Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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PIXEL ARRAY MEDICAL DEVICES AND METHODS
RELATED APPLICATIONS
This application claims the benefit of United States (US) Patent Application
Number 62/044,060, filed August 29, 2014.
This application claims the benefit of US Patent Application Number
62/044,078,
filed August 29, 2014.
This application claims the benefit of US Patent Application Number
62/044,089,
filed August 29, 2014.
This application claims the benefit of US Patent Application Number
62/044,102,
filed August 29, 2014.
This application is a continuation in part of US Patent Application Number
14/099,380, filed December 6, 2013, which claims the benefit of US Patent
Application
Number 61/734,313, filed December 6, 2012.
This application is a continuation in part of US Patent Application Number
12/972,013, filed December 17, 2010, which claims the benefit of US Patent
Application
Number 61/288,141, filed December 18, 2009.
This application is a continuation in part of United States (US) Patent
Application
Number 14/505,090, filed October 2, 2014.
TECHNICAL FIELD
The embodiments herein relate to medical systems, instruments or devices, and
methods and, more particularly, to medical instrumentation and methods applied
to the
surgical management of burns, skin defects, and hair transplantation.
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BACKGROUND
The aging process is most visibly depicted by the development of dependent
skin
laxity. This life long process may become evident as early as the third decade
of life and
will progressively worsen over subsequent decades. Histological research has
shown that
dependant stretching or age related laxity of the skin is due in part to
progressive dermal
atrophy associated with a reduction of skin tensile strength. When combined
with the
downward force of gravity, age related dermal atrophy will result in the two
dimensional
expansion of the skin envelope. The clinical manifestation of this physical-
histological
process is redundant skin laxity. The most affected areas are the head and
neck, upper
arms, thighs, breasts, lower abdomen and knee regions. The most visible of all
areas are
the head and neck. In this region, prominent "turkey gobbler" laxity of neck
and "jowls"
of the lower face are due to an unaesthetic dependency of skin in these areas.
Plastic surgery procedures have been developed to resect the redundant lax
skin.
These procedures must employ long incisions that are typically hidden around
anatomical
boundaries such as the ear and scalp for a facelift and the inframammary fold
for a breast
uplift (mastopexy). However, some areas of skin laxity resection are a poor
tradeoff
between the aesthetic enhancement of tighter skin and the visibility of the
surgical
incision. For this reason, skin redundancies of the upper arm, suprapatellar
knees, thighs
and buttocks are not routinely resected due to the visibility of the surgical
scar.
The frequency and negative societal impact of this aesthetic deformity has
prompted the development of the "Face Lift" surgical procedure. Other related
plastic
surgical procedures in different regions are the Abdominoplasty (Abdomen), the
Mastopexy (Breasts), and the Brachioplasty (Upper Arms). Inherent adverse
features of
these surgical procedures are post-operative pain, scarring and the risk of
surgical
complications. Even though the aesthetic enhancement of these procedures is an
acceptable tradeoff to the significant surgical incisions required, extensive
permanent
scarring is always an incumbent part of these procedures. For this reason,
plastic
surgeons design these procedures to hide the extensive scarring around
anatomical
borders such as the hairline (Facelift), the inframmary fold (Mastopexy), and
the inguinal
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crease (Abdominoplasty). However, many of these incisions are hidden distant
to the
region of skin laxity, thereby limiting their effectiveness. Other skin laxity
regions such
as the Suprapatellar (upper-front) knee are not amendable to plastic surgical
resections
due to the poor tradeoff with a more visible surgical scar.
More recently, electromagnetic medical devices that create a reverse thermal
gradient (i.e., Thermage) have attempted with variable success to tighten skin
without
surgery. At this time, these electromagnetic devices are best deployed in
patients with a
moderate amount of skin laxity. Because of the limitations of electromagnetic
devices
and potential side effects of surgery, a minimally invasive technology is
needed to
circumvent surgically related scarring and the clinical variability of
electromagnetic
heating of the skin. For many patients who have age related skin laxity (neck
and face,
arms, axillas, thighs, knees, buttocks, abdomen, bra line, ptosis of the
breast), fractional
resection of excess skin could augment a significant segment of traditional
plastic
surgery.
Even more significant than aesthetic modification of the skin envelope is the
surgical management of burns and other trauma related skin defects.
Significant burns
are classified by the total body surface burned and by the depth of thermal
destruction.
First-degree and second-degree burns are generally managed in a non-surgical
fashion
with the application of topical creams and burn dressings. Deeper third-degree
burns
involve the full thickness thermal destruction of the skin. The surgical
management of
these serious injuries involves the debridement of the burn eschar and the
application of
split thickness grafts.
Any full thickness skin defect, most frequently created from burning, trauma,
or
the resection of a skin malignancy, can be closed with either skin flap
transfers or skin
grafts using current commercial instrumentation. Both surgical approaches
require
harvesting from a donor site. The use of a skin flap is further limited by the
need of to
include a pedicle blood supply and in most cases by the need to directly close
the donor
site.
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The split thickness skin graft procedure, due to immunological constraints,
requires the harvesting of autologous skin grafts, that is, from the same
patient.
Typically, the donor site on the burn patient is chosen in a non-burned area
and a partial
thickness sheet of skin is harvested from that area. Incumbent upon this
procedure is the
creation of a partial thickness skin defect at the donor site. This donor site
defect is itself
similar to a deep second-degree burn. Healing by re-epithelialization of this
site is often
painful and may be prolonged for several days. In addition, a visible donor
site deformity
is created that is permanently thinner and more de-pigmented than the
surrounding skin.
For patients who have burns over a significant surface area, the extensive
harvesting of
skin grafts may also be limited by the availability of non-burned areas.
For these reasons, there is a need in the rapidly expanding aesthetic market
for
instrumentation and procedures for aesthetic surgical skin tightening. There
is also a
need for systems, instruments or devices, and procedures that enable the
repeated
harvesting of skin grafts from the same donor site while eliminating donor
site deformity.
INCORPORATION BY REFERENCE
Each patent, patent application, and/or publication mentioned in this
specification
is herein incorporated by reference in its entirety to the same extent as if
each individual
patent, patent application, and/or publication was specifically and
individually indicated
to be incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows the PAD Kit placed at a target site, under an embodiment.
Figure 2 is a cross-section of a scalpet punch or device including a scalpet
array,
under an embodiment.
Figure 3 is a partial cross-section of a scalpet punch or device including a
scalpet
array, under an embodiment.
Figure 4 shows the adhesive membrane with backing (adherent substrate)
included in a PAD Kit, under an embodiment.
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Figure 5 shows the adhesive membrane (adherent substrate) when used with the
PAD Kit frame and blade assembly, under an embodiment.
Figure 6 shows the removal of skin pixels, under an embodiment.
Figure 7 is a side view of blade transection and removal of incised skin
pixels
with the PAD Kit, under an embodiment.
Figure 8 is an isometric view of blade/pixel interaction during a procedure
using
the PAD Kit, under an embodiment.
Figure 9 is another view during a procedure using the PAD Kit (blade removed
for clarity) showing both harvested skin pixels or plugs transected and
captured and non-
transected skin pixels or plugs prior to transection, under an embodiment.
Figure 10A is a side view of a portion of the pixel array showing scalpets
secured
onto an investing plate, under an embodiment.
Figure 10B is a side view of a portion of the pixel array showing scalpets
secured
onto an investing plate, under an alternative embodiment.
Figure 10C is a top view of the scalpet plate, under an embodiment.
Figure 10D is a close view of a portion of the scalpet plate, under an
embodiment.
Figure 11A shows an example of rolling pixel drum, under an embodiment.
Figure 11B shows an example of a rolling pixel drum assembled on a handle,
under an embodiment.
Figure 11C depicts a drum dermatome for use with the scalpet plate, under an
embodiment.
Figure 12A shows the drum dermatome positioned over the scalpet plate, under
an embodiment.
Figure 12B is an alternative view of the drum dermatome positioned over the
scalpet plate, under an embodiment.
Figure 13A is an isometric view of application of the drum dermatome (e.g.,
Padgett dermatome) over the scalpet plate, where the adhesive membrane is
applied to
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the drum of the dermatome before rolling it over the investing plate, under an
embodiment.
Figure 13B is a side view of a portion of the drum dermatome showing a blade
position relative to the scalpet plate, under an embodiment.
Figure 13C is a side view of the portion of the drum dermatome showing a
different blade position relative to the scalpet plate, under an embodiment.
Figure 13D is a side view of the drum dermatome with another blade position
relative to the scalpet plate, under an embodiment.
Figure 13E is a side view of the drum dermatome with the transection blade
clip
showing transection of skin pixels by the blade clip, under an embodiment.
Figure 13F is a bottom view of the drum dermatome along with the scalpet
plate,
under an embodiment.
Figure 13G is a front view of the drum dermatome along with the scalpet plate,
under an embodiment.
Figure 13H is a back view of the drum dermatome along with the scalpet plate,
under an embodiment.
Figure 14A shows an assembled view of the dermatome with the Pixel Onlay
Sleeve (PUS), under an embodiment.
Figure 14B is an exploded view of the dermatome with the Pixel Onlay Sleeve
(PUS), under an embodiment.
Figure 14C shows a portion of the dermatome with the Pixel Onlay Sleeve
(PUS), under an embodiment.
Figure 15A shows the Slip-On PAD being slid onto a Padgett Drum Dermatome,
under an embodiment.
Figure 15B shows an assembled view of the Slip-On PAD installed over the
Padgett Drum Dermatome, under an embodiment.
Figure 16A shows the Slip-On PAD installed over a Padgett Drum Dermatome
and used with a perforated template or guide plate, under an embodiment.
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Figure 16B shows skin pixel harvesting with a Padgett Drum Dermatome and
installed Slip-On PAD, under an embodiment.
Figure 17A shows an example of a Pixel Drum Dermatome being applied to a
target site of the skin surface, under an embodiment.
Figure 17B shows an alternative view of a portion of the Pixel Drum Dermatome
being applied to a target site of the skin surface, under an embodiment.
Figure 18 shows a side perspective view of the PAD assembly, under an
embodiment.
Figure 19A shows a top perspective view of the scalpet device for use with the
PAD assembly, under an embodiment.
Figure 19B shows a bottom perspective view of the scalpet device for use with
the PAD assembly, under an embodiment.
Figure 20 shows a side view of the punch impact device including a vacuum
component, under an embodiment.
Figure 21A shows a top view of an oscillating flat scalpet array and blade
device,
under an embodiment.
Figure 21B shows a bottom view of an oscillating flat scalpet array and blade
device, under an embodiment.
Figure 21C is a close-up view of the flat array when the array of scalpets,
blades,
adherent membrane and the adhesive backer are assembled together, under an
embodiment.
Figure 21D is a close-up view of the flat array of scalpets with a feeder
component, under an embodiment.
Figure 22 shows a cadaver dermal matrix cylindrically transected similar in
size
to the harvested skin pixel grafts, under an embodiment.
Figure 23 is a drum array drug delivery device, under an embodiment.
Figure 24A is a side view of a needle array drug delivery device, under an
embodiment.
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Figure 24B is an upper isometric view of a needle array drug delivery device,
under an embodiment.
Figure 24C is a lower isometric view of a needle array drug delivery device,
under an embodiment.
Figure 25 shows the composition of human skin.
Figure 26 shows the physiological cycles of hair growth.
Figure 27 shows harvesting of donor follicles, under an embodiment.
Figure 28 shows preparation of the recipient site, under an embodiment.
Figure 29 shows placement of the harvested hair plugs at the recipient site,
under
an embodiment.
Figure 30 shows placement of the perforated plate on the occipital scalp donor
site, under an embodiment.
Figure 31 shows scalpet penetration depth through skin when the scalpet is
configured to penetrate to the subcutaneous fat layer to capture the hair
follicle, under an
embodiment.
Figure 32 shows hair plug harvesting using the perforated plate at the
occipital
donor site, under an embodiment.
Figure 33 shows creation of the visible hairline, under an embodiment.
Figure 34 shows preparation of the donor site using the patterned perforated
plate
and spring-loaded pixilation device to create identical skin defects at the
recipient site,
under an embodiment.
Figure 35 shows transplantation of harvested plugs by inserting harvested
plugs
into a corresponding skin defect created at the recipient site, under an
embodiment.
Figure 36 shows a clinical end point using the pixel dermatome instrumentation
and procedure, under an embodiment.
Figure 37 is an image of the skin tattooed at the corners and midpoints of the
area
to be resected, under an embodiment.
Figure 38 is an image of the post-operative skin resection field, under an
embodiment.
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Figure 39 is an image at 11 days following the procedure showing resections
healed per primam, with measured margins, under an embodiment.
Figure 40 is an image at 29 days following the procedure showing resections
healed per primam and maturation of the resection field continuing per primam,
with
measured margins, under an embodiment.
Figure 41 is an image at 29 days following the procedure showing resections
healed per primam and maturation of the resection field continuing per primam,
with
measured lateral dimensions, under an embodiment.
Figure 42 is an image at 90 days post-operative showing resections healed per
primam and maturation of the resection field continuing per primam, with
measured
lateral dimensions, under an embodiment.
DETAILED DESCRIPTION
Embodiments described herein satisfy the expanding aesthetic market for
instrumentation and procedures for aesthetic surgical skin tightening.
Additionally, the
embodiment enable the repeated harvesting of skin grafts from the same donor
site while
eliminating donor site deformity. The embodiments described herein are
configured to
resect redundant lax skin without visible scarring so that all areas of
redundant skin laxity
can be resected by the pixel array dermatome and procedures may be performed
in areas
that were previously off limits due to the visibility of the surgical
incision. The technical
effects realized through the embodiments described herein include smooth,
tightened skin
without visible scarring or long scars along anatomical borders.
Embodiments described in detail herein, which include pixel skin grafting
instrumentation and methods, are configured to provide the capability to
repeatedly
harvest split thickness skin grafts without visible scarring of the donor
site. During the
procedure, a Pixel Array Dermatome (PAD) is used to harvest the skin graft
from the
chosen donor site. During the harvesting procedure, a pixilated skin graft is
deposited
onto a flexible, semi-porous, adherent membrane. The harvested skin
graft/membrane
composite is then applied directly to the recipient skin defect site. The
fractionally
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resected donor site is closed with the application of an adherent sheeting or
bandage (e.g.,
Flexzan sheeting, etc.) that functions for a period of time (e.g., one week,
etc.) as a
large butterfly bandage. The intradermal skin defects generated by the PAD are
closed to
promote a primary healing process in which the normal epidermal-dermal
architecture is
realigned in an anatomical fashion to minimize scarring. Also occurring
postoperatively,
the adherent membrane is desquamated (shed) with the stratum corneum of the
graft; the
membrane can then be removed without disruption of the graft from the
recipient bed.
Numerous effects realized by the pixel skin grafting procedure deserve
explanation. Because the skin graft is pixelated it provides interstices for
drainage
between skin plug components, which enhances the percentage of "takes,"
compared to
sheet skin grafts. During the first post-operative week, the skin graft
"takes" at the
recipient site by a process of neovascularization in which new vessels from
the recipient
bed of the skin defect grow into the new skin graft. The semiporous membrane
conducts
the exudate into the dressing.
The flexible membrane is configured with an elastic recoil property that
promotes
apposition of component skin plugs within the graft/membrane composite;
promoting
primary adjacent healing of the skin graft plugs and converting the pixilated
appearance
of the skin graft into a more uniform sheet morphology. Furthermore, the
membrane
aligns the micro-architectural components skin plugs, so epidermis aligns with
epidermis
and dermis aligns with dermis, promoting a primary healing process that
reduces
scarring.
There are numerous major clinical applications for the dermatomes described in
detail herein, including fractional skin resection for skin tightening,
fractional hair
grafting for alopecia, and fractional skin harvesting for skin grafting.
Fractional skin
resection of an embodiment comprises harvesting skin plugs using an adherent
membrane, however the fractionally incised skin plugs can be evacuated without
harvesting. The paradigm of incising, evacuating and closing is most
descriptive of the
clinical application of skin tightening. The embodiments described herein are
configured
to facilitate incising and evacuating and, in order to provide for a larger
scalpet array with
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a greater number of scalpets, the embodiments include a novel means of
incising the skin
surface.
Pixel array medical systems, instruments or devices, and methods are described
for skin grafting and skin resection procedures, and hair transplantation
procedures. In
the following description, numerous specific details are introduced to provide
a thorough
understanding of, and enabling description for, embodiments herein. One
skilled in the
relevant art, however, will recognize that these embodiments can be practiced
without
one or more of the specific details, or with other components, systems, etc.
In other
instances, well-known structures or operations are not shown, or are not
described in
detail, to avoid obscuring aspects of the disclosed embodiments.
The following terms are intended to have the following general meaning as they
may be used herein. The terms are not however limited to the meanings stated
herein as
the meanings of any term can include other meanings as understood or applied
by one
skilled in the art.
"First degree burn" as used herein includes a superficial thermal injury in
which
there is no disruption of the epidermis from the dermis. A first-degree burn
is visualized
as erythema (redness) of the skin.
"Second degree burn" as used herein includes a relatively deeper burn in which
there is disruption of the epidermis from the dermis and where a variable
thickness of the
dermis is also denatured. Most second-degree burns are associated with blister
formation. Deep second-degree burns may convert to full thickness third degree
burns,
usually by oxidation or infection.
