U.S. patent application number 13/616633 was filed with the patent office on 2013-03-28 for method of enhanced removal of heat from subcutaneous lipid-rich cells and treatment apparatus having an actuator.
This patent application is currently assigned to Zeltiq Aesthetics, Inc.. The applicant listed for this patent is Mitchell E. Levinson, Jesse N. Rosen. Invention is credited to Mitchell E. Levinson, Jesse N. Rosen.
Application Number | 20130079684 13/616633 |
Document ID | / |
Family ID | 38616622 |
Filed Date | 2013-03-28 |
United States Patent
Application |
20130079684 |
Kind Code |
A1 |
Rosen; Jesse N. ; et
al. |
March 28, 2013 |
METHOD OF ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH
CELLS AND TREATMENT APPARATUS HAVING AN ACTUATOR
Abstract
A treatment device for removing heat from subcutaneous
lipid-rich cells of a subject having an actuator that provides
mechanical energy to the tissue. The mechanical energy provided may
include a vibratory component that can range between low and
ultra-high frequencies, and such energy may include various
combinations of two or more frequencies tailored to produce the
desired effect on the subcutaneous tissue. Disruption of adipose
tissue cooled by an external treatment device may be enhanced by
applying mechanical energy to cooled tissue. Furthermore, such
mechanical energy may impart a vibratory effect, a massage effect,
a pulsatile effect, or combinations thereof on the tissue.
Inventors: |
Rosen; Jesse N.; (Albany,
CA) ; Levinson; Mitchell E.; (Pleasanton,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rosen; Jesse N.
Levinson; Mitchell E. |
Albany
Pleasanton |
CA
CA |
US
US |
|
|
Assignee: |
Zeltiq Aesthetics, Inc.
Pleasanton
CA
|
Family ID: |
38616622 |
Appl. No.: |
13/616633 |
Filed: |
September 14, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11750953 |
May 18, 2007 |
|
|
|
13616633 |
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Current U.S.
Class: |
601/11 |
Current CPC
Class: |
A61H 7/001 20130101;
A61F 2007/0228 20130101; A61H 9/00 20130101; A61F 2007/0075
20130101; A61H 2201/5082 20130101; A61F 2007/0056 20130101; A61H
23/0263 20130101; A61H 9/0057 20130101; A61H 9/005 20130101; A61H
9/0007 20130101; A61H 2230/50 20130101; A61F 2007/029 20130101;
A61F 7/10 20130101; A61H 23/0254 20130101; A61H 7/008 20130101;
A61H 2201/165 20130101; A61H 7/00 20130101 |
Class at
Publication: |
601/11 |
International
Class: |
A61H 7/00 20060101
A61H007/00 |
Claims
1-26. (canceled)
27. A treatment device for removing heat from subcutaneous
lipid-rich cells of a subject having skin, comprising: a cup having
a wall defining a reservoir configured to receive at least a
portion of the skin and the subcutaneous lipid-rich cells under
vacuum; a treatment unit attached to the cup, the treatment unit
having a heat exchanging interface element coupled to the wall of
the cup and a thermoelectric cooler contacting a backside of the
heat exchanging interface element; and an actuator operably coupled
to the cup and configured to provide mechanical energy to the
subcutaneous lipid-rich cells, the actuator including-- a variable
speed pump; and a pressure line operably coupling the variable
speed pump to the cup, wherein the actuator is configured to adjust
a pressure level in the cup by varying an operating speed of the
variable speed pump.
28. The treatment device of claim 27, further comprising: a sensor
positioned to detect the pressure level; and a processing unit
operably coupled to the sensor and to the variable speed pump,
wherein the processing unit is configured to vary the speed of the
variable speed pump in response to a signal from the sensor.
29. The treatment device of claim 27 wherein the actuator applies
and at least partially releases a vacuum at a frequency in a range
of about 0.1 Hz to about 10 Hz.
30. The treatment device of claim 27 wherein the actuator provides
the mechanical energy to create a massage effect.
31. The treatment device of claim 27 wherein the actuator produces
a vacuum level equal to or higher than about 2 inches of
mercury.
32. The treatment device of claim 27, further comprising a band
adapted to secure the treatment device to the subject, and wherein
the actuator is further configured to adjust the pressure level
between a positive pressure and a negative pressure.
33. The treatment device of claim 27 wherein the actuator further
includes a valve, and wherein the pressure line operably couples
the pump to the cup via the valve.
34. The treatment device of claim 33, further comprising an
accumulator operably coupled to the pressure line and configured to
maintain the pressure level at a predetermined level.
35. The treatment device of claim 27, further comprising a
regulator operably coupled to the pressure line and configured to
maintain the pressure level at a predetermined level.
36. The treatment device of claim 27, further comprising a
thermally conductive coupling agent for application to an interface
between the treatment device and the skin of the subject to
increase thermal conductivity between the treatment device and the
skin of the subject.
37. The treatment device of claim 27 wherein the heat exchanging
interface element is configured to reduce a temperature of a target
region such that subcutaneous lipid-rich cells in the region are
affected while non-lipid-rich cells proximate to the heat
exchanging interface element are not significantly affected.
38. A system for removing heat from lipid-rich cells of a subject,
comprising: a cup having a wall defining an interior portion of the
cup; a plurality of treatment units attached to the cup, wherein
individual treatment units have a contact plate in the wall of the
cup and a thermoelectric cooler, wherein the thermoelectric cooler
is configured to reduce a temperature of a target region beneath an
epidermis of the subject to reduce the temperature of lipid-rich
cells in the target region such that the lipid-rich cells are
substantially affected while non-lipid-rich cells in the epidermis
are not substantially affected; and a vacuum actuator configured to
draw the lipid-rich cells in the target region at least partially
into the cup, the vacuum actuator including: a variable speed
vacuum pump; and a vacuum line operably coupling the variable speed
vacuum pump to the cup, such that the vacuum actuator is capable of
imparting a massage effect to the subcutaneous lipid-rich cells in
the target region.
39. The system of claim 38, further comprising a sensor positioned
to detect a vacuum level in the cup and a processor in
communication with the sensor and the vacuum pump, the processor
configured to vary the speed of the pump to change the vacuum level
from a first vacuum level of at least 2 inches of mercury to a
second vacuum level, wherein the second vacuum level is at least 5
inches of mercury and is greater than the first vacuum level.
40. The system of claim 39 wherein individual treatment units
include a heat sink having a fluid conduit configured to circulate
a coolant.
41. The system of claim 38, further comprising: a fluid source; a
heat sink; and a fluid line between the heat sink and the fluid
source, wherein the heat sink is in fluid communication with the
fluid source.
42. A treatment device for removing heat from subcutaneous
lipid-rich cells of a subject, the treatment device comprising: a
substrate configured to receive tissue of a target region of a
subject; a plurality of treatment units attached to the substrate,
individual treatment units being movable relative to adjacent
treatment units; and a vacuum actuator operably coupled to the
substrate, the vacuum actuator having a variable speed pump
configured to draw the tissue of the target region proximate to at
least one of the treatment units and provide mechanical energy to
the subcutaneous lipid-rich cells.
43. The treatment device of claim 42 wherein the vacuum actuator is
configured to provide the mechanical energy to impart a massage
effect to the subcutaneous lipid-rich cells at a frequency in the
range of about 0.1 Hz to about 10 Hz.
44. The treatment device of claim 42 wherein the vacuum actuator
further comprises a sensor configured to measure a vacuum level
produced by the variable speed pump and a processor operably
coupled to the sensor and the pump, wherein the processor is
configured to adjust the speed of the pump to vary the vacuum level
from a first vacuum level of at least 2 inches of mercury to a
second vacuum level, and wherein the second vacuum level is at
least 5 inches of mercury and is greater than the first vacuum
level.
