U.S. patent application number 15/342182 was filed with the patent office on 2017-02-23 for esthetic device for beautifying skin and methods thereof.
This patent application is currently assigned to VENUS CONCEPT LTD.. The applicant listed for this patent is VENUS CONCEPT LTD.. Invention is credited to Vadim POLYAKOV, Oded RON EDOUTE, Orit RON EDOUTE, Almog ZAHAVI.
Application Number | 20170050019 15/342182 |
Document ID | / |
Family ID | 46758683 |
Filed Date | 2017-02-23 |
United States Patent
Application |
20170050019 |
Kind Code |
A1 |
RON EDOUTE; Oded ; et
al. |
February 23, 2017 |
ESTHETIC DEVICE FOR BEAUTIFYING SKIN AND METHODS THEREOF
Abstract
A device for improving the cosmetic appearance of the skin is
disclosed, wherein said device comprises RF generating means for
generating N independent RF signals of predetermined waveforms,
frequencies, amplitudes, and relative phases; control means for
controlling the output of said RF generating means, said control
means in communication with said RF generating means; N pairs of RF
electrodes, each of said pairs in independent communication with
said RF generating means, said RF electrodes configured to transmit
RF energy to said skin; and an electrically insulating casing
adapted to hold said RF electrodes such that said RF electrodes may
be placed in simultaneous physical contact with said skin.
Inventors: |
RON EDOUTE; Oded; (TEL AVIV,
IL) ; RON EDOUTE; Orit; (TEL AVIV, IL) ;
POLYAKOV; Vadim; (PETACH TIKVA, IL) ; ZAHAVI;
Almog; (TEL-AVIV, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VENUS CONCEPT LTD. |
Karmiel |
|
IL |
|
|
Assignee: |
VENUS CONCEPT LTD.
Karmiel
IL
|
Family ID: |
46758683 |
Appl. No.: |
15/342182 |
Filed: |
November 3, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13603628 |
Sep 5, 2012 |
9532832 |
|
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15342182 |
|
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61531025 |
Sep 5, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/0047 20130101;
A61B 2018/00452 20130101; A61N 5/0625 20130101; A61B 18/18
20130101; A61B 18/14 20130101; A61B 2018/00791 20130101; A61N 7/02
20130101; A61N 2007/0034 20130101; A61B 2018/1467 20130101; A61F
2007/0052 20130101; A61N 1/403 20130101; A61N 1/06 20130101; A61N
5/0616 20130101; A61F 7/007 20130101; A61B 2018/00005 20130101;
A61B 18/203 20130101; A61N 1/328 20130101; A61N 1/0476
20130101 |
International
Class: |
A61N 1/32 20060101
A61N001/32; A61N 5/06 20060101 A61N005/06; A61N 1/06 20060101
A61N001/06; A61F 7/00 20060101 A61F007/00; A61N 1/04 20060101
A61N001/04; A61N 7/02 20060101 A61N007/02; A61N 1/40 20060101
A61N001/40 |
Claims
1. A device for improving the cosmetic appearance of the skin,
comprising: a. an RF generator that is configured to generate N
independent RF signals of predetermined waveforms, frequencies,
amplitudes, and relative phases; b. N pairs of RF electrodes, each
of said N pairs of electrodes characterized by a proximal end and a
distal end, each of said pairs in independent communication with
said RF generator, said RF electrodes configured to transmit RF
energy to said skin; c. a controller that is configured to control
the output of said RF generator, said controller in communication
with said RF generator; and, d. an electrically insulating casing
configured to hold said N pairs of RF electrodes at said proximal
end such that said N pairs of RF electrodes may be placed in
simultaneous physical contact with said skin; wherein said N
independent RF signals are phase shifted relative to one another;
further wherein said distal ends of said electrodes are in a
substantially horizontal configuration.
2. The device according to claim 1, wherein at least one of the
following is being held true: a. the time-dependent amplitude
A.sub.t,m of the mth of said N independent RF signals is given by
the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which is greater than or
equal to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.mis a predetermined phase shift of the mth RF signal; for
each of said N independent RF signals, .phi..sub.m=.pi.k(j-1)/N,
where 0.ltoreq.k.ltoreq.1, m=1, 2, 3 . . . N and j is an integer
equal to or greater than 1; where N is the amount of said RF
electrode pairs; Fm is chosen from a group consisting of sine,
cosine, tan, cotangents (cot), sawtooth wave, triangular wave,
square wave, rectangular wave, trapezoidal wave, and any
combination of the above; b. each of said predetermined frequencies
is between about 1 Hz and about 100 MHz. c. said RF signals are
transmitted in either a continuous mode or in pulses; when the RF
is applied in pulses, the length of said pulses is between about
0.01 micro-sec and about 1 ms; length of said pulses is between
about 0.1 and about 1000 ms; d. additionally comprising a mechanism
configured to apply Pulsed Electromagnetic Field Therapy (PEMF); e.
further comprising at least one temperature sensor configured to
measure the temperature of the surface of said skin; said at least
one sensor chosen from a group consisting of impedance meter
configured to measure impedance across at least one of said N pairs
of RF electrodes; thermal sensor; thermometer; and any combination
thereof; said at least one temperature sensor is configured to
either come into contact with the skin or not be in contact with
the skin; said controller is programmed to regulate the amount of
RF energy transmitted to said skin such that the temperature of
said skin remains within a predetermined range; said predetermined
range is between ambient temperature and 42.degree. C.; f. said N
pairs of RF electrodes are disposed about the distal end of said
casing in a geometry chosen from a group consisting of linear;
zigzag; on the perimeter of a shape chosen from substantially
polygonal, circular, oval, or irregular; within the area of a shape
chosen from polygonal, circular, oval, or irregular; and any
combination of the above; g. the power transmitted by said RF
electrodes and said RF generator to said skin is between 1 W and
700 W; h. said cosmetic improvement is chosen from a group
consisting of skin rejuvenation, reduction of the number of
wrinkles, reduction of the depth of wrinkles, reduction of
cellulite, skin tightening, circumferential reduction, and any
combination of the above; i. further comprising cooling means
configured to cool said skin; j. said cooling means are chosen from
a group consisting of a Peltier effect cooling device, irrigation
with cool water, and means for blowing air across the skin; k. said
N pairs of RF electrodes are further configured to provide heat to
said skin; l. additionally comprising a skin massaging section;
and, m. at least one of said N pairs of RF electrodes comprises a
hypodermic syringe for penetrating into subcutaneous tissue.
3. The device according to claim 1, further comprising a deep
tissue diathermy device.
4. The device according to claim 3, wherein at least one of the
following is being held true: a. said deep tissue diathermy device
is chosen from a group consisting of: a device emitting RF
radiation and any other means configured for producing electrical
current absorbed by subcutaneous tissue; b. said deep tissue
diathermy device further comprises at least one electrical output
device configured to generate RF electromagnetic energy; and, at
least two electrodes electrically coupled to said electrical output
device and placed on said skin region, wherein all said electrodes
are configured to simultaneously apply said RF electromagnetic
energy to said skin;. c. said deep tissue diathermy device further
comprises at least one electrical output device configured to
generate electrical current; and, at least two electrodes
electrically coupled to said electrical output device and placed on
said skin region, wherein all of said electrodes are configured to
simultaneously apply said electrical current to said skin;. d. said
deep tissue diathermy device is chosen from a group consisting of:
an acoustic diathermy device, an optical diathermy device, an
electromagnetic induction diathermy device, a device for producing
sound waves, an ultrasonic diathermy device, and a device for
direct application of heat; e. said deep tissue diathermy device is
an optical device configured to emit light in wavelengths absorbed
by subcutaneous tissue such that said subcutaneous tissue is
heated; f. said deep tissue diathermy device is a device configured
to emit sound waves of a frequency absorbed by the subcutaneous
tissue such that said subcutaneous tissue is heated; g. said
controller is configured to monitor physical tissue parameters and
to change at least one of a group consisting of: (a) the amount of
heat applied and (b) the form of said RF in response to the values
of said physical tissue parameters; and, h. said controller further
comprises: a processor that is configured to direct the storage, in
a communicable database, of predetermined parameters defining safe
and unsafe treatment parameters, said parameters chosen from a
group consisting of time of said treatment, temperature of said
skin, frequency, power, energy applied by said RF generator, depth
to which said device operates, magnetic field intensity, tissue
impedance, specific absorption rate, superficial muscle
contractions and any combination thereof; a sensor that is
configured to sense electromagnetic radiation and heat radiation
parameters chosen from a group consisting of time of said
treatment, temperature of said tissue, frequency, power, intensity
of ultrasound irradiation, energy applied by said RF generator,
depth to which said device operates, magnetic field intensity,
tissue impedance, specific absorption rate, superficial muscle
contractions and any combination thereof; and, a regulator that is
configured to stop the operation of said device if said parameters
are determined to be unsafe.
