(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
`
`(43) International Publication Date
`27 December 2013 (27.12.2013)
`
`WIPO!IPCT
`
`\a
`
`(10) International Publication Number
`WO 2013/191699 Al
`
`GD)
`
`International Patent Classification:
`A6I1F 7/00 (2006.01)
`
`(21)
`
`International Application Number:
`
`PCT/US2012/043540
`
`(22)
`
`International Filing Date:
`
`21 June 2012 (21.06.2012)
`
`(25)
`
`(26)
`
`(72)
`(71)
`
`(74)
`
`(81)
`
`Filing Language:
`
`Publication Language:
`
`English
`
`English
`
`(84)
`
`Inventor; and
`Applicant : PAEZ, Liliana [US/US]; 29 E. San Marino
`Drive, Miami Beach, FL 33139 (US).
`
`Agents: HANRAHAN, Benjamin, M. et al.; Malloy &
`Malloy, P.A., 2800 S.W. Third Avenue, Miami, FL 33129
`(US).
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CIL, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, HN,
`IIR, ITU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
`MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ,
`OM,PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
`TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FL FR, GB, GR, HR, HU,IE,IS, IT, LT, LU, LV,
`MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM,
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`ML, MR,NE, SN, TD, TG).
`
`[Continued on next page]
`
`(57) Abstract: The present invention is
`directed to a device for cooling and dis-
`rupling subcutaneous fat cells in a sub-
`ject. The device is composed of a cool-
`ing assembly with a cooling surface, a
`control module with control inputs, and
`a handheld, portable enclosure. The en-
`closure cncompasses all components
`such that
`the device is compact and
`portable.
`
`(34) Title: COOLING DEVICE FOR LIPID-RICH CELL DISRUPTION
`
`40
`
`
`
`wo2013/191699A1[IIITUNITTAAA
`
`

`

`WO 2013/191699 A1 IMMUN TIAITMACM TE MATTUAE A TATA
`
`Published:
`
`— with international search report (Art. 21(3))
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`i
`
`Description
`
`
`
`
`
`
`
`
`
`
`
`
`COOLING DEVICE FOR LIPID-RICH CELL DISRUPTION
`
`
`
`
`
`
`
`
`
`BACKGROUND OF THE
`INVENTION
`
`
`
`Field of the Invention
`
`
`
`
`
`The present invention relates to a handheld or mobile device
`
`
`used in connection with and for the disruption of subcutaneous,
`
`
`
`lipid-rich cells.
`
`embodiments of the present
`
`In particular,
`
`the
`
`device of
`
`the various
`
`
`
`invention comprises an internal cooling
`
`assembly and an external cooling surface
`
`which is applied to the
`
`a
`
`subject’s
`
`skin,
`
`or
`
`in certain embodiments,
`
`an
`
`the course of a
`
`
`
`
`
`intermediate membrane disposed between the subject’s skin and the
`
`predetermined amount of
`
`Over
`
`the cooling surface is structured to disrupt, cool or freeze
`
`time,
`
`
`
`the subcutaneous,
`
`lipid-rich cells, which are then ultimately
`
`removed by the natural processes of the body.
`
`
` Description of the Related Art
`
`
`
`
`
`Obesity is a major problem,
`
`types of diseases,
`
`developing numerous
`
`increasing the likelihood of
`
`diabetes, and high blood pressure. Aside
`
`consequences,
`
`by
`
`fat
`
`
`
`also detracts
`
`body
`
`forming cellulite, which
`appearance
`
`
`
`
`malformation of the surface of the skin.
`
`from the negative health
` from one’s personal
`
`can manifest
`
`in the
`
`There are numerous surgical methods
`
`fat,
`
`such
`
`as
`
`liposuction and
`
`“tummy
`
`tucks”;
`
`however,
`
`such
`
`
`procedures are invasive surgical procedures and can have painful
`
`recovery times. Also,
`
`
`from complications from the procedures.
`
`
`
`such procedures can sometimes prove fatal
`
`such as heart disease,
` for removing excess body
`
`
`There are various “non-surgical” procedures
`
`excessive body fat as well. These include weight-loss pills,
`
`
`do not find benefits in
`
`
`for battling
`
`
`
`exercise, and diet. However,
`
`some people
`
`these procedures because of busy schedules,
`
`and/or other health problems that prevent
`
`
`
`
`ineffective methods,
`
`use of such procedures.
`
`Others have recently described newer methods of
`
`reducing
`
`
`
`
`
`
`
`
`
`
`
`surface of
`
`
`
`
`
`
`cooling surface.
`
`
`
`10
`
`15
`
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`25
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`

`WO2013/191699
`
`PCT/US2012/043540
`
`2
`
`subcutaneous fat cells,
`
`
`
`lipid-rich cells causing damage to t
`
`natural removal processes by the body.
`
`
`
`which involve the controlled cooling of
`
`he cells targeting them for
` During the cooling process,
`
`
`
`the target area are cooled
`
`the epidermal and subdermal regions of
`
`by a device. Lipid-rich
`
`cells are more sensitive to the lower
`
`to lipid-rich cells while sparing the surrounding non-lipid
`
`to the surrounding cells causing selective
`
`lipid-rich cells are damaged by the lower
`
`
`
`they are ultimately removed by the natural processes
`
`damage
`
`rich cells. Once the
`
`temperatures,
`
`of the body.
