(12) STANDARD PATENT
`
`(11) Application No. AU 2014203094 B2
`
`(19) AUSTRALIAN PATENT OFFICE
`
`Title
`
`Device, system and method of removing heat from subcutaneous lipid-rich cells
`
`International Patent Classification(s)
`A61F 7/00 (2006.01)
`A61F 7/10 (2006.01)
`A61B 18/02 (2006.01)
`
`Application No:
`
`2014203094
`
`(22)
`
`Date of Filing:
`
`2014.06.06
`
`US 2008/0077211 A1
`
`Publication Date:
`Publication Journal Date:
`
`2014.07.03
`2014.07.03
`
`Accepted Journal Date:
`
`2015.07.23
`
`Divisional of:
`2010242785
`
`Applicant(s)
`Zeltiq Aesthetics, Inc.
`
`lnventor(s)
`Albert
`Paul William;Ollerdessen,
`Joseph;Martens,
`Baker, Mark;Coakley,
`L.;Pennybacker, William Patrick;Rosen, Jesse Nicasio;Yee, Peter;Allison, John
`W.;Weber, Bryan
`
`Agent [Attorney
`Spruson & Ferguson, L 35 St Martins Tower 31 Market St, Sydney, NSW, 2000
`
`Related Art
`US 2009/0018624 A1
`
`

`

`201420309406Jun2014
`
`DEVICE, SYSTEM AND METHOD OF REMOVING HEAT FROM
`
`SUBCUTANEOUS LIPID-RICH CELLS
`
`ABSTRACT
`
`A device for treating subcutaneous lipid-rich cells, comprises: a rigid portion (200)
`
`including a thermal conductor having an inside surface and an outside surface positioned
`
`opposite the inside surface; and a flexible portion (100) having an inner surface, an outer surface
`
`positioned opposite the inner surface, and a cutout extending between the inner and outer
`
`surfaces. The thermal conductor is positioned in the cutout and the flexible and rigid portions
`
`define a body having an interior surface including the inside face of the rigid portion and the
`
`inner surface of the flexible portion; and an exterior surface including the outside face of the
`
`rigid portion and the outer surface of the flexible portion.
`
`

`

`201420309406Jun2014
`
`DEVICE, SYSTEM AND METHOD OF REMOVING
`HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS
`
`CROSS-REFERENCE TO RELATED APPLICATION(S)
`
`This patent application claims the benefit under 35 U.S.C. § 119 of U.S.
`[0001]
`Provisional Patent Application No. 61/174,487,
`filed on April 30,2009, entitled
`"Device, System and Method of Removing Heat from Subcutaneous Lipid-rich
`
`Cells." That application is incorporated herein in its entirety by reference.
`
`INCORPORATION BY REFERENCE OF COMMONLY—OWNED APPLICATIONS
`
`[0002]
`
`The
`
`following
`
`commonly-assigned U.S. Patent Applications
`
`are
`
`incorporated herein by reference in their entirety:
`
`U.S. Patent Publication No. 2008/0287839 entitled “METHOD OF
`[0003]
`ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS
`
`AND TREATMENT APPARATUS HAVING AN ACTUATOR";
`
`“FREEZING METHOD FOR
`U.S. Patent No. 6,032,675 entitled
`[0004]
`CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION";
`
`U.S. Patent Publication No. 2007/0255362 entitled “CRYOPROTECTANT
`[0005]
`FOR USE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF
`
`SUBCUTANEOUS LIPID—RICH CELLS";
`
`U.S. Patent Publication No. 2007/0198071 entitled “COOLING DEVICE
`[0006]
`FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”:
`
`[0007]
`
`U.S. Patent Publication No. 2008/0077201 entitled “COOLING DEVICES
`
`WITH FLEXIBLE SENSORS”;
`
`U.S. Patent Publication No. 2008/0077211 entitled “COOLING DEVICE
`[0008]
`HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE
`
`A PREDETERMINED COOLING PROFILE";
`
`entitled “METHOD AND
`U.S. Patent Publication No. 2009/0118722
`[0009]
`APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE";
`
`