"Third degree burn" as used herein includes a burn associated with the full
thickness thermal destruction of the skin including the epidermis and the
dermis. A third
degree burn may also be associated with thermal destruction of deeper,
underlying tissues
(subcutaneous and muscle layers).
"Ablation" as used herein includes the removal of tissue by destruction of the
tissue e.g., thermal ablation of a skin lesion by a laser.
"Autograft" as used herein includes a graft taken from the same patient.
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"Backed Adherent Membrane" as used herein includes the elastic adherent
membrane that captures the transected skin plugs. The Backed Adherent Membrane
of
an embodiment is backed on the outer surface to retain alignment of the skin
plugs during
harvest. After harvesting of the skin plugs, the backing is removed from the
adherent
membrane with harvested skin plugs. The membrane of an embodiment is porous to
allow for drainage when placed at the recipient site. The membrane of an
embodiment
also possesses an elastic recoil property, so that when the backing is
removed, it brings
the sides of the skin plugs closer to each other to promote healing at the
recipient site as
a sheet graft.
"Bum Scar Contraction" as used herein includes the tightening of scar tissue
that
occurs during the wound healing process. This process is more likely to occur
with an
untreated third degree burn.
"Bum Scar Contracture" as used herein includes a band of scar tissue that
either
limits the range of motion of a joint or band of scar tissue that distorts the
appearance of
the patient i.e., a burn scar contracture of the face.
"Dermatome" as used herein includes an instrument that "cuts skin" or harvests
a
sheet split thickness skin graft. Examples of drum dermatomes include the
Padgett and
Reese dermatomes. Electrically powered dermatomes are the Zimmer dermatome and
one electric version of the Padgett dermatome.
"Dermis" as used herein includes the deep layer of skin that is the main
structural
support and primarily comprises non-cellular collagen fibers. Fibroblasts are
cells in the
dermis that produce the collagen protein fibers.
"Donor Site" as used herein includes the anatomical site from which a skin
graft
is harvested.
"Epidermis" as used herein includes the outer layer of skin comprising viable
epidermal cells and nonviable stratum comeum that acts as a biological
barrier.
"Excise" as used herein includes the surgical removal of tissue.
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"Excisional Skin Defect" as used herein includes a partial thickness or, more
typically, a full thickness defect that results from the surgical removal
(excision/resection) of skin (lesion).
"FTSG" as used herein includes a Full Thickness Skin Graft in which the entire
thickness of the skin is harvested. With the exception of an instrument as
described
herein, the donor site is closed as a surgical incision. For this reason, FTSG
is limited in
the surface area that can be harvested.
"Granulation Tissue" as used herein includes highly vascularized tissue that
grows in response to the absence of skin in a full-thickness skin defect.
Granulation
Tissue is the ideal base for a skin graft recipient site.
"Healing by primary intention" as used herein includes the wound healing
process
in which normal anatomical structures are realigned with a minimum of scar
tissue
formation. Morphologically the scar is less likely to be visible.
"Healing by secondary intention" as used herein includes a less organized
wound
healing process wherein healing occurs with less alignment of normal
anatomical
structures and with an increased deposition of scar collagen. Morphologically,
the scar is
more likely to be visible.
"Homograft" as used herein includes a graft taken from a different human and
applied as a temporary biological dressing to a recipient site on a patient.
Most
homografts are harvested as cadaver skin. A temporary "take" of a homograft
can be
partially achieved with immunosuppression but homografts are eventually
replaced by
autografts if the patient survives.
"Incise" as used herein includes the making of a surgical incision without
removal
of tissue.
"Mesh Split Thickness Skin Graft" as used herein includes a split thickness
skin
graft that is expanded in its surface area by repetitiously incising the
harvested skin graft
with an instrument called a "mesher". A meshed split thickness skin graft has
a higher
percentage of "take" than a sheet graft because it allows drainage through the
graft and
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conforms better to the contour irregularities of the recipient site. However,
it does result
in an unsightly reticulated appearance of the graft at the recipient site.
"PAD" as used herein includes a Pixel Array Dermatome, the class of
instruments
for fractional skin resection.
"PAD Kit" as used herein includes the disposable single use procedure kit
comprising the perforated guide plate, scalpet stamper, the guide plate frame,
the backed
adherent membrane and the transection blade.
"Perforated Guide Plate" as used herein includes a perforated plate comprising
the
entire graft harvest area in which the holes of the guide plate are aligned
with the scalpets
of the handled stamper or the Slip-on PAD. The plate will also function as a
guard to
prevent inadvertent laceration of the adjacent skin. The perforations of the
Guide Plate
can be different geometries such as, but not limited to, round, oval, square.
rectangular,
and/or triangular.
"Pixelated Full Thickness Skin Graft" as used herein includes a Full Thickness
Skin Graft that has been harvested with an instrument as described herein
without
reduced visibly apparent scarring at the donor site. The graft will also
possess an
enhanced appearance at the recipient site similar to a sheet FTSG but will
conform better
to recipient site and will have a higher percentage of 'take' due to drainage
interstices
between skin plugs. Another significant advantage of the pixelated FTSG in
comparison
to a sheet FTSG is the ability to graft larger surface areas that would
otherwise require a
STSG. This advantage is due to the capability to harvest from multiple donor
sites with
reduced visible scarring.
"Pixelated Graft Harvest" as used herein includes the skin graft harvesting
from a
donor site by an instrument as described in detail herein.
"Pixelated Spilt Thickness Skin Graft" as used herein includes a partial
thickness
skin graft that has been harvested with an SRG instrument. The skin graft
shares the
advantages of a meshed skin graft without unsightly donor and recipient sites.
"Recipient Site" as used herein includes the skin defect site where a skin
graft is
applied.
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"Resect" as used herein includes excising.
"Scalpel" as used herein includes the single-edged knife that incises skin and
soft
tissue.
"Scalpet" as used herein includes the term that describes the small
geometrically-
shaped (e.g., circle, ellipse, rectangle, square, etc.) scalpel that incises a
plug of skin.
"Scalpet Array" as used herein includes the arrangement or array of multiple
scalpets secured to a substrate (e.g., a base plate, stamper, handled stamper,
tip,
disposable tip, etc.).
"Scalpet Stamper" as used herein includes a handled scalpet array instrument
component of the PAD Kit that incises skin plugs through the perforated guide
plate.
"Scar" as used herein includes the histological deposition of disorganized
collagen following wounding, or the morphological deformity that is visually
apparent
from the histological deposition of disorganized collagen following wounding.
"Sheet Full Thickness Skin Graft" as used herein includes reference to
application
of the FTSG at the recipient site as continuous sheet. The appearance of an
FTSG is
superior to the appearance of a STSG and for this reason it is primarily used
for skin
grafting in visually apparent areas such as the face.
"Sheet Split Thickness Skin Graft" as used herein includes a partial thickness
skin
graft that is a continuous sheet and is associated with the typical donor site
deformity.
"Skin Defect" as used herein includes the absence of the full thickness of
skin that
may also include the subcutaneous fat layer and deeper structures such as
muscle. Skin
defects can occur from a variety of causes i.e., burns, trauma, surgical
excision of
malignancies and the correction of congenital deformities.
"Skin Pixel" as used herein includes a piece of skin comprising epidermis and
a
partial or full thickness of the dermis that is cut by the scalpet; the skin
pixel may include
skin adnexa such as a hair follicle with or without a cuff of subcutaneous
fat; also
includes Skin Plug.
"Skin Plug" as used herein includes a circular (or other geometric shaped)
piece
of skin comprising epidermis and a partial or full thickness of the dermis
that is incised
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by the scalpet, transected by the transection blade and captured by the
adherent-backed
membrane.
"STSG" as used herein includes the Partial Thickness Skin Graft in which the
epidermis and a portion of the dermis is harvested with the graft.
"Subcutaneous Fat Layer" as used herein includes the layer that is immediately
below the skin and is principally comprised of fat cells referred to as
lipocytes. This
layer functions as principle insulation layer from the environment.
"Transection Blade" as used herein includes a horizontally-aligned single
edged
blade that can be either slotted to the frame of the perforated plate or
attached to the
outrigger arm of the drum dermatome as described in detail herein. The
transection blade
transects the base of the incised skin plugs.
"Wound Healing" as used herein includes the obligate biological process that
occurs from any type of wounding whether it be one or more of thermal, kinetic
and
surgical.
"Xenograft" as used herein includes a graft taken from a different species and
applied as a temporary biological dressing to a recipient site on a patient.
Multiple embodiments of pixel array medical systems, instruments or devices,
and
methods for use are described in detail herein. The systems, instruments or
devices, and
methods described herein comprise minimally invasive surgical approaches for
skin
grafting and for skin resection that tightens lax skin without visible
scarring via a device
used in various surgical procedures such as plastic surgery procedures, and
additionally
for hair transplantation. In some embodiments, the device is a single use
disposable
instrument. The embodiments herein circumvent surgically related scarring and
the
clinical variability of electromagnetic heating of the skin and perform small
multiple
pixilated resections of skin as a minimally invasive alternative to large
plastic surgical
resections of skin. The embodiments herein can also be employed in hair
transplantation,
and in areas of the body that may be off limits to plastic surgery due to the
visibility of
the surgical scar. In addition, the approach can perform a skin grafting
operation by
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harvesting the transected incisions of skin from a tissue site of a donor onto
a skin defect
site of a recipient with reduced scarring of the patient's donor site.
For many patients who have age related skin laxity (for non-limiting examples,
neck and face, arms, axillas, thighs, knees, buttocks, abdomen, bra line,
ptosis of the
breast, etc.), the minimally invasive pixel array medical devices and methods
herein
perform pixilated transection/resection of excess skin, replacing plastic
surgery with its
incumbent scarring. Generally, the procedures described herein are performed
in an
office setting under a local anesthetic with minimal perioperative discomfort,
but are not
so limited. In comparison to a prolonged healing phase from plastic surgery,
only a short
recovery period is required, preferably applying a dressing and a support
garment worn
over the treatment area for a pre-specified period of time (e.g., 5 days, 7
days, etc.).
There will be minimal or no pain associated with the procedure.
The relatively small (e.g., in a range of approximately 0.5 mm to 4.0 mm) skin
defects generated by the instrumentation described herein are closed with the
application
of an adherent Flexanl sheet. Functioning as a large butterfly bandage, the
Flexan4i9
sheet can be pulled in a direction ("vector") that maximizes the aesthetic
contouring of
the treatment area. A compressive elastic garment is applied over the dressing
to further
assist aesthetic contouring. After completion of the initial healing phase,
the multiplicity
of small linear scars within the treatment area will have reduced visibility
in comparison
to larger plastic surgical incisions on the same area. Additional skin
tightening is likely
to occur over several months due to the delayed wound healing response. Other
potential
applications of the embodiments described herein include hair transplantation
as well as
the treatment of Alopecia, Snoring/Sleep apnea, Orthopedics/Physiatry, Vaginal
Tightening, Female Urinary incontinence, and tightening of gastrointestinal
sphincters.
Significant burns are classified by the total body surface burned and by the
depth
of thermal destruction, and the methods used to manage these burns depend
largely on
the classification. First-degree and second-degree burns are usually managed
in a non-
surgical fashion with the application of topical creams and burn dressings.
Deeper third-
degree burns involve the full thickness thermal destruction of the skin,
creating a full
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thickness skin defect. The surgical management of this serious injury usually
involves
the debridement of the burn eschar and the application of split thickness
grafts.
A full thickness skin defect, most frequently created from burning, trauma, or
the
resection of a skin malignancy, can be closed with either skin flap transfers
or skin grafts
using conventional commercial instrumentation. Both surgical approaches
require
harvesting from a donor site. The use of a skin flap is further limited by the
need of to
include a pedicle blood supply and in most cases by the need to directly close
the donor
site.
The split thickness skin graft procedure, due to immunological constraints,
requires the harvesting of autologous skin grafts from the same patient.
Typically, the
donor site on the burn patient is chosen in a non-burned area and a partial
thickness sheet
of skin is harvested from that area. Incumbent upon this procedure is the
creation of a
partial thickness skin defect at the donor site. This donor site defect itself
is similar to a
deep second-degree burn. Healing by re-epithelialization of this site is often
painful and
may be prolonged for several days. In addition, a visible donor site deformity
is typically
created that is permanently thinner and more de-pigmented than the surrounding
skin.
For patients who have burns over a significant surface area, the extensive
harvesting of
skin grafts may also be limited by the availability of non-burned areas.
Both conventional surgical approaches to close skin defects (flap transfer and
skin
grafting) are not only associated with significant scarring of the skin defect
recipient site
but also with the donor site from which the graft is harvested. In contrast to
the
conventional procedures, embodiments described herein comprise Pixel Skin
Grafting
Procedures, also referred to as a pixel array procedures, that eliminate this
donor site
deformity and provide a method to re-harvest skin grafts from any pre-existing
donor site
including either sheet or pixelated donor sites. This ability to re-harvest
skin grafts from
pre-existing donor sites will reduce the surface area requirement for donor
site skin and
provide additional skin grafting capability in severely burned patients who
have limited
surface area of unburned donor skin.
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The Pixel Skin Grafting Procedure of an embodiment is used as a full thickness
skin graft. Many clinical applications such as facial skin grafting, hand
surgery, and the
repair of congenital deformities are best performed with full thickness skin
grafts. The
texture, pigmentation and overall morphology of a full thickness skin graft
more closely
resembles the skin adjacent to a defect than a split thickness skin graft. For
this reason,
full thickness skin grafting in visibly apparent areas is superior in
appearance than split
thickness skin grafts. The main drawback to full thickness skin grafts under
conventional
procedures is the extensive linear scarring created from the surgical closure
of the full
thickness donor site defect; this scarring limits the size and utility of full
thickness skin
grafting.
In comparison, the full thickness skin grafting of the Pixel Skin Grafting
Procedure described herein is less limited by size and utility as the linear
donor site scar
is eliminated. Thus, many skin defects routinely covered with split thickness
skin grafts
will instead be treated using pixelated full thickness skin grafts.
The Pixel Skin Grafting Procedure provides the capability to harvest split
thickness and full thickness skin grafts with minimal visible scarring of the
donor site.
During the procedure, a Pixel Array Dermatome (PAD) device is used to harvest
the skin
graft from a chosen donor site. During the harvesting procedure, the pixilated
skin graft
is deposited onto an adherent membrane. The adherent membrane of an embodiment
includes a flexible, semi-porous, adherent membrane, but the embodiment is not
so
limited. The harvested skin graft/membrane composite is then applied directly
to the
recipient skin defect site. The fractionally resected donor site is closed
with the
application of an adherent Flexan sheeting that functions for one week as a
large
butterfly bandage. The relatively small (e.g., 1.5 mm) intradermal circular
skin defects
are closed to promote a primary healing process in which the normal epidermal-
dermal
architecture is realigned in an anatomical fashion to minimize scarring. Also
occurring
approximately one week postoperatively, the adherent membrane is desquamated
(shed)
with the stratum corneum of the graft; the membrane can then be removed
without
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disruption of the graft from the recipient bed. Thus, healing of the donor
site occurs
rapidly with minimal discomfort and scarring.
Because the skin graft at the recipient defect site using the Pixel Skin
Grafting
Procedure is pixelated it provides interstices for drainage between skin pixel
components,
which enhances the percentage of "takes," compared to sheet skin grafts.
During the first
post-operative week (approximate), the skin graft will "take" at the recipient
site by a
process of neovascularization in which new vessels from the recipient bed of
the skin
defect grow into the new skin graft. The semi-porous membrane will conduct the
transudate (fluid) into the dressing. Furthermore, the flexible membrane is
designed with
an elastic recoil property that promotes apposition of component skin pixels
within the
graft/membrane composite and promotes primary adjacent healing of the skin
graft
pixels, converting the pixilated appearance of the skin graft to a uniform
sheet
morphology. Additionally, the membrane aligns the micro-architectural
component skin
pixels, so epidermis aligns with epidermis and dermis aligns with dermis,
promoting a
primary healing process that reduces scarring. Moreover, pixelated skin grafts
more
easily conform to an irregular recipient site.
Embodiments described herein also include a Pixel Skin Resection Procedure,
also referred to herein as the Pixel Procedure. For many patients who have age
related
skin laxity (neck and face, arms, axillas, thighs, knees, buttocks, abdomen,
bra line, ptosis
of the breast, etc.), fractional resection of excess skin could replace a
significant segment
of plastic surgery with its incumbent scarring. Generally, the Pixel Procedure
will be
performed in an office setting under a local anesthetic. The post procedure
recovery
period includes wearing of a support garment over the treatment area for a pre-
specified
number (e.g., five, seven, etc.) of days (e.g., five days, seven days, etc.).
Relatively little
or no pain is anticipated to be associated with the procedure. The small
(e.g., 1.5 mm)
circular skin defects will be closed with the application of an adherent
Flexan sheet.
Functioning as a large butterfly bandage, the Flexan sheet is pulled in a
direction
("vector") that maximizes the aesthetic contouring of the treatment area. A
compressive
elastic garment is then applied over the dressing to further assist aesthetic
contouring.
