WO2025240891A1 - Applicator system and method for flank contouring - Google Patents

Abstract

Systems, methods, and devices for treating a subject are described herein. In some embodiments, an applicator for selectively affecting the subcutaneous tissue of a subject's flank or side abdomen is provided. For example, the applicator can include a treatment cup that defines a tissue-receiving cavity and includes a temperature-controlled surface. The applicator can include a thermal device configured to receive energy and to cool the temperature-controlled surface. The applicator can also include a vacuum port configured to provide a vacuum to draw the subject's tissue into the tissue-receiving cavity and against at least a portion of a treatment area of the temperature-controlled surface to selectively damage and/or reduce the subcutaneous tissue of the flank or side abdomen of the subject.

Description

APPLICATOR SYSTEM AND METHOD FOR FLANK CONTOURING

RELATED APPLICATION DATA

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Patent Application No. 63/649,273, filed on May 17, 2024, which is hereby incorporated by reference in its entirety and for all purposes.

INCORPORATION BY REFERENCE OF APPLICATIONS AND PATENTS

[0002] The following commonly assigned U.S. Patent Applications and U.S. Patents are incorporated herein by reference in their entireties:

[0003] 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”;

[0004] U.S. Patent No. 6,032,6175 entitled “FREEZING METHOD FOR CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION”;

[0005] U.S. Patent Publication No. 2007/0255362 entitled “CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICH CELLS”;

[0006] U.S. Patent No. 7,854,754 entitled “COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

[0007] U.S. Patent No. 8,337,539 entitled “COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

[0008] U.S. Patent Publication No. 2008/0077201 entitled “COOLING DEVICES WITH

FLEXIBLE SENSORS”;

[0009] U.S. Patent No. 9,132,031 entitled “COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE”; [0010] U.S. Patent Publication No. 2009/0118722, filed October 31, 2007, entitled “METHOD AND APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE”;

[0011] U.S. Patent Publication No. 2009/0018624 entitled “LIMITING USE OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES”;

[0012] U.S. Patent No. 8,523,927 entitled “SYSTEM FOR TREATING LIPID-RICH REGIONS”;

[0013] U.S. Patent Publication No. 2009/0018625 entitled “MANAGING SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS”;

[0014] U.S. Patent Publication No. 2009/0018627 entitled “SECURE SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS”;

[0015] U.S. Patent Publication No. 2009/0018626 entitled “USER INTERFACES FOR

A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS”;

[0016] U.S. Patent No. 6,041,787 entitled “USE OF CRYOPROTECTIVE AGENT COMPOUNDS DURING CRYOSURGERY”;

[0017] U.S. Patent No. 8,285,390 entitled “MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE TISSUE”;

[0018] U.S. Patent No. 8,275,442 entitled “TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS”;

[0019] U.S. Patent Application Serial No. 12/275,002 entitled “APPARATUS WITH HYDROPHILIC RESERVOIRS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS”;

[0020] U.S. Patent Application Serial No. 12/275,014 entitled “APPARATUS WITH HYDROPHOBIC FILTERS FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID- RICH CELLS”;

[0021] U.S. Patent No. 8,603,073 entitled “SYSTEMS AND METHODS WITH INTERRUPT/RESUME CAPABILITIES FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS”;

[0022] U.S. Patent No. 8,192,474 entitled “TISSUE TREATMENT METHODS”; [0023] U.S. Patent No. 8,702,774 entitled “DEVICE, SYSTEM AND METHOD FOR

REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

[0024] U.S. Patent No. 8,676,338 entitled “COMBINED MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR BODY CONTOURING APPLICATIONS”;

[0025] U.S. No. 9,314,368 entitled “HOME-USE APPLICATORS FOR NON- INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”;

[0026] 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”;

[0027] U.S. Publication No. 2012/02317023 entitled “DEVICES, APPLICATION SYSTEMS AND METHODS WITH LOCALIZED HEAT FLUX ZONES FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

[0028] U.S. Patent No. 9,545,523 entitled “MULTI-MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR ALTERING SUBCUTANEOUS LIPID- RICH TISSUE”;

[0029] U.S. Patent Publication No. 2014/0277302 entitled “TREATMENT SYSTEMS WITH FLUID MIXING SYSTEMS AND FLUID-COOLED APPLICATORS AND METHODS OF USING THE SAME”;

[0030] U.S. Patent No. 9,132,031 entitled “COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE”;

[0031] U.S. Patent No. 8,285,390 entitled “MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE TISSUE”;

[0032] U.S. Patent Publication No. 2016/0054101 entitled “TREATMENT SYSTEMS, SMALL VOLUME APPLICATORS, AND METHODS FOR TREATING SUBMENTAL TISSUE”; [0033] U.S. Patent Publication No. 2018/0310950 entitled “SHALLOW SURFACE CRYOTHERAPY APPLICATORS AND RELATED TECHNOLOGY”;

[0034] U.S. Patent Publication No. 2020/0038234 entitled “METHODS, DEVICES, AND SYSTEMS FOR IMPROVING SKIN CHARACTERISTICS”; and

[0035] U.S. Patent Application No. 16/557,814 entitled “COMPOSITIONS, TREATMENT SYSTEMS, AND METHODS FOR FRACTIONALLY FREEZING TISSUE;” AND

[0036] U.S. Patent Application No. 17/402,354 entitled “MULTI- APPLICATOR SYSTEM FOR BODY CONTOURING.”

TECHNICAL FIELD

[0037] The present disclosure relates generally to cryotherapy treatment systems and applicators of unique geometries for treatment of a flank or side abdomen of a patient.

BACKGROUND

[0038] Excess body fat, or adipose tissue, may be present at various locations of a subject’s body and may detract from personal appearance. Aesthetic improvement of the human body often involves the selective removal of adipose tissue located at the thighs, buttocks, knees, submental region, face, and arms, as well as other locations. Invasive procedures (e.g., liposuction), however, tend to be associated with relative high costs, long recovery times, and increased risk of complications. Injection of drugs for reducing adipose tissue can cause significant swelling, bruising, pain, numbness, and/or induration.

[0039] Conventional non-invasive treatments for reducing adipose tissue often include regular exercise, application of topical agents, use of weight-loss drugs, dieting, or a combination of these treatments. One drawback of these non-invasive 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. Topical agents and orally administered weight-loss drugs are not an option if, as another example, they cause an undesirable reaction, such as an allergic or negative reaction. Additionally, non-invasive treatments may be ineffective for selectively reducing specific regions of adiposity, such as localized adipose tissue along the hips, abdomen, thighs, or the like. [0040] Cryolipolysis (e.g., the destruction of adipose tissue via exposure thereof to low temperatures) can be used to reduce adipose tissue along the thighs, buttocks, knees, submental region, face, and arms, as well as other locations. As described in the applications incorporated by reference above, conventional cryolipolysis systems use applicators to create a vacuum seal around a portion of a patient’s skin. Tissue sealed and drawn into the applicator is sufficiently cooled so as to induce apoptosis in the adipose tissue.

[0041 ] Conventional applicator systems have geometries ill-suited for delivering cryolipolysis therapy to anatomical sites having large degrees of curvature (e.g., the side abdomen and/or flank). Thus, there is a need in the art to design new and improved applicators that have optimal geometries, dimensions, and cooling capacities for targeting curved anatomical sites on a patient.

SUMMARY

[0042] The present application discloses applicators for selectively affecting subcutaneous adipose tissue in a flank of a subject and a method of administering cryolipolysis treatment to a cryolipolysis treatment patient using an applicator. In an embodiment, an applicator for selectively affecting subcutaneous adipose tissue in a flank of a subject comprises a housing and a treatment cup mounted in the housing. The treatment cup defines a tissuereceiving cavity comprising a cavity perimeter and includes a temperature-controlled surface. The applicator further comprises at least one thermal device coupled to the treatment cup and configured to cool the temperature-controlled surface. The applicator additionally comprises at least one vacuum port coupled to the treatment cup, wherein the treatment cup is configured to draw the subject’s tissue into the tissue -receiving cavity to ensure the tissue contacts at least a portion of the temperature-controlled surface to selectively damage and/or reduce the subject’s subcutaneous adipose tissue. The application further comprises a sealing element coupled to the cup at an interface, and the sealing element comprises a sealing element perimeter defining a first curvature profile. The interface defines a second curvature profile, and the first and second curvature profiles are configured to conform to the flank of the subject to facilitate a vacuum seal between the applicator and the flank of the subject to achieve the selective damage and/or reduction of the subject’s subcutaneous adipose tissue along the flank.

[0043] In some embodiments, the first and second curvature profiles are configured to facilitate the drawing of tissue of the flank of the subject against the temperature-controlled surface of the tissue-receiving cavity. In certain embodiments, each of the first and second curvature profiles are defined in terms of respective first and second ellipses. In further embodiments, at least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse. In some embodiments, the first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, a minor axis of between about 240 millimeters and about 250 millimeters, and the first arc of the first ellipse is configured to subtend an angle of a center of the first ellipse of between about 90 degrees and about 150 degrees.

[0044] In further embodiments, at least a second segment of the interface is configured to coincide with an arc of the second ellipse. In certain embodiments, the second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, a minor axis of between about 100 millimeters and about 200 millimeters, and the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees.

[0045] In some embodiments, the ratio of the major axis of the first ellipse to the major axis of the second ellipse is between about 0.9 and about 1.25. In certain embodiments, the ratio of the minor axis of the first ellipse to the minor axis of the second ellipse is between about 1.25 and about 2.4.

[0046] In further embodiments, the flank of the subject has a radius of between about 70 millimeters and about 155 millimeters. In certain embodiments, the sealing element comprises injection-molded liquid silicone rubber. In some embodiments, the cup comprises aluminum.

[0047] In further embodiments, a first height of a tallest point of the sealing element relative to a lowest point of a top of the sealing element is between about 34 millimeters and about 38 millimeters. In certain embodiments, a second height of a tallest point of the interface relative to a lowest point of the interface is between about 23 millimeters and about 27 millimeters. In some embodiments, the ratio of the first height to the second height is between about 1.2 and about 1.65.

[0048] In further embodiments, the patient’s tissue type is generally characterized as being more pliable and less fibrous compared to an average tissue type. In some embodiments, the target patient’s tissue type for the subject applicator is generally characterized as being more pliable and less fibrous compared to an average tissue type.

[0049] In an embodiment, an applicator for selectively affecting subcutaneous adipose tissue in a flank of a subject, the applicator comprises a housing and a treatment cup mounted in the housing. The treatment cup defines a tissue-receiving cavity comprising a cavity perimeter and includes a temperature-controlled surface. The applicator further comprises at least one thermal device coupled to the treatment cup and configured to cool the temperature- controlled surface. The applicator additionally comprises at least one vacuum port coupled to the treatment cup. The treatment cup is configured to draw the subject’s tissue into the tissuereceiving cavity to ensure the tissue contacts at least a portion of the temperature-controlled surface to selectively damage and/or reduce the subject’s subcutaneous adipose tissue. The applicator further comprises a sealing element coupled to the cup at an interface. The sealing element comprises a sealing element perimeter defining a first curvature profile, and the interface defines a second curvature profile. The first and second curvature profiles are configured to conform to the flank of the subject to facilitate a vacuum seal between the applicator and the flank of the subject to achieve the selective damage and/or reduction of the subject’s subcutaneous adipose tissue along the flank. The first and second curvature profiles are further configured to facilitate the drawing of tissue of the flank of the subject against the temperature-controlled surface of the tissue-receiving cavity. Each of the first and second curvature profiles are defined in terms of respective first and second ellipses. At least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse. The first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, a minor axis of between about 240 millimeters and about 250 millimeters, and the first arc of the first ellipse is configured to subtend an angle of a center of the first ellipse of between about 90 degrees and about 150 degrees. At least a second segment of the interface is configured to coincide with an arc of the second ellipse. The second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, a minor axis of between about 100 millimeters and about 200 millimeters, and the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees. A ratio of the major axis of the first ellipse to the major axis of the second ellipse is between about 0.9 and about 1.25. A ratio of the minor axis of the first ellipse to the minor axis of the second ellipse is between about 1.25 and about 2.4. A first height of a tallest point of the sealing element relative to a lowest point of a top of the sealing element is between about 34 millimeters and about 38 millimeters. A second height of a tallest point of the interface relative to a lowest point of the interface is between about 23 millimeters and about 27 millimeters. The ratio of the first height to the second height is between about 1.2 and about 1.65. The flank of the subject has a radius of between about 70 millimeters and about 155 millimeters. The patient’s tissue type is generally characterized as being more pliable and less fibrous compared to an average patient’s tissue type.

