U.S. patent application number 17/075071 was filed with the patent office on 2021-04-01 for system for targeted application of topical agents to an isolated body part.
The applicant listed for this patent is JOHNSON & JOHNSON CONSUMER INC.. Invention is credited to Marc Alary, Jan-Joo Liu, Erik Lunde, Emanuel Morano, Bharat Patel.
Application Number | 20210093072 17/075071 |
Document ID | / |
Family ID | 1000005240316 |
Filed Date | 2021-04-01 |
United States Patent
Application |
20210093072 |
Kind Code |
A1 |
Alary; Marc ; et
al. |
April 1, 2021 |
SYSTEM FOR TARGETED APPLICATION OF TOPICAL AGENTS TO AN ISOLATED
BODY PART
Abstract
A system includes an applicator mask having an applicator
surface having a three-dimensional shape corresponding to the
isolated body part; and at least one membrane releasably disposed
on the applicator surface and having an outer surface in facing
relation with the applicator surface and inner adhesive surface
opposite thereof. The membrane includes one or more benefit agents
disposed in one or more treatment zones.
Inventors: |
Alary; Marc; (Newtown,
PA) ; Liu; Jan-Joo; (Belle Mead, NJ) ; Lunde;
Erik; (Morganville, NJ) ; Patel; Bharat;
(Princeton, NJ) ; Morano; Emanuel; (Totowa,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
JOHNSON & JOHNSON CONSUMER INC. |
Skillman |
NJ |
US |
|
|
Family ID: |
1000005240316 |
Appl. No.: |
17/075071 |
Filed: |
October 20, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15848963 |
Dec 20, 2017 |
10842242 |
|
|
17075071 |
|
|
|
|
62437815 |
Dec 22, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A45D 44/002 20130101;
A61K 8/0241 20130101 |
International
Class: |
A45D 44/00 20060101
A45D044/00; A61K 8/02 20060101 A61K008/02 |
Claims
1.-10. (canceled)
11. A system for targeted application of topical agents to an
isolated body part comprising: (a) an applicator mask having an
applicator surface having a three-dimensional shape configured to
cover and to contact a corresponding contoured surface area of the
isolated body part; and (b) a membrane releasably disposed on the
applicator surface and having adhesive properties and an outer
surface in facing relation with the applicator surface and inner
adhesive surface opposite thereof, the membrane comprising one or
more benefit agents disposed in one or more treatment zones wherein
the releasable membrane is pre-configured to cover and contact the
contoured surface of the isolated body part and the adhesion of the
membrane to the isolated body part is greater than the adhesion of
the membrane to the applicator surface, and at least one of the one
or more benefit agents disposed in at least one of the has one or
more treatment zones has a lower concentration proximate edges to
the treatment zone.
12. A system for targeted application of topical agents to an
isolated body part comprising: (a) an applicator mask having an
applicator surface having a three-dimensional shape configured to
cover and to contact a corresponding contoured surface area of the
isolated body part; and (b) a stack of membranes releasably
disposed on the applicator surface from a releasable membrane
adhered to the applicator surface to an exposed releasable
membrane, each releasable membrane having adhesive properties and
comprising one or more benefit agents disposed in one or more
treatment zones wherein the releasable membranes are pre-configured
to cover and contact the contoured surface of the isolated body
part and the adhesion of the exposed releasable membrane to the
isolated body part is greater than the adhesion of the releasable
membrane to the applicator surface and to a releasable membrane
disposed adjacent to the exposed releasable membrane in the
stack.
13. The system of claim 12 wherein each of the plurality of
releasable membranes further comprises the one or more benefit
agents.
14. The system of claim 12 wherein at least two of the plurality of
releasable membranes are substantially identical.
15. The system of claim 12 wherein one of the plurality of
releasable membranes comprises at least one benefit agent that
differs from the one or more benefit agents in an adjacent
releasable membrane.
16. The system of claim 12 wherein at least one of the one or more
benefit agents disposed in at least one of the has one or more
treatment zones has a lower concentration proximate edges to the
treatment zone.
17. The system of claim 12 wherein the isolated body part is the
face.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a system for targeted
application of topical agents to an isolated body part. More
specifically, the present invention is directed to a system for
treating common consumer skin flaws including an applicator mask
having a three-dimensional shape corresponding to the isolated body
part used in combination with an active substance containing
membrane structure for delivery of active substance in the membrane
structure to the skin of the consumer, and methods of using the
system.
BACKGROUND OF THE INVENTION
[0002] Ageless, flawless, youthful skin appearance is the desire of
many people around the world. Common skin flaws include: acne, age
spots, birthmarks, dry skin, eczema, hyperpigmentation, large
pores, moles, psoriasis, rosacea, scars, sun spots, under eye
circles, warts, and wrinkles.
[0003] Consumers are always looking for the next product or
treatment that will treat these flaws and keep them younger
looking, and in particular, safer and more effective methods and
products for rejuvenating the skin. There are many known
formulation in the form of creams, lotions, powders and oils which
consumers apply to their face, hands, feet and bodies specifically
targeting the various common skin flaws. Many have active
substances, or benefit agents for use in treating the flaws.
[0004] Commercial available two-dimensional products, such as
facial mask sheet or cloth like materials are homogeneous
structures which are worn across the entire face. Such sheets are
also known for use on other isolated body parts such as arms,
hands, legs, or feet. These types of products are not personalized
for consumers in terms of treatments, size and configuration to
perfectly fit a consumer's anatomy and treat a consumer's personal
needs. For instance, in facial treatments, the same facial
treatment ingredient is applied to chin, cheeks and to nose,
despite significant differences among the skin conditions found on
the chin, cheek and nose in different patients.
[0005] In addition, since the above-mentioned sheets are formed in
two dimensions, it is impossible to precisely conform it to
three-dimensional profile of human face and therefore it could not
precisely deliver target treatments for such as red spots, acnes,
pigmentation, fine line wrinkles, etc. In addition, the application
of conventional facial mask is often in wet form. It is easy to
fall during wearing.
[0006] In summary, two-dimensional skin care sheet-like products
are not able to precisely deliver target the delivery of benefit
agents to isolated body parts of the human body such as face, such
as arms, hands, legs, or feet. They are not personalized for
consumers in terms of treatments, size and configuration to
perfectly fit a consumer's anatomy and treat a consumer's personal
needs. Needed to avoid these limitations are systems for targeted
application of topical agents to an isolated body part, as well as
methods of using the system.
SUMMARY OF THE INVENTION
[0007] Surprisingly, we have found that carefully targeted
application of topical agents to an isolated body part can be
accurately achieved using a system including an applicator mask
having an applicator surface having a three dimensional shape
corresponding to the isolated body part; and at least one membrane
releasably disposed on the applicator surface and having an outer
surface in facing relation with the applicator surface and inner
adhesive surface opposite thereof. The membrane includes one or
more benefit agents disposed in one or more treatment zones.
[0008] In addition we have identified a method for targeted
application of topical agents to an isolated body part comprising
the steps of capturing an image of the isolated body part,
transforming the image data to mathematical model of the geometry
of the isolated body part, forming an applicator mask having an
applicator surface having a three dimensional shape corresponding
to the isolated body part, forming a releasable membrane on the
applicator surface of the applicator mask comprising one or more
benefit agents disposed in one or more treatment zones of the
applicator, where the adhesion of the membrane to the isolated body
part is greater than the adhesion of the membrane to the applicator
surface, disposing the applicator mask on the isolated body part so
that the releasable membrane is in contact with the isolated body
part, and removing the applicator mask from the isolated body part
so that the membrane remains in contact with the isolated body
part.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a front perspective view of a first face
embodiment of the system of the present invention;
[0010] FIG. 2 is a rear perspective view of the first face
embodiment of the system of FIG. 1;
[0011] FIG. 3 is a rear exploded view of the first face embodiment
of the system of FIG. 1;
[0012] FIG. 4. is a side cross sectional view of the system of FIG.
