, there exist
various treatments that are designed to alleviate the often
debilitating pain and discomfort caused by dry eye conditions. Such
treatments include: artificial tear solutions, moisture chamber
glasses, and punctal occlusion.
[0008] The most common treatment for people with dry, irritated, or
tired eyes is artificial tear solutions, both prescription and
over-the-counter eye drops. Artificial tear solutions may or may
not contain preservatives. The preservatives used in artificial
tear solutions have little or no toxicity; however, artificial tear
solutions with preservatives can cause irritation if used
frequently. In fact, artificial tear solutions with preservatives
are not recommended for frequent use. CDED patients typically need
to frequently apply artificial tears, which prohibits the use of
artificial tears with preservatives. Preservative-free solutions
are available; however, they are expensive and prone to bacterial
contamination. While artificial tears primarily increase the
comfort of people suffering from dry, irritated eyes, when used
frequently they may rinse away the natural tears necessary to
reestablish a normal tear film. Frequent use of artificial tears is
also expensive; individuals suffering from CDED can spend
approximately $300 a year on artificial tears.
[0009] Another treatment for dry, irritated eyes is ointments.
Typically used for nighttime relief, ointments often blur vision,
are messy, awkward to apply, and often do not provide an effective
treatment.
[0010] Another treatment includes the use of moisture chamber
glasses. Moisture chamber glasses are custom-made products designed
to alleviate the pain and discomfort caused by dry eye conditions.
There are no commercially available moisture chamber glasses, they
must be custom fit by an optician, and can be prohibitively
expensive for the average consumer. Studies have suggested that
conventional swim goggles may also be helpful in preserving
moisture in dry eyes, as well as protecting eyes from exposure to
air currents, such as air conditioning and wind gusts. See, e.g.,
Donald R. Korb, O. D., et al., Effect of Periocular Humidity on the
Tear Film Lipid Layer, Cornea, Vol. 15, no. 2 (1996), pp. 129-134.
However, conventional swim goggles are not designed for prolonged
use and can be uncomfortable to the wearer. Although conventional
swim goggles are well designed for the intended use of swimming,
the application of conventional swim goggles as a moisture chamber
has numerous drawbacks, including: 1) the optics and field of view
are designed for swimming; 2) conventional swim goggles typically
have a narrow orbital seal that is designed to keep water out and
which is located inside the orbital bone and supported by the
sensitive inner ocular area; 3) the straps are designed for
short-term wear, under tension, and are not designed for sleeping;
4) the lens and body design is manufactured of a polycarbonate
rigid plastic, which is inherently uncomfortable because of its
rigid nature and because the exterior contour creates pressure on
the eye socket when the wearer is laying down; 5) conventional swim
goggles encompass a smaller surface area around the eye, thereby
reducing the potential to trap moisture and heat from the skin
surrounding the eye; 6) conventional swim goggle designs tend to
cut off capillary blood vessels of the skin in the area surrounding
the eyes; 7) conventional swim goggle lenses are typically treated
with an anti-fog coating, which is either hydrophobic, hydrophilic,
or a blend of the two, and which can cause irritation to the
eyes.
[0011] Punctal occlusion, the closure of the tear ducts, is another
type of treatment for dry eyes that can provide an increased volume
of tears remaining in the eye area by decreasing drainage. Under
this method of treatment, the lower puncta, which carry away the
majority of tears, are sealed using a collagen or silicone plug, or
by surgery, via electrocautery or an argon laser. Plugging is
typically done for evaluation purposes or when the sufferer's dry
eye conditions vary in severity. A collagen plug lasts only a short
time, may not occlude completely, and is eventually absorbed. The
silicone plug is not absorbed, but can easily be removed. Surgical
occlusion is a permanent treatment option for dry eye sufferers;
however, surgery may have to be repeated because the puncta tend to
reopen. Punctal occlusion can be an expensive treatment for dry eye
conditions, ranging in price from $500 to $650.
[0012] Thus, a need exists for an apparatus, system and method for
treating dry eye and/or irritated eye conditions that is natural,
easy to use, comfortable and safe to the wearer, inexpensive, and
which provides therapeutic benefits for the eyes without the
discomfort, invasiveness, and limited use of the currently
available treatments. A need also exists for an apparatus, system
and method that can be used to promote healthy eyes and can reduce
the possibility of developing CDED by improving the health of the
lipid layer.
SUMMARY OF THE INVENTION
[0013] Generally speaking, the present invention is directed
towards an apparatus, system and method for treating dry eye and/or
irritated eye conditions and which helps control, maintain and/or
increase the temperature and humidity around the eyes to aid in
limiting evaporation of natural and/or artificial tears. The
present invention is also directed towards an apparatus, system and
method for promoting healthy eyes by aiding in thickening the lipid
layer. The present invention is also directed towards an apparatus,
system and method that provides for controlled application of
medicine to the eyes.
[0014] The apparatus of the present invention comprises two soft,
pliable eyecups, that each include a curved lens and contoured
frame. The eyecups are connected by a soft, pliable bridge. The
soft lenses of the present invention are maintained within the soft
contoured frame, which is designed and constructed to encircle the
orbital bones of the eye sockets, creating a custom, comfortable
fit and effective seal over each eye. In a preferred embodiment,
attached to each frame is a gasket that further aids in sealing the
apparatus over the eyes and which provides additional comfort to
the wearer. A contoured strap, which is attached to the eyecups,
maintains the proper positioning of the apparatus on the
wearer.