`

`201420309406Jun2014
`
`[0010]
`
`U.S. Patent Publication No. 2009/0018624 entitled “LIMITING USE OF
`
`DISPOSABLE SUBJECT PROTECTION DEVICES";
`
`[0011]
`
`U.S. Patent Publication No. 2009/0018623 entitled “SYSTEM FOR
`
`TREATING LIPID—RICH REGIONS";
`
`“MANAGING
`U.S. Patent Publication No. 2009/0018625 entitled
`[0012]
`SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS”;
`
`[0013]
`
`U.S. Patent Publication No. 2009/0018627 entitled “SECURE SYSTEM
`
`FOR REMOVING HEAT FROM LIPID-RICH REGIONS”;
`
`U.S. Patent Publication No. 2009/0018626 entitled "USER INTERFACES
`[0014]
`FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS";
`
`U.S. Patent No. 6,041,787 entitled “USE OF CRYOPROTECTIVE
`[0015]
`AGENT COMPOUNDS DURING CRYOSURGER ”;
`
`U.S. Patent Publication No. 2009/0149929 entitled “MONITORING THE
`[0016]
`COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING
`
`OF ADIPOSE TISSUE";
`
`U.S. Patent Publication No. 2010/0081971
`[0017]
`PLANNING
`SYSTEMS
`AND METHODS
`FOR
`
`entitled “TREATMENT
`BODY
`CONTOURING
`
`APPLICATIONS";
`
`U.S. Patent Application Serial No. 12/337,544 entitled “SYSTEMS AND
`[0018]
`METHODS WITH lNTERRUPT/RESUME CAPABILITIES
`FOR COOLING
`
`SUBCUTANEOUS LIPID-RICH CELLS”;
`
`[0019]
`
`U.S.
`
`Patent
`
`Publication
`
`No.
`
`2008/0077202
`
`entitled
`
`“TISSUE
`
`TREATMENT METHODS”; and
`
`U.S. Provisional Patent Application Serial No. 61/298,175 entitled "HOME
`[0020]
`CARE METHODS AND SYSTEMS FOR REDUCING SUBCUTANEOUS FAT."
`
`U.S. Patent Publication No. 2007/0270925 entitled "METHOD AND
`[0021]
`APPARATUS
`FOR
`NON-INVASIVELY
`REMOVING
`HEAT
`FROM
`
`SUBCUTANEOUS LIPID RICH CELLS INCLUDING A COOLANT HAVING A
`
`PHASE TRANSITION TEMPERATURE";
`
`

`

`201420309406Jun2014
`
`[0022]
`
`U.S. Provisional Patent Application Serial No. 61/297,238 entitled
`
`"COMPOSITIONS FOR USE WITH A SYSTEM FOR IMPROVED COOLING OF
`
`SUBCUTANEOUS LIPID-RICH CELLS".
`
`TECHNICAL FIELD
`
`[0023]
`
`The present application relates generally to treatment devices, systems,
`
`and methods for removing heat from subcutaneous lipid-rich cells.
`
`In particular,
`
`several embodiments are directed toward a treatment device including a vacuum
`
`applicator to effect heat removal or extraction from subcutaneous lipid-rich cells.
`
`BACKGROUND
`
`Excess body fat, or adipose tissue, may be present in various locations of
`[0024]
`the body, including, for example, the thigh, buttocks, abdomen, knees, back, face,
`arms, chin, 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.
`
`A variety of methods have been used to treat individuals having excess
`[0025]
`body fat and,
`in many instances, non—invasive removal of excess subcutaneous
`adipose tissue can eliminate unnecessary recovery time and discomfort associated
`with invasive procedures such as liposuction. 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 often cannot be achieved using general or
`
`systemic weight-loss methods.
`
`

