(12) STANDARD PATENT
`
`(11) Application No. AU 2011265424 B2
`
`(19) AUSTRALIAN PATENT OFFICE
`
`Title
`
`Cooling device for removing heat from subcutaneous lipid-rich cells
`
`International Patent Classification(s)
`A61F 7/10 (2006.01)
`
`Application No:
`
`2011265424
`
`(22)
`
`Date of Filing:
`
`2011.12.21
`
`US 2005/0251120 A1
`
`Publication Date:
`Publication Journal Date:
`
`2012.01.19
`2012.01.19
`
`Accepted Journal Date:
`
`2014.07.31
`
`Divisional of:
`2007220847
`
`Applicant(s)
`Zeltiq Aesthetics, Inc.
`
`|nventor(s)
`Ting, Joseph;Robinson, Timothy;Tolkoff, Samuel W.;Wisdom, Richard
`
`Agent / Attorney
`Spruson & Ferguson, L 35 St Martins Tower 31 Market St, Sydney, NSW, 2000
`
`Related Art
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`

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`201126542421Dec2011
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`COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH
`
`CELLS
`
`Abstract
`
`A method of applying a handheld cooling device configured to be grasped by a
`
`hand of an operator, the cooling device having two cooling elements configured for
`
`removing heat from subcutaneous lipid rich cells, comprises the steps of: positioning the
`
`two cooling elements relative to each other; cooling heat exchanging surfaces of the two
`
`cooling elements to a desired temperature; holding the cooling device by a hand; placing
`
`the cooling device such that the cooled heat exchanging surfaces are proximate to the skin
`
`of a subject; and reducing a temperature of a region under the epidermis of the subject such
`
`that lipid rich cells in the region of the skin are affected while non lipid rich cells in the
`
`epidermis are not affected.
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`5846638-12EEB
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`201126542421Dec2011
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`
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`S&F Ref: 878008D1
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`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 7139 Koll Center Parkway
`Suite 300, Pleasanton, California, 94566, United States
`of America
`
`Joseph Ting
`Timothy Robinson
`Samuel W. Tolkoff
`
`Richard Wisdom
`
`Spruson & Ferguson
`St Martins Tower Level 35
`31 Market Street
`
`Sydney NSW 2000
`
`(CCN 3710000177)
`
`Invention Title:
`
`Cooling device for removing heat from subcutaneous
`lipid-rich cells
`
`The following statement is a full description of this invention, including the best method of
`performing it known to me/us:
`
`
`
`5845c(5853756_1)
`
`

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`201126542421Dec2011
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`
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`COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS
`LIPID-RICH CELLS
`
`TECHNICAL FIELD
`
`[0001]
`
`‘. The present application relates to cooling devices. systems. and methods
`
`for removing heat from subcutaneous lipid-rich cells.
`
`BACKGROUND
`
`[0002]
`
`As statistics have shown. excess body fat
`
`increases the likelihood of
`
`developing various types of diseases such as heart disease. high blood pressure.
`
`osteoarthrosis, bronchitis. hypertension. diabetes. deep-vein thrombosis, pulmonary
`
`emboli, varicose veins. gallstones, hernias. and several other conditions.
`
`[0003]
`
`In addition to being a serious health risk. excess body fat can also detract
`
`from personal appearance and athletic performance. For example. excess body fat can
`
`form cellulite that causes an "orange peel" effect at the surface of the skin. Cellulite
`
`forms when subcutaneous fat protrudes into the derrnls and creates dimples where the
`
`skin ls attached to underlying structural fibrous strands. Cellulite and excessive
`
`amounts of fat are often considered to be unappealing. Thus, in light of the serious
`
`health risks and aesthetic concerns associated with excess fat. an effective way of
`controlling excess accumulation of body fat is urgently needed.
`
`[0004]
`
`Liposuction is a method for selectively removing body fat to sculpt a
`
`person's body. Liposuction is typically performed by plastic surgeons using specialized
`
`surgical equipment that mechanically removes subcutaneous fat cells via suction. One
`drawback of liposuction Is that It is a serious surgical procedure, and the recovery may
`be painful. Liposuction can have serious and occasionally even fatal complications.
`In
`
`addition. the cost for liposuction Is usually substantial.