`
`
`
`
`
` temperatures compared
`
`
`
`
`
`
`
`
`
`One of the drawbacks of
`
`
`
`the cooling method described is that
`
`large
`
`and bulky equipment which
`
`treatment. Thus,
`
`there is
`
`portable devices that can
`
`
`
`it requires rather expensive,
`
`significantly limits the availability of
`
`
`a significant need for less-expensive,
`
`provide a “cooling” ef
`Fect
`to subcutaneous Llipid-rich cells while
`
`ts in a variety of
`
`availability of
`
`allowing for treatmen
`
`opening up
`
`the
`
`population.
`
`locations and conditions,
`
`such procedures
`
`to a
`
`larger
`
`
`
`
`
`
`
`
`Summary of the Invention
`
` for
`
`The present invention described herein addresses the need
`
`freeze and/or
`facilitates the ability to cool,
` for large and
`
`an apparatus that
`
`otherwise disrupt
`
`1]
`
`cumbersome equipment.
`
`As such,
`
`ipid-rich cells without the need
`
`
`
`
`
`to a portable and h
`
`cells in a subject.
` In particular,
`
`
`
`andheld device
`
`
`the device of
`
`
`
`the various embodiments of
`
`the present invention is directed
`
`for disrupting subcutaneous fat
`
`present invention includes at least
`
`one cooling assembly,
`
`which in
`
`turn,
`
`comprises a corresponding
`
`when disposed in an operating posit
`
` of a subject’s skin,
`
`
`toi
`tio
`the cooling suri
`
`n face of the presen nven
`
`t
`is structured to decreas
`rature of
`subcutaneous
`fat
`he
`temp
`
`the
`
`
`
` erwise when
`
`
`cooling surface.
`
`tion in contact with the
`
`Specifically,
`sur
`
`face
`
`
` ntially adjacent
`
`
`
`the contact
`
`
`the
`cular, operational use of
`
`
` In parti
`
`cells within the subject and
`
`area of the subject’s skin.
`
`device is obtained when the devic
`
`substa
`
`
`the cooling surface
`
`is
`
`structured to maintain a predetermined
`
`is turned on or oth
`
`10
`
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`
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`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`3
`
`and when the cooling surface is place in contact with
`
`temperature,
`
`the subject’s skin or an
`
`intermediate membrane.
`
`As will be described in
`
`further detail
`
`herein,
`
`the device
`
` of
`
`the various embodiments
`
`further includes ac
`
`
`
`
`
` The control
`
`ontrol module with one
`
`
`
`or
`
`Or more control
`
`inputs.
`
`inputs
`
`are controllably
`
`linked to the cooling assembly via internal
`
`corresponding software and/or hardware com
`
`the control
`
`
`
`
`control circuitry and
`
`Specifically,
`
`f
`
`
`inputs are structured to turn the device on or o
`
`
`
`
`program the device to automatically turn off after a selected
`
`predetermined time,
`
`or
`
`in order
`
`to
`
`select
`
`a
`
`temperature
`
`or
`
`operational mode.
`
`Moreover,
`
`in order
`
`to
`
`
` use,
`facilitate ease of
`
`10
`
`15
`
`
`
`device in a subject’s home,
`
`invention,
`
`in at least one embodiment,
`
`components of
`
`enclosure or housi
`
`ng which is struct
`
`tured to
`
`be in
`
`the
`
`device
`
`is
`
`contained
`
`ina
`
`single
`
`and/or personal use of
`
`
`
`each of
`the aforementio
`
`
`
`use of
`the
`
`the present
`
`ned
`
`portable
`
`fia
`Form of
`
`
`ner
`
`
` ponents.
`the
`
` the subject’s
`
`
`handheld device.
`
`the
`
`
`
`comprises a securing assembly,
`
`other like structure,
`
`
` In one embodiment,
` preferably
`which is capable of
`
`predetermined operating position
`
`device of at
`
`Therefore, while
`
`the
`
`against
`
`least
`
`
`considered handheld by virtue of
` of
`
`the single enclosure,
`
`the small,
`
`compact configuration
`
`the securing assembly of
`
`one
`
`embodiment
`
`skin.
`
`is
`
`
`
`one embodiment
`
`handheld device
`
`
`
`
`the
`form of
`
`in
`
` furt
`
`a belt
`
`se
`
`curing the device 1
`
`or
`
` na
`the the
`
`will securely hold the device in place without
`
`the need for
`
`user to continuously hold the device against
`
`the subject’s s
`
`the
`
`kin
`
`the enclosure is
`
`
`that
`the
`
`
`
`ure
`
`during operation.
`Furthermore, another aspect of
`
`
`
`
`
`cooling assembly is disposed and configured within the enclos
`
`
`
`such that the cooling surface thereof
`is exposed
`externally of
`
`enclosure.
`the cooling sur! face is exposed on
`
`In other words,
`
`facilitate direct
`
`
`
`
`outside of the enclosure or housing in order to
`
`contact with the subject’s skin or other operational contact
`
`area.
