Note: Descriptions are shown in the official language in which they were submitted.
CA 02611655 2007-11-20
J&J5278USNP
SKIN-PIERCING DEVICE FOR TREATMENT OF ACNE
BACKGROUND OF INVENTION
Acne is a common skin disease characterized by pimples on the face, chest, and
back.
It occurs when the pores of he skin become clogged with oil, dead skin cells
and bacteria.
Inflamed lesions may cause pain, tenderness, itching, or swelling. The most
troubling aspects
of these lesions are negative cosmetic effects.
Pimple popping has been a pervasive, but sometime impulsive, behavior to
quickly
reduce the elevation of raised acne, especially pustule type of lesions. The
current pimple
popping practice is to use fmgers to squeeze the pimple, which can carry the
risks of
infections, post-inflammatory hyperpigmentation, and even scarring. While
sterilized
hypodermal needles can be used to break the tip of the pimple to release the
pus, such needles
do not control the depth of and size of cut, which can cause unwanted bleeding
and skin
damages. Thus, there is clearly a need to provide a safe and hygienic way to
pop the pimple
and reduce the symptoms of pimple.
The present invention discloses a new method and device to safely assist
popping
pimple to remove puss and/or treat acne as well as other skin disorders such
as cold sores,
warts, razor bumps, and age spots.
SUMMARY OF THE IlVVENTION
In one aspect, the present invention features a skin-piercing device
including: a
housing having a skin-contacting surface, wherein the housing includes an
opening in the
skin-contacting surface; a piercing element disposed within the housing; a
forcing assembly
urging the piercing element in a direction to project the tip of the piercing
element from
within the housing through the opening in the skin-contacting surface of the
housing; a
trigger assembly with a portion contained within the housing arranged to
retain the piercing
element in a retracted position energizing the forcing assembly and a second
portion outside
the housing manually actuable to release the piercing element to cause the tip
to have a
momentary position projecting from the opening; and a fluid-absorbent material
affixed to
the outside of the housing.
In another aspect, the invention features a method of treating acne, wherein
the
method includes contacting skin in need of such treatment with the skin-
contacting surface of
a skin-piercing device including: a housing having a skin-contacting surface,
wherein the
housing includes an opening in the skin-contacting surface; a piercing element
disposed
CA 02611655 2007-11-20
J&J5278USNP
within the housing; a forcing assembly urging the piercing element in a
direction to project
the tip of the piercing element from within the housing through the opening in
the skin-
contacting surface of the housing; and a trigger assembly with a portion
contained within the
housing arranged to retain the piercing element in a retracted position
energizing the forcing
assembly and a second portion outside the housing manually actuable to release
the piercing
element to cause the tip to have a momentary position projecting from the
opening; wherein
the method includes actuating the trigger mechanism to release the piercing
element to cause
the tip to pierce the skin.
In another aspect, the invention features a kit including a skin-piercing
device, the
skin-piercing device including: a housing having a skin-contacting surface,
wherein the
housing includes an opening in the skin-contacting surface; a piercing element
disposed
within the housing; a forcing assembly urging the piercing element in a
direction to project
the tip of the piercing element from within the housing through the opening in
the skin-
contacting surface of the housing; and a trigger assembly with a portion
contained within the
housing arranged to retain the piercing element in a retracted position
energizing the forcing
assembly and a second portion outside the housing manually actuable to release
the piercing
element to cause the tip to have a momentary position projecting from the
opening; wherein
the kit further includes at least one of the following additional items: (i) a
composition
including an anti-acne agent, (ii) a re-cocking element to position the
piercing element into
the retracted position following the release the piercing element, and (iii)
an aiming device to
assist in positioning the skin-piercing device over the area of skin to be
pierced.
Other aspects, features, and advantages of the present invention will be
apparent from
the detailed description of the invention and from the claims.
DETAILED DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side cross-section view of a skin-piercing device of the present
invention
in an unused, un-cocked orientation.
FIG. 2 is a side cross-section view of a skin-piercing device of the present
invention
in a cocked orientation.
FIG. 3 is a side cross-section view of a skin-piercing device of the present
invention
in a piercing orientation.
FIG. 4 is a side cross-section view of a skin-piercing device of the present
invention
in a used orientation.
