U.S. patent application number 14/535762 was filed with the patent office on 2015-08-20 for method of destroying tissue cells by electroporation.
This patent application is currently assigned to AngioDynamics, Inc.. The applicant listed for this patent is AngioDynamics, Inc.. Invention is credited to Victor Chornenky, Ali Jaafar.
Application Number | 20150230855 14/535762 |
Document ID | / |
Family ID | 43428048 |
Filed Date | 2015-08-20 |
United States Patent
Application |
20150230855 |
Kind Code |
A1 |
Chornenky; Victor ; et
al. |
August 20, 2015 |
Method of Destroying Tissue Cells by Electroporation
Abstract
An apparatus and method for performing noninvasive treatment of
the human face and body by electroporation in lieu of cosmetic
surgery is provided. The apparatus comprises a high voltage pulse
generator and an applicator having two or more electrodes in close
mechanical and electrical, contact with the patient's skin for
applying the pulses to the patient's skin. The applicator may
consist of two pieces with one electrode having a sharp tip and
another having a flat surface. High voltage pulses delivered to the
electrodes create at the tip of the sharp electrode an electric
field high enough to cause death of relatively large subcutaneous
fat cells by electroporation. Moving the electrode tip along the
skin creates a line of necrotic subcutaneous fat cells, which later
are metabolized by the body. Multiple applications of the electrode
along predetermined lines on the face or neck create shrinkage of
the skin and the subcutaneous fat volume underlying the treated
area.
Inventors: |
Chornenky; Victor;
(Minnetonka, MN) ; Jaafar; Ali; (Eden Prairie,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AngioDynamics, Inc. |
Latham |
NY |
US |
|
|
Assignee: |
AngioDynamics, Inc.
Latham
NY
|
Family ID: |
43428048 |
Appl. No.: |
14/535762 |
Filed: |
November 7, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14176889 |
Feb 10, 2014 |
8906006 |
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14535762 |
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13556455 |
Jul 24, 2012 |
8647338 |
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14176889 |
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12501225 |
Jul 10, 2009 |
8251986 |
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13556455 |
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11106835 |
Apr 15, 2005 |
7938824 |
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12501225 |
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09931672 |
Aug 17, 2001 |
6892099 |
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11106835 |
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60267106 |
Feb 8, 2001 |
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60225775 |
Aug 17, 2000 |
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Current U.S.
Class: |
606/41 |
Current CPC
Class: |
A61B 2018/00452
20130101; A61B 18/1477 20130101; A61B 2018/143 20130101; A61B
2018/0047 20130101; A61B 2018/0016 20130101; A61B 18/1206 20130101;
A61N 1/0412 20130101; A61B 18/14 20130101; A61B 2018/1425 20130101;
A61B 18/1445 20130101; A61B 2018/00613 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 18/12 20060101 A61B018/12 |
Claims
1. A system for sculpting a human body comprising: an applicator
comprising first and second electrodes defining a treatment area
therebetween, the treatment area adapted to accept a portion of the
human body comprising at least one of skin, subcutaneous tissue,
and fat; and a generator operably connected to the applicator and
adapted to apply a plurality of electrical pulses between the first
and second electrodes in an amount sufficient to irreversibly open
pores in fat cells of the portion of the human body.
2. The system of claim 1, wherein the applicator is adapted to
retain the portion of the human body within the treatment area
during the application of electrical pulses.
3. The system of claim 1, wherein the first and second electrodes
are positioned on opposing sides of the treatment area.
4. The system of claim 1, wherein the generator is further adapted
to apply electrical pulses whose amplitude is in a range of 20
Volt/mm and 2000 Volt/mm.
5. The system according to claim 1, wherein the generator is
further adapted to apply electrical pulses whose amplitude is above
20 Volt/mm.
6. The system of claim 1, wherein the generator is further adapted
to apply electrical pulses whose duration is in a range of 10
microseconds and 100 milliseconds.
7. The system of claim 1, wherein the generator is further adapted
to apply electrical pulses whose amplitude is in a range of 20
Volt/mm and 2000 Volt/mm and whose duration is in a range of 10
microseconds and 100 milliseconds.
