U.S. patent application number 14/152486 was filed with the patent office on 2014-05-22 for eyelid margin wipes comprising chemical means for temperature adjustment.
This patent application is currently assigned to Optometric Technology Group LTD.. The applicant listed for this patent is Optometric Technology Group LTD.. Invention is credited to Michel Lucien GUILLON, Cecile Adrienne MAISSA.
Application Number | 20140142668 14/152486 |
Document ID | / |
Family ID | 9947251 |
Filed Date | 2014-05-22 |
United States Patent
Application |
20140142668 |
Kind Code |
A1 |
GUILLON; Michel Lucien ; et
al. |
May 22, 2014 |
Eyelid Margin Wipes Comprising Chemical Means for Temperature
Adjustment
Abstract
An eyelid margin wipe comprising chemical means for adjusting
the temperature of the wipe relative to the ambient temperature.
The wipe is particularly useful for treatment of disorders of the
eyelid or eyelid margin such as meibomian gland dysfunction.
Inventors: |
GUILLON; Michel Lucien; (St.
Laurence, JE) ; MAISSA; Cecile Adrienne; (London,
GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Optometric Technology Group LTD. |
London |
|
GB |
|
|
Assignee: |
Optometric Technology Group
LTD.
London
GB
|
Family ID: |
9947251 |
Appl. No.: |
14/152486 |
Filed: |
January 10, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13932426 |
Jul 1, 2013 |
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14152486 |
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11120757 |
May 3, 2005 |
8506539 |
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13932426 |
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PCT/GB2003/004782 |
Nov 5, 2003 |
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11120757 |
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Current U.S.
Class: |
607/112 ;
607/114 |
Current CPC
Class: |
A61P 27/02 20180101;
A61M 2202/0488 20130101; A61K 8/20 20130101; A61K 8/0208 20130101;
A61F 7/03 20130101; A61L 15/18 20130101; A61K 8/19 20130101; A61K
2800/242 20130101; A61K 2800/244 20130101; A61K 9/0048 20130101;
A61P 27/14 20180101; A61F 2007/0004 20130101; A61F 2007/0095
20130101; A61K 8/26 20130101; A61K 2800/31 20130101; A61K 2800/5922
20130101; A61L 15/42 20130101; A61K 8/23 20130101; A61M 35/003
20130101; A61F 2007/0292 20130101; A61F 7/034 20130101; A61M
2205/364 20130101; A61Q 19/10 20130101; A61F 9/0017 20130101 |
Class at
Publication: |
607/112 ;
607/114 |
International
Class: |
A61F 7/03 20060101
A61F007/03 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 5, 2002 |
GB |
0225795.4 |
Claims
1-40. (canceled)
41. An eyelid wipe for treatment of a disorder of an eye, eyelid,
or eyelid margin, comprising: a) at least two components adapted to
lower a temperature of the eyelid wipe from an ambient temperature
to a desired temperature upon a reaction of the at least two
components, b) a water-impermeable container for preventing the at
least two components from coming into contact with a closed eye
when in use, c) a seal for keeping the at least two components
separate until a temperature change is initiated, and d) at least
one agent selected from the group consisting of soothing agents,
cleansing agents, and surfactant agents.
42. The eyelid wipe of claim 41, wherein the disorder is
blepharitis, dryness, irritation, redness, inflammation, meibomian
gland dysfunction, hay fever, a condition associated with use of
eye cosmetics, or a condition associated with contact-lens
wear.
43. The eyelid wipe of claim 41, wherein the reaction is an
endothermic reaction.
44. The eyelid wipe of claim 41, wherein one of the at least two
components is a hydratable inorganic salt.
45. The eyelid wipe of claim 41, wherein one of the at least two
components is NH.sub.4NO.sub.3.
46. The eyelid wipe of claim 41, wherein the at least two
components comprise NH.sub.4NO.sub.3 and water.
47. The eyelid wipe of claim 41, wherein the at least two
components comprise an oxidising agent and a reducing agent.
48. The eyelid wipe of claim 41, wherein the desired temperature is
from about 0.degree. C. to about 25.degree. C.
49. The eyelid wipe of claim 41, wherein the desired temperature is
from about 5.degree. C. to about 10.degree. C.
50. The eyelid wipe of claim 41, wherein the desired temperature is
reached within 2 minutes after the temperature change is
initiated.
51. The eyelid wipe of claim 41, wherein the desired temperature is
reached within 1 minute after the temperature change is
initiated.
52. The eyelid wipe of claim 41, wherein the desired temperature is
reached in less than about 60 seconds after the temperature change
is initiated.
53. The eyelid wipe of claim 41, wherein the desired temperature is
reached in from about 30 to about 60 seconds after the temperature
change is initiated.
54. The eyelid wipe of claim 41, wherein the desired temperature is
maintained for at least about 5 minutes.
55. The eyelid wipe of claim 41, wherein the desired temperature is
maintained for at least about 8 minutes.
56. The eyelid wipe of claim 41, wherein the desired temperature is
maintained for at least about 10 minutes.
57. The eyelid wipe of claim 41, wherein the desired temperature is
maintained for from about 5 minutes to about 30 minutes.
58. The eyelid wipe of claim 41, wherein the eyelid wipe is
sterile.
59. The eyelid wipe of claim 41, wherein the eyelid wipe is square,
rectangular, circular, ovoid, eye-shaped, curved to correspond to a
contour of an eye, sized to be used on one eye region, or sized to
be used on two eyes simultaneously.
60. The eyelid wipe of claim 41, further comprising a band, a
pocket, or a layer for holding the eyelid wipe for a period of
time.
61. The eyelid wipe of claim 60, comprising the band that is
elastic.
62. The eyelid wipe of claim 41, further comprising an adhesive
portion on a part or the whole of one side of the eyelid wipe.
63. The eyelid wipe of claim 62, wherein the adhesive portion
comprises one or more adhesive materials selected from the group
consisting of acrylic adhesives, hydrocolloidal or hydrogel
adhesives, natural rubber, synthetic rubber, and any combination
thereof.
64. The eyelid wipe of claim 41, further comprising a removal strip
to protect an adhesive portion.
65. The eyelid wipe of claim 64, wherein the removal strip is a
polymer or paper strip treated with silicone.
66. The eyelid wipe of claim 41, wherein the eyelid wipe is coated
with a polymeric material capable of moulding to a surface of an
eye.
67. The eyelid wipe of claim 41, wherein the seal is a frangible
seal.
68. The eyelid wipe of claim 41, wherein the at least one agent is
at least one cleansing agent or at least one surfactant agent.
69. The eyelid wipe of claim 41, wherein the at least one agent is
PEG-80 sorbitan laurate, sodium trideceth sulfate, PEG-150
distearate, cocamidopropyl hydroxysultaine, sodium laureth-13
carboxylate, disodium lauroamphodiacetate, polysorbate 80,
polysorbate 20, poloxamer 184, ammonium laureth sulfate, ceteareth
20, ceteareth 25, cocamidopropyl betaine, disodium laureth
sulfosuccinate, disodium lauriminodipropionate, disodium
lauroamphodipropionate, glycol stearate, hydrogenated castor oil,
laureth-23, magnesium laureth, oleth sulfate, PEG-20 stearate,
PEG-35 castor oil, PEG-40 hydrogenated castor oil, PEG-60
hydrogenated castor oil, PEG-7 hydrogenated castor oil, PEG-75
lanolin, poloxamer, sodium laureth sulfate, sodium trideceth
sulfate, sodium C12-15 pareth 15 sulfonate, sodium C14-16 olefin
sulfonate, or any combination thereof.
70. The eyelid wipe of claim 41, further comprising a drug delivery
system.
71. The eyelid wipe of claim 41, further comprising at least one
additional agent selected from the group consisting of
anti-inflammatory agents, anti-bacterial agents, decongestants,
antistatic agents, preservatives, antioxidants, antimicrobial
agents, chelating agents, emollients, emulsifying agents,
buffering/neutralising agents, humectants, thickeners, viscosity
controlling agents, antistatic agents, conditioning agents, and any
combination thereof.
72. The eyelid wipe of claim 71, comprising the viscosity
controlling agent that is polyethylene glycol (PEG).
73. The eyelid wipe of claim 41, further comprising a reflective
layer or a conductive layer to direct cooling towards a surface of
the eyelid wipe.
74. The eyelid wipe of claim 41, further comprising an indicator
which confirms to a user that the desired temperature is
reached.
75. The eyelid wipe of claim 74, wherein the indicator is a
temperature sensitive color indicator configured to change from a
first color to a second color when the desired temperature is
reached.