1 along the 4-4 plane disposed on a user's face prior to removal of
the applicator portion of the system;
[0013] FIG. 5. is a side cross sectional view of the system of FIG.
1 along the 4-4 plane disposed on a user's face after removal of
the applicator portion of the system;
[0014] FIG. 6. is a rear perspective view of a second face
embodiment of the system of the present invention;
[0015] FIG. 7. is a rear exploded view of the second face
embodiment of the system of FIG. 7;
[0016] FIG. 8. is a rear perspective view of a third face
embodiment of the system of the present invention; and
[0017] FIG. 9 is a rear exploded view of the third face embodiment
of the system of FIG. 8;
DETAILED DESCRIPTION OF THE INVENTION
[0018] The present invention relates to systems for the
administration of active substances to the skin of a consumer and
methods employing the system. The following description is
presented to enable one of ordinary skill in the art to make and
use the invention. Various modifications to the embodiments and the
generic principles and features described herein will be readily
apparent to those skilled in the art. Thus, the present invention
is not intended to be limited to the embodiments shown, but is to
be accorded the widest scope consistent with the features described
herein.
[0019] As used herein the specification and the claims, the term
"topical" and variants thereof mean of or applied to an isolated
part of the body. This includes, without limitation skin, mucosa,
and enamel.
[0020] As used herein, "benefit agent" means an ingredient or
material that provides a benefit, e.g., improves, relieves,
reduces, or treats symptoms or conditions of the skin, ether
cosmetic or therapeutic.
[0021] The method for treating common consumer skin flaws described
herein uses an applicator having a three-dimensional shape
corresponding to the isolated body part used in combination with a
benefit agent containing membrane structure for delivery of
benefiting agent substance in the membrane structure to the skin of
the consumer, and methods of using the system. The
three-dimensional conformal applicator has varying personalized
area-specific treatment zones to enable the treatment application
more effectively. With a three-dimensional conformal applicator
matched to the individual user's body part profile as physical
guides, the application becomes easier and more effective, and can
help in locating specific target zones to the precise area for
applications.
[0022] Referring to the drawings, FIGS. 1 and 2 are front and rear
perspective views, respectively, of a first embodiment of a skin
treatment system 10 which may be used in the present invention.
FIG. 3 is a rear exploded view of system 10. Skin treatment system
10 includes applicator 20 having a first surface 22, and a second
surface 24. In this embodiment, applicator 20 is shown as a facial
mask.
[0023] Applicator 20 in this embodiment has eye openings 26, a nose
opening 27, and a mouth opening 28, and is sized to cover the full
face of the user. It is important to note that in other facial mask
type embodiments, applicator 20 may be sized to partially cover the
face of the user, and may be without any of the openings described
above.
[0024] Disposed on second surface 24 of applicator 20 are active
membranes 40a, 40b, 40c, and 40d. This plurality of active
membranes is releasably disposed on second surface 24 of applicator
20, and contain one or more benefit agents. Active membranes 40a,
40b, 40c, and 40d have first surfaces and second surfaces. FIG. 3
shows first surface 42d of active membrane 40d, as well as second
surfaces 44a, 44c, and 44d of active membranes 40a, 40c, and 40d,
respectively. The bond between applicator 20 and active membranes
40a, 40b, 40c, and 40d occur between second surface 24 of
applicator 20 and first surfaces of the active membranes.
[0025] Active membrane 40a is located in the forehead region of
facial mask applicator 20, while active membranes 40b and 40c are
located in the cheek region of facial mask applicator 20 and active
membrane 40d is located in the chin region of facial mask
applicator 20. Although the embodiment shown has an applicator 20
with four releasably disposed active membranes (40a, 40b, 40c, and
40d), other embodiments may have more or less releasably disposed
membranes. Some embodiments may have one or more active membrane,
or two or more active membranes, or four or more active membranes,
or six or more active membranes, or eight or more active membranes,
or twelve or more active membranes. The number and location of
active membranes 40 depend on the common consumer skin flaw(s)
being treated.
[0026] Active membranes 40 contain one or more benefit agents. In
some embodiments, active membranes may contain two, three, four, or
more benefit agents. Also, if there are two or more active
membranes, each active membrane may contain the same beneficial
agent(s), or each active membrane may contain different beneficial
agent(s). In some embodiments, individual active membranes may
contain more than one benefit agent. Also, different regions of the
active membrane may contain different active agents, or may contain
a gradient of active agent from one region to another. For example,
the active agent may have a lower concentration proximate the edges
to "feather" the treatment effect.
[0027] Active membranes 40 may also have a variety of shapes,
depending on the location of skin treatment. Possible shapes of the
footprint left by active membranes 40 include, but are not limited
to, squares, rectangles, triangles, circles, ovals, kidneys, stars,
crosses, characters, etc. The corners of such shapes, if any, may
be angular or curved to reduce potential lift/removal points. The
zone of the treatment could be greater than about 1,000 cm.sup.2,
about 1,000 cm.sup.2, or about 100 cm.sup.2, or about 10 cm.sup.2,
or about 1 cm.sup.2, or less than 1 cm.sup.2.
[0028] In use, skin treatment system 10 of the present invention
will be disposed on the user's skin, and the applicator portion
will be removed therefrom. FIGS. 4 and 5 are side cross sectional
views of system 10 along the 4-4 plane of FIG. 1 disposed on a
user's face prior to, as well as after, removal of the applicator
portion of the system. The figures show sections of applicator 20
with first surface 22 and second surface 24, active membranes 40a
and 40d with first surfaces 42a, 42d and second surfaces 44a, 44d,
and user's face 50 with face surface 52. The sections of applicator
20 seen in the figures are those above nose opening 27, between
nose opening 27 and mouth opening 28, and below mouth opening
28.
[0029] FIG. 4 shows that when skin treatment system 10 is disposed
on the user's face 50, second surfaces 44a, 44d of active membranes
40a and 40d are in contact with surface 52 of face 50. Second
surface 24 of applicator 20 remains in contact with first surfaces
42a, 42d of active membranes 40a and 40d until removed by the user.
Removal of applicator 20 by the user results in the structure shown
in FIG. 5. When applicator 20 is removed, second surfaces 44a, 44d
of active membranes 40a and 40d remains in contact with surface 52
of face 50 at the treatment zone.
[0030] In accordance with a more particular aspect of the present
invention, second surface 24 of applicator 20 releasably attaches
to first surfaces 42a, 42d of active membranes 40a and 40d. The
attachment strength of applicator 20 to active membranes 40a and
40d is less than the adhesive strength of membranes 40a and 40d to
skin. So, when applicator 20 is removed by the user, active
membranes 40a and 40d remains adhered to skin 50. In some
embodiments, membranes 40a and 40d are held in place by spot
application of adhesive.
[0031] In some embodiments, the shear strength of applicator 20 to
active membranes 40a and 40d is less than the shear strength of
membranes 40a and 40d to skin. So, when applicator 20 is removed by
the user, active membranes 40a and 40d remains adhered to skin
50.
[0032] In some embodiments, a plurality of releasable membranes is
formed in a stack on the applicator surface of the applicator mask,
each releasable membrane comprising one or more benefit agents
disposed in one or more treatment zones of the applicator. The
adhesion of the membrane to the isolated body part is greater than
the adhesion of the membrane to the applicator surface and to an
adjacent membrane in the stack.
[0033] FIGS. 6 and 7 are views of a second face embodiment of the
system 100 of the present invention. FIG. 6 is a rear perspective,
while FIG. 7 is a rear exploded view of system 100. The skin
treatment system 100 includes applicator 120 having a first surface
122, and a second surface 124. In this embodiment, applicator 120
is shown as a facial mask.
[0034] Applicator 120 in this embodiment has eye openings 126, a
nose opening 127, and a mouth opening 128, and is sized to cover
the full face of the user. It is important to note that in other
facial mask type embodiments, applicator 120 may be sized to
partially cover the face of the user, and may be without any of the
openings described above.