`

`4
`
`19§hn12015
`2014203094
`
`[0026] Other methods designed to reduce subcutaneous adipose tissue include laser—assisted
`
`liposuction and mesotherapy. Newer non—invasive methods include applying radiant energy to
`
`subcutaneous lipid—rich cells via, e.g., radio frequency and/or light energy, such as described in
`
`U.S. Patent Publication No. 2006/0036300 and U.S. Patent No. 5, 143,063, or via, e.g., high
`
`intensity focused ultrasound (HIFU) radiation such as described in U.S. Patent Nos. 7,258,674
`
`and 7,347,855. In contrast, methods and devices for non-invasively reducing subcutaneous
`
`adipose tissue by cooling are disclosed in U.S. Patent No. 7,367,341 entitled "METHODS AND
`
`DEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED
`
`COOLING" to Anderson et al. and U.S. Patent Publication No. 2005/0251120 entitled
`
`"METHODS AND DEVICES FOR DETECTION AND CONTROL OF SELECTIVE
`
`DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING" to Anderson et al., the
`
`entire disclosures of which are incorporated herein by reference.
`
`OBECT
`
`[0026a] It is the object of the present invention to substantially overcome or at least ameliorate
`
`one or more of the disadvantages of the prior art, or at least provide a useful alternative.
`
`SUMMARY
`
`[0026b] Accordingly, the present invention provides a device for treating subcutaneous
`
`lipid—rich cells, comprising:
`
`a rigid portion including a thermal conductor having an inside surface and an outside
`
`surface positioned opposite the inside surface; and
`
`a flexible portion having an inner surface, an outer surface positioned opposite the inner
`
`surface, and a cutout extending between the inner and outer surfaces;
`
`wherein the thermal conductor is positioned in the cutout and the flexible and rigid
`
`portions define a body having —
`
`an interior surface including the inside face of the rigid portion and the inner surface of
`
`the flexible portion; and
`
`an exterior surface including the outside face of the rigid portion and the outer surface of
`
`the flexible portion.
`
`AH26(1015369971):SPM
`
`

`

`l9.hu12015
`2014203094
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`4a
`
`[0027] 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 necessarily 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 necessarily intended to convey any
`
`information regarding the actual shape of the particular elements, and are generally selected for
`
`ease of recognition in the drawings.
`
`[0028] Figure 1 is an isometric view schematically illustrating a treatment system [or treating
`
`subcutaneous lipid—rich regions of a subject 11 in accordance with an embodiment of the
`
`disclosure.
`
`[0029] Figure 2 is a schematic illustrating a treatment device for treating subcutaneous lipid—rich
`
`areas of a subject 11 in accordance with an embodiment of the disclosure.
`
`[0030] Figure 3A is a side view showing an embodiment of a device for a treatment to removing
`
`or extracting heat from subcutaneous lipid—rich cells.
`
`AH26(1015369971):SPM
`
`

`

`201420309406Jun2014
`
`[0031]
`
`Figure BB is a top view showing a control panel of the treatment device
`
`shown in Figure 3A.
`
`[0032]
`
`Figure 3C is a bottom view showing the treatment device shown in Figure
`
`3A.
`
`[0033]
`
`Figure 3D is a partially exploded perspective view of the treatment device
`
`shown in Figure 3A.
`
`[0034]
`
`Figure 3E is a detail view of a component of the treatment device shown
`
`in Figure 3A.
`
`[0035]
`
`Figures 4A-4D show different stages of assembling an embodiment of a
`
`rigid portion of the treatment device shown in Figure 3A.
`
`[0036]
`
`Figure 5A shows a front view of an embodiment of a flexible portion of the
`
`treatment device shown in Figure 3A.
`
`[0037]
`
`Figure 5B is an end view of the flexible portion shown in Figure 5A.
`
`[0038]
`
`Figure 5C is atop view of the flexible portion shown in Figure 5A.
`
`[0039]
`
`Figure 5D is a bottom view of the flexible portion shown in Figure 5A.
`
`[0040]
`
`Figure 6A is a perspective view showing an embodiment of a subject 11
`
`liner for the treatment device shown in Figure 3A.
`
`[0041]
`
`Figure GB is an exploded view of the subject 11 liner shown in Figure 6A.
`
`[0042]
`
`Figure 6C is a perspective view of the subject 11 liner shown in Figure
`
`6A.
`
`[0043]
`
`Figure 7A shows a perspective view of an embodiment of a token
`
`interfacing with the treatment device shown in Figure 3A.
`
`[0044]
`
`Figure YB shows a perspective view of the token shown in Figure 6A.
`
`[0045]
`
`Figure 7C shows a perspective view of an embodiment of a receptacle for
`
`receiving the token shown in Figure 7A.
`
`[0046]
`
`Figure 7D shows another embodiment of a receptacle for the treatment
`
`device shown in Figure 3A.
`
`[0047]
`
`Figure 7E shows another embodiment of a token for the treatment device
`
`shown in Figure 3A.
`
`