`
`[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
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`1
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`2011265424
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`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 weight—loss drugs.
`
`[0006] Other non—invasive treatment methods include applying heat to a zone of subcutaneous
`
`lipid—rich cclls. 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 septa 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 can cause thermal damage to adjacent tissue.
`
`[0007] Another promising method of reducing subcutaneous fat cells is to cool the target cells as
`
`disclosed in US. Patent Publication No. 2003/0220674, the entire disclosure of which ls
`
`incorporated herein. This publication discloses, among other things, reducing the temperature of
`
`lipid—rich subcutaneous fat cells to selectively affect the fat cells without damaging the cells in
`
`the epidermis. Although this publication provides promising methods and devices, several
`
`improvements for enhancing the Implementation of these methods and devices would be
`
`desirable.
`
`[0008] US. Patent Publication No. 2003/0220674 also discloses methods for selective removal
`
`of lipid—rich cells, and avoidance of damage to other structures Including dermal and epidermal
`
`cells. A method for inducing collagen compaction, remodeling and formation is also needed for
`
`treatment of loose or sagging skin, age- or sun-damaged skin or a variety of other skin disorders.
`
`Therefore, a method for simultaneously removing lipid-rich cells while providing beneficial
`
`collagen effects is also needed.
`
`OBJECT
`
`[0008a] It is the object of the present invention to address the above needs.
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`(881366871):SPM
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`SUMMARY
`
`2a
`
`[0008b] The present invention provides a method of applying a handheld cooling device
`
`configured to be grasped by a hand of an operator, the cooling device having two opposing
`
`spaced apart cooling elements configured for removing heat from subcutaneous lipid—rich cells,
`
`each cooling element having a heat exchanging surface, wherein one or both of the heat
`
`exchanging surfaces are concave or convex, the method comprising:
`
`(i)
`
`rotating the two cooling elements relative to each other;
`
`(ii)
`
`cooling the heat exchanging surfaces of the two cooling elements to a desired
`
`temperature;
`
`(iii)
`
`holding the cooling device by a hand;
`
`(iv)
`
`placing the cooling device such that the cooled heat exchanging surfaces are
`
`proximate to the skin of a subject; and
`
`(v)
`
`reducing a temperature of a region under the epidermis of the subject such that
`
`lipid—rich cells in the region of the skin are affected while non-lipid-rich cells in the epidermis
`
`are not affected.
`
`[0008c] The present invention also provides a system for removing heat from subcutaneous
`
`lipid—rich cells, comprising:
`
`a portable cooling device having a first cooling element including a first heat
`
`exchanging surface, a second cooling element including a second heat exchanging surface, a
`
`handheld assembly having a handhold configured to be grasped by a hand of an operator, and a
`
`support extending from the handhold, wherein the first and second cooling elements are coupled
`
`to the support such that at least one of the first and second cooling elements is movable with
`
`respect to the support, and wherein the cooling device is configured for reducing a temperature
`
`of lipid—rich cells in a region of a subject such that the lipid—rich cells are affected while non—
`
`lipid—rich cells at the epidermis are not affected; and
`
`a heat sink coupled to the cooling device to dissipate heat generated by the cooling
`
`device.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0009] Figure l is an isometric view of a system for removing heat from subcutaneous lipid—rich
`
`cells in accordance with an embodiment of the invention.
`
`(881366871):SPM
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`

`

`2b
`
`[0010] Figures 2A, 28 and 2C are isometric views of a cooling device for removing heat from
`
`subcutaneous lipid—rich cells in accordance with embodiments of the invention.
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`201126542421Dec2011
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`[0011]
`
`Figure 3A is an end view and Figure SB is a side cross-sectional view
`
`partially illustrating a cooling device for removing heat from subcutaneous lipid-rich cells
`in accordance with an embodiment of the invention.
`
`[0012]
`
`Figure 4 is a side 'elevation view illustrating a cooling device having
`
`thermoelectric cooling elements in accordance with another embodiment of
`invention.
`
`the
`
`Figure 5 is a side elevation view of a cooling device; having curved heat
`[0013]
`exchanging surfaces in accordance with another embodiment of the invention.