[0050] In an embodiment, a method of administering cryolipolysis treatment to a cryolipolysis treatment patient using an applicator comprises applying an applicator to a portion of tissue of a flank of the patient, drawing a vacuum with the applicator so that the portion of tissue of the flank of the patient is drawn into the applicator; and extracting heat from the portion of tissue of the flank of the patient.

[0051] In some embodiments, the method further comprises applying an applicator that comprises a housing and a treatment cup mounted in the housing. The treatment cup defines a tissue-receiving cavity comprising a cavity perimeter and includes a temperature-controlled surface. The applicator further comprises at least one thermal device coupled to the treatment cup and configured to cool the temperature-controlled surface. The applicator additionally comprises at least one vacuum port coupled to the treatment cup and configured to draw the subject's tissue into the tissue-receiving cavity and against at least a portion of the temperature- controlled surface. The applicator also comprises a sealing element coupled to the cup at an interface. The sealing element comprises a sealing element perimeter defining a first curvature profile. The interface defines a second curvature profile. The first and second curvature profiles are configured to conform facilitate cryolipolysis treatment for the flank of the subject.

[0052] In further embodiments, the first and second curvature profiles are configured to facilitate the drawing of the flank tissue of the subject against the temperature-controlled surface of the tissue-receiving cavity. In some embodiments, each of the first and second curvature profiles are defined in terms of respective first and second ellipses. In certain embodiments, at least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse. In further embodiments, the first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, and the first arc of the first ellipse is configured to subtend and angle of a center of the first ellipse of between above 90 degrees and about 150 degrees.

[0053] In some embodiments, at least a second segment of the interface is configured to coincide with an arc of the second ellipse. In certain embodiments, the second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, and the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees. In further embodiments, the method further comprises, before the step of applying, determining a pliability of the portion of the tissue of the flank of the patient. In some embodiments, the pliability of the portion of the tissue of the flank of the patient is determined to be one of very pliable, somewhat pliable, pliable, fibrous, somewhat fibrous, and very fibrous. In some embodiments, the patient has a narrower, more petite, body profile and/or is generally of a smaller stature.

[0054] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0055] In the drawings, identical reference numbers identify similar elements or acts.

[0056] FIG. 1A is a partially schematic, isometric view of a treatment system for non- invasively affecting target flank regions of a subject in accordance with an embodiment of the technology;

[0057] FIG. IB is a schematic cross-sectional view of an applicator taken along line 1B- 1B of FIG. 1A;

[0058] FIG. 1C is a schematic cross-sectional view of a connector taken along line 1C- 1C of FIG. 1A;

[0059] FIG. 2A is a schematic block diagram illustrating components of a treatment system configured in accordance with embodiments of the present technology;

[0060] FIG. 2B is a schematic diagram of a cooling system of the treatment system of FIG. 2A;

[0061 ] FIG. 2C is a schematic diagram of a vacuum system of the treatment system of FIG. 2 A;

[0062] FIGS. 3A-3J illustrate a vacuum applicator configured in accordance with embodiments of the present technology;

[0063] FIGs. 4A and 4B illustrate curvature profiles of components of applicator systems in accordance with exemplary embodiments; [0064] FIGs. 5A and 5B illustrate perspective views of a cup and a sealing element in accordance with exemplary embodiments;

[0065] FIGs. 6A and 6B illustrate cross-section views of a cup and a sealing element in accordance with exemplary embodiments;

[0066] FIGs. 7A - 7C illustrate perspective and cross-section views of a cup in accordance with exemplary embodiments;

[0067] FIGs. 8A and 8B illustrate isotherms taken along perpendicular axes as generated by the applicators according to the exemplary embodiments described herein;

[0068] FIG. 9 shows tables containing subject demographics and tested body areas of one study conducted to determine the efficacy of applicator geometries in accordance with embodiments described herein;

[0069] FIG. 10 shows tables containing results from the study conducted to determine the efficacy of applicator geometries in accordance with embodiments described herein;

[0070] FIG. 11 is a flowchart of a method for treating a subject in accordance with embodiments of the present technology;

[0071 ] FIG. 12 illustrates an exemplary applicator geometry in accordance with embodiments described herein to applicator geometries ill-suited for administering cryolipolysis therapy to a flank of a patient;

[0072] FIGs. 13 A and 13B illustrate an applicator and connector assembly in accordance with embodiments of the present technology;

[0073] FIGs. 14A-14C illustrate a control unit configured in accordance with embodiments of the present technology; and

[0074] FIG. 15 is a schematic block diagram illustrating subcomponents of a controller in accordance with embodiments of the present technology.

DETAILED DESCRIPTION

[0075] The present disclosure describes treatment systems, applicators, and methods for affecting targeted sites, and particularly for affecting the tissue of a flank or side abdomen of a patient. Conventional applicator systems have geometries ill-suited for delivering cryolipolysis therapy to anatomical sites having large degrees of curvature e.g., the side abdomen and/or flank). Clinicians attempting to administer cryolipolysis therapies to such anatomical sites often report insufficient seals formed between an applicator and a patient’s tissue. Such insufficient seals can result in inconsistent treatment and applicators popping off the patient’s tissue during use, both of which can increase treatment time and cost, as well as patient frustration and discomfort. This problem is particularly exacerbated for patients that have narrower, more petite, body profiles and/or are of a generally smaller stature.

[0076] The applicator geometries described herein are uniquely suited for administering cryolipolysis therapies to anatomical sites having large degrees of curvature, such as a flank or a side abdomen of a patient, reducing the frequency of pop-offs, improving consistency of treatment, and providing greater comfort to patients. The enhanced performance of the instant applicator, in particular, was confirmed in multiple clinical evaluations relative to applicators having different geometries and dimensions, including variant versions of the instant applicator, as well as relative to other conventional applicators, including the Cl 00, Cl 20, and Cl 50 ELITE applicators. In each instance, clinicians favored the instant applicator described herein when treating anatomical sites having large degrees of curvature, such as the flank or side abdomen of a patient.

[0077] The unique combination of cup geometries, cup dimensions, and cooling capacity elements of the instant applicator described and claimed herein make it an optimal applicator for effectively treating anatomical sites having large degrees of curvature, such as a flank or a side abdomen of a patient, in addition to those patients having narrower flank and/or side abdomen profiles, and patients having more pliable skin either alone or in combination with narrower flank and/or abdomen profiles.

[0078] Several general embodiments are directed to treatment systems having one or more of the following features:

(a) an applicator that can be rapidly connected and/or disconnected from the system, thus allowing the applicators to be exchanged with each other as appropriate to tailor the treatment to a particular patient and/or treatment region; individual applicators can have treatment surfaces and sealing elements particularly shaped to provide better contact with the skin surface of the flank of a patient and improve patient comfort;

(b) a cooling unit configured to provide faster and more efficient cooling of the flank tissue via the applicator(s); (c) one or more vacuum units configured to provide more rapid and responsive application of vacuum pressure along the skin surface of the flank via the applicator(s);

(d) a control unit housing the electronic components for controlling and monitoring the treatment procedure;

(e) a connector configured to releasably couple to the applicators and/or the control unit to allow for rapid and simple interchange of system components, and also to facilitate cleaning and storage; and/or

(f) additional components and accessories.

[0079] 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.

[0080] Some aspects of the technology are directed to an applicator for selectively affecting the subcutaneous tissue of a subject's flank. The applicator can include a housing and a treatment cup mounted in the housing. The treatment cup can define a tissue-receiving cavity and include a temperature-controlled surface. The applicator can also include at least one thermal device coupled to the treatment cup and configured to receive energy via a flexible connector coupled to the applicator and to cool the temperature-controlled surface. The applicator can further include at least one vacuum port coupled to the treatment cup and configured to provide a vacuum to draw the subject's flank tissue into the tissue-receiving cavity and against at least a portion of a treatment area of the temperature-controlled surface to selectively damage and/or reduce the subject’s subcutaneous tissue along the subject’s flank. The applicator can have a ratio of the treatment area to tissue-draw depth greater than or equal to 8 inches.

[0081 ] In another aspect, the present technology includes an apparatus for treating a subject’s flank tissue. The apparatus includes at least one heat-exchanger plate having a cooling surface and at least one thermal unit thermally contacting the at least one heat-exchanger plate.

[0082] In a further aspect, the present technology includes a kit for treating a subject’s flank tissue. The kit includes an applicator including a treatment cup defining a tissue-receiving cavity and having a temperature-controlled surface configured to cool and selectively reduce the subject’s flank tissue. The kit also includes a connector configured to operably couple a single applicator to a control unit of a treatment system. Each applicator can include an interconnect section configured to releasably couple the applicator to the connector.

[0083] In yet another aspect, the present technology includes a treatment system for cooling and selectively affecting a subject’s flank tissue. The treatment system can include at least one applicator including a treatment cup configured to be in thermal communication with the subject's flank tissue, and a control unit operably coupled to the at least one applicator. The control unit can include a cooling unit configured to cool the treatment cup of the at least one applicator, and at least one vacuum unit configured to apply a vacuum unit to the subject's flank tissue via the treatment cup. The at least one vacuum unit can be configured to reach a target vacuum pressure with at least one of (a) an amount of overshoot that is no more than 10% of the target pressure or (b) an amount of undershoot that is no more than 10% of the target pressure.

[0084] In still another aspect, the present technology includes a gel trap for fluidically coupling a vacuum line to a tissue-receiving cavity of an applicator. The gel trap includes a container configured to capture gel, and at least one sealing member configured to sealingly engage the applicator to fluidically couple the vacuum line to a vacuum port of the applicator such that the container captures gel drawn out of the tissue-receiving cavity while allowing air flow between the tissue-receiving cavity and the vacuum line to hold a subject’s flank tissue in the tissue-receiving cavity.

[0085] The embodiments disclosed herein can be for cosmetically beneficial alterations of a patient’s flank regions. Some cosmetic procedures may be for the sole purpose of altering the flank region to conform to a cosmetically desirable look, feel, size, shape and/or other desirable cosmetic characteristic or feature. Accordingly, at least some embodiments of the cosmetic procedures can be performed without providing an appreciable therapeutic effect (e.g., no therapeutic effect). For example, some cosmetic procedures may not include restoration of health, physical integrity, or the physical well-being of a subject. The cosmetic methods can target subcutaneous regions of the flank to change a human subject’s appearance. In other embodiments, however, cosmetically desirable treatments may have therapeutic outcomes (whether intended or not), such as psychological benefits, alteration of body hormone levels (by the reduction of adipose tissue along the flank), etc. [0086] Reference throughout this specification to “one example,” “an example,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example of the present technology. Thus, the occurrences of the phrases “in one example,” “in an example,” “one embodiment,” or “an embodiment” in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, routines, stages, or characteristics may be combined in any suitable manner in one or more examples of the technology.

[0087] The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the technology.

A. Overview of the Technology

[0088] FIGs. 1 A-1C and the following discussion provides a brief, general description of a treatment system 100 in accordance with some embodiments of the technology. Referring first to FIG. 1A, the treatment system 100 can be a temperature-controlled system for exchanging heat with a cryolipolysis treatment patient 101 and can include at least one non- invasive tissue-cooling apparatus in the form of a cooling cup applicator (“applicator”) configured to selectively cool tissue to affect targeted tissue along the flank of a patient. In the illustrated embodiment, the treatment system 100 includes a first applicator 102a and a second applicator 102b (collectively, “applicators 102”). Each of the applicators 102 is configured to be disposed along the flank of a patient, the flank being a portion of the torso extending along a side thereof. Each of the applicators 102 of FIG. 1 A is shown positioned along the flank of the patient of FIG. 1A.