[0035] Disposed on second surface 124 of applicator 120 is membrane
130, which is releasably disposed on second surface 124 of
applicator 120. Membrane 130 has a first surface 132, and a second
surface 134, and has active regions 140a, 140b, 140c, and 140d
which contain one or more benefit agents. The bond between
applicator 120 and membrane 130 occurs between second surface 124
of applicator 120 and first surface 132 of the membrane 130.
[0036] Membrane 130 in this embodiment has eye openings 136, a nose
opening 137, and a mouth opening 138, and is sized to cover the
full face of the user. It is important to note that in other
embodiments, membrane 130 may be sized to partially cover the face
of the user, and may be without any of the openings described
above.
[0037] In this embodiment, active region 140a is located in the
forehead region of facial mask applicator 120, while active regions
140b and 140c are located in the cheek region of facial mask
applicator 120 and active region 140d is located in the chin region
of facial mask applicator 120. Although the embodiment shown has an
applicator 120 having releasably disposed membrane 130 with four
active regions (140a, 140b, 140c, and 140d), other embodiments may
have membranes 130 with more or less active regions. Some
embodiments may have one or more active regions, or two or more
active regions, or four or more active regions, or six or more
active regions, or eight or more active regions, or twelve or more
active regions. The number and location of the active regions 140
depend on the common consumer skin flaw(s) being treated.
[0038] As mentioned earlier, active regions 140 contain one or more
benefit agents. In some embodiments, active regions may contain
two, three, four, or more benefit agents. Also, if there are two or
more active regions, each active region may contain the same
beneficial agent(s), or each active region may contain different
beneficial agent(s).
[0039] Active regions 140 may also have a variety of shapes,
depending on the location of skin treatment. Possible shapes of the
active regions 140 include, but are not limited to, squares,
rectangles, triangles, circles, ovals, kidneys, stars, crosses,
characters, etc. The zone of the treatment could be greater than
about 1,000 cm.sup.2, about 1,000 cm.sup.2, or about 100 cm.sup.2,
or about 10 cm.sup.2, or about 1 cm.sup.2, or less than 1
cm.sup.2.
[0040] In accordance with a more particular aspect of the present
invention, second surface 124 of applicator 120 releasably attaches
to first surface 132 of membrane 130. The attachment strength of
applicator 120 to membrane 130 is less than the adhesive strength
of membrane 130 to skin. So, when applicator 120 is removed by the
user, membrane 130 remains adhered to the skin at the location of
the treatment zone.
[0041] FIGS. 8 and 9 are views of a third face embodiment of the
system 200 of the present invention. FIG. 8 is a rear perspective,
while FIG. 9 is a rear exploded view of system 200. The skin
treatment system 200 includes applicator 220 having a first surface
222, and a second surface 224. In this embodiment, applicator 220
is shown as a facial mask.
[0042] Applicator 220 in this embodiment has eye openings 226, a
nose opening 227, and a mouth opening 228, and is sized to cover
the full face of the user. It is important to note that in other
facial mask type embodiments, applicator 220 may be sized to
partially cover the face of the user, and may be without any of the
openings described above.
[0043] Disposed on second surface 224 of applicator 220 is membrane
230, which is releasably disposed on second surface 224 of
applicator 220. Membrane 230 has a first surface 232, and a second
surface 234. The bond between applicator 220 and membrane 230
occurs between second surface 224 of applicator 220 and first
surface 232 of membrane 230.
[0044] Membrane 230 in this embodiment has eye openings 236, a nose
opening 237, and a mouth opening 238, and is sized to cover the
full face of the user. It is important to note that in other
embodiments, membrane 230 may be sized to partially cover the face
of the user, and may be without any of the openings described
above.
[0045] Disposed on second surface 234 of membrane 230 are active
membranes 240a, 240b, 240c, and 240d. In some embodiments, these
active membranes are releasably disposed on second surface 234 of
membrane 230, and contain one or more benefit agents. Active
membranes 240a, 240b, 240c, and 240d have first surfaces and second
surfaces. FIG. 9 shows first surface 242d of membrane 240d, as well
as second surfaces 244a, 244c, and 244d of active membranes 240a,
240c, and 240d, respectively. The bond between membrane 230 and
active membranes 240a, 240c, and 240d occur between second surface
234 of membrane 230 and first surfaces of the membranes.
[0046] In this embodiment, active membrane 240a is located in the
forehead region of membrane 230, while active membranes 240b and
240c are located in the cheek region of membrane 230 and active
membrane 240d is located in the chin region of membrane 230.
Although the embodiment shown has a membrane 230 with four active
membranes (240a, 240b, 240c, and 240d), other embodiments may have
more or less active membranes. Some embodiments may have one or
more active membranes, or two or more active membranes, or four or
more active membranes, or six or more active membranes, or eight or
more active membranes, or twelve or more active membranes. The
number and location of the active membranes 240 depend on the
common consumer skin flaw(s) being treated.
[0047] As mentioned earlier, active membranes 240 contain one or
more benefit agents. In some embodiments, membranes may contain
two, three, four, or more benefit agents. Also, if there are two or
more active membranes, each active membrane may contain the same
beneficial agent(s), or each active membrane may contain different
beneficial agent(s).
[0048] Active membranes 240 may also have a variety of shapes,
depending on the location of skin treatment. Possible shapes of the
active membranes 240 include, but are not limited to, squares,
rectangles, triangles, circles, ovals, kidneys, stars, crosses,
characters, etc. The zone of the treatment could be greater than
about 1,000 cm.sup.2, about 1,000 cm.sup.2, or about 100 cm.sup.2,
or about 10 cm.sup.2, or about 1 cm.sup.2, or less than 1
cm.sup.2.
[0049] In accordance with a more particular aspect of the present
invention, second surface 224 of applicator 220 releasably attaches
to first surface 232 of membrane 230. The attachment strength of
applicator 220 to membrane 230 is less than the adhesive strength
of membrane 230 to skin. So, when applicator 220 is removed by the
user, membrane 230 remains adhered to the skin at the location of
the treatment zone.
[0050] It is important to note that although skin treatment systems
10, 100 and 200 in the embodiments of the present invention use
applicators 20, 120 and 220 in the form of a facial mask, skin
treatment systems may also be used on other isolated body parts,
such as arms, hands, legs, or feet, for example. In these other
embodiments, applicators 20, 120 and 220 will be shaped as
appropriate for other isolated body parts.
[0051] Applicators 20, 120 and 220 are made of a flexible,
biocompatible material which is capable of forming to the site of
treatment on the skin of the consumer. There are numerous flexible,
biocompatible material materials which may be used to form
applicators. These materials include, but are not limited to:
polyolefins like poly(ethylene) (PE) or poly(propylene) (PP);
poly(tetrafluoroethylene) (PTFE); poly(vinyl chloride) (PVC);
silicones like poly(dimethyl silane) (PDMS); polyacylates like
poly(methyl methacrylate) (PMMA) or poly(hydroxyethyl methacrylate)
(pHEMA); polyesters like poly(ethylene terephthalate) (PET),
poly(glycolic acid) (PGA), poly-L-lactic acid (PLA), or
polydioxanone (PDO); polyethers like polyether ether ketone (PEEK)
or polyether sulfone (PES); polyamide (Nylon); or polyurethane
(PU), polycaprolactone, or combinations of the above. The method of
forming applicator 20 will be discussed later.
[0052] In accordance with a more particular aspect of the present
invention, the attachment strength of the applicator to the
membrane is less than the adhesive strength of the membranes to
skin. So, when the applicator is removed by the user, the membrane
remains adhered to the skin at the location of treatment zone.
