Note: Descriptions are shown in the official language in which they were submitted.
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
PIXEL ARRAY MEDICAL SYSTEMS, DEVICES AND METHODS
Inventor:
Edward KNOWLTON
RELATED APPLICATIONS
This application claims the benefit of United States (US) Patent Application
Number 62/294,136, filed February 11, 2016.
This application is a continuation in part of US Patent Application Number
15/016,954, filed February 5, 2016.
This application is a continuation in part of US Patent Application Number
15/017,007, filed February 5, 2016.
This application is a continuation in part of US Patent Application Number
14/840,274, filed August 31, 2015.
This application is a continuation in part of US Patent Application Number
14/840,284, filed August 31, 2015.
This application is a continuation in part of US Patent Application Number
14/840,267, filed August 31, 2015.
This application is a continuation in part of US Patent Application Number
14/840,290, filed August 31, 2015.
This application is a continuation in part of US Patent Application Number
14/840,307, filed August 31, 2015.
This application is a continuation in part of US Patent Application Number
14/505,090, filed October 2, 2014.
This application is a continuation in part of US Patent Application Number
14/505,183, filed October 2, 2014.
This application is a continuation in part of US Patent Application Number
14/099,380, filed December 6, 2013.
1
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
This application is a continuation in part of US Patent Application Number
14/556,648, filed December 1, 2014, which is a continuation of US Patent
Application
Number 12/972,013, filed December 17, 2010, now US Patent Number 8,900,181.
This application is related to US Patent Application Number 62/456,775, filed
February 9, 2017.
TECHNICAL FIELD
The embodiments herein relate to medical systems, instruments or devices, and
methods and, more particularly, to medical instrumentation and methods applied
to
fractional resection of skin and fat.
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
2
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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.
3
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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
4
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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.
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.
5
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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 dennatome (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.
Figure 14A shows an assembled view of the dermatome with the Pixel Onlay
Sleeve (POS), under an embodiment.
6
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Figure 148 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.
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.
7
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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.
8
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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.
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.
Figure 43 is a scalpet showing the applied rotational and/or impact forces,
under
an embodiment.
Figure 44 shows a geared scalpet and an array including geared scalpets, under
an
embodiment.
Figure 45 is a bottom perspective view of a resection device including the
scalpet
assembly with geared scalpet array, under an embodiment.
9
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
Figure 46 is a bottom perspective view of the scalpet assembly with geared
scalpet array (housing not shown), under an embodiment.
Figure 47 is a detailed view of the geared scalpet array, under an embodiment.
Figure 48 shows an array including scalpets in a frictional drive
configuration,
under an embodiment.
Figure 49 shows a helical scalpet (external) and an array including helical
scalpets (external), under an embodiment.
Figure 50 shows side perspective views of a scalpet assembly including a
helical
scalpet array (left), and the resection device including the scalpet assembly
with helical
scalpet array (right) (housing shown), under an embodiment.
Figure 51 is a side view of a resection device including the scalpet assembly
with
helical scalpet array assembly (housing depicted as transparent for clarity of
details),
under an embodiment.
Figure 52 is a bottom perspective view of a resection device including the
scalpet
assembly with helical scalpet array assembly (housing depicted as transparent
for clarity
of details), under an embodiment.
Figure 53 is a top perspective view of a resection device including the
scalpet
assembly with helical scalpet array assembly (housing depicted as transparent
for clarity
of details), under an embodiment.
Figure 54 is a push plate of the helical scalpet array, under an embodiment.
Figure 55 shows the helical scalpet array with the push plate, under an
embodiment.
Figure 56 shows an inner helical scalpet and an array including inner helical
scalpets, under an embodiment.
Figure 57 shows the helical scalpet array with the drive plate, under an
embodiment.
Figure 58 shows a slotted scalpet and an array including slotted scalpets,
under an
embodiment.
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Figure 59 shows a portion of a slotted scalpet array (e.g., four (4) scalpets)
with
the drive rod, under an embodiment.
Figure 60 shows an example slotted scalpet array (e.g., 25 scalpets) with the
drive
rod, under an embodiment.
Figure 61 shows an oscillating pin drive assembly with a scalpet, under an
embodiment.
Figure 62 shows variable scalpet exposure control with the scalpet guide
plates,
under an embodiment.
Figure 63 shows a scalpet assembly including a scalpet array (e.g., helical)
configured to be manually driven by an operator, under an embodiment.
Figure 64 shows forces exerted on a scalpet via application to the ski.
Figure 65 depicts steady axial force compression using a scalpet, under an
embodiment.
Figure 66 depicts steady single axial force compression plus kinetic impact
force
using a scalpet, under an embodiment.
Figure 67 depicts moving of the scalpet at a velocity to impact and pierce the
skin, under an embodiment.
Figure 68 depicts a multi-needle tip, under an embodiment.
Figure 69 shows a square scalpet without teeth (left), and a square scalpet
with
multiple teeth (right), under an embodiment.
Figure 70 shows multiple side, front (or back), and side perspective views of
a
round scalpet with an oblique tip, under an embodiment.
Figure 71 shows a round scalpet with a serrated edge, under an embodiment.
Figure 72 shows a side view of the resection device including the scalpet
assembly with scalpet array and extrusion pins (housing depicted as
transparent for
clarity of details), under an embodiment.
Figure 73 shows a top perspective cutaway view of the resection device
including
the scalpet assembly with scalpet array and extrusion pins (housing depicted
as
transparent for clarity of details), under an embodiment.
11
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
Figure 74 shows side and top perspective views of the scalpet assembly
including
the scalpet array and extrusion pins, under an embodiment.
Figure 75 is a side view of a resection device including the scalpet assembly
with
scalpet array assembly coupled to a vibration source, under an embodiment.
Figure 76 shows a scalpet array driven by an electromechanical source or
scalpet
array generator, under an embodiment.
Figure 77 is a diagram of the resection device including a vacuum system,
under
an embodiment.
Figure 78 shows a vacuum manifold applied to a target skin surface to
evacuate/harvest excised skin/hair plugs, under an embodiment.
Figure 79 shows a vacuum manifold with an integrated wire mesh applied to a
target skin surface to evacuate/harvest excised skin/hair plugs, under an
embodiment.
Figure 80 shows a vacuum manifold with an integrated wire mesh configured to
vacuum subdermal fat, under an embodiment.
Figure 81 depicts a collapsible docking station and an inserted skin pixel,
under
an embodiment. The docking station is formed from elastomeric material but is
not so
limited.
Figure 82 is a top view of a docking station (e.g., elastomeric) in stretched
(left)
and un-stretched (right) configuration, under an embodiment, under an
embodiment.
Figure 83 depicts removal of lax excess skin without apparent scarring, under
an
embodiment.
Figure 84 depicts tightening of skin without apparent scaring, under an
embodiment.
Figure 85 depicts three-dimensional contouring of the skin envelop, under an
embodiment.
Figure 86 depicts variable fractional resection densities in a treatment area,
under
an embodiment.
Figure 87 depicts fractional resection of fat, under an embodiment.
Figure 88 depicts cobblestoning of the skin surface.
12
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Figure 89 depicts topographic mapping for a deeper level of fractional fat
resection, under an embodiment.
Figure 90 depicts multiple treatment outlines, under an embodiment.
Figure 91 depicts a curvilinear treatment pattern, under an embodiment.
Figure 92 depicts a digital image of a patient with rendered digital wire mesh
program, under an embodiment.
Figure 93 depicts directed closure of a fractionally resected field, under an
embodiment.
Figure 94 depicts directed fractional resection of skin, under an embodiment.
Figure 95 depicts shortening of incisions through continuity fractional
procedures, under an embodiment.
Figure 96 is an example depiction of "dog ear" skin redundancies in breast
reduction and abdominoplasty.
Figure 97 is a scalpet device including a single skived scalpet with depth
control,
under an embodiment.
Figure 98 is a scalpet device including a standard single scalpet, under an
embodiment.
Figure 99 is a scalpet device including a pencil-style gear-reducing carrier,
under
an embodiment.
Figure 100 is a scalpet device including a multi-scalpet (e.g,, 3x3) array,
under an
embodiment.
Figure 101 shows the scalpet device including a cordless surgical drill
carrier,
under an embodiment.
Figure 102 shows an example scalpet device comprising a 5x5 centerless array
used with a surgical drill carrier, under an embodiment.
Figure 103 is a scalpet device including a vacuum assisted pneumatic resection
device, under an embodiment.
13
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Figure 104 is a detailed view of the distal region of the VAPR scalpet device
including the scalpet assembly coupled to a carrier drill using a CAC, under
an
embodiment.
Figure 105 shows the scalpet assembly of the VAPR in a ready state (left), and
an
extended treatment state (right), under an embodiment.
Figure 106 depicts the SAVR device in a ready state (left), and a retracted
state
(right), under an embodiment.
DETAILED DESCRIPTION
Embodiments include devices and methods configured to fractionally resect skin
and/or fat. Fractional resection is applied as a stand-alone procedure in
anatomical areas
that are off-limits to conventional plastic surgery due to the poor tradeoff
between the
visibility of the incisional scar and amount of enhancement obtained.
Fractional
resection is also applied as an adjunct to established plastic surgery
procedures such as
liposuction, and is employed to significantly reduce the length of incisions
required for a
particular application. The shortening of incisions has application in both
the aesthetic
and reconstructive realms of plastic surgery.
Embodiments include a device comprising a carrier, and a chuck coupled to a
distal region of the carrier. The device includes a scalpet assembly
comprising at least
one scalpet and a depth control device. The scalpet assembly includes a shank
configured for retention in the chuck. The at least one scalpet includes a
tube comprising
a hollow region and a sharpened distal end configured to penetrate tissue at a
target site.
The depth control device is configured to control a depth of the penetration
of the at least
one scalpet into the tissue.
Embodiments include a device comprising a carrier comprising a proximal region
and a distal region. The proximal region is configured to be hand-held. The
device
includes a scalpet assembly comprising a plurality of scalpets. The scalpet
assembly
includes a drive assembly configured to impart a rotational force to the
plurality of
scalpets to rotate each scalpet around a central axis. Each scalpet includes a
scalpet shaft
14
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
comprising a proximal end, and a distal end configured to penetrate tissue at
a target site.
The scalpet shaft includes a hollow region adjacent to the distal end and
configured to
pass tissue received through the distal end. The scalpet shaft includes an
orifice coupled
to the hollow region and configured to pass the received tissue out of the
scalpet shaft.
Embodiments include a method comprising configuring a resection device to
include a scalpet assembly comprising a scalpet array and a depth control
device. The
scalpet array includes a plurality of scalpets, and each scalpet includes a
tube comprising
a hollow region and a distal end configured to penetrate tissue at a target
site. The distal
end includes at least one of a sharpened region and a blunt region. The depth
control
device is configured to control a depth of the penetration of the scalpet
array into the
tissue. The method includes configuring the resection device for operation at
the target
site according to a protocol including a map of fractional resections. The
method
includes configuring the resection device for performing the fractional
resections by
incising skin pixels at the target site. The method includes configuring the
resection
device for removing at least one of the fractionally resected skin pixels and
fat from the
target site.
Systems, instruments, and methods are described in which a scalpet device
comprises a housing configured to include a scalpet assembly. The scalpet
assembly
includes a scalpet array and one or more guide plates. The scalpet array
includes a set of
scalpets, and in embodiments the set of scalpets include multiple scalpets.