8. The system of claim 1, wherein the applicator comprises a grip
and first and second opposed arms configured to move toward each
other to forcibly retain the portion of the human body by
compression.
9. The system of claim 1, wherein the portion of the human body is
a skin fold.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. application Ser. No.
14/176,889, filed Feb. 10, 2014, which is a continuation of U.S.
application Ser. No. 13/556,455, filed Jul. 24, 2012, now U.S. Pat.
No. 8,647,338, which is a continuation of U.S. application Ser. No.
12/501,225, filed Jul. 10, 2009, now U.S. Pat. No. 8,251,986, which
is a continuation of U.S. application Ser. No. 11/106,835, now U.S.
Pat. No. 7,938,824, filed Apr. 15, 2005, which is a continuation of
U.S. application Ser. No 09/931,672, filed Aug. 17, 2001, now U.S.
Pat. No. 6,892,099, which claims priority to U.S. provisional
application Ser. No. 60/267,106, filed Feb. 8, 2001 and to U.S.
provisional application Ser. No. 60/225,775, filed Aug. 17, 2000,
all of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to electroporation
of tissues and, specifically, to apparatus and methods for reducing
subcutaneous fat deposits, performing virtual face lifts, and body
sculpturing.
BACKGROUND OF THE INVENTION
[0003] "Cosmetic surgery" is a phrase used to describe broadly
surgical changes made to a human body with the usual, though not
always, justification of enhancing appearance. This area of medical
practice constitutes an ever-growing industry around the world.
Obviously, where such a procedure fails to deliver an enhanced
appearance, the procedure fails to meet the desired goal. One of
the reasons that the majority of current procedures fail to deliver
upon their promise is that, for the most part, current procedures
are invasive, requiring incisions and suturing, and can have
serious and unpleasant side effects, including but not limited to
scarring, infection, and loss of sensation.
[0004] One of the more common forms of cosmetic surgery is the
"face-lift." A face-lift is intended to enhance facial appearance
by removing excess facial skin and tightening the remaining skin,
thus removing wrinkles. A face-lift is traditionally performed by
cutting and removing portions of the skin and underlying tissues on
the face and neck. Two incisions are made around the ears and the
skin on the face and neck is separated from the subcutaneous
tissues. The skin is stretched, excess tissue and skin are removed
by cutting with a scissors or scalpel, and the skin is pulled back
and sutured around the ears. The tissue tightening occurs after
healing of the incisions because less skin covers the same area of
the face and neck and also because of the scars formed on the
injured areas are contracting during the healing process.
[0005] Traditional face-lift procedures are not without potential
drawbacks and side effects. One drawback of traditional cosmetic
surgery is related to the use of scalpel and scissors. The use of
these devices sometimes leads to significant bleeding, nerve
damage, possible infection and/or lack of blood supply to some
areas on the skin after operation. Discoloration of the skin,
alopecia (boldness), is another possible side effect of the
standard cosmetic surgery. The overall quality of the results of
the surgery is also sometimes disappointing to the patients because
of possible over-corrections, leading to undesired changes in the
facial expression. Additionally, face-lift procedures require a
long recovery period before swelling and bruising subside.
[0006] The use of lasers to improve the appearance of the skin has
been also developed. Traditional laser resurfacing involves
application of laser radiation to the external layer of the
skin--the epidermis. Destruction of the epidermis leads to
rejuvenation of the epidermis layer. The drawback of the laser
resurfacing procedure is possible discoloration of the skin (red
face) that can be permanent.
[0007] Another laser procedure involves using optical fibers for
irradiation of the subcutaneous tissues, such as disclosed in U.S.
Pat. No. Re36,903. This procedure is invasive and requires multiple
surgical incisions for introduction of the optical fibers under the
skin. The fibers deliver pulsed optical radiation that destroys the
subcutaneous tissues as the tip of the fiber moves along
predetermined lines on the face or neck. Debulking the subcutaneous
fat and limited injury to the dermis along the multiple lines of
the laser treatment results in contraction of the skin during the
healing process, ultimately providing the face lift. The drawback
of the method is its high price and possibility of infection.