76. The eyelid wipe of claim 75, wherein the indicator is
configured to undergo a reversible color change, such that when the
eyelid wipe is no longer at the desired temperature or falls
outside of a desired temperature range, the indicator reverts to
the first color.
77. The eyelid wipe of claim 74, wherein at least a part of the
eyelid wipe is coated with a temperature reactive ink or a
temperature reactive dye.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
13/932,426, filed on Jul. 1, 2013, which is a divisional of
application Ser. No. 11/120,757, filed on May 3, 2005, now U.S.
Pat. No. 8,506,539, which is a continuation, under 35 U.S.C.
.sctn.120, of International Patent Application No.
PCT/GB2003/004782, filed on Nov. 5, 2003 under the Patent
Cooperation Treaty (PCT), which was published by the International
Bureau in English on May 21, 2004, which designates the United
States and which claims the benefit of Great Britain Patent
Application No. GB 0225795.4, filed Nov. 5, 2002. All
above-referenced prior applications are incorporated by reference
herein in their entirety and are hereby made a portion of this
specification.
FIELD OF THE INVENTION
[0002] The present invention relates to wipes. More particularly,
it relates to eyelid margin wipes. In a further aspect, the present
invention relates to a method of treatment of disorders of the
eyelid margin such as those caused by meibomian gland
dysfunction.
BACKGROUND OF THE INVENTION
[0003] Meibomian glands, which are positioned throughout the eyelid
margins, provide lipid like secretions (known as meibum) to the
surface of the eye. When blinking occurs, the upper eyelid moves
downwardly over the eye and assists the lipid secretion between the
margins of the eyelids. Upon eye opening, the upper lid moves
upwardly and pulls a sheet of lipid upwardly to form a film over
the eye. This lipid sheet coats the aqueous part of the tear layer
which in turn coats the surface of the eye. The presence of this
lipid sheet restricts evaporation of the tear layer such that the
surface of the eye is maintained in a moist environment. Failure of
the meibomian glands will mean that the required lipid layer is not
properly formed and evaporation of the tear layer will occur
rapidly which will lead to sensations of dryness, irritation and
burning.
[0004] The main cause of failure of the meibomian glands is due to
their becoming clogged. A number of factors may lead to clogging.
For example, hormonal changes, particularly in levels of oestrogen,
can result in thickening of the oils which will in turn clog the
glands. In addition, it has been suggested that changes in
oestrogen levels may cause staphylococcal bacteria, which naturally
inhabit the eye, to proliferate. Unfortunately, this proliferation
may cause the bacteria to invade the meibomian glands which can
cause a decrease in the secretion of lipids from the glands.
[0005] Additionally or alternatively the clogging may be caused by
immunological factors such as sebhorreic blepharitis or systemic
diseases such as acne rosacae. Blepharitis also affects the lid
margin and is often associated with meibomian gland dysfunction.
Blepharitis occurs in increasing prevalence with the age of the
patient. Where blepharitis occurs, inflammation of the lid margins
may be noted often in combination with redness. In addition,
scales, crusts and/or marginal ulcers may be observed.
[0006] Mechanical failure may also cause the glands to dysfunction.
Further information relating to the aetiology of meibomian gland
dysfunction may be found in Gutgessel V J et al (1982)
Histopathology of Meibomian Gland Dysfunction. Ma. J. Opthal 94:
383-388.
[0007] An increased disfunction of the meibomian gland is noted
with age and in addition may be seen to be higher in contact lens
wearers. In Ong B L and Lark J R (1990) Meibomian Gland
Dysfunction: Some Chemical, Biochemical and Physical Observations,
Opthal: Physiol Opt 10: 144-148 a 30% prevalence of gland
dysfunction was noted in contact lens wearers and 23% in
non-contact lens wearers in a preliminary study involving 140
subjects, half of which were contact lens wearers.
[0008] In Ong B L (1996) "Relation Between Contact Lens Wear and
Meibomian Gland Dysfunction" Optom & Vis Sci 73: 208-210, 231
subjects were evaluation of which 81 were contact lens wearers. A
prevalence to meibomian gland dysfunction was noted in 43% of the
contact lens wearers and 35% of the non-contact lens wearers.
[0009] The effect of age was considered by Horn M M et al in
"Prevalence of Meibomian Gland Dysfunction 1990 Optom & Vis Sci
67: 710-712. Here 298 patients aged from 10 to over 60 were tested.
The results reported an overall prevalence to dysfunction of 39%.
However, the levels were low at a young age with a marked increase
being noted as age increased. For each decade up to 49 years there
was an increase with the maximum being at 40%. From 50 to 59 years
a prevalence of 51% was noted, and for patients over 60, the
prevalence was noted to have risen to greater than 67%.
[0010] In addition to contact lens wearing and aging, abnormal
behaviour of the meibomian glands may be exacerbated by illness or
the use of cosmetics.
[0011] The severity of meibomian gland dysfunction is variable and
depends on the stages of the dysfunction. In the initial stages
increased secretion is noted. This leads to over development of the
epithelial cells lining the duct of the glands and to modification
of the lipid composition. These cells may be excreted from the
glands producing dandruff-like scales.
[0012] In the intermediate stage, the change in lipid composition
leads to an increase in the melting point of the lipid, such that
it becomes a paste like solid at eyelid temperature which leads to
partial or total blockage of the meibomian glands. The further
production and accumulation of desquamated epithelial cells adds to
the blockage of the gland orifices.
[0013] In the advanced stages, long term blockage of the glands can
lead to the meibomian glands becoming atrophied. It is essential to
commence treatment before the final stage is reached since once the
glands have become atrophic, the dysfunction is irreversible.
[0014] The slow evolutionary nature of the dysfunction means that
the stages of meibomian gland dysfunction is often different for
different glands along the same eyelid margin.
[0015] Conventionally, the blocked glands are treated with a cloth,
facecloth or towel which is immersed in boiling water, allowed to
partially cool and then placed over closed eyes. The aim of the
treatment is to melt the solidified lipids and to loosen the debris
which has collected around the glands and at the base of the
eyelashes. It is sometimes suggested that salt should be applied to
the cloth.
[0016] Whilst this treatment may be effective if correctly
performed, it does suffer from certain disadvantages and drawbacks.
The main drawback is that the user must estimate when the cloth is
at the correct temperature before placing it over the eyes. If the
cloth is too hot, there is a risk that the patient will be scalded.
Conversely, if the cloth has cooled too much, the treatment will be
ineffective. Further, it is a cumbersome and awkward treatment
which cannot readily be utilised outside of the home. Since the
procedure is complex and time consuming it is often abandoned by
the patient before the required benefits are obtained. A further
disadvantage of this method is that even if the cloth is at the
correct temperature at the start of the treatment, it will rapidly
cool such that the required temperature is only maintained for a
short period of time.
[0017] An additional drawback is that there is a risk of bacterial
contamination as the cloth is not sterile. This is a particularly
serious problem for contact lens wearers.
[0018] A second stage of treatment is to treat the eyelid margin
with cleaning agents. Examples of suitable cleaning agents are
those sold under the trade marks "Lid-Care" by CibaVision and
"Supranettes" by Alcon.
[0019] Whilst the use of hot cloths and cleaning agents may go some
way to addressing the symptoms of meibomian gland dysfunction,
there is still a need for a treatment system which will overcome
the above-mentioned disadvantages and which can be readily used by
patients with busy lifestyles.
[0020] Other eye problems may benefit from treatment with a hot
wipe or in some circumstances with a cooled wipe. These problems
include the eye symptoms encountered by hayfever sufferers and the
swelling/edema caused by trauma. The application of a cooled wipe
to the eye region may also be beneficial in the treatment of
headaches. It is recommended that, for example for the treatment of
swelling, cooling with cold water at about 8.degree. C. for about
30 minutes is recommended. Although for ice therapy the application
time may be significantly shorter. Conventionally, where the
extreme treatment in which ice is applied it is necessary to take
extra care to ensure that ice is not applied directly to the skin
since burning can occur.
SUMMARY OF THE INVENTION
[0021] It is therefore desirable to provide a treatment which
provides the user with control over the temperature and which is
simple to operate.
[0022] Whilst various proposals have been made for heating bandages
and the like, such as those systems described in U.S. Pat. No.
5,662,624, WO 98/29079, U.S. Pat. No. 6,465,709, WO 01/03619 and
U.S. Pat. No. 6,265,631 none provide the required level of control
over the temperature and maintenance of temperature. Further, they
are not configured to be suitable for use in the delicate and
sensitive eye area.
[0023] Thus according to the first aspect of the present invention
there is provided an eyelid margin wipe comprising chemical means
for adjusting the temperature of the wipe relative to the ambient
temperature.