[0015] The present invention is also directed to a system
comprising the apparatus described above used in conjunction with a
moisture pad. The moisture pad can be inserted between the
apparatus and the eyes of the wearer to provide further aid in
treating dry eye and/or irritated eye conditions. The moisture pad
can be moistened, moistened and heated, or moistened and cooled to
further aid in alleviating dry eye and/or irritated eye
conditions.
[0016] Accordingly, it is an object of the invention to provide an
apparatus and system, and methods for using such an apparatus and
system, to provide an improved treatment for sufferers of dry eyes,
dry eye syndrome, CDED, and irritated eyes that is simple and
comfortable.
[0017] Another object of this invention is to provide an apparatus
and system, and methods for using such an apparatus and system, to
provide improved treatment for sufferers of dry eyes, dry eye
syndrome, CDED, and irritated eyes that can be used for immediate
and long-lasting relief.
[0018] A further object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that improves quality of rest or sleep and reduces the need
for other dry eye treatments, such as artificial solutions and
ointments.
[0019] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that improves comfort during air travel.
[0020] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that creates a moisture retaining chamber around each eye,
which promotes the health of the eyes while at the same time
preventing and/or inhibiting the development of severe dry
eyes.
[0021] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that can alleviate, reduce, and/or prevent dry eye syndrome
and/or CDED.
[0022] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that increases hydration of the eyes.
[0023] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that can promote healthy eyes.
[0024] Still another object of this invention is to provide an
apparatus and system, and methods for using such an apparatus and
system, that aids in the application of particular medicines.
[0025] The invention accordingly comprises the features of
construction, combination of elements, and arrangement of parts
which will be exemplified by the constructions hereinafter set
forth, and the scope of the invention will be indicated in the
claims.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0026] In the drawing figures, which are not to scale, and which
are merely illustrative and wherein like reference characters
denote similar elements throughout the several views:
[0027] FIG. 1 is a front perspective view of an apparatus for
treating dry eye conditions constructed in accordance with one
aspect of the present invention.
[0028] FIG. 2 is a back perspective view of an apparatus for
treating dry eye conditions constructed in accordance with one
aspect of the present invention.
[0029] FIG. 3 is a front plan view of an apparatus for treating dry
eye conditions constructed in accordance with one aspect of the
present invention.
[0030] FIG. 4 is a top plan view of an apparatus for treating dry
eye conditions constructed in accordance with one aspect of the
present invention.
[0031] FIG. 5 is a side plan view of an apparatus for treating dry
eye conditions constructed in accordance with one aspect of the
present invention.
[0032] FIG. 6 is a detailed exploded front view of an apparatus for
treating dry eye conditions constructed in accordance with one
aspect of the present invention.
[0033] FIG. 7 is a detailed exploded back view of an apparatus for
treating dry eye conditions constructed in accordance with one
aspect of the present invention.
[0034] FIG. 8 is a front view of an alternate embodiment of an
apparatus for treating dry eye conditions.
[0035] FIG. 9 is a side plan view of an alternate embodiment of an
apparatus for treating dry eye conditions.
[0036] FIG. 10 is a back view of an alternate embodiment of an
apparatus for treating dry eye conditions.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0037] Generally speaking, the present invention is directed
towards an apparatus, system and method for treating dry eye and/or
irritated eye conditions and which helps control, maintain and/or
increase the temperature and humidity around the eyes to aid in
limiting evaporation of natural and/or artificial tears. The
present invention is also directed towards an apparatus, system and
method for promoting healthy eyes by aiding in thickening the lipid
layer. The present invention is also directed towards an apparatus,
system and method that provides for controlled application of
medicine.
[0038] In developing the apparatus, system and method of the
present invention, the following information and design
characteristics were taken into consideration:
[0039] Description of the Orbits from Gray's Anatomy--The orbits
are two quadrilateral, pyramidal cavities, situated at the upper
and anterior part of the face, their bases directed forward and
outward, and their apices backward and inward so the axes of the
two, if continued backward, would meet over the body of the
sphenoid bone. Each orbit is formed of seven bones, i.e., frontal,
sphenoid, ethmoid, superior maxillary, malar, lachrymal, and
palate, three of which are shared by both orbits, i.e., the
frontal, ethmoid, and sphenoid.
[0040] Anatomical Considerations in the Design of the
Invention--The design of the present invention takes into account
the shape and contour of the bones of the face and the orbit region
and uses this structure as support for the apparatus. Specifically,
the frontal (supra-orbital ridge), superior maxillary, malar, and
nasal bones were considered when determining the shape and contour
of the apparatus. Due to ethnic variation, size, and gender, an
optimized profile was determined that minimizes the pressure points
on critical areas of this sensitive area. The present invention
also is designed to minimize tissue pressure and occlusion of
various vessels and nerves in the area of contact. Specifically,
the present invention utilizes the bone structure for support and
relies upon the muscle structure of the orbit area as additional
protection of the arteries, veins, lymph vessels, and nerves.
