(12) STANDARD PATENT
`
`(11) Application No. AU 2013207657 B2
`
`(19) AUSTRALIAN PATENT OFFICE
`
`Title
`
`Cryoprotectant for use with a treatment device for improved cooling of subcu-
`taneous lipid-rich cells
`
`International Patent Classificati0n(s)
`A61F 2/00 (2006.01)
`A61F 7/12 (2006.01)
`A61F 7/00 (2006.01)
`
`Application No:
`
`2013207657
`
`(22)
`
`Date of Filing:
`
`2013.07.22
`
`US 3786814 A
`
`Publication Date:
`Publication Journal Date:
`
`2013.08.15
`2013.08.15
`
`Accepted Journal Date:
`
`2015.11.19
`
`Divisional of:
`2010241393
`
`Applicant(s)
`Zeltiq Aesthetics, Inc.
`
`lnventor(s)
`Bucks, Daniel;Johnson, Donald;Ebbers, Edward A.;Preciado, Jessica;Levinson,
`Mitchell E.
`
`Agent [Attorney
`Spruson & Ferguson, L 35 St Martins Tower 31 Market St, Sydney, NSW, 2000
`
`Related Art
`WO 98/41156 A1
`
`

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`201320765722Jul2013
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`CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR
`
`IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICH CELLS
`
`ABSTRACT
`
`A cryoprotectant for use with a treatment device for improved removal of heat from
`
`subcutaneous lipid-rich cells of a subject having skin is provided. The cryoprotectant is a non-
`
`freezing liquid, gel, or paste for allowing pre-cooling of the treatment device below 0°C while
`
`preventing the formation of ice thereon. The cryoprotectant may also prevent freezing of the
`
`treatment device to the skin or ice from forming from moisture seeping out from the skin. The
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`cryoprotectant may further be hygroscopic, thermally conductive, and biocompatible.
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`AH25(764805571):GGG
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`201320765722Jul2013
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`CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR
`IMPROVED COOLING OF SUBCUTANEOUS LIPID—RICH CELLS
`
`CROSS-REFERENCE TO RELATED APPLICATION(S):
`
`[0001]
`
`This application claims priority to U.S. Provisional Application No.
`
`60/794,799, filed on April 28, 2006, the disclosure of which is incorporated herein by
`
`reference in its entirety. This application is also related to U.S. Patent Application No.
`
`11/750,953 (US Patent Application Publication No. 20080287839), entitled ”METHOD
`
`OF ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND
`
`COOLING APPARATUS HAVING AN ACTUATOR,” Attorney Docket No. 57968-8017US,
`
`the disclosure of which is incorporated herein by reference in its entirety.
`
`TECHNICAL FIELD
`
`[0002]
`
`The present application relates to a cryoprotectant for use with treatment
`
`devices, systems, and methods for removing heat from subcutaneous lipid-rich cells.
`
`BACKGROU ND
`
`[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 is therefore is needed.
`
`[0004]
`
`Liposuction is a method for selectively removing adipose tissue to ”sculpt”
`
`a person’s body.
`
`Liposuction typically is performed by plastic surgeons or
`
`dermatologists
`
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`201320765722Jul2013
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`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 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]
`
`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 is 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.
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`201320765709Oct2015
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`[0008]
`
`U.S. 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.
`
`SUMMARY
`
`[0008a]
`
`In one aspect the invention provides a method for treating a patient at an
`
`anatomical region including skin and subcutaneous lipid-rich tissue, the method comprising:
`
`positioning an absorbent material and a treatment device relative to the skin such
`
`that the absorbent material is located between the skin and the treatment device;
`
`cooling the lipid-rich tissue by transferring heat from the lipid-rich tissue through the
`
`skin and through the absorbent material to a cooling element of the treatment device for a
`
`period of time while maintaining the cooling element at a temperature within a range from
`
`about —20°C to about 20°C; and
`
`supplying a bioabsorbable cryoprotectant from the absorbent material to the skin for
`
`the period of time while cooling the lipid-rich tissue.
