U.S. patent application number 12/061090 was filed with the patent office on 2008-10-09 for method and apparatus for surgical dissection.
Invention is credited to Edward W. Knowlton.
Application Number | 20080249526 12/061090 |
Document ID | / |
Family ID | 31999565 |
Filed Date | 2008-10-09 |
United States Patent
Application |
20080249526 |
Kind Code |
A1 |
Knowlton; Edward W. |
October 9, 2008 |
Method and apparatus for surgical dissection
Abstract
An apparatus for dissecting tissue in a substantially uniform
plane of dissection includes a housing configured to be advanced
under a tissue layer, and control one of a depth of dissection or
tissue flap thickness. The housing thermally shields at least a
portion of the tissue flap. A roller is coupled to the housing. The
roller is configured to smoothly advance housing over tissue. An
energy delivery device is coupled to housing. The energy delivery
device is configured to be coupled to an energy source. The energy
delivery device has a geometry that substantially defines a plane
of dissection.
Inventors: |
Knowlton; Edward W.; (Zehpyr
Cove, NV) |
Correspondence
Address: |
Goodwin Procter LLP;Attn: Patent Administrator
135 Commonwealth Drive
Menlo Park
CA
94025-1105
US
|
Family ID: |
31999565 |
Appl. No.: |
12/061090 |
Filed: |
April 2, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10620311 |
Jul 14, 2003 |
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12061090 |
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60396038 |
Jul 14, 2002 |
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60416206 |
Oct 3, 2002 |
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60418089 |
Oct 13, 2002 |
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Current U.S.
Class: |
606/45 |
Current CPC
Class: |
A61B 17/32093
20130101 |
Class at
Publication: |
606/45 |
International
Class: |
A61B 18/18 20060101
A61B018/18 |
Claims
1. A method of creating a tissue effect, comprising: providing an
electro-surgical device that includes an energy delivery device
with an energy delivery surface, a housing coupled to the electrode
with a guide that provides for cutting a skin layer and an
underlying thickness of subcutaneous tissue while preserving an
adjacent plane of tissue; positioning the energy delivery surface
at the skin surface; delivering sufficient energy from the energy
delivery device to cut the skin surface, create a plane of
dissection at a controlled depth with a substantially uniform
thickness while minimizing injury to tissue or structures within
the flap, wherein the plane of dissection is a surgical plane of
soft tissue where different or the same soft tissue components have
been separated from or within each other.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Ser. No.
10/620,311 filed Jul. 14, 2003, which application claims the
benefit of U.S. Ser. No. 60/396,038, filed Jul. 14, 2002, U.S. Ser.
No. 60/416,206, filed Oct. 3, 2002, and U.S. Ser. No. 60418,089
filed Oct. 13, 2002, all of which applications are fully
incorporated herein by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This invention relates to a method and apparatus for
treating tissue. More particularly, the invention relates to a
method for treating tissue using the delivery of energy. Still more
particularly the invention relates to a method and apparatus for
treating tissue using the delivery of energy to perform
electro-surgical procedures.
[0003] The human skin is composed of two elements: the epidermis
and the underlying dermis. The epidermis with the stratum corneum
serves as a biological barrier to the environment. In the basilar
layer of the epidermis, pigment-forming cells called melanocytes
are present. They are the main determinants of skin color. The
dermis is composed mainly of an extra-cellular protein called
collagen.
[0004] There are many causes of skin irregularities and deformities
including skin laxity, sun damage etc. These irregularities are the
result of changes in the structure and properties of the skin and
underlying tissue layers. One of the more prominent causes of
surface irregularities is cellulite which results in a dimpled,
lumpy, or bulging skin surface. Cellulite appears in the
subcutaneous level of skin tissue, that is the level below the
dermis. Fat cells in the subcutaneous layer are arranged in
chambers surrounded by connective tissue called septae. As fat
cells increase in size to the deposition of intracellular of fat,
the fibrous septae, which encase fat loculations and which connect
the deep aspect of the dermis to the subjacent muscle fascia, are
placed under increasing tension.
[0005] The growth in size of the fat loculations and the increase
in tension of the fibrous septae are combined with a progressive
laxity of skin due to age. This multifactorial complex of
increasing tension of the fibrous septae, increasing size of fat
loculations and progressive age related skin laxity results in a
three dimensional dimpling of the skin. This results in areas of
the skin being held down while other sections bulge outward,
resulting in the lumpy, `cottage-cheese` appearance.
[0006] As described above, the dermis is composed mainly of an
extracellular protein called collagen. Collagen is produced by
fibroblasts and synthesized as a triple helix with three
polypeptide chains that are connected with heat labile and heat
stable chemical bonds. When collagen-containing tissue is heated,
alterations in the physical properties of this protein matrix occur
at a characteristic temperature. The structural transition of
collagen contraction occurs at a specific "shrinkage" temperature.
The shrinkage and remodeling of the collagen matrix with heat is
the basis for the technology.
[0007] Collagen crosslinks are either intramolecular (covalent or
hydrogen bond) or intermolecular (covalent or ionic bonds). The
thermal cleavage of intramolecular hydrogen crosslinks is a scalar
process that is created by the balance between cleavage events and
relaxation events (reforming of hydrogen bonds). No external force
is required for this process to occur. As a result, intermolecular
stress is created by the thermal cleavage of intramolecular
hydrogen bonds. Essentially, the contraction of the tertiary
structure of the molecule creates the initial intermolecular vector
of contraction.
[0008] Collagen fibrils in a matrix exhibit a variety of spatial
orientations. The matrix is lengthened if the sum of all vectors
acts to distract the fibril. Contraction of the matrix is
facilitated if the sum of all extrinsic vectors acts to shorten the
fibril. Thermal disruption of intramolecular hydrogen bonds and
mechanical cleavage of intermolecular crosslinks is also affected
by relaxation events that restore preexisting configurations.
However, a permanent change of molecular length will occur if
crosslinks are reformed after lengthening or contraction of the
collagen fibril. The continuous application of an external
mechanical force will increase the probability of crosslinks
forming after lengthening or contraction of the fibril.
[0009] Hydrogen bond cleavage is a quantum mechanical event that
requires a threshold of energy. The amount of (intramolecular)
hydrogen bond cleavage required corresponds to the combined ionic
and covalent intermolecular bond strengths within the collagen
fibril. Until this threshold is reached, little or no change in the
quaternary structure of the collagen fibril will occur. When the
intermolecular stress is adequate, cleavage of the ionic and
covalent bonds will occur. Typically, the intermolecular cleavage
of ionic and covalent bonds will occur with a ratcheting effect
from the realignment of polar and non-polar regions in the
lengthened or contracted fibril.
[0010] Cleavage of collagen bonds also occurs at lower temperatures
but at a lower frequency. Low level thermal cleavage is frequently
associated with relaxation phenomena in which bonds are reformed
without a net change in molecular length. An external force that
mechanically cleaves the fibril can reduce the probability of
relaxation phenomena and provides a means to lengthen or contract
the collagen matrix at lower temperatures while reducing the
potential of surface ablation.
[0011] Soft tissue remodeling is a biophysical phenomenon that
occurs at cellular and molecular levels. Molecular contraction or
partial denaturization of collagen involves the application of an
energy source, which destabilizes the longitudinal axis of the
molecule by cleaving the heat labile bonds of the triple helix. As
a result, stress is created to break the intermolecular bonds of
the matrix. This is essentially an immediate extracellular process,
whereas cellular contraction can require a lag period for the
migration and multiplication of fibroblasts into the wound as
provided by the wound healing sequence. In higher developed animal
species, the wound healing response to injury involves an initial
inflammatory process that subsequently leads to the deposition of
scar tissue.
[0012] The initial inflammatory response consists of the
infiltration by white blood cells or leukocytes that dispose of
cellular debris. Seventy-two hours later, proliferation of
fibroblasts at the injured site occurs. These cells differentiate
into contractile myofibroblasts, which are the source of cellular
soft tissue contraction. Following cellular contraction, collagen
is laid down as a static supporting matrix in the tightened soft
tissue structure. The deposition and subsequent remodeling of this
nascent scar matrix provides the means to alter the consistency and
geometry of soft tissue for aesthetic purposes.
[0013] Dissection is the surgical separation of soft tissue
components or the creation of a separation interface within a soft
tissue component. The plane of dissection is the surgical plane of
soft tissue where different or the same soft tissue components have
been separated from or within each other. The plane of dissection
implies a horizontal orientation along soft tissue components.
Incise implies a vertical orientation of dissection through soft
tissue components. The undermined area is the area in a plane of
dissection that is separated from the subjacent soft tissue.
Referring to FIGS. 1(a)-1(f), the cutaneous flap, shown in FIG.
1(a) is a composite isolate of skin and subcutaneous soft tissue
that has been surgically separated along a horizontal plane of
dissection from the subjacent soft tissue. The subdermal plexus is
the superficial vascular supply of a cutaneous flap. Flap can also
mean an isolate of skin and soft tissue that will be advanced or
moved to an adjacent recipient site or used to close an adjacent
soft tissue defect. A synonymous term is `random cutaneous
flap`.
[0014] The myocutaneous flap, shown in FIG. 1(b) is a thicker
composite isolate of skin, subcutaneous soft tissue and muscle that
has been surgically separated from surrounding soft tissue. The
myocutaneous perforators (e.g. arteries) are the deeper and more
robust vascular supply of a myocutaneous flap. Flap necrosis is a
nonviable portion of a flap that has an inadequate vascular supply.
Flap necrosis is more likely to occur in cutaneous flaps because of
their less robust vascular supply. Other types of flaps will
exhibit a less or more robust vascular supply.
[0015] The fasciocutaneous flap shown in FIG. 1(c) that consists of
the skin, subcutaneous layer, and fascia is more robust in it's
circulation than the cutaneous flap which consists of the skin and
a viable thickness of subcutaneous layer. In comparison, the
fascio-subcutaneous flap (shown in FIG. 1(d)) which consists of the
variable amount in the deep portion of the subcutaneous layer with
the subjacent fascia, is less robust than the fasciocutaneous flap
but more robust than a subcutaneous flap (shown in FIG. 1(e)) that
consists only of the subcutaneous layer. However the most robust
flap is the myofascial flap (shown in FIG. 1(f)) with has an axial
circulation that runs longitudinally through the length of the
flap. Flaps may also be combination flaps (shown in FIG. 1(g))
where the proximal portion of the flap involves a deeper tissue
component such as the muscle or fascia but which extend distally
with more superficial components such as the subcutaneous layer
and/or skin.
[0016] There are a number of surgical, reconstructive, cosmetic,
dermatological procedures tissue where it is useful to dissect a
selected tissue layer having a uniform thickness while minimizing
injury to surrounding tissue. Such procedures include tissue
reconstructions, mastectomy and breast reconstruction, mastopexy,
face lifts, liposuction, buttocks lifts and the like. There is a
need for instruments for such procedures. Further, there are also a
number of surgical, cosmetic, dermatological procedures that lend
themselves to treatments which in addition to surgical remodeling,
thermal energy is delivered to the skin and underlying tissue to
cause a contraction of collagen, and/or initiate a wound healing
response so as to tighten or rejuvenate the skin and underlying
tissue at the tissue site. Such procedures include tissue
reconstructions, breast reconstruction, breast repositioning,
liposuction, face lift skin remodeling, resurfacing, skin
tightening, wrinkle removal and the like.
[0017] There is a need for an improved dissection, cutting device
that dissects tissues at a controlled depth.
SUMMARY OF THE INVENTION
[0018] Accordingly, an object of the present invention is to
provide an apparatus, and its methods of use, that delivers energy
to a tissue site and dissect a tissue plane at a controlled
depth.
[0019] Another object of the present invention is to provide an
apparatus, and its methods of use, that delivers energy to a tissue
site, dissect a tissue plane at a controlled depth, produces a
tissue flap with a substantially uniform thickness while protecting
or minimizing injury to tissue or structures within the flap
[0020] Still another object of the present invention is to provide
an apparatus, and its methods of use, that used RF energy to
dissect tissue and create one or more tissue flaps with a
substantial uniform thickness.
[0021] A further object of the present invention is to provide an
apparatus, and its methods of use, that creates a uniform surgical
release and mass shifting of overlying soft tissue structures from
subjacent tissue structures by uniformly dissecting the overlying
structures from the underlying tissue.
[0022] Yet another object of the present invention is to provide an
apparatus, and its methods of use, that creates a uniform surgical
release and a shifting of overlying soft tissue structures.
[0023] Another object of the present invention is to provide an
apparatus, and its methods of use, that creates a means to
surgically shift soft tissue through smaller less visible
incisions.
[0024] These and other objects of the present invention are
achieved in an apparatus for dissecting tissue in a substantially
uniform plane of dissection. A housing is configured to be advanced
under a tissue layer and control one of a depth of dissection or
tissue flap thickness. The housing thermally shields at least a
portion of the tissue flap. A roller is coupled to the housing. The
roller is configured to smoothly advance housing over tissue. An
energy delivery device is coupled to housing. The energy delivery
device is configured to be coupled to an energy source. The energy
delivery device has a geometry that substantially defines a plane
of dissection.
[0025] In another embodiment, an electro-surgical apparatus
includes an electrode with a cutting edge. A housing is coupled to
the electrode. The housing includes a top with a top proximal
section and a bottom with a bottom proximal section. The top
proximal section has a geometry that facilitates creation of a skin
flap with a substantially uniform thickness that includes a skin
layer and an adjacent layer of subcutaneous tissue. The bottom
proximal section has a geometry that preserves a plane of tissue
that is positioned adjacent to the adjacent layer of subcutaneous
tissue
[0026] In another embodiment, a dissection apparatus includes an
energy delivery device with an energy delivery surface. A housing
is coupled to the energy delivery device. The housing includes a
guide configured to permit the energy delivery surface provide a
surgical plane of dissection to free a skin section and an
underlying thickness of subcutaneous tissue while preserving an
adjacent plane of tissue.
[0027] In another embodiment, a tissue dissection apparatus
includes an electrosurgical energy delivery device with an
electrosurgical cutting edge. A housing is coupled to the energy
delivery device. The housing includes a guard that guides and
facilitates a dissection to create a surgical plane of dissection
to free a skin section and an underlying thickness of subcutaneous
tissue while preserving an adjacent plane of tissue.
[0028] In another embodiment, a method of creating a tissue effect
provides an electro-surgical device that includes an energy
delivery device with an energy delivery surface. A housing is
coupled to the electrode with a guide that provides for cutting a
skin layer and an underlying thickness of subcutaneous tissue while
preserving an adjacent plane of tissue. The energy delivery surface
is positioned at the skin surface. Sufficient energy is delivered
from the energy delivery device to cut the skin surface and the
underlying thickness of subcutaneous tissue at a selected depth
while preserving the adjacent plane of tissue.
[0029] In another embodiment, a method of creating a tissue effect
provides an electro-surgical device that includes an electrode with
a cutting edge, a housing coupled to the electrode with a guide
that provides for cutting a skin layer and an underlying thickness
of subcutaneous tissue while preserving an adjacent plane of
tissue. The cutting edge is positioned at the skin surface. The
skin surface and a layer of an adjacent underlying tissue are cut.
A tissue effect is created.
BRIEF DESCRIPTION OF THE FIGURES
[0030] FIGS. 1(a) through 1(g) illustrated cross-sectional views of
a skin surface, and various underlying structures.
[0031] FIG. 2(a) is a cross-sectional view of one embodiment of an
apparatus for dissecting or cutting tissue of the present
invention.
[0032] FIG. 2(b) is a cross-sectional view of another embodiment of
the an apparatus for dissecting or cutting tissue of the present
invention.
[0033] FIG. 2(c) is a top down view of another embodiment of the an
apparatus for dissecting or cutting tissue of the present invention
that includes a chamber.
[0034] FIG. 3 is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue that includes
suction capability.
[0035] FIGS. 4 and 5(a) are cross-sectional views of an apparatus
of the present invention for dissecting or cutting tissue with a
housing that can function as a tissue guide and a tissue guard, or
guide-guard to guide the electrode through tissue to produce a
uniform plane of dissection.
[0036] FIG. 5(b) is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue that includes a
buffer section on one or both electrode ends to bound the
electrode.
[0037] FIG. 5(c) is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue with a housing
that includes a sheath.
[0038] FIG. 5(d) is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue that can be
configured to allow the surgeon to advance the housing through the
skin with the housing in a pitched-up fashion.
[0039] FIG. 5(e) is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue that with an
extender that can include a deflectable section.
[0040] FIGS. 6, 7 and 8 are cross-sectional views of an apparatus
of the present invention for dissecting or cutting tissue that
include a roller.
[0041] FIGS. 9 and 10 are cross-sectional views of an apparatus of
the present invention for dissecting or cutting tissue that that
has a flat rectangular section positioned proximally behind) the
housing 14 and provide stabilization.
[0042] FIGS. 11(a) and 11(b) are cross-sectional view of an
apparatus of the present invention for dissecting or cutting tissue
that element with a substantially U-shaped section positioned
proximal to housing.
[0043] FIG. 12 is a cross-sectional view of an apparatus of the
present invention for dissecting or cutting tissue that with a
stabilizing element that can be positioned between a first roller
and a second roller.
[0044] FIGS. 13a and 13b illustrate an apparatus of the present
invention for dissecting or cutting tissue with a gap distance
between the electrode and the roller configured to control or
facilitate control of the thickness of the skin envelope or tissue
flap and/or the dissection depth.
[0045] FIGS. 14-18 illustrate an apparatus of the present invention
for dissecting or cutting tissue that include trans-cutaneous
markers.
[0046] FIGS. 16(a) and 16(b) illustrate an apparatus of the present
invention for dissecting or cutting tissue with a pattern of bumps
which corresponding to different dissection depths, to provide the
physician with a real time visual indication of the depth of
dissection.
[0047] FIG. 17 illustrates an apparatus of the present invention
for dissecting or cutting tissue with different bump shapes
[0048] FIG. 18 illustrates an apparatus of the present invention
for dissecting or cutting tissue with marking ridges to provide a
visual bracketing or cue of the width of the plane of
dissection.
[0049] FIGS. 19(a) through 20b illustrate an apparatus of the
present invention for dissecting or cutting tissue with a
detachable section or movable or variable shaped contour.
[0050] FIGS. 21 through 22(b) illustrate an apparatus of the
present invention for dissecting or cutting tissue that provides a
guarding function of the housing to protect the dermal and
sub-dermal vascular and neural plexus or other selected layer of
the skin envelope or tissue flap from thermal injury and/or
necrosis. FIGS. 23 through 25 illustrate an apparatus of the
present invention for dissecting or cutting tissue that includes
delivery of a cooling fluid
[0051] FIG. 24 illustrate an apparatus of the present invention for
dissecting or cutting tissue with apertures to direct or infuse a
cooling solution onto the skin envelope or tissue flap.
[0052] FIG. 25 illustrate an apparatus of the present invention for
dissecting or cutting tissue with a porous section coupled to the
housing 14 and fluidically coupled to one or more lumens.
[0053] FIGS. 26 through 28 illustrate an apparatus of the present
invention for dissecting or cutting tissue that is configured to
dissect tissue in deeper planes of dissection than the dermis or
superficial fascia.
[0054] FIGS. 29(a) and 29(b) illustrate an apparatus of the present
invention for dissecting or cutting tissue configured to dissect
fascial layers by a variety of different approaches.
[0055] FIGS. 30(a) through 30(c) illustrate an apparatus of the
present invention for dissecting or cutting tissue that include a
port device.
[0056] FIGS. 31(a) through 31(c) illustrate an apparatus of the
present invention for dissecting or cutting tissue configured to
provide a uniform surgical release and mass shifting of overlying
soft tissue structures from subjacent tissue structures by
uniformly dissecting the overlying structures from the underlying
tissue.
[0057] FIGS. 32 through 34 illustrate an apparatus of the present
invention for dissecting or cutting tissue with a housing
fabricated from any number of medical polymers.
[0058] FIG. 35 illustrate an apparatus of the present invention for
dissecting or cutting tissue with a housing configured to vary the
amount that the electrode can be advanced or retracted in an out of
the housing.
[0059] FIGS. 36(a) through 37 illustrate an apparatus of the
present invention for dissecting or cutting tissue with a housing
that can include one or both of a linear or curved or contoured
portions.
[0060] FIG. 37 illustrates an apparatus of the present invention
for dissecting or cutting tissue with a plurality of conformable
portions having different flexural moduli.
[0061] FIG. 38 illustrates an apparatus of the present invention
for dissecting or cutting tissue that is configured to move over a
curved tissue surface and still maintain a substantially uniform
depth of dissection.
[0062] FIGS. 39(a) through 39(c) illustrate an apparatus of the
present invention for dissecting or cutting tissue configured to
provide advancement of housing on curved surfaces.
[0063] FIGS. 40 through 44 illustrate an apparatus of the present
invention for dissecting or cutting tissue with one or more roller
devices that can also be a sliding or linear translation
device.
[0064] FIGS. 42 and 43 illustrate an apparatus of the present
invention for dissecting or cutting tissue with rollers located
above and below the electrode 18.
