U.S. patent application number 17/518243 was filed with the patent office on 2022-09-29 for device and method for unattended treatment of a patient.
The applicant listed for this patent is BTL Healthcare Technologies a.s.. Invention is credited to Lucia JEL NKOV, Vojtech KUBIK, Tomas SCHWARZ.
Application Number | 20220305275 17/518243 |
Document ID | / |
Family ID | 1000006417522 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220305275 |
Kind Code |
A1 |
SCHWARZ; Tomas ; et
al. |
September 29, 2022 |
DEVICE AND METHOD FOR UNATTENDED TREATMENT OF A PATIENT
Abstract
An unattended approach can increase the reproducibility and
safety of the treatment as the chance of over/under treating of a
certain area is significantly decreased. On the other hand,
unattended treatment of uneven or rugged areas can be challenging
in terms of maintaining proper distance or contact with the treated
tissue, mostly on areas which tend to differ from patient to
patient (e.g. facial area). Delivering energy via a system of
active elements embedded in a flexible pad adhesively attached to
the skin offers a possible solution. The unattended approach may
include delivering of multiple energies to enhance a visual
appearance.
Inventors: |
SCHWARZ; Tomas; (Prague,
CZ) ; JEL NKOV ; Lucia; (Prague, CZ) ; KUBIK;
Vojtech; (Prague, CZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BTL Healthcare Technologies a.s. |
Prague 2 |
|
CZ |
|
|
Family ID: |
1000006417522 |
Appl. No.: |
17/518243 |
Filed: |
November 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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PCT/IB2021/000300 |
May 3, 2021 |
|
|
|
17518243 |
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63019619 |
May 4, 2020 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/40 20130101 |
International
Class: |
A61N 1/40 20060101
A61N001/40 |
Claims
1. A device for non-invasive treatment for an improvement of a
visual appearance of a patient comprising: a primary
electromagnetic generator generating an electromagnetic energy; a
secondary generator generating a secondary energy; a switching
circuitry; a pad configured to be attached to a treatment area of
the body of the patient; at least one active element attached to
the treatment area configured to deliver electromagnetic energy
from the primary electromagnetic generator or the secondary energy
from the secondary generator to the treatment area; a CPU
controlling an energy delivered from the primary electromagnetic
generator and the secondary energy generator to the at least one
active element, wherein the at least one active element is disposed
in the pad.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of International
Application no. PCT/IB2021/00300, filed May 3, 2021, now pending,
which claims priority to U.S. Provisional Application No.
63/019,619, filed on May 4, 2020, both of which are incorporated
herein by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to methods and apparatus for
patient treatment by means of active elements delivering
electromagnetic energy and/or secondary energy in such a way that
the treatment area is treated homogeneously without the need for
manipulation of the active elements during the therapy.
BACKGROUND OF THE INVENTION
[0003] Skin ages with time mostly due to UV exposure--a process
known as photoaging. Everyday exposure to UV light gradually leads
to decreased skin thickness and a lower amount of the basic
building proteins in the skin--collagen and elastin. The amounts of
a third major skin component are also diminished, those of
hyaluronic acid. These changes appear more quickly on the visible
parts of the body, most notably the face. There are several
technologies used for facial non-invasive skin rejuvenation such as
lasers, high-intensity focused ultrasound and radiofrequency. It is
expected that the ultrasound and RF fields also lead to an increase
in levels of hyaluronic acid in the dermis.
[0004] Delivering various forms of electromagnetic energy into a
patient for medical and cosmetic purposes has been widely used in
the past. These common procedures for improvement of a visual
appearance include, but are by no means limited to, skin
rejuvenation, wrinkle removal, rhytides, skin tightening and
lifting, cellulite and fat reduction, treatment of pigmented
lesions, tattoo removal, soft tissue coagulation and ablation,
vascular lesion reduction, face lifting, muscle contractions and
muscle strengthening, temporary relief of pain, muscle spasms,
increase in local circulation etc.
[0005] Besides many indisputable advantages of thermal therapies,
these procedures also bring certain limitations and associated
risks. Among others is the limited ability of reproducible results
as these are highly dependent on applied treatment techniques and
the operator's capabilities. Moreover, if the therapy is performed
inappropriately, there is an increased risk of burns and adverse
events.
[0006] It is very difficult to ensure a homogeneous energy
distribution if the energy delivery is controlled via manual
movement of the operator's hand which is the most common procedure.
Certain spots can be easily over- or under-treated. For this
reason, devices containing scanning or other mechanisms capable of
unattended skin delivery have emerged. These devices usually
deliver energy without direct contact with the treated area, and
only on a limited, well-defined area without apparent unevenness.
Maintaining the same distance between the treated tissue and the
energy generator or maintaining the necessary tissue contact may be
challenging when treating uneven or rugged areas. Therefore, usage
of commonly available devices on such specific areas that moreover
differ from patient to patient (e.g. the face) might be virtually
impossible.
[0007] Facial unattended application is, besides the complications
introduced by attachment to rugged areas and necessity of
adaptation to the shapes of different patients, specific by its
increased need for protection against burns and other side effects.
Although the face heals more easily than other body areas, it is
also more exposed, leading to much higher requirements for
treatment downtime. Another important aspect of a facial procedure
is that the face hosts the most important human senses, whose
function must not be compromised during treatment. Above all, eye
safety must be ensured throughout the entire treatment.
[0008] The current aesthetic market offers either traditional
manually controlled radiofrequency or light devices enabling facial
tissue heating to a target temperature in the range of 40.degree.
C.-100.degree. C. or unattended LED facial masks whose operation is
based on light effects (phototherapy) rather than thermal effects.
These masks are predominantly intended for home use and do not pose
a risk to patients of burns, overheating or overtreating. The
variability in facial shapes of individual patients does not
represent any issue for these masks as the delivered energy and
attained temperatures are so low that the risk of thermal tissue
damage is minimized and there is no need for homogeneous treatment.
Also, due to low temperatures, it is not important for such devices
to maintain the predetermined distance between the individual
diodes and the patient's skin, and the shape of the masks is only a
very approximate representation of the human face. But their use is
greatly limited by the low energy and minimal to no thermal effect
and they are therefore considered as a preventive tool for daily
use rather than a method of in-office skin rejuvenation with
immediate effect.
[0009] Nowadays, the aesthetic market feels the needs of the
combination of the heating treatment made by electromagnetic energy
delivered to the epidermis, dermis, hypodermis or adipose tissue
with the secondary energy providing muscle contraction or muscle
stimulation in the field of improvement of visual appearance of the
patient. However, none of the actual devices is adapted to treat
the uneven rugged areas like the face. In addition, the
commercially available devices are usually handheld devices that
need to be operated by the medical professional during the whole
treatment.
[0010] Thus it is necessary to improve medical devices providing
more than one treatment energy (e.g. electromagnetic energy and
electric current), such that both energies may be deliver via
different active elements or the same active element (e.g.
electrode). Furthermore, the applicator or pad of the device needs
to be attached to the patient which allows unattended treatment of
the patient and the applicator or pad needs to be made of flexible
material allowing sufficient contact with the uneven treatment area
of the body part of the patient.
SUMMARY OF THE INVENTION
[0011] In order to enable well defined unattended treatment of the
uneven, rugged areas of a patient (e.g. facial area) while
preserving safety, methods and devices of minimally invasive to
non-invasive electromagnetic energy delivery via a single or a
plurality of active elements have been proposed.
[0012] The patient may include skin and a body part, wherein a body
part may refer to a body area.
[0013] The desired effect of the improvement of visual appearance
of the patient may include tissue (e.g. skin) heating in the range
of 37.5.degree. C. to 55.degree. C., tissue coagulation at
temperatures of 50.degree. C. to 70.degree. C. or tissue ablation
at temperatures of 55.degree. C. to 130.degree. C. depending on the
patient. Various patients and skin conditions may require different
treatment approaches--higher temperatures allow better results with
fewer sessions but require longer healing times while lower
temperatures enable treatment with no downtime but limited results
within more sessions. Another effect of the heating may lead to
decreasing the number of the fat cells.
[0014] Another desired effect may be muscle contraction causing
muscle stimulation (e.g. strengthening or toning) for improving the
visual appearance of the patient.
[0015] An arrangement for contact or contactless therapy has been
proposed.
[0016] For contact therapy, the proposed device and methods
comprise at least one electromagnetic energy generator inside a
main unit that generates an electromagnetic energy which is
delivered to the treatment area via at least one active element
attached to the skin. At least one active element may be embedded
in a pad made of flexible material that adapts to the shape of the
rugged surface. An underside of the pad may include of an adhesive
layer allowing the active elements to adhere to the treatment area
and to maintain necessary tissue contact. Furthermore, the device
may employ a safety system capable of adjusting one or more therapy
parameters based on the measured values from at least one sensor,
e.g. thermal sensors or impedance measurement sensors capable of
measuring quality of contact with the treated tissue.
[0017] For contactless therapy, the proposed device and methods
comprise at least one electromagnetic energy generator inside a
main unit that generates an electromagnetic energy which is
delivered to the treatment area via at least one active element
located at a defined distance from the tissue to be treated. A
distance of at least one active element from the treatment area may
be monitored before, throughout the entire treatment or
post-treatment. Furthermore, the device may employ a safety system
capable of adjusting one or more therapy parameters based on the
measured values from at least one sensor, for example one or more
distance sensors. Energy may be delivered by a single or a
plurality of static active elements or by moving a single or a
plurality of active elements throughout the entire treatment area,
for example via a built-in automatic moving system, e.g. an
integrated scanner. Treatment areas may be set by means of laser
sight--the operator may mark the area to be treated prior to the
treatment.
[0018] The active element may deliver energy through its entire
surface or by means of a so-called fractional arrangement when the
active part includes a matrix formed by points of defined size.
These points may be separated by inactive (and therefore untreated)
areas that allow faster tissue healing. The points surface may make
up from 1% to 99% of the active element area.
[0019] The electromagnetic energy may be primarily generated by a
laser, laser diode module, LED, flash lamp or incandescent light
bulb or by radiofrequency generator for causing the heating of the
patient. Additionally, an acoustic energy or electric or
electromagnetic energy, which does not heat the patient, may be
delivered simultaneously, alternately or in overlap with the
primary electromagnetic energy.
[0020] The active element may deliver more than one energy
simultaneously (at the same time), successively or in overlap. For
example, the active element may deliver a radiofrequency energy and
subsequently an electric energy (electric current). In another
example, the active element may deliver the radiofrequency energy
and the electric energy at the same time.
[0021] Furthermore the device may be configured to deliver the
electromagnetic field by at least one active element and
simultaneously (at the same time) to deliver e.g. electric energy
by a different elements.
[0022] Thus the proposed methods and devices may lead to
improvement of a visual appearance including, but by no means
limited to a proper skin rejuvenation, wrinkle removal, skin
tightening and lifting, cellulite and fat reduction, treatment of
pigmented lesions, rhytides, tattoo removal, soft tissue
coagulation and ablation, vascular lesions reduction, temporary
relief of pain, muscle spasms, increase in local circulation, etc.
of uneven rugged areas without causing further harm to important
parts of the patient's body, e.g. nerves or internal organs. The
proposed method and devices may lead to an adipose tissue
reduction, e.g. by fat cells lipolysis or apoptosis.
[0023] Furthermore, the proposed methods and devices may lead to
improvement of a visual appearance, e.g. tissue rejuvenation via
muscle strengthening or muscle toning through muscle contractions
caused by electric current or electromagnetic energy and via
elastogenesis and/or neocolagenesis and/or relief of pain and/or
muscle spasms and/or increase in local circulation through heating
by radiofrequency energy.
[0024] Alternatively, the proposed devices and methods may be used
for post-surgical treatment, e.g. after liposuction, e.g. for
treatment and/or healing of the wounds caused by surgery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 shows a block diagram of an apparatus for contact
therapy.
[0026] FIG. 2 is an illustration of an apparatus for contact
therapy.
[0027] FIG. 3A represents pad shapes and layout.
[0028] FIG. 3B represents pad shapes and layout.
[0029] FIG. 3C represents one possible pad shape and layout for
treatment of a forehead.
[0030] FIG. 3D represent one possible pad shape and layout for
treatment of a cheek.
[0031] FIG. 4A, FIG. 4B, FIG. 4C, and FIG. 4D represent side views
of the pad intended for contact therapy.
[0032] FIG. 5A represents a top view of one variant of the pad.
[0033] FIG. 5B represents a detail view of one possible arrangement
of the slot in the substrate.
[0034] FIG. 6 shows one variant of energy delivery by switching
multiple active elements.
[0035] FIG. 7 shows a block diagram of an apparatus for contactless
therapy.
[0036] FIG. 8 is an illustration of an apparatus for contactless
therapy.
[0037] FIG. 9A is an illustration of the framed grated
electrode.
[0038] FIG. 9B is an illustration of another framed grated
electrode.
[0039] FIG. 9C is an illustration of a framed grated electrode with
thinning conductive lines.
[0040] FIG. 9D is an illustration of a non-framed grated
electrode.
[0041] FIG. 9E is an illustration of an electrode with
openings.
[0042] FIG. 9F is one possible illustration of an electrode.
[0043] FIG. 9G is another illustration of an electrode.
[0044] FIG. 9H is another illustration of an electrode.
[0045] FIG. 10 is an illustration of a forehead pad treatment.
DETAILED DESCRIPTION
[0046] The presented methods and devices may be used for
stimulation and/or treatment of a tissue, including but not limited
to skin, epidermis, dermis, hypodermis or muscles. The proposed
apparatus is designed for minimally to non-invasive treatment of
one or more areas of the tissue to enable well defined unattended
treatment of the uneven, rugged areas (e.g. facial area) by
electromagnetic energy delivery via a single or a plurality of
active elements without causing further harm to important parts of
the patient's body, e.g. nerves or internal organs.
[0047] Additionally the presented methods and devices may be used
to stimulate body parts or body areas like head, neck, bra fat,
love handles, torso, back, abdomen, buttocks, thighs, calves, legs,
arms, forearms, hands, fingers or body cavities (e.g. vagina, anus,
mouth, inner ear etc.).
[0048] The proposed methods and devices may include a several
protocols improving of visual appearance, which may be preprogramed
in the control unit (e.g. CPU--central processing unit, which may
include a flex circuit or a printed circuit board and may include a
microprocessor or memory for controlling the device).
[0049] The desired effect may include tissue (e.g. a surface of the
skin) heating (thermal therapy) in the range of 37.5.degree. C. to
55.degree. C. or in the range of 38.degree. C. to 53.degree. C. or
in the range of 39.degree. C. to 52.degree. C. or in the range of
40.degree. C. to 50.degree. C. or in the range of 41.degree. C. to
45.degree. C., tissue coagulation at temperatures in the range of
50.degree. C. to 70.degree. C. or in the range of 51.degree. C. to
65.degree. C. or in the range of 52.degree. C. to 62.degree. C. or
in the range of 53.degree. C. to 60.degree. C. or tissue ablation
at temperatures in the range of 55.degree. C. to 130.degree. C. or
in the range of 58.degree. C. to 120.degree. C. or in the range of
60.degree. C. to 110.degree. C. or in the range of 60.degree. C. to
100.degree. C. The device may be operated in contact or in
contactless methods. For contact therapy a target temperature of
the skin may be typically within the range of 37.5.degree. C. to
95.degree. C. or in the range of 38.degree. C. to 90.degree. C. or
in the range of 39.degree. C. to 85.degree. C. or in the range of
40.degree. C. to 80.degree. C. while for contactless therapy a
target temperature of the skin may be in the range of 37.5.degree.
C. to 130.degree. C. or in the range of 38.degree. C. to
120.degree. C. or in the range of 39.degree. C. to 110.degree. C.
or in the range of 40.degree. C. to 100.degree. C. The temperature
within the range of 37.5.degree. C. to 130.degree. C. or in the
range of 38.degree. C. to 120.degree. C. or in the range of
39.degree. C. to 110.degree. C. or in the range of 40.degree. C. to
100.degree. C. may lead to stimulation of fibroblasts and formation
of connective tissue--e.g. collagen, elastin, hyaluronic acid etc.
Depending on the target temperature, controlled tissue damage is
triggered, physiological repair processes are initiated, and new
tissue is formed. Temperatures within the range of 37.5.degree. C.
to 130.degree. C. or in the range of 38.degree. C. to 120.degree.
C. or in the range of 39.degree. C. to 110.degree. C. or in the
range of 40.degree. C. to 100.degree. C. may further lead to
changes in the adipose tissue. During the process of apoptosis
caused by high temperatures, fat cells come apart into apoptotic
bodies and are further removed via the process of phagocytosis.
During a process called necrosis, fat cells are ruptured due to
high temperatures, and their content is released into an
extracellular matrix. Both processes may lead to a reduction of fat
layers enabling reshaping of the face. Removing fat from the face
may be beneficial for example in areas like submentum or
cheeks.
[0050] Another desired effect may include tissue rejuvenation, e.
g. muscle strengthening through the muscle contraction caused by
electric or electromagnetic energy, which doesn't heat the patient,
or the muscle relaxation caused by a pressure massage. The combined
effect of muscle contractions via electric energy and tissue (e.g.
skin) heating by electromagnetic field in accordance to the
description may lead to significant improvement of visual
appearance.
[0051] FIG. 1 and FIG. 2 are discussed together. FIG. 1 shows a
block diagram of an apparatus 1 for contact therapy. FIG. 2 is an
illustration of an apparatus 1 for contact therapy. The apparatus 1
for contact therapy may comprise two main blocks: main unit 2 and a
pad 4. Additionally, the apparatus 1 may comprise interconnecting
block 3 or neutral electrode 7. However, the components of
interconnecting block 3, may be implemented into the main unit
2.
[0052] Main unit 2 may include one or more generators: a primary
electromagnetic generator 6, which may preferably deliver
radiofrequency energy in the range of 10 kHz to 300 GHz or 300 kHz
to 10 GHz or 400 kHz to 6 GHz, or in the range of 100 kHz to 550
MHz or 250 kHz to 500 MHz or 350 kHz to 100 MHz or 400 kHz to 80
MHz, a secondary generator 9 which may additionally deliver
electromagnetic energy, which does not heat the patient, or deliver
electric current in the range of 1 Hz to 10 MHz or 5 Hz to 5 MHz or
in the range of 10 Hz to 1 MHz or in the range of 20 Hz to 1 kHz or
in the range of 40 Hz to 500 Hz or in the range of 50 Hz to 300 Hz
and/or an ultrasound emitter 10 which may furthermore deliver an
acoustic energy with a frequency in the range of 20 kHz to 25 GHz
or 20 kHz to 1 GHz or 50 kHz to 250 MHz or 100 kHz to 100 MHz. In
addition, the frequency of the ultrasound energy may be in the
range of 20 kHz to 80 MHz or 50 kHz to 50 MHz or 150 kHz to 20
MHz.
[0053] The output power of the radiofrequency energy may be less
than or equal to 450, 300, 250 or 220 W. Additionally, the
radiofrequency energy on the output of the primary electromagnetic
generator 6 (e.g. radiofrequency generator) may be in the range of
0.1 W to 400 W, or in the range of 0.5 W to 300 W or in the range
of 1 W to 200 W or in the range of 10 W to 150 W. The
radiofrequency energy may be applied in or close to the ISM bands
of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz, 433.92 MHz, 915 MHz,
2.45 GHz and 5.8 GHz.
[0054] Main unit 2 may further comprise a human machine interface 8
represented by a display, buttons, a keyboard, a touchpad, a touch
panel or other control members enabling an operator to check and
adjust therapy and other device parameters. For example, it may be
possible to set the power, treatment time or other treatment
parameters of each generator (primary electromagnetic generator 6,
secondary generator 9 and ultrasound emitter 10) independently. The
human machine interface 8 may be connected to control unit 11 (e.g.