`
`[0008b]
`
`In one aspect the invention a method for treating a patient at an anatomical
`
`region including skin and subcutaneous lipid—rich tissue, the method comprising:
`
`supplying a bioabsorbable cryoprotectant from a cryoprotectant reservoir to the skin
`
`such that at least a portion of the supplied cryoprotectant is absorbed into the skin;
`
`reducing the lipid—rich tissue by transferring heat from the lipid—rich tissue through the
`
`skin and through the cryoprotectant reservoir to a cooling element of a treatment device; and
`
`replenishing the cryoprotectant reservoir while reducing the lipid-rich tissue.
`
`[0008c]
`
`In one aspect the invention provides a method for treating a patient at an
`
`anatomical region including skin and subcutaneous lipid-rich tissue, the method comprising:
`
`releasing a bioabsorbable cryoprotectant from an absorbent pad toward the lipid-rich
`
`tissue through a first side of the absorbent pad such that at least a portion ofthe released
`
`cryoprotectant absorbs into the skin;
`
`removing heat from the lipid—rich tissue via a thermal gradient extending from the
`
`lipid-rich tissue through the skin and through the absorbent pad to a cooling element at a
`
`second side of the absorbent pad, the second side of the absorbent pad being opposite to
`
`the first side of the absorbent pad; and
`
`reducing the lipid-rich tissue by removing heat from the lipid-rich tissue.
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`3a
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`BRIEF DESCRIPTION OF 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 a side elevation view of a coupling device in accordance with an
`
`embodiment of the invention.
`
`[0011]
`
`Figure 3 is an isometric view of a coupling device in accordance with
`
`another embodiment of the invention.
`
`[0012]
`
`Figure 4 is a flow chart illustrating a method for pre-cooling a treatment
`
`device in accordance with embodiments of the invention.
`
`[0013]
`
`Figure 5 is a flow chart illustrating a method for pre-cooling a treatment
`
`device in accordance with further embodiments of the invention.
`
`[0014]
`
`Figure 6 is a flow chart illustrating a method for protecting the skin of a
`
`subject with a cryoprotectant in accordance with further embodiments of the invention.
`
`[0015]
`
`Figure 7 is an isometric view of a treatment device for removing heat from
`
`subcutaneous lipid-rich cells in accordance with an embodiment of the invention.
`
`[0016]
`
`Figures 8A-B are isometric views of a treatment device for removing heat
`
`from subcutaneous lipid—rich cells in accordance with a further embodiment .of the
`
`invention.
`
`[0017]
`
`Figure 9 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.
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`201320765722Jul2013
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`[0018]
`
`Figure 10 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.
`
`DETAILED DESCRIPTION
`
`A.
`
`Overview
`
`[0019]
`
`The present disclosure describes devices, systems, and methods for
`
`cooling subcutaneous lipid-rich cells with a heat exchanging element and a thermally
`
`conductive cryoprotectant. 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.
`
`It may 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 may include other embodiments that are within the scope of the claims but are
`
`not described in detail with respect to the Figures.
`
`B.
`
`System for Selectively Reducing Lipid-rich Cells
`
`[0020]
`
`Figure 1 is an isometric view of a treatment system 100 for exchanging heat
`
`from subcutaneous lipid-rich cells of a subject 101 in accordance with an embodiment of
`
`the invention. The treatment system 100 may include a treatment device 104 placed at
`
`an abdominal area 102 of the subject 101 or another area where reduction of the
`
`subcutaneous fat, or fat layer, is desired. The treatment device 104 may be fastened to
`
`the subject 101 using,
`
`for example, a mechanical fastener (e.g., a belt 105), an
`
`adhesive (e.g., an epoxy), suction (e.g., a vacuum or reduced pressure), or any other
`
`mechanisms. The treatment device 104 may be configured to heat and/or cool the
`
`subject 101.