2
CA 02611655 2007-11-20
J&J5278USNP
FIG. 5 is a side cross-section view of a portion of a skin-piercing device of
the
present invention containing a fluid-absorbent material on the skin-contacting
surface.
FIG. 6 is a side cross-section view of a portion of a skin-piercing device of
the present
invention containing a ridge on the skin-contacting surface.
FIG. 7 is a side cross-section view of a skin-piercing device of the present
invention
that is capable of being repositioned in the cocked orientation.
FIG. 8A is a top view of an aiming device of the present invention.
FIG. 8B is a bottom view of an ainling device of the present invention.
FIG. 9 is a side view of the use of the skin-piercing device and aiming device
of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
It is believed that one skilled in the art can, based upon the description
herein, utilize
the present invention to its fullest extent. The following specific
embodiments can be
construed as merely illustrative, and not limitative of the remainder of the
disclosure in any
way whatsoever.
Unless defined otherwise, all technical and scientific terms used herein have
the same
meaning as commonly understood by one of ordinary skill in the art to which
the invention
belongs. Also, all publications, patent applications, patents, and other
references mentioned
herein are incorporated by reference. As used herein, all percentages are by
weight unless
otherwise specified.
In one embodiment, the present invention is directed to a skin-piercing device
and the
use of that device for treating a skin-condition such as acne. The treatment
involves
disrupting the stratum corneum of the skin and may or may not further include
the application
of a composition that permeates into the disrupted skin, such as a composition
containing an
anti-acne agent. A benefit of such a treatment includes localizing the
treatment to a certain
area of skin in need of such treatment.
Definitions
What is meant by a "product" is a product in finished packaged form. In one
embodiment, the package is a container such as a plastic, metallic, or
cardboard box for
storing such skin-piercing device and/or kit. In one embodiment, the product
contains
instructions directing the user to apply the skin-piercing device to the skin
(e.g., for the
treatment of a skin condition such as acne).
3
CA 02611655 2007-11-20
J&J5278USNP
What is meant by "promoting" is promoting, advertising, or marketing. Examples
of
promoting include, but are not limited to, written, visual, or verbal
statements made on the
product or in stores, magazines, newspaper, radio, television, internet, and
the like. For
promoting the treatment of acne, examples of such statements include, but are
not limited to,
"treats acne," "safely pops pimples," "eliminates acne and/or
pimples/blemishes", and
"visibly reduces the symptoms and/or appearance of pimples." Similar
statements can be
made for other skin disorders.
The term "treating" or "treatment" of a skin disorder means the treatment
(e.g.,
complete or partial alleviation or elimination of symptoms and/or cure) and/or
prevention or
inhibition of the skin disorder.
As used herein, "composition" means a composition suitable for administration
to the
skin.
As used herein, "cosmetically-acceptable" means that the ingredients or
compositions
which the term describes are suitable for use in contact with the skin without
undue toxicity,
incompatibility, instability, irritation, allergic response, and the like.
This term is not
intended to limit the ingredient/composition to which it describes for use
solely as a cosmetic
(e.g., the ingredient/composition may be a pharmaceutical agent).
As used herein, "safe and effective amount" means an amount of the active
agent,
compound, carrier, or of the composition sufficient to induce the desired
effect, but low
enough to avoid serious side effects. The safe and effective amount of the
compounds or
composition will vary with the area being treated, the age, health and
skin/tissue type of the
end user, the duration and nature of the treatment, the specific compound or
composition
employed, the particular cosmetically-acceptable carrier utilized, and like
factors.
Skin-piercing device
In one embodiment (as depicted in the FIG. 1), the skin-piercing device of the
present
invention is a single-use, skin-piercing device 10. Other configurations of
single-use lancet
devices may also be used, such as those depicted in US Patent Nos. 5,487,748,
6,258,112,
and 6,764,496.
The skin-piercing device 10 includes housing 15. Housing 15 may be made of
various rigid materials, including but not limited to plastic and metal. The
housing 15
includes two openings, piercing element opening 16 (from which piercing
element tip 21
exits the housing 15) on the skin-contacting surface 25 of housing 15 and
trigger opening 24
(from which trigger button 26 can be accessed through housing 15).