`
`[0014]
`
`Figure 6 is a block diagram showing computing system software modules
`
`for removing heat from subcutaneous lipid-rich cells-
`
`DETAILED DESCRIPTION
`
`A
`
`Overview
`
`[0015]
`
`The present disclosure describes devices, systems, and methods for
`
`cooling subcutaneous lipid-rich cells. The term "subcutaneous tissue" means tissue
`
`lying underneath the dermis and includes adipocytes (fat cells) and subcutaneous fat.
`
`it
`
`will be appreciated that several of the details set forth below are provided to describe
`
`the following embodiments in a manner sufficient to enable a person skilled in the
`relevant art to make and use the disclosed embodiments. Several of the details and
`
`advantages described below, however. may not be necessary to practice certain
`embodiments of
`the invention.
`Additionally,
`the invention can include other
`
`embodiments that are within the scope of the claims but are not described in detail with
`
`respect to Figures 1—6.
`
`[0016]
`
`One aspect is directed toward a cooling device for removing heat from
`
`subcutaneous lipid-rich cells. The cooling device includes a support with a first portion
`
`and a second portion. a first cooling element having a first heat exchanging surface, and
`
`a second cooling element having a second heat exchanging surface. The first cooling
`
`element is located at the first portion of the support. and the second cooling element Is
`
`located at the second portion of the support. At least one of the first and second cooling
`
`elements is movable along the support, and at least one of the first and second cooling
`
`elements is configured to rotate for adjusting an angle between the first and second
`
`heat exchanging surfaces. The first and second cooling elements, for example. can be
`.3-
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`201126542421Dec2011
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`rotatable either in two dimensions or In three dimensions. The cooling elements can
`
`use a number of cooling technologies including 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 that
`
`could be used and that the cooling elements need not be limited to those described
`
`here. Further aspects include that the cooling device can be configured as a handheld
`device.
`
`[0017]
`
`Another aspect is directed toward a cooling device having a cooling member
`
`using thermoelectric principles or other cooling technologies. The cooling device also
`
`includes a heat dissipating member in thermal communication with the cooling member
`and an interface member having a heat exchanging surface configured to contact a
`
`subject's skin. The cooling member can be capable of reducing a temperature of a
`
`region such that lipid-rich cells in the region are affected while non-llpid-rich cells are not
`
`generally affected. Further aspects include that the heat exchanging surface can be a
`
`curved surface for concentrating the cooling effects.
`
`[0018]
`
`Another aspect is directed toward a method of applying a cooling device
`
`having two cooling elements rotatable relative to each other. The cooling elements can
`
`have heat exchanging surfaces capable of removing heat from the subject's skin. The
`
`method includes rotating the cooling elements to achieve a desired orientation between
`
`the two heat exchanging surfaces, cooling the heat exchanging surfaces of the two
`
`cooling elements to a desired temperature, placing the cooled heat exchanging surfaces
`
`proximate to the subject's skin. and reducing a temperature of a region such that lipid-
`
`rich cells in the region are affected while non-lipid-rich cells in the epiderrnls are not
`
`generally affected. Further aspects include holding the cooling device by at least one
`
`hand of an operator.
`
`[0019]
`
`Another aspect
`
`is directed toward a system for
`
`removing heat
`
`from
`
`subcutaneous lipid—rich cells.
`
`The system includes a cooling device having two
`
`rotatable cooling elements capable of achieving a desired orientation between each
`
`other, and a heat sink coupled to the cooling device to dissipate heat generated by the
`
`cooling device. When placed proximate to a subjects skin, the two cooling elements
`
`can be 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
`
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`201126542421Dec2011
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`
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`generally affected. Further aspects include that the cooling device can be configured as
`a handheld device.
`
`B.
`
`System for Selectively Reducing Lipid-rich Cells
`
`[0020]
`
`Figure 1
`
`is an Isometric view of a system 100 for removing heat from
`
`subcutaneous lipid-rich cells of a subject 101 in accordance with an embodiment of the
`
`invegtign,___The system 100 canwinclude a cooling device 104 placed EL?" abdominal
`
`area 102 of the subject 101 or another suitable area for removing heat from the
`
`subcutaneous lipid-rich cells of the subject 101. Various embodiments of the cooling
`
`device 104 are described in more detail below with reference to Figures 2-5.
`
`[0021]
`
`The system 100 can further Include a cooling unit 106 and fluid lines 1088-!)
