ivi
`
`Innovation, Sciences et
`
`Développement économique Canada
`Office de la Propriété Intellectuelle du Canada
`
`Innovation, Science and
`
`Economic Development Canada
`Canadian Intellectual Property Office
`
`CA 3023821 A1 2017/11/16
`ey 3 023 821
`42) DEMANDE DE BREVET CANADIEN
`CANADIAN PATENT APPLICATION
`13) A1
`
`(86) Date de dépét PCT/PCTFiling Date: 2017/04/27
`
`(87) Date publication PCT/PCT Publication Date: 2017/11/16
`
`(85) Entrée phase nationale/National Entry: 2018/11/08
`
`(86) N° demande PCT/PCT Application No.: US 2017/029887
`
`(87) N° publication PCT/PCT Publication No.: 2017/196548
`
`(30) Priorités/Priorities: 2016/05/10 (US62/334, 317);
`2016/05/10 (US62/334 213), 2016/05/10 (USE62/334 337).
`2016/05/10 (US62/334 330)
`
`(51) CLInt.Aint.Cl. AG7F 7/10 (2006.01),
`AGTF 7/00 (2006.01)
`
`(71) Demandeur/Applicant:
`ZELTIQ AESTHETICS, INC., US
`
`(72) Inventeurs/Inventors:
`DEBENEDICTIS, LEONARD C., US:
`JIMINEZ LOZANO, JOEL N., US;
`ZENG, LIKE, US;
`FRANGINEAS, GEORGE, JR., US;
`PHAM, LINDA D., US
`
`(74) Agent: OYEN WIGGS GREEN & MUTALA LLP
`
`
`
`
`(54) Titre : SYSTEMES DE CONGELATION DE LA PEAU POUR LE TRAITEMENTDE L'ACNE ET D'AFFECTIONS
`CUTANEES
`(54) Title: SKIN FREEZING SYSTEMS FOR TREATING ACNE AND SKIN CONDITIONS
`
`(57) Abrégé/Abstract:
`A method and system in accordance with a particular embodiments of the technology includes applying a substance onto skin of a
`human subject. An applicator is then applied to the subject to cool a region of the subject. After cooling the tissue, a nucleation
`initiator is used to initiate a freeze event in the tissue. The nucleation initiator can be an ice crystal that inoculates the skin upon
`contact to create a predictable freeze event therein. The time of contact between the ice crystal and the skin can be controlled to
`achieve desired effects.
`
`
`
`50 rueVictoria
`50 Victoria Street
`
`© www.opic.ic.gc.ca
`© Gatineau, (Québec) K1A0OC9
`e Place du Portage 1
`« PlaceduPortage1 ¢ Gatineau, Quebec
`K1AOC9 © www.cipo.ic.gc.ca
`
`al } a
`
`a
`
`

`

`CA 03023821 2018-11-08
`
`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(10) International Publication Number
`WO 2017/196548 Al
`
`= a
`
`WIPO! PCT
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`(43) International Publication Date
`16 November 2017 (16.11.2017)
`
`(51) International Patent Classification:
`A61F 7/16 (2006.01)
`A61F 7/00 (2006.01)
`
`(21) International Application Number:
`
`PCT/US2017/029887
`
`LOZANO,Joel, N.; 5025 Haven Place, Apt. 313, Dublin,
`CA 94568 (US). ZENG, Like; 8165 Mountain View Dri-
`ve, Unit D, Pleasanton, CA 94588 (US). FRANGINEAS,
`Jr., George; 235 Quinault Way, Fremont, CA 94539 (US).
`PHAM,Linda, D.; 265 Arlington Ave, Kensington, CA
`94707 CUS).
`
`(22) International Filing Date:
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`27 April 2017 (27.04.2017)
`
`English
`
`(74)
`
`Agent: KLASSEN,Karl, L.et al.; Perkins Coie LLP, P.O.
`Box 1247, Scattle, WA 98111-1247 (US).
`
`English
`
`(81)
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO,AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW,BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO,
`DZ, EC, EE, EG, ES, FL GB, GD, GE, GH, GM, GT, HN,
`HR,HU,ID,IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR,
`KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
`MK, MN, MW, MX, MY, MZ, NA, NG, NL NO, NZ, OM,
`PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 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.
`
`(30) Priority Data:
`62/334,330
`62/334,337
`62/334,213
`62/334,317
`
`10 May 2016 (10.05.2016)
`10 May 2016 (10.05.2016)
`10 May 2016 (10.05.2016)
`10 May 2016 (10.05.2016)
`
`US
`US
`US
`US
`
`[US/US];
`INC.
