U.S. patent application number 13/789229 was filed with the patent office on 2013-07-25 for devices and methods for skin tightening.
This patent application is currently assigned to NEODYNE BIOSCIENCES, INC.. The applicant listed for this patent is NEODYNE BIOSCIENCES, INC.. Invention is credited to Kin CHAN, Reinhold H. DAUSKARDT, Geoffrey C. GURTNER, Melanie HARRIS, Kenneth N. HORNE, Michael T. LONGAKER, Bankim H. MEHTA, Joseph RIMSA, Michael H. ROSENTHAL, Sergio SALINAS, Greg SPOONER.
Application Number | 20130190673 13/789229 |
Document ID | / |
Family ID | 46753737 |
Filed Date | 2013-07-25 |
United States Patent
Application |
20130190673 |
Kind Code |
A1 |
GURTNER; Geoffrey C. ; et
al. |
July 25, 2013 |
DEVICES AND METHODS FOR SKIN TIGHTENING
Abstract
The methods, procedures, kits, and devices described herein
assist with the healing process of tissue that was previously or
simultaneously treated for a therapeutic or cosmetic effect. The
methods, procedures, kits, and devices described herein can also
provide temporary simulated results of a cosmetic procedure to
allow for visual assessment to select the type of procedure or for
treatment planning in advance of the surgical procedure.
Inventors: |
GURTNER; Geoffrey C.; (Palo
Alto, CA) ; LONGAKER; Michael T.; (Atherton, CA)
; DAUSKARDT; Reinhold H.; (Menlo Park, CA) ;
HORNE; Kenneth N.; (San Francisco, CA) ; MEHTA;
Bankim H.; (San Ramon, CA) ; ROSENTHAL; Michael
H.; (Menlo Park, CA) ; RIMSA; Joseph; (Palo
Alto, CA) ; SALINAS; Sergio; (Redwood City, CA)
; HARRIS; Melanie; (Santa Ana, CA) ; SPOONER;
Greg; (San Francisco, CA) ; CHAN; Kin; (Menlo
Park, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NEODYNE BIOSCIENCES, INC.; |
Menlo Park |
CA |
US |
|
|
Assignee: |
NEODYNE BIOSCIENCES, INC.
Menlo Park
CA
|
Family ID: |
46753737 |
Appl. No.: |
13/789229 |
Filed: |
March 7, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13411443 |
Mar 2, 2012 |
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13789229 |
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61448809 |
Mar 3, 2011 |
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61476163 |
Apr 15, 2011 |
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61605717 |
Mar 1, 2012 |
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Current U.S.
Class: |
602/53 |
Current CPC
Class: |
A61F 2013/00374
20130101; A61F 13/0223 20130101; A61B 2018/0047 20130101; A61F
13/023 20130101; A61F 2013/006 20130101; A61B 2017/00765 20130101;
A61F 13/00 20130101; A61F 13/0256 20130101; A61B 18/203 20130101;
A61F 13/00029 20130101; A61F 13/00038 20130101; A61F 13/0226
20130101; A61F 13/0259 20130101 |
Class at
Publication: |
602/53 |
International
Class: |
A61F 13/00 20060101
A61F013/00 |
Claims
1. A skin treatment device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/411,443, filed Mar. 2, 2012, which claims benefit under 35
U.S.C. .sctn.119(e) to a) U.S. Provisional Application Ser. No.
61/448,809, filed on Mar. 3, 2011, b) U.S. Provisional Application
Ser. No. 61/476,163, filed on Apr. 15, 2011, and c) U.S.
Provisional Application Ser. No. 61/605,717, filed on Mar. 1, 2012,
all of which are hereby incorporated by reference in their
entirety. This application is also related to U.S. application Ser.
No. 11/888,978, filed on Aug. 3, 2007, U.S. application Ser. No.
12/854,859, filed on Aug. 11, 2010, and U.S. application Ser. No.
13/345,524, filed Jan. 6, 2012, all of which are hereby
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices,
kits and methods used for improved healing of skin after a
therapeutic injury. For example, such devices, kits and methods can
be used to produce improved tightening of skin after a therapeutic
treatment. The devices, kits and methods can also be used to
produce a temporary cosmetic effect by displacing skin to stimulate
a clinical effect.
BACKGROUND OF THE INVENTION
[0003] Many procedures involve producing a therapeutic injury to
tissue to produce an improved therapeutic or cosmetic effect in the
tissue. Skin tightening is one such therapy that involves creating
an injury to produce an improved cosmetic appearance of the skin
near or around the site of the therapeutic injury. Skin tightening
can be performed many different ways ranging from invasive
treatments to less invasive procedures such as IPL (intense pulsed
light). Typically invasive procedures appear to be the most
effective but require significant recuperative periods, while less
invasive procedures are less effective than invasive procedures but
the recuperative periods are shorter. In any case, the healing
process that occurs subsequent to the therapeutic injury can
determine the effectiveness of the procedure.
[0004] Again, in referring to skin tightening as one example,
during the procedure a physician or medical practitioner induces a
controlled trauma in the skin. This is typically performed by
applying energy to the tissue to either ablate (vaporize) or
non-ablatively heat the skin to create either patterns of lesions
or a localized area of treatment. There are limits when creating
therapeutic injury to tissue, if there is variability in the lesion
or hole created in the tissue the healing process may not produce
the optimal effect. For example, if the therapeutic treatment
creates openings in the tissue that are too large, the tissue may
not heal as desired.
[0005] In one variation, a skin treatment system is provided,
comprising an dressing with a load per millimeter width of at least
0.1 Newtons at a strain of at least 0.01, 0.05, 0.1, 0.2, 0.3, 0.4,
0.5, 0.6, 0.7, 0.8, 0.9 or higher, and a limiting member coupled to
the dressing and configured to resist straining of the dressing
beyond a predetermined strain. The limiting member may comprise a
first handle at a first end of the at least one limiting member,
and a second handle at a second end of the at least one limiting
member. The skin treatment system may comprise at least two
elongate strain limiting structures. The first handle may be
contiguously or non-contiguously coupled to the dressing between
the first ends of the at least two elongate strain limiting
structures. The second handle may also be contiguously or
non-contiguously coupled to the dressing between the second ends of
the at least two elongate strain limiting structures. The
predetermined strain may be at least 0.01, 0.02, 0.03, 0.04, 0.05,
0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9
or higher. The limiting member may be releasably coupled to the
dressing. The limiting member may be adhered to the dressing using
an adhesive. The adhesive may comprise a shear-resistance to a
force level that is greater than the T-peel resistance to the force
level. The first handle and the second handle may comprise a
substantially inelastic material relative to the dressing, which
may optionally be a semi-rigid or rigid material. The limiting
member may comprise at least one flexible, inelastic elongate
element. The dressing may comprise an unstrained configuration in
which a distance between a first attachment region of the limiting
member and a second attachment region of the limiting member is
less than a length of the limiting member between the first
attachment region and the second attachment region, and may
comprise a strained configuration at the predetermined strain
wherein the distance between the first attachment region of the
limiting member and a second attachment region of the limiting
member is substantially equal to the a length of the limiting
member between the first attachment region and the second
attachment region. The limiting member may comprise a folded board
with at least three two folds, or a ratchet and pawl mechanism. The
limiting member may be selectively configured to resist straining
of the dressing beyond a plurality of predetermined strains. The
plurality of predetermined strains may comprise graphical indicia
on the limiting member.
[0006] In another variation, the skin treatment system comprises an
dressing, comprising a tensioning axis, and a limiting member
coupled to the dressing and configured to resist straining of the
dressing beyond a predetermined strain, wherein the attachment of a
first end of the limiting member to the dressing is contiguous
across a dimension of the dressing transverse to the tensioning
axis. The dressing may have a load per millimeter width of at least
0.1 Newtons at a strain of at least 0.01, 0.02, 0.03, 0.04, 0.05,
0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,
0.9, or higher. The limiting member may comprise a first handle at
a first end of the at least one limiting member, and a second
handle at a second end of the at least one limiting member. The
skin treatment system may comprise at least two elongate strain
limiting structures. The first handle may be contiguously coupled
to the dressing between the first ends of the at least two elongate
strain limiting structures. The second handle may also be
contiguously coupled to the dressing between the second ends of the
at least two elongate strain limiting structures. The predetermined
strain may be at least 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6,
0.7, 0.8, 0.9, or higher. The limiting member may be releasably
coupled to the dressing. The limiting member may be adhered to the
dressing using an adhesive. The adhesive may comprise a
shear-resistance to a force level that is greater than the T-peel
resistance to the force level. The first handle and the second
handle may comprise a substantially inelastic material relative to
the dressing, which may optionally be a semi-rigid or rigid
material. The limiting member may comprise at least one flexible,
inelastic elongate element. The dressing may comprise an unstrained
configuration in which a distance between a first attachment region
of the limiting member and a second attachment region of the
limiting member is less than a length of the limiting member
between the first attachment region and the second attachment
region, and may comprise a strained configuration at the
predetermined strain wherein the distance between the first
attachment region of the limiting member and a second attachment
region of the limiting member is substantially equal to the a
length of the limiting member between the first attachment region
and the second attachment region. The limiting member may comprise
a folded board with at least three two folds, or a ratchet and pawl
mechanism. The limiting member may be selectively configured to
resist straining of the dressing beyond a plurality of
predetermined strains. The plurality of predetermined strains may
comprise graphical indicia on the limiting member.