[0065] FIG. 44 illustrate an apparatus of the present invention for
dissecting or cutting tissue with a roller that can generate
sufficient frictional force with the contacting tissue so as to put
all or a portion of the subjacent tissue layers in contact with the
housing.
[0066] FIGS. 45(a) through 45(b) illustrate an apparatus of the
present invention for dissecting or cutting tissue with a housing
that provides a force application surface configured to allow the
physician to press down on the housing to apply a downward force
from the rollers to the underlying tissue layer.
[0067] FIG. 45(c) illustrate an apparatus of the present invention
for dissecting or cutting tissue with other means for force
application.
[0068] FIGS. 46 through 48 illustrate an apparatus of the present
invention for dissecting or cutting tissue with an electrode 18
that is fabricated from a variety of conductive materials
[0069] FIG. 49 illustrate an apparatus of the present invention for
dissecting or cutting tissue with an electrode that has a wedge
shaped or "cow catcher shaped" that provides a wedge or force
concentration affect in cutting through the tissue.
[0070] FIG. 50 illustrate an apparatus of the present invention for
dissecting or cutting tissue with one or both ends of the electrode
attached to the sides of the housing.
[0071] FIGS. 51(a) through 51(b) illustrate an apparatus of the
present invention for dissecting or cutting tissue with the
electrode coupled to the housing with a strut member.
[0072] FIG. 52 illustrate an apparatus of the present invention for
dissecting or cutting tissue with an electrode that is
electromagnetically coupled to an energy source.
[0073] FIGS. 53(a) and 53(b) illustrate an apparatus of the present
invention for dissecting or cutting tissue configured to use high
frequency, high power RF energy in conjunction with injection or
infusion of an electro-conductive or electrolytic solution.
[0074] FIGS. 56 through 57 illustrate an apparatus of the present
invention for dissecting or cutting tissue with a hand piece
configured to be attached to the electrode housing to provide
similar tactile sensation.
[0075] FIGS. 58 through 59 illustrate an apparatus of the present
invention for dissecting or cutting tissue with a housing
configured to be deployable in situ to allow subcutaneous insertion
of all or portion of the housing 14 through a single incision.
[0076] FIG. 60 illustrates an apparatus of the present invention
for dissecting or cutting tissue that provides transcutaneous
visualization.
[0077] FIG. 61 illustrates an apparatus of the present invention
for dissecting or cutting tissue that is configured to be monitor
by temperature of tissue adjacent or near the housing.
[0078] FIG. 62 illustrates an apparatus of the present invention
for dissecting or cutting tissue with cooling that can be achieved
by irrigation of the tissue surface or selected portions of the
tissue site with a cooled fluid.
[0079] FIG. 63 illustrate an apparatus of the present invention for
dissecting or cutting tissue that provides cooling of the skin and
adjacent tissue by suctioning off, capturing or cooling a vapor
produced from vaporization of tissue during energy delivery.
[0080] FIGS. 64(a) through 64(f) illustrate use of an apparatus of
the present invention in the performance of a skin preservation
mastectomy in which no breast skin is resected.
[0081] FIG. 65 illustrate use of an apparatus of the present
invention for a facelift patient with redundant skin the cheeks,
jowls and neck.
[0082] FIGS. 66 and 67 illustrate the use of an apparatus of the
present invention for a patient with breast ptosis.
[0083] FIGS. 68 through 71 illustrate the use of an apparatus of
the present invention for the aesthetic surgical discipline of
`closed advancement` using a closed flap dissection with a uniform
flap.
[0084] FIG. 72 illustrates the use of an apparatus of the present
invention with an open or closed loop feedback
system/resources.
[0085] FIG. 73 illustrates the use of an apparatus of the present
invention with a current sensor and voltage sensor.
[0086] FIG. 74 illustrates the use of an apparatus of the present
invention with a temperature and impedance feedback system.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0087] Embodiments of the invention provide a method and apparatus
for use in various surgical procedures such as plastic surgery
procedures and minimally invasive surgical procedures. In an
embodiment, the apparatus can comprise an electro-surgical
instrument configured to use radio-frequency (RF) or other
electromagnetic energy to perform various surgical procedures
including, but not limited to, cutting, dissection, coagulation and
the like. In an embodiment, the apparatus can be configured to be
used in surgical dissection procedures to produce one or more
tissue flaps having a substantially uniform thickness.
[0088] Referring now to FIGS. 2(a) through 7, these figures
illustrate embodiments of an apparatus 10 that can be configured to
dissect tissue or treat tissue at a target tissue site 8 such as a
subcutaneous tissue site and create a selected plane of dissection
8pd having a selectable and substantially uniform depth of
dissection 8dd and a selectable and substantially uniform flap
thickness 8t.
[0089] In various embodiments, apparatus 10 can create (i) a
uniform plane of flap dissection, including but not limited to
electrosurgical, a uniform flap thickness of or a uniform flap of
variable thickness, (ii) a reduced surface area in a plane of
dissection due to flap uniformity, (iii) a more uniform plane of
wound healing with a reduction on volumetric scarring within the
plane of dissection, uniform thermal tightening of the dissected
skin flap, (iv) a uniform primary tightening, which is a thermal
molecular collagen contraction within the plane of dissection, (v)
a uniform secondary tightening: delayed secondary wound healing
contraction within the plane of dissection, (vi) a reduction in
iatrogenic surface contour irregularities of the flap surface,
(vii) a uniform release of subjacent soft tissue structures, and
the like.
[0090] Apparatus 10 can also be utilized to create secondary
aesthetic guide effects including but not limited to, (i) 3
dimensional contour enhancement from flap advancement, (ii) 2
dimensional surface area tightening from primary and secondary
thermal tightening of the skin flap, (iii) creation of a surgical
portal for suction curettment of a liposuction treatment site that
can provide a more uniform contour reduction than standard
liposuction, (iv) provide a surgical portal for lifting plication
of the subjacent soft tissue, (v) create a uniform release of
pre-existing tethering fibrous septae which causes cellulite
dimpling of the skin surface.
[0091] Apparatus 10 can have guard effects, relative to tissue
dissection and/or cutting, that can be utilized for a variety of
applications and result in, (i) a reduction of electrosurgical
complications of flap dissection, (ii) a reduced incidence of full
thickness flap lacerations (button holing), (iii) a reduced
incidence of deep tissue injuries of the subjacent vital structures
such as nerves, vessels and muscle either from transaction or
thermal conductive damage, (iv) a reduced incidence of flap
necrosis due to interruption of flap blood supply, (v) a reduced
incidence of electrosurgical burns of the flap, and the like.
[0092] FIGS. 1 and 2(a) through 2(c) illustrate an embodiment of
apparatus 10 that can include a housing 14 having proximal and
distal portions 14p and 14d (here distal refers to the front of
housing 14 that is advanced into tissue and proximal refers to the
trailing end of housing 14). A hand piece 15 is coupled to proximal
portions 14p and can be fixedly coupled or pivotally coupled via a
pivotal coupling 14cop. Handpiece 15 can include or be coupled to
an extension member 22. The distal portions 15d of the hand piece
or extension member can be at least partially recessed within
housing 14 to reduce friction or drag from the handpiece. An
electrode or other energy delivery device 18 having an electrode
cutting edge 18ce is coupled to distal portions 14d of housing 14
directly or via an insulative coupling 14icop.
[0093] Electrode 18 can be positioned distally to housing 14 and is
configured to cut or dissect through tissue via the use of RF
energy (other electromagnetic energy) to produce a selected plane
of dissection within or between one or more tissue layers such as
the subcutaneous layer of the skin or the muscle fascia. Electrode
18 and/or apparatus 10 can be configured to be coupled to a power
source 20 via a power connecting member 20cm. In various
embodiments, one or more rollers or roller elements 17 can be
coupled to housing 14. Rollers 17 can be positioned at the distal
portions 14d of housing 14, can be positioned adjacent, above or
below electrode 18 or can be attached to the bottom 14b or the top
of housing 14t. Rollers 17 positioned above the electrode, are
configured to assist in rolling or advancing the nascently
dissected tissue flap over housing 14. Rollers 17 positioned below
can be configured to allow housing 14 to roll over underlying
tissue as housing 14 is advanced in the dissection pocket 8dp at
the target tissue site 8 or elsewhere.
[0094] Referring now to FIGS. 2(b) and 2(c), in one embodiment
housing 14 is configured to be advanced under a tissue layer and
control one of a depth of dissection or tissue flap thickness.
Housing 14 thermally shields at least a portion of the tissue flap.
Roller 17 can be coupled to housing 14, as more fully explained
hereafter. Roller 17 is configured to smoothly advance housing 14
over tissue. Electrode 18 is coupled to housing 14 and has a
geometry that substantially defines a plane of dissection.
[0095] In another embodiment, housing 14 includes a top with a top
proximal section 14' and a bottom with a bottom proximal section
14''. Top proximal section 14' has a geometry that facilitates
creation of a skin flap with a substantially uniform thickness that
includes a skin layer and an adjacent layer of subcutaneous tissue.
Bottom proximal section 14'' has a geometry that preserves a plane
of tissue that is positioned adjacent to the adjacent layer of
subcutaneous tissue
[0096] In one embodiment, illustrated in FIG. 2(b), bottom proximal
section 14"has a most proximal point at "A", and the top proximal
section has a most proximal point at "B", wherein A is more
proximal than B. Bottom proximal section 14'' is defined by point A
and a more distal point "C". Electrode 18 extends from point A to
point B. Electrode 18 forms the hypoteneus of a triangle defined by
points A, B, and a point D which is positioned at a more proximal
position than point B. Bottom proximal section 14'' forms a
hypotenuse of a triangle defined by points A, C and a point E,
wherein E is more proximal than point C. In various embodiments,
the distance between points D and A can be in the range of 1 mm to
2.5 cm, the distance between points D and B can be in the range of
0 mm to 1.5 cm, the distance between points A and E can be in the
range of 0 mm to 1.5 cm, and the distance between points E and C
can be in the range of 0 mm to 1.5 cm.
[0097] As illustrated in FIG. 2(c), housing 14 can include a
chamber that facilitates creation of the skin flap.
[0098] In an embodiment shown in FIGS. 4 and 5(a), housing 14 can
be substantially hood shaped with a configuration that allows
housing 14 to function as a tissue guide and a tissue guard, or
guide-guard to guide the electrode through tissue to produce a
uniform plane of dissection and protect subjacent and overlying
tissue layers from thermal injury as will be discussed more fully
herein. The distal portion 14d of housing 14 or hood 14 can include
a small recessed area 12 and the proximal portion of the hood can
also include a recessed area 13, one or both of which can be
substantially vertically centered on the vertical center line 14vc
of the hood. The two recessed areas 12 and 13 can be curved or
rectangular in profile.
[0099] Electrode 18 can be approximately positioned in the vertical
center line 12vc of the recessed area with the cutting edge of the
electrode 18ce protruding distally in front of housing 14 and out
of recessed area 12 by a selectable distance (e.g. 1 to 40 mms).
The electrode can be attached to housing 14 near the sides 12s of
the recessed area 12. The distal portion of the hand piece 15d or
extender 22d can be recessed under the proximal portions 14p of the
hood housing 14 and can be attached in recessed area 13. The
attachment can be via pivotal couple 14cop such as an axel that
allows hand piece 15 to pivot up and down with respect to the
vertical center 14vc of the hood. Alternatively, the hand piece 15
or extender 22 can be fixedly attached using a screw, nut, adhesive
bond or other mechanical attachment 14am means known in the
art.
[0100] In various embodiments, housing 14 can also be configured to
avoid lacerating the skin envelope including full thickness
lacerations. Such lacerations are also known in the surgical arts
as "button holing". Means for avoiding skin lacerations or button
holing (e.g. skin laceration avoidance means) can include one or
more of the following configurations of housing 14: (i) configuring
housing 14 such that the distal top portions of housing 14 are
above the electrode (that is that 14he height of housing 14 is
substantially above the electrode as is discussed herein, (ii)
coupling the electrode to housing 14 the such that electrode and/or
electrode plane is vertically bounded by the top an bottom portions
of housing 14, (iii) positioning the electrode on housing 14 such
that electrode plane or cutting plane is substantially aligned with
the vertical center of housing 14, (iv) configuring housing 14
width to be greater than the electrode width (iv) configuring the
electrode ends to be bounded on either side by housing 14 and (iv)
configuring housing 14 to have a sheath portion on either end of
the electrode.
[0101] One or more of these features can also be utilized to have
housing 14 protect subjacent tissue from unwanted perforation, or
laceration as housing 14 is advanced through tissue. Such subjacent
tissue can include, without limitation, muscle, nerve, blood
vessels, arteries, veins tendons and the like.
[0102] As shown in FIG. 5(b), in an embodiment for reducing button
holing, housing 14 width 14w can be greater than the electrode
width 18w and can be further configured to have a buffer section
14bs on one or both electrode ends 18e to bound the electrode. As
shown in FIG. 5(c), housing 14 can also include sheath portions
14shp on either end of the electrode. Sheath portion 14shp can be
configured to reduce button holing by shielding or overlying the
electrode ends to keeping the electrode ends from protruding into
the skin. This can be further facilitated by fabricating sheath
portions 14shp from pliable polymers such that the sheath portions
will at least partially deform when pressed into the skin envelope
so as not to perforate or lacerate the skin envelope and also
provide sufficient structural support and/or elastic cushioning to
keep the electrode from do so.
[0103] Suitable pliable materials for sheath portions 14shp can
include silicone and polyurethane elastomers and other resilient
polymers known in the art such as PEBAX. Other means for reducing
button holing can include the use of insulated sections 18l
disposed near the electrode ends of the electrode as is discussed
herein.
[0104] In a related embodiments shown in FIGS. 5d and 5e, housing
14 can be configured to allow the surgeon to advance housing 14
through the skin with housing 14 in a pitched-up fashion. In use,
advancing housing 14 in a pitched-up fashion helps to protect
subjacent tissue layers (such as muscle, nerve and blood vessels,
etc) as well as providing a tenting of the skin visually indicating
to the surgeon where apparatus 10 is at least partially under the
skin and that subjacent tissues are not being dissected. In various
embodiments, housing 14 pitch can be accomplished by manual
manipulation of the handpiece 15 and/extender 22 by the surgeon
such that he or she sees the skin tenting or protuberance 8tent
produced by and indicative of housing 14 being pitched up.
[0105] Alternatively in an embodiment shown in FIG. 5e, extender 22
can include a deflectable section 22def which the surgeon can
manipulate by virtue of a actuating member 39 or deflection
mechanism 25 and an actuator 15a' on the hand piece which can be
configured to allow the surgeon to deflect extender selectable
amount to pitch housing 14 at a selectable angel of attack 14aa
with respect to skin surface or tissue layer 81 Actuator 15a' can
be a slide mechanisms known in the art and can include graduated
markings 15gm indicting angle of attack 14aa.
[0106] Also in this and related embodiments, electrode 18 can be
configured to be swivelable through a selectable arc 18arc to have
selected cutting angle 18aa by virtue of swivel or pivot mechanism
18sw. Swivel or pivot mechanism 18sw can be any swivel or pivot
mechanism known in the art including a bearing mechanism. Also in
an embodiment, swivel mechanism 18sw can be coupled to an actuator
15a'' on hand piece 15 (by an actuating member 39), where actuator
15a'' is configured to allow the surgeon to swivel electrode 18 to
a selectable cutting angle 18aa.
[0107] Actuator 15a'' can also be a slide mechanisms known in the
art and can include graduated markings 15gm indicting cutting angle
18aa. In use, swivel mechanism 18sw can be configured to allow the
surgeon to dissect tissue along a selected tissue plane 8pd (which
can be substantially parallel to a select tissue layer 81) even
while housing 14 is pitched up or pitched down.
[0108] In an embodiment shown in FIGS. 6 and 7, apparatus 10 can
comprise a roller 17 pivotably coupled to a hand piece 15 (or hand
piece extender 22) via an axel 17a. The distal end 15d or 22d of
the hand piece 15 or hand piece extender 22 can be substantially
crescent shaped, with sufficient clearance space 15s to allow for
movement of roller 17 and/or pivotal movement of the hand piece 15
or hand piece extender 22. Electrode 18 can be attached to the
roller axis 17a, to the distal end 15d of the hand piece 15 or the
distal end 22d of the hand piece extender 22.
[0109] In either configuration, the electrode and roller are in a
fixed vertical relationship with each. The electrode can be
positioned distally in front of the roller and preferably is
substantially vertically aligned with the center of roller 17cen,
but can also be positioned above or below the roller center. The
electrode is positioned far enough in front of the roller to allow
the developing skin envelope to slide over the roller after
dissection by the electrode.
[0110] In various embodiments, this distance known as the electrode
gap distance 18gd, can be 1 to 40 mm. Roller 17 can be configured
to roll or advance subcutaneously over underlying tissue by the
application of force from hand piece 15 and advance electrode 18
through tissue (such as subcutaneous tissue) to uniformly dissect a
plane of dissection 8pd.
[0111] As described herein, in various embodiments, housing 14 can
be configured to act as a tissue guide for advancing the electrode
through tissue to produce a substantially uniform plane of
dissection 8pd and also as guard to protect tissue and tissue
layers 81 above and below the plane of dissection. In these
embodiments, housing 14 can thus be a tissue guide-guard for
performing uniform depth tissue flap dissection using an energized
cutting means such an RF electrode. The above lying protected
tissue layers can include the skin envelope including the dermal
and sub-dermal plexus. The subjacent protected tissue can include
nerves, muscle, tendon, arteries, veins and the like.
[0112] As a tissue guide, housing 14 can be configured to guide and
stabilize the electrode through tissue to produce a plane of
dissection 8pd having a uniform depth of dissection 8dd. More
specifically it can be configured to function as a guide for
generating a uniform depth of dissection 8dd during a minimally
invasive procedure to undermine or dissect selected tissue layers
81 such as the skin envelope 8se using an electro-cautery cutting
electrode 18 or other energy delivery device configured for tissue
dissection or cutting.
[0113] The guiding function of housing 14 is to guide the electrode
through tissue and control the dissection depth and the tissue flap
thickness 8t can be accomplished by a variety of means including
the shape, structure and material and mechanical properties of
housing 14. For example, as described herein, the distal portion
14d of housing 14 can have a curved shape configured to facilitate
smooth advancement of the dissected skin envelope 8se over the top
of housing 14. This reduces the frictional and other forces, which
may act on housing 14 to push the electrode and thus the electrode
plane 18pe up or down and out of the selected plane of dissection
8pd.
[0114] In other embodiments the guiding function of housing 14 can
also be accomplished by configuring housing 14 to function to
stabilize the plane of the electrode 18pe (which substantially
defines the plane of dissection) relative to the selected plane of
dissection 8pd such that electrode plane 18pe does not
substantially pitch up or pitch down into tissue as housing 14 is
advanced or otherwise moved through tissue. This stabilization
function can be accomplished through several means. First the plane
of the electrode 18pe can be configured to resist tissue applied
forces tending to deform its shape through the use of rigid
materials for electrode 18 and/or strut members 19 (described
herein) coupled to the electrode and housing 14 or a roller axel
17a described herein.
[0115] Housing 14 can be configured to resist or otherwise
attenuate tissue applied forces causing the electrode plane to dip
down or dip up. Referring now to FIG. 8, this can be accomplished
by configuring housing 14 to act as a counterbalancing lever arm
14cla (at the point where housing 14 couples to the electrode such
as the roller axel) to counter balance downward or upward tissue
applied forces (or other forces) on the electrode. This in turn can
be accomplished by configuring housing 14 to have sufficient length
14l and/or shape such that normal forces from tissue on housing 14
will counteract tissue applied forces on the electrode. In such
embodiments the length of housing 14 can be between 1/4 to 4
inches.
[0116] Housing 14 can have sufficient mass and/or length relative
to the distance the electrode projects in front of housing 14 (also
called electrode gap distance 18gd discussed herein) such that
tissue applied forces and resulting torque or moment on the
electrode will not be sufficient to overcome the counterbalancing
torque/moment forces of housing 14. In embodiments the mass of
housing 14 can exceed that of the electrode by a range of ratios
from 1:10 to 1:100 and the length of housing 14 can exceed that of
the electrode plane by a ratio range of 1:5 to 1:100. Also housing
14 can be configured to stabilize the electrode by having a center
of mass 14cm (that of housing 14) located substantially at its
geometric center 14gc or in a selected axis (e.g. x, y or z).
[0117] In other embodiments, stabilization can be achieved by
configuring housing 14's center of mass 14 cm to be located below
housing 14s vertical center 14vc in a range of about 5 to 99% of
half of housing 14 height 14ht with specific embodiments of 10, 25
and 75%.
[0118] Referring now to FIGS. 9-12 (showing embodiments of a
stabilizing element) in other embodiments, stabilization of the
electrode plane 18pe can be achieved by means of a stabilizing
element 27 positioned proximally to housing 14 and coupled to
housing 14 or the roller axis 17a. Similar to the description
above, the stabilizing element serves to provide a counter
balancing torque or moment arm opposing forces on the electrode or
housing 14 causing the electrode plane 18pe to pitch up or
down.