`

`201420309406Jun2014
`
`[0048]
`
`Figure 7F shows an adjustor for the treatment devices described herein.
`
`[0049]
`
`Figure 8 is a perspective view showing an embodiment of another
`
`applicator for a treatment to remove or extract heat from lipid-rich cells disposed
`
`under a cutaneous layer.
`
`[0050]
`
`Figure 9A is an elevation view of a flexible portion of the applicator shown
`
`in Figure 8.
`
`[0051]
`
`Figure 9B is a side view of a flexible portion of the applicator shown in
`
`Figure 8.
`
`[0052]
`
`Figure 9C is a plan view of a flexible portion of the vacuum applicator
`
`shown in Figure 8.
`
`[0053]
`
`Figure 9D is a bottom view of a flexible portion of the vacuum applicator
`
`shown in Figure 8.
`
`[0054]
`
`Figure ’10 is a perspective view of a panel of a rigid portion of the vacuum
`
`applicator shown in Figure 8.
`
`[0055]
`
`Figure 11A is an exploded perspective view a frame of the vacuum
`
`applicator shown in Figure 8.
`
`[0056]
`
`Figure 113 is a perspective view of a first frame portion of the frame
`
`shown in Figure 11A.
`
`[0057]
`
`Figure 11C is a perspective view of a second frame portion of the frame
`
`shown in Figure 11A.
`
`Figure 12A is an exploded side view of a subassembly of the vacuum
`[0058]
`applicator shown in Figure 8 including the panels and the second frame portions.
`
`Figure 123 is an exploded, perspective view of an assembly of the
`[0059]
`vacuum applicator shown in Figure 8 including the flexible portion, the first frame
`
`portions, and the subassembly shown in Figure 12A.
`
`Figure 13A is a cross-section view showing an embodiment of a fluid
`[0060]
`separator in fluid communication between an interior cavity and a port of the vacuum
`
`applicator shown in Figure 8.
`
`

`

`201420309406Jun2014
`
`[0061]
`
`Figure 133 is a cross-section view showing another embodiment of a fluid
`
`separator in fluid communication between an interior cavity and a port of the vacuum
`
`applicator shown in Figure 8.
`
`[0062]
`
`Figure 14 is a plan view of a personal protection device usable with a
`
`vacuum applicator in accordance with an embodiment of the disclosure.
`
`[0063]
`
`Figures 15A and 153 illustrate an embodiment of an applicator according
`
`to the present invention.
`
`[0064]
`
`Figures 16A and 1GB illustrate another embodiment of an applicator
`
`according to the present invention.
`
`[0065]
`
`Figures 17A and 17B illustrate yet another embodiment of an applicator
`
`according to the present invention.
`
`DETAILED DESCRIPTION
`
`My
`
`Devices, systems, and methods for monitoring and closed loop controlling
`[0066]
`of the treatment (including cooling) of subcutaneous tissue, such as adipose tissue,
`are described. Several of the details set forth below are provided to describe the
`following examples 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
`examples and methods of the technology. Additionally, the technology may include
`other examples and methods that are within the scope of the claims but are not
`
`described in detail.
`
`Reference throughout this specification to "one example," "an example,"
`[0067]
`"one embodiment," or "an embodiment" means that a particular feature, structure, or
`
`characteristic described in connection with the example is included in at least one
`
`example of the present technology. Thus, the occurrences of the phrases "in one
`example," "in an example," "one embodiment," or "an embodiment" in various places
`throughout this specification are not necessarily all referring to the same example.
`Furthermore, the particular features, structures, routines, steps, or characteristics
`may be combined in any suitable manner in one or more examples of the
`
`-7-
`
`

