U.S. patent application number 16/907252 was filed with the patent office on 2021-01-28 for non-invasive fat removal.
The applicant listed for this patent is POLLOGEN LTD.. Invention is credited to Zion Azar, Pinchas Shalev.
Application Number | 20210023364 16/907252 |
Document ID | / |
Family ID | 1000005137148 |
Filed Date | 2021-01-28 |
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United States Patent
Application |
20210023364 |
Kind Code |
A1 |
Shalev; Pinchas ; et
al. |
January 28, 2021 |
NON-INVASIVE FAT REMOVAL
Abstract
A device for massaging skin, including, a RF generator adapted
to generate a radio frequency AC current to heat fat tissue in the
adipose layer of the skin, an electrical pulse generator adapted to
generate pulses of DC current to provide electrical muscle
stimulation for the muscles below the adipose layer, an applicator
including one or more heads adapted to be placed in contact with
the user's skin; and wherein the heads serve as massage contacts to
massage the outer layer of a user's skin above the adipose layer or
as electrodes to deliver the AC current and DC current, or as
both.
Inventors: |
Shalev; Pinchas; (Herzeliya,
IL) ; Azar; Zion; (Shoham, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
POLLOGEN LTD. |
Tel Aviv |
|
IL |
|
|
Family ID: |
1000005137148 |
Appl. No.: |
16/907252 |
Filed: |
June 21, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15587487 |
May 5, 2017 |
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16907252 |
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13510062 |
May 16, 2012 |
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PCT/IL10/00947 |
Nov 16, 2010 |
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15587487 |
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61261381 |
Nov 16, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/322 20130101;
A61H 2201/5007 20130101; A61H 2230/50 20130101; A61N 1/36003
20130101; A61H 2201/10 20130101; A61B 18/04 20130101; A61H 9/0057
20130101; A61H 2207/00 20130101; A61H 23/00 20130101; A61N 1/328
20130101; A61B 2018/00452 20130101 |
International
Class: |
A61N 1/32 20060101
A61N001/32; A61H 9/00 20060101 A61H009/00; A61H 23/00 20060101
A61H023/00; A61N 1/36 20060101 A61N001/36; A61B 18/04 20060101
A61B018/04 |
Claims
1-24. (canceled)
25. A non-invasive fat removal device for fat reduction in a
patient's skin treatment area by causing liquification and release
of fat from fat cells contained in an adipose tissue layer into an
extra cellular tissue of the patient's skin treatment area for
lymphatic drainage therefrom, the adipose tissue layer overlying a
muscle layer, the non-invasive fat removal device comprising: an
electrical pulse generator to provide electrical muscle stimulation
(EMS) to the muscle layer located below the adipose tissue layer; a
radio frequency (RF) generator to provide RF energy to heat fat
tissue in the adipose tissue layer of the patient's skin treatment
area to cause liquification of the fat cells; and a handheld
applicator including at least two electrodes to be placed in
contact with the patient's skin treatment area for applying
electrical energy thereto; at least one electrode of said at least
two electrodes being in electrical contact with said electrical
pulse generator; at least one electrode of said at least two
electrodes being in electrical contact with said RF generator; said
handheld applicator being intended to be manually pressed on the
patient's skin treatment area and moved back and forth thereby
positively massaging the patient's skin treatment area from above;
a control board configured to control the radio frequency (RF)
generator and the electrical pulse generator; said control board
controlling said RF generator to provide RF energy to heat fat
tissue in the adipose tissue layer to cause liquification of the
fat cells while said electrical pulse generator applies electrical
energy in the form of electrical muscle stimulation (EMS) to the
patient's skin treatment area for stimulating muscles below the
adipose tissue layer during said back and forth motion of the
handheld application so that the adipose tissue layer is
pressurized from above and below; wherein such heating of the fat
tissue in the adipose tissue layer by the RF energy applied with
pressurization by the electrical muscle stimulation (EMS) during
said repeated back and forth motion of the handheld applicator to
cause reduction of the fat tissue in the adipose tissue layer by
acceleration of natural fat cell metabolism causing the release of
liquefied fat from the fat cells into the patient's extra cellular
tissue for lymphatic drainage therefrom; and wherein RF energy
further heats collagen fibers to stimulate fibroblast metabolism,
leading to skin tightening and new collagen production.