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After completion of the initial healing phase, the multiplicity of small
linear scars within
the treatment area will not be visibly apparent. Furthermore, additional skin
tightening
will subsequently occur over several months due to the delayed wound healing
response.
Consequently, the Pixel Procedure is a minimally invasive alternative to the
extensive
scarring of Plastic Surgery.
The pixel array medical devices of an embodiment include a PAD Kit. Figure 1
shows the PAD Kit placed at a target site, under an embodiment. The PAD Kit
comprises a flat perforated guide plate (guide plate), a scalpet punch or
device that
includes a scalpet array (Figures 1-3), a backed adhesive membrane or adherent
substrate
(Figure 4), and a skin pixel transection blade (Figure 5), but is not so
limited. The
scalpet punch of an embodiment is a handheld device but is not so limited. The
guide
plate is optional in an alternative embodiment, as described in detail herein.
Figure 2 is a cross-section of a PAD Kit scalpet punch including a scalpet
array,
under an embodiment. The scalpet array includes one or more scalpets. Figure 3
is a
partial cross-section of a PAD Kit scalpet punch including a scalpet array,
under an
embodiment. The partial cross-section shows the total length of the scalpets
of the
scalpet array is determined by the thickness of the perforated guide plate and
the
incisional depth into the skin, but the embodiment is not so limited.
Figure 4 shows the adhesive membrane with backing (adherent substrate)
included in a PAD Kit, under an embodiment. The undersurface of the adhesive
membrane is applied to the incised skin at the target site.
Figure 5 shows the adhesive membrane (adherent substrate) when used with the
PAD Kit frame and blade assembly, under an embodiment. The top surface of the
adhesive membrane is oriented with the adhesive side down inside the frame and
then
pressed over the perforated plate to capture the extruded skin pixels, also
referred to
herein as plugs or skin plugs.
With reference to Figure 1, the perforated guide plate is applied to the skin
resection/donor site during a procedure using the PAD Kit. The scalpet punch
is applied
through at least a set of perforations of the perforated guide plate to incise
the skin pixels.
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The scalpet punch is applied numerous times to a number of sets of
perforations when the
scalpet array of the punch includes fewer scalpets then the total number of
perforations of
the guide plate. Following one or more serial applications with the scalpet
punch, the
incised skin pixels or plugs are captured onto the adherent substrate. The
adherent
substrate is then applied in a manner so the adhesive captures the extruded
skin pixels or
plugs. As an example, the top surface of the adherent substrate of an
embodiment is
oriented with the adhesive side down inside the frame (when the frame is used)
and then
pressed over the perforated plate to capture the extruded skin pixels or
plugs. As the
membrane is pulled up, the captured skin pixels are transected at their base
by the
transection blade.
Figure 6 shows the removal of skin pixels, under an embodiment. The adherent
substrate is pulled up and back (away) from the target site, and this act
lifts or pulls the
incised skin pixels or plugs. As the adherent substrate is being pulled up,
the transection
blade is used to transect the bases of the incised skin pixels. Figure 7 is a
side view of
blade transection and removal of incised skin pixels with the PAD Kit, under
an
embodiment. Pixel harvesting is completed with the transection of the base of
the skin
pixels or plugs. Figure 8 is an isometric view of blade/pixel interaction
during a
procedure using the PAD Kit, under an embodiment. Figure 9 is another view
during a
procedure using the PAD Kit (blade removed for clarity) showing both harvested
skin
pixels or plugs transected and captured and non-transected skin pixels or
plugs prior to
transection, under an embodiment. At the donor site, the pixelated skin
resection sites are
closed with the application of Flexan sheeting.
The guide plate and scalpet device are also used to generate skin defects at
the
recipient site. The skin defects are configured to receive the skin pixels
harvested or
captured at the donor site. The guide plate used at the recipient site can be
the same
guide plate used at the donor site, or can be different with a different
pattern or
configuration of perforations.
The skin pixels or plugs deposited onto the adherent substrate during the
transection can next be transferred to the skin defect site (recipient site)
where they are
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applied as a pixelated skin graft at a recipient skin defect site. The
adherent substrate has
an elastic recoil property that enables closer alignment of the skin pixels or
plugs within
the skin graft. The incised skin pixels can be applied from the adherent
substrate directly
to the skin defects at the recipient site. Application of the incised skin
pixels at the
recipient site includes aligning the incised skin pixels with the skin
defects, and inserting
the incised skin pixels into corresponding skin defects at the recipient site.
The pixel array medical devices of an embodiment include a Pixel Array
Dermatome (PAD). The PAD comprises a flat array of relatively small circular
scalpets
that are secured onto a substrate (e.g., investing plate), and the scalpets in
combination
with the substrate are referred to herein as a scalpet array, pixel array, or
scalpet plate.
Figure 10A is a side view of a portion of the pixel array showing scalpets
secured onto
an investing plate, under an embodiment. Figure 10B is a side view of a
portion of the
pixel array showing scalpets secured onto an investing plate, under an
alternative
embodiment. Figure 10C is a top view of the scalpet plate, under an
embodiment.
Figure 10D is a close view of a portion of the scalpet plate, under an
embodiment. The
scalpet plate is applied directly to the skin surface. One or more scalpets of
the scalpet
array include one or more of a pointed surface, a needle, and a needle
including multiple
points.
Embodiments of the pixel array medical devices and methods include use of a
harvest pattern instead of the guide plate. The harvest pattern comprises
indicators or
markers on a skin surface on at least one of the donor site and the recipient
site, but is not
so limited. The markers include any compound that may be applied directly to
the skin to
mark an area of the skin. The harvest pattern is positioned at a donor site,
and the scalpet
array of the device is aligned with or according to the harvest pattern at the
donor site.
The skin pixels are incised at the donor site with the scalpet array as
described herein.
The recipient site is prepared by positioning the harvest pattern at the
recipient site. The
harvest pattern used at the recipient site can be the same harvest pattern
used at the donor
site, or can be different with a different pattern or configuration of
markers. The skin
defects are generated, and the incised skin pixels are applied at the
recipient site as
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described herein. Alternatively, the guide plate of an embodiment is used in
applying the
harvest pattern, but the embodiment is not so limited.
To leverage established surgical instrumentation, the array of an embodiment
is
used in conjunction with or as a modification to a drum dermatome, for example
a Padget
dermatome or a Reese dermatome, but is not so limited. The Padget drum
dermatome
referenced herein was originally developed by Dr. Earl Padget in the 1930s,
and
continues to be widely utilized for skin grafting by plastic surgeons
throughout the world.
The Reese modification of the Padget dermatome was subsequently developed to
better
calibrate the thickness of the harvested skin graft. The drum dermatome of an
embodiment is a single use (per procedure) disposable, but is not so limited.
Generally, Figure 11A shows an example of a rolling pixel drum 100, under an
embodiment. Figure 11B shows an example of a rolling pixel drum 100 assembled
on a
handle, under an embodiment. More specifically, Figure 11C depicts a drum
dermatome
for use with the scalpet plate, under an embodiment.
Generally, as with all pixel devices described herein, the geometry of the
pixel
drum 100 can be a variety of shapes without limitation e.g., circular,
semicircular,
elliptical, square, flat, or rectangular. In some embodiments, the pixel drum
100 is
supported by an axel/handle assembly 102 and rotated around a drum rotational
component 104 powered by, e.g., an electric motor. In some embodiments, the
pixel
drum 100 can be placed on stand (not shown) when not in use, wherein the stand
can also
function as a battery recharger for the powered rotational component of the
drum or the
powered component of the syringe plunger. In some embodiments, a vacuum (not
shown) can be applied to the skin surface of the pixel drum 100 and outriggers
(not
shown) can be deployed for tracking and stability of the pixel drum 100.
In some embodiments, the pixel drum 100 incorporates an array of scalpets 106
on the surface of the drum 100 to create small multiple (e.g., 0.5-1.5 mm)
circular
incisions referred to herein as skin plugs. In some embodiments, the border
geometry of
the scalpets can be designed to reduce pin cushioning ("trap door") while
creating the
skin plugs. The perimeter of each skin plug can also be lengthened by the
scalpets to, for
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a non-limiting example, a, semicircular, elliptical, or square-shaped skin
plug instead of a
circular-shaped skin plug. In some embodiments, the length of the scalpets 106
may vary
depending upon the thickness of the skin area selected by the surgeon for skin
grafting
purposes, i.e., partial thickness or full thickness.
When the drum 100 is applied to a skin surface, a blade 108 placed internal of
the
drum 100 transects the base of each skin plug created by the array of
scalpets, wherein
the internal blade 108 is connected to the central drum axel/handle assembly
102 and/or
connected to outriggers attached to the central axel assembly 102. In some
alternative
embodiments, the internal blade 108 is not connected to the drum axel assembly
102
where the base of the incisions of skin is transected. In some embodiments,
the internal
blade 108 of the pixel drum 100 may oscillate either manually or be powered by
an
electric motor. Depending upon the density of the circular scalpets on the
drum, a
variable percentage of skin (e.g., 20%, 30%, 40%, etc.) can be transected
within an area
of excessive skin laxity.
In some embodiments, an added pixel drum harvester 112 is placed inside the
drum 100 to perform a skin grafting operation by harvesting and aligning the
transected/pixilated skin incisions/plugs (pixel graft) from tissue of a pixel
donor onto an
adherent membrane 110 lined in the interior of the pixel drum 100. A narrow
space is
created between the array of scalpets 106 and the adherent membrane 110 for
the internal
blade 108.
In an embodiment, the blade 108 is placed external to the drum 100 and the
scalpet array 106 where the base of the incised circular skin plugs is
transected. In
another embodiment, the external blade 108 is connected to the drum axel
assembly 102
when the base of the incisions of skin is transected. In an alternative
embodiment, the
external blade 108 is not connected to the drum axel assembly 102 when the
base of the
incisions of skin is transected. The adherent membrane 110 that extracts and
aligns the
transected skin segments is subsequently placed over a skin defect site of a
patient. The
blade 108 (either internal or external) can be a fenestrated layer of blade
aligned to the
scalpet array 106, but is not so limited.
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The conformable adherent membrane 110 of an embodiment can be semi-porous
to allow for drainage at a recipient skin defect when the membrane with the
aligned
transected skin segments is extracted from the drum and applied as a skin
graft. The
adherent semi-porous drum membrane 110 can also have an elastic recoil
property to
bring the transected/pixilated skin plugs together for grafting onto the skin
defect site of
the recipient, i.e., the margins of each skin plug can be brought closer
together as a more
uniform sheet after the adherent membrane with pixilated grafts extracted from
the drum
100. Alternatively, the adherent semi-porous drum membrane 110 can be
expandable to
cover a large surface area of the skin defect site of the recipient. In some
embodiments, a
sheet of adhesive backer 111 can be applied between the adherent membrane 110
and the
drum harvester 112. The drum array of scalpets 106, blade 108, and adherent
membrane
110 can be assembled together as a sleeve onto a preexisting drum 100, as
described in
detail herein.
The internal drum harvester 112 of the pixel drum 110 of an embodiment is
disposable and replaceable. Limit and/or control the use of the disposable
components
can be accomplished by means that includes but is not limited to electronic,
EPROM,
mechanical, durability. The electronic and/or mechanical records and/or limits
of number
of drum rotations for the disposable drum as well as the time of use for the
disposable
drum can be recorded, controlled and/or limited either electronically or
mechanically.
During the harvesting portion of the procedure with a drum dermatome, the PAD
scalpet array is applied directly to the skin surface. To circumferentially
incise the skin
pixels, the drum dermatome is positioned over the scalpet array to apply a
load onto the
subjacent skin surface. With a continuing load, the incised skin pixels are
extruded
through the holes of the scalpet array and captured onto an adherent membrane
on the
drum dermatome. The cutting outrigger blade of the dermatome (positioned over
the
scalpet array) transects the base of extruded skin pixels. The membrane and
the pixelated
skin composite are then removed from the dermatome drum, to be directly
applied to the
recipient skin defect as a skin graft.
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With reference to Figure 11C, an embodiment includes a drum dermatome for use
with the scalpet plate, as described herein. More particularly, Figure 12A
shows the
drum dermatome positioned over the scalpet plate, under an embodiment. Figure
12B is
an alternative view of the drum dermatome positioned over the scalpet plate,
under an
embodiment. The cutting outrigger blade of the drum dermatome is positioned on
top of
the scalpet array where the extruded skin plugs will be transected at their
base.
Figure 13A is an isometric view of application of the drum dermatome (e.g.,
Padgett dermatome) over the scalpet plate, where the adhesive membrane is
applied to
the drum of the dermatome before rolling it over the investing plate, under an
embodiment. Figure 13B is a side view of a portion of the drum dermatome
showing a
blade position relative to the scalpet plate, under an embodiment. Figure 13C
is a side
view of the portion of the drum dermatome showing a different blade position
relative to
the scalpet plate, under an embodiment. Figure 13D is a side view of the drum
dermatome with another blade position relative to the scalpet plate, under an
embodiment. Figure 13E is a side view of the drum dermatome with the
transection
blade clip showing transection of skin pixels by the blade clip, under an
embodiment.
Figure 13F is a bottom view of the drum dermatome along with the scalpet
plate, under
an embodiment. Figure 13G is a front view of the drum dermatome along with the
scalpet plate, under an embodiment. Figure 13H is a back view of the drum
dermatome
along with the scalpet plate, under an embodiment.
Depending upon the clinical application, the disposable adherent membrane of
the
drum dermatome can be used to deposit/dispose of resected lax skin or
harvest/align a
pixilated skin graft
Embodiments described herein also include a Pixel Onlay Sleeve (POS) for use
with the dermatomes, for example the Padget dermatomes and Reese dermatomes.
Figure 14A shows an assembled view of the dermatome with the Pixel Onlay
Sleeve
(POS), under an embodiment. The POS comprises the dermatome and blade
incorporated with an adhesive backer, adhesive, and a scalpet array. The
adhesive
backer, adhesive, and scalpet array are integral to the device, but are not so
limited.
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Figure 14B is an exploded view of the dermatome with the Pixel Onlay Sleeve
(PUS),
under an embodiment. Figure 14C shows a portion of the dermatome with the
Pixel
Onlay Sleeve (PUS), under an embodiment.
The PUS, also referred to herein as the "sleeve," provides a disposable drum
dermatome onlay for the fractional resection of redundant lax skin and the
fractional skin
grafting of skin defects. The onlay sleeve is used in conjunction with either
the Padget
and Reese dermatomes as a single use disposable component. The PUS of an
embodiment is a three-sided slip-on disposable sleeve that slips onto a drum
dermatome.
The device comprises an adherent membrane and a scalpet drum array with an
internal
transection blade. The transection blade of an embodiment includes a single-
sided
cutting surface that sweeps across the internal surface of the scalpet drum
array.
In an alternative blade embodiment, a fenestrated cutting layer covers the
internal
surface of the scalpet array. Each fenestration with its cutting surface is
aligned with
each individual scalpet. Instead of sweeping motion to transect the base of
the skin
plugs, the fenestrated cutting layer oscillates over the scalpet drum array. A
narrow space
between the adherent membrane and the scalpet array is created for excursion
of the
blade. For multiple harvesting during a skin grafting procedure, an insertion
slot for
additional adherent membranes is provided. The protective layer over the
adherent
membrane is pealed away insitu with an elongated extraction tab that is pulled
from an
extraction slot on the opposite side of the sleeve assembly. As with other
pixel device
embodiments, the adherent membrane is semi-porous for drainage at the
recipient skin
defect site. To morph the pixilated skin graft into a more continuous sheet,
the
membrane may also have an elastic recoil property to provide closer alignment
of the
skin plugs within the skin graft.
Embodiments described herein include a Slip-On PAD that is configured as a
single-use disposable device with either the Padgett or Reese dermatomes.
Figure 15A
shows the Slip-On PAD being slid onto a Padgett Drum Dermatome, under an
embodiment. Figure 15B shows an assembled view of the Slip-On PAD installed
over
the Padgett Drum Dermatome, under an embodiment.
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The Slip-on PAD of an embodiment is used (optionally) in combination with a
perforated guide plate. Figure 16A shows the Slip-On PAD installed over a
Padgett
Drum Dermatome and used with a perforated template or guide plate, under an
embodiment. The perforated guide plate is placed over the target skin site and
held in
place with adhesive on the bottom surface of the apron to maintain
orientation. The
Padgett Dermatome with Slip-On PAD is rolled over the perforated guide plate
on the
skin.
Figure 16B shows skin pixel harvesting with a Padgett Drum Dermatome and
installed Slip-On PAD, under an embodiment. For skin pixel harvesting, the
Slip-On
PAD is removed, adhesive tape is applied over the drum of the Padgett
dermatome, and
the clip-on blade is installed on the outrigger arm of the dermatome, which
then is used to
transect the base of the skin pixels. The Slip-on PAD of an embodiment is also
used
(optionally) with standard surgical instrumentation such as a ribbon retractor
to protect
the adjacent skin of the donor site.
Embodiments of the pixel instruments described herein include a Pixel Drum
Dermatome (PD2) that is a single use disposable instrument or device. The PD2
comprises a cylinder or rolling/rotating drum coupled to a handle, and the
cylinder
includes a Scalpet Drum Array. An internal blade is interlocked to the drum
axle/handle
assembly and/or interlocked to outriggers attached to the central axle. As
with the PAD
and the POS described herein, small multiple pixilated resections of skin are
performed
directly in the region of skin laxity, thereby enhancing skin tightening with
minimal
visible scarring.