`
`connecting the cooling device 104 to the cooling unit 106. The cooling unit 106 can
`
`remove heat from a coolant to a heat sink and provide the chilled coolant to the cooling
`
`device 104 via the fluid lines 108a-b. Examples of the circulating coolant include water.
`glycol. synthetic heat transfer fluid. oil, a refrigerant and any other suitable heat
`
`conducting fluids. The fluid lines 108a-b can be hoses or other conduits constructed
`
`from polyethylene, polyvinyl chloride, polyurethane, and other materials that can
`
`accommodate the particular circulating coolant. The cooling unit 106 can be a
`
`refrigeration unit. a cooling tower. a thermoelectric chiller. or any other device capable of‘
`
`removing heat from a coolant.
`
`[0022]
`
`As explained in more detail below. the cooling device 104 can include one
`
`or more thermoelectric cooling elements, such as Peltler—type thennoelectric elements.
`
`In such cases. the system 100 can further include a power supply 110 and a processing
`
`unit 114 operatively coupled to the cooling device 104.
`
`In one embodiment. the power
`
`supply 110 can provide a direct current voltage to the cooling device 104 to effectuate a
`
`heat removal rate from the subject 101. The processing unit 114 can monitor process
`
`parameters via sensors (not shown) placed proximate to the cooling device 104 and
`
`adjust the heat removal rate based on the process parameters. The processing unit
`
`114 can include any processor, Programmable Logic Controller. Distributed Control
`
`System. and the like.
`
`[0023]
`
`In another aspect.
`
`the processing unit 114 can be in
`
`electrical
`
`communication with an Input device 118. an output device 120. and/or a control panel
`
`122. The input device 118 can include a keyboard. a mouse. a touch screen. a push
`~5-
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`201126542421Dec2011
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`button, a switch. a potentiometer, and any other devices suitable for accepting user
`
`Input. The output device 120 can Include a display screen. a printer, a medium reader,
`
`an audio device, and any other devices suitable for providing user feedback. The
`
`control panel 122 can include indicator lights. numerical displays, and audio devices.
`
`In
`
`the embodiment shown In Figure 1. the processing unit 114, power supply 110, control
`
`panel 122, cooling unit 106, Input device 118, and output device 120 are carried by a
`
`rack 124 with wheels 126 for portability.
`
`In another embodiment.
`
`the various
`
`Components can be fixedly installed at a treatment site.
`
`[0024]
`
`One expected advantage of the system 100 Is that the cooling device 104
`
`can be applied to the subject 101 irrespective of the current physical condition of the
`
`subject 101. For example. the system 100 can be applied even when the subject 101 is
`
`not ambulatory or is ill. Another expected advantage is that the system 100 can remove
`
`or affect fat non-invasively without piercing the skin of the subject 101. Yet another
`
`expected advantage is that the system 100 is compact and can be used in an outpatient
`
`.
`
`facility or a doctor's office. A further expected advantage is that the system 100 can
`
`quickly cool lipid—rich cells In a subcutaneous layer without requiring high-voltage power
`
`supplies.
`
`C.
`
`Cooling Devices With Rotatable Cooling Elements
`
`[0025]
`
`Figure 2A Is an Isometric view of a cooling device 104 in accordance with
`
`one example of the inventlon suitable for use in the system 100.
`
`In this example, the
`
`cooling device 104 Includes a support 128 having a first portion 129a and a second
`
`portion 129b, a first cooling element 130a located at the first portion 129a. and a second
`
`cooling element 130b located at the second portion 129b. The cooling device 104 is
`
`generally configured to be a handheld unit for manual operation. and/or it can be
`
`strapped or othewvise configured to be reieasably attached to the subject. The first
`
`cooling element 130a and/or the second cooling element 130b can be configured to
`
`move along the support 128 and/or rotate to position the cooling elements 130a-b for
`
`applying pressure to the treatment area during operation. These features are described
`
`In more detail below with reference to specific examples of the cooling devices.