[0119] In an embodiment, stabilizing element 27 can be
substantially planer having a thickness 27t thinner than the
thickness 14t of housing 14 or roller diameter 17d, and having a
plane 27p that this is substantially parallel to the electrode
plane 18pe. Stabilizing element 27 can have a variety of shapes
including, square, rectangular, rectangular with radiused edges,
circular, semicircular, or fin-shaped.
[0120] In an embodiment shown in FIGS. 9 and 10 the stabilizing
element 27 can comprise a flat rectangular section positioned
proximally (e.g. behind) housing 14 or roller 17. The element can
be coupled to the roller axel 17a or the proximal section 14p of
housing 14. In another embodiment, shown in FIGS. 11a and 11b
element 27 can be a substantially U-shaped section positioned
proximal to housing 14 or roller 17, with the apex of the U 27a,
pointing away from the back (proximal direction) of housing 14.
[0121] In yet another embodiment shown in FIG. 12, the stabilizing
element 27 can be positioned between a first roller 17f and a
second roller 17s. In a related embodiment, stabilizing element 27
can comprise a connecting section 27cs between the two rollers. In
a related embodiment, the stabilizing element 27 can comprise a
stabilizing strut member 27m connecting the first roller to the
second roller.
[0122] In various embodiments, the thickness 27t of the stabilizing
element can be in the range of 0.05 to 0.5 inches with specific
embodiments of 0.1, 0.2 and 0.3 inches. Also the ratio of the
thickness of the stabilizing element to the thickness/height of
housing 14 14h or diameter 17d of roller 17 can be in the range of
1:1 to 10:1, with specific embodiments of 2:1, 4:1 and 6:1.
[0123] Element 27 can be fabricated from biocompatible polymers
known in the art and described herein. In an embodiment, element 27
can be fabricated from low friction materials or have a lubricous
coating 27c such as TEFLON.RTM. or other PTFE known in the art. In
use the stabilization element, by stabilizing the electrode plane,
helps the surgeon maintain a uniform depth of dissection as the
electrode and housing 14 are advanced through tissue.
[0124] Referring now to FIGS. 13a and 13b, in various embodiments,
the gap distance 18gd between the electrode and the roller and or
between electrode and upper distal end of housing 14ude can be
configured to control or facilitate control of the thickness 8t of
the skin envelope or tissue flap and/or the dissection depth 8dd.
The distance between the electrode and housing 14 can be in the
range of 0.05 to 1 inch with specific embodiments of 0.1, 0.2,
0.25, 0.3. 0.5 and 0.75 inches. Smaller gaps can be employed for
procedures utilizing smaller tissue flaps thickness and larger gaps
for procedures using large flap thickness. Preferably, but not
necessarily, electrode distance 18gd height is less than height
14he (the height of housing 14 above the electrode) and for
embodiments using rollers 18gd is less than the radius 17r of 17
roller (or less than the diameter 17d for upper roller
embodiments). Also height 14he can be configured to have the top of
housing 14 high enough above the electrode to minimize button
holing of apparatus 10 through the skin envelope (as discussed
herein). In various embodiments this can be accomplished with a
height 14he in the range of 0.25 to 2 inches with specific
embodiments of 0.3, 0.5, 0.75, and 1.5 inches.
[0125] In related embodiments, flap thickness 8t and/or the depth
of dissection 8dd can also be controlled by manipulation of (i) the
ratio of the gap distance 18gd to distance 14he, defined as the gap
to height ratio and/or (ii) the ratio of distance 18gd to the
radius 17r (or less than the diameter 17d for upper roller
embodiments) of roller 17, defined as the gap to radius ratio. In
various embodiments, either of these two ratios can be in the range
of 1:1 to 1:10 (i.e., the radius of the roller is 10 times greater
than the electrode gap distance) with specific embodiment of 1:2,
1:4, 1:5 and 1:7. In addition, control of the depth of dissection
and skin flap thickness manipulation of one or both of these
ratios, can be used to control or affect (i) the amount of
conductive heat transfer to the dissected skin envelope/tissue
flap, (ii) temperature of the dissected skin envelope/tissue flap,
(iii) the amount of tightening of the skin envelope, (iv) the
tension of the nascent skin envelope and (v) the amount of cutting
or separation force applied to tissue at the plane of dissection.
Large ratios will more readily push the nascent skin envelope away
from the electrode after dissection and thus reduce the amount of
conductive heat transfer to portions of the envelope (from RF
energy delivery) and also provide a thermal shielding to the
envelope/tissue flap. Larger ratios may also by used to produce
more of a cutting or wedge affect in the tissue.
[0126] Referring now to FIGS. 14-18 (illustrations showing
embodiments having trans-cutaneous markers), in another approach
for facilitating control of dissection depth and flap thickness in
various embodiments, housing 14 can have one or more ridges 21r,
protuberances or bumps 21b or patterns 21pb of bumps having a
substantially parallel orientation (or other selected orientation)
to the longitudinal axis 14la of housing 14 as shown in FIG. 14.
The ridges or bumps can be configured as trans-cutaneous markers 21
to provide trans-cutaneous visualization of one or more of the
following: (i) the depth of dissection, (ii) the width of the
dissection plane, and (iii) the path of the plane of dissection. In
related an embodiment shown in FIG. 15, roller 17 can have one or
more ridges 21r or bumps 21b configured as trans-cutaneous markers
to provide similar visualizations.
[0127] As shown in FIGS. 16a and 16b, the pattern of bumps 21bp can
include different patterns of bumps (for example a first bump
pattern 21bp' such as a square and a second bump pattern 21bp''
such as a circle) having different heights 21h' and 21h''
corresponding to different dissection depths 8dd, to provide the
physician with a real time visual indication of the depth of
dissection, including any variations in the desired depth as
housing 14 is advanced over the selected tissue plane. In use,
these and related embodiments can be configured to provide the
physician with both a qualitative and quantitative indication of
the depth of dissection. In related embodiments, the height of the
ridges or bumps can be adjustable to allow the physician to have
trans-cutaneous visualization of pr at different depths of
dissection. This can be accomplished using an adjustment means 21a
known in the art including a setscrew, ratchet, swage fitting,
locking device, clamp and the like.
[0128] In various embodiments, the shape of the visualization bumps
21bs can include round, square, diamond oval triangular and
combinations thereof. In an embodiment shown in FIG. 17, different
bump shapes can have different heights 21h, which correspond to
different dissection depths 8dd. Specifically bumps 21 can include
a first bump 21b' having a first height 21h' and second bump 21b''
having a second height 21h''. For example, a diamond shape bump
could have a height that correspond to a dissection depth of 4 mm
and round shaped bump could have a height that corresponds to a
dissection depths of 8 mm. In use these and related embodiments of
housing 14 having a pattern-height specific visualization bumps 21
allows the surgeon to readily discern the dissection depth as well
as changes there to without having to palpitate the skin,
endoscopically view the plane of dissection or remove the device
from the tissue site. Further these and related embodiments can
also allow the surgeon to readily discern the slope of housing 14
advancement and thus readily make adjustment to maintain the plane
of dissection or change it if so desired without having to remove
either hand from the hand piece. This in turn provides for a
greater degree of control of the dissection procedure.
[0129] Also in an embodiment shown in FIG. 18, housing 14 or roller
17 can have a pair of marking ridges 21mr, corresponding
approximately to dissection width 18wd of the electrode to provide
a visual bracketing or cue of the width 8wd of the plane of
dissection. In a related embodiment, housing 14 or roller can
include a third ridge 21rc whose position corresponds to the
lateral center 18c of the electrode, to provide an indication of
the center line 8cl of the plane of dissection. In another
embodiment, the guard/guide components of housing 14 can be
configured to mimic the visual impression that a surgical
instrument, such as Metzenbaum scissors, make on the skin surface
during the dissection process.
[0130] Referring now to FIGS. 19a-19b and 20a-20b (Figures
illustrating an embodiment having a detachable section or movable
or variable shaped contour). In various embodiments, the shape,
contour or height of housing 14 can be selectable and can be
adjustable using an adjustment mechanism known in the art such as a
telescoping mechanism or articulated mechanism or using a variable
size roller device 17. Also in various embodiments, the electrode
housing can have different widths and different dissection depths.
The width 14w and/or dissection depth 8dd of housing 14 can be
pre-selected or adjusted depending on the surgical application
(e.g. cutting into dermal, fascia or fat tissue, face lift etc). In
various embodiments, the dissection depth 8dd can be in the range
of 0 to 2 inches with specific embodiments of 0.1, 0.2, 0.25, 0.5,
0.75 and 1.0 inches.
[0131] An embodiment for adjusting the height or other dimension of
housing 14 can include a detachable section or shim 14ds.
Detachable section 14ds can attach to the bottom 14b, top 14t or
other area of housing 14 using a snap fit, spring loaded latch or
other reversible detachment mechanism 14dm known in the art.
Detachable section 14ds can be of varying height, but can otherwise
have the same dimensional footprint or profile as housing 14. In
various embodiments, all or portions of housing 14 can be variable
shape portions 14vs configured to be variable in shape, contour
and/or dimension. Means for varying the shape and dimensions of
housing 14 can include configuring portions of housing 14 to be
expandable or include an integral expandable member 14im (such as
expandable balloon described herein and also known in the medical
device arts) or use of a lifting or force generating mechanism 37
such as a spring, cam or lever that is integral or otherwise
disposed within housing 14. Expandable member 14im can be
configured to be operator actuable via device 15a which is coupled
to an inflation device 24id which can be pressure source 24p.
[0132] Lifting mechanism 37 can also be configured to be operator
actuable via mean of a control wire, rod or other actuating member
39 coupled to the hand piece 15 via an actuating device 15a. In
embodiment actuating device 15a can be a slide, thumb switch,
rocker arm and the like. In embodiment force generating mechanism
37 can also comprise deflection mechanism 25 described herein.
[0133] In various embodiments, variable shaped portions 14vs can be
configured to control or alter one more of the following
parameters: (i) change the electrode gap distance 18gd, (ii) change
the height of housing 14, (iii) change the height of housing 14
above the electrode, (iv) change the contour of housing 14 for
example increase or decrease an amount of taper or concavity (v)
change the angle at which the skin envelope slides over housing 14,
(vi) change the height of the nascent dissected skin envelope above
housing 14, (vi) change the distance between the newly dissected
superior and inferior tissue layers, (vii) change the amount of
tension in the developing skin envelope, (viii) change the
stabilizing function of housing 14 and (ix) change the wedge or
tissue separating qualities of housing 14. Manipulation of one or
more of these parameters can in turn allow the physician to vary
the shape of housing 14 to control one or more of (i) tissue flap
thickness, (ii) the angle of the plane of dissection, (iii) the
amount of heat transfer to the selected portions of the skin
envelop/tissue flap and the associated temperature of those
portions, (iv) the amount of thermal conductive tightening of
selected portions of the skin envelope/tissue flap and (v) the
amount of thermal injury of selected portions of the skin
envelope/tissue flap.
[0134] For example, in an embodiment shown in FIGS. 20a and 20b
(drawing showing use of a variable shaped housing 14 to expand or
contract an insulatory pocket between the electrode and the skin
envelope) tissue expandable variable shape portion 14vs can be used
to vary the height 14h of housing 14 to vary the vertical distance
14dse between the electrode 18 and where the nascent skin
envelope/tissue flap 8se first contacts the top of housing 14t so
as to create, increase or decrease an insulatory space or pocket
81p between the electrode and the developing skin envelope/tissue
flap. This serves in turn to decrease or increase the amount of
conductive heat transfer to the skin envelope which can be used to
control the amount of collagen contraction and/or thermal injury of
selected portions of the skin envelope.
[0135] Referring now to FIGS. 1-4, 13, 21, 22a and 22b in various
embodiments, the guarding function of housing 14 can be configured
to protect the dermal and sub-dermal vascular and neural plexus or
other selected layer of the skin envelope or tissue flap from
thermal injury and/or necrosis directly or indirectly resulting
from the delivery of energy from electrode 18 (or other energy
delivery device) during the dissection procedure. This is
accomplished by configuring housing 14 to shield, insulate or
otherwise distance portions of the skin envelope or tissue flap
from RF current and/or thermal current (e.g. via conduction heat
transfer) resulting from RF energy delivery to the target tissue
site 8 (e.g. the plane of dissection).
[0136] One or more of these functions of housing 14 can in turn be
accomplished through selection of one or more of the shape,
dimensions, mechanical and material properties of housing 14. For
example, in an embodiment shown in FIG. 4, the top of housing 14t
can have a curved or curved tapered shape 14cs at or near its
distal portion 14d that is configured to guide or direct the
nascent skin envelope 8se over housing 14 and away from the
electrode 17. By directing the skin envelope in the manner, the
shape of housing 14 reduces the amount of heat transfer from the
electrode to the skin envelope after dissection.
[0137] This skin envelope/tissue flap directing function can also
be facilitated by selection of the electrode gap distance 18gd
described herein. The electrode gap 18gd distance can be adjusted
(by electrode advancement means described herein) for variations in
flap thickness, tissue type and tissue mechanical properties (e.g.
bending modulus) to optimize flap/envelope slide over. For example,
electrode gap distance can be increased for more rigid tissue (e.g.
cartilage or muscle one versus adipose tissue) and similarly, the
degree of curvature of section 14cs can be decreased (e.g. the
radius of curvature is increased). In various embodiments,
electrode gap distance can be adjusted between 1 and 60 mm.
[0138] In an embodiment shown in FIG. 21 (embodiment of apparatus
10 with a roller positioned at top of housing 14), the skin
envelope sliding process (and thus the shielding function of
housing 14) can facilitated by the placement of a roller 17 on the
distal upper portion 14du of housing 14 above and proximal to the
electrode. The roller 17 serves to reduce friction between housing
14 and the skin envelope. In embodiments shown in FIGS. 4 and 22a,
reduced friction between housing surface 16 and the skin envelope
and thus smooth slide over can also be facilitated by use of a
lubricous coating 14lc over the top 14t or other portions of
housing 14, particularly the distal top portions to reduce friction
between housing surface 16 and the skin envelope 8se.
[0139] The shielding function of housing 14 can also be facilitated
by configuring the distal 14d and top portions 14t of housing 14
surface to have a thermally and electrically insulative coating
14ic described herein which can be configured to shield the nascent
skin envelope from direct ohmic heating by the electrode as well as
conductive heating from one or more of the electrode, tissue vapor
and heat of the surrounding tissue (see FIGS. 4 and 22b).
[0140] Referring now to FIG. 23-25 (Figure showing embodiments of
housing 14 having fluid distribution ports) In various embodiments,
the tissue protective or shielding function of housing 14 can also
be accomplished by the delivery of cooling fluid through one or
more fluid distributions ports or apertures 33 as is shown FIG. 23.
Apertures 33 can be fluidically coupled to one or more lumens 24'
and can be configured (by virtue of their size and shape) to ooze,
infuse or spray a cooling fluid 29 to the cool all or selected
portions of the overlying skin envelope/tissue flap and/or
underlying tissue (e.g. muscle) as well. This and related
embodiments can be configured to produce a reverse thermal gradient
in the skin envelope or tissue flap. That is subjacent layers/or
structures in contact with the cooling solution such as the
dermal-subdermal plexus are cooled while the overlying collagen
containing layers such as the dermis are at a selected elevated
temperature due to conductive heat transfer from RF energy delivery
from electrode 18.
[0141] In this way, embodiments using cooling solution can allow
for collagen contraction of the dermis and, hence skin tightening,
while preventing or minimizing damage of the dermal and sub-dermal
plexus and thus facilitates or helps to maintain the viability of
the newly dissected skin envelope or tissue flap both in the short
after it is reattached and in the long term. Thus embodiment using
cooling solution can be configured to improve the postoperative
viability of the tissue flap or skin envelope. Moreover,
embodiments of apparatus 10 and methods of the invention that
employ cooling of the skin envelope via cooling solution or other
cooling means can also be utilized to reduce the incidence of one
or more post operative complications such as tissue necrosis, nerve
or sensation loss, infection, skin discoloration or un even
coloration which can occur due to damage of sub-dermal dermal
plexus.
[0142] Apertures 33 can be positioned throughout the surface of
housing 14 including tissue contact surface 16, singularly or in
selectable patterns such as a substantially circular or linear
pattern. In one embodiment apertures 33 can be configured and
distributed on the surface of housing 14 to produce a film 29f of
cooling fluid 29 that oozes or wicks out of the apertures and cools
the skin envelope by combination of convective and conductive
cooling. Film 29f can also be configured as a lubricous film that
reduces the friction of housing 14 with overlying and underlying
tissue layers and thus facilitates smooth advancement of housing 14
between tissue layers during dissection process or positioning of
housing 14 within the tissue pocket.
[0143] All or portions of apertures 33 can also be configured as
nozzles 33n to spray cooling fluid (which can be a liquid or a gas)
onto the skin envelope and/or onto portions of electrode 18. In a
particular embodiment apertures 33 or nozzles 33n can be positioned
on the distal portions 14d of housing 14 so as to infuse or spray
cooling solution onto the electrode to cool the electrode or
otherwise prevent the buildup of charred tissue on the electrode.
In another embodiment apertures or nozzles 33n can be positioned on
the top and/or top distal portions of housing 14 to infuse or spray
cooling solution onto the skin envelope or tissue flap which is in
close proximity to the electrode so as to cool the skin
envelope/tissue flap immediately or near immediately after it is
dissected from underlying tissue layers.
[0144] In a related embodiment shown in FIG. 24, apertures 33 can
positioned or otherwise directed to infuse or spray cooling
solution onto the skin envelope or tissue flap at a selectable
distance proximal from the electrode. In use this configuration can
allow the skin flap to continue to be heated or otherwise remain at
an elevated temperature (e.g. cook) for a selectable time
sufficient to cause thermal collagen contraction but stay below a
level of thermal injury to damage the subdermal plexus. In related
embodiments apertures 33 or nozzles 33n can also be configured to
provide irrigation within the pocket of dissection 8pd and/or
surrounding tissue layers to remove debris and blood and assist in
endoscopic visualization.
[0145] In various embodiments, apertures 33 can be substantially
round, oval or other shape and can be produced by molding, machine
drilling, laser drilling and like methods known in the medical
device arts. Apertures 33 can have a diameter 33d in the range of
0.0001 to 0.5 inches with specific embodiments of 0.001, 0.005,
0.01, 0.05, 0.1 and 0.25 inches. Larger aperture diameters can used
for infusing embodiments and smaller diameters for oozing
embodiments. For oozing embodiments, apertures 33 can have a
diameter 33d in the range 0.001 to 0.01 inches. Aperture 33 can
also be configured for the delivery of other fluids as well such as
electro-conductivity enhancing solutions (e.g. saline), medicament
solutions (e.g. anesthetics), irrigating solutions, and other
solutions used in plastic surgery procedures.
[0146] In an embodiments shown in FIG. 25, apertures 33 can also
comprise a porous section 33P coupled to surface of housing 14 and
fluidically coupled to one or more lumens 24'. Porous section 33P
can be configured (by virtue of their porosity, and wetting
characteristics) to ooze or wick fluid 29 including a fluid film
29f. In an embodiment, porous section 33P can be made from a porous
polymer membranes or polymer foam known in the art such including
but not limited to knitted polyester, continuous filament
polyester, polyester-cellulose, rayon, polyamide, polyurethane,
polyethylene and the like. Suitable commercial products include,
(i). OPCELL available from Centinal Products (Corp., Hyannis,
Mass.), (ii). ULTRASORB, HC 4201 or HT 4644 MD available from
Wilshire Contamination Control, (Carlsbad, Calif.) and
polyethersulfone membranes (SUPER MEMBRANE) manufactured by the
Pall Corporation (Ann Arbor, Mich. or East Hills, N.Y.).
[0147] Referring now to FIGS. 26-28, in other embodiments apparatus
10 can be configured to dissect tissue in deeper planes of
dissection than the dermis or superficial fascia. In one
embodiment, apparatus 10 can be configured to produce a plane of
dissection 8pd as deep as the muscle facial layer or deeper. In an
and related embodiment shown in FIG. 26, housing 14 can include two
rollers 17 or four wheels 17w. Hand piece 15 is pivotally coupling
either directly to housing 14 at pivotal coupling 14pcop or
indirectly via the coupling of extender 22 to housing 14 at pivotal
coupling 14pcop. The pivotal coupling 14pcop can be configured to
allow the hand piece and extender to swing through and arc of
180.degree. or greater while housing 14 is located within the
tissue pocket and under one or more tissue layers. Portions of the
extender or hand piece, such as distal portions 15d and 22d can be
configured to be deflectable portions 15def or 22def via means of
an actuation member 15am (e.g. pull wires and the like) or other
deflection mechanism 25
[0148] In use, deflectable embodiments of the hand piece or
extender can be configured to allow the surgeon to gain access to
obstructed or difficult to reach target tissue layers by deflecting
the extender or hand piece around the obstruction (e.g. bone, blood
vessels, cartilage, organs) and still transmit axial force to
advance housing 14 through an embodiment of method for doing a
deeper tissue dissections is illustrated in FIG. 28 here apparatus
10 can be utilized to produce a deep plane of dissection to dissect
the glandular breast tissue from the Pectoralis Fascia. In this
embodiment, dissection of the fascia can be initiated at a tissue
perimeter 8tp where the skin envelope or tissue flap merges
directly merges with the muscle fascia layer. This dissection of
the muscle fascia can be done after or before the skin envelope is
dissected from the tissue site. Embodiments of this method can be
utilized for one or more of a skin sparing mastectomy, lumpectomy
or even biopsy procedures. They can be utilized for skin sparing
implant procedures of pace makers; cardiac device battery, power
packs, energy converters, or control devices; or insulin pumps and
the like in the breast, pectorolis or even other regions such as
the abdominal regions through the selected tissue plane.