`(71) Applicant: ZELTIQ AESTHETICS,
`4410 Rosewood Drive, Pleasanton, CA 94588 (US).
`
`(72) Inventors: DEBENEDICTIS, Leonard, C.; 5200 Iron
`Horse Parkway #553, Dublin, CA 94568 (US). JIMINEZ
`
`(54) Title: SKIN FREEZING SYSTEMS FOR TREATING ACNE AND SKIN CONDITIONS
`
`149
`
`(57) Abstract: A method and system in accordance with a particular embodiments of the technology includes applying a substance
`onto skin of a human subject. An applicator is then applied to the subject to cool a region of the subject. After cooling the tissue, a
`nucleation initiator is used to initiate a freeze event in the tissue. The nucleation initiator can be an ice crystal that inoculates the skin
`upon contact to create a predictable freeze event therein. The time of contact between the ice crystal and the skin can be controlled
`to achieve desired effects.
`
`[Continued on next page]
`
`
`
`
`
`wo2017/196548A1IIITNIIITANITATAC0TAAA
`
`

`

`CA 03023821 2018-11-08
`
`WO2017/196548 A IMITATION!TAMUTT AAU
`
`(84) 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, ST, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`LE, LS, FL, FR, GB, GR, HR, WU, I, 1S, 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,
`KM, ML, MR, NE, SN, TD, TG).
`
`Declarations under Rule 4.17:
`
`— asto applicant's entitlement to apply for and be granted a
`patent (Rule 4.17(ii))
`— as to the applicant's entitlement to claim the priority of the
`earlier application (Rule 4.17(iii))
`Published:
`
`— with international search report (Art. 21(3))
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`SKIN FREEZING SYSTEMS FOR TREATING ACNE AND SKIN
`
`CONDITIONS
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present international application claims the benefit of and priority
`
`to U.S. Provisional Patent Application No. 62/334,213,
`
`filed May 10, 2016; U.S.
`
`Provisional Patent Application No. 62/334,317, filed May 10, 2016; U.S. Provisional
`
`Patent Application No. 62/334,330, filed May 10, 2016; and U.S. Provisional Patent
`
`Application No. 62/334,337,
`
`filed May 10, 2016; which are incorporated herein by
`
`referencein their entireties.
`
`INCORPORATION BY REFERENCE
`
`[0002]
`
`The following U.S. Patent Applications and U.S. Patents are
`
`incorporated herein by referencein their entireties:
`
`[0003]
`
`U.S. Patent
`
`No. 7,854,754 entitled "COOLING DEVICE FOR
`
`REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0004]
`
`U.S. Patent No. 8,337,539 entitled "COOLING DEVICE FOR
`
`REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0005]
`
`U.S. Patent Publication No. 2013/0158636 entitled "COOLING
`
`DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0006]
`
`U.S. Patent No.
`
`8,192,474
`
`entitled
`
`"TISSUE TREATMENT
`
`METHODS";
`
`[0007]
`
`U.S. Patent Publication No.
`
`2013/0066309 entitled
`
`"TISSUE
`
`TREATMENT METHODS";
`
`[0008]
`
`U.S. Patent Publication No.
`
`2015/0328077 entitled
`
`"TISSUE
`
`TREATMENT METHODS";
`
`[0009]
`
`U.S. Patent No. 9,132,031 entitled "COOLING DEVICE HAVING A
`
`PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A
`
`PREDETERMINED COOLING PROFILE";
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`[0010]
`
`U.S. Patent No. 9,375,345 entitled "COOLING DEVICE HAVING A
`
`PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A
`
`PREDETERMINED COOLING PROFILE";
`
`[0011]
`
`U.S. Publication No. 2015/0342780 entitled "COOLING DEVICE
`
`HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A
`
`PREDETERMINED COOLING PROFILE";
`
`[0012]
`
`U.S. Patent Publication No. 2008/0077201 entitled "COOLING
`
`DEVICES WITH FLEXIBLE SENSORS";
`
`[0013]
`
`U.S.
`
`Patent
`
`Publication
`
`No.
`
`2007/0255362
`
`entitled
`
`"CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED
`
`COOLING OF SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0014]
`
`U.S.
`
`Patent
`
`Publication
`
`No.