[0053] This relative adhesive strength is provided by modifying the
material of the applicator, at least on the second surface (24,
124, or 224) of the applicator (the surface that is directed toward
the skin during use), or the first surface (42, 132, or 232) of the
membrane (the surface that is directed away from the skin during
use). Adding a tackifier to the material in the applicator or the
membrane can increase the attachment strength between the two. The
attachment strength between the applicator (20, 120 or 220) and the
accompanying membrane (40, 130, or 240) is also affected by the
surface texture of the surface of the applicator in contact with
the membrane. Imparting a texture, such as a plurality of parallel
grooves, a bead-blasted texture, and the like, can increase the
attachment strength therebetween.
[0054] Membranes 40, 130, and 240 of the present invention are
provided in forms that are comfortable to wear and readily
removable after remaining in place for an extended period of time,
e.g., at least half an hour, or at least one hour, or at least
about six (6) to eight (8) hours, or at least about twelve (12)
hours, or about twenty-four (24) hours, if desired. Membranes 40,
130, and 240 are readily removable either by low adhesion to skin,
or upon application of water thereto. By readily removable upon
application of water thereto, it is meant that the membrane
structure may dissolve or disintegrate upon application of water to
the membrane structure, such that it may be removed from the skin
without scrubbing, or the like. In some embodiments, the membranes
may lose adhesion over time and fall off of the sight. Membranes
40, 130, and 240 preferably are a topically-applied skin care film,
patch, applique, etc. (hereinafter "film structure" for the sake of
convenience, without intent to limit) that preferably is relatively
flexible.
[0055] Membranes 40, 130, and 240 of the present invention
preferably are relatively thin and flexible, as described in
further detail below, so that they preferably readily conform to
the user's skin and are comfortable to wear, both because of the
flexibility and conformability, as well as from the thinness.
Membranes 40, 130, and 240 of the present invention intended for
extended wear preferably are also formed to be aesthetically
elegant without either peeling, wrinkling, cracking, or appearing
greasy or tacky, or otherwise unpleasant or unsightly in nature.
Membranes 40, 130, and 240 preferably are formed with sufficient
rigidity and integrity to be able to withstand normal use when on
the skin. For instance, membranes 40, 130, and 240 of the invention
preferably are formed with sufficient strength to stay intact on
the skin when exposed to normal external forces that the skin may
experience, e.g., rubbing of clothing, pillow, etc.
[0056] If desired, membranes 40, 130, and 240 of the present
invention may be formed to have structural integrity. As used
herein, structural integrity is to be understood as the physical
capability of the membranes to maintain a substantially monolithic
form or structure and to resist tearing or fracture while being
manipulated independent of the applicator.
[0057] It will be appreciated that structural integrity of
membranes 40, 130, and 240 of the present invention preferably also
contributes to the membranes' ability to remain intact during
manipulation and use, and to conform to the contours of the
application site to which they are applied, as discussed in further
detail below. For instance, it is desirable that each membrane have
sufficient structural integrity so that the membrane does not
readily tear when manipulated, worn, or otherwise used. It will be
appreciated that selection of one or more film formers that
contribute to a product's ability to achieve a pliable, cohesive,
and continuous covering on an application site such as skin, is one
manner of achieving the desired structural integrity of a membrane
of the present invention. In some embodiments, selection of one or
more plasticizers for producing or promoting plasticity and
flexibility and reducing brittleness, is another manner of
achieving the desired structural integrity of a membrane of the
present invention. The structural integrity of membranes 40, 130,
and 240 of the present invention typically may be correlated with
the tensile strength or modulus and thickness of their structure.
In connection with the present invention, structural integrity
typically increases as thickness and yield strength increase.
However, such properties must be balanced with their effect on
whether the membrane is comfortable to be worn, as discussed in
further detail below. Tensile strength contributes to the
structural integrity of membranes 40, 130, and 240 used in
accordance with principles of the present invention for such
purposes as handling and/or removing the membranes 40, 130, and 240
from the skin. Tensile strength affects, inter alia, whether the
membrane resists being fractured when being handled and/or removed
from the skin. For instance, membranes 40, 130, and 240 of the
present invention preferably have an elastic modulus of about 500
psi to about 10,000 psi. An elastic modulus of about 2,500 psi has
been found in one embodiment to provide the desired stiffness to be
comfortable during use. Typical samples with a 3/4 inch (1.905 cm)
width and a 0.1 mm thickness have a rupture-strength of about 2 lbf
(pound force), although it will be appreciated that a useful range
of rupture strengths is from about 0.5 lbf to about 5 lbf. The
membrane's adhesion values are preferably between 225 gms/25 mm to
1500 gms/25 mm (8-50 oz/in). However, in some circumstances that
will be recognized by the person of ordinary skill in the art, the
adhesion values may be as large as 3000 gms/25 mm (100 oz/in). The
shear values for the membrane are preferably greater than 250-500
minutes on a PSTC-107 (ASTM D3654)--procedure A.
[0058] The adhesion between the applicator and the membrane is
preferably about 2-3 oz/in or 10-20% lower adhesion than the
adhesion between the membrane and the topical surface to which it
is applied (whichever is higher). If membranes are stacked in the
applicator, a similar relation between adhesion of the
body-contacting membrane to the topical surface and the adhesion of
the body-contacting membrane to an adjacent membrane can be
used.
[0059] The thickness of the membrane also affects structural
integrity. For instance, the thickness of a membrane of the present
invention may be between about 0.05 mm to about 2 mm, and
preferably between about 0.05 mm and 0.3 mm. A thickness of
approximately 0.1 mm has been found to provide the desired
mechanical properties for handling, applying, and ultimately
removing the membrane, such that the membrane maintains its
structural integrity throughout such use, as well as while being
worn on a given application site, as discussed in further detail
below.
[0060] In accordance with one aspect of the present invention,
membranes 40, 130, and 240 of the present invention are
self-adhesive, i.e., the membrane adheres to a user's skin upon
contact with the skin, preferably without additional steps, such as
addition of another composition, such as water.
[0061] In one embodiment, water soluble bio adhesive polymers can
be used for enhancing skin adhesive property. Examples useful for
the invention include, but are not limited to, cellulose and its
derivatives, polyvinyl pyrrolidone, water soluble celluloses,
polyvinyl alcohol, ethylene maleic anhydride copolymer, methylvinyl
ether maleic anhydride copolymer, acrylic acid copolymers, anionic
polymers of methacrylic acid and methacrylate, cationic polymers
with dimethyl-aminoethyl ammonium functional groups, polyethylene
oxides, water soluble polyamide or polyester, polyethylene glycol,
water soluble acrylic polymers, water soluble polyesters,
hydroxyalkyl starches, casein, gelatin, solubilized proteins,
polyacrylamide, polyamines, polyquaternium amines, styrene maleic
anhydride resins, polyethylene amines, The water soluble
carbohydrate can form hydrogen or covalent bonding to the water
soluble or hydrophilic polymer in the membrane.
[0062] In accordance with one aspect of the present invention, the
adhesive quality of membranes 40, 130, and 240 of the present
invention are preferably capable of fixing the membrane to the skin
of a user for an extended period of time, as discussed herein
above, without irritating the skin. Preferably, the membrane is
capable of adhering to the application site for as long as
reasonable and/or indicated to have a membrane in place at such
site. Thus, an upper temporal limit to adhesion time is not
important, since the user or wearer typically will want to remove
the membrane before the membrane would naturally wear off of the
application site on its own. In embodiments where membranes 40,
130, and 240 are readily removable upon application of water
thereto, the amount of time a membrane of the present invention is
to adhere to a given application site is dictated by the amount of
time the application area can withstand not being exposed to water.
For instance, it will be appreciated that some surgical sites are
not to be exposed to water for extended periods of time, such as
several days. Membranes for application to such sites should
accordingly be capable of adhering to such site for so long as the
site is not exposed to water, if desired. As may be appreciated,
the adhesive preferably is selected for application onto a skin
surface which typically is not considered to be moist, in contrast
with mucosal tissue. It will be appreciated that by being capable
of adhering to the user's skin, the membrane simply is capable of
adhering, but need not necessarily adhere if such property is not
desired or unnecessary for a particular application.