[0007] In another variation, a skin treatment system is provided,
comprising an elastic structure, first and second handles attached
to opposite regions of the elastic structure, wherein the first and
second handles are coupled to the elastic structure and configured
to provide a substantially uniform tensile force across the elastic
structure; and a strain indicator. The strain indicator may
comprises graphical or numerical indicia of the degree of
strain.
[0008] In one variation, a skin treatment device is provided,
comprising a first layer comprising an elastic material
prestretched to a predetermined strain level and a second layer
coupled to the first layer and comprising a brace configured to
maintain the first layer at the predetermined strain level while
the device is attached to a skin layer of a subject; and comprising
at least one second layer opening positionable for treatment of
skin therethrough, and a securing element configured to secure the
device to skin of a subject during treatment through said at least
one second layer opening. The first layer may comprise at least one
elastic material opening through the elastic material configured to
be aligned with the at least one opening of the second layer for
treatment through the aligned openings. The brace may further
comprise a mating element configured to secure the first layer in a
strained configuration on the brace. The brace may be rigid. The
brace may comprise a plurality of segments bendable with respect to
another of the plurality of segments to provide a variable contour
of the brace. The brace may be configured to be bendable in a
plurality of directions. Each of the plurality of segments may be
configured to be bent in a plurality of directions. The second
layer may comprise a mask having a pattern of openings. The pattern
of openings comprises a treatment pattern. The skin treatment
device may further comprise a connection element configured to
connect the device to an energy emitting skin treatment device.
Each second layer opening may correspond to at least one individual
treatment zone. The second layer may be removable from the first
layer after treatment is provided through the at least one second
layer opening.
[0009] In another variation, a multilayered elastic dressing is
provided, comprising a plurality of elastic layers, wherein each
layer removably coupled to another layer of said plurality of
elastic layers; wherein said plurality of elastic layers comprises
a base layer having a skin adhesive layer on a skin adhesive side
of the base layer and at least one additional layer. Each said at
least one additional elastic layer may be removable from the base
layer after the dressing has been strained and adhered to skin of a
subject to thereby selectively alter the stresses placed on the
skin through the base layer.
[0010] In another variation, a method of treating a subject is
provided, comprising creating a plurality of lesions on a subject's
skin and placing a dressing over the lesions on the subject's
skin.
[0011] In another variation, a method treating a subject is
provided, comprising placing a dressing over a skin region and
creating lesions in the skin region through the dressing. Creating
lesions in the skin regions may be performed using an energy-based
modality. The dressing may comprise a mask region configured to
selectively block the energy-based modality and a treatment region
configured to selectively permit energy from the energy-based
modality to pass through the dressing. The treatment region
comprises an uninterrupted structure configured to selectively
permit energy to pass through the uninterrupted structure. The
uninterrupted structure may be an optically clear structure. The
method may further comprise aligning a treatment device to indicia
located on the dressing. The method may further comprise aligning a
treatment device to pre-existing openings in the dressing. The
pre-existing openings may be pre-existing potential openings in the
dressing. The pre-existing potential openings may comprise slits.
The method may further comprise creating a plurality of openings in
the dressing using a treatment device.
[0012] In another variation, a method of treating a subject is
provided, comprising maintaining a strain in an elastic dressing,
placing the strained dressing over skin of a subject, creating at
least one lesion on the skin of the subject through the dressing;
and then releasing the dressing so that compressive forces from the
dressing are applied to the skin of the subject.
[0013] A need remains for devices, kits and/or procedures to
improve the outcome of such medical procedures by improving the
healing process of the tissue subsequent to the treatment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIGS. 1A to 1C illustrate the process of a conventional skin
tightening procedure performed on a section of skin.
[0015] FIG. 2A illustrates an example of a wound dressing that
assists in the healing process to improve the outcome of a cosmetic
procedure or provides temporary movement of tissue.
[0016] FIGS. 2B to 2D show an example of a dressing assisting in a
wound healing process.
[0017] FIGS. 2E to 2G show another example of application of a
dressing to assist in the wound healing process.
[0018] FIGS. 2H and 2I illustrate an example of a second dressing
or frame placed upon an initial dressing.
[0019] FIGS. 3A and 3B respectively show an expanded or strained
dressing and a dressing in an unstrained or relaxed profile.
[0020] FIGS. 3C to 3F show additional variations of dressings.
[0021] FIGS. 3G and 3H respectively depicted a dressing with slit
openings in an unstrained and strained profile.
[0022] FIGS. 3I and 3J depict additional variations of dressings
with reinforced openings.
[0023] FIGS. 4A and 4B illustrates a dressing and frame
respectively, where the frame maintains the dressing in a strained
configuration for eventual placement on tissue.
[0024] FIG. 4C shows the dressing of FIG. 4A positioned on the
frame of FIG. 4B.
[0025] FIG. 4D shows a cross sectional view taken along the line
4D-4D of FIG. 4C.
[0026] FIG. 4E illustrates an optional applicator used to assist in
positioning the dressing of FIG. 4A from a frame to tissue.
[0027] FIG. 4F depicts a dressing with reinforced retention
openings.
[0028] FIGS. 5A to 5C illustrate another variation of a dressing
according to the present disclosure.
[0029] FIGS. 6A and 6B shows a dressing having one or more limiting
members to pre-determine a strain capacity of the dressing.
[0030] FIGS. 6C and 6D illustrate a variation of a dressing that
incorporates a bio-active substance that is intended for delivery
to or near the site of the lesion.
[0031] FIGS. 6E and 6F show a variation of a dressing having a
varying adhesive pattern on the dressing.
[0032] FIGS. 6G and 6H show a dressing that has regions of varying
elasticity or stretchability.
[0033] FIGS. 6I to 6K show additional variations of dressings that
provide directional or vectored application of force.
[0034] FIG. 7A illustrates a contoured shape multi-layer dressing
having regions of varying thickness to allow for customization of a
strain amount of the dressing.
[0035] FIG. 7B illustrates a further variation of a dressing that
includes a thermally responsive material.
[0036] FIGS. 7C and 7D illustrate various mechanisms for
application of a dressing.
[0037] FIGS. 8A and 8B show a dressing positioned adjacent to
treatment devices that are used to create lesions within
tissue.
[0038] FIGS. 9A and 9B show an adjustable frame that permits
shaping of the frame to adjust to a contour of a surface of
tissue.
[0039] FIG. 9C shows a variation of a frame employing an expandable
member or bladder to compress tissue within the perimeter of the
bladder.
[0040] FIG. 9D illustrates another example of an adjustable frame
that is used to compress tissue or expand a dressing.
[0041] FIGS. 10A to 10C illustrate a settable adhesive for use with
dressings of the present disclosure.
[0042] FIG. 11A illustrates an exemplary plot of power versus time
for a laser treatment application so that a single laser can create
an opening in a dressing and a subsequent lesion at the site of the
opening.
[0043] FIGS. 11B to 11E illustrate another variation of using
multiple laser sources to create lesions in solid dressing.
[0044] FIGS. 12A and 12B shows an example of a dressing having
registration features that allow for detection by the treatment
device.
[0045] FIGS. 13A to 13E show another variation of a dressing
covered by a mask that directs laser energy to openings within the
dressing to control placement of lesions.
[0046] FIGS. 14A to 14D illustrate various types of lesions that
can be created in situ with a solid dressing.
[0047] FIGS. 15A to 15D illustrate another use for dressings of the
present disclosure.
[0048] FIG. 16 depicts an additional use of a dressing as a mask to
direct creation of a lesion.
[0049] FIGS. 17A and 17B provides a top view to demonstrate
compression or application of force to a lesion.
[0050] FIGS. 18A to 18F show variations of shaped lesions having
geometries to prevent high stress areas when compressed.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The methods, procedures, kits, and devices described herein
are intended to assist with the healing process of tissue that was
previously or simultaneously treated for a therapeutic or cosmetic
effect. Assisting in the healing process can produce an improved
outcome and in some cases can eliminate or reduce variability with
the healing process. The combined therapeutic process of treating
tissue and assisting the ensuing healing process can produce a
consistent skin tightening procedure and improve the outcome of the
procedure. It is noted that combinations of variations of the
methods, kits, and/or procedures as well as combination of specific
aspects of methods, kits, and/or procedures are within the scope of
this disclosure even though such embodiments may not be
specifically shown.
[0052] U.S. Pat. No. 7,683,234 to Gurtner et al describes devices
and methods intended for the amelioration of scar and/or keloid
formation and include a discussion of wound healing as well other
information that can be combined with the novel methods, devices,
and kits of the present invention. Accordingly, the entirety of
this reference is incorporated by reference herein.