26. A device according to claim 25, wherein said RF energy and said
electrical muscle stimulation (EMS) are adapted to be applied to
the patient's skin treatment area upon placing said handheld
applicator in contact therewith.
27. A device according to claim 25, wherein said RF energy and said
electrical muscle stimulation (EMS) are adapted to be activated by
activating a switch.
28. A device according to claim 25, wherein the electrodes in the
applicator of the device represent a first pole and an electrode
external to the handheld applicator provides the opposite pole to
form a closed circuit.
29. A device according to claim 25, wherein said handheld
applicator includes at least two spaced apart discrete heads for
positively massaging the patient's skin treatment area and some of
said at least two spaced apart heads serve as said at least two
electrodes.
30. A device according to claim 25, wherein less than all of said
at least two electrodes only deliver said RF energy and less than
all of said at least two electrodes only deliver said electrical
muscle stimulation.
31. A device according to claim 25, wherein the control board is
configured to control operation of the device responsive to
temperature measurements from the surface of the patient's skin
treatment area.
32. A device according to claim 31, further comprising a
temperature sensor in said handheld applicator to provide
temperature measurements from the surface of the patient's skin
treatment area.
33. A method of reducing fat in a patient's skin treatment area by
causing the liquification and release of liquefied fat from fat
cells contained in an adipose tissue layer into an extra cellular
tissue of the patient's skin treatment area for lymphatic drainage
therefrom, the adipose tissue layer overlying a muscle layer, the
method comprising: providing a control board for controlling the
radio frequency (RF) generator and the electrical pulse generator;
providing a handheld applicator including at least two electrodes
for placing in intimate contact with the patient's skin treatment
area for applying electrical energy thereto; wherein at least one
electrode of the at least two electrodes being in electrical
contact with a RF generator for applying RF energy to the adipose
tissue layer of the patient's skin treatment area; and wherein at
least one electrode of the at least two electrodes being in
electrical contact with an electrical pulse generator for applying
electrical muscle stimulation (EMS) to the muscle layer underlying
the adipose tissue layer of the patient's skin treatment area,
manually applying the handheld applicator back and forth on the
patient's skin treatment area to positively massage same; while the
control board causes the radio frequency (RF) generator to heat the
fat cells contained in the adipose tissue layer of the patient's
skin treatment area during the handheld applicator's back and forth
motion to liquefy the fat cells; while the electrical pulse
generator applies electrical energy in the form of electrical
muscle stimulation (EMS) stimulates the muscle layer below the
adipose tissue layer-during the handheld applicator's repeated back
and forth motion; wherein the heating of the fat cells by RF energy
simultaneously with manually applying the handheld applicator while
pressurization by said stimulating by the electrical pulse
generator applying electrical muscle stimulation (EMS) accelerates
natural fat cell metabolism causing the release of liquefied fat
from the fat cells into the patient's extra cellular tissue; and
wherein the RF energy further heats collagen fibers to stimulate
fibroblast metabolism, leading to skin tightening and new collagen
production.
34. A method according to claim 33, wherein said heating and said
stimulating are adapted to be activated when the handheld
applicator is placed in contact with the patient's skin treatment
area.
35. A method according to claim 33, wherein less than all of said
at least two of electrodes perform stimulating and heating and less
than all of said at least two of electrodes form a closed circuit
through the body of the patient.
36. A method according to claim 33, wherein all electrodes are
adapted to perform stimulating and heating.
37. A device according to claim 25, wherein the electrical pulse
generator is adapted to generate pulses in the range of 100 to 500
milliamperes.
38. A method according to claim 33, wherein stimulating the muscle
layer occurs with electrical current pulses in the range of 100 to
500 milliamperes.