[0041] Muscle Structure Considerations in the Design of the
Invention--The apparatus of the present invention mimics the
contour and general shape of the orbicularis palpebrarum, also
referred to as the orbicularis oculi muscle, muscle structure. The
frontalis portion of the occipito-frontalis muscle, the
continuation of the pyramidalis nasi, and the corruggator
supercilii, further protect the upper and nasal portions of the
contact area.
[0042] Nerve Considerations in the Design of the Invention--The
facial nerve divides in front of the ear into six branches that
serve the scalp, forehead, eyelids, muscles of facial expression,
cheeks, and jaw. The design of the present invention avoids the
main trunk and minimizes pressure points on these nerves when the
invention is worn, or if the patient were to lie on a pillow
placing extra pressure on this area during sleep.
[0043] Blood Vessel Considerations in the Design of the
Invention--The angular artery, orbital artery, and branches of the
anterior temporal artery anastomose with the infra-orbital, and
after supplying the lachrymal sac and orbicularis palpebrarum
muscle, terminate by anastomosing with the nasal branch of the
ophthalmic artery. Closing off the blood supply, or reducing the
anastomosing, reduces blood flow in the area. Blood flow is further
reduced if the capillaries are compressed by producing a design
that compromises these delicate structures.
[0044] Primarily, the frontal vein and the communicating branch
with the ophthalmic vein were considered in the shaping of the
present invention in the nasal area. The nasal arch vein is avoided
by the clearance provided by a flexible nose bridge. As the frontal
vein moves down the face alongside the inner nasal, the present
invention also avoids pressuring the angular vein.
[0045] The important anastomosis of the angular vein and the sinus
is associated with proper circulation and is within the contact
area of the invention. Thus, the present invention design in the
described areas was modified to optimize fit and minimize the
occlusion of these important veins. The health and well-being of
the vein structures around the eye are associated with visual
beauty in modern society; therefore, it is important in the design
of the present invention to maximize health and beauty aspects of
the invention, thus, occlusion of the veins should be avoided.
[0046] Lymphatic Vessels in the Orbital Area--Superficial lymphatic
vessels of the face are numerous and generally accompany the
frontal vessels in the area of the orbits. Compression of the
superficial lymphatic vessels is minimized by the minimal localized
pressure exerted by the apparatus of the present invention.
[0047] Fitting the greatest range of face sizes, ages, bone
structures, and accommodating sensitive skin, determined the
combination of materials of the present invention. Raw
anthropomorphic data was utilized from ANSI Z87.1 1989, Alderson
Head Form data and percentiles, and from The Measure of Man &
Woman: Human Factors in Design, Revised Edition, by Alvin R. Tilley
and Stephen B. Wilcox, December 2001.
[0048] Application and intended use were other factors taken into
consideration for the design of the present invention, namely, when
and how to use a dry eye treatment to derive the greatest
therapeutic benefits. The present invention is designed for use
when resting or sleeping. The design of the apparatus and system of
the present invention prevents a sufferer of dry eye conditions
from inadvertently touching or rubbing the eyes during the night,
which can be a significant problem after many types of eye surgery.
Also, incomplete closure of the eyelids while sleeping causes
excessive drying of the eye that may cause significant damage to
the cornea. These problems can be avoided if the present invention
is utilized at night. As such, the present invention can improve
the quality of sleep, support post-eye surgery healing, and aid in
the acceleration of healing due to the improved conditions when the
present invention is worn.
[0049] Taking into account all of the above design considerations,
the apparatus of the present invention comprises two soft eyecups,
that each include a soft lens and a soft frame, and which are
connected by a soft, pliable bridge. The lenses, which are curved,
and the frames are each made of a soft, pliable material. The
lenses are maintained within a soft, pliable, and contoured frame
that is designed and constructed to encircle the orbital bone of
the eye sockets, creating a custom, comfortable fit and effective
seal over each eye. In a preferred embodiment, attached to each
frame is a gasket that further aids in sealing the apparatus over
the eyes and which provides additional comfort to the wearer. A
contoured strap, which is attached to each frame, helps maintain
the proper positioning of the apparatus on the wearer.
[0050] Referring now to FIGS. 1 through 5, the apparatus for
treating dry eyes and irritated eyes, generally indicated as 10,
has curved lenses, generally indicated as 12, which may be either
translucent, opaque, transparent, and/or of optical quality in
order to provide maximum comfort to the wearer. Lenses 12 are
coupled to frames, generally indicated as 14, which together make
up the eyecup and which are connected to a second eyecup by a
bridge, generally indicated as 16. A gasket, generally indicated as
18, is coupled to each frame 14. A strap, generally indicated as
20, is affixed to frames 14 via fasteners 22 to maintain apparatus
10 on the wearer. The apparatus of the present invention, when
constructed of the appropriate materials and used as described
herein, helps maintain and/or increase the humidity within the
apparatus thus aiding in alleviating, treating, preventing and/or
reducing the effects of dry eye syndrome and CDED.