[0053] The present disclosure describes the methods, procedures,
kits, and devices for use with skin tightening, treatment of skin
laxity, skin contraction, skin shrinkage, and maybe even body
sculpting procedures for purposes of illustration. However, the
invention is not limited to skin tightening unless specifically
noted otherwise. The benefits of the present disclosure can be
applied in any number of medical procedures requiring providing
augmentation of the healing process of a therapeutic or cosmetic
treatment. For example, the devices herein may be used for
sutureless wound closure, skin splinting or other supportive uses.
Other uses for these skin treatment devices may or may not include
without limitation, for example, amelioration or prevention of scar
formation, treating skin related conditions such as acne,
blemishes, rosacea, warts, rashes (including but not limited to
erythematous, macular, papular and/or bullous conditions),
psoriasis, skin irritation/sensitivity, allodynia, telangiectasia,
port wine stains and other arterio-venous malformations, and
ectopic dermatitis; treating or improving existing scars, wrinkles,
stretch marks, loose or sagging skin or other skin irregularities;
lifting, pinning, holding, moving skin for various purposes such as
during pre-operative preparation, during surgical procedures for
example as a low-profile tissue retractor, to stabilize blood
vessels during needle or catheter insertion, postoperatively, pre
or post operatively for pre-treating or preconditioning skin for
example, prior to scar revision, wound incision, body contouring,
in mastectomy skin expansion, during weight loss, or for aesthetic
purposes; hair removal or hair loss; treating and/or closing skin
injuries for example, incisions, wounds, chronic wounds, bed sores,
ulcers (including venous stasis ulcers), preventing or reducing the
incidence of wound dehiscence, diabetic skin or wound conditions,
burn healing and/or relief; acting as an occlusive or
negative-pressure wound dressing; protecting incisions or wounds,
e.g. prevention of splitting or opening, protecting newborn belly
buttons after cutting umbilical cord. Such treatments may include
use of a drug or other therapeutic agent that may be applied to the
skin with such device. The agents may include but are not limited
to antibiotics, anti-fungals, immune modulators including
corticosteroids and non-steroidal immune modulators. The agents may
be provided in any of a variety of formulations, including but not
limited powders, gels, lotions, creams, pastes, suspensions, etc.
The devices may also be used for purposes of delivering a drug to
the skin or through the skin, for example by stretching the skin
and applying a drug thereto. Different configurations of the device
may be amenable to the size or geometry of different body regions.
The treatments may be applied to regions of any shape (e.g. linear,
curved, stellate), size or depth, and to one or more regions of the
body, including but not limited to the scalp, forehead, face (e.g.
nose, eyelid, cheeks, lips, chin), ears, neck, shoulder, upper arm,
lower arm, palm, dorsum of the hand, fingers, nailbed, axilla,
chest, nipple, areola, back, abdomen, inguinal region, buttocks,
perineal region, labia, penis, scrotum, thigh, lower leg, plantar
surface of the foot, dorsal surface of the foot, and/or toes.
[0054] A number of procedures for tightening of skin are commonly
known. One non-invasive approach involves the use of laser energy
to ablate (vaporize) or non-ablatively heat the skin. Ablative
procedures are generally more invasive (i.e. longer down time) and
effective. These types of lasers do not produce consistent skin
tightening, and presently none of these lasers are FDA indicated
for skin tightening. In general, the procedure relies on a lesion
(if an area is treated) or a number of lesions to heal after the
injury to produce a tightened appearance in or around the skin that
was treated. However, if the holes or lesion made by the treatment
device are too large, the skin surface will not heal well. In
addition, the procedure might not produce an optimal outcome if the
healing process is not consistent between the lesions. Furthermore,
care must be taken to prevent environmental factors from
interfering with the healing process. Additionally many
non-ablative tightening procedures rely on collagen contraction to
produce volume changes in the collagen by a thermal denaturation
process that produces dimensional changes in skin in one or more
axes. See, for example, the RF product THERMAGE.RTM. (Solta Corp.,
Hayward, Calif.) or the IR product TITAN.RTM. (Cutera, Inc.,
Brisbane, Calif.). The devices herein may also be used with other
skin treatments (aesthetic or not) or resurfacing procedures
whether topical or subdermal, whether or not using an energy
modality such as, for example, microwave, radio-frequency ablation,
high-intensity focused ultrasound, laser, infrared, incoherent
light, thermal (heat and/or cold, ablative or non-ablative), use of
vacuum or suction, vibration or massage (e.g. ENDERMOLOGIE.RTM.,
LPG Systems, France). The methods, kits, and devices described
herein can optionally be used with such non-ablative tightening
procedures as well. For example, a water jet can be used to create
lesions by directing water or other liquid, and/or a mix of liquid
and particles to create the lesions. Furthermore, the water or
fluid can be used to swell or expand tissue. Once expanded the
tissue can be treated such that upon reversion to a normal
non-swelled state, the tissue engages in natural compression.
[0055] FIGS. 1A to 1C illustrate the process of a conventional skin
tightening procedure performed on a section of skin. As illustrated
in FIG. 1A, the dermis 10 is located over a region of subcutaneous
fat 12. During a skin tightening procedure, as shown in FIG. 1B, a
physician creates one or more lesions 14 (i.e., areas of treated
tissue or actual openings in tissue) in the dermal region 10. The
skin tightening procedure relies on the adjacent healthy tissue to
produce a healing response 16 or scar tissue that contracts the
adjacent regions of the dermis layer 10 as shown by arrows 18. The
purpose of the scar tissue 16 is to create a state of traction for
the adjacent region of tissue to produce a tissue tightening
effect. The single lesion shown in the figures is for illustrative
purposes only. Clearly, the number of lesions 14 created during the
procedure will vary. Moreover, the location of the treatment
depends upon the particular procedure and region of skin to be
cosmetically treated.
[0056] In conventional skin tightening procedures, there is
variability in the healing phase of the dermis 10. This variability
can lessen the desired cosmetic effect. The dressings described
herein are intended to reduce this variability and provide an
improved effect as a result of the healing process. FIG. 2A
illustrates one example of a wound dressing 100 according to the
present disclosure that assists in the healing process to improve
the outcome of the procedure. The dressing 100 can have any number
of shapes as desired by the intended application. For example, the
dressing shown in FIG. 2A has a rectangular shape. However,
variations include dressings 100 having contoured shapes to
accommodate placement of the dressing around or near various
anatomic features. Moreover, the dressing can be cut to fit to a
desired anatomic region or to alter the characteristics of the
dressing as described below. Alternatively, the dressing can be fit
to the desired anatomic region and cut or shaped after it is placed
on the region. Exemplary construction and/or material(s) used for
the dressing may include those disclosed in U.S. application Ser.
No. 12/854,859, filed on Aug. 11, 2010, which was alreadyhereby
incorporated by reference in its entirety herein. In some
variations, the dressing comprises an elastic material configured
with a load per width of at least 0.35 Newtons per mm at an
engineering strain of 60% or a load per width of at least 0.25
Newtons per mm at an engineering strain of 45%. The elastic
material may have a load per width of no greater than about 2
Newtons per mm at the engineering strain of about 45% to 60%, about
1 Newtons per mm at the engineering strain of about 45% to 60%,
about 0.7 Newtons per mm at the engineering strain of about 45% to
60%, or no greater than about 0.5 Newtons per mm at the engineering
strain of about 45% to 60%. The elastic material may have a load
per width that does not decrease from an engineering strain of 0%
to 60%, a load per width plot that increases linearly from an
engineering strain of 0% to 60%, or a load per width plot that is
not convex from an engineering strain of 0% to 60%. The elastic
material may comprise an adhesive configured to maintain a
substantially constant stress in the range of 200 kPa to about 500
kPa for at least 8 hours when strained to an engineering strain of
about 20% to 30% and attached to a surface. The elastic material
may comprise an adhesive configured to maintain a substantially
constant stress in the range of 200 kPa to about 400 kPa for at
least 8 hours when strained to an engineering strain of about 20%
to 30% and attached to a surface. The substantially constant stress
may vary by less than 10% over at least 8 hours, or by less than 5%
over at least 8 hours.
[0057] FIG. 2A shows one variation of a dressing 100. In this
example, the dressing can comprise an elastomeric dressing (e.g.
fabricated from silicone) that can optionally stretch as shown in
directions 102 to expand the dressing 100 to an expanded profile
106. The dressing device 100 can further optionally include any
configuration of adhesive 104 to adhere to skin. The adhesive
should not prevent the skin and/or the lesions from compressing as
described herein. Alternatively, variations of dressings can allow
for adhesive to be applied prior to or during application of the
dressing on tissue.
[0058] The device can be placed on the dermis 10 as shown in FIG.
2B. As discussed below, the dressing 100 can be placed on the
dermis 10 either prior to, during, or subsequent to creation of the
lesion 14. Once the lesion 14 is created (or during creation of the
lesion 14), the dressing 100 applies a closure force F to contract
the lesion 14 so that the dressing 100 causes the opening 14 in
tissue to close as illustrated in FIG. 2C. The tissue formed 20 as
a result of the healing response then maintains the dermis 10 in a
state of traction even after removal of the dressing 100 as shown
in FIG. 2D. The closure force F can be applied in a single
direction/axis or in a planar direction (e.g., X-Y axes).