39. The method of claim 33, wherein the RF energy heats the
patient's skin treatment area surface to a level of no more than
45.degree. C.
40. The device of claim 31, wherein the RF energy heats the
patient's skin treatment area's surface temperature is controlled
by the control board to a level of no more than 45.degree. C.
Description
RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
application Ser. No. 15/587,487, filed May 5, 2017, which is a
continuation application of U.S. application Ser. No. 13/510,062,
filed May 16, 2012, now abandoned, which is a U.S. National Stage
application from PCT Application No. PCT/IL2010/00947, filed Nov.
16, 2010, which claims priority from U.S. provisional application
No. 61/261,381 filed on Nov. 16, 2009 the disclosures of which are
incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to a system and
method for non-invasive fat removal and more specifically to a
system and method that enhances lymphatic fat drainage.
BACKGROUND OF THE INVENTION
[0003] Skin tissue comprises an outer epidermal layer overlaying a
dermal layer. The dermal layer is in contact with a subcutaneous
adipose layer referred to as fatty tissue. Massaging the skin is
known to improve blood circulation in the subcutaneous adipose
tissue and help release fat from the cells of the fatty tissue into
the surrounding cellular matrix. The fat is then removed by the
body's lymphatic system.
[0004] U.S. Pat. No. 5,961,475 to Guitay discloses a massaging
device in which negative pressure is applied to the user's skin
while massaging. The combined treatment increases the blood
circulation in the subcutaneous adipose tissue and breaks
connections between adipose cells in the tissue.
[0005] U.S. Pat. No. 6,273,884 to Altshuler et al. discloses
simultaneous application of optical energy and negative pressure to
the user's skin for treating skin defects.
[0006] There is however a need for improved methods to enhance the
release of fat from adipose tissue to increase lymphatic
drainage.
SUMMARY OF THE INVENTION
[0007] An aspect of an embodiment of the invention, relates to an
apparatus and method for accelerating lymphatic drainage. The
method includes applying RF energy to heat the adipose layer.
Additionally the method includes massaging the skin above the area
that is heated by RF energy. Further additionally the method
includes electrical muscle stimulation (EMS) to contract the
muscles below the heated area thus providing pressure on the
adipose layer from below. The apparatus is designed to apply the
above three methods either separately or any combination of them
simultaneously: namely, massaging the skin from above, causing
electrical muscle stimulation from below, and heating the fatty
tissue with RF radiation.
[0008] In an exemplary embodiment of the invention, the RF energy
is provided by a high frequency AC current, and the EMS energy is
provided by a low current DC pulse signal. Optionally, the
electrical energies (RF and EMS) are provided by a mono-polar
configuration wherein the apparatus applied to the user's skin is
provided with a first electrode of one polarity, and a second
electrode of the opposite polarity is attached to the user or held
by the user to form a closed circuit. Alternatively, the electrical
energy may be provided by a bi-polar configuration wherein the
apparatus applied to the user's skin includes two electrodes to
form a closed circuit without attaching electrodes external to the
apparatus to the body of the user. In some embodiments of the
invention, the apparatus uses a multi-pole configuration wherein
the apparatus includes multiple electrodes of both poles of the
circuit.
[0009] In some embodiments of the invention, some electrodes
provide RF energy and other electrodes provide EMS energy.
Alternatively, the same electrodes are designed to synchronize the
pulses and deliver any of the two currents by control of the
apparatus.
[0010] In an exemplary embodiment of the invention, the skin
massage may be performed by applying positive pressure, for example
in the form of vibrations, pushing, pounding and the like.
Alternatively or additionally, the skin massage may be performed by
applying negative pressure, for example using a vacuum or suction
and the like. Optionally, the element of the apparatus applying the
pressure may be heated or cooled while applying the pressure.
[0011] In an exemplary embodiment of the invention, when the
apparatus is placed in contact with the user's skin an electric
circuit is formed and electric current flows automatically from the
electrode to the user. Optionally, the RF energy may be coordinated
with the EMS energy so that both will be activated simultaneously
or separately by control of the apparatus.