[0051] The lenses and the frames are designed and constructed to
balance the planned material, primary physical properties of Flex
Modulus, 6000 psi and ASTM D790, Durometer Hardness, a scale "90"
ASTM D2240, and Compression Set, 20% ASTM D395 73.degree. F., 22
hr., with the mechanical shape and how it is influenced by these
factors. Anthropomorphic data was applied in the design and ranges
of fit were established for the area around the less sensitive
occipital bones. This area varies within the established ranges,
and to make the apparatus as comfortable as possible, the apparatus
self-conforms and seals this area for moisture retention. Comfort
is a primary concern and established comfort criteria include
reduction of pressure points in the contact area. The design of the
apparatus of the present invention also takes into consideration
that the patient may create additional pressure loading on the
mechanism by lying on the pillow face down or turning during the
night.
[0052] The eyecup is functionally unique in that the hemispherical
lens provides a resilient support mechanism for the flowing
anthropomorphic frame area. On any point of the frame area the
anthropomorphic shape is designed to flex, follow, and move as
needed by the individual's unique facial contour. Additionally, if
the pressure on the gasket, which will be described in greater
detail below, exceeds the limit of comfortable compression, the
frame will then accommodate the pressure maintaining the seal and
comfort. The actual flexibility of the invention is primarily
achieved by the combination of the flexural modulus of the material
and engineered shaping of the hemispherical area and frame. The
variable part thickness also influences the final performance and
characteristics to create the unique attributes described for this
invention. Commonly, products for the eye protection industry are
manufactured with a hemispherical rigid lens and a frame based on
simple geometric shapes. These rigid materials and non-specific
designs are ineffective at sealing the complex area of the
occipital bone structure or providing the comfort required for
people who need to use this type of product.
[0053] The eyecup, including a lens and frame, and the bridge of
the present invention can be manufactured using a thermoplastic,
including, but not limited to: ABS (Acrylonitrile Butadiene
Styrene), Acetal (POM)-(Acetal (polyacetal)), Acrylic (Acrylic),
Acrylic (PMMA)-(Polymethyl Methacrylate), Acrylic (SMMA)-(Styrene
Methyl Methacrylate Copolymer), Cellulose Acetate, Cellulose
Acetate Butyrate, Ethylene Vinyl Acetate, HDPE (polyethylene, high
density), HIPS (polystyrene, high impact), Ionomer, LPDE
(polyethylene, low density), MDPE (polyethylene, medium density),
Nylon (Polyamide-nylon), PBT (Polybutylene Terephthalate), PC
(polycarbonate), PCT (Polycyclohexylene Terephthalate), PCTG
(Polycyclohexylene Dimethylene Terephthalate), Polyethylene, PET
(Polyethylene Terephthalate), PETG (Polyethylene Terephthalate
Glycol Comonomer), PP (Polypropylene), PPO (Polyphenylene Oxide),
PS (Polystyrene), PUR (Polyurethane), PVC (Polyvinyl Chloride),
PVC+PUR (Polyvinyl Chloride+Polyrurethane Alloy), Polyester TP
(Polyester, thermoplastic), Polyester TS (Polyester Thermoset), SAN
(Styrene Acrylonitrile), SB (Styrene Butadiene Block Copolymer),
SBS (Styrene Butadiene Styrene Block), SEBS (Styrene Ethylene
Butylene Styrene Block Copolymer), SIS (Styrene Isoprene Styrene
Block Copolymer), TPE (Thermoplastic Elastomer),
TPO--(Thermoplastic Olefin Elastomer), TPU (Polyurethane,
Thermoplastic Elastomer-TPE).
[0054] The following thermoset materials, which have similar
properties, are also appropriate for application to the present
invention: silicone, Rubber, neoprene, Buna-N (nitrile) Rubber,
Butyl Rubber, EPDM (ethylene-propylenediene methylene), SBR rubber
(styrene butadiene), Epichlorohydrin Sponge Rubber, Gum Rubber,
Hypalon Rubber, Latex (Natural Rubber), Neoprene Rubber,
Polyurethane Rubber, and any other thermoset not listed but with
properties appropriate for application to this invention.
[0055] Additionally, the eyecup and the bridge could be
manufactured from a flexible cellular material, including, but not
limited to: Polyurethane ether based foam, Polyurethane ester based
foam, Polyethylene foam, Polyethylene cross-linked foam, Ethylene
Vinyl Acetate foam, Silicone foam, PVC (Polyvinyl Chloride) foam,
Polyimide foam, Ionomer foam, and any other flexible cellular
material.
[0056] Alternatively, in addition to the thermoplastic and
thermoset materials, the eyecup and the bridge can be manufactured
using a gel, fluid, or particle-filled structure.
[0057] There are any number of ways of manufacturing the eyecup and
the bridge of the present invention, including, but not limited to:
injection molding, compression molding, vacuum forming, pressure
forming, mechanical forming, casting, hot sealing, sonic welding,
or other methods used in the fabrications of the above listed
materials.
[0058] Lenses 12, depicted in FIGS. 1 through 7, are curved to
create a humidity chamber above the wearer's eyes. In a preferred
embodiment, lenses 12 have an eight-base curvature to allow for
blinking. Lenses 12 are made of a soft, pliable material, such as
silicone or flexible polyurethane, or any one of the materials
listed above, and can be translucent, opaque, transparent, and/or
of optical quality to provide maximum comfort to the wearer. In a
preferred embodiment, lenses 12 are formed of flexible
polyurethane. Lenses 12 can also be colored to promote additional
therapeutic benefits such as light and/or color therapy.
