(12) STANDARD PATENT
`(19) AUSTRALIAN PATENT OFFICE
`
`(11) Application No. AU 2012244313 B2
`
`International Patent Classification(s)
`A61B 18/02 (2006.01)
`
`Application No:
`
`2012244313
`
`(22)
`
`Date of Filing:
`
`2012.10.31
`
`Publication Date:
`Publication Journal Date:
`Accepted Journal Date:
`
`2012.11.22
`2012.11.22
`2014.11.27
`
`Divisional of:
`2007353791
`
`Applicant(s)
`Zeltiq Aesthetics, Inc.
`
`Title
`Device for enhanced removalof heat from subcutaneouslipid-rich cells having an
`actuator
`
`WO 2003/078596
`
`Inventor(s)
`Levinson, Mitchell E.;Rosen, Jesse Nicasio
`
`Agent / Attorney
`Spruson & Ferguson, L 35 St Martins Tower 31 Market St, Sydney, NSW, 2000
`
`Related Art
`WO 2004/000098
`
`

`

`31Oct2012
`
`2012244313
`
`DEVICE FOR ENHANCED REMOVAL OF HEAT FROM
`
`SUBCUTANEOUS LIPID-RICH CELLS HAVING AN ACTUATOR
`
`ABSTRACT
`
`A treatment device (104) for removing heat from subcutaneouslipid-rich cells of a subject (101)
`
`having an actuator (105) that provides mechanical energy to the tissue. The mechanical energy
`
`provided mayinclude a vibratory componentthat can range between low andultra-high
`
`frequencies, and such energy may include various combinations of two or more frequencies
`
`tailored to produce the desired effect on the subcutaneoustissue. Disruption of adiposetissue
`
`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.
`
`
`
`AH25(6830717_1):MLW
`
`
`

`

`31Oct2012
`
`2012244313
`
`S&F Ref: 929465D1
`
`AUSTRALIA
`
`PATENTS ACT 1990
`
`COMPLETE SPECIFICATION
`
`FOR A STANDARD PATENT
`
`Name and Address
`of Applicant:
`
`Actual Inventor(s):
`
`Address for Service:
`
`Zeltiq Aesthetics, Inc., of 4698 Willow Road, Suite 100,
`Pleasanton, California, 94588, United States of America
`
`Mitchell E. Levinson
`Jesse Nicasio Rosen
`
`Spruson & Ferguson
`St Martins Tower Level 35
`31 Market Street
`Sydney NSW 2000
`(CCN 3710000177)
`
`Invention Title:
`
`Device for enhanced removal of heat from subcutaneous
`lipid-rich cells having an actuator
`
`The following statementis a full description of this invention, including the best method of
`performing it known to me/us:
`
`5845c(6832870_1)
`
`

`

`
`
`DEVICE FOR ENHANCED REMOVAL OF HEAT FROM
`
`SUBCUTANEOUS LIPID-RICH CELLS HAVING AN ACTUATOR
`
`CROSS-REFERENCETO RELATED APPLICATION
`
`[0001] This application claims the benefit of U.S. Patent Application No.
`11/750,953,
`filed May 18, 2007, and entitled METHOD OF ENHANCED
`REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND
`
`TREATMENT APPARATUS HAVING AN ACTUATOR, which is incorporated
`herein by reference.
`
`TECHNICAL FIELD
`
`[0002] The present application relates generally to treatment devices,
`systems, and methods for removing heat from subcutaneouslipid-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
`subcutaneouslipid-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 ofcellulite, which forms
`when subcutaneousfat 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 bodyfat therefore is needed.
`
`31Oct2012
`
`2012244313
`
`
`
`
`
`