`
`[0026]
`
`The first and second cooling elements 130a—b can have many similar
`
`features. As such, the features of the first cooling element 130a are described below
`
`with reference symbols followed by an "a", and corresponding features of the second
`
`-6-
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`

`

`
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`cooling element 130b are shown and noted by the same reference symbol followed by a
`
`"b." The first cooling element 130a can include a housing 139a and fluid ports 138a-b
`
`coupled to the fluid lines 108a-b. The housing 139a can be constructed from polymeric
`
`materials. metals. ceramics, woods, and/or other suitable materials. The example of the
`
`housing 139a shown in Figure 2A is generally rectangular but it can have any other
`
`desired shape.
`
`[0027]
`
`The first cooling element 130a can further include a first interface member
`
`132a having a first heat exchanging surface 131a for transferring heat to/from the
`
`subject 101 .
`
`In one example. the first heat exchanging surface 131a is generally planar.
`
`but
`
`In other examples. the first heat exchanging surface 131a is non-planar (9.9.,
`
`curved, faceted, etc.) The first interface member 132a can be constructed from any
`
`suitable material with a thermal conductivity greater than 0.05 Watts/Meter °Kelvin. and
`
`in many examples. the thermal conductivity Is more than 0.1 Watts/Meter °Kelvin.
`
`Examples of suitable materials include aluminum, other metals, metal alloys. graphite,
`
`ceramics. some polymeric materials. composites. or fluids contained In a flexible
`
`membrane. As further described below with reference to Figures 4 and 5, portions of
`
`the first heat exchanging surface 131a can be an insulating material with a thermal
`
`conductivity less than 0.05 Watts/Meter “Kelvin.
`
`[0028]
`
`The first cooling element 130a can also include at
`
`least one sensing
`
`element 135a proximate to the first heat exchanging surface 131a. The sensing
`
`element 135a, for example, can be generally flush with the heat exchanging surface
`
`131a. Altematlvely.
`
`It may be recessed or protrude from the surface. The sensing
`
`element 135a can include a temperature sensor. a pressure sensor. a transmisslvity
`
`sensor, a bio-resistance sensor. an ultrasound sensor, an optical sensor, an infrared
`
`sensor, or any other desired sensor.
`
`In one example. the sensing element 135a can be
`
`a temperature sensor configured to measure the temperature of the first heat
`
`exchanging surface 131a and/or the temperature of the skin of the subject 101. For
`
`example, the temperature sensor can 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 (6.9.. neutron-
`
`transmutation-doped germanium thermistors). and infrared radiation temperature
`
`sensors.
`
`In another example. the sensing element 135a can be an ultrasound sensor
`
`configured to measure crystallization of subcutaneous fat in the treatment region of a
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`201126542421Dec2011
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`
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`subject
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`In yet another example. the sensing element 135a can 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. The sensing element 135a can be in
`
`electrical communication with the processing unit 114 via, for example, a direct wired
`
`connection. a networked connection and/or a wireless connection.
`
`[0029]
`
`The cooling device 104 can further include a mounting element 136a that
`
`couples the first cooling element 130a to the first portion 129a of the support 128. The
`
`mounting element 136a, for example, can be a pin, a ball joint, a bearing. or other types
`
`of rotatable joints. Suitable bearings include, but are not limited to, ball bearings, roller
`
`bearings,
`
`thrust bearings. and journal bearings. The mounting element 136a can
`
`accordingly be configured to rotatabiy couple the first cooling element 130a to the
`
`support 128.
`
`in certain embodiments, the first cooling element 130a can rotate relative
`
`to the support 1 28 in two dimensions (indicated by arrow A) such that the angle between
`
`the first and second heat exchanging surfaces 131 a-b can be adjusted.
`
`in another
`
`embodiment, the first cooling element 130a can rotate in three dimensions relative to
`
`the support 128 (as indicated by arrows A and B).
`
`A specific example of the mounting element 136a includes a first mounting
`[0030]
`base 1343 and a flange 137a coupled to the base 134a by a rotatable or pivotable Joint.
`By rotatably mounting at least one of the first and second cooling elements 130a—b to
`
`the support 128, the angle between the first and second heat exchanging surfaces
`
`131a-b can be adjusted. For example, as shown in Figure 2A, the first and second
`
`cooling elements 130a-b can be generally parallel to each other. i.e., have an angle of
`
`generally 0" between the first and second heat exchanging surfaces 131a—b. As shown
`
`in Figure 28, the first and second cooling elements 130a-b can be generally co-planar,
`
`i.e., have an angle of generally 180° between the first and second heat exchanging
`
`surfaces 131a—b. With the rotatable mounting elements 136a-b. any angle of about 0°
`
`to about 180° between the first and second heat exchanging surfaces 131 a-b can be
`achieved.