`
`For example,
`
`in one embodiment,
`
`the present
`
`invention
`
`comprises an intermediate membrane disposed between the subject’s
`
`skin and the cooling surface.
`
`The membrane, which may be in
`
`form of
`
`a glycerin membrane and/or a gelatinous substance,
`
`is
`
`
`
`ner
`
` the
`
` furt
`
`20
`
`25
`
`30
`
`35
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`4
`
`structured to minimize or prevent disruption or damage to
`
`outer skin layer of
`the operational contact area of
`skin.
`
`These
`
`presente
`
`and other objects,
`
`ill becom
`clearer when the
`
`invention w
`
`the subject’s
`
` features and advantages of
`
`the
`
`drawings as well as
`
`detailed description are taken into consideration.
`
`the Brief
`
`
`
`
`
`
`
`the
`Drawings
`Description of
`
`For a fuller
`
`understanding of
`
`the nature of
`
`the present
`
`10
`
`invention,
`
`
`referen
`
`ce
`
`should be had to
`
`the
`following detailed
`
`description taken in connection with
`
`the accompanying drawings in
`
`
`
`
`
`which:
`
`Figure 1
`
`
`illustrates a perspective view of
`
`disclosed in accordance with at
`
`least one
`
`a device as
`
`embodiment of
`
`the
`
`present invention.
`
`
`
`Figure 2 illustrates a side view of
`the device of
`the present
`
`invention.
`
`
`
`
`
`
`
`
`
`
`
`Figure 3 illustrates a side view of
`the device of
`
`
`
`the present
`
`invention.
`
`
`
`Figure 4 illustrates a top view of the device of the present
`
`
`
`
`
`illustrates a bottom view of
`
`present invention showing the cooling surface.
`
`invention.
`
`Figure 5
`
`Figure 6
`
`Figure 7
`
`being placed on an
`
`
`
`
`
`
`
`
`
`
`being placed on an
`
`
`the device of
`
`the
`
`
`
`invention
`
`invention
`
`
`
`illustrates the device of
`
`area of skin on a subject.
`
`the present
`
`the present
`
`illustrates the device of
`
`area of skin on a subject with a belt attached.
`
`fer to like parts throughout the several
`
`
`
`
`the Preferred Embodiment reference to EF
` form cooling of
` t the need
`
`Like reference nume
`
`rals re
`
`views of
`
`the drawings.
`
` Detailed
`
`
`Description of
`
`
`
`
`
`As
`
`handheld apparatus
`
`the present
`
`shown in the accompanying drawings,
`
`
` GURE 1,
`
`or device that
`
`ntion is directed to a
`inve
`
`
`facil itates
`
`and with particular
`
`
`
`the ability to
`
` for
`large and
`
`per
`
`cumbersome equipm
`
`lipid-rich cells without
`ent.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`

`

`with
`
`
`It
`
`and
`
`the
`
`
`full understanding of
`
`
`
` at
`
`inary skill in the relevant art,
`
`however,
`
`the invention can be practiced without
`
`
`
`invention. One having ord
`
`
`one or more of
`
`WO2013/191699
`
`PCT/US2012/043540
`
`2
`
`
`several aspects of
`
`re
`
`ference to the drawings
`
`the invention are described below,
` for
`
`illustrative purposes
`numerous
`
`specific
`
`only.
`
`details
`
`should
`
`be
`
`that
`understood
`
`
`th
`relationships are set for
`to provide a
`
` will readily recognize th
`
`
`the specific details.
`
`Unless otherwise defined,
`
`other scientific terms or terminology used herein are intended to
`
`y understood by those of skill
`in the art
`
`terms with
`In some cases,
`
`
`ngs are defined herein
`
`the inclusion of such definitions herein
`
`
`all terms of
`
`art,
`
`notations and
`
`10
`
`have the meanings commonl
`
`to which this invention
`
`pertains.
`
`commonly understood meani
`
`for cl ari
`
`
` ty and/or
`
`
`
`for ready reference, and
`
`should not necessarily be construed to represent a substantial
`
`15
`ference over what is generally understood in the art. It will
` further
`
`defined
`
`understood that
`
`terms,
`
`such as
`
`those
`
`
`
`in
`
` dit
`
`be
`
`commonly used dictionaries,
`
`
`
`meaning that
`
`the relevant
`
`
`
`should be
`
`interpreted as having a
`
`nt with their meaning in the context of
`
`is consiste
`
`
`
`fined herein.
`
`20
`
`The
`
`terminology used herein is
`
` for
`
`
`the purpose of
`
`art and/or as otherwise
`
`d
`
`particular embodiments only and is not
`
`the invention.
`
`As used herein,
`
`and "the"
`
`should be understood to include plural ret
`
`the inde
`
`describing
`
`intended to be limiting of
`
`finite articles
`
`Ww a Ww
`
`Ww an YW
`
`
`Ference unless
`
`
`
`
`
`25
`
`30
`
`35
`
`the context clearly indicates otherwise.
`
`The phrase
`
`"and/or,"
`
`mean "either or both" of
`
`the elements so conjoined,
`
`L.e.,
`
`as used herein,
`
`should be understood
`
`tO
`
`elements
`
`that are conjunctively present
`
`in some cases and disjunctively
`
`present in other cases.