4
CA 02611655 2007-11-20
J&J5278USNP
In one embodiment, the skin-contacting surface 25 has a surface area of less
than 50
mm'', such as from about 0.5 mm2 to about 50 mm2, such as from about 1 mm2 to
about 25
m'
m . Such a small surface area allows the user to feel where the piercing
element tip 21 will
exit the skin-piercing device, for example, to position the piercing element
opening 16 over
the pimple.
In one embodiment, the skin-contacting surface 25 includes a concave shape and
piercing element opening 16 is within this concave shape. Such shape allows
the user to
place the skin-contacting surface, and consequently the piercing element
opening 22, over the
pimple. In one embodiment, the skin-contacting 25 includes a circumferential
ridge 68
(shown in FIG 6) around piercing element opening 16. Such as ridge can assist
the user in
positioning the device on the skin surface and/or enhance the vertical
pressure on the skin
before, during, and after the skin is pierced by the piercing element tip 21,
thereby assisting
in the removal of the bodily fluids (such as pus from a pimple).
Piercing element 30 includes at least one piercing element tip 21 that pierces
the skin
following activation of skin-piercing device 10. In one embodiment, piercing
element 30
includes from about 2 to about 10 piercing elements tips. Piercing element tip
21 may be
made of into shapes, including a needle (either solid or hollow) or a blade.
In one
embodiment, the piercing element tip is a needle having a gauge of at least
15, such as from
about gauge 18 to about gauge 35, such as from about gauge 21 to about gauge
30. Piercing
element tip 21 may be made of rigid materials capable of piercing the skin,
such as metal.
Piercing element 30 is arranged within housing 20, such that it can move from
an unused, un-
cocked orientation as depicted in FIG. 1, then to a cocked orientation as
depicted in FIG. 2,
then to a piercing orientation as depicted in FIG. 3 (during which tip 21
temporarily exits the
housing 15 through piercing element opening 16), and then to a used
orientation as depicted
in FIG 4.
Piercing element 30 preferably moves through housing 15 in a substantially
linear
direction. In one embodiment, the movement of piercing element 30 through
housing 15 is
maintained in a linear direction by the inclusion of one or more ridges (not
shown) extending
from piercing element 30 into one or more linear tracks in the inner wall of
housing 15.
Skin-piercing device 10 in preferable obtained by user prior to use in the
unused, un-
cocked orientation as depicted in FIG. 1, however, it may also be obtained by
the user in the
cocked orientation. In one embodiment, tip cover 35 extends into the housing
15 through
piercing element opening 16 and at least partially covers tip 21. In one
embodiment, tip
cover 35 serves the purpose of maintaining the sterility of piercing element
tip 21.
5
CA 02611655 2007-11-20
J&J5278USNP
Tip cover 35 is arranged such that it may be pushed inward into the housing by
the
user in order to position the piercing element 30 further away from the
piercing element
opening 16, thereby positioning the piercing element 30 into a cocked
orientation as depicted
in FIG. 2. Once in this cocked orientation, tip cover 30 may be disengaged
from piercing
element 30 (thereby uncovering piercing element tip 21) and removed from
housing 15.
Skin-piercing device 10 further includes forcing assembly 40 to urge piercing
element
30 in a direction to project piercing element tip 21 from within housing 15
through the
piercing element opening 16 with sufficient force such that the tip 21 is
capable of piercing
the skin. Forcing assembly 40 is configured within housing 15 in order to move
piercing
element 30 from a cocked orientation as depicted in FIG. 2 to a piercing
orientation as
depicted in FIG. 3 (during which tip 21 temporarily exits the housing 15
through piercing
element opening 16). In one embodiment, as depicted in the Figures, the
forcing assembly 40
is positioned between housing 15 and the piercing element 30. The forcing
assembly 38 may
be a spring, as depicted in the Figures. The forcing assembly 38, however, may
also be an
compressible, elastic material (such a solid silicone material or urethane
foam) or a
pneumatic or hydraulic assembly.
