(12) STANDARD PATENT
`
`(11)App|icati0n N0. AU 2012244313 B2
`
`(19) AUSTRALIAN PATENT OFFICE
`
`Title
`
`Device for enhanced removal of heat from subcutaneous lipid-rich cells having an
`actuator
`
`International Patent Classification(s)
`A61B 18/02 (2006.01)
`
`Application No:
`
`2012244313
`
`(22)
`
`Date of Filing:
`
`2012.10.31
`
`WO 2003/078596
`
`Publication Date:
`Publication Journal Date:
`
`2012.11.22
`2012.11.22
`
`Accepted Journal Date:
`
`2014.11.27
`
`Divisional of:
`2007353791
`
`Applicant(s)
`Zeltiq Aesthetics, Inc.
`
`|nventor(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
`
`

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`31Oct2012
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`2012244313
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`DEVICE FOR ENHANCED REMOVAL OF HEAT FROM
`
`SUBCUTANEOUS LIPID-RICH CELLS HAVING AN ACTUATOR
`
`ABSTRACT
`
`A treatment device (104) for removing heat from subcutaneous lipid-rich cells of a subject (10])
`
`having an actuator (105) 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.
`
`
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`AHZS(6830717_1):MLW
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`

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`31Oct2012
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`2012244313
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`S&F Ref: 929465D1
`
`AUSTRALIA
`
`PATENTS ACT 1990
`
`COMPLETE SPECIFICATION
`
`FOR A STANDARD PATENT
`
`Name and Address
`
`of Applicant :
`
`Actual lnventor(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 statement is a full description of this invention, including the best method of
`performing it known to me/us:
`
`58450(6832870_1)
`
`

`

`
`
`DEVICE FOR ENHANCED REMOVAL OF HEAT FROM
`
`SUBCUTANEOUS LIPID-RICH CELLS HAVING AN ACTUATOR
`
`CROSS-REFERENCE TO 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 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.
`'
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`

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`[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. Patent 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
`
`othenrvlse 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.
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`201224431328Oct2014
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`3
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`selectively affect them without damaging the cells in the epidermis and other surrounding tissue.
`
`Although the methods and devices disclosed in these publications are promlsmg, 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 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 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 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;
`
`

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`201224431328Oct2014
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`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 pump to 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 tissue of the target region proximate to at least one
`
`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 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] Figure 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] 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 segment of a
`
`treatment device in accordance with an embodiment of the invention.
`
`

`

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`201224431328Oct2014
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`3b
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`[0012] Figure 4a is an isometric view of an actuator for use with a treatment device in
`
`accordance with an embodiment of 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 embodiment of the actuator of Figure 4 in accordance
`
`with an embodiment of the invention.
`
`[0014] Figure 6 is a schematic view of an embodiment of the actuator of Figure 4 in accordance
`
`with an alternative embodiment of the invention.
`
`[0015] Figure 7 is a schematic view of an embodiment of the actuator of Figure 4 in accordance
`
`with an alternative embodiment of the invention.
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`
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`[0016]
`
`Figure 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]
`
`Figure 9 is an exploded Isometric view of the treatment device of
`
`Figure 8 further illustrating additional components of the treatment device in
`
`accordance with another embodiment of the invention.
`
`[0018]
`
`Figure 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]
`
`Figure 11 is an isometric bottom view of the alternative treatment
`
`device of Figure 10.
`
`[0020]
`
`Figure 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]
`
`Figure 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.
`
`- Figure 14 is a block diagram showing computing system software
`[0022]
`,
`modules for removing heat from subcutaneous lipid-rich cells in accordance with
`
`another embodiment of 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 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
`.4.
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`

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`31Oct2012
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`
`
`
`
`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. dlanption of adipose tissue cooled by an external
`treatment device may be enhanced by vibrating the cooledtissue. 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. Ntematively. or additionally the tissue may “a
`.5_
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`31Oct2012
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`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
`
`releasabiy coupled ‘ to any portion of the interconnected hinged or coupled
`
`segment. Altemativeiy. the one or more actuators may be on or embedded in a
`
`fle)dble 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 an'dlor 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 mile from one or more actuators. The actuator
`
`may provide mechanical energy imparted to the tissue. Depending on t‘“
`.5.
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`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.
`
`toward
`Furflter embodiments disclosed below are directed.
`[0030]
`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 patientincluding 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 ls capable of reducing a temperature of a region such that lipid-
`
`rich cells in the region are affected whfle non-lipid-rich cells in the epidermis
`
`and/or dermis are not generally affected.
`
`8 stem for
`
`E
`
`l Se
`
`ivel Reducin L 'd-Rlc Cells
`
`[0031]
`
`Figure 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
`
`-7.
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`31Oct2012
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`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 Figures
`
`2-12.
`
`[0032] The system 100 may further include a treatment unit 106 and
`supply and retum 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 108a7b 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 Peitier-type thermoelectric element. and the treatment device 104
`
`may have a plurality of individually controlled treatment units to create a custom
`
`spatial cooling proflle 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 Figure 1; alternatively, processing unit 114 may be connected to
`
`treatment device (and/or any number of other components of system 100 as
`-a-
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`31Oct2012
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`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 Figure
`
`1 without any support structure. Alternatively. power line 116 and line 112 (and
`
`other lines inciuding, 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, 8 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, 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.
`
`0.
`
`Actuator for Use with a Treatment Device
`
`Figures 2, 3 .and 4 are isometric views of embodiments of
`[0035]
`actuators 105 for use with a treatment device 104 suitable for use in the system
`
`-9-
`
`