`
`As used herein,
`
`"or
`
`"should be understood to have the same
`
`
`
`fined above. For example,
`
`when separating
`
`or" or
`
`"or" shall be interpreted as being
`
`usion of at least one,
`
`but also including
`
`
`
`a number of
`
`items, and,
`
`optionally,
`
`meaning as "and/or"
`
`a listing of items,
`
`as de
`
`"and/
`
`the incl
`
`inclusive, 1.¢.,
`
`more than one, of
`
`unlisted items.
`
`Only terms clearly indicated to the contrary,
`
`"exactly one of," or,
`such as "only one of" or
`
`
`
` exactly
`will refer to the inclusion of
`claims, "consisting of,"
`
`additional
`
`
`
`the
`
`when used in
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`6
`
`
`one element oi
`
`fF a number or list of
`
`elements.
`
`
`In general,
`
`the term
`
`"or"
`
`as used
`
`herein
`
`shall only
`
`be
`
`interpreted as
`
`indicating
`
`ernatives (i
`
`.@.,
`
`"one or
`
`the other but not both")
`
`
`
`exclusive alt
`
`
`
`when preceded
`
`"only one of,
`
`
`by terms of
`W or
`
`exclusivity,
`
`"exactly one of."
`
`
`such as "either," "one of,"
`
`As used herein,
`
`the terms
`
`"including", "includes", "having",
`
`, OY variants thereof,
`
`are intended to be inclusive
`
`
`
`"comprising."
`
`the term
`
`
`“subcutaneous” is used in reference
`
`"has", "with"
`
`similar to the term
`
`As used herein,
`
` fat,
`
`
`
`10
`
`15
`
`the tissues and cells lyl
`
`to
`
`include subcutaneous
`
`ng beneath the dermis. Such layers
`
`which are composed of lipid-rich cells,
`
`
`
`
`
`
`
`or adipocytes
`
`lipid content
`
`composed of
`
`With pri
`
`. Lipid-rich cell]
`
`s may have a total
`
`intracellular
`
`of between about
`
`20% to about 99%, which may be
`
`about 20% to about 50% saturated triglycerides.
`
`
`
`
`mary reference to FIGURES 1,
`2 and 3,
`
`invention is directed to a device, generally indicated as 10,
`
`disrupting and cooling subcutaneous fat cells in a subject. The
`
`the present
`
`for
`
`20
`
`25
`
`30
`
`device 10
`
`includes
`
`
`cooling surface 110.
`
`The
`
`a
`
`a cooling assembly 100, which comprises
`
`
`cooling surface 110 is structured to
`
`subcutaneous fat cells when applied to
`
`In particular,
`
`decrease the
`
`the
`
`the
`
`
`temperature of
`
`skin surface of
`
`subject.
`
`herein,
`
`when the cooling surface 110
`
`as described
`
`
`
`1s disposed in contacting
`
`nal contact area, e.g., an area of
`the
`
`and the device is turned on or operating such
`
`
`ing surface
`110 is cooled, as described herein,
` fat cells adj
`
`acent
`
`the
`
`relation with
`
`an operatio
`
`subject outer
`that the cool
`
`subcutaneous
`
`skin,
`
`
`
`be removed
`
`
`
`the operational contact area will
`temperatures from the device 10
`
`
`egion or any extremities including the
`
`be cooled or disrupted to
`
`from the body via the body’s natural
`
`the point
`
`that the cells will
`
`
`thereafter
`
`occurrences.
`
`In
`
`
`
`
`not
`
`particular,
`
`when exposed to cold
`
`invention,
`the present
`
`thereafter regenerat
`liver via a
`
`of
`
`the subject’s
`
`
`
`Further,
`
`the cells will crystallize, die and will
`
`The cells are then eliminated through
`
`process called apoptosis.
`
`onal contact area may be virtually any
`
` the operati
`
`location on the subject,
`
`including, but certainly not Limited to,
`
`35
`
`the subject’s
`
`arms and legs.
`
`abdominal r
`
`The coolin
`
`
`
`
`
`
`110 of the various embodiments
`g surface
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`is structured
`
`
`for disposition directly against or in contact with
`
`J
`
`the subject’s skin at the operational contact area.
`
`However, as
`
`will be described below,
`
`certain embodiments
`
`further include the
`
`
`
`use of
`
`subs
`
`tance in order
`
`to
`
`the subject’s skin.
`
`an intermediate membrane and/or
`
`
`protect the outer surface
`layer of
`
`The device 10
`
`further includes a control module or internal
`
`control circuitry (not shown) with one or more external control
`
`In particular,
`
`inputs
`
`210.
`
`controllably linked to the
`
`the
`
`control
`
`inputs
`
`210
`
`are
`
`cooling assembly of
`
`the present
`
`
`
`the device 10 to be
`invention in order to preprogram or preset
` for
`
`or operational mode
`
`a certain desired
`
`disposed in an “on”
`
`
`
`
`
`
`
`
`
`
`
`
`
`10
`
`15
`
`20
`
`amount of
`
`time.