Figure 17A shows an example of a Pixel Drum Dermatome being applied to a
target site of the skin surface, under an embodiment. Figure 17B shows an
alternative
view of a portion of the Pixel Drum Dermatome being applied to a target site
of the skin
surface, under an embodiment.
The PD2 device applies a full rolling/rotating drum to the skin surface where
multiple small (e.g., 1.5 mm) circular incisions are created at the target
site with a
"Scalpet Drum Array". The base of each skin plug is then transected with an
internal
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blade that is interlocked to the central drum axel/handle assembly and/or
interlocked to
outriggers attached to the central axel. Depending upon the density of the
circular
scalpets on the drum, a variable percentage of skin can be resected. The PD2
enables
portions (e.g., 20%, 30%, 40%, etc.) of the skin's surface area to be resected
without
visible scarring in an area of excessive skin laxity, but the embodiment is
not so limited.
Another alternative embodiment of the pixel instruments presented herein is
the
Pixel Drum Harvester (PDH). Similar to the Pixel Drum Dermatome, an added
internal
drum harvests and aligns the pixilated resections of skin onto an adherent
membrane that
is then placed over a recipient skin defect site of the patient. The
conformable adherent
membrane is semi-porous to allow for drainage at a recipient skin defect when
the
membrane with the aligned resected skin segments is extracted from the drum
and
applied as a skin graft. An elastic recoil property of the membrane allows
closer
approximation of the pixilated skin segments, partially converting the
pixilated skin graft
to a sheet graft at the recipient site.
The pixel array medical systems, instruments or devices, and methods described
herein evoke or enable cellular and/or extracellular responses that are
obligatory to the
clinical outcomes achieved. For the pixel dermatomes, a physical reduction of
the skin
surface area occurs due to the pixilated resection of skin, i.e., creation of
the skin plugs.
In addition, a subsequent tightening of the skin results due to the delayed
wound healing
response. Each pixilated resection initiates an obligate wound healing
sequence in
multiple phases as described in detail herein.
The first phase of this sequence is the inflammatory phase in which
degranulation
of mast cells release histamine into the "wound". Histamine release may evoke
dilatation
of the capillary bed and increase vessel permeability into the extracellular
space. This
initial wound healing response occurs within the first day and will be evident
as erythema
on the skin's surface.
The second phase (of Fibroplasia) commences within three to four days of
"wounding". During this phase, there is migration and mitotic multiplication
of
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fibroblasts. Fibroplasia of the wound includes the deposition of neocollagen
and the
myofibroblastic contraction of the wound.
Histologically, the deposition of neocollagen can be identified
microscopically as
compaction and thickening of the dermis. Although this is a static process,
the tensile
strength of the wound significantly increases. The other feature of
Fibroplasia is a
dynamic physical process that results in a multi-dimensional contraction of
the wound.
This component feature of Fibroplasia is due to the active cellular
contraction of
myofibroblasts. Morphologically, myoblastic contraction of the wound will be
visualized
as a two dimensional tightening of the skin surface. Overall, the effect of
Fibroplasia is
dermal contraction along with the deposition of a static supporting
scaffolding of
neocollagen with a tightened framework. The clinical effect is seen as a
delayed
tightening of skin with smoothing of skin texture over several months. The
clinical
endpoint is generally a more youthful appearing skin envelope of the treatment
area.
A third and final phase of the delayed wound healing response is maturation.
During this phase there is a strengthening and remodeling of the treatment
area due to an
increased cross-linkage of the collagen fibril matrix (of the dermis). This
final stage
commences within six to twelve months after "wounding" and may extend for at
least one
to two years. Small pixilated resections of skin should preserve the normal
dermal
architecture during this delayed wound healing process without the creation of
an evident
scar that typically occurs with a larger surgical resection of skin. Lastly,
there is a related
stimulation and rejuvenation of the epidermis from the release of epidermal
growth
hormone. The delayed wound healing response can be evoked, with scar collagen
deposition, within tissues (such as muscle or fat) with minimal pre-existing
collagen
matrix.
Other than tightening skin for aesthetic purposes, the pixel array medical
systems,
instruments or devices, and methods described herein may have additional
medically
related applications. In some embodiments, the pixel array devices can
transect a
variable portion of any soft tissue structure without resorting to a standard
surgical
resection. More specifically, the reduction of an actinic damaged area of skin
via the
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pixel array devices should reduce the incidence of skin cancer. For the
treatment of sleep
apnea and snoring, a pixilated mucosal reduction (soft palate, base of the
tongue and
lateral pharyngeal walls) via the pixel array devices would reduce the
significant
morbidity associated with more standard surgical procedures. For birth
injuries of the
vaginal vault, pixilated skin and vaginal mucosal resection via the pixel
array devices
would reestablish normal pre-partum geometry and function without resorting to
an A&P
resection. Related female stress incontinence could also be corrected in a
similar fashion.
The pixel array dermatome (PAD) of an embodiment, also referred to herein as a
scalpet device assembly, includes a system or kit comprising a control device,
also
referred to as a punch impact hand-piece, and a scalpet device, also referred
to as a tip
device. The scalpet device, which is removeably coupled to the control device,
includes
an array of scalpets positioned within the scalpet device. The removeable
scalpet device
of an embodiment is disposable and consequently configured for use during a
single
procedure, but the embodiment is not so limited.
The PAD includes an apparatus comprising a housing configured to include a
scalpet device. The scalpet device includes a substrate and a scalpet array,
and the
scalpet array includes a plurality of scalpets arranged in a configuration on
the substrate.
The substrate and the plurality of scalpets are configured to be deployed from
the housing
and retracted into the housing, and the plurality of scalpets is configured to
generate a
plurality of incised skin pixels at a target site when deployed. The proximal
end of the
control device is configured to be hand-held. The housing is configured to be
remove ably coupled to a receiver that is a component of a control device. The
control
device includes a proximal end that includes an actuator mechanism, and a
distal end that
includes the receiver. The control device is configured to be disposable, but
alternatively
the control device is configured to be at least one of cleaned, disinfected,
and sterilized.
The scalpet array is configured to be deployed in response to activation of
the
actuator mechanism. The scalpet device of an embodiment is configured so the
scalpet
array is deployed from the scalpet device and retracted back into the scalpet
device in
response to activation of the actuator mechanism. The scalpet device of an
alternative
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embodiment is configured so the scalpet array is deployed from the scalpet
device in
response to activation of the actuator mechanism, and retracted back into the
scalpet
device in response to release of the actuator mechanism.
Figure 18 shows a side perspective view of the PAD assembly, under an
embodiment. The PAD assembly of this embodiment includes a control device
configured to be hand-held, with an actuator or trigger and the scalpet device
comprising
the scalpet array. The control device is reusable, but alternative embodiments
include a
disposable control device. The scalpet array of an embodiment is configured to
create or
generate an array of incisions (e.g., 1.5 mm, 2 mm, 3 mm, etc.) as described
in detail
herein. The scalpet device of an embodiment includes a spring-loaded array of
scalpets
configured to incise the skin as described in detail herein, but the
embodiments are not so
limited.
Figure 19A shows a top perspective view of the scalpet device for use with the
PAD assembly, under an embodiment. Figure 19B shows a bottom perspective view
of
the scalpet device for use with the PAD assembly, under an embodiment. The
scalpet
device comprises a housing configured to house a substrate that is coupled to
or includes
a plunger. The housing is configured so that a proximal end of the plunger
protrudes
through a top surface of the housing. The housing is configured to be
removeably
coupled to the control device, and a length of the plunger is configured to
protrude a
distance through the top surface to contact the control device and actuator
when the
scalpet device is coupled to the control device.
The substrate of the scalpet device is configured to retain numerous scalpets
that
form the scalpet array. The scalpet array comprises a pre-specified number of
scalpets as
appropriate to the procedure in which the scalpet device assembly is used. The
scalpet
device includes at least one spring mechanism configured to provide a
downward, or
impact or punching, force in response to activation of the scalpet array
device, and this
force assists generation of incisions (pixelated skin resection sites) by the
scalpet array.
Alternatively, the spring mechanism can be configured to provide an upward, or
retracting, force to assist in retraction of the scalpet array.
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One or more of the scalpet device and the control device of an embodiment
includes an encryption system (e.g., EPROM, etc.). The encryption system is
configured
to prevent illicit use and pirating of the scalpet devices and/or control
devices, but is not
so limited.
During a procedure, the scalpet device assembly is applied one time to a
target
area or, alternative, applied serially within a designated target treatment
area of skin
laxity. The pixelated skin resection sites within the treatment area are then
closed with
the application of Flexan sheeting, as described in detail herein, and
directed closure of
these pixelated resections is performed in a direction that provides the
greatest aesthetic
correction of the treatment site.
The PAD device of an alternative embodiment includes a vacuum component or
system for removing incised skin pixels. Figure 20 shows a side view of the
punch
impact device including a vacuum component, under an embodiment. The PAD of
this
example includes a vacuum system or component within the control device to
suction
evacuate the incised skin pixels, but is not so limited. The vacuum component
is
removeably coupled to the PAD device, and its use is optional. The vacuum
component
is coupled to and configured to generate a low-pressure zone within or
adjacent to one or
more of the housing, the scalpet device, the scalpet array, and the control
device. The
low-pressure zone is configured to evacuate the incised skin pixels.
The PAD device of another alternative embodiment includes a radio frequency
(RF) component or system for generating skin pixels. The RF component is
coupled to
and configured to provide or couple energy within or adjacent to one or more
of the
housing, the scalpet device, the scalpet array, and the control device. The RF
component
is removeably coupled to the PAD device, and its use is optional. The energy
provided
by the RF component includes one or more of thermal energy, vibrational
energy,
rotational energy, and acoustic energy, to name a few.
The PAD device of yet another alternative embodiment includes a vacuum
component or system and an RF component or system. The PAD of this embodiment
includes a vacuum system or component within the handpiece to suction evacuate
the
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incised skin pixels. The vacuum component is removeably coupled to the PAD
device,
and its use is optional. The vacuum component is coupled to and configured to
generate
a low-pressure zone within or adjacent to one or more of the housing, the
scalpet device,
the scalpet array, and the control device. The low-pressure zone is configured
to
evacuate the incised skin pixels. Additionally, the PAD device includes an RF
component coupled to and configured to provide or couple energy within or
adjacent to
one or more of the housing, the scalpet device, the scalpet array, and the
control device.
The RF component is removeably coupled to the PAD device, and its use is
optional.
The energy provided by the RF component includes one or more of thermal
energy,
vibrational energy, rotational energy, and acoustic energy, to name a few.
As one particular example, the PAD of an embodiment includes an
electrosurgical
generator configured to more effectively incise donor skin or skin plugs with
minimal
thermo-conductive damage to the adjacent skin. For this reason, the RF
generator
operates using relatively high power levels with relatively short duty cycles,
for example.
The RF generator is configured to supply one or more of a powered impactor
component
configured to provide additional compressive force for cutting, cycling
impactors,
vibratory impactors, and an ultrasonic transducer.
The PAD with RF of this example also includes a vacuum component, as
described herein. The vacuum component of this embodiment is configured to
apply a
vacuum that pulls the skin up towards the scalpets (e.g., into the lumen of
the scalpets,
etc.) to stabilize and promote the RF mediated incision of the skin within the
fractional
resection field, but is not so limited. One or more of the RF generator and
the vacuum
appliance is coupled to be under the control of a processor running a software
application. Additionally, the PAD of this embodiment can be used with the
guide plate
as described in detail herein, but is not so limited.
In addition to fractional incision at a donor site, fractional skin grafting
includes
the harvesting and deposition of skin plugs (e.g., onto an adherent membrane,
etc.) for
transfer to a recipient site. As with fractional skin resection, the use of a
duty-driven RF
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cutting edge on an array of scalpets facilitates incising donor skin plugs.
The base of the
incised scalpets is then transected and harvested as described in detail
herein.
The timing of the vacuum assisted component is processor controlled to provide
a
prescribed sequence with the RF duty cycle. With software control, different
variations
are possible to provide the optimal sequence of combined RF cutting with
vacuum
assistance. Without limitation, these include an initial period of vacuum
prior to the RF
duty cycle. Subsequent to the RF duty cycle, a period during the sequence of
an
embodiment includes suction evacuation of the incised skin plugs.
Other potential control sequences of the PAD include without limitation
simultaneous duty cycles of RF and vacuum assistance. Alternatively, a control
sequence
of an embodiment includes pulsing or cycling of the RF duty cycle within the
sequence
and/or with variations of RF power or the use of generators at different RF
frequencies.
Another alternative control sequence includes a designated RF cycle occurring
at
the depth of the fractional incision. A lower power longer duration RF duty
cycle with
insulated shaft with an insulated shaft an active cutting tip could generate a
thermal-
conductive lesion in the deep dermal/subcutaneous tissue interface. The deep
thermal
lesion would evoke a delayed wound healing sequence that would secondarily
tighten the
skin without burning of the skin surface.
With software control, different variations are possible to provide the
optimal
sequence of combined RF cutting and powered mechanical cutting with vacuum
assistance. Examples include but are not limited to combinations of powered
mechanical
cutting with vacuum assistance, RF cutting with powered mechanical cutting and
vacuum
assistance, RF cutting with vacuum assistance, and RF cutting with vacuum
assistance.
Examples of combined software controlled duty cycles include but are not
limited to
precutting vacuum skin stabilization period, RF cutting duty cycle with vacuum
skin
stabilization period, RF cutting duty cycle with vacuum skin stabilization and
powered
mechanical cutting period, powered mechanical cutting with vacuum skin
stabilization
period, post cutting RF duty cycle for thermal conductive heating of the
deeper dermal
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and/or subdermal tissue layer to evoke a wound healing response for skin
tightening, and
a post cutting vacuum evacuation period for skin tightening.
Another embodiment of pixel array medical devices described herein includes a
device comprising an oscillating flat array of scalpets and blade either
powered
electrically or deployed manually (unpowered) and used for skin tightening as
an
alternative to the drum/cylinder described herein. Figure 21A shows a top view
of an
oscillating flat scalpet array and blade device, under an embodiment. Figure
21B shows
a bottom view of an oscillating flat scalpet array and blade device, under an
embodiment.
Blade 108 can be a fenestrated layer of blade aligned to the scalpet array
106. The
instrument handle 102 is separated from the blade handle 103 and the adherent
membrane
110 can be peeled away from the adhesive backer 111. Figure 21C is a close-up
view of
the flat array when the array of scalpets 106, blades 108, adherent membrane
110 and the
adhesive backer 111 are assembled together, under an embodiment. As assembled,
the
flat array of scalpets can be metered to provide a uniform harvest or a
uniform resection.
In some embodiments, the flat array of scalpets may further include a feeder
component
115 for the adherent harvesting membrane 110 and adhesive backer 111. Figure
21D is a
close-up view of the flat array of scalpets with a feeder component 115, under
an
embodiment.
In another skin grafting embodiment, the pixel graft is placed onto an
irradiated
cadaver dermal matrix (not shown). When cultured onto the dermal matrix, a
graft of full
thickness skin is created for the patient that is immunologically identical to
the pixel
donor. In embodiments, the cadaver dermal matrix can also be cylindrical
transected
similar in size to the harvested skin pixel grafts to provide histological
alignment of the
pixilated graft into the cadaver dermal framework. Figure 22 shows a cadaver
dermal
matrix cylindrically transected similar in size to the harvested skin pixel
grafts, under an
embodiment. In some embodiments, the percentage of harvest of the donor site
can be
determined in part by the induction of a normal dermal histology at the skin
defect site of
the recipient, i.e., a normal (smoother) surface topology of the skin graft is
facilitated.
With either the adherent membrane or the dermal matrix embodiment, the pixel
drum
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harvester includes the ability to harvest a large surface area for grafting
with visible
scarring of the patient's donor site significantly reduced or eliminated.
In addition to the pixel array medical devices described herein, embodiments
include drug delivery devices. For the most part, the parenteral delivery of
drugs is still
accomplished from an injection with a syringe and needle. To circumvent the
negative
features of the needle and syringe system, the topical absorption of
medication
transcutaneously through an occlusive patch was developed. However, both of
these
drug delivery systems have significant drawbacks. The human aversion to a
needle
injection has not abated during the nearly two centuries of its use. The
variable systemic
absorption of either a subcutaneous or intramuscular drug injection reduces
drug efficacy
and may increase the incidence of adverse patient responses. Depending upon
the lipid
or aqueous carrier fluid of the drug, the topically applied occlusive patch is
plagued with
variable absorption across an epidermal barrier. For patients who require
local anesthesia
over a large surface area of skin, neither the syringe/needle injections nor
topical
anesthetics are ideal. The syringe/needle "field" injections are often painful
and may
instill excessive amounts of the local anesthetic that may cause systemic
toxicity.
Topical anesthetics rarely provide the level of anesthesia required for skin
related
procedures.