CPU). The power supply 5 located in the main unit 2 may include a
transformer, disposable battery, rechargeable battery, power plug
or standard power cord. The output power of the power supply 5 may
be in the range of 10 W to 600 W, or in the range of 50 W to 500 W,
or in the range of 80 W to 450 W.
[0055] In addition the human machine interface 8 may also display
information about the applied therapy type, remaining therapy time
and main therapy parameters.
[0056] Interconnecting block 3 may serve as a communication channel
between the main unit 2 and the pad 4. It may be represented by a
simple device containing basic indicators 17 and mechanisms for
therapy control. Indicators 17 may be realized through the display,
LEDs, acoustic signals, vibrations or other forms capable of
providing adequate notice to an operator and/or the patient.
Indicators 17 may indicate actual patient temperature, contact
information or other sensor measurements as well as a status of a
switching process between the active elements, quality of contact
with the treated tissue, actual treatment parameters, ongoing
treatment, etc. Indicators 17 may be configured to warn the
operator in case of suspicious therapy behavior, e.g. temperature
out of range, improper contact with the treated tissue, parameters
automatically adjusted etc. Interconnecting block 3 may be used as
an additional safety feature for heat-sensitive patients. It may
contain emergency stop button 16 so that the patient can stop the
therapy immediately anytime during the treatment. Switching
circuitry 14 may be responsible for switching between active
elements or for regulation of energy delivery from primary
electromagnetic generator 6, secondary generator 9 or ultrasound
emitter 10. The rate of switching between active elements 13 may be
dependent on the amount of delivered energy, pulse length etc,
and/or on the speed of switching circuitry 14 and control unit 11
(e.g. CPU). The switching circuitry 14 may include relay switch,
transistor (bipolar, PNP, NPN, FET, JFET, MOSFET) thyristor, diode
or opto-mechanical switch or any other suitable switch know in the
prior art. The switching circuitry in connection with the control
unit (e.g. CPU) may control the switching between the primary
electromagnetic energy generated by the primary electromagnetic
generator 6 and the secondary energy generated by the secondary
generator 9 on the at least one active element 13.
[0057] Additionally, the interconnecting block 3 may contain the
primary electromagnetic generator 6, the secondary generator 9 or
ultrasound emitter 10 or only one of them or any combination
thereof.
[0058] In one not limiting aspect, the main unit 2 may comprise the
primary electromagnetic generator 6, the interconnecting block 3
may comprise the secondary generator 9, and ultrasound emitter 10
may not be present at all.
[0059] The control unit 11 (e.g. CPU) controls the primary
electromagnetic generator 6 such that the primary electromagnetic
energy may be delivered in a continuous mode (CM) or a pulse mode
to the at least one active element, having a fluence in the range
of 10 mJ/cm.sup.2 to 50 kJ/cm.sup.2 or in the range of 100
mJ/cm.sup.2 to 10 kJ/cm.sup.2 or in the range of 0.5 J/cm.sup.2 to
1 kJ/cm.sup.2. The electromagnetic energy may be primarily
generated by a laser, laser diode module, LED, flash lamp or
incandescent light bulb or by radiofrequency generator for causing
the heating of the patient. The CM mode may be operated for a time
interval in the range of 0.05 s to 60 min or in the range of 0.1 s
to 45 min or in the range of 0.2 s to 30 min. The pulse duration of
the energy delivery operated in the pulse regime may be in the
range of 0.1 ms to 10 s or in the range of 0.2 ms to 7 s or in the
range of 0.5 ms to 5 s. The primary electromagnetic generator 6 in
the pulse regime may be operated by a control unit 11 (e.g. CPU) in
a single shot mode or in a repetition mode. The frequency of the
repetition mode may be in the range of 0.05 to 10 000 Hz or in the
range of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in the
range of 0.5 to 1000 Hz. Alternatively, the frequency of the
repetition mode may be in the range of 0.1 kHz to 200 MHz or in the
range of 0.5 kHz to 150 MHz or in the range of 0.8 kHz to 100 MHz
or in the range of 1 kHz to 80 MHz. The single shot mode may mean
generation of just one electromagnetic pulse of specific parameters
(e.g. intensity, duration, etc.) for delivery to a single treatment
area. The repetition mode may mean generation of an electromagnetic
pulses, which may have the specific parameters (e.g. intensity,
duration, etc.), with a repetition rate of the above-mentioned
frequency for delivery to a single treatment area. The control unit
(e.g. CPU) 11 may provide treatment control such as stabilization
of the treatment parameters including treatment time, power, duty
cycle, time period regulating switching between multiple active
elements, temperature of the device 1 and temperature of the
primary electromagnetic generator 6 and secondary generator 9 or
ultrasound emitter 10. The control unit 11 (e.g. CPU) may drive and
provide information from the switching circuitry 14. The control
unit 11 (e.g. CPU) may also receive and provide information from
sensors located on or in the pad 4 or anywhere in the device 1. The
control unit (e.g. CPU) 11 may include a flex circuit or a printed
circuit board and may include a microprocessor or memory for
controlling the device.
[0060] The control unit (e.g. CPU) 11 may control the secondary
generator 9 such that secondary energy (e.g electric current or
magnetic field) may be delivered in a continuous mode (CM) or a
pulse mode to the at least one active element, having a fluence in
the range of 10 mJ/cm.sup.2 to 50 kJ/cm.sup.2 or in the range of
100 mJ/cm.sup.2 to 10 kJ/cm.sup.2 or in the range of 0.5 J/cm.sup.2
to 1 kJ/cm.sup.2 on the surface of the at least one active element.
Applying the secondary energy to the treatment area of the patient
may cause a muscle contractions of the patient. The CM mode may be
operated for a time interval in the range of 0.05 s to 60 min or in
the range of 0.1 s to 45 min or in the range of 0.2 s to 30 min.
The pulse duration of the delivery of the secondary energy operated
in the pulse regime may be in the range of 0.1 .mu.s to 10 s or in
the range of 0.2 .mu.s to 1 s or in the range of 0.5 .mu.s to 500
ms, or in the range of 0.5 to 10 s or in the range of 1 to 8 s or
in the range of 1.5 to 5 s or in the range of 2 to 3 s. The
secondary generator 9 in the pulse regime may be operated by a
control unit 11 (e.g. CPU) in a single shot mode or in a repetition
mode. The frequency of the repetition mode may be in the range of
0.1 to 12 000 Hz or in the range of 0.1 to 8000 Hz or in the range
of 0.1 to 5000 Hz or in the range of 0.5 to 1000 Hz.
[0061] The proposed device may be multichannel device allowing the
control unit (e.g. CPU) 11 to control the treatment of more than
one treated area at once.
[0062] Alternatively, the interconnecting block 3 may not be a part
of the device 1, and the control unit (e.g. CPU) 11, switching
circuitry 14, indicators 17 and emergency stop button 16 may be a
part of the main unit 2 or pad 4. In addition, some of the control
unit (e.g. CPU) 11, switching circuitry 14, indicators 17 and
emergency stop button 16 may be a part of the main unit 2 and some
of them part of pad 4, e.g. control unit (e.g. CPU) 11, switching
circuitry 14 and emergency stop button 16 may be part of the main
unit 2 and indicators 17 may be a part of the pad 4.
[0063] Pad 4 represents the part of the device which may be in
contact with the patient's skin during the therapy. The pads 4 may
be made of flexible substrate material--for example polymer-based
material, polyimide (PI) films, Teflon.RTM., epoxy, polyethylene
terephthalate (PET), polyamide or PE foam with an additional
adhesive layer on an underside, e.g. a hypoallergenic adhesive gel
(hydrogel) or adhesive tape that may be bacteriostatic,
non-irritating, or water-soluble. The substrate may also be a
silicone-based substrate. The substrate may also be made of a
fabric, e.g. non-woven fabric. The adhesive layer may have the
impedance for a current at a frequency of 500 kHz in the range of 1
to 150.OMEGA. or in the range of 5 to 130.OMEGA. or in the range of
10 to 100.OMEGA., and the impedance for a current at a frequency of
100 Hz or less is three times or more the impedance for a current
at a frequency of 500 kHz. The adhesive hydrogel may be made of a
polymer matrix or mixture containing water, a polyhydric alcohol, a
polyvinylpyrrolidone, a polyisocyanate component, a polyol
component or has a methylenediphenyl structure in the main chain.
Additionally, a conductive adhesive may be augmented with metallic
fillers, such as silver, gold, copper, aluminum, platinum or
titanium or graphite that make up 1 to 90% or 2 to 80% or 5 to 70%
of adhesive. The adhesive layer may be covered by "ST-gel.RTM." or
"Tensive.RTM." conductive adhesive gel which is applied to the body
to reduce its impedance, thereby facilitating the delivery of an
electric shock.
[0064] The adhesive layer, e.g. hydrogel may cover exactly the
whole surface of the pad facing the body area of the patient. The
thickness of the hydrogel layer may be in the range of 0.1 to 3 mm
or in the range of 0.3 to 2 mm or in the range of 0.4 to 1.8 mm or
in the range of 0.5 to 1.5 mm.
[0065] The adhesive layer under the pad 4 may mean that the
adhesive layer is between the surface of the pad facing the patient
and the body of the patient. The adhesive layer may have impedance
1.1 times, 2 times, 4 times or up to 10 times higher than the
impedance of the skin of the patient under the pad 4. A definition
of the skin impedance may be that it is a portion of the total
impedance, measured between two equipotential surfaces in contact
with the epidermis, that is inversely proportional to the electrode
area, when the internal current flux path is held constant. Data
applicable to this definition would be conveniently recorded as
admittance per unit area to facilitate application to other
geometries. The impedance of the adhesive layer may be set by the
same experimental setup as used for measuring the skin impedance.
The impedance of the adhesive layer may be higher than the
impedance of the skin by a factor in the range of 1.1 to 20 times
or 1.2 to 15 times or 1.3 to 10 times.
[0066] The impedance of the adhesive layer may have different
values for the different types of energy delivered to the patient,
e.g. the impedance may be different for radiofrequency and for
electric current delivery. The impedance of the hydrogel may be in
the range of 100 to 2000 Ohms or in the range of 150 to 1800 Ohms
or 200 to 1500 Ohms or 300 to 1200 Ohms in case of delivery of the
electric current (e.g. during electrotherapy). In one aspect, the
impedance of an adhesive layer (e.g. hydrogel) for AC current at 1
kHz may be in the range of 1000 to 3000 Ohms, or of 1200 to 2800
Ohms, or of 1500 to 2500 Ohms. In another aspect, the impedance of
the adhesive layer (e.g. hydrogel) for AC current at 10 Hz may be
in the range of 2000 to 4000 Ohms, or of 2300 to 3700 Ohms, or of
2500 to 3500 Ohms.
[0067] The electric conductivity of the adhesive layer at
radiofrequency of 3.2 MHz may be in the range of 20 to 200 mS/m or
in the range of 50 to 140 mS/m or in the range of 60 to 120 mS/m or
in the range of 70 to 100 mS/m.
[0068] Alternatively, the adhesive layer may be a composition of
more elements, wherein some elements may have suitable physical
properties (referred to herein as adhesive elements), e.g. proper
adhesive and/or conductivity and/or impedance and/or cooling
properties and so on; and some elements may have nourishing
properties (referred to herein as nourishing elements), e.g. may
contain nutrients, and/or vitamins, and/or minerals, and/or organic
and/or inorganic substances with nourishing effect, which may be
delivered to the skin of the patient during the treatment. The
volumetric ratio of adhesive elements to nourishing elements may be
in the range of 1:1 to 20:1, or of 2:1 to 10:1, or of 3:1 to 5:1,
or of 5:1 to 50:1, or of 10:1 to 40:1, or of 15:1. In one aspect,
the adhesive layer composition may contain a hydrogel as an
adhesive element and a hyaluronic acid as a nourishing element. In
another aspect, the adhesive layer composition may contain a
hydrogel as an adhesive element and one or more vitamins as
nourishing elements. In another aspect, the adhesive layer
composition may contain a hydrogel as an adhesive element and one
or more minerals as nourishing elements. In another aspect, the
adhesive layer composition may contain a hydrogel as an adhesive
element and one or more minerals as nourishing elements.
[0069] In one aspect, the nourishing element may be released
continuously by itself during the treatment. In another aspect, the
nourishing element may be released due to delivery of a treatment
energy (e.g. radiofrequency, light, electric current or
ultrasound), which may pass through the nourishing element and thus
cause its release to the skin of the patient.
[0070] The pad 4 may also have a sticker on a top side of the pad.
The top side is the opposite side from the underside (the side
where the adhesive layer may be deposited) or in other words the
top side is the side of the pad that is facing away from the
patient during the treatment. The sticker may have a bottom side
and a top side, wherein the bottom side of the sticker may comprise
a sticking layer and the top side of the sticker may comprise
non-sticking layer (eg. polyimide (PI) films, Teflon.RTM., epoxy,
polyethylene terephthalate (PET), polyamide or PE foam, PE film or
PVC foam). The sticker covers the top side of the pad and may also
cover some sensors situated on the top side of the pad (e.g.
thermal sensors).
[0071] The sticker may have the same shape as the pad 4 or may have
additional overlap over the pad. The sticker may be bonded to the
pad such that the sticking layer of the bottom side of the sticker
is facing toward the top side of the pad 4. The top side of the
sticker facing away from the pad 4 may be made of a non-adhesive
layer. The linear dimension of the sticker with additional overlap
may exceed the corresponding dimension of the pad in the range of
0.1 to 10 cm, or in the range of 0.1 to 7 cm, or in the range of
0.2 to 5 cm, or in the range of 0.2 to 3 cm, or in the range of 0.3
to 1 cm. This overlap may also comprise an adhesive layer and may
be used to form additional and more proper contact of the pad with
the patient. The thickness of the sticker may be in the range of
0.05 to 3 mm or in the range of 0.1 to 2 mm or in the range of 0.5
to 1.5 mm. The top side of the sticker may have a printed
inscription for easy recognition of the pad, e.g. the brand of the
manufacturer or the proposed treated body area.
[0072] In one aspect, the adhesive layer, e.g. hydrogel, on the
underside of the pad facing the body area of the patient may cover
the whole surface of the pad and even overlap the surface of the
pad and cover at least partially the overlap of the sticking layer.
In another aspect, the underside of the adhesive layer and/or the
overlap of the sticker (both parts facing towards the patient) may
be covered by a liner, which may be removed just before the
treatment. The liner protects the adhesive layer and/or the overlap
of the sticker, thus when the liner is removed the proper adhesion
to the body area of the patient is ensured.
[0073] Alternatively, the pad 4 may comprise at least one suction
opening, e.g. small cavities or slits adjacent to active elements
or the active element may be embedded inside a cavity. The suction
opening may be connected via connecting tube to a pump which may be
part of the main unit 2. When the suction opening is brought into
contact with the skin, the air sucked from the suction opening
flows toward the connecting tube and the pump and the skin may be
slightly sucked into the suction opening. Thus by applying a vacuum
the adhesion of pad 4 may be provided. Furthermore, the pad 4 may
comprise the adhesive layer and the suction openings for combined
stronger adhesion.
[0074] In addition to the vacuum (negative pressure), the pump may
also provide a positive pressure by pumping the fluid to the
suction opening. The positive pressure is pressure higher than
atmospheric pressure and the negative pressure or vacuum is lower
than atmospheric pressure. Atmospheric pressure is a pressure of
the air in the room during the therapy.
[0075] The pressure (positive or negative) may be applied to the
treatment area in pulses providing a massage treatment. The massage
treatment may be provided by one or more suction openings changing
pressure value to the patient's soft tissue in the meaning that the
suction opening apply different pressure to patient tissue.
Furthermore, the suction openings may create a pressure gradient in
the soft tissue without touching the skin. Such pressure gradients
may be targeted on the soft tissue layer, under the skin surface
and/or to different soft tissue structure.
[0076] Massage accelerates and improves treatment therapy by
electromagnetic energy, electric energy or electromagnetic energy
which does not heat the patient, improves blood and/or lymph
circulation, angioedema, erythema effect, accelerates removing of
the fat, accelerate metabolism, accelerates elastogenesis and/or
neocolagenesis.
[0077] Each suction opening may provide pressure by a suction
mechanism, airflow or gas flow, liquid flow, pressure provided by
an object included in the suction opening (e.g. massaging object,
pressure cells etc.) and/or in other ways.
[0078] Pressure value applied on the patient's tissue means that a
suction opening providing massaging effect applies positive,
negative and/or sequentially changing positive and negative
pressure on the treated and/or adjoining patient's tissue
structures and/or creates a pressure gradient under the patient's
tissue surface
[0079] Massage applied in order to improve body liquid flow (e.g.
lymph drainage) and/or relax tissue in the surface soft tissue
layers may be applied with pressure lower than during the massage
of deeper soft tissue layers. Such positive or negative pressure
compared to the atmospheric pressure may be in a range of 10 Pa to
30 000 Pa, or in a range of 100 Pa to 20 000 Pa or in a range of
0.5 kPa to 19 kPa or in a range of 1 kPa to 15 kPa.
[0080] Massage applied in order to improve body liquid flow and/or
relaxation of the tissue in the deeper soft tissue layers may be
applied with higher pressure. Such positive or negative pressure
may be in a range from 12 kPa to 400 kPa or from 15 kPa to 300 kPa
or from 20 kPa to 200 kPa. An uncomfortable feeling of too high
applied pressure may be used to set a pressure threshold according
to individual patient feedback.
[0081] Negative pressure may stimulate body liquid flow and/or
relaxation of the deep soft tissue layers (0.5 cm to non-limited
depth in the soft tissue) and/or layers of the soft tissue near the
patient surface (0.1 mm to 0.5 cm). In order to increase
effectiveness of the massage negative pressure treatment may be
used followed by positive pressure treatment.
[0082] A number of suction openings changing pressure values on the
patient's soft tissue in one pad 4 may be between 1 to 100 or
between 1 to 80 or 1 to 40 or between 1 to 10.
[0083] Sizes and/or shapes of suction openings may be different
according to treated area. One suction opening may cover an area on
the patient surface between 0.1 mm.sup.2 to 1 cm.sup.2 or between
0.1 mm.sup.2 to 50 mm.sup.2 or between 0.1 mm.sup.2 to 40 mm.sup.2
or between 0.1 mm.sup.2 to 20 mm.sup.2. Another suction opening may
cover an area on the patient surface between 1 cm.sup.2 to 1
m.sup.2 or between 1 cm.sup.2 to 100 cm.sup.2 or between 1 cm.sup.2
to 50 cm.sup.2 or between 1 cm.sup.2 to 40 cm.sup.2.
[0084] Several suction openings may work simultaneously or
switching between them may be in intervals between 1 ms to 10 s or
in intervals between 10 ms to 5 s or in intervals between 0.5 s to
2 s.