45. The treatment device of claim 42 wherein the individual
treatment units include a thermoelectric cooler configured to
reduce a temperature of the target region beneath an epidermis of
the subject to reduce the temperature of lipid-rich cells in the
target region such that the lipid-rich cells are substantially
affected while non-lipid-rich cells in the epidermis are not
substantially affected.
46. The treatment device of claim 42 wherein the substrate
comprises a portion of a wall of a cup configured to receive the
tissue of the target region.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S. patent
application Ser. No. 11/750,953, filed May 18, 2007, the disclosure
of which is incorporated herein by reference in its entirety.
TECHNICAL FIELD
[0002] The present application relates generally to treatment
devices, systems, and methods for removing heat from subcutaneous
lipid-rich cells; more particularly, but not exclusively, several
embodiments are directed toward a treatment device including an
actuator such as a vibration device, a pneumatic device and/or a
massage device and at least one treatment unit to affect
subcutaneous lipid-rich cells.
BACKGROUND
[0003] Excess body fat, or adipose tissue, can detract from
personal appearance and athletic performance. Excess adipose tissue
may be present in various locations of the body, including, for
example, the thigh, buttocks, abdomen, knees, back, face, arms, and
other areas. Moreover, excess adipose tissue is thought to magnify
the unattractive appearance of cellulite, which forms when
subcutaneous fat protrudes into the dermis and creates dimples
where the skin is attached to underlying structural fibrous
strands. Cellulite and excessive amounts of adipose tissue are
often considered to be unappealing. Moreover, significant health
risks may be associated with higher amounts of excess body fat. An
effective way of controlling or removing excess body fat therefore
is needed.
[0004] Liposuction is a method for selectively removing adipose
tissue to "sculpt" a person's body. Liposuction typically is
performed by plastic surgeons or dermatologists using specialized
surgical equipment that invasively removes subcutaneous adipose
tissue via suction. One drawback of liposuction is that it is a
surgical procedure, and the recovery may be painful and lengthy.
Moreover, the procedure typically requires the injection of
tumescent anesthetics, which is often associated with temporary
bruising. Liposuction can also have serious and occasionally even
fatal complications. In addition, the cost for liposuction is
usually substantial. Other emerging techniques for removal of
subcutaneous adipose tissue include mesotherapy, laser-assisted
liposuction, and high intensity focused ultrasound.
[0005] Conventional non-invasive treatments for removing excess
body fat typically include topical agents, weight-loss drugs,
regular exercise, dieting, or a combination of these treatments.
One drawback of these treatments is that they may not be effective
or even possible under certain circumstances. For example, when a
person is physically injured or ill, regular exercise may not be an
option. Similarly, weight-loss drugs or topical agents are not an
option when they cause an allergic or negative reaction.
Furthermore, fat loss in selective areas of a person's body cannot
be achieved using general or systemic weight-loss methods.
[0006] Other non-invasive treatment methods include applying heat
to a zone of subcutaneous lipid-rich cells. U.S. Pat. No. 5,948,011
discloses altering subcutaneous body fat and/or collagen by heating
the subcutaneous fat layer with radiant energy while cooling the
surface of the skin. The applied heat denatures fibrous septae made
of collagen tissue and may destroy fat cells below the skin, and
the cooling protects the epidermis from thermal damage. This method
is less invasive than liposuction, but it still may cause thermal
damage to adjacent tissue, and can also be painful and
unpredictable.
[0007] Additional methods of reducing subcutaneous adipocytes cool
or otherwise selectively remove or target them, as disclosed for
example in U.S. Patent Publication Nos. 2003/0220674 and
2005/0251120, the entire disclosures of which are incorporated
herein. These publications disclose, among other things, the
concept of reducing the temperature of subcutaneous adipocytes to
selectively affect them without damaging the cells in the epidermis
and other surrounding tissue. Although the methods and devices
disclosed in these publications are promising, several improvements
for enhancing the implementation of these methods and devices would
be desirable.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In the drawings, identical reference numbers identify
similar elements or acts. The sizes and relative positions of
elements in the drawings are not necessarily drawn to scale. For
example, the shapes of various elements and angles are not drawn to
scale, and some of these elements are arbitrarily enlarged and
positioned to improve drawing legibility. Further, the particular
shapes of the elements as drawn are not intended to convey any
information regarding the actual shape of the particular elements,
and have been solely selected for ease of recognition in the
drawings.
[0009] FIG. 1 is an isometric view of a system for removing heat
from subcutaneous lipid-rich cells in accordance with an embodiment
of the invention.
[0010] FIG. 2 is an isometric view of an actuator for use with a
treatment device in accordance with an embodiment of the
invention.
[0011] FIG. 3 is an isometric view of the actuator of FIG. 2
coupled to a frame segment of a treatment device in accordance with
an embodiment of the invention.
[0012] FIG. 4a is an isometric view of an actuator for use with a
treatment device in accordance with an embodiment of the invention.
FIG. 4b is an isometric and exploded view of the treatment device
of FIG. 4a.
[0013] FIG. 5 is a schematic view of an embodiment of the actuator
of FIG. 4 in accordance with an embodiment of the invention.
[0014] FIG. 6 is a schematic view of an embodiment of the actuator
of FIG. 4 in accordance with an alternative embodiment of the
invention.
[0015] FIG. 7 is a schematic view of an embodiment of the actuator
of FIG. 4 in accordance with an alternative embodiment of the
invention.
[0016] FIG. 8 is an isometric view of a treatment device for
removing heat from subcutaneous lipid-rich cells in accordance with
embodiments of the invention.
[0017] FIG. 9 is an exploded isometric view of the treatment device
of FIG. 8 further illustrating additional components of the
treatment device in accordance with another embodiment of the
invention.
[0018] FIG. 10 is an isometric top view of an alternative treatment
device for removing heat from subcutaneous lipid-rich cells in
accordance with an embodiment of the invention.
[0019] FIG. 11 is an isometric bottom view of the alternative
treatment device of FIG. 10.
[0020] FIG. 12 is an isometric and exploded view of a treatment
device for removing heat from subcutaneous lipid-rich cells in
accordance with a further embodiment of the invention.
[0021] FIG. 13 is an isometric and exploded view of a vibrator
disposed in the treatment device for removing heat from
subcutaneous lipid-rich cells in accordance with yet another
embodiment of the invention.
[0022] FIG. 14 is a block diagram showing computing system software
modules for removing heat from subcutaneous lipid-rich cells in
accordance with another embodiment of the invention.
DETAILED DESCRIPTION
A. Overview
[0023] This document describes devices, systems, and methods for
cooling subcutaneous adipose tissue. The term "subcutaneous tissue"
means tissue lying beneath the dermis and includes subcutaneous
fat, or adipose tissue, which primarily is composed of lipid-rich
cells, or adipocytes. Several of the details set forth below are
provided to describe the following embodiments and methods in a
manner sufficient to enable a person skilled in the relevant art to
practice, make and use them. Several of the details and advantages
described below, however, may not be necessary to practice certain
embodiments and methods of the invention. Additionally, the
invention may include other embodiments and methods that are within
the scope of the claims but are not described in detail.
[0024] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
the occurrences of the phrases "in one embodiment" or "in an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment. Furthermore, the
particular features, structures, or characteristics may be combined
in any suitable manner in one or more embodiments. The headings
provided herein are for convenience only and do not limit or
interpret the scope or meaning of the claimed invention.
[0025] The present invention is directed toward a treatment device
for removing heat from subcutaneous lipid-rich cells of a subject
and methods for using such a device. The treatment device includes
an actuator that provides mechanical energy to the tissue. The
mechanical energy provided may include a vibratory component that
can range between low and ultra-high frequencies, and such energy
may include various combinations of two or more frequencies
tailored to produce the desired effect on the subcutaneous tissue.