[0024] It should be noted that in general the primary function of
the wipe is to clean away one or more of: dead cells; debris;
meibomian secretions; and the like. Whilst in some arrangements of
the present invention secretions may be adsorbed onto the surface
of the wipe, in general the wipe of the present invention would not
be regarded as an absorbent article.
[0025] By "adjusting the temperature" we mean that the temperature
of the wipe will change relative to ambient temperature to a
pre-determined temperature. The change in temperature may be a
heating or cooling of the wipe.
[0026] The temperature to which the wipe will be adjusted will be
dependent on the end-use to which it is to be put. However, it will
be understood that by selection of the appropriate chemical means,
the required temperature to achieve the desired results can be
reproducibly achieved with each wipe thereby obviating the problems
associated with the prior art where the cloth may not be adjusted
to the correct temperature.
[0027] For the treatment of the symptoms of meibomian gland
dysfunction, the required temperature is that required to melt the
set lipid. As meibomian secretion is usually a mixture of lipids
there is normally no sharp melting point and the various lipids
present may have melting points over a wide temperature range. Ong
B L and Larke J R in Meibomian Glad Dysfunction: Some Clinical,
Biochemical & Physical Observations (Opthal. Physiol. Opt 1990,
10, April: 144-148) reported a range of from 32.degree. C. to
40.degree. C. with a significant difference in melting points being
noted between normal and abnormal lipid samples.
[0028] Other experiments have suggested different temperature
ranges. For example, Tiffany J M & Marsden R G in The Influence
of Composition On Physical Properties of Meibomian Secretion In The
Preocular Tear Film in Health, Disease and Contact Lens Wear (Dry
Eye Institute, Lubbock Tx 1986; 597-608) reported a range of from
19.5.degree. C. to 32.9.degree. C.
[0029] These differences are attributable to the make-up of the
secretion. The secretion is generally fluid enough to flow from the
glands and spread to form a superficial tear film layer.
[0030] For the wipes of the present invention, in the circumstances
in which the temperature adjustment is to be a rise in temperature
for example for the treatment of meibomian gland dysfunction,
temperatures in the region of from about 40.degree. C. to about
55.degree. C. will generally be desirable with temperatures in the
region of from about 45.degree. C. to about 52.degree. C. being
particularly preferred.
[0031] The adjusted temperature is preferably maintainable for at
least about 5 minutes, preferably about 8 minutes and most
preferably about 10 or more minutes.
[0032] For the wipes of the present invention, in the circumstances
in which the temperature adjustment is to be a lowering in
temperature for example to treat swelling/edema following trauma
temperatures in the range of from about 0.degree. C. to about
25.degree. C. are desirable with temperatures in the range of about
5.degree. C. to about 10.degree. C. being particularly preferred.
It is desirable that cooling can be maintained from about 5 minutes
to about 30 minutes.
[0033] To assist the user, the wipe may incorporate an indicator
which confirms to the user that the required temperature has been
reached. The indicator may be a temperature sensitive colour
indicator which will change colour from a first to a second colour
when the required temperature is achieved. In one arrangement the
colour change will be reversible such that when the wipe is no
longer at the desired temperature or has fallen outside the desired
temperature range the indicator will revert to the first colour.
The colour indicator may be provided by any suitable means. In one
arrangement at least a part of the wipe may be coated with a
temperature reactive ink or treated with a temperature reactive
dye. Thus the user will be advised to wait until a particular
colour is achieved before using the wipe and to cease use once the
particular colour disappears.
[0034] The wipe of the present invention may be of any suitable
configuration. In one arrangement it may be a sheet-like material.
In one alternative arrangement, the wipe may have increased
thickness. The material may be impregnated with or coated with the
chemical temperature adjusting means.
[0035] The wipe may be a cloth-type material. Where the wipe is
formed from a cloth-type material, the cloth may be of any suitable
material and may be formed by any technique including weaving,
air-laying and the like. Thus the material may be woven or
non-woven. The cloth may be made from natural or synthetic fibres
or a mixture of both. The material may be selected for its
compatibility with the chemical means used for adjusting the
temperature of the wipe. Additionally or alternatively, the
material may be selected for more aesthetic considerations such as
softness and eye-appeal. The cloth may be of any suitable
thickness. Suitable thicknesses include those from about 0.2 mm to
about 5 mm, more preferably from about 1 to about 4 mm. However,
thicker arrangements may be desirable in some circumstances.
[0036] In a second alternative material, the wipe, rather than
being formed of a cloth-type material, may be formed from a
sponge-type material. The sponge may be a natural or synthetic
sponge. The sponge-type material wipe may be of any suitable size
and may have a thickness greater than that noted for the cloth-type
material wipe.
[0037] In a third alternative arrangement, the wipe may be provided
as a multi-layered material. The material in each layer may be the
same or different. For example, the wipe may comprise a sponge
material having attached to one or both surfaces thereof a
cloth-type material. Where the cloth-type material is applied to
two opposing faces of a sponge-type material, the material used in
each face may be the same or different. The multi-layered wipe may
be of any suitable thickness.
[0038] The wipe may comprise several layers of cloth-type material,
each of which may be different. Where a layered structure is used,
the temperature adjusting means may be located in or on one or more
of the layers.
[0039] Where the wipe is to be coated with one or more temperature
adjusting materials, it may be coated on one or both sides of the
wipe. However, the chemical means is preferably only applied to one
side to allow an uncoated free side of the wipe. In some
arrangements the uncoated side may be applied to the eye. In
alternative arrangements, the uncoated side may be used for
application of materials such as therapeutic materials, cleaning
fluids or the like.
[0040] Where the wipe is impregnated with temperature adjusting
material, the material may be located throughout the wipe or, for
example, may be provided in such a manner that particles of the
temperature adjusting material will not come into contact with the
eye when in use. The temperature adjusting material may be
immobilised in a non-woven pad which is provided, for example, as
the cloth-type material or as one layer in a multi-layered
arrangement.
[0041] In a further alternative arrangement, or where required by
the temperature adjusting means selected, the wipe may be an
arrangement comprising a pocket or the like into which the
temperature adjusting components may be placed, either directly or
in a separate container. In an alternative arrangement the material
from which the wipe is formed surrounds the temperature adjusting
means, for example is wrapped around the temperature adjusting
means which may be placed in a suitable container.
[0042] The temperature adjusting component may be a self-heating or
cooling device or a device relying on external sources of heat or
cold. Where external devices are used to cause the temperature
adjusting means to change temperature, these may be conventional
sources such as ovens, microwave ovens, refrigerators and the like.
In one alternative arrangement, the external device may be a
purpose-built device. In one arrangement, the chemical temperature
adjusting means may be activated by a conducting foil-strip located
in the wipe which may be connected to an energy source.
[0043] The wipe is preferably single use but in one alternative,
although not-preferred, arrangement, the wipe may be re-usable.
Where multi-use is desirable, the wipe will generally be configured
such that it comprises a pocket for containing the temperature
adjusting means which is preferably located in a separate
container. On re-use, the temperature adjusting means container
will generally be removed and replaced with a fresh container.
Where the wipe is to be re-used in this manner, it is preferably
produced from washable material.
[0044] The wipe may be of any suitable shape and/or configuration.
Suitable shapes include squares, rectangles, circles and ovals. In
one arrangement, the wipe may be finger-shaped. The wipe may be of
any suitable size. It may be sized to be approximately the size of
one eye region or may be sized such that it could be used on two
eyes simultaneously. In this latter arrangement, a band, such of
elastic, may be provided so that the user can wear the wipe for a
period of time.
[0045] The wipe may be shaped to have a profile which assists its
operation. For example, the wipe whether of a square, rectangular,
circular or ovoid shape may be curved such that when laid over the
closed eye, it will follow the curvature of the eye and ensure that
the temperature is provided across the entire eyelid and eyelid
margin.
[0046] In one arrangement the wipe may be coated, at least on one
surface, with a material, such as a polymeric material which is
soft such that it moulds to the shape of the users eye and thereby
ensures that the temperature is provided across the entire eyelid
and eyelid margin. In one arrangement the polymeric material may
not be soft at room temperature but softens as the temperature of
the wipe increases.
[0047] In one preferred arrangement the wipe may include a pocket
into which the user may insert one or more fingers. This
arrangement will facilitate the user when performing any rubbing of
the eyelid margin which may be desirable, for example as part of
the treatment of meibomian gland dysfunction. In a most preferred
arrangement, the wipe may be shaped to correspond to the shape of a
finger. One benefit of this arrangement is that the user will be
able to readily control the wipe during any rubbing motion.