[0085] Suction openings in order to provide massaging effect may be
guided according to one or more predetermined massage profile
included in the one or more treatment protocols. The massage
profile may be selected by the operator and/or by a control unit
(e.g. CPU) with regard to the patient's condition. For example a
patient with lymphedema may require a different level of
compression profile and applied pressure than a patient with a
healed leg ulcer.
[0086] Pressure applied by one or more suction openings may be
gradually applied preferably in the positive direction of the lymph
flow and/or the blood flow in the veins. According to specific
treatment protocols the pressure may be gradually applied in a
direction opposite or different from ordinary lymph flow. Values of
applied pressure during the treatment may be varied according to
the treatment protocol.
[0087] A pressure gradient may arise between individual suction
openings. Examples of gradients described are not limited for this
method and/or device. The setting of the pressure gradient between
at least two previous and successive suction openings may be: 0%,
i.e. The applied pressure by suction openings is the same (e.g.
pressure in all suction openings of the pad is the same);
[0088] 1%, i.e. The applied pressure between a previous and a
successive suction opening decreases and/or increases with a
gradient of 1% (e.g. the pressure in the first suction opening is 5
kPa and the pressure in the successive suction opening is 4.95
kPa);
[0089] 2%, i.e. The pressure decreases or increases with a gradient
of 2%. The pressure gradient between two suction openings may be in
a range 0% to 100% where 100% means that one suction openings is
not active and/or does not apply any pressure on the patient's soft
tissue.
[0090] A treatment protocol that controls the application of the
pressure gradient between a previous and a successive suction
opening may be in a range between 0.1% to 95%, or in a range
between 0.1% to 70%, or in a range between 1% to 50%.
[0091] The suction opening may also comprise an impacting massage
object powered by a piston, massage object operated by filling or
sucking out liquid or air from the gap volume by an inlet/outlet
valve or massage object powered by an element that creates an
electric field, magnetic field or electromagnetic field.
Additionally, the massage may be provided by impacting of multiple
massage objects. The multiple massage objects may have the same or
different size, shape, weight or may be created from the same or
different materials. The massage objects may be accelerated by air
or liquid flowing (through the valve) or by an electric, magnetic
or electromagnetic field. Trajectory of the massage objects may be
random, circular, linear and/or massage objects may rotate around
one or more axes, and/or may do other types of moves in the gap
volume.
[0092] The massage unit may also comprise a membrane on the side
facing the patient which may be accelerated by an electric,
magnetic, electromagnetic field or by changing pressure value in
the gap volume between wall of the chamber and the membrane. This
membrane may act as the massage object.
[0093] During the treatment, it may be convenient to use a
combination of pads with adhesive layer and pads with suction
openings. In that case at least one pad used during the treatment
may comprise adhesive layer and at least additional one pad used
during the treatment may comprise suction opening. For example, pad
with adhesive layer may be suited for treatment of more uneven
areas, e.g. periorbital area, and pad with suction openings for
treatment of smoother areas, e.g. cheeks.
[0094] The advantage of the device where the attachment of the pads
may be provided by an adhesion layer or by a suction opening or
their combination is that there is no need of any additional
gripping system which would be necessary to hold the pads on the
treatment area during the treatment, e.g. a band or a felt, which
may cause a discomfort of the patient.
[0095] Yet in another aspect, it is possible to fasten the flexible
pads 4 to the face by at least one band or felt which may be made
from an elastic material and thus adjusted for an individual face.
In that case the flexible pads, which may have not the adhesive
layer or suction opening, are placed on the treatment area of the
patient and their position is then fastened by a band or felt to
avoid deflection of the pads from the treatment areas.
Alternatively, the band may be replaced by a mask, e.g. an elastic
mask that covers from 5% to 100% or from 30% to 99% or from 40% to
95% or from 50% to 90% of the face and may serve to secure the
flexible pads on the treatment areas. In another aspect, the mask
may be rigid or semi rigid. The mask may contain one connecting
part comprising conductive leads which then distributes the
conductive leads to specific pads. Furthermore, it may be possible
to use the combination of the pad with adhesive layer or suction
opening and the fastening band, felt or mask to ensure strong
attachment of the pads on the treatment areas.
[0096] Additionally, the fastening mechanism may be in the form of
a textile or a garment which may be mountable on a user's body
part. In use of the device, a surface of the active element or pad
4 lays along an inner surface of the garment, while the opposite
surface of the active element or pad 4 is in contact with the
user's skin, preferably by means of a skin-active element hydrogel
interface.
[0097] The garment may be fastened for securement of the garment to
or around a user's body part, e.g. by hook and loop fastener,
button, buckle, stud, leash or cord, magnetic-guided locking system
or clamping band and the garment may be manufactured with flexible
materials or fabrics that adapt to the shape of the user's body or
limb. The pad 4 may be in the same way configured to be fastened to
the inner surface of the garment. The garment is preferably made of
breathable materials. Non limiting examples of such materials are
soft Neoprene, Nylon, polyurethane, polyester, polyamide,
polypropylene, silicone, cotton or any other material which is soft
and flexible. All named materials could be used as woven,
non-woven, single use fabric or laminated structures.
[0098] The garment and the pad may be modular system, which means
module or element of the device (pad, garment) and/or system is
designed separately and independently from the rest of the modules
or elements, at the same time that they are compatible with each
other.
[0099] The pad 4 may be designed to be attached to or in contact
with the garment, thus being carried by the garment in a stationary
or fixed condition, in such a way that the pads are disposed on
fixed positions of the garment. The garment ensures the correct
adhesion or disposition of the pad to the user's skin. In use of
the device, the surface of one or more active elements not in
contact with the garment is in contact with the patient's skin,
preferably by means of a hydrogel layer that acts as pad-skin
interface. Therefore, the active elements included in the pad are
in contact with the patient's skin.
[0100] The optimal placement of the pad on the patient's body part,
and therefore the garment which carries the pad having the active
elements, is determined by a technician or clinician helping the
patient.
[0101] In addition, the garment may comprise more than one pad or
the patient may wear more than one garment comprising one or more
pads during one treatment session.
[0102] The pad 4 may contain at least one active element 13 capable
of delivering energy from primary electromagnetic generator 6 or
secondary generator 9 or ultrasound emitter 10. In various aspects,
the active element is an electrode, an optical element, an acoustic
window, an ultrasound emitter, or other energy delivering elements
known in the art. The electrode may be a radiofrequency (RF)
electrode. The RF electrode may be a dielectric electrode coated
with insulating (e.g. dielectric) material. The RF electrode may be
monopolar, bipolar, unipolar or multipolar. The bipolar arrangement
may consist of electrodes that alternate between active and return
function and where the thermal gradient beneath electrodes is
almost the same during treatment. Bipolar electrodes may form
circular or ellipsoidal shapes, where electrodes are concentric to
each other. However, a group of bipolar electrode systems may be
used as well. A unipolar electrode or one or more multipolar
electrodes may be used as well. The system may alternatively use
monopolar electrodes, where the so-called return electrode (or
neutral electrode or ground electrode or grounding electrode) has
larger area than so-called active electrode. The thermal gradient
beneath the active electrode is therefore higher than beneath the
return electrode. The active electrode may be part of the pad and
the passive electrode having larger surface area may be located at
least 5 cm, 10 cm, or 20 cm from the pad. A neutral electrode may
be used as the passive electrode. The neutral electrode may be on
the opposite side of the patient's body than the pad is attached. A
unipolar electrode may also optionally be used. During unipolar
energy delivery there is one electrode, no neutral electrode, and a
large field of RF emitted in an omnidirectional field around a
single electrode. Capacitive and/or resistive electrodes may be
used. Radiofrequency energy may provide energy flux on the surface
of the RF electrode or on the surface of the treated tissue (e.g.
skin) in the range of 0.001 W/cm.sup.2 to 1500 W/cm.sup.2 or 0.01
W/cm.sup.2 to 1000 W/cm.sup.2 or 0.5 W/cm.sup.2 to 500 W/cm.sup.2
or 0.5 W/cm.sup.2 to 100 W/cm.sup.2 or 1 W/cm.sup.2 to 50
W/cm.sup.2. The energy flux on the surface of the RF electrode may
be calculated from the size of the RF electrode and its output
value of the energy. The energy flux on the surface of the treated
tissue may be calculated from the size of the treated tissue
exactly below the RF electrode and its input value of the energy
provided by the RF electrode. In addition, the RF electrode
positioned in the pad 4 may act as an acoustic window for
ultrasound energy.
[0103] The active element 13 may provide a secondary energy from
secondary generator 9 in the form of an electric current or a
magnetic field. By applying the secondary energy to the treated
area of the body of the patient, muscle fibers stimulation (e.g.
muscle contractions) may be achieved and thus increasing muscle
tone, muscle strengthening, restoration of feeling the muscle,
relaxation of the musculature and/or stretching musculature.
[0104] The proposed device may provide an electrotherapy in case
that the secondary energy delivered by the active element 13 (e.g a
radiofrequency electrode or simply referred just as an electrode)
is the electric current generated by the secondary generator 9. The
main effects of electrotherapy are: analgesic, myorelaxation,
iontophoresis, anti-edematous effect or muscle stimulation causing
a muscle fiber contraction. Each of these effects may be achieved
by one or more types of electrotherapy: galvanic current, pulse
direct current and alternating current.
[0105] Galvanic current (or "continuous") is a current that may
have constant electric current and/or absolute value of the
electric current is in every moment higher than 0. It may be used
mostly for iontophoresis, or its trophic stimulation (hyperemic)
effect is utilized. At the present invention this current may be
often substituted by galvanic intermittent current. Additionally,
galvanic component may be about 95% but due to interruption of the
originally continuous intensity the frequency may reach 5-12 kHz or
5-10 kHz or 5-9 kHz or 5-8 kHz.
[0106] The pulse direct current (DC) is of variable intensity but
only one polarity. The basic pulse shape may vary. It includes e.g.
diadynamics, rectangular, triangular and exponential pulse of one
polarity. Depending on the used frequency and intensity it may have
stimulatory, tropic, analgesic, myorelaxation, iontophoresis, at
least partial muscle contraction and anti-edematous effect and/or
other.
[0107] Alternating Current (AC or biphasic) where the basic pulse
shape may vary--rectangular, triangular, harmonic sinusoidal,
exponential and/or other shapes and/or combination of mentioned
above. It can be alternating, symmetric and/or asymmetric. Use of
alternating currents in contact electrotherapy implies much lower
stress on the tissue under the electrode. For these types of
currents the capacitive component of skin resistance is involved,
and due to that these currents are very well tolerated by the
patients.
[0108] AC therapies may be differentiated into five subtypes: TENS,
Classic (four-pole) Interference, Two-pole Interference, Isoplanar
Interference and Dipole Vector Field. It also exist some specific
electrotherapy energy variants and modularity of period, shape of
the energy etc.
[0109] Due to interferential electrotherapy, different nerves and
tissue structures by medium frequency may be stimulated in a range
of 500 Hz to 12 kHz or in a range of 500 Hz to 8 kHz, or 500 Hz to
6 kHz, creating pulse envelopes with frequencies for stimulation of
the nerves and tissues e.g. sympathetic nerves (0.1-5 Hz),
parasympathetic nerves (10-150 Hz), motor nerves (10-50 Hz), smooth
muscle (0.1-10 Hz), sensor nerves (90-100 Hz) nociceptive fibers
(90-150 Hz).
[0110] Electrotherapy may provide stimulus with currents of
frequency in the range from 0.1 Hz to 12 kHz or in the range from
0.1 Hz to 8 kHz or in the range from 0.1 Hz to 6 kHz.
[0111] Muscle fiber stimulation by electrotherapy may be important
during and/or as a part of the RF treatment. Muscle stimulation
increases blood flow and lymph circulation. It may improve removing
of treated cells and/or prevent of hot spots creation. Moreover
internal massage stimulation of adjoining tissues improves
homogeneity of tissue and dispersing of the delivered energy. The
muscle fiber stimulation by electrotherapy may cause muscle
contractions, which may lead to improvement of a visual appearance
of the patient through muscle firming and strenghtening, Another
beneficial effect is for example during fat removing with the RF
therapy. RF therapy may change structure of the fat tissue. The
muscle fiber stimulation may provide internal massage, which may be
for obese patient more effective than classical massage.
[0112] Muscle stimulation may be provided by e.g. intermittent
direct currents, alternating currents (medium-frequency and TENS
currents), faradic current as a method for multiple stimulation
and/or others.
[0113] Frequency of the currents may be in the range from 0.1 Hz to
1500 Hz or from 0.1 to 1000 Hz or from 0.1 Hz to 500 Hz or from 0.1
to 300 Hz.
[0114] Frequency of the current envelope is typically in the range
from 0.1 Hz to 500 Hz or from 0.1 to 250 Hz or from 0.1 Hz to 150
Hz or from 0.1 to 140 Hz.
[0115] The electrostimulation may be provided in a combined manner
where various treatments with various effects may be achieved. As
an illustrative example, the electromagnetic energy with the
electrostimulation may be dosed in trains of pulses of electric
current where the first train of electrostimulation may achieve
different effect than second or other successive train of
stimulation. Therefore, the treatment may provide muscle fibers
stimulation or muscle contractions followed by relaxation, during
continual or pulsed radiofrequency thermal heating provided by
electromagnetic energy provided by electromagnetic energy
generator.
[0116] The electrostimulation may be provided by monopolar,
unipolar, bipolar or multipolar mode.
[0117] Absolute value of voltage between the electrotherapy
electrodes operated in bipolar, multipolar mode (electric current
flow between more than two electrodes) and/or provided to at least
one electrotherapy electrode may be in a range between 0.8 V and 10
kV; or in a range between 1 V and 1 kV; or in a range between 1 V
and 300 V or in a range between 1 V and 100 V or in a range between
10 V and 80 V or in a range between 20 V and 60 V or in a range
between 30 V and 50 V. In one embodiment, the absolute value of
voltage between the electrotherapy electrodes operated in bipolar,
multiplar mode and/or provided to at least one electrotherapy
electrode may be determined based on a measurement across a 500 Ohm
load.
[0118] Current density of electrotherapy for a non-galvanic current
may be in a range between 0.1 mA/cm.sup.2 and 150 mA/cm.sup.2, or
in a range between 0.1 mA/cm.sup.2 and 100 mA/cm.sup.2, or in a
range between 0.1 mA/cm.sup.2 and 50 mA/cm.sup.2, or in a range
between 0.1 mA/cm.sup.2 and 20 mA/cm.sup.2; for a galvanic current
may be preferably in a range between 0.05 mA/cm.sup.2 and 3
mA/cm.sup.2, or in a range between 0.1 mA/cm.sup.2 and 1
mA/cm.sup.2, or in a range between 0.01 mA/cm.sup.2 and 0.5
mA/cm.sup.2. The current density may be calculated on the surface
of the electrode providing the electrotherapy to the patient. In
one aspect, the current density of electrotherapy for a
non-galvanic current may be in a range between 0.1 mA/cm.sup.2 and
200 mA/cm.sup.2, or in a range between 0.5 mA/cm.sup.2 and 150
mA/cm.sup.2, or in a range between 1 mA/cm.sup.2 and 120
mA/cm.sup.2, or in a range between 5 mA/cm.sup.2 and 100
mA/cm.sup.2.
[0119] During electrotherapy, e.g. bipolar electrotherapy, two or
more electrodes may be used. If polarity of at least one electrode
has a non-zero value in a group of the electrodes during bipolar
mode, the group of the electrodes has to include at least one
electrode with opposite polarity value. Absolute values of both
electrode polarities may or may not be equal. In bipolar
electrostimulation mode stimulating signal passes through the
tissue between electrodes with opposite polarities.
[0120] A distance between two electrodes operating in bipolar mode
may be in a range between 0.1 mm and 4 cm or in a range between 0.2
mm to 3 cm or in a range between 0.5 mm and 2 cm or in a range
between 1 mm and 1 cm or in the range of 0.1 cm and 40 cm or in a
range between 1 cm and 30 cm, or in the range between 1 cm and 20
cm, wherein the distance is between the two closest points of two
electrodes operating in bipolar mode.
[0121] During monopolar electrotherapy mode stimulating signal may
be induced by excitement of action potential by changing polarity
of one electrode that change polarization in the nerve fiber and/or
neuromuscular plague.
[0122] During the electrotherapy, one of the bipolar or monopolar
electrotherapy mode may be used or bipolar or monopolar
electrotherapy mode may be combined.
[0123] The ultrasound emitters may provide focused or defocused
ultrasound energy. The ultrasound energy may be transferred to the
tissue through an acoustic window. The output power of the
ultrasound energy on the surface of the active element 13 may be
less than or equal to 20 W or 15 W or 10 W or 5 W. Ultrasound
energy may provide energy flux on the surface of the active element
13 or on the surface of the treated tissue (e.g. skin) in the range
of 0.001 W/cm.sup.2 to 250 W/cm.sup.2, or in the range of 0.005
W/cm.sup.2 to 50 W/cm.sup.2, or in the range of 0.01 W/cm.sup.2 to
25 W/cm.sup.2, or in the range of 0.05 W/cm.sup.2 to 20 W/cm.sup.2.
The treatment depth of ultrasound energy may be in the range of 0.1
mm to 100 mm or 0.2 mm to 50 mm or 0.25 mm to 25 mm or 0.3 mm to 15
mm. At a depth of 5 mm the ultrasound energy may provide an energy
flux in the range of 0.01 W/cm.sup.2 to 20 W/cm.sup.2 or 0.05
W/cm.sup.2 to 15 W/cm.sup.2. An ultrasound beam may have a beam
non-uniformity ratio (RBN) in the range of 0.1 to 20 or 2 to 15 to
4 to 10. In addition, an ultrasound beam may have a beam
non-uniformity ratio below 15 or below 10. An ultrasound beam may
be divergent, convergent and/or collimated. The ultrasound energy
may be transferred to the tissue through an acoustic window. It is
possible that the electrode may act as the acoustic window.
Furthermore, the ultrasound emitter 10 may be a part of the active
element 13, thus ultrasound emitter 10 may be a part of the pad
4.
[0124] At least some of the active elements 13 may be capable of
delivering energy from primary electromagnetic generator 6 or
secondary generator 9 or ultrasound emitter 10 simultaneously (at
the same time) successively or in an overlapping method or in any
combination thereof. For example, the active element 13 (e.g.
electrode) may be capable of delivering radiofrequency energy and
electric current sequentially, which may mean that firstly the
active element 13 may provide primary electromagnetic energy
generated by the primary electromagnetic generator 6 and
subsequently the active element 13 may provide the secondary energy
generated by the secondary generator 9. Thus the active element 13
may e.g. apply radiofrequency energy to the tissue of the patient
and then the same active element 13 may apply e.g. electrical
current to the tissue of the patient.
[0125] Pad 4 may further comprise thermal sensors 15 enabling
temperature control during the therapy, providing feedback to
control unit (e.g. CPU) 11, enabling adjustment of treatment
parameters of each active element and providing information to the
operator. The thermal sensor 15 may be a contact sensor,
contactless sensor (e.g. infrared temperature sensor) or invasive
sensor (e.g. a thermocouple) for precise temperature measurement of
deep layers of skin, e.g. epidermis, dermis or hypodermis. The
control unit (e.g. CPU) 11 may also use algorithms to calculate the
deep or upper-most temperatures. A temperature feedback system may
control the temperature and based on set or pre-set limits alert
the operator in human perceptible form, e.g. on the human machine
interface 8 or via indicators 17. In a limit temperature condition,
the device may be configured to adjust one or more treatment
parameters, e.g. output power, switching mode, pulse length, etc.
or stop the treatment. A human perceptible alert may be a sound,
alert message shown on human machine interface 8 or indicators 17
or change of color of any part of the interconnecting block 3 or
pad 4.