The guide
plate maintains a configuration of the set of scalpets. The set of scalpets is
configured to
be deployed from and retracted into the housing, and is configured to generate
incised
skin pixels at a target site when deployed. The incised skin pixels are
harvested.
The scalpet device described herein satisfies the expanding aesthetic market
for
instrumentation and procedures for aesthetic surgical skin tightening.
Additionally, the
embodiments 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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
16
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
17
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
"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.
"Burn 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.
"Burn 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.
18
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
"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 corneum that acts as a biological
barrier.
"Excise" as used herein includes the surgical removal of tissue.
"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
19
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
partially achieved with immunosuppression but homografts are eventually
replaced by
auto grafts 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
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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
"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.
21
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
"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
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
22
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
perfourr 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 Flexan0 sheet. Functioning as a large butterfly bandage, the
Flexan
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
23
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
24
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
recipient skin defect site. The fractionally resected donor site is closed
with the
application of an adherent Flexanll 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
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
26
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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 Flexan0 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.
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.
27
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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
28
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
transection, under an embodiment. At the donor site, the pixelated skin
resection sites are
closed with the application of Flexan0 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
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
29
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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.
31
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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.
32
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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 131) 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.
33
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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 (PUS) 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
(PUS), under an embodiment. The PUS 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.
Figure 148 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
34
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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.
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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
36
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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
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
37
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
38
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
control device is configured to be hand-held. The housing is configured to be
removeably 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
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
39
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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.
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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
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
41
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
42
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
43
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
44
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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
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
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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.
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
46
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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.
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.
47
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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
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
48
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
49
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
51
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
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
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
52
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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
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
53
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
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.
Fractional resection as described herein is performed intradermally or through
the
entire thickness of the dermis. The ability to incise skin with a scalpet
(e.g., round,
square, elliptical, etc.) is enhanced with the addition of additional
force(s). The
additional force includes force applied to the scalpet or scalpet array, for
example, where
the force comprises one or more of rotational force, kinetic impact force, and
vibrational
force, all of which are described in detail herein for skin fractional
resection.
The scalpet device of an embodiment generally includes a scalpet assembly and
a
housing. The scalpet assembly includes a scalpet array, which comprises a
number of
54
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
scalpets, and force or drive components. The scalpet assembly includes one or
more
alignment plates configured to retain and position the scalpets precisely
according to the
configuration of the scalpet array, and to transmit force (e.g., z-axis) from
the operator to
the subject tissue targeted for resection. The scalpet assembly includes
spacers
configured to retain alignment plates at a fixed distance apart and coaxial
with the scalpet
array, but is not so limited.
A shell is configured to retain the spacers and the alignment plates, and
includes
attachment point(s) for the housing and drive shaft. The alignment plates
and/or the
spacers are attached or connected (e.g., snapped, welded (e.g., ultrasonic,
laser, etc.),
heat-staked, etc.) into position in the shell, thereby providing a rigid
assembly and
discourages tampering or re-purposing of the scalpet array. Additionally, the
shell
protects the drive mechanism or gearing and scalpets from contamination during
use and
allows lubrication (if required) to be applied to the gearing to reduce the
torque
requirement and increase the life of the gears.
As an example of the application of force using the embodiments herein, the
ability to incise skin with a circular scalpet is enhanced with the addition
of a rotational
torque. The downward axial force used to incise the skin is significantly
reduced when
applied in combination with a rotational force. This enhanced capability is
similar to a
surgeon incising skin with a standard scalpel where the surgeon uses a
combination of
movement across the skin (kinetic energy) with the simultaneous application of
compression (axial force) to more effectively cut the skin surface.
For piercing the skin, the amount of surface compression required is
significantly
reduced if a vertical kinetic force is employed simultaneously. For example, a
dart
throwing technique for injections has previously been used by healthcare
providers for
piercing skin. An "impactor" action imparted on skin by a circular scalpet of
an
embodiment enhances this modality's cutting capability by simultaneously
employing
axial compressive and axial kinetic forces. The axial compressive force used
to incise the
skin surface is significantly reduced if applied in combination with kinetic
force.
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Conventional biopsy punches are intended for a single use application in the
removal of tissue, which is generally achieved by pushing the punch directly
into the
tissue along its central axis. Similarly, the fractional resection of an
embodiment uses
scalpets comprising a circular configuration. While the scalpets of an
embodiment can be
used in a stand-alone configuration, alternative embodiments include scalpet
arrays in
which scalpets are bundled together in arrays of various sizes configured to
remove
sections of skin, but are not so limited. The force used to pierce the skin
using the
fractional resection scalpet is a function of the number of scalpets in the
array, so that as
the array size increases the force used to pierce the skin increases.
The ability to incise skin with a circular scalpet is significantly enhanced
with a
reduction in the force needed to pierce the skin introduced through the
addition of a
rotational motion around its central axis and/or an impact force along its
central axis.
Figure 43 is a scalpet showing the applied rotational and/or impact forces,
under an
embodiment. This enhanced rotational configuration has an affect similar to a
surgeon
incising skin with a standard scalpel where the surgeon uses a combination of
movement
across the skin (kinetic energy) with the simultaneous application of
compression (axial
force) to more effectively cut the skin surface. The impact force is similar
to the use of a
staple gun or by quickly moving a hypodermic needle prior to impacting the
skin.
A consideration in the configuration of the scalpet rotation is the amount of
torque
used to drive multiple scalpets at a preferred speed, because the physical
size and power
of the system used to drive the scalpet array increases as the required torque
increases.
To reduce the incisional force required in a scalpet array, rows or columns or
segments of
the array may be individually driven or sequentially driven during an array
application.
Approaches for rotating the scalpets include but are not limited to geared,
helical, slotted,
inner helical, pin driven, and frictional (elastomeric).
The scalpet array configured for fractional resection using combined rotation
and
axial incision uses one or more device configurations for rotation. For
example, the
scalpet array of the device is configured to rotate using one or more of
geared, external
helical, inner helical, slotted, and pin drive rotating or oscillating
mechanisms, but is not
56
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
so limited. Each of the rotation mechanisms used in various embodiments is
described in
detail herein.
Figure 44 shows a geared scalpet and an array including geared scalpets, under
an
embodiment. Figure 45 is a bottom perspective view of a resection device
including the
scalpet assembly with geared scalpet array, under an embodiment. The device
comprises
a housing (depicted as transparent for clarity of details) configured to
include the geared
scalpet array for the application of rotational torque for scalpet rotation.
Figure 46 is a
bottom perspective view of the scalpet assembly with geared scalpet array
(housing not
shown), under an embodiment. Figure 47 is a detailed view of the geared
scalpet array,
under an embodiment.
The geared scalpet array includes a number of scalpets as appropriate to a
resection procedure in which the array is used, and a gear is coupled or
connected to each
scalpet. For example, the gear is fitted over or around a scalpet, but the
embodiment is
not so limited. The geared scalpets are configured as a unit or array so that
each scalpet
rotates in unison with adjacent scalpets. For example, once fit, the geared
scalpets are
installed together in alignment plates so that each scalpet engages and
rotates in unison
with its adjacent four scalpets and is thereby retained in precise alignment.
The geared
scalpet array is driven by at least one rotating external shaft carrying a
gear at the distal
end, but is not so limited. The rotational shaft(s) is configured to provide
or transmit the
axial force, which compresses the scalpets of the array into the skin during
incision.
Alternatively, axial force may be applied to the plates retaining the
scalpets.
In an alternative embodiment, a frictional drive is used to drive or rotate
the
scalpets of the arrays. Figure 48 shows an array including scalpets in a
frictional drive
configuration, under an embodiment. The frictional drive configuration
includes an
elastomeric ring around each scalpet, similar to gear placement in the geared
embodiment, and frictional forces between the rings of adjacent scalpets in
compression
results in rotation of the scalpets similar to the geared array.
The resection devices comprise helical scalpet arrays, including but not
limited to
external and internal helical scalpet arrays. Figure 49 shows a helical
scalpet (external)
57
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
and an array including helical scalpets (external), under an embodiment.
Figure 50
shows side perspective views of a scalpet assembly including a helical scalpet
array (left),
and the resection device including the scalpet assembly with helical scalpet
array (right)
(housing shown), under an embodiment. Figure 51 is a side view of a resection
device
including the scalpet assembly with helical scalpet array assembly (housing
depicted as
transparent for clarity of details), under an embodiment. Figure 52 is a
bottom
perspective view of a resection device including the scalpet assembly with
helical scalpet
array assembly (housing depicted as transparent for clarity of details), under
an
embodiment. Figure 53 is a top perspective view of a resection device
including the
scalpet assembly with helical scalpet array assembly (housing depicted as
transparent for
clarity of details), under an embodiment.
The helical scalpet configuration comprises a sleeve configured to fit over an
end
region of the scalpet, and an external region of the sleeve includes one or
more helical
threads. Once each scalpet is fitted with a sleeve, the sleeved scalpets are
configured as a
unit or array so that each scalpet rotates in unison with the adjacent
scalpets.
Alternatively, the helical thread is formed on or as a component of each
scalpet.
The helical scalpet array is configured to be driven by a push plate that
oscillates
up and down along a region of the central axis of the scalpet array. Figure 54
is a push
plate of the helical scalpet array, under an embodiment. The push plate
includes a
number of alignment holes corresponding to a number of scalpets in the array.
Each
alignment hole includes a notch configured to mate with the helical (external)
thread on
the scalpet sleeve. When the push plate is driven it causes rotation of each
scalpet in the
array. Figure 55 shows the helical scalpet array with the push plate, under an
embodiment.
The resection devices further comprise internal helical scalpet arrays. The
device
comprises a housing configured to include the helical scalpet array assembly
for the
application of rotational torque for scalpet rotation. Figure 56 shows an
inner helical
scalpet and an array including inner helical scalpets, under an embodiment.
The inner
helical scalpet includes a twisted square rod (e.g., solid, hollow, etc.) or
insert that is
58
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
fitted into an open end of the scalpet. Alternatively, the scalpet is
configured to include a
helical region. The twisted insert is held in place by bonding (e.g.,
crimping, bonding,
brazing, welding, gluing, etc.) a portion of the scalpet around the insert.
Alternative, the
insert is held in place with an adhesive bond. Inner helical scalpets are then
configured
as a unit or array so that each scalpet is configured to rotate in unison with
the adjacent
scalpets. The helical scalpet array is configured to be driven by a drive
plate that moves
or oscillates up and down along the helical region of each scalpet of the
scalpet array.
The drive plate includes a number of square alignment holes corresponding to a
number
of scalpets in the array. When the drive plate is driven up and down it causes
rotation of
each scalpet in the array. Figure 57 shows the helical scalpet array with the
drive plate,
under an embodiment.
Figure 58 shows a slotted scalpet and an array including slotted scalpets,
under an
embodiment. The slotted scalpet configuration comprises a sleeve configured to
fit over
an end region of the scalpet, and the sleeve includes one or more spiral
slots.
Alternatively, each scalpet includes the spiral slot(s) without use of the
sleeve. The
sleeved scalpets are configured as a unit or array so that the top region of
the slots of each
scalpet are aligned adjacent one another. An external drive rod is aligned and
fitted
horizontally along the top of the slots. When the drive rod is driven
downward, the result
is a rotation of the scalpet array. Figure 59 shows a portion of a slotted
scalpet array
(e.g., four (4) scalpets) with the drive rod, under an embodiment. Figure 60
shows an
example slotted scalpet array (e.g., 25 scalpets) with the drive rod, under an
embodiment.