`
`
`Furthermore, each of
`
`the aforementioned componen
`
`device 10 is contained in a single enclosure or hou
`Ss
`os
`tructured to be
`in the form of a
`
`as shown in F
`
`in certain embodiments,
`
`i
`
`
` subject
`
`handheld device.
`
`of at least one embodiment
`
`
`Specifically,
` of
`
`the present inve
`
`or more handholds or handles 310 configured
`
`Or person treating an area on aé
`
`5s
`
`GURE 1,
`
`the device
`
`ntion comprises one
`
`to be grasped by a
`
`In other
`tion
`
`ubject.
`
`
`
`
`
`
`
`ts of
`the
`
`
`
`sing 300 which,
`
`embodiments,
`
`described below,
`
`the handholds 300 may also
`
`
`as part of
`
`a securing assembl
`
`ly in that a belt
`
`
`
` func
`
`strap or other
`
`securing device may pass through the
`
`device to the user.
`
`handhodls and secure the
`
`oF
`
`Particularly,
`
`the
`
`device
`
`10
`
` of
`
`the
`
`various
`
`embodiments
`
`comprises a single,
`
`compact
`
`enclosure thereby allowing the device
`
`without
`
`the need
`for assistance or physician supervision.
`
`
`fa subject’s home and by the subject,
`AS can
`
`be appreciated by the description herein,
`
`
`the device 10 of
`
`the
`
`presente
`
`invention is operational without the use of
`
`anesthesia and
`
`10 to be used in leisure o
`
`
`le is also disposed within
`
`is non-invasive.
`
`
`Another aspect of
`
`the enclosure 300
`
`is
`
`nd cont
`assembly 100 is disposed a
`Figured within
`
`the cooling suri
`110 is exposed
`
`such that
`
` face
`
`enclosure 300.
`
`enclosure 300 s
`
`
`
`The
`
`conttrol modu
`
`uch thatt
`
`the con
`
`
`
`exposed.
`
` trol
`
`
`
` externally of
`
`
`th
`
`th
`
`
`
`at
`
`the cooling
`
`e enclosure 300
`
`the
`
` the
`
`inputs 210 are exter
`
`nally
`
`25
`
`30
`
`35
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`8
`
`
`
`
`
`As shown in FIGURES
`
`an ON/OFF button 212. As
`
`
`
`
`inputs 210 are timing buttons 214 that control the length of
`
`the control inputs 210 is
`and 2, one of
`
`
`
`
`some of
`shown in FIGURE
`
`
`
`3,
`
`the control
`
`
`
`time
`
`the
`
` at
`
`cooling assembly 10900
`
`providing an
`
`once the requisite/desired length of
`
`is
`
`in operation,
`
`thus
`
`time is
`
`automatic turn-off
`
`tained. The control module interacts with the cooling assembly
`
`
`100 to automatically turn of
`
`ff the cooling assembly 100 once the
`
`
`
`timing increments,
`
`Such
`
`30,
`
`or 60 minutes by
`
`requisite time is reached.
`timing buttons 214 may provide
` for example, of 5, 15,
`
`
`The buttons may also be illuminated in
`
`
`to provide a visual indicator of
`the timing to be utilized.
`
`
`the
`embodiments of
`the various
`he cooling assembly of
`
`pressing the proper button.
`
`10
`
`order
`
`T
`
`
`
`
`
`
`
`present
`
`invention may employ a variety ol!
`
`known
`
`in the art,
`
`such as,
`
`but
`
`F cooling technologies
`not
`
`limited to,
`
`
`
`
`
`certainly
`led
`fluid, phase change
`lements.
`
`15
`
`thermoelectric coolers,
`
`eryogenic devices,
`
`future cooling technology will
`
`recirculating chil
`
`
`
`and vapor compression el
`
`be useful in the present invention
`
`it
`
`subcutaneous fat cells when applied to the skin surface of
`
`Regardless of
`
`as
`
`long as
`
`is
`
`20
`
`subject.
`
`cooling assembly 100
`
`capable of decreasing the
`
`the technology utilized,
`
`(aside from any electrical cord and power
`
`the entire
`
`re 300
`
`such that
`
`the
`
`
`
`temperature of
`
`
`
`
`
`
`
`the
`
`Any current or
`
`adaptor)
`
`is
`
`contained within the enclosu
`
`device 10 is self-contained, handheld and portable.
`
`vol
`
`tage
`
`power
`
`supplies
`
`are necessary.
`
`
`
`contained
`
`aspect of
`
`the device
`
`10,
`
`it
`
`may
`
`
`
`Because
`
`Also, no high—
`
`self-
`
`the
`
`of
`
`include a
`
`heat
`
`dissipating structure 120,
`
`G
`
` FIGURE 4,
`
`n
`
`
`some embodiments,
`
`such as a heatsink,
`
`ustrated in
`as ill
`
`the cooling suri{
`
`
` Face 1
`
`The cooli
`ng sur
`
`Is.
`In at least
`lipid-rich cel
`
`O may be a
`
`
` face 110 is
`
`
` planar
`
`the cooling
`
`
`surface 110
`
`between about
`
`-100C and
`
`—-4o0C and
`
`in
`
`a
`
`—20C.