[0126] The pad may comprise at least one electromyography (EMG)
sensing electrode configured to monitor, to record or to evaluate
the electrical activity produced by skeletal muscles (e.g. twitch
or contraction) in response to delivered energy (e.g. electric
current). The at least one EMG sensing electrode being disposed on
the pad may be electrically insulated from the active elements
(e.g. electrodes used for treatment). An electromyograph detects
the electric potential generated by muscle cells when these cells
are electrically or neurologically activated. The signals can be
analyzed to detect abnormalities, activation level, or recruitment
order, or to analyze the biomechanics of the patient's movement.
The EMG may be one of a surface EMG or an intramuscular EMG. The
surface EMG can be recorded by a pair of electrodes or by a more
complex array of multiple electrodes. EMG recordings display the
potential difference (voltage difference) between two separate
electrodes. Alternatively the active elements, e.g. electrodes, may
be used for EMG. The intramuscular EMG may be recorded by one
(monopolar) or more needle electrodes. This may be a fine wire
inserted into a muscle with a surface electrode as a reference; or
more fine wires inserted into muscle referenced to each other.
Muscle tissue at rest is normally electrically inactive. After the
electrical activity caused by delivered energy (e.g. electric
current), action potentials begin to appear. As the strength of a
muscle contraction is increased, more and more muscle fibers
produce action potentials. When the muscle is fully contracted, a
disorderly group of action potentials of varying rates and
amplitudes should appear (a complete recruitment and interference
pattern).
[0127] The pad may also comprise at least one capacitive sensor for
measurement of the proper contact of the pad with the patient. The
capacitive sensor may be connected to at least two complementary
metal-oxide-semiconductor (CMOS) integrated circuit (IC) chips, an
application-specific integrated circuit (ASIC) controller and a
digital signal processor (DSP) which may be part of the control
unit. The capacitive sensor may detect and measure the skin based
on the different dielectric properties than the air, thus when the
pad is detached from the patient a change in the signal may be
detected and further processed by the control unit. The capacitance
sensor may be configured in a surface capacitance or in a projected
capacitance configuration. For better information about the contact
and for higher safety, a single pad may comprise 3 to 30 or 4 to 20
or 5 to 18 or 6 to 16 or 7 to 14 capacitance sensors.
[0128] Memory 12 may include, for example, information about the
type and shape of the pad 4, its remaining lifetime, or the time of
therapy that has already been performed with the pad. The memory
may also provide information about the manufacturer of the pad or
information about the designated area of use on the body of the
patient. The memory may include RFID, MRAM, resistors, or pins.
[0129] Neutral electrode 7 may ensure proper radiofrequency energy
distribution within the patient's body for mono-polar
radiofrequency systems. The neutral electrode 7 is attached to the
patient's skin prior to each therapy so that the energy may be
distributed between active element 13 (e.g. electrode) and neutral
electrode 7. In some bipolar or multipolar radiofrequency systems,
there is no need to use a neutral electrode--radiofrequency energy
is distributed between multiple active elements 13 (e.g.
electrodes). Neutral electrode 7 represents an optional block of
the apparatus 1 as any type of radiofrequency system can be
integrated.
[0130] Additionally, device 1 may include one or more sensors. The
sensor may provide information about at least one physical quantity
and its measurement may lead to feedback which may be displayed by
human machine interface 8 or indicators 17. The one or more sensors
may be used for sensing delivered electromagnetic energy, impedance
of the skin, resistance of the skin, temperature of the treated
skin, temperature of the untreated skin, temperature of at least
one layer of the skin, water content of the device, the phase angle
of delivered or reflected energy, the position of the active
elements 13, the position of the interconnecting block 3,
temperature of the cooling media, temperature of the primary
electromagnetic generator 6 and secondary generator 9 and
ultrasound emitter 10 or contact with the skin. The sensor may be a
thermal, acoustic, vibration, electric, magnetic, flow, positional,
optical, imaging, pressure, force, energy flux, impedance, current,
Hall or proximity sensor. The sensor may be a capacitive
displacement sensor, acoustic proximity sensor, gyroscope,
accelerometer, magnetometer, infrared camera or thermographic
camera. The sensor may be invasive or contactless. The sensor may
be located on or in the pad 4, in the main unit 2, in the
interconnecting block 3 or may be a part of a thermal sensor 15.
One sensor may measure more than one physical quantity. For
example, the sensor may include a combination of a gyroscope, an
accelerometer and/or a magnetometer. Additionally, the sensor may
measure one or more physical quantities of the treated skin or
untreated skin.
[0131] A resistance sensor may measure skin resistance, because
skin resistance may vary for different patients, as well as the
humidity--wetness and sweat may influence the resistance and
therefore the behavior of the skin in the energy field. Based on
the measured skin resistance, the skin impedance may also be
calculated.
[0132] Information from one or more sensors may be used for
generation of a pathway on a model e.g. a model of the human body
shown on a display of human machine interface 8. The pathway may
illustrate a surface or volume of already treated tissue, presently
treated tissue, tissue to be treated, or untreated tissue. A model
may show a temperature map of the treated tissue providing
information about the already treated tissue or untreated
tissue.
[0133] The sensor may provide information about the location of
bones, inflamed tissue or joints. Such types of tissue may not be
targeted by electromagnetic energy due to the possibility of
painful treatment. Bones, joints or inflamed tissue may be detected
by any type of sensor such as an imaging sensor (ultrasound sensor,
IR sensor), impedance sensor, and the like. A detected presence of
these tissue types may cause general human perceptible signals or
interruption of generation of electromagnetic energy. Bones may be
detected by a change of impedance of the tissue or by analysis of
reflected electromagnetic energy.
[0134] The patient's skin over at least one treatment portion may
be pre-cooled to a selected temperature for a selected duration,
the selected temperature and duration for pre-cooling may be
sufficient to cool the skin to at least a selected temperature
below normal body temperature. The skin may be cooled to at least
the selected temperature to a depth below the at least one depth
for the treatment portions so that the at least one treatment
portion is substantially surrounded by cooled skin. The cooling may
continue during the application of energy, and the duration of the
application of energy may be greater than the thermal relaxation
time of the treatment portions. Cooling may be provided by any
known mechanism including water cooling, sprayed coolant, presence
of an active solid cooling element (e.g. thermoelectric cooler) or
air flow cooling. A cooling element may act as an optical element.
Alternatively, the cooling element may be a spacer. Cooling may be
provided during, before or after the treatment with electromagnetic
energy. Cooling before treatment may also provide an environment
for sudden heat shock, while cooling after treatment may provide
faster regeneration after heat shock. The temperature of the
coolant may be in the range of -200.degree. C. to 36.degree. C. The
temperature of the cooling element during the treatment may be in
the range of -80.degree. C. to 36.degree. C. or -70.degree. C. to
35.degree. C. or -60.degree. C. to 34.degree. C. or -20.degree. C.
to 30.degree. C. or 0.degree. C. to 27.degree. C. or 5.degree. C.
to 25.degree. C. Further, where the pad is not in contact with the
patient's skin, cryogenic spray cooling, gas flow or other
non-contact cooling techniques may be utilized. A cooling gel on
the skin surface might also be utilized, either in addition to or
instead of, one of the cooling techniques indicated above.
[0135] FIG. 3A and FIG. 3B show different shapes and layouts of pad
4 used by an apparatus for contact therapy. Pads 4 comprise at
least one active element 13 (e.g. electrode) and may be available
in various shapes and layouts so that they may cover a variety of
different treatment areas and accommodate individual patient needs,
e.g. annular, semicircular, elliptical, oblong, square,
rectangular, trapezoidal, polygonal or formless (having no regular
form or shape). The shapes and layouts of the pad 4 may be shaped
to cover at least part of one or more of the periorbital area, the
forehead (including frown lines), the jaw line, the perioral area
(including Marionette lines, perioral lines--so called smoker
lines, nasolabial folds, lips and chin), cheeks or submentum, etc.
The shape of the pad 4 and distribution, size and number of active
elements 13 (e.g. electrodes) may differ depending on the area
being treated, e.g. active elements 13 inside the pad 4 may be in
one line, two lines, three lines, four lines or multiple lines. The
pad 4 with active elements 13 may be arranged into various shapes,
e.g. in a line, where the centers of at least two active elements
13 lie in one straight line, while any additional center of an
active element 13 may lie in the same or different lines inside the
pad 4.
[0136] In addition, the pad 4 may be used to treat at least
partially neck, bra fat, love handles, torso, back, abdomen,
buttocks, thighs, calves, legs, arms, forearms, hands, fingers or
body cavities (e.g. vagina, anus, mouth, inner ear etc.).
[0137] The pad 4 may have a rectangular, oblong, square,
trapezoidal form, or of the form of a convex or concave polygon
wherein the pad 4 may have at least two different inner angles of
the convex or concave polygon structure. Additionally, the pad 4
may form at least in part the shape of a conic section (also called
conic), e.g. circle, ellipse, parabola or hyperbola. The pad 4 may
have at least in part one, two, three, four, five or more
curvatures of a shape of an arc with the curvature k in the range
of 0.002 to 10 mm.sup.-1 or in the range of 0.004 to 5 mm.sup.-1 or
in the range of 0.005 to 3 mm.sup.-1 or in the range of 0.006 to 2
mm.sup.-1. The pad 4 may have at least one, two, three, four, five
or more arcs with the curvature k or may have at least two
different inner angles of a convex or concave polygon structure,
and may be suitable for the treatment of chin, cheeks, submental
area (e.g. "banana shape 1" 4.2), for treating jaw line, perioral
area, Marionette lines and nasolabial folds (e.g. "banana shape 2"
4.4), for the treatment of periorbital area (e.g. "horseshoe shape"
4.3) or other regions of face and neck. The "banana shape" pad 4.2
or 4.4 may have a convex-concave shape, which means that one side
is convex and the opposite side is concave, that occupies at least
5% to 50% or 10% to 60% or 15% to 70% or 20% to 90% of a total
circumference of the pad 4 seen from above, wherein the shortest
distance between the endpoints 4.21a and 4.21b of the "banana
shape" pad 4.2 (dashed line in FIG. 3A) is longer than the shortest
distance between the endpoint 4.21a or 4.21b and the middle point
4.22 of the "banana shape" (full line in pad 4.2 in FIG. 3A). The
"horseshoe shape" 4.3 seen from above may have the convex-concave
shape that occupies at least 15% to 50% or 20% to 60% or 25% to 70%
or 30% to 90% of its total circumference, wherein the shortest
distance between the endpoints 4.31a and 4.31b of the "horseshoe
shape" pad 4.3 (dashed line in FIG. 3B) is equal or shorter than
the shortest distance between the endpoint 4.31a or 4.31b and the
middle point 4.32 of the "horseshoe shape" (full line in pad 4.3 in
FIG. 3B). When seen from above, if the longest possible center
curve, which may be convex or concave and whose perpendiculars at a
given point have equidistant distance from perimeter edges of the
pad at each of its points (dotted line in pad 4.2 in FIG. 3A),
intersects the circumference of the pad 4 then this point is the
endpoint of the pad, e.g. endpoint 4.21a or 4.21b. The middle
point, e.g. 4.22, is then given as the middle of the center curve,
wherein the total length of the center curve is given by two
endpoints, e.g. 4.21a and 4.21b, thus the length of the center
curve (dotted line in pad 4.2 in FIG. 3A) from point 4.21a to point
4.22 is the same as the length from point 4.21b to point 4.22. The
total length of the center curve may be in the range of 0.1 to 30
cm or in the range of 0.5 to 25 cm or in the range of 1 to 20
cm.
[0138] In addition, the center curve may have at least in part
circular, elliptical, parabolic, hyperbolic, exponential, convex or
concave curve such that the straight line connecting endpoint of
the pad 4 with the middle point of the center curve forms an angle
alpha with the tangent of the middle of the center curve. The angle
alpha may be in a range of 0.1.degree. to 179.degree. or in a range
of 0.2.degree. to 170.degree. or in a range of 0.5.degree. to
160.degree. or in a range of 10 to 150.degree..
[0139] The pad 4 whose shape has at least two concave arcs with the
curvature k or has at least two concave inner angles of the polygon
structure may be suitable for the treatment of the forehead like
the "T shape" 4.1 in FIG. 3A. The "T shape" 4.1 may be also
characterized by the arrangement of the active elements 13 where
the centers of at least two active elements 13 lie in one straight
line and center of at least one additional element 13 lies in a
different line.
[0140] Another possible non-limiting configuration of the pad 4
used for the treatment of the forehead is depicted in FIG. 3C. In
this non-limiting example, a forehead pad (pad 4 used for treatment
of the forehead) my contain two lines of active elements 13 (e.g.
electrodes)--active elements 13a-13f as shown in FIG. 3C, wherein
the active elements 13a-13f in one line may be at least partially
separated by slots 43 for better flexibility of the pad 4. A first
line of active elements comprises active elements (e.g. electrodes)
depicted in the dotted box 131a in FIG. 3C--active elements 13d,
13e and 13f. The second line of active elements (e.g. electrodes)
comprises active elements depicted in the dashed box 131b in FIG.
3C--active elements 13a, 13b, 13c. Dotted and dashed boxes 131a and
131b are used only for visualization of the first and second lines
of active elements (e.g. electrodes), respectively. Such pad 4 may
have a shape that has a total number of convex and/or concave arcs
in a range of 14 to 36 or in a range of 18 to 32 or in a range of
20 to 30 or in a range of 22 to 28 with a curvature k.
Additionally, the pad 4 may have a number of concave inner angles
in a range of 2 to 20 or in a range of 5 to 17 or in a range of 7
to 15 or in a range of 9 to 13, or the pad 4 may have a number of
convex inner angles in a range of 2 to 20 or in a range of 5 to 17
or in a range of 10 to 16 or in a range of 11 to 15.
[0141] FIG. 3C also shows the sticker 44 on a top side of the pad
4. The top side is the opposite side from the underside (the side
where the adhesive layer or the active elements may be deposited on
the substrate of the pad 4) or in other words, the top side is the
side of the pad 4 that is facing away from the patient during the
treatment. The sticker may have a bottom side and a top side,
wherein the bottom side of the sticker may comprise a sticking
layer and the top side of the sticker may comprise a non-sticking
layer (eg. polyimide (PI) films, Teflon.RTM., epoxy, polyethylene
terephthalate (PET), polyamide or PE foam).
[0142] As shown in FIG. 3C, the sticker may have the same shape as
the pad 4 with an additional overlap over the pad 4. The overlap is
hatched in FIG. 3C. The sticker may be bonded to the pad 4 such
that the sticking layer of the bottom side of the sticker is facing
toward the top side of the pad 4. The overlap of the sticker may
exceed the pad 4 in the range of 0.1 to 10 cm, or in the range of
0.1 to 7 cm, or in the range of 0.2 to 5 cm, or in the range of 0.2
to 3 cm, or in the range of 0.3 to 1 cm. This overlap may also
comprise an adhesive layer and may be used to form additional and
more proper contact of the pad 4 with the patient.
[0143] The forehead pad (pad 4 used for treatment of the forehead)
may comprise edge active elements (e.g. electrodes)--13a, 13c, 13d
and 13f in FIG. 3C and middle active elements (e.g.
electrodes)--13b and 13e in FIG. 3C. The forehead pad 4 may be
divided into an upper side --active elements (e.g. electrodes) in
box 131a; and bottom side--active elements (e.g. electrodes) in box
131b as well as a left side--active elements (e.g. electrodes) 13a
and 13f, and a right side--active elements (e.g. electrodes) 13c
and 13d. Edge active elements (e.g. electrodes)--13a, 13c, 13d and
13f in the forehead pad 4 depicted in FIG. 3C may have a surface
area in the range of 1 to 10 cm.sup.2 or in the range of 2 to 6.5
cm.sup.2 or in the range of 2.3 to 6 cm.sup.2 or in the range of
2.5 to 5.5 cm.sup.2, which may be the same for all edge active
elements. The middle active elements (e.g. electrodes) 13b and 13e
in FIG. 3C may have a larger surface area than the edge active
elements (e.g. electrodes), wherein the surface area of the middle
active elements (e.g. electrodes) may be in the range of 1 to 20
cm.sup.2 or in the range of 2 to 15 cm.sup.2 or in the range of 3
to 12 cm.sup.2 or in the range of 4 to 10 cm.sup.2. In one aspect,
each active element (e.g. electrode) may have a different surface
area. The ratio of a surface area of one middle active element
(e.g. electrode) to a surface area of one edge active element (e.g.
electrode) on the forehead pad may be in a range of 0.8 to 2.5 or
in a range of 1 to 2.3 or in a range of 1.1 to 2.2.
[0144] The distance d.sub.edge between the closest points of the
bottom edge active elements (e.g. electrodes)--active elements 13a
and 13c in the FIG. 3C or the upper edge active elements (e.g.
electrodes)--13d and 13f in the FIG. 3C may be in the range of 2 to
8 cm or in the range of 3 to 7 cm or in the range of 4 to 6 cm or
in the range of 4.5 to 5.5 cm. The distance between the upper edge
active elements (e.g. electrodes) and the distance between the
bottom edge active elements (e.g. electrodes) may be the same.
[0145] The distance d.sub.vert between the closest points of the
upper active elements (e.g. electrodes) and the bottom active
elements (e.g. electrodes) on one side (left, middle,
right)--active elements 13a and 13f or active elements 13b and 13e
or active elements 13c and 13d in FIG. 3C may be in the range of
0.5 to 20 mm or in the range of 1 to 10 mm or in the range of 1.5
to 6 mm or in the range of 2 to 5 mm. The distance d.sub.vert may
be the same for the left, middle and right active elements.
[0146] Such distances (d.sub.edge and d.sub.vert) are optimized to
effectively treat the Frontalis muscle or Procerus muscle during
the treatment. The edge active elements (e.g. electrodes)--13a,
13c, 13d and 13f in FIG. 3C are used for treatment of Frontalis
muscle and/or Corrugator supercilii and the middle active elements
(e.g. electrodes)--13b and 13e in FIG. 3C are used for treatment of
Procerus muscle.
[0147] The forehead pad (pad 4 used for treatment of the forehead)
in FIG. 3C also shows a possible arrangement of the bottom middle
part of the pad 4 comprising the bottom middle active element (e.g.
electrode)--13b. The pad 4 may comprise a convex protrusion 4p
and/or concave depression in the bottom middle part. Also the
active element 13b may be designed in a shape proximate to an
oblong or rectangular shape with a convex protrusion 13p and/or
concave depression in the middle of the bottom part of the active
element 13b copying a shape of the pad 4 with the protrusion 4p
and/or depression of the pad. This protrusion 4p and/or depression
may serve as a focus point for a correct coupling of the pad 4 to
the forehead area of the patient, wherein the protrusion 4p and/or
depression should be aligned with the middle of the nose of the
patient (e.g. in the middle of Procerus muscle) and at the same
time the bottom edge of the pad 4 should be coupled slightly over
the eyebrows of the patient.