`
`2014/0005760
`
`entitled
`
`"CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED
`
`COOLING OF SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0015]
`
`U.S. Patent Publication No. 2007/0270925 entitled " METHOD AND
`
`APPARATUS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS
`
`LIPID RICH CELLS INCLUDING A COOLANT HAVING A PHASE TRANSITION
`
`TEMPERATURE”;
`
`[0016]
`
`U.S. Patent Publication No. 2009/0118722 entitled "METHOD AND
`
`APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE";
`
`[0017]
`
`U.S. Patent Publication No. 2008/0287839 entitled "METHOD OF
`
`ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND
`
`TREATMENT APPARATUS HAVING AN ACTUATOR";
`
`[0018]
`
`U.S. Patent Publication No. 2013/0079684 entitled "METHOD OF
`
`ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND
`
`TREATMENT APPARATUS HAVING AN ACTUATOR";
`
`[0019]
`
`U.S. Patent No. 8,285,390 entitled "MONITORING THE COOLING
`
`OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE
`
`TISSUE";
`
`~2e
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`[0020]
`
`U.S. Patent No. 9,408,745 entitled "MONITORING THE COOLING
`
`OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE
`
`TISSUE";
`
`[0021]
`
`U.S. Patent Publication No. 2013/0116758 entitled "MONITORING
`
`THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING
`
`OF ADIPOSE TISSUE";
`
`[0022]
`
`U.S. Patent No. 8,523,927 entitled "SYSTEM FOR TREATING
`
`LIPID-RICH REGIONS";
`
`[0023]
`
`U.S. Patent Publication No. 2014/0067025 entitled "SYSTEM FOR
`
`TREATING LIPID-RICH REGIONS";
`
`[0024]
`
`U.S. Patent Publication No. 2009/0018624 entitled "LIMITING USE
`
`OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES";
`
`[0025]
`
`U.S. Patent Publication No. 2009/0018625 entitled "MANAGING
`
`SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS";
`
`[0026]
`
`U.S.
`
`Patent
`
`Publication No.
`
`2009/0018626
`
`entitled
`
`"USER
`
`INTERFACES FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH
`
`REGIONS";
`
`[0027]
`
`U.S. Patent Publication No. 2009/0018627 entitled "SECURE
`
`SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS";
`
`[0028]
`
`U.S. Patent No. 8,275,442 entitled "TREATMENT PLANNING
`
`SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS";
`
`[0029]
`
`U.S. Patent Publication No. 2013/0158440 entitled "TREATMENT
`
`PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS";
`
`[0030]
`
`U.S. Patent Application Serial No. 12/275,002 entitled "APPARATUS
`
`WITH HYDROPHILIC RESERVOIRS FOR COOLING SUBCUTANEOUS LIPID-RICH
`
`CELLS";
`
`[0031]
`
`U.S. Patent Application Serial No. 12/275,014 entitled "APPARATUS
`
`WITH HYDROPHOBIC FILTERS FOR REMOVING HEAT FROM SUBCUTANEOUS
`
`LIPID-RICH CELLS":
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`[0032]
`
`U.S. Patent No.
`
`8,676,338 entitled
`
`"COMBINED MODALITY
`
`TREATMENT SYSTEMS, METHODS AND APPARATUS FOR BODY CONTOURING
`
`APPLICATIONS";
`
`[0033]
`
`U.S. Patent Publication No. 2014/0316393 entitled "COMBINED
`
`MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR BODY
`
`CONTOURING APPLICATIONS";
`
`[0034]
`
`U.S. Patent No. 8,603,073 entitled "SYSTEMS AND METHODS
`
`WITH INTERRUPT/RESUME CAPABILITIES FOR COOLING SUBCUTANEOUS
`
`LIPID-RICH CELLS";
`
`[0035]
`
`U.S. Patent Publication No. 2013/0245731 entitled "SYSTEMS AND
`
`METHODS WITH
`
` INTERRUPT/RESUME
`
`CAPABILITIES
`
`FOR
`
`COOLING
`
`SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0036]
`
`U.S. Patent No. 8,702,774 entitled "DEVICE, SYSTEM AND
`
`METHOD FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS":
`
`[0037]
`
`U.S. Patent Publication No. 2014/0257443 entitled "DEVICE,
`
`SYSTEM AND METHOD FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-
`
`RICH CELLS";
`
`
`
`
`
`[0038] 2014/0257443_entitledU.S. Patent Publication No. "
`
`
`
`
`
`
`
`
`
`COMPOSITIONS FOR USE WITH A SYSTEM FOR IMPROVED COOLING OF
`
`SUBCUTANEOUS LIPID-RICH TISSUE”;
`
`[0039]
`
`U.S.
`
`Publication
`
`No.