[0012] In an exemplary embodiment of the invention, the frequency
of the RF energy is selected to heat the user's skin mainly at the
adipose layer positioned under the apparatus. The EMS flow is
designed to contract the muscles below the adipose layer causing
pressure on the fatty cells from below.
[0013] In some embodiments of the invention, parameters related to
the RF energy are user selectable, for example signal intensity,
frequency, duration and the like, to optimize usage of the
apparatus for different users or different positions on the body of
the user. Optionally, the parameters related to the EMS energy can
be modified to fit the needs of the user, for example by selecting
intensity, frequency, duration and the like.
[0014] In some embodiments of the invention, parameters related to
massaging the skin are user selectable, for example the vibration
rate, duration of vibrations, intensity, temperature of the
massaging element and the like. Alternatively, the massaging may be
performed by manually pressing the apparatus on the user's skin and
moving it over a designated area.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The present invention will be understood and better
appreciated from the following detailed description taken in
conjunction with the drawings. Identical structures, elements or
parts, which appear in more than one figure, are generally labeled
with the same or similar number in all the figures in which they
appear, wherein:
[0016] FIG. 1 is a schematic illustration of a fat reduction device
deployed upon a user's skin, according to an exemplary embodiment
of the invention;
[0017] FIG. 2 is a schematic illustration of liquefied fat exiting
from fat cells into the extra cellular matrix responsive to the use
of the fat reduction device, according to an exemplary embodiment
of the invention;
[0018] FIG. 3 is a schematic illustration of a fat reduction device
applying an electrical current to stimulate a user's muscles,
according to an exemplary embodiment of the invention;
[0019] FIG. 4 is a schematic illustration of a fat reduction device
and the user's skin following use of the fat reduction device,
according to an exemplary embodiment of the invention;
[0020] FIG. 5 is a schematic block diagram of the elements of a fat
reduction device, according to an exemplary embodiment of the
invention; and
[0021] FIG. 6 is a schematic illustration of an RF signal combined
with an EMS signal, according to an exemplary embodiment of the
invention.
DETAILED DESCRIPTION
[0022] FIG. 1 is a schematic illustration of a fat reduction device
110 deployed upon a user's skin 120, according to an exemplary
embodiment of the invention. The skin 120 includes an upper
epidermal layer 160, a lower dermal layer 170, and an adipose layer
140 (fat tissue layer). Muscles 150 are located below the adipose
layer 140.
[0023] In an exemplary embodiment of the invention, fat reduction
device 110 includes one or more heads 115 that serve as massage
contacts and optionally also as electrodes for applying electrical
energy. Optionally, fat reduction device 110 is adapted to perform
at least three actions:
[0024] 1. Massaging the outer layer of skin 120;
[0025] 2. Heating the adipose layer 140 using RF energy 130 (e.g.
with a frequency between 0.5 MHz to 2 MHz);
[0026] 3. Stimulating the muscles 150 below the adipose layer 140
with an electrical muscle stimulation (EMS) signal (e.g. with
pulses of DC current between+/-500 ma).
[0027] In an exemplary embodiment of the invention, fat reduction
device 110 is deployed upon the user's skin 120 and applies
pressure with heads 115 to massage the skin 120. Optionally the
pressure may be in the form of vibrations, pushing, pounding, or
other tactile forms. Alternatively or additionally, the massaging
may be in a negative form, for example by applying a vacuum or
suction or similar form. FIG. 1 demonstrates how the skin 120 takes
an uneven form due to the physical pressure exerted upon it. In
some embodiments of the invention, fat reduction device 110
includes an element that applies the pressure, for example a motor
a piezoelectric chip or other devices known in the art.
Alternatively, the pressure may be exerted by manually pressing
heads 115 against the user's skin.