Stretching of the dressing 100 can be uniform or non-uniform
depending upon the area of placement. As described below,
variations of the dressing 100 can be configured to provide for
stretching in pre-determined directions or amounts.
[0059] In those variations where the dressing 100 is elastomeric
and pre-stretched, the release of the dressing 100 from the
stretching force creates the closure force F that is applied on
tissue. In alternate variations, the dressing 100 can provide a
closure force via thermal, electrical, chemical or other activation
of an appropriately configured dressing 100. In such cases, the
dressing applies little or no force unless activated.
[0060] As shown above, the dressing 100 can have openings adjacent
to the lesion 14. FIG. 3A illustrates these openings 108 in a
dressing 100 where the dressing is strained or expanded. The
openings 108 can be pre-made in the dressing 108 or can be created
during the application of energy to the tissue. As shown in FIG.
3B, the openings 108 reduce in size or can close when the dressing
100 returns to the compressed or reduced state. The openings 108
can serve an additional purpose of allowing moisture to pass
through the dressing 100. Accordingly, variations of the dressing
100 can include additional openings 108 solely allow for passing of
moisture through the dressing 100.
[0061] The openings may have any of a variety of shapes, including
circles, ovals, triangles, square, rectangular, star-shaped, etc.
Each of the In some variations, the openings (or a portion of the
openings) may comprise potential openings which appear to be slits
or cuts in the dressing, which then open or spread apart upon
tensioning. FIGS. 3G and 3H depict one example of a dressing 100 in
a unstrained and strained configuration, respectively, with
openings 108 comprising slits which are transversely oriented to
the direction of tensioning, which form double-tapered openings
upon straining. The slits or cuts may be linear or curved, isolated
or branching, etc.
[0062] In some further variations, one or more of the openings may
be reinforced with a thicker or non-elastic material to reduce or
control excessive strain in the dressing material about the
openings, in comparison to regions without openings. In some
variations, the reinforcement may comprise open or closed
perimeter, ring-like structures surrounding the openings. Materials
that may be used for the reinforcement structures include but are
not limited to low-density polyethylene (LDPE), fluorinated
ethylene propylene (FEP) or nylon. The openings 108 of the dressing
100 may comprise individual reinforcement structures 124, as
depicted in FIG. 31, or a regional reinforcement structure 125 that
reinforced multiple openings 108, as depicted in FIG. 3J. In other
variations, the reinforcement structure may comprise a layer of
material embedded or attached to a surface of the dressing, the
layer of material comprising an inelastic material or a material
with reduced elasticity relative to the dressing. The layer of
material may comprise identical openings, slits or cuts as the
dressing, or may have a different configuration. In still other
variations, no openings, cuts, or slits are provided in the
dressing, but indicia may be provided on the dressing to facilitate
the formation of a skin lesion pattern through the dressing. In
some variations, the indicia may comprise a uniform graphical grid
depicted on the dressing, but in other variations, a non-uniform
grid or other non-uniform pattern is provided.
[0063] FIGS. 2E to 2G show another variation of application of a
dressing 100 for use in the methods and devices described herein.
In this variation, as shown in FIG. 2E, the tissue is placed under
a state of traction or is strained as shown by application of a
straining force 18 and the lesions 14 (or a single lesion) are
created. Next, as shown in FIG. 2F, a physician positions a
dressing 100 adjacent to or on the region of tissue 10 and over the
lesions 14. The dressing 100 can have openings over the site of the
lesions 14 or the dressing 100 can be continuous. FIG. 2G shows
removal of the strain from the tissue 10 which causes closure of
the lesion 14. Once the strain is removed and the tissue relaxes is
the dressing adhered to the tissue 10. Adhering of the dressing can
occur via an adhesive on the dressing, activation of the dressing,
or application of an adhesive between the dressing and tissue.
[0064] FIGS. 2H and 2I illustrate another aspect of a use of
dressings 100 that can be combined with the methods and devices
described herein. In this variation, a dressing 100 is placed upon
one or more lesions 14 as described herein. However, a second
dressing or frame 101 is positioned to overlap the first dressing
100.
[0065] The dressing 100 can be retained on the skin by any number
of mechanisms. For example, some variations include an adhesive
located between the skin and dressing. Alternate variations include
the use of a tape or other sealing means placed around or at edges
of the dressing 100. The use of mechanical fasteners, e.g.,
staples, sutures, etc. is also within the scope of this
disclosures.
[0066] FIG. 3C illustrates another variation of a dressing 100
under the present disclosure. In this variation, the dressing
comprises a stretchable layer as discussed above with any number of
optional window or openings 106. Once the dressing 100 is
stretched, a frame or brace 110 can be applied to the dressing 100
to maintain the dressing 100 in the stretched configuration. This
may be accomplished through a fastening system (e.g., clamps or
teeth) or via a temporary adhesive. The brace 110 can include any
number of windows or openings to provide an unobstructed path to
the tissue to create the lesions. Once the treatment occurs, the
brace 110 can be removed from the dressing 110 to permit the
dressing 100 to compress the lesions. In some variations, the brace
110 comprises a flexible but inelastic or incompressible material
configured to resist a compression load per millimeter width of at
least about 0.1 Newtons, about 0.2 Newtons, about 0.3 Newtons,
about 0.4 Newtons, or about 0.5 Newtons, or more. In still other
variations, the brace 110 may comprise a malleable material or a
substantially inflexible or rigid material. In further variations,
in the brace 110 may be pre-shaped with a generally planar shape,
but in other variations, may be pre-shaped to a semi-cylindrical or
other arcuate shape along one dimension of the brace 110.
[0067] FIGS. 3D to 3F show another variation of a dressing 100. In
this variation, instead of openings, the dressing 114 includes any
number of raised surfaces 114. Prior to application on tissue, this
variation of the dressing 100 is stretched out, as shown in FIG.
3E. When applied to tissue the dressing 100 reverts to its
pre-stretched shape so that the raised surfaces 114 separate from
the surface of the tissue as shown in FIG. 3F. In such a variation,
adhesive can be applied to the planar portion of the dressing 100
around the raised areas 114.
[0068] Any of the dressings 100 shown above (and/or braces) can be
mated or aligned with the lesion-creating device so that the
dressing can be applied with a single device. Alternatively, a
number of dressings 100 can be fitted to the treatment device in a
cartridge-like form so that the physician can position a dressing
onto the treatment device prior to application of the device to
tissue.
[0069] FIG. 4A illustrates another variation of a dressing 100 for
use as described herein. In this variation, the dressing 100
includes any number of openings 108 that allow for creation of the
lesions. In additional variations, the dressing 100 may not have
any lesion-openings 108. In such a case, the treatment could take
place through the dressing 100 or the openings 108 could be created
after the treatment. In any case, this dressing variation includes
one or more retention openings 109. The retention openings 109 are
designed so that the dressing can be stretched over a mask or brace
110 as shown in FIG. 4B. The brace 110 will include a number of
mating retention tabs 116 so that the dressing can be stretched
across the brace 110 and retained on the tabs 116. In this
variation, the brace 110 includes a single central opening 118.
However, as described above, the brace 110 can include any number
of openings (i.e., to match the openings on the dressing, or to
provide structural rigidity to allow for stretching.) Typically,
the brace 110 is stiff or inflexible when compared to the dressing
100. However, variations can include a brace 110 that is stiff when
compared to the dressing 100 but is malleable so that the brace can
conform to the contours of a targeted region of tissue. As
mentioned previously, the lesion-openings 108 (or other drainage or
access openings of the dressing) may be individually reinforced or
regionally reinforced to reduce or control any relative greater
strain that may occur in regions with openings 108 in comparison to
regions of the dressing 100 without opening. As depicted in FIG.
4F, the retention openings 109 of the dressing 100 may also be
reinforced with a reinforcement structure 126, which may facilitate
manual stretching and attachment of the dressing 100 to the brace
110 by the user. Reinforcement of the retention openings 109 may be
beneficial reducing excessive straining of the dressing region 127
between the retention opening 109 and the closest adjacent edge 128
of the dressing 100.
[0070] FIG. 4C illustrates the dressing 110 stretched across the
brace 110 with the retention tabs 116 inserted into the retention
openings 109 of the dressing 100. FIG. 4D illustrates a cross
sectional view taken along the line 4D-4D from FIG. 4C. To release
the dressing 100 from the brace 110, the ends of the dressing 100
can be pulled away from the brace when the dressing engages tissue.
As discussed herein, the dressing 100 can include an adhesive to
secure the dressing onto tissue. Alternatively, an adhesive or
other fastening means can be applied to the dressing when the
physician places the dressing on tissue. FIG. 4E illustrates a
variation of a dressing 100 located on a frame 116 with an
applicator that can be used to secure the dressing 100 against
tissue as the dressing 100 is released from the retention tabs
116.
[0071] FIGS. 5A to 5C illustrate another variation of a dressing
100 according to the present disclosure. In this variation, the
dressing can be configured to provide a uni-axial compression
(compression along one axis) where required or a unidirectional
compression (i.e., movement of the dressing occurs in a
pre-determined direction). FIG. 5A shows a series of lesions 16
created on a face 1 of a patient. In this example, the therapeutic
procedure creates the lesions 16 in a line array type pattern as
opposed to a plurality of points or dots, where the lines of
lesions 16 are arranged or aligned in a pre-determined direction.