The skin-piercing device 10 is also preferably arranged such that after the
piercing
element tip 21 has exited the housing through piercing element opening 16, the
piercing
element tip 21 tends to be retracted (e.g., by the forcing assembly 38) back
into the housing
(as depicted in the used orientation of FIG 4). Such orientation assists in
preventing the
accidental reuse of the piercing element tip 21.
In one embodiment, the skin-piercing device 10 is adapted such that when
piercing
element tip 21 exits the housing 20, the piercing element tip 21 has an
effective length of less
than 1 mm, such as from about 150 microns to about 500 microns, such as from
about 150
microns to about 350 microns. What is meant be effective length is the length
of the piercing
element tip adapted to penetrate into the skin (e.g., the length from the
piercing element tip
that will penetrate the skin upon activating the skin-piercing device).
Skin-piercing device 10 includes a trigger assembly 50 that serves to both
retain the
piercing element 30 in a retracted position energizing the forcing assembly 38
and later
release piercing element 30 from its cocked orientation. A variety of trigger
assemblies can
be utilized in the skin-piercing device to serve this purpose. In one
embodiment, trigger
assembly 50 includes trigger button 26, which is secure to piercing element 30
and is
structured to temporarily protrude from housing 15 through trigger opening 24,
thereby
holding the piercing element 30 in the cocked orientation as depicted in FIG
2. Other trigger
6
CA 02611655 2007-11-20
J&J5278USNP
assemblies may also be used, such as one secured to the housing as described
in US Patent
No. 5,487,748. In one embodiment (not shown), the trigger assembly is secured
to the
piercing element and is also used to position the piercing element into the
cocked orientation.
The piercing element 30 may be moved by the forcing assembly 38 from the
cocked
orientation as depicted in FIG 2 to a piercing orientation as depicted in FIG.
3 by pushing the
trigger button 26 back through trigger opening 24 and into the housing 15.
In one embodiment, skin-piercing device 10 further includes restrictor
assembly 70,
which has the purpose of inhibiting piercing element 30 from being
repositioned in the
cocked orientation once it has moved into the used orientation. In one
embodiment, restrictor
assembly 70 includes piercing element protrusion 72 (secured to piercing
element 30) and
housing protrusion 74 (secured to housing 20). The restrictor assembly 70 is
arranged such
that piercing element protrusion 72 may pass over housing protrusion 74 when
piercing
element 30 moves from the cocked orientation as depicted in FIG. 2 to a
piercing orientation
as depicted in FIG. 3. However, once piercing element 30 has moved from a
piercing
orientation as depicted in FIG. 3 (during which tip 21 temporarily exits the
housing 15
through piercing element opening 16) to the used orientation as depicted in
FIG. 4, housing
protrusion 74 inhibits the movement of piercing element 30 into the cocked
orientation by
contacting piercing element protrusion 72, as depicted in FIG. 4. Other
restrictor assemblies
can also be used, such as that disclosed in PCT Patent Application W002/43591.
As shown in the Figures, piercing element protrusion 72 is structured such
that as it
moves from the cocked orientation over housing protrusion 74, the sloped
arrangements of
piercing element protrusion 72 and housing protrusion 64 permit piercing
element protrusion
to bend toward piercing element 30, thereby allowing piercing element
protrusion 72 to pass
over housing protrusion 74 as piercing element 30 moves from the cocked
orientation as
depicted in FIG. 2 to a piercing orientation as depicted in FIG. 3. Piercing
element protrusion
72 is also structured such that once in the used orientation, the piercing
element protrusion 72
and housing protrusion 74 abut each other, thereby inhibiting the piercing
element 30 from
being reengaged by the user into the cocked orientation.
In one embodiment, the skin-piercing device of the present invention includes
fluid-
absorbent materia160. Absorbent materia160 allows the skin-piercing device 10
to collect
bodily fluids such as pus from a pimple pierced by piercing element tip 34.
The fluid-
absorbent material may be secured to the skin-contacting sui-face of the skin-
piercing device,
or to another surface of the skin-piercing device (such as the opposite end of
the skin-piercing
device as depicted in the Figures).
7
CA 02611655 2007-11-20
J&J5278USNP
In one embodiment, the surface of the fluid-absorbent material includes a
guide
structure 67 having a diameter of from about 0.5 mm to about 3nun. In one
embodiment, the
structure is harder than the fluid-absorbent material. Such structure assists
the user in
position the fluid-absorbent material on the pimple to be treated.