[0048] In one alternative arrangement, the configuration of the
wipe may correspond to two or more finger shapes, conjoined, for
example by a web of material. In one arrangement, each fingered
shaped portion would be arranged to receive at least part of one
finger. In a preferred arrangement of the present invention one or
more finger portions would include the heating means and one or
more other finger portions would be of non-heated fabric which
might be used for massaging or for the application of, for example,
cleansing agent.
[0049] In one arrangement, the wipe, however configured, may
include an adhesive portion so that it can be left in place on the
eye to warm or cool the eye prior to massaging taking place. In one
arrangement, the adhesive portion may comprise at least a part of
one side of the wipe. In one alternative arrangement the whole of
one side may be adhesive. In this arrangement, the user will
normally turn the wipe over prior to massaging/wiping such that
massaging/wiping is carried out with a non-adhesive side of the
wipe. Where an adhesive portion is used, the wipe will generally be
provided with a removal strip, such as a polymer strip or a paper
strip surface treated with silicone, in place to protect the
adhesive material. Any suitable adhesive material may be used which
enable the wipe to be held in place without causing irritation to
the delicate eye area and which will enable the wipe to be readily
removed without causing discomfort to the user. Examples of
adhesive materials include acrylic adhesives, liquid absorbing
adhesives, such as a hydrocolloidal or hydrogel adhesives, natural
rubber or synthetic rubber.
[0050] The adjustment in the temperature of the eyelid wipe may be
achieved by any suitable means. However, the selection of the
appropriate means will generally be dependent on the required
temperature for the wipe and the suitability of any chemical
components for use in the delicate eyelid region. The ability of
the material to maintain the temperature for the required period of
time may also be a factor which will be taken into consideration
when selecting the heat adjusting means. Where chemicals are to be
used which are not suitable for direct application to the skin or
eyelid margin, the arrangement in which the heat adjusting means
are placed in a separate container within the wipe will generally
be utilised, although any means for separating them from the skin
may be used.
[0051] The method chosen to accomplish the adjustment in
temperature preferably enables the wipe to reach the desired
temperature in a short period of time, usually less than about 60
seconds. Times in the order of from about 30 to about 60 seconds
are particularly preferred.
[0052] In one arrangement, the wipe, however configured, may alter
in temperature on exposure to oxygen, generally the oxygen in the
air. Examples include the use of wipes impregnated with, or coated
with, material which on exposure to air oxidises and in doing so
generates heat. In one arrangement, the material which on exposure
to air oxidises to generate heat may be placed in an
oxygen-permeable bag which may be enclosed within the wipe or
placed in a pocket in the wipe.
[0053] Suitable materials include those which form an oxide when
reacted with oxygen at room temperature including: iron, aluminium,
magnesium, titanium, manganese, zinc, molybdenum and tin oxide (II)
with iron powder being particularly preferred. The material will
generally be provided in powder form to provide a large surface
area on which oxidation may occur. The material used may be a
mixture of two or more of the foregoing. Further examples of
suitable materials include: metal sulphides, polysulphides or
hydrosulphides mixed with a catalyst carried on a carbonaceous
material; powdered solids such as elemental iron, mixed with salts
and water; mixtures of iron powder, water, cellulose, salt and
vermiculite activated carbon; iron powder, water, salt and
activated charcoal; iron or other metals mixed with alkali metal
salts and a catalyst; redox systems such as metal powder (usually
ferrous), a metal chloride, water and a water absorber; and
alkaline earth metal oxides, such as magnesium oxide, with
chlorides or sulfides of alkali metals or alkaline earth metals. It
will be understood that some of the components of the mixtures
listed do not directly contribute to the heat generating reaction
but are present to modify or control the reaction. For example,
catalysts, assistants, fillers and moisteners may be present.
[0054] Where the temperature adjustment means operates on exposure
to air, the wipes will generally be provided to the user in an
airtight package. Examples of airtight packages include plastic
envelopes and foil, particularly aluminium foil, pouches. As the
package is opened, the wipe will be exposed to air and the
adjustment in temperature will commence.
[0055] In one alternative arrangement, the wipe, however
configured, may alter in temperature on exposure to water. In this
arrangement, material impregnated into, coated on, or enclosed
within the wipe may be based on chemical substances which generate
heat when in the presence of water. The heat generated may be, for
example, heat of hydration, dissolution or oxidation. The material
which generates heat on contact with water may be placed in a
water-permeable bag which may be enclosed within the wipe or placed
in a pocket in the wipe.
[0056] In use, these wipes would need to be treated with water, or
an aqueous solution in order for the heat to be generated. Suitable
aqueous solutions include saline, potassium salts, calcium salts,
aluminium chloride, calcium chloride, magnesium chloride, potassium
sulphate, magnesium sulphate, sodium sulphate and the like. Other
solutions may also be used to "wet" the wipe, including those
solutions commonly used in contact lens care regimes. The water or
other solution may be applied by immersing the wipes in the water
or solution or the water/solution may be poured or sprayed onto the
wipe.
[0057] Suitable materials for altering the temperature of the wipe
when contacted with water or other suitable solution include sodium
hydroxide, cobalt, chromium, iron, iron hydroxide, magnesium,
manganese, molybdenum, tin oxide (II), titanium and calcium
hydroxide. These powdered solids may be used alone or in
combination. Also suitable are powdered solids such as iron. These
may be used alone or with other components such as salt and
activated charcoal, or with alkali metals salts and a catalyst. In
addition, hydratable organic or inorganic salts such as calcium
chloride, calcium sulfate, cerous chloride, sodium carbonate,
aluminum chloride, magnesium chloride, magnesium sulfate, zinc
citrate, zinc sulfate, zinc nitrates, alkali metal carbonates,
alkali metal borates, alkali metal acetates, alkali metal citrates
or alkali metal phosphonates may be used. Similarly mixtures such
as: anhydrous calcium chloride, cerous chloride, cesium hydroxide,
sodium carbonate and organic oxide or salts such as calcium oxide,
aluminium chloride or calcium nitrate; sodium chloride with an
organic oxide or salt; hypochlorite salts with cellulosic or
cellulosic-containing materials; anhydrous calcium chloride and
calcium oxide; anhydrous calcium chloride, anhydrous sodium acetate
and calcium oxide; boron compounds having a boron-oxygen-boron
bond; anhydrous glycol; silica gel; activated alumina; and
synthetic zeolites may be used. Anhydrous zeolites, hydratable
organic or inorganic salts, magnesium sulphate, magnesium chloride,
calcium chloride and calcined gypsum are particularly preferred.
Each of these would produce an exothermic reaction when mixed with
water.
[0058] Also suitable are ammonium nitrate, sodium nitrate, ammonium
sulphurate, potassium nitrate, sodium thiosulphate, ammonium
chloride, ammonium bromide, ammonium iodide, potassium chloride and
tin chloride dihydrate which each produce an endothermic reaction
when mixed with water.
[0059] Whichever method is used to alter the temperature,
additional materials may be used to control or extend the
reaction.
[0060] In a further alternative arrangement, the wipe may contain
two components which are kept separate until temperature adjustment
is required at which time they are allowed to mix.
[0061] This technology may be provided by placing one of the
components in a frangible container which may be enclosed within
the wipe or, where appropriate, the wipe may comprise a pocket for
holding a container comprising one of the components or a container
comprising both components separated by any suitable means. In one
alternative arrangement, a single container may be used which
comprises two or more chambers, each containing one component. When
required, the components may be mixed, for example, by the breakage
of a frangible seal separating the two chambers such that a
reaction between the two components can occur. Where the reaction
is an exothermic reaction, heating will occur. Similarly where the
reaction is an endothermic reaction, cooling will be achieved.
[0062] The container may be made of any suitable material. Where
the component to be included in the container is water or an
aqueous solution, the material from which the component is
manufactured will be water-impermeable. Any suitable
water-impermeable material may be used provided that it has the
sufficient level of brittleness to rupture when pressure is
applied. Suitable materials include polymers such as polyethylene,
polypropylene, polyvinyl acetate, polyurethane, silicone rubber and
polyvinyl chloride.
[0063] The container may be constructed such that the contents can
be delivered to the other component in a pre-determined and
controlled manner, such that the temperature change can be
maintained for the desired period of time. For example, the
container may be a flexible container having sealed orifices which
open when pressure is applied to the container. The size of the
orifices will determine the time period over which the component
will be released from the container.
[0064] In an alternative arrangement one of the components may be
located on the wipe or may be impregnated in the material of the
wipe and the other component may be located within a container
which is frangible or which has a frangible seal, and which is
located within the wipe or within a pocket in the wipe.