For example, the pattern can be made in alignment with, against,
and/or orthogonal to Langer's lines, also referred to as cleavage
lines. Langer's lines are topological lines drawn on a map of the
human body. These lines correspond to the natural orientation of
collagen fibers in the dermis and epidermis and can be defined by
the direction in which the skin of a human cadaver splits when
struck with a sharp point. In practice, a series of dressing can be
applied with differing orientations corresponding to typical or
mapped Langer's Lines.
[0072] For example, the physician can create lesions aligned to a
directional path that is similar to sutures that could be used to
tighten the tissue. FIG. 5B illustrates a dressing 100 stretched in
direction 102 and having a plurality of openings 108 that open
along the stretched direction. As discussed above, the dressing 100
can include an adhesive for securing to tissue. Alternatively, the
adhesive can be applied between the skin and dressing or another
mode of fixation can be employed. FIG. 5C shows the dressing 100
upon reaching a pre-stretched or relaxed state. As shown, the
openings 108 reduce in thickness to compress the lesions when
forming the tissue 20 generated as a result of the healing
process.
[0073] In another variation, a dressing 100 can be adhered to
tissue or skin without significantly stretching and then is
stretched. Stretching the tissue in this manner uniformly and
gently stretches the skin underlying the dressing in a direction
along Langer's lines along with the dressing.
[0074] When the skin is then treated through the dressing in a
stretched condition, releasing the stretch as well as removing the
dressing will allow a gentle closure force due to the skin's own
natural elasticity. Presently, physicians stretch tissue using
their fingers to stretch the tissue area as they treat. However,
this process increases overall procedure time since the physician
is only able to treat small areas at any given time. A variation of
present invention includes a dressing that is stretched after being
applied to the skin to stretch the skin along Langer's lines. Once
the tissue is treated, the dressing is removed. This permits the
natural resiliency of the skin to provide a gentle closure force
without having to leave the dressing in place.
[0075] FIGS. 6A and 6B illustrate an aspect of dressings 100
described herein. In this example, the dressing 100 includes one or
more limiting members 122 to pre-determine a strain capacity of the
dressing 100. For example, as shown in FIG. 6A, the limiting
members 122 are shown in a compressed configuration. When the
dressing is stretched, as shown in FIG. 6B, the limiting members
122 approach their predetermined length to limit the maximum strain
of the dressing 100. Accordingly, a physician can be provided with
a number of dressings 100 each having a varying amount of maximum
strain. Although FIGS. 6A and 6B illustrate a dressing having
uni-directional strain or deflection, variations of the invention
contemplate limiting members that limit strain in a bi-axial
direction. The limiting members 122 can be comprised of a shape
memory alloy such as a super-elastic alloy or a heat activated
alloy that extends or contracts in response to a temperature shift.
Although a zig-zag shape is depicted for the limiting member 122 in
FIG. 6A, in other variations, the limiting member may comprise an
undulating configuration or other curved configuration, or any
non-linear configuration. The limiting member may comprise any of a
variety of relaxed threads, strings, wires or other elongate,
elongatable, straightenable or stretchable members that straighten,
lengthen and/or stretch to a desired amount, degree, and/or preset
limit. The limiting members may be configured with a sufficient
tensile strength to prevent, resist or otherwise control
over-stretching of the dressing. The skin treatment device may be
constructed of multiple layers of an elastic material such as
silicone with an adhesive between layers to which the members are
attached initially in the relaxed, undulating, sinusoidal,
unstraightened or other unstretched configuration. According to a
variation, the shape limiting strings or other devices may prevent
straining in regions where straining or less strain is desired. For
example, the threads may be straight at the edges of the skin
treatment device to prevent straining at the edges. In some
variations with multiple limiting members, the limiting members may
be equally spaced apart and have uniform lengths and uniform
attachment points across a transverse dimension to the tensioning
axis of the dressing. In other variations, the limiting members may
have a variable or non-uniform spacing, may have non-uniform
lengths, non-uniform attachment points, and may also be serially
arranged along the tensioning axis. The opposing ends of the
limiting members 122 may also optionally have removable (or
non-removable) manipulation elements 123 attached to the ends to
provide for a more even or uniform strain, and may comprise an
inelastic material which is the same or different as the limiting
members 122. The manipulation elements 123 may span the entire
transverse dimension of the device 100 to the axis of tensioning,
as depicted in FIGS. 6A and 6B, but in other variations may be less
than the entire transverse dimension (e.g. having a transverse
dimension sufficient to span a plurality of limiting member 122,
but less than the full transverse dimension of the dressing 100.
Such elements may comprise planar members, handle members, flexible
members and/or inflexible members. They may be attached and removed
in a variety of manners, for example as described herein.
[0076] FIG. 6C illustrates another variation of a dressing 100 that
incorporates a bio-active substance that is intended for delivery
to or near the site of the lesion. In one example, the dressing 100
includes a polymer layer (e.g., silicone) and an adhesive layer
184. The dressing 100 can also include a bio-active substance 182.
Although the bio-active substance is shown as a separate layer 182,
variations of the dressings can include a bio-active substance that
is infused with the polymer layer 180 and/or adhesive layer 184.
Alternatively, the bio-active substance can be a separate layer.
FIG. 6D illustrates the dressing 100 of FIG. 6C after an opening
108 is made in the dressing 100 during creation of a lesion 14. As
shown, creation of the opening causes the bio-active substance to
enter the lesion 14 as represented by arrows 186. The bioactive
substance can be an activated substance, such as a Rose Bengal dye
(a photosensitive dye typically used to cross-link collagen and is
activated by light having wavelengths of 514 nm, 532 nm or 458 nm).
Alternatively, the bioactive substance can be any drug or
pharmaceutical substance delivered for a particular effect on the
lesion or tissue. In further examples, the substance can be a
material that causes cross-linking of collagen, such as riboflavin
and/or glucose. Examples of other bio-active agents that may be
used include hemostatic or coagulative agents to help reduce
bleeding. Such agents include chitosan, calcium-loaded zeolite,
microfibrillar collagen, cellulose, anhydrous aluminum sulfate,
silver nitrate, potassium alum, titanium oxide, fibrinogen,
epinephrine, calcium alginate, poly-N-acetyl glucosamine, thrombin,
coagulation factor(s) (e.g. II, VII, VII, X, XIII, Von Willebrand
factor), procoagulants (e.g. propyl gallate), antifibrinolytics
(e.g. epsilon aminocaproic acid), and the like. In some variations,
the agents may be freeze-dried and integrated into the dressing and
activated upon contact with blood or other fluid. In some further
variations, an activating agent may be applied to the dressing or
the treatment site before the dressing is used on the subject. In
still other examples, the hemostatic agent may be applied
separately and directly to the wound before application of the
dressing, or after application to the dressing via a catheter or
tube. The devices may also comprise one or more other active agents
that may be useful in aiding in some aspect of the wound healing
process. For example, the active agent may be a pharmaceutical
compound, a protein (e.g., a growth factor), a vitamin (e.g.,
vitamin E), or combinations thereof. A further example of such
medicament may include, but is not limited to various antibiotics
(including but not limited to cephalosporins, bactitracin,
polyxyxin B sulfate, neomycin, polysporin), antiseptics (such as
iodine solutions, silver sulfadiazine, chlorhexidine), antifungals
(such as nystatin), antiproliferative agents (sirolimus,
tacrolimus, zotarolimus, biolimus, paclitaxel), grow factors (such
as VEGF) and other treatments (e.g. botulism toxin. Of course, the
devices may comprise more than one medicament or agent, and the
devices may deliver one or more medicaments or agents.
[0077] FIGS. 6E and 6F show another variation of a dressing 100
having an adhesive pattern 104 that varies on the dressing 100 as
opposed to being located on the entire surface of the dressing 100.
FIG. 6E shows one example of a varying adhesive pattern 104 where
the adhesive layers alternate with uncovered sections 107. When
applied to tissue 10 and released from the strained condition, the
dressing 100 contracts at the uncovered regions 107 causing the
tissue 10 to buckle at the uncovered regions 107 as shown in FIG.
6F. Other examples of variable adhesive patterns on the dressing
are described in U.S. Pub. No. 2011/0152738, filed on Aug. 11,
2010, which was already incorporated by reference in its entirety
herein.
[0078] FIG. 6G shows another variation of a dressing 100 for use as
described herein. In this variation, the dressing comprises a
varying elasticity across different sections. For example, as
shown, a dressing can have an elastic section 126 coupled to a
relatively less-elastic section 127. The illustrated variation
shows the elastic section 126 as being thinner than the
less-elastic section 127. However, any number of configurations can
provide varying stretch or elasticity. For example, the different
sections can have different reinforcements, different materials
with varying durometers. One such use of the varying dressing 100
is shown in FIG. 6H, which shows the less elastic section 127
placed in an area where stretching of the skin is not desired and
the elastic section 126 being used to produce a pulling force in a
desired direction as shown by arrows 128. Other examples of
dressings with variable elasticity regions are described in U.S.