5. The device according to claim 1, wherein said controller is
configured to change said N independent RF signals according to
predetermined medical needs, and comprising: a. at least one sensor
that is configured to monitor electrotherapy parameters related to
the level of skin rejuvenation and viability; b. a processor that
is configured to determine the degree of esthetic improvement in at
least one tissue parameter related to the level of skin
rejuvenation and vitality; and, c. a regulator that is configured
to stop the operation of said device when said degree of esthetic
improvement reaches a predetermined value.
6. The device according to claim 5, wherein at least one of the
following is being held true: a. said electrotherapy parameters are
chosen from a group consisting of dermal tensile forces, tissue
impedance, muscle contraction forces, skin elasticity, and any
combination thereof; b. said at least one tissue parameter is
chosen from a group consisting of dermal tensile forces, tissue
impedance, muscle contraction forces, skin elasticity, and any
combination thereof; c. said at least one sensor that is configured
to monitor electrotherapy parameters is chosen from a group
consisting of time of said treatment, temperature of said tissue,
frequency, power, tissue impedance, superficial muscle contractions
and any combination thereof; and, d. said processor is configured
to direct the storage, in a communicable database, of predetermined
parameters defining safe and unsafe treatment conditions; said
predetermined parameters are chosen from a group consisting of time
of said safe and unsafe treatment, temperature of said tissue,
frequency, power, tissue impedance, superficial muscle
contractions, and any combination thereof.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. application Ser.
No. 13/603,628, filed Sep. 5, 2012, which claims priority from U.S.
Provisional Application No. 61/531,025, filed Sep. 5, 2011. All of
these applications are hereby incorporated by reference in their
entirety.
FIELD OF THE INVENTION
[0002] This invention generally relates to a device used to improve
skin viability and skin rejuvenation via electrotherapy, and a
method of using the device.
BACKGROUND OF THE INVENTION
[0003] Improving the appearance of the skin has been the goal of
many esthetic products and procedures for many years, since a tight
skin, without wrinkles or cellulite, has a younger and more
appealing appearance. Apart from age related changes, the skin also
suffers from exposure to chemical and physical injuries, such as
tobacco, cosmetics, esthetics and radiation from the sun and other
sources. Those factors contribute to the decrease in collagen
production, to reduced elasticity, and the appearance of
wrinkles.
[0004] The skin and muscles of the face are structured differently
than other places on the body. One side of the facial muscles is
connected to the bone and the other to the skin. As the muscle
deteriorates through the aging process, the attached facial skin
loses it elasticity. Loss of elasticity causes the skin to sag and
wrinkle. Strengthening relevant muscle groups restores and
maintains the original shape and contour of the muscles. As facial
muscles get stronger, they get shorter and flatter, causing the
attached skin to become firmer, and smoothing wrinkles, improving
facial appearance. Additionally, a contracting muscle's blood
supply is 10 times greater than a muscle at rest. This fresh blood
supply delivers vital oxygen and nutrients to the skin,
revitalizing the tissue.
[0005] The most common method of heating the dermis, is the use of
RF radiation, applied by antenna or electrodes. For example,
WO98005380 discloses a method of tightening skin using an RF
electromagnetic energy delivery device. However, the manner (and
specifically, the protocol) in which the RF is transmitted to the
region of interest is highly important. Some methods will have no
effect and others may have the opposite effect.
[0006] U.S. Pat. Appl. 20100016850 discloses an invention that
demonstrates that application of electrical currents of about 1
milliampere, and voltages greater than 4V have a much greater
esthetic effect on the skin than application of lower currents and
voltages known in the prior art. This application further discloses
that simultaneous application of electrical currents on the skin
yields better esthetic results.
[0007] All of the RF devices known in the prior art irradiate the
tissue with RF energy that has a single phase. This means of
irradiation is relatively inefficient, because the waveform
necessarily passes through zero twice per cycle; that is, there
will inevitably be periods of irradiation during which no energy is
being transferred to the skin.
[0008] Thus, means for providing RF (or in general, any kind of
energy) to the region of treatment (e.g., the skin) in which an
essentially continuous transfer of the energy (e.g., the RF) to the
skin remains a long-felt, yet unmet, need.
SUMMARY OF THE INVENTION
[0009] The present invention is designed to meet this long-felt
need. The present invention discloses a device for skin
rejuvenation, adapted to apply any energy according to a
predetermined protocol.
[0010] Specifically, the present invention discloses a device for
skin rejuvenation, adapted to apply RF energy to the skin that
comprises a plurality of pairs of RF electrodes in which each pair
of electrodes transmits RF energy shifted in phase relative to the
other pairs of electrodes. By this means, an essentially constant
amount of RF energy can be transmitted to the skin while
maintaining the benefits of RF irradiation discussed above.
However, it should be pointed out that any Energy could be applied
(e.g., acoustic energy, ultrasound, light, laser, electrical
energy, magnetic field and any combination thereof).
[0011] It is therefore an object of the present invention to
disclose a device for improving the cosmetic appearance of the
skin, comprising (a) N pairs of RF electrodes, each of said pairs
in independent communication with said RF generating means, said RF
electrodes configured to transmit RF energy to said skin; (b) RF
generating means for generating N independent RF signals of
predetermined waveforms, frequencies, amplitudes, and relative
phases; (c) control means for controlling the output of said RF
generating means, said control means in communication with said RF
generating means; and, (d) an electrically insulating casing
adapted to hold said RF electrodes such that said RF electrodes may
be placed in simultaneous physical contact with said skin. It is
within the essence of the invention wherein said N independent RF
signals are phase shifted relative to one another.
[0012] It is a further object of this invention to disclose such a
device, wherein the time-dependent amplitude A.sub.t,m of the mth
of said N independent RF signals is given by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth RF
signal.
[0013] It is a further object of this invention to disclose such a
device, wherein for each of said N independent RF signals,
.phi.=.pi.k(j-1)/N, where 0.ltoreq.k.ltoreq.1 and m=1, 2, 3 . . .
N, j=1,2,3 . . . ; where N is the number of said pairs of
electrodes. For example, for one electrode k=1, N=4 and the phase
is 135 degrees and for another electrode the phase will be 45
degrees, and another numbers can be combined.
[0014] It is a further object of this invention to disclose such a
device, wherein F.sub.m is chosen from the group consisting of
sine, cosine, tan, cotangents (cot), sawtooth wave, triangular
wave, square wave, rectangular wave, trapezoidal wave, and any
combination of the above.
[0015] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein each of said
predetermined frequencies is between about 1 Hz and about 100
MHz.
[0016] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein said RF signals are
transmitted either in a continues mode or in pulses.
[0017] It is a further object of this invention to disclose such a
device, wherein, if said RF is applied in pulses, the length of
said pulses is between about 0.01 micro-sec and about 1 ms.
[0018] It is a further object of this invention to disclose such a
device as defined in any of the above, additionally comprising
means adapted to apply Pulsed Electromagnetic Field Therapy
(PEMF).
[0019] It is a further object of this invention to disclose such a
device, wherein the length of said PEMF is between about 0.1 ms and
about 1000 ms.
[0020] It is a further object of this invention to disclose such a
device as defined in any of the above, further comprising
temperature measuring means adapted to measure the temperature of
the surface of said skin.
[0021] It is a further object of this invention to disclose such a
device, wherein said temperature measuring means comprises at least
one sensor chosen from the group consisting of impedance meter
adapted to measure impedance across at least one of said pairs of
RF electrodes; thermal sensor; thermometer; and any combination
thereof.
[0022] It is a further object of this invention to disclose such a
device, wherein said control means are programmed to regulate the
amount of RF energy transmitted to said skin such that the
temperature of said skin remains within a predetermined range.
[0023] It is a further object of this invention to disclose such a
device, wherein said predetermined range is between ambient
temperature and 42.degree. C.
[0024] It is a further object of this invention to disclose such a
device, wherein said predetermined range is between ambient
temperature and 50.degree. C.
[0025] It is a further object of this invention to disclose such a
device, wherein said predetermined range is between 30.degree. C.
and 100.degree. C.
[0026] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein said electrodes are
disposed about the distal end of said casing in a geometry chosen
from the group consisting of linear; zigzag; on the perimeter of a
shape chosen from substantially polygonal, circular, oval, or
irregular; within the area of a shape chosen from substantially
polygonal, circular, oval, or irregular; and any combination of the
above.
[0027] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein the power
transmitted by said RF electrodes and said RF generating means to
said skin is between 1 W and 700 W.
[0028] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein said cosmetic
improvement is chosen from the group consisting of skin
rejuvenation, reduction of the number of wrinkles, reduction of the
depth of wrinkles, reduction of cellulite, skin tightening,
circumferential reduction, and any combination of the above.