[0089] The applicators 102 as described herein can deliver cryolipolysis treatments to patients having a range of physical attributes. As described further below with respect to exemplary studies, patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, have weights between 100 pounds and 200 pounds. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 70 millimeters and about 155 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 75 millimeters and about 150 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 80 millimeters and about 145 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 85 millimeters and about 140 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 80 millimeters and about 135 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 85 millimeters and about 130 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 90 millimeters and about 125 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of between about 95 millimeters and about 105 millimeters. Patients for whom the applicator design described herein may be particularly effective at administering cryolipolysis therapy may, for example, also have flanks with radii of about 100 millimeters.

[0090] Each of the applicators 102 can draw a vacuum to provide suitable thermal contact with the subject’s skin to cool subcutaneous adipose tissue along the flank. As described herein, each of the applicators 102 has a geometry that is configured to facilitate a high amount of thermal contact with the subject’s skin along the flank by minimizing, limiting, or substantially eliminating air gaps at the applicator/tissue interface. The entire flank skin surface of the retained volume of tissue can be cooled for efficient treatment. Each applicator 102 can have a relatively shallow tissue-receiving chamber to avoid or limit pop offs from the flank (e.g., when an applicator pops off the subject due to a vacuum leak), air gaps, excess stretching of tissue, pooling of blood, rupturing of blood vessels, patient discomfort, and so forth.

[0091 ] The applicators 102 can be used to perform medical treatments to provide therapeutic effects and/or cosmetic procedures for cosmetically beneficial effects. Without being bound by theory, selective effects of cooling are believed to result in, for example, membrane disruption, cell shrinkage, disabling, disrupting, damaging, destroying, removing, killing, and/or other methods of lipid-rich cell alteration. Such alteration is believed to stem from one or more mechanisms acting alone or in combination. It is thought that such mechanism(s) trigger an apoptotic cascade, which is believed to be the dominant form of lipid- rich cell death by non-invasive cooling. In any of these embodiments, the effect of tissue cooling can be the selective reduction of lipid-rich cells by a desired mechanism of action, such as apoptosis, lipolysis, or the like. In some procedures, the applicators 102 can cool the skin surface and/or targeted tissue of the flank to cooling temperature in a range of from about -25 °C to about 20 °C. In other embodiments, the cooling temperatures can be from about -20 °C to about 10 °C, from about -18 °C to about 5 °C, from about -15 °C to about 5 °C, or from about -15 °C to about 0 °C. In further embodiments, the cooling temperatures can be equal to or less than -5 °C, -10 °C, -15 °C, or in yet another embodiment, from about -15 °C to about -25 °C. Other cooling temperatures and temperature ranges can be used.

[0092] Apoptosis, also referred to as “programmed cell death”, is a genetically-induced death mechanism by which cells self-destruct without incurring damage to surrounding tissues. An ordered series of biochemical events induce cells to morphological change. These changes include cellular blebbing, loss of cell membrane asymmetry and attachment, cell shrinkage, chromatin condensation, and chromosomal DNA fragmentation. Injury via an external stimulus, such as cold exposure, is one mechanism that can induce cellular apoptosis in cells. Nagle, W.A., Soloff, B.L., Moss, A.J. Jr., Henle, K.J. “Cultured Chinese Hamster Cells Undergo Apoptosis After Exposure to Cold but Nonfreezing Temperatures” Cryobiology 27, 439-451 (1990).

[0093] One aspect of apoptosis, in contrast to cellular necrosis (a traumatic form of cell death causing local inflammation), is that apoptotic cells express and display phagocytic markers on the surface of the cell membrane, thus marking the cells for phagocytosis by macrophages. As a result, phagocytes can engulf and remove the dying cells (e.g., the lipid- rich cells) without eliciting an immune response. Temperatures that elicit these apoptotic events in lipid-rich cells may contribute to long-lasting and/or permanent reduction and reshaping of subcutaneous adipose tissue.

[0094] One mechanism of apoptotic lipid-rich cell death by cooling is believed to involve localized crystallization of lipids within the adipocytes at temperatures that do not induce crystallization in non-lipid-rich cells. The crystallized lipids may selectively injure these cells, inducing apoptosis (and may also induce necrotic death if the crystallized lipids damage or rupture the bi-lipid membrane of the adipocyte). Another mechanism of injury involves the lipid phase transition of those lipids within the cell’s bi-lipid membrane, which results in membrane disruption or dysfunction, thereby inducing apoptosis. This mechanism is well- documented for many cell types and may be active when adipocytes, or lipid-rich cells, are cooled. Mazur, P., “Cryobiology: the Freezing of Biological Systems” Science, 68: 939-949 (1970); Quinn, P.J., “A Lipid Phase Separation Model of Low Temperature Damage to Biological Membranes” Cryobiology, 22: 128-147 (1985); Rubinsky, B., “Principles of Low Temperature Preservation” Heart Failure Reviews, 8, 277-284 (2003). Other possible mechanisms of adipocyte damage, described in U.S. Patent No. 8,192,474, relate to ischemia/reperfusion injury that may occur under certain conditions when such cells are cooled as described herein. For instance, during treatment by cooling as described herein, the targeted adipose tissue along the flank may experience a restriction in blood supply and thus be starved of oxygen due to isolation as a result of applied pressure, cooling which may affect vasoconstriction in the cooled tissue, or the like. In addition to the ischemic damage caused by oxygen starvation and the buildup of metabolic waste products in the tissue during the period of restricted blood flow, restoration of blood flow after cooling treatment may additionally produce reperfusion injury to the adipocytes due to inflammation and oxidative damage that is known to occur when oxygenated blood is restored to tissue that has undergone a period of ischemia. This type of injury may be accelerated by exposing the adipocytes to an energy source (via, e.g., thermal, electrical, chemical, mechanical, acoustic, or other means) or otherwise increasing the blood flow rate in connection with or after cooling treatment as described herein. Increasing vasoconstriction in such adipose tissue by, e.g., various mechanical means (e.g., application of pressure or massage), chemical means or certain cooling conditions, as well as the local introduction of oxygen radical-forming compounds to stimulate inflammation and/or leukocyte activity in adipose tissue may also contribute to accelerating injury to such cells. Other yet-to-be understood mechanisms of injury may exist.

[0095] In addition to the apoptotic mechanisms involved in lipid-rich cell death, local cold exposure is also believed to induce lipolysis (i.e., fat metabolism) of lipid-rich cells and has been shown to enhance existing lipolysis which serves to further increase the reduction in subcutaneous lipid-rich cells. Vallerand, A.L., Zamecnik. J., Jones, P.J.H., Jacobs, I. “Cold Stress Increases Lipolysis, FFA Ra and TG/FFA Cycling in Humans” Aviation, Space and Environmental Medicine 70, 42-50 (1999).

[0096] One expected advantage of the foregoing techniques is that the subcutaneous lipid-rich cells in the target flank region can be reduced generally without collateral damage to non-lipid-rich cells in the same region. In general, lipid-rich cells can be affected at low temperatures that do not affect non-lipid-rich cells. As a result, lipid-rich cells, such as those associated with highly localized adiposity (e.g., adiposity along the abdomen, submental adiposity, submandibular adiposity, facial adiposity, etc.), can be affected while non-lipid-rich cells (e.g., myocytes) in the same generally region are not damaged. The unaffected non-lipid- rich cells can be located underneath lipid-rich cells (e.g., cells deeper than a subcutaneous layer of fat), in the dermis, in the epidermis, and/or at other locations.

[0097] In some procedures, the treatment system 100 can remove heat from underlying tissue through the upper layers of tissue and create a thermal gradient with the coldest temperatures near the cooling surface, or surfaces, of the applicators 102 (i.e., the temperature of the upper layer(s) of the skin can be lower than that of the targeted underlying target cells). It may be challenging to reduce the temperature of the targeted cells low enough to be destructive to these target cells (e.g., induce apoptosis, cell death, etc.) while also maintaining the temperature of the upper and surface skin cells high enough so as to be protective (e.g., non-destructive). The temperature difference between these two thresholds can be small (e.g., approximately, 5 °C to about 20 °C, less than 5 °C, less than 10 °C, less than 15 °C, less than 20 °C, etc.). Protection of the overlying cells (e.g., typically water-rich dermal and epidermal skin cells) from freeze damage during dermatological and related aesthetic procedures that involve sustained exposure to cold temperatures may include improving the freeze tolerance and/or freeze avoidance of these skin cells by using, for example, cryoprotectants for inhibiting or preventing such freeze damage.

[0098] If an inadvertent partial skin freeze occurs, tissue can be rapidly rewarmed as soon as practicable after a partial skin freeze event has occurred to limit, reduce, or prevent damage and adverse side effects associated with the skin freeze event. After a partial skin freezing event begins, tissue can be rapidly warmed as soon as possible to minimize or limit damage to tissue, such as the epidermis. In some procedures, skin tissue is partially or completely intentionally frozen for a predetermined period of time and then warmed. According to one embodiment, an applicator can warm shallow tissue using, for example, thermoelectric elements in the device. Thermoelectric elements can include Peltier devices capable of operating to establish a desired temperature (or temperature profile) along the surface. In other embodiments, the applicator outputs energy to warm tissue. In some procedures, the tissue can be warmed at a rate of about 1 °C/s, 2 °C/s, 2.5 °C/s, 3 °C/s, 5 °C/s, or other rate selected to thaw frozen tissue after the tissue has been partially or completely frozen for about 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, or other suitable length of time. If the subject 101 experiences discomfort (e.g., discomfort associated with skin freezing, excessive tissue draw, etc.), the subject 101 can use a notifier device 103 to summon the operator, clinician, physician, etc. In some embodiments, when the subject 101 presses a button of the notifier device 103, a healthcare worker is notified via a mobile device, such as a pager, a smartphone, etc. The healthcare worker can evaluate the subject 101 during and after warming of tissue. The system 100 can also perform additional monitoring in response to notifications to identify and monitor adverse events. The notifier device 103 can also include buttons for two-way communication (e.g., two-way talking via a local network or a wide area network), indicating discomfort level, or the like.

[0099] FIG. IB is a schematic cross-sectional view of the first applicator 102a of FIG. 1 A, the first applicator 102a of FIG. 1 A being configured to deliver cryolipolysis treatment to the patient of FIG. 1A. Applicator 102a includes a housing 150 and a contoured lip or sealing element 152. The sealing element 152 can conform closely to contours of the subject’s flank to sealingly engage a skin surface 155. The housing 150 can support a cup 156 defining a tissuereceiving cavity 158 for holding tissue. The cup 156 can include a temperature-controlled surface 160 and a vacuum port 162. Suction can be applied to the patient’s tissue via the vacuum port 162 to draw the skin surface 155 into contact with the temperature-controlled surface 160. As described herein, the geometry of applicator 102a can be configured so that applicator 102a is particularly suited for cryo lipolysis on the flank of the patient. As described further herein, contoured lip or sealing element 152 and cup 156 of applicator 102a can have geometries that are configured to facilitate a vacuum seal 154 against a flank of a cryolipolysis treatment patient.

[00100] If a liner or gel pad (not shown) is used with the applicator 102a, the sealing element 152 can engage the liner or gel pad overlying the treatment site. For example, the liner can line the cup 156 and can be perforated such that a vacuum can be drawn through the liner to urge the subject’s skin against the liner, thereby maintaining thermal contact between the tissue and the cup 156 via the liner. The cup 156 can be thermally conductive to efficiently cool the entire volume of targeted tissue retained in the applicator 102a. The liner or gel pad contains an excess of cryoprotectant gel to ensure adequate coverage of the patient’s skin, and effective thermal conductivity to enhance efficacy of the cryolipolysis treatment.