`
`(flat)
`
`Sy
`
`or ina
`
`non—-planar
`
`
` use ina
`
`
` Pel
`cooling s
`
`
`
`tier-typ
`
`capable of
`
`one embodiment of
`
`
`
`thermoelectric element.
`
`ubcutaneous,
`
`the present invention,
`
`
`is structured to maintain a temperature of
`tween
`
`ferred embodiment be
`
`The
`
`cooling
`
`surface
`
`as
`
`illustrated
`
`be
`110 may
`
` GURE
`in F
`
`
`
`QOoC,
`
`and in pre
`
`con
`
`con
`
`figuration,
`
`figuration
`
`
`
`
`
`
`
`
`25
`
`30
`
`35
`
`planar and non-planar cont
`
`figurations allow
`
`(e.g., curved inwardly or outwardly). The various
`
`
`for ease of
`
`

`

`WO 2013/191699
`
`PCT/US2012/043540
`
`9
`
`the cooling
`
`variety of positions on the human body. Furthermore,
`
`
`
`surface 110 may be constructed of a variety of materials that are
`
`capable of providing thermal conductivity great enough to provide
`
`
`
`for the rapid and continual cooling of subdermal tissue,
`
`as would
`
`
`
`
`
`be understood by those skilled in the art,
`
`facilitate the practice of the present invention in the intended
`
`manner. Exemplary materials include, but are certainly not limited
`
`and in order
`
`to
`
`
`
`to metal alloys, aluminum, graphite, ceramics, polymers,
`
`composite
`
`materials and the like.
`
`
`
`As illustrated in FIGURE 6,
`
`the device 10 may be utilized in
`
`connection with an intermediate membrane M disposed between the
`
`In
`subject’s body region
`cooling surface 110
`
`and the
`
`particular,
`
`the outer
`
`subject’s
`
`the intermediate membrane M is structured to protect
`
`
`
`skin layer of
`the operational contact area of
`the
`
`
`from the
`skin from damage or disruption resulting
`
`
`
`cooling temperatures of
`
`the cooling surface 110. Accordingly,
`
`such membranes M may be composed of any substrate and/or solution
`art
`to
`
`skilled in the
`those
`understood by
`be
`that would
`
`
`
`
`
`
`effectively and efficiently provide a buffer between t
`
`
`
`body region BR and the cooling surface 110 in order to
`
`
`
`he subject’s
`
`prevent any
`
`110.
`
`In
`
`
`
`
`
`
`
`
`
`
`
`
`
`skin surface damage by the cooling of the cooling sur{
`
`
`
`
`
`the cloth or other structure may be mixed with the solution at the
`
`
`
`
`some
`
`embodiments,
`
`particular,
`
`
`
`a glycerin membrane may
`
`
`the membrane M of at least one embodiment comprises a
`
`be utilized.
`
`[In
`
`cloth soaked in a glycerin solution or other solution.
`
`As an
`
`example,
`
`the cloth may be prepackaged in the solution such that
`
`when removed from the packaging,
`
`
`
`
`
`the cloth or membrane M is
`
`precoated in the solution and ready for disposition between the
`
`
`
`In other embodiments,
`subject ’s skin and the cooling surface
`110.
`
`
`time of use and then disposed between the subject’s skin and the
`
`
`
`cooling surface.
`It should also be noted that some membranes M of
`
`the various embodiments may be utilized multiple times,
`
`intended for single use
`
`other membranes M may be structured or
`
`only.
`
`configured to cover the entire cooling surface 110 of
`
`The membrane M of a preferred embodiment
`
`is
`
`
`sized and
`
`the device
`
`10 such that the cooling surface 110 does not directly contact the
`
`whereas
`
`
`
`
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`10
`
`subject’s
`
`skin.
`
`As
`
`an
`
`example
`
`1
`
`the membrane
`
`M may
`
`be
`
`
`approximately the size of an 8.5 x 1]
`
` to cover the cooling suri
`
`big enough
` In so
`
`
`1 sheet of paper,
`
`face 110, as just
`
`me embodiments, as illustrated in FIGURE 7
`or
`
`10 may
`
`also
`
`include
`
`a
`
`securin
`
`assembly
`
`Specifical
`
`ly,
`
`the belt or
`
`securing assembly
`
`400
`
` g
`
`
`
`
`or otherwise
`
`described.
`
`,
`
`the device
`
`belt
`
`400.
`
` of certain
`
`embodiments is configured to engage the enclosu
`
`re 300 or device 10
`
`such that the device 10 can be securely and releasably positioned
`
`on a body portion of a subject. Moreover, as illustrated,
`
`the
`
`
`
`with one o
`
`
`
`
`
`belt 400 may be configured such that it attaches to or engages
`
`
`gr more of
`the handholds 310 of the device 10. The belt
`
`
`400 may either directly attach to one or more of the handholds 310
`
`or run thr
`
`ough one of the handholds
`
`
`of the device 10 and then through another handhold 310.