[0008] Electrosurgical devices and methods utilizing high frequency
electrical energy to treat a patient's skin, including resurfacing
procedures and removal of pigmentation, scars, tattoos and hairs
have been developed lately, such as disclosed in U.S. Pat. No.
6,264,652. The principle drawback of this technology is collateral
damage to the surrounding and underlying tissues, which can lead to
forming scars and skin discoloration.
[0009] Other forms of cosmetic surgery are also known. One example
is liposuction, which is an invasive procedure that involves
inserting a suction device under the skin and removing fat tissues.
As with other invasive surgical procedures, there is always a risk
of infection. In addition, because of the invasive nature of the
procedure, physicians usually try to minimize the number of times
the procedure must be performed and thus will remove as much fat
tissue as possible during each procedure. Unfortunately, this
procedure has resulted in patient deaths when too much tissue was
removed. Assuming successful removal of excess fat tissue, further
invasive surgery may be required to accomplish desired skin
tightening.
[0010] The prior art to date, then, does not meet the desired goal
of performing cosmetic surgery in a noninvasive manner while
causing minimal or no scarring of the exterior surface of the skin
and at the same time resulting in the skin tightening.
OBJECTS OF THE INVENTION
[0011] It is an object of the present invention to provide an
apparatus and method which uses electroporation to cause necrosis
of cells in the subcutaneous layer of fat and the interior side of
the dermis, resulting in the contraction and tightening of the
skin. In particular, it is an object of the present invention to
provide method and, apparatus for performing face and neck lift and
others similar procedures on the face in a non-invasive manner.
[0012] Another object of the present invention is to provide an
apparatus and method for significant bulk reduction of the number
of subcutaneous fat cells in the body, resulting in a significant
weight loss.
[0013] Still another object of the present invention is to provide
non-invasive apparatus and method for cosmetic and weight loss
procedures.
[0014] Still another object of the invention is to provide an
apparatus and method for selective removal of fat in different
areas to enable changing the shape of the body, or body
sculpturing.
SUMMARY OF THE DISCLOSURE
[0015] The present invention provides an apparatus and method for
creation of a controlled injury or alteration to the subcutaneous
tissue and/or underside of the dermis, with the following healing
process leading to the contraction of the skin; and/or to the
controlled destruction of fat cells, leading to their permanent
loss. In the present invention the damage to the subcutaneous
tissue, underside of the dermis, and/or fat cells is caused by
electroporation.
[0016] An apparatus in accord with the current invention comprises
a voltage pulse generator, an applicator with two or multiple
electrodes of different shapes and sizes and a cable connecting the
electrodes to the pulse generator. The pulse generator produces set
of high voltage pulses of predetermined amplitude, duration and
number to cause necrosis in a treated area of subcutaneous
tissues.
[0017] A method in accord, with the current invention comprises
application of electrical pulses to the electrodes positioned on
the skin in a treatment area. For a face lift, flat and needle-like
electrodes are used, the last one providing a strong and
non-uniform electric field predominantly normal to the surface of
the skin. The amplitude, duration and number of applied pulses are
selected to cause necrosis of fat cells to a predetermined depth in
the subcutaneous tissue and a limited necrosis of the underside of
the dermis. A number of lines of predetermined pattern are exposed
to electroporation. Later, during the healing process the skin on
the treated area contracts. The injury to the tissues made by
electroporation is very gentle and selective; it does not produce
scars on the epidermis, the most external layer of the skin.
[0018] A method of weight loss and body sculpturing in accord with
the present invention comprises application of electroporation
pulses to a significant volume of fat tissue. In this case both
electrodes are fiat and attached to the arms of a forceps. The
electrodes are moveable towards and away from each other and are
capable of pinching skin with underlying subcutaneous fat and
electroporating it. Application of flat, parallel electrodes
produces a electric field is uniform in the tissue that effects
only fat cells.
[0019] For weight loss a voltage generator coupled to multiple
needle type electrodes may be used.