[0148] One possible non-limiting configuration of the pad 4 used
for the treatment of the left cheek is depicted in FIG. 3D. In this
non-limiting example, middle active elements (e.g.
electrodes)--active elements 13g, 13h, 13i and 13j may be separated
on the substrate and the distance d.sub.mid between the closest
points of two neighboring middle active elements (e.g. electrodes)
may be in the range of 0.5 to 5 mm or in the range of 0.8 to 3 mm
or in the range of 1 to 2.5 mm or in the range of 1.2 to 2.3 mm.
The left cheek pad (the pad 4 used for the treatment of the left
cheek) depicted in FIG. 3D may be designed to be coupled to the
patient such that the bottom of the pad 4 is aligned and slightly
above the left part of the base of the mandible, represented by the
number 301 in FIG. 3D. The middle active elements (e.g. electrodes)
13g, 13h, 13i and 13j in FIG. 3D may have a surface area in the
range of 1 to 15 cm.sup.2 or in the range of 2 to 8 cm.sup.2 or in
the range of 2.5 to 6 cm.sup.2 or in the range of 3 to 5 cm.sup.2.
The edge active elements (e.g. electrodes) 13k, 13l and 13m may
have a surface area in the range of 1 to 20 cm.sup.2 or in the
range of 2 to 10 cm.sup.2 or in the range of 2.5 to 8 cm.sup.2 or
in the range of 3.5 to 7 cm.sup.2. The ratio of a surface area of
the edge active element (e.g. electrode)--one of 13k, 13l or 13m,
to a surface area of the middle active element (e.g.
electrode)--one of 13g, 13h, 13i or 13j in FIG. 3D, may be in a
range of 0.5 to 3 or in a range of 0.8 to 2.5 or in a range of 1 to
2 or in a range of 1 to 1.8.
[0149] The middle active elements (e.g. electrodes) 13g, 13h, 13i
and 13j in FIG. 3D are optimally configured to treat the
Buccinator, Risorius, Zygomaticus and/or Masseter muscle. The
middle active elements (e.g. electrodes) 13g, 13h, 13i and 13j in
FIG. 3D are optimally configured to treat the Platysma, Depressor
and/or Lavator labii superioris muscles.
[0150] The pad 4 used for the treatment of the right cheek may be
symmetrically arranged to the left cheek pad 4 depicted in FIG.
3D.
[0151] Pads may have different sizes with the surface areas ranging
from 0.1 to 150 cm.sup.2 or from 0.2 to 125 cm.sup.2 or from 0.5 to
100 cm.sup.2 or in the range of 1 to 50 cm.sup.2 or in the range of
10 to 50 cm.sup.2 or in the range of 15 to 47 cm.sup.2 or in the
range of 18 to 45 cm.sup.2. The pad may occupy approximately 1 to
99% or 1 to 80% or 1 to 60% or 1 to 50% of the face. The number of
active elements 13 (e.g. electrodes) within a single pad 4 ranges
from 1 to 100 or from 1 to 80 or from 1 to 60 or from 2-20 or from
3 to 10 or from 4 to 9. A thickness at least in a part of the pad 4
may be in the range of 0.01 to 15 mm or in the range of 0.02 to 10
mm or in the range of 0.05 to 7 mm or in the range of 0.1 to 2
mm.
[0152] Furthermore the pads 4 may have a shape that at least
partially replicates the shape of galea aponeurotica, procerus,
levatar labii superioris alaeque nasi, nasalis, lavator labii
superioris, zygomaticus minor, zygomaticus major, levator angulis
oris, risorius, platysma, depressor anguli oris, depressor labii
inferioris, occipitofrontalis (frontal belly), currugator
supercilii, orbicularis oculi, buccinator, masseter, orbicularis
oris or mentalis muscle when the pad 4 is attached to the surface
of the patient skin.
[0153] The pad 4 may be characterized by at least one
aforementioned aspect or by a combination of more than one
aforementioned aspect or by a combination of all aforementioned
aspects.
[0154] The electromagnetic energy generator 6 or the secondary
generator 9 inside the main case may generate an electromagnetic or
secondary energy (e.g. electric current) which may be delivered via
a conductive lead to at least one active element 13 (e.g.
electrode) attached to the skin, respectively. The active element
13 may deliver energy through its entire surface or by means of a
so-called fractional arrangement. Active element 13 may be an
active electrode in a monopolar, unipolar, bipolar or multipolar
radiofrequency system. In the monopolar radiofrequency system,
energy is delivered between an active electrode (active element 13)
and a neutral electrode 7 with a much larger surface area. Due to
mutual distance and difference between the surface area of the
active and neutral electrode, energy is concentrated under the
active electrode enabling it to heat the treated area. In the
monopolar radiofrequency system, the energy may be delivered with
the frequency in the range of 100 kHz to 550 MHz or in the range of
200 kHz to 300 MHz or in the range of 250 kHz to 100 MHz or in the
range of 300 kHz to 50 MHz or in the range of 350 kHz to 14 MHz. In
the unipolar, bipolar or multipolar radiofrequency system, there is
no need for neutral electrode 7. In the bipolar and multipolar
radiofrequency system, energy is delivered between two and multiple
active electrodes with similar surface area, respectively. The
distance between these electrodes determines the depth of energy
penetration. In the unipolar radiofrequency system, only a single
active electrode is incorporated and energy is delivered to the
tissue and environment surrounding the active electrode. The
distance between the two nearest active elements 13 (e.g. the
nearest neighboring sides of electrodes) in one pad 4 may be in the
range of 0.1 to 100 mm or in the range of 0.3 to 70 mm or in the
range of 0.5 to 60 mm or in the range of 0.7 to 30 mm or in the
range of 1 to 10 mm or in the range of 1 to 5 mm. The distance
between the two nearest neighboring sides of the electrodes may
mean the distance between the two nearest points of neighboring
electrodes.
[0155] A distance between the nearest point of the active element
13 (e.g. electrode) and the nearest edge of the pad 4 may be in the
range of 0.1 to 10 mm or in the range of 0.5 to 5 mm or in the
range of 1 to 4 mm or in the range of 1 to 3 mm.
[0156] FIG. 4A-D represents a side view of possible configurations
of the pad 4 configured for contact therapy. Pads 4 may be made of
flexible substrate material 42--polyimide (PI) films, teflon, PET,
epoxy or PE foam with an additional adhesive layer 40 on the
underside. They may be of different shapes to allow the operator to
choose according to the area to be treated. Active elements 13
(e.g. electrodes) may have a circumference of annular,
semicircular, elliptical, oblong, square, rectangular, trapezoidal
or polygonal shape with a surface area in the range from 0.1 to 70
cm.sup.2 or from 0.5 to 50 cm.sup.2 or from 1 to 25 cm.sup.2 or
from 1 to 10 cm.sup.2 or from 2 to 9.5 cm.sup.2 or from 2.5 to 9
cm.sup.2. The material used for active elements (e.g. electrodes)
may be copper, aluminum, lead or any other conductive medium that
can be deposited or integrated in the pad 4. Furthermore the active
elements 13 (e.g. electrodes) may be made of silver, gold or
graphite. Electrodes in the pad 4 may be printed by means of
biocompatible ink, such as silver ink, graphite ink or a
combination of inks of different conductive materials.
[0157] In one aspect, the electrodes may have a sandwich structure
where multiple conductive materials are deposited gradually on each
other, e.g. a copper-nickel-gold structure. For example the copper
may be deposited on the substrate with a thickness in the range of
5 to 100 .mu.m or in the range of 15 to 55 .mu.m or in the range of
25 to 45 .mu.m. The nickel may be deposited on the copper with a
thickness in the range of 0.1 to 15 .mu.m or in the range of 0.5 to
8 .mu.m or in the range of 1 to 6 .mu.m. And the gold may be
deposited on the nickel with a thickness in the range of 25 to 200
nm or in the range of 50 to 100 nm or in the range of 60 to 90 nm.
Such a sandwich structure may be made for example by an ENIG
process.
[0158] In another aspect, the electrodes may be made of copper and
covered with another conductive layer, e.g. silver or
silver-chloride ink, carbon paste, or aluminum segments coupled to
the copper by conductive glue.
[0159] The active element 13 (e.g. electrode) may have a shape that
has a total number of convex or concave arcs in a range of 1 to 12
or in a range of 2 to 10 or in a range of 3 to 9 or in a range of 4
to 8. Additionally, the active element (e.g. electrode) may have a
number of concave inner angles in a range of 1 to 7 or in a range
of 1 to 6 or in a range of 1 to 5 or in a range of 2 to 4, or the
active element (e.g. electrode) may have a number of convex inner
angles in a range of 1 to 10 or in a range of 1 to 9 or in a range
of 2 to 8 in a range of 3 to 7. A possible arrangement of
convex-concave active elements 13 (e.g. electrodes) is depicted in
FIG. 3C.
[0160] The active element 13 (e.g. electrode providing
radiofrequency energy and/or electric current) may be full-area
electrode that has a full active surface. This means that the whole
surface of the electrode facing the patient is made of conductive
material deposited or integrated in the pad 4 as mentioned
above.
[0161] In one aspect, the electrode (made of conductive material)
facing the patient may be with e.g. one or more apertures, cutouts
and/or protrusions configured for example to improve flexibility of
the electrode and/or pad, and/or reduce the edge effects and/or
improve homogeneity of delivered energy density and/or improve
homogeneity of provided treatment. Apertures may be an opening in
the body of the electrode. A cutout may be an opening in the body
of the electrode along the border of the electrode. Openings in the
body of the electrode may be defined by view from floor
projections, which shows a view of the electrode from above. The
openings, e.g. apertures, cutouts and/or areas outside of
protrusions may be filed by air, dielectric material, insulation
material, substrate of the pad, air or hydrogel. The electrode is
therefore segmented in comparison to a regular electrode by
disruption of the surface area (i.e., an electrode with no
apertures or cutouts). The two or more apertures or cutouts of the
one electrode may be asymmetrical. The one or more aperture and
cutout may have e.g. rectangular or circular shape. The apertures
and/or cutouts may have regular, irregular, symmetrical and/or
asymmetrical shapes. When the electrode includes two or more
apertures or cutouts, the apertures or cutouts may have the same
point of symmetry and/or line of symmetry. The distance between two
closest points located on the borders of two different apertures
and/or cutouts of the electrode may be in a range from 1 .mu.m to
10 mm or from 10 .mu.m to 8 mm or from 20 .mu.m to 5 mm or from 50
.mu.m to 3 mm or from 100 .mu.m to 2 mm.
[0162] The electrode with one or more openings (e.g. apertures
and/or cutouts) and/or protrusions may be framed by the conductive
material and the inside of the frame may have a combination of
conductive material and the openings. The frame may create the
utmost circumference of the electrode from the side facing the
patient. The frame may have a form of annular, semicircular,
elliptical, oblong, square, rectangular, trapezoidal or polygonal
shape. The inside of the frame 801 may have a structure of a grid
802 as shown in FIGS. 9A and 9B with the apertures 803. The frame
801 and the grid lines 802 are made of conductive material and are
parts of the electrode 800. The frame 801 may be of the same
thickness as the thickness of the grid lines 802 or the thickness
of the frame 801 may be thicker than the grid lines 802 in the
range of 1% to 2000% or in the range of 10% to 1000% or in the
range of 20% to 500% or in the range of 50% to 200%. Additionally
the frame 801 may be thinner than the grid lines 802 in the range
of 0.01 times to 20 times or in the range of 0.1 times to 10 times
or in the range of 0.2 times to 5 times or in the range of 0.5
times to 2 times. It may be also possible to design the electrode
such that the conductive material of the electrode is getting
thinner from the center 804 of the electrode 800 as shown in FIG.
9C. The thinning step between adjacent grid lines 802 in the
direction from the center 804 may be in the range of 0.1 times to
10 times or in the range of 0.2 times to 5 times or in the range of
0.5 times to 2 times with the frame 801 having the thinnest line of
conductive material.
[0163] In a first aspect, the total area of the electrode 800
(comprising the frame 801 and the grid lines 802) and all apertures
803 inside the frame 801 of said electrode 800 may be in the range
of 1 to 15 cm.sup.2 or in the range of 2 to 8 cm.sup.2 or in the
range of 2.5 to 6 cm.sup.2 or in the range of 3 to 5 cm.sup.2.
[0164] In a second aspect, the total area of the electrode 800
(comprising the frame 801 and the grid lines 802) and all apertures
803 inside the frame 801 of said electrode 800 may be in the range
of 1 to 20 cm.sup.2 or in the range of 2 to 10 cm.sup.2 or in the
range of 2.5 to 8 cm.sup.2 or in the range of 3.5 to 7
cm.sup.2.
[0165] In a third aspect, the total area of the electrode 800
(comprising the frame 801 and the grid lines 802) and all apertures
803 inside the frame 801 of said electrode 800 may be in the range
of 1 to 10 cm.sup.2 or in the range of 2 to 6.5 cm.sup.2 or in the
range of 2.3 to 6 cm.sup.2 or in the range of 2.5 to 5.5
cm.sup.2.
[0166] In a fourth aspect, the total area of the electrode 800
(comprising the frame 801 and the grid lines 802) and all apertures
803 inside the frame 801 of said electrode 800 may be in the range
of 1 to 20 cm.sup.2 or in the range of 2 to 15 cm.sup.2 or in the
range of 3 to 12 cm.sup.2 or in the range of 4 to 10 cm.sup.2.
[0167] A ratio of the area of the conductive material of the
electrode 800 (i.e. the frame 801 and the gridlines 802) to the
total area of all apertures inside the frame 801 of the electrode
800 may be in the range of 1% to 50%, or in the range of 2% to 45%
or in the range of 5% to 40% or in the range of 8% to 35% or in the
range of 10% to 33%. Additionally the ratio may be in the range of
1% to 20%, or in the range of 10% to 40% or in the range of 33% to
67% or in the range of 50% to 70% or in the range of 66% to
100%.
[0168] Alternatively, the electrode 800 may not be framed, e.g. it
may have a form of a grid with no boundaries formed by openings 803
as shown in FIG. 9D. A ratio of conductive material to cutouts
and/or apertures of the electrode may be in the range of 1% to 50%,
or in the range of 2% to 45% or in the range of 5% to 40% or in the
range of 8% to 35% or in the range of 10% to 33%. Additionally, the
ratio of conductive material to openings of the electrode may be in
the range of 1% to 20%, or in the range of 10% to 40% or in the
range of 33% to 67% or in the range of 50% to 70% or in the range
of 66% to 100%. Such a grated electrode may be very advantageous.
It may be much more flexible, it may ensure contact with the
patient that is more proper and it may have much better
self-cooling properties than full-area electrode.
[0169] With reference to FIG. 9E, a distance between the two
closest parallel grid lines 802a and 802b may be illustrated by at
least one circle 820, which may be hypothetically inscribed into an
aperture and/or cutout 803 and between the two closest parallel
grid lines 802a and 802b and have at least one tangential point
located on the first grid line 802a and at least one tangential
point located on the second grid line 802b, thus having a diameter
equal to the distance between the two closest parallel grid lines
802a and 802b. The at least one hypothetical circle 820 may have a
diameter in a range from 0.001 to 10 mm or 0.005 mm to 9 mm, or
from 0.01 mm to 8 mm or 0.05 mm to 7 mm or from 0.1 mm to 6 mm, or
from 0.2 mm to 5 mm or from 0.3 mm to 5 mm or from 0.5 mm to 5
mm.
[0170] With reference to FIG. 9F, in one aspect, an electrode 800
may have multiple protrusions in the form of radial conductive
lines 808 separated by cutouts 803, wherein the multiple radial
conductive lines 808 are projected from one point of the electrode
805. The multiple radial conductive lines 808 are merged near the
point 805 of the electrode and together create a full conductive
surface 810 around the point of the electrode 805. The radial
conductive lines 808 projected from the point 805 may have the same
length or may have different lengths. Additionally, some of the
radial conductive lines 808 projected from the point 805 may have
the same length and some may have different lengths.
[0171] With reference to FIG. 9G, in another aspect, the electrode
800 may have a base part 806 of a defined shape and protrusions
(radial conductive lines) 808 separated by cutouts 803. The base
part 806 may have a shape of annular, semicircular, elliptical,
oblong, square, rectangular, trapezoidal or polygonal. The base
part 806 may be connected to the conductive leads.
[0172] With reference to FIG. 9H, in yet in another aspect, the
electrode 800 may have a base conductive line 807 and multiple
protrusions (radial conductive lines) 808 separated by cutouts 803.
The base conductive line 807 is connected to all the radial
conductive lines 808 as shown in FIG. 9H. The base conductive line
may also be connected to the conductive lead. The radial conductive
lines 808 emerging from the base conductive line 807 may have the
same lengths and/or may have different lengths.
[0173] The distance between two closest protrusions 808 may be
illustrated as at least one circle (similarly to the circle 820 in
FIG. 9E), which may be hypothetically inscribed into an aperture
and/or cutout 803 and between two closest protrusions 808 and have
at least one tangential point located on the first protrusion and
at least one tangential point located on the second protrusion,
thus having a diameter equal to the distance between the two
closest protrusions. The at least one circle may have a diameter in
a range from 0.001 to 10 mm or 0.005 mm to 9 mm, or from 0.01 mm to
8 mm or 0.05 mm to 7 mm or from 0.1 mm to 6 mm, or from 0.2 mm to 5
mm or from 0.3 mm to 5 mm or from 0.5 mm to 5 mm.
[0174] The protrusions 808 or cutouts 803 may have a symmetrical,
asymmetrical, irregular and/or regular shape. The size, shape
and/or symmetry of individual radial conductive lines may be the
same and/or different across the electrode. For example each
protrusion 808 may have the same shape, the same dimension, the
same direction and/or symmetry. The protrusions 808 may be
characterized by a thickness and a length of the protrusion,
wherein the length is larger than the thickness by factor in the
range of 2 to 100, or in the range of 4 to 80, or in the range of 5
to 70. The thickness of a protrusion may be in the range of 1 .mu.m
to 5 mm or in the range of 20 .mu.m to 4 mm or in the range of 50
.mu.m to 3 mm or in the range of 100 .mu.m to 2.5 mm or in the
range of 120 .mu.m to 2 mm or in the range of 150 .mu.m to 1.5 mm
or in the range of 200 .mu.m to 1 mm. The length of the protrusions
may be in the range of 0.05 to 50 mm or in the range of 0.1 to 30
mm or in the range of 0.5 to 20 mm. The number of protrusions that
one electrode may comprise may be in a range of 1 to 1000, or of 5
to 500, or of 10 to 300, or of 15 to 250, or of 20 to 240.
[0175] The surface area of the electrode 800 with the protrusions
808 may be in the range of 0.1 to 10 cm.sup.2 or in the range of
0.3 to 9.5 cm.sup.2 or in the range of 0.4 to 9 cm.sup.2 or in the
range of 0.5 to 8.5 cm.sup.2.
[0176] In addition, all the possible electrode arrangements
depicted in FIG. 9F-H may be framed with a conductive frame 801,
e.g. as shown in FIG. 9A, wherein the frame 801 is also a part of
the electrode.
[0177] The total number of apertures and/or cutouts in one
electrode regardless of the parallel cuts may be in a range of 5 to
250, or of 10 to 200, or of 15 to 170, or of 20 to 150, or of 300
to 1500, or of 400 to 1400, or of 500 to 1300, or of 600 to
1200.