`
`In certain embodiments, the treatment device 104 may contain a non-
`
`freezing cryoprotectant to, among other advantages, allow pre-cooling of the treatment
`
`device 104 to a temperature around or below the freezing point of water (0° C) while
`
`preventing ice from forming. Various embodiments of the treatment device 104 are
`
`described in more detail below with reference to Figures 7-10.
`
`In other embodiments,
`
`the treatment system 100 may also include a coupling device (not shown in Figure 1) for
`
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`201320765722Jul2013
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`supplying the cryoprotectant to the treatment device 104 or the skin of the subject 101,
`
`as described in more detail below with reference to Figure 2 and Figure 3.
`
`[0021]
`
`In one embodiment,
`
`the treatment device 104 is configured to cool
`
`subcutaneous lipid-rich cells of the subject 101.
`
`In such cases, the treatment system
`
`100 may further include a fluid source 106 and fluid lines 108a-b connecting the
`
`treatment device 104 to the fluid source 106. The fluid source 106 may remove heat
`
`from a coolant to a heat sink and provide the 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 any other suitable heat conducting
`
`fluids. The fluid lines 108a-b may be hoses or other conduits constructed from
`
`polyethylene, polyvinyl chloride, polyurethane, steel, aluminum, copper and other
`
`materials that may accommodate the particular circulating coolant. The fluid source 106
`
`may be a refrigeration unit, a cooling tower, a thermoelectric chiller, or any other device
`
`capable of removing heat from a coolant or municipal water supply.
`
`[0022]
`
`The treatment device 104 may also include one or more thermoelectric
`
`elements, such as Peltier—type thermoelectric elements.
`
`In such cases, the treatment
`
`system 100 may further include a power supply 110 and a processing unit 114
`
`operatively coupled to the treatment device 104 via electrical cables 112, 116.
`
`In one
`
`embodiment, the power supply 110 may provide a direct current voltage to the treatment
`
`device 104 remove heat from the subject 101. The processing unit 114 may monitor
`
`process parameters via sensors (not shown in Fig. 1) placed proximate to the treatment
`
`device 104 and adjust the heat removal rate based on the process parameters. The
`
`processing unit 114 may include any processor, Programmable Logic Controller,
`
`Distributed Control System, and the like.
`
`[0023]
`
`The processing unit 114 may be in electrical communication with an input
`
`device 118, an output device 120, and/or a control panel 122. The input device 118
`
`may include a keyboard, a mouse, a touch screen, a push button, a switch, a
`
`potentiometer, and any other device suitable for accepting user input. The output
`
`device 120 may include a display screen, a printer, a medium reader, an audio device,
`
`and any other device suitable for providing user feedback. The control panel 122 may
`
`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, fluid
`
`source 106, input device 118, and output device 120 are carried by a rack 124 with
`
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`201320765722Jul2013
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`wheels 126 for portability.
`
`In another embodiment, the various components may be
`
`fixedly installed at a treatment site.
`
`[0024]
`
`As explained in more detail below, a cryoprotectant applied to the treatment
`
`device 104 may allow the treatment device 104 to be pre-cooled prior to being applied to
`
`the subject 101 for more efficient treatment. Further, the cryoprotectant can also enable
`
`the treatment device 104 to be maintained at a desired temperature while preventing ice
`
`from forming on a surface of the treatment device 104, and thus reduces the delay in
`
`reapplying the treatment device 104 to the subject. Yet another advantage is that the
`
`cryoprotectant may prevent the treatment device 104 from freezing to the skin of the
`
`subject.
`
`If
`
`the cryoprotectant
`
`is hygroscopic,
`
`it can adsorb moisture from the
`
`atmosphere and/or from the skin, which might otherwise form ice.