[0063] Because membranes 40, 130, and 240 of the present invention
preferably are formed to remain adhered to the application site for
an extended period of time, as described above, non skin-contacting
surfaces (first surfaces 42, 132, and 244 of membranes 40, 130, and
240, respectively), preferably have desirable properties and
features to facilitate such an intended use of the membrane. For
instance, because a membrane is designed to adhere to an
application site, if the membrane is designed to adhere to an
application site for an extended period of time, then an adhesive
outwardly-facing surface may unintentionally or inadvertently
adhere to another surface or object during use of the membrane.
Such unintentional or inadvertent occurrence may cause the membrane
to become dislodged, or, worse, disengaged (partially or even
fully) from the application site. Moreover, it will be appreciated
that an adhesive material typically attracts dust or dirt or other
debris, which would likely be considered by the wearer to be
unsightly and undesirable. Accordingly, it is preferable that non
skin-contacting surfaces (first surfaces 42, 132, and 244 of
membranes 40, 130, and 240, respectively) of the present invention
are non-tacky; not adhesive, and create low or no static when
rubbed. Thus, for membranes 40, 130, and 240 of the present
invention, to remain adhered to an application site for an extended
period of time, preferably have first surfaces 42, 132, and 244
that are non-tacky; non-adhesive.
[0064] If first surfaces 42, 132, and 244 rub against or are rubbed
by something or otherwise contacts or is contacted by another
surface or Membranes 40, 130, and 240, the membranes 40, 130, and
240 should not adhere to such surface or membrane.
[0065] Membranes 40, 130, and 240 may be tinted or pigmented to
match the skin tone of the user so to be aesthetically pleasing, or
at least not unaesthetic or unsightly, when worn.
[0066] Membranes 40, 130, and 240 may be formed to be clear to be
discrete in situ. Further properties may be selected to render
membranes 40, 130, and 240 of the present invention visually
discrete when in situ so that if the membrane is worn during the
day its noticeability is minimized as much as possible. For
instance, the thinner the membrane is, the less visible the
structure typically is. In addition, or alternatively, the color,
texture (e.g., rough, slick, smooth, or otherwise textured such as
an "orange peel" surface to match substantially the texture of the
skin to which the membrane is applied so that the membrane is not
starkly smooth relative to the skin with its natural
imperfections), shine (shiny or dull depending on application
site), etc., may be modified as desired to facilitate blending in
of the membrane with the application site. Because membranes 40,
130, and 240 of the present invention may be configured to be worn
for an extended period of time (e.g., more than an hour, such as
described above, and/or even overnight), the membrane preferably is
formed or configured to be comfortable when worn. A variety of
factors (individually or in any combination) may be considered in
achieving the desired comfort and level of comfort, including,
without limitation, tactile properties, material thickness
(affecting not only durability, but also weight on the application
site), stiffness and permeability. Tactile properties that may
contribute to comfort include smoothness, and/or stickiness of the
adhesive used to adhere the membrane structure to a selected
application site, etc. Additional tactile properties that may
contribute to comfort include softness, smoothness, and texture of
the membrane, such as determined by modulus of elasticity and
coefficient of friction (rather than merely the aesthetic aspects
of such properties).
[0067] Thickness affects a variety of additional factors, including
stiffness--a stiffer membrane typically being less comfortable than
a less stiff membrane. Material properties (a function of the
composition of the material, independent of form) as well as
structural properties (the form of the membrane) may affect the
achievable comfort level of a membrane used in accordance with
principles of the present invention when worn by a user. It will be
appreciated that all the desired properties for a membrane used in
accordance with principles of the present invention must be
balanced, wherein some properties complementary, yet others have
opposing dimensions. With regard to comfort, it will be appreciated
that properties contributing to comfort must be balanced with
properties contributing to structural integrity. There are at least
three structural properties that affect "comfort": flexibility
(about a single, bending direction; generally, flexibility is
considered a combination of thickness and flexural modulus),
stretchability (in a single axial direction; generally,
stretchability is considered a combination of thickness and elastic
modulus), and conformability (generally considered a combination of
flexibility and physical shape in multiple directions, about
complex surface). Comfort may be achieved by minimizing both the
thickness and the elastic modulus. It will be appreciated that
flexibility and stretchability are both functions of the elastic
modulus of the material. More particularly, flexibility generally
is dictated by the thickness of the material as well as the
flexural modulus. Stretchability is a function of thickness and
elastic modulus. When the material is thicker, stiffness increases
(which property correlates with comfort) and flexibility and
stretchability are reduced, generally adversely impacting comfort.
The elastic modulus generally affects how rubbery or brittle a
material is, and is tied to comfort because it determines
flexibility of the material. Increasing the flexural or elastic
modulus of a material makes the material less flexible or
stretchable, respectively. Specifically, a higher flexural or
elastic modulus results in a stiffer material, so the material
consequently is less flexible and less stretchable. Given a
constant flexural or elastic modulus, a higher material thickness
will make the material less flexible or stretchable. As may be
appreciated, comfort may be achieved by minimizing thickness of a
given film to the lowest practical limit. The lower limit is
dictated by providing enough structure to handle and manipulate the
self-supporting adhesive film and to facilitate application and
removal of the self-supporting adhesive film. From a material
standpoint, the elastic modulus is most strongly linked to comfort.
The lower the elastic modulus, the more comfortable the film
structure typically is. An elastic modulus of from about 500 psi to
about 10,000 psi provides an acceptable degree of comfort for a
user, with a more preferred range of elastic modulus of from about
1,000 psi to about 5,000 psi, with a preferred elastic modulus of
about 2,500 psi. Conformability, such as the ability to conform to
a given site (typically a surface with a complex curvature), not
only involves flexibility, in general, but also relates to
multidirectional flexibility and stretchability (e.g., so the
membrane may stretch if placed over a joint). Conformability
generally must be defined in terms of the physical shape or contour
of the application site, and is determined with respect to a
surface in conjunction with flexibility. A membrane may need to
have a particular planar shape to be able to conform to a complex
surface. Preferably, a membrane used in accordance with principles
of the present invention has substantially the same properties in
all directions.
[0068] If membranes 40, 130, and 240 used in accordance with
principles of the present invention are to remain on the
application site for an extended period of time, such membrane
preferably has a desired degree of breathability. Breathability may
also be important for obtaining desired skin moisturization or
proper skin moisture content balance for the functionality of the
membrane in providing such benefit. Breathability relates to and is
a function of oxygen exchange, which affects skin barrier as well
as consumer perception. Breathability also is a function of water
transmission. Membranes 40, 130, and 240 used in accordance with
principles of the present invention preferably are sufficiently
breathable so that the skin moisture content remains balanced. Of
course, if one of the desired outcomes of use of the present
invention is to improve or to increase skin moisture content, then
the breathability of the membrane preferably may be selected to
facilitate such moisturization, as discussed in further detail
below. A semi-occlusive film will at least partially inhibit water
loss and therefore hold moisture within the skin. Membranes 40,
130, and 240 used in accordance with principles of the present
invention preferably provide resistance to moisture transmission,
and may have a moisture transmission rate of approximately 50-150
grams of water per hour per square meter. Such membrane has been
found to block or occlude evaporation that would occur without a
film barrier by approximately 87%.
[0069] Membranes 40, 130, and 240 used in accordance with
principles of the invention, as further described below, may be
semi-occlusive (preferably approximately 50-85% occlusive) not only
to maintain breathability, but also to provide other benefits
discovered to result from covering the application site with a
semi-occlusive membrane. In some embodiments, membranes 40, 130,
and 240 of the present invention may comprise a top layer to
further contribute to the overall semi-occlusive nature of the
membrane. In particular, a top layer may function in conjunction
with a hygroscopic skin-contacting layer. Once such a
skin-contacting layer hydrates further, it may further lose
structural integrity, and transform from a film-type substance to a
gel phase without structural integrity independent of a top layer.