[0065] In one example of a two component system, the first
component may be a compound which generates heat on contact with
water, such as calcium oxide, anhydrous magnesium sulphate,
colloidal clay or any other of the compounds identified as
generating heat on contact with water above and the second
component, separated from the first, may be water, saline or other
aqueous solution, including surfactant solutions. The second
component may additionally include active agents such as
anti-inflammatory or anti-bacterial agents.
[0066] Other two component systems include: magnesium/iron alloys
and electrolytes (suitable electrolytes include saline); magnesium
chloride with ethylene glycol; sodium thiosulfate with ethylene
glycol; boron-compounds having a boron-oxygen-boron bond with a
protic material such as water, methanol, ethanol, propanol,
isopropanol, butanol, lower amines, lower alkanol amine, aliphatic
oxides and polyols.
[0067] In another example of a two component system, the first
component may be a compound which cools down on contact with water
such as sodium nitrate and the second component separated from the
first until activation of the device may be saline, water or other
aqueous solutions such as surfactants. The second component may
additionally contain active agents such as anti-inflammatory or
anti-bacterial agents.
[0068] A further example of a two component system is an
oxido-reduction system in which an oxidising agent and a reducing
agent are used which undergo reaction when combined to generate
heat. Examples of oxidising agents include hydrogen peroxide, urea
hydrogen peroxide, sodium peroxide, sodium perborate, sodium
persulfate, ammonium persulfate and potassium persulfate. Examples
of reducing agents include thiourea compounds such as
1-phenyl-2-thio-barbituric acid. Preferred reactions include: a
hydride such as an alkali metal or alkaline earth metal borohydride
such as sodium, potassium or calcium borohydrides with an aldehyde
such as glyceraldelyde, a ketone such as acetone, a peroxide or a
sulfoxide; thiooxypyrimidine or 2-thio-4 oxypyrimidine with
hydrogen peroxide or sodium perborate; thiourea with hydrogen
peroxide; or alkali metal salts or manganese and chromium oxides
such as potassium permanganate or potassium chromate and alcohols
or polyols such as glycerin.
[0069] A still further example of a two component system includes
the reaction between an aqueous salt solution, such as aqueous
sodium solution, and seed crystals or metallic triggers that, on
contact with the aqueous salt solution, will activate
crystallisation and thereby generate heat. Examples include aqueous
sodium acetate solution and sodium acetate seed crystals. One
benefit of using a system in which crystallisation occurs is that
the presence of the resultant crystals within the wipe may be
beneficial during massaging of the eye. Some reactions in a two
component such as magnesium sulphate and water, a first exothermic
reaction will occur followed by a crystallisation which will also
generate heat thereby prolonging the heating of the wipe.
[0070] Whichever systems are used to adjust the temperature of the
wipe, materials may be present to regulate the reaction that causes
the adjustment of temperature. Suitable materials include gelling
agents, polymers and the like.
[0071] It will be understood that some mixtures identified include
materials which do not contribute to the heat adjusting reaction
but are adjuncts present to control the reaction. Similarly,
materials may be present to extend the temperature adjusting
reaction. For example, where the heat adjusting reaction is an
exothermic reaction, water-containing material that will release
water above a particular temperature may be present.
[0072] In addition, physical means may be included in the wipe to
control the temperature delivered to the user. For example, one or
more insulating layers, may be included. Similarly one or more
diffusing layers may be incorporated. In one alternative
arrangement a covering may be applied to the wipe which assists in
the temperature control. The thickness of the one or more layers in
the wipe may be selected to assist with temperature control.
[0073] Thus, the wipe may include a reflective layer and/or a
conductive layer to direct the heating or cooling towards one
surface of the wipe. The reflective layer and/or the conductive
layer may be made of any suitable material. Examples of suitable
materials include metal foils such as aluminium foil. Also suitable
are amorphous metallic oxide layers which are very thin and which
may be translucent.
[0074] The layered wipe including for example diffusion layers,
insulating layers and the like and the heat adjusting means located
in a container, may have any suitable thickness but will generally
be in excess of about 5 mm.
[0075] It will be understood that whatever method of heat control
is selected, by selection of particular chemical reactions, a
required temperature can be achieved and controlled without any
decisions having to be taken by the user. In addition the structure
of the wipe can be selected to optimise the temperature and control
its application to the user.
[0076] A further advantage of the present invention is that the
chemical means may be selected such that the required temperature
can be maintained for sufficient time to allow effective treatment
to be carried out.
[0077] Further, since the reaction will be reproducible in each
wipe containing the same temperature adjusting means, the user can
be assured of the appropriate temperature to achieve efficacy at
each treatment without the risk of burning of the delicate skin in
the eye region.
[0078] Whilst the present invention is described with particular
reference to the treatment of meibomian gland dysfunction, it will
be understood, that dependent on the temperature of the wipe, there
may be a variety of uses. For example, a cooled wipe may be useful
in the treatment of the symptoms of, for example, hay fever. The
wipes may also be useful in the lid care of contact lens wearers
and the sufferers of dry eye and also in the removal of eye
cosmetics. In this latter arrangement, in addition to the heat
management means, the wipe may include solutions particularly
suitable for the removal of eye make-up and/or having lipid
solubilising properties.
[0079] The eyelid wipe may be provided in a sealed pack formed from
any suitable material. Examples of suitable materials include
plastics and metal foils. The wipe is preferably sterile.
[0080] Where the temperature adjusting means is immobilised in the
wipe rather than being placed in a container within the wipe or a
pocket in the wipe a binder may be used. Suitable binders include
cellulose polymers, polyacrylic polymers, polyurethanes polymers,
gelatins and gums. Specific examples include
hydroxymethylcellulose, hydroxyethylcellulose,
hydroxypropylcellulose, cellulose acetates, polyvinylidene and
copolymers of polyacrylic acid and polyacrylates.
[0081] Whilst the foregoing discussion relates to the temperature
adjusting means being located within the wipe, the temperature
adjusting means may be located within the packaging in which the
wipe is provided. Any of the arrangements detailed herein may be
incorporated within the packaging. In use, the user will activate
the chemical adjusting means while the wipe is within the
packaging, allow the wipe to reach the required temperature and
then remove the wipe from the packaging for use. In this
arrangement, the wipe will generally be formed from a cloth-type
material.
[0082] In a preferred arrangement, the eyelid wipe will
additionally be impregnated with cleansing agents, surfactant
agents or cleansing and surfactant agents. The surfactants may be
effective as cleaning agents and/or solubilising agents. Any
suitable cleansing or surfactant agents may be used and examples
include PEG-80 sorbitan laurate, sodium trideceth sulfate, PEG-150
distearate, cocamidopropyl hydroxysultaine, sodium laureth-13
carboxylate, disodium lauroamphodiacetate, polysorbate 80,
polysorbate 20, poloxamer 184, ammonium laureth sulfate, ceteareth
20,25, cocamidopropyl betaine, disodium laureth sulfosuccinate,
disodium lauriminodipropionate, disodium lauroamphodipropionate,
glycol stearate, hydrogenated castor oil, laureth-23, magnesium
laureth, oleth sulfate, PEG-20 stearate, PEG-35 castor oil, PEG-40
hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-7
hydrogenated castor oil, PEG-75 lanolin, poloxamers, sodium laureth
sulfate, sodium trideceth sulfate, sodium C12-15 pareth 15
sulfonate, and sodium C14-16 olefin sulfonate.
[0083] Thus the invention in preferred embodiments provides for the
controlled delivery of an appropriate temperature with controlled
delivery of agents such as cleaning agents, surfactant agents or
soothing agents.
[0084] The wipe may also include one or more of antistatic agents,
preservatives, antioxidants, antimicrobial agents, chelating
agents, emollients, emulsifying agents, buffering/neutralising
agents, humectants, thickeners/viscosity controlling agents and
antistatic/conditioning agents.
[0085] One example of a suitable preservative is imidazolidinyl
urea. Suitable antioxidants include tocopherol and tocopheryl
acetate. Suitable antimicrobial agents include quaternium-15. EDTA
is one example of a suitable chelating agent. Sodium methylparaben,
sodium propylparabem and quaternium 8,14 may also be present.
[0086] Examples of emollients include natural or mineral oils or
esters. Specific examples include potassium C12-13 monoalkyl
phosphate polysorbate 60, potassium C12-13 monoalkyl phosphate,
calendula officinalis, almond oil PEG-6 esters, capric/caprylic
triglyceride, cetearyl alcohol, cocoa butter, decyl oleate,
dimethicone, dimethicone copolyol, glyceryl stearate, glyceryl
caprylate, glyceryl oleate, glycol stearate, glycol oleate,
hydrogenated castor oil, hydrogenated soybean oil, laneth-10
acetate, lanolin, lanolin alcohol, acetylated lanolin alcohol,
lecithin, PEG-11 castor oil, PEG-75 lanolin, petrolatum, PPG-26
oleate, PEG-10 butanediol or stearyl alcohol.