[0059] Lenses 12 can be either permanently affixed to frames 14, or
may be removably mounted or maintained within frames 14 in a manner
known in the art. For example, lenses 12 can be constructed to snap
into a groove (not shown) located in the inner perimeter of frames
14. In an alternate embodiment, the frames and lenses can be formed
of a single unitary piece.
[0060] Frames 14 also are made of a soft, pliable material, such as
silicone or flexible polyurethane, or any one of the materials
listed above, and are preferably contoured to conform to the
orbital bone around the eye socket to provide a snug, comfortable,
and effective fit for the wearer. Bridge 16 connects frames 14 and
can be adjustable to provide a custom, comfortable fit for the
wearer. Bridge 16 is also constructed of a soft, pliable material
such as flexible polyurethane. In an alternate embodiment, the
frames, lenses, and bridge can be formed of a single unitary
piece.
[0061] Gasket 18, as depicted in FIGS. 1 through 2 and 4 through 7,
can be coupled to frames 14 to provide additional comfort to the
wearer and to also provide a more effective seal around the eye
sockets. In one embodiment, gasket 18 is permanently affixed to
frames 14. In an alternate embodiment, gasket 18 can be removable
from frames 14. For example, as shown in FIGS. 6 and 7, apparatus
10 can further comprise an attaching mechanism, generally indicated
as 24, which is coupled to frames 14, to which gasket 18 can
removably attach. The attaching mechanism 24 can also be formed
integrally with frames 14 as a matter of application specific
design choice. Although attaching mechanism 24 can take any number
of forms and materials as known in the art to achieve its intended
function, in a preferred embodiment, attaching mechanism 24
comprises a Velcro.RTM. strip to facilitate easy and quick
interchanging of gasket 18. To attach gasket 18 to attaching
mechanism 24, gasket 18 can have a compatible attaching mechanism,
such as a Velcro.RTM.-compatible material affixed to one side. In
such an embodiment the wearer can replace gasket 18 upon extended
use or the like.
[0062] Gasket 18 can be formed of any type of material that will
provide a comfortable fit for the wearer while at the same time
meeting the functional requirements of the gasket, for example,
foam or a thin silicone member. In a preferred embodiment, gasket
18 is made of a visco-elastic, thermal-forming foam, such as the
commercially-available foam supplied by PAC Foam Products
Corporation in Costa Mesa, Calif. Such a foam gasket will conform
to the wearer's orbital bone structure, especially when warmed by
body heat, to thereby create a comfortable and effective seal
around the eyes.
[0063] In the preferred embodiment, balancing Indention Force
Deflection (IFD) @25%, IFD @65%, and specific pound density of the
present invention, relieves pressure points along the orbital area.
This balancing works in combination with the tension of strap 20
and the anthropomorphic design of the eyecup.
[0064] In an alternate embodiment, gasket 18 is integral with the
eyecup. For example, gasket 18 may be an extension of the
hemispherical section of the lens, a portion of the frame, or a
structure that is emanating from any or all of these sections and,
as such, gasket 18 can be formed of any one of the materials listed
above for the eyecup. In this alternate embodiment, the desired
balance between the IFD @25%, the IFD @65%, and the pound density
can be achieved by, for example, the frame itself without the
addition of a separate gasket 18.
[0065] In an alternate embodiment, gasket 18 is an inflated
structure comprised of a bladder that surrounds the orbital
area.
[0066] In an alternate embodiment, gasket 18 is a gel-, fluid-, or
particle-filled structure that self-conforms to the orbital
structure. Gasket 18, when a filled structure, can be heated or
cooled to promote the therapeutic benefits of the present
invention.
[0067] Strap 20 is preferably made of a soft, and flexible or
elastic material and is coupled to frames 14, preferably at
opposite outer sides of frames 14. In the embodiment depicted in
FIGS. 1 through 7, strap 20 is coupled to fasteners 22, which can
be made of a flexible polyurethane or any one of the materials
listed above for use in the eyecup, and which are coupled to
opposite outer sides of frames 14. The design of fasteners 22
permits the wearer to sleep with the apparatus and contact the
pillow or bedding without unnecessary pressure points on the
wearer. See para. 42, Nerve Considerations in the Design of the
Invention. In an alternate embodiment, frames 14 include two
parallel slits on opposite outer sides for affixing strap 20 to
frames 14. Other means of attaching strap 20 to frames 14 are known
in the art. Strap 20 can be both removable and adjustable.
[0068] In a preferred embodiment, strap 20 is formed of an elastic
material, such as a two-way stretch polyester blend, four-way
stretch polyester blend, or cotton, polyester, and lycra blend
materials, or any combination thereof, which aids in preventing
snagging and pulling, thereby providing additional comfort to the
wearer. In a preferred embodiment, strap 20 is shaped as shown in
FIGS. 2 and 7, that is, strap 20 has a greater width at its
mid-point, which further aids in holding the apparatus on the
wearer and provides greater comfort to the wearer.
[0069] In the preferred embodiment, strap 20 is designed for low
tension and maintains position of the apparatus with minimal
interference to the capillary blood vessels of the skin and blood
supply to glands and structure in the area surrounding the eyes.