`
`[0025]
`
`The treatment device 104, the cryoprotectant, and/or other components of
`
`the treatment system'100 can be included in a kit (not shown) for removing heat from
`
`subcutaneous lipid rich cells of the subject 101. The cryoprotectant can have a freezing
`
`point in the range of about -40°C to about 0°C and be configured to be applied to an
`
`interface between the treatment device 104 and the skin of the subject 101. The kit can
`
`also include instruction documentation containing information regarding how to (a) apply
`
`the cryoprotectant to a target region and/or a heat exchanging surface of the treatment
`
`device 104 and (b) reduce a temperature of the target region such that lipid rich cells in
`
`the region are affected while preserving non-lipid rich cells proximate to the heat
`
`exchanging surface.
`
`C.
`
`Coupling Device
`
`[0026]
`
`Figure 2 is a side elevation view illustrating a coupling device 502 suitable to
`
`be used in the treatment system 100 of Figure 1 and configured in accordance with an
`
`embodiment of the invention. The coupling device 502 may be placed adjacent to a
`
`treatment region 501 of the subject 101. The coupling device 502 may include
`
`attachment features 510 for releasably or fixedly attaching the coupling device 502 to a
`
`heat exchanging element 130 of the treatment device 104 (Figure 1).
`
`In the illustrated
`
`embodiment, the attachment features 510 include tensioning clips. During assembly,
`
`the coupling device 502 may be snapped onto the heat exchanging element 130 with
`
`the backside portion 504 facing the treatment device 104.
`
`In other embodiments, the
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`201320765722Jul2013
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`attachment features 510 may include screws, pins, hinges, and/or any other suitable
`
`attachment devices.
`
`[0027]
`
`The coupling device 502 may include a backside portion 504 proximate to
`
`the heat exchanging element 130, a front side portion 508 spaced apart from the
`
`backside portion 504, and an intermediate portion 506 between the backside portion
`
`504 and the front side portion 508.
`
`In certain embodiments, the coupling device 502
`
`optionally may include a protective layer (e.g., a polymeric film, not shown) attached to
`
`the front side portion 508. The protective layer may isolate the front side portion 508
`
`from the environment and may be peeled off to expose the front side portion 508 before
`
`treatment.
`
`[0028]
`
`The backside portion 504 may be a film, a plate, a sheet, or other structure
`
`constructed from a metal, a metal alloy, ceramics, a polymeric material, or other suitable
`
`conductive material. The backside portion 504 may transfer heat between the heat
`
`exchanging element 130 and the treatment region 501. The backside portion 504 may
`
`also isolate the heat exchanging element 130 from the treatment region 501 for
`
`sanitation purposes.
`
`[0029]
`
`The intermediate portion 506 may be a reservoir constructed from a mesh, a
`
`foam material, a porous plastic and/or metal, or other materials that may at
`
`least
`
`temporarily contain a fluid and/or a gel.
`
`In one embodiment, the intermediate portion
`
`506 contains, or is loaded with, a cryoprotectant before a treatment process begins.
`
`In
`
`another embodiment, the intermediate portion 506 may be generally empty before a
`
`treatment process begins and only loaded with cryoprotectant immediately before and/or
`
`during the treatment process.
`
`In any of these embodiments, the intermediate portion
`
`506 may be pressurized with the cryoprotectant or may be at a generally atmospheric
`
`pressure during treatment.
`
`[0030]
`
`The front side portion 508 may be a film constructed from a polymeric
`
`material, a plastic material, or other material that is at least partially flexible. The front
`
`side portion 508 may include one or more apertures 516 in fluid communication with the
`
`intermediate portion 506. During treatment, the aperture or apertures 516 may allow the
`
`cryoprotectant contained in the intermediate portion 506 to escape to the treatment
`
`region 501 of the subject 101 through capillary actions or other mechanisms.
`
`For
`
`example, the intermediate portion 506 may continually supply the cryoprotectant to the
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`201320765722Jul2013
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`treatment region 501 during treatment.