`

`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
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`connection with a single treatment device 104 in any desired combination. For
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`example, an eccentric weight actuator may be associated with one treatment
`device 104 while a pneumatic motor may be associated with another section of
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`the same treatment device.
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`This, for example, would give the operator of
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`treatment system 100 options for differential treatment of lipid rich cells within a
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`single region or among multiple regions of subject 101. The use of one or more
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`actuators and actuator types in various combinations and configurations with
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`treatment device 104 is possible with all the embodiments of the invention.
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`Treatment Device Having an Actuator Such as a \fibratory Device
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`[0036]
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`Figure 2 shows an actuator 105 including a motor 150 containing
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`an eccentric weight 151 to create mechanical vibration, pulsing and/or cycling
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`effect. Power is supplied to the motor 150 through power lines 152. Altemativeiy,
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`the motor 150 could be battery powered or could include an electrical plug.
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`Alternatively, vibration, pulsing and/or cycling can be induced by a mechanism
`using hydraulic, electric. electromechanical, solenoid, or mechanical devices as
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`are known in the art Figure 3 shows the motor 150 of Figure 2 affixed to a
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`selected portion of the treatment device 104 as described further herein.
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`[0037] According to one embodiment, an actuator 105 is affixed by
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`screws 154 or other mechanical fixation devices to a housing 156 of the treatment
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`device 104 to transmit mechanical energy mrough the treatment device 104 to the
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`tissue of a patient. Alternatively, the actuator 105 may be strapped in place
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`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
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`embodiments, the actuator 105 may be incorporated into the treatment device
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`104 to provide an integrated treatment device with an activator for providing
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`mechanical energy.
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`[0038] According to altemative' embodiments, the treatment device 104
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`includes a plurality of links that are mechanically coupled with a plurality of hinges
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`and a single actuator to transfer mechanical vibratory energy through adjacent
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`links to the skin. Altemately, the actuator can be incorporated into more than one
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`link, or a plurality of actuators may be used with a single treatment device.
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`[0039]
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`in specific embodiments of the motor 150. the eccentric weight
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`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
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`other relatively dense material. According to further embodiments. the motor
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`used is a brushed DC motor. alternatively. any electric motor could be used, or
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`any other means of rotating the mass as is known in the art.
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`[0040] The actuator 105 need not have a rotating eccentric weight:
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`rather. other embodiments may have an electrical coil or the like to create a
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`varying or pulsing energy. The electrical coil. for example. may include a
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`solenoid, a vibrating armature or a voice coil. According to an embodiment using
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`a solenoid. a coil Is energized to create a magnetic field that moves a steel or iron
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`armature. The armature may be attached to a mass and can be driven into a
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`hard stop to produce a pulse.
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`if the hard stop is mechanically coupled to the
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`device applied to the skin, this energy will be transferred into the tissue. This
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`method of imparting mechanical energy to lipid—rich cells so to create a massage
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`or massage—like effect is suited, but not necessarily limited. to lower frequencies
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`and higher impulse energies.
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`[0041] A specific embodiment of a vibrating armature or voice coil has a
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`coil driven by an alternating current to move or oscillate the armature back and
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`forth. The inertia of this motion may be transferred through the link into the tissue
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`to provide an actuator for enhancing the vibratory effect on the lipid-rich cells.
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`{0042] According to still further'embodiments. the mechanical force may
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`create a massage massage-like effect using a water hammer. Water, or any of a
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`number of other heat transfer fluids suitable for cooling the thermoelectric coolers.
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`can have significant mass, and when flowing through tubing. these fluids can
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`commensurately have significant momentum. By quickly halting the flow of such
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`a fluid. such as, e.g.. by placing a solenoid valve in the fluid line and closing the
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`flow path, a properly designed system transfers the momentum of the fluid to the
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`treatment device 104 and into the tissue.
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`According to aspects of this
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`embodiment,
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`such
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`a water hammer
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`or
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`similar momentum-transferring
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`arrangement is suited to low frequencies. Further, such an arrangement may
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`reduce the heat transfer rate. which may be desirable for certain applications.
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`[0043]
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`In operation, the motor 150 shown in Figure 2 rotates an eccentric
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`weight
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`to provide mechanical energy. The motor is rigidly attached to the
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`treatment device 104, for example. to a housing 156 of the treatment device 104
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`as shown in Figure 3. Mechanical energy creating a pulsing, cycling. or oscillation
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`effect is applied by the centripetal force generated as the eccentric weight rotates,
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`creating a varying or pulsing mechanical energy. This energy is transferred
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`through the treatment device 104 to the patients skin and underlying tissue. The
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`frequency of the vibration can be increased by increasing the rotational rate of the
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`weight. A higher frequency also increases the applied force of the vibration.
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`According to one embodiment. the frequency of massage (or vibration) is in the
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`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;
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`the frequency of massage (or vibration) can be higher or lower. The motor 150
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`may further include passive or active damping materials (not shown). The force
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`applied during each rotation of the weight may be increased, for example, by
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`increasing the mass of the weight or increasing the distance between the center
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`of gravity of the weight and its axis of rotation. Similarly. decreasing the mass of
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`the weight or decreasing the distance between the center of graw'ty of the weight
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`and its axis of rotation may. for example, decrease the force applied during each
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`rotation