`

`201420309406Jun2014
`
`technology. The headings provided herein are for convenience only and are not
`
`intended to limit or interpret the scope or meaning of the claimed technology.
`
`[0068]
`
`Aspects of the present invention are generally directed toward a device
`
`for treating subcutaneous lipid-rich cells. One aspect of certain embodiments is
`
`directed toward a rigid portion and a flexible portion. The rigid portion includes a
`
`thermal conductor that has an inside surface and an outside surface positioned
`
`opposite the inside surface. The flexible portion has an inner surface, an outer
`
`surface positioned opposite the inner surface, and a cutout extending between the
`
`inner and outer surfaces. The thermal conductor is positioned in the cutout and the
`
`flexible and rigid portions define a body. The body has an interior surface and an
`
`exterior surface. The interior surface includes the inside face of the rigid portion and
`
`the inner surface of the flexible portion, and the exterior surface includes the outside
`
`face of the rigid portion and the outer surface of the flexible portion.
`
`[0069]
`
`Other aspects of the present invention are generally directed toward a
`
`system for treating subcutaneous lipid-rich cells in a target area. One aspect of
`
`certain embodiments is directed toward a treatment device and a token. The
`
`treatment device includes an applicator that is configured to operably engage the
`
`target area. The applicator includes a heat removal source that is configured to
`
`remove heat from the lipid-rich cells. The token interfaces with the treatment device
`
`to permit a treatment with the treatment device.
`
`The token includes a
`
`microelectronic device that is electrically coupled with the heat removal source while
`
`the token interfaces with the treatment device.
`
`[0070]
`
`Other aspects of the present invention are generally directed toward a
`
`method for treating subcutaneous lipid-rich cells in a target area. One aspect of
`
`certain embodiments is directed toward configuring a treatment device for the target
`
`area, permitting use of the treatment device within a predetermined limit, verifying
`
`that continued use of the treatment device is within the predetermined limit and
`
`prohibiting use of the treatment device when the predetermined limit is exceeded.
`
`The treatment device includes a heat removal source configured to remove heat
`
`from the lipid rich cells.
`
`[0071]
`
`Other aspects of the present invention are generally directed toward a
`
`vacuum applicator for treating subcutaneous lipid-rich cells with a cooling/heating
`
`-8-
`
`

`

`201420309406Jun2014
`
`unit. One aspect of certain embodiments is directed toward a rigid portion and a
`
`flexible portion. The rigid portion has an inside surface, an outside surface, and a
`
`rigid edge that extends between the inside and outside surfaces. The rigid portion
`
`includes a thermal conductor coupling the inside and outside surfaces. The flexible
`
`portion has an inner surface, an outer surface positioned opposite the inner surface,
`and a flexible edge that extends between the inner and outer surfaces. The flexible
`and rigid portions define a body that has an interior surface, an exterior surface, and
`an aperture. The interior surface includes the inside face of the rigid portion and the
`inner surface of the flexible portion. The exterior surface includes the outside face of
`the rigid portion and the outer surface of the flexible portion. The aperture includes
`the rigid edge of the rigid portion and the flexible edge of the flexible portion.
`
`Other aspects of the present invention are generally directed toward a
`[0072]
`method for treating lipid—rich cells disposed under a cutaneous layer. One aspect of
`certain embodiments is directed toward coupling a heat removal source to an
`
`exterior surface of a thermally conductive plate of a vacuum applicator, coupling a
`
`suction source to an interior cavity of the vacuum applicator, placing the vacuum
`applicator on the cutaneous layer, activating the suction source to draw the
`cutaneous layer into the interior cavity of the vacuum applicator, and activating the
`
`heat removal source to remove heat from the lipid-rich cells.
`
`Other aspects of the present invention are generally directed toward a
`[0073]
`device for treating lipid-rich cells disposed under a cutaneous layer. One aspect of
`certain embodiments is directed toward a base, a fitting, and a thermal conductor.
`
`The base includes a first attachment. The fitting includes a first portion of a contour
`
`that defines a mouth of a cavity. The fitting also includes a second attachment that
`is coupled to the first attachment in a first device arrangement and is decoupled from
`the first attachment in a second device arrangement. The thermal conductor is
`disposed about at least a portion of the cavity and is configured for heat transfer with
`respect to the lipid-rich cells when the contour engages the cutaneous layer in the
`
`first device arrangement.
`
`Other aspects of the present invention are generally directed toward a
`[0074]
`device for treating lipid-rich cells disposed under a cutaneous layer. One aspect of
`certain embodiments is directed toward a vacuum cup that defines an interior cavity,
`
`a thermal conductor disposed about at least a portion of the cavity, and an adjustor.
`
`-9-
`
`