[0087] Examples of emulsifying agents include PEG-6 caprylic/capric
glyceride, ceteareth 20,25, cetearyl alcohol, glycereth-20
stearate, glyceryl stearate, glyceryl caprylate, glyceryl oleate,
glycol stearate, glycol oleate, hydrogenated castor oil, laneth-10,
laneth 10 acetate, lanolin, lanolin alcohol, laureth-23, lecithin,
PEG-20 stearate, PEG-150 distearate, PEG-40 hydrogenated castor
oil, PEG 60 hydrogenated castor oil, PEG 7 hydrogenated castor oil,
PEG-11 castor oil, PEG-35 castor oil, PEG-15 tallow polyamine,
PEG-75 lanolin, poloxamer, polysorbate 20,80, sodium laureth-13
carboxylate, sodium trideceth sulfate and stearic acid.
[0088] Examples of buffering/neutralising agents include
dipotassium phosphate, sodium hydroxide, potassium phosphate,
disodium phosphate, citric acid, aminomethyl propanediol, sodium
hydroxide, diethanolamine bisulfate, ethanolamine, hydrochloric
acid, lactic acid, sodium phosphate and triethanolamine.
[0089] Examples of humectants include propylene glycol,
glycereth-20, glycerin, hyaluronic acid, inositol, lactic acid,
methyl gluceth-20, PEG-8, PEG-20 stearate, sodium PCA and
sorbitol.
[0090] Examples of thickeners/viscosity controlling agents such as
carbomers, caprylic alcohol, cetearyl alcohol, dextran, disodium
lauroamphodiacetate, guar gum hydrogenated castor oil, laneth-10,
magnesium sulfate, PEG-150 distearate, stearyl alcohol and xanthan
gum.
[0091] Examples of antistatic/conditioning agents include
dimethicone copolyol, disodium lauriminodipropionate, disodium
lauroamphodiacetate, disodium lauroamphodipropionate, glycol
oleate, hyaluronic acid, inositol, lanolin, lanolin alcohol,
lecithin, panthenol, PEG 15 tallow polyamine, petrolatum,
polyquaternium 7,11,16,44 and sodium PCA.
[0092] The wipes may additionally or alternatively be impregnated
with one or more of the commercially available cleansing agents
including those sold under the trade names "Lid-Care" available
from CibaVision, "Eye-Scrub" available from Novartis Opthalmics,
"Lid Scrub", "Igiene Daily Eyelid Cleanser" available from Igenics,
"Blephasol" available from Laboratoire Thea and "Supranettes"
available from Alcon.
[0093] Additionally or alternatively, the eyelid wipe may be
impregnated with active agents such as anti-inflammatory and
anti-bacterial agents and/or decongestants. The use of the
combination of heating, optionally also with cleaning, at the time
that the active agents are applied to the eyelid, is believed to
improve the efficacy of the active agents. It will therefore be
understood that in this embodiment, the invention provides the
controlled delivery of an appropriate temperature with controlled
delivery of the appropriate amount of active agent, optionally with
controlled delivery of the required amounts of cleansing
solution.
[0094] In one arrangement, one or more of cleansing agents,
pharmaceutical compositions, active agents and the like may be
located in a layer on the outer surface of the wipe which is formed
from a thermo-responsive polymer which on heating would soften so
that the polymer matrix will reduce the active agent.
[0095] In one preferred arrangement, the temperature adjusting
means provide cooling and one or more active agents such as
anti-inflammatory agents, anti-bacterial agents and/or
decongestants are present. Such wipes are particularly useful in
the treatment of the symptoms of, for example, hayfever.
[0096] The wipe may include, or may be combined with, a drug
delivery system such that there is achieved a system which enables
the controlled delivery of an appropriate temperature in
combination with controlled delivery of a pharmaceutical.
[0097] It will be understood that care will be taken in the
selection of heat adjusting means and any other components present
to ensure that components and products of reaction are not liable
to cause damage to the delicate eye region. Where a selection is
made where direct contact with the eye region is not advisable, the
materials will generally be enclosed within a container in the
wipe.
[0098] Where the wipe is multi-layered, or where the wipe includes
a container for one or more of the components of the chemical heat
adjusting means, the edges of the wipe may be sealed either
directly or via an intermediate sealing means. Any suitable means
of sealing may be used. Suitable means include the use of adhesive,
including hot melt and pressure sensitive adhesive, double sided
adhesive tape, heat sealing or ultrasonic bonding. In general, the
sealing means will be selected such that there is no hard residue
which would be uncomfortable when the wipe is in use.
[0099] The present invention also provides the use of the wipe of
the above-mentioned first aspect in the treatment of disorders of
the eyelid or eyelid margin. In a preferred arrangement of this
second aspect of the present invention, there is provided the use
of the wipe of the above-mentioned first aspect in the treatment of
meibomian gland disorder. In an alternative arrangement of this
second aspect of the present invention, there is provided the use
of the wipe of the above-mentioned first aspect in the treatment of
inflammation of the eyelid. In this arrangement, the temperature
adjustment of the wipe is preferably cooling.
[0100] In a further aspect of the present invention, the
application also provides a method of treating meibomian gland
dysfunction and/or blepharitis comprising allowing the wipe of the
above first aspect to reach temperature and then massaging the
eyelid margin with the wipe. Cleansing agents or the like may be
applied to the wipe before massaging is commenced.
[0101] In use, it may be desirable for the user to leave the wipe
against the eye for a short period prior to commencing massaging of
the eyelid margin with the wipe. The period of time required may be
of the order of about 5 minutes to about 10 minutes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0102] The wipe of the present invention will now be described by
way of example, with reference to the accompanying drawings in
which:
[0103] FIG. 1 illustrates a circular wipe with heat delivery
system;
[0104] FIG. 2 illustrates a tubular wipe with heat delivery
system;
[0105] FIG. 3 illustrates an alternative tubular wipe with heat
delivery system;
[0106] FIG. 3a illustrates the sides of the tubular wipe of FIG.
3;
[0107] FIG. 3b illustrates a modification to the tubular wipe of
FIG. 3;
[0108] FIG. 4a illustrates an ovoid shaped wipe with an alternative
heat delivery system;
[0109] FIG. 4b illustrates an alternative arrangement for the ovoid
shaped wipe;
[0110] FIG. 5 illustrates a folded cloth-like wipe;
[0111] FIG. 6 is a graph representing the results of the
Comparative Example 2;
[0112] FIG. 7 is a graph representing the temperature changes noted
for the formulation of Example 1;
[0113] FIG. 8 is a graph representing the temperature changes noted
for the formulation of Example 2;
[0114] FIG. 9 is a graph representing the temperature changes noted
for the formulation of Example 3;
[0115] FIG. 10 is a graph representing the temperature changes
noted for the formulation of Example 4;
[0116] FIG. 11 is a graph representing the temperature changes
noted for the formulation of Example 5;
[0117] FIG. 12 is a graph representing the temperature changes
noted for the formulation of Example 6;
[0118] FIG. 13 is a graph representing the temperature changes
noted for the formulation of Example 7;
[0119] FIG. 14 is a graph representing the temperature changes
noted for the formulations of Examples 8 to 10;
[0120] FIG. 15 is a graph representing the temperature changes
noted for the formulations of Examples 11 to 13;
[0121] FIG. 16 is a graph representing the temperature changes
noted for the formulations of Examples 14 to 17;
[0122] FIG. 17 is a graph representing the temperature changes
noted for the formulations of Examples 18 to 20;
[0123] FIG. 18 is a graph representing the temperature changes
noted for the formulations of Examples 21 to 30;
[0124] FIG. 19 is a graph representing the temperature changes
noted for the formulations of Examples 31 to 34;
[0125] FIG. 20 is a schematic representation of the wipe of Example
35;
[0126] FIG. 21 is a further schematic representation of the wipe of
Example 35 at activation;
[0127] FIG. 22 is a picture of the water bubbles used in Example
35;
[0128] FIG. 23 is a picture of part of a prototype wipe of Example
35;
[0129] FIG. 24 is a graph of the temperature profile achieved for
the wipe of Example 35;
[0130] FIG. 25 is a graph representing the temperature changes
noted for the formulations of Examples 36 to 46;
[0131] FIG. 26 is a graph representing the temperature changes
noted for the formulations of Examples 47 to 49;
[0132] FIG. 27 is a picture of uncoated cooling prototype;
[0133] FIG. 28 is a graph representing the temperature changes
noted for the formulations of Example 50;
[0134] FIG. 29 is a schematic representation of the wipe of Example
51;
[0135] FIG. 30 is a further schematic representation of the wipe of
Example 51 at activation;
[0136] FIG. 31 is a picture of an alternative cooling
prototype;
[0137] FIG. 32 is a graph representing the temperature changes
noted for the formulations of Example 51; and
[0138] FIG. 33 is a graph representing the temperature changes
noted for the finger shaped arrangement of Example 52.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0139] In one embodiment of the present invention as described in
FIG. 1, the wipe 1 is of circular configuration and is formed from
a layered structure. The layers present comprise a porous outer
layer 2, a layer 3 impregnated with cleaning agent, a heat
generating layer 4 comprising material which on exposure to air or
water generates heat. This layer is optionally backed by a heat
reflective layer 5 which serves to direct the heat released by the
heat generating layer 4 towards the outer layer 2. These layers are
supported on a holding layer 6 which is generally cloth-like and
will form the outer layer which the user will hold in their hand.