According to an embodiment, for example, disruption of adipose
tissue cooled by an external treatment device may be enhanced by
vibrating the cooled tissue. As applied to the tissue, then, such
vibration may impart a vibratory effect, a massage effect, a
pulsatile effect, combinations thereof, etc.
[0026] Several embodiments of treatment devices for removing heat
from subcutaneous lipid-rich cells include at least one actuator
and a treatment unit. The actuator may connect directly to the
treatment unit, or the actuator may be affixed to a housing for the
treatment unit. Alternatively, the treatment device may further
include a flexible substrate containing a treatment unit and the
actuator is connected to the flexible substrate. The actuator may
provide mechanical energy to the tissue. This may be done in a
number of different ways; for example, varying mechanical energy,
such as vibratory energy, may be imparted through the applicator.
Alternatively, or additionally the tissue may be directly
manipulated with varying pneumatic pressure. The actuator may
include a motor with an eccentric weight or other vibratory motors
such as hydraulic motors, electric motors, solenoids, other
mechanical motors, or piezoelectric shakers to provide the energy
to the treatment site. The treatment units may use a number of
cooling technologies including, for example, thermoelectric
coolers, recirculating chilled fluid, vapor compression elements,
or phase change cryogenic devices. One skilled in the art will
recognize that there are a number of other cooling technologies and
mechanical movement technologies that could be used such that the
treatment units and mechanical devices need not be limited to those
described herein.
[0027] Another embodiment of a treatment device may include one or
more actuators coupled to at least one of a plurality of
interconnected hinged or coupled segments; the hinged or coupled
segments allow the treatment device to conform to a body portion.
The one or more actuators may rigidly be affixed or releasably
coupled to any portion of the interconnected hinged or coupled
segment. Alternatively, the one or more actuators may be on or
embedded in a flexible substrate which further contains the
treatment units.
[0028] In yet another embodiment, a treatment device comprises one
or more actuators controllable to provide varying intensity,
frequency, location and/or duration of motion during treatment. The
motion profile can, for example, be configured to provide motion
along a selected region of the treatment device for a pre-selected
or controlled time period. Alternatively, the motion profile may,
for example, be configured to provide periods of increased
intensity. In other embodiments, the motion profile may vary over
time to provide a decreasing or an increasing intensity during
treatment according to a predetermined pattern. In still other
embodiments, different actuators may simultaneously provide
different types of motion or motion of varying intensity,
frequency, location and/or duration between or among the actuators,
or some actuators may be deactivated while others are activated in
varying patterns throughout the course of treatment.
[0029] Additional embodiments disclosed below are directed toward
methods of affecting lipid-rich cells by applying a treatment
device and imparting mechanical energy to the target cells from one
or more actuators. The actuator may provide mechanical energy
imparted to the tissue. Depending on the frequency and amplitude of
the mechanical energy, the mechanical energy may yield an effect
such as a vibratory effect, a massage effect, a pulsatile effect,
or any combination thereof that sends mechanical energy to the
patient via or in connection with the treatment device. One
embodiment of such a method includes arranging a treatment device
in a desired configuration, cooling a heat exchanging surface of a
treatment unit to a desired temperature, placing the cooled heat
exchanging surface proximate to the subject's skin, activating an
actuator that imparts mechanical energy to the tissue, and reducing
the temperature of a region such that lipid-rich cells in the
region are affected while non-lipid-rich cells in the region
generally are not affected. Alternatively, the actuator and the
treatment units may be on and/or within a flexible substrate.
[0030] Further embodiments disclosed below are directed toward
systems for efficiently removing heat from subcutaneous lipid-rich
cells. An embodiment of a system includes a treatment device having
one or more actuators coupled to a hinge, frame, substrate or other
portion of the treatment device. The actuator is configured to
impart mechanical motion relative to the skin of a patient,
including positive and negative pressure; for example, the actuator
may include a pneumatic feature, such as vacuum, for drawing and/or
pressuring the subject's tissue away from and/or towards,
respectively, the treatment device. In another embodiment, the
actuator may include a vibratory device for providing mechanical
vibration transferred to the subject's tissue via the treatment
device. In yet another embodiment, the actuator may provide
mechanical energy to produce a massage effect, thus providing
mechanical massage to the treated region. When placed proximate to
a subject's skin, the treatment device is capable of reducing a
temperature of a region such that lipid-rich cells in the region
are affected while non-lipid-rich cells in the epidermis and/or
dermis are not generally affected.
B. System for More Effectively Selectively Reducing Lipid-Rich
Cells
[0031] FIG. 1 is an isometric view of an embodiment of a treatment
system 100 for removing heat from subcutaneous lipid-rich cells of
a subject 101. The system 100 may include a treatment device 104
including an actuator 105. The treatment device 104 may be placed,
for example, at an abdominal area 102 of the subject 101 or another
suitable area for cooling or removing heat from the subcutaneous
lipid-rich cells of the subject 101. Various embodiments of the
treatment device 104 are described in more detail below with
reference to FIGS. 2-12.
[0032] The system 100 may further include a treatment unit 106 and
supply and return fluid lines 108a-b between the treatment device
104 and the fluid source 106. The fluid source 106 can remove heat
from a coolant to a heat sink and provide a chilled coolant to the
treatment device 104 via the fluid lines 108a-b. Examples of the
circulating coolant include water, glycol, synthetic heat transfer
fluid, oil, a refrigerant, and/or any other suitable
heat-conducting fluid. The fluid lines 108a-b may be hoses or other
conduits constructed from polyethylene, polyvinyl chloride,
polyurethane, and/or other materials that can accommodate the
particular circulating coolant. The treatment unit 106 may be a
refrigeration unit, a cooling tower, a thermoelectric chiller, or
any other device capable of removing heat from a coolant.
Alternatively, a municipal water supply (i.e., tap water) may be
used in place of the treatment unit.
[0033] As explained in more detail below, the treatment device 104
includes at least one actuator 105 and at least one treatment unit.
The treatment unit may be a Peltier-type thermoelectric element,
and the treatment device 104 may have a plurality of individually
controlled treatment units to create a custom spatial cooling
profile and/or a time-varying cooling profile. The system 100 may
further include a power supply 110 and a processing unit 114
operatively coupled to the treatment device 104 and the actuator
105. In one embodiment, the power supply 110 provides a direct
current voltage to a thermoelectric treatment device 104 and/or the
actuator 105 to remove heat from the subject 101. The processing
unit 114 may monitor process parameters via sensors (not shown)
placed proximate to the treatment device 104 through power line 116
to, among other things, adjust the heat removal rate based on the
process parameters. The processing unit 114 may further monitor
process parameters to adjust actuator 105 based on the process
parameters. The processing unit 114 may be in direct electrical
communication with treatment device 104 through electrical line 112
as shown in FIG. 1; alternatively, processing unit 114 may be
connected to treatment device (and/or any number of other
components of system 100 as discussed below) via a wireless or an
optical communication link. Processing unit 114 may be any
processor, Programmable Logic Controller, Distributed Control
System, and the like. Note that power line 116 and line 112 are
shown in FIG. 1 without any support structure. Alternatively, power
line 116 and line 112 (and other lines including, but not limited
to fluid lines 108a-b) may be bundled into or otherwise accompanied
by a conduit or the like to protect such lines, enhance user safety
and ergonomic comfort, ensure unwanted motion (and thus potential
inefficient removal of heat from subject 101) is minimized, and to
provide an aesthetic appearance to system 100. Examples of such a
conduit include a flexible polymeric, fabric, or composite sheath,
an adjustable arm, etc. Such a conduit may be designed (via
adjustable joints, etc.) to "set" the conduit in place for the
treatment of subject 101.