The layer thus essentially caps and contains the skin-contacting
surface at the application site so that the skin-contacting surface
can hydrate the application site.
[0070] In some embodiments, membranes 40, 130, and 240 used in
accordance with principles of the present invention dissolve or
disintegrate with only the addition of water. Preferably, no
mechanical agitation is required to facilitate the removal of the
self-supporting adhesive film. Preferably, membranes 40, 130, and
240 used in the present invention preferably completely dissolves
within the parameters of a typical consumer washing regimen for the
application site if no membrane is present, so no additional
washing time is required by the consumer. Preferably, membranes 40,
130, and 240 used in the present invention are quick-dissolving for
ready removal from the application site on the user (when washing
one's face, preferably less than about 5 minutes, and even less
than about 1 minute, and even about 30 seconds after addition of a
water thereto). It will be appreciated that a longer dissolution
rate is acceptable for sites on other parts of the body that are
typically washed for more than 5 minutes, but preferably not so
long a dissolution time that scrubbing is required to achieve
removal). With simulated cleansing water flow of about 4 feet/sec
(parallel flow to surface of film), complete dissolution was
measured in about 67 seconds with initial breach of the outer film
surface occurring at about 30 seconds. In another embodiment, the
membrane can be removed with a wet cloth, sheet, or pad made of
woven or nonwoven materials.
[0071] The primary mechanical strength of the membrane is created
by the film former (preferably polyvinyl alcohol (PVA)), which for
membranes which breakdown with exposure to water, typically is also
selected based on its ability to permit ready breakdown of the
membrane as desired. It will be appreciated that in one embodiment,
the film former preferably is selected to achieve the desired
ability to dissolve or disintegrate the membrane for removal upon
application of water thereto, and may be the first component of the
membrane composition that is selected, other components being
selected to interact as desired with the already-selected film
former. Flexibility is achieved by the addition of a plasticizer,
such as glycerin, to the film former. Film formers and/or
plasticizers typically are the primary contributors to structural
integrity, and are typically a component of the composition used to
form the outwardly-facing top layer with properties such as
described above. Exemplary film formers and plasticizers are set
forth in greater detail below. Looking at solids content, PVA can
be 70% by weight of the dry ingredients of a film structure used in
accordance with principles of the present invention, with glycerin
at 20% by weight. The glycerin can range from as little as 10% to
30% by weight of the film structure, and the PVA can be as much as
90% by weight of the dry ingredients.
[0072] Some hydrophilic film-forming polymers suitable for
producing the topical skin membranes 40, 130, and 240 used in the
present invention may be of synthetic, semisynthetic, or natural
origin. Such hydrophilic film forming polymers include, without
limitation, cellulose ethers, polyvinyl alcohols, polyvinyl
acetate, polyvinyl pyrrolidone, polysaccharides, as well as
derivatives, copolymers or polymers thereof. The multi-layer
topical skin membrane may be made into a wide variety of product
forms that include but are not limited to the form films.
[0073] The membranes 40 and 240, as well as the active regions 140
of the present invention contain at least one active substance,
active agent, or benefit agent. The benefit agents that may be used
in film structures of the invention include cosmetic agents and
therapeutic agents. Such substances may be any of a variety of
compositions, including, without limitation, hyaluronic acid;
hydroxyl acids (e.g., glycolic acid, lactic acid, malic acid,
salicylic acid, citric acid, tartaric acid); anti-acne agents
(e.g., salicylic acid, retinol, retinoids, or other keratolytics,
and benzoyl peroxide, or other antimicrobial agents used to treat
acne); shine control agents (e.g., rice protein, cotton powder,
elubiol (dichlorophenyl-imidazoltioxolan); a retinoid or its
derivative such as tretinoin, isotretinoin, motretinide, adapalene,
tazarotene, azelaic acid, and retinol; a 5-alpha-reductase
inhibitor of amino acids, e.g., glycine derivatives; hydrolyzed
vegetable proteins, including soy protein and wheat protein, etc.,
green tea (camellia sinesis) extract, and cinnamon bark extract);
moisturizers; anti-microbial agents (e.g., cationic antimicrobials
such as benzylkonium chloride, benzethonium chloride, triclocarbon,
polyhexamethylene biguanide, cetylpyridium chloride, methyl and
benzothonium chloride; salts of chlorhexidine, such as lodopropynyl
butylcarbamate, diazolidinyl urea, chlorhexidene digluconate,
chlorhexidene acetate, chlorhexidine isethionate, and chlorhexidene
hydrochloride; halogenated phenolic compounds, such as
2,4,4'-trichloro-2-hydroxy diphenyl ether (Triclosan);
parachlorometa xylenol (PCMX); short chain alcohols, such as
ethanol, propanol, and the like); antibiotics or antiseptics
(mupirocin, neomycin sulfate bacitracin, polymyxin B, 1-ofloxacin,
tetracyclines (chlortetracycline hydrochloride, oxytetracycline-10
hydrochloride and tetracycline hydrochloride), clindamycin
phosphate, gentamicin sulfate, metronidazole, hexylresorcinol,
methylbenzethonium chloride, phenol, quaternary ammonium compounds,
tea tree oil, and their pharmaceutically acceptable salts and
prodrugs), anti-inflammatory agents (e.g., suitable steroidal
anti-inflammatory agents such as corticosteroids such as
hydrocortisone, hydroxyl triamcinolone alpha methyl dexamethasone,
dexamethasone-phosphate, beclomethasone dipropionate, clobetasol
valerate, desonide, desoxymethasone, desoxycorticosterone acetate,
dexamethasone, dichlorisone, diflorasone diacetate, diflucortolone
valerate, fluadrenolone, fluclarolone acetonide, fludrocortisone,
flumethasone pivalate, fluosinol one acetonide, fluocinonide,
flucortine butyl ester, fluocortolone, fluprednidene
(fluprednylidene) acetate, flurandrenolone, halcinonide,
hydrocortisone acetate, hydrocortisone butyrate,
methylprednisolone, triamcinolone acetonide, cortisone,
cortodoxone, flucetonide, fludrocortisone, difluorosone diacetate,
fluradrenalone acetonide, medrysone, amciafel, amcinafide,
betamethasone, chlorprednisone, chlorprednisone acetate,
clocortelone, clescinolone, dichlorisone, difluprednate,
flucloronide, flunisolide, fluoromethalone, fluperolone,
fluprednisolone, hydrocortisone valerate, hydrocortisone
cyclopentylproprionate, hydrocortamate, meprednisone,
paramethasone, prednisolone, prednisone, beclomethasone
dipropionate, betamethasone dipropionate, triamcinolone, and salts,
nonsteroidal anti-inflammatory agents, feverfew (Tanacetum
parthenium), goji berry (Lycium barbarum), milk thistle extract
(Silybum marianum), amaranth oil (Amaranthus cruentus), pomegranate
(Punica granatum), yerbe mate (Ilex paraguariensis leaf extract),
white lily flower extract (Lilium Candidum), olive leaf extract
(Olea europaea) and phloretin (apple extract));
anti-mycotic/antifungal agents (e.g., miconazole, econazole,
ketoconazole, sertaconazole, itraconazole, fluconazole,
voriconazole, clioquinol, bifoconazole, terconazole, butoconazole,
tioconazole, oxiconazole, sulconazole, saperconazole, clotrimazole,
undecylenic acid, haloprogin, butenafine, tolnaftate, nystatin,
ciclopirox olamine, terbinafine, amorolfine, naftifine, elubiol,
griseofulvin, and their pharmaceutically acceptable salts and
prodrugs; an azole, an allylamine, or a mixture thereof); external
analgesics (e.g., ibuprofen- or diclofenac; capsaicin, fentanyl,
and salts thereof such fentanyl citrate; paracetamol (as
acetaminophen); non-steroidal anti-inflammatory drugs (NSAIDs) such
as salicylates; opioid drugs such as morphine and oxycodone;
ibuprofen- or diclofenac-containing gel); anti-oxidants (e.g.,