`
`In certain embodiments,
`
`the intermediate
`
`portion 506 is pre-Ioaded with excess cryoprotectant. As a portion of the cryoprotectant
`
`escapes from the apertures 516, additional cryoprotectant may be supplied from the
`
`intermediate portion 506 to the skin of the subject during treatment.
`
`In other
`
`embodiments, the intermediate portion 506 may be constantly replenished to provide a
`
`continuous supply of the cryoprotectant. The cryoprotectant can be absorbed by the
`
`skin in the treatment region 501. The degree of cryoprotectant absorption by the skin
`
`depends on a number of factors,
`
`the most
`
`important of which are cryoprotectant
`
`concentration, duration of contact, solubility, and the physical condition of the skin.
`
`[0031]
`
`The coupling device 502 optionally may include at least one sensor 514
`
`proximate to the front side portion 508 to measure at least one parameter of the
`
`treatment process. The sensor 514 may be a temperature sensor, a pressure sensor, a
`
`transmissivity sensor, a bio-resistance sensor, an ultrasound sensor, an optical sensor,
`
`an infrared sensor, a heat flux sensor, any other desired sensors, or any combination
`
`thereof. An operator may adjust
`
`the treatment process based on the measured
`
`parameter.
`
`[0032]
`
`In the illustrated embodiment,
`
`the treatment device 104 optionally may
`
`include a supply device 520 connected to a port 515 of the coupling device 502 by a
`
`conduit 522 for supplying and/or replenishing the cryoprotectant in the intermediate
`
`portion 506.
`
`In the illustrated embodiment, the supply device 520 is a syringe holding a
`
`volume of the cryoprotectant.
`
`In other embodiments, the supply device 520 may include
`
`a pump coupled to a cryoprotectant storage (not shown), or other suitable supply
`
`configurations.
`
`[0033]
`
`Optionally, a pressure sensor 524 (shown schematically) may be used for
`
`monitoring a cryoprotectant pressure in the intermediate portion 506. The pressure
`
`sensor 524 may be operatively coupled to the conduit 522, the intermediate portion 506,
`
`or the supply device 520. During treatment, the pressure sensor 524 may provide an
`
`electric, visual, or other signal indicating the cryoprotectant pressure in the intermediate
`
`portion 506.
`
`In one embodiment, an operator may manually adjust the output of the
`
`supply device 520 based on the indicated pressure.
`
`In another embodiment, the signal
`
`from the pressure sensor 524 may be used as a process variable to automatically
`
`control the output of the supply device 520.
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`201320765722Jul2013
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`[0034]
`
`Several embodiments of the treatment system 100 may continually protect
`
`the skin of the subject against freezing damage. According to conventional techniques,
`
`a cryoprotectant may be topically applied to the skin before a treatment begins. The
`
`skin then absorbs the applied cryoprotectant, which dissipates over a period of time.
`
`After the cryoprotectant dissipates, in conventional techniques, the skin may be subject
`
`to freezing damage.
`
`As a
`
`result, by continually replenishing the dissipated
`
`cryoprotectant from the intermediate portion 506, the treatment system 100 may at least
`
`reduce the risk of freezing damage, or even prevent such freezing damage, during
`
`treatment.
`
`[0035]
`
`Several embodiments of the treatment system 100 may also reduce the risk
`
`of air pockets that can reduce the heat transfer efficiency between the treatment region
`
`501 and the treatment device 104. As the cryoprotectant escapes through the aperture
`
`or apertures 516 during treatment,
`
`the pressure in the intermediate portion 506
`
`decreases, and air pockets may form. The air pockets may interfere with the heat
`
`transfer efficiency between the treatment region 501 and the treatment device 104. As
`
`a result, maintaining the intermediate portion 506 at a constant pressure may at least
`
`reduce the risk of air pocket formation, and thus improve the efficiency of such heat
`
`transfer.
`
`[0036]
`
`Even though the coupling device 502 is illustrated as having the attachment
`
`features 510, in certain embodiments, the attachment features 510 may be omitted, and
`
`the coupling device 502 may be configured and/or incorporated into other structures.