Figure 61 shows an oscillating pin drive assembly with a scalpet, under an
embodiment. The assembly includes a lower plate and a middle plate coupled or
connected to the scalpet(s) and configured to retain the scalpet(s). A top
plate, or drive
plate, is positioned in an area above the scalpet and the middle plate, and
includes a drive
slot or slot. A pin is coupled or connected to a top portion of the scalpet,
and a top region
of the pin extends beyond a top of the scalpet. The slot is configured to
receive and
loosely retain the pin. The slot is positioned relative to the pin such that
rotation or
59
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
oscillation of the top plate causes the scalpet to rotate or oscillate via
tracking of the pin
in the slot.
One or more components of the scalpet device include an adjustment configured
to control the amount (e.g., depth) of scalpet exposure during deployment of
the scalpet
array at the target site. For example, the adjustment of an embodiment is
configured to
collectively control a length of deployment of the scalpets of a scalpet
array. The
adjustment of an alternative embodiment is configured to collectively control
a length of
deployment of a portion or set of scalpets of a scalpet array. In another
example
embodiment, the adjustment is configured to separately control a length of
deployment of
each individual scalpet of a set of scalpets or scalpet array. The scalpet
depth control
includes numerous mechanisms configured for adjustable control of scalpet
depth.
The depth control of an embodiment includes an adjustable collar or sleeve on
each scalpet. The collar, which is configured for movement (e.g., slideable,
etc.) along a
length of the scalpet, is configured to prevent penetration of the scalpet
into target tissue
beyond a depth controlled by a position of the collar. The position of the
collar is
adjusted by a user of the scalpet device prior to use in a procedure, where
the adjustment
includes one or more of a manual adjustment, automatic adjustment, electronic
adjustment, pneumatic adjustment, and adjustment under software control, for
example.
The depth control of an alternative embodiment includes an adjustable plate
configured for movement along a length of scalpets of the scalpet array. The
plate is
configured to prevent penetration of the scalpets of the scalpet array into
target tissue
beyond a depth controlled by a position of the plate. In this manner, the
scalpet array is
deployed into the target tissue to a depth equivalent to a length of the
scalpets protruding
beyond the plate. The position of the plate is adjusted by a user of the
scalpet device
prior to use in a procedure, where the adjustment includes one or more of a
manual
adjustment, automatic adjustment, electronic adjustment, pneumatic adjustment,
and
adjustment under software control, for example.
As an example of depth control adjustment using a plate, the variable length
scalpet exposure is controlled through adjustments of the scalpet guide plates
of the
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
scalpet assembly, but is not so limited. Figure 62 shows variable scalpet
exposure
control with the scalpet guide plates, under an embodiment. Alternative
embodiments
control scalpet exposure from within the scalpet array handpiece, and/or under
one or
more of software, hardware, and mechanical control.
Embodiments include a mechanical scalpet array in which axial force and
rotational force are applied manually by the compressive force from the device
operator.
Figure 63 shows a scalpet assembly including a scalpet array (e.g., helical)
configured to
be manually driven by an operator, under an embodiment.
Embodiments include and/or are coupled or connected to a source of rotation
configured to provide optimal rotation (e.g., RPM) and rotational torque to
incise skin in
combination with axial force. Optimal rotation of the scalpets is configured
according to
the best balance between rotational velocity and increased cutting efficiency
versus
increased frictional losses. Optimal rotation for each scalpet array
configuration is based
on one or more of array size (number of scalpets), scalpet cutting surface
geometry,
material selection of scalpets and alignment plates, gear materials and the
use of
lubrication, and mechanical properties of the skin, to name a few.
Regarding forces to be considered in configuration of the scalpets and scalpet
arrays described herein, Figure 64 shows forces exerted on a scalpet via
application to
the skin. The parameters considered in determining applicable forces under an
embodiment include the following:
Average Scalpet Radius: r
Scalpet Rotation Rate: co
Scalpet Axial Force: Fn (scalpet applied normal to skin)
Skin Friction Coefficient: 11
Friction Force: Ff
Scalpet Torque:
Motor Power: Phi,
61
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Upon initial application, the torque used to rotate the scalpet is a function
of the
axial force (applied normally to the surface of the skin) and the coefficient
of friction
between the scalpet and the skin. This friction force initially acts on the
cutting surface
of the scalpet. At initial application of scalpet to skin:
Ff=tF0
= Fr
Php = 0a/63025
The initial force for the scalpet to penetrate the skin, is a function of the
scalpet
sharpness, the axial force, the tensile strength of the skin, the coefficient
of friction
between the skin and the scalpet. Following penetration of the scalpet into
the skin, the
friction force increases as there are additional friction forces acting on the
side walls of
the scalpet.
Resection devices of embodiments include kinetic impaction incision devices
and
methods for non-rotational piercing of the skin. Approaches for direct
compression of
the scalpet into the skin include, but are not limited to, axial force
compression, single
axial force compression plus kinetic impact force, and moving of the scalpet
at a high
velocity to impact and pierce the skin. Figure 65 depicts steady axial force
compression
using a scalpet, under an embodiment. Steady axial force compression places
the scalpet
in direct contact with the skin. Once in place, a continuous and steady axial
force is
applied to the scalpet until it pierces the skin and proceeds through the
dermis to the
subcutaneous fat layer.
Figure 66 depicts steady single axial force compression plus kinetic impact
force
using a scalpet, under an embodiment. Steady single axial force compression
plus kinetic
impact force places the scalpet in direct contact with the skin. An axial
force is applied to
maintain contact. The distal end of the scalpet is then struck by another
object, imparting
additional kinetic energy along the central axis. These forces cause the
scalpet to pierce
the skin and proceed through the dermis to the subcutaneous fat layer.
62
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
Figure 67 depicts moving of the scalpet at a velocity to impact and pierce the
skin, under an embodiment. The scalpet is positioned a short distance away
from a target
area of the skin. A kinetic force is applied to the scalpet to achieve a
desired velocity for
piercing the skin. The kinetic force causes the scalpet to pierce the skin and
proceed
through the dermis to the subcutaneous fat layer.
Scalpets of an embodiment include numerous cutting surface or blade geometries
as appropriate to an incision method of a procedure involving the scalpet. The
scalpet
blade geometries include, for example, straight edge (e.g., cylindrical),
beveled, multiple-
needle tip (e.g., sawtooth, etc.), and sinusoidal, but are not so limited. As
but one
example, Figure 68 depicts a multi-needle tip, under an embodiment.
The scalpets include one or more types of square scalpets, for example. The
square scalpets include but are not limited to, square scalpets without
multiple sharpened
points, and square scalpets with multiple sharpened points or teeth. Figure 69
shows a
square scalpet without teeth (left), and a square scalpet with multiple teeth
(right), under
an embodiment.
The fractional resection devices of an embodiment involve the use of a square
scalpet assembled onto a scalpet array that has multiple sharpened points to
facilitate skin
incising through direct non-rotational kinetic impacting. The square geometry
of the
harvested skin plug provides side-to-side and point-to-point approximation of
the
assembled skin plugs onto the adherent membrane. Closer approximation of the
skin
plugs provides a more uniform appearance of the skin graft at the recipient
site. In
addition, each harvested component skin plug will have additional surface area
(e.g., 20-
25%).
Further, the scalpets include one or more types of elliptical or round
scalpets. The
round scalpets include but are not limited to, round scalpets with oblique
tips, round
scalpets without multiple sharpened points or teeth, and round scalpets with
multiple
sharpened points or teeth. Figure 70 shows multiple side, front (or back), and
side
perspective views of a round scalpet with an oblique tip, under an embodiment.
Figure
71 shows a round scalpet with a serrated edge, under an embodiment.
63
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The resection device of an embodiment is configured to include extrusion pins
corresponding to the scalpets. Figure 72 shows a side view of the resection
device
including the scalpet assembly with scalpet array and extrusion pins (housing
depicted as
transparent for clarity of details), under an embodiment. Figure 73 shows a
top
perspective cutaway view of the resection device including the scalpet
assembly with
scalpet array and extrusion pins (housing depicted as transparent for clarity
of details),
under an embodiment. Figure 74 shows side and top perspective views of the
scalpet
assembly including the scalpet array and extrusion pins, under an embodiment.
The extrusion pins of an embodiment are configured to clear retained skin
plugs,
.. for example. The extrusion pins of an alternative embodiment are configured
to inject
into fractional defects at the recipient site. The extrusion pins of another
alternative
embodiment are configured to inject skin plugs into pixel canisters of a
docking station
for fractional skin grafting.
Embodiments herein include the use of a vibration component or system to
facilitate skin incising with rotation torque/axial force and to use vibration
to facilitate
skin incising with direct impaction without rotation. Figure 75 is a side view
of a
resection device including the scalpet assembly with scalpet array assembly
coupled to a
vibration source, under an embodiment.
Embodiments herein include an electro-mechanical scalpet array generator.
Figure 76 shows a scalpet array driven by an electromechanical source or
scalpet array
generator, under an embodiment. The function of the generator is powered but
is not
electronically controlled, but embodiments are not so limited. The platform of
an
embodiment includes control software.
Embodiments include and/or are coupled or connected to a supplementary energy
or force configured to reduce the axial force used to incise skin (or another
tissue surface
such as mucosa) by a scalpet in a scalpet array. Supplemental energies and
forces include
one or more of rotational torque, rotational kinetic energy of rotation (RPM),
vibration,
ultrasound, and electromagnetic energy (e.g., RF, etc.), but are not so
limited.
64
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
Embodiments herein include a scalpet array generator comprising and/or coupled
to an electromagnetic radiation source. The electromagnetic radiation source
includes,
for example, one or more of a Radio Frequency (RF) source, a laser source, and
an
ultrasound source. The electromagnetic radiation is provided to assist cutting
with the
scalpets.
Embodiments include a scalpet mechanism configured as a "sewing machine"
scalpet or scalpet array in which the scalpets are repeatedly retracted and
deployed under
one or more of manual, electromechanical, and electronic control. This
embodiment
includes a moving scalpet or scalpet array to resect a site row-by-row. The
resection can,
for example take the form of a stamping approach where the scalpet or scalpet
array
moves, or the array could be rolled over the surface to be treated and the
scalpet array
resection at given distances traveled to achieve the desired resection
density.
The fractional resection devices described herein are configured for
fractional
resection and grafting in which the harvesting of fractionally incised skin
plugs is
performed with a vacuum that deposits the plugs within the lumen of each
scalpet shaft.
The skin plugs are then inserted into a separate docking station described
herein by a
proximal pin array that extrudes the skin plug from within the shaft of the
scalpet.
Figure 77 is a diagram of the resection device including a vacuum system,
under
an embodiment. The vacuum system comprises vacuum tubing and a vacuum port
on/in
the device housing, configured to generate a vacuum within the housing by
drawing air
out of the housing. The vacuum of an embodiment is configured to provide
vacuum
stenting/fixturing of the skin for scalpet incising, thereby providing
improved depth
control and cutting efficiency.
The vacuum of an alternative embodiment is configured for vacuum evacuation or
harvesting of skin plugs and/or hair plugs through one or more of a scalpet
lumen and an
array manifold housing. Figure 78 shows a vacuum manifold applied to a target
skin
surface to evacuate/harvest excised skin/hair plugs, under an embodiment. The
vacuum
manifold, which is configured for direct application onto a skin surface, is
coupled or
connected to a vacuum source. Figure 79 shows a vacuum manifold with an
integrated
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
wire mesh applied to a target skin surface to evacuate/harvest excised
skin/hair plugs,
under an embodiment.