In one embodiment, the fluid-absorbent material may also be used to administer
a
topical fluid composition (e.g., containing an anti-acne agent as discussed
below to the skin
in need of such treatinent. The skin-piercing device may be packaged such that
a
composition is (i) added to the fluid-absorbent material proximate to use or
(ii) contained
within the fluid-absorbent material during storage.
What is meant by fluid-absorbent material is a material that is capable of
absorbing
fluids in an amount of at least 25 percent of its weight. Examples of
absorbent, compressible
materials include, but are not limited to, woven and nonwoven
materials,.hydrogels,
hydrocolloids, silicone rubbers, celluloses (e.g., cotton and rayon or their
derivatives), wool,
polyamides (e.g., nylon), and silk.
In one embodiment (depicted in FIG. 5), fluid-absorbent material 60 encases a
reservoir 65 that contains a fluid composition that is expelled from the
reservoir 65 upon
puncture of the fluid-absorbent materia160 by the piercing element tip. In one
embodiment,
the fluid composition contains an anti-acne active.
Recockable Skin-niercing Device
In one embodiment, the piercing element 30 may be repositioned in the cocked
orientation once it has moved into the used orientation. As shown in the
embodiment of FIG.
7, skin-piercing device 10 does not include housing protrusion 74. Thus, by
inserting re-
cocking element 36 into skin-piercing device 10, piercing element 30 may be
reposition into
the cocked position following use of skin-piercing device 10. In one
embodiment, sterilizing
section 37 of re-cocking element 36 engages piercing element 30. Sterilizing
section 37 may
comprise an absorbent material (such as a woven material, non-woven material,
or porous
urethane foam) that further contains a antimicrobial agent, such as hydrogen
peroxide,
guanidinium thiocyanate, sodium hydroxide, alcohol (such as ethanol or
propanol),
benzalkonium chloride, benzethonium chloride, methyl benzethonium chloride,
lauric
argainate, sugarquat, cetylpyridiunium chloride, and 2,4,4'-trichloro-2-
hydroxy
diphenylether. The antimicrobial agent provides that when sterilizing section
37 contacts
piercing element tip 21, it cleans piercing element tip 21 of any residual
blood, pus, or other
fluids from its prior use.
8
CA 02611655 2007-11-20
J&J5278USNP
Multiple-Use Skin-piercing device
In one embodiment, the skin-piercing device includes multiple piercing
elements. In
one embodiment, the skin-piercing device is adapted such that each piercing
element may
only be used once. Examples of such a skin-piercing device include the ACCU-
CHEK
Multiclix Lancet Device (Roche Diagnostics, Basel, Switzerland) and devices
set forth U.S.
Patent Application No. 2004/0260325. In one embodiment, the device is adapted
such that
the piercing elements can be replaced after use (e.g., disposable storage case
can containing
multiple piercing element such as that described in European Patent
Application No.
638465).
Aiming Device
In one embodiment, the user utilizes an aiming device to assist in positioning
the skin-
piercing device over the area of skin to be pierced (e.g., the pimple). In one
embodiment, the
aiming device is first positioned over the area of skin, following which the
skin-piercing
device is then secured to such aiming device such that upon activation, the
skin-piercing
device pierces that desired area of skin.
An example of such an aiming device is set forth in FIGS. 8A and 8B. As set
forth in
FIG. 8A, the aiming device 100 has a handle portion 105 and a skin-contacting
portion 106.
The top of skin-contacting portion 106, which is adapted to secure the device
to the aiming
device 100, has a device-contacting recess 115 that includes securing tabs 116
and orifice
110. In one embodiment, the aiming device 100 is made of a transparent
material, such as
plastic, such that user can determine that the orifice is positioned in the
desired location (e.g.,
over the pimple to be treated).
As shown in FIG. 8b, the bottom of skin-contacting portion 106 is adaped tro
contact
the skin, and includes orifice 110 within ring 120. By pressing ring 120
against the pimple,
the ring 120 applies force on the sides of the pimple, thereby assisting in
the removal of pus
from the pimple.