[0029] It is a further object of this invention to disclose such a
device as defined in any of the above, further comprising cooling
means adapted to cool said skin.
[0030] It is a further object of this invention to disclose such a
device, wherein said cooling means are chosen from the group
consisting of a Peltier effect cooling device, irrigation with cool
water, and means for blowing air across the skin.
[0031] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein said RF electrodes
are further adapted to provide heat to said skin.
[0032] It is a further object of this invention to disclose such a
device as defined in any of the above, further comprising a deep
tissue diathermy device.
[0033] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device is chosen from
the group consisting of any devices emitting RF radiation and any
other means adapted for producing electrical current absorbed by
subcutaneous tissue.
[0034] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device further comprises
(a) at least one electrical output device adapted to generate RF
electromagnetic energy; and (b) at least two electrodes
electrically coupled to said electrical output device and placed on
said skin region, wherein all said electrodes are adapted to
simultaneously apply said RF energy to said skin.
[0035] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device further comprises
(a) at least one electrical output device adapted to generate
electrical current; (b) at least two electrodes electrically
coupled to said electrical output device and placed on said skin
region, wherein all of said electrodes are adapted to
simultaneously apply said electrical current to said skin.
[0036] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device is chosen from
the group consisting of acoustic (e.g., ultrasonic) diathermy
devices, optical diathermy devices, electromagnetic induction
diathermy devices, devices for producing sound waves, ultrasonic
diathermy devices, and devices for direct application of heat.
[0037] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device is an optical
device adapted to emit light in wavelengths absorbed by
subcutaneous tissue such that said subcutaneous tissue is
heated.
[0038] It is a further object of this invention to disclose such a
device, wherein said deep tissue diathermy device is a device for
producing sound waves adapted to emit sound waves of a frequency
absorbed by the subcutaneous tissue such that said subcutaneous
tissue is heated.
[0039] It is a further object of this invention to disclose such a
device, wherein said control means are adapted to monitor physical
tissue parameters and to change at least one of (a) the amount of
heat applied and (b) the form of said RF in response to the values
of said physical tissue parameters.
[0040] It is a further object of this invention to disclose such a
device, wherein said control means further comprise (a) processing
means adapted to store in a communicable database predetermined
parameters defining safe and unsafe treatment parameters, said
parameters chosen from the group consisting of time of said
treatment, the temperature of said skin, frequency, power, energy
applied by said RF generating means, depth to which said device
operates, magnetic field intensity, tissue impedance, specific
absorption rate, superficial muscle contractions and any
combination thereof; (b) sensing means adapted to sense
electromagnetic radiation and heat radiation parameters chosen from
a group consisting of time of said treatment, temperature of said
tissue, frequency, power, intensity of ultrasound irradiation,
energy applied by said RF generating means, depth to which said
device operates, magnetic field intensity, tissue impedance,
specific absorption rate, superficial muscle contractions and any
combination thereof; and (c) regulating means adapted to stop the
operation of said device if said parameters are determined to be
unsafe.
[0041] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein said control means
additionally comprise a feedback mechanism, adapted to change said
RF signal according to predetermined medical needs, and comprising
(a) sensing means adapted to monitor electrotherapy parameters
related to the level of skin rejuvenation and viability; (b)
processing means, adapted to determine the degree of esthetic
improvement in at least one tissue parameter related to the level
of skin rejuvenation and vitality; and (c) regulating means adapted
to stop the operation of said device when said degree of esthetic
improvement reaches a predetermined value.
[0042] It is a further object of this invention to disclose such a
device, wherein said electrotherapy parameters are chosen from the
group consisting of dermal tensile forces, tissue impedance, muscle
contraction forces, skin elasticity, and any combination
thereof.
[0043] It is a further object of this invention to disclose such a
device, wherein said at least one tissue parameter is chosen from
the group consisting of dermal tensile forces, tissue impedance,
muscle contraction forces, skin elasticity, and any combination
thereof.
[0044] It is a further object of this invention to disclose such a
device, wherein said sensing means are adapted to sense
electrotherapy parameters are chosen from the group consisting of
time of said treatment, temperature of said tissue, frequency,
power, tissue impedance, superficial muscle contractions and any
combination thereof.
[0045] It is a further object of this invention to disclose such a
device, wherein said processing means are adapted to store in a
communicable database predetermined parameters defining safe and
unsafe treatment conditions.
[0046] It is a further object of this invention to disclose such a
device, wherein said predetermined parameters are chosen from the
group consisting of time of said treatment, temperature of said
tissue, frequency, power, tissue impedance, superficial muscle
contractions, and any combination thereof.
[0047] It is a further object of this invention to disclose such a
device as defined in any of the above, additionally comprising
means for massaging said skin.
[0048] It is a further object of this invention to disclose such a
device as defined in any of the above, wherein at least one of said
RF electrodes comprises a hypodermic syringe for penetrating into
subcutaneous tissue.
[0049] It is a further object of this invention to disclose a
method for providing cosmetic improvement to the skin, comprising
(a) providing (i) N pairs of RF electrodes, each of said pairs in
independent communication with RF generating means, said RF
electrodes configured to transmit RF energy to said skin; (ii) RF
generating means for generating N independent RF signals of
predetermined waveforms, frequencies, amplitudes, and relative
phases; (iii) control means for controlling the output of said RF
generating means, said control means in communication with said RF
generating means;
[0050] (b) generating N independent RF signals of predetermined
waveforms, frequencies, amplitudes, and relative phases; (c)
transmitting each of said N independent RF signals to a pair of
electrodes; (d) placing said electrodes in physical contact with
said skin; and (d) transmitting energy carried by said RF signals
to said skin. It is within the essence of the invention wherein
said N independent RF signals are phase-shifted relative to one
another.
[0051] It is a further object of this invention to disclose such a
method, wherein said step of generating N independent RF signals
further comprises generating N independent RF signals such that the
time-dependent amplitude A.sub.t,m of the mth of said N independent
RF signals is given by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth RF
signal.
[0052] It is a further object of this invention to disclose such a
method, further comprising a step of providing said phase shift
.phi..sub.m for each of said N independent RF signals according to
the relationship .phi..sub.m=.pi.k(j-1)/N where
0.ltoreq.k.ltoreq.1, m=1, 2, 3 . . . N and j=1,2,3 . . . ; where N
is the number of said pairs of electrodes.
[0053] It is a further object of this invention to disclose such a
method, further comprising a step of choosing F.sub.m from the
group consisting of sine, cosine, tan, cotangents (cot), sawtooth
wave, triangular wave, square wave, rectangular wave, trapezoidal
wave, and any combination of the above.
[0054] It is a further object of this invention to disclose such a
method as defined in any of the above, wherein said step of
generating N independent RF signals of predetermined waveforms,
frequencies, amplitudes, and relative phases comprises a step of
generating N independent RF signals with frequencies between about
1 Hz and about 100 MHz.
[0055] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
transmitting said RF signals either in a continues node or in
pulses.
[0056] It is a further object of this invention to disclose such a
method, wherein, when the RF is applied in pulses, the length of
said pulses is between about 0.01 micro-sec and about 1 ms.
[0057] It is a further object of this invention to disclose such a
method as defined in any of the above, additionally comprising
means adapted to apply Pulsed Electromagnetic Field Therapy
(PEMF).
[0058] It is a further object of this invention to disclose such a
method, wherein said step of transmitting said PEMF signals in
pulses further comprises transmitting said pulses with pulse
lengths of between about 0.1 and about 1000 ms.
[0059] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
measuring the temperature of the surface of said skin.
[0060] It is a further object of this invention to disclose such a
method, wherein said step of measuring the temperature of the
surface of said skin further comprises measuring the temperature of
the surface of said skin by means of at least one sensor chosen
from the group consisting of impedance meter adapted to measure
impedance across at least one of said pairs of RF electrodes;
thermal sensor; thermometer; and any combination thereof.
[0061] It is a further object of this invention to disclose such a
method, further comprising a step of regulating the amount of RF
energy transmitted to said skin such that the temperature of said
skin remains within a predetermined range.
[0062] It is a further object of this invention to disclose such a
method, wherein said step of regulating the amount of RF energy
transmitted to said skin further comprises regulating the amount of
RF energy transmitted to said skin such that the temperature of
said skin remains between ambient temperature and 37.degree. C.
[0063] It is a further object of this invention to disclose such a
method, wherein the temperature of said skin remains between
ambient temperature and 50.degree. C.
[0064] It is a further object of this invention to disclose such a
method, wherein the temperature of said skin remains between
30.degree. C. and 100.degree. C.