Additionally, the design of strap 20 minimizes the potential
interference of the lachrymal glands and ducts. See paras. 39 and
40, Description of the Orbits from Gray's Anatomy and Anatomical
Considerations in the Design of the Invention, respectively. This
is achieved with a combination of the low-required strap tension
and the rebound characteristics of the visco-elastic foam.
[0070] In the preferred embodiment, the "dynamic tension" which
strap 20 and gasket 18 work together to achieve is the key to the
long-term wearing comfort of the apparatus of the present
invention. In the preferred embodiment, gasket 18 is made of a foam
material that has an IFD @ 25% in a ratio to the strap tension and
in combination with the pound density, although surface area of
contact has a bearing on the comfort factors. The second measure of
IFD is at 65%, which determines that the foam will not bottom out
under normal strap tension, which brings into play the flexibility
and design of the eyecup and its particular structural design.
[0071] The attachment mechanism of strap 20 can also include, but
is not limited to: elastic head strap; synthetic and/or
non-synthetic head strap; fabric head strap; stretch fabric head
strap; designs that utilize the ear as the locator and support of
any of the materials listed; designs that are open and woven in the
fashion of a hair net; designs of a fabric, synthetic,
non-synthetic, foam or plastic that encircle the head at or about
the coronal line as defined by ANSI Z87.1-1989; designs that are
adjustable or non-adjustable for straps, bands, or ear located
attachments; designs that utilize snaps, Velcro.RTM., buttons,
other standard fasteners or custom fasteners to attach strap 20 or
that are used to adjust the tension or the combination of both;
designs that utilize gravity, such as weighted fixtures that
position and create the dynamic tension necessary to seal the unit
to the orbital area, these would be used when a patient was being
provided a spa facial and the head in a position to be conducive to
dry eye therapy; designs that utilize an adhesive to attach the
unit to the face, such as an adhesive that directly attaches to the
eyecup and is located on the surface of the eyecup that comes into
direct contact with the skin; methods such as placing the eyecup
into position and taping the apparatus from the exterior, this type
of application has particular value for juvenile patient
applications or patients who may accidentally remove the apparatus
or when critical cleanliness is required; or any combination of the
attachment methods listed above can be used.
[0072] In another aspect of the present invention, in a system for
treating dry eye and/or irritated eye conditions, shown in FIG. 4,
apparatus 10 further comprises a moisture pad, generally indicated
as 26. As shown in FIG. 4, moisture pad 26 can be inserted between
apparatus 10 and the eyes of the wearer in direction A. In a
preferred embodiment, the moisture pads are made of viscous-elastic
foam, which, when moistened, further help maintain, increase,
and/or regulate the temperature and humidity within the chamber
around the eye socket. The moisture pads can be moistened using
water, artificial tears, or any other solution known in the art. In
addition to being moistened, the moisture pads can be moistened and
heated, or moistened and cooled, prior to being inserted into the
cavity of lenses 12. The wearer can apply the apparatus including
the moisture pads for a set amount of time, after which the wearer
can remove the moisture pads and continue to wear the apparatus.
The moisture pads, when used in combination with the apparatus of
the present invention, can further increase and maintain the
relative humidity within the chamber surrounding the eye socket for
aiding in treating the effects of dry eyes, irritated eyes, and for
promoting healthy eyes.
[0073] Moisture pad 26 and/or gasket 18 can be manufactured from
materials including, but not limited to: visco-elastic polyurethane
foam, hydrophilic polyurethane foam (e.g., Aquazone product by
Foamex), polyurethane ether based foam, polyethylene foam,
polyethylene cross-linked foam, ethylene vinyl acetate foam,
silicone foam, PVC (Polyvinyl Chloride), Polyimide foam, Ionomer
foam, Polyester based foam, latex foam, anti-microbial materials
(e.g., anti-microbial foam or fabric), sponge (natural or
synthetic), gauze, pulp, fiber, fabric (natural or synthetic),
paper products, or any synthetic or natural material, which has the
capacity to absorb and release moisture or other liquids.
[0074] Moisture pad 26 and/or gasket 18 can be made of a material
listed above, and then covered, in whole or in part, in a fabric to
further increase comfort to the wearer or add specific
characteristics to the product.
[0075] In an alternate embodiment, the moisture pad can be used to
administer medicine, for example, medicine can be infused into the
moisture pad material and then delivered in a controlled manner.
Specifically, medicines could evaporate, sublimate, or combine with
the natural moisture present in the apparatus and be delivered to
the eye. Moisture pad 26 can be used to administer medicinal eye
drops by absorbing the medicinal eye drops. This type of
administration would contain the medicinal eye drops in a superior
manner by containing the medicine within the orbital area. Moisture
pad 26 and/or gasket 18 also can be infused with an herbal
treatment or a counter-irritant.
[0076] In another aspect of the present invention, gasket 18 can be
used for medicinal administration via skin contact. For example,
hormone therapy, which is typically administered via a skin patch
and which can be used to alleviate dry eye conditions, could be
administered via gasket 18, which is in contact with the skin of
the wearer when wearing the apparatus of the present invention.