`

`Liposuction is a method for selectively removing adiposetissue to
`[0004]
`"sculpt" a person's body. Liposuction typically is performed by plastic surgeons or
`dermatologists using specialized surgical equipment
`that
`invasively removes
`subcutaneous adiposetissue via suction. One drawbackofliposuctionis thatit is
`a surgical procedure, and the recovery maybe 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 personis physically injuredorill, regular exercise may not be an
`option. Similarly, weight-loss drugsor topical agents are not an option when they
`cause anallergic or negative reaction. Furthermore, fat loss in selective areasof
`a person's body cannot be achieved using general or systemic weightloss
`methods.
`
`[0006} Other non-invasive treatment methodsinclude applying heatto a
`zone of subcutaneouslipid-rich cells.. U.S. Patent No. 5,948,011 discloses
`altering subcutaneous body fat and/or collagen by heating the subcutaneousfat
`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
`methodis Jess 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
`-2-
`
`31Oct2012
`
`2012244313
`
`
`
`
`

`

`
`
`201224431328Oct2014
`
`3
`
`selectively affect them without damagingthe cells in the epidermis and other surroundingtissue.
`
`Although the methods and devices disclosed in these publications are prom1smg, several
`
`improvements for enhancing the implementation of these methods and devices would be
`
`desirable.
`
`OBJECT
`
`[0007a] It is the object of the present invention to substantially overcome or ameliorate one or
`
`more of the above disadvantages.
`
`SUMMARY
`
`[0007b] The present invention provides 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 coupledto 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 a speed of the variable
`
`speed pump.
`
`[0007c] The present invention also provides a system for removing heat from subcutaneous
`
`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, the treatment units each having a
`
`contact plate in the wall of the cup, and a thermoelectric cooler, the thermoelectric cooler
`
`configured to reduce a temperature of a target region beneath an epidermis of the subjectto
`
`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;
`
`

`

`
`
`201224431328Oct2014
`
`and
`
`3a
`
`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 vacuum pumpto the cup, wherein the vacuum
`
`actuator is further configured to impart a massage effect to the subcutaneous lipid-rich cells in
`
`the target region.
`
`[0007d] The present invention further provides a treatment device for removing heat from
`
`subcutaneous lipid-rich cells of a subject, the device comprising:
`
`a substrate configured to receive tissue of a target region of a subject;
`
`a plurality of treatment units attached to the substrate, each treatment unit being movable
`
`relative to an adjacent treatment unit; and
`
`a vacuum actuator operably coupled to the substrate, the vacuum actuator having a
`
`variable speed pump configured to draw the tissuc of the target region proximate to at Icast onc
`
`of the treatment units and provide mechanical energy to the subcutaneous lipid-rich cells.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0008] In the drawings, identical reference numbersidentify 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 clements and angles are not drawn to scalc, and some of these
`
`elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the
`
`particular shapes of the elements as drawnare 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] Figure 1 Is an Isometric vicw of a system for removing heat from subcutancous lipid-rich
`
`cells in accordance with an embodiment of the invention.
`
`[0010] Figure 2 is an isometric view of an actuator for use with a treatment device in accordance
`
`with an embodiment of the invention.
`
`[0011] Figure 3 is an isometric view of the actuator of Figure 2 coupled to a frame segmentof a
`
`treatment device in accordance with an embodiment of the invention.
`
`

`

`
`
`201224431328Oct2014
`
`3b
`
`[0012] Figure 4a is an isometric view of an actuator for use with a treatment device in
`
`accordance with an embodimentof the invention. Figure 4b is an isometric and exploded view
`
`of the treatment device of Figure 4a.
`
`[0013] Figure 5 is a schematic view of an embodimentof the actuator of Figure 4 in accordance
`
`with an embodiment of the invention.
`
`[0014] Figure 6 is a schematic view of an embodimentof the actuator of Figure 4 in accordance
`
`with an alternative embodiment of the invention.
`
`[0015] Figure 7 is a schematic view of an embodimentof the actuator of Figure 4 in accordance
`
`with an alternative embodiment of the invention.
`
`