`
`2012/0239123
`
`entitled
`
`"DEVICES,
`
`APPLICATION SYSTEMS AND METHODS WITH LOCALIZED HEAT FLUX ZONES
`
`FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
`
`[0040]
`
`U.S. Patent No. 6,041,787 entitled "USE OF CRYOPROTECTIVE
`
`AGENT COMPOUNDS DURING CRYOSURGERY";
`
`[0041]
`
`U.S. Patent No. 6,032,675 entitled "FREEZING METHOD FOR
`
`CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION";
`
`[0042]
`
`U.S. Patent No. 9,314,368 entitled "HOME-USE APPLICATORS
`
`FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH
`
`-4-
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES, SYSTEMS
`
`AND METHODS";
`
`[0043]
`
`U.S.
`
`Publication
`
`No.
`
`2011/0238051
`
`entitled
`
`"“HOME-USE
`
`APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS
`
`LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED
`
`DEVICES, SYSTEMS AND METHODS";
`
`[0044]
`
`U.S.
`
`Patent
`
`No.
`
`9,545,523
`
`entitled
`
`"MULTI-MODALITY
`
`TREATMENT
`
`SYSTEMS, METHODS AND APPARATUS
`
`FOR’ ALTERING
`
`SUBCUTANEOUS LIPID-RICH TISSUE";
`
`[0045]
`
`U.S. Patent Publication No. 2014/0277302 entitled "TREATMENT
`
`SYSTEMS WITH FLUID MIXING SYSTEMS AND FLUID-COOLED APPLICATORS
`
`AND METHODS OF USING THE SAME";
`
`[0046]
`
`U.S. Patent Publication No. 2015/0216720 entitled "TREATMENT
`
`SYSTEMS, METHODS, AND APPARATUSES FOR IMPROVING THE APPEARANCE
`
`OF SKIN AND PROVIDING FOR OTHER TREATMENTS”;
`
`[0047]
`
`U.S.
`
`Patent
`
`Publication
`
`No.
`
`2015/0216816
`
`entitled
`
`"COMPOSITIONS, TREATMENT SYSTEMS AND METHODS FOR’
`
`IMPROVED
`
`COOLING OF LIPID-RICH TISSUE”;
`
`[0048]
`
`U.S. Patent Publication No. 2015/0216719 entitled “TREATMENT
`
`SYSTEMS AND METHODS FOR TREATING CELLULITE AND FOR PROVIDING
`
`OTHER TREATMENTS’;
`
`[0049]
`
`U.S. Patent Application Serial No. 14/662,181 entitled “TREATMENT
`
`SYSTEMS, DEVICES, AND METHODS FOR COOLING TARGETED TISSUE”:
`
`[0050]
`
`U.S. Patent Application Serial No. 14/710,407 entitled “TREATMENT
`
`SYSTEMS WITH ADJUSTABLE GAP APPLICATORS AND METHODS
`
`FOR
`
`COOLING TISSUE’;
`
`[0051]
`
`U.S. Patent Publication No. 2016/0054101 entitled “TREATMENT
`
`SYSTEMS, SMALL VOLUME APPLICATORS, AND METHODS FOR TREATING
`
`SUBMENTAL TISSUE’;
`
`5
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`[0052]
`
`U.S. Patent Publication No. 2016/0051308 entitled “STRESS
`
`RELIEF COUPLINGS FOR CRYOTHERAPY APPARATUSES”;
`
`[0053]
`
`U.S. Patent Publication No. 2016/0089550 entitled “TREATMENT
`
`SYSTEMS, METHODS, AND APPARATUSES FOR ALTERING THE APPEARANCE
`
`OF SKIN”;
`
`[0054]
`
`U.S. Patent Publication No. 2017/0007309 entitled “TREATMENT
`
`SYSTEMS AND METHODS FOR AFFECTING GLANDS AND OTHER TARGETED
`
`STRUCTURES’;
`
`[0055]
`
`U.S. Patent Publication No. 2016/0317346 entitled “SYSTEMS AND
`
`METHODS FOR MONITORING COOLING OF SKIN AND TISSUE TO IDENTIFY
`
`FREEZE EVENTS’;
`
`
`
`
`
`
`
`
`
`[0056] 15/271,121—entitledU.S. Patent Application Serial No.