`

`201420309406Jun2014
`
`The vacuum cup includes a contour that defines a mouth of a cavity. The thermal
`
`conductor is configured for heat transfer with respect to the lipid-rich cells when the
`
`contour engages the cutaneous layer. The adjustor is configured to adjust at least
`
`one of (a) dimensions of the interior cavity, and (b) position of the thermal conductor
`
`with respect to the interior cavity.
`
`Other aspects of the present invention are generally directed toward a
`[0075]
`system for treating subcutaneous lipid-rich cells in a target area. One aspect of
`certain embodiments is directed toward a base, a first fitting, a second fitting, and a
`
`thermal conductor. The base includes a first attachment. The first fitting includes a
`
`portion of a first contour that defines a first mouth of a first cavity. The fitting
`includes a second attachment that is coupled to the first attachment in a first device
`
`in a second device
`arrangement and is decoupled from the first attachment
`arrangement. The second fitting includes a portion of a second contour that defines
`a second mouth of a second cavity. The second fitting includes a third attachment
`that is coupled to the first attachment in a third device arrangement. The thermal
`conductor is disposed about at least a portion of the cavity. The thermal conductor
`is configured for heat transfer with respect to the lipid-rich cells when the first
`contour engages the cutaneous layer in the first arrangement and when the second
`
`contour engages the cutaneous layer in the third arrangement.
`
`Other aspects of the present invention are generally directed toward a
`[0076]
`method. One aspect of certain embodiments is directed toward coupling a first
`fitting to a base of a vacuum applicator, placing the first fitting on a first cutaneous
`layer area,
`transferring heat between a thermal conductor and lipid—rich cells
`disposed under the first cutaneous layer area, displacing the first fitting from the first
`cutaneous layer area, decoupling the first fitting from the base, coupling a second
`fitting to the base, placing the second fitting on a second cutaneous layer area, and
`transferring heat between the thermal conductor and lipid—rich cells disposed under
`
`the second cutaneous layer area.
`
`Suitable Treatment System
`
`Figure 1 and the following discussion provide a brief, general description
`[0077]
`of a suitable treatment system 10 in which aspects of the disclosure can be
`implemented. Those skilled in the relevant art will appreciate that the disclosure can
`
`-10-
`
`