sulfhydryl compounds and their derivatives (e.g., sodium
metabisulfite and N-acetyl cysteine), lipoic acid and dihydrolipoic
acid, resveratrol, lactoferrin; ascorbic acid, ascorbic acid
esters, and ascorbic acid derivatives (e.g., ascorbyl palmitate and
ascorbyl polypeptide); butylhydroxy anisole, butylated
hydroxytoluene (butylhydroxy toluene), retinoids (e.g., retinol and
retinyl palmitate), tocopherols (e.g., tocopherol acetate),
tocotrienols, and ubiquinone; cysteine, N-acetylcysteine, sodium
bisulfite, sodium metabisulfite, sodium formaldehydesulfoxylate,
acetone sodium bisulfite, tocopherols, and nordihydroguaiaretic
acid; extracts containing flavonoids and isoflavonoids and their
derivatives (e.g., genistein and diadzein); extracts containing
resveratrol and the like; grape seed, green tea, pine bark, and
propolis; plant-derived polyphenol antioxidants such as clove,
cinnamon, oregano, turmeric, cumin, parsley, basil, curry powder,
mustard seed, ginger, pepper, chili powder, paprika, garlic,
coriander, onion and cardamom; typical herbs such as sage, thyme,
marjoram, tarragon, peppermint, oregano, savory, basil and dill
weed)); depilatory agents (e.g., calcium thioglycolate or potassium
thioglycolate); vitamins (e.g., Vitamin A, Vitamin B, Vitamins C,
Vitamin E; either alpha, beta, gamma or delta tocopherols, niacin
or niacinamide) and vitamin salts or derivatives such as ascorbic
acid diglucoside and vitamin E acetate or palmitate; sunblock
(e.g., titanium dioxide) and/or sunscreen (e.g., inorganic
sunscreens such as titanium dioxide and zinc oxide; organic
sunscreens such as octyl-methoxy cinnamates, octyl salicylate,
homosalate, avobenzone); vasodilators (e.g., niacin); humectants
(e.g., glycerin); anti-aging agents (e.g., retinoids;
dimethylaminoathanol (DMAE), copper containing peptides); alpha
hydroxy acids or fruit acids and their precursors such as glycolic
acid, citric acid, lactic acid, malic acid, mandelic acid, ascorbic
acid, alpha-hydroxybutyric acid, alpha-hydroxyisobutyric acid,
alphahydroxyisocaproic acid, atrrolactic acid,
alpha-hydroxyisovaleric acid, ethyl pyruvate, galacturonic acid,
glucoheptonic acid, glucoheptono 1,4-lactone, gluconic acid,
gluconolactone, glucuronic acid, glucuronolactone, isopropyl
pyruvate, methyl pyruvate, mucic acid, pyruvic acid, saccharic
acid, saccaric acid 1,4-lactone, tartaric acid, and tartronic acid;
beta hydroxy acids such as beta-hydroxybutyric acid,
beta-phenyl-lactic acid, and beta-phenylpyruvic acid; zinc and zinc
containing compounds such as zinc oxides; botanical extracts such
as green tea, soy, milk thistle, algae, aloe, angelica, bitter
orange, coffee, goldthread, grapefruit, hoellen, honeysuckle, Job's
tears, lithospermum, mulberry, peony, puerarua, nice, and
safflower, and salts and prodrugs thereof); carotenoids, ceramides,
fatty acids, enzymes, enzyme inhibitors, minerals, steroids,
peptides, amino acids, botanical extracts, colorants, etc. The
substances may affect the skin in any of a variety of manners, such
as by moisturizing; enhancing skin tone or color (such as with
pigments); treating or at least mitigating various skin conditions
(such as dry or severe dry skin, eczema, psoriasis, atopic
dermatitis, allergic rashes, acne, blackheads, pustules, comedones,
rosacea, shingles, wrinkles, cold sores, herpes, corns, warts,
sunburn, insect bites, poison ivy, etc.); applying a mechanical
force (such as shrinkage) to smooth wrinkles; or, more generally,
treating or mitigating the symptoms and appearance of undesired
skin imperfections (such as under eye dark circle, redness of acne,
fine lines and wrinkles, post inflammatory hyperpigmentation (PIH),
redness, inflammation, cellulite, wrinkles, age spots, mottled
pigmentation, dark spots, liver spots, under eye puffiness);
removing unwanted facial or body hair; aiding in wound healing;
etc.. For instance, lotions, creams, oils, and even masks may be
applied to skin to treat or otherwise to affect the skin. Such
personal or consumer healthcare substances are absorbed into the
skin generally following the principles of diffusion, under which
the rate of diffusion or transport across the skin is correlated
with the difference in active concentration on both sides of the
skin.
[0074] Method of Making the System
[0075] A system and method are also provided that comprise at least
(a) an imaging device system that capture user's digital face
geometry and images of face condition for skin analysis, and feeds
its outputs to a center computer system comprising a connection
center, cloud based-hub computing data system where the digital
data of user's face geometry and images of face condition can be
uploaded, stored and shared, (b) a 2D to 3D reconstruction and
artificial intelligent (machine learning) algorithms for geometry
and appearance reconstruction, (c) a skin feature database for skin
comparison and grading, (d) skin analysis algorithms that provide
skin analysis output images, face maps, evaluation results and
treatment recommendations to user, (e) an internet portal site
provided for user access for inputs and treatment selections.
Outputs from the central computer system are provided for download
to local computer, treatment formulator, and 3D printing or digital
computational thermo-vacuum former and 6-axis robot
treatment-deposition device which deposit various treatments onto
membrane to face of mask body to generate a personalized conformal
facial mask with area-specific personalized treatment for that
particular user. Similar approach can be applied to individual
patch or a group of patches.
[0076] Method of Using the System
[0077] In addition we have identified a method for targeted
application of topical agents to an isolated body part comprising
the steps of capturing an image of the isolated body part,
transforming the image data to mathematical model of the geometry
of the isolated body part, forming an applicator mask having an
applicator surface having a three dimensional shape corresponding
to the isolated body part, forming a releasable membrane on the
applicator surface of the applicator mask comprising one or more
benefit agents disposed in one or more treatment zones of the
applicator, where the adhesion of the membrane to the isolated body
part is greater than the adhesion of the membrane to the applicator
surface, disposing the applicator mask on the isolated body part so
that the releasable membrane is in contact with the isolated body
part, and removing the applicator mask from the isolated body part
so that the membrane remains in contact with the isolated body
part.
[0078] In use, a system scans a patient's body part positioned in
the field of scan, and being scanned by an imaging device. This
imaging device is capable of sensing many characteristics (shapes
and micro geometries) from the patient's body part. For instance,
device may sense local body geometry shape with white light (LED),
infrared emissions from area of increased heat, reflectivity
sensing oiliness or dryness of skin, and local body defects
(micro-geometry) such as spots, wrinkles, blemishes, texture,
pores, UV spots, brown spots red areas, porphyrins, acne, etc. with
different light sources, for example, commercial available image
device VISIA, VISIONFACE 1000D, Sony Beauty Explorer, and the like.
These characteristics are merely exemplary a preferred embodiment,
however, it is to be appreciated that such examples are not
intended to limit the functionality of imaging device as any
imaging device known in the art is fully contemplated herein.
[0079] The imaging device provides an output which is in electrical
communication to a central computer system where the computer
software and associated computing device is programmed to process
the data and generate a customized skin profile for that individual
user showing various skin conditions and corresponding locations of
skin conditions in the captured images. The system is also
programmed to generate recommendations for treatment of various
skin conditions identified in the skin profile.