`
`
`
`"TRANSCUTANEOUS
`
`TREATMENT
`
`SYSTEMS,
`
`COOLING DEVICES,
`
`AND
`
`METHODS FOR COOLING NERVES”:
`
`[0057]
`
`U.S. Patent Application Serial No. 15/296,853 entitled "VASCULAR
`
`TREATMENT SYSTEMS, COOLING DEVICES, AND METHODS FOR COOLING
`
`VASCULAR STRUCTURES’;
`
`
`
`
`
`
`
`
`
`[0058] 15/400,885—entitledU.S. Patent Application Serial No.
`
`
`
`"TEMPERATURE-DEPENDENT ADHESION BETWEEN APPLICATOR AND SKIN
`
`DURING COOLING OF TISSUE”; and
`
`"COOLING CUP APPLICATORS WITH CONTOURED HEADS AND_LINER
`
`[0059]
`
`U.S. Provisional Patent Application Serial No. 62/297,054 entitled
`
`ASSEMBLIES”.
`
`TECHNICAL FIELD
`
`[0060]
`
`The present disclosure relates generally to systems for cooling
`
`tissue.
`
`In particular, several embodiments are directed to treatment systems, methods,
`
`and substancesfor controllably cooling tissue to treat acne or other conditions.
`
`Se
`
`

`

`WO 2017/196548
`
`PCT/US82017/029887
`
`CA 03023821 2018-11-08
`
`BACKGROUND
`
`[0061]
`
`Exocrine glands found in the skin have a role in maintaining skin
`
`health,
`
`including lubricating, waterproofing, cleansing and/or cooling the skin or hair
`
`follicles of the body by excreting water-based, oily and/or waxy substances through skin
`
`pores or hair follicles. Overproduction and/or oversecretion of these substances by
`
`certain exocrine glands, such as sebaceous glands and sudoriparous glands (e.g.,
`
`sweat glands), can cause unappealing skin disorders that have proved difficult to treat.
`
`For example, overproduction of sebum, a waxy substance produced and secreted by
`
`sebaceous glands, can lead to the formation of comedones (e.g., blackheads,
`
`whiteheads, etc.) and other inflammatory conditions of the skin associated with acne
`
`(e.g., inflamed papules, pustules, nodules, etc.), which can potentially lead to scarring
`
`of the skin. Overproducing sebaceous glands associated with hair follicles are mostly
`
`found in highly visible regions of the body, such as along the face, neck, upper chest,
`
`shoulders and back.
`
`[0062]
`
`Hyperhidrosis is a condition associated with excessive sweating
`
`caused by the overproduction and secretion of sweat from sweat glands in the skin of
`
`mammals. Excessive sweating from eccrine sweat glands, which are distributed almost
`
`all over the body, can cause discomfort and embarrassment.
`
`For example, focal
`
`hyperhidrosis can occur on the palms of the hands, soles of the feet, face and scalp.
`
`Apocrine sweat glands, particularly in the axilla (i.e., armpits), have oil-producing cells
`
`that can contribute to undesirable odor.
`
`[0063]
`
`Treatments for these and other skin and tissue conditions are often
`
`ineffective, non-lasting, and/or have undesirable side-effects.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0064]
`
`Many aspects of the present invention can be better understood with
`
`reference to the following 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.
`
`[0065]
`
`Figure 1
`
`is a schematic cross-sectional view of the skin, dermis, and
`
`subcutaneous tissue of a subject.
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`[0066]
`
`Figure 2 is a schematic cross-sectional view of the skin, dermis, and
`
`subcutaneous tissue of the subject in Figure 1 after treating sebaceous glands.
`
`[0067]
`
`Figure 3 is a partially schematic,
`
`isometric view of a treatment
`
`system for non-invasively treating targeted structures in a human subject's body in
`
`accordance with an embodiment of the technology.
`
`[0068]
`
`Figure 4 is a cross-sectional view of a conduit of the treatment
`
`system of Figure 3.
`
`[0069]
`
`Figure 5 is a flow diagram illustrating a method for treating a
`
`subject's skin in accordance with an embodimentof the technology.
`
`[0070]
`
`Figure 6 is a plot of temperature versus time for a treatment involving
`
`minimal or no skin supercooling when an applicator is initially placed on a patient's skin
`
`to initiate a freeze event.
`
`[0071]
`
`Figure 7 is a plot of temperature versus time for a treatment involving
`
`substantial skin cooling.
`
`[0072]
`
`Figure 8 is a flow diagram illustrating a method for treating a
`
`subject's skin in accordance with an embodimentof the technology.
`
`[0073]
`
`Figures 9A-9C show stages of a method for preparing a treatment
`
`site in accordance with an embodimentof the disclosed technology.