`

`31Oct2012
`
`2012244313
`
`
`
`Figure 8 is an isometric view of a treatment device for removing
`[0016]
`heat from subcutaneouslipid-rich cells in accordance with embodiments of the
`invention.
`
`Figure 9 is an exploded Isometric view of the treatment device of
`[0017]
`Figure 8 further illustrating additional components of the treatment device in
`accordance with another embodimentof the invention.
`
`Figure 10 is an isometric top view of an alternative treatment
`[0018]
`device for removing heat from subcutaneouslipid-rich cells in accordance with an
`embodimentof the invention.
`
`{0019}
`
`Figure 11 is an isometric bottom view of the alternative treatment
`
`device of Figure 10.
`
`Figure 12 is an isometric and exploded view of a treatment device
`[0020]
`for removing heat from subcutaneouslipid-rich cells In accordance with a further
`embodimentof the invention.
`
`Figure 13 is an isometric and exploded view of a vibrator disposed
`[0021]
`in the treatment device for removing heat from subcutaneous lipid-rich cells in
`accordance with yet another embodimentof the invention.
`_
`[0022]
`. Figure 14 is a block diagram showing computing system software
`modules for removing heat from subcutaneouslipid-rich cells in accordance with
`another embodimentof the invention.
`
`DETAILED DESCRIPTION
`
`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 subcutaneousfat, or adiposetissue,
`which primarily is composed oflipid-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
`4.
`
`

`

`31Oct2012
`
`2012244313
`
`
`
`
`
`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
`
`ene embodiment” or “in an embodiment" in various places throughout
`this
`specification are not necessarily ail
`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 notlimit or interpret the scope or
`meaningof the claimed invention.
`
`[0025} The present invention is directed toward a treatment device for
`removing heat from subcutaneouslipid-rich cells of a subject and methods for
`using such a device. The treatment device includes an actuator that provides
`mechanicat energy to the tissue. The mechanical energy provided mayinclude a
`vibratory componentthat can range between low andultra-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 extemal
`treatment device may be enhanced byvibrating 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 subcutaneouslipid-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 energyto the tissue. This may be done in a numberofdifferent ways;
`for example, varying mechanical energy, such as vibratory energy, may be
`imparted through the applicator. Alternatively, or additionally the tissue may “~
`-—-
`
`

`

`31Oct2012
`
`2012244313
`
`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 numberof cooling technologies including, for example, thermoelectric coolers,
`recirculating chilled fluid, vapor compression elements, or phase change
`cryogenic devices. Oneskilled in the art will recognize that there are a numberof
`other cooling technologies and mechanica! movementtechnologies that could be
`used such that the treatment units and mechanical devices need not belimited 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 mayrigidly 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 embeddedin a
`flexible substrate which further contains the treatmentunits.
`
`!n yet another embodiment, a treatment device comprises one or
`[0028]
`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 overtime to provide a decreasing or an
`Increasing intensity during treatment according to a predetermined patter.
`Instill
`other embodiments, different actuators may simultaneously provide different
`types of motion or motion ofvarying 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 f*-
`
`

`

`31Oct2012
`
`2012244313
`
`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 orin
`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-tich 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.
`
`Further embodiments disclosed below are directed toward
`[0030]
`systems for efficiently removing heat from subcutaneouslipid-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
`massageto the treated region. When placed proximate to a subject's skin, the
`treatment device is capable of reducing a temperature of a region such thatlipid-
`rich cells in the region are affected while non-lipid-rich cells in the epidermis
`and/or dermis are not generally affected.
`
`System for
`
`E
`
`ly Selectively Reducing Lipid-Rich Cells
`
`Figure 1 is an isometric view of an embodiment of a treatment
`[0031]
`system 100 for removing heat from subcutaneouslipid-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
`
`-T-
`
`