Figure 23 is a drum array drug delivery device 200, under an embodiment. The
drug delivery device 200 successfully addresses the limitations and drawbacks
of other
drug delivery systems. The device comprises a drum/cylinder 202 supported by
an
axel/handle assembly 204 and rotated around a drum rotation component 206. The
handle assembly 204 of an embodiment further includes a reservoir 208 of drugs
to be
delivered and a syringe plunger 210. The surface of the drum 202 is covered by
an array
of needles 212 of uniform length, which provide a uniform intradermal (or
subdermal)
injection depth with a more controlled volume of the drug injected into the
skin of the
patient. During operation, the syringe plunger 210 pushes the drug out of the
reservoir
208 to be injected into a sealed injection chamber 214 inside the drum 202 via
connecting
tube 216. The drug is eventually delivered into the patient's skin at a
uniform depth when
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the array of needles 212 is pushed into a patient's skin until the surface of
the drum 202
hits the skin. Non-anesthetized skip area is avoided and a more uniform
pattern of
cutaneous anesthesia is created. The rolling drum application of the drug
delivery device
200 also instills the local anesthetic faster with less discomfort to the
patient.
Figure 24A is a side view of a needle array drug delivery device 300, under an
embodiment. Figure 24B is an upper isometric view of a needle array drug
delivery
device 300, under an embodiment. Figure 24C is a lower isometric view of a
needle
array drug delivery device 300, under an embodiment. The drug delivery device
300
comprises a flat array of fine needles 312 of uniform length positioned on
manifold 310
can be utilized for drug delivery. In this example embodiment, syringe 302 in
which
drug for injection is contained can be plugged into a disposable adaptor 306
with handles,
and a seal 308 can be utilized to ensure that the syringe 302 and the
disposable adaptor
306 are securely coupled to each other. When the syringe plunger 304 is
pushed, drug
contained in syringe 302 is delivered from syringe 302 into the disposable
adaptor 306.
The drug is further delivered into the patient's skin through the flat array
of fine needles
312 at a uniform depth when the array of needles 312 is pushed into a
patient's skin until
manifold 310 hits the skin.
The use of the drug delivery device 200 may have as many clinical applications
as
the number of pharmacological agents that require transcutaneous injection or
absorption.
For non-limiting examples, a few of the potential applications are the
injection of local
anesthetics, the injection of neuromodulators such as Botulinum toxin (Botox),
the
injection of insulin and the injection of replacement estrogens and
corticosteroids.
In some embodiments, the syringe plunger 210 of the drug delivery device 200
can be powered by, for a non-limiting example, an electric motor. In some
embodiments,
a fluid pump (not shown) attached to an IV bag and tubing can be connected to
the
injection chamber 214 and/or the reservoir 208 for continuous injection. In
some
embodiments, the volume of the syringe plunger 210 in the drug delivery device
200 is
calibrated and programmable.
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Another application of pixel skin graft harvesting with the PAD (Pixel Array
Dermatome) device as described in detail herein is Alopecia. Alopecia is a
common
aesthetic malady, and it occurs most frequently in the middle-aged male
population, but
is also observed in the aging baby boomer female population. The most common
form of
alopecia is Male Pattern Baldness (MPB) that occurs in the frontal-parietal
region of the
scalp. Male pattern baldness is a sex-linked trait that is transferred by the
X chromosome
from the mother to male offspring. For men, only one gene is needed to express
this
phenotype. As the gene is recessive, female pattern baldness requires the
transfer of both
X linked genes from both mother and father. Phenotypic penetrance can vary
from
patient to patient and is most frequently expressed in the age of onset and
the amount of
frontal/partial/occipital alopecia. The patient variability in the phenotypic
expression of
MPB is due to the variable genotypic translation of this sex-linked trait.
Based upon the
genotypic occurrence of MPB, the need for hair transplantation is vast. Other
non-
genetic related etiologies are seen in a more limited segment of the
population. These
non-genetic etiologies include trauma, fungal infections, lupus erythematosus,
radiation
and chemotherapy.
A large variety of treatment options have been proposed to the public. These
include FDA approved topical medications such as Minoxidil and Finasteride
which have
had limited success as these agents require the conversion of dormant hair
follicles into
an anagen growth phase. Other remedies include hairpieces and hair weaving.
The
standard of practice remains surgical hair transplantation, which involves the
transfer of
hair plugs, strips and flaps from the hair-bearing scalp into the non hair-
bearing scalp.
For the most part, conventional hair transplantation involves the transfer of
multiple
single hair micrographs from the hair-bearing scalp to the non hair-bearing
scalp of the
same patient. Alternately, the donor plugs are initially harvested as hair
strips and then
secondarily sectioned into micrographs for transfer to the recipient scalp.
Regardless,
this multi-staged procedure is both tedious and expensive, involving several
hours of
surgery for the average patient.
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The conventional hair transplantation market has been encumbered by lengthy
hair grafting procedures that are performed in several stages. A typical hair
grafting
procedure involves the transfer of hair plugs from a donor site in the
occipital scalp to a
recipient site in the balding frontal-parietal scalp. For most procedures,
each hair plug is
transferred individually to the recipient scalp. Several hundred plugs may be
transplanted
during a procedure that may require several hours to perform. Post procedure
"take" or
viability of the transplanted hair plugs is variable due to factors that limit
neovascularization at the recipient site. Bleeding and mechanical disruption
due to
motion are key factors that reduce neovascularization and "take" of hair
grafts.
Embodiments described herein include surgical instrumentation configured to
transfer
several hair grafts at once that are secured and aligned en masse at a
recipient site on the
scalp. The procedures described herein using the PAD of an embodiment reduce
the
tedium and time required with conventional instrumentation.
Figure 25 shows the composition of human skin. Skin comprises two
horizontally stratified layers, referred to as the epidermis and the dermis,
acting as a
biological barrier to the external environment. The epidermis is the
enveloping layer and
comprises a viable layer of epidermal cells that migrate upward and "mature"
into a non-
viable layer called the stratum corneum. The stratum corneum is a lipid-
keratin
composite that serves as a primary biological barrier, and this layer is
continually shed
and reconstituted in a process called desquamation. The dermis is the
subjacent layer that
is the main structural support of the skin, and is predominately extracellular
and is
comprised of collagen fibers.
In addition to the horizontally stratified epidermis and dermis, the skin
includes
vertically-aligned elements or cellular appendages including the pilosebaceous
units,
comprising the hair folical and sebacious gland. Pilosebaceous units each
include a
sebaceous oil gland and a hair follicle. The sebaceous gland is the most
superficial and
discharges sebum (oil) into the shaft of the hair follicle. The base of the
hair follicle is
called the bulb and the base of the bulb has a deep generative component
called the
dermal papilla. The hair follicles are typically aligned at an oblique angle
to the skin
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surface. Hair follicles in a given region of the scalp are aligned parallel to
each other.
Although pilosebaceous units are common throughout the entire integument, the
density
and activity of these units within a region of the scalp is a key determinate
as to the
overall appearance of hair.
In additional to pilosebaceous units, sweat glands also course vertically
through
the skin. They provide a water-based transudate that assists in
thermoregulation.
Apocrine sweat glands in the axilla and groin express a more pungent sweat
that is
responsible for body odor. For the rest of the body, eccrine sweat glands
excrete a less
pungent sweat for thermoregulation.
Hair follicles proceed through different physiological cycles of hair growth.
Figure 26 shows the physiological cycles of hair growth. The presence of
testosterone in
a genetically-prone man will produce alopecia to a variable degree in the
frontal-parietal
scalp. Essentially, the follicle becomes dormant by entering the telogen phase
without
return to the anagen phase. Male Pattern Baldness occurs when the hair fails
to return
from the telogen phase to the anagen phase.
The PAD of an embodiment is configured for en-masse harvesting of hair-bearing
plugs with en-masse transplantation of hair bearing plugs into non hair-
bearing scalp,
which truncates conventional surgical procedures of hair transplantation.
Generally, the
devices, systems and/or methods of an embodiment are used to harvest and align
a large
multiplicity of small hair bearing plugs in a single surgical step or process,
and the same
instrumentation is used to prepare the recipient site by performing a multiple
pixelated
resection of non hair-bearing scalp. The multiple hair-plug graft is
transferred and
transplanted en-masse to the prepared recipient site. Consequently, through
use of an
abbreviated procedure, hundreds of hair bearing plugs can be transferred from
a donor
site to a recipient site. Hair transplantation using the embodiments described
herein
therefore provides a solution that is a single surgical procedure having ease,
simplicity
and significant time reduction over the tedious and multiple staged
conventional process.
Hair transplantation using the pixel dermatome of an embodiment facilitates
improvements in the conventional standard follicular unit extraction (FUT)
hair
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transplant approach. Generally, under the procedure of an embodiment hair
follicles to
be harvested are taken from the Occipital scalp of the donor. In so doing, the
donor site
hair is partially shaved, and the perforated plate of an embodiment is located
on the scalp
and oriented to provide a maximum harvest. Figure 27 shows harvesting of donor
follicles, under an embodiment. The scalpets in the scalpet array are
configured to
penetrate down to the subcutaneous fat later to capture the hair follicle.
Once the hair
plugs are incised, they are harvested onto an adhesive membrane by transecting
the base
of the hair plug with the transection blade, as described in detail herein.
Original
alignment of the hair plugs with respect to each other at the donor site is
maintained by
applying the adherent membrane before transecting the base. The aligned matrix
of hair
plugs on the adherent membrane will then be grafted en masse to a recipient
site on the
frontal-parietal scalp of the recipient.
Figure 28 shows preparation of the recipient site, under an embodiment. The
recipient site is prepared by resection of non-hair bearing skin plugs in a
topographically
identical pattern as the harvested occipital scalp donor site. The recipient
site is prepared
for the mass transplant of the hair plugs using the same instrumentation that
was used at
the donor site under an embodiment and, in so doing, scalp defects are created
at the
recipient site. The scalp defects created at the recipient site have the same
geometry as
the harvested plugs on the adherent membrane.
The adherent membrane laden with the harvested hair plugs is applied over the
same pattern of scalp defects at the recipient site. Row-by-row, each hair-
bearing plug is
inserted into its mirror image recipient defect. Figure 29 shows placement of
the
harvested hair plugs at the recipient site, under an embodiment. Plug-to-plug
alignment
is maintained, so the hair that grows from the transplanted hair plugs lays as
naturally as
it did at the donor site. More uniform alignment between the native scalp and
the
transplanted hair will also occur.
More particularly, the donor site hair is partially shaved to prepare for
location or
placement of the perforated plate on the scalp. The perforated plate is
positioned on the
occipital scalp donor site to provide a maximum harvest. Figure 30 shows
placement of
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the perforated plate on the occipital scalp donor site, under an embodiment.
Mass
harvesting of hair plugs is achieved using the spring-loaded pixilation device
comprising
the impact punch hand-piece with a scalpet disposable tip. An embodiment is
configured
for harvesting of individual hair plugs using off-the-shelf FUE extraction
devices or
biopsy punches; the holes in the perforated plates supplied are sized to
accommodate off-
the-shelf technology.
The scalpets comprising the scalpet array disposable tip are configured to
penetrate down to the subcutaneous fat later to capture the hair follicle.
Figure 31 shows
scalpet penetration depth through skin when the scalpet is configured to
penetrate to the
subcutaneous fat layer to capture the hair follicle, under an embodiment. Once
the hair
plugs are incised, they are harvested onto an adhesive membrane by transecting
the base
of the hair plug with the transection blade, but are not so limited. Figure 32
shows hair
plug harvesting using the perforated plate at the occipital donor site, under
an
embodiment. The original alignment of the hair plugs with respect to each
other is
maintained by applying an adherent membrane of an embodiment. The adherent
membrane is applied before transecting the base of the resected pixels, the
embodiments
are not so limited. The aligned matrix of hair plugs on the adherent membrane
is
subsequently grafted en masse to a recipient site on the frontal-parietal
scalp.
Additional single hair plugs may be harvested through the perforated plate, to
be
used to create the visible hairline, for example. Figure 33 shows creation of
the visible
hairline, under an embodiment. The visible hairline is determined and
developed with a
manual FUT technique. The visible hairline and the mass transplant of the
vertex may be
performed concurrently or as separate stages. If the visible hairline and mass
transplant
are performed concurrently, the recipient site is developed starting with the
visible
hairline.
Transplantation of harvested hair plugs comprises preparing the recipient site
is
prepared by resecting non-hair bearing skin plugs in a topographically
identical pattern as
the pattern of the harvested occipital scalp donor site. Figure 34 shows
preparation of
the donor site using the patterned perforated plate and spring-loaded
pixilation device to
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create identical skin defects at the recipient site, under an embodiment. The
recipient site
of an embodiment is prepared for the mass transplant of the hair plugs using
the same
perforated plate and spring-loaded pixilation device that was used at the
donor site. Scalp
defects are created at the recipient site. These scalp defects have the same
geometry as
the harvested plugs on the adherent membrane.
The adherent membrane carrying the harvested hair plugs is applied over the
same
pattern of scalp defects at recipient site. Row-by-row each follicle-bearing
or hair-
bearing skin plug is inserted into its mirror image recipient defect. Figure
35 shows
transplantation of harvested plugs by inserting harvested plugs into a
corresponding skin
defect created at the recipient site, under an embodiment. Plug-to-plug
alignment is
maintained, so the hair that grows from the transplanted hair plugs lays as
naturally as it
did at the donor site. More uniform alignment between the native scalp and the
transplanted hair will also occur.
Clinical endpoints vary from patient to patient, but it is predicted that a
higher
percentage of hair plugs will "take" as a result of improved
neovascularization. Figure
36 shows a clinical end point using the pixel dermatome instrumentation and
procedure,
under an embodiment. The combination of better "takes", shorter procedure
times, and a
more natural-looking result, enable the pixel dermatome instrumentation and
procedure
of an embodiment to overcome the deficiencies in conventional hair transplant
approaches.
Embodiments of pixelated skin grafting for skin defects and pixelated skin
resection for skin laxity are described in detail herein. These embodiments
remove a
field of skin pixels in an area of lax skin where skin tightening is desired.
The skin
defects created by this procedure (e.g., in a range of approximately 1.5-3 mm-
diameter)
are small enough to heal per primam without visible scarring; the wound
closure of the
multiple skin defects is performed directionally to produce a desired
contouring effect.
Live animal testing of the pixel resection procedure has produced excellent
results.
The pixel procedure of an embodiment is performed in an office setting under a
local anesthetic but is not so limited. The surgeon uses the instrumentation
of an
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embodiment to rapidly resect an array of skin pixels (e.g., circular,
elliptical, square,
etc.). Relatively little pain is associated with the procedure. The
intradermal skin defects
generated during the procedure are closed with the application of an adherent
Flexan
(3M) sheet, but embodiments are not so limited. Functioning as a large
butterfly
bandage, the Flexan sheet is pulled in a direction that maximizes the
aesthetic contouring
of the treatment area. A compressive elastic garment is then applied over the
dressing to
assist aesthetic contouring. During recovery, the patient wears a support
garment over
the treatment area for a period of time (e.g., 5 days, etc.). After initial
healing, the
multiplicity of small linear scars within the treatment area is not visibly
apparent.
Additional skin tightening will occur subsequently over several months from
the delayed
wound healing response. Consequently, the pixel procedure is a minimally
invasive
alternative for skin tightening in areas where the extensive scarring of
traditional
aesthetic plastic surgery is to be avoided.
The pixel procedure evokes cellular and extracellular responses that are
obligatory
to the clinical outcomes achieved. A physical reduction of the skin surface
area occurs
due to the fractional resection of skin, which physically removes a portion of
skin directly
in the area of laxity. In addition, a subsequent tightening of the skin is
realized from the
delayed wound healing response. Each pixilated resection initiates an obligate
wound
healing sequence. The healing response effected in an embodiment comprises
three
phases, as previously described in detail herein.
The first phase of this sequence is the inflammatory phase in which
degranulation
of mast cells releases histamine into the "wound". Histamine release evokes
dilatation of
the capillary bed and increases vessel permeability into the extracellular
space. This
initial wound healing response occurs within the first day and will be evident
as erythema
on the skin's surface.
Within days of "wounding", the second phase of healing, fibroplasia,
commences.
During fibroplasia, there is migration and mitotic multiplication of
fibroblasts.
Fibroplasia has two key features: the deposition of neocollagen and the
myofibroblastic
contraction of the wound. Histologically, the deposition of neocollagen is
identified
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microscopically as compaction and thickening of the dermis. Although this is a
static
process, the tensile strength of the skin significantly increases.
Myofibroblastic
contraction is a dynamic physical process that results in two-dimensional
tightening of
the skin surface. This process is due to the active cellular contraction of
myofibroblasts
and the deposition of contractile proteins within the extracellular matrix.
Overall, the
effect of fibroplasia will be dermal contraction and the deposition of a
static supporting
scaffolding of neocollagen with a tightened framework. The clinical effect is
realized as
a delayed tightening of skin with smoothing of skin texture over some number
of months.
The clinical endpoint is a more youthful appearing skin envelope of the
treatment area.
A third and final phase of the delayed wound healing response is maturation.