`
`[0074]
`
`Figure 10A shows patterned hydrogel suitable for cryotherapy in
`
`accordance with an embodiment of the disclosed technology.
`
`[0075]
`
`Figures 10B and 10C are plots of propylene glycol concentration
`
`versus length for patterned hydrogels.
`
`[0076]
`
`Figures 11A and 11B are side views of hydrogel substances with ice
`
`nucleating regions in accordance with embodiments of the technology.
`
`[0077]
`
`Figure 12A shows an emulsifier or surfactant with a hydrophilic head
`
`and a hydrophobic tail.
`
`[0078]
`
`Figure 12B shows an agent entrapped by emulsifiers.
`
`[0079]
`
`Figures 13A and 13B show an oil-in-water emulsion and a water-in-
`
`oil emulsion.
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`[0080]
`
`Figure 14 is a table with melting/freezing point temperaturesfor fats.
`
`[0081]
`
`Figures 15A and 15B show test
`
`results performed on skin in
`
`accordance with some embodiments of the disclosed technology.
`
`[0082]
`
`Figure 16 shows a treatment cycle temperature profile and a
`
`temperature response measured by a temperature sensor at an applicator surface-
`
`tissue interface.
`
`[0083]
`
`Figure 17 showsthe temperature of the applicator surface lowered at
`
`a constant rate and then held at a generally constant value in accordance with an
`
`embodimentof the technology.
`
`[0084]
`
`Figure 18 is a plot of temperature versus time showing an exemplary
`
`treatment cycle for controlled supercooling and for controlled freezing of tissue by
`
`lowering the skin temperature in accordance with an embodiment of the technology.
`
`[0085]
`
`Figures 19A-19E are cross-sectional views of an applicator applied
`
`to a treatment site and thermal modeling.
`
`[0086]
`
`Figures 20A-20F illustrate stages of one method of freezing tissue
`
`without supercooling.
`
`[0087]
`
`Figure 21 is a plot of temperature versus time for freezing skin
`
`multiple times in accordance with an embodiment of the disclosed technology.
`
`[0088]
`
`Figure 22A shows an unfrozen liquid coupling media that can serve
`
`as an insulator for ice inoculation of skin.
`
`[0089]
`
`Figure 22B shows the coupling media of Figure 22A with a shifted
`
`temperature profile.
`
`[0090]
`
`Figure 23 is a plot of temperature versus propylene glycol
`
`(PG)
`
`concentration in water in accordance with an embodiment of the disclosed technology.
`
`[0091]
`
`Figures 24A-24F show stages of a method for supercooling the skin
`
`and then initiating a freeze event in accordance with an embodiment of the disclosed
`
`technology.
`
`[0092]
`
`Figure 25 is a plot of temperature versus time for supercooling and
`
`freezing tissue.
`
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`[0093]
`
`Figure 26 is a plot of temperature versus time for a procedure that
`
`cycles two times to supercool tissue and then triggers a freeze.
`
`[0094]
`
`Figures 27A-27C show an applicator and a coupling media at
`
`various stages during a procedure.
`
`[0095]
`
`Figure 28 shows an applicator applied to a treatment site in
`
`accordance with an embodiment of the disclosed technology.
`
`[0096]
`
`Figure 29 is a plot of temperature versus time for a temperature
`
`profile for triggering ice nucleation by activating an ice nucleator.
`
`[0097]
`
`Figure 30 shows an applicator and an ice nucleating agent (INA)
`
`applied to a treatment site in accordance with an embodiment of the disclosed
`
`technology.
`
`[0098]
`
`Figure 31 showsa plot of temperature versus time for delivering an
`
`INA for nucleation.
`
`[0099]
`
`Figures 32A-32D are IR images showing stages of a process using
`
`hydrogel to freeze supercooled tissue.
`
`[00100]
`
`Figures 33A-33D are IR images showing tissue freeze inoculation
`
`using combined materials.
`
`[00101]
`
`Figures 34A and 34B are cross-sectional views of an applicator
`
`applied to a treatment site in accordance with some embodiments of the disclosed
`
`technology.
`
`[00102]
`
`Figure 35 is a plot of temperature versus time for triggering a freeze
`
`agent using a hydrogel.
`
`[00103]
`
`Figure 36 shows an applicator positioned to produce a controlled
`
`freeze in a coupling material
`
`in accordance with an embodiment of the disclosed
`
`technology.
`
`[00104]
`
`Figure 37 shows an applicator with an external nucleating element
`
`configured to initiate a freeze event at a location external
`
`to an applicator-hydrogel
`
`interface.