[0149] In related method embodiments shown in FIGS. 29a and 29b,
apparatus 10 can be configured to dissect fascial layers by several
different approaches. One method is to start the facial dissection
at a tissue perimeter where the fascia and the dermal
layer/subcutaneous layers converge such as the perimeter of the
breast. Another approach is make an angled dissection or cut down
to the deeper layer using the transcutaneous markers to assess the
dissection depth 8dd and the angle; the third approach is to make
an incision down to the fascia or deeper tissue layer and then
insert or advance housing 14 through incision to facial layer. In
an embodiment, housing 14 can be inserted vertically through the
incision and then pivoted or reoriented to a horizontal position on
the selected tissue layer to be dissected using a pull/push wire or
rod 15w or other actuating member 15am (or other deflection
mechanism 25 known in the art) disposed within extender 22 or hand
piece 15 and operable by actuator 15a on or coupled to the hand
piece.
[0150] Pivoting of housing 14 can be configured to occur at pivotal
coupling 14cop or other point. In a related embodiment using this
approach (advancement through an incision), embodiments of
apparatus 10 having a deployable housing 14 can be utilized whereby
housing 14 is advanced through the incision in a non deployed state
and then deployed to the deployed state (using a deployment
mechanism described herein or known in the medical device arts such
as a pull wire or deployable balloon) once the selected tissue
layer is reached. Also in embodiments for doing deep plane
dissection all, or portions of electrode(s) 18 can be wedge shaped
(as described herein) to assist in applying force to initiate can
continue the plane of dissection.
[0151] Referring now to FIG. 30a-30c embodiments are illustrated
showing use of apparatus 10 with a port device. In various
embodiments, for doing deep plane dissection or even skin enveloped
dissection, apparatus 10 can be configured to be introduced through
a surgical port, sheath or other introducing device 30 known in the
art. Port 30 can be configured to facilitate access and positioning
of apparatus 10 within the tissue pocket 8dp at the target tissue
site 8. This can be facilitated by fabricating all or portions of
port 30 from lubricous biocompatible materials known in the art
such as PTFE.
[0152] Port 30 can also be configured via its shape 30s and size to
help initiate or define the dissection pocket 8dp. The port opening
30o can have a sufficient shape and diameter to allow passage of
extender 22 and/or hand piece 15 and an endoscope, suction tube or
laproscopic or surgical instrument The opening 30o of port device
30 can configured to have an entry diameter 30d in the range of
0.25 to 5 inches with specific embodiments of 0.5, 1, 2.5 and 4
inches. Also port opening 30o can have a variety of shapes
including circular, semicircular, crescent, oval, square,
rectangular and the like. In an embodiment, the port opening can
include a openings 30o including a first port opening 30o1 and a
second opening 30o2. The first opening can be configured for the
introduction of a first device such as apparatus 10 and the second
opening can be configured for the introduction of a second device
such as an endoscope.
[0153] Port 30 can also be configured to stabilize unwanted
movement of the extender or hand piece in one or more axises. This
can be accomplished by selecting the entry diameter 30d to be
slightly larger (e.g. by several mms) than the extender or hand
piece diameter 22dia and 15dia. It can also be accomplished through
selection of the shape of the port opening 30o. In an embodiment
shown in FIG. 30c, port 30 can have a substantially rectangular or
slot shaped opening 30o having a thickness 30t close to that of the
extender or hand piece diameter 15dia or 22dia so as to
substantially limit movement of either (and subsequently housing
14) in a direction parallel to the longitudinal axis 301a of
opening 30o.
[0154] In other methods embodiments, apparatus 10 can be utilized
to perform deep plane dissection for various procedures to create a
full thickness subcutaneous flap by dissecting the deep aspect of
the subcutaneous tissue (e.g. adipose tissue) from the subjacent
muscle fascia. The deeper plane of dissection can be reached using
one or more of the three approaches described above. In such
embodiments trans-cutaneous markers 21 can be configured or
adjusted to a selected height 21h sufficient to indicate the proper
dissection depth 8dd and/or when the desired plane of dissection
has been reached. This depth can be determined by making an
incision (at or near the target tissue site) down to the desired
tissue layer and then measuring the proper dissection depth. The
marker height 21h can then be adjusted accordingly accounting for
the height of housing 14. In use, this approach compensates for
variations in thickness in one or tissue layers including
subcutaneous adipose tissue.
[0155] Other surgical method applications for utilizing embodiments
apparatus 10 for doing deep plane dissection (e.g. to the facial or
deep layers) can include, without limitation, abdominoplasty,
buttock lift, thigh lift, subglandular breast augmentation with
endoscopic visualization (through the axilla or umbilicus).
Extender length 221, electrode and housing 14 size can be sized to
the needs of each procedure. In these and related embodiments
apparatus 10 can be used to generate a plane of dissection 8pd by
being configured to advance or mow over the muscle fascia or other
desired subjacent tissue layer. Accordingly in these and related
embodiments, apparatus 10 can include one or more rollers 17 and a
pivotable hand piece 15 or extender 22, configured to allow housing
14 or roller to make multiple passes over the selected plane of
dissection. Once the surgeon is finished going in one direction
he/she can use the hand piece or extender to withdrawal housing 14
back over the selected plane in the opposite direction and make
additional passes on the same tissue path or start a new tissue
path. In use, this configuration allows the surgeon to go back over
the dissection plane as many times as he or she desires to do one
or more of the following: (i) smooth out the plane of dissection,
(ii) widen the width of dissected skin envelope or other tissue
flap; (iii) go back over the dissection plane to coagulate any
bleeding tissue or vessels, (iv) deliver additional amounts of heat
to the skin envelope or selected tissue flap to titrate the amount
of collagen contraction and resultant skin tightening.
[0156] Referring now to FIG. 31a-31c other embodiments provide
methods and apparatus to provide a uniform surgical release and
mass shifting of overlying soft tissue structures from subjacent
tissue structures by uniformly dissecting the overlying structures
from the underlying tissue. The uniform surgical release of soft
tissue creates a separation interface or uniform plane of surgical
dissection which allows for mass shifting of soft tissue in a
uniform fashion. A related embodiment also provides a means to
surgically shift soft tissue through smaller, less visible
incisions 8 is. This skin is then shifted to a more aesthetically
pleasing location.
[0157] In related embodiments, apparatus 10 can also be configured
and used to surgically alter or facilitate the surgical alteration
of the subjacent soft tissue or tissue structure underlying the
skin or the dissected skin envelope.
[0158] This can be done using apparatus 10 to dissect and release
one or more tissue flaps that lie within or include the soft tissue
structure to be modified or portions (e.g. layers) thereof using
methods described herein. Such tissue flaps can include without
limitation, the dissected skin envelope, cutaneous flaps (the skin
and subcutaneous tissue), subcutaneous flaps, fasciocutaneous (the
fascia, the subcutaneous layer and the skin) myocutaneous flaps,
fascial subcutaneous flap (includes subcutaneous fat layer and the
fascia, but not the skin) and myofascial-subcutaneous flaps (these
include subcutaneous tissue or portions of it, the fascia and the
muscle, but not the skin; subcutaneous means below the skin but
above the fascia). The subjacent soft tissue structure can be
shifted by plication where a flap is not raised but instead the
tissue is tightened by stapling or suturing of adjacent tissue
together.
[0159] After the flap 8f is released it can then be advanced to the
desired attachment site 8a, the redundant tissue is excised and the
flap is attached using surgical staples, mooring sutures or other
surgical attachment means or procedure known in the art.
Alternatively the excised skin need not be removed but can be
folded or otherwise hidden within the attachment site depending on
its size and shape. In an embodiment, apparatus 10 can be
configured to allow such attachment with apparatus 10 in place or
it can be removed. For the former case, this can be accomplished by
configuring apparatus 10 to allow the passage in the dissection
pocket of one or more surgical instruments over or through the
apparatus. For example, instruments can be advanced through one or
more lumens 24' which can have sufficient diameter for the passage
of such instruments including endoscopic or laproscopic surgical
instruments known in the art. For deployable embodiments of
apparatus/housing 10, apparatus 10 can be put in the non-deployed
state (or at least partially) to allow passage of appropriate
surgical instruments.
[0160] In various method embodiments, apparatus 10 can be used to
dissect a tissue flap using an incision and/or attachment site 8
is, 8a that is more removed from the target tissue site to be
reconstructed than is typical for standard face lift and other flap
dissection related surgical procedures. This in turn allows for the
incision and/or attachment site to be placed in a location that is
hidden or less visible such as the scalp. Further in, apparatus 10
can also allow for the incision site to be much smaller and less
obtrusive than current facelift and other flap dissection related
surgical procedures.
[0161] In various method embodiments, apparatus 10 can be
configured to dissect a tissue flap or skin envelope than can be
re-attached via the use of mooring sutures. More specifically,
mooring sutures can be used to moor or secure the dissected skin
envelope down to the subjacent soft tissue structure with or
without skin excision. Sutures are placed on the deep surface of
the dissected skin envelope to secure or moor the advanced skin
envelope to the deeper structures. The mooring suture is placed in
the deep surface/or deeper aspects of the dissected skin envelope
and secured down to the deeper structures. The sutures are placed
just proximal to point of redundancy in the dissected skin envelope
to hold it down in place at the point. This procedure serves to
maintain the level of surgical advancement of the skin envelope or
tissue flap and thus the aesthetic correction or new shape of the
skin.
[0162] Turning now to a further discussion of housing 14 and with
reference to FIGS. 2-5 and 32-33, in various embodiments, housing
14 can be fabricated from any number of medical polymers known in
the art such as thermoset, or moldable polymers such as ABS,
acrylic, polycarbonate and the like and other medical polymers
known in the art. Also all or portions of housing 14 can also be
made from materials having high dielectric strength and thermal
resistance such as Ultem.RTM. 1000, available from the General
Electric Corporation. Also housing 14 can be disposable and can
include a tissue contact layer or surface 16 which can include one
or more fluid distribution ports 33. Surface 16 can also be
fabricated from material that is both thermally resistant and has a
high dielectric strength. Surface 16 can also be configured to
substantially atraumatic and can be made from biocompatible
biomaterials known in the art.
[0163] Also in an embodiment all, or portions, of housing 14,
including tissue surface 16 can have a coating 14c which can be an
insulative coating 14ic, an electrical conductive coating 14ec, a
lubricous coatings 14lc or a thermally reflective coating 14trc.
These and other coatings can be applied using dip coating, spray
coating, electro-deposition, plasma coating, lithographic and other
coating methods known in the art.
[0164] For purposes of this application, an insulative coating is
defined to be both an electrical and a thermal insulative coating.
In an embodiment, housing 14 has an insulative coating 14ic that
insulates against the transmission of RF energy. Coating 14ic can
be made from electrically and thermally insulative polymers known
in the art including, but not limited to, TEFLON.RTM., PTFE and
other fluorocarbons known in the art, polyamide, polyamide and
copolymers thereof. Such coatings can range in thickness 14ct from
0.0001 to 0.1 inches, which in an embodiment can be 0.001 to 0.003
inches
[0165] In a related embodiment, coating 14c can be a non-stick or
lubricous coating 14lc configured to keep surface 16 (or other
portion of housing 14) from sticking to tissue in the dissection
plane 8p or the skin envelope 8se before during or after, RF energy
delivery (e.g. cutting) and/or advancement of housing 14. Such
coatings can include PARALENE, PTFE, TEFLON.RTM. and other
fluorocarbon polymers, silicones, and other low surface tension
non-stick coatings known in the art.
[0166] In still other embodiments coating 14c can be a patterned
coating 14pc configured to increase the coefficient of friction
with tissue layer 81 in one or more directions. In particular
embodiments patterned coating 14pc can be a directionally biased
pattern coating configured to increase the coefficient of friction
in one direction and serve to stabilize or limit the movement of
housing 14 in that direction. In an embodiment shown in FIG. 32,
coating 14pc can be a direction pattern coating 14dpc configured to
have an increased coefficient of friction with respect to the
lateral axis 14lata of housing 14 (i.e. a lateral friction bias)
but still permit free movement in the longitudinal direction.
Coatings 14dpc configured in this manner provide a lateral
stabilization function, that is they serves to stabilize or reduce
side to side movement of housing 14 during movement of housing 14
over or through tissue. Further such coating 14dpc can also be
configured on housing 14 to provide a lateral stabilization
function to the developing skin envelope 8se to facilitate its
sliding over housing 14 in a longitudinal direction with reduced or
minimal lateral movement of the envelope. This can be accomplished
by having directional coating 14dpc on top portions 14t of housing
14. Coating or pattern 14pc can also be configured to be
substantially tissue atraumatic. This can be accomplished through
the use of biocompatible materials described herein such as PTFE or
silicone.
[0167] Suitable patterns for a directional coating can include a
pattern of ridges 14r and channels 14ch oriented parallel to the
longitudinal axis 14la of housing 14 as shown in FIGS. 33a and 33b.
Ridges 14r can have a height 14rh from 0.001 to 0.025 inches with
specific embodiments of 0.002, 0.005, 0.01, 0.05 and 0.1 inches.
Also the distance between ridges or channel width 14chw, can be
0.0005 to 0.2 inches with specific embodiments of 0.001, 0.002,
0.005, 0.01, 0.05 and 0.1 inches. Suitable pattern coating
materials can include polyethylene, HDPE, LDPE, polyurethane,
acrylic and silicone. Ridges 14r can be formed using hot stamping
or polymer molding methods known in the art. Ridges 14r can be
flexible and can be fabricated from elastomeric polymers such as
silicone and other resilient polymers known in the art. Ridges 14r
can also have a curved tip 14rt. Also the channel width 14chw, can
be sufficient to allow tissue to press into the channels so as to
be able to exert a normal force against the longitudinal axis 14la
of ridges 14r and in turn exert an opposing lateral force in
response to lateral movement of housing 14. This opposing lateral
force can configured to stabilize housing 14 in the lateral
direction. In an embodiment, channel width 14wch can be 0.0005 to
0.01 inches.
[0168] Housing 14 can have a variety of shapes depending upon the
medical application or procedure. Referring now to FIGS. 34a-34e,
in various embodiments, housing 14 can be disc, square,
rectangular, spherical, semi-spherical shaped or crescent shaped
and combinations thereof. In an embodiment, housing 14 can be
rectangular shaped having side radiused edges 14re and a top raised
edge 14te which can be radiused or not. Alternatively, housing 14
can be disc shaped again having a radiused perimeter edge 14re and
one or more raised top edge 14te which is substantially straight.
In either embodiment, the distance between the two top edges 14w
can be configured to be greater than the working or cutting width
18w of electrode 18. In an embodiment housing 14 width and widths
14w and 18w can be configured to be provide a buffer space of
housing 14 on either end of the electrode. This buffer space can be
configured to reduces button-holing or lacerations of the skin
envelope as is discussed herein. Another configuration for reducing
buttonholing is shown in FIG. 34e in which the distal end of
housing 14 is flared back. In another embodiment 14w can
substantially equivalent to the working or cutting width 18w of
electrode 18.
[0169] As discussed herein in various embodiments, housing 14 can
be adjustable to control a number of dimensional and other
parameters relating to the dissection procedure. Referring now to
FIG. 35, for example, in an embodiment, housing 14 can be
configured to vary the amount that the electrode 18 including
cutting edge 18ce can be advanced or retracted in an out of housing
14. This can be accomplished using an advancement/locking mechanism
25 known in the art such as a pull wire, cam mechanism, ratchet or
gear driven mechanism.
[0170] Referring now to FIGS. 36a, 36b and 37, in various
embodiments, housing 14 can include one or both of a linear 14lin
portion or curved or contoured portions 14cp as is shown in FIG.
36a. The curvature can be selected to substantially match or
conform all or in part to the contour 8c of a selected tissue site
8.
[0171] In various embodiments, the curved portions 14cp can be
configured to match one or more of the contours of the following
anatomical sites: the face, the breast, the buttocks, the abdomen
and the like. In an embodiment shown in 36b, the curved portion
14cp can include only a single radius of curvature, 14cr1, a second
radius of curvature 14cr2, or a varying radius of curvature 14crv
and combinations thereof.
[0172] The amount of curvature of housing 14 can be pre-selected or
can shaped by the physician for malleable embodiments of housing 14
described herein. This can accomplished through the use of an
articulated housing 14, or a housing 14 made from pliable,
malleable and/or conformable polymers known in the art such as
silicone rubber or polyurethane and copolymers thereof. In
alternative embodiments, it can also be achieved through the use of
shape memory metals and associated methods known in the art such as
nickel titanium alloys.
[0173] Also all or portion of housing 14 can include a conformable
portion 14 con made of conformable or malleable materials that are
sufficiently flexible to conform to various anatomical contours.
Examples of conformable materials include without limitation,
silicone rubber, butyl rubber, polyurethane and copolymers thereof.
The bending strength or flexural modulus (also known as a bending
modulus) of the conformable portion can be selected to conform to
the resistive forces offered by one of bone, cartilage, muscle,
adipose or a skin layer. Accordingly, in various embodiments, the
flexural modulus of conformable portion 14con can be selected to be
below the bending or compressive modulus of bone, muscle,
cartilage, fat or skin all of which are known in biomechanical
arts. In various embodiments, the flexural modulus of conformable
portion 14con can be in the range of 0.001 to 10 GPa with specific
embodiment of 0.01, 0.05, 0.1, 0.5, 1 and 5 GPa.
[0174] Also in an embodiment shown in FIG. 37, conformable portion
14con can a plurality of conformable portions having different
flexural moduli include a first portion 14con1 having a first
flexural modulus 14fm1 and second portion 14con2 having a second
flexural modulus 14fm2. In use, embodiments of housings 14 with
multiple conformal portions 14con, can be configured to allow
housing 14 to bend or otherwise conform different amounts for
different tissue structures to facilitate movement of housing 14
over curved or irregular shaped anatomical surfaces such as the
face having multiple tissue components (e.g. bone and cartilage)
with different mechanical properties. This in turn facilitates
maintenance of the dissection depth 8dd during advancement of
housing 14 through or within the dissection pocket 8dp or tissues
site 8.
[0175] In one embodiment of a method of shaping and using a pliable
or moldable housing 14, the physician could shape a housing 14 made
out of shapable metal such as spring steel by (i) shaping housing
14 by hand, (ii) shaping by pressing housing 14 against the contour
of the desired tissue site, or (iii) shaping using a shaping
template or tool or even a surgical tool. In another embodiment the
medical practitioner could shape housing 14 by sufficiently heating
housing 14 to make it pliable (e.g. heat above the glass transition
temperature for the material selected) to (i) shape housing 14 by
hand, (ii) shape by pressing housing 14 against the contour of the
desired tissue site, or (iii) shape using a shaping template or
tool or even a surgical tool and then after the shaping was
completed cool housing 14 (below the glass transition temperature)
to set the shape by quenching in chilled water, ice water,
cryogenic gas or other cooling fluid or medium known in the art.
The sequence of these steps is exemplary and need not be done in
this order. In such embodiments housing 14 could be made of variety
of resilient polymers or metals known in the art that have glass
transition temperatures above room temperature.
[0176] Referring now to FIGS. 2-7, 36-38, apparatus 10 can also be
configured to move over a curved tissue surface 8c and still
maintain a substantially uniform depth of dissection. In an
embodiment, this can be accomplished through the use of a movable
or pivoting hand piece 15 coupled to housing 14 via a pivotal
coupling 14pcop. Pivotal coupling 14pcop can be any pivoting device
or mechanism known in the art including gimbals, ratchet, bearing
and cam mechanisms known in the art. In use pivotal coupling 14pcop
serves to maintain or assist in maintaining the tissue contacting
portion of housing 14 in substantially parallel contact (or other
selected orientation) with respect to a tissue plane 8pd as housing
14 is advanced along a contoured or uneven tissue plane using hand
piece 15. This can be achieved for longitudinal, lateral or
curvilinear translation of housing 14 along the tissue plane by
configuring pivot coupling 14pcop to pivot in a longitudinal or
lateral axis (or both) with respect to the direction of travel
(e.g. advancement) 14dt of housing 14. In an shown in embodiments
pivot mechanism 14pcop can include and indexing mechanism 14pci
configured to allow the user to select the pivot axis(es) 15pa of
hand piece 15 such that hand piece only pivots in the selected axis
through an arc 15arc. Alternatively the mechanism can be configured
to allow movement of hand piece 15 in multiple axes.
[0177] Referring now to FIGS. 39a-39c, other means for advancing
housing 14 on curved surfaces can include housing 14 having an
articulated portion 14art, a bendable elastic portion 14b, or a
precurved portion 14prc. The bendable portion can be fabricated
from bendable elastomers known in the art such as silicone,
polyurethane or butyl rubber and the like. The curved portion can
have a factory fabricated amount of curvature selected by the
physician for the particular tissue site or can be shaped by the
physician using procedures described herein.