Additionally, an external vacuum manifold is used with a suction-assisted
lipectomy machine to percutaneously evacuate superficial sub-dermal fat
through
fractionally resection skin defects in a fractionally created field for the
treatment of
cellulite. Figure 80 shows a vacuum manifold with an integrated wire mesh
configured
to vacuum subdermal fat, under an embodiment.
The external vacuum manifold can also be configured to include and be deployed
with an incorporated docking station (described herein) to harvest skin plugs
for grafting.
The docking station can be one or more of static, expandable, and/or
collapsible.
The fractional resection devices described herein comprise a separate docking
station configured as a platform to assemble the fractionally harvested skin
plugs into a
more uniform sheet of skin for skin grafting. The docking station includes a
perforated
grid matrix comprising the same pattern and density of perforations as the
scalpets on the
scalpet array. A holding canister positioned subjacent to each perforation is
configured to
retain and maintain alignment of the harvested skin plug. In an embodiment,
the
epidermal surface is upward at the level of the perforation. In an alternative
embodiment,
the docking station is partially collapsible to bring docked skin plugs into
closer
approximation prior to capture onto an adherent membrane. The captured
fractional skin
graft on the adherent membrane is then defatted with either an incorporated or
non-
incorporated transection blade. In another alternative embodiment, the
adherent
membrane itself has an elastic recoil property that brings or positions the
captured skin
plugs into closed alignment. Regardless of embodiment, the contracted
fractional skin
graft/adherent membrane composite is then directly applied to the recipient
site defect.
Embodiments include a collapsible docking station or tray configured to accept
and maintain orientation of harvested skin and/or hair plugs once they have
been
removed or ejected from the scalpets via the extrusion pins. Figure 81 depicts
a
collapsible docking station and an inserted skin pixel, under an embodiment.
The
docking station is formed from elastomeric material but is not so limited. The
docking
66
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
station is configured for stretching from a first shape to a second shape that
aligns the
pixel receptacles with the scalpet array on the handpiece. Figure 82 is a top
view of a
docking station (e.g., elastomeric) in stretched (left) and un-stretched
(right)
configuration, under an embodiment, under an embodiment.
The pixels are ejected from the scalpet array into the docking station until
it is
full, and the docking station is then relaxed to its pre-stretched shape,
which has the
effect of bringing the pixels in closer proximity to each other. A flexible
semi-permeable
membrane with adhesive on one side is then stretched and placed over the
docking station
(adhesive side down). Once the pixels are adhered to the membrane, it is
lifted away
from the docking station. The membrane then returns to its normal un-stretched
state,
which also has the effect of pulling the pixels closer to each other. The
membrane is then
placed over the recipient defect.
Resection devices described herein include delivery of therapeutic agents
through
resectioned defects generated with the resection devices described herein. As
such, the
resection sites are configured for use as topically applied infusion sites for
delivery or
application of therapeutic agents for the reduction of fat cells (lipolysis)
during or after a
resectioning procedure.
Embodiments herein are configured for hair transplantation that includes
vacuum
harvesting of hair plugs into the scalpet at the donor site, and direct mass
injection
(without a separate collection reservoir) of harvested hair plugs into the
fractionally
resected defects of the recipient site. Under this embodiment, the donor
scalpet array
deployed at the occipital scalp comprises scalpets having a relatively larger
diameter than
the constituent scalpets of the scalpet array deployed to generate defects at
the recipient
site. Following harvesting of hair plugs at the donor site, the defects
generated at the
recipient site are plugged using the harvested hair plugs transferred in the
scalpet array.
Due to the elastic retraction of the incised dermis, the elastically retracted
diameter of the hair plug harvested at the occipital scalp will be similar to
the elastically
retracted diameter of the fractionally resected defect of the recipient site
at the frontal-
parietal- occipital scalp. In an embodiment, hair plugs harvested within the
donor scalpet
67
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
array are extruded directly with proximal pins in the lumen of the scalpet
into a same
pattern of fractionally defects created by the recipient site scalpet array.
The scalpets
(containing the donor hair plugs) of the scalpet array deployed at the donor
site are
aligned (e.g., visually) with the same pattern of fractionally resected field
of defects at the
recipient scalp site. Upon alignment, a proximal pin within the shaft of each
scalpet is
advanced down the shaft of the scalpet to extrude the hair plug into the
fractionally
resected defect of the recipient site, thereby effecting a simultaneous
transplantation of
multiple hair plugs to the recipient site. This mass transplantation of hair
plugs into a
fractionally resected recipient site (e.g., of a balding scalp) is more likely
to maintain the
hair shaft alignment with other mass transplanted hair plugs of that recipient
scalp site.
Directed closure of the donor site field is performed in the most clinically
effective
vector, but is not so limited.
The fractional resection devices described herein are configured for tattoo
removal. Many patients later in life desire removal of pigmented tattoos for a
variety of
.. reasons. Generally, removal of a tattoo involves the removal of the
impregnated pigment
within the dermis. Conventional tattoo removal approaches have been described
from
thermal ablation of the pigment to direct surgical excision. Thermal ablation
by lasers
frequently results in depigmentation or area surface scarring. Surgical
excision of a
tattoo requires the requisite linear scarring of a surgical procedure. For
many patients,
.. the tradeoff between tattoo removal and the sequela of the procedure can be
marginal.
The use of fractional resection to remove a tattoo allows for fractional
removal of
a significant proportion of the dermal pigment with minimal visible scarring.
The
fractional resection extends beyond the border of the tattoo to blend the
resection into the
non- resected and non-tattooed skin. Most apparently, de-delineation of the
pattern of the
tattoo will occur even if all residual pigment is not or cannot be removed. In
an
embodiment, initial fractional resections are performed with a scalpet array,
and any
subsequent fractional resections are performed by singular scalpet resections
for residual
dermal pigment. As with other applications described herein, directed closure
is
performed in the most clinically effective vector.
68
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
The fractional resection devices described herein are configured for treatment
of
cellulite. This aesthetic deformity has resisted effective treatment for
several decades as
the pathologic mechanism of action is multifactorial. Cellulite is a
combination of age or
weight loss skin laxity with growth and accentuation of the superficial fat
loculations.
The unsightly cobblestone appearance of the skin is commonly seen in the
buttocks and
lateral thighs. Effective treatment should address each contributing factor of
the
deformity.
The fractional resection devices described herein are configured for
fractional
resection of the skin in order to tighten the affected skin and to
simultaneously reduce the
prominent fat loculations that are contributing to the cobblestone surface
morphology.
Through the same fractionally resected defects created for skin tightening,
topically
applied vacuum is used to suction the superficial fat loculations
percutaneously. In an
embodiment, a clear manifold suction cannula is applied directly to the
fractionally
resected skin surface. The appropriate vacuum pressure used with the suction-
assisted
lipectomy (SAL) unit is determined by visually gauging that the appropriate
amount of
sub-deimal fat being suction resected. The appropriate time period of manifold
application is also a monitored factor in the procedure. When combined with
fractional
skin tightening, only a relatively small amount of fat is suction resected to
produce a
smoother surface morphology. As with other applications described herein, the
fractionally resected field will be closed with directed closure.
The fractional resection devices described herein are configured for revision
of
abdominal striae and scarring. Visually apparent scarring is a deformity that
requires
clear delineation of the scar from the adjacent normal skin. Delineation of
the scar is
produced by changes in texture, in pigment and in contour. To make a scar less
visibly
apparent, these three components of scarring must be addressed for a scar
revision to
significantly reduce the visual impact. Severe scars called contractures
across a joint may
also limit the range of motion. For the most part, scar revisions are
performed surgically
where the scar is elliptically excised and carefully closed by careful
coaptation of excised
margins of the non-scarred skin. However, any surgical revision reintroduces
and
69
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
replaces the pre-existing scar with an incumbent surgical scar that may be
also be
delineated or only partially de-delineated by a Z or W plasty.
Scarring is bifurcated diagnostically into hypertrophic and hypotrophic types.
The hypertrophic scar typically has a raised contour, irregular texture and is
more deeply
pigmented. In contrast, the hypotrophic scar has a depressed contour below the
level of
the adjacent normal unscarred skin. In addition, the color is paler
(depigmented) and the
texture is smoother than the normal adjacent skin. Histologically,
hypertrophic scars
posses an abundance of disorganized dermal scar collagen with hyperactive
melanocytes.
Hypotrophic scars have a paucity of dermal collagen with little or no
melanocytic
activity.
The fractional resection devices described herein are configured for
fractional scar
revision of a scar that does not reintroduce additional surgical scarring but
instead
significantly de-delineates the visual impact of the deformity. Instead of a
linear
surgically induced scar, the fractional resection of the scar results in a net
reduction of the
pigmentary, textural and contour components. A fractional revision is
performed along
the linear dimension of the scar and also extends beyond the boundary of the
scar into the
normal skin. The fractional revision of a scar involves the direct fractional
excision of
scar tissue with micro-interlacing of the normal non-scarred skin with the
residual scar.
Essentially, a micro W-plasty is performed along the entire extent of the
scar. As with
other applications, the fractionally resected field is closed with directed
closure. An
example of the use of fractional revision includes revising a hypotrophic post-
partum
abdominal stria. The micro-interlacing of the depressed scar epithelium and
dermis of
the stria with the adjacent normal skin significantly reduces the depressed,
linear and
hypo-pigmented appearance of this deformity.
The fractional resection devices described herein are configured for vaginal
repair
for postpartum laxity and prolapse. The vaginal delivery of a full term fetus
involves in
part the massive stretching of the vaginal introitus and vaginal canal. During
delivery,
elongation of the longitudinal aspect of the vaginal canal occurs along with
cross-
sectional dilatation of the labia, vaginal introitus and vaginal vault. For
many patients,
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
the birth trauma results in a permanent stretching of the vaginal canal along
the
longitudinal and cross-sectional aspects. Vaginal repair for prolapse is
typically
performed as an anterior-posterior resection of vaginal mucosa with insertion
of
prosthetic mesh. For patients with severe prolapse, this procedure is required
as addition
support of the anterior and posterior vaginal wall is needed. However, many
patients
with post-partum vaginal laxity may be candidates for a less invasive
procedure.
The fractional resection devices described herein are configured for
fractional
resection of the vaginal mucosa circumferentially to narrow the dilated
vaginal canal at
the labia and the introitus. The pattern for fractional resection can also be
performed in a
longitudinal dimension when the vaginal canal is elongated. Directed closure
of the
fractional field can be assisted with a vacuum tampon that will act as stent
to shaped the
fractionally resected vaginal canal into a pre-partum configuration.
The fractional resection devices described herein are configured for treatment
of
snoring and sleep apnea. There are few health implications of snoring but the
disruptive
auditory effect upon the relationship of sleeping partners can be severe. For
the most
part, snoring is due to the dysphonic vibration of intraoral and pharyngeal
soft tissue
structures within the oral, pharyngeal and nasal cavities during inspiration
and expiration.
More specifically, the vibration of the soft palate, nasal turbinates, lateral
pharyngeal
walls and base of the tongue are the key anatomic structures causing snoring.
Many
surgical procedures and medical devices have had limited success in
ameliorating the
condition. Surgical reductions of the soft palate are frequently complicated
with a
prolonged and painful recovery due to bacterial contamination of the incision
site.