Pub. No. 2011/0152738, which was already incorporated by reference
in its entirety herein. In one particular example, a dressings may
be tapered near its edges to reduce thickness. A tapered edge may
also ameliorate peak tensile forces acting on skin tissue adjacent
to the adhesive edges of the dressing. This may or may not reduce
the risk of skin blistering or other tension-related skin trauma.
In other variations, the edges of the dressing may be thicker than
the middle of the dressing. It is hypothesized that in some
configurations, a thicker dressing edge may provide a relative
inward shift of the location of the peak tensile forces acting near
the dressing edge, compared to dressings of uniform thickness.
[0079] FIGS. 6I to 6K show additional variations of dressings 100
that provide directional or vectored application of force. As
shown, the dressings 100 can include adhesive 104 such that when
applied to tissue the dressing is pulled to provide a strain in
tissue in a desired direction. Benefits of such a variation include
providing the physician with control over the degree of strain.
Furthermore, the dressings can be treated with, for example, a
chromophore to monitor the degree of strain in the dressing. Other
examples of a color change material or structure that may be used
or incorporated into the dressing are described in U.S. Pub. No.
2006/0246802 to Hughes et al, which is herein incorporated by
reference in its entirety.
[0080] FIG. 7A illustrates another variation of a dressing 130 that
includes a contoured shape for suited for placement on specific
anatomy (for example, the illustrated dressing 130 can be placed on
a face of a patient having a larger area at a lower region to
accommodate placement along the jaw-line and a smaller surface area
at a top region to accommodate placement close to the ear). FIG. 7A
also illustrates the dressing 130 as having a varying thickness
across the length of the dressing 130. The varying thickness allows
for a physician to adjust the amount of strain that the dressing
130 applies to tissue. For example, section 132 can include the
greatest number of layers, which translates into the highest strain
rate. To reduce the strain rate, the physician or medical
practitioner would cut or remove section 132 from the dressing 130.
Removing section 132 leaves sections having fewer layers and as a
result, lower strain rates. Although the figure illustrates three
sections 132, 134, 136, any number of sections is within the scope
of this disclosure.
[0081] FIG. 7B illustrates a further variation of a dressing 100
that includes a thermally responsive material. In this variation
the dressing 100 can include one or more openings 108 but the
construction of the dressing 100 allows for customization of the
location as well as degree of strain that the dressing 100 will
apply on tissue. The dressing can be adjusted using visible or UV
light, or it can be activated using a chemical response or via
heat. The dressing can also include a separate layer that drives
shrinkage of the dressing upon activation (e.g., via a laser, heat,
other irradiation). In any case, use of a shrinkable dressing
permits customization to create tension or strain in a desired
direction during the treatment procedure.
[0082] FIGS. 7C and 7D illustrate another mechanism for application
of a dressing 100. As shown, a dressing 100 can be applied using a
roller applicator 160. The roller applicator 160 can strain the
dressing 100 as it applies the dressing 100 to tissue 10 over the
lesions 14. Alternatively, the roller applicator 160 can apply a
pre-strained dressing 100 that compresses tissue 10 and the lesions
14 upon positioning on the tissue 10. FIG. 7D illustrates a roller
applicator 160 that is coupled to a lesion creating device 146,
which creates the lesion 14 and where movement of the device 146
causes the roller 160 to apply the dressing 100. The device 146 can
also include one or more sensors 148 to provide feedback of
location to the system or can be used to detect movement of the
device 146. In some variations, the roller applicator 160 may
comprise a ribbon spring (or other spring mechanism or tension
control mechanism) to resist rotation of the roller until a
specific tension threshold is achieved.
[0083] FIG. 8A shows another application of a dressing 100 as
described herein. In this variation, the dressing 100 is coupled to
a treatment device 140. The treatment device 140 can create a
lesion through any variety of treatment modes where the active
elements 142 of the treatment members pass through openings in the
dressing. For example, the treatment device 140 can create the
therapeutic lesion using RF energy, plasma, cryogenic energy,
microwave energy, laser, optical energy (non-laser) chemical,
resistive heat, ultrasound energy, or via mechanical energy. As
shown, a dressing 100 can be coupled to the treatment device 140 so
that after creation of the lesions, the treatment device 140 can be
removed leaving the dressing in place to apply compression to the
lesions. Alternatively, the treatment device 140 can be directly
applied over a dressing 100 that was previously positioned. In some
variations, the dressing 100 may comprise a pattern of treatment
openings with predetermined size, spacing or location, and the
treatment device 140 may comprise a matched pattern or array of
treatment elements 142 with the same spacing or location. In some
variations, the pattern of treatment openings in the dressing 100
may comprise a repeating sub-pattern, and the treatment device 140
may comprise a matched pattern or array of treatment elements 142
to the dressing subpattern of openings. In these variations, the
dressing 100 may comprise indicia to delineate the locations of the
subpatterns. Thus, the treatment device 140 may be used at multiple
regions of the dressing 100. The pattern or array of treatment
elements 142 of the device 140 may comprise at least 2, 3, 4, 5, 6,
7, 8, 9, 10, 15, or 20 treatment elements.
[0084] FIG. 8B illustrates another variation of a dressing 100 in
combination with a treatment device 144. In this variation, the
treatment device 144 creates openings within the dressing 100
before or during the actual treatment. For example, the treatment
device can employ a laser, optical/light, chemical, ultrasound or
electrical energy to create an opening through the dressing while
creating the therapeutic lesion in tissue beneath the dressing.
Moreover, device 144 can apply energy to a dressing 100 to activate
the dressing 100 induce or adjust strain. In such a case, the
dressing can be in an unstrained condition prior to activation by
the device 144. Alternatively, or in combination, the device 144
can reduce or increase a strain in the dressing depending upon the
desired application. FIG. 8B illustrates lesion creating elements
145 positioned adjacent to the dressing 100. In the event that the
device 144 employs a laser to create lesions, the laser is emitted
from the elements 145 and can either pass through the dressing 100
or can create openings in the dressing. In those variations where
the lesion creating elements 145 comprise electrodes or mechanical
members, the elements 145 can pass through the dressing when
advanced from the device 144.
[0085] In many cases, the dressings described herein are intended
for positioning on contoured tissue surfaces rather than planar
surface. Accordingly, there may be a need to provide a dressing
that can approximate the contoured shape prior to affixing to the
tissue surface. FIGS. 9A and 9B show one possible solution to
adjust a contour of a dressing described herein. FIG. 9A shows a
variation of an adjustable frame 150. In this example, the frame
150 includes a plurality of adjustable links 154 coupled between
two end-pieces 152. However, variations of the frame 150 include
adjustable links 154 forming the entire periphery of the frame. As
discussed above, the frame 150 can include one or more fixtures to
permit retention of the dressing. FIG. 9B illustrates the
adjustable frame 150 where one or more of the plurality of links
154 can be adjusted or extended to permit a portion or all of the
frame 150 to form a contoured shape. Although not illustrated, a
dressing attached to the frame 150 will then be in a better
configuration when being secured to a contoured tissue surface.
[0086] In additional variations, a frame can be used without a
dressing to apply strain to the tissue in a similar manner as a
dressing. For example, a deformable frame can apply a compression
force to the tissue and then can be affixed to the tissue in a
manner as described herein (e.g., adhesive, mechanical fasteners,
sutures, etc.) Doing so allows the frame itself to compress tissue
to assist healing of the treated region.
[0087] FIG. 9C shows another variation of a frame 156. In this
variation, the frame 156 employs an expandable member or bladder
158. When affixed to tissue the bladder can be inflated or expanded
to position 160 to provide compression within the area bounded by
the frame 156 and bladder 158. In other variations, a foam (open
cell or closed cell) may be provide within the bladder to maintain
the bladder in an expanded state, and negative pressure may be
applied to reduce the bladder/foam size. In still other variations,
the frame may comprise a foam member in lieu of a bladder member to
provide a resilient or contouring surface or structure for the
frame.
[0088] FIG. 9D illustrates another example of an adjustable frame
that is used to compress tissue. In this example, the frame 170 can
have hinges or joints 176 that transmit a force 172 applied at the
joints to result in an expansion force 174 at the edges of the
frame. In some variations, the frame is biased to return to its
initial shape upon application of a force. In such a case, after
force 172 is applied to the frame, the frame 170 provides
compression within the area bounded by the perimeter of the frame
170. In use, a physician could apply the activation force 172 to
the frame, then adhere portions of the frame 170 to tissue. As the
frame 170 attempts to return to its initial shape, the return force
compresses tissue within the frame. In an alternate variation, the
frame 170 is not biased. Instead, the frame 170 can be affixed to
an elastic dressing (not shown) as described above. In this
example, application of force 172 causes expansion or straining of
the elastic dressing in direction 174. A physician or medical
practitioner can then affix the strained dressing 170 to tissue
where the resiliency of the tissue compresses the tissue.