[00101 ] The geometries of the cup 156 and sealing element 152 can be selected to conform to a contour of a cutaneous layer of a patient having a smaller stature. For example, the flank or side abdomen of the exemplary cryolipolysis treatment patient as shown in FIG. 1 may have a relatively small radius of curvature (corresponding to a large degree of curvature). Accordingly, the tissue-receiving cavity 158 of the cup 156 can have a substantially U-shaped cross section or a partially circular/elliptical cross-section, as well as or other cross-sectional shapes suitable for receiving tissue and matching flank contours. The thermal properties, shape, and/or configuration of the cup 156 are designed to provide efficient and effective treatment of the flank, such as for patients having more narrow torso dimensions, including examples of such patients provided herein. The maximum depth of the tissue-receiving cavity 158 is also selected based on such narrow-torso patients, as well as, for example, the volume of targeted flank tissue, characteristics of the targeted flank tissue (including skin type and pliability), and/or desired level of patient comfort. Embodiments of the tissue-receiving cavity 158 for treating large volumes of tissue along the flank can have a maximum depth equal to or less than about 48 cm, 49 cm, or 50 cm, for example. The sealing element 152 can be fitted to individual lipid-rich cell deposits to achieve an approximately air-tight seal along the flank, achieve the vacuum pressure for drawing flank tissue into the tissue-receiving cavity 158, maintain suction to hold the flank tissue, and use little or no force to maintain contact between the applicator 102a and a patient.

[00102] The applicator 102a can further include one or more thermal devices 164 coupled to, embedded in, or otherwise in thermal communication with the temperature-controlled surface 160 of the cup 156. The thermal devices 164 can include, without limitation, one or more thermoelectric elements (e.g., Peltier-type elements), fluid-cooled elements, heatexchanging units, or combinations thereof. In a cooling mode, fluid-cooled elements can cool the backside of the thermoelectric elements to keep the thermoelectric elements at or below a target temperature. In a heating mode, fluid-cooled elements can heat the backside of the thermoelectric elements to keep the thermoelectric elements at or above a target temperature. In some embodiments, the thermal devices 164 include only fluid-cooled elements or only nonfluid-cooled elements. The thermal devices 164 can be coupled to, embedded in, or associated with the cup 156. Although the illustrated embodiment has two thermal devices 164, in other embodiments applicator 102a can have any desired number of thermal devices 164. The number, positions, configurations, and operating temperatures of the thermal devices 164 can be selected based on cooling/heating suitable for treatment, desired power consumption, or the like.

[00103] The applicator 102a can be used to cool a subcutaneous target flank region 166, e.g., by transferring heat from subcutaneous, lipid-rich tissue 168 via the cup 156 to the thermal devices 164. The temperature-controlled surface 160 can thermally contact an area of the subject’s skin less than or equal to about 100 cm², 105 cm², 110 cm², or other suitable area. The temperature-controlled surface 160 can be cooled to a temperature equal to or less than a selected temperature (e.g., 5 °C, 4°C, 0 °C, -2 °C, -5 °C, -7 °C, -10 °C, -11°C, -13 °C, -14 °C -15 °C, -20 °C, -25 °C, etc.) to cool most of the skin surface 155 of the retained tissue. In one embodiment, most of the temperature-controlled surface 160 can be cooled to a temperature equal to or less than about 5°C, 4°C, 0°C, -2°C, -5°C, -10°C, -11°C, -13 °C, -14 °C or -15°C. In some embodiments, the temperature-controlled surface 160 is cooled to a temperature of about -1 1 °C, the skin surface 155 is cooled to a temperature of about -10 °C, and the subcutaneous target region 166 is cooled to temperatures within a range from about -8 °C to about 10 °C. The cooled temperature of the subcutaneous target region 166 can vary based on the tissue depth, e.g., subcutaneous tissue within 1.5 mm of the skin surface 155 can be cooled to about -8 °C, subcutaneous tissue within 11.5 mm of the skin surface 155 can be cooled to about 4 °C, and subcutaneous tissue deeper than 11.5 mm can be cooled to about 10 °C.

[00104] The heat extracted from the target region 166 can be carried away from the thermal devices 164 via a circulating coolant (not shown), as described in greater detail below. In some embodiments, the cooling treatment primarily affects lipid-rich cells in the target region 166 with little or no reduction or damage to non-lipid-rich cells in or near the region 166 (e.g., cells in the dermis 170 and/or epidermis 172).

[00105] Applicator 102a can include a trap 165 that selectively captures substances (e.g., cryoprotectant gel, liquid, condensation, etc.) drawn into the vacuum port 162. The trap 165 can hold the captured substances away from the applicator-skin interface to maintain a high area of thermal contact and prevent the substances from reaching downstream components. The trap 165 can include a chamber 171, an outlet 173, and an air-permeable element 167 (e.g., an air-permeable and gel-impermeable membrane) covering the outlet 173. In some embodiments, the trap 165 functions as a gel trap. When the vacuum is started, air (indicated by arrows) can be drawn into and through the vacuum port 162. Gel 169 can also be drawn through the vacuum port 162 and into the trap 165. Air in the chamber 171 can flow through the air-permeable element 167 and into a passageway 177 between the trap 165 and a backside receiving feature or manifold 175. The air ultimately flows away from the applicator 102a via the connector 104a (FIG. 1A). The accumulated gel 169 is held away from heat flow paths between the cup 156 and the subject’s tissue. The trap 165 is viewable from a backside of the applicator during treatment to confirm installation. The trap 165 can be emptied of accumulated gel 169 when the vacuum is stopped (e.g., between treatment sessions, after completion of a set of sessions, etc.). The number, configuration, holding capacity, and filtering capabilities of traps can be selected based on the procedure to be performed.

[00106] Referring again to FIG. 1A, the treatment system 100 includes a first connector 104a and a second connector 104b (collectively, “connectors 104”) that extend from a control unit or module 106 to the first applicator 102a and the second applicator 102b, respectively. The connectors 104 can provide suction for drawing tissue into the applicators 102, and can also deliver energy (e.g., electrical energy) and fluid (e.g., coolant) from the control unit 106 to the applicators 102. In some embodiments, each connector 104 is configured to releasably couple to the applicator 102 and/or the control unit 106 (e.g., via a bayonet connection).

[00107] FIG. 1C is a cross-sectional view of the first connector 104a and shows the connector 104a including a main body 179, a supply fluid line or lumen 180a (“supply fluid line 180a”), and a return fluid line or lumen 180b (“return fluid line 180b”). The main body 179 may be configured (via one or more adjustable joints) to “set” in place for the treatment of the subject 101. The supply and return fluid lines 180a, 180b can be conduits comprising, in whole or in part, polyethylene, polyvinyl chloride, polyurethane, and/or other materials that can accommodate circulating coolant, such as water, glycol, synthetic heat transfer fluid, oil, a refrigerant, and/or any other suitable heat conducting fluid for passing through fluid-cooled elements (e.g., thermal devices 164 of FIG. IB), or other components. In one embodiment, each fluid line 180a, 180b can be a flexible hose surrounded by the main body 179.

[00108] The connector 104a can also include one or more electrical lines 112 for providing power to the applicator 102a and one or more control lines 116 for providing communication between the control unit 106 (FIG. 1A) and the applicator 102a (FIGs. 1A and IB). The electrical lines 112 can provide power to the thermoelectric elements, sensors, and so forth. To provide suction, the connector 104a can include one or more vacuum lines 125. In various embodiments, the connector 104a can include a bundle of fluid conduits, a bundle of power lines, wired connections, vacuum lines, and other bundled and/or unbundled components selected to provide ergonomic comfort, minimize unwanted motion (and thus potential inefficient removal of heat from the subject), and/or to provide an aesthetic appearance to the treatment system 100.

[00109] Referring again to FIG. 1A, the control unit 106 can include a cooling or fluid system, a power supply, and a controller carried by a housing. The cooling system can include one or more fluid chambers, refrigeration units, cooling towers, thermoelectric chillers, heaters, or any other devices capable of controlling the temperature of coolant in the fluid chamber. The coolant can be continuously or intermittently delivered to the applicators 102 via the supply fluid line 180a (FIG. 1C) and can circulate through the applicators 102 to absorb heat. The coolant, which has absorbed heat, can flow from the applicators 102 back to the control unit 106 via the return fluid line 180b (FIG. 1C). The control unit 106 can have multiple refrigeration units, and in some embodiments, each of the multiple refrigeration units can be responsible for cooling coolant from one of the applicators 102. For warming periods, the control unit 106 can heat the coolant that is circulated through the applicators 102. Alternatively, a municipal water supply (e.g., tap water) can be used in place of or in conjunction with the control unit 106. Additional examples of cooling systems are discussed below in connection with FIGs. 2A and 2B.

[00110] A pressurization device or vacuum system can provide suction to the applicator 102 via the vacuum line 125 (FIG. 1C) and can include one or more vacuum sources (e.g., pumps). Air pockets between the subject’s tissue and the temperature-controlled surface 160 of the applicator 102a can impair heat transfer with the tissue and, if large enough, can affect treatment efficacy. The pressurization device can provide a sufficient vacuum to eliminate such air gaps (e.g., large air gaps between the tissue and the temperature-controlled surface 160 of FIG. IB) such that substantially no air gaps impair non-invasively cooling of the subject’s subcutaneous lipid-rich cells to a treatment temperature. Additional examples of pressurization devices/vacuum systems are discussed below in connection with FIGs. 2A and 2C.

[00111] Air pressure can be controlled by one or more regulators located between the pressurization device and the applicator 102. The control unit 106 can control the vacuum level to, for example, draw tissue into the applicator 102 while maintaining a desired level of comfort. If the vacuum level is too low, a liner assembly, gel pad, tissue, etc. may not be drawn adequately (or at all) into and/or held within the applicator 102. If the vacuum level is too high when preparing the applicator 102, a liner assembly can break (e.g., rupture, tear, etc.). If the vacuum level is too high during treatment, the patient can experience discomfort, bruising, or other complications. According to certain embodiments, approximately 0.5 inHg, 1 inHg, 2 inHg, 3 inHg, 5 inHg, 7 inHg, 8 inHg, 10 inHg, or 12 inHg vacuum is applied to draw or hold the liner assembly, tissue, etc. Other vacuum levels can be selected based on the characteristics of the tissue, desired level of comfort, and vacuum leakage rates. Vacuum leak rates of the applicator 102 can be equal to or less than about 0.2 LPM, 0.5 LPM, 1 LPM, or 2 LPM at the pressure levels disclosed herein. For example, the vacuum leak rate can be equal to or less than about 0.2 LPM at 8 inHg, 0.5 LPM at 8 inHg, 1 LPM at 8 inHg, or 2 LPM at 8 inHg. The configuration of the pressurization device 123 and applicator 102 can be selected based on the desired vacuum levels, leakage rates, and other operating parameters.

[00112] The power supply can provide a direct current voltage for powering electrical elements of the applicators 102 via the line 112 (FIG. 1C). The electrical elements can be thermal devices, sensors, actuators, controllers (e.g., a controller integrated into the applicators 102), or the like. An operator can use an input/output device (e.g., a screen) of the controller to control operation of the treatment system 100, and the input/output device can display the state of operation of the treatment system 100 and/or progress of a treatment protocol. In some embodiments, the controller can exchange data with the applicator 102 via the line (e.g., line 116 of FIG. 1C), a wireless communication link, or an optical communication link and can monitor and adjust treatment based on, without limitation, one or more treatment profiles and/or patient-specific treatment plans, such as those described, for example, in commonly assigned U.S. Patent No. 8,275,442. The controller can contain instructions to perform the treatment profiles and/or patient-specific treatment plans, which can include one or more segments, and each segment can include temperature profiles, vacuum levels, and/or specified durations (e.g., 1 minute, 5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, etc.). For example, the controller can be programmed to cause the pressurization device to operate to pull tissue into the applicator. After tissue draw, the pressurization device can operate to hold the subject’s flank skin in thermal contact with appropriate features while the cup 156 (FIG. IB) conductively cools tissue. If a sensor detects tissue moving out of thermal contact with the cup 156, the vacuum can be increased to reestablish suitable thermal contact. In some embodiments, the controller is programmed to cause the pressurization device to provide a sufficient vacuum to keep substantially all of each region of the temperature-controlled surface 160 (FIG. IB) between air-egress features in thermal contact with the subject’s skin. This provides a relatively large contact interface for efficient heat transfer with the target flank tissue.