[0065] It is a further object of this invention to disclose such a
method, wherein said step of regulating the amount of RF energy
transmitted to said skin further comprises regulating the amount of
RF energy transmitted to said skin such that the temperature of
said skin remains between 30.degree. C. and 80.degree. C.
[0066] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
disposing said electrodes within an electrically insulating
casing.
[0067] It is a further object of this invention to disclose such a
method, further comprising a step of disposing about the distal end
of said casing in a geometry chosen from the group consisting of
linear; zigzag; on the perimeter of a shape chosen from
substantially polygonal, circular, oval, or irregular; within the
area of a shape chosen from substantially polygonal, circular,
oval, or irregular; and any combination of the above.
[0068] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
transmitting to said skin a power of between 1 W and 700 W by said
RF electrodes and said RF generating means.
[0069] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
providing a cosmetic/esthetic improvement to the skin chosen from
the group consisting of skin rejuvenation, reduction of the number
of wrinkles, reduction of the depth of wrinkles, reduction of
cellulite, skin tightening, circumferential reduction, and any
combination of the above.
[0070] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
cooling said skin.
[0071] It is a further object of this invention to disclose such a
method, wherein said step of cooling said skin further comprises
cooling said skin by the use of means chosen from the group
consisting of a Peltier effect cooling device, irrigation with cool
water, and means for blowing air across the skin.
[0072] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
heating said skin by means of said RF electrodes.
[0073] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
performing deep tissue diathermy.
[0074] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises performing deep tissue diathermy by a method
chosen from the group consisting of emitting RF radiation and
producing electrical current absorbed by subcutaneous tissue.
[0075] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises (a) generating RF electromagnetic energy by use
of at least one electrical output device; (b) coupling at least two
electrodes to said at least one electrical output device; and (c)
applying simultaneously said RF energy to said skin.
[0076] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises (a) generating electrical current by means of at
least one electrical output; (b) coupling electrically at least two
electrodes electrically to said electrical output; (c) placing said
electrodes on said skin; and (d) applying simultaneously said
electrical current to said skin.
[0077] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises performing deep tissue diathermy by a means
chosen from the group consisting of ultrasonic diathermy devices,
optical diathermy devices, electromagnetic induction diathermy
devices, devices for producing sound waves, ultrasonic diathermy
devices, and devices for direct application of heat.
[0078] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises performing deep tissue diathermy by means of an
optical device adapted to emit light in wavelengths absorbed by
subcutaneous tissue such that said subcutaneous tissue is
heated.
[0079] It is a further object of this invention to disclose such a
method, wherein said step of performing deep tissue diathermy
further comprises performing deep tissue diathermy by means of a
device for producing sound waves adapted to emit sound waves of a
frequency absorbed by the subcutaneous tissue such that said
subcutaneous tissue is heated.
[0080] It is a further object of this invention to disclose such a
method, further comprising steps of (a) monitoring physical tissue
parameters; and (b) changing at least one of (i) the amount of heat
applied and (ii) the form of said RF in response to the values of
said physical tissue parameters.
[0081] It is a further object of this invention to disclose such a
method, further comprising steps of (a) storing in a communicable
database predetermined parameters defining safe and unsafe
treatment parameters, said parameters chosen from the group
consisting of time of said treatment, the temperature of said skin,
frequency, power, energy applied by said RF generating means, depth
to which said device operates, magnetic field intensity, tissue
impedance, specific absorption rate, superficial muscle
contractions and any combination thereof; (b) sensing
electromagnetic radiation and heat radiation parameters chosen from
a group consisting of time of said treatment, temperature of said
tissue, frequency, power, intensity of ultrasound irradiation,
energy applied by said RF generating means, depth to which said
device operates, magnetic field intensity, tissue impedance,
specific absorption rate, superficial muscle contractions and any
combination thereof; and (c) ceasing the continued performance of
said method if said parameters are determined to be unsafe.
[0082] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising steps of
(a) monitoring electrotherapy parameters related to the level of
skin rejuvenation and viability; (b) determining the degree of
esthetic improvement in at least one tissue parameter related to
the level of skin rejuvenation and vitality; and (c) ceasing the
continued performance of said method when said degree of esthetic
improvement reaches a predetermined value.
[0083] It is a further object of this invention to disclose such a
method, wherein said step of monitoring electrotherapy parameters
further comprises monitoring at least one parameter chosen from the
group consisting of dermal tensile forces, tissue impedance, muscle
contraction forces, and skin elasticity.
[0084] It is a further object of this invention to disclose such a
method, wherein said step of determining the degree of esthetic
improvement in at least one tissue parameter related to the level
of skin rejuvenation and vitality further comprises a of
determining the degree of esthetic improvement in at least one
parameter chosen from the group consisting of dermal tensile
forces, tissue impedance, muscle contraction forces, and skin
elasticity.
[0085] It is a further object of this invention to disclose such a
method, further comprising a step of monitoring electrotherapy
parameters chosen from the group consisting of time of said
treatment, temperature of said tissue, frequency, power, tissue
impedance, superficial muscle contractions and any combination
thereof.
[0086] It is a further object of this invention to disclose such a
method, further comprising a step of storing in a communicable
database predetermined parameters defining safe and unsafe
treatment conditions.
[0087] It is a further object of this invention to disclose such a
method, wherein said step of storing in a communicable database
predetermined parameters defining safe and unsafe treatment
conditions further comprises storing in a communicable database at
least one parameters chosen from the group consisting of time of
said treatment, temperature of said tissue, frequency, power,
tissue impedance, and superficial muscle contractions.
[0088] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
massaging said skin.
[0089] It is a further object of this invention to disclose such a
method as defined in any of the above, further comprising a step of
incorporating a hypodermic syringe for penetrating into
subcutaneous tissue into at least one of said electrodes.
[0090] It is another object of the present invention to provide a
device for improving the cosmetic/esthetic appearance of the skin,
comprising: [0091] N pairs of electrodes, each of said pairs in
independent communication with energy generating means, said
electrodes configured to transmit said energy to said skin; [0092]
energy generating means for generating N independent energy signals
of predetermined waveforms, frequencies, amplitudes, and relative
phases; [0093] control means for controlling the output of said
energy generating means, said control means in communication with
said energy generating means; and, [0094] an electrically
insulating casing adapted to hold said electrodes such that said
electrodes may be placed in simultaneous physical contact with said
skin; wherein said N independent energy signals are phase shifted
relative to one another.
[0095] It is another object of the present invention to provide the
device as defined above, wherein the time-dependent amplitude
A.sub.t,m of the mth of said N independent energy signals is given
by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth energy
signal
[0096] It is another object of the present invention to provide the
device as defined above, wherein for each of said N independent
energy signals, .phi..sub.m=.pi.k(j-1)/N, where
0.ltoreq.k.ltoreq.1, m=1, 2, 3 . . . N and j=1,2,3 . . . ; where N
is the amount of said electrodes pairs.
[0097] It is another object of the present invention to provide the
device as defined above, wherein F.sub.m is chosen from the group
consisting of sine, cosine, tan, cotangents (cot), sawtooth wave,
triangular wave, square wave, rectangular wave, trapezoidal wave,
and any combination of the above.
[0098] It is another object of the present invention to provide the
device as defined above, wherein said energy is selected from a
group consisting of ultrasound, light, laser, electrical energy,
magnetic field and any combination thereof.
[0099] It is another object of the present invention to provide the
device as defined above, wherein said N output signals are
transmitted in either continues mode or in pulses.
[0100] It is a further object of this invention to disclose such a
device, wherein, when the RF is applied in pulses, the length of
said pulses is between about 0.01 micro-sec and about 1 ms.
[0101] It is a further object of this invention to disclose such a
device as defined in any of the above, additionally comprising
means adapted to apply Pulsed Electromagnetic Field Therapy
(PEMF).
[0102] It is another object of the present invention to provide the
device as defined above, wherein the length of said PEMF is between
about 0.1 ms and about 1000 ms.
[0103] It is another object of the present invention to provide the
device as defined above, further comprising temperature measuring
means adapted to measure the temperature of the surface of said
skin.
[0104] It is another object of the present invention to provide the
device as defined above, wherein said temperature measuring means
comprises at least one sensor chosen from the group consisting of
impedance meter adapted to measure impedance across at least one of
said pairs of RF electrodes; thermal sensor; thermometer; and any
combination thereof.
[0105] It is another object of the present invention to provide the
device as defined above, further comprising control means; wherein
said control means are programmed to regulate the amount of energy
transmitted to said skin such that the temperature of said skin
remains within a predetermined range.
[0106] It is another object of the present invention to provide the
device as defined above, wherein said predetermined range is
between ambient temperature and 42.degree. C.
[0107] It is a further object of this invention to disclose such a
device, wherein said predetermined range is between ambient
temperature and 50.degree. C.