[0034] In another aspect, the processing unit 114 may be in
electrical or other communication with an input device 118, an
output device 120, and/or a control panel 122. The input device 118
may be a keyboard, a mouse, a touch screen, a push button, a
switch, a potentiometer, any combination thereof, and any other
device or devices suitable for accepting user input. The output
device 120 may be include a display screen, a printer, a medium
reader, an audio device, any combination thereof, and any other
device or devices suitable for providing user feedback. The control
panel 122 may include visual indicator devices or controls (lights,
numerical displays, etc.) and/or audio indicator devices or
controls. In alternative embodiments, the control panel 122 may be
contained in, attached to, or integrated with the treatment device
104. In the embodiment shown in FIG. 1, processing unit 114, power
supply 110, control panel 122, treatment unit 106, input device
118, and output device 120 are carried by a rack or cart 124 with
wheels 126 for portability. In alternative embodiments, the
processing unit 114 may be contained in, attached to, or integrated
with the treatment device 104 and/or the actuator 105. In yet
another embodiment, the various components may be fixedly installed
at a treatment site.
C. Actuator for Use with a Treatment Device
[0035] FIGS. 2, 3 and 4 are isometric views of embodiments of
actuators 105 for use with a treatment device 104 suitable for use
in the system 100. The actuator may provide mechanical energy to
create a vibratory, massage, and/or pulsatile effect. The actuator
may include one or more various motors, for example, motors with
eccentric weight, or other vibratory motors such as hydraulic
motors, electric motors, pneumatic motors, solenoids, other
mechanical motors, piezoelectric shakers, etc. to provide vibratory
energy to the treatment site. Further embodiments include a
plurality of actuators 105 for use in connection with a single
treatment device 104 in any desired combination. For example, an
eccentric weight actuator may be associated with one treatment
device 104 while a pneumatic motor may be associated with another
section of the same treatment device. This, for example, would give
the operator of treatment system 100 options for differential
treatment of lipid rich cells within a single region or among
multiple regions of subject 101. The use of one or more actuators
and actuator types in various combinations and configurations with
treatment device 104 is possible with all the embodiments of the
invention.
D. Treatment Device Having an Actuator Such as a Vibratory
Device
[0036] FIG. 2 shows an actuator 105 including a motor 150
containing an eccentric weight 151 to create mechanical vibration,
pulsing and/or cycling effect. Power is supplied to the motor 150
through power lines 152. Alternatively, the motor 150 could be
battery powered or could include an electrical plug. Alternatively,
vibration, pulsing and/or cycling can be induced by a mechanism
using hydraulic, electric, electromechanical, solenoid, or
mechanical devices as are known in the art. FIG. 3 shows the motor
150 of FIG. 2 affixed to a selected portion of the treatment device
104 as described further herein.
[0037] According to one embodiment, an actuator 105 is affixed by
screws 154 or other mechanical fixation devices to a housing 156 of
the treatment device 104 to transmit mechanical energy through the
treatment device 104 to the tissue of a patient. Alternatively, the
actuator 105 may be strapped in place proximate to the treatment
device 104 to transmit mechanical energy through the treatment
device 104 of the tissue of the patient. According to still further
embodiments, the actuator 105 may be incorporated into the
treatment device 104 to provide an integrated treatment device with
an activator for providing mechanical energy.
[0038] According to alternative embodiments, the treatment device
104 includes a plurality of links that are mechanically coupled
with a plurality of hinges and a single actuator to transfer
mechanical vibratory energy through adjacent links to the skin.
Alternately, the actuator can be incorporated into more than one
link, or a plurality of actuators may be used with a single
treatment device.
[0039] In specific embodiments of the motor 150, the eccentric
weight may be a weight machined out of brass; alternatively, the
mass may be fabricated from steel, aluminum, alloys thereof, high
density polymeric materials, or any other relatively dense
material. According to further embodiments, the motor used is a
brushed DC motor; alternatively, any electric motor could be used,
or any other means of rotating the mass as is known in the art.
[0040] The actuator 105 need not have a rotating eccentric weight;
rather, other embodiments may have an electrical coil or the like
to create a varying or pulsing energy. The electrical coil, for
example, may include a solenoid, a vibrating armature or a voice
coil. According to an embodiment using a solenoid, a coil is
energized to create a magnetic field that moves a steel or iron
armature. The armature may be attached to a mass and can be driven
into a hard stop to produce a pulse. If the hard stop is
mechanically coupled to the device applied to the skin, this energy
will be transferred into the tissue. This method of imparting
mechanical energy to lipid-rich cells so to create a massage or
massage-like effect is suited, but not necessarily limited, to
lower frequencies and higher impulse energies.
[0041] A specific embodiment of a vibrating armature or voice coil
has a coil driven by an alternating current to move or oscillate
the armature back and forth. The inertia of this motion may be
transferred through the link into the tissue to provide an actuator
for enhancing the vibratory effect on the lipid-rich cells.
[0042] According to still further embodiments, the mechanical force
may create a massage massage-like effect using a water hammer.
Water, or any of a number of other heat transfer fluids suitable
for cooling the thermoelectric coolers, can have significant mass,
and when flowing through tubing, these fluids can commensurately
have significant momentum. By quickly halting the flow of such a
fluid, such as, e.g., by placing a solenoid valve in the fluid line
and closing the flow path, a properly designed system transfers the
momentum of the fluid to the treatment device 104 and into the
tissue. According to aspects of this embodiment, such a water
hammer or similar momentum-transferring arrangement is suited to
low frequencies. Further, such an arrangement may reduce the heat
transfer rate, which may be desirable for certain applications.
[0043] In operation, the motor 150 shown in FIG. 2 rotates an
eccentric weight to provide mechanical energy. The motor is rigidly
attached to the treatment device 104, for example, to a housing 156
of the treatment device 104 as shown in FIG. 3. Mechanical energy
creating a pulsing, cycling, or oscillation effect is applied by
the centripetal force generated as the eccentric weight rotates,
creating a varying or pulsing mechanical energy. This energy is
transferred through the treatment device 104 to the patient's skin
and underlying tissue. The frequency of the vibration can be
increased by increasing the rotational rate of the weight. A higher
frequency also increases the applied force of the vibration.
According to one embodiment, the frequency of massage (or
vibration) is in the range of about 0.1 Hz to about 50 MHz, and
more preferably in the range of between about 200 Hz and about 400
Hz, according to alternative embodiments; the frequency of massage
(or vibration) can be higher or lower. The motor 150 may further
include passive or active damping materials (not shown). The force
applied during each rotation of the weight may be increased, for
example, by increasing the mass of the weight or increasing the
distance between the center of gravity of the weight and its axis
of rotation. Similarly, decreasing the mass of the weight or
decreasing the distance between the center of gravity of the weight
and its axis of rotation may, for example, decrease the force
applied during each rotation of the weight. The appropriate force
is dependent on the mass of the housing 156 or other component of
the treatment device 104 to which the motor 150 is applied.
According to embodiments, a more massive housing assembly requires
a more massive eccentric weight so that the vibratory force is
transferred through the housing 156 into the tissue to which the
treatment device 104 is applied.
[0044] The illustrated embodiment of the actuator as shown in FIG.
2 can allow a compact and relatively low power actuator 105 to be
coupled to one or more of the link assemblies of a treatment device
104. By coupling the actuator 105 to the treatment device 104,
mechanical energy may be applied at any time in the cooling or
heating process without necessarily removing the applicator.
Alternatively, the applicator may be removed and an actuator such
as a commercial massage device may be applied to the tissue or the
tissue may be manually massaged.
[0045] In addition, the illustrated embodiment may provide
acceleration and enhancement of the ischemic reperfusion damage to
adipose tissue through mechanical massage or vibration. Further,
the illustrated embodiment of the actuator and the treatment device
combine to provide an enhanced ability to disrupt crystallized
adipose cells and further affect lipid-rich cells.