[0178] In one aspect, where one or more active elements are in the
form of an electrode, which is grated (FIGS. 9A-9D), the energy
flux of one or more grated electrodes may be calculated as an
energy flux of the grid 802 and/or the frame 801 of the active
element and may be in the range of 0.001 W/cm.sup.2 to 1500
W/cm.sup.2 or 0.01 W/cm.sup.2 to 1000 W/cm.sup.2 or 0.5 W/cm.sup.2
to 500 W/cm.sup.2 or 0.5 W/cm.sup.2 to 200 W/cm.sup.2 or 0.5
W/cm.sup.2 to 100 W/cm.sup.2 or 1 W/cm.sup.2 to 70 W/cm.sup.2.
[0179] In another aspect, where one or more active elements are in
the form of an electrode with openings and/or protrusions (FIGS.
9F-9H), the energy flux of one or more protruded electrodes may be
calculated as an energy flux of the base part 806 or base
conductive line 807 and the protrusions 808 of the active element
and may be in the range of 0.001 W/cm.sup.2 to 1500 W/cm.sup.2 or
0.01 W/cm.sup.2 to 1000 W/cm.sup.2 or 0.5 W/cm.sup.2 to 500
W/cm.sup.2 or 0.5 W/cm.sup.2 to 200 W/cm.sup.2 or 0.5 W/cm.sup.2 to
100 W/cm.sup.2 or 1 W/cm.sup.2 to 70 W/cm.sup.2.
[0180] As shown in FIGS. 4A and 4B, the active elements 13 (e.g.
electrode) may be partially embedded within the flexible substrate
layer 42 or adhesive layer 40 or in the interface of the flexible
substrate layer 42 and adhesive layer 40. The active elements 13
(e.g. electrode) may be supplied and controlled independently by
multiple conductive leads 41a (FIG. 4A) or they may be conductively
interconnected and supplied/controlled via a single conductive lead
41b (FIG. 4B). The multiple conductive leads 41a may be connected
to the active elements 13 (e.g. electrode) via a free space (e.g.
hole) in the flexible substrate layer 42. The free space (e.g.
hole) may have dimensions such that each conductive lead 41a may
fit tightly into the substrate layer 42, e.g. the conductive lead
41a may be encapsulated by a flexible substrate layer 42.
Furthermore, the free space (e.g. hole) itself may be metalized and
serve as a connection between respective conductive leads 41a and
active elements 13 (e.g. electrodes). As shown in FIG. 4A, the
active elements 13 (e.g. electrodes) may also be deposited on the
underside of the flexible substrate 42 and may be covered by the
adhesive layer 40 on the sides, which are not coupled to the
substrate 42.
[0181] In another aspect, the active elements 13 (e.g. electrodes)
may be embedded in the flexible substrate 42 such, that the
underside of the substrate 401 and the underside of the active
elements 13A-D are in one plane, as shown in FIG. 4C. For clarity,
the flexible substrate 42 is hatched in FIG. 4C. The substrate 42
may have no free space for conductive leads 41a, as the conductive
lead may be directly coupled to the top side of the active element
(e.g. electrode) as shown in active elements 13A and 13B in FIG.
4C. Alternatively, the flexible substrate may have a free space
(e.g. hole or metalized hole) for coupling the conductive leads 41a
to the active elements (e.g. electrodes), which may be thinner than
the substrate, as shown in active elements 13C and 13D in FIG.
4C.
[0182] Another possible arrangement of the active elements (e.g.
electrodes) in the pad 4 is represented in FIG. 4D. In a first
aspect, the active element 13E may be deposited on the top side of
the substrate 402 such, that the underside of the active element
13E is deposited on the top side of the substrate 402, creating an
interface of the active element 13E and substrate 42 on the top
side of the substrate 402. In a second aspect, the active element
13F may be embedded in the substrate 42 from the top side of the
substrate 402, such that the top side of the active element (e.g.
electrode) and the top side of the substrate 402 lies in one plane.
In this case, the thickness of the active element 13F is less than
thickness of the substrate 42. In a third aspect the active element
13G may be deposited on the top side of the surface 402 similarly
to the active element 13E but even more, the active element 13G is
partially embedded in the substrate 42 from the top side of the
substrate. In all these cases (active elements 13E-G), the
substrate 42 is perforated allowing the coupling of adhesive layer
40 with the active elements 13E-G through the perforations 403.
[0183] Alternatively, the active element (e.g. electrode) may be
fully embedded in the substrate and protrude from its top side or
underside. Thus, the thickness of the active element (e.g.
electrode) may be bigger than the thickness of the substrate.
[0184] In addition, combinations of pad 4 structures mentioned
above may be possible, e.g. one active element (e.g. first
electrode) is deposited on the underside of the pad 4 and another
active element (e.g. second electrode) is embedded in the pad
4.
[0185] In case of a single conductive lead connection, the active
elements 13 (e.g. electrode) may be partially embedded inside the
flexible substrate 42 or adhesive layer 40 or in the interface of
the flexible substrate layer 42 and adhesive layer 40, and the
active elements 13 (e.g. electrode) may be connected via single
conductive lead 41b which may be situated in the flexible substrate
42 or at the interface of the flexible substrate 42 and adhesive
layer 40, as shown in FIG. 4B. The single conductive lead 41b may
leave the pad 4 on its lateral or top side in a direction away from
the patient. In both cases the conductive lead 41a or 41b does not
come into contact with the treatment area.
[0186] Additionally, the active elements 13 (e.g. electrode) may be
partially embedded within the flexible substrate 42 and the
adhesive layer 40 may surround the active elements 13 such that a
surface of active elements 13 may be at least partially in direct
contact with the surface of a treatment area.
[0187] Moreover, the top side of the pad 4 may be protected by a
cover layer 410, which is shown for simplicity only in FIG. 4C.
[0188] A pad 4 may include flexible substrate 500, which may
comprise a central part 501 and one or more segments 502, which may
move at least partially independently from each other as shown in
FIG. 5A. The flexible substrate may have a thickness in a range of
1 to 200 .mu.m or in a range of 5 to 100 .mu.m or in a range of 10
to 75 .mu.m or in a range of 15 to 65 .mu.m. The central part or
the segments may include a sensor 15. The number of segments on the
pad 4 may be in the range of 1 to 100, or in the range of 1 to 80
or in the range of 1 to 60 or in the range of 2 to 20 or in the
range of 3 to 10 or in the range of 4 to 9, wherein each segment
may comprise at least one active element 13 (e.g. electrode). The
neighboring segments may be at least partially separated by slots
503.
[0189] Conventional therapy pads have routinely been made on a
single non-segmented substrate which in some cases includes a
flexible metal material or a polymeric material with a layer of
metallic material deposited thereon.
[0190] As seen in FIG. 5A, the proposed segmented pad 4 may be more
flexible and may provide a greater amount of contact with the
patient than conventional pads routinely used. The substrate 500 of
the pad 4 is divided into central part 501 and a plurality of
connected segments 502. The plurality of segments 502 may move at
least partially independently from one another. The individual
segments 502 may be at least partially physically detached from one
another by, for example, one or more slots 503, or other open area
between neighboring segments 502. The plurality of segments 502 may
be physically coupled together by a central part 501 including one
or more conductive leads 506. In one aspect, the central part 501
may also include one or more active elements 13 (e.g. electrodes).
In another aspect, each active element 13 (e.g. electrode) may be
partially deposited in the central part 501 and partially in the
corresponding segment 502. In another aspect, some active elements
(e.g. electrodes) may be deposited on the central part and some
active elements (e.g. electrodes) may be deposited at least
partially on the segments.
[0191] As shown in FIG. 5A, the slots 503 may extend from the
central part 501 of the substrate 500 of the pad 4 proximate to a
conductive lead 508 and between neighboring segments 502 to an edge
of the substrate 500. Providing for the plurality of segments 502
of the pad 4 to move at least partially independently from one
another may facilitate conformance of the pad 4 to curves or
contours of a patient's body. A segmented pad 4 as illustrated in
FIG. 5A may provide for a greater area, or a greater percentage of
the total area, of the pad 4 portion to be in contact with the
patient's body than if the pad 4 were formed as a single,
non-segmented substrate. In addition, the segments 502 may comprise
a perforated gap 503' shown in FIG. 5A, which also provides greater
conformance of the pad 4 to curves or contours of a patient's
body.
[0192] The shapes and positions of the segments 502 and/or the
slots 503 may be provided in different configurations from those
illustrated in FIG. 5A. For example, the segments 502 may include
rounded or squared ends or have different dimensional ratios than
illustrated. The slots 503 may be curved, squared, triangular,
oblong, polygonal or may include re-entrant portions extending
between one of the segments 502 and the central part 501. The slots
503 may also be a combination of the shapes mentioned above, e.g. a
combination of a triangular slot with the curved end as illustrated
in FIG. 5B representing a detail of one possible slot arrangement
between two neighboring segments 502' and 502''. The slots may be
very thin or may be wide, wherein the width of the slot ts may be
illustrated in one example as follows: First, an imaginary curved
or straight line 520 passes through the center of the slot such
that it divides the slot into two symmetrical parts 503a and 503b,
respectively. The width is then given by a second imaginary line
530 which is perpendicular to the first imaginary line 520 and
which would connect the edges of the neighboring segments facing
towards the slot 502a and 502b, and where the second imaginary line
530 is at a distance of at least 1 mm away from the beginning of
the slot 503c. The beginning of the slot 503c is a point in the
slot 503 closest to the central part 501 of the substrate 500 of
the pad 4 as seen in FIG. 5B. The first imaginary line 520 is
represented by a dashed line in the FIG. 5B and the second
imaginary line 530 is represented as a dotted line in FIG. 5B. The
width of the slot ws may be in the range of 100 .mu.m to 10 mm or
in the range of 500 .mu.m to 8 mm or in the range of 600 .mu.m to 7
mm or in the range of 800 .mu.m to 5 mm.
[0193] Each segment 502 of the substrate 500 may comprise an active
element 13 (e.g. electrode) on a portion of, or the entirety of,
the segment 502.
[0194] The central part 501 may have a proximal end 504 and a
distal end 505, wherein the proximal end 504 of the central part
501 may pass or may be connected to the connecting part 507. The
central part 501 is connected to the connecting part 507 in the
area of a dotted circle in FIG. 5A. Connecting part 507 may
comprise a conductive lead 508 for each active element 13 (e.g.
electrode)--13a-13f in FIG. 5A, or sensor(s) 15 included in a pad
4, wherein all conductive leads of the connecting part are entering
the pad 4 in the proximal end of the central part of the pad 4.
Conductive leads are mainly led by the central part until they
reach the respective segment and its active element(s) or
sensor(s), thus there may be no conductive lead at the distal end
505 of the central part 501 as shown in FIG. 5A. The conductive
leads 506 may be led on the top side of the substrate--side facing
away from the patient; and may be covered by a cover layer, e.g. by
synthetic polymer like polyimide. In one aspect, the underside of
the pad 4 (the side facing towards the body area of the patient)
may also be at least partially covered by the cover layer, mainly
in the area where the pad 4 is coupled to the connecting part
507--dotted circle in FIG. 5A, avoiding the active elements 13; to
improve mechanical reinforcements of this part of the pad 4, among
other benefits. The cover layer (e.g. polyimide film or foam) may
have a thickness in a range of 5 to 50 .mu.m or in a range of 7 to
35 .mu.m or in a range of 10 to 30 .mu.m.
[0195] The connecting part 507 may be flexible or partially
elastic. The connecting part may be made of flexible PCB with the
cover layer as an isolation layer on the top side and/or the
underside of the connecting part 507. The connecting part may have
a connector at its ends, which may be rigid. The connector may be
one of a USB type A, USB type B, USB type C, USB Micro B, DC power
cord, AC power cord, computer power cable, firewire, RJ11, fiber
connector, USB 3.0, mini display, pin connector, SMA, DVI, BNC,
IDE, PS/2, RCA, display port, PSU, SATA, mSATA, DB9, RJ45, RS232 or
any other connector know in the art. The pin connector may have
number of pins in a range of 5 to 60 or in a range of 10 to 44 or
in a range of 15 to 36 or in a range of 20 to 34. Alternatively,
the connector may be made on the flexible PCB with an attached
stiffener underneath used to stiffen the connector against out of
plane deformation. The stiffener may be made of a non-conductive
material including but not limited to plastic or fiberglass. The
stiffener may have a thickness in a range of 0.1 to 5 mm or in a
range of 0.5 to 2 mm or in a range of 1 to 1.5 mm. The flexible PCB
connector may comprise a number of contacts in the range of 5 to 60
or in a range of 10 to 44 or in a range of 15 to 36 or in a range
of 20 to 34.
[0196] In one aspect, the pad 4, the connecting part 507 and the
connector may all be part of the applicator.
[0197] The interconnecting block 3 or the main unit 2 may comprise
one or more sockets configured to connect the connecting part via
the connector on the opposite side to the side where the pad 4 is
situated, wherein the one or more sockets are configured to connect
an arbitrary pad and/or applicator. Alternatively, the
interconnecting block or the main unit may comprise multiple
sockets, each socket configured to connect one specific pad and/or
applicator for a specific treatment area. The socket may be
configured such that it will automatically determine a currently
connected pad and/or applicator. The information about the
connected pad and/or applicator may be read out from the memory of
the pad. Alternatively, the memory may be part of the connector.
After the connection, the connector may be linked with the control
unit 11 (e.g. CPU). The control unit 11 (e.g. CPU) may provide one
or more predetermined treatment protocols to the user via the human
machine interface 8 after the detection of the pad in the socket.
For example if only a forehead pad is connected, the system may
automatically detect this specific pad and propose only a treatment
of a forehead of the patient, not allowing the user to set a
treatment of other body parts of the patient. Furthermore, the
connector may comprise cutouts, grooves, slots, holes and/or
notches for locking the connector in the socket. The socket may
also comprise a safeguard preventing unintentional connection of
the connector in the socket.
[0198] In one aspect, the connector may comprise a symbol
indicating on which body part the pad and/or the applicator is
designated to treat.
[0199] In addition, a supplementary connection may be used between
the main unit 2 and the connecting part; or between the
interconnecting block 3 and the connecting part in order to extend
the connection between the main unit 3 and the pad 4 or
interconnecting block 3 and the pad 4.
[0200] Average pad thickness may be in the range of 10 .mu.m to
2000 .mu.m or in the range of 50 .mu.m to 1000 .mu.m or in the
range of 80 .mu.m to 300 .mu.m or in the range of 100 .mu.m to 200
.mu.m.
[0201] The apparatus configured in a fractional arrangement may
have the active element 13 (e.g. electrode) comprising a matrix
formed by active points of defined size. These points are separated
by inactive (and therefore untreated) areas that allow faster
tissue healing. The surface containing active points may make up
from 1 to 99% or from 2 to 90% or from 3 to 80% or from 4 to 75% of
the whole active element area (active and inactive area). The
active points may have blunt ends at the tissue contact side that
do not penetrate the tissue, wherein the surface contacting tissue
may have a surface area in the range of 500 .mu.m.sup.2 to 250 000
.mu.m.sup.2 or in the range of 1000 .mu.m.sup.2 to 200 000
.mu.m.sup.2 or in the range of 200 .mu.m.sup.2 to 180 000
.mu.m.sup.2 or in the range of 5000 .mu.m.sup.2 to 160 000
.mu.m.sup.2. The blunt end may have a radius of curvature of at
least 0.05 mm. A diameter of the surface contacting tissue of one
active point may be in the range of 25 .mu.m to 1500 .mu.m or in
the range of 50 .mu.m to 1000 .mu.m or in the range of 80 .mu.m to
800 .mu.m or in the range of 100 .mu.m to 600 .mu.m.
[0202] Additionally, the device may employ a safety system
comprising thermal sensors and a circuit capable of adjusting the
therapy parameters based on the measured values. One or more
thermal sensors, depending on the number and distribution of active
elements 13 (e.g. electrodes), may be integrated onto pad 4 to
collect data from different points so as to ensure homogeneity of
heating. The data may be collected directly from the treatment area
or from the active elements 13 (e.g. electrodes). If uneven heating
or overheating is detected, the device may notify the operator and
at the same time adjust the therapy parameters to avoid burns to
the patient. Treatment parameters of one or more active elements
(e.g. electrodes) might be adjusted. The main therapy parameters
are power, duty cycle and time period regulating switching between
multiple active elements 13 (e.g. electrodes). Therapy may be
automatically stopped if the temperature rises above the safe
threshold.
[0203] Furthermore, impedance measurement may be incorporated in
order to monitor proper active element 13 (e.g. electrodes) to skin
contact. If the impedance value is outside the allowed limits, the
therapy may be automatically suspended and the operator may be
informed about potential contact issues.
[0204] Control unit 11 (e.g. CPU) may be incorporated onto the pad
4 itself or it may form a separate part conductively connected to
the pad 4. In addition to the control mechanism, control unit 11
(e.g. CPU) may also contain main indicators (e.g. ongoing therapy,
actual temperature and active element to skin contact).
[0205] FIG. 6 shows some delivery approaches of apparatus for
contact therapy.
[0206] It is possible to switch between multiple active elements 13
(e.g. electrodes) within the single pad 4 in such a way so that the
multiple active elements 13 deliver energy simultaneously,
successively or in an overlapping method or any combination
thereof. For example, in the case of two active elements: in the
simultaneous method, both active elements (e.g. electrodes) are
used simultaneously during the time interval e.g., 1-20 s. In the
successive method, the first active element (e.g. first electrode)
is used during the first time interval e.g., from 1 s to 10 s. The
first active element is then stopped and the second active element
(e.g. second electrode) is immediately used in a subsequent time
interval e.g., from 10 s to 20 s. This successive step may be
repeated. In the overlapping method, the first active element (e.g.
first electrode) is used during a time interval for e.g., 1-10 s,
and the second active element (e.g. second electrode) is used in a
second overlapping time interval for e.g., 1-10 s, wherein during
the second time interval the first active element and the second
active element are overlapping e.g., with total overlapping method
time of 0.1-9.9 s. Active elements 13 (e.g. electrodes) may deliver
energy sequentially in predefined switching order or randomly as
set by operator via human machine interface 8. Schema I in FIG. 6
represents switching between pairs/groups formed of non-adjacent
active elements 13 (e.g. electrodes) located within a pad 4. Every
pair/group of active elements 13 (e.g. electrodes) is delivering
energy for a predefined period of time (dark gray elements in FIG.
6--in schema I elements 1 and 3) while the remaining pairs/groups
of active elements 13 (e.g. electrodes) remain inactive in terms of
energy delivery (light gray elements in FIG. 6--in schema I
elements 2 and 4). After a predefined period of time, energy is
delivered by another pair/group of active elements 13 (e.g.
electrodes) and the initial active elements (e.g. electrodes)
become inactive. This is indicated by arrows in FIG. 6. Switching
between pairs/groups of active elements 13 (e.g. electrodes) may
continue until a target temperature is reached throughout the
entire treatment area or a predefined energy is delivered by all
active elements 13 (e.g. electrodes). Schema II in FIG. 6
represents switching of all active elements 13 (e.g. electrodes)
within the pad 4 between state ON when active elements (e.g.
electrodes) are delivering energy and OFF when they are not
delivering energy. The duration of ON and OFF states may vary
depending on predefined settings and/or information provided by
sensors, e.g. thermal sensors. Schema III in FIG. 6 shows
sequential switching of individual active elements 13 (e.g.
electrodes) within a pad 4. Each active element 13 (e.g. electrode)
is delivering energy for predefined periods of time until a target
temperature is reached throughout the entire treatment area or a
predefined energy is delivered by all active elements 13 (e.g.
electrodes). This sequential switching may be executed in a
clockwise or anticlockwise order. Schema IV in FIG. 6 represents a
zig-zag switching order during which preferably non-adjacent active
elements 13 (e.g. electrodes) deliver energy sequentially until all
active elements 13 (e.g. electrodes) within a pad 4 have been
switched ON. Each active element 13 (e.g. electrode) delivers
energy for a predefined period of time until a target temperature
is reached throughout the entire treatment area or a predefined
energy is delivered by all active elements (e.g. electrodes).