[0020] In another embodiment of the present invention, an
electroporation apparatus for bulk weight loss may comprise
apparatus for production of a pulsed magnetic field and its
application to the area to be treated. In this embodiment of the
present invention, a curl electric field for the electroporation of
subcutaneous fat is created by the pulsed magnetic field. Curl
electric field causes eddy currents in the tissue and at an
appropriate amplitude above kills the fat cells.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The objects and advantages of the present invention will be
appreciated from the following specification when read in
conjunction with the accompanying drawings wherein:
[0022] FIG. 1 is a schematic illustration of an apparatus with an
applicator having an array of symmetric electrodes shown during
electroporation treatment.
[0023] FIG. 2 is a schematic illustration of an apparatus with an
applicator having one flat electrode and one a needle like
electrode shown during electroporation treatment.
[0024] FIGS. 3A, 3B, and 3C are schematic illustrations of
different applicators of the present apparatus wherein FIG. 3A
illustrates an applicator with two needle like electrodes; FIG. 3B
illustrates an applicator having an array of needle like
electrodes; and FIG. 3C illustrates applicator having one flat
electrode and one needle like electrode.
[0025] FIG. 4a is a perspective view of a forceps type applicator
with two flat electrodes in an open position.
[0026] FIG. 4b is a schematic illustration of the forceps flat
electrodes in closed position shown during electroporation
treatment.
[0027] FIG. 5 is a schematic illustration of an apparatus for
electroporation treatment for weight loss with electrodeless
applicator.
[0028] FIG. 6 is a frontal view of a human head with schematically
shown electroporation treatment for removal of the forehead
wrinkles and glabellar frown lines.
[0029] FIG. 7 is a lateral view of a human head with schematically
shown electroporation treatment for a neck lift.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0030] The term "electroporation" (EP) refers to the use of
electric field pulses to induce microscopic pores in the cell
membranes called "electropores". Depending on the parameters of the
electric pulse, an electroporated cell can survive the pulse or
die. The cause of death of an electroporated cell is believed to be
a chemical imbalance, resulting from the fluid communication with
the extra cellular environment through the pores. The number and
size of electropores created depends on the product of the
amplitude E and duration t of the pulse. Below a certain limit, no
electropores are induced at all. This limit is different for
different cells and depends, principally, on their sizes. The
smaller the cell, the higher the product of the amplitude and
duration must be to induce pores. Above the lower limit the number
of pores and their effective diameter increases with the product
Et. Until an upper limit is achieved, cells survive pulsing and
restore their viability thereafter. Above the upper limit the pores
diameters and number become too large for a cell to survive. It
cannot repair itself by any spontaneous or biological process and
dies. As noted, a cell's vulnerability to an electric field depends
on its size: the larger the cell, the lower the electric field
required for killing it. If cells of different sizes are exposed to
the same electric field, the largest cells are the first to die.
Thus, application of an electric field having preselected
parameters can result in selectively killing particular cells.
[0031] A desirable target for cell death using the present
invention is adipose tissue, commonly called fat. Adipose cells do
not proliferate in adults. Their number is fixed at a very early
age. Adipose cells can change their size by by accumulating or
loosing lipids and be responsible for significant, up to two-fold
increase in the body weight. Cutting down in the number of large
adipose cells results in a significant weight loss in the fat
tissue and the whole body. If fat cells are destroyed by any means,
their content is metabolized by the body, i.e., scavenged by
macrophages, and their number is not restored. The loss of adipose
cells, then, is permanent.
[0032] Adipose tissue consists of lipid-filled cells ranging in
size from 25 to 200 microns. An applied electric field affects the
various sized cells differently as previously mentioned. For
example, if an electric field, equal to the upper electroporation
limit for 100 micron cells (about 10-20 V/mm) is applied to a fat
tissue, all cells with sizes from 100 micron and above, will die.
The dead cells will be disposed later by macrophages, and the body
will metabolize the lipids stored in these cells. Small adipose
cells, for which the applied electric field is below the upper
electroporation limit, survive any number of electric pulses
without any morphological or functional damage.