[0108] It is a further object of this invention to disclose such a
device, wherein said predetermined range is between 30.degree. C.
and 100.degree. C.
[0109] It is another object of the present invention to provide the
device as defined above, wherein said electrodes are disposed about
the distal end of said casing in a geometry chosen from the group
consisting of linear; zigzag; on the perimeter of a shape chosen
from substantially polygonal, circular, oval, or irregular; within
the area of a shape chosen from substantially polygonal, circular,
oval, or irregular; and any combination of the above.
[0110] It is another object of the present invention to provide the
device as defined above, wherein the power transmitted by said
device to said skin is between 1 and 700 W.
[0111] It is another object of the present invention to provide the
device as defined above, wherein said cosmetic improvement is
chosen from the group consisting of skin rejuvenation, reduction of
the number of wrinkles, reduction of the depth of wrinkles,
reduction of cellulite, skin tightening, circumferential reduction,
and any combination of the above.
[0112] It is another object of the present invention to provide the
device as defined above, further comprising cooling means adapted
to cool said skin.
[0113] It is another object of the present invention to provide the
device as defined above, wherein said cooling means are chosen from
the group consisting of a Peltier effect cooling device, irrigation
with cool water, and means for blowing air across the skin.
[0114] It is another object of the present invention to provide the
device as defined above, wherein said energy is adapted to provide
heat to said skin.
[0115] It is another object of the present invention to provide the
device as defined above, further comprising a deep tissue diathermy
device.
[0116] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
is chosen from the group consisting of any devices emitting RF
radiation and any other means adapted for producing electrical
current absorbed by subcutaneous tissue.
[0117] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
further comprises: [0118] at least one electrical output device
adapted to generate RF electromagnetic energy; and, [0119] at least
two electrodes electrically coupled to said electrical output
device and placed on said skin region, wherein all said electrodes
are adapted to simultaneously apply said RF energy to said
skin.
[0120] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
further comprises: [0121] at least one electrical output device
adapted to generate electrical current; and, [0122] at least two
electrodes electrically coupled to said electrical output device
and placed on said skin region, wherein all of said electrodes are
adapted to simultaneously apply said electrical current to said
skin.
[0123] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
is chosen from the group consisting of acoustic (e.g., ultrasonic)
diathermy devices, optical diathermy devices, electromagnetic
induction diathermy devices, devices for producing sound waves,
ultrasonic diathermy devices, and devices for direct application of
heat.
[0124] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
is an optical device adapted to emit light in wavelengths absorbed
by subcutaneous tissue such that said subcutaneous tissue is
heated.
[0125] It is another object of the present invention to provide the
device as defined above, wherein said deep tissue diathermy device
is a device for producing sound waves adapted to emit sound waves
of a frequency absorbed by the subcutaneous tissue such that said
subcutaneous tissue is heated.
[0126] It is another object of the present invention to provide the
device as defined above, additionally comprising control means;
wherein said control means additionally comprise a feedback
mechanism, adapted to change said energy signal according to
predetermined medical needs, and comprising: [0127] sensing means
adapted to monitor electrotherapy parameters related to the level
of skin rejuvenation and viability; [0128] processing means,
adapted to determine the degree of esthetic improvement in at least
one tissue parameter related to the level of skin rejuvenation and
vitality; and, [0129] regulating means adapted to stop the
operation of said device when said degree of esthetic improvement
reaches a predetermined value.
[0130] It is another object of the present invention to provide the
device as defined above, wherein said electrotherapy parameters are
chosen from the group consisting of dermal tensile forces, tissue
impedance, muscle contraction forces, skin elasticity, and any
combination thereof.
[0131] It is another object of the present invention to provide the
device as defined above, wherein said at least one tissue parameter
is chosen from the group consisting of dermal tensile forces,
tissue impedance, muscle contraction forces, skin elasticity, and
any combination thereof.
[0132] It is another object of the present invention to provide the
device as defined above, wherein said sensing means are adapted to
sense electrotherapy parameters are chosen from the group
consisting of time of said treatment, temperature of said tissue,
frequency, power, tissue impedance, superficial muscle contractions
and any combination thereof.
[0133] It is another object of the present invention to provide the
device as defined above, wherein said processing means are adapted
to store in a communicable database predetermined parameters
defining safe and unsafe treatment conditions.
[0134] It is another object of the present invention to provide the
device as defined above, wherein said predetermined parameters are
chosen from the group consisting of time of said treatment,
temperature of said tissue, frequency, power, tissue impedance,
superficial muscle contractions, and any combination thereof.
[0135] It is another object of the present invention to provide the
device as defined above, additionally comprising means for
massaging said skin.
BRIEF DESCRIPTION OF THE DRAWINGS
[0136] The invention will now be described with reference to the
drawings, wherein
[0137] FIG. 1 presents a schematic view of one embodiment of the
invention herein disclosed;
[0138] FIG. 2 presents a face-on schematic view of the electrodes
according to one embodiment of the invention herein disclosed;
[0139] FIG. 3 presents a series of graphs illustrating the RF
signal as a function of time for various embodiments of the
invention; and,
[0140] FIG. 4 presents a schematic view of a second embodiment of
the invention herein disclosed.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0141] In the following description, various aspects of the
invention will be described. For the purposes of explanation,
specific details are set forth in order to provide a thorough
understanding of the invention. It will be apparent to one skilled
in the art that there are other embodiments of the invention that
differ in details without affecting the essential nature thereof.
Therefore the invention is not limited by that which is illustrated
in the figures and described in the specification, but only as
indicated in the accompanying claims, with the proper scope
determined only by the broadest interpretation of said claims.
[0142] With respect to parameters that characterize the invention
disclosed herein and the cosmetic treatment effected thereby,
"unsafe" parameters are understood to be parameters that will cause
tissue damage or excessive discomfort to the person undergoing
treatment, e.g. overheating, transmitting energy to tissue layers
below the skin, etc. According to one embodiment, the device of the
present invention automatically prevents the parameters from
reaching the unsafe zone and maintains the same within the safe
zone.
[0143] The invention comprises a novel device for improving the
cosmetic appearance of the skin, which is described in detail
below. In preferred embodiments of the invention, the cosmetic
improvement achieved includes at least one of skin rejuvenation;
reduction in the number of wrinkles; reduction of the depth of
wrinkles; reduction of cellulite; skin tightening; circumferential
reduction.
[0144] The present invention provides a device for improving the
cosmetic appearance of the skin, comprising: [0145] N pairs of
electrodes, each of said pairs in independent communication with
energy generating means, said electrodes configured to transmit
said energy to said skin; [0146] energy generating means for
generating N independent energy signals of predetermined waveforms,
frequencies, amplitudes, and relative phases; [0147] control means
for controlling the output of said energy generating means, said
control means in communication with said energy generating means;
and, [0148] an electrically insulating casing adapted to hold said
electrodes such that said electrodes may be placed in simultaneous
physical contact with said skin; [0149] wherein said N independent
energy signals are phase shifted relative to one another.
[0150] As an example, the present invention further provides a
device for skin rejuvenation, adapted to apply RF energy to the
skin that comprises a plurality of pairs of RF electrodes in which
each pair of electrodes transmits RF energy shifted in phase
relative to the other pairs of electrodes. By this means, an
essentially constant amount of RF energy can be transmitted to the
skin while maintaining the benefits of RF irradiation discussed
above.
[0151] Yet more, it is an object of the present invention to
disclose the device as disclosed above, wherein the energy emitted
is RF energy.
[0152] Thus, it is another object of the present invention to
provide a device for improving the cosmetic appearance of the skin,
comprising (a) N pairs of RF electrodes, each of said pairs in
independent communication with said RF generating means, said RF
electrodes configured to transmit RF energy to said skin; (b) RF
generating means for generating N independent RF signals of
predetermined waveforms, frequencies, amplitudes, and relative
phases; (c) control means for controlling the output of said RF
generating means, said control means in communication with said RF
generating means; and, (d) an electrically insulating casing
adapted to hold said RF electrodes such that said RF electrodes may
be placed in simultaneous physical contact with said skin. It is
within the essence of the invention wherein said N independent RF
signals are phase shifted relative to one another.
[0153] It is a further object of this invention to disclose such a
device, wherein the time-dependent amplitude A.sub.t,m of the mth
of said N independent RF signals is given by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth RF
signal.
[0154] It is a further object of this invention to disclose such a
device, wherein for each of said N independent RF signals,
.phi..sub.m=.pi.k(j-1)/N , where 0.ltoreq.k.ltoreq.1, m=1, 2, 3 . .
. N and j=1,2,3 . . . ; where N is the number of said pairs of
electrodes.
[0155] The following description is provided to the application of
RF energy, however it is to be emphasized that the following method
can be applied to any type of energy and it is not limited to the
application of merely RF.