The wipe 1 will generally be sealed around the edge. The edge
margin may comprise solely the porous outer layer 2 and the holding
layer 6 bonded together.
[0140] As illustrated in FIG. 2, the wipe 1A may be provided as a
tube into which the user may insert a finger to facilitate the
massaging step required in use. Here the wipe 1A is formed in a
similar manner to the circular wipe of FIG. 1. It will generally be
formed as a rectangular material comprising a porous outer layer 2,
a layer impregnated with cleaning agent 3, a heat generating layer
4, a heat reflective layer 5 and a holding layer 6. When this
rectangle is formed into a tube, the holding layer 6 becomes the
inner wall of the tube. In this arrangement, the inner wall may be
cloth-like or sponge-like.
[0141] A modification of the tubular wipe is a wipe having a closed
end so that the user's finger does not protrude through the wipe.
The wipe 1B may have the same configuration throughout the sides of
the wipe such as in the tubular arrangement of FIG. 2 as
illustrated in FIG. 3B or in the alternative arrangement
illustrated in FIG. 3A the wipe may have a side A' which will, in
use, be placed against the eye. The user would normally have this
side located on the inside of their finger. The wipe of FIG. 3B
will also have a plain holding layer B' for the exterior of the
finger. In this arrangement the side A' of the finger wipe will
have a similar structure to that of the circular wipe of FIG.
1.
[0142] An alternative arrangement is illustrated in FIG. 4a. In
this arrangement, the wipe 1C has an ovoid configuration to mirror
the overall eye shape. In the centre of the ovoid is a pressure
point 7 which when pressed activates the chemical reaction. In this
wipe, a two-component means is used to cause the adjustment of
temperature. The wipe contains an inner breakable pouch 8 which in
A contains seed crystals and in B a metallic trigger. When the user
depresses the wipe at the pressure point 7, the pouch breaks such
that the seed crystals/metallic trigger come into contact with an
aqueous salt solution in which the wipe is first soaked. The wipe
of FIG. 4 additionally comprises an optional self-adhesive layer 9.
As illustrated in FIG. 4b the pressure point 7 may be located to
one side of the wipe.
[0143] In FIG. 5, the wipe 1D, which on this occasion is a folded
cloth-like wipe impregnated with substances which will generate
heat when treated with an aqueous solution. Cleaning agents are
also impregnated into the wipe. The folded wipe is provided in a
moisture impermeable pouch 10.
[0144] The invention will now be described with reference to the
following examples.
Comparative Example 1
Determination of Target Temperature for a Hot Wipe in Particular
for Use in the Treatment of Meibomian Gland Dysfunction
[0145] A cloth was immersed in boiling water and then removed. The
temperature of the cloth was measured and the skin tolerance to the
cloth was evaluated. The skin tolerance was evaluated by placing
the cloth on the inside of the wrist. It was found that the
temperature reached was much higher than was acceptable in terms of
skin tolerance and that therefore if such a cloth were to be used
as a hot compress in the treatment of, for example, meibomian gland
dysfunction, there was a risk that injury could occur to the
patient. The tolerance level was found to be in the region of
53.degree. C. Temperatures of 43.degree. C. and below were said by
the subjects to be not hot enough for any beneficial effect to be
felt. The results are summarised in Table 1
TABLE-US-00001 TABLE 1 WARM CLOTH Temperature Out of boiling water
approx 63.degree. C. Max tolerable to skin approx 52-53.degree. C.
"Not hot enough" (skin) approx 43.degree. C.
Comparative Example 2
[0146] Comparative Example 1 was repeated using a cloth impregnated
with heated saline solution. The compress was applied to a closed
eye to mimic the routine used by a patient following the
conventional treatment for meibomian gland dysfunction. The average
results for 10 subjects are summarised in Table 2 below and in the
graph of FIG. 6.
TABLE-US-00002 TABLE 2 WARM CLOTH Temperature "Too hot" approx
>54.degree. C. "Bearable" (eye area) approx 53.degree. C.
"Comfortable" (eye area) approx 51.degree. C.
[0147] Thus it was noted that a temperature of above 54.degree. C.
was uncomfortable. It was often expressed as being too hot for the
subjects. The optimal temperature was found to be in the region of
51.degree. C. Thus a temperature range of from about 45.degree. C.
to about 52.degree. C. is preferred. For maximum efficacy the
temperature should be sustained for 10 minutes.
[0148] Various formulations for the chemical temperature adjusting
means were investigated.
Example 1
Air Triggered System
[0149] A sealed pouch was prepared into which a powder comprising
59% iron powder, 21% water, 10.5% vermiculite, 4% activated
charcoal and 5% salt had been placed. The pouch was opened and the
temperature changes were noted. These are represented graphically
in FIG. 7.
Example 2
Water Triggered System A
[0150] A sealed pouch was prepared into which anhydrous sodium
carbonate had been placed. Water was added to the pouch and the
temperature changes were noted. These are represented graphically
in FIG. 8.
Example 3
Water Triggered System B
[0151] A sealed pouch was prepared into which anhydrous magnesium
sulphate had been placed. Water was added to the pouch and the
temperature changes were noted. These are represented graphically
in FIG. 9.
Example 4
Water Triggered System C
[0152] A sealed pouch was prepared into which anhydrous magnesium
sulphate (25% w/w) and propylene glycol (75% w/w) or PEG400 (75%
w/w) had been placed. Water was added to the pouch and the
temperature changes were noted. These are represented graphically
in FIG. 10.
Example 5
Water Triggered System D
[0153] A sealed pouch was prepared into which anhydrous sodium
potassium aluminosilicate 3 .ANG. (35% w/w), PEG200 (55% w/w) and
glycerin (10% w/w) had been placed. Water was added to the pouch
and the temperature changes were noted. These are represented
graphically in FIG. 11.
Example 6
Two Component System A
[0154] A two component system was prepared. The first component
comprised the reducing agent thiourea and the second comprised the
oxidation agent hydrogen peroxide solution (approx 8%). The two
components were mixed and the temperature changes were measured.
These are represented graphically in FIG. 12.
Example 7
Two Component System B Utilising a Supersaturated Salt Solution
[0155] 10 g anhydrous sodium acetate were mixed with 7.5 g water.
After the addition of a few salt seed crystals, the temperature
changes were measured and are represented in FIG. 13.
Examples 8 to 30
Optimisation Of Temperature Profile
[0156] In order to optimise the temperature profile for an
inorganic salt/water system various compositions as detailed in
Table 3 were investigated. The temperature changes measured are
represented graphically in FIGS. 14 to 19.