The fractional resection devices described herein are configured for
fractional
resection of the oropharyngeal mucosa in order to reduce the age related
mucosal
redundancy (and laxity) of intraoral and pharyngeal soft tissue structures and
not be
complicated with prolonged bacterial contamination of the fractional resection
sites. The
reduction in size and laxity of these structures reduces vibration caused by
the passage of
air. A perforated (to spray a topical local anesthetic onto the fractional
resection field)
intraoral dental retainer (that is secured to the teeth and wraps around the
posterior aspect
71
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
of the soft palate) is used to provide directed closure in the anterior-
posterior dimension
of the soft palate. A more severe condition called sleep apnea does have
serious health
implications due to the hypoxia caused by upper airway obstruction during
sleep.
Although CPAP has become a standard for the treatment of sleep apnea,
selective
fractional resection of the base of the tongue and the lateral pharyngeal
walls can
significantly reduce sleep related upper airway obstruction.
The fractional resection devices described herein are configured for
fractional
skin culturing/expansion, also referred to herein as "Culturespansion". The
ability to
grow skin organotypically would be a major accomplishment for patients with
large skin
defects such as burns and trauma and major congenital skin malformations such
port-
wine stains and large 'bathing trunk' nevi. Conventional capability is limited
to
providing prolonged viability of harvested skin, although some reports have
indicated
that wound healing has occurred with organotypic skin cultured specimens. It
has been
reported that enhanced cultured outcomes will occur with better substrates,
cultured
media and more effective filtration of metabolic byproducts. The use of gene
expression
proteinomics for growth hormone and wound healing stimulation is also
promising. To
date however, there is no report that skin has been grown organotypically.
The fractional harvesting of autologous donor skin for skin grafting under an
embodiment provides an opportunity in the organotypic culture of skin that did
not
previously exist. The deposition of a fractionally harvested skin graft onto a
collapsible
docking station, as provided by the embodiments described herein, enables skin
plugs to
be brought into contact apposition with each other. The induction of a primary
wound
healing process can convert a fractional skin graft into a solid sheet by
known or soon to
be developed organotypic culture methodology. Further, the use of mechanical
skin
expansion can also greatly increase the surface area of the organotypically
preserved/
grown skin. Invitro substrate device iterations include without limitation, an
expandable
docking station comprising fractionally harvested skin plugs and a separate
substrate
(e.g., curved, flat, etc.) expander that is controllable to provide a gradual
and continual
expansion of the full thickness organotypically cultured skin. Additionally,
the use of
72
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
organotypic skin expansion may provide a continual and synergistic wound-
healing
stimulus for organotypic growth. A gradual and continual expansion is less
likely to
delaminate (the basement membrane) the epidermis from the dermis.
Additionally,
organotypic skin expansion helps avoid the surgical risk and pain associated
in-vivo skin
expansion.
The fractional resection devices described herein enable methods for the
organotypic expansion of skin. The methods comprise an autologous fractional
harvest
of skin from a donor site of a patient. The use of a square scalpet array, for
example,
provides upon transfer side-to-side and tip-to-tip coaptation of fractionally
harvested skin
plugs. The method comprises transfer of the fractional skin plugs to a
collapsible
docking station that maintains orientation and provides apposition of skin
plugs. The
docked skin plugs are captured onto a porous adherent membrane that maintains
orientation and apposition. The semi-elastic recoil property of the adherent
membrane
provides additional contact and apposition of skin plugs. The method includes
transfer of
the adherent membrane/fractional graft composite to a culture bay ocmprising a
substrate
and a culture media that retains viability and promotes organotypic wound
healing and
growth. Following healing of skin plug margins, the entire substrate is placed
into a
culture bath that has a mechanical expander substrate. Organotypic expansion
is then
initiated in a gradual and continuous fashion. The expanded full thickness
skin is then
autologously grafted to the patient's recipient site defect.
Organotypic skin expansion can be performed on non-fractional skin grafts or
more generally, on any other tissue structure as organotypic expansion. The
use of
mechanical stimulation to evoke a wound healing response for organotypic
culture can
also be an effective adjunct.
The embodiments described herein are used with and/or as components of one or
more of the devices and methods described in detail herein and in the Related
Applications incorporated herein by reference. Additionally, the embodiments
described
herein can be used in devices and methods relating to fractional resection of
skin and fat.
73
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Embodiments include a novel minimally invasive surgical discipline with far-
reaching advantages to conventional plastic surgery procedures. Fractional
resection of
skin is applied as new stand-alone procedures in anatomical areas that are off
limits to
conventional plastic surgery due to the poor tradeoff between the visibility
of the
incisional scar and amount of enhancement obtained. Fractional resection of
skin is also
applied as an adjunct to established plastic surgery procedures such as
liposuction, and is
employed to significantly reduce the length of incisions required for a
particular
application. The shortening of incisions has application in both the aesthetic
and
reconstructive realms of plastic surgery. Without limitation, both the
procedural and
apparatus development of fractional resection are described in detail herein.
Embodiments described herein are configured to remove multiple small sections
of skin without scarring in lieu of the conventional linear resections of
skin. The removal
of multiple small sections of skin includes removal of lax excess skin without
apparent
scarring. As an example, Figure 83 depicts removal of lax excess skin without
apparent
scarring, under an embodiment. The removal of multiple small sections 8302 of
skin also
includes tightening of skin without apparent scaring, for example, Figure 84
depicts
tightening of skin without apparent scaring, under an embodiment. The removal
of
multiple small sections of skin 8402 further includes fractional skin
tightening in which
the clinical endpoint results in three-dimensional tightening and contouring
8404 of the
skin envelop.
Figure 85 depicts three-dimensional contouring of the skin envelop, under an
embodiment. The removal of multiple small sections of skin 8502 further
includes
fractional skin tightening in which the clinical endpoint results in three-
dimensional
tightening and contouring 8504 of the skin envelop.
The clinical effectiveness of any surgical manipulation requires a through
understanding of the underlying processes that lead reliably to a clinical
endpoint. For
fractional skin tightening and contouring, a number of mechanisms of action
are
described herein. The principle mechanism of action identified is the
conversion of two-
dimensional fractional skin tightening into three-dimensional aesthetic
contouring (e.g.,
74
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
see Figure 3). Contributory to that principle clinical endpoint are secondary
mechanisms
of action that serve in concert with each other. The contributory mechanisms
of action
are described herein according to their capability to achieve the clinical
endpoint, but are
not so limited.
The density of fractional resection within an outlined fractional field is a
primary
determinate of two-dimensional skin tightening contributing to three-
dimensional
contouring. Generally, the density is the percentage of fractionally resected
skin within
the fractional field but is not so limited. Figure 86 depicts variable
fractional resection
densities 8602 in a treatment area 8604, under an embodiment. The density of
fractional
resection ("fractional density") can be varied to provide more selected skin
tightening and
contouring while providing smoother transitions into non-fractionally resected
areas.
Therefore, for example, transitions into non-fractionally resected areas
include a
reduction in the fractional density but are not so limited.
Additional embodiments include the fractional resection of fat associated with
fractional skin resection. Figure 87 depicts fractional resection of fat,
under an
embodiment. Immediately subjacent to the skin are the sub-dermal and
subcutaneous fat
layers where a variable amount of fat (based on depth and/or amount) can be
fractionally
resected in anatomical continuity with the resected skin plug. A variable
amount of fat
fractionally resected, and hence an amount of skin tightening and contouring,
is
controlled in an embodiment by controlling one or more of a depth of the
resection at the
target site and an amount of fat resected. Thus, the density of fractional
resection
("fractional density") can be varied by controlling one or more of fractional
density,
resection depth, and amount of fact resected in order to provide more selected
skin
tightening and contouring while providing smoother transitions into non-
fractionally
resected areas. Therefore, for example, transitions into non-fractionally
resected areas
include a reduction in a combination of fractional density, resection depth,
and amount of
fact resected, but are not so limited.
An additional modality for fractional fat resection is the percutaneous vacuum
resection (PVR) of fat directly through the skin fractional defects. Numerous
clinical
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
applications of fractional fat resection are anticipated in the embodiments
herein. The
most significant aesthetic application of fractional fat resection is the
reduction of
cellulite. The combined in-continuity application of fractional skin and fat
resection
directly addresses the underlying pathology of this aesthetic deformity. The
skin laxity
and prominent loculations of fat producing visible surface cobblestoning of
skin
morphology are each resolved in concert with the application of this minimally
invasive
resection capability. Figure 88 depicts cobblestoning 8802 of the skin
surface.
Furthermore, another general application includes the ability to alter three-
dimensional contour abnormalities with a combined in-continuity approach of
fractional
skin tightening and inward contouring from fractional fat resection. The pre-
operative
topographical contour mapping of the fractional field assists in providing a
more
predictable clinical outcome. Essentially, a topographical mapping of two-
dimensional
fractional skin resection is combined with a variable marking for fat
resection. Figure 89
depicts topographic mapping (dotted lines) 8902 for a deeper level of
fractional fat
resection, under an embodiment. Mapping also includes the feathering or
transition
zones into non-resected areas where the fractional density is reduced.
Depending upon
the pre-operative topographical marking of the patient, a variable amount of
fat is
fractionally resected in continuity with fractional skin resection.
Areas to be corrected comprising convex contours undergo deeper fractional fat
resections. Concave (or depressed) areas to be corrected are corrected using
fractional
skin resection. The net result within the mapped fractional field is overall
smoothing of
three-dimensional contours with two-dimensional tightening of the skin.
The use of combined fractional resection is most apparent with the reduction
in
the length required for conventional plastic surgery incisions and with the
elimination of
iatrogenic incisional skin redundancies ("Dog Ears"). Standard resection of
skin lesions
does not require the additional scarring of elliptical incisions but is
significantly reduced
in the linear dimension required for closure of an excised lesion (see Figure
94).
An additional mechanism of action associated with fractional skin resection is
the
size of the overall outlined pattern of the fractional resection field. The
overall amount of
76
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
fractionally resected skin also depends on the size of the fractionally
resected field. The
larger the field, the more skin tightening occurs with a specified density of
fractional
resection. Further, the complete fractionally resected field can include one
or more
treatment regions (e.g., different resection densities in different fields,
etc.). Figure 90
depicts multiple treatment outlines 9002, 9004, under an embodiment.
The mechanism of action of a patterned outline includes the selective
curvilinear
patterning of each particular anatomical area for each particular patient. A
topographical
analysis with a digitally captured image of the patient involving a rendered
(and re-
rendered to an enhanced contour) digital wire mesh program assists in
formatting the size
and curvilinear outline for a selected anatomical region and patient. The
pattern of
standard aesthetic plastic surgery excisions for a particular anatomic region
also assists in
the formatting of the fractional resection pattern. Figure 91 depicts a
curvilinear
treatment pattern 9102, under an embodiment. Figure 92 depicts a digital image
of a
patient with rendered digital wire mesh 9202 program, under an embodiment.
Directed closure of a fractionally resected field of an embodiment provides
the
capability of selectively tightening skin to achieve enhanced aesthetic
contouring. For
most applications, the closure occurs at right angles to Langer's lines but
may also be
done at a different direction that achieves maximal aesthetic contour such as
closures that
are based on resting skin tension lines. Figure 93 depicts directed closure
9302 of a
fractionally resected field, under an embodiment. The directed closure may
also follow
known vectors of closure used in conventional plastic surgery procedures
(e.g., facelift
for the facial/submental component of the facelift is upwards (corresponding
to a
horizontal directed closure of a fractional field) and the neck component
below the
cervical mandibular angle is more obliquely posterior (corresponding to a more
vertical
directed closure of the fractional field)). Multiple vectors of directed
closure may also be
used in more complicated topographical regions such as the face and neck.