[00113] Different vacuum levels can be utilized during treatment sessions. For example, relatively strong vacuums can be used to pull the subject’s flank tissue into the applicator 102. A weaker vacuum can be maintained to hold the subject’s flank tissue against the thermally conductive surface. If suitable thermal contact is not maintained (e.g., the subject’s skin moves away from the thermally conductive surface), the vacuum level can be increased to reestablish suitable thermal contact. In other procedures, a generally constant vacuum level can be used throughout the treatment session.

[00114] In some embodiments, a treatment profile includes specific profiles for each applicator 102 to concurrently or sequentially treat multiple treatment sites, including, but not limited to, sites along the subject’s flank and side abdomen. The vacuum level and cup configuration can be selected based on the treatment site and desired volume of tissue to be treated. In some embodiments, the controller can be incorporated into the applicators 102 or another component of the treatment system 100. Additional examples of control units and controllers are described below in connection with FIGs. 2A, 14A-14C, and 15.

B. Treatment System

[00115] FIG. 2A is a schematic block diagram illustrating a treatment system 200 configured in accordance with embodiments of the present technology. The components of the treatment system 200 can be identical or generally similar to the components of the treatment system 100. For example, as shown in FIG. 2A, the treatment system 200 includes a first applicator 202a and a second applicator 202b (collectively, “applicators 202”), a first connector 204a and a second connector 204b (collectively, “connector 204”), and a control unit 206. The first applicator 202a is coupled to the control unit 206 via the first connector 204a, and the second applicator 202b is coupled to the control unit 206 via the second connector 204b. Each applicator 202 includes a respective treatment cup 208 (e.g., first and second treatment cups 208a, 208b) for receiving and cooling a patient’s tissue. The treatment cups 208 can include and/or be coupled to thermal devices configured to draw heat from the patient’s tissue. Each treatment cup 208 can be coupled to a respective circuit board 210 (e.g., first and second circuit boards 210a, 210b) including electronic components for monitoring the treatment applied to the tissue and routing control and/or power signals, as described in greater detail below.

[00116] The control unit 206 includes various components for controlling the treatment applied to the patient’s tissue via the applicators 202. In some embodiments, for example, the control unit 206 includes an embodiment of cooling system or unit 212 operably coupled to the treatment cups 208 of the applicators 202. As shown in FIG. 2A, the cooling system 212 can be configured to deliver a coolant to the applicators 202 (e.g., via supply fluid lines 214a, 214b) that circulates through the system 200 to absorb heat from the patient’s tissue. The heated coolant can flow from the applicators 202 back to the cooling system 212 (e.g., via return fluid lines 216a, 216b). The cooling system 212 can reduce the temperature of the returned coolant and recirculate the coolant to the applicators 202. Additional details of the cooling system 212 are provided further below in connection with FIG. 2B.

[00117] The control unit 206 optionally includes a first vacuum system or unit 218a operably coupled to the first treatment cup 208a via a first vacuum line 220a, and a second vacuum system or unit 218b operably coupled to the second treatment cup 208b via a second vacuum line 220b. Although the first and second vacuum systems 218a, 218b (collectively, “vacuum systems 218”) are illustrated as separate components, in other embodiments the first and second vacuum systems 218a, 218b can be replaced with a single vacuum system for both applicators 202. Similar to the pressurization device described above, the vacuum systems 218 can provide suction to draw the patient’s flank tissue into contact with the surfaces of the treatment cups 208 for more efficient cooling. In some embodiments, each applicator 202 has a vacuum-based tissue retention factor that may be expressed as a ratio of a treatment area of the applicator 202 to the weight of the applicator 202. The vacuum-based tissue retention factor can be sufficiently high such that the applicator 202 can remain secured to the subject only via the applied vacuum. For example, the vacuum-based tissue retention factor can be greater than or equal to 5 square inches per lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. Additional details of the vacuum systems 218 are provided further below in connection with FIG. 2C.

[00118] The control unit 206 can include various hardware and software components for controlling the applicators 202, cooling system 212, and vacuum systems 218. In the illustrated embodiment, for example, the control unit 206 includes a main controller 222, a first applicator controller 224a, and a second applicator controller 224b. The main controller 222 can be operably coupled to the cooling system 212, vacuum systems 218, and the first and second applicator controllers 224a, 224b (collectively, “applicator controllers 224”) to control the operation thereof. In some embodiments, the main controller 222 is electrically coupled to each of these components to provide power and control signals thereto, and can also receive status signals, sensor data (e.g., moisture data, flow rates, etc.), and/or other data from the components. For example, the main controller 222 can send control signals to the cooling system 212 to control the amount and/or rate of cooling, coolant flow rates, and/or other operational parameters. The main controller 222 can also receive sensor data from the cooling system 212 (e.g., temperature data, flow data, coolant level data) to assess the status of the cooling system 212. As another example, the main controller 222 can independently send control signals to the first and second vacuum systems 218a, 218b to control the amount of vacuum applied via the first and second applicators 202a, 202b, respectively. The main controller 222 can also receive sensor data from the first and/or second vacuum systems 218a, 218b (e.g., pressure data, flow data, etc.) to determine whether a suitable amount of pressure is being applied, or whether the pressure level should be adjusted.

[00119] In the illustrated embodiment, the main controller 222 is not directly connected to the circuit boards 210, and is instead indirectly coupled via the respective applicator controllers 224. The circuit boards 210 located within the applicators 202 can be configured to perform a limited set of operations, such as routing data and/or signals between the applicator controllers 224 and the applicator components associated with the treatment cups 208 (e.g., thermal devices, sensors, etc.). The remaining operations (e.g., data processing, control of applicator components, etc.) can be performed by the main controller 222 and/or the applicator controllers 224. In some embodiments, the first and second applicator controllers 224a, 224b can be operated independently from each other so that the first and second applicators 202a, 202b can apply different treatment profiles to the patient (e.g., based on the particular patient location to be treated).

[00120] The treatment system 200 further includes a computing device 226. The computing device 226 can be configured to receive input from an operator of the treatment system 200 via user interface elements such as a display 228 (e.g., a monitor or touchscreen). The computing device 226 can transmit the user input to the main controller 222, which converts the user input into control signals for operating the various system components (e.g., applicators 202, cooling system 212, and/or vacuum systems 218). Conversely, data received from the system components can be transmitted by the main controller 222 to the computing device 226 and be displayed to the user via the display 228. Optionally, the computing device 226 can be operably coupled to a card reader 230. The card reader 230 can be configured to receive a card that provides security information, treatment profile information, patient information, and/or other information relevant to the operation of the treatment system 200, as described in greater detail below in connection with FIGs. 14A-14C.

[00121] The operation of the treatment system 200 can be powered by a power system or unit 232. The power system 232 can receive power from an external power source such as an electrical wall outlet (not shown), and can be electrically coupled to the main controller 222 and computing device 226 to provide power thereto. The external power source can have a line voltage within a range from 100 V to 240 V, such as 100 V, 120 V, 200 V, 220 V, or 240 V. The main controller 222 can provide power to the remaining components of the treatment system 200 (e.g., circuit boards 210, cooling system 212, vacuum systems 218, and/or applicator controllers 224). The power system 232 can be configured to allow the treatment system 200 to operate with a variety of different voltages from the external power source. For example, the power system 232 can include a transformer circuit that automatically detects the line voltage from the external power source (e.g., 100- 120, 200-240 V at 50-60 Hz) and converts the line voltage to the system voltages used by the system components (e.g., 24 V for the main controller 222, 12 V for the computing device 226). In some embodiments, the transformer circuit can automatically measure the input line voltage and AC cycles, and convert the input into a constant output (e.g., 230 V at 50-60 Hz).

[00122] It will be appreciated that the treatment system 200 can be configured in many different ways. In other embodiments, for example, some of the components of the treatment system 200 can be combined with each other (e.g., the vacuum systems 218, the main controller 222, and applicator controllers 224). Alternatively, some of the components of the treatment system 200 can be provided as discrete, separate components (e.g., the main controller 222 can be separated into two or more discrete modules). Additionally, some of the components of the treatment system 200 can be omitted in other embodiments (e.g., the second applicator 202b, second connector 240b, and second vacuum system 218b). The treatment system 200 can also include components known to those of skill in the art that are omitted from FIG. 2A merely for purposes of clarity.

C. Cooling System

[00123] FIG. 2B is a schematic diagram of the cooling system 212 of the treatment system 200 of FIG. 2A. The cooling system 212 can be configured to remove heat from a patient via at least one applicator (e.g., applicators 202 of FIG. 2A) during a course of a cooling treatment applied to the patient. Optionally, the cooling system 212 can also remove heat from electronics or other components of the applicators 202 and/or treatment system 200 (e.g., circuit boards 210 of FIG. 2A). In some embodiments, the majority of the heat removed from the applicator 202 originates from the patient’ s tissue, rather than from internal components of the applicator 202 (e.g., at least 70%, 80%, 90%, 95% of the heat originates from the patient’s tissue). In some embodiments, heat produced by drivers, control circuitry, etc. can be generated remotely from the applicator 202. For example, as discussed in greater detail below, applicator controllers or drivers can be part of the control unit 206 such that a majority of heat (e.g., at least 70%, 80%, 90%, or 95% of the heat) produced by circuity (e.g., drive circuitry, control circuitry, etc.) is generated within the control unit 206 and away from the applicators 202. In some embodiments, a ratio of heat absorbed by the applicator 202 from the subject’s tissue to the heat actively removed (e.g., via circulating coolant) from the applicator by the treatment system is equal to greater than 0.7, 0.8, 0.9, or 0.95 during a portion or most of the treatment. The removed heat can be transferred to the room environment in which the treatment system 200 is operating.

[00124] The cooling system 212 can be configured in many different ways. In some embodiments, for example, the cooling system 212 includes a fluid chamber 240 for storing a coolant. The cooling system 212 can include a first coolant pump 242a for circulating the coolant to the first applicator 202a (FIG. 2 A) via the supply fluid line 214a, and a second coolant pump 242b for circulating the coolant to the second applicator 202b (FIG. 2A) via the supply fluid line 214b. Optionally, the first and second coolant pumps 242a, 242b can be replaced with a single coolant pump. The coolant can be circulated through the applicators 202 to absorb heat from the patient. The heated coolant then returns to the cooling system 212 via the return fluid lines 216a, 216b, respectively, for cooling. In embodiments where the multiple applicators 202 are used concurrently, the cooling system can cool the coolant from each applicator 202 independently or together. For example, the cooling system 212 can include a manifold 243 for combining the coolant from the return fluid lines 216a, 216b before cooling. In some embodiments, the cooling system 212 includes a vapor compression subsystem 244 for cooling the heated coolant. The vapor compression subsystem 244 can include components such as pumps, evaporators, condensers, fans, compressors, refrigerants, etc. For example, in the illustrated embodiment, the heated coolant flows through an evaporator 246, where the heat is transferred from the coolant to a refrigerant (e.g., R-134a). Once cooled, the cooled coolant can be returned to the fluid chamber 240 for re-circulation. Optionally, a filter 248 can be used to filter the coolant before it re-enters the fluid chamber 240.