[0089] The dressings of the present invention can also provide
temporary results to simulate a clinical effect. These temporary
results can allow a patient or physician to determine the type or
amount of treatment desired. For example, a physician can position
pre-strained dressings on a patient to show the patient the results
of a procedure given a pre-determined amount of shrinkage or lift.
Such a feature allows a physician to position dressings having a
pre-determined amount of strain on a patient so that the patient
can visually see the results of the given reduction. For example, a
physician can position dressings that lift the skin by a given
amount so that the patient can determine whether more or less lift
is desired. The goal is to simulate clinical results and allow a
patient to see a real time simulated clinical result via the
application of the dressings. Such pre-strained dressings can be
provided as a kit having varying ranges of displacement with
corresponding templates to assist the physician in applying apply
therapeutic treatments to match the temporary state of the tissue.
In this way, a patient can observe the simulated clinical result,
once a desired result is achieved; the physician can select
treatment templates based on the dressings that are used to produce
the temporary effect. Use of the dressings to simulate a clinical
effect can be used in any number of cosmetic procedures outside of
skin tightening. In additional variations, the simulated clinical
effect can be used to establish a treatment plan. Such a treatment
plan can include the amount of or location where the therapeutic
treatment. The simulated clinical effect can be processed through a
computer analysis to provide the physician with a treatment plan
based on the type of dressing used or amount of lift used to
produce acceptable or desired results.
[0090] FIGS. 10A to 10C illustrate another aspect for use with
dressings of the present invention. As shown in FIG. 10A, a
dressing 100 that is placed over a lesion 14 when used to apply
compression to the dermal layer 10 of skin. In this variation, the
dressing 100 includes an adhesive layer 104. In some variations,
the adhesive layer 104 is sufficient to prevent creeping or
movement of the tissue 10 subsequent to placement of the dressing
100. However, in certain circumstances, as shown in FIG. 10B, the
tissue 10 contacting the adhesive layer 104 can begin to creep
causing the lesion to move in the direction shown by arrows 162
resulting in opening of the lesion 14. The creep of the tissue 10
can occur due to the restoring force of the skin, which may be
higher in a particular target location. Alternatively, creeping of
tissue can occur due to the thickness of the elastic layer or when
the adhesive layer is non-rigid and/or deformable and takes time to
secure the dressing to the tissue.
[0091] FIG. 10C provides a representation of an alternate variation
of a dressing 100 having an adhesive material 105 that can be
activated or set. In some variations the settable adhesive material
105 is set from a liquid or viscous phase to a solid phase via UV
or IR irradiation or even oxidative curing. In some variations, use
of oxidative curing allows for securing of the dressing without
heating of the tissue and/or dressing. As shown in FIG. 10C, the
adhesive material 105 solidifies to keep the lesion closed but also
remains pliable to allow the dressing 100 to remain pliable and
conform to the curvature of the tissue.
[0092] In additional variations a dressing can be used to limit the
lesion size or to minimize collateral damage to tissue. For
example, a solid dressing can be applied to tissue as described
above. Next, a laser can then be used to create openings in the
dressing as well as to create the lesion. For instance, an Er:YAG
laser or an Er:YsGG may be used with a Cr2+:or CR2t:ZnSe
Q-switching device, or a Cr2+:Cr2t:ZnS Q-switching device to apply
a pulse in a Q switched mode followed by a free running mode or
normal mode. The pulse could be used to remove a portion of the
dressing since the pulse produces a plasma initiation and expansion
to photomechanically remove the layer of the dressing (e.g., a
silicone layer). The free running mode operation creates a micro
lesion via photothermal ablation of the tissue.
[0093] FIG. 11A illustrates an exemplary plot of power versus time
for a laser treatment application so that a single laser can create
an opening in a dressing and a subsequent lesion at the site of the
opening. As shown, the first applied pulse 166 reaches a power
level much greater than that of the subsequent free running mode
pulse 168. One benefit of creating openings in the dressing
simultaneously or immediately prior to creating the lesions is to
eliminate alignment of the openings and lesions.
[0094] FIGS. 11B and 11C illustrate another variation of using a
solid dressing and creating openings in the dressing once the
dressing contacts the tissue. As illustrated in FIG. 11C, the
treatment can include two ore more different types of lasers 174,
176, where one of the lasers 174 can be selected such that it is
highly absorbed by the dressing 10. While the second laser 176 can
be selected such that it is highly absorbed in tissue. For example,
a CO2 and Er:YAG laser can be used together. The wavelength of the
CO2 laser is highly absorbed by silicone and the wavelength of the
Er:YAG laser is highly absorbed in skin. In one example, the
wavelength required to create openings in the dressing is 10.6
.mu.m while the wavelength for creating lesions could range from
1.9 to 3.3 .mu.m. The lasers can be arranged so that they are
either co-axial or confocal (e.g., the laser elements if FIG. 11C
can be rotated or moved so that each laser targets the same
region.) Alternatively, the lasers can be configured to deliver
light in a concentric manner. In use, the lasers are time-delayed
as shown in FIG. 11B, which illustrates a graph of power versus
time. As shown, the first laser 174 delivers a first pulse 170 to
create the opening in the dressing 10. The pulse 172 from the
second laser 176 can be staggered or delayed to allow for ejection
and/or removal of debris. While any variation of lasers can be used
in this configuration, one desirable variation can include the use
of two low power lasers to provide each source of light.
Alternatively, a more complicated dual wavelength system can be
used. Such a system could deliver multiple wavelengths of light as
described above.
[0095] FIG. 11D shows the system of FIG. 11C, where the first laser
174 creates an opening 108 in the dressing 100 but not the skin
since the laser is not absorbed by the skin. FIG. 11E shows the
second laser 174 creating the lesion 14 through the previously
created opening 14.
[0096] The above system or configuration allows for a skin
tightening therapy with an adhesive patch applied to skin with the
skin and patch ablated in situ. The patch is applied to untreated
skin under tension with an adhesive. The patch initially does not
have holes over the areas where lesions are to be formed. The
entire patch may be solid or may have holes or other features to
position and/or stretch the patch. An initial laser beam ablates
holes or other features in the patch to expose certain areas of the
skin. The exposed areas can then be treated through holes in the
patch. The laser parameters are such that the patch material is
cleanly ablated with a minimum of thermal damage to the underlying
skin. A second laser beam of possibly different character is then
used to ablate a controlled amount of skin. An additional benefit
of creating openings in the dressing and subsequently creating
lesions is that the lesion pattern and/or openings in the dressing
can be customized during a procedure rather than needing to follow
the pattern of a pre-configured dressing.
[0097] One benefit of creating openings in the dressing in situ is
that there is no need for orienting a dressing having pre-made
openings with previously created lesions. Yet another benefit of
creating openings in-situ is that the pattern or features of the
holes in the dressing are customized to match the lesions.
[0098] FIG. 12A shows an example of a dressing 100 having one or
more registration features 202, 204 allowing for detection and/or
recognition regarding characteristics of the dressing. For example,
FIG. 12A shows registration features 202 and 204, which allow for
optical scanning or reflecting light that can be used to confirm
alignment of the treatment device. Alternatively, or in
combination, the presence or relative position of the registration
features 202 and 204 can provide any range of information regarding
the pattern of openings 108 or even the location where treatment
should occur. For example, in FIG. 12A, lesions are created in the
openings that are within specific registration features 202 and
204.
[0099] Once the system obtains feedback regarding the registration
features, the system can confirm that the treatment device is in
the correct position. Subsequently, image analysis hardware and
software can be used to recognize the patterns or openings 108 in
the dressing 100 to either control the treatment parameters, to
maintain a database of treatment areas, or to perform some other
custom treatment depending upon type of dressing or orientation of
the dressing.
[0100] One approach is to position a handheld scanning handpiece
directed at the approximate location of the treatment. The system
can determine whether positioning of the handpiece is within an
acceptable tolerance using an optical detection of one or more
registration features 202, 204. Once the system confirms correct or
acceptable positioning, the system can then permit or trigger a
treatment cycle. For example, a laser scan pattern can be released
on a time scale sufficiently rapid enough (<50 msec) such that
inadvertent motion of the handheld scanning handpiece does not
appreciably affect the pattern. The handheld scanning handpiece can
be repositioned to treat the next zone, and the optical detection
of registration features at the correction positioning of the
dressing with respect to the handpiece will again trigger the
release of a laser scan pattern.
[0101] Alternatively, a handpiece with either scanning patterns or
fixed patterns (including a single shot) can be manually positioned
laterally to the dressing, with optical detection of the
registration features 202, 204 triggering individual firing events.
One example involves the use of an optical mouse-type arrangement
in which a light source such as an LED projects onto the dressing
surface and the reflected or scattered light from the dressing is
re-imaged into an optical detector as the handheld device is
manually moved laterally across the dressing.
[0102] Alternatively, a complete image may be acquired by an
imaging system, and image-processing software may be used to create
a custom scan pattern to be delivered. The positioning of the
dressing with respect to the laser delivery system, the particular
configuration of the dressing, the desired pattern of lesions may
all be processed to determine a customized laser scanning pattern
appropriate for a particular dressing and patient. In this
realization, a relatively large area may be treated by a scanned
laser pattern, which may require a duration that is long enough
that movements of the patient with respect to the laser delivery
device may occur. The invention may interrupt delivery of laser
pulses is motion of the registration features 202, 204 is detected.