[0178] In one method embodiment of using apparatus 10 to dissect
tissue along a curved surface, the physician would select or shape
housing 14 to have a degree of curvature corresponding to a tissue
contour such as the contour of the fascia over the pectorolis
muscle for mastectomy and related procedures. For use of a bendable
housing 14 having bendable or articulated portion 14b or 14c, the
physician could press or form fit the curvature of the bendable or
articulated portion to match that of the desired contour.
[0179] Referring now to FIGS. 2-3 and 40-44 in various embodiments,
housing 14 can include on or more roller devices, 17 which can also
be a sliding or linear translation device 17s. Roller or sliding
device 17 functions to roll or move housing 14 smoothly along a
tissue plane to allow the surgeon to advance housing 14 in a smooth
lawn mover like fashion over a tissue plane. Roller device 17 can
be configured to roll or glide in a substantially atraumatic
fashion along a tissue plane or tissue surface 81s such as the
sub-dermal, fascia, subfascia or muscle tissue layers. Also roller
device 17 can be configured to substantially maintain the position
of electrode 18 with respect to the plane of dissection 8pd so as
to produce a substantially uniform dissection depth 8DD as the
surgeon advances housing 14 over a selected tissue surface at a
target tissue site 8.
[0180] Embodiments of roller device 17 can comprise one or more
rollers movably or rotably coupled to housing 14. In various
embodiments, roller device can comprise between 1-20 roller
bearings, with specific embodiments of 2, 4, 6, and 10 roller
bearings. In an embodiment, the roller can be located behind the
electrode with the center of the roller 17cen corresponding to the
height of the electrode 18h (with respect to the roller bottom 17b)
or otherwise located on the electrode plane 18pe. In various
embodiments, the gap distance or clearance 18gt between the
electrode and the face of the roller 17w can be between 0.01 and 1
inch with specific embodiments of 0.05, 0.1, 0.25 and 0.5
inches.
[0181] In an embodiment shown in FIG. 42, the rollers 17 can be
located above and below the electrode 18 and the corresponding
electrode plane 18pe. The upper roller 17u can be configured to
roll or otherwise guide the nascent skin envelope 8se, or tissue
flap 8f over the roller and away from the electrode (e.g. in a
proximal direction) and thus protect the skin envelope from further
thermal exposure. In performing this function, the upper roller
also facilitates maintenance of the uniformity of the thickness 8t
of the tissue flap 8f by doing one or more of the following:
reducing the tendency of the nascent skin flap to bunch up, crimp
or otherwise come back in contact with the electrode after the
first pass and uniformly guide the skin flap away from the
electrode after the first pass. The lower roller 171 is configured
to smoothly advance housing 14 over the selected tissue plane.
[0182] Examples of suitable rollers include roller bearings known
in the art including needle bearings. Rollers 17 can be fabricated
from bearing metals known in the art or polymers such as acrylic,
polycarbonate, PTFE or other bearing polymers known in the art.
Examples of suitable bearing include those manufactured by the SKF
Corporation and the Timken Corporation. In a embodiment shown in
FIG. 42, rollers 17 can be movably coupled to housing 14 using a
spring coupling mechanism 14sc known in the art. Spring coupling
mechanism 14sc can be configured to perform a stabilizing or shock
absorbing function to allow housing 14 to maintain a substantially
horizontal and/or parallel alignment with a tissue layer 81 despite
roughness or unevenness on tissue layer surface 81s. In various
embodiments, spring coupling mechanism 14sc can include a coiled
spring, a leaf spring and other springs known in the art.
[0183] Spring mechanism 14sc can be configured to have sufficient
spring force to compensate for protuberance or unevenness in the
tissue plane and allow housing 14 to maintain a substantially
parallel orientation with respect to all or portions of the tissue
plane as housing 14 is advanced over the tissue plane. In various
embodiments, spring mechanism 14sc can have between about 0.01 and
about 1 lb of spring force or more, with specific embodiments of
0.05, 0.1, 0.2, 0.5 and 0.7 lbs of force.
[0184] In various embodiments, all or portions of rollers 17 or
slide 17s can be thermally or electrically insulative or both. In a
particular embodiment, all or portions of rollers 17 or slide 17s
can be insulative to RF energy. An example of a suitable thermally
and electrically insulative material includes polyetherimide, other
materials can include polyimide, polycarbonate and insulative
ceramics known in the art.
[0185] In other embodiments, device 17 can be include a low
friction coating or layer 17c configured to allow housing 14 to
slide smoothly along a tissue plane. Coating 17c can include low
surface tension coatings configured to have both low coefficients
of friction and/or minimize or substantially prevent tissue
adhesion to housing 14. Examples of low surface energy materials
are described above and can include TEFLON.RTM. or other PTFE
polymer or copolymer known in the art. Also layer 17c can include
surface modification coatings known in the art such those produced
using, plasma treatment, vacuum sputtering, chemical vapor
deposition, and electro deposition methods known in the art to
reduce the surface energy of coating 17c. Also, layer 17c can also
be thermally and/or electrically insulative.
[0186] Also all or portions of rollers 17 can be fabricated from
low surface energy materials to minimize or substantially prevent
tissue adhesion to rollers 17 or housing 14. Examples of low
surface energy materials or coating include Polytetrafluoroethylene
(PTFE) available as TEFLON.RTM. from the Dupont Corporation,
silicone rubber (including RTV and silica free silicon),
polyurethane, polyethylene, HDPE, and copolymers thereof known in
the art. Coatings 17c can also include surface modification
coatings.
[0187] In use, roller device 17 can be configured to allow the
surgeon to smoothly and atraumatically advance housing 14 over a
tissue surface 81s or layer 81 within the dissection pocket 8dp and
use electrode 18 to produce a tissue flap having a substantially
uniform dissection depth 8dd. Embodiments of apparatus 10 having
rollers 17 can be adapted for a number of surgical or minimally
invasive surgical procedures including without limitation, plastic
surgery procedures such as face lifts, breast lifts, liposuction,
eyelifts and the like, dermatological procedures such as biopsies,
mole or tissue removal and other surgical procedures such as
removal of tissue masses such as lipomas, cysts and the like as
well as other procedures described herein.
[0188] The dissection depth 8dd can be selected for each procedure
and controlled by physician manipulation of housing 14 within the
dissection pocket, as well as by selection of the configuration of
housing 14, roller device 17 or both.
[0189] In various embodiments, different rollers 17 or roller
mechanisms can employed for different dissection procedures and
tissue locations as needed. Also the number and frictional
characteristics of rollers 17 or roller bearing 17b can be varied
depending on the procedure. For example, more rollers can be
employed for rough or uneven tissue surfaces such as dissection
through muscular or fibrous tissue. Similarly, lower friction
materials (e.g. PTFE) can employed in such settings or other tissue
locations to reduce rolling friction and/or reduce tissue adhesion
to the rollers or surface 17s. In various embodiments, the surface
energy of the materials in rollers can be less about 50, 40, 30, or
20 dynes/cm.
[0190] Referring now to FIG. 44, in other embodiments the
frictional or material properties of roller 17 or surface 17s can
be configured to generate sufficient frictional force with the
contacting tissue so as to put all or a portion of the subjacent
tissue layers in contact with housing 14 in tension. This can be
accomplished by configuring all or portions of roller 17 or surface
17s to have sufficient friction to grip and pull the contacting
tissue 8ct in an opposite direction to the direction of travel 14dt
of housing 14. This puts the segment of skin 8ss and/or contacting
layer 81 between roller 17 or surface 17s and electrode 18 in
tension. Thus, roller 17 or surface 17s can be so configured to act
as tissue tensioning element 17te via a tissue gripping portions
17tgs.
[0191] Means for tensioning by tensioning element 17te or tissue
gripping surface 17tgs can include one or more the following
configurations: (i) use of a textured surface over all or a portion
of roller 17 or surface 17s (ii) use of rubberized otherwise
compressible gripping layers over all or a portion of roller 17 or
surface 17s, (iii) use of a gripping fiber surface over all or a
portion of roller 17 or surface 17s, (iv) use of vacuum ports over
all or a portion of roller 17 or surface 17s to adhere the tissue
against roller 17 or surface 17s via vacuum pressure, wherein the
ports are coupled to a vacuum source 24v via lumens 24'. Examples
of texturized surface can include knitted or woven DACRON.RTM., or
texturized rubber having a criss-cross, diamond or other pattern
known in the art. Also in these and related embodiments higher
coefficients of friction of surface 17tgs, by selection of the
material properties of roller 17 or 17s including use of materials
with higher surface energies.
[0192] Higher surface energies can be achieved by vacuum
sputtering, CVD, electro-deposition, plasma, chemical etching,
shot-peening and other surface modification coating treatments
known in the art for plastics or metals. In various embodiments,
the surface energy of gripping portion 17tgs can be above 50
dynes/cm, above 80 dynes/cm or above 100 dynes/cm
[0193] In various embodiments, tensioning element 17te can be
configured to maintain tissue layers 81 (either or super or
subjacent) in between 0.01 and 3 lbs of tension with specific
embodiments of 0.1, 0.2, 0.5, 1 and 2 lbs of tension. Tissue
tensioning can be facilitated by the application of downward force
(e.g. a force normal to tissue layer 81 or dissection plane 8pl) on
housing 14. Referring now to FIGS. 45a-45b, this can be
accomplished by the physician pressing down on the top portions 14t
of housing 14, or use of the downward force from the overlying
tissue layers 81 (which may be in a condition of tension as housing
14 is advanced into the tissue plane) or both.
[0194] Accordingly, in embodiments shown in FIGS. 45a-45b, housing
14 can have a force application surface 14fs or fixture configured
to allow the physician to press down on housing 14 to apply a
downward force from rollers 17 to the underlying tissue layer 81.
Force application surface/fixture 14fs can be located on the top or
other portion of housing 14 and can also be located on or coupled
to hand-piece 15 or extender 22.
[0195] In an embodiment, all or portions of housing 14, such as top
14t or bottom 14b, can be configured as a force application surface
14fs. Surface 14fs can be substantially flat, concave, convex and
combinations thereof. Force application surface 14fs can be
configured to apply a downward force over all or portion of
subjacent tissue layer 81 in contact with the bottom of housing 14.
In an embodiment shown in FIG. 45b, surface 14fs can be configured
to substantially only a apply a downward force to tissue gripping
surface 17tgs and the underlying tissue.
[0196] Referring now to FIG. 45c, other means for force application
can include use of vacuum ports 24vp located on all or portions of
housing 14 as is shown in FIG. 45c. Vacuum ports 24vp can be
configured to be coupled to vacuum source 24v. The placement and
number of ports 24vp can be further configured to apply a vacuum
force to a selected portions 8pl of layers 81 to at least partially
adhere those layers to all or portions of housing 14 such that when
housing 14 is advanced, layers 81 are put in tension.
[0197] In use, the physician can employ the tensioning element
17te, or vacuum ports 24vp to put selected portions of a tissue
layer in tension before, during or after the application of RF
energy to the tissue site. In one method embodiment the physician
can use apparatus 10 to pre-stress the selected tissue 81 before
the application of RF energy for cutting or skin tightening. This
can be accomplished by advancing the front of housing 14 into the
developing dissection pocket 8dp or incision site 8 is while
maintaining a slight downward pressure on housing 14 to keep the
roller in contact with subjacent tissue layers and so generate
friction between the roller and subjacent tissue.
[0198] Also in use, embodiments having a tensioning element 17te
can be configured to facilitate the dissection of tissue layers 81
at tissue site 8 by keeping the selected tissues layers 81 in
tension and preventing them from bunching up or otherwise deforming
as electrode 18 is advanced through the plane of dissection. This
in turn facilitates maintenance of a substantially uniform
dissection depth 8dd.
[0199] Turning now to a discussion of electrode 18 and with
reference to FIGS. 2-5 and 46-48, in various embodiments, electrode
18 can be fabricated from a variety of conductive materials known
in the art including stainless steel, 304 v stainless steel, shape
memory metals and alloys thereof. Electrode 18 can also have one or
more lumens 18l for passage of fluids and/or gases for cooling,
heating, conduction, irrigation or aspiration. In various
embodiments, electrode 18 can have a variety of shapes and
geometries including but not limited to a blade or scalpel
configuration, ring-like, ball, hemispherical, cylindrical,
conical, needle or needle-like
[0200] In an embodiment shown in FIGS. 46a and 46b, electrode 18
can be made from conductive wire and can be fabricated to have a
curved shaped 18cs using wire or metal working methods known in the
art. Shape 18cs can be semicircular, U-shaped, parabolic, or any
curve with a selectable amount of arc 18arc (e.g. degrees). In an
embodiment, shape can 18cs can also be configured to be
substantially contained or bounded in single plane, also called
electrode plane 18pe. In other embodiments shape 18cs can be in two
or more planes.
[0201] Also in various embodiments, shape 18cs can have a single
radius of curvature, 18rc or multiple radii of curvature 18rc. The
diameter 18d of curve 18cs can be in the range of 0.1 to 5 inches
with specific embodiment of 0.25, 0.5. 1, 1.5, 2, 3 and 4 inches.
For face lift applications diameter 18d can be about 0.4 to about 1
inch and for abdominal and other large tissue sites, such as the
abdomen diameter 18d can be in the range of about 2 to about 4
inches. Electrode 18 can also be configured to allow the diameter
18d to be adjusted by the physician depending upon the tissue site
and procedure. This can be accomplished by electrode adjusting
means described herein.
[0202] In these and related embodiments electrode 18 can be
configured to have sufficient strength including bending strength
(e.g. bending or flexural modulus) to substantially maintain its
curved shape as its through tissue and/or maintain the electrode
plane 18pe. In an embodiment, the bending modulus is selected to
substantially maintain shape 18cs as it is advanced through soft
tissue such as the skin, adipose tissue, fascia and muscle but to
deform upon contact with more rigid tissue such as bone. In other
embodiments, electrode 18 can be configured to maintain its shape
on contact with skin and adipose tissue but deform upon contact
with muscle and/or other harder tissue such as bone, cartilages. In
use this selectable deformability of electrode 18 can be configured
to provide the physician with tactile feedback of the tissue type
that electrode 18 is being advanced into. The bending strength of
electrode 18 can be controlled through the selection of one or more
of the 18 wire diameter 18d, material composition (e.g. alloys) and
metal treatment (e.g. annealing, work hardening etc.)
[0203] Electrode 18 can be spring-loaded or otherwise have shape
memory such that if it is deformed due to tissue-applied forces it
will substantially reassume its shape upon removal of the force. In
these and related embodiments, where the electrode is configured to
have a shape memory it fabricated from spring steels or shape
memory materials such as nickel titanium alloys using shape memory
processing methods known in the art. In these and related
embodiments electrode 18 can have sufficient spring force to
substantially maintain its shape as it cuts or dissections through
a variety of soft tissues such skin, adipose tissue, fascia and the
like. In various embodiments, electrode 18 can be configured to
have between 0.1 to 5 lbs of spring force with specific embodiments
of 0.2, 0.5, 1 and 2.5 lbs of force.
[0204] In an embodiment shown in FIG. 47, shape 18cs can consist of
three sections, a first section 18s1, attaching to a first side
14s1 or front edge of housing 14, a second section 18s2 and a third
section 18s3 attaching to the other side or front edge of housing
14s2, wherein sections 18s1, 18s2 and 18s3 have radii of curvature
18rc1, 18rc2 and 18rc3. In an embodiment, sections 18rc1 and 18rc3
can be substantially more curved than section 18rc2; in another
embodiment this configuration can be reversed. Also radii of
curvature 18s1 and 18s3 can be substantially less than 18s2. In an
embodiment, the electrode 18 can be configured to have camber,
which is configured to substantially maintain its shape in response
to a selectable amount of normal or other force tending to deform
the electrode as the electrode is advanced through tissue.
[0205] Also, in an embodiment shown in FIGS. 48a-48b, all or
portions of electrode 18 can be tapered portions 18t. The taper can
be produced using wire grinding and drawing methods known in the
art. In one embodiment the tapered portion 18t can have a
decreasing taper (e.g. decreasing diameter) moving in a direction
from section 18s1 to 18s2. In another embodiment, the taper can be
increasing. The taper can be configured to control the rigidity of
portions of the electrode, for to provide increased strength or
rigidity to side sections 18rc1 and 18rc3 by having making those
sections have a larger diameter.
[0206] The taper can also be configured to vary the electro-cautery
cutting characteristics of the electrode. A decreasing taper can be
used to increase the current density over selected portions of the
electrode, for example section 18s2 so as to increase the "cutting
current" in that portion. In other embodiments curved electrodes 18
can be configured to have a cutting or sharpened edge 18ce on the
leading edge of the electrode. Cutting edge 18ce facilitates
dissection through tissue by acting like a knife-edge as well as
increasing the cutting current at the edge.
[0207] Referring now to FIG. 49, in an embodiment shown in FIG. 49,
the electrode can be wedge shaped or "cow catcher shaped" to have a
wedge or force concentration affect in cutting through the tissue.
This shape can be configured to simultaneously cut and undermine or
separate tissue layers 81 by cutting the tissue at the point or
apex 18a of the electrode wedge and then force the tissue over
wedge. This shape can be particularly useful when starting the
beginning of the dissection. Also selected portions of the wedge
can have an electrical and/or thermally insulative layer 18l. In an
embodiment, the point portion 18a of the electrode can be
conductive and the remainder insulated, this configuration serves
to provide a cutting force concentration affect and thermally
shield or otherwise minimize heat transfer to the nascent tissue
flap in close proximity to the electrode.
[0208] Referring now to FIG. 50, one or both ends 18e of electrode
18 can be attached to the sides 14s of housing 14, either directly
or via an insulative coupling 14icop. Examples of insulative
coupling can ceramics, insulative polymers and other insulators
known in the art having a high dielectric strength. In related
embodiments insulative coupling can comprise an insulative coating
on the electrode portion in proximity to housing 14. Examples of
suitable insulative coatings can include, polyimide, polyamide,
TEFLON, NYLON PARALENE and other insulative polymers known in the
art. In various embodiments, insulative coatings 18l can extend a
selected length over the electrode and can be slidably movable over
the length of the electrode (e.g. by sliding in and out of the
interior of housing 14) in order to select a length of active
electrode 18ae. The coating can be configured to be slid or
advanced a fixed length and held in place by virtue of friction
between the coating and the electrode or locking device 18ld
positioned at the juncture between the electrode and housing 14 or
insulative coating. Examples of locking devices can include a bolt,
screw or clamp known in the art.
[0209] Referring now to FIGS. 51a and 51b, in various embodiments,
electrode 18 can be coupled to housing 14 via a strut member 19.
Strut member 19 can be configured to provide sufficient structural
support to electrode 18 to substantially maintain the shape of the
electrode (e.g. in a U shape) as the electrode is advanced through
tissue. In various embodiments, a single strut member 19 can be
located at a locus 18loc of the center curve of the electrode. In
another embodiment, two strut members can be coupled to electrode
18 and can be substantially equidistant from each In or embodiments
three or more strut member can employed strut members can be of
metals such as steel, 304 v steel or tool steel, or rigid polymers
such as polycarbonate, acrylic, or Nylon. Member 19 can also have
sufficient column strength to substantially maintain the shape of
electrode 18 in response to forces applied by tissue (e.g. normal
forces) tending to deform the shape of the electrode as the
electrode is advanced through issues.
[0210] In an alternative embodiment, the column strength and
position of strut member(s) 19 can be also configured to provide
for some flex in the shape or camber of electrode 18. The amount of
flex can be configured to provide the surgeon with tactile feedback
of the resistance encountered by the electrode as it is advanced
through tissue. Further this amount of flex can be configured to
allow the surgeon to discriminate between softer tissue such as
dermal adipose tissue, less soft tissue such as muscle,
vascularized, fibrous and cartilage tissue and rigid tissue such as
bone.
[0211] In an embodiment, electrode 18 and strut member(s) 19 can be
configured to vary the shape of the cutting surface of the
electrode 18ce in response to tissue applied forces. In an another
embodiment, electrode 18 and strut member 19 be configured to have
electrode 18 deform into a pointed or curved arrow head shape in
response to a selectable amount of applied tissue force as the
electrode is advanced into tissue. These and related embodiments
can be configured to facilitate smoother advancement of the
electrode and/or a more uniform width of dissection 8wd (also
called dissection swath 8wd) particularly for tissue
non-uniformities (e.g. scar tissue), uneven tissue, or anatomical
deformities.
[0212] This can be accomplished by having the electrode assume a
pointed shape when encountering more resistance from tissue, thus
concentrating the current density (due to edge effects) and the
cutting or tissue shearing force in the tip or point of the
electrode. This biases cutting or dissection in the horizontal
center of the plane of dissection and in so doing, facilitates a
more even horizontal dissection and reduces the likelihood of the
electrode veering out of the selected plane of dissection. Once the
more resistive tissue is cut through, the electrode is configured
to have sufficient spring force to spring back to its original
curved shape or degree of camber.