[0033] Pulsed electric fields can be applied to fat deposits inside
the body by different methods. In a first method two electrodes are
applied to the skin over the fat tissue at some distance from each
other and electric microsecond pulses are applied by the electrodes
to the tissue. The pulse electric field, created by these two
electrodes is non-uniform, it is higher near the electrodes and
decreases with the depth. The electric field at the fat deposits
should reach several tens of volts per mm to be able to kill
adipose cells of large diameters. At the skin level the non-uniform
electric field will be significantly higher. To be harmless for the
skin cells, the field should not exceed the value of the upper
electroporation limit for skin cells. The cells in the epidermic
basal layer of the skin, which is responsible for the mitotic
division and continuous rejuvenation of the skin, have dimensions
of about 10 microns or less (6-10 microns). This is 10 or more
times less than that of the targeted adipose cells, which is about
100 microns and larger as noted earlier. The upper electroporation
limit for the skin cells in accordance with their size is therefore
about 10 times higher than that of adipose cells of 100 microns
diameter.
[0034] A second method of applying an electric field to the
subcutaneous adipose tissue or the skin is by applying short
magnetic pulses preferentially normally to the skin. The transient
magnetic field creates curl electric field in the skin and the
underlying tissues. This curl electric field causes eddy currents
in the cells. If the magnitude of this transient electric field
reaches the upper electroporation limit for the cells, it will kill
them exactly as does the potential electric field created by
charged electrodes.
[0035] The depth of penetration of the electric field in the skin
and the fat, tissue under it depends on the distance between the
electrodes, their shape and size. The larger the size of electrodes
and the distance between them, the deeper the penetration will be.
If the electrodes are small enough and the distance between them is
short, the electric field penetrates only into the skin and does
not reach the underlying tissues.
[0036] If pulsed electric field penetrates only in the skin and its
amplitude is high enough to kill skin cells (several hundred volts
per mm), electroporation can be used for selective cell killing.
The dead cells are removed by macrophages and the skin shrinks
during the healing process. This skin shrinkage can be planned in
advance both in terms of directions and degree. By selecting a
number, direction and length of the electroporation "cuts" the
operator can control the future shrinks. This method can be used
for correcting wrinkles and skin pouches on the face, the neck, and
on the upper and lower eye lids.
[0037] The skin electroporation treatment together with fat
reducing electroporation treatment can be used as alternative to
cosmetic surgery for the face lift, the upper and lower eye lid
surgery, the forehead lift and body sculpturing practically in all
parts of the human body.
[0038] An electroporation treatment presents several notable
advantages over present cosmetic surgery procedures. First, an
electroporation treatment is sterile. The most upper layer of the
skin, comprising horny dead cells, is very resistant to any damage
from an electroporation treatment; it protects the lower layers of
the skin from infection.
[0039] The electroporation virtual facelift and body sculpturing
can be performed in step by step fashion in a multi-session
process. This method allows taking into account actual results of
previous sessions and directs process of reshaping of the face or
body to desired objectives. The treatment can be performed by a
medical professional or by the patient him/herself.
[0040] With the foregoing generalized explanation of the present
invention, apparatus in accord therewith may be described.
Referring to FIG. 1, an electroporation system 10 in accord with
the invention is schematically shown with a cross section of a
piece of skin 12 with subcutaneous tissue 14 during electroporation
treatment. Electroporation system 10 includes a power supply 16 for
generating high voltage pulses that are sent though an appropriate
electrical connector 18 to an applicator 20. Applicator 20
includes, electrodes 22 and 24 that engage skin 12 and will be
appropriately insulated to ensure safe handling. Additionally, the
applicator will preferably be configured so as to ensure ease of
handling, and thus could take many forms. The electrodes 22 and 24
may take the form of needle electrodes. The electric field created
between the electrodes 22 and 24 is depicted with field lines 20
and is applied to the skin 12 and subcutaneous tissue or fat 14. In
the areas close to the electrodes the electric field has an
amplitude exceeding the upper electroporation limit, thus causing
death to fat cells. This area of fat cell necrosis is indicated at
28.