[0080] All the data captured from user will be output to a center
computer system comprising a connection center, cloud based-hub
computing data system where the digital data of user's face
geometry and images of face skin condition can be uploaded, stored
and shared for downstream process.
[0081] For example, commercially available imaging devices that can
be used for capturing local body shape in the present invention
include, for example, Digital 3D scanner Go!scan20.TM. from
CREAFORM, ISENSE from 3D system, ARTEC SPIDER, NIKON MODELMAKER
MMCx, OPTIX 500S form 3D Digital CORP, etc.
[0082] For instance, the face image of the present invention may be
captured with digital 3D scanner such as Go! scan20.TM., or with
high end digital camera or video camera, or just a consumer grade
camera, such as, for example, a cell phone through 2D to 3D
reconstruction software algorithm. Preferably, more than one image
of the user is captured, each from a different angle such that an
analysis can be accomplished, for example, of the entire face.
Along with the images, positioning information is acquired with
respect to the captured images. The acquired positioning
information on the images may be analyzed to determine surface
topography for mapping local body defect area or treatment
areas.
[0083] In one embodiment of the present invention a 3D model of the
anatomically customized mask is created using multidimensional data
from an individual's face. The data may be acquired through 3D
scanner, multiple image or video cameras and digital 2D to 3D
reconstruction software, point cloud or triangulate scans from
digital image scanners, or any number of 3D modeling technologies.
Once the digital data of the individual face 3D surface captured in
the system, software in the system may further customize the mask
applicator 20 to provide automatically rendering, cleaning scan
noise and enhanced functionally aesthetics.
[0084] Digital 3D images of entire face, for example, captured with
digital 3D scanner Go! Scan20.TM. can be formatted and digitally
stored in central computer system where computer software Geomagic
Design X from 3D system provide 3D rendering and cleaning noise of
the 3D scanned data, and associated software (e.g., Solidworks or
Inventor) is programmed to process the 3D rendering data and
generate a 3D model for applicator 20. The 3D model then can be
downloading to 3D printer to print the applicator 20 by utilizing
plastic thermoset material or plastic materials.
[0085] One the example of the present invention provides a
customized mask applicator formed utilizing 3D printing
technologies for conforming to the unique facial features of the
user. The mask applicator 20 embodiments of the present invention
are customizable for each user to provide matching contours of the
human face for increased comfort when the mask is worn.
[0086] Since 3D printing technology is used in the present
invention, any digitized model must be mathematically translated
into 3D printable format of the desired print-out. Importantly, to
ensure customized fit of the face mask, the customized, contoured
facial mask applicator face portion, is constructed and configured
to cover and to contact a corresponding contoured surface area of
human face, is unitarily and integrally formed by 3D printing
technology, and is formed of non-toxic synthetic material,
thermoset plastic or plastic. Preferably, a soft plastic layer or
rubberlike layer is provided on the surface that contacts the face
of user. For example, commercial available 3D printing technology
such as Fused deposition modeling (FDM), Fused filament fabrication
(FFF), Stereo lithography (SLA), Digital Light Processing (DLP),
Powder bed and inkjet head 3D printing (3DP) Selective heat
sintering (SHS), and Selective Laser sintering (SLS) can be
utilized to form applicator 20 with different type of
thermoplastic, thermoplastic powders, and thermoset photopolymer.
For example, applicators in the present invention can be formed by
utilizing Stratasys Connex 3 3D printer with so called digital
materials (include primary material: TANGOPLUS FLX930 and secondary
material: VEROCLEAR RDG 810, or VEROWHITEPLUS RGD835) controlled
with different layer's softness between 35 to 95 Shore Hardness
(A).
[0087] Applicator 20 then can be physically transferred to 6-axis
robot treatment-deposition device which deposit prefer benefit
agents on to second surface 24 of applicator 20.
EXAMPLES
[0088] The present invention will be further understood by
reference to the following specific example that is illustrative of
the composition, form and method of producing the device of the
present invention
Example 1: Formation of Skin Treatment System 200
[0089] With reference to FIGS. 8-9, a user with the desire to treat
acne in several regions of her face uses an imaging device system
to capture her digital face geometry as well as images of face
condition for skin analysis. The image output is sent to a center
computer system comprising a connection center, cloud based-hub
computing data system where the digital data of her face geometry
and images of face condition can be uploaded, stored and shared
with a mask forming system. The face forming system creates an
individualized skin treatment system 200, in the form of an acne
treatment facial mask for the user.
[0090] Skin treatment system 200 includes applicator 220 having a
first surface 222, and a second surface 224. Applicator 220,
comprised of poly(ethylene) is formed using a thermo-vacuum former
(Formech thermos-vacuum former machine 300XQ) with a mold cavity in
the shape of a human face, at conditions required to mold the PE
into the face-mask shape. The temperature is about 260.degree. F.
to about 360.degree. F., and the vacuum is between about 750 mbar
to about 914 mbar). Alternatively, the applicator 220 is formed
using a Stratasys 3D printer Connex 3X and Objet 24 with model
material VEROWHITEPLUS RGD835 and support material Sup705
(temperature 73.degree. C. for both material during 3D printing
process).
[0091] Second surface 224 of applicator 220 is treated with a
release agent such as a cross-linkable silicone solution. Membrane
230 is disposed on second surface 224 of applicator 220 using a
6-axis robot treatment-deposition device, such as a DENSO Model:
VP-6242E/GM device.
[0092] Table 1 shows several formulations which are used to form
membrane 230.
TABLE-US-00001 TABLE 1 Compositions for membrane 230 (wt %).
Ingredients 230A 230B 230C 230D Selvol 805 16.86 16.86 16.86 16.86
Vitacel Oat Fiber HF600-30 11.82 11.82 11.82 11.82 Salicyclic Acid,
USP, Powder 1.14 1.25 1.02 1.06 Polysorbate 80 1.80 1.80 1.80 1.8
Dow Corning 2501 Cosmetic Wax 1.24 1.24 1.24 1.24 Kester Wax K-24
1.24 1.24 1.24 1.24 Glycerin 99.7%, USP 10.30 10.30 10.30 10.3
Lactic Acid, Ritalac LA 5.61 5.61 5.61 5.61 Water, Purified 50.00
49.89 50.11 50.07 TOTAL (wt %) 100.00 100.00 100.00 100.00
[0093] Membrane 230 has a first surface 232, and a second surface
234. Active regions 240a, 240b, 240c, and 240d which contain the
acne treatment benefit agents, are formed using a 6-axis robot
treatment-deposition device. Table 2 shows several formulations
which are used to form active regions 240.
TABLE-US-00002 TABLE 2 Compositions for active regions 240 (wt %).
Ingredients 240A 240B 240C 240D Plasdone S-630 28.19 28.19 28.19
28.19 Polyox WSR N-10 6.40 6.40 6.40 6.4 Vitacel Oat Fiber HF600-30
6.98 6.98 6.98 6.98 Glycerox 767 1.16 1.16 1.16 1.16 Salicyclic
Acid, USP, Powder 1.14 1.25 1.02 1.06 Monomuls 90-O18 2.93 2.93
2.93 2.93 Aquacoat ECD, Ethylcellulose 9.75 9.75 9.75 9.75
Dispersion (30%) Feverfew 1.37 1.37 1.37 1.37 Water, Purified 42.07
41.96 42.19 42.16 TOTAL wt % 100.00 100.00 100.00 100.00
[0094] The membrane is then transferable from the applicator to the
user's isolated body part. After a desired treatment time, the
membrane may be removed from the user with a soap and water
wash.
[0095] Although shown and described is what is believed to be the
most practical and preferred embodiments, it is apparent that
departures from specific designs and methods described and shown
will suggest themselves to those skilled in the art and may be used
without departing from the spirit and scope of the invention. The
present invention is not restricted to the particular constructions
described and illustrated, but should be constructed to cohere with
all modifications that may fall within the scope of the appended
claims.
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