[0213] In these and related embodiments electrode 18 can be
fabricated from flexible wire, spring steel or nickel titanium
alloys. This can be accomplished by positioning a single strut
member 19 in the center or locus 18loc of curved electrode 18 and
can configuring the electrode to have sufficient elasticity to
deform inwardly in one of a curved, a convex curved, inward
parabolic curved, or hyperbolic curved manner in response to a
selected amount of force.
[0214] In an another embodiment, member 19 can be advancable in and
out of housing 14 in order to change the advanced length 19al of
the strut member. This can be accomplished by virtue of slot 14st
in housing 14 and a locking device 14ld, such as a locking screw,
or bolt positioned at the slot opening 14st in housing 14.
Embodiments having an advancable strut member 19 can be configured
to change the shape and overall dimensions of the electrode. More
specifically the amount of curvature 18cs of the electrode can be
varied as well as the diameter 18d, for example from a first
curvature and diameter 18cs1, 18d1 to a second curvature and
diameter 18cs2, 18d2.
[0215] Housing 14 can also have slots 14so for advancement and
retraction of the electrode as well in and out of housing 14 as
well as an associated locking mechanisms. Other electrode adjusting
means can include an actuation member 15am such as pull wires and
the like coupled directly or indirectly to the electrode.
[0216] In use, an advancable member 19 can allow the physician to
change the shape so as to in turn vary one or more of the
electro-cautery, cutting or dissection characteristics of electrode
to meet the needs of the a selected tissue site and tissue type.
For example member 19 can be extended to produce a more oblong
shape for tougher more fibrous tissue and retracted to produce a
flatter curve for softer tissue. Embodiments of apparatus 10 having
an extendable electrode can also be configured to vary the amount
of tension in electrode 18 and hence the stiffness of the electrode
as well. By extending member 19, the tension in electrode 19 can be
increased making the electrode stiffer (e.g. less deformable) and
better able to hold its shape in response to tissue-applied forces.
Similarly electrode 18, the electrode can be made more flexible by
the shortening or withdrawal of member 19 back into housing 14.
[0217] In another embodiment member 19 can be configured to be
reciprocating in and out housing 14 to during the dissection
procedure and facilitate cutting or dissection by acting in a
jackhammer like fashion. This can be accomplished by coupling
member 19 to a reciprocating mechanism known in the art, which can
include a pneumatic mechanism coupled to a pneumatic pressure
source.
[0218] The column strength of member 19 can be manipulated by
selection of the diameter and material strength (e.g. compressive
modulus) for member 19. The diameter 19d of member 19 can be in the
range of 0.005 to 0.3 inches with specific embodiments of 0.05,
0.1, 0.2 inches. Also the column strength of the strut member can
be in the range of 0.1 to 10 lbs, with specific embodiments of 0.5,
1, 2, 5 and 7.5 lbs. Strut members 19 can be made from insulative
material or can be coating with an electrically insulative coating
191 described herein.
[0219] Electrode 18 can be made of a variety of conductive
materials, both metallic and non-metallic. Suitable materials for
electrode 18 include, steel such as 304 stainless steel of
hypodermic quality, platinum, gold, silver and alloys and
combinations thereof. Also, electrode 18 can be made of conductive
solid or hollow straight wires of various shapes such as round,
flat, triangular, rectangular, hexagonal, elliptical and the like.
In a specific embodiment all or portions of electrodes 18 can be
made of a shaped memory metal, such as NiTi, commercially available
from Raychem Corporation, Menlo Park, Calif. A radiopaque or
echogenic marker 18m can be coated on electrodes 18 for
visualization purposes using x-ray, ultrasound and other medical
imaging methods known in the art. Marker 18m can be made from
radio-opaque and/or echogenic materials known in the art.
[0220] In various embodiments, energy delivery device 18 and power
source 20 can be configured to operate within the following
parameters: (i) provide a controlled delivery of electromagnetic
energy to the skin surface that does not exceed, 1,000 joules/cm2,
or 500 joules/sec/cm2; (ii) provide a controlled delivery of
electromagnetic energy to the skin surface not exceeding 2000
joules/cm2 during a single treatment session (during a twenty-four
hour period); provides a controlled delivery of electromagnetic
energy to the skin surface not exceeding 200 joules/cm2 during a
single treatment session, or not exceeding 10 joules/sec/cm2; (iii)
operate in an impedance range at the skin surface of, 70 ohms cm2
(measured at a frequency of 88 Hz) to 40 Kohms cm2 (measured at a
frequency of 10 KHz); (iv) provides a controlled delivery of
electromagnetic energy to operate in a range of skin thermal
conductivities (at or near the skin surface) of 0.20 to 1.2 k
(where k=1*[W/(m .degree. C.)]); and (v) operate in a range of
compression forces applied to the skin surface and/or the
underlying soft tissue anatomical structure not exceeding 400 mmHg,
not exceeding 300 mm, not exceeding 200 mmHg or not exceeding 100
mmHg.
[0221] Suitable energy sources 20 that may be employed in one or
more embodiments of the invention include, but are not limited to,
the following: (i) a radio-frequency (RF) source coupled to an RF
electrode, (ii) a coherent source of light coupled to an optical
fiber, (iii) an incoherent light source coupled to an optical
fiber, (iv) a heated fluid coupled to a catheter with a closed
channel configured to receive the heated fluid, (v) a heated fluid
coupled to a catheter with an open channel configured to receive
the heated fluid, (vi) a cooled fluid coupled to a catheter with a
closed channel configured to receive the cooled fluid, (vii) a
cooled fluid coupled to a catheter with an open channel configured
to receive the cooled fluid, (viii) a cryogenic fluid, (ix) a
resistive heating source, (x) a microwave source providing energy
from 915 MHz to 2.45 GHz and coupled to a microwave antenna, (xi)
an ultrasound power source coupled to an ultrasound emitter,
wherein the ultrasound power source produces energy in the range of
300 KHZ to 3 GHz, (xii) a microwave source or (xiii) a fluid
jet.
[0222] For ease of discussion, the energy delivery device 18 is one
or more RF electrodes 18 and the power source utilized is an RF
power supply. However, all other energy delivery devices and power
sources are equally applicable. Referring now to FIG. 52,
electrode(s) 18 are electromagnetically coupled to energy source
20. The coupling can be direct from energy source 20 to each
electrode 18 respectively, or indirectly by using connector member
20cm such as a collet, sleeve, connector, cable, cord 40w, and the
like which couple electrodes 18 to energy source 20. Electrodes 18
can also be multiplexed to power source 20 through a multiplexing
device 20m and associated multiplexing methods known in the
art.
[0223] In various embodiments, RF power source 20 and electrode 18
can be configured to deliver RF energy in one of a monopolar mode
or a bipolar mode, as is known in the art. Further RF power source
can be configured to switch or toggle back and forth between
monopolar and bipolar mode on operator command or via control
system 60. In various embodiment RF electrode 18 and power source
20 can be configured to delivery RF energy to perform one or more
surgical procedures including without limitation cutting,
coagulation, ablation and combinations thereof. Accordingly, power
source 20 can be configured to generate RF energy in one or more
procedural modes known in the electro-surgical arts including
without limitation, cut mode, coagulation mode and blended mode. In
each of these modes RF generator 20 can be configured to generate a
waveform 2xwA that has specific shape, frequency, voltage and
current properties to produce selected tissue effects. Again
generator 20 can be configured to switch back and forth among these
or other electro-surgical modes known in the art. This switching
can be automatically controlled by logic resources 201r, or a
control system integral or coupled to generator 20 or manually by
the surgeon, (e.g. using a foot switch 20fs) or both.
[0224] In the cut mode, energy (current) is delivered continuously
delivery with a waveform having an undamped sinusoidal shape. The
intracellular fluid in the targeted tissue heats to the
vaporization state causing cells in the affected tissue to explode
which disrupts/destroys the structure of the affected tissue.
[0225] Coagulation mode is characterized by a discontinuous
waveform that consists of a dampened cut wave that is duty cycled
(e.g. has an on time then an off time) and has higher voltages than
a cut waveform. The off time allows cell to cool between heating
which in turn allows for the formation of a coagulum and providing
a high degree of hemostasis. The blended mode can have a waveform
that combines features of the cut and coagulation waveform allowing
for an RF current that cuts with varying degrees of hemostasis. The
blended wave has an increased duty (e.g. more on time) and lower
voltages than a coagulation wave form but higher voltage than a
pure cut waveform. Increased levels of coagulation can be obtained
by lowering the duty cycle and vice versa. Example blended wave
forms can have duty cycles that include but are not limited to the
following on off ratios: 50% on 50% off; 40% on 60% off; and 25% on
75% off.
[0226] Apparatus 10 can be configured to operate with numerous
conventional, commercially available, electro-surgical energy
generators.
[0227] An example of a suitable electro-surgical or RF energy
generator 20 can include a unitary mono-polar-bipolar RF generator,
such as the Valleylab "FORCE 2" RF Generator manufactured by
Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow
Drive, Boulder, Colo., 80301-2199, U.S.A. Apparatus 10 can be
coupled to power source 20 using a conventional power cord 40,
which may be long (for example, over two meters) and connect
directly to electro-surgical energy generator 20 via standardized,
monopolar or bipolar connectors, which are well-known in the art.
Power cord 40 may also be short (less than one third of a meter,
for example) and have a standardized, conventional monopolar or
bipolar connection (also well-known in the art) to another, longer
power cord, which is normally reusable and available with
electro-surgical energy generator 20. An operator uses a
foot-activated switch of electro-surgical energy generator 20 to
supply energy through instrument 20 to the electrode 18 and the
tissue being treated. The operator can adjusts one or more power
settings on electrosurgical energy generator 20, such as the wave
form, maximum power setting to be in a sufficiently effective range
(e.g. 10 to 100 watts) depending upon the type of tissue to be
dissected (e.g. the skin envelope v.s. the fascial layer), size of
the dissection path, and amount of skin tightening desired. The
foot switch may also have a multi-pedal design to allow the
operator to both initiate the delivery of RF energy as well switch
between RF wave forms (e.g. thus for cut, versus coagulation or
collagen tightening.
[0228] In another embodiment, apparatus 10 can be configured to use
high frequency high power RF energy and thus can be configured to
be coupled to high power high frequency electro-surgical energy
generator. In these and related embodiments apparatus 10 can be
configured to utilize RF energy having a frequency range of about 1
to about 15 MHz with specific embodiments of 2.5, 3.5, 10 and 14
MHz; voltage up to about 700 volts rms, a current up to about 2
amps and a delivered power up to about 500 or up to about 1000
watts. The delivered power can be pulsed or continuous, with peak
pulsed power capable of exceeding 1000 watts. Further description
of high frequency, high power RF generators and their use in
electro-cautery and other RF medical procedures is found in PCT
application No. PCT/US01/149207 (Publication No. WO 02/053048) and
U.S. patent application Ser. No. 09/752,978 which are fully
incorporated by reference herein.
[0229] Referring now to FIGS. 53a and 53b in related embodiments
apparatus 10 can be configured to use high frequency high power RF
energy in conjunction with injection or infusion of an
electro-conductive or electrolytic solution 29e at the tissue site
to create an enhanced or tumescent electrode 18en. Enhanced
electrode is created by the delivery of sufficient RF power to
increase the current density in the electro-conductive fluid
surrounding or adjacent electrode 18 to the point where that fluid
acts as an electro-cautery electrode or energy delivery device to
cut, ablate, vaporize or coagulate tissue in contact with or
proximate to the enhanced electrode.
[0230] In various embodiments, electro-conductive solution 29e can
include various saline solutions known in the medical arts
including, buffered saline solutions, 0.9% saline solutions and
carrier saline solutions such as tumescent saline carrier solutions
infused as part of a liposuction procedure (containing epinephrine
and anesthetic such as lidocaine) or saline carrier solution used
for injection of local anesthetics such as lidocaine as part of
face lift and other plastic surgery procedures using localized
injection of an anesthetic. Additionally, the solutions (saline or
non-saline solutions) containing lidocaine and/or its chemical
derivatives can also be used as electro-conductive solutions by
virtue of the electro-conductivity of lidocaine which is itself
electro-conductive in solution.
[0231] In an embodiment of a method of using high power/high
frequency RF energy for flap dissection, the surgeon would
pre-infuse the target tissue site with tumescent saline solution, a
saline-based anesthetic solution or other saline or
electro-conductive solution 29e. The amount of infused saline can
vary depending upon the procedure from 0.001 to 5 liters, with
specific embodiment of 0.005, 0.1, 0.5, 1 and 2.5 liters. For
liposuction the infused volume can be between 0.5 to 4 liters, for
face lift procedures it can be between 0.05 to 0.5 liters.
[0232] An incision would be made and the apparatus 10 placed within
the incision with subsequent saline infusion or injection as
needed. Electrode 18 would then be energized by high frequency
power source 20hf with the power levels and frequencies adjusted
manually or automatically to produce enhanced electrode 18en. After
energizing the electrode and generating the enhanced electrode, the
surgeon would then advance apparatus 10 within the tissue pocket
and use the enhanced electrode 18en to dissect one or more selected
tissue flaps. (Alternatively the surgeon could start the dissection
procedure with electrode 18 configured as a normal RF electrode and
convert to enhanced electrode 18en via manual command or automatic
control of power source 20 or control system 60).
[0233] Additional saline infusion or injection could be made as
needed and could be done so responsive to monitored impedance
and/or temperature levels at the tissue site using impedance and/or
temperature sensors including the electrode. The
infusions/injection could be done under manual control using an
infusion pump 24ip or could be controlled using a control system
described herein. In an embodiment, continuous, duty cycled or
intermittent infusion could be done throughout the period of RF
energy delivery.
[0234] To facilitate use of the above and related methods using an
enhanced electrode for more commonly performed plastic surgery
procedures that utilize saline infusion or injection such as
liposuction, face lifts and the like, in various embodiments, power
source 20 can be configured to allow the surgeon to enter the type
of infusion/injection solution used including the saline and/or
other solute concentration. The power source 20 could then use a
power control algorithm or computer program 404pc to adjust the RF
power levels (e.g. voltage and current) and frequencies based on
the electro-conductivity and/or solute concentrations of the
infused solution 29e to produce the desired enhanced electrode or
enhanced electrode effect (e.g. increased tissue temperatures,
etc.). Program 404pc could be resident within processor that is
part of power source 20 or could be resident within a processor
that is part of control system 60 that is coupled or integral to
power source 20.
[0235] Enhanced electrode 18en comprises both the original metal or
wire electrode 18 and charged or electrically energized fluid 29ef
surrounding the electrode, known as the fluidic component 18f. In
various embodiments, enhanced electrode 18en can also be configured
to generate higher tissue temperatures than standard RF electrode
and thus provide an enhanced electro-cautery cutting and ablation
effect. This is due to the fact that: (i) the use of the infusion
solution with the enhanced electrode reduces or prevents the
buildup of charred matter on a wire or metal electrode 18 which can
cause a shut down of the generator due to the development of
excessive impedance and (ii) the fluidic component 18f of the
enhanced electrode is itself not subject to the buildup of charred
matter.
[0236] These two factors singularly or combined allow for greater
amounts of current and hence power to be delivered to the enhanced
electrode resulting in higher temperatures (due to Ohm's law) at
the electrode and surrounding tissue.
[0237] In an embodiment, the delivered power levels to create an
enhanced electrode 18en can be about 500 watts or greater at a
frequency of about 1 MHz or greater. The size and/or shape of the
enhanced electrode can be controlled or modulated by control of one
or more of the frequency, power, voltage or current of the RF
signal from RF generator. The size of the enhanced electrode can be
increased by increasing the RF power, frequency or both. Increasing
of one or both of these parameters also serves to increase the
electrodes tissue cutting, dissection and ablation and abilities by
producing higher current densities and thus higher electrode/tissue
temperatures which vaporize, cut or ablate contacting tissue faster
and more thoroughly. In various embodiments, enhanced electrode
18en can have the same basic shape or proportions as electrode 18
only larger depending upon the delivered power. Alternatively the
enhanced electrode can be a different shape such as spherical,
cylindrical depending upon the distribution of the electrolytic
fluid 29e and RF parameters.
[0238] Thus embodiments of the invention utilizing an enhanced
electrode can be configured to allow or facilitate faster more
uniform tissue flap dissections by virtue of one or more of the
increased temperature, size and electro-cautery properties of the
enhanced electrode.
[0239] Turning now to a discussion of extenders 22 and referring to
FIG. 3, in various embodiments, extenders 22 can be attached to the
electrode housing 14 and/or hand piece 15. Extenders 22 can also be
of variable length. This can be achieved by configuring extenders
22 to be telescoping or otherwise having a slidable extension
mechanism known in the art. In an embodiment, this can be
accomplished through telescoping sections 22t which are coaxial
and/or swaged or are otherwise attached together. Extenders 22 can
be made from thermoset, thermoplastic or moldable polymers known in
the art such as ABS, acrylic, polystyrene, polyetherimide and the
like. Extenders 22 can also be made from metal such as steel, 304 v
steel or tool steel and can be coated with a thermally and/or
electrically insulative layer 221. Alternatively, all or portions
of extenders 22 can be fabricated from superelastic metals known in
the art
[0240] Referring now to FIGS. 2 and 3, in an embodiment, apparatus
10 can be configured to have a suction capability via a suction
device 24 which can include a suction lumen or port 24' running
through all or a portion of apparatus 10. This can include portions
of housing 14 and/or the extender 22. Suction device 24 can be
configured to be coupled to a vacuum source known 24v in the art.
Suction device 24 can also be configured to have sufficient suction
to suction off steam, water vapor or gases created during use of
apparatus 10 in an electro-surgical procedure. Suction can be
configured to minimize thermal damage from steam created in a
closed system during use of the device. Also suction can be
incorporated into apparatus 10 (via suction device 24 other suction
means known in the art) as a means of convection cooling of the
dissection pocket 8dp created during use of apparatus 10. In an
embodiment, suction device 24 can configured to provide between 1
and 760 torr of vacuum. Also all or portions of suction device 24
can be made from heat resistant polymers known in the art such as
polyetherimides, polyethers, polyesters, polyamides, polyimides and
polybenzoxazole. An example of suitable heat resistant polymer
includes Ultem.RTM., available from the General Electric
Corporation. Suction device 24 can also be an aspiration device
known in the art and in an embodiment, can be the same aspiration
device used to perform the liposuction. In an embodiment, suction
device 24 or ports 24' can be coupled to a smoke evacuation device
24se known in the electro-surgical arts.
[0241] In related embodiments suction device 24 can also be
configured as insufflation device 24i to allow the surgeon to
insufflate all or portions of the tissue site 8 including the
dissection pocket 8dp and the skin envelope 8se. In use
insufflation can allow the surgeon to observe the developing plane
of dissection 8pd and adjacent tissue either directly or using an
endoscope or other viewing device known in the art. Insufflation
device 24i can be configured to be coupled to a pressure source 24p
such as compressed air source known in the medical arts.
[0242] In various embodiments, apparatus 10 can be configured for
endoscopic viewing capability or to be used in conjunction with an
endoscope. This can be achieved through use of an endoscopic or
viewing device 24e that is integral to or movably positionable
within apparatus 10 or used as separate adjunct device. In various
embodiments, endoscopy can also be performed through lumen 24' or
another lumen 24'' which can each be configured to allow the
passage of an endoscopic device, viewing scope and the like. In an
embodiment, apparatus 10 and/or endoscopy device 24e, or an adjunct
endoscopy device can be configured to allow endoscopic
visualization of subcutaneous tissue sites in the operating site
including the subcutaneous plane of dissection. These and related
embodiments can be configured to be utilized during electro-cautery
procedures such as electro-cautery hemostasis to allow the surgeon
to view all or a portion of the subcutaneous plane of dissection to
ascertain hemostasis and other tissue conditions. Alternatively, a
suction assisted lipectomy canula or lumen 24'lc can also be
employed.
[0243] Referring now to FIGS. 56-57, in an embodiment, hand piece
15 can be configured to attached to the electrode housing 14 and
can be configured to provide similar tactile sensation (e.g. feel
and visual appearance) as standard surgical instruments such as a
Metzenbaum scissors (see FIG. 3). This can be accomplished by
having hand piece 15 have a similar grip as Metzenbaum scissors
and/or similar mechanical properties. Hand piece 15 can also be
configured to attach to a disposable housing 14 and can include a
quick detach mechanism 14dm described herein or known in the art.
In use, detach mechanism 14dm can be configured to allow the
physician to rapidly detach and replace housing 14 the same or
different housing (e.g. having a different height or electrode
shape) depending upon the requirements of the procedure. In one
embodiment the physician could detach housing 14 when switching
from an dissection procedure to an excision procedure or when
switching from performing a procedure on a subcutaneous flap to a
myocutaneous flap and vice a versa.
[0244] Referring now to FIGS. 58-59, in various embodiments,
electrode-housing 14 can be configured as to be deployable in situ
to allow subcutaneous insertion of all or portion of housing 14 or
apparatus 10 through a single incision can be in the range of 0.25
to four inches in length. After insertion, deployment of housing 14
or portions thereof creates an initial dissection pocket 8dp for
the deployed dissector. Thus, housing 14 can have a non-deployed
state shown in FIG. 58 and a deployed state shown in FIG. 59. This
can be accomplished having all or portions of housing 14 pivotally
coupled to extender 22 using a pivot, hinge or cam mechanism known
in the art. Also, all or a portion, of housing 14 can be
articulated to be movable from a non-deployed state to a deployed
state. This can be accomplished by means of pull wire/rod or pull
mechanism known in the medical device/catheter art. It can also be
accomplished pneumatically or hydraulically by configuring all or
portions of housing 14 to be actuable by pneumatic or hydraulic
means such as the use of a hydraulic or pneumatic device or force
application device (e.g. a hydraulic press).