E. Treatment Device Having an Actuator Such as a Vacuum Device
[0046] FIGS. 4a and 4b show a vacuum device 160 suitable for use
with a treatment device for applying a vacuum to the subject's
tissue before, during and/or after cooling. As discussed with
reference to FIG. 3, the actuator 105, shown as a vacuum device 160
in this embodiment, may include treatment units 408a, 408b affixed
to the vacuum device 160. The vacuum device 160 may provide
mechanical energy to a treatment region. Imparting mechanical
vibratory energy to the patient's tissue by repeatedly applying and
releasing a vacuum to the subject's tissue, for instance, creates a
massage action. Alternatively, massage devices as are known in the
art may be used to enhance the desired effect on lipid-rich cells.
FIGS. 5-7 illustrate schematic diagrams of embodiments of the
vacuum device 160.
[0047] As described herein, techniques for incorporating massage
into a treatment device 105 may include using a pressure
differential to draw the skin against a thermally controlled plate
or plates. In an actuator such as the vacuum device 160 shown in
FIGS. 4a and 4b, a vacuum line 162 can be connected to the vacuum
device 160. In operation, air is evacuated from a chamber in the
vacuum device 160 create a pressure differential which draws a fold
of the subject's skin and subcutaneous tissue up inside a reservoir
430 of the vacuum device 160 and against the treatment units 408a,
408b.
[0048] The vacuum device 160 defines the reservoir 430 for
receiving tissue of a subject during treatment. The vacuum device
160 may further include treatment units 408a, 408b positioned at
opposite sides of the vacuum 160. Alternatively, the treatment
units 408a, 408b may be adjacent one another. Further, vacuum
device 160 may comprise a single treatment unit or more than two
treatment units. As shown in the example of FIG. 4b, one or both of
the treatment units 408a, 408b may include a heat exchanging
interface 420 for transferring heat to/from the subject 101. A
cryoprotectant or coupling agent (not shown) may be applied to the
heat exchanging interface 420 to prevent ice from forming thereon
when the temperature is reduced to a temperature around or below
the freezing point of water (0.degree. C.). In one embodiment, the
heat exchanging interface 420 is generally planar, but in other
embodiments, the heat exchanging interface 420 is non-planar (e.g.,
curved, faceted, etc.) The interface 420 may be constructed from
any suitable material with a thermal conductivity greater than 0.05
Watts/Meter K, and in many embodiments, the thermal conductivity is
more than 0.1 Watts/Meter K Examples of suitable materials include
aluminum, other metals, metal alloys, graphite, ceramics, some
polymeric materials, composites, or fluids contained in a flexible
membrane. Portions of the heat exchanging element 420 may be an
insulating material with a thermal conductivity less than about
0.05 Watts/Meter K.
[0049] The heat exchanging interface 420 may also include at least
one sensing element (not shown) proximate to the heat exchanging
interface 420. The sensing element, for example, may be generally
flush with the heat exchanging interface 420. Alternatively, it may
be recessed or protrude from the surface. The sensing element may
include a temperature sensor, a pressure sensor, a transmissivity
sensor, a bio-resistance sensor, an ultrasound sensor, an optical
sensor, an infrared sensor, a sensor for measuring blood flow, or
any other desired sensor. In one embodiment, the sensing element
may be a temperature sensor configured to measure the temperature
of the heat exchanging interface 420 and/or the temperature of the
skin of the subject. For example, the temperature sensor may be
configured as a probe or as a needle that penetrates the skin
during measurement. Examples of suitable temperature sensors
include thermocouples, resistance temperature devices, thermistors
(e.g., neutron-transmutation-doped germanium thermistors), and
infrared radiation temperature sensors. In another embodiment, the
sensing element may be an ultrasound sensor configured to measure
the thickness of a fat layer in the subject or crystallization of
subcutaneous fat in the treatment region of a subject. In yet
another embodiment, the sensing element may be an optical or
infrared sensor configured to monitor an image of the treatment
region to detect, for example, epidermal physiological reactions to
the treatment. In yet another embodiment, the sensing element may
be a device to measure blood flow. The sensing element may be in
electrical communication with the processing unit 114 via, for
example, a direct wired connection, a networked connection, and/or
a wireless connection.
[0050] The vacuum device 160 may further include a mounting element
406 that couples the treatment units 408a, 408b to the vacuum
device 160. The mounting element 406, for example, may be a
bracket, frame or other suitable fixture. The treatment units 408a,
408b may include a heat sink 402 with a cover 401, and a
thermoelectric cooler 404 disposed between the heat sink 402 and
the heat exchanging interface 420. The thermoelectric cooler 404
may be a single Peltier-type element or a plurality of Peltier-type
elements. One suitable thermoelectric cooler is a Peltier-type heat
exchanging element (model # CP-2895) produced by TE Technology,
Inc. in Traverse City, Mich.
[0051] In the illustrated embodiment, the heat sink 402 includes a
serpentine shaped fluid conduit at least partially embedded in the
heat sink 402. In the illustrated embodiment, the heat sink
includes fluid ports 410a, 410b that may be coupled to a
circulating fluid source (not shown) via the fluid lines 108a-b. In
other embodiments, the heat sink 402 may include a plate-type heat
exchange, a tube and a shell heat exchanger, and/or other types of
heat exchanging devices.
[0052] Vacuum pressure may be supplied by any pump (not shown)
capable of creating a pressure differential. Air pressure can
either be controlled with a regulator between the vacuum source and
the applicator, or pressure may be reduced up to the maximum
capacity of the pump. For example, systems incorporating a
regulator immediately downstream of the pump are designed to
eliminate the regulator by sizing a pump with an appropriate
maximum pressure capacity. According to one embodiment,
approximately 5 inches Hg of vacuum is applied; in alternative
embodiments, higher or lower vacuum levels are applied. In this
embodiment, if the vacuum level is too low, the tissue will not be
drawn adequately (or at all) inside reservoir 430 of the vacuum
device 160; if the vacuum level is too high, undesirable discomfort
to the patient and/or tissue damage could occur.
[0053] By alternating between two different vacuum levels inside
the vacuum device 160, the force applied to the tissue will
concomitantly increase and decrease, having the effect of a
massaging action on the tissue. This may be accomplished, for
instance, by ensuring the minimum vacuum level is high enough to
keep the tissue drawn into the vacuum device 160, and have the
tissue drawn further inside vacuum device 160 when the higher
vacuum level is applied. If the tissue is drawn inside the
applicator to the largest extent possible, friction between the
walls of the applicator and the tissue may cause the tissue to
maintain its overall position or assist the tissue in maintaining
such a position. The change in vacuum pressure level at a desired
frequency pulses the tissue, moving the area of tissue exposed to
the vacuum to alternating positions within vacuum device 160. This
is possible in part because initially, a higher pressure
differential is required to draw the tissue past the sealing
surface of the reservoir 430 and up inside the reservoir 430;
however, once the tissue has been drawn into place, the force (and
therefore the vacuum level) required to hold the tissue in place is
lower. In this embodiment, the lower vacuum level (nearer to
ambient pressure) may be very low, potentially as low as 1 inch of
Hg or lower. The higher pulsing pressure can be 2 inches of mercury
vacuum or higher. In operations, increasing the difference between
the two vacuum levels increases the massage force. Further,
increasing the cycle rate between the two pressures increases the
massage frequency. Accordingly, the tissue can be pulsed in the
range of approximately 0.1 Hz or lower and 10 Hz or higher. It is
also possible to select the two vacuum levels (and possibly other
parameters such as frequency, etc.) sufficient to draw the tissue
into the vacuum device reservoir 430 and to impart a massage or
pulsatile effect to the tissue while keeping the tissue position
relatively constant inside reservoir 430 as alternating levels of
vacuum are applied. This may be accomplished, for example, by
decreasing the relative difference between vacuum levels applied to
the tissue but by keeping the lower vacuum level high enough to
keep the tissue drawn into the reservoir 430 of vacuum device 160
during treatment.