[0207] The control unit (e.g. CPU) may be configured to control the
stimulation device and provide treatment by at least one treatment
protocol improving of visual appearance. Treatment protocol is set
of parameters of the primary electromagnetic energy and the
secondary energy ensuring the desired treatment effect. Each pad
may be controlled to provide same or alternatively different
protocol. Pair areas or areas where symmetrical effect is desired
may be treated by the same treatment protocol. Each protocol may
include one or several sections or steps.
[0208] As a non-limiting example: in case of applying the
radiofrequency energy by the active elements (e.g. electrodes) one
by one as shown in Schema III and IV in FIG. 6, the time when one
active element (e.g. electrode) delivers the radiofrequency energy
to the tissue of the patient may be in the range of 1 ms to 10 s or
in the range of 10 ms to 5 s or in the range of 50 ms to 2 s or in
the range of 100 ms to 1500 ms. Two consecutive elements may be
switched ON and OFF in successive or overlapping method.
Additionally, the delivery of the radiofrequency energy by two
consecutive active elements (e.g. electrodes) may be separated by
the time of no or low radiofrequency stimulation, such that non of
the two consecutive active elements (e.g. electrodes) provides a
radiofrequency energy causing heating of the treatment tissue. The
time of no or low radiofrequency stimulation may be in the range of
1 .mu.s to 1000 ms, or in the range of 500 .mu.s to 500 ms or in
the range of 1 ms to 300 ms or in the range of 10 ms to 250 ms.
[0209] In case of the treatment when more than one pad is used, the
sequential switching of the active elements (e.g. electrodes)
providing radiofrequency treatment may be provided within each pad
independently of the other pads or active elements (e.g.
electrodes) may deliver energy sequentially through all pads.
[0210] As an example for three dependent pads, each with two active
elements (e.g. electrodes):
first step--the radiofrequency energy may be provided by active
element one in the first pad, wherein other active elements are
turned off, second step--the active element two of the first pad is
turned on and the rest of the active elements are turned off, third
step--the active element one of the second pad is turned on and the
rest of the active elements are turned off, fourth step--the active
element two of the second pad is turned on and the rest of the
active elements are turned off, fifth step--the active element one
of the third pad is turned on and the rest of the active elements
are turned off, sixth step--the active element two of the third pad
is turned on and the rest of the active elements are turned
off.
[0211] Another non-limiting example may be:
first step--the radiofrequency energy may be provided by active
element one in the first pad, wherein other active elements are
turned off, second step--the active element one of the second pad
is turned on and the rest of the active elements are turned off,
third step--the active element one of the third pad is turned on
and the rest of the active elements are turned off, fourth
step--the active element two of the first pad is turned on and the
rest of the active elements are turned off, fifth step--the active
element two of the second pad is turned on and the rest of the
active elements are turned off, sixth step--the active element two
of the third pad is turned on and the rest of the active elements
are turned off.
[0212] In case that the pads are treating pair areas (e.g. cheeks,
thighs or buttocks), where symmetrical effect is desired, the pair
pads may be driven by the same protocol at the same time.
[0213] An example of treatment protocol for one pad delivering the
radiofrequency energy for heating of the patient and the electric
current causing the muscle contractions is as follow. The protocol
may include a first section where electrodes in one pad may be
treated such that the electrodes provide an electric current pulses
modulated in an envelope of increasing amplitude modulation
(increasing envelope) followed by constant amplitude (rectangle
envelope) followed by decreasing amplitude modulation (decreasing
envelope), all these three envelopes may create together a
trapezoidal amplitude modulation (trapezoidal envelope). The
trapezoidal envelope may last 1 to 10 seconds or 1.5 to 7 seconds
or 2 to 5 seconds. The increasing, rectangle, or decreasing
envelope may last for 0.1 to 5 seconds or 0.1 to 4 seconds or 0.1
to 3 seconds. The increasing and decreasing envelope may last for
the same time, thus creating a symmetrical trapezoid envelope.
Alternatively, the electric current may be modulated to a
sinusoidal envelope or rectangular envelope or triangular envelope.
The respective envelopes causing muscle contractions may be
separated by time of no or low current stimulation, such that no
muscle contraction is achieved or by a radiofrequency energy
causing the heating of the tissue. During this time of no muscle
contraction, the pressure massage by suction openings may be
provided, which may cause the relaxation of the muscles. The first
section may be preprogrammed such that electrodes on various places
of the pad may be switched in time to provide alternating current
pulses wherein some other electrodes in the pad may not provide any
alternating current pulses but only RF pulses causing heating of
the tissue. All electrodes in the pad may ensure providing (be
switched by the switching circuitry 14 to provide) RF pulses for
heating the tissue during the section of protocol or protocol,
while only a limited amount of the electrodes may provide (be
switched by the switching circuitry 14 to provide) alternating
currents for muscle contracting during the section of protocol or
protocol. The device may be configured such that the first section
lasts for 1-5 minutes.
[0214] A second section may follow the first section. The second
section may be preprogrammed such that different electrodes than
the ones used in the first section on various places of the pad may
be switched in time to provide alternating current pulses wherein
some other electrodes (same or different electrodes than the ones
used in the first section) in the pad may not provide any
alternating current pulses but only RF pulses causing heating of
the tissue.
[0215] A third section may follow the second section. The third
section may be preprogrammed such that different electrodes than
the ones used in the second section on various places of the pad
may be switched in time to provide alternating current pulses
wherein some other electrodes (same or different electrodes than
the ones used in the second section) in the pad may not provide any
alternating current pulses but only RF pulses causing heating of
the tissue.
[0216] An example of a treatment protocol for three dependent pads,
e.g. one pad for treatment of the forehead (forehead pad) and two
pads for treatment of the left and right cheeks (left and right
cheek pad), delivering radiofrequency energy for heating of the
patient and electric current causing muscle contractions is as
follows: The first pad, e.g. for treatment of the forehead, may
have six active elements, e.g. electrodes E1-E6; the second pad,
e.g. for treatment of the left cheek, may comprise seven active
elements, e.g. electrodes E7-E13; and the third pad, e.g. for
treatment of the right cheek, may comprise seven active elements,
e.g. electrodes E14-E20. Some electrodes may be configured to
provide radiofrequency energy and some electrodes may be configured
to provide both radiofrequency energy and electric current.
[0217] The radiofrequency energy may be a monopolar radiofrequency
energy with a frequency in the range of 100 kHz to 550 MHz or in
the range of 250 kHz to 500 MHz or in the range of 350 kHz to 100
MHz or in the range of 350 kHz to 14 MHz. The radiofrequency energy
may be delivered with a rectangular envelope which may last for 200
to 3000 ms or for 250 to 2000 ms or for 300 to 1800 ms or for 350
to 1500 ms. Alternatively, the radiofrequency envelope (hereinafter
RF envelope) may be modulated to a sinusoidal envelope or
triangular envelope or trapezoidal envelope.
[0218] The electric current may be a bipolar rectangular AC TENS
current with a frequency in the range of 10 Hz to 10 kHz or in the
range of 25 Hz to 1 kHz or in the range of 50 to 500 Hz or in the
range of 100 to 300 Hz modulated to a trapezoidal envelope, which
may last 1 to 10 seconds or 1.5 to 7 seconds or 2 to 5 seconds. An
increasing, rectangular, or decreasing envelope of the trapezoidal
envelope may last for 0.1 to 5 seconds or 0.1 to 4 seconds or 0.1
to 3 seconds. The increasing and decreasing envelopes may have the
same duration, thus creating a symmetrical trapezoidal envelope.
Alternatively, the electric current envelope (hereinafter EC
envelope) may be modulated to a sinusoidal envelope or rectangular
envelope or triangular envelope.
[0219] The protocol may have a cycle that includes sections. The
number of protocol sections in one cycle may be the same number as
the total number of used electrodes within all pads used for the
treatment or may be different. The number of sections per pad may
be in the range of 1 to 100, or of 1 to 80, or of 1 to 60, or of 2
to 20, or of 3 to 10, or of 4 to 9. The number of sections per
cycle may be in the range of 1 to 100, or of 1 to 80, or of 1 to
60, or of 2 to 40, or of 3 to 35, or of 4 to 30. Each protocol
section may follow the previous protocol section, e.g. the second
section follows the first section. Each protocol section may last
for 200 to 3000 ms or for 250 to 2000 ms or for 300 to 1800 ms or
for 350 to 1500 ms. The cycle may repeat from 30 to 300, or from 50
to 250, or from 80 to 220, or from 100 to 200, times per treatment.
Alternatively, the cycle may repeat from 150 to 600, or from 190 to
550, or from 200 to 520, or from 210 to 500, times per treatment.
In one aspect the treatment protocol may repeat the same cycle. In
another aspect the treatment protocol may repeat different cycles,
wherein the cycles may be different in the number of sections,
and/or duration of sections, and/or sequence of activating and/or
deactivating the electrodes, and/or parameters set for RF and/or EC
envelopes (e.g. shape of envelope, amplitude, frequency, duration
and so on), and/or parameters set for radiofrequency and/or
parameters of electric current.
[0220] An example of a cycle including 20 sections may be as
follows:
[0221] In the first section, the electrode E2 delivers the RF
envelope.
[0222] In the second section, the electrode E7 delivers the RF
envelope.
[0223] In the third section, the electrode E14 delivers the RF
envelope.
[0224] In the fourth section, the electrode E5 delivers the RF
envelope.
[0225] In the fifth section, the electrode E8 delivers the RF
envelope.
[0226] Throughout the first to fifth sections, the electrode pairs
E1-E4, E3-E6, E9-E10, E11-E12, E16-E17 and electrode pair E18-E19
deliver the EC envelope causing muscle contractions under the
first, second and third pads, e.g. under the forehead pad, the left
cheek pad and the right cheek pad.
[0227] In the sixth section, the electrode E15 delivers the RF
envelope.
[0228] In the seventh section, the electrode E13 delivers the RF
envelope.
[0229] In the eighth section, the electrode E20 delivers the RF
envelope.
[0230] In the ninth section, the electrode E1 delivers the RF
envelope.
[0231] In the tenth section, the electrode E3 delivers the RF
envelope.
[0232] Throughout the sixth to tenth sections, the electrode pairs
E9-E10, E11-E12, E16-E17 and electrode pair E18-E19 deliver the EC
envelope causing muscle contractions under the second and third
pads, e.g. under the left and right cheek pads.
[0233] In the eleventh section, the electrode E6 delivers the RF
envelope.
[0234] In the twelfth section, the electrode E4 delivers the RF
envelope.
[0235] In the thirteenth section, the electrode E9 delivers the RF
envelope.
[0236] In the fourteenth section, the electrode E16 delivers the RF
envelope.
[0237] In the fifteenth section, the electrode E12 delivers the RF
envelope.
[0238] Throughout the eleventh to fifteenth sections, no electrode
pairs deliver the EC envelope, causing the muscles to relax.
[0239] In the sixteenth section, the electrode E19 delivers the RF
envelope.
[0240] In the seventeenth section, the electrode E10 delivers the
RF envelope.
[0241] In the eighteenth section, the electrode E17 delivers the RF
envelope.
[0242] In the nineteenth section, the electrode E11 delivers the RF
envelope.
[0243] In the twentieth section, the electrode E18 delivers the RF
envelope.
[0244] Throughout the sixteenth to twentieth sections, the
electrode pairs E1-E4 and E3-E6 deliver the EC envelope causing
muscle contractions under the first pad, e.g. under the forehead
pad.
[0245] The treatment protocol may be preprogrammed such that each
electrode used during the treatment may deliver the RF envelope
once per cycle and some electrode pairs (e.g. E1-E4) may deliver EC
envelope twice per cycle. Alternatively, each electrode may deliver
the RF envelope 2 to 10, or 2 to 8, or 2 to 5 times per cycle; and
some electrode pairs may deliver the EC envelope 1 to 10, or 1 to
8, or 1 to 5 times per cycle.
[0246] In one aspect, the treatment protocol may be preprogrammed
such that only one electrode delivers the RF envelope per section.
In another aspect, 2 to 20, or 2 to 15, or 2 to 10, or 2 to 5, or 2
to 3 electrodes deliver RF envelopes in each section
simultaneously, wherein the RF envelopes may be the same or may be
different. In another aspect, no RF envelopes may be delivered
during at least one section.
[0247] The treatment protocol may be preprogrammed such that during
a single treatment the RF envelopes are delivered 25 to 300, or 50
to 250, or 80 to 200, or 100 to 180 times by each electrode with an
RF pause time between each delivery of the RF envelope. The RF
pause time--the time during which the electrode is not providing a
radiofrequency energy to the patient between two consecutive
deliveries of RF envelopes--may be in the range of 0.5 to 20 s, or
of 1 to 15 s, or of 1.5 to 12 s, or of 2 to 10 s.
[0248] In one aspect, the radiofrequency energy may be controlled
by a control unit (e.g. CPU) in order to provide a constant heating
radiofrequency power (CHRP) on each electrode, which means that
each electrode provides homogenous heating of the patient. A CRP
setting may be preprogrammed in the treatment protocol for each
specific electrode in each specific pad based on the dimensions of
the electrode and/or its position in the pad and/or its position on
the body area of the patient. In another aspect, the radio
frequency power may be controlled by the control unit based on
feedback from at least one thermal sensor measuring the temperature
of the treated body area and/or the temperature of the electrode
providing the radiofrequency energy such that when the desired
temperature is reached, the electrodes are controlled to keep the
temperature at this desired level. A typical treatment temperature
of the body area under the electrode is in the range of
37.5.degree. C. to 55.degree. C. or in the range of 38.degree. C.
to 53.degree. C. or in the range of 39.degree. C. to 52.degree. C.
or in the range of 40.degree. C. to 50.degree. C. or in the range
of 41.degree. C. to 45.degree. C.
[0249] The treatment protocol may be preprogrammed such that during
a single treatment the EC envelopes are delivered 25 to 1000, or 50
to 900, or 100 to 750, or 120 to 600, or 150 to 500 times by at
least one pair of electrodes with an EC pause time between each
delivery of the EC envelope. The EC pause time--the time when the
electrode pair is not providing electric current to the patient
between two consecutive deliveries of EC envelopes--may be in the
range of 0.5 to 20 s, or of 1 to 15 s, or of 1.5 to 12 s, or of 2
to 10 s. Alternatively, the electrode pair may deliver EC envelopes
one after another without the EC pause time.
[0250] In another aspect, radiofrequency energy may be delivered
constantly through all electrodes during the whole treatment and
only the EC envelopes may be delivered sequentially.
[0251] A single treatment may last for 1 to 60 min, or for 5 to 45
min, or for 10 to 30 min, or for 15 to 25 min, or for 18 to 23 min
based on the number of pads used during the treatment. The number
of pads used in single treatment may be 1, 2, 3, 4, 5, 6, 7, 8, 9,
10 or up to 100. The protocol may be preprogrammed such, that the
electrodes providing the electric current causing the muscle
contractions are switched to provide radiofrequency heating after
they produce one, two, three, four or five contractions on
maximum.
[0252] The respective sections are assembled by the control unit
(CPU) in the treatment protocol to provide at least 60-900
contractions or 90-800 contractions, or 150-700 contractions by a
single pad per treatment.
[0253] In addition, the respective electrode pairs providing
electric current to the patient are controlled by the control unit
(CPU) to provide at least 50-1000 contractions or 60-900
contractions or 90-800 contractions, or 100-450 contractions per
treatment.
[0254] The forehead pad may include a layout of electrodes such
that the anatomical area 1 and anatomical area 2 are stimulated by
alternating currents which may cause muscle contractions while
anatomical area 3 is not stimulated by alternating currents causing
muscle contraction as shown in FIG. 10. The control unit (CPU) is
configured to provide a treatment protocol energizing by
alternating electric currents only those electrodes located in
proximity or above the anatomical area 1 and 2; and energizing
electrode/electrodes in proximity of or above anatomical area 3 by
radiofrequency energy only as shown in FIG. 10. The anatomical area
1 and 2 may comprise the Frontalis muscles and the anatomical area
3 may comprise the center of the Procerus muscle. The forehead pad
may also treat the Corrugator supercilii muscle or Orbicularis
oculi with radiofrequency energy.
[0255] The pad used for a treatment of the cheek (either side of
the face below the eye) may include a layout of electrodes such
that the anatomical area comprising the Buccinator muscle, the
Masseter muscle, the Zygomaticus muscles or the Risorius muscle are
stimulated by electrical currents, which may cause muscle
contractions, wherein the other anatomical area may be only heated
by the radiofrequency energy. A cheek pad may also be used for
contraction of the Lavator labii superioris.
[0256] On the contrary the pad may be configured such that the
layout of electrodes close to the eyes (e.g. body part comprising
Orbicularis oculi muscles) or teeth (e.g. body part comprising
Orbicularis oris muscles) may not provide energy causing muscle
contractions.
[0257] The pad used for a treatment of the submentum or submental
area may include a layout of electrodes such that the anatomical
area comprising the Mylohyoid muscle or the Digastric muscle is
stimulated with electrical current, which may cause muscle
contractions, wherein the other anatomical area may only be heated
by the radiofrequency energy. In one aspect, a submentum pad (pad
used for treatment of the submentum) may not provide electric
current to an Adam's apple, but may provide heating with
radiofrequency energy to the Adam's apple.
[0258] The treatment device may be configured such, that in each
section or step the impedance sensor provides the information about
the contact of the pad or active element (e.g. electrode) with the
patient to the control unit (e.g. CPU). The control unit (e.g. CPU)
may determine based on the pre-set conditions if the contact of the
pad or active element (e.g. electrode) with the patient is
sufficient or not. In case of sufficient contact, the control unit
(e.g. CPU) may allow the treatment protocol to continue. In case
that the contact is inappropriate, the valuated pad or active
element (e.g. electrode) is turned off and the treatment protocol
continues to consecutive pad or active element (e.g. electrode) or
the treatment is terminated. The determination of proper contact of
the pad or active element (e.g. electrode) may be displayed on the
human machine interface 8.
[0259] The impedance measurement may be made at the beginning of
the section/step, during the section/step or at the end of the
section/step. The impedance measurement and/or the proper contact
evaluation may be determined only on the active electrodes for the
given section/step or may be made on all electrodes of all pads
used during the section/step.