During maturation, there is a strengthening and remodeling of the treatment
area due to
increased cross-linkage of the collagen fibril matrix (of the dermis). This
final stage
commences within 6 to 12 months after "wounding" and may extend for at least 1-
2
years. Small pixilated resections of skin should preserve the normal dermal
architecture
during maturation, but without the creation of a visually evident scar that
typically occurs
with a larger surgical resection of skin. Lastly, there is a related
stimulation and
rejuvenation of the epidermis from the release of epidermal growth hormone.
Figures 37-42 show images resulting from a pixel procedure conducted on a live
animal, under an embodiment. Embodiments described herein were used in this
proof-of-
concept study in an animal model that verified the pixel procedure produces
aesthetic
skin tightening without visible scarring. The study used a live porcine model,
anesthetized for the procedure. Figure 37 is an image of the skin tattooed at
the corners
and midpoints of the area to be resected, under an embodiment. The field
margins of
resection were demarcated with a tattoo for post-operative assessment, but
embodiments
are not so limited. The procedure was performed using a perforated plate
(e.g., 10x10
pixel array) to designate the area for fractional resection. The fractional
resection was
performed using biopsy punches (e.g., 1.5 mm diameter). Figure 38 is an image
of the
post-operative skin resection field, under an embodiment. Following the pixel
resection,
the pixelated resection defects were closed (horizontally) with Flexan
membrane.
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Eleven days following the procedure, all resections had healed per primam in
the
area designated by the tattoo, and photographic and dimensional measurements
were
made. Figure 39 is an image at 11 days following the procedure showing
resections
healed per primam, with measured margins, under an embodiment. Photographic
and
dimensional measurements were subsequently made 29 days following the
procedure.
Figure 40 is an image at 29 days following the procedure showing resections
healed per
primam and maturation of the resection field continuing per primam, with
measured
margins, under an embodiment. Figure 41 is an image at 29 days following the
procedure showing resections healed per primam and maturation of the resection
field
continuing per primam, with measured lateral dimensions, under an embodiment.
Photographic and dimensional measurements were repeated 90 days post-
operative, and
the test area skin was completely smooth to touch. Figure 42 is an image at 90
days
post-operative showing resections healed per primam and maturation of the
resection
field continuing per primam, with measured lateral dimensions, under an
embodiment.
Embodiments include an apparatus comprising a housing configured to include a
scalpet device. The scalpet device comprises a substrate and a scalpet array.
The scalpet
array includes a plurality of scalpets arranged in a configuration on the
substrate. The
substrate and the plurality of scalpets is configured to be deployed from the
housing and
retracted into the housing. The plurality of scalpets is configured to
generate a plurality
of incised skin pixels at a target site when deployed.
Embodiments include an apparatus, comprising: a housing configured to include
a
scalpet device; and the scalpet device comprising a substrate and a scalpet
array, wherein
the scalpet array includes a plurality of scalpets arranged in a configuration
on the
substrate, wherein the substrate and the plurality of scalpets is configured
to be deployed
from the housing and retracted into the housing, wherein the plurality of
scalpets is
configured to generate a plurality of incised skin pixels at a target site
when deployed.
The housing is configured to be removeably coupled to a receiver.
The receiver is a component of a control device.
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The control device comprises a proximal end and a distal end, wherein the
proximal end includes an actuator mechanism and the distal end includes the
receiver.
The scalpet array is configured to be deployed in response to activation of
the
actuator mechanism.
The proximal end of the control device is configured to be hand-held.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device and retracted back into the scalpet device in response to activation of
the actuator
mechanism.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device in response to activation of the actuator mechanism.
The scalpet device is configured so the scalpet array is retracted back into
the
scalpet device in response to release of the actuator mechanism.
The control device is configured to be disposable.
The control device is configured to be at least one of cleaned, disinfected,
and
sterilized.
The apparatus comprises an adherent substrate configured to capture the
plurality
of incised skin pixels.
The scalpet device is configured to include the adherent substrate.
The housing is configured to include the adherent substrate.
The adherent substrate comprises a flexible substrate.
The adherent substrate comprises a semi-porous membrane.
The apparatus comprises a vacuum component.
The vacuum component is coupled to the housing.
The vacuum component is coupled to the scalpet device.
The vacuum component is coupled to the scalpet device via the housing.
The vacuum component is configured to generate a low-pressure zone within at
least one of the scalpet device and the control device.
The low-pressure zone is configured to evacuate the plurality of incised skin
pixels.
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The housing is configured to be removeably coupled to a control device,
wherein
the vacuum component is coupled to the control device.
The apparatus comprises a radio frequency (RF) component.
The RF component is configured to provide thermal energy to at least one of
the
scalpet device and the scalpet array.
The RF component is configured to provide vibrational energy to at least one
of
the scalpet device and the scalpet array.
The RF component is configured to provide rotational energy to at least one of
the
scalpet device and the scalpet array.
The RF component is configured to provide acoustic energy to at least one of
the
scalpet device and the scalpet array.
The RF component is coupled to the housing.
The RF component is coupled to the scalpet device.
The RF component is coupled to the scalpet device via the housing.
The RF component is coupled to the scalpet array.
The RF component is coupled to the scalpet array via the housing.
The RF component is coupled to at least one scalpet of the scalpet array.
The RF component is coupled to the at least one scalpet of the scalpet array
via
the housing.
The housing is configured to be removeably coupled to a control device,
wherein
the RF component is coupled to the control device.
The apparatus comprises a vacuum component coupled to at least one of the
scalpet device and the housing, and a radio frequency (RF) component coupled
to at least
one of the scalpet device, the scalpet array, and the housing.
The vacuum component is configured to generate a low-pressure zone within at
least one of the scalpet device and the housing
The RF component is configured to provide energy to at least one of the
scalpet
device, the scalpet array, and the housing.
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The energy comprises at least one of thermal energy, vibrational energy,
rotational energy, and acoustic energy.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The target site includes a donor site, wherein the plurality of incised skin
pixels is
harvested at the donor site.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The apparatus comprises an adherent substrate configured to capture the
plurality
of incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to
the recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The adherent substrate is configured to apply the incised skin pixels to the
skin
defects at the recipient site.
The adherent substrate is configured to align the incised skin pixels with the
skin
defects at the recipient site.
The adherent substrate is configured to insert each incised skin pixel into a
corresponding skin defect at the recipient site.
The apparatus comprises at least one bandage configured for application at the
target site.
The at least one bandage is configured to apply force to close the target
site.
The at least one bandage is configured to apply directional force to control a
direction of the closure at the target site.
The at least one bandage includes a first bandage configured for application
at the
donor site.
The at least one bandage includes a second bandage configured for application
at
the recipient site.
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The scalpet device is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
The scalpet array is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
The scalpet device is configured to be disposable.
The scalpet device is configured to be at least one of cleaned, disinfected,
and
sterilized.
The apparatus comprises a template configured for positioning at the target
site.
The scalpet device is configured to align with the template.
The scalpet array is configured to align with the template.
The template is on a skin surface at the target site.
The template comprises an indicator on the skin surface at the target site.
The template includes a guide plate configured for positioning at the target
site
and comprising perforations arranged in a pattern.
The scalpet array is removeably coupled to the scalpet device.
The scalpet array is disposable.
A shape of each scalpet of the scalpet array is elliptical.
A shape of each scalpet of the scalpet array is circular.
A shape of each scalpet of the scalpet array is semicircular.
A shape of each scalpet of the scalpet array is one of square, rectangular,
and flat.
Each scalpet of the at least one scalpet includes a beveled surface.
Each scalpet of the plurality of scalpets includes at least one pointed
surface.
Each scalpet of the plurality of scalpets includes at least one needle.
The at least one needle comprises at least one needle including multiple
points.
The scalpet array generates the incised skin pixels using at least one of
piercing
force, impact force, and rotational force.
The scalpet array generates the incised skin pixels using radio frequency (RF)
energy.
The scalpet array generates the incised skin pixels using vibrational energy.
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At least one scalpet of the scalpet array comprises a through orifice.
At least one diametric dimension of each scalpet of the scalpet array is
approximately in a range 0.5 millimeters to 4.0 millimeters.
The apparatus comprises a guide plate configured for positioning as a template
at
the target site, wherein the guide plate includes perforations arranged in a
pattern.
The scalpet array is configured to align with the perforations in the guide
plate.
The scalpet array is applied to a donor site via the perforations in the guide
plate,
wherein the plurality of skin pixels are incised.
The scalpet array is applied to a recipient site via the perforations in the
guide
plate, wherein a plurality of skin defects are generated.
The target site includes the donor site and the recipient site.
The plurality of incised skin pixels and the plurality of skin defects are
generated
according to the pattern.
The apparatus comprises an adherent substrate configured to capture the
plurality
of incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to
the recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The scalpet array is applied to the donor site directly through the
perforations and
the skin pixels are incised.
The scalpet array is applied to the recipient site directly through the
perforations
and the skin defects are generated.
The guide plate is at least one of adherent, rigid, semi-rigid, conformable,
non-
conformable, and non-deformable.
The guide plate includes at least one of metal, plastic, polymer, and
membranous
material.
The guide plate is configured to transmit a load to a skin surface of at least
one of
the donor site and the recipient site.
The guide plate is positioned directly on a skin surface at the target site.
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The guide plate is configured to extrude the plurality of incised skin pixels.
The plurality of skin pixels is extruded through the perforations in response
to an
applied load.
The plurality of skin pixels is extruded through the incised skin surface in
response to an applied load.
The apparatus comprises a cutting member.
The incised skin pixels are transected by the cutting member.
The apparatus comprises an adherent substrate configured to capture the
incised
skin pixels.
The cutting member is coupled to a frame.
The frame is coupled to a guide plate, wherein the guide plate is configured
as a
guide for the scalpet device.
The adherent substrate is coupled to at least one of the frame and the guide
plate.
The incised skin pixels include hair follicles.
The skin defects are configured to evoke neovascularization in the incised
skin
pixels inserted at the recipient site.
The skin defects are configured to evoke a wound healing response in the
incised
skin pixels inserted at the recipient site.
Embodiments include an apparatus, comprising: a housing including a scalpet
device; and the scalpet device comprising a scalpet array that includes a
plurality of
scalpets arranged in a pattern, wherein the plurality of scalpets is
deployable from the
housing to generate a plurality of incised skin pixels at a target site.
Embodiments include an apparatus comprising a housing including a scalpet
device. The scalpet device comprises a scalpet array that includes a plurality
of scalpets
arranged in a pattern. The plurality of scalpets is deployable from the
housing to generate
a plurality of incised skin pixels at a target site.
Embodiments include a system comprising a control device comprising a
proximal end and a distal end. The proximal end includes an actuator mechanism
and the
distal end includes a receiver. The system includes a scalpet device
configured to be
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removeably coupled to the receiver of the control device. The scalpet device
includes a
substrate and a scalpet array comprising a plurality of scalpets arranged in a
configuration
on the substrate. The substrate and the plurality of scalpets are configured
to be deployed
in response to activation of the actuator mechanism. The plurality of scalpets
is
configured to generate a plurality of incised skin pixels at a target site
when deployed.
Embodiments include a system comprising: a control device comprising a
proximal end and a distal end, wherein the proximal end includes an actuator
mechanism
and the distal end includes a receiver; and a scalpet device configured to be
removeably
coupled to the receiver of the control device, wherein the scalpet device
includes a
substrate and a scalpet array comprising a plurality of scalpets arranged in a
configuration
on the substrate, wherein the substrate and the plurality of scalpets are
configured to be
deployed in response to activation of the actuator mechanism, wherein the
plurality of
scalpets is configured to generate a plurality of incised skin pixels at a
target site when
deployed.
The proximal end of the control device is configured to be hand-held.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The target site includes a donor site, wherein the plurality of incised skin
pixels is
harvested at the donor site.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to the
recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The adherent substrate is configured to apply the incised skin pixels to the
skin
defects at the recipient site.
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The adherent substrate is configured to align the incised skin pixels with the
skin
defects at the recipient site.
The adherent substrate is configured to insert each incised skin pixel into a
corresponding skin defect at the recipient site.
The system comprises at least one bandage configured for application at the
target
site.
The at least one bandage is configured to apply force to close the target
site.
The at least one bandage is configured to apply directional force to control a
direction of the closure at the target site.
The at least one bandage includes a first bandage configured for application
at the
donor site.
The at least one bandage includes a second bandage configured for application
at
the recipient site.
The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels.
The scalpet device is configured to include the adherent substrate.
The adherent substrate comprises a flexible substrate.
The adherent substrate comprises a semi-porous membrane.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device and retracted back into the scalpet device in response to activation of
the actuator
mechanism.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device in response to activation of the actuator mechanism.
The scalpet device is configured so the scalpet array is retracted back into
the
scalpet device in response to release of the actuator mechanism.
The scalpet device is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
The scalpet array is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
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The scalpet device is configured to be disposable.
The scalpet device is configured to be at least one of cleaned, disinfected,
and
sterilized.
The control device is configured to be disposable.
The control device is configured to be at least one of cleaned, disinfected,
and
sterilized.
The system comprises a template configured for positioning at the target site.
The scalpet device is configured to align with the template.
The scalpet array is configured to align with the template.
The template is on a skin surface at the target site.
The template comprises an indicator on the skin surface at the target site.
The template includes a guide plate configured for positioning at the target
site
and comprising perforations arranged in a pattern.
The scalpet array is removeably coupled to the scalpet device.
The scalpet array is disposable.
A shape of each scalpet of the scalpet array is elliptical.
A shape of each scalpet of the scalpet array is circular.
A shape of each scalpet of the scalpet array is semicircular.
A shape of each scalpet of the scalpet array is one of square, rectangular,
and flat.
Each scalpet of the at least one scalpet includes a beveled surface.
Each scalpet of the plurality of scalpets includes at least one pointed
surface.
Each scalpet of the plurality of scalpets includes at least one needle.
The at least one needle comprises at least one needle including multiple
points.
The scalpet array generates the incised skin pixels using at least one of
piercing
force, impact force, and rotational force.
The scalpet array generates the incised skin pixels using radio frequency (RF)
energy.
The scalpet array generates the incised skin pixels using vibrational energy.
At least one scalpet of the scalpet array comprises a through orifice.
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At least one diametric dimension of each scalpet of the scalpet array is
approximately in a range 0.5 millimeters to 4.0 millimeters.
The system comprises a vacuum component.
The vacuum component is coupled to the control device.
The vacuum component is coupled to the scalpet device.
The vacuum component is coupled to the scalpet device via the control device.
The vacuum component is configured to generate a low-pressure zone within at
least one of the scalpet device and the control device.
The low-pressure zone is configured to evacuate the plurality of incised skin
pixels.
The system comprises a radio frequency (RF) component.
The RF component is configured to provide thermal energy to at least one of
the
scalpet device, the scalpet array, and the control device.
The RF component is configured to provide vibrational energy to at least one
of
the scalpet device, the scalpet array, and the control device.
The RF component is configured to provide rotational energy to at least one of
the
scalpet device, the scalpet array, and the control device.
The RF component is configured to provide acoustic energy to at least one of
the
scalpet device, the scalpet array, and the control device.
The RF component is coupled to the control device.
The RF component is coupled to the scalpet device.
The RF component is coupled to the scalpet device via the control device.
The RF component is coupled to the scalpet array.
The RF component is coupled to the scalpet array via the control device.
The RF component is coupled to at least one scalpet of the scalpet array.
The RF component is coupled to the at least one scalpet of the scalpet array
via
the control device.
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The system comprises a vacuum component coupled to at least one of the scalpet
device and the control device, and a radio frequency (RF) component coupled to
at least
one of the scalpet device, the scalpet array, and the control device.
The vacuum component is configured to generate a low-pressure zone within at
least one of the scalpet device and the control device
The RF component is configured to provide energy to at least one of the
scalpet
device, the scalpet array, and the control device.
The energy comprises at least one of thermal energy, vibrational energy,
rotational energy, and acoustic energy.
The system comprises a guide plate configured for positioning as a template at
the
target site, wherein the guide plate includes perforations arranged in a
pattern.
The scalpet array is configured to align with the perforations in the guide
plate.
The scalpet array is applied to a donor site via the perforations in the guide
plate,
wherein the plurality of skin pixels are incised.
The scalpet array is applied to a recipient site via the perforations in the
guide
plate, wherein a plurality of skin defects are generated.
The target site includes the donor site and the recipient site.
The plurality of incised skin pixels and the plurality of skin defects are
generated
according to the pattern.
The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to the
recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The scalpet array is applied to the donor site directly through the
perforations and
the skin pixels are incised.
The scalpet array is applied to the recipient site directly through the
perforations
and the skin defects are generated.
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The guide plate is at least one of adherent, rigid, semi-rigid, conformable,
non-
conformable, and non-deformable.
The guide plate includes at least one of metal, plastic, polymer, and
membranous
material.
The guide plate is configured to transmit a load to a skin surface of at least
one of
the donor site and the recipient site.
The guide plate is positioned directly on a skin surface at the target site.
The guide plate is configured to extrude the plurality of incised skin pixels.
The plurality of skin pixels is extruded through the perforations in response
to an
applied load.
The plurality of skin pixels is extruded through the incised skin surface in
response to an applied load.
The system comprises a cutting member.
The incised skin pixels are transected by the cutting member.
An adherent substrate configured to capture the incised skin pixels.
The cutting member is coupled to a frame.
The frame is coupled to a guide plate, wherein the guide plate is configured
as a
guide for the scalpet device.