`

`31Oct2012
`
`2012244313
`
`of the subject 101 or another suitable area for cooling or removing heat from the
`subcutaneouslipid-rich cells of the subject 101. Various embodiments of the
`treatment device 104 are described in more detail below with reference to Figures
`
`2-12.
`
`[0032] The system 100 mayfurther 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 coolantto 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
`accommodatethe particularcirculating 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 ofthe treatmentunit.
`
`the treatment device 104
`[0033} As explained in more detail below,
`includes at least one actuator 105 andatleast 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 powerline 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 maybein direct
`electrical communication with treatment device 104 through electrical line 112 as
`shown in Figure 1; alternatively, processing unit 114 may be connected to
`treatment device (and/or any number of other components of system 100 as
`-8-
`
`

`

`31Oct2012
`
`2012244313
`
`discussed below) via a wireless or an optical communicationlink. Processing unit
`114 may be any processor, Programmable Logic Controller, Distributed Control
`System, and the like. Note that powerline 116 and line 112 are shown in Figure
`14 without any support structure. Alternatively, power line 116 and line 112 (and
`otherlines including, but notlimited to fluid lines 108a-b) may be bundledinto 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.
`
`In another aspect, the processing unit 114 maybein electrical or
`[0034]
`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 userinput. 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 suitabie 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 Figure 1, processing unit 114, power supply 110, contro! 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 maybefixedly installed at a treatmentsite.
`
`Actuator for Use with a Treatment Device
`[0035]
`Figures 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
`
`-9-
`
`

`

`The actuator may provide mechanical energy to create a vibratory,
`100.
`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
`treatmentsite. Further embodiments include a plurality of actuators 105 for usein
`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 sectionof
`the same treatment device.
`This, for example, would give the operator of
`treatment system 100 options fordifferential treatmentof lipid rich celts 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.
`
`Treatment Device Having an Actuator Such as a Vibratory Device
`
`Figure 2 shows an actuator 105 including a motor 150 containing
`[0036]
`an eccentric weight 151 to create mechanical vibration, pulsing and/or cycling
`effect. Power is supplied to the motor 150 through powerlines 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. Figure 3 shows the motor 150 of Figure 2 affixed to a
`selected portion of the treatment device 104 as describedfurther herein.
`
`[0037] According to one embodiment, an actuator 105 is affixed by
`screws 154 or other mechanicalfixation 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.
`
`31Oct2012
`
`2012244313
`
`
`
`

`

`31Oct2012
`
`2012244313
`
`
`
`[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.
`
`In specific embodiments of the motor 150, the eccentric weight
`[0039]
`may be a weight machinedoutof brass;alternatively, the mass may befabricated
`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 meansofrotating the mass as Is knownin 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 movesa steeloriron
`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 mechanlcally 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 embodimentof 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
`numberof other heattransferfluids suitable for cooling the thermoelectric coolers,
`can havesignificant mass, and whenflowing 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 solenold valve in the fluld line and closing the
`
`-11-
`
`

`

`31Oct2012
`
`2012244313
`
`
`
`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
`
`similar momentum-transferring
`or
`a water hammer
`such
`embodiment,
`arrangementis suited to low frequencies. Further, such an arrangement may
`reduce the heat transfer rate, which may be desirable for certain applications.
`
`In operation, the motor 150 shown in Figure 2 rotates an eccentric
`[0043]
`to provide mechanical energy. The motor is rigidly attached to the
`weight
`treatment device 104, for example, to a housing 156 of the treatment device 104
`as shownin Figure 3. Mechanical energy creating a pulsing, cycling, or oscillation
`effect is applied by the centripetal force generated as the eccentric weightrotates,
`creating a varying or pulsing mechanical energy. This energy is transferred
`through the treatment device 104to the patient's skin and underlying tissue. The
`frequencyof the vibration can be increased by increasingthe rotational rate of the
`weight. A higher frequency also increases the applied force of the vibration.
`According to one embodiment, the frequency of massage (orvibration)is in the
`range of about 0.1Hz 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
`mayfurther 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 ofthe weight or increasing the distance between the center
`of gravity of the weight andits axis of rotation. Similarly, decreasing the massof
`the weight or decreasing the distance between the centerof gravity of the weight
`andits 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 componentofthe 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
`apolied.
`
`[0044] The illustrated embodiment of the actuator as shown in