`
`[0031]
`
`The cooling device 104 can further include a shaft 133, and the first
`
`mounting base 134a can be attached to the shaft 133. As explained in more detail
`
`below, at least one of the cooling elements 1303—b moves along the shaft 133 and/or
`
`the shaft 133 moves relative to the support 128 toadjust the distance between the first
`
`and second cooling elements 130a-b (shown by arrow C). The shaft 133. more
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`201126542421Dec2011
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`
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`specifically, extends between the first and second cooling elements 130a~b to enable
`
`movement of at least one of the cooling elements 130a-b relative to the support 128.
`
`In
`
`the embodiment shown in Figure 2A, the first mounting base 134a is fixedly attached to
`
`the shaft 133, and a second mounting base 134b of the second coollng element 130b is
`
`configured such that the second mounting base 134b can slide along .the shaft 133.
`
`In
`
`other embodiments. both the first mounting base 134a and the second mounting base
`
`134b can be configured to slide along the shaft 133. The shaft 133 is generally
`
`constructed from polymeric materials, metals, ceramics, woods, or other suitable
`materials.
`
`[0032]
`
`The cooling device 104 further includes a handle 140 slidably coupled to the
`
`shaft 133 or formed as a part of the shaft 133. The handle 140 is configured to be held
`
`by a hand of an operator. For example, the handle 140 can have a grip with grooves to
`
`Improve stability of the cooling device 104 when held by the operator. The handle 140
`
`furflter includes an actuator 142 that operates with the shaft 133 to move the second
`
`cooling element 13Gb relatlve to the shaft 133.
`
`in the example shown in Figure 2A, the
`
`actuator 142 Is a lever that engages the shaft 133 to incrementally advance the second
`
`cooling element 13Gb in an axial motion (arrow C) along the shaft 133.
`
`[0033]
`
`In operation. an operator can hold the cooling device 104 In one hand by
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`grasplng the handle 140. Then, the cooling elements 130a-b can be rotated via the
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`mounting elements 136a-b to achieve a desired orientation. The operator can place the
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`cooling devlce 104 having the cooling elements 130a-b In the desired orientatlon
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`proximate to the subject's skin to remove heat from a subcutaneous region of the
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`subject 101.
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`In one embodiment, the operator can clamp a portion of the subject's skin
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`between the heat exchanging surfaces 131a—b when the surfaces 131 a-b are generally
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`parallel to each other.
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`In another embodiment,
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`the operator can press the heat
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`exchanging surfaces 131a-b against the subject's skin when the surfaces 131a—b are
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`generally co-planar.
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`ln certaln embodiments,
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`the operator can use thermoelectric
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`coolers to remove heat
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`from the subcutaneous region as described below with
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`reference to Figure 4. The operator can also monitor and control the treatment process
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`by collecting measurements, such as skin temperatures, from the sensing element
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`1353.
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`By cooling the subcutaneous tissues to a temperature lower than 37°C,
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`subcutaneous lipld-rlch cells can be selectively affected. The affected cells are then
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`resorbed into the patient through natural processes.
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`201126542421Dec2011
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`[0034]
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`One expected advantage of using the cooling device 104 is
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`that
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`subcutaneous lipid-rich cells can be reduced generally without collateral damage to non-
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`lipid-rich cells in the same region.
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`In general, lipid-rich cells can be affected at low
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`temperatures that do not affect non-lipid-n‘ch cells. As a result, lipid-rich cells. such as
`those forming the cellulite. can be affected while other cells In the same region are
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`generally not damaged even though the non—lipld—n'ch cells at the surface are subject to
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`even lower temperatures. Another expected advantage of the cooling device 104 is that
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`it is relatively compact because the cooling device 104 can be configured as a handheld
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`device. Yet another advantage is that the cooling device can be applied to various
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`regions of the subject's body because the two cooling elements 130a-b can be adjusted
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`to conform to any body contour. Another expected advantage is that by pressing the
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`cooling device 104 against the subject's skin. blood flow through the treatment region
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`can be reduced to achieve efficient cooling. Still another expected advantage is that the
`power requirement is reduced for each of the cooling elements 1308-b because heat is
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`removed from the skin through the two heat exchanging surfaces 131a-b instead of a
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`single cooling element.