[0054] One method of creating this pneumatic massaging action is
with a variable speed pump. Using pressure feedback to control the
pump speed, the pump may electronically be controlled between two
different vacuum levels. According to this embodiment, there is a
mechanical lag in the time it takes the pump to change speeds,
therefore, this embodiment may not be capable of pulsing at a
frequency as high as some of the other embodiments described
herein. According to yet another embodiment, a large piston is
coupled to the treatment device 104; the piston is driven back and
forth, either pneumatically or mechanically, to create a pressure
wave in the system.
[0055] In an alternate embodiment shown in FIG. 5, one pump, two
regulators and a 3-way valve may be used to switch between the two
regulators. Alternative embodiments may be created, for example, by
removing the higher vacuum pressure regulator or moving the 3-way
valve in front of the regulators. In yet another embodiment, the
3-way valve could be replaced with two 2-position valves. According
to this embodiment, the valves are solenoid valves, however,
according to further embodiments, pneumatically controlled valves
could be used.
[0056] Alternately, as shown in FIG. 6, two pumps and two
regulators may be used. According to aspects of this embodiment,
the dynamic response of the system is improved. Further, this
embodiment may optionally be coupled with pneumatic cylinders to
improve the pneumatic response of the system and provide for higher
massage frequencies. According to still further embodiments, the
regulators may be removed to allow the pumps to operate to their
maximum pressure capacities. Other embodiments include systems in
which the regulators take on different positions relative to the
pumps or those in which different types of regulators are used.
[0057] As shown in FIG. 7, a valve and a backpressure regulator may
be installed in the system. In operation, when the valve is opened,
the pressure in the system reduces to the pressure set by the
regulator. According to further embodiments, the regulator may be
removed and the valve may be controlled by the processing unit 114.
Further, the valve may be opened and air can be vented through an
orifice (not shown) to limit the flow rate. The valve could be
closed when the lower pressure limit is reached as measured by the
pressure transducer, and the system would be returned to the higher
vacuum pressure by the pump. One advantage of this embodiment is
that the pressure relief would occur very quickly, thus possibly
affording higher massage frequencies, among other advantages.
[0058] The illustrated embodiments of the actuator 105 combined
with the treatment device 104 can enhance disruption of adipose
tissue cooled by an external skin treatment device. Further, the
illustrated embodiment may reduce treatment time, reduce discomfort
to the patient and increase efficacy of treatment. For example, in
an alternative embodiment, the vacuum device 160 may be employed
without any vibratory, pulsing, or massage effect on the tissue
drawn therein; rather, the vacuum may statically draw tissue into
the reservoir 430 of the vacuum device 160, and hold the tissue in
the reservoir 430 while cooling through a portion of or up to the
entire duration of the treatment time, and releasing it only when
the cooling treatment protocol is completed. Without being bound by
theory, it is believed that while drawn into the vacuum device
reservoir 430, the relative physical isolation of the target
subcutaneous adipose tissue beneath the epidermis from the thermal
mass of tissue normally below such tissue that is not drawn into
reservoir 430 (e.g., underlying vasculature, muscles, etc.) and the
reduction in blood circulation through the tissue drawn into
reservoir 430 allow for a more efficient temperature reduction of
lipid-rich cells such that the lipid-rich cells are substantially
affected while non-lipid-rich cells in the epidermis are not
substantially affected. This may have the advantage of increasing
the efficacy of treatment and/or reducing treatment times.
F. Treatment Device Having a Plurality of Treatment Units
[0059] FIG. 8 is an isometric view of a treatment device 800 in
accordance with a specific embodiment of a treatment device 800 for
use with an actuator 105. In this embodiment, the treatment device
800 includes a control system housing 202 and treatment unit
housings 204a-g. The actuator 105 may be coupled with, affixed to
or contained within the control system housing 202 or the treatment
unit housings 204a-g. The control system housing 202 includes a
sleeve 308 (FIG. 9) that may slide into collar 310 and/or may
mechanically attach to the treatment unit housings. The actuator
105 may further couple with, affix to, or be contained within, or
encircle the sleeve 308.
[0060] The treatment unit housings 204a-g are connected to the heat
exchanging elements (not shown) by attachment device 206. The
attachment device may be any mechanical attachment device such as a
screw or pin as is known in the art. The plurality of treatment
unit housings 204a-g may have many similar features. As such, the
features of the first treatment unit housing 204a are described
below with reference symbols followed by an "a," corresponding
features of the second treatment unit housing 204b are shown and
noted by the same reference symbol followed by a "b," and so forth.
The treatment unit housing 204a may be constructed from polymeric
materials, metals, ceramics, woods, and/or other suitable
materials. The example of the treatment unit housing 204a shown in
FIG. 2A-C is generally rectangular, but it can have any other
desired shape.
[0061] The control system housing 202 may house that actuator 105
and/or a processing unit for controlling the treatment device 800
and/or fluid lines 108a-b and/or electrical power and communication
lines. The control system housing 202 includes a harness port 210
for electrical and supply fluid lines (not shown for purposes of
clarity). The control system housing 202 may further be configured
to serve as a handle for a user of the treatment device 800.
Alternatively, a plurality of actuators (not shown) may be
contained on any one of the treatment unit housing segments
204a-g.
[0062] As shown in FIG. 8, the treatment device 800 may further
include at each end of the treatment device 800 retention devices
208a and 208b coupled to a frame 304. According to embodiments of
the invention, the actuator 105 may further be coupled to the
retention devices 208a and 208b. The retention devices 208a and
208b are rotatably connected to the frame by retention device
coupling elements 212a-b. The retention device coupling elements
212a-b, for example, can be a pin, a ball joint, a bearing, or
other type of rotatable joints.
[0063] The treatment device 104 includes a frame 304 having a
plurality of rotatably connected segments 305a-g. The rotatably
connected segments 305a-g are connected by hinges 306a-g, and,
according to one embodiment, the actuator 105 is attached to at
least one of the hinges 306a-g. Alternatively, the rotatably
connected segments 305a-g of the frame 304 could be connected by a
connection that allows rotation, such as a pin, a living hinge or a
flexible substrate such as webbing or fabric or the like. According
to one aspect of the invention, the links or hinges are made of
plastic to insulate the treatment units from each other.
[0064] FIG. 9 is an exploded isometric view of the treatment device
of FIG. 8 in accordance with one example of the invention for use
in the system 100 as further described in U.S. patent application
Ser. No. 11/528,225, which is herein incorporated in its entirety
by reference. This further exploded view is substantially similar
to previously described examples, and common acts and structures
are identified by the same reference numbers. Only significant
differences in operation and structure are described below. As can
be appreciated by one skilled in the art, the actuator may be
coupled to the treatment device at a variety of points; for
example, the actuator may be contained within the housing, coupled
to an outer surface of the housing, affixed to the frame at the
hinge or along a segment, coupled to the treatment units, or
coupled by any combination of connection points by any appropriate
connection means as are known in the art.
[0065] FIG. 10 is an isometric view of a plurality of
thermoelectric coolers contained in a matrix design according to
yet another treatment device that may be used with an actuator. As
shown in FIGS. 10 and 11, the treatment device 810 includes a
treatment unit 804 configured in a planar matrix. According to one
embodiment, the actuator 105 may be integral to the planar matrix,
may attach to a portion of the planar matrix or may be releasably
coupled to the planar matrix. The treatment device 810 may further
include a band 812 for retaining the treatment unit 804 in place
during use and the actuator can be contained within or coupled to
the band 812. The treatment device may further include a handle
814, a wiring harness 818 and a flap 816 for releasably securing
the band 812 to the treatment unit 804. The actuator 105 may be
contained within or coupled to the handle 814, wiring harness 818
and/or flap 816.