The adherent substrate is coupled to at least one of the frame and the guide
plate.
The incised skin pixels include hair follicles.
The skin defects are configured to evoke neovascularization in the incised
skin
pixels inserted at the recipient site.
The skin defects are configured to evoke a wound healing response in the
incised
skin pixels inserted at the recipient site.
Embodiments include a system comprising a control device. The system includes
a scalpet device removeably coupled to the control device. The scalpet device
includes a
scalpet array comprising a plurality of scalpets arranged in a pattern. The
plurality of
scalpets is configured to deploy and retract in response to activation by the
control device
and generate a plurality of incised skin pixels at a target site.
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Embodiments include a system comprising: a control device; and a scalpet
device
removeably coupled to the control device, wherein the scalpet device includes
a scalpet
array comprising a plurality of scalpets arranged in a pattern, wherein the
plurality of
scalpets are configured to deploy and retract in response to activation by the
control
device and generate a plurality of incised skin pixels at a target site.
Embodiments include a system comprising a control device comprising an
actuator mechanism. The system includes a scalpet device configured to be
removeably
coupled to the control device. The scalpet device includes a substrate and a
scalpet array
comprising a plurality of scalpets arranged in a pattern on the substrate. The
substrate
and the plurality of scalpets are configured to at least one of deploy and
retract in
response to activation of the actuator mechanism. The plurality of scalpets is
configured
to generate a plurality of incised skin pixels at a target site when deployed.
Embodiments include a system comprising: a control device comprising an
actuator mechanism; and a scalpet device configured to be removeably coupled
to the
control device, wherein the scalpet device includes a substrate and a scalpet
array
comprising a plurality of scalpets arranged in a pattern on the substrate,
wherein the
substrate and the plurality of scalpets are configured to at least one of
deploy and retract
in response to activation of the actuator mechanism, wherein the plurality of
scalpets is
configured to generate a plurality of incised skin pixels at a target site
when deployed.
Embodiments include a system comprising a housing configured to include a
scalpet device. The scalpet device comprises a substrate and a scalpet array.
The scalpet
array includes a plurality of scalpets arranged in a configuration on the
substrate. The
substrate and the plurality of scalpets is configured to be deployed from the
housing and
retracted into the housing. The plurality of scalpets is configured to
generate a plurality
of incised skin pixels at a target site when deployed. The system includes a
vacuum
component configured to generate a low-pressure zone adjacent the scalpet
device.
Embodiments include a system, comprising: a housing configured to include a
scalpet device; the scalpet device comprising a substrate and a scalpet array,
wherein the
scalpet array includes a plurality of scalpets arranged in a configuration on
the substrate,
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wherein the substrate and the plurality of scalpets is configured to be
deployed from the
housing and retracted into the housing, wherein the plurality of scalpets is
configured to
generate a plurality of incised skin pixels at a target site when deployed;
and a vacuum
component configured to generate a low pressure zone adjacent the scalpet
device.
The vacuum component is coupled to the housing.
The vacuum component is coupled to the scalpet device.
The vacuum component is coupled to the scalpet device via the housing.
The vacuum component is configured to generate the low-pressure zone within
the housing.
The low pressure zone is configured to evacuate the plurality of incised skin
pixels.
The housing is configured to be removeably coupled to a receiver.
The receiver is a component of a control device.
The control device comprises a proximal end and a distal end, wherein the
proximal end includes an actuator mechanism and the distal end includes the
receiver.
The scalpet array is configured to be deployed in response to activation of
the
actuator mechanism.
The proximal end of the control device is configured to be hand-held.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device and retracted back into the scalpet device in response to activation of
the actuator
mechanism.
The scalpet device is configured so the scalpet array is deployed from the
scalpet
device in response to activation of the actuator mechanism.
The scalpet device is configured so the scalpet array is retracted back into
the
scalpet device in response to release of the actuator mechanism.
The control device is configured to be disposable.
The control device is configured to be at least one of cleaned, disinfected,
and
sterilized.
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The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels.
The scalpet device is configured to include the adherent substrate.
The housing is configured to include the adherent substrate.
The adherent substrate comprises a flexible substrate.
The adherent substrate comprises a semi-porous membrane.
The system comprises a radio frequency (RF) component.
The RF component is configured to provide thermal energy to at least one of
the
scalpet device and the scalpet array.
The RF component is configured to provide vibrational energy to at least one
of
the scalpet device and the scalpet array.
The RF component is configured to provide rotational energy to at least one of
the
scalpet device and the scalpet array.
The RF component is configured to provide acoustic energy to at least one of
the
scalpet device and the scalpet array.
The RF component is coupled to the housing.
The RF component is coupled to the scalpet device.
The RF component is coupled to the scalpet device via the housing.
The RF component is coupled to the scalpet array.
The RF component is coupled to the scalpet array via the housing.
The RF component is coupled to at least one scalpet of the scalpet array.
The RF component is coupled to the at least one scalpet of the scalpet array
via
the housing.
The housing is configured to be removeably coupled to a control device,
wherein
the RF component is coupled to the control device.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The target site includes a donor site, wherein the plurality of incised skin
pixels IS
harvested at the donor site.
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The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to the
recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The adherent substrate is configured to apply the incised skin pixels to the
skin
defects at the recipient site.
The adherent substrate is configured to align the incised skin pixels with the
skin
defects at the recipient site.
The adherent substrate is configured to insert each incised skin pixel into a
corresponding skin defect at the recipient site.
The system comprises at least one bandage configured for application at the
target
site.
The at least one bandage is configured to apply force to close the target
site.
The at least one bandage is configured to apply directional force to control a
direction of the closure at the target site.
The at least one bandage includes a first bandage configured for application
at the
donor site.
The at least one bandage includes a second bandage configured for application
at
the recipient site.
The scalpet device is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
The scalpet array is configured to transfer a load to subjacent skin surface
that
includes the target site, wherein the skin pixels are incised by application
of the load.
The scalpet device is configured to be disposable.
The scalpet device is configured to be at least one of cleaned, disinfected,
and
sterilized.
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The system comprises a template configured for positioning at the target site.
The scalpet device is configured to align with the template.
The scalpet array is configured to align with the template.
The template is on a skin surface at the target site.
The template comprises an indicator on the skin surface at the target site.
The template includes a guide plate configured for positioning at the target
site
and comprising perforations arranged in a pattern.
The scalpet array is removeably coupled to the scalpet device.
The scalpet array is disposable.
A shape of each scalpet of the scalpet array is elliptical.
A shape of each scalpet of the scalpet array is circular.
A shape of each scalpet of the scalpet array is semicircular.
A shape of each scalpet of the scalpet array is one of square, rectangular,
and flat.
Each scalpet of the at least one scalpet includes a beveled surface.
Each scalpet of the plurality of scalpets includes at least one pointed
surface.
Each scalpet of the plurality of scalpets includes at least one needle.
The at least one needle comprises at least one needle including multiple
points.
The scalpet array generates the incised skin pixels using at least one of
piercing
force, impact force, and rotational force.
The scalpet array generates the incised skin pixels using radio frequency (RF)
energy.
The scalpet array generates the incised skin pixels using vibrational energy.
At least one scalpet of the scalpet array comprises a through orifice.
At least one diametric dimension of each scalpet of the scalpet array is
approximately in a range 0.5 millimeters to 4.0 millimeters.
The system comprises a guide plate configured for positioning as a template at
the
target site, wherein the guide plate includes perforations arranged in a
pattern.
The scalpet array is configured to align with the perforations in the guide
plate.
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The scalpet array is applied to a donor site via the perforations in the guide
plate,
wherein the plurality of skin pixels are incised.
The scalpet array is applied to a recipient site via the perforations in the
guide
plate, wherein a plurality of skin defects are generated.
The target site includes the donor site and the recipient site.
The plurality of incised skin pixels and the plurality of skin defects are
generated
according to the pattern.
The system comprises an adherent substrate configured to capture the plurality
of
incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to the
recipient site.
The adherent substrate is configured to maintain relative positioning of the
plurality of incised skin pixels during transfer to and application at the
recipient site.
The scalpet array is applied to the donor site directly through the
perforations and
the skin pixels are incised.
The scalpet array is applied to the recipient site directly through the
perforations
and the skin defects are generated.
The guide plate is at least one of adherent, rigid, semi-rigid, conformable,
non-
conformable, and non-deformable.
The guide plate includes at least one of metal, plastic, polymer, and
membranous
material.
The guide plate is configured to transmit a load to a skin surface of at least
one of
the donor site and the recipient site.
The guide plate is positioned directly on a skin surface at the target site.
The guide plate is configured to extrude the plurality of incised skin pixels.
The plurality of skin pixels is extruded through the perforations in response
to an
applied load.
The plurality of skin pixels is extruded through the incised skin surface in
response to an applied load.
The system comprises a cutting member.
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The incised skin pixels are transected by the cutting member.
The system comprises an adherent substrate configured to capture the incised
skin
pixels.
The cutting member is coupled to a frame.
The frame is coupled to a guide plate, wherein the guide plate is configured
as a
guide for the scalpet device.
The adherent substrate is coupled to at least one of the frame and the guide
plate.
The incised skin pixels include hair follicles.
The skin defects are configured to evoke neovascularization in the incised
skin
pixels inserted at the recipient site.
The skin defects are configured to evoke a wound healing response in the
incised
skin pixels inserted at the recipient site.
Embodiments include a system comprising a housing including a scalpet device.
The scalpet device comprises a scalpet array that includes a plurality of
scalpets arranged
in a pattern. The plurality of scalpets is deployable from the housing to
generate a
plurality of incised skin pixels at a target site. The system includes a
vacuum component
configured to generate a low-pressure zone adjacent the scalpet device.
Embodiments include a system, comprising: a housing including a scalpet
device;
and the scalpet device comprising a scalpet array that includes a plurality of
scalpets
arranged in a pattern, wherein the plurality of scalpets is deployable from
the housing to
generate a plurality of incised skin pixels at a target site; and a vacuum
component
configured to generate a low pressure zone adjacent the scalpet device.
Embodiments include a method comprising positioning at a target site a housing
comprising a scalpet device. The scalpet device includes a substrate and a
scalpet array.
The scalpet array includes a plurality of scalpets arranged in a configuration
on the
substrate. The method includes deploying the scalpet array from the housing
into tissue
at the target site and generating a plurality of incised skin pixels at the
target site. The
method includes retracting the scalpet array into the housing from the target
site.
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Embodiments include a method comprising: positioning at a target site a
housing
comprising a scalpet device, wherein the scalpet device includes a substrate
and a scalpet
array, wherein the scalpet array includes a plurality of scalpets arranged in
a
configuration on the substrate; deploying the scalpet array from the housing
into tissue at
the target site and generating a plurality of incised skin pixels at the
target site; and
retracting the scalpet array into the housing from the target site.
The method comprises coupling the housing to a receiver that is a component of
a
control device.
The control device comprises a proximal end and a distal end, wherein the
proximal end includes an actuator mechanism and the distal end includes the
receiver.
The deploying comprising deploying the scalpet array in response to activation
of
the actuator mechanism.
The scalpet array in response to activation of the actuator mechanism.
The retracting comprises retracting the scalpet array in response to release
of the
actuator mechanism.
The proximal end of the control device is configured to be hand-held.
The method comprises decoupling the scalpet device from the receiver and
disposing of the scalpet device.
The method comprises at least one of cleaning, disinfecting, and sterilizing
the
control device.
The method comprises capturing the plurality of incised skin pixels using an
adherent substrate.
The scalpet device includes the adherent substrate.
The housing includes the adherent substrate.
The adherent substrate comprises a flexible substrate.
The adherent substrate comprises a semi-porous membrane.
The method comprises harvesting the plurality of incised skin pixels.
The harvesting comprises evacuating the plurality of incised skin pixels.
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The harvesting comprises generating a low-pressure zone within at least one of
the scalpet device and the housing.
The generating of the low-pressure zone comprises using a vacuum component.
The vacuum component is coupled to the housing.
The vacuum component is coupled to the scalpet device.
The vacuum component is coupled to the scalpet device via the housing.
The housing is configured to be removeably coupled to a control device,
wherein
the vacuum component is coupled to the control device.
The generating of the plurality of incised skin pixels comprises providing
energy
to at least one of the scalpet device, the scalpet array, and the housing.
The providing the energy comprises using a radio frequency (RF) component.
The energy comprises at least one of thermal energy, vibrational energy,
rotational energy, and acoustic energy.
The providing the energy comprises providing thermal energy to at least one of
the scalpet device and the scalpet array.
The providing the energy comprises providing vibrational energy to at least
one of
the scalpet device and the scalpet array.
The providing the energy comprises providing rotational energy to at least one
of
the scalpet device and the scalpet array.
The providing the energy comprises providing acoustic energy to at least one
of
the scalpet device and the scalpet array.
The RF component is coupled to the housing.
The RF component is coupled to the scalpet device.
The RF component is coupled to the scalpet device via the housing.
The RF component is coupled to the scalpet array.
The RF component is coupled to the scalpet array via the housing.
The RF component is coupled to at least one scalpet of the scalpet array.
The RF component is coupled to the at least one scalpet of the scalpet array
via
the housing.
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The housing is configured to be removeably coupled to a control device,
wherein
the RF component is coupled to the control device.
The method comprises harvesting the plurality of incised skin pixels using a
vacuum component, wherein the generating of the plurality of incised skin
pixels
comprises using radio frequency (RF) energy.
The vacuum component is configured to generate a low-pressure zone within at
least one of the scalpet device and the housing.
The RF component is configured to provide energy to at least one of the
scalpet
device, the scalpet array, and the housing.
The energy comprises at least one of thermal energy, vibrational energy,
rotational energy, and acoustic energy.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The target site includes a donor site, wherein the plurality of incised skin
pixels is
harvested at the donor site.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The method comprises capturing the plurality of incised skin pixels using an
adherent substrate and transferring the plurality of incised skin pixels to
the recipient site.
The method comprises the adherent substrate maintaining relative positioning
of
the plurality of incised skin pixels during the transferring to the recipient
site.
The method comprises applying the plurality of incised skin pixels from the
adherent substrate to the skin defects at the recipient site.
The method comprises aligning the plurality of incised skin pixels with the
skin
defects at the recipient site using the adherent substrate.
The method comprises inserting each incised skin pixel from the adherent
substrate into a corresponding skin defect at the recipient site.
The method comprises applying at least one bandage at the target site.
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The applying the at least one bandage comprises applying force to close the
target
site.
The applying the at least one bandage comprises applying directional force to
control a direction of the closure at the target site.
The applying of the at least one bandage comprises applying a first bandage at
the
donor site.
The applying of the at least one bandage comprises applying a second bandage
at
the recipient site.
The generating the plurality of incised skin pixels comprises transferring a
load
via the scalpet device to subjacent skin surface that includes the target
site, wherein the
skin pixels are incised by application of the load.
The generating the plurality of incised skin pixels comprises transferring a
load
via the scalpet array to subjacent skin surface that includes the target site,
wherein the
skin pixels are incised by application of the load.
The scalpet device is configured to be disposable.
The scalpet device is configured to be at least one of cleaned, disinfected,
and
sterilized.
The method comprises positioning a template at the target site.
The method comprises aligning the scalpet device with the template.
The method comprises aligning the scalpet array with the template.
The positioning comprises positioning the template on a skin surface at the
target
site.
The template comprises an indicator on the skin surface at the target site.
The template includes a guide plate configured for positioning at the target
site
and comprising perforations arranged in a pattern.
The method comprises removeably coupling the scalpet array to the scalpet
device.
The scalpet array is disposable.
A shape of each scalpet of the scalpet array is elliptical.
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A shape of each scalpet of the scalpet array is circular.
A shape of each scalpet of the scalpet array is semicircular.
A shape of each scalpet of the scalpet array is one of square, rectangular,
and flat.
Each scalpet of the plurality of scalpets includes a beveled surface.
Each scalpet of the plurality of scalpets includes at least one pointed
surface.
Each scalpet of the plurality of scalpets includes at least one needle.
The at least one needle comprises at least one needle including multiple
points.
The generating of the plurality of incised pixels comprises generating using
at
least one of piercing force, impact force, and rotational force.
The generating of the plurality of incised pixels comprises generating using
radio
frequency (RF) energy.
The generating of the plurality of incised pixels comprises generating using
vibrational energy.
At least one scalpet of the scalpet array comprises a through orifice.
At least one diametric dimension of each scalpet of the scalpet array is
approximately in a range 0.5 millimeters to 4.0 millimeters.
The method comprises positioning a guide plate as a template at the target
site,
wherein the guide plate includes perforations arranged in a pattern.
The method comprises aligning the scalpet array with the perforations in the
guide
plate.
The method comprises applying the scalpet array to a donor site via the
perforations in the guide plate, wherein the plurality of skin pixels are
incised.
The method comprises applying the scalpet array to a recipient site via the
perforations in the guide plate, wherein a plurality of skin defects are
generated.
The target site includes the donor site and the recipient site.
The method comprises generating the plurality of incised skin pixels and the
plurality of skin defects according to the pattern.
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The method comprises capturing with an adherent substrate the plurality of
incised skin pixels at the donor site and transferring the plurality of
incised skin pixels to
the recipient site.