`be noted t
`
`hat the securing assembly 400 may be removably secured
`
`Or attache
`
`d to the device 10, and in particular the housing 300
`
`thereof. However,
`
`in other embodiments,
`
`It should
`
`
`
`310, across the back surface
`
`
`
`10
`
`15
`
`the securing assembly 400
`
`may be permanently secured or attached to one or more portions of
`
`g 300. Any securing assembly 400 or device structured
`
`implementation of
`
`the present
`
`invention in the
`
`
`
`
`
`
`
`the housin
`
`
`to facilitate
`
`intended manner may be used,
`
`
`to a VELCRO closure belt, or a be
`
`includi
`
`20
`
`25
`
`30
`
`
`
`
`
`ng, but certainly not limited
`
`lt,
`
`strap or other securing
`
`
`
`device comprising snaps, buttons,
`
`the various
`securing assembly 400 of
`
`
`
`
`interfere with the cooling surface
`110 and should therefore not be
`disposed across the cooling suri Face 110 or between the cooling
`
`loops, etc.
`
`
`
`
`
`embodiments
`
`In any event,
`
`the
`
`should not
`
`
`
`surface 110 and the membrane M or operational contact area such as
`the subjec t’s skin.
`
`The device may additionally include one or more cemperature
`
`
`
`sensors configured or disposed proximate to the cooling surface
`
`In
`110.
`
`sensor (s)
`
`of
`
`such
`
`an
`
`temperature
`
`
`may be configured to be flush with the cooling surface
`
`the cooling surface 110,
`
`In any event,
`
`the cooling
`
`ensor(s) may be
`
`le
`
`or
`
`internal
`
` of
`
`the cooling
`
`particular,
`
`the
`
`
`
`
`
`embodiment
`
`110, below
`
`
`surface 110.
`
`the
`
`35
`
`communicat
`
`circuitry
`
`ively connected to the
`
`for providing temperature readings
`
`control modu
`
`Or protrude
`
`temperature s
`
`
`
`
`from
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`11
`
`
`surface
`
`110
`
`and/or
`
`the
`
`
`surface
`
`of
`
`the
`
`subject’s
`
`skin.
`
`The
`
`module in
`
`temperature sensor (s)
`
`
`order for
`the control module to control the operatio
`
`
`
`provide temperature readings to the control
`
`n of
`
`
` the proper operating
`
`
`the cooling assembly 100 in maintenance of
`
`
`
`
`for ef
`fective and saz
`temperatures
`
`
`
`fe cooling of the subcutaneous
`
`lipid-rich cells.
`It
`
`is
`
`to be
`
`appreciated
`
`that
`
`the
`
`
`foregoing
`
`
`Detailed
`
`
`Description section,
`
`and not the Abstract section,
`
`is intended to
`
`be used to interpret
`
`the claims.
`
`The Abstract section may set
`
`10
`
`forth one
`
`or more, but not all,
`
`exemplar
`
`y embodiments of
`
`present invention as contemplated by the inventor(s),
`
`and thus,
`
`
`
`the
`
`is
`
`not
`
`inten
`
`claims in
`
`The
`
`
`
`ded to limit
`
`the present
`
`invention and the appended
`
`any way.
`
`
`
`
`fic embodiments should
`foregoing description of
`the speci
`
`15
`
`fully reveal
`
`
`
`the general nature of
`
`
`
`the invention so that others
`
`without undue experim
`
`concept of
`
`the pr
`
`variations and chan
`
`embodiments,
`
`the
`
`that all
`
`entation,
`esent
`
`
`
`invention.
`
`Since many
`
`the invention,
`
`it is intended
`
`g description and shown in
`
`
`
`
`can,
`by applying knowledge within the skill of
` modify
`
`for
`
`and/or
`
`adapt
`
`various
`
`applications
`
`such
`
`the art, readily
`
`specific
` from
`
`without departing
`
`
`
`general
` modifications,
`ges in detail can be made to
` preferred embodiment of
`described
`
`matters in the foregoin
`
`accompanying drawings be interpreted as illustrative and not 1
`
`
`the
`scope of
`s and
`
`limiting
`de
`
`sense.
`
`Thus,
`
`the
`
`termined by the appended clai
`
`invention should
`
`their legal equivalen
`
`
`
`the pre
`
`sent
`
`invention sho
`
`
`
`Moreover,
`nowt
`
`be
`
`1
`
`imited by
`
`the
`
`the breadth and scope of
`
`any of
`
`
`
`illustrative embodiments,
`
`but shoul
`
`accordance with the
`
`
`following claims and their equivalents.
`
`Now that the invention has been described,
`
`above-described
`
`exemplary and
`
`ld similarly be defined only in
`
`the
`
`the
`
`na
`
`be
`
`ts.
`
`uld
`
`20
`
`25
`
`30
`
`

`

`WO2013/191699
`
`PCT/US2012/043540
`
`Claims
`
`1.