[00125] The vapor compression subsystem 244 can further include a compressor 250, a condenser 252, and a fan 254. The heated refrigerant from the evaporator 246 can be circulated through the compressor 250 and the condenser 252 before returning to the evaporator 246. The compressor 250 can be a fixed speed compressor or a variable speed compressor. A fixed speed compressor may only have two compressor speed/power settings (e.g., on (100% power) and off (0% power)), while a variable speed compressor may have multiple speed/power settings (e.g., within a range from 0% power to 100% power). For example, the cooling system can have a variable speed compressor having power settings that are variable within a range from 40% power to 100% power in order to provide different cooling capacities. The power setting of the variable speed compressor can be varied based on the particular treatment procedure, applicator, and/or target efficiency. The use of a variable speed compressor may be advantageous for improving efficiency and reducing power consumption.

[00126] The cooling system 212 can include various types of sensors (e.g., flow sensors, temperature sensors, fluid level sensors) to monitor coolant circulation and/or temperature at various points in the system (e.g., at the fluid supply and/or return lines, fluid reservoir, etc.). For example, the cooling system 212 can include a fluid level sensor 256 and/or a fluid temperature sensor 258 in the fluid chamber 240. The cooling system 212 can also include first and second flow sensors 260a, 260b at the return fluid lines 216a, 216b. The cooling system 212 can also include an air temperature sensor 262 at the condenser 252.

[00127] In some embodiments, the cooling system 212 includes a cooling controller 264 (e.g., a microcontroller). The cooling controller 264 can be configured to receive data from the various sensors, and output power and/or control signals for various components such as the first and second coolant pumps 242a, 242b, the compressor 250, and the fan 254. Optionally, the cooling controller 264 can be operably coupled to a compressor controller 266 which controls the operation of the compressor 250 and receives status signals from the compressor 250.

[00128] In some embodiments, the cooling controller 264 is configured to anticipate the heating load on the system 212 and adjust the compressor speed accordingly. For example, the compressor speed can be increased if a relatively high heating load is expected (e.g., for multiapplicator procedures and/or procedure using an applicator with a relatively large treatment surface area). The control algorithm for the variable compressor speed can provide nonproportional cooling for managing peak cooling. The cooling controller 264 can also regulate operations of the fan 254 to reduce system noise.

[00129] The cooling system 212 can be configured to operate with various types of coolants, such water, a water/ethylene glycol mixture, a water/propylene glycol mixture, a water/methanol mixture, or any other suitable coolant. The cooling system 212 can be configured to maintain the coolant at a target temperature during operation of the treatment system 200. The target temperature can be less than or equal to 5°C, 4°C, 0 °C, -5 °C, -10 °C, or -15 °C. The cooling system 212 can take approximately 10 minutes from the start of the treatment procedure to reach steady state. During operation, the coolant can be circulated through the cooling system 212 at a flow rate within a range from 0.8 LPM to 1.2 LPM. The fluid supply and return lines 214, 216 for circulating coolant to and from the applicators 202 can have an inner diameter of approximately 0.187 inches.

[00130] In some embodiments, the cooling system 212 is configured to cool the applicator surface at a rate within a range from 0.1 °C/s to 5 °C/s, or 0.2 °C/s to 3 °C/s. For example, the cooling rate can be 0.1 °C/s, 0.2 °C/s, 0.3 °C/s, 0.4 °C/s, 0.5 °C/s, 0.6 °C/s, 0.7 °C/s, 0.8 °C/s, 0.9 °C/s, 1 °C/s, 1.5 °C/s, 2 °C/s, 2.5 °C/s, 3 °C/s, 3.5 °C/s, 4 °C/s, 4.5 °C/s, or 5 °C/s. The cooling rate can be measured based on temperatures of the applicator surface during the initial cooling phase (e.g., within the first 10 minutes of cooling). The transient rate of heat removal from the applicator 202 and/or patient (e.g., the rate upon initial contact) can be greater than or equal to 200 W, such as at least 210 W, 220 W, 230 W, 240 W, 250 W, 260 W, 270 W, 280 W, 290 W, 300 W, or more. The steady state rate of heat removal from the applicator 202 and/or patient can be greater than or equal to 150 W, such as at least 160 W, 170 W, 180 W, 190 W, 200 W, 210 W, 220 W, 230 W, 240 W, 250 W, or more. The efficiency of the cooling system 212 (e.g., as expressed as the ratio between the heat removal rate and power usage) can be greater than or equal to 75%, or within a range from 50% to 95%. For example, the efficiency can be at least 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95%. The improved efficiency of the cooling system 212 can reduce the amount of heating of the surrounding environment during the treatment procedure.

[00131] In some embodiments, the cooling system 212 is configured to precool the coolant to the target temperature before starting the treatment procedure, e.g., to avoid pumping excess heat into the room during the start of the procedure. Precooling can be performed on a small volume of coolant using a TEC -based system. The treatment procedure can then be initiated using the chilled coolant.

D. Vacuum System

[00132] FIG. 2C is a schematic diagram of a vacuum system 218 of the treatment system 200 of FIG. 2 A. The vacuum system 218 is configured to apply vacuum to a patient’s tissue during the course of a cooling treatment applied to the patient. Optionally, the vacuum can also be applied after the cooling treatment, e.g., to deliver a post-treatment vacuum massage. [00133] As previously described with respect to FIG. 2A, each applicator 202 can be connected to a respective independent vacuum system 218 via a respective vacuum line 220. The vacuum line 220 can have an inner diameter of approximately 0.187 inches. In some embodiments, the vacuum system 218 further includes a fluid trap 270 (e.g., located within the control unit 206 of FIG. 2A) for trapping and/or removing fluid that enters the vacuum line 220 (e.g., gel, water condensed on the applicator surface and/or other system components, residue on the applicator from prior cleaning, etc.) and which is not otherwise trapped by a gel trap located in the applicator 202 (e.g., trap 165 of FIG. IB). The use of a fluid trap 270 in the control unit 206 can be beneficial for improving vacuum performance, reducing maintenance frequency, and/or increasing the lifetime of the vacuum system 218. The fluid trap 270 can include one or more membranes, filters, valves, and/or other components configured to capture gel, liquid (e.g., water), or other contaminants in the vacuum line 220.

[00134] After exiting the fluid trap 270, the air passes through a proportional valve 272 and a vacuum pump 274, and exits the vacuum system 218. Optionally, the vacuum system 218 can include a bleed valve 276 between the fluid trap 270 and proportional valve 272. In some embodiments, the vacuum system 218 is a single-stage vacuum system (e.g., includes a single proportional valve 272 between the vacuum pump 274 and the applicator 202). The vacuum pump 274 can be configured to produce an air flow rate that is sufficiently high to rapidly evacuate air from the treatment system 200 (e.g., tubing, gel traps, etc.). For example, the air flow rate (e.g., as measured at the pump 274) can be at least 10 LPM, 15 LPM, or 20 LPM.

[00135] In some embodiments, the vacuum system 218 is configured to rapidly reach and maintain a target vacuum pressure with little or no oscillation (e.g., little or no overshoot and/or undershoot of the target pressure). The target vacuum pressure can be within a range from 3 inHg to 12 inHg, such as 8 inHg. The amount of time to reach the target vacuum pressure can be less than or equal to 5 seconds, 4 seconds, 3 seconds, 2 seconds, or 1 second. The amount of overshoot can be less than or equal to 20%, 15%, 10%, or 5% of the target vacuum pressure. The amount of undershoot can be less than or equal to 20%, 15%, 10%, or 5% of the target vacuum pressure. The dampening ratio of the overshoot to undershoot (e.g., upon initial vacuum draw and/or after a disturbance to the applied vacuum) can be within a range from 0.3 to 0.7, or approximately 0.7, 0.5, or 0.3. In some embodiments, for example, the vacuum system 218 reaches the target pressure in no more than 3 seconds with no more than 20% overshoot/undershoot. [00136] Additionally, the vacuum system 218 can be configured to maintain the target vacuum pressure during the treatment procedure with little or no pressure drop or loss. In some embodiments, the total pressure drop or loss is no more than 50%, 40%, 30%, 20%, 10%, or 5% of the target pressure value. For example, the total pressure drop and/or loss across the vacuum system 218 can be no more than 3 inHg for a flow rate of 15 LPM. As described in greater detail below, the fittings between the vacuum system 218 and the other components of the treatment system 200 (e.g., between the connector 204 of FIG. 2 A) can be configured to reduce or minimize leaks and/or other sources of pressure loss. The vacuum system 218 can also be configured to maintain a substantially constant amount of pressure, while avoiding excessively high and/or low vacuum pressures. For example, during operation of the vacuum system 218 (e.g., while vacuum pressure is being applied to the patient’s tissue), the maximum vacuum pressure can be less than or equal to 12 inHg, and the minimum pressure can be greater than or equal to 3 inHg.

[00137] The vacuum system 218 can include various types of sensors (e.g., pressure sensors, flow sensors) to detect whether the applied vacuum pressure is too high or too low. In some embodiments, for example, the vacuum system 218 can include at least one sensor 278 configured to monitor air flow within the vacuum system 218. The vacuum system 218 can use the flow measurements to reliably detect conditions that may lead to “pop off’ (e.g., vacuum pressure too low), “pop on” (e.g., vacuum pressure too high), leaks, or an improper seal between the applicator and the patient tissue. Pop off may occur if the vacuum pressure is less than a particular value (e.g., a value of 3 inHg, or within a range from 3 inHg to 7 inHg) for a certain time period (e.g., at least 3 seconds). Pop on may occur if the vacuum pressure is greater than a particular value (e.g., a value of 7 inHg, or within a range from 7 inHg to 12 inHg) for a particular time period (e.g., at least 3 seconds). Optionally, the sensor 278 can be located along the portion of the vacuum line near the vacuum pump 274, such as between the proportional valve 272 and the fluid trap 270. The flow-based techniques described herein for detecting pop off/pop on may be more robust and accurate than other techniques (e.g., pressure-based detection), and can be used to avoid vacuum conditions that are likely to adversely affect patient treatment. In some embodiments, the sensor 278 is configured to determine air flow based on pressure measurements (e.g., by calculating flow rate based on the pressure drop between two spaced-part pressure sensors). In other embodiments, the sensor 278 can directly measure air flow (e.g., by directly detecting a mass or volume rate of air flow). Optionally, the vacuum system 218 can also include a sensor 280 configured to measure vacuum pressure between the fluid trap 270 and the flow sensor 278.

[00138] The vacuum system 218 can also include a vacuum controller 282 (e.g., a microcontroller) for monitoring and controlling operation of the various components (e.g., vacuum pump 274, proportional valve 272, and/or bleed valve 276). The sensor(s) of the vacuum system 218 (e.g., sensor 278, 280, etc.) can provide feedback to a vacuum controller 282 to monitor and maintain the vacuum pressure applied by the vacuum system 218. Optionally, if the sensor data indicates that a malfunction has or is likely to occur (e.g., pop off, pop on, leaks, etc.), the vacuum controller 282 can take appropriate steps, such as adjusting the operation of the vacuum system 218 and/or alerting the user.

E. Vacuum Applicators

[00139] FIGs. 3A-7C illustrate various embodiments of vacuum applicators suitable for use with the treatment systems described herein (e.g., treatment system 100 of FIG. 1A, treatment system 200 of FIG. 2A). The vacuum applicators of FIGs. 3A-7C can be fluidly connected to a vacuum system (e.g., vacuum system 218 of FIG. 2C) in order to apply suction to the patient’s tissue. Additionally, the vacuum applicators can be fluidly connected to a cooling system (e.g., cooling system 212 of FIG. 2B) that circulates coolant in order to cool a patient’s tissue.

[00140] FIGs. 3A-3J illustrate a vacuum applicator 300 (“applicator 300”) configured in accordance with embodiments of the present technology. Referring first to FIGs. 3A (top perspective view), 3B (top view) and 3C (side cross-sectional view) together, the applicator 300 has an elongated shape with a proximal end 301a, a distal end 301b, and a cup assembly 302 between the proximal and distal ends 301a, 301b. The cup assembly 302 can also have an elongated shape, with the longitudinal axis of the cup assembly 302 being aligned with the proximal -distal axis of the applicator 300. The cup assembly 302 can be used for cooling tissue and/or applying suction to tissue. The proximal end 301a of the applicator 300 can be configured to couple to a connector (e.g., connectors 104a and 104b of FIG 1A; connectors 204a and 204b of FIG. 2A) that provides coolant, vacuum, power, etc. to the cup assembly 302.