`
`[00105]
`
`Figure 38 is a cross-sectional view of an applicator applied to a
`
`treatment site and capable of providing energy-based activation.
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`[00106]
`
`Figure 39 is a plot of temperature versus time for supercooling skin
`
`prior to initiating a freeze event.
`
`[00107]
`
`Figure 40 is a plot of
`
`temperature versus time where, after
`
`supercooling and before freezing, a temperature of the applicator is adjusted to warm
`
`the epidermis.
`
`[00108]
`
`Figure 41 shows a plot of temperature versus time for a cooling
`
`protocol and three cross-sectional views of an applicator and skin tissue and
`
`temperature distributions.
`
`[00109]
`
`Figure 42 shows a temperature profile in the epidermis/dermis and
`
`temperature distribution for one treatment protocol.
`
`[00110]
`
`Figure 43 shows a temperature profile into the epidermis/dermis for
`
`one treatment protocol.
`
`[00111]
`
`Figure 44 shows a stage in one method of creating an intradermal
`
`tissue freeze using an injectable substance.
`
`[00112]
`
`Figure 45 is a flow diagram illustrating a method for preparing and
`
`freezing tissue in accordance with an aspect of the present technology.
`
`[00113]
`
`Figure 46 is a schematic block diagram illustrating subcomponents
`
`of a computing device in accordance with an embodiment of the disclosure.
`
`DETAILED DESCRIPTION
`
`A.
`
`Overview
`
`[00114]
`
`The present disclosure describes treatment systems for improving
`
`the appearance, function and health of tissue and for performing other treatments.
`
`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 technology but are not described in detail.
`
`[00115]
`
`Various aspects of the technology are directed to cooling a surface
`
`of a patient's skin to produce a cooling event (e.g., a partial freeze event, a total freeze
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`event, etc.) that affects tissue, cells, structures, appendages, or targeted features.
`
`Systems disclosed herein can target glands (e.g., exocrine glands, sebaceous glands,
`
`sweat glands, sudoriparous glands, etc.), structures in the skin (e.g., hair follicles,
`
`superficial nerves, etc.), and/or layer(s) of tissue (e.g., dermal layer, epidermal layer,
`
`subcutaneous layer,
`
`sub-layer(s) of the epidermis, dermis, subcutaneous, etc.).
`
`In
`
`some embodiments,
`
`the cooling event
`
`reduces or
`
`limits overproduction and/or
`
`oversecretion of exocrine glands to treat comedones and/or other
`
`inflammatory
`
`conditions of the skin associated with acne, such as inflamed papules, pustules,
`
`nodules, etc. For example, the cooling event can cause an effective amount of thermal
`
`injury to glands to reduce or limit overproduction and/or oversecretion by those glands
`
`to reduce or eliminate acne or other skin conditions. The cooling event can include
`
`freezing a region of the dermal layer containing the targeted exocrine glands without
`
`affecting non-targeted tissue. Treatment applicators can be configured for use along
`
`the face, neck, upper chest, shoulders, back, and other treatment sites and can target
`
`specific layers in the skin, subcutaneous tissue, specific structures, particular cells, etc.
`
`[00116]
`
`In certain embodiments, a method for predictably freezing a subject's
`
`skin at a desired predictable time includes lowering a temperature of the skin below a
`
`freezing point of fluid in the skin so that the skin is at a first temperature. An ice crystal
`
`contacts the skin to inoculate the skin and to create a predictable freeze event therein.
`
`A time of contact between the ice crystal and the skin is controlled so that
`
`the
`
`predictable freeze occurs at a desired time.
`
`In some procedures, the method can be
`
`performed using an applicator that is applied to the subject’s skin.
`
`[00117]
`
`In some embodiments, a method for freezing dermal tissue more
`
`than once while freezing epidermal tissue only once includes applying a coupling media
`
`to an applicator. The coupling media has a medium therein capable of forming ice
`
`crystals. A temperature of the applicator is lowered below a freezing point of the
`
`medium to at least partially freeze the medium. The coupling media, which is carried by
`
`the applicator, is placed on a subject's skin surface. The temperature of the applicator
`
`can be adjusted to a treatment temperature for freezing at least a portion of the medium
`
`in contact with the skin surface to freeze dermal and epidermal
`
`tissue.
`
`In some
`
`procedures, the applicator is warmed an amountsufficient to allow the dermal tissue to
`
`thaw but not enough to allow the epidermal tissue to thaw. After the dermal tissue at
`
`least partially thaws, the temperature of the applicator is adjusted to a second treatment
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`temperature such that the at least some of the thawed dermal tissue refreezes and the
`
`epidermal tissue remains frozen.