G. Operation of the Treatment Device
[0066] Without being bound by theory, it is believed that in
operation effective cooling from the treatment device, which cools
through conduction, depends on a number of factors. Exemplary
factors that impact heat removal from the skin area and related
tissue are the surface area of the treatment unit, the temperature
of the interface member and the mechanical energy delivered to the
tissue.
[0067] According to illustrated embodiments, the actuator 105 and
the treatment device 104 combine to enhance disruption of cooled
adipose tissue. Further, the illustrated embodiments may provide
reduced treatment time, reduced discomfort to the patient and
increased efficacy of treatment.
[0068] The illustrated embodiments can provide the treatment device
104 and the actuator 105 which reduce subcutaneous lipid-rich cells
generally without collateral damage to non-lipid-rich cells in the
treatment region. In general, lipid-rich cells can be affected at
low temperatures that do not affect non-lipid-rich cells. As a
result, lipid-rich cells, such as subcutaneous adipose tissue, can
be affected while other cells in the same region are generally not
damaged even though the non-lipid-rich cells at the surface are
subject to even lower temperatures. The mechanical energy provided
by the actuator further enhances the affect on lipid-rich cells by
disrupting the affected lipid-rich cells.
[0069] In alternative embodiments, a cryoprotectant is used with
the treatment device to, among other advantages, prevent freezing
of the tissue during treatment as is described in U.S. patent
application Ser. No. 11/741,271, filed Apr. 27, 2007, and entitled
"Cryoprotectant for use with a Treatment Device for Improved
Cooling of Subcutaneous Lipid-Rich Cells," herein incorporated in
its entirety by reference.
H. Spatially Controlled Treatment Unit Profile
[0070] According to aspects of the invention, a spatially
controlled profile can provide more efficient cooling to the
treatment region. The plurality of actuators and/or thermoelectric
coolers allows the treatment device to accommodate spatial cooling.
For example, actuators may be contained at the perimeter of the
treatment device to provide additional mechanical energy (via
increased amplitude, or intensity, or via a longer duration, or any
combination thereof) than mechanical energy provided by actuators
contained at the interior of the treatment device because of
different boundary conditions in the different areas of the
treatment zone. Alternatively, individual actuators, or groups of
individual actuators, may be actuated at varying times or with
varying frequency in any combination to provide a varying spatial
profile of imparted mechanical energy over the treatment
region.
[0071] According to aspects of the invention, the device can
accommodate spatially controlled treatment profiles which may
provide at least the following advantages: (1) increased
efficiency; (2) decreased power consumption with comparable
efficacy; (3) increased patient comfort; or (4) decreased treatment
time. For example, according to aspects of the invention, the
plurality of actuators will allow adjustment for anatomical
differences between patients by selectively enabling or disabling
portions of the apparatus based on anatomical differences of the
patient. This selective enablement may be accomplished by varying
both the mechanical actuation mechanism and/or the cooling profile
in any number of ways.
[0072] For instance, another alternative involves the
implementation of a particular pattern of controlled cooling which
may be customized to match an individual patient's pattern of
cellulite, or subcutaneous fat, thus increasing the efficacy of the
treatment and allowing the "sculpting" or contouring of the
patient's tissue to achieve a desired aesthetic or other effect.
Similarly, treatment regions requiring a higher intensity of
treatment may be pre-identified by ultrasound or other devices. The
device can then be spatially controlled to provide higher intensity
treatment to those pre-identified areas. Further advantages include
increased patient comfort and safety by allowing spatial control of
cooling to accommodate special features of a particular patient's
anatomy (e.g., lumps such as lipomas, blemishes or scars, areas
having excess hair, areas containing implants or jewelry, or areas
of heightened sensitivity such as nipples or wounds).
[0073] A further advantage of spatial control of the device
includes utilizing only a subset of the actuators in order to treat
only the region requiring treatment. It is advantageous to use one
device that can accommodate small and large treatment regions
without over treating (e.g. a large device that cannot be spatially
controlled) or having to move the device multiple times thus
extending the treatment time (e.g. a treatment device smaller than
the treatment region). Thus, according to aspects of the invention,
a selected region of actuators can be controlled to provide
mechanical energy to select regions. Alternatively, a first
actuator of the treatment device can be turned off while a second
actuator of the treatment device is activated, such that only a
selected region of the subject is treated with mechanical energy,
thus limiting the treatment region. Other advantageous spatially
controlled patterns include treating areas within the treatment
region more intensely, conserving power by alternating actuators,
increasing mechanical energy at a perimeter in order to provide a
uniform energy distribution across the treatment area, and a
combination of these spatially controlled patterns in order to
increase treatment efficacy, reduce treatment time, decrease power
consumption and provide for patient comfort and safety.
[0074] It is expressly understood that embodiments of the invention
specifically contemplate utilizing, via spatial control or even a
randomly selected profile, varying combinations of actuation to
impart mechanical energy as described herein with applying
treatment devices to affect the lipid-rich cells in any number of
ways (e.g., varying frequency, intensity (amplitude), duration,
start and stop times, temperature, etc.), applying mechanical
energy alone without cooling, applying cooling alone without
mechanical energy, utilizing reheating to accelerate damage to
lipid-rich cells, to achieve the desired effect.
I. Method of Applying Treatment Devices
[0075] In one mode of operation, the actuator is coupled to a
treatment device. The treatment device may be configured to be a
handheld device such as the device disclosed in U.S. patent
application Ser. No. 11/359,092, entitled "Treatment device For
Removing Heat From Subcutaneous Lipid-Rich Cells", filed on Feb.
22, 2006, herein incorporated in its entirety by reference. The
treatment device may be configured to be a plurality of treatment
devices contained in a flexible substrate or in a rotatable housing
such as the device disclosed in U.S. patent application Ser. No.
11/528,225, entitled "Cooling Devices Having a Plurality of
Controllable Treatment units to Provide a Predetermined Cooling
Profile", filed on Sep. 26, 2006, herein incorporated in its
entirety by reference.
[0076] Applying the treatment device with pressure to the subject's
skin or pressing against the skin can be advantageous to achieve
efficient cooling. In general, the subject 101 has a body
temperature of about 37.degree. C., and the blood circulation is
one mechanism for maintaining a constant body temperature. As a
result, blood flow through the dermis and subcutaneous layer of the
region to be treated may be viewed as a heat source that
counteracts the cooling of the subdermal fat. As such, cooling the
tissue of interest requires not only removing the heat from such
tissue but also that of the blood circulating through this tissue.
Thus, temporarily reducing or eliminating blood flow through the
treatment region, by means such as, e.g., applying the treatment
device with pressure, can improve the efficiency of tissue cooling
and avoid excessive heat loss through the dermis and epidermis.
[0077] By cooling the subcutaneous tissue to a temperature lower
than 37.degree. C., subcutaneous lipid-rich cells can be
selectively affected. In general, the epidermis and dermis of the
subject 101 have lower amounts of unsaturated fatty acids compared
to the underlying lipid-rich cells forming the subcutaneous
tissues. Because non-lipid-rich cells usually can withstand colder
temperatures better than lipid-rich cells, the subcutaneous
lipid-rich cells can be selectively affected while maintaining the
non-lipid-rich cells in the dermis and epidermis. An exemplary
range for the treatment unit 302a-g can be from about -20.degree.
C. to about 20.degree. C., preferably from about -20.degree. C. to
about 10.degree. C., more preferably from about -15.degree. C. to
about 5.degree. C., more preferably from about -10.degree. C. to
about 0.degree. C.