`
`For example, Figure 3 illustrates another embodiment, in which the coupling device 502
`
`is incorporated into a sleeve 162 that attaches to the heat exchanging element 130.
`
`The coupling device 502 can define a first sleeve portion 164, and the sleeve 162 can
`
`also have a second sleeve portion 166. For example, the first sleeve portion 164 may
`
`include the backside portion 504, the front side portion 508, and the intermediate portion
`
`506 (Figure 3). The second sleeve portion 166 may be an isolation layer extending from
`
`the first sleeve portion 164.
`
`For example,
`
`the second sleeve portion 166 may be
`
`constructed from latex,
`
`rubber, nylon, polyimide, polyethylene, Kevlar®, or other
`
`substantially impermeable or semi-permeable material. The second sleeve portion 166
`
`may prevent any contact between the skin of the subject and the heat exchanging
`element 130.
`In one embodiment,
`the sleeve 162 may be reusable.
`In other
`
`embodiments, the sleeve 162 may be disposable. The sleeve 162 may be provided
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`201320765722Jul2013
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`sterile or non-sterile.
`
`In one embodiment, the sleeve is fabricated from a flex circuit
`
`material such as polyimide or polyethylene, with etched traces to connect sensors to
`
`electronics resident in, e.g., the processing unit 114.
`
`[0037]
`
`The second sleeve portion 166 may also include attachment features to
`
`affix the sleeve 162 to the treatment device 104.
`
`In the illustrated embodiment, the
`
`second sleeve portion 166 includes four brackets 172 (identified individually as 172a-d),
`
`each located at a corner of the second sleeve portion 166.
`
`Individual brackets 172
`
`include an aperture 174 (identified individually as 174a—d)
`
`that corresponds to an
`
`attachment point 170 of the treatment device 104. During assembly, the apertures 174
`
`of the brackets 172 may fit over the attachment point 170 such that the second sleeve
`
`portion 166 at least partially encloses the heat exchanging element 130.
`
`[0038]
`
`In another embodiment,
`
`the second sleeve portion 166 may include
`
`brackets that may engage each other. For example, the bracket 172a may include a pin
`
`that may engage the aperture 174d of the bracket 172d. During assembly, the second
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`sleeve portion 166 may wrap around the treatment device 104 and be held in place by
`
`engaging the brackets 172 with each other.
`
`In a further embodiment, the second sleeve
`
`portion 166 may include a flexible member (not shown, e.g., an elastic band) at an outer
`
`edge 176 of the second sleeve portion 166 that may hold the sleeve 162 over the
`
`treatment device 104 during assembly.
`
`In a further embodiment, the second sleeve
`
`portion 166 may include a releasable attachment member (not shown, e.g., Velcro® or
`
`snaps) at the outer edge 176 of the second sleeve portion 166 that may hold the sleeve
`
`162 over the treatment device 104 during assembly.
`
`In yet another embodiment,
`
`adhesive may hold the second sleeve portion 166 to the treatment device 104.
`
`[0039]
`
`In addition to the expected advantages described above, one expected
`
`advantage of using the sleeve 162 is the improved sanitation of using the treatment
`
`device 104. The sleeve 162 may prevent cross-contamination between the skin of the
`
`subject and the heat exchanging element 130 because the sleeve 162 is substantially
`
`impermeable. Also, operating expense of the treatment device 104 may be reduced
`
`because the heat exchanging element 130 does not need to be sanitized after each
`use.
`
`[0040]
`
`The sleeve 162 may have many additional embodiments with different
`
`and/or additional features without detracting from its operation. For example, the first
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`201320765722Jul2013
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`and second sleeve portions 164, 166 may be constructed from the same material (e.g.,
`
`polyimide) or different materials. The sleeve 162 may include an adhesive layer (not
`
`shown) that binds the sleeve 162 to the treatment device 104.
`
`D.