[0260] In one aspect, the impedance may be monitored through all
active elements (e.g. electrodes) while the therapy is being
provided to the patient. The device monitors the impedance between
the active element (e.g. electrode) and the skin of the patient
while the treatment energy (e.g. radiofrequency or electric
current) is being delivered to the patient, analyzes the monitored
impedance at two or more different time instances in order to
determine a change in the size of the electrode-skin contact area,
and if the change in the monitored impedance reaches a
pre-determined threshold, alters the stimulation being delivered to
the patient or terminates the treatment. The change in the
impedance value at a given time may be quantified by an impedance
ratio between the impedance value at that time and a baseline
impedance, which is a first impedance value from the history of
impedance measurement of a given active element (e.g.
electrode).
[0261] FIG. 7 and FIG. 8 are discussed together. FIG. 7 shows a
block diagram of an apparatus for contactless therapy 100. FIG. 8
is an illustration of an apparatus for contactless therapy 100.
Apparatus for contactless therapy 100 may comprise two main blocks:
main unit 2 and a delivery head 19 interconnected via fixed or
adjustable arm 21.
[0262] Main unit 2 may include a primary electromagnetic generator
6 which may generate one or more forms of electromagnetic radiation
wherein the electromagnetic radiation may be e.g., in the form of
incoherent light or in the form of coherent light (e.g. laser
light) of predetermined wavelength. The electromagnetic field may
be primarily generated by a laser, laser diode module, LED, flash
lamp or incandescent light bulb. The electromagnetic radiation may
be such that it may be at least partially absorbed under the
surface of the skin of the patient. The wavelength of the applied
radiation may be in the range of 100 to 15000 nm or in the range of
200 to 12000 nm or in the range of 300 to 11000 nm or in the range
of 400 to 10600 nm or it may be in the form of second, third,
fourth, fifth, sixth, seventh or eighth harmonic wavelengths of the
above mentioned wavelength ranges. Main unit 2 may further comprise
a human machine interface 8 represented by display, buttons,
keyboard, touchpad, touch panel or other control members enabling
an operator to check and adjust therapy and other device
parameters. The power supply 5 located in the main unit may include
a transformer, disposable battery, rechargeable battery, power plug
or standard power cord. The output power of the power supply 5 may
be in the range of 10 W to 600 W, or in the range of 50 W to 500 W,
or in the range of 80 W to 450 W. Indicators 17 may provide
additional information about the current status of the device
independently on human machine interface 8. Indicators 17 may be
realized through the display, LEDs, acoustic signals, vibrations or
other forms capable of adequate notice.
[0263] Delivery head 19 may be interconnected with the main unit
via arm 21 which may form the main optical and electrical pathway.
Arm 21 may comprise transmission media, for example wires or
waveguide, e.g. mirrors or fiber optic cables, for electromagnetic
radiation in the form of light or additional electric signals
needed for powering the delivery head 19. The control unit (e.g.
CPU) 11 controls the primary electromagnetic generator 6 which may
generate a continuous electromagnetic energy (CM) or a pulses,
having a fluence in the range of 0.1 pJ/cm.sup.2 to 1000 J/cm.sup.2
or in the range of 0.5 pJ/cm.sup.2 to 800 J/cm.sup.2 or in the
range of 0.8 pJ/cm.sup.2 to 700 J/cm.sup.2 or in the range of 1
pJ/cm.sup.2 to 600 J/cm.sup.2 on the output of the electromagnetic
generator. The CM mode may be operated for a time interval in the
range of 0.1 s to 24 hours or in the range of 0.2 s to 12 hours or
in the range of 0.5 s to 6 hours or in the range of 1 s to 3 hours.
The pulse duration of the electromagnetic radiation operated in the
pulse regime may be in the range of 0.1 fs to 2000 ms or in the
range of 0.5 fs to 1500 ms or in the range of 1 fs to 1200 ms or in
the range of 1 fs to 1000 ms. Alternatively the pulse duration may
be in the range of 0.1 fs to 1000 ns or in the range of 0.5 fs to
800 ns or in the range of 1 fs to 500 ns or in the range of 1 fs to
300 ns. Alternatively, the pulse duration may be in the range of
0.3 to 5000 .mu.s or in the range of 1 to 4000 .mu.s or in the
range of 5 to 3500 .mu.s or in the range of 10 to 3000 .mu.s. Or
alternatively the pulse duration may be in the range of 0.05 to
2000 ms or in the range of 0.1 to 1500 ms or in the range of 0.5 to
1250 ms or in the range of 1 to 1000 ms. The primary
electromagnetic generator 6 in the pulse regime may be operated by
control unit (e.g. CPU) 11 in a single shot mode or in a repetition
mode or in a burst mode. The frequency of the repetition mode or
the burst mode may be in the range of 0.05 to 10 000 Hz or in the
range of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in the
range of 0.5 to 1000 Hz. Alternatively the frequency of the
repetition mode or the burst mode may be in the range of 0.1 kHz to
200 MHz or in the range of 0.5 kHz to 150 MHz or in the range of
0.8 kHz to 100 MHz or in the range of 1 kHz to 80 MHz. The single
shot mode may be configured to generate a single electromagnetic
energy of specific parameters (e.g. intensity, duration, etc.) for
irradiation of a single treatment area. The repetition mode may be
configured to generate an electromagnetic energy, which may have
one or more specific parameters (e.g. intensity, duration, etc.),
with a repetition rate of the above-mentioned frequency for
irradiation of a single treatment area. The burst mode may be
configured to generate multiple consecutive electromagnetic
energies, which may have variable parameters (e.g. intensity,
duration, delay etc.), during one sequence, wherein the sequences
are repeated with the above-mentioned frequency and wherein the
sequence may include the same or different sets of consecutive
electromagnetic energies.
[0264] Alternatively, the device may contain more than one primary
electromagnetic generator 6 for generation of the same or a
different electromagnetic energy, e.g. one primary electromagnetic
generator is for generation of an ablative electromagnetic energy
and the other is for generation of a non-ablative electromagnetic
energy. In this case, it is possible for an operator to select
which primary electromagnetic generators may be used for a given
treatment or the clinician can choose a required treatment through
the human machine interface 8 and the control unit (e.g. CPU) 11
will select which primary electromagnetic generators will be used.
It is possible to operate one or more primary electromagnetic
generators of the device 100 simultaneously, successively or in an
overlapping method. For example in the case of two primary
electromagnetic generators: in the simultaneous method, both
primary electromagnetic generators are used simultaneously during a
time interval e.g., 1-20 ps. In the successive method, the first
primary electromagnetic generator is used during the first time
interval e.g., from 1 to 10 ps. The first primary electromagnetic
generator is then stopped and the second primary electromagnetic
generator is immediately used in a subsequent time interval e.g.,
from 10 to 20 ps. Such a sequence of two or more successive steps
may be repeated. In the overlapping method, the first primary
electromagnetic generator is used during a time interval, e.g.,
1-10 ps, and the second primary electromagnetic generator is used
in a second overlapping time interval for e.g., 2-11 ps, wherein
during the second time interval the first primary electromagnetic
generator and the second primary electromagnetic generator are
overlapping e.g., with total overlapping method time for 2-10 ps.
In the case of more than two primary electromagnetic generators,
the activating and deactivating of the primary electromagnetic
generators in a successive or overlap method may be driven by
control unit (e.g. CPU) 11 in the order which is suitable for a
given treatment, e.g. first activating the pre-heating primary
electromagnetic generator, then the ablation primary
electromagnetic generator and then the non-ablative primary
electromagnetic generator.
[0265] The active elements 13 in the delivery head 19 may be in the
form of optical elements, which may be represented by one or more
optical windows, lenses, mirrors, fibers or diffraction elements.
The optical element representing active element 13 may be connected
to or may contain primary electromagnetic generator 6 inside the
delivery head 19. The optical element may produce one beam of
electromagnetic energy, which may provide an energy spot having an
energy spot size defined as a surface of tissue irradiated by one
beam of light. One optical element may provide one or more energy
spots e.g. by splitting one beam into a plurality of beams. The
energy spot size may be in the range of 0.001 cm.sup.2 to 1000
cm.sup.2, or in the range of 0.005 cm.sup.2 to 700 cm.sup.2, or in
the range of 0.01 cm.sup.2 to 300 cm.sup.2, or in the range of 0.03
cm.sup.2 to 80 cm.sup.2. Energy spots of different or the same
wavelength may be overlaid or may be separated. Two or more beams
of light may be applied to the same spot at the same time or with a
time gap ranging from 0.1 s to 30 seconds. Energy spots may be
separated by at least 1% of their diameter, and in addition, energy
spots may closely follow each other or may be separated by a gap
ranging from 0.01 mm to 20 mm or from 0.05 mm to 15 mm or from 0.1
mm to 10 mm.
[0266] The control unit (e.g. CPU) may be further responsible for
switching between active elements 13 or for moving the active
elements 13 within the delivery head 19 so that the electromagnetic
radiation may be delivered homogeneously into the whole treatment
area marked with aiming beam 18. The rate of switching between
active elements 13 may be dependent on the amount of delivered
energy, pulse length, etc. and the speed of control unit (e.g. CPU)
or other mechanism responsible for switching or moving the active
elements 13 (e.g. scanner). Additionally, a device may be
configured to switch between multiple active elements 13 in such a
way that they deliver energy simultaneously, successively or in an
overlapping method. For example, in the case of two active
elements: in the simultaneous method, both active elements are used
simultaneously during the time interval e.g., 1-20 ps. In the
successive method, the first active element is used during the
first time interval e.g., from 1 to 10 ps. The first active element
is then stopped and the second active element is immediately used
in a subsequent time interval e.g., from 10 to 20 ps. This
successive step may be repeated. In the overlapping method, the
first active element is used during a time interval for e.g., 1-10
ps, and the second active element is used in a second overlapping
time interval for e.g., 2-11 ps, wherein during the second time
interval the first active element and the second active element are
overlapping e.g., with total overlapping method time for 2-10
ps.
[0267] The aiming beam 18 has no clinical effect on the treated
tissue and may serve as a tool to mark the area to be treated so
that the operator knows which exact area will be irradiated and the
control unit 11 (e.g. CPU) may set and adjust treatment parameters
accordingly. An aiming beam may be generated by a separate
electromagnetic generator or by the primary electromagnetic
generator 6. Aiming beam 18 may deliver energy at a wavelength in a
range of 300-800 nm and may supply energy at a maximum power of 10
mW.
[0268] In addition, the pad may contain a control unit 11 (e.g.
CPU) driven distance sensor 22 for measuring a distance from active
element 13 to the treated point within the treated area marked by
aiming beam 18. The measured value may be used by CPU 11 as a
parameter for adjusting one or more treatment parameters which may
depend on the distance between the active element and a treating
point, e.g. fluence. Information from distance sensor 22 may be
provided to control unit 11 (e.g. CPU) before every switch/movement
of an active element 13 so that the delivered energy will remain
the same across the treated area independent of its shape or
unevenness.
[0269] The patient's skin may be pre-cooled to a selected
temperature for a selected duration over at least one treatment
portion, the selected temperature and duration for pre-cooling
preferably being sufficient to cool the skin to at least a selected
temperature below normal body temperature. The skin may be cooled
to at least the selected temperature to a depth below the at least
one depth for the treatment portions so that the at least one
treatment portion is substantially surrounded by cooled skin. The
cooling may continue during the application of radiation, wherein
the duration of the application of radiation may be greater than
the thermal relaxation time of the treatment portions. Cooling may
be provided by any known mechanism including water cooling, sprayed
coolant, presence of an active solid cooling element (e.g.
thermoelectric cooler) or air flow cooling. A cooling element may
act as an optical element. Alternatively, a spacer may serve as a
cooling element. Cooling may be provided during, before or after
the treatment with electromagnetic energy. Cooling before treatment
may also provide an environment for sudden heat shock, while
cooling after treatment may provide faster regeneration after heat
shock. The temperature of the coolant may be in the range of
-200.degree. C. to 36.degree. C. The temperature of the cooling
element during the treatment may be in the range of -80.degree. C.
to 36.degree. C. or -70.degree. C. to 35.degree. C. or -60.degree.
C. to 34.degree. C. or -20.degree. C. to 30.degree. C. or 0.degree.
C. to 27.degree. C. or 5.degree. C. to 25.degree. C. Further, where
the pad is not in contact with the patient's skin, cryogenic spray
cooling, gas flow or other non-contact cooling techniques may be
utilized. A cooling gel on the skin surface might also be utilized,
either in addition to or instead of, one of the cooling techniques
indicated above.
[0270] Additionally, device 100 may include one or more sensors.
The sensor may provide information about at least one physical
quantity and its measurement may lead to feedback which may be
displayed by human machine interface 8 or indicators 17. The one or
more sensors may be used for sensing a variety of physical
quantities, including but not limited to the energy of the
delivered electromagnetic radiation or backscattered
electromagnetic radiation from the skin, impedance of the skin,
resistance of the skin, temperature of the treated skin,
temperature of the untreated skin, temperature of at least one
layer of the skin, water content of the device, the phase angle of
delivered or reflected energy, the position of the active elements
13, the position of the delivery element 19, temperature of the
cooling media or temperature of the primary electromagnetic
generator 6. The sensor may be a temperature, acoustic, vibration,
electric, magnetic, flow, positional, optical, imaging, pressure,
force, energy flux, impedance, current, Hall or proximity sensor.
The sensor may be a capacitive displacement sensor, acoustic
proximity sensor, gyroscope, accelerometer, magnetometer, infrared
camera or thermographic camera. The sensor may be invasive or
contactless. The sensor may be located on the delivery element 19
or in the main unit 2 or may be a part of a distance sensor 22. One
sensor may measure more than one physical quantity. For example, a
sensor may include a combination of a gyroscope, an accelerometer
or a magnetometer. Additionally, the sensor may measure one or more
physical quantities of the treated skin or untreated skin.
[0271] The thermal sensor measures and monitors the temperature of
the treated skin. The temperature can be analyzed by a control unit
11 (e.g. CPU). The thermal sensor may be a contactless sensor (e.g.
infrared temperature sensor). The control unit 11 (e.g. CPU) may
also use algorithms to calculate a temperature below the surface of
the skin based on the surface temperature of the skin and one or
more additional parameters. A temperature feedback system may
control the temperature and based on set or pre-set limits alert
the operator in human perceptible form e.g. on the human machine
interface 8 or via indicators 17. In a limit temperature condition,
the device may be configured to adjust treatment parameters of each
active element, e.g. output power, activate cooling or stop the
treatment. Human perceptible form may be a sound, alert message
shown on human machine interface 8 or indicators 17 or change of
color of any part of the device 100.
[0272] A resistance sensor may measure the skin resistance, since
it may vary for different patients, as well as the
humidity--wetness and sweat may influence the resistance and
therefore the behavior of the skin in the energy field. Based on
the measured skin resistance, the skin impedance may also be
calculated.
[0273] Information from one or more sensors may be used for
generation of a pathway on a convenient model e.g. a model of the
human body shown on a display of human machine interface 8. The
pathway may illustrate a surface or volume of already treated
tissue, presently treated tissue, tissue to be treated, or
untreated tissue. A convenient model may show a temperature map of
the treated tissue providing information about the already treated
tissue or untreated tissue.
[0274] The sensor may provide information about the location of
bones, inflamed tissue or joints. Such types of tissue may not be
targeted by electromagnetic radiation due to the possibility of
painful treatment. Bones, joints or inflamed tissue may be detected
by any type of sensor such as an imaging sensor (ultrasound sensor,
IR sensor), impedance and the like. A detected presence of these
tissue types may cause general human perceptible signals or
interruption of generation of electromagnetic radiation. Bones may
be detected for example by a change of impedance of the tissue or
by analysis of reflected electromagnetic radiation.
[0275] Furthermore, the device 100 may include an emergency stop
button 16 so that the patient can stop the therapy immediately
anytime during the treatment.
[0276] It may be part of the invention that the method of treatment
includes the following steps: preparation of the tissue;
positioning the proposed device; selecting or setting up the
treatment parameters; and application of the energy. More than one
step may be executed simultaneously.
[0277] Preparation of the tissue may include removing make-up or
cleansing the patient's skin. For higher target temperatures,
anesthetics may be applied topically or in an injection.
[0278] Positioning the device may include selecting the correct
shape of the pad according to the area to be treated and affixing
the pad or the neutral electrode to the patient, for example with
an adhesive layer, vacuum suction, band or mask, and verifying
proper contact with the treated tissue in the case of contact
therapy. In the case of contactless therapy, positioning of the
device may include adjusting the aiming beam of proposed device so
that the device can measure the distance of the active element(s)
from the treatment area and adjust the treatment parameters
accordingly.
[0279] Selecting or setting up the treatment parameters may include
adjusting treatment time, power, duty cycle, delivery time and mode
(CM or pulsed), active points surface density/size for fractional
arrangement and mode of operation. Selecting the mode of operation
may mean choosing simultaneous, successive or overlapping methods
or selecting the switching order of active elements or groups of
active elements or selecting the proper preprogrammed protocol.
[0280] Application of the energy may include providing at least one
type of energy in the form of RF energy, electric current,
ultrasound energy or electromagnetic energy in the form of
polychromatic or monochromatic light, or their combination. The
energy may be provided from at least one active element into the
skin by proposed device. Energy may be delivered and regulated
automatically by the control unit (e.g. CPU) according to
information from thermal sensors and impedance measurements and, in
the case of contactless therapy, distance sensors. All automatic
adjustments and potential impacts on the therapy may be indicated
on the device display. Either the operator or the patient may
suspend therapy at any time during treatment. A typical treatment
might have a duration of about 1 to 60 min or 2 to 50 min or 3 to
40 min or 5 to 30 min or 8 to 25 min or 10 to 20 min depending on
the treated area and the size and number of active elements located
within one or more pads. A typical treatment with 1, 2, 3, 4, 5 or
up to 10 pads may have a total duration of about 1 to 60 minutes or
2 to 50 minutes or 3 to 40 minutes 5 to 30 minutes or 8 to 25
minutes or 10 to 20 minutes. A typical treatment with one pad may
have a total duration of about 1 to 30 minutes or 2 to 25 minutes
or 3 to 22 minutes 5 to 20 minutes or 5 to 15 minutes or 5 to 12
minutes.
[0281] In one example, application of energy to the tissue may
include providing radiofrequency energy and/or electric current
and/or ultrasound energy or any combination of these, from the
active elements embedded in the pad, to the skin of the patient. In
such embodiment, active elements providing radiofrequency energy
are capacitive or resistive RF electrodes and the RF energy may
cause heating, coagulation or ablation of the skin. The electric
current is provided by the RF electrodes and may cause muscle
contractions. Ultrasound energy may be provided through an acoustic
window and may rise the temperature in the depth which may suppress
the gradient loss of RF energy and thus the desired temperature in
a germinal layer may be reach. In addition, the RF electrode may
act as an acoustic window for ultrasound energy.
[0282] Alternatively, the application of the energy to the tissue
may include providing electromagnetic energy in the form of
polychromatic or monochromatic light from the active elements into
the skin of the patient. In such case, active elements providing
the electromagnetic energy may comprise optical elements described
in the proposed device. Optical elements may be represented by an
optical window, lens, mirror, fiber or electromagnetic field
generator, e.g. LED, laser, flash lamp, incandescent light bulb or
other light sources known in the state of art. The electromagnetic
energy in the form of polychromatic or monochromatic light may
entail the heating, coagulation or ablation of the skin in the
treated area.
[0283] After reaching the required temperature and therapy time the
therapy is terminated, the device accessories may be removed and a
cleansing of the patient's skin may be provided.
* * * * *