[0077] In another aspect of the present invention, the current
realization of the moisture pad places the surface away from the
eye, actually allowing room for uninterrupted blinking action;
however, the moisture pad can be designed and administered to apply
controlled pressure onto the closed eye. The pressure would be
controlled by factors previously described in measuring the
thickness, IFD @25%, IFD @65%, and the density.
[0078] In another aspect of the present invention, moisture pad 26
and/or gasket 18 can be constructed of a material that has
endothermic or exothermic properties. That is, moisture pad 26
and/or gasket 18 can be constructed of a material that
automatically heats or cools the apparatus of the present invention
and thereby improve eye comfort and health. For example, moisture
pads 26 can be comprised of the same materials as used in hot
packs, which are used for muscle comfort or warmth, such as for
winter outdoor activities.
[0079] In another aspect of the present invention, the apparatus
and system, including moisture pad 26, can be heated or cooled to
provide further comfort to the wearer. For example, the apparatus,
along with moisture pad 26, could be placed in a microwave for a
short period of time.
[0080] In alternate embodiments, shown in FIGS. 8 and 9, the
apparatus of the present invention can be used to aid moisture
delivery by adding moisture to lens within the eyecup. FIG. 8
depicts an alternate embodiment, generally indicated as 28, in
which the delivery system that feeds the moisture into the eyecup
can be through a tube, generally indicated as 30, from a separate
remote reservoir, generally indicated as 32. Alternately, FIG. 9
depicts an alternate embodiment in which the delivery system can
feed moisture into the eyecup by an internal reservoir system built
into the eyecup, generally indicated as 34. For example, as shown
in FIG. 9, the internal reservoir can be a pocket or a double lens
design, generally indicated as 36, that is filled with moisture and
is designed to slowly transfer into the chamber surrounding the
eyes. This transfer of moisture into the orbital area can be by
direct openings in the reservoir or membrane technology, such as a
Gortex membrane, or wicking mechanism which utilizes a material to
wick the moisture from the reservoir into the orbital area.
[0081] In another method for adding moisture to the eyecup,
generally indicated as 38 in FIG. 10, the interior surface design
of the eyecup is molded with a textured pattern, for example, a
shallow honeycomb design. This honeycomb texture can be sized to
accept moisture into the pockets, yet the diameter would be small
enough so that the meniscus of the liquid would retain the moisture
rather than allowing the liquid to run out of the honeycomb pockets
by gravity. This design can hold the pre-charge of moisture and
create a large surface area for evaporation, thereby raising the
relative humidity in the eyecup without the addition of a moisture
pad.
[0082] In another method for adding moisture to the eyecup, the
interior surface of the eyecup can be sprayed with water,
artificial tear solution, spray eye mist, for example Biomist, or
any other solution known in the art, before the wearer dons the
apparatus of the present invention.
[0083] Data from tests of the apparatus and system of the present
invention confirms the utility and efficacy of the invention.
Specifically, testing confirms that use of the invention increases
the temperature and relative humidity of the area surrounding the
eyes, thereby reducing, and possibly preventing evaporation of
natural and/or artificial tears, and/or preventing problems
associated with increased evaporation, i.e., the dry eye conditions
discussed above.
[0084] The results of testing the apparatus and system of the
present invention on subjects without dry eye conditions are
depicted in Table 1 below. For each test, temperature and humidity
were measured over time, using a traceable hygrometer/thermometer,
model no. 35519-020, calibrated to comply with ISO 17025. In Test 1
the subject wore the apparatus of the present invention for
approximately 30 minutes during which the subject's eyes were
closed 50% of the time and open 50% of the time. As Table 1
depicts, the temperature around the eyes increased 7.29% and the
relative humidity increased by 52.29%. Use of the invention
together with the moisture pads caused an even greater increase in
temperature and relative humidity of the area surrounding the eyes.
Notably, in Test 3 in which the subject wore the invention for ten
minutes with the moisture pads and continued wearing the product
for an additional forty-seven minutes, the temperature increased by
8.11% and the relative humidity increased by 83.90%. The other
tests, which included varying the length of time the subject wore
the invention with the moisture pads, and base line relative
humidity in the room, also demonstrate increases in the temperature
and relative humidity of the area surrounding the eyes.