`

`201420309406Jun2014
`
`be practiced with other treatment systems and treatment protocols,
`
`including
`
`invasive, minimally invasive, other non-invasive medical treatment systems, and/or
`
`combinations of one or more of the above for treating a subject 11.
`
`In general, the
`
`term “treatment system”, as used generally herein, refers to any of the above system
`
`categories of medical treatment as well as any treatment regimes or medical device
`
`usage.
`
`[0078]
`
`The treatment system 10 is suitable for treating a subject's subcutaneous
`
`adipose tissue, such as by cooling. "Subcutaneous tissue" can include tissue lying
`
`beneath the dermis and includes subcutaneous fat, or adipose tissue that may be
`
`composed primarily of lipid-rich cells, or adipocytes. When cooling subcutaneous
`
`tissues to a temperature lower than 37°C, subcutaneous lipid-rich cells can be
`
`affected selectively.
`
`In general, the epidermis and dermis of the subject 11 lack
`
`lipid-rich cells compared to the underlying lipid-rich cells forming the adipose tissue.
`
`Because non-lipid-rich cells usually can withstand colder temperatures better than
`
`lipid-rich cells, the subcutaneous lipid-rich cells can be affected selectively without
`
`affecting the non-Iipid-rich cells in the dermis, epidermis and other surrounding
`
`tissue.
`
`In some embodiments,
`
`the treatment system 10 can apply cooling
`
`temperatures to the skin of the subject 11 in a range of from about -20°C to about
`
`20°C.
`
`In other embodiments, the cooling temperatures can be from about -20°C to
`
`about 10°C, from about 0°C to about 20°C, from about -15°C to about 5°C, from
`
`about -5°C to about 15°C, or from about -10°C to about 0°C.
`
`[0079] Without being bound by theory, the selective effect of cooling on lipid—rich
`
`cells is believed to result
`
`in, for example, membrane disruption, cell shrinkage,
`
`disabling, destroying, removing, killing or other method of lipid-rich cell alteration.
`
`Such alteration is believed to stem from one or more mechanisms acting alone or in
`
`combination.
`
`It is thought that such mechanism or mechanisms trigger an apoptotic
`
`cascade, which is believed to be the dominant form of lipid—rich cell death by non-
`
`invasive cooling.
`
`[0080]
`
`Apoptosis, also referred to as “programmed cell death”, is a genetically-
`
`induced death mechanism by which cells self-destruct without incurring damage to
`
`surrounding tissues. An ordered series of biochemical events induce cells to
`
`morphologically change. These changes include cellular blebbing,
`
`loss of cell
`
`membrane asymmetry and attachment, cell shrinkage, chromatin condensation, and
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`-11-
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`201420309406Jun2014
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`chromosomal DNA fragmentation.
`
`Injury via an external stimulus, such as cold
`
`exposure,
`
`is one mechanism that can induce cellular apoptosis in cells. Nagle,
`
`W.A., Soloff, B.L., Moss, A.J. Jr., Henle. K.J. “Cultured Chinese Hamster Cells
`
`Undergo Apoptosis After Exposure to Cold but Nonfreezing Temperatures”
`
`Cryobiology 27, 439-451 (1990).
`
`[0081]
`
`One aspect of apoptosis, in contrast to cellular necrosis (a traumatic form
`
`of cell death causing local inflammation), is that apoptotic cells express and display
`
`phagocytic markers on the surface of the cell membrane, thus marking the cells for
`
`phagocytosis by macrophages. As a result, phagocytes can engulf and remove the
`
`dying cells
`
`(e.g.,
`
`the lipid-rich cells) without eliciting an immune response.
`
`Temperatures that elicit these apoptotic events in lipid-rich cells may contribute to
`
`long-lasting and/or permanent reduction and reshaping of subcutaneous adipose
`
`tissue.
`
`[0082]
`
`One mechanism of apoptotic lipid-rich cell death by cooling is believed to
`
`involve localized crystallization of lipids within the adipocytes at temperatures that do
`
`not induce crystallization in non-Iipid-rich cells. The crystallized lipids selectively
`
`may injure these cells, inducing apoptosis (and may also induce necrotic death if the
`
`crystallized lipids damage or rupture the bi-lipid membrane of the adipocyte).
`
`Another mechanism of injury involves the lipid phase transition of those lipids within
`
`the cell’s bi-lipid membrane, which results
`
`in membrane disruption,
`
`thereby
`
`compromising the integrity and/or function of the cell membrane and inducing
`
`apoptosis. This mechanism is well-documented for many cell types and may be
`
`active when adipocytes, or lipid-rich cells, are cooled. Mazur, P., “Cryobiology: the
`