The positioning may be restored and laser firing resumed.
Alternatively, a new image may be acquired and a new laser delivery
pattern computed and delivered.
[0103] FIG. 12B provides a partial illustration of another
variation of a dressing 100. In this variation, a dressing 100 can
include a surface that provides a particular optical or other
identifiable property that can be recognized by the treatment
device to alter treatment parameters or lesion location based upon
pre-determined parameters. For example, the dressing 100 can
include a particular, reflective, absorptive, or scattering
characteristic that is recognized by the treatment device. In
addition, as shown, a dressing can include a first region 206
having a first set of characteristics, and a second region 208
having a second set of characteristics.
[0104] FIGS. 13A to 13E show another variation of a dressing 100
covered by a mask 128 where the dressing 100 and mask 128 allow for
a treatment device to create lesions at specific areas, thereby
eliminating the need to align the dressing with the lesion. As
shown, the mask 128 can include openings 129 that are in alignment
with opening 108 in the dressing. Optionally, the mask 128 can
apply strain to the dressing 100. FIG. 13A illustrates the dressing
100 in a strained configuration to place the tissue 12 in a state
of traction. The dressing 100 and mask 128 are exposed to the
treatment energy 120 (e.g, a laser or other treatment modality).
The therapeutic energy 120 creates ablation patterns 14 and 131 in
the tissue 12 and the mask 128 respectively. FIG. 13C shows removal
of the mask 128 and eventual compression/closure of the lesions 14
as the dressing 100 contracts. FIGS. 13D and 13E illustrate top
planer view of a dressing 100 and mask 128 having respective
openings 108 and 129. FIG. 13D shows the dressing 100 and mask 128
pre-treatment. FIG. 13E shows the dressing 100 and mask 128 after
the ablation process. As shown, the ablation pattern 14 and 131 can
be created over a wider area than the opening 14 in the dressing
108 but only forms lesions 14 in the tissue in a limited manner at
the exposed areas.
[0105] FIG. 14A illustrates another advantage of creating a lesion
14 in situ with the dressing 100. As shown in FIG. 14A, the lesion
14 as well as the opening 108 in the dressing 100 can be made to
have a unique shape that can be made or modified during the
procedure. For example, FIG. 14A shows a dressing 100 with a lesion
14 in tissue, where both the lesion 14 and opening 108 are made to
have a longer dimension when viewed along 14C-14C (as shown in FIG.
14C), when compared to direction 14-B-14B (and as shown in FIG.
14D). Furthermore, the lesion pattern can be a non-linear design.
An additional example of such patterns is shown in FIG. 14D
[0106] FIGS. 15A to 15D illustrate another use for dressings of the
present disclosure.
[0107] FIG. 15A illustrates an array 190 of electrodes 192 adapted
to penetrate subdermal tissue, such as subcutaneous layers 12. FIG.
15B illustrates a dressing 100 as described herein, where the
dressing is strained and placed over the electrodes 192 as shown in
FIG. 15B. The electrodes 192 (e.g., RF electrodes or any other
energy modality described herein) applies energy to the
subcutaneous fat layer 12 to lyse, burn, or otherwise breakdown the
fat to create a lesion 22 or cavity 22. FIG. 15C illustrates
removal of the electrode array 190 leaving the dressing 100 in
place against the dermal region 10 of tissue. Because the dressing
100 is in a strained configuration, removal of the dressing 100
from the electrode array causes movement of the dressing 100 to
close the openings 108 as described above.
[0108] FIG. 16 depicts an additional use of a dressing 100 as a
mask to direct creation of the lesion 14. As illustrated, an
electrode 142 or other lesion creation element is placed against a
dressing 100 such that activation of the element 142 creates
lesions 14 through openings 108 in the dressing 100. As discussed
above, creating lesions 14 through openings 108 in the dressing 100
eliminates the need to match openings in the dressing to lesions.
The use of the dressing 100 as a mask type element eliminates the
need for electrodes penetrating into tissue.
[0109] Elastomeric dressings of the present disclosure can also be
used by affixing to the tissue, stretching or straining once placed
on tissue. Then creating the lesions in the tissue. The dressing
can then be released to compress the lesion. The dressing can also
be removed so that the natural elasticity of the skin or tissue
helps appose the lesion openings. Accordingly, the dressing can be
removed.
[0110] In additional variations, the dressings or frames described
herein can be affixed to external structures placed on a patient to
provide the degree of lift or tissue movement required for an
acceptable clinical effect. For example, a cap or similar structure
can be placed on a patient's head and serve an anchoring type
device that allows the dressings or frames to displace tissue for
an acceptable simulated visual result.
[0111] The devices, methods and kits described herein can be used
for applying force to any portion of tissue to compress,
reposition, or lift tissue as required by the intended cosmetic
application (e.g., lifting of the breast, stretching scalp tissue
to increase a density of implanted, underarm, abdominal procedures,
etc. The dressing described herein can be fabricated from any
biocompatible material that can provide the compressive force
necessary to achieve
[0112] the intended result. For example, the dressings can comprise
a polymer, a shape memory polymer (e.g., acrylate-based,
styrene-based and epoxy-based shape memory polymers), or
biocompatible polymer (e.g., silicone). The dressings and/or frame
can be transparent or opaque or have other features as required by
the intended application. The strain rates of the dressings and
frames described herein can range from 1% to 100% either
uni-directional, uni-axial, or bi-axial.
[0113] The fixation means described above can include any
conventionally known means to secure similar dressings or frames to
tissue. For example, the devices can be secured to tissue in a
variety of ways (either temporarily affixed or affixed until the
fixation means is removed). For example, the devices can be
removably secured to the tissue with an adhesive, with a skin
piercing device, or the like. Suitable adhesives include pressure
sensitive adhesives, such as polyacrylatebased,
polyisobutylene-based, temperature activated adhesives, chemically
activated adhesives and silicone-based pressure sensitive
adhesives. Suitable skin-piercing devices include clamps, needles,
microneedles, sutures, anchors, staples, microtines and the
like.
[0114] The devices may have any suitable or desirable shape or
size. In some examples, the shape of the dressings or frames can be
adjusted before, during or after the procedure. For example, the
devices may have a shape selected from the group consisting of
rectangles, circles, squares, trapezoids, toroids, ovals, or
segments and combinations thereof. For example, some devices may be
substantially circular, others may be substantially toroidal, and
still others may be substantially rectangular.
[0115] In another aspect, altering the geometry of a lesion to
assist in wound healing can be combined with methods and devices
described herein to improve the outcome of a treatment. For
example, FIG. 17A provides a representative illustration of a top
view of a lesion 14 without application of any compressive force.
FIG. 17B illustrates the lesion 14 of FIG. 17A, where a compressive
force, as described above and illustrated by arrows 26, attempts to
close the lesion 14. However, the lesions 14 circular geometry
creates regions of increased stress 28. The high stress regions 28
are not desirable for a number of reasons. For example, the high
stress regions 28 can impede the healing process. Moreover, the
high stress regions 28 caused increased resistance when attempting
to close the lesion 14. For example, the high stress regions 28 can
provide an opposing force to the dressing and ultimately render the
procedure less effective. FIG. 18A shows a variation of a shaped
lesion 30 intended to reduce areas of high stress when the lesion
30 is compressed as discussed herein. The lesion 30 can be created
via a single treatment or can comprise a number of treatments to
produce a desired shape. For example, in FIG. 18A the lesion 30 can
be created to be asymmetrical so that portions 32 of the lesion 30
do not generate high areas of stress when the lesion is compressed
(see e.g., FIG. 18B). In one example, a shaped lesion 30 is created
via a slit in tissue and superimposing a circular lesion on the
slit portion. Alternatively, as shown in FIG. 18C, a standard
lesion 14 is created and then a secondary process creates one or
more additional lesions 32 to create a shaped lesion 30 as shown in
FIG. 18D. The creation of the base lesion 14 can be made by any
conventional means (e.g. a CO.sub.2 laser) that creates a lesion of
the desired size. The additional lesions 32 can be created using a
means that allows creation of smaller lesions.
[0116] FIG. 18E illustrates another variation of a lesion 14 with
features 32 to prevent high stress areas upon compression of the
tissue. Such complex lesions can be created using a masking
approach or creating series of therapeutic treatment lesions
similar to that shown in FIG. 18D. FIG. 18F illustrates another
lesion geometry conducive to avoiding high stress areas upon
compression of tissue. In this variation, the lesion 14 includes a
relatively simple geometric configuration (oval as opposed to
circular).
[0117] The applications of the disclosed invention discussed above
are not limited to certain treatments or regions of the body, but
may include any number of other treatments and areas of the body.
Modification of the above-described methods and devices for
carrying out the invention, and variations of aspects of the
invention that are obvious to those of skill in the arts are
intended to be within the scope of this disclosure. Moreover,
various combinations of aspects between examples are also
contemplated and are considered to be within the scope of this
disclosure as well.
* * * * *