[0078] The lipid-rich cells can be affected by disrupting,
shrinking, disabling, destroying, removing, killing, or otherwise
being altered. Without being bound by theory, selectively affecting
lipid-rich cells is believed to result from localized
crystallization of highly saturated fatty acids at temperatures
that do not induce crystallization in non-lipid-rich cells. The
crystals can rupture the bi-layer membrane of lipid-rich cells to
selectively necrose these cells. Thus, damage of non-lipid-rich
cells, such as dermal cells, can be avoided at temperatures that
induce crystal formation in lipid-rich cells. Cooling is also
believed to induce lipolysis (e.g., fat metabolism) of lipid-rich
cells to further enhance the reduction in subcutaneous lipid-rich
cells. Lipolysis may be enhanced by local cold exposure, inducing
stimulation of the sympathetic nervous system.
Additional Embodiments of Treatment Device
[0079] FIG. 12 is an isometric and exploded view of a treatment
device 104 in accordance with another embodiment of the invention.
The treatment device 104 may include a housing 300, a cooling
assembly 308 at least partially disposed in the housing 300, and
retention devices 318 configured for fastening the cooling assembly
308 to the housing 300. The treatment device 104 may also include a
vibration member disposed in the housing 300, as described in more
detail below with reference to FIG. 13.
[0080] The cooling assembly 308 may include a heat sink 312, a
thermally conductive interface member 309, and a thermoelectric
cooler 314 disposed between the heat sink 312 and the interface
member 309. The thermoelectric cooler 314 may be connected to an
external power supply (not shown) via connection terminals 316. In
the illustrated embodiment, the heat sink 312 includes a U-shaped
fluid conduit 310 at least partially embedded in a thermally
conductive portion 313 of the heat sink 312. The fluid conduit 310
includes fluid ports 138a-b that may be coupled to a circulating
fluid source (not shown) via the fluid lines 108a-b. In other
embodiments, the heat sink 312 may include a plate-type heat
exchanger, a tube and shell heat exchanger, and/or other types of
heat exchanging device. The interface member 309 may include a
plate constructed from a metal, a metal alloy, and/or other types
of thermally conductive material. The thermoelectric cooler 314 may
be a single Peltier-type element or an array of Peltier-type
elements. One suitable thermoelectric cooler is a Peltier-type heat
exchanging element (model # CP-2895) produced by TE Technology,
Inc. in Traverse City, Mich.
[0081] Individual retention devices 318 may include a plate 330 and
a plurality of fasteners 306 extending through a plurality of
apertures 332 (two are shown for illustrative purposes) of the
plate 330. In the illustrated embodiment, the fasteners 306 are
screws that may be received by the housing 300. In other
embodiments, the fasteners 306 may include bolts, clamps, clips,
nails, pins, rings, rivets, straps, and/or other suitable
fasteners. During assembly, the cooling assembly 308 is first at
least partially disposed in the internal space 303 of the housing
300. Then, the retention devices 318 are positioned proximate to
the cooling assembly 308, and the fasteners 306 are extended
through the apertures 332 of the plate 330 to engage the housing
300. The fasteners 306, the plates 330, and the housing 300
cooperate to hold the cooling assembly 308 together.
[0082] By applying power to the thermoelectric cooler 314, heat may
be effectively removed from the skin of the subject to a
circulating fluid in the fluid conduit 310. For example, applying a
current to the thermoelectric cooler 314 may achieve a temperature
generally below 37.degree. C. on the first side 315a of the
thermoelectric cooler 314 to remove heat from the subject via the
interface member 309. The thermoelectric cooler 314 transfers the
heat from the first side 315a to the second side 315b. The heat is
then transferred to the circulating fluid in the fluid conduit
310.
[0083] FIG. 13 is an isometric and exploded view of a vibrator 322
disposed in the treatment device 104 of FIG. 12. The vibrator 322
may include a frame 324, a motor 325 carried by the frame 324, a
rotating member 328 operatively coupled to the motor 325, and a
plurality of fasteners 326 (e.g., screws) for fixedly attaching the
frame 324 to the housing 300. In the illustrated embodiment, the
motor 325 has an output shaft (not shown) generally centered about
a body axis 327 of the motor 325. One suitable motor is a direct
current motor (model # Pittman 8322S008-R1) manufactured by Ametek,
Inc., of Harleysville, Pa. The rotating member 328 has a generally
cylindrical shape and is off-centered from the body axis 327. In
other embodiments, the motor 325 may have an off-centered shaft
that is operatively coupled to the rotating member 328.
[0084] In operation, applying electricity to the motor 325 may
cause the rotating member 328 to rotate around the body axis 327 of
the motor 325. The off-centered rotating member 328 causes the
vibrator 322 to be off-balanced about the body axis 327, and
vibration in the frame 324 and the housing 300 may result.
J. Computing System Software Modules
[0085] FIG. 14 is a functional diagram showing exemplary software
modules 940 suitable for use in the processing unit 114. Each
component may be a computer program, procedure, or process written
as source code in a conventional programming language, such as the
C++ programming language, and can be presented for execution by the
CPU of processor 942. The various implementations of the source
code and object and byte codes can be stored on a computer-readable
storage medium or embodied on a transmission medium in a carrier
wave. The modules of processor 942 can include an input module 944,
a database module 946, a process module 948, an output module 950,
and, optionally, a display module 951. In another embodiment, the
software modules 940 can be presented for execution by the CPU of a
network server in a distributed computing scheme.
[0086] In operation, the input module 944 accepts an operator
input, such as process setpoint and control selections, and
communicates the accepted information or selections to other
components for further processing. The database module 946
organizes records, including operating parameters 954, operator
activities 956, and alarms 958, and facilitates storing and
retrieving of these records to and from a database 952. Any type of
database organization can be utilized, including a flat file
system, hierarchical database, relational database, or distributed
database, such as provided by a database vendor such as Oracle
Corporation, Redwood Shores, Calif.
[0087] The process module 948 generates control variables based on
sensor readings 960, and the output module 950 generates output
signals 962 based on the control variables. For example, the output
module 950 can convert the generated control variables from the
process module 948 into 4-20 mA output signals 962 suitable for a
direct current voltage modulator. The processor 942 optionally can
include the display module 951 for displaying, printing, or
downloading the sensor readings 960 and output signals 962 via
devices such as the output device 120. A suitable display module
951 can be a video driver that enables the processor 942 to display
the sensor readings 960 on the output device 120.
[0088] Unless the context clearly requires otherwise, throughout
the description and the claims, the words "comprise," "comprising,"
and the like are to be construed in an inclusive sense as opposed
to an exclusive or exhaustive sense; that is to say, in a sense of
"including, but not limited to." Words using the singular or plural
number also include the plural or singular number, respectively.
When the claims use the word "or" in reference to a list of two or
more items, that word covers all of the following interpretations
of the word: any of the items in the list, all of the items in the
list, and any combination of the items in the list.
[0089] The various embodiments described above can be combined to
provide further embodiments. All of the U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications and non-patent publications
referred to in this specification and/or listed in the Application
Data Sheet are incorporated herein by reference, in their entirety.
Aspects of the invention can be modified, if necessary, to employ
treatment devices and actuators with a plurality of treatment
units, thermally conductive devices with various configurations,
and concepts of the various patents, applications, and publications
to provide yet further embodiments of the invention.
[0090] These and other changes can be made to the invention in
light of the above-detailed description. In general, in the
following claims, the terms used should not be construed to limit
the invention to the specific embodiments disclosed in the
specification and the claims, but should be construed to include
all cooling that operates in accordance with the claims.
Accordingly, the invention is not limited by the disclosure, but
instead its scope is to be determined entirely by the following
claims.
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