1TABLE 1 Testing of Apparatus on Subjects with Normal Eyes Tem- %
Change Relative % Change pera- from Base Humidity from Base Time
ture Temperature (RH) RH Comments Test 1: Pleasanton, CA, Apr. 20,
2003 7:44 PM 73.5 41.47 No moisture 7:46 PM 75 2.04% 47 13.33%
added. 7:50 PM 76.32 3.84% 52.2 25.87% 7:55 PM 77.5 5.44% 55.89
34.77% Eyes 50% 8:00 PM 77.9 5.99% 58.23 40.41% open/50% 8:05 PM
78.35 6.60% 60.3 45.41% closed. 8:16 PM 78.86 7.29% 63.36 52.79%
Test 2: Pleasanton, CA, Apr. 20, 2003 8:33 PM 75 44.4 Warm cloth
8:40 PM 81 8.00% 67.21 51.37% on face for 5 8:43 PM 81 8.00% 70.49
58.76% minutes. Eyes closed. Test 3: Pleasanton, CA, Apr. 21, 2003
3:50 PM 74.45 43.78 No moisture added, eyes closed. 3:58 PM 77
3.43% 45.3 3.47% Warm, moist 4:20 PM 83.75 12.49% 69.48 58.70%
moisture 4:40 PM 77.89 4.62% 79 80.45% pads inserted 4:55 PM 80.49
8.11% 80.51 83.90% for 10 minutes. Test 4: Pleasanton, CA, Apr. 22,
2003 7:30 PM 70 48 Warm, moist 7:35 PM 71 1.43% 65 35.42% moisture
7:40 PM 71 1.43% 70 45.83% pads 7:50 PM 70 0.00% 74.7 55.63%
inserted. 8:00 PM 70 0.00% 76 62.50% Eyes closed. Test 5: New York,
NY, Apr. 24, 2003 10:21 63.74 26.63 Warm, moist 10:40 71 11.39% 66
147.84% moisture 10:50 71 11.39% 72 170.37% pads inserted for 5
minutes. Eyes closed. Test 6: New York, NY, Apr. 25, 2003 8:15 PM
70 35 Generous 8:30 PM 73 4.29% 67 91.43% spray of 8:40 PM 73 4.29%
73 108.57% Nature's 8:45 PM 74 5.71% 75 114.29% Tears eye 8:51 PM
74 5.71% 78 122.86% mist added. 9:00 PM 74 5.71% 79 125.71%
[0085] The results of the testing the apparatus and system of the
present invention on subjects with dry eye conditions are depicted
in Table 2 below. As Table 2 depicts, the temperature and relative
humidity increased over time during each test. Notably, the longer
the subject wore the apparatus of the present invention, the
greater the temperature and humidity increased. Additionally,
patients who participated in the tests experienced significant
relief from their dry eye conditions for up to six hours following
the use of the present invention.
2TABLE 2 Testing of Apparatus on Subjects with Dry Eye Conditions
Tem- % Change Relative % Change pera- from Base Humidity from Base
Time ture Temperature (RH) RH Comments Test 7: Campbell, CA, May
29, 2003 6:20 PM 74 44 Added 6:26 PM 76 2.70% 62 40.91% Moisture
Pad 6:30 PM 75 1.35% 70.2 59.55% Removed 6:35 PM 76 2.70% 72 63.64%
Moisture Pad 6:40 PM 76 2.70% 74 68.18% 6:45 PM 77 4.05% 77.54
76.23% Test 8: Campbell, CA, May 29, 2003 7:02 PM 74 46 Added 7:07
PM 75.5 2.03% 63.6 38.26% Moisture 7:14 PM 78 5.41% 67 45.65% Pads
7:22 PM 77 4.05% 73 58.70% Removed 7:28 PM 77.4 4.59% 76 65.22%
Moisture Pads Test 9: Campbell, CA, May 29, 2003 7:56 PM 73 45
Added 8:05 PM 76 4.11% 78 73.33% Moisture 8:08 PM 76 4.11% 81.1
80.22% Pads 8:14 PM 78.44 7.45% 85.82 90.71% Removed 8:19 PM 79
8.22% 85.03 88.96% Moisture 8:25 PM 80 9.59% 86.6 92.44% Pads
[0086] The results of testing the apparatus and system of the
present invention on subjects in a low-humidity environment, i.e.,
on an airplane, are depicted in Table 3 below. As Table 3 depicts,
the temperature and relative humidity increased over time for each
test. Notably, the relative humidity increased by over 100% for
each test. Additionally, the relative humidity of the area
surrounding the eyes continued to increase, even while the relative
humidity within the plane continued to decline, even upon descent
of the airplane.
3TABLE 3 Testing of Apparatus on Subjects with Dry Eye Conditions
Tem- % Change Relative % Change pera- from Base Humidity from Base
Time ture Temperature (RH) RH Comments Test 10: Airplane, Jun. 18,
2003 10:01 AM 74 21 Added 10:11 AM 76 2.70% 52 147.62% little
moisture to lens cavity (1 drop, spread around lens cavity) 10
minutes at 10,000 ft. Test 11: Airplane, Jun. 18, 2003 10:23 AM 74
17.1 Sprayed eyes 10:40 AM 77 4.05% 61 256.73% lightly with Biomist
13 minutes at 10,000 ft.
[0087] As evident from the data of Tables 1, 2, and 3 the present
invention fulfills a long-felt need in the industry to treat and/or
alleviate dry eye symptoms while at the same time promoting healthy
eyes. The present invention overcomes various shortcomings of the
currently available treatments, including providing a natural,
inexpensive, easy to use and comfortable device that can be used in
the treatment of dry eye conditions and to promote overall eye
health.
[0088] It will thus be seen that the objects set forth above, among
those made apparent from the preceding description, are efficiently
attained and, since certain changes may be made in the above
construction without departing from the spirit and the scope of the
invention, it is intended that all matter contained in the above
description and shown in the accompanying drawings shall be
interpreted as illustrative and not in a limiting sense.
[0089] It is also to be understood that the following claims are
intended to cover all the generic and specific features of the
invention herein described and all statements of the scope of the
invention which, as a matter of language, might be said to fall
therebetween.
* * * * *