[0028] In an exemplary embodiment of the invention, the RF energy
130 is delivered through the skin to the adipose layer 140. The RF
energy 130 accelerates natural fat cell metabolism causing the
release of liquefied fat from the cells into the extra cellular
matrix. Additionally, the RF energy 130 heats collagen fibers and
stimulates fibroblast metabolism resulting in tightening of the
skin 120 and an increase in new collagen production.
[0029] Optionally, the physical pressure loosens the ties between
the fat cells and together with the heating from the RF energy 130
accelerates release of liquefied fat from the fat cells. The
heating and massaging also increase blood flow thus providing more
nourishment to the area and removing dead cells and other
impurities at all increased rate.
[0030] FIG. 2 is a schematic illustration of liquefied fat 220
exiting from fat cells 210 into the extra cellular matrix
responsive to the use of the fat reduction device 110, according to
an exemplary embodiment of the invention. In an exemplary
embodiment of the invention, the RF energy is set to heat the fat
cells 210 to a level wherein the temperature on the surface of the
skin does not exceed 40.degree. C.-45.degree. C. to prevent skin
damage. Optionally, higher temperature ranges may be possible for
short durations.
[0031] FIG. 3 is a schematic illustration of fat reduction device
110 applying an electrical current 310 to stimulate the user's
muscles 150, according to an exemplary embodiment of the invention.
In an exemplary embodiment of the invention, electrical current 310
from the electrical muscle stimulation (EMS) pulse causes the
muscles 150 to contract below the adipose layer 140, which causes a
dual force to be applied to the fat cells 210. From above the
adipose layer 140 is pressured physically by fat reduction device
110 and from below the EMS signals cause the muscles 150 to exert
pressure on adipose layer 140. In some embodiments of the
invention, the RF energy 130 and/or the EMS pulse may be activated
by an activation switch on fat reduction device 110. Alternatively,
they may be activated upon contact with the user's skin, for
example by closing a circuit through the user's skin or by applying
pressure on the head of fat reduction device 110.
[0032] FIG. 4 is a schematic illustration of fat reduction device
110 and the user's skin 120 following use of fat reduction device
110, according to an exemplary embodiment of the invention.
Optionally, after applying fat reduction device 110 the distance
between the muscles 150 and the epidermal layer 160 is reduced due
to the exit of liquefied fat from the fat cells 210 of the adipose
layer 140. Additionally, the epidermal layer 160 becomes smoother
due to the tightening resulting from the collagen production as
described above.
[0033] FIG. 5 is a schematic block diagram of the elements of fat
reduction device 110, according to an exemplary embodiment of the
invention. In an exemplary embodiment of the invention, fat
reduction device 110 includes an RF generator 510 to provide an AC
current in the form of a radio frequency (RF) electrical pulse for
heating the user's skin 120. Optionally the AC signal is a low
current signal, for example of about 1-10 ma, 24 VAC with a
frequency between 0.5 MHz-2 MHz to prevent damage to the user's
skin 120. In an exemplary embodiment of the invention, fat
reduction device 110 also includes an electric pulse (EP) generator
520 that provides low current DC pulse signals, for example between
+500 ma to -500 ma to cause the muscles 150 to expand and contract.
In an exemplary embodiment of the invention, fat reduction device
110 includes a control board 530 that determines the actions of the
device. Optionally, control board 530 may be a general purpose
computer or a dedicated circuit. Control board 530 controls the
duration, intensity, frequency and any other parameters of the
electric pulses of the electrical current 310 for stimulating the
muscles 150, and the RF energy 130 for heating the adipose layer
140. Additionally, the control board 530 determines the timing for
applying the EP signal and the RF signal. In some embodiments of
the invention, control board 530 includes a CPU, a memory, and
input/output devices, for example a keypad and a screen.
[0034] In some embodiments of the invention, the control board
accepts measurements from various sensors and controls fat
reduction device 110 responsive to the measurements, for example
temperature readings from a temperature sensor 550, which may
include a thermistor or thermocouple monitoring the skin
temperature. Optionally, the sensors may be placed in head 115, for
example adjacent to the electrodes.