FIG. 9 is a depiction of the aiming device 100 being used in conjunction with
skin-
piercing device 10. Aiming device 100 is first pressed on the surface of skin
200 such that
ring 120, and consequently orifice 110, is positioned over pimple 220. Skin-
contacting
surface 25 of skin-piercing device 10 is then positioned within device-
contacting recess 115
and secured with securing tabs 116 (not shown) such that the piercing element
opening 16 is
positioned over orifice 110 and consequently over pimple 220. Upon activation
of skin-
9
CA 02611655 2007-11-20
J&J5278USNP
piercing device 10, piercing element tip 21 exits skin-piercing device 10 and
enters pimple
220.
Topical Compositions
In one embodiment, the skin-piercing device includes, or is used in
conjunction with a
topical composition. The composition may be solid, semisolid, liquid, or any
combination
thereof. In particular, examples of solid compositions include but are not
limited to bars,
sticks, powders, masks, and patches. Examples of semisolid compositions
include but are not
limited to creams, lotions, gels, ointments, hydrogels, hydrocolloids, foams,
mousses,
emulsions, and micro-emulsions. Examples of liquid compositions include but
are not
limited to liquid cleansers, toners, sennns, sprays, and aerosols.
In one embodiment, the topical composition includes an anti-acne agent. What
is
meant by an anti-acne agent is an compound that has been approved by the U.S.
Food and
Drug Administration for the topical treatment of acne. Examples of anti-acne
agents include,
but are not limited to, salicylic acid, benzoyl peroxide, sulphur, retinoic
acid, isotretinoin,
candida bombicola/glucose/methyl rapeseedate ferment, peat water, resorcinol,
silt, peat,
permethin, azelaic acid, tazorotene, clindamycin, adapalene, erythromycin,
sodium
sulfacetamide, and combinations thereof. In one embodiment, the amount of anti-
acne agent
in the composition is from about 0.01% to about 10%, for example from about
0.1% to about
5%, or from about 0.5% to about 2% by weight, based on the total weight of the
composition.
In one embodiment, the topical composition includes an active agent for the
treatment of
warts, age spots, razor bumps. Examples of such active agents include ascorbic
acid,
salicylic acid, and salts and esters thereof.
In one embodiment, the active agent and/or composition is applied to the skin
proximate to the time of the piercing of the skin with the skin-piercing
device (e.g., within
about an hour before or after the piercing, such as within about fifteen
minutes or within
about five minutes).
Pre-softening Treatment
In one embodiment, the skin is softened prior to piercing, thereby allowing
the skin to
be more easily pierced and/or fluids (such as pus) to be more easily removed.
Examples of
such pre-softening treatments include application of an occlusive or semi-
occlusive dressing
to the skin piercing site (such as hydrocolloids, hydrogels and transparent
film dressings) or
hydrating the site (such as cleansing with warm water). Other pre-softening
treatments
CA 02611655 2007-11-20
J&J5278USNP
include wanning the skin site (e.g., to a temperature from about 35-50 C) or
the application
of skin softening agents such as enzymes or acids (e.g., hydroxyl acids).
Kit
In one embodiment, skin-piercing device(s) of the present invention and
optionally
companion item(s) are packaged together and marketed as a kit. The examples of
the items in
the kit may include, but are not limited to, one or more of (i) the skin-
piercing devices, (ii)
topical compositions in a suitable container/dispenser (such as a tube, a
bottle, a pump, a jar,
a dropper, a or unit-dose dispenser) to be used before, during, or after the
stratum-corneum
piercing skin-piercing device application, (iii) aiming devices, and/or (iv)
re-cocking
elements. Additionally, the kit may also contain a cleansing product to be
used to
sanitize/sterilize the skin prior to the skin-piercing device application. The
kit may also
include a film forming composition or bandage to be used after treatment to
protect the
treated skin site, fiuther assist in the removal of pus, and/or to enhance the
therapeutic
efficacies for the treated skin.
It is understood that while the invention has been described in conjunction
with the
detailed description thereof, that the foregoing description is intended to
illustrate and not
limit the scope of the invention, which is defined by the scope of the
appended claims. Other
aspects, advantages, and modifications are within the claims.
What is claimed is:
11