`Freezing of Biological Systems” Science, 68: 939—949 (1970); Quinn, P.J., “A Lipid
`
`Phase Separation Model of Low Temperature Damage to Biological Membranes”
`
`Cryobiology, 22: 128-147 (1985); Rubinsky, B., “Principles of Low Temperature
`
`Preservation” Heart Failure Reviews, 8, 277-284 (2003). Other yet-to—be understood
`
`apoptotic mechanisms may exist, based on the relative sensitivity of lipid-rich cells to
`
`cooling compared to non-lipid rich cells.
`
`[0083]
`
`In addition to the apoptotic mechanisms involved in lipid-rich cell death,
`
`local cold exposure also is believed to induce lipolysis (i.e., fat metabolism) of lipid-
`
`rich cells and has been shown to enhance existing lipolysis which serves to further
`
`increase the reduction in subcutaneous lipid-rich cells. Vallerand, A.L., Zamecnik.
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`-12-
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`201420309406Jun2014
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`J., Jones, P.J.H., Jacobs, I. “Cold Stress Increases Lipolysis, FFA Ra and TG/FFA
`
`Cycling in Humans” Aviation, Space and Environmental Medicine 70, 42-50 (1999).
`
`[0084]
`
`In various embodiments, the treatment system 10 includes a controller, a
`
`computing device, a data acquisition device, a chiller, and one or more applicators.
`
`The treatment system 10 can employ these components in various embodiments to
`
`receive a selection of a treatment profile and apply the selected treatment to a
`
`subject 11.
`
`[0085]
`
`Figure 1
`
`is a perspective view illustrating a treatment system 10 for
`
`non-invasively removing heat from subcutaneous lipid-rich target areas of a subject
`
`11 such as an abdominal area 12 or another suitable area. The system 10 may
`
`include a treatment device 14 that engages the target area of the subject 11 for
`
`cooling or removing heat from the subcutaneous lipid-rich cells of the subject 11.
`
`It
`
`will be understood that treatment devices 14 can have various, configurations,
`
`shapes and sizes suitable for different body parts such that removing heat from any
`
`subcutaneous lipid-rich target area of the subject 11 can be achieved.
`
`[0086]
`
`The treatment device 14 includes an applicator 15 that cools a target area
`
`of the subject 11, such as a human or animal (i.e., “subject 11"). Various types of
`
`applicators may be applied during treatment, such as a vacuum applicator (which
`
`may be used in combination with a massage or vibrating capability). Each applicator
`
`may be designed to treat target areas of the patient’s body, such as chin, cheeks,
`
`arms, pectoral areas, thighs, calves, buttocks, back, abdomen, “iove handles,” and
`
`so forth. For example, a vacuum applicator may be applied at the back region with
`
`or without massage or vibration. Examples of applicators and their configurations
`
`usable with system 10 are described variously in, e.g., commonly assigned U.S.
`
`Patent Publication Nos. 2007/0198071, 2008/0077201, and 2008/0077211 and in
`
`U.S. Patent Application Serial No. 11/750,953.
`
`In certain embodiments, the system
`
`10 may also include a patient protective device, e.g., a sleeve or liner, for preventing
`
`direct contact between the applicator 15 and a patient's skin, and thereby reducing
`
`the likelihood of cross-contamination between patients, minimizing cleaning
`
`requirements for the applicator 15, etc.
`
`In certain other embodiments, the patient
`
`protection device may also include or incorporate various storage, computing, and
`
`communications devices,
`
`such as
`
`a
`
`radio frequency identification
`
`(RFID)
`
`component, allowing for example, use to be monitored and/or metered. Examples of
`
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`201420309406Jun2014
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`liners or patient protection devices are described herein and in commonly assigned
`
`U.S. Patent Publication No. 2008/0077201.
`
`The system 10 may further include a treatment unit 16 and supply and
`[0087]
`return fluid lines 18a and 18b between the treatment device 14 and the treatment
`
`unit 16. The treatment unit 16 can remove heat from a coolant to a heat sink and
`
`provide a chilled coolant to the treatment device 14 via the fluid lines 18a and 18b.
`Alternatively, the treatment unit 16 can circulate warm coolant to the treatment
`device 14 during periods of warming. 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 18a and 18b 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 16 may be a refrigeration unit, a cooling tower, a thermoelectric chiller or cooler,
`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.
`Furthermo