[0041] In FIG. 2 an alternative embodiment 40 of the present
invention is shown with an applicator having two members: a
needle-like electrode 42 and a flat electrode 44. If desired, the
system 40 may include an insulating handle 46 configured to be held
by an operator to facilitate the manual manipulation of the
electrode 42. The high voltage pulse power supply 16 is connected
to the applicator electrodes 42 and 44 by appropriate electrical
connectors 48. Both electrodes 42 and 44 are engaged with skin 12.
Electric field ones 26 depict an electric field be twee the
electrodes 42 and 44. The area 28, were the electric field is the
highest, is the treatment area where the amplitude of the electric
field exceeds the upper electroporation limit and causes cell
death.
[0042] In FIGS. 3A-3C, different versions of applicators are
schematically shown. FIG. 3A illustrates an applicator 60 with two
needle-like electrodes 64. FIG. 3B shows an applicator 64 with an
array of needle-like electrodes 64. FIG. 3C depicts an applicator
66 like that shown in FIG. 2 and comprising a needle-like electrode
42 and a flat electrode such as electrode 44.
[0043] FIGS. 4a and 4b illustrate another embodiment 80 of an
electroporation system in accord with the present invention useful
for bulk fat reduction. System 80 includes an applicator 82
comprising a body or support member 84 supporting calipers or
forceps apparatus 86, The calipers apparatus 86 includes a pair of
pivotable arms 88 mounted at the distal end thereof. The arms 88
support a pair of electrodes 90 and 92. Applicator 82 may include a
pistol grip 94 mounted on a proximal end of the elongated tubular
support member 84 for enabling ease of manipulation of same. The
electrodes 90 and 92 are mounted on a moveable linkage so that the
electrodes are moveable toward and away from each other. A power
supply 16 and electrical connectors 48 are also included within a
system 80 to provide pulse electrical power to the electrodes 90
and 92.
[0044] FIG. 4b schematically illustrates an electroporation
treatment utilizing system 80. As shown in the figure, a "fold" of
skin 12 with underlying subcutaneous tissue--fat--14 is compressed
between arms 88 and thus electrodes 90 and 92. A uniform electric
field 26 is applied to the skin 12 and subcutaneous tissue 14
clamped between electrodes. Only the large fat cells are killed in
this field configuration because the cells of the dermis are spared
death because of their small size.
[0045] FIG. 5 schematically illustrates another embodiment of the
present invention including an electrodeless system 100. System 100
includes a high pulse current power supply 16 and an appropriate
electrical connector 18 extending to an applicator 102. Applicator
102 comprises a housing 104 and an electromagnetic coil 106
disposed therein. Coil 106 generates a magnetic field 108 that is
applied to the skin 12 and the subcutaneous tissues 14. The pulsed
magnetic field 108 in the tissue exists only about 10 microseconds.
The energy of rapidly changing magnetic field transforms into a
curl electric field 110, which creates eddy currents in tissue and
provides the electroporation treatment for killing the fat cells in
the tissue 14. Preferably, the curl electric field generated in the
subcutaneous tissue is in the range of 30 to 50 Volt/mm, and the
duration of the pulses is 5 to 20 microseconds.
[0046] FIG. 6 schematically illustrates a frontal view of human
head 120 with glabellar frown lines 122 and forehead wrinkles 124.
An embodiment of the present invention Such as system 40 is shown
in application. Electrode 44 is shown applied to the forehead and
the needle electrode 42 is moved over the skin where treatment is
desired. Moving the electrode tip along the skin creates a line of
necrotic subcutaneous fat cells, which later are metabolized by the
body. An exemplary line of treatment 126 is shown in the Figure.
Multiple applications of the electrode along predetermined lines on
the face or neck create shrinkage of the skin and the subcutaneous
fat volume underlying the treated area.
[0047] FIG. 7 depicts a lateral view of a human head 130 during a
neck lift electroporation procedure using an electroporation system
in accord with the present invention such as system 40. The figure
illustrates an exemplary line of electroporation treatment 132.
[0048] The present invention having thus been described, other
modifications, alterations, or substitutions may now suggest
themselves to those skilled in the art, all of which are within the
spirit and scope of the present invention. It is therefore intended
that the present invention be limited only by the scope of the
attached claims below.
* * * * *