Embodiments include directed fractional resection of skin, which enhances the
effectiveness of the procedure. Figure 94 depicts directed fractional
resection of skin,
under an embodiment. This process is performed by pre-stretching 9402 the skin
at right
77
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
angles to the preferred direction of maximal skin resection, and performing
the fractional
resection 9404 on the stretched skin.
Embodiments include aesthetic contouring resulting from the mechanical pull
(or
vector) created from an adjacent fractional field adjacent to the targeted
contour. This
effect for a fractional field is based on plastic surgical procedures that are
directed a
distance from the targeted contour. Further, variable topographical
transitioning of
resection densities within the field and along the pattern outline are
realized, which
provide selective contouring and smoother transitioning into non-resected
areas.
Additionally, variable topographical transitioning of scalpet size resections
within a
patterned outline (and with different scalpet sizes within an array) provides
selective two-
dimensional skin tightening and three-dimensional contouring.
Embodiments described herein evoke a selective wound healing sequence with
promotion of primary healing during the immediate post-operative period and
delayed
secondary contraction of skin during the collagen proliferative phase.
Promotion of
accurate coaptation of the skin margins is inherent to the multiple
(fractional) resections
of small segments of skin i.e., skin margins are more closely aligned prior to
closure than
larger linear resections of skin that are common with standard plastic surgery
incisions.
Subsequent evoking of wound contraction is also inherent to a fractionally
resected field
where elongation of the pattern of fractional resection provides a directed
wound healing
response along the longitudinal dimension of the fractionally resected
pattern.
Clinical methods of fractional skin resection involve methods of directional
closure. Depending upon the anatomical area, the directed closure of
excisional skin
defects within a fractional resection field is achieved by following Langer's
lines, the
resting skin lines, and/or in a direction that achieves the maximal of
aesthetic contouring.
The direction in which closure is most easily achieved can also be used as a
guide for the
most effective vector of directed closure. For many applications, the use of
Langer's
lines is used as a guide to provide maximal aesthetic tightening. Following
the original
work of Dr. Langer, the fractionally resected defects will elongate in the
direction of a
Langer line. The directed closure is performed at right angles to Langer's
lines in an
78
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
anatomical region where the skin margins of each fractional resection defect
are in
closest approximation.
In continuity fractional procedures that are deployed adjacent or in
continuity
with plastic surgery incisions, the most significant capability provided by
the
embodiments herein includes the ability to shorten incisions. The need for
elliptical
excisions of skin tumors is reduced in both the application of this technique
and in the
length of the incision. Thus, the need to excise the lateral extension of a
tumor resection
is obviated by the fractional resection at that same lateral aspect. Figure 95
depicts
shortening of incisions through continuity fractional procedures, under an
embodiment.
As the fractional field under an embodiment heals without visible scarring,
the net
result is significant reduction in the length of the excisional scar. Another
application
within this category is the shortening of conventional plastic surgery
incisions used for
breast reduction, Mastopexy and abdominoplasty. The lateral extent of these
incisions
can be shortened without the creation of "dog ear" skin redundancies that
would
otherwise occur with the same length incision. Figure 96 is an example
depiction of
"dog ear" skin redundancies in breast reduction and abdominoplasty. For
example,
extensions of the incision beyond the lateral inframmary fold for breast
reduction or
beyond the Iliac crest for abdominoplasty would no longer be required.
Fractional
revisions of post-operative "dog ear" skin redundancies could also be
performed without
extension of the existing incision.
Embodiments include combined procedures that provide aesthetic enhancement at
both the fractional resection harvest site and a recipient site. The most
apparent
application of this method is the use of fractional harvesting of the cervical
beard for hair
transplantation in the frontal and parietal scalp. A dual benefit is created
by the
procedure in which aesthetic contouring is created along the anterior neck and
with
restoration of the hair bearing scalp.
Embodiments include separate fractional procedures in anatomical areas that
are
not currently addressed by plastic surgery due to the poor tradeoff between
the visibility
of the surgical incision and the amount of aesthetic enhancement. Several
examples exist
79
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
in this category such as the supra-patellar knee, the upper arm, the elbow,
bra skin
redundancy of the back, and the medial and lateral thighs and the infragluteal
folds.
Embodiments include adjunct fractional procedures that are deployed with
conventional plastic surgery incisions in a non-contiguous fashion. This
category
includes suction-assisted lipectomy in which subcutaneous fat is removed by
suction in
areas of lipodystrophy such as the lateral hips and thighs. However, many
patients have
pre-existing skin laxity that is aggravated by suction lipectomy. The
tightening of the
skin envelope over these areas by fractional resection has several benefits to
these
patients. Many patients with skin laxity and lipodystrophy become candidates
for
.. liposuction who otherwise not qualify for the procedure. For patients
without preexisting
skin laxity but with more significant lipodystrophy, a larger contour
reduction can be
performed without iatrogenic skin laxity. The procedure can be deployed as a
single
combined procedure for smaller fractional resections or as a staged procedure.
Directed closure of the fractional field is performed without suturing and is
achieved with the application of an adhesive stent membrane as described in
detail
herein. The fractional field is closed with an adhesive membrane using a
number of
methods. An example method includes anchoring the membrane outside the
perimeter of
the fractional field. Tension is then applied to the opposite end of the
adhesive
membrane. The body of the adhesive membrane is then applied to the fractional
field
row by row to the remaining skin within the field. The direction of
application follows
the selected vector of directed closure. This direction of application at
times is at right
angles to Langer's lines but is not so limited, and any direction of
application can be
chosen that provides maximal aesthetic contouring.
Another method includes use of the elastic property of the adherent stent
dressing
to selectively close a fractional field. With this method, the ends of the
elastic stent
dressing are stretched or preloaded, and the stent dressing is then applied to
the fractional
field. Upon release of the ends of the membrane, the elastic recoil of the
stent dressing
closes the fractional defects in a direction that is at right angles to the
elastic recoil.
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Embodiments described in detail herein include a skin Pixel Array Dermatome
(sPAD), also referred to herein as a scalpet device. Generally, the scalpet
device includes
a carrier, and a chuck coupled to a distal region of the carrier. The device
includes a
scalpet assembly comprising one or more scalpets and a depth control device.
The
scalpet assembly includes a shank configured for retention in the chuck. Each
scalpet
includes a tube comprising a hollow region and a sharpened distal end
configured to
penetrate tissue at a target site. The depth control device is configured to
control a depth
of the penetration of the at least one scalpet into the tissue.
The scalpet device of embodiments includes a ganged multiple-scalpet array
comprising a multiplicity of individual circular scalpels. The circular
scalpet
configuration enables rotational torque to be applied to the skin to
facilitate incising.
Embodiments couple or link the scalpet assembly and the scalpets to an
electromechanical power source via a series of gears or other drive components
between
each scalpet and a drive shaft, as described herein. In addition, embodiments
couple a
vacuum source to the housing and generate a vacuum within the housing. The
vacuum is
configured for use to one or more of remove or evacuate fractionally resected
material
(e.g., skin, fat, etc.), and for stenting stabilization during incising. The
same vacuum
capability can also be applied as a pneumatic assist to apply additional axial
(Z-axis)
force during the incising duty cycle.
The scalpet device includes numerous configurations as described in detail
herein.
Figure 97 is a scalpet device including a single skived scalpet with depth
control, under
an embodiment. The skive scalpet device includes a carrier coupled to the
skive scalpet.
The carrier includes a pencil-style carrier (e.g., Figure 99, etc.), but is
not so limited. The
skive scalpet includes a hollow tube on the distal end (nearest patient) and
solid on the
proximal end (farthest from patient). A skive including a radial slot on the
hollow tube,
is positioned axially to allow resected tissue to be diverted radially
outboard of the
scalpet. The skive scalpet includes a set position from along the length of
the tubing and
bottoms out inside the handpiece chuck, accurately positioning the skive
feature with
respect to the handpiece nose. The skive scalpet device includes a depth
control device
81
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
of varying axial length used together with the skive scalpet to control the
depth of cut into
tissue depending on the treatment site. The depth control device of an
embodiment
couples or connects directly to an outside diameter of the carrier nose, but
is not so
limited.
Figure 98 is a scalpet device including a standard single scalpet, under an
embodiment. The scalpet device includes a carrier coupled to the scalpet. The
carrier
includes a pencil-style carrier (e.g., Figure 99, etc.), but is not so
limited. The single
scalpet includes a hollow tube running the entire length of the scalpet, but
is not so
limited. Resected tissue that lodges in the scalpet travels up the scalpet
bore and is
deposited or lodges within an internal cavity or receptacle included in or
coupled or
connected to the carrier. An adapter is configured as an interface between an
outside
diameter or surface of the scalpet and the inside region of the carrier chuck.
The adapter
is positioned along the scalpet axis, and the subassembly is placed into the
chuck where
the chuck is configured to securely camp the scalpet and adapter to prevent
axial shifting.
The adapter of an embodiment is configured to be used as a depth stop to
achieve full
tissue resecting depth based on the treatment area.
Figure 99 is a scalpet device including a pencil-style gear-reducing carrier,
under
an embodiment. The pencil-style carrier is configured to allow close-in work
with a
lighter, more ergonomic handpiece. Carriers of an embodiment include motors
having
increased torque capabilities, but embodiments are not so limited.
Figure 100 is a scalpet device including a multi-scalpet (e.g., 3x3) array,
under an
embodiment. The scalpet array 10001 of this example includes a 3X3 centerless
array,
but is not so limited. The scalpet device operates as described herein with
reference to
scalpet devices of different configurations, so that the housing is configured
to interface
with a pencil-style carrier and is configured as or includes a depth control
device 10002.
A drive shaft 10004 centrally located to the scalpet array is mounted into the
carrier
chuck. The scalpet assembly 10010 including the 3X3 array 10001 does not
include a
center scalpet (opposite the drive shaft), but is not so limited. The scalpets
of the array
82
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
10001 include sharpened thin-wall tubing and allow the resected tissue to
migrate up the
scalpet bore and be deposited into the housing proximal end (closer to
physician).
An embodiment includes a scalpet device comprising a carrier comprising a
surgical drill. Figure 101 shows the scalpet device including a cordless
surgical drill
carrier 10102, under an embodiment. The surgical drill is an option for use
with
relatively large arrays that require more torque to resect tissue on larger
body areas (e.g.,
abdomen, buttocks, arms, etc.). The scalpet device using the drill carrier
includes a
Carrier Array Coupling (CAC) 10104 for resected tissue management to transport
large
volumes of resected tissue away from the housing proximal end as described in
detail
herein. The CAC of an embodiment fixes the scalpet assembly housing to the
drill, but
embodiments are not so limited.
Figure 102 shows an example scalpet device comprising a 5x5 centerless array
10202 used with a surgical drill carrier, under an embodiment. The scalpet
device using
the drill carrier includes a CAC 10204 coupled to a scalpet assembly 10206.
The CAC is
configured for resected tissue management to transport large volumes of
resected tissue
away from the housing proximal end as described in detail herein. The CAC of
an
embodiment fixes the scalpet assembly housing to the drill, but embodiments
are not so
limited.
Scalpet device embodiments include a Vacuum Assisted Pneumatic Resection
(VAPR) device, or "VAPR". Figure 103 is a scalpet device including a vacuum
assisted
pneumatic resection device, under an embodiment. The VAPR includes vacuum
pressure
configured to drive the scalpets from the scalpet assembly into the treatment
site. The
VAPR is coupled or connected to the drill via a CAC.