[00141] The applicator 300 also includes a housing 304 that supports and protects the cup assembly 302 and the internal components of the applicator 300. The housing 304 can be a waterproof housing, e.g., according to at least one of IPX1, IPX3, IPX4, or IPX7. The housing 304 can include an upper housing portion 305a and a lower or bottom housing portion 305b, and the cup assembly 302 can be mounted in the upper housing portion 305a. The upper housing portion 305a and lower housing portion 305b can be anti-condensation housings. In some embodiments, the housing 304 has a length within a range from 13.5 inches to 14.5 inches (e.g., 13.99 inches), a width within a range from 9 inches to 11 inches (e.g., 10.5 inches), and a height within a range from 3 inches to 5 inches (e.g., 4.5 inches). The total weight of the applicator 300 can be within a range from 1.5 lbs to 5 lbs (e.g., 1.8 or 4.7 lbs).

[00142] The cup assembly 302 can include a cup 306 and a contoured sealing element 308. The cup 306 can be contoured to define a tissue-receiving cavity 310 (“cavity 310”) with a concave heat-exchange surface 312 (“surface 312”). A midpoint of the proximal-distal axis of the applicator 300 taken along surface 312 defines a deepest or bottom point 317 of the cavity 310. Contoured sealing element 308 has, at each point along its perimeter, a height defined with respect to the bottom point 317 of the cavity 310. The height of each point along the perimeter 31 1 of the contoured sealing element 308 defines a first curvature profile that is configured to facilitate a vacuum seal of the patient’s skin by the applicator 300 during operation of the applicator 300.

[00143] Similarly, the cavity 310 of the cup 306 has at each point thereon, including along the perimeter of the cavity 310 defined by sidewalls 316a and 316b, a height defined with respect to the bottom point 317 of the cavity 310. The height of each point along the perimeter 315 of the cavity 10 defines a second curvature profile at an interface between sidewalls 316a and 316b and sealing element 308 (e.g., a cup-sealing element interface 309, as shown in FIG. 3C). The first curvature profile of the perimeter 311 of the sealing element 308 and the second curvature profile of the perimeter 315 of the cavity 310 of cup 306, which defines cup-sealing element interface 309 cooperate to create a vacuum seal between the skin of a flank of a patient and the applicator 300 during operation of applicator 300. The first and second curvature profiles are described further below with respect to FIGs. 4 A and 4B.

[00144] During operation of the applicator 300, a vacuum is applied to the patient’ s tissue to draw the flank tissue into the cavity 310 and into thermal communication with the surface 312. The cup 306 can be made partially or entirely of a thermally conductive material (e.g., a metal such as aluminum) to allow for efficient heat transfer to and/or from the patient’s tissue. The cup 306 can also be in thermal communication with one or more thermal devices located within the housing 304, as described below. The first and second curvature profiles facilitate the application of the vacuum to the patient’s tissue. [00145] To provide a suitable vacuum against the flank tissue, the sealing element 308 can extend along the perimeter or mouth of the cavity 310 and can sealingly engage, for example, a liner assembly, the patient’s skin (e.g., if the applicator 300 is placed directly against skin), a cryoprotectant gel pad, or other surface. The sealing element 308 can be configured for forming airtight seals with the skin and can be made, in whole or in part, of silicon, rubber, soft plastic, or other suitable highly compliant materials. The mechanical properties, thermal properties, shape, and/or dimensions of the sealing element 308 can be selected based on, for example, whether it contacts the skin, a liner assembly, a cryoprotectant gel pad, or the like. In particular, the sealing element 308 can possess the first curvature profile that facilitates the formation of a vacuum seal when the applicator 300 is placed against the flank of a patient. Similarly, the cup-sealing element interface 309 formed between cup 306 and the sealing element 308 can have the second curvature profile that, with the first curvature profile of sealing element 308, helps to facilitate a vacuum seal of a patient’ s skin during operation of the applicator 300. Such first and second curvature profiles allow the embodiments of applicator 300 as described herein to deliver effective cryolipolysis therapy to patients having smaller statures, and corresponding flanks with large degrees of curvature.

[00146] The shape of the cup 306 can be designed to conform to the patient’s flank tissue to increase the volume of tissue that can be treated and improve treatment efficacy. For example, as can be seen in FIGs. 3A and 3B, the cup 306 can have a rounded, “banana-like” shape having a bottom 314 and spaced-apart sidewalls 316a, 316b. The bottom 314 and sidewalls 316a, 316b can be continually curved so that there are no “sharp” edges or corners within the cup 306; instead, the bottom 314 and sidewalls 316a, 316b are connected by smooth and gradual transitions. As described above, the proximal-distal axis of applicator 300 has a midpoint that defines a bottom point 317 of cup assembly 302 along bottom 314. The heights of each point along the perimeter 311 of sealing element 308 and along the cup-sealing element interface define first and second curvature profiles that together are configured to facilitate a vacuum seal between the skin of the flank of a patient and the cup assembly 300. The first and second curvature profiles allow the embodiments of applicator 300 as described herein to effectively deliver cryolipolysis therapies to the flanks and side abdomens of patients with generally smaller statures, as such patients may have flanks and side abdomens with corresponding large degrees of curvature.

[00147] As shown in FIGs. 3C and 3J, the perimeter 315 of cavity 310 of cup 306 forms the cup-sealing element interface 309 having a second curvature profile that facilitates the formation of a vacuum seal against and between the skin of the cryolipolysis patient and the cup 306 of the applicator 300. Cavity 310 of the cup 306 also comprises a continually curved shape to effectively conform to tissue along the flank of a patient. In some embodiments, the continually curved shape of the cup 306 allows flank tissue to be drawn into full contact against the surface 312 with few or no gaps or air pockets. An applicator with the first and second curvature profiles as described herein is particularly suited for cryolipolysis treatments of the flank, torso, or side abdomen due to the large degree of curvature of those regions of the body.

[00148] The dimensions of the cup 306 can be varied as desired. In some embodiments, for example, the width Wi of the cup 306 (FIG. 3B) is within a range from 2 inches to 3 inches (e.g., 2.18 inches), the length LI of the cup 306 (FIG. 3C) is within a range from 5 inches to 6 inches (e.g., 5.31 inches), the depth DI of the cup 306 (FIG. 3C) is within a range from 1.5 inches to 2.5 inches (e.g., 1.95 inches), and the height D2 of the sealing element 308 above the cup 306 is within a range from 0.5 inches to 1.5 inches (e.g., 0.9 inches). The total treatment surface area (e.g., the area of surface 312) can be within a range from 10 square inches to 20 square inches (e.g., 16.3 square inches). In some embodiments, the dimensions of cup 306 along its proximal-distal axis are described by a parabolic equation. In certain embodiments, the height (h) of a point along the proximal-distal axis of the cup 306 relative to the bottom point 317 of the cup 306 is related to the distance of the point (x) along the proximal-distal axis of the point by the equation h = 0.002 lx² + 0.055%. In certain embodiments, the height (y) of a point along the proximal-distal axis of sealing element 308 relative to a bottom point 317 of sealing element 308 is related to the distance of the point (r) along the proximal-distal axis of the sealing element 308 be the equation y = 0.0017%² + 0.0742%.

[00149] In general, the dimensions of the cup are selected such that the first and second curvature profiles cooperate to facilitate a vacuum seal between the skin of a flank of a patient and cup 306 of applicator 300. As described further below with respect to FIGs. 4 A and 4B, the first and second curvature profiles may be defined with respect to respective first and second ellipses. Each of the first and second ellipses has dimensions such that the first and second curvature profiles facilitate a vacuum seal between the skin of a flank of a cryolipolysis treatment patient and cup 306 of applicator 300.

[00150] In some embodiments, the applicator 300 has a treatment area to weight (of applicator 300) ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 300 can have a treatment area to tissue-draw depth ratio greater than or equal to 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, or 17 inches. The tissue-draw depth of the cup 306 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth DI.

[00151] The cup 306 can be configured to apply the vacuum to the patient’ s tissue via a vacuum port 318 (best seen in FIGs. 3B and 3C). The vacuum port 318 can be in fluid communication with the cavity 310. In the illustrated embodiment, the vacuum port 318 is positioned at the bottom 314 of the cavity 310 to comfortably draw the tissue deep into the cavity. The first curvature profile of the perimeter 311 of the sealing element 308 and the second curvature profile of the cup-sealing element interface 309 can have dimensions configured to facilitate the vacuum seal formed between the patient flank tissue and the cup 306. Such first and second curvature profiles allow the embodiments of applicator 300 described herein to deliver effective cryolipolysis therapy to patients having smaller statures, and corresponding flanks or side abdomens with large degrees of curvature. Optionally, one or more vacuum grooves or air-egress features 320 (best seen in FIG. 3B) can be formed in the cup 306 near the vacuum port 318. The air-egress features 320 can help distribute the vacuum across the cup/tissue interface to enhance patient comfort, prevent air gaps (e.g., air gaps at the tissue/cup interface during tissue draw), and/or reduce vacuum leaks. After the subject's tissue fills the tissue-receiving cavity 310, the air-egress features 320 can continue to distribute the vacuum across a large area of the tissue-cup interface to keep the subject’s tissue in the cavity 310. During subcutaneous treatments, the subject's skin can extend across the air-egress features 320, illustrated as grooves or channels spreading outwardly from a central region of the cup 306. Constant or varying vacuum levels can be used to keep the tissue in thermal contact with the cup 306.

[00152] The air-egress features 320 can be grooves or channels that are machined into the surface 312 of the cup 306. For example, in the illustrate embodiment, the air-egress features 320 have a branching shape that extends from the vacuum port 318 along the bottom 314 and towards the sidewalls 316a, 316b. The number, positions, and geometries of the air-egress features 320 can be selected to define an airflow pattern suitable for evacuating air between the tissue and the cup 306. The air-egress features 320 also reduce the likelihood of air bubbles between the tissue and the cup 306. The air-egress features 320 can be positioned at locations at which air tends to become trapped. If ambient air is inadvertently sucked between the cup 306 and the subject's skin, it can serve as a thermal insulator and reduce heat transfer between the applicator 300 and the subject's tissue. Such air can be removed via the air-egress features 320 to maintain suitable thermal contact throughout the entire treatment session, including relatively long sessions (e.g., sessions equal to or longer than 20 minutes, 30 minutes, 45 minutes, 1 hour, or 2 hours). In some embodiments, the vacuum port 318 is positioned at central region of the cup 306 to draw the tissue into the deepest region of the tissue-receiving cavity 310, and the air-egress features 320 extend toward a peripheral portion of the surface 12. During cooling/heating, the tissue can fill substantially the entire cavity 310. In various embodiments, the air-egress features 320 can maintain airflow paths extending to the peripheral portion of the cup 306 such that the tissue occupies at least 80%, 90%, 92.5%, 95%, 99%, or 100% of the volume of the cavity 310. Accordingly, the subject’s tissue can substantially fill an entire volume of the cavity 310. In one application, the subject’s tissue fills 90% or more of the volume of the cavity 310.

[00153] In some embodiments, the surfaces of the applicator 300 (e.g., the exposed surfaces of the housing 304 and cup 306) have a smooth surface finish. For example, the roughness of the surfaces can be less than or equal to Ra 65, 60, 55, 50, 45, 40, 35, 32, or 30. In some embodiments, the surface 312 of the cup 306 has an Ra less than or equal to 32, and a backside of the cup 306 has an Ra less than or equal to 63. For example, most or substantially all of the surface 312 can have an average Ra less than or equal to 25, 30, or 35. Smooth surfaces can be produced, for example, by machining followed by an anodizing process. In some embodiments, the surface 312 can be a metal surface (e.g., an aluminum surface, a metal alloy surface, etc.) that is machined, polished, and/or anodized. A smoother surface can facilitate cleaning of the applicator 300, e.g., particularly the air-egress features 320.