TABLE-US-00003 TABLE 3 Example Formulation FIG. 8 2.5 g
MgSO.sub.4/7.5 g PEG 400: 40 ml H.sub.2O 14 9 2.5 g MgSO.sub.4/7.5
g PEG 400: 20 ml H.sub.2O 14 10 2.5 g MgSO.sub.4/7.5 g PEG 400: 10
ml H.sub.2O 14 11 2.5 g MgSO.sub.4: 10 ml H.sub.2O 15 12 2.5 g
MgSO.sub.4/7.5 g glyerol: 10 ml H.sub.2O 15 13 2.5 g MgSO.sub.4/7.5
g PEG 400: 10 ml H.sub.2O 15 14 5 g MgSO.sub.4/5 g PEG 400: 10 ml
H.sub.2O 16 15 5 g MgSO.sub.4/10 g PEG 400: 10 ml H.sub.2O 16 16 5
g MgSO.sub.4/15 g PEG 400: 10 ml H.sub.2O 16 17 5 g MgSO.sub.4/10 g
PEG 400/5 g glycerol: 10 ml H.sub.2O 16 18 4 g MgSO.sub.4/8 g PEG
400/4 g glycerol: 10 ml H.sub.2O 17 19 4 g MgSO.sub.4/12 g PEG 400:
10 ml H.sub.2O 17 20 3 g MgSO.sub.4/9 g PEG 400: 10 ml H.sub.2O 17
21 2.5 g MgSO.sub.4: 10 ml H.sub.2O 18 22 2.5 g MgSO.sub.4/7.5 g
glycerol: 10 ml H.sub.2O 18 23 2.5 g MgSO.sub.4/7.5 g PEG 400: 10
ml H.sub.2O 18 24 5 g MgSO.sub.4/5 g PEG 400: 10 ml H.sub.2O 18 25
5 g MgSO.sub.4/10 g PEG 400: 10 ml H.sub.2O 18 26 5 g MgSO.sub.4/15
g PEG 400: 10 ml H.sub.2O 18 27 5 g MgSO.sub.4/10 g PEG 400/5 g
glycerol: 10 ml H.sub.2O 18 28 4 g MgSO.sub.4/8 g PEG 400/4 g
glycerol: 10 ml H.sub.2O 18 29 4 g MgSO.sub.4/12 g PEG 400: 10 ml
H.sub.2O 18 30 3 g MgSO.sub.4/9 g PEG 400: 10 ml H.sub.2O 18
[0157] For the formulations of Examples 23 and 30 the heat
generated was better sustained between 7 and 10 minutes post
activation and therefore offered advantages when compared with the
other formulations.
Examples 31 to 34
[0158] Further tests were carried out to optimise the salt mixture
system with MgSO4 from 2.5 g to 4 g. The details are set out in
Table 4 and the temperature profile are represented graphically in
FIG. 19.
TABLE-US-00004 TABLE 4 Example Formulation FIG. 31 2.5 g
MgSO.sub.4/7.5 g PEG 400: 10 ml H.sub.2O 19 32 3 g MgSO.sub.4/9 g
PEG 400: 10 ml H.sub.2O 19 33 3.5 g MgSO.sub.4/10.5 g PEG 400: 10
ml H.sub.2O 19 34 4 g MgSO.sub.4/12 g PEG 400: 10 ml H.sub.2O
19
[0159] The formulation of Example 33 sustained a temperature of
just below 45.degree. C. after 7 minutes and was therefore chosen
for use in Example 35 in the production of a prototype wipe.
Example 35
Prototype Heating Wipe
[0160] A prototype was produced based on a water triggered system
which was activated by pressure. The heat produced was the result
of the exothermic reaction of the inorganic salt mixture with
water. The water was provided as a water bubble within a frangible
plastic envelope of polyethylene as illustrated in FIG. 22. Two
water bubbles were used each containing 5 ml water. The water
bubbles and the salt mixture of 3.5 g MgSO.sub.4/10.5 g PEG 400
were inserted in a sealable water-tight pouch to form the
heat-generating compartment 11 of FIG. 20. The heat generating
compartment 11 is coated on one side 12 with a sheet of aluminium
foil covered with gauze and on the other side 13 with a cotton pad.
In use it is the side 12 which is applied to the closed eyelids for
the heat treatment. After heat treatment side 13 can be impregnated
with cleaning solution and used to wipe the lid margin. The pad on
side 13 may, in an alternative arrangement, be pre-impregnated with
the cleaning solution. A picture of the prototype wipe is in FIG.
23. In production the wipe will generally be of an optimum size and
shape for use by the user.
[0161] The operation of wipe is illustrated schematically in FIG.
21. Gentle pressure on the external surfaces of the wipe causes the
water bubbles 14 to burst so that the water comes into contact with
the inorganic salt mixture 15 so that heat is released. The
temperature profile is illustrated graphically in FIG. 24. As
indicated above, a temperature of from 45 to 52.degree. C. is
desirable. The wipe reached the required temperature within 1
minute of activation and the temperature was maintained for 10
minutes. Crystallisation occurred.
Example 36 to 46
Water Triggered System for Cooling
[0162] Various compositions were prepared as detailed in Table 5
and the temperature profiles on the addition of water were
measured. The results are illustrated graphically in FIG. 25.
TABLE-US-00005 TABLE 5 Example Formulation FIG. 36 5 g
NH.sub.4NO.sub.3: 10 ml H.sub.2O 25 37 7.5 g NH.sub.4NO.sub.3: 10
ml H.sub.2O 25 38 10 g NH.sub.4NO.sub.3: 10 ml H.sub.2O 25 39 7.5 g
NH.sub.4NO.sub.3/7.5 ml glycerol: 10 ml H.sub.2O 25 40 7.5 g
NH.sub.4NO.sub.3/7.5 ml PEG400: 10 ml H.sub.2O 25 41 10 g
NH.sub.4NO.sub.3/5 ml glycerol: 10 ml H.sub.2O 25 42 10 g
NH.sub.4NO.sub.3/1 g Carbopol 25 ETD2020: 10 ml H.sub.2O 43 10 g
NH.sub.4NO.sub.3/0.75 g Carbopol 25 ETD2020: 10 ml H.sub.2O 44 10 g
NH.sub.4NO.sub.3/0.5 g Carbopol 25 ETD2020: 10 ml H.sub.2O 45 15 g
NH.sub.4NO.sub.3/0.75 g Carbopol 25 ETD2020: 10 ml H.sub.2O 46 12.5
g NH.sub.4NO.sub.3/0.75 g Carbopol 25 ETD2020: 10 ml H.sub.2O 47 10
g NHNO.sub.3/0.75 g Carbopol 26 ETD2020: 10 ml H.sub.2O 48 12.5 g
NH.sub.4NO.sub.3/0.75 g Carbopol 26 ETD2020: 10 ml H.sub.2O 49 15 g
NH.sub.4NO.sub.3/0.75 g Carbopol 26 ETD2020: 10 ml H.sub.2O
Example 50
Prototype Cooling Wipe
[0163] A prototype was produced based on a water triggered system
which was activated by pressure. The cold produced was the result
of the endothermic reaction of the ammonium nitrate with water. The
water was provided as a water bubble within a frangible plastic
envelope of polyethylene as illustrated in FIG. 22. One water
bubble was used containing 10 ml water. The water bubble and the
salt mixture of 10 g to 15 g NH.sub.4NO.sub.3/0.75 g ETD2020 (as
detailed in Table 6) were inserted in a sealable water-tight pouch
to form the cold-generating compartment 21 of FIG. 29. In this
example, the cold generating compartment 21 was left uncoated.
Pressure was applied to the water bubble such that the water mixed
with the ammonium nitrate and cold was generated. The temperature
profiles are illustrated graphically in FIG. 28.
TABLE-US-00006 TABLE 6 Run Formulation FIG. A 10 g
NH.sub.4NO.sub.3/0.75 g ETD2020: 10 ml H.sub.2O 28 B 12.5 g
NH.sub.4NO.sub.3/0.75 g ETD2020: 10 ml H.sub.2O 28 C 15 g
NH.sub.4NO.sub.3/0.75 g ETD2020: 10 ml H.sub.2O 28
Example 51
Prototype Cooling Wipe 2
[0164] Example 51 was repeated except that the wipe was left
uncoated on one side 22 and was coated on the other side 23 with a
cotton pad. In use it is the side 22 which is to be applied to the
closed eyelids for the cooling treatment. After cooling treatment
side 23 can be impregnated with any applicable treatment solution
and used to wipe the lid margin. The pad on side 23 may be
pre-impregnated with the cleaning solution. A picture of the
prototype wipe is in FIG. 31. In production the wipe will generally
be of an optimum size and shape for use by the user.
[0165] The operation of the wipe is illustrated schematically in
FIG. 30. Gentle pressure on the external surfaces of the wipe
causes the water bubble 24 to burst so that the water comes into
contact with the inorganic salt mixture 25 so that cooling is
released. The temperature profile is illustrated graphically in
FIG. 32.
Example 52
Prototype Finger Shaped Heating Wipe
[0166] Example 35 was repeated except that the water bubbles and
the salt mixture in the sealable water-tight pouch were placed in
the thumb of a glove. The temperature profile achieved is
illustrated graphically in FIG. 33.
Example 53
Alternative Prototype
[0167] Two plastics sheets comprising three layers, an outer layer
of polypropylene, an amorphous intermediate metallic oxide layer
and an inner layer of polyethylene, are thermo-sealed around three
sides to form a pouch. The pouch is then further sealed with a
rupturable seal in the middle to create two chambers. A salt/PEG
mixture is placed in one chamber and water into the other. The
mouth of the pouch is then thermo-sealed. One external face of the
pouch is coated with a polystyrene insulating layer and gauze is
applied to the other face which when the wipe is in use will be in
contact with the eyelid margin.
* * * * *