Figure 104 is a detailed view of the distal region of the VAPR scalpet device
including the scalpet assembly coupled to a carrier drill using a CAC, under
an
embodiment. The CAC fixes the housing of the VAPR to the drill, while the
tubing (e.g.,
hexagonal tubing) is configured to allow the VAPR drive shaft to slide up and
down
during the treatment. An externally supplied vacuum (not shown) is coupled or
connected to the VAPR via the vacuum port, but embodiments are not so limited.
83
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Figure 105 shows the scalpet assembly of the VAPR in a ready state (left), and
an
extended treatment state (right), under an embodiment. With the vacuum and
drill
operating, a single treatment cycle comprises placing the VAPR against the
treatment
site, creating a seal between the housing and the treatment site. Once this
seal is
established, the vacuum coupled to the assembly housing pulls the piston with
the
rotating gears into the treatment site. After the desired depth of cutting has
been achieved
the VAPR is pulled away from the treatment site. This breaks the seal, and the
spring
inside the sPAD forces it back into the ready state. The cycle can now be
repeated at a
different treatment site.
Embodiments include a Spring Assisted Vacuum Resection (SAVR) scalpet
device, which operates in a similar manner to the VAPR device. Figure 106
depicts the
SAVR device in a ready state (left), and a retracted state (right), under an
embodiment.
The SAVR is coupled or connected to the drill via the CAC. The vacuum port is
attached
or coupled to a separate vacuum supply but is not so limited. The drive shaft
slides back
and forth within the tube attached to the drill.
The spring and vacuum locations of the SAVR device are generally reversed from
those of the VAPR. The spring and vacuum port are both located on the proximal
side of
the piston but are not so limited. The vacuum assists in drawing the skin
pixels out
through the scalpets and hence away from the treatment site. The spring
provides the
axial force for the rotating scalpets to drive into the treatment site and
resect the skin.
The scalpets are extended outside the housing in array ready state.
The treatment cycle starts with the placement of the scalpets over the desired
treatment location. The vacuum is turned on and the drill is applied downward,
forcing
the piston and scalpets back up into the housing (retracted state). The drill
is turned,
causing the scalpets to rotate. The spring force coupled with the scalpet
rotation results
in the resection. The vacuum draws the pixels generated by the resection up
into and
subsequently out of the housing. Once the desired cutting depth has been
achieved, the
SAVR is lifted off the treatment site and the cycle can be repeated at a
different treatment
site.
84
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
Embodiments include a device comprising a carrier, and a chuck coupled to a
distal region of the carrier. The device includes a scalpet assembly
comprising at least
one scalpet and a depth control device. The scalpet assembly includes a shank
configured for retention in the chuck. The at least one scalpet includes a
tube comprising
a hollow region and a sharpened distal end configured to penetrate tissue at a
target site.
The depth control device is configured to control a depth of the penetration
of the at least
one scalpet into the tissue.
Embodiments include a device comprising: a carrier; a chuck coupled to a
distal
region of the carrier; a scalpet assembly comprising at least one scalpet and
a depth
control device, wherein the scalpet assembly includes a shank configured for
retention in
the chuck, wherein the at least one scalpet includes a tube comprising a
hollow region
and a sharpened distal end configured to penetrate tissue at a target site,
wherein the
depth control device is configured to control a depth of the penetration of
the at least one
scalpet into the tissue.
The scalpet assembly includes a scalpet comprising a scalpet shaft including a
distal end and a proximal end.
The scalpet shaft includes a hollow region proximate to the distal end and a
solid
region proximate to the proximal end.
The proximal end includes a region configured as the shank.
The scalpet includes a distal region proximate to the distal end configured to
incise and receive tissue.
The scalpet includes at least one of an orifice and slot positioned axially in
the
scalpet adjacent the hollow region.
The at least one of the orifice and the slot are configured to divert the
received
tissue radially outward from an interior region of the scalpet.
The depth control device is configured to couple to the distal region of the
carrier.
The depth control device includes a vacuum manifold configured to generate a
seal between the vacuum manifold and the target site.
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The scalpet assembly includes a scalpet comprising a scalpet shaft including a
distal end and a proximal end, wherein the scalpet shaft includes a hollow
interior region
between the distal end and the proximal end.
The proximal end includes a region configured as the shank.
The scalpet includes a distal region proximate to the distal end configured to
incise and receive tissue.
The proximal end is configured to pass the received tissue.
The carrier includes a reservoir in an internal region, wherein the proximal
end of
the scalpet is coupled to the reservoir, wherein the reservoir is configured
to retain the
received tissue.
The depth control device includes an adapter configured to receive the scalpet
shaft.
The chuck is configured to secure an axial position of the adapter and the
scalpet
in the carrier.
The depth control device includes a vacuum manifold configured to generate a
seal between the vacuum manifold and the target site.
The device includes a motor coupled to the chuck and configured to drive the
scalpet assembly.
Thee carrier is configured to be hand-held.
The scalpet assembly includes a plurality of scalpets.
The plurality of scalpets are arranged to form a scalpet array.
The scalpet array is a rectangular array.
The scalpet array includes one of a 3-by-3 array and a 5-by-5 array.
Each scalpet is configured to rotate around a central axis of the scaplet.
The scalpet assembly includes a drive assembly coupled to each scalpet,
wherein
the drive assembly is configured to impart a rotational force to a proximal
region of each
scalpet, wherein the rotational force rotates each scalpet around the central
axis.
The drive assembly comprises a gear drive system.
The drive assembly comprises a frictional drive system.
86
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The shank is configured as a drive shaft comprising a proximal end configured
to
couple to the chuck, and a distal end configured to couple to the drive
assembly.
The device includes a motor coupled to the chuck and configured to drive the
drive assembly via the drive shaft.
The device includes a housing configured as the depth control device.
The housing is configured to at least partially house the scalpet array.
Each scalpet includes a scalpet shaft including a distal end and a proximal
end,
and a hollow interior region proximate to at least the distal end, wherein the
distal end is
configured to incise and receive tissue.
The device includes a housing configured to form a vacuum at the target site,
wherein the vacuum includes an internal pressure in the housing relatively
lower than
ambient air pressure.
A distal region of the housing is configured to form a vacuum seal when in
contact with proximate tissue adjacent the target site.
The housing includes a port coupled to a vacuum source.
The vacuum is configured to evacuate resected material from the target site.
The vacuum is configured to evacuate subdermal fat via voids generated at the
target site from incised skin pixels.
The scalpet assembly includes a spring device configured to control a position
of
the scalpet array.
The spring device is configured to apply axial force to the scalpet array to
control
movement of the scalpet array in a direction of contact with the target site.
The vacuum is configured to control a position of the scalpet array relative
to the
target site.
The scalpet assembly includes a spring device configured to control the
position
of the scalpet assembly in concert with the vacuum.
The vacuum is configured to control movement of the scalpet array in a
direction
of contact with the target site.
87
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The spring device is configured to apply axial force to the scalpet array to
control
movement of the scalpet array in a direction away from the target site.
The housing is configured as the depth control device.
The housing is configured to at least partially house the scalpet array.
The device includes a scalpet assembly coupling configured to couple the
housing
to the carrier.
The at least one scalpet is configured to transmit an axial force to the
target site.
The axial force comprises at least one of a continuous axial force, an impact
force,
and a continuous axial force and an impact force.
The at least one scalpet comprises a cylindrical scalpet including a cutting
surface
on a distal end of the at least one scalpet.
The cutting surface includes at least one of a sharpened edge, at least one
sharpened point, and a serrated edge.
The cutting surface includes a blunt edge.
Embodiments include a device comprising a carrier comprising a chuck coupled
to a distal region. The device includes a scalpet assembly comprising a
scalpet array and
a depth control device. The scalpet assembly is configured for retention in
the chuck.
The scalpet array includes a plurality of scalpets, and each scalpet includes
a tube
comprising a hollow region and a sharpened distal end configured to penetrate
tissue at a
target site. The depth control device is configured to control a depth of the
penetration of
the scalpet array into the tissue.
Embodiments include a device comprising: a carrier comprising a chuck coupled
to a distal region; and a scalpet assembly comprising a scalpet array and a
depth control
device, wherein the scalpet assembly is configured for retention in the chuck,
wherein the
scalpet array includes a plurality of scalpets, and each scalpet includes a
tube comprising
a hollow region and a sharpened distal end configured to penetrate tissue at a
target site,
wherein the depth control device is configured to control a depth of the
penetration of the
scalpet array into the tissue.
88
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
Embodiments include a device comprising a carrier comprising a proximal region
and a distal region. The proximal region is configured to be hand-held. The
device
includes a scalpet assembly comprising at least one scalpet, and a depth
control device
configured to control a depth of penetration of the at least one scalpet into
tissue at a
target site. The at least one scalpet includes a scalpet shaft comprising a
proximal end,
and a distal end configured to penetrate the tissue. The scalpet shaft
includes a hollow
region adjacent to the distal end and configured to pass tissue received
through the distal
end. The scalpet shaft includes an orifice coupled to the hollow region and
configured to
pass the received tissue out of the scalpet shaft.
Embodiments include a device comprising: a carrier comprising a proximal
region
and a distal region, wherein the proximal region is configured to be hand-
held; and a
scalpet assembly comprising at least one scalpet, and a depth control device
configured to
control a depth of penetration of the at least one scalpet into tissue at a
target site,
wherein the at least one scalpet includes a scalpet shaft comprising a
proximal end, and a
distal end configured to penetrate the tissue, wherein the scalpet shaft
includes a hollow
region adjacent to the distal end and configured to pass tissue received
through the distal
end, wherein the scalpet shaft includes an orifice coupled to the hollow
region and
configured to pass the received tissue out of the scalpet shaft.
Embodiments include a device comprising a carrier comprising a proximal region
and a distal region. The proximal region is configured to be hand-held. The
device
includes a scalpet assembly comprising a plurality of scalpets. The scalpet
assembly
includes a drive assembly configured to impart a rotational force to the
plurality of
scalpets to rotate each scalpet around a central axis. Each scalpet includes a
scalpet shaft
comprising a proximal end, and a distal end configured to penetrate tissue at
a target site.
The scalpet shaft includes a hollow region adjacent to the distal end and
configured to
pass tissue received through the distal end. The scalpet shaft includes an
orifice coupled
to the hollow region and configured to pass the received tissue out of the
scalpet shaft.
Embodiments include a device comprising: a carrier comprising a proximal
region
and a distal region, wherein the proximal region is configured to be hand-
held; and a
89
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
scalpet assembly comprising a plurality of scalpets, wherein the scalpet
assembly
includes a drive assembly configured to impart a rotational force to the
plurality of
scalpets to rotate each scalpet around a central axis, wherein each scalpet
includes a
scalpet shaft comprising a proximal end, and a distal end configured to
penetrate tissue at
a target site, wherein the scalpet shaft includes a hollow region adjacent to
the distal end
and configured to pass tissue received through the distal end, wherein the
scalpet shaft
includes an orifice coupled to the hollow region and configured to pass the
received
tissue out of the scalpet shaft.
Embodiments include a method comprising generating a protocol using patient
data. The protocol includes at least one target site and a topographical map
of fractional
skin resections configured for application at the at least one target site.