`
`for disrupting subcutaneous
`
`A device
`
`said device co
`
`mprising:
`
`
`fat cells in a subject,
`
`comprising a
`assembly
`surface decreases
`the
`
`cooling
`
`cooling
`
`cells when applied to the skin
`
`a cooling assembly,
`
`face, wherein said
`
`said
`
`cooling sur
`
`
`temperature of
`
`surface of the
`
`
`subcutaneous fat
`
`subject;
`
`
`
`a control
`
`inked
`controllably 1
`
`
`
`module with control
`
`inputs,
`
`said control module
`
`to said cooling assembly;
`
`and
`
`le enclosure structured to be in the
`
`
`
`
`form of a
`
`
`
`
`
`10
`
`15
`
`a single portabl
`
`handheld device,
`
`wherein said cooling assembly is disposed within
`
`said
`
`enclosure
`
`such
`
`that
`
`said
`
`cooling
`
`surface
`
`is
`
`exposed
`
`
`externally of
`
`said enclosure,
`
`wherein
`
`said control
`
`
`
`
`
`module
`
`is
`
`inputs are
`
`disposed within said enclosure such that said control
`
`exposed externally of
`
`said enclosure.
`
`2.
`
`The device as
`
`recited in
`
`claim lL
`
`wherein
`
`said portable
`
`enclosure comprises two oppositely disposed handles configured to
`
`facilitate a subject’s gripping engagement therewith.
` further
`in
`
`claim 2
`
`recited
`
`The
`
`
`assembly
`5.
`
`is removably attached to
`in
`
`device as
`
`recited
`recited
`
`in
`
`claim 3
`
` claim 4
`
`wherein
`
`said securing
`
`said enclosure.
`
`wherein
`
`said securing
`
`3.
`
`The
`
`device
`
`as
`
`comprising a
`
`securing assembly coni
`
`
`
`Figured and attached to said enclosure such
`
`that the device can be securely positioned on a body portion of
`
` the subject.
`
`4,
`
`The
`
`device as
`
`assembly compr
`
`ises a belt
`
`positioned through said two oppositely
`
`disposed handl
`
`es.
`
`6.
`
`The
`
`device
`
`as
`
`recited
`
`in
`
`claim 1
`
` further
`
`temperature se
`
`nsor coni
`
`
`
`Figured proximate to said cooling surface,
`
`comprising a
`
`
`
`wherein said temperature sensor is communicatively connected to
`
`for providing temperature readings of
`
`
`
`said
`
`said control module
`
`
`cooling surfac
`
`e.
`
`7.
`
`The device as
`
`recited
`
`in claim 1
`
` further
`
`intermediate
`
`the skin sur
`
`device.
`
`the
`
`said
`
`comprising an
`
`membrane disposed between said cooling surface and
`
`
`face of
`subject during operation use of
`
`20
`
`25
`
`30
`
`35
`
`

`

`WO 2013/191699
`
`PCT/US2012/043540
`
`13
`
`e device as recited in claim 7 wherein said membrane is
`
`8.
`
`Th
`
`
`sized larger than said cooling surface.
`
`
`
`9.
`
`Th
`
`membran
`
`10.
`
`Th
`
`
`
`11.
`
`Th
`
`is main
`
`during
`
`10
`
`12.
`
`Th
`
`
`
`e device as recited in claim 7 wherein said intermediate
`
`e comprises a glycerin membrane.
`
`e device as
`
`recited in claim 7 wherein said membrane
`
`
`e device as recited in claim 1 wherein said cooling surface
`
`tained at a temperature between approximately -50C and O0oC
`
`operational use of said device.
`
`e device as
`
`recited in claim 11 wherein said cooling
`
`comprises a cloth material presoaked in glycerin solution.
`
`
`surface
`
`is maintained at a temperature between approximately -40C
`
`and -—20C during operational use of said device.
`A
`
`
`handheld, portable device for disrupting subcutaneous fat
`
`
`
`13.
`
`cells in a subject, said device comprising:
`
`15
`
`a portable enclosure,
`
`cooling assembly disposed at
`
`least partially within said
`
`tabl
`
`e enclosure,
`
`said cooling assembly comprising a cooling
`
`face
`
` face
`
`a p
`
`or
`
`sur
`
`sur
`
`disposed external to said portable enclosure, said cooling
`
`
`of
`decreas
`th
`temperature
`being Structured
`
`
`
`subcutaneous fat cells when applied to the skin surface of
`
`to
`
`the
`
`20
`
`25
`
`30
`
`35
`
`subject,
`
`a control module disposed within said portable enclosure,
`
`control module controllably linked with a plurality of control
`
`said
`
`
`
`inputs,
`
`a securing assembly removably disposed in securing relation with a
`
`selected portion of
`sur
` face
`
`the subject’s body, wherein said cooling
`
`is disposed in a facing relation with the skin of
`
`
`
`the
`
`
`
`subject, and
`
`CoFPF0ODFRCt
`
`
`rmediate membrane disposed between said cooling surface and
`
`he skin surface of the subject.
`
`inte
`
`
`
`4.
`
`The device as
`
`recited in claim 13 wherein said portable
`
`nclosure comprises at least one handle structured for gripping
`
`ngagement by the subject.
`
`The device as
`
`recited in claim 14 wherein said portable
`
`nclosure comprises two oppositely disposed handles.
`
`
`
`5.
`
`

`

`WO 2013/191699
`
`PCT/US2012/043540
`
`14
`
`16.
`
`The device as
`
`recited in claim 15 wherein said securing
`
`assembly comprises a belt
`
`removably disposed through said two
`
`oppositely dispo