[0035] In an exemplary embodiment of the invention, fat reduction
device 110 includes an applicator 540 for applying the actions
described above. In an exemplary embodiment of the invention, fat
reduction device 110 is fed from a power source 590. Optionally,
the power source 590 may be an internal power source, for example a
battery. Alternatively, power source 590 may be an external power
source, for example by connecting a power cable to a standard
household power outlet.
[0036] In an exemplary embodiment of the invention, applicator 540
includes one or more heads 115 that serve as massage contacts 560,
and electrodes 570. In some embodiments of the invention, the
applicator may include an activation switch 580 to turn on and off
fat reduction device 110, Optionally, activation switch 580 may be
independently controlled by the user or may be automatically
controlled, for example by placing fat reduction device 110 in
contact with the user's body so that an electric circuit is formed
or by pressing the fat reduction device 110 against the user's body
causing the activation switch 580 to be depressed.
[0037] In some embodiments of the invention, fat reduction device
110 may use a mono-polar configuration wherein one pole of the
circuit is represented by one or more electrodes on heads 115 and
placed in contact with the user's skin. Optionally, the opposite
pole is placed as a patch on the user's body or on a handle for
grasping fat reduction device 110, to form a closed circuit.
Alternatively, fat reduction device 110 may use a bi-polar
configuration wherein both poles are represented by electrodes on
the head 115 of the device, and no external electrodes are
required. In some embodiments of the invention, a multi-polar
configuration is used, with multiple electrodes wherein some of the
electrodes on head 115 represent a first pole of the circuit and
some represent the opposite pole. Optionally, the polarity of the
electrodes may be controlled by control board 530, and their
polarity may alternate during use of fat reduction device 110.
[0038] In some embodiments of the invention, some of the electrodes
deliver RF energy 130 and some deliver electrical current 310.
Alternatively, the same electrodes may deliver RF energy 130 and
electrical current 310 intermittently. In some embodiments of the
invention, electrical current 310 from the electrical muscle
stimulation (EMS) signal is applied independent of the RF energy
signal 130.
[0039] In an exemplary embodiment of the invention, control 530
controls the actions of the massage contacts 560. Optionally, the
massage contacts 560 may include a motor, a piezoelectric element,
a suction, a vacuum or other devices to massage the user's skin
either positively or negatively. In an exemplary embodiment of the
invention, the action of massage contacts 560 are synchronized with
the electrical muscle stimulation (EMS) so that the adipose layer
will be pressurized on both sides simultaneously. Alternatively,
each function may act independently. In some embodiments of the
invention, the massage is applied manually by pressing massage
contacts 560 against the user's skin 120, and optionally moving
them back and forth across the user's skin 120. Optionally, massage
contacts 560 may be made from a soft material or hard material
selected for providing a comfortable feeling to the user while
massaging the user's skin 120. In some embodiments of the
invention, the massage contacts 560 may include a heater to warm
the contacts to enhance comfort and/or effectiveness of the
massage.
[0040] FIG. 6 is a schematic illustration of an RF energy signal
synchronized with an EMS signal, according to an exemplary
embodiment of the invention. In an exemplary embodiment of the
invention, an electric pulse 610 of for example 100 micro-seconds
is provide during an interval of 1 ms after which a RF energy
signal 620 is applied, for example for a duration of 9 ms. This
sequence is applied repetitively while the fat reduction device is
activated. Optionally, other duration may be used, for example the
duration of electric pulse 610 may be longer than the duration of
RF radiation signal 620 or vice versa.
[0041] It should be appreciated that the above described methods
and apparatus may be varied in many ways, including omitting or
adding steps, changing the order of steps and the type of devices
used. It should be appreciated that different features may be
combined in different ways. In particular, not all the features
shown above in a particular embodiment are necessary in every
embodiment of the invention. Further combinations of the above
features are also considered to be within the scope of some
embodiments of the invention.
[0042] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather the scope of the present
invention is defined only by the claims, which follow.
* * * * *