[0156] Reference is now made to FIG. 1, which presents a schematic
view (not to scale) of one embodiment 10 of the device disclosed in
the present invention. The embodiment comprises a plurality of N
pairs of electrodes (i.e. a total of 2 N electrodes) 100. The
electrodes are in communication 110 with a source of RF radiation,
which is in communication with control means for controlling the
output of the RF source. Both the RF source and control means are
not shown in the figure. Any suitable means known in the art for
production of RF radiation and control of the resulting RF output
may be used. While the means for communication shown in FIG. 1
incorporate a hardwired connection, any appropriate means of
communication with the RF source, including wireless communication
means, may be used. The electrodes are configured to transmit RF
radiation received from the RF source to the skin undergoing
cosmetic treatment. The electrodes and electrical connections are
enclosed within a casing 120 that is made of electrically
non-conducting material such as, for example, plastic. In preferred
embodiments, the electrodes are disposed about the distal end of
the casing such that all of the electrodes may be placed
simultaneously in physical contact with the skin undergoing
cosmetic treatment. While in preferred embodiments, the electrodes
are disposed about the circumference of a circle, the actual
geometrical arrangement of the electrodes may be any suitable
arrangement; non-limiting examples include linear, zigzag, on the
perimeter and/or within the area of a substantially polygonal,
circular, oval, or irregular shape, or any combination of the
above.
[0157] In order to ensure the user's safety, in preferred
embodiments of the invention, the device is adapted to operate
according to a medical electrical equipment standard chosen from
the group consisting of IEC 60601-2-35, IEC 60601-2-33, IEC
60601-2-29, IEC 60601-2-9, IEC 60601-2-5, IEC 60601-2-3, IEC
60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-3, IEC
60601-1-2, IEC 60601-1-1 and any combination thereof.
[0158] Reference is now made to FIG. 2, which shows a schematic
(not to scale) face-on view of an arrangement of electrodes on the
face of the distal portion of casing 120 according to one
embodiment of the invention. In this embodiment, the electrodes 100
are arranged about the circumference of a circle, and N=4 (N is the
number of pairs of electrodes). The four pairs of electrodes, where
each pair comprises electrodes connected by a diameter of the
circle, are labeled A, B, C, and D.
[0159] The RF generating means comprises means for producing N
independent RF signals of predetermined waveforms, frequencies,
amplitudes, and relative phases (it should be noted that N is also
the number of pairs of electrodes). Means for production of RF
signals with several independent output channels are well-known in
the art. In preferred embodiments, the waveforms, frequencies, and
amplitudes are chosen to be those that are most effective for skin
treatment. In preferred embodiments, the frequencies of the RF
signals are between about 1 Hz and about 100 MHz, and the power
transmitted by said RF electrodes and said RF generating means to
the skin undergoing cosmetic treatment is between 1 W and 700
W.
[0160] The RF output may be continuous wave or pulsed. In preferred
embodiments in which the RF output is pulsed, the pulses have
duration of between about 0.01 micro-sec and about 1 ms. However,
it should be pointed that the RF can be applied in a continues
mode.
[0161] According to another embodiment of the present invention,
there are provided means adapted to apply Pulsed Electromagnetic
Field Therapy (PEMF). In preferred embodiments in which the RF
output is pulsed, the pulses have duration of between about 0.1 ms
and about 1000 ms.
[0162] Uniquely to the invention disclosed herein relative to
devices and methods known in the art, the N independent RF signals
are phase-shifted relative to one another. The time dependent
amplitude A.sub.t,m of the mth RF signal is thus given according to
the relation
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a normalization constant (which is greater than or
equals to 1), F.sub.m is a periodic function of time, .omega..sub.m
is the angular frequency of the mth signal, and .phi..sub.m is the
phase shift of the mth signal. Note that while in preferred
embodiments of the invention, A.sub.0,m, F.sub.m, and .omega..sub.m
are the same for all N signals (it should be noted that N is
greater than or equals 1), and the phase shift between successive
signals is the same, embodiments in which any or all of these
parameters vary for the different signals are contemplated by the
inventor as being within the scope of the invention. In preferred
embodiments, F.sub.m is chosen from sine, cosine, square wave,
triangular wave, trapezoidal wave, sawtooth, and any combination
thereof. In embodiments in which the relative phase shifts from
signal to signals are equal, .phi..sub.m for the mth signal of the
N is given by the relation .phi..sub.m=.pi.k(j-1)N, where
0.ltoreq.k.ltoreq.1, m=1, 2, 3 . . . N and j=1,2,3 . . . ; where N
is the number of said pairs of electrodes.
[0163] Reference is now made to FIG. 3, which presents graphical
representations of non-limiting examples of RF signals that may be
applied to the electrode arrangement shown in FIG. 2. In these
graphs, the normalized amplitude of the signal is given as a
function of cot. In each graph, the curve corresponding to the
signal transmitted to a particular pair of electrodes is labeled
with the same letter as the corresponding pair of electrodes.
[0164] FIG. 3A presents an embodiment in which N is 4, F.sub.m is a
sine function, .phi..sub.m=.pi.k (j-1)/N where k=1 and N=4; and
A.sub.0, m is 1.
[0165] FIG. 3B presents an embodiment in which N is 4, F.sub.m is a
sine function, .phi..sub.m=.pi.k (j-1)/N where k=1 and N=4, and
A.sub.0, m is 1.
[0166] FIG. 3C presents an embodiment in which N is 4, F.sub.m is a
square wave function, .phi..sub.m=.pi.k (j-1)/N where k=1 and N=4;
in this case, for clarity of presentation, two cycles are shown
(i.e. the x-axis is actually 2 .omega.t), and the amplitudes of
curves B, C, and D have been offset from 1. Thus, A.sub.0, m for A
is 1; A.sub.0,m for B is 0.95, A.sub.0,m for C is 0.9; and,
A.sub.0,m for D is 0.85.
[0167] FIG. 3D presents an embodiment in which the waveform is a
sawtooth function and .phi..sub.m=.pi.k (j-1)/N where k=1 and N=4,
and A.sub.0,m is 1.
[0168] In some embodiments of the device, it also comprises means
for measuring the temperature of the skin being treated.
[0169] In preferred embodiments, the temperature measuring is
incorporated into casing 120 and disposed in such a manner that the
temperature sensor makes contact with the skin while the device is
in use.
[0170] In preferred embodiments of the invention that include a
temperature sensor, the sensor is chosen from the group consisting
of an impedance meter adapted to measure impedance across at least
one of said pairs of RF electrodes; a thermal sensor; a
thermometer; and any combination thereof.
[0171] In more preferred embodiments of the invention that include
a temperature sensor, control means 140 are programmed to regulate
the amount of RF energy transmitted to the skin such that the
temperature of the surface of the skin remains within a
predetermined range. Feedback mechanisms for raising or lowering
the output of a signal generator in response to and in correlation
with an input from an external sensor and means for incorporating
them into control mechanisms for signal generators are well-known
in the art, and any such feedback mechanism appropriate for the
control means may be used. In the most preferred embodiments that
include a temperature sensor, the temperature range may be (a) from
ambient temperature to 42.degree. C. or (b) between 30.degree. C.
and 100.degree. C.
[0172] It should be noted that according to one embodiment of the
present invention, the temperature sensors are embedded within the
device and according to another embodiment, the temperature sensors
are position on the surface of the device. According to other
embodiments, the temperature sensors come in contact with the skin
and according to another embodiment, the sensors are not in contact
with the skin.
[0173] In other embodiments of the invention, the device
incorporates cooling means adapted to cool the skin being treated.
In preferred embodiments that incorporate such cooling means, the
cooling means is chosen from the group consisting of wherein said
cooling means are chosen from the group consisting of a Peltier
effect cooling device, irrigation with cool water, and means for
blowing air across the skin. The cooling means may be integrated
into case 120 or applied outside of the casing either as a cooling
unit attached to the casing or as a separate unit.
[0174] In yet other embodiments of the invention, the RF electrodes
are further adapted to provide heat to the skin being treated.
[0175] Reference is now made to FIG. 4, which presents a schematic
(not to scale) illustration of one embodiment 20 of a device
according to the present invention that additionally incorporates a
device 200 for performing deep tissue diathermy. In preferred
embodiments of the invention that include a device for performing
deep tissue diathermy, the device is selected from the group
consisting of any devices emitting RF radiation and any other means
adapted for producing electrical current absorbed by subcutaneous
tissue.
[0176] In more preferred embodiments of the invention in which a
deep tissue diathermy device is incorporated, the electrodes that
provide the pulsed electromagnetic field (PEMF) therapy also
provide RF electrical current for the diathermy treatment. Examples
of how to incorporate deep tissue diathermy devices into a device
for PEMF therapy are disclosed in detail in U. S. Pat. Appl.