[0245] In an embodiment, this can this can be accomplished by use
of using an inflatable member 14im known in the medical device arts
(such as inflatable polyethylene or silastic or latex balloon)
which is disposed or otherwise coupled to the interior of housing
14. In another means for deployment, housing 14 can include a
deployment spring 14ds (either a coil or leaf spring) which can be
actuable by an actuating member wire 39 coupled to hand piece
15.
[0246] Deployable embodiments of apparatus 10 can be configured to
have a non-deployed profile or footprint to allow access through
small incision sites directly or through surgical sheaths and
introducing devices known in the art. Thus in use, deployable
embodiments of apparatus 10 can also allow for reduction of the
size of the incision site 8 is to access the target tissue site 8
versus standard plastic surgery procedures such as face lift. This
reduced incision size can also allow the incision site to less
visible upon healing as well as placed in less visible locations
such as the scalp
[0247] Apparatus 10 can be used by the surgeon to dissect and
separate selected tissue layers 81 in a selected plane of
dissection 8pd. This can be done in one pass to dissect a skin
envelope 8se or tissue flap 8f corresponding in width to the width
of 18w of electrode 18 or can be done in multiple passes for larger
tissue flaps.
[0248] The larger the advancement flap, the greater the number of
passes that can be done. Although multiple passes may be needed,
the overall thickness of the flap will be uniform. This allows the
surgeon to preserve or substantially preserve the subdermal
vascular plexus of the advancement flap and also avoid or
substantially avoid damage to vital subjacent structures such as
muscles, nerves and blood vessels.
[0249] After the surgeon has dissected a desired area of a selected
tissue layer 81 such as the skin envelope 8se, the surgeon can then
make further passes at substantially the same site to dissect
subjacent or deeper tissue layers such as the adipose layers,
breast tissue, or scar layers or transect the fibrous septae to
correct cellulite or other selected such as a keloid scar, or cyst
or lipoma. Also multiple passes can be done over the same area to
sculpt or contour a selected layer, such as an adipose layer to
produce a desired contour such as the contour in the buttocks or
breast area. In use these and related embodiments can allow the
surgeon to produce a desired skin contour by controlling one or
more of (i) the depth of dissection and (ii) the number of layers
dissected. Further such embodiments can also allow the surgeon to
produce a varying contour such as that in the buttocks area by
varying the thickness of dissected adipose or tissue layers. This
can be done by doing one pass in one location and/or multiple
passes in another adjacent or other location.
[0250] Referring back to FIGS. 14-18, in various embodiments,
apparatus 10 can be configured to allow a surgical dissection to be
performed in a closed or `blind` fashion without the surgeon
needing to directly visualize the plane of dissection. Instead, the
prominence of the superficial guide in situ can be visualized
through the skin by the surgeon. As discussed herein this can be
facilitated by configuring housing 14 to have a raised side contour
21rsc or ridges 21r which can function as transcutaneous markers 21
discussed. Raised side contour 21rcs or ridges 21r can be curved,
u-shaped, triangular, square and combinations thereof.
[0251] Referring now to FIG. 60, in another embodiment,
transcutaneous visualization can be accomplished by use of an LED
or other light source 34 integral or attached to housing 14. Light
source 34 can configured to have a wavelength and intensity
sufficient to illuminate through the skin. Suitable lights sources
34 include LEDs used for pulse oximeters as known in the art. In a
related embodiment, light source 34 can also be configured as a
thickness measurement device 34t to provide a measurement of the
thickness 8t of the skin envelope 8se or selected tissue flap. This
can be accomplished using optical range/thickness finding
technology known in the art. In an embodiment, this can be
accomplished using a light source 34 such as a LED (which can be in
the red or infrared range) and photo-detector 34pd to measure the
amount of light absorbed by the skin.
[0252] A correlation can be established between the amount of light
absorbance and skin thickness using one or more numerical or curve
fitting methods known in the art such as cubic spline, least
squares and polynomial curve fitting methods. In various
embodiments, photo-detector 34pd can be configured to be placed on
top of the skin or substantially adjacent light source 34 where it
is configured to measures reflected/scattered light from skin
envelope, where the amount of reflected light is proportional
(inversely or otherwise) to skin envelope thickness.
[0253] Measurement device 34t can be configured to provide the
physician with a real time indication of the skin envelope or
tissue flap thickness 8t and thus the dissection depth 8dd as well.
Measurement device 34t can be coupled to a display instrument which
34d can include associated logic resource 341r and an optical power
source. Optical measurement device 34t can be pre calibrated or can
be configured to be calibrated using the patient's skin to account
for variations in skin composition (e.g. pigmentation, vascularity,
etc.).
[0254] By providing feedback of skin envelop thickness, measurement
device 34t can be configured to allow the physician to one or more
of the following: (i) have finer control over the dissection
procedure including the skin envelope/flap thickness, (ii) make
adjustment of apparatus 10 as needed to maintain the selected
thickness (iii) obtain a more uniform or precise thickness of the
skin envelope or tissue flap over a selected length of dissected
tissue; (iv) controllably vary the envelope/flap thickness over a
selected length of tissue.
[0255] In a related embodiment, light source 34 or measurement
device 34t can be configured to detect for the preservation or
damage of the dermal or sub-dermal vascular plexus. This can be
accomplished by using LEDs or laser diode in the a red (660 nm)
and/or an infrared (940 .mu.m) range to detect the presence of
blood in the plexus. Should the should the oxygenated signal drop
or decrease in slope the surgeon is provided with an indication of
thermal affects to the plexus before significant damage occurs and
can thus stop the dissection procedure, decrease the power levels
from the RF or other energy source, increase the level of cooling
to tissue site, or a combination thereof.
[0256] In various embodiments, apparatus 10 can be configured to
treat one or more of the following anatomical or dermatological
deformities, including without limitation, Facial Cervical Rhytids,
Breast Ptosis, Brachial Skin Redundancy, Post Partum Laxity of the
Abdomen with Lipodystrophy, Lipodystrophy of the Hips and Thighs
With Skin Laxity, Buttock Ptosis and Knee Ptosis with
Lipodystrophy. Accordingly, in related method embodiments of the
invention, apparatus 10 can used to perform one or more of the
following surgical or medical procedures including, without
limitation, Liposuction (Suction Assisted Lipectomy), Face lift
(Rhytidectomy), Breast Reduction (Reduction Mammoplasty), Tummy
Tuck (Abdominoplasty), Buttock Lift and combinations thereof.
Liposuction (Suction Assisted Lipectomy), Face lift (Rhytidectomy),
Mastectomy, Breast Reduction (Reduction Mammoplasty), Tummy Tuck
(Abdominoplasty), Buttock Lift and combinations thereof.
[0257] Referring back to FIGS. 2-7, apparatus 10 can be configured
to produce a substantially uniform depth of dissection for one or
more of theses procedures. This can be achieved by selection of the
size and shape of housing 14 (e.g. height), electrode 18 and
extenders 22. For example, the height 14h of housing 14 can be
adjusted (increased or decreased using embodiments described
herein) to produce different depths of dissection for a breast
reduction vs. a tummy tuck procedure. Also a smaller housing 14 can
be used for procedures with smaller tissue flaps and/or dissection
pockets and requiring more precise control of the area or plane of
dissection such as face lift procedure. Further housing 14 can be
narrow for target tissue areas having tight or narrow access.
[0258] In various method embodiments, apparatus 10 can be used to
perform one or more surgical techniques that can be useful for
producing a desired aesthetic tissue affect. For example, in an
embodiment, apparatus 10 can be used to correct buttock ptosis with
reduced or minimal scarring as well as produce diminishment of
cellulite in the plane of dissection. This can be accomplished by
using apparatus 10 to transect eliminating or reducing dimpling of
the skin in the dissected area.
[0259] In another embodiment, apparatus 10 can be used as an
adjunct to aesthetic procedures such as liposuction where contour
reduction from liposuction can be accompanied with smoothing and
tightening of the overlying skin envelope. In these and related
procedures apparatus 10 can be configured to be used to produce
tightening of the undermined skin envelope. This can be
accomplished from one or more effects of closed electro-surgical
dissection including but not limited to: (i) closed advancement and
(ii) thermal tightening of the tissue flap. Thermal conductive
tightening of the skin envelope occurs from primary collagen
contraction of the released fibrous septae of the subcutaneous
tissue and from primary collagen contraction of the dermis due to
heating of the these tissues at or above the temperature of
collagen contraction.
[0260] Energy can also be delivered to produce a delayed wound
healing tightening of the skin envelope that will occur during
subsequent months. Also the combined procedure can function as a
portal for closed application contouring of the subcutaneous tissue
with endoscopic staples. In these and related embodiments,
apparatus 10 can be configured for the use of an endoscope as well
as introduction of endoscopic staples. This can be accomplished by
configuring one or more lumens 24' to have sufficient diameter to
allow the passage of an endoscope. In such embodiments lumens can
be 5-20 french in diameter.
[0261] In an embodiment, the RF energy delivered to the tissue site
to dissect the tissue plane can also be configured to heat the
developing tissue flap immediately overlying the electrodes. This
in turn, heats the skin envelope directly or indirectly through
conduction, convection or both. This heating in turn will result in
contraction, causing tightening of the skin envelope because of
tightening of the dermis and fibrous septa. Subjacent tissue can be
electro-surgically dissected and contoured and during this process
the overlying skin envelope/tissue flap can be tightened by thermal
conduction to selected portions of the skin envelope.
[0262] The delivery of energy can be titrated to on the one hand,
raise collagen components of the flap to a temperature sufficient
to cause shrinkage collegenous matrix of the overlying dermis with
a subsequent wound healing response, but on the other stay below a
temperature and/or total heat delivery that would cause damage or
necrosis of the subdermal plexus.
[0263] In various embodiments, configuration of RF energy for skin
tightening can be accomplished by manipulation of the RF energy
waveform (e.g. frequency, amplitude, duty cycle etc). In an
embodiment, the RF generator can be configured to have two modes of
power delivery, one configured for cutting and the second
configured for heating of the skin envelope to collagen contraction
for skin tightening. The heating waveform can have lower power
levels and lower frequencies than the cut waveform. In various
embodiments, the power level and frequency of the heating waveform
can be in the range of about 5 to about 30 watts and about 250 to
about 750 kHz respectively.
[0264] Power source 20 or a coupled control system 60 (described
herein) can be configured to alternate between two wave forms in
selected duty cycle or alternatively the physician can manually
toggle back and forth between the two via means of a foot switch or
other manual control means. Further description of methods and
techniques of tissue tightening and remodeling the skin through
heating of collagen containing tissue (e.g. the skin) by RF energy
and other means is found in U.S. Pat. Nos. 5,919,219, 6,241,753,
6,311,090 and 6,350,276, which are all fully incorporated by
reference herein.
[0265] Referring back to FIGS. 23-25, reduction or prevention of
thermal injury or necrosis of the subdermal plexus and/or dermal
layers can be further facilitated by use of cooling fluid 29 that
can be delivered to tissue layers and structures above and below
the plane of dissection such as sub-dermal plexus or even to the
skin surface to prevent excessive thermal injury (e.g. erythemia,
blistering, burns etc.) to the dermal layer or skin surface. In
various embodiments, cooling fluid 29 can be delivered through
lumens 24' or via one or more fluid distributions ports or
apertures 33 position on housing 14. Further description of methods
and techniques of tissue tightening and remodeling through heating
of collagen containing tissue (e.g. the skin) by RF energy and
other sources and mechanisms is found in U.S. Pat. Nos. 5,919,219,
6,241,753, 6,311,090 and 6,350,276, which are all fully
incorporated by reference herein.
[0266] Referring now to FIG. 61, in various embodiments, apparatus
10 can be configured to monitor the temperature of tissue adjacent
or near housing 14. This can be accomplished by the use of one or
more temperature sensors 23 coupled, integral or disposed on within
housing 14. Temperature sensors 23 can the be coupled to a feedback
control system described herein or logic resources 201r coupled to
the power source 20 to regulated the delivery of energy to
electrode 18 and tissue site 8.
[0267] In use, temperature monitoring can be configured to titrate
or otherwise control the delivery of energy to the target tissue
site 8.
[0268] Further, in various method embodiments temperature
monitoring can be used to control energy delivery to the tissue
site to perform or facilitate of one or more of the following: (i)
tightening of the skin envelope via collagen contraction, (ii)
tightening of the skin envelop via a wound healing response, (iii)
produce a substantially uniform plane of tissue dissection using
electro-cautery or other EM cutting energy; and (iv) prevent or
minimize thermal injury or necrosis to selected tissue layers such
as the subdermal plexus, musculocutaneous and perforator
arteries.
[0269] In a particular embodiment, temperature monitoring can be
used to titrate the delivery of energy to tighten the skin from
thermal collagen contraction and wound healing while minimizing or
preventing thermal injury to the dermal-subdermal plexuses.
[0270] Suitable temperatures sensors 23 that can be employed
include thermisters, thermocouples and other solid state or optical
temperature sensors known in the art. In various embodiments,
sensors 23 can be positioned on the top 14t, bottom 14b or sides
14s of housing 14 as well as on or near suction device 24.
[0271] In a particular embodiment sensors 23 can be positioned on
both the top and bottom of housing 14 so as to provide simultaneous
temperature monitoring capability of both superior tissue layers
(e.g., the skin envelope) and subjacent or inferior tissue layers.
These and related configuration can be used to control delivery of
energy to the tissue site to dissect out a selected tissue plane
using electrode 18 and deliver energy to the skin envelope to
tighten the envelope (via thermal contraction of collagen) while
minimizing injury to the subdermal plexus and/or other subjacent
tissue structures.
[0272] In related embodiments, sensors 23 can be distributed along
a longitudinal axis 14la and/or lateral axis 14lata of housing 14
with the distribution configured to generate a lateral or a
longitudinal temperature profile 23p of superior or subjacent
contacting tissue layers. The temperature profile can used to
monitor, control or perform one or more of the following functions:
(i) delivery of energy to the tissue site, (ii) delivery of cooling
to the tissue site, (iii) rate of advancement of housing 14 by the
physician, (iv) direction of advancement of housing 14 (iv)
positioning of housing 14 by the physician.
[0273] In other embodiments sensors 23 can be positioned to measure
one or more temperature gradients 23g such as temperature gradient
between tissue in contact with the electrode and tissue in the
nascent skin envelope or tissue flap. Accordingly in such
embodiments sensors 23 can be positioned on or near electrode 18
and also on the top portions 14t of housing 14 or the roller. Such
temperature gradients can be utilized by the physician and/or a
control system to monitor the delivery of energy for one or more of
the following: (i) assure sufficient temperature at or near the
electrode for electro-surgical cutting, (ii) assure proper
temperature for collagen contraction of selected portions of the
skin envelope/tissue flap or (iii) assure temperatures stay below a
threshold that would cause thermal damage or severe thermal damage
to flap layers containing the sub-dermal plexus or other tissue
structures.
[0274] In related method embodiment, the delivered RF power levels
can be controlled (by a control system, by the physician, or
combination of both) to maintain a selected temperature gradient,
such as the gradient between the tissue proximate the electrode and
superior tissue in the developing skin envelope. This type of
control and associated control systems and algorithms can be
employed independently or in conjunction with control systems
and/or algorithm that utilize absolute temperature as an input. In
another method embodiment, temperature a gradient across the
horizontal surface of the electrode can be monitored to assure a
substantially uniform (or other selected temperature profile)
cutting temperature across the electrode. If a portion of the
electrode becomes too hot or too cool, the control system can
figured to dynamically respond by changing one or more of the
following (i) the delivered RF power level, (ii) the RF wave form
or shape, (iii) the power duty cycle, (iv) the shape of the
electrode (via strut member 19 or other mechanical means) to alter
the current density at that portion of the electrode; or (v) the
rate of cooling fluid delivered to selected portions of the
electrode (e.g. the hot portions) via cooling apertures or other
directed cooling or cooling means.
[0275] In other embodiments, sensors 23 can also be positioned
adjacent or near electrode 18 such as on or in the suction device
24 to monitor the temperature of the vapor being generated at the
tissue site. This temperature can be utilized to control a vapor
cooling element 29e and/or the delivery of cooling fluid 29 to
portions of apparatus 10 and the tissue site.
[0276] Tissues temperatures that can be monitored include without
limitation that of superior layers such as the skin envelope
including dermal-sub-dermal plexus and subjacent layers such as
subcutaneous layer, fascial and muscular layers. Suitable
temperature sensors can include thermisters, thermocouples, fiber
optic, solid state or other temperature sensors known in the
art.
[0277] In various embodiments, adjacent tissue and superjacent skin
can be cooled by one or more methods to prevent or minimize thermal
injury, damage or tissue necrosis to selected tissue layers in the
tissue flap and/or subjacent layers. Cooling can be accomplished by
the use of a cooling media 29 to cool non-target tissue by
convection, conduction or a combination of both. The cooling media
29 can be a fluid 29 which can be a liquid or a gas, or a
combination of both. Examples of suitable cooling fluids include,
water, saline solution and ethanol and combinations thereof. Other
embodiments can utilize a cooling fluid or gas which serves to cool
adjacent tissue by ebullient cooling or Joule Thomson Effect
cooling as well as the mechanisms described above. Embodiments
utilizing Joule-Thomson Effect cooling can have a nozzle-shaped
aperture 33n to provide for expansion of a cooling fluid 29.
Examples of cooling fluid 29 include, but are not limited to,
Freon, CO.sub.2, and liquid nitrogen. The amount of cooling can be
controlled by control of one or more of the following parameters
(i) temperature of the cooling solution (ii) flow rates of the
cooling solution (iii) heat capacity (e.g. specific heat) of the
cooling solution.
[0278] Referring now to FIG. 62, in another embodiment, cooling can
be achieved by irrigation of the tissue surface or selected
portions of the tissue site with a cooled fluid 29 as is used
during lavage and related surgical procedures known in the art.
Accordingly in these and related embodiments, apparatus 10 can
include be configured to be used in conjunction with an irrigation
device 24i, or suction device 24 can also be configured as an
irrigation or lavage device 24i. In an embodiment, the lavage
device can be a pulsatile lavage irrigator known in the art.
Examples of suitable pulsed lavage irrigators include, but are not
limited to, the Davol.RTM. Simpulse.RTM. Solo (Manufactured by the
Davol Corporation), the Stryker Surgilav.RTM. Plus.RTM.
(Manufactured by the Stryker Corporation) and the Zimmer
Pulsavac.RTM. III (Manufactured by the Zimmer Corporation).
[0279] Referring now to FIG. 63, in an embodiment, cooling of the
skin and adjacent tissue can be achieved by suctioning off,
capturing or cooling the vapor (steam etc) produced from
vaporization of tissue during energy delivery (e.g. via
electro-cautery) to the tissue site from electrode 18 or other
energy delivery device described herein. Suctioning of steam can be
accomplished using suction device 24 or a separate suction or
device coupled to a vacuum source. In an embodiment, suction can be
performed by the same aspiration device used to perform
liposuction. Alternatively, a cooling element 29e can utilized to
condense or otherwise cool vapor produced during energy delivery
from energy delivery device 18 to the tissue site such as during
cutting or coagulation from electro-cautery procedures. Cooling
element 29e can be coupled to or positioned sufficiently proximate
to energy delivery device 18 to condense and cool the generated
vapor. In an embodiment, cooling element 29e can itself be cooled
by a cooling fluid source 29s, such as a cryogenic gas 29g, coupled
to element 29e. Cooling element 29e can have a variety of shapes
including a coiled shape, spiraled helical shape, or a fin-shape,
one or more configured to maximize surface area for conductive
and/or convective heat transfer.
[0280] Apparatus 10 can also be configured to provide cooling of
electrodes 18 via lumens 24' to prevent tissue from the development
of excessive impedance at electrode 18 from the deposition of
charred tissue on the surface of electrode 18. Further description
of tissue and skin cooling methods are found in U.S. Pat. Nos.
6,350,276 and 6,377,854 which are fully incorporated by reference
herein.
[0281] As discussed herein, in various method embodiments,
apparatus 10 can be used to perform one or more surgical techniques
that can be useful for producing a desired aesthetic tissue affect.
Further, by maintaining a substantially uniform skin envelope
thickness during dissection, apparatus 10 facilitates the removal
or reduction of contour irregularities for example, the dimpled
skin appearance resulting from cellulite. This can be accomplished
by configuring apparatus 10 to produce a uniform skin envelope,
transect the fibrous septae that are attached to the skin and
muscle fascia and deliver thermal energy from the electrode to
substantially uniformly tighten the released skin envelope by
thermal collagen contraction and a subsequent wound healing
response discussed herein. By applying RF energy to a skin envelope
having a substantially uniform thickness, as opposed to a
non-uniform thickness, the resulting tightening of the skin by RF
energy application is itself made more uniform. More simply put,
starting with a more uniform tissue layer to be tightened results
in a more uniformly tightened layer. Apparatus 10 can be configured
to facilitate this process by providing the physician qualitative
and/or a quantitative assessment of the uniformity of skin envelope
thickness pre and/or post tightening through either the use of
trans-cutaneous visualization of the developing skin envelope
and/or use of skin thickness measurement methods both described
herein.