The method
includes positioning at the target site a carrier including a scalpet assembly
comprising at
least one scalpet and a depth control device. The at least one scalpet
includes a tube
comprising a hollow region and a sharpened distal end configured to penetrate
tissue at
the at least one target site. The method includes performing fractional
resection by
circumferentially incising skin pixels at the at least one target site using
the scalpet
assembly, and controlling a depth of penetration of the incising using the
depth control
device. The method includes removing the fractionally resected skin pixels
from the at
least one target site via an orifice in the at least one scalpet.
Embodiments include a method comprising: generating a protocol using patient
data, wherein the protocol includes at least one target site and a
topographical map of
fractional skin resections configured for application at the at least one
target site;
positioning at the target site a carrier including a scalpet assembly
comprising at least one
scalpet and a depth control device, wherein the at least one scalpet includes
a tube
comprising a hollow region and a sharpened distal end configured to penetrate
tissue at
the at least one target site; performing fractional resection by
circumferentially incising
skin pixels at the at least one target site using the scalpet assembly, and
controlling a
depth of penetration of the incising using the depth control device; and
removing the
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
fractionally resected skin pixels from the at least one target site via an
orifice in the at
least one scalpet.
The protocol includes at least one of fractional skin tightening and
contouring.
The fractional resection comprises fractional resection of at least one of
skin and
fat.
The fractional resection comprises fractional resection of skin.
The method includes determining parameters of a fractional field. The
parameters
include at least one of location, size, and contour.
The contour includes a plurality of contours corresponding to a plurality of
.. locations.
The contour includes curvilinear patterning.
The method includes determining a density of the fractional resection of the
skin.
The density includes a percentage of fractionally resected skin within the
fractional field.
An amount of the fractional skin tightening is proportional to the density.
The method includes varying the density between a plurality of regions of the
fractional field.
The method includes defining a transition region between the fractional field
and
adjacent non-resected regions. The transition region has a relatively lower
density than at
least one other region of the fractional field.
The method includes variable topographical transitioning of the density at
least
one of within and along a perimeter of the fractional field. Selective
contouring and
smoother transitions into non-resected areas are produced.
The method includes variable topographical transitioning of a size of the at
least
one scalpet within the fractional field. Selective contouring is produced.
The fractional resection comprises fractional resection of fat.
The method includes determining a border region within the fractional field.
The
fractional resection in the border region includes the fractional resection of
the fat.
The fractional resection of the fat comprises percutaneous vacuum resection of
the fat.
91
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The percutaneous vacuum resection of the fat is via a separate incision.
The fractional resection of the fat comprises topical percutaneous vacuum
resection of the fat through fractional defects.
The fractional defects are generated using the fractional resection of skin.
The fractional resection of skin comprises directed fractional resection at
the at
least one target site. The directed fractional resection includes pre-
stretching skin at right
angles to a preferred direction of maximal skin resection at the at least one
target site.
The fractional resection includes combined fractional resection comprising the
fractional resection of skin and the fractional resection of fat.
The fraction resection of fat comprises fractional resection of tissue of at
least one
of a sub-dermal fat layer and a subcutaneous fat layer.
The fractional resection of fat comprises fractionally resecting at least one
layer of
fat in anatomical continuity with the fractional resection of the skin
adjacent the at least
one layer of fat.
The fractional resection of fat comprises percutaneous vacuum resection of fat
through fractional defects generated by the fractional resection of skin.
The fractional resection of the fat comprises percutaneous vacuum resection of
the fat.
The percutaneous vacuum resection of the fat is via a separate incision.
The fractional resection of the fat comprises topical percutaneous vacuum
resection of the fat through fractional defects.
The fractional defects are generated using the fractional resection of skin.
The method includes determining an amount of tissue for removal during the
fractional resection of fat according to an amount of dimensional contouring
of the
topographical map. The contouring includes three-dimensional contouring.
The method includes removing a relatively greater amount of tissue in areas
comprising convex contours.
The method includes limiting the protocol to the fractional resection of skin
in
areas comprising at least one of concave contours and flat contours.
92
CA 03014431 2018-08-13
WO 2017/139773 PCT/US2017/017683
The protocol includes closing an incision using the combined fractional
resection.
At least one of a dimension of the incision is reduced and iatrogenic
incisional skin
redundancies are eliminated.
The method includes closing a fractional field of the fractional resection
using
directed closure. The directed closure selectively enhances the contouring in
an area of
the fractional field.
The directed closure comprises at least one of closure substantially in a
first
direction, substantially horizontal closure, substantially vertical closure,
and directed
closure in a plurality of directions.
The directed closure comprises use of Langer's lines.
The directed closure comprises use of resting skin tension lines.
The directed closure comprises use of closure vectors of surgical skin
resection
procedures.
The directed closure comprises at least one of a bandage and an adherent
membrane instead of suturing.
The at least one scalpet includes a plurality of scalpets arranged to form a
scalpet
array.
The method includes capturing digital images of the patient, wherein the
patient
data represents the digital images.
The protocol is configured for at least one area of a human body.
The at least one area includes at least one region of at least one of a face
and neck.
The at least one area includes at least one region of a breast.
The at least one area includes at least one region of at least one of an arm,
upper
arm, elbow, leg, medial thigh, lateral thigh, knee, and supra-patellar knee.
The at least one area includes at least one region of at least one of an
abdomen,
back, buttock, and infragluteal fold.
The method includes receiving the resected skin pixels in a receptacle.
The carrier includes the receptacle.
93
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The method includes generating a plurality of skin defects at a recipient site
using
the carrier.
The method includes applying the resected skin pixels to the skin defects by
inserting each incised skin pixel into a corresponding skin defect at the
recipient site.
The method includes applying the resected skin pixels to at least one skin
defect
recipient site
The method includes configuring the at least one scalpet with a scalpet shaft
including a distal end and a proximal end.
The method includes configuring the at least one scalpet to include a distal
region
proximate to the distal end configured to incise and receive tissue.
The method includes configuring the at least one scalpet to include at least
one of
an orifice and slot positioned axially in the scalpet adjacent the hollow
region. The at
least one of the orifice and the slot are configured to divert the received
tissue radially
outward from an interior region of the scalpet.
The method includes configuring the depth control device to control a depth of
the incision.
The method includes configuring the at least one scalpet to include a scalpet
shaft
including a distal end and a proximal end. The scalpet shaft includes a hollow
interior
region between the distal end and the proximal end.
The method includes configuring the at least one scalpet to include a distal
region
proximate to the distal end configured to incise and receive tissue, and the
proximal end
to pass the received tissue.
The method includes configuring the at least one scalpet to include a
cylindrical
scalpet including a cutting surface on a distal end of the at least one
scalpet. The cutting
surface includes at least one of a sharpened edge, at least one sharpened
point, and a
serrated edge.
The method includes applying a rotational force to the at least one scalpet.
The
rotational force rotates the at least one scalpet around a central axis of the
at least one
scalpet.
94
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
The method includes configuring the carrier to include a housing in a distal
region, and applying a vacuum at the target site via the housing. The vacuum
includes an
internal pressure in the housing relatively lower than ambient air pressure.
The method includes configuring at least one of a spring in the housing and
the
vacuum to control a position of the at least one scalpet relative to the
target site.
The method includes the vacuum for the removing at least one of the
fractionally
resected skin pixels and fractionally resected fat.
Embodiments include a method comprising generating a protocol including a
target site and a topographical map of fractional skin resections configured
for
application at the target site. The method includes positioning at the target
site a carrier
comprising a plurality of scalpets. Each scalpet includes a scalpet shaft
comprising a
proximal end, and a distal end configured to penetrate tissue at the at least
one target site.
At least one region of the scalpet shaft adjacent the distal end is configured
to pass tissue
received through the distal end out of an orifice of the scalpet shaft. The
method includes
.. performing fractional resection by incising skin pixels at the target site
with the plurality
of scalpets. The method includes removing at least one of the fractionally
resected skin
pixels and fat from the target site.
Embodiments include a method comprising: generating a protocol including a
target site and a topographical map of fractional skin resections configured
for
.. application at the target site; positioning at the target site a carrier
comprising a plurality
of scalpets, wherein each scalpet includes a scalpet shaft comprising a
proximal end, and
a distal end configured to penetrate tissue at the at least one target site,
wherein at least
one region of the scalpet shaft adjacent the distal end is configured to pass
tissue received
through the distal end out of an orifice of the scalpet shaft; performing
fractional
resection by incising skin pixels at the target site with the plurality of
scalpets; and
removing at least one of the fractionally resected skin pixels and fat from
the target site.
Embodiments include a method comprising configuring a resection device to
include a scalpet assembly comprising a scalpet array and a depth control
device. The
scalpet array includes a plurality of scalpets, and each scalpet includes a
tube comprising
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
a hollow region and a distal end configured to penetrate tissue at a target
site. The distal
end includes at least one of a sharpened region and a blunt region. The depth
control
device is configured to control a depth of the penetration of the scalpet
array into the
tissue. The method includes configuring the resection device for operation at
the target
site according to a protocol including a map of fractional resections. The
method
includes configuring the resection device for performing the fractional
resections by
incising skin pixels at the target site. The method includes configuring the
resection
device for removing at least one of the fractionally resected skin pixels and
fat from the
target site.
Embodiments include a method comprising: configuring a resection device to
include a scalpet assembly comprising a scalpet array and a depth control
device, wherein
the scalpet array includes a plurality of scalpets, and each scalpet includes
a tube
comprising a hollow region and a distal end configured to penetrate tissue at
a target site,
wherein the distal end includes at least one of a sharpened region and a blunt
region,
wherein the depth control device is configured to control a depth of the
penetration of the
scalpet array into the tissue; configuring the resection device for operation
at the target
site according to a protocol including a map of fractional resections;
configuring the
resection device for performing the fractional resections by incising skin
pixels at the
target site; and configuring the resection device for removing at least one of
the
fractionally resected skin pixels and fat from the target site.
Embodiments include a method comprising generating a protocol including a
target site and a topographical map of fractional skin resections configured
for
application at the target site. The method includes configuring a resection
device to
include a scalpet assembly comprising at least one scalpet, and a depth
control device
configured to control a depth of penetration of the at least one scalpet into
tissue at a
target site. The at least one scalpet includes a scalpet shaft comprising a
proximal end,
and a distal end configured to penetrate the tissue. The scalpet shaft
includes a hollow
region adjacent to the distal end and configured to pass tissue received
through the distal
end. The scalpet shaft includes an orifice coupled to the hollow region and
configured to
96
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
pass the received tissue out of the scalpet shaft. The method includes
configuring the
resection device for performing the fractional resections by incising skin
pixels at the
target site according to the protocol. The method includes configuring the
resection
device for removing at least one of the fractionally resected skin pixels and
fat from the
target site.
Embodiments include a method comprising: generating a protocol including a
target site and a topographical map of fractional skin resections configured
for
application at the target site; configuring a resection device to include a
scalpet assembly
comprising at least one scalpet, and a depth control device configured to
control a depth
of penetration of the at least one scalpet into tissue at a target site,
wherein the at least
one scalpet includes a scalpet shaft comprising a proximal end, and a distal
end
configured to penetrate the tissue, wherein the scalpet shaft includes a
hollow region
adjacent to the distal end and configured to pass tissue received through the
distal end,
wherein the scalpet shaft includes an orifice coupled to the hollow region and
configured
to pass the received tissue out of the scalpet shaft; configuring the
resection device for
performing the fractional resections by incising skin pixels at the target
site according to
the protocol; and configuring the resection device for removing at least one
of the
fractionally resected skin pixels and fat from the target site.
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.
97
CA 03014431 2018-08-13
WO 2017/139773
PCT/US2017/017683
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.
98