`
`[00118]
`
`In further embodiments, a method for freezing dermal tissue more
`
`than once while freezing epidermal tissue only once includes at least partially freezing
`
`the dermal tissue and epidermal tissue using an applicator configured to cool a skin
`
`surface of a subject. While the epidermal tissue remains frozen,
`
`the applicator is
`
`warmed an amount sufficient to allow at least some of the dermal tissue to thaw, and
`
`after thawing at least some of the dermal tissue, cooling the applicator to re-freeze at
`
`least some of the dermal tissue.
`
`[00119]
`
`In one embodiment,
`
`a method for predictably freezing skin
`
`comprises supercooling a subject's skin using a coupling media and an applicator at a
`
`first applicator temperature.
`
`The first applicator temperature is higher than a freezing
`
`point of the coupling media. The coupling media includes a freezing point depressant
`
`which inhibits freezing of the coupling media and the skin. The skin is inoculated to
`
`freeze the skin without
`
`lowering a temperature of the applicator below the first
`
`applicator temperature.
`
`[00120]
`
`In some further embodiments, a method for treating skin includes
`
`lowering a temperature of a subject's skin below a freezing point of target tissue of the
`
`skin. Cooling of the skin is monitored so that freezing therein does not occur. An
`
`amount of non-freezing cooling treatment delivered to the skin is controlled so that the
`
`target tissue reaches a predetermined first
`
`level of cooling. After the target tissue
`
`reaches the predeterminedfirst level, the skin is frozen. An amount of freezing cooling
`
`treatment delivered to the skin is controlled so that
`
`the target
`
`tissue reaches a
`
`predetermined second level of cooling
`
`[00121]
`
`A system for treating a subject includes an applicator configured to
`
`cool a subject's skin surface when the applicator is applied to the subject and a
`
`controller. The controller can be programmed to cause the applicator to, for example,
`
`create or maintain at least one ice crystal and/or induce a freeze event in the subject's
`
`skin via the at least one ice crystal.
`
`[00122]
`
`At
`
`least some of the embodiments disclosed herein can be for
`
`cosmetically beneficial treatments. As such, some treatment procedures maybe for the
`
`sole purpose of altering a treatment site to conform to a cosmetically desirable look,
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`feel, size, shape or other desirable cosmetic characteristic or feature. Accordingly,
`
`cosmetic procedures can be performed without providing any or minimal therapeutic
`
`effect. For example, some treatment procedures may be directed to goals, such as the
`
`reduction of acne, that do not include restoration of health, physical integrity, or the
`
`physical well-being of a subject.
`
`In some embodiments, methods can target skin
`
`irregularities, wrinkles, and sebaceous glands to treat acne; sweat glands to treat
`
`hyperhidrosis; hair follicles to injure and remove hair; or other targeted cells to change a
`
`subject's appearance or address a condition.
`
`Treatments may have therapeutic
`
`outcomes (whether intended or not), such as, psychological benefits, alteration of body
`
`hormone levels (by the reduction of adipose tissue), etc. Various aspects of the
`
`methods disclosed herein can include cosmetic treatment methods for achieving a
`
`cosmetically beneficial alteration of a portion of tissue within the target region. Such
`
`cosmetic methods can be administered by a non-medically trained person.
`
`The
`
`methods disclosed herein can also be used to (a) improve the appearance of skin by
`
`tightening the skin,
`
`improving skin tone and texture, eliminating or reducing wrinkles,
`
`increasing skin smoothness,
`
`thickening the skin,
`
`(b)
`
`improve the appearance of
`
`cellulite, and/or (c) treat sebaceous glands, hair follicles, and/or sweat glands.
`
`[00123]
`
`At least some embodiments of the technology include producing one
`
`or more controlled freeze events. The location and extent of freezing can be controlled
`
`to produce a therapeutic or cosmetic effect. Nucleation initiators, nucleation inhibitors,
`
`and/or treatment substances can be used before, during, and/or after the freeze event.
`
`The nucleation initiators can include, without limitation, ice nucleation agents, injectable
`
`substances(e.g., saline, ice slurries, etc.), energy that promotes ice nucleation, or other
`
`initiators that affect freezing. Nucleation inhibitors can include, without
`
`limitation,
`
`cryoprotectant solutions, freeze temperature depressants, and/or heaters.
`
`[00124]
`
`According to one aspect of the technology, a subject's skin is
`
`lowered to below its melting