`
`Method of Pre—Cooling a Treatment device Using a Cmogrotectant
`
`[0041]
`
`Figure 4 is a flow chart illustrating a method suitable to be performed in the
`
`treatment system 100 of Figure 1 and in accordance with an embodiment of the
`
`invention. The method may include applying a cryoprotectant to a heat exchanging
`
`element contained in a treatment device (block 10).
`
`In certain embodiments,
`
`the
`
`cryoprotectant may be applied to the skin of a subject or both the skin and the heat
`
`exchanging element. The temperature of the heat exchanging element may be reduced
`
`to a desired temperature (block 12). Once the temperature of the heat exchanging
`
`element is reduced to a desired temperature, for example, around or below the freezing
`
`point of water (0° C), the heat exchanging element may be placed adjacent to the skin
`
`of a subject (block 14). Placing the heat exchanging element adjacent to the skin of a
`
`subject reduces the temperature of a region such that lipid-rich cells in the region are
`
`selectively affected while non-lipid-rich cells in the epidermis and/or dermis are not
`
`generally affected (block 16).
`
`In certain embodiments, the temperature of the treatment
`
`device optionally may be further reduced to a treatment temperature once the heat
`
`exchanging element is placed adjacent to the skin of a subject (block 15).
`
`[0042]
`
`After a selected period of time, the treatment device may then be removed
`
`from the skin of the subject (block 18), and the process may then end (block 20). Once
`
`the treatment device is removed from the skin of the subject, the reduced temperature
`
`of the heat exchanging element optionally may be maintained at a desired temperature
`
`(block 22).
`
`In certain embodiments, the heat exchanging element optionally may be
`
`placed adjacent to another region of the skin of the subject to selectively affect lipid-rich
`
`cells in a different region of the skin of the subject
`
`(block 24). Once the heat
`
`exchanging element is placed adjacent to another region of the skin of the subject, the
`
`lipid-rich cells are affected (block 16). The treatment device may then be removed from
`
`the skin of the subject (block 18) and then the process may end (block 20). Optionally,
`
`the cryoprotectant may be reapplied to the heat exchanging element, the skin of the
`
`subject, or to an interface between the treatment device and the skin of the subject
`
`(block 28) prior to placing the heat exchanging element on another region of the skin of
`
`the subject.
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`[0043]
`
`In another embodiment, a cryoprotectant may be applied to the heat
`
`exchanging element,
`
`the skin of the subject, or an interface between the treatment
`
`device and the skin of the subject to prevent the formation of ice (block 10) as the
`
`temperature of the heat exchanging element is reduced to a desired temperature. The
`
`heat exchanging element is placed adjacent to the skin of the subject in a desired region
`
`(block 14), and the lipid-rich cells are selectively affected (block 16). After a selected
`
`period of time, the heat exchanging element may then be removed from the skin of the
`
`subject (block 18). Optionally, the cryoprotectant is reapplied to the heat exchanging
`
`element, the skin of the subject, and/or an interface between the treatment device and
`
`the skin of the subject (block 28), and the temperature of the heat exchanging element
`
`is maintained at a desired temperature (block 22). The process of treating the selected
`
`region of the skin of the subject optionally may be repeated to selectively affect the lipid-
`
`rich cells in a region of the subject while non-Iipid-rich cells in the epidermis and/or
`
`dermis are not generally affected (block 26).
`
`[0044]
`
`Figure 5 illustrates another method for pre-cooling the heat exchanging
`
`element by applying a cryoprotectant on the heat exchanging element prior
`
`to
`
`decreasing the temperature of the heat exchanging element to prevent icing.
`
`In one
`
`embodiment, a cryoprotectant is placed-on the heat exchanging element to prevent the
`
`heat exchanging element from icing (block 50). The heat exchanging element is then
`
`pre-cooled by decreasing the temperature to at or below 0°C (block 52). The heat
`
`exchanging element is applied to the skin of the subject in a first treatme