US2011/0130618; one of ordinary skill in the art will readily
understand how to apply the information disclosed in that
application to the device disclosed in the present invention.
[0177] In preferred embodiments of the invention in which it
incorporates a deep tissue diathermy device, the deep tissue
diathermy device further incorporates at least one electrical
output device adapted to generate RF electromagnetic energy; and at
least two electrodes electrically coupled to said electrical output
device and placed on said skin region, wherein all said electrodes
are adapted to simultaneously apply said RF energy to said
skin.
[0178] In more preferred embodiments of the invention in which it
incorporates a deep tissue diathermy device, the deep tissue
diathermy device incorporates in addition at least one electrical
output device adapted to generate electrical current; and at least
two electrodes electrically coupled to said electrical output
device and placed on said skin region, wherein all of said
electrodes are adapted to simultaneously apply said electrical
current to said skin.
[0179] In the most preferred embodiments in which the device
incorporates a deep tissue diathermy device, it is chosen from the
group consisting of ultrasonic diathermy devices, optical diathermy
devices, electromagnetic induction diathermy devices, devices for
producing sound waves, acoustic, ultrasonic diathermy devices, and
devices for direct application of heat. In preferred embodiments in
which the deep tissue diathermy device is an optical device, it is
adapted to emit light in wavelengths absorbed by subcutaneous
tissue such that said subcutaneous tissue is heated. In other
preferred embodiments in which the deep tissue diathermy device is
a sonic or ultrasonic deep tissue diathermy device, it comprises a
device for producing sound waves adapted to emit sound waves of a
frequency absorbed by the subcutaneous tissue such that said
subcutaneous tissue is heated. All of these means for performing
deep tissue diathermy are well-known in the art, and any suitable
means for adapting or accommodating them to the present invention
may be used.
[0180] In yet other preferred embodiments of the invention, control
means 140 further comprise processing means adapted to store in a
communicable database predetermined parameters defining safe and
unsafe treatment parameters, said parameters chosen from the group
consisting of time t of said treatment, the temperature of said
skin, frequency, power, energy applied by said RF generating means,
depth to which said device operates, magnetic field intensity,
tissue impedance, specific absorption rate, superficial muscle
contractions and any combination thereof; sensing means adapted to
sense electromagnetic radiation and heat radiation parameters
chosen from a group consisting of time of said treatment,
temperature of said tissue, frequency, power, intensity of
ultrasound irradiation, energy applied by said RF generating means,
depth to which said device operates, magnetic field intensity,
tissue impedance, specific absorption rate, superficial muscle
contractions and any combination thereof; and regulating means
adapted to stop the operation of said device if said parameters are
determined to be unsafe. Such measuring, processing, and regulating
means are well-known in the art, and one skilled in the art will
readily understand how to incorporate them into the present
device.
[0181] In yet other preferred embodiments of the device, control
means 140 further comprise a feedback mechanism, adapted to change
the RF signal according to predetermined medical needs, and
comprising: sensing means adapted to monitor electrotherapy
parameters related to the level of skin rejuvenation and viability;
processing means, adapted to determine the degree of esthetic
improvement in at least one tissue parameter related to the level
of skin rejuvenation and vitality; and regulating means adapted to
stop the operation of said device when said degree of esthetic
improvement reaches a predetermined value. In more preferred
embodiments, the electrotherapy parameters and/or the tissue
parameters are chosen from the group consisting of dermal tensile
forces, tissue impedance, muscle contraction forces, skin
elasticity, and any combination thereof. In other preferred
parameters, the sensing means are adapted to sense electrotherapy
parameters are chosen from the group consisting of time of said
treatment, temperature of said tissue, frequency, power, tissue
impedance, superficial muscle contractions and any combination
thereof. Means for measuring these parameters and for providing
such a feedback mechanism and incorporating it into the device are
well-known in the art.
[0182] In yet other preferred embodiments of the device in which
control means 140 incorporate a feedback mechanism, the said
processing means are adapted to store in a communicable database
predetermined parameters defining safe and unsafe treatment
conditions. As above, "unsafe" treatment conditions include those
in which tissue damage or discomfort to the person being treated is
likely to result. In other preferred parameters, the predetermined
parameters are chosen from the group consisting of time of said
treatment, temperature of said tissue, frequency, power, tissue
impedance, superficial muscle contractions, and any combination
thereof.
[0183] In yet other embodiments of the invention disclosed herein,
it additionally comprises means for massaging said skin.
[0184] In yet other embodiments of the invention disclosed herein,
at least one of said RF electrodes additionally comprises a
hypodermic syringe for penetrating into subcutaneous tissue. By
means of such a syringe, a substance with appropriate activity may
be injected into the skin during treatment. Non-limiting examples
of such substances include a dye to absorb light in embodiments
that use optical means for effecting deep tissue diathermy, a
muscle relaxant, a local anesthetic, etc.
[0185] It is also within the scope of the invention to disclose a
method for providing cosmetic improvement to the skin, comprising
(a) generating N independent RF signals of predetermined waveforms,
frequencies, amplitudes, and relative phases; (b) transmitting each
of said N independent RF signals to a pair of electrodes; (c)
placing said electrodes in physical contact with said skin; and (d)
transmitting energy carried by said RF signals to said skin. It is
within the essence of the invention wherein said N independent RF
signals are phase-shifted relative to one another. In preferred
embodiments, the method is performed by using a device according to
any of the embodiments described in detail above.
[0186] It is also within the scope of the invention wherein said
step of generating N independent RF signals further comprises
generating N independent RF signals such that the time-dependent
amplitude A.sub.t,m of the mth of said N independent RF signals is
given by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth RF signal.
While in preferred embodiments of the method, the step of
generating N independent RF signals comprises a step in which
A.sub.0,m, F.sub.m, and .omega..sub.m are substantially the same
for all N signals, and .phi..sub.m is substantially the same for
any two pairs of signals m and m+1, this restriction is by no means
required, and it is within the scope of the invention to disclose a
method in which any or all of them are not identical for all N
signals. In preferred embodiments of the method in which
.phi..sub.m is substantially the same for all pairs of signals m
and m+1, the method further includes a step of providing said phase
shift .phi..sub.m for each of said N independent RF signals
according to the relationship .phi..sub.m=.pi.k(j-1)/N, where
0.ltoreq.k.ltoreq.1, m=1, 2, 3 . . . N and j=1,2,3 . . . ; where N
is the number of said pair of electrodes. For example, for one
electrode k=1, N=4 and the phase is 135 degrees and for another
electrode the phase will be 45 degrees, and another numbers can be
combined.
[0187] In preferred embodiments of the method, it further includes
a step of choosing F.sub.m from the group consisting of sine,
cosine, tan, cotangents (cot), sawtooth wave, triangular wave,
square wave, rectangular wave, trapezoidal wave, and any
combination of the above.
[0188] In other preferred embodiments of the method, the step of
generating N independent RF signals of predetermined waveforms,
frequencies, amplitudes, and relative phases comprises a step of
generating N independent RF signals with frequencies between about
1 Hz and about 100 MHz.
[0189] In other embodiments of the method, it further comprises a
step of transmitting said RF signals in pulses. In preferred
embodiments of the method in which the RF signals are transmitted
in pulses, the step of transmitting said RF signals in pulses
further comprises transmitting said pulses with pulse lengths of
between about 0.01 micro-sec and about 1 ms.
[0190] According to another embodiment, PEMF are provided.
According to another embodiment, the length of said PEMF is between
about 0.1 and about 1000 ms.
[0191] In other preferred embodiments of the method, it further
comprises a step of measuring the temperature of the surface of the
skin undergoing cosmetic treatment. In more preferred embodiments
of the method in which it further comprises a step of measuring the
temperature of the surface of the skin undergoing cosmetic
treatment, the step of measuring the temperature of the surface of
said skin further comprises measuring the temperature of the
surface of said skin by means of at least one sensor chosen from
the group consisting of impedance meter adapted to measure
impedance across at least one of said pairs of RF electrodes;
thermal sensor; thermometer; and any combination thereof.
[0192] In other preferred embodiments of the method, it further
comprises a step of regulating the amount of RF energy transmitted
to the skin undergoing cosmetic treatment such that the temperature
of said skin remains within a predetermined range. In more
preferred embodiments of the method in which the amount of RF
energy transmitted is regulated, the step of regulating the amount
of RF energy transmitted to said skin further comprises regulating
the amount of RF energy transmitted to said skin such that the
temperature of said skin remains in a range of (a) between ambient
temperature and 42.degree. C. or (b) between 30.degree. C. and
100.degree. C.