[0282] Skin deformities can be further improved by using apparatus
10 to uniformly transect the fibrous septae at the tissue site with
each pass of apparatus 10 through the selected plane of dissection.
Accordingly, apparatus 10 can be specifically configured to
transect the fibrous septae by configuration of one or more of the
electrode dimensions (e.g. diameter), shape, stiffness, edge and
electro-cautery properties. For example, the electrode stiffness
can be increased and/or the electrode can have a sharpened edge. By
providing a means for uniformly transecting the fibrous septae,
apparatus 10 facilitates more uniform tightening because the skin
is no longer being pulled down or constrained at intermittent
locations to the underlying facia.
[0283] In an embodiment of a method for using apparatus 10 to
correct a skin deformity, the surgeon makes an incision at or
adjacent the tissue site. The surgeon then selects the desired
tissue plane to dissect for example, the skin envelope from the
underlying subcutaneous layers such as facia. The surgeon can
visually acquire the desired dissection plane through direct
visualization of the tissue within the incision site or through use
of endoscopic visualization. If needed the surgeon can pre-adjust
apparatus 10 to produce the desire depth of dissection by
manipulation of one or more of the electrode, housing 14 or the
roller.
[0284] If desired, the surgeon can manually start the plane of
dissection and isolate or separate the respective tissue layers
using his/her hands or via means of a surgical instrument such as
scalpel, scissors or bovie and the like. The surgeon then inserts
apparatus 10 through the incision and into the tissue pocket. For
deployable embodiments, the surgeon inserts apparatus 10 in a
non-deployed state and then deploys apparatus 10 within tissue
pocket. The surgeon can adjust apparatus 10 in situ to produce the
desired depth of dissection by manipulation of one or more of the
electrode, housing 14 or the roller. Alternatively, the surgeon can
remove apparatus 10to make such adjustments. After connection to an
RF power source (via the hand piece), the surgeon then energizes
the electrode (using a footswitch or other activating means) to
deliver RF energy and advances apparatus 10 through the selected
dissection plane to dissect and separate the skin envelope (or
other tissue layer) and transect the fiber septae. Advancement can
be done by gripping the hand piece or the extender.
[0285] As discussed above, the surgeon can pre-isolate and start
the plane of dissection manually or he/she can do so using
apparatus 10. As the skin envelope is dissected by the RF
electrode, delivery of thermal energy from the electrode cause
thermal contraction of collagen within the skin envelope causing
immediate tightening of the skin and subsequent tightening from a
wound healing response. As the skin envelope is dissected and
separated by the electrode it is guided (by the shape of housing 14
or roller) to slide over housing 14 or roller and is shielded from
further heating; thus, protecting the dermal and subdermal plexes
from thermal injury and necrosis.
[0286] This shielding can be further facilitated by the use of a
cooling fluid delivered to the skin envelope from an irrigation
means (e.g. apertures 33, nozzles 33n, lumens 24', etc.) coupled to
housing 14 (e.g. via irrigation ports on the surface of housing 14)
or an external irrigation means. The surgeon can continuously
ascertain one or more of the path and depth of the developing
dissection plane as well as the amount of skin tightening by
transcutaneous visualization of marker ridges or bumps on housing
14 or roller or by using tissue thickness monitor.
[0287] This information is used by the surgeon can make adjustments
as need to either the path of dissection or the depth of dissection
by manipulation of one or more of the hand piece, extender or RF
energy level. There is no need stop advancement or otherwise remove
a hand from the hand piece to palpitate the skin to determine the
path or depth of dissection (although the surgeon can do this if
he/she desires. This results in one or more of (i) a more uniform
dissection and uniform tissue flap/skin envelope, (ii) a better
aesthetic outcome with smaller incisions and (iii) well as faster
procedure times then procedures where it is necessary to stop
advancement to palpitate the skin or otherwise remove one or both
hands from a dissection instrument to do so.
[0288] The surgeon can advance apparatus 10 to stop at a selected
end point within the tissue site. Then using the hand piece, the
surgeon can withdraw housing 14 back to the incision site or some
selected point in between. The surgeon can then observe the
dissection plane either transcutaneously or through endoscopic
visualization. Observation can be facilitated by using apparatus 10
or adjunct device(s) to irrigate and/or aspirate the newly
dissected tissue plane as well insufflate the dissected area of
tissue. If desired, the surgeon can then make multiple passes over
the same area of the dissection plane to do one or more of the
following: (i) smooth out the plane of dissection, (ii) widen the
width of dissected skin envelope or other tissue flap; (iii) go
back over the dissection plane to coagulate any bleeding tissue or
vessels, (iv) deliver additional amounts of heat to the skin
envelope or selected tissue flap to titrate the amount of collagen
contraction and resultant skin tightening, or (v) dissect out a
deeper tissue plane. For the last step, the surgeon can, if
desired, readjust apparatus 10 to change the depth of
dissection.
[0289] After completion of dissection within a given tissue area or
path, the surgeon can then reposition housing 14 either at the
existing incision to start a new path or swath of dissection or
make a new incision and reposition housing 14 within the new
incisions and then repeat one or more of the preceding steps to
dissect a new area of tissue to create a continuous skin envelope
(either in width lengths or both) or separate skin envelopes. One
or more dissected skin envelopes or flaps can be advanced and
surgically reattached (e.g. by suturing, stapling etc.) to a
different tissue site, or alternatively separate envelopes can
themselves by surgically reattached. Prior to attachment a selected
area (e.g. length) of the skin envelope can be removed in order to
create a selected contour or tightening affect at the target tissue
site.
[0290] Accordingly, in various embodiments, housing 14 or roller
can be configured to facilitate the attachment by serving as an
underlying support for suturing, stapling or otherwise attaching
the skin envelope or tissue flap to the edge of another incision or
another tissue flap. In an embodiment, that incision can be in a
concealed site such as the temporal scalp above the ear or
occipital scalp behind the ear. Housing 14 or roller can also be
configured to actually cut or transect sections of the skin
envelope 8se either using electrode 18 or again serving as a
support or guide for another surgical instrument such as a scalpel
or surgical scissors.
[0291] Once the surgeon has completed the desired procedure, he/she
can remove apparatus 10 through the original incision site or
through another incision. In the latter case the surgeon advances
housing 14 or roller to the second incision and then pulls it out
directly or using forceps or other surgical tool. In these
embodiments the hand piece or extender can be configured to be
sufficiently flexible and atraumatic to be advanced under the skin
through the dissection plane and then pulled out the second
incision site. This can be accomplished by (i) fabricating the hand
piece from flexible polymers and/or metals described herein
otherwise known in the art such as superelastic metals (e.g.
nitinol) and/or (ii) configuring the diameter of the hand piece or
extender to fit through a small incision site (e.g. less 1, 0.5 or
0.25 inches). Once the surgeon has removed housing 14 and apparatus
10 he or she can then suture the incision site(s). The order of the
above steps is exemplary and other order are equally
applicable.
[0292] The following examples illustrate embodiments of methods of
use of the invention using one more embodiments of apparatus
10.
EXAMPLE 1
[0293] Referring now to FIGS. 64a-64f, an application of an
embodiment of apparatus 10 can be the performance of a skin
preservation mastectomy in which no breast skin is resected . . .
only the nipple areolar complex is resected with the subjacent
breast tissue. With a uniform flap dissecting embodiment of
apparatus 10, a subcutaneous flap of the preserved breast skin is
`closed dissected` without direct visualization of the plane of
dissection. Due to the superficial guide component of the electrode
housing, a uniform flap thickness if created with the dissection of
the breast skin envelope. The predetermined flap thickness will
preserve the subdermal vascular plexus and thereby limit breast
skin envelope necrosis. The correct flap thickness will also
enhance the oncological effectiveness of the procedure by not
leaving breast tissue on the breast skin flap. In other words, an
uneven dissection with the side effects of a too thin or a too
thick plane of dissection will be avoided. Lastly, scarring is
reduced; the entire procedure is performed through a small
periareolar incision instead of a larger standard mastectomy
incision that extends across the chest.
EXAMPLE 2
[0294] Referring now to FIG. 65, for a facelift patient with
redundant skin the cheeks, jowls and neck, a large continuous
incision is made that starts in the temporal scalp, extends around
the ear and ends in the occipital scalp. With a uniform flap
dissecting embodiment of apparatus 10, only 3 small (2 cm)
incisions are made as insertion portals for the device. A
continuous uniform flap of the scalp, face and neck is developed.
With a process termed `closed advancement`, the uniform
subcutaneous flap is then advanced upwards (superiorly) on the face
and temporal scalp and the flap is advanced backwards (posteriorly)
on the neck and occipital scalp.
[0295] Without resection of skin, the flap is secured in an
advanced position with subdermal sutures at the incision portals.
With this technique, a more youthful appearance of the face and
neck can be achieved without the unsightly scars of the atypical
facelift incision. Because the advancement is maintained with a
series of subdermal fixation sutures in the temporal and scalp, any
skin redundancy will be hidden in those areas. To provide
additional postoperative support and compression, an elastic
garment can be worn by the patient until the flap has adhered in an
elevated position. As a surgical adjunct, the procedure can use
liposuction to jowls and neck through the same incisions.
EXAMPLE 3
[0296] Referring now to FIGS. 66 and 67, for a patient with breast
ptosis, large mastopexy (breast uplift incisions that are anchor
shaped) incisions can be avoided with closed dissection of the
breast skin envelope. Leaving the nipple-areolar complex attached
to the underlying breast tissue, the entire breast skin envelope is
closed dissected with a uniform flap dissecting embodiment of
apparatus 10. For more severe cases of breast ptosis, the entire
breast skin envelope including the nipple areolar complex is
dissected as a uniform breast skin flap. The uniform breast skin
envelope is then advanced superiorly to provide an uplifted contour
of the breast. A specifically designed supportive bra can be worn
by the patient for 24 hours a day for 3 weeks until adherence of
the breast skin flap occurs.
EXAMPLE 4
[0297] Referring now to FIGS. 68-71, the aesthetic surgical
discipline of `closed advancement` using a closed flap dissection
with a uniform flap dissecting embodiment of apparatus 10 can
create new aesthetic procedures in areas that are currently off
limits to standard skin resection procedures because the trade off
between an unsightly scar is poor in comparison to the Aesthetic
benefit. For a patient with buttock ptosis, a uniform subcutaneous
flap is raised with closed dissection over the buttocks and the
superior aspect of the posterior lateral thigh. The flap is then
advanced superiorly, securing the flap in an elevated position with
subdermal mooring sutures in the infragluteal fold. Additional
support is provided with a specifically designed girdle that is
worn by the patient 24 hours a day for 3 weeks.
EXAMPLES 5
[0298] In this example the patient is an elderly woman who required
a mastectomy for extensive in situ ductal carcinoma of the right
breast. During the reconstruction of the right breast, the patient
also requires a mastopexy/repositioning of the left breast to
achieve symmetry with the reconstructed right breast. A closed
electro-surgical dissection with upward advancement and thermal
conductive tightening of the dissected breast envelope could
provide necessary repositioning of the left breast for symmetry
with the reconstructed right breast. The typical inverted "T"
shaped scar was avoided on the repositioned breast.
EXAMPLES 6
[0299] In this example the patient is a middle-aged man with
transaction of the left facial nerve from a motor vehicular
accident. Surgical repair of the nerve was performed initially but
the patient was left with a residual paresis that produced a severe
facial deformity with ptosis of the left face and hyperactivity of
the non-injured right face. To correct the post traumatic
deformity, a facial reconstruction could be performed on the left
face that involved a closed electro-surgical dissection with upward
advancement and thermal conductive tightening of the dissected skin
envelope of the left. Visible preauricular incisions were avoided
and the post surgical scars were hidden in the temporal and
occipital scalp.
EXAMPLES 7
[0300] In this example the patient is a young woman who sustained a
severe contusion to the left lateral thigh from a bicycle accident.
As result, a contusion lipolysis occurred that resulted in a
traumatic contour depression of the left lateral thigh. To correct
the contour depression, a thigh reconstruction could be performed
that involved liposuction of the adjacent subcutaneous tissue
surrounding the contour depression with closed electro-surgical
dissection with redistribution and thermal conductive tightening of
the dissected skin envelope of the thigh. The reconstruction could
be performed through small incisions that are typically used for
liposuction.
(1) OTHER EXAMPLES
[0301] Various embodiments of apparatus 10 can be configured to
assist the surgeon in generating a variety of types of tissue flaps
and flap patterns known in the surgical arts depending upon the
tissue site and/or tissue condition. Apparatus 10 can be configured
to facilitate dissection without limitation of a myocutaneous flap,
a random patter skin flap, an omental flap, an axial flap and the
like all known in the surgical arts. Also apparatus 10 can be
configured to allow the surgeon to substantially preserve all
portions or the vasculature in the flap such as a musculocutaneous
artery, a perforator artery, a segmental artery, or a sub-dermal
plexus. This can be accomplished by embodiments of apparatus 10
having endoscopic viewing capability (described herein) as the use
of sensors (such as thermal, ultrasound or optical sensor) coupled
to the front or other portion of housing 14 to detect the presence
of an artery. In a specific embodiment an ultrasound sensor can be
coupled to housing 14 and configured to detect the presence of the
flowing blood in artery by virtue of a Doppler ultrasound signal
using gated ultrasound technology known in the art. In another
embodiment an infrared sensor 23 can be used to detect the higher
concentrations of oxygenated blood within the artery (versus other
tissue) using pulse oximetry technology known in the art.
[0302] Referring now to FIG. 72, in an embodiment, apparatus 10 can
be coupled to an open or closed loop feedback system/resources 60.
As shown in FIG. 72, feedback system 60 couples sensor 346 to power
source 392. For purposes of illustration, energy delivery device
314 is one or more RF electrodes 314 and power source 392 is an RF
generator, however all other energy delivery devices and power
sources discussed herein are equally applicable.
[0303] The temperature of the tissue, or of RF electrode 314 is
monitored, and the output power of energy source 392 adjusted
accordingly. The physician can, if desired, override the closed or
open loop system. A controller 394 or microprocessor 394 can be
included and incorporated in the closed or open loop system 60 to
switch power on and off, as well as modulate the power between one
or more modes or waveforms (e.g. monopolar, bipolar; cut and
coagulate etc). The closed loop system utilizes microprocessor 394
to serve as a controller to monitor the temperature, adjust the RF
power, analyze the result, refeed the result, and then modulate the
power. More specifically, controller 394 governs the power levels,
cycles, and duration that the radio frequency energy is distributed
to the individual electrodes 314 to achieve and maintain power
levels appropriate to achieve the desired treatment objectives and
clinical endpoints such as tissue dissection and conductive heating
skin tightening. Controller 394 can also in tandem, govern the
delivery of cooling fluid. Controller 394 can be integral to or
otherwise coupled to power source 392 and can also be coupled to a
fluid delivery apparatus. In one embodiment controller 394 is an
Intel.RTM. Pentium.RTM. microprocessor, however it will be
appreciated that any suitable microprocessor or general purpose
digital or analog computer can be used to perform one or more of
the functions of controller 394 stated herein.
[0304] With the use of sensor 346 and feedback control system 60
tissues layers (adipose tissue, fascia etc.) adjacent to RF
electrode 314 can be maintained at a desired temperature for a
selected period of time without causing a shut down of the power
circuit to electrode 314 due to the development of excessive
electrical impedance at electrode 314 or adjacent tissue. Each RF
electrode 314 is connected to resources which generate an
independent output. The output maintains a selected energy at RF
electrode 314 for a selected length of time.
[0305] Current delivered through RF electrode 314 is measured by
current sensor 396. Voltage is measured by voltage sensor 398.
Impedance and power are then calculated at power and impedance
calculation device 400. These values can then be displayed at user
interface and display 402. Signals representative of power and
impedance values are received by a controller 404.
[0306] A control signal is generated by controller 404 that is
proportional to the difference between an actual measured value,
and a desired value. The control signal is used by power circuits
406 to adjust the power output in an appropriate amount in order to
maintain the desired power delivered at respective RF electrodes
314.
[0307] In a similar manner, temperatures detected at sensor 346
provide feedback for maintaining a selected power. Temperature at
sensor 346 is used as a safety means to interrupt the delivery of
energy when maximum pre-set temperatures are exceeded. The actual
temperatures are measured at temperature measurement device 408,
and the temperatures are displayed at user interface and display
402. A control signal is generated by controller 404 that is
proportional to the difference between an actual measured
temperature and a desired temperature. The control signal is used
by power circuits 406 to adjust the power output in an appropriate
amount in order to maintain the desired temperature delivered at
the sensor 346. A multiplexer can be included to measure current,
voltage and temperature at sensor 346. Energy can be delivered to
RF electrode 314 in monopolar or bipolar fashion.
[0308] Controller 404 can be an analog or digital controller, or a
computer with driven by control software. When controller 404 is a
computer it can include a CPU coupled through a system bus. On the
system can be a keyboard, disk drive, or other non-volatile memory
systems, a display, and other peripherals,
[0309] as are well known in the art. Also coupled to the bus are a
program memory and a data memory. Also, controller 404 can be
coupled to imaging systems including, but not limited to,
ultrasound, thermal and impedance monitors.
[0310] The output of current sensor 396 and voltage sensor 398 are
used by controller 404 to maintain a selected power level at RF
electrode 314. The amount of RF energy delivered controls the
amount of power. A profile of the power delivered to electrode 314
can be incorporated in controller 404 and a preset amount of energy
to be delivered may also be profiled.
[0311] Circuitry, software and feedback to controller 404 result in
process control, the maintenance of the selected power setting
which is independent of changes in voltage or current, and is used
to change the following process variables: (i) the selected power
setting, (ii) the duty cycle (e.g., on-off time), (iii) bipolar or
monopolar energy delivery; and, (iv) fluid delivery, including flow
rate and pressure. These process variables are controlled and
varied, while maintaining the desired delivery of power independent
of changes in voltage or current, based on temperatures monitored
at sensor 346.
[0312] Referring now to FIG. 73, current sensor 396 and voltage
sensor 398 are connected to the input of an analog amplifier 410.
Analog amplifier 410 can be a conventional differential amplifier
circuit for use with sensor 346. The output of analog amplifier 410
is sequentially connected by an analog multiplexer 412 to the input
of A/D converter 414. The output of analog amplifier 410 is a
voltage which represents the respective sensed temperatures.
Digitized amplifier output voltages are supplied by A/D converter
414 to microprocessor 394.
[0313] Microprocessor 394 sequentially receives and stores digital
representations of impedance and temperature. Each digital value
received by microprocessor 394 corresponds to different
temperatures and impedances. Calculated power and impedance values
can be indicated on user interface and display 402. Alternatively,
or in addition to the numerical indication of power or impedance,
calculated impedance and power values can be compared by
microprocessor 394 to power and impedance limits. When the values
exceed predetermined power or impedance values, a warning can be
given on user interface and display 402, and additionally, the
delivery of RF energy can be reduced, modified or interrupted. A
control signal from microprocessor 394 can modify the power level
supplied by energy source 392.
[0314] FIG. 74 illustrates a block diagram of a temperature and
impedance feedback system that can be used to control the delivery
of energy to tissue site 416 by energy source 392 and the delivery
of cooling solution 29 or gas 29g to electrode 314 and/or tissue
site 416 by flow regulator 418. Energy is delivered to RF electrode
314 by energy source 392, and applied to tissue site 416. A monitor
420 ascertains tissue impedance, based on the energy delivered to
tissue, and compares the measured impedance value to a set value.
If the measured impedance exceeds the set value, a disabling signal
422 is transmitted to energy source 392, ceasing further delivery
of energy to RF electrode 314. If the measured impedance is within
acceptable limits, energy continues to be applied to the
tissue.
[0315] The control of the flow of cooling solution 29 to electrode
314 and/or tissue site 416 is done in the following manner. During
the application of energy, temperature measurement device 408
measures the temperature of tissue site 416 and/or RF electrode
314. A comparator 424 receives a signal representative of the
measured temperature and compares this value to a pre-set signal
representative of the desired temperature. If the tissue
temperature is too high, comparator 424 sends a signal to a flow
regulator 418 (which can be integral to a pump 418) representing a
need for an increased cooling solution flow rate. If the measured
temperature has not exceeded the desired temperature, comparator
424 sends a signal to flow regulator 418 to maintain the cooling
solution flow rate at its existing level.
[0316] The foregoing description of various embodiments of the
invention has been presented for purposes of illustration and
description. Various methods of the invention are applicable to
variety of medical, dermatological and surgical methods including
reconstructive and plastic surgery procedures and minimally
invasive procedures. It is not intended to limit the invention to
the precise forms disclosed. Many modifications, variations and
different combinations of embodiments will be apparent to
practitioners skilled in this art. Further, elements from one
embodiment can be readily recombined with one or more elements from
other embodiments.
* * * * *