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`[0035]
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`The first and second cooling elements 130a-b can have many additional
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`embodiments with different and/or additional features without detracting from the
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`operation of both elements. For example, the second cooling element 130b may or may
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`not have a sensing element proximate to the second heat exchanging surface 131D.
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`The second cooling element 13Gb can be constmcted from a material that is different
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`from that of the first cooling element 130a. The second mounting base 134b can have a
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`shape and/or a surface configuration different from that of the first mounting base 134a.
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`The first cooling element 130a can be rotatable, but the second cooling element 130!)
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`may be non-rotatable.
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`[0036]
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`Figure 20 is an alternative example of the cooling device 104 in accordance
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`with one example of the invention for use in the system 100. This alternative example,
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`and those aitemative examples and other alternatives described herein.
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`are
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`substantially similar to previously-described examples, and common acts and structures
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`are identified by the same reference numbers. Only significant differences in operation
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`and structure are described below.
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`In this example, the cooling device 104 includes a
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`support 128 having a portion 129D and a portion 160. a cooling element 130b located at
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`the portion 129b, and a reciprocating element 164 located at the portion 160. The
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`201126542421Dec2011
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`cooling device 104 is generally configured to be a handheld unit for manual operation.
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`and/or it can be strapped or otherwise configured to be releasably attached to the
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`subject.
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`In this example. the reciprocating element 164 can be configured to move
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`along the support 128 and/or rotate to position the reciprocating element 164 to apply
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`pressure to the treatment area during. operation. The reciprocating element 164 can
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`include a housing 166 and a sensing element 162. The housing 166 can be constructed
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`from polymeric materials, metals. ceramics, woods, and/or other suitable materials. The
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`example of the housing 166 shown in Figure 20 is generally rectangular. but can have
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`any other desired shape.
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`least. one sensing
`The reciprocating element 164 can also include at
`[0037]
`element 162 proximate to the skin (not shown). The sensing element 162. for example.
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`can be generally flush with a face of the reciprocating element 164. Aitematively; it may
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`be recessed or protrude from the surface. The sensing element 162 can include a
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`temperature sensor. a pressure sensor. a transmissity sensor. a bioresistance sensor.
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`an ultrasound sensor, an optical sensor, an infrared sensor, or any other desired sensor,
`as discussed in detail herein.
`
`[0038]
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`Figure 3A is an end view and Figure SB is a side elevation view of the
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`embodiment of the cooling device 104 shown In Figures 2A and 23. UKe reference
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`symbols refer to like features and components in Figures 1-33.
`
`In one aspect, the first
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`cooling element 1303 can include a fluid chamber 150a within the housing 139a. The
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`fluid chamber 150a can be in fluid communication with the fluid ports 138a-b such that
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`fluid can circulate through the fluid chamber 150a. Optionally. the fluid chamber 150a
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`can Include one or more flow elements to promote uniform or otherwise controlled fluid
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`circulation through the fluid chamber 1508. For example, the fluid chamber 150a can
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`include baffles, static mixers, nozzles, ventures. orifices or any combination of these
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`flow elements. The fluid chamber 150a can be configured to accept fluid coclants. such
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`as water. glycol. a synthetic heat transfer fluid. oil. refrigerants. air. carbon dioxide.
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`nitrogen. and argon.
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`[0039]
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`The first interface member 132a can be a diffuser disposed in the housing
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`139a such that the first heat exchanging surface 131a faces away from the fluid
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`chamber 150a.
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`The first
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`interface member 132a
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`is accordingly In thermal
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`communication with the fluid chamber 150a to transfer heat between the first heat
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`exchanging surface 131a and the fluid chamber 150a.
`-11..
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`in one embodiment.
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`the
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`201126542421Dec2011
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`Interface member 132a ls releasably attached to the housing 139a using mechanical
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`fasteners to allow access to the fluid chamber 150a or the backside of the first Interface
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`member 132a. The sensing element 135a can be placed in the first Interfac