[0193] In the most preferred embodiments of the method, it further
comprises a step of disposing said electrodes within an
electrically insulating casing. This step may include disposing
about the distal end of said casing in a geometry chosen from the
group consisting of linear; zigzag; on the perimeter of a shape
chosen from substantially polygonal, circular, oval, or irregular;
within the area of a shape chosen from substantially polygonal,
circular, oval, or irregular; and any combination of the above.
[0194] In other preferred embodiments of the method, it further
comprises a step of transmitting to said skin a power of between 1
W and 700 W by said RF electrodes and said RF generating means.
[0195] In other preferred embodiments of the method, it further
comprises a step of providing a cosmetic improvement to the skin
chosen from the group consisting of skin rejuvenation, reduction of
the number of wrinkles, reduction of the depth of wrinkles,
reduction of cellulite, skin tightening, circumferential reduction,
and any combination of the above.
[0196] In other preferred embodiments of the method, it further
comprises a step of cooling the skin undergoing cosmetic treatment.
In the most preferred embodiments of the method in which it
comprises a step of cooling the skin undergoing cosmetic treatment,
the step of cooling said skin further comprises cooling said skin
by the use means chosen from the group consisting of a Peltier
effect cooling device, irrigation with cool water, and means for
blowing air across the skin.
[0197] In other preferred embodiments of the method, it further
comprises a step of heating said skin by means of said RF
electrodes.
[0198] In other preferred embodiments of the method, it further
comprises a step of performing deep tissue diathermy. In more
preferred embodiments of the invention in which it comprises a step
of performing deep tissue diathermy, the of performing deep tissue
diathermy further comprises performing deep tissue diathermy by a
method chosen from the group consisting of emitting RF radiation
and producing electrical current absorbed by subcutaneous
tissue.
[0199] In the most preferred embodiments of the method in which it
includes a step of performing deep tissue diathermy, the step of
performing deep tissue diathermy further comprises generating RF
electromagnetic energy by use of at least one electrical output
device; coupling at least two electrodes to said at least one
electrical output device; and applying simultaneously said RF
energy to said skin. Additionally or alternatively, the step of
performing deep tissue diathermy may further comprise generating
electrical current by means of at least one electrical output;
coupling electrically at least two electrodes electrically to said
electrical output; placing said electrodes on said skin; and
applying simultaneously said electrical current to said skin.
[0200] In other preferred embodiments of the method that include a
step of performing deep tissue diathermy, the step of performing
deep tissue diathermy further comprises performing deep tissue
diathermy by a means chosen from the group consisting of ultrasonic
diathermy devices, optical diathermy devices, electromagnetic
induction diathermy devices, devices for producing sound waves,
ultrasonic diathermy devices, and devices for direct application of
heat.
[0201] In other preferred embodiments of the method that include a
step of performing deep tissue diathermy, the step of performing
deep tissue diathermy further comprises performing deep tissue
diathermy by means of an optical device adapted to emit light in
wavelengths absorbed by subcutaneous tissue such that said
subcutaneous tissue is heated.
[0202] In other preferred embodiments of the method that include a
step of performing deep tissue diathermy, the step of performing
deep tissue diathermy further comprises performing deep tissue
diathermy by means of a device for producing sound waves adapted to
emit sound waves of a frequency absorbed by the subcutaneous tissue
such that said subcutaneous tissue is heated.
[0203] In other preferred embodiments of the method that include a
step of performing deep tissue diathermy, the method further
comprises steps of monitoring physical tissue parameters; and
changing at least one of (a) the amount of heat applied and (b) the
form of said RF in response to the values of said physical tissue
parameters.
[0204] In yet other preferred embodiments of the method that
include a step of performing deep tissue diathermy, it further
comprises steps of storing in a communicable database predetermined
parameters defining safe and unsafe treatment parameters, said
parameters chosen from the group consisting of time t of said
treatment, the temperature of said skin, frequency, power, energy
applied by said RF generating means, depth to which said device
operates, magnetic field intensity, tissue impedance, specific
absorption rate, superficial muscle contractions and any
combination thereof; sensing electromagnetic radiation and heat
radiation parameters chosen from a group consisting of time of said
treatment, temperature of said tissue, frequency, power, intensity
of ultrasound irradiation, energy applied by said RF generating
means, depth to which said device operates, magnetic field
intensity, tissue impedance, specific absorption rate, superficial
muscle contractions and any combination thereof; and ceasing the
continued performance of said method if said parameters are
determined to be unsafe.
[0205] In yet other preferred embodiments of the method that
include a step of performing deep tissue diathermy, it further
comprises steps of monitoring electrotherapy parameters related to
the level of skin rejuvenation and viability; determining the
degree of esthetic improvement in at least one tissue parameter
related to the level of skin rejuvenation and vitality; and ceasing
the continued performance of said method when said degree of
esthetic improvement reaches a predetermined value. In more
preferred embodiments, the step of monitoring electrotherapy
parameters further comprises monitoring at least one parameter
chosen from the group consisting of dermal tensile forces, tissue
impedance, muscle contraction forces, and skin elasticity.
Alternatively or additionally, the step of determining the degree
of esthetic improvement in at least one tissue parameter related to
the level of skin rejuvenation and vitality further comprises a of
determining the degree of esthetic improvement in at least one
parameter chosen from the group consisting of dermal tensile
forces, tissue impedance, muscle contraction forces, and skin
elasticity; it may further include a step of monitoring
electrotherapy parameters chosen from the group consisting of time
of said treatment, temperature of said tissue, frequency, power,
tissue impedance, superficial muscle contractions and any
combination thereof. In yet other preferred embodiments of the
method that include a step of performing deep tissue diathermy, it
further comprises a step of storing in a communicable database
predetermined parameters defining safe and unsafe treatment
conditions. In more preferred embodiments, the step of storing in a
communicable database predetermined parameters defining safe and
unsafe treatment conditions further comprises storing in a
communicable database at least one parameters chosen from the group
consisting of time of said treatment, temperature of said tissue,
frequency, power, tissue impedance, and superficial muscle
contractions.
[0206] In yet other preferred embodiments of the method, it further
comprises a step of massaging the skin undergoing cosmetic
treatment.
[0207] In yet other preferred embodiments of the method, it further
comprises a step of incorporating a hypodermic syringe for
penetrating into subcutaneous tissue into at least one of said
electrodes.
[0208] It should be emphasized that the above mentioned application
of RF energy is given as an example and the same method can be
applied by using any type of energy source (e.g., ultrasound,
light, laser, electrical energy, magnetic field and any combination
thereof).
[0209] Therefore, it is a core concept of the present invention to
provide a device for improving the cosmetic appearance of the skin,
comprising: [0210] N pairs of electrodes, each of said pairs in
independent communication with energy generating means, said
electrodes configured to transmit said energy to said skin; [0211]
energy generating means for generating N independent energy signals
of predetermined waveforms, frequencies, amplitudes, and relative
phases; [0212] control means for controlling the output of said
energy generating means, said control means in communication with
said energy generating means; and, [0213] an electrically
insulating casing adapted to hold said electrodes such that said
electrodes may be placed in simultaneous physical contact with said
skin; [0214] wherein said N independent energy signals are phase
shifted relative to one another.
[0215] According to another embodiment of the present invention,
the time-dependent amplitude A.sub.t,m of the mth of said N
independent energy signals is given by the relationship
A.sub.t,m=A.sub.0,mF.sub.m(.omega..sub.mt+.phi..sub.m), where
A.sub.0,m is a predetermined constant which greater than or equals
to 1, F.sub.m is a predetermined periodic function of time,
.omega..sub.m is the angular frequency of the mth RF signal, and
.phi..sub.m is a predetermined phase shift of the mth energy
signal.
[0216] According to another embodiment of the present invention,
for each of said N independent energy signals,
.phi..sub.m=.pi.k(j-1)/N , where 0.ltoreq.k.ltoreq.1, m=1, 2, 3 . .
. N and j=1,2,3 . . . ; where Nis the amount of said electrodes
pairs.
[0217] According to another embodiment of the present invention,
the energy is selected from a group consisting of ultrasound,
laser, light, electrical energy, magnetic field and any combination
thereof.
[0218] According to another embodiment of the present invention,
F.sub.m is chosen from the group consisting of sine, cosine, tan,
cotangents (cot), sawtooth wave, triangular wave, square wave,
rectangular wave, trapezoidal wave, and any combination of the
above. [0219] Although the invention has been described in
conjunction with specific embodiments thereof, it is evident that
many alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the scope of the appended claims, with the proper scope
determined only by the broadest interpretation of the claims.
[0220] All publications, patents and patent applications mentioned
in this specification are herein incorporated in their entirety by
reference into the specification, to the same extent as if each
individual publication, patent or patent application was
specifically and individually indicated to be incorporated herein
by reference. In addition, citation or identification of any
reference in this application shall not be construed as an
admission that such reference is available as prior art to the
present invention.
* * * * *