[00154] FIG. 3D is a bottom perspective view of the applicator 300. As can be seen in FIGs. 3C and 3D together, the vacuum port 318 can be in fluid communication with a manifold 322 for receiving a gel trap (e.g., trap 165 of FIG. IB). The manifold 322 can be located beneath the cup 306. The bottom housing portion 305b can include an aperture 324 providing access to the manifold 322 for placement and removal of the gel trap. The gel trap can be configured to collect gel and/or other fluid that may be drawn into the vacuum port 318, as described in greater detail below. In some embodiments, the air-egress features 320 are also configured to facilitate flow of gel and/or other fluid into the gel trap.

[00155] Referring again to FIGs. 3A-3C together, the cup 306 can further include one or more sensors 326 on the surface 312 configured to monitor the patient’ s tissue during treatment. In some embodiments, the sensors 326 are temperature sensors (e.g., thermistors) that are configured to measure the temperature of the tissue. In other embodiments, the sensors 326 can include other types of sensors, such as pressure sensors, contact sensors, impedance sensors, and so on. The cup 306 can include any suitable number of sensors 326, such as one, two, three, four, five, six, seven, eight, nine, ten, or more sensors 326. The sensors 326 can be part of a flexible circuit that is embedded within the surface 312 of the cup 306. The sensor data generated by the sensors 326 can be transmitted to other components of the treatment system (e.g., circuit boards 210, applicator controllers 224 and/or main controller 222 of FIG. 2A) to monitor the treatment procedure and/or provide feedback for controlling the operation of the applicator 300.

[00156] FIGs. 3E-3I illustrate the applicator 300 at various stages during an assembly procedure. Referring first to FIG. 3E, which is an exploded view of the cup assembly 302 during a stage of the assembly procedure, the sealing element 308 can be attached to the edges of the cup 306 (e.g., via glue, sealant, or other adhesives; or by overmolding). The sensors 326 can be inserted into and secured within shallow recesses 328 formed in the sidewalls 316a, 316b of the cup 306. The recesses 328 can prevent the edges of the sensors 326 from being caught and peeled off during cleaning of the cup 306. Additionally, the configuration of the sensors 326 and recesses 328 can allow the sidewalls 316a, 316b to be continuously curved.

[00157] Referring next to FIG. 3F, which is a bottom perspective view of the cup assembly 302 during another stage of the assembly procedure, a first thermal device 330a and a second thermal device 330b (collectively, “thermal devices 330”) can be mounted to the bottom surface of the cup 306. The thermal devices 330 can be positioned on opposite sides of the cup 306 and can be oriented generally along the longitudinal axis of the cup 306. Each thermal device 330 can include one or more thermoelectric elements 332 for cooling/heating the cup 306. For example, the thermoelectric elements 332 can be thermoelectric coolers (TECs). The TECs can be configured to operate in both a cooling mode and a heating mode. The thermoelectric elements 332 can be coupled to the bottom surface of the cup 306 (e.g., either directly or indirectly via thermal pads or other thermally conductive materials). As previously described, the cup 306 can be made of a thermally conductive material so that the cooling/heating applied by the thermoelectric elements 332 is transferred via the cup 306 to the patient’s tissue. Optionally, each thermal device 330 can include one or more temperature sensors 333 (e.g., thermistors) for monitoring the temperature of the thermoelectric elements 332. The temperature sensors 333 can be separate from the temperature sensors 326 located on the surface 312 of the cup 306. For example, a thermistor can be located between each thermoelectric element 332 and the bottom surface of the cup 306.

[00158] In the illustrated embodiment, each thermal device 330 has three thermoelectric elements 332 such that the applicator 300 includes a total of six thermoelectric elements 332 corresponding to six cooling/heating zones. In other embodiments, each thermal device 330 can have a different number of the thermoelectric elements 332 (e.g., one, two, four, five, or more) and cooling/heating zones. Additionally, the sizes of the thermoelectric elements 332 can be varied as desired to provide different cooling/heating capabilities. In general, the thermoelectric elements or TECs 332 can be configured of a particular size and of a particular level of power consumption such that the applicators as described can sufficiently cool the flank or side abdomen tissue of the cryolipolysis patient. For example, each thermoelectric element 332 can be approximately 30 mm by 40 mm in size. The thermoelectric elements 332 can be addressable thermoelectric elements that are each independently controllable (e.g., by a remote applicator controller, as discussed in greater detail below).

[00159] Each thermal device 330 can also include a fluid-cooled element 334 attached to the backside of the thermoelectric elements 332 for cooling/heating the thermoelectric elements 332. In a cooling mode, the fluid-cooled element 334 can cool the hot backside of the thermoelectric elements 332 to keep the thermoelectric elements 332 at or below a target temperature. In a heating mode, the fluid-cooled element 334 can heat the backside of the thermoelectric elements 332 to keep the thermoelectric elements 332 at or above a target temperature. A cold frontside of the thermoelectric elements 332 can then cool the treatment area 312 of cup 306. The fluid-cooled element 334 can include internal fluid channels or passages (not shown) and ports 335 for circulation of a coolant from a cooling system (e.g., cooling system 212 of FIG. 2B). The total weight of the applicator 300 can increase less than 1 %, 2%, 3%, 4%, or 5% when filled with fluid coolant (e.g., water). In general, the total weight of the applicator 300 can increase by a small enough amount so as to not increase the occurrence of pop offs due to coolant flows, changes in coolant flow, etc.

[00160] FIG. 3G is a bottom perspective view of the cup assembly 302 during another stage of the assembly procedure. Referring to FIGs. 3F and 3G together, an insulating material 336 (e.g., foam) can be positioned over the bottom surface of the cup 306 and the backsides of the thermal devices 330. The gel trap manifold 322 can be attached to the bottom surface of the cup 306 near the vacuum port 318. A bypass tube 337 can be used to fluidly couple the fluid-cooled elements 334. [00161] A first circuit board 338a and a second circuit board 338b (collectively, “circuit boards 338”) can be electrically coupled to the thermoelectric elements 332, the sensors 326, the sensors 333, and/or other electronic components of the applicator 300. Optionally, the circuit boards 338 can be electrically coupled to each other via a cable 340 or other electrical connector. The circuit boards 338 may be identical or generally similar to the circuit boards 210 of FIG. 2A. The circuit boards 338 can be configured to obtain data (e.g., voltage data, current data, etc.) from the thermoelectric elements 332, the sensors 326, the sensors 333, and/or other electronic components of the applicator 300. In some embodiments, the circuit boards 338 perform little or no processing of the data. Instead, the circuit boards 338 can simply transmit the data to a component remote from the applicator 300, such as a control unit (e.g., control unit 206 of FIG. 2A). Additionally, the circuit boards 338 can route control and/or power signals generated by a control unit or other remote component to the corresponding applicator components (e.g., thermoelectric elements 332, sensors 326, sensors 333, and/or other electronic components).

[00162] Optionally, each circuit board 338 can include a contamination circuit configured to detect the presence and/or ingress of fluid. For example, fluids such as water (e.g., from drip condensation) or coolant (e.g., due to leaks) may be present in the applicator 300 during operation. Fluid ingress may be caused by submerging the applicator 300 in liquid for extended periods of time. Fluid accumulation near thermistors can adversely affect temperature measurements. Fluid can also cause electrical shorts and/or damage the internal components of the applicator 300. Accordingly, the contamination circuit can be used to detect whether fluid has entered the applicator 300, and, if so, shut down operation of the applicator 300. For example, the contamination circuit can initially be in an open state, and can switch to a closed state if water enters the applicator 300. For example, the contamination circuit can include one or more water detectors. FIG. 3G-1 shows a water detector in the form of an open switch 339. When water contacts the switch 339, the switch is closed indicating the presence of water (e.g., freestanding liquid capable of contacting circuitry within the applicator 300). A controller in communication with the switch 339 can be programmed to identify detection of moisture based on one or more signals from the switch 339. The number, positions, and configurations of water detectors can be selected based on the configuration of the circuit board 338, locations susceptible to condensation, location of electrical components, etc. In some embodiments, water detectors are positioned proximate to or on anti-condensation housings, integrated into circuit boards, coupled to exposed cooled metal surfaces inside the applicator 300, or the like. [00163] The limited functionality of the circuit boards 338 can provide various benefits, such as reducing the thermal footprint of the applicator 300 — excess heat can increase the load on the thermoelectric elements 332, create condensation that may adversely affect electronic components within the applicator 300, create safety issues (e.g., overheating), and reduce treatment efficacy. This approach can also reduce the electrical load for operating the applicator 300, and thus the amount and size of the wiring, which can allow for a more flexible connector cable with detachable bayonet connections. For example, the wiring used in the applicator 300 can be less than or equal to 20 AWG, or less than or equal to 28 AWG. Additionally, the size, weight, and cost of the applicator 300 can be reduced. A lighter applicator 300 can be more comfortable for the patient, easier to secure to the patient’s body (e.g., via straps or adhesive coupling gel), and less likely to pop off during operation.

[00164] FIGs. 3H and 31 are a bottom view and exploded view, respectively, of the applicator 300 during another stage of the assembly procedure. Referring to FIGs. 3H and 31 together, the cup assembly 302 and associated components can be positioned within and attached to the upper housing portion 305a. A supply fluid line 342a and a return fluid line 342b can be fluidly coupled to the fluid-cooled elements 334 (not shown) so that coolant can circulate through the fluid-cooled elements 334 (e.g., as indicated by arrows in FIG. 3H). In the illustrated embodiment, the fluid supply and return lines 342a, 342b are located at or near the proximal end 301a of the applicator 300 while the bypass tube 337 is located at or near the distal end 301b.

[00165] The supply fluid line 342a and return fluid line 342b can be coupled to an interconnect assembly 344 at the distal end 301b of the applicator 300. The interconnect assembly 344 can also include interfaces 346 for receiving a vacuum line (not shown) connected to the gel trap manifold 322 (e.g., via hose barb 348), and one or more electrical lines (not shown) connected to the circuit boards 338. As described in greater detail below, the assembly receptacle 344 can include features for releasably coupling the applicator 300 to a connector (e.g., connectors 104a and 104b of FIG. 1 A; connectors 204a and 204b of FIG. 2A). This approach allows the applicator 300 to be separated from the connector, e.g., for more convenient cleaning and/or storage.

[00166] As shown in FIG. 31, the bottom housing portion 305b can be attached to the upper housing portion 305 a to enclose the internal components of the applicator 300. The upper housing portion 305a and bottom housing portion 305b can be configured to form a water-tight seal. This approach allows the applicator 300 to be partially or fully submerged without fluid entering the interior of the applicator 300, which may allow for more simpler, easier, and more effective cleaning procedures.

[00167] FIG. 4A illustrates an exemplary first curvature profile of the perimeter of an exemplary sealing element 400, such as perimeter 31 1 of sealing element 308 of FIG. 3 A. The first curvature profile of the perimeter 311 of sealing element 400 can be defined, at least in part, by a first ellipse 410, as shown in FIG. 4A. The first ellipse 410 shown in FIG. 4A is not intended to be drawn to scale, and is simply shown for illustrative purposes. As shown in FIG. 4A, an arc 412 of the first ellipse 410 can extend along at least a segment of the perimeter 311 of sealing element 308, thus defining the first curvature profile of sealing element 400. The arc 412 of the first ellipse 410 can, for example, subtend a first angle 414 of a center of the first ellipse 414. The first angle 414 of the first ellipse 410 may be configured to be between about 90 degrees and about 140 degrees. The first ellipse 410 may be configured to have, for example, a major axis of between about 365 millimeters and about 375 millimeters, and a minor axis of between about 240 millimeters and about 250 millimeters. The dimensions of the first ellipse 410, as well as those of