The method comprises maintaining with the adherent substrate relative
positioning of the plurality of incised skin pixels during transferring to and
application at
the recipient site.
The method comprises applying the scalpet array to the donor site directly
through the perforations and the skin pixels are incised.
The method comprises applying the scalpet array to the recipient site directly
through the perforations and the skin defects are generated.
The guide plate is at least one of adherent, rigid, semi-rigid, conformable,
non-
conformable, and non-deformable.
The guide plate includes at least one of metal, plastic, polymer, and
membranous
material.
The guide plate is configured to transmit a load to a skin surface of at least
one of
the donor site and the recipient site.
The method comprises positioning the guide plate directly on a skin surface at
the
target site.
The method comprises extruding the plurality of incised skin pixels using the
guide plate.
The method comprises extruding the plurality of skin pixels through the
perforations in response to an applied load.
The method comprises extruding the plurality of skin pixels through the
incised
skin surface in response to an applied load.
The generating of the plurality of incised skin pixels comprises incising with
a
cutting member.
The method comprises transceting the incised skin pixels with the cutting
member.
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The method comprises capturing the incised skin pixels with an adherent
substrate.
The cutting member is coupled to a frame.
The frame is coupled to a guide plate, wherein the guide plate is configured
as a
guide for the scalpet device.
The adherent substrate is coupled to at least one of the frame and the guide
plate.
The incised skin pixels include hair follicles.
The method comprises using the skin defects to evoke neovascularization in the
incised skin pixels inserted at the recipient site
The method comprises using the skin defects to evoke a wound healing response
in the incised skin pixels inserted at the recipient site.
Embodiments include a method comprising: forming a coupling between a control
device and a scalpet device, wherein the control device includes an actuator,
wherein the
scalpet device includes a scalpet array comprising a plurality of scalpets
arranged in a
pattern; aligning the scalpet device at a target site; and generating a
plurality of incised
skin pixels and a plurality of skin defects by deploying the scalpet array
into tissue at the
target site, wherein the scalpet array is deployed in response to activation
of the actuator.
Embodiments include a method comprising: forming a coupling between a control
device and a scalpet device, wherein the control device includes an actuator,
wherein the
scalpet device includes a scalpet array comprising a plurality of scalpets
arranged in a
pattern; aligning the scalpet device at a target site; and generating a
plurality of incised
skin pixels and a plurality of skin defects by deploying the scalpet array
into tissue at the
target site, wherein the scalpet array is deployed in response to activation
of the actuator.
Embodiments include a method comprising: positioning a housing at a target
site,
wherein the housing includes a scalpet array comprising a plurality of
scalpets arranged
in a pattern; deploying the scalpet array into tissue at the target site;
generating a plurality
of incised skin pixels at the target site when the target site is a donor
site; generating a
plurality of skin defects at the target site when the target site is a
recipient site; and
harvesting the plurality of incised skin pixels.
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Embodiments include a method comprising: positioning a housing at a target
site,
wherein the housing includes a scalpet array comprising a plurality of
scalpets arranged
in a pattern; deploying the scalpet array into tissue at the target site;
generating a plurality
of incised skin pixels at the target site when the target site is a donor
site; generating a
plurality of skin defects at the target site when the target site is a
recipient site; and
harvesting the plurality of incised skin pixels.
Embodiments include a method comprising: positioning a housing at a donor
site,
wherein the housing includes a scalpet array comprising a plurality of
scalpets arranged
in a pattern; deploying the scalpet array into tissue at the donor site and
generating a
plurality of incised skin pixels; capturing the plurality of incised skin
pixels at the donor
site and transferring the incised skin pixels to a recipient; positioning the
housing at the
recipient site, and deploying the scalpet array into tissue at the recipient
site and
generating a plurality of skin defects; and applying the plurality of incised
skin pixels to
the skin defects at the recipient site.
Embodiments include a method comprising: positioning a housing at a donor
site,
wherein the housing includes a scalpet array comprising a plurality of
scalpets arranged
in a pattern; deploying the scalpet array into tissue at the donor site and
generating a
plurality of incised skin pixels; capturing the plurality of incised skin
pixels at the donor
site and transferring the incised skin pixels to a recipient; positioning the
housing at the
recipient site, and deploying the scalpet array into tissue at the recipient
site and
generating a plurality of skin defects; and applying the plurality of incised
skin pixels to
the skin defects at the recipient site.
Embodiments include a method comprising: configuring a housing to include a
scalpet device; and configuring the scalpet device to include a substrate and
a scalpet
array, wherein the scalpet array is configured to include a plurality of
scalpets arranged in
a configuration on the substrate, wherein the substrate and the plurality of
scalpets is
configured to be deployed from the housing and retracted into the housing,
wherein the
plurality of scalpets is configured to generate a plurality of incised skin
pixels at a target
site when deployed.
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Embodiments include a method comprising: configuring a housing to include a
scalpet device; and configuring the scalpet device to include a substrate and
a scalpet
array, wherein the scalpet array is configured to include a plurality of
scalpets arranged in
a configuration on the substrate, wherein the substrate and the plurality of
scalpets is
configured to be deployed from the housing and retracted into the housing,
wherein the
plurality of scalpets is configured to generate a plurality of incised skin
pixels at a target
site when deployed.
The method comprises configuring the housing to be removeably coupled to a
receiver.
The receiver is a component of a control device.
The method comprises configuring the control device to include a proximal end
and a distal end, wherein the proximal end includes an actuator mechanism and
the distal
end includes the receiver.
The method comprises configuring the scalpet array to be deployed in response
to
activation of the actuator mechanism.
The method comprises configuring the proximal end of the control device to be
hand-held.
The method comprises configuring the scalpet device so the scalpet array is
deployed from the scalpet device and retracted back into the scalpet device in
response to
activation of the actuator mechanism.
The method comprises configuring the scalpet device so the scalpet array is
deployed from the scalpet device in response to activation of the actuator
mechanism.
The method comprises configuring the scalpet device so the scalpet array is
retracted back into the scalpet device in response to release of the actuator
mechanism.
The method comprises configuring the control device to be disposable.
The method comprises configuring the control device to be at least one of
cleaned, disinfected, and sterilized.
The method comprises configuring an adherent substrate to capture the
plurality
of incised skin pixels.
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The method comprises configuring the scalpet device to include the adherent
substrate.
The method comprises configuring the housing to include the adherent
substrate.
The adherent substrate comprises a flexible substrate.
The adherent substrate comprises a semi-porous membrane.
The method comprises configuring at least one of the housing, the scalpet
device,
and the scalpet array for use with a vacuum component.
The method comprises configuring the housing for coupling to the vacuum
component.
The method comprises configuring the scalpet device for coupling to the vacuum
component for coupling to the scalpet device.
The method comprises configuring the scalpet device for coupling to the vacuum
component via the housing.
The method comprises configuring at least one of the scalpet device and the
control device to include a low-pressure zone.
The method comprises configuring the low-pressure zone to evacuate the
plurality
of incised skin pixels.
The method comprises configuring the housing to be removeably coupled to a
control device, wherein the vacuum component is coupled to the control device.
The method comprises configuring at least one of the housing, the scalpet
device,
and the scalpet array for use with a radio frequency (RF) component.
The method comprises configuring the RF component to provide thermal energy
to at least one of the scalpet device and the scalpet array.
The method comprises configuring the RF component to provide vibrational
energy to at least one of the scalpet device and the scalpet array.
The method comprises configuring the RF component to provide rotational
energy to at least one of the scalpet device and the scalpet array.
The method comprises configuring the RF component to provide acoustic energy
to at least one of the scalpet device and the scalpet array.
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The method comprises coupling the RF component to the housing.
The method comprises coupling the RF component to the scalpet device.
The method comprises coupling the RF component to the scalpet device via the
housing.
The method comprises coupling the RF component to the scalpet array.
The method comprises coupling the RF component to the scalpet array via the
housing.
The method comprises coupling the RF component to at least one scalpet of the
scalpet array.
The method comprises coupling the RF component to the at least one scalpet of
the scalpet array via the housing.
The method comprises configuring the housing to be removeably coupled to a
control device, wherein the RF component is coupled to the control device.
The method comprises coupling a vacuum component at least one of the scalpet
device and the housing, and coupling a radio frequency (RF) component at least
one of
the scalpet device, the scalpet array, and the housing.
The method comprises configuring at least one of the scalpet device and the
housing to include a low-pressure zone.
The method comprises configuring at least one of the scalpet device, the
scalpet
array, and the housing to receive energy from the RF component.
The energy comprises at least one of thermal energy, vibrational energy,
rotational energy, and acoustic energy.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
The target site includes a donor site, wherein the plurality of incised skin
pixels is
harvested at the donor site.
The target site includes a recipient site, wherein the incised skin pixels
generate
skin defects at the recipient site.
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The method comprises configuring an adherent substrate to capture the
plurality
of incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to
the recipient site.
The method comprises configuring the adherent substrate to maintain relative
positioning of the plurality of incised skin pixels during transfer to and
application at the
recipient site.
The method comprises configuring the adherent substrate to apply the incised
skin
pixels to the skin defects at the recipient site.
The method comprises configuring the adherent substrate to align the incised
skin
pixels with the skin defects at the recipient site.
The method comprises configuring the adherent substrate to insert each incised
skin pixel into a corresponding skin defect at the recipient site.
The method comprises configuring at least one bandage for application at the
target site.
The method comprises configuring the at least one bandage to apply force to
close
the target site.
The method comprises configuring the at least one bandage to apply directional
force to control a direction of the closure at the target site.
The at least one bandage includes a first bandage configured for application
at the
donor site.
The at least one bandage includes a second bandage configured for application
at
the recipient site.
The method comprises configuring the scalpet device to transfer a load to
subjacent skin surface that includes the target site, wherein the skin pixels
are incised by
application of the load.
The method comprises configuring the scalpet array to transfer a load to
subjacent
skin surface that includes the target site, wherein the skin pixels are
incised by
application of the load.
The method comprises configuring the scalpet device to be disposable.
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The method comprises configuring the scalpet device to be at least one of
cleaned,
disinfected, and sterilized.
The method comprises configuring a template for positioning at the target
site.
The method comprises configuring the scalpet device to align with the
template.
The method comprises configuring the scalpet array to align with the template.
The template is on a skin surface at the target site.
The template comprises an indicator on the skin surface at the target site.
The template includes a guide plate configured for positioning at the target
site
and comprising perforations arranged in a pattern.
The scalpet array is removeably coupled to the scalpet device.
The scalpet array is disposable.
A shape of each scalpet of the scalpet array is elliptical.
A shape of each scalpet of the scalpet array is circular.
A shape of each scalpet of the scalpet array is semicircular.
A shape of each scalpet of the scalpet array is one of square, rectangular,
and flat.
Each scalpet of the at least one scalpet includes a beveled surface.
Each scalpet of the plurality of scalpets includes at least one pointed
surface.
Each scalpet of the plurality of scalpets includes at least one needle.
The at least one needle comprises at least one needle including multiple
points.
The method comprises configuring the scalpet array to generate the incised
skin
pixels using at least one of piercing force, impact force, and rotational
force.
The method comprises configuring the scalpet array to generate the incised
skin
pixels using radio frequency (RF) energy.
The method comprises configuring the scalpet array to generate the incised
skin
pixels using vibrational energy.
At least one scalpet of the scalpet array comprises a through orifice.
At least one diametric dimension of each scalpet of the scalpet array is
approximately in a range 0.5 millimeters to 4.0 millimeters.
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The method comprises configuring a guide plate for positioning as a template
at
the target site, wherein the guide plate includes perforations arranged in a
pattern.
The method comprises configuring the scalpet array to align with the
perforations
in the guide plate.
The method comprises configuring the scalpet array to be applied to a donor
site
via the perforations in the guide plate, wherein the plurality of skin pixels
are incised.
The method comprises configuring the scalpet array to be applied to a
recipient
site via the perforations in the guide plate, wherein a plurality of skin
defects are
generated.
The target site includes the donor site and the recipient site.
The plurality of incised skin pixels and the plurality of skin defects are
generated
according to the pattern.
The method comprises configuring an adherent substrate to capture the
plurality
of incised skin pixels at the donor site and transfer the plurality of incised
skin pixels to
the recipient site.
The method comprises configuring the adherent substrate to maintain relative
positioning of the plurality of incised skin pixels during transfer to and
application at the
recipient site.
The method comprises configuring the scalpet array to be applied to the donor
site
directly through the perforations to incise the skin pixels.
The method comprises configuring the scalpet array to be applied to the
recipient
site directly through the perforations to generate the skin defects.
The method comprises configuring the guide plate to be at least one of
adherent,
rigid, semi-rigid, conformable, non-conformable, and non-deformable.
The method comprises configuring the guide plate to include at least one of
metal,
plastic, polymer, and membranous material.
The method comprises configuring the guide plate to transmit a load to a skin
surface of at least one of the donor site and the recipient site.
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The method comprises configuring the guide plate to be positioned directly on
a
skin surface at the target site.
The method comprises configuring the guide plate to extrude the plurality of
incised skin pixels.
The plurality of skin pixels is extruded through the perforations in response
to an
applied load.
The plurality of skin pixels is extruded through the incised skin surface in
response to an applied load.
The method comprises configuring at least one of the housing, the scalpet
device,
and the scalpet array for use with a cutting member.
The incised skin pixels are transected by the cutting member.
The method comprises configuring an adherent substrate to capture the incised
skin pixels.
The method comprises configuring the cutting member to be coupled to a frame.
The frame is coupled to a guide plate, wherein the guide plate is configured
as a
guide for the scalpet device.
The method comprises configuring the adherent substrate to be coupled to at
least
one of the frame and the guide plate.
The incised skin pixels include hair follicles.
The method comprises configuring the skin defects to evoke neovascularization
in
the incised skin pixels inserted at the recipient site.
The method comprises configuring the skin defects to evoke a wound healing
response in the incised skin pixels inserted at the recipient site.
Embodiments include a method comprising configuring a housing to include a
scalpet device. The method includes configuring the scalpet device to include
a scalpet
array comprising a plurality of scalpets arranged in a pattern. The plurality
of scalpets is
configured to be deployed from the housing and generate a plurality of incised
skin pixels
at a target site.
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Embodiments include a method comprising: configuring a housing to include a
scalpet device; and configuring the scalpet device to include a scalpet array
comprising a
plurality of scalpets arranged in a pattern, wherein the plurality of scalpets
is configured
to be deployed from the housing and generate a plurality of incised skin
pixels at a target
site.
Embodiments include a method comprising configuring a control device to
include a proximal end and a distal end. The proximal end includes an
actuator. The
method includes configuring a housing to include a scalpet device and for
removeable
coupling to the distal end of the control device. The method includes
configuring the
scalpet device to include a scalpet array comprising a plurality of scalpets
arranged in a
pattern. The plurality of scalpets is configured to be deployed from the
housing to
generate a plurality of incised skin pixels at a target site when deployed.
Embodiments include a method comprising: configuring a control device to
include a proximal end and a distal end, wherein the proximal end includes an
actuator;
configuring a housing to include a scalpet device and for removeable coupling
to the
distal end of the control device; and configuring the scalpet device to
include a scalpet
array comprising a plurality of scalpets arranged in a pattern, wherein the
plurality of
scalpets is configured to be deployed from the housing to generate a plurality
of incised
skin pixels at a target site when deployed.
Unless the context clearly requires otherwise, throughout the description, the
words "comprise," "comprising," and the like are to be construed in an
inclusive sense as
opposed to an exclusive or exhaustive sense; that is to say, in a sense of
"including, but
not limited to." Words using the singular or plural number also include the
plural or
singular number respectively. Additionally, the words "herein," "hereunder,"
"above,"
"below," and words of similar import, when used in this application, refer to
this
application as a whole and not to any particular portions of this application.
When the
word "or" is used in reference to a list of two or more items, that word
covers all of the
following interpretations of the word: any of the items in the list, all of
the items in the
list and any combination of the items in the list.
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The above description of embodiments is not intended to be exhaustive or to
limit
the systems and methods to the precise forms disclosed. While specific
embodiments of,
and examples for, the medical devices and methods are described herein for
illustrative
purposes, various equivalent modifications are possible within the scope of
the systems
and methods, as those skilled in the relevant art will recognize. The
teachings of the
medical devices and methods provided herein can be applied to other systems
and
methods, not only for the systems and methods described above.
The elements and acts of the various embodiments described above can be
combined to provide further embodiments. These and other changes can be made
to the
medical devices and methods in light of the above detailed description.
In general, in the following claims, the terms used should not be construed to
limit
the medical devices and methods and corresponding systems and methods to the
specific
embodiments disclosed in the specification and the claims, but should be
construed to
include all systems that operate under the claims. Accordingly, the medical
devices and
methods and corresponding systems and methods are not limited by the
disclosure, but
instead the scope is to be determined entirely by the claims.
While certain aspects of the medical devices and methods and corresponding
systems and methods are presented below in certain claim forms, the inventors
contemplate the various aspects of the medical devices and methods and
corresponding
systems and methods in any number of claim forms. Accordingly, the inventors
reserve
the right to add additional claims after filing the application to pursue such
additional
claim forms for other aspects of the medical devices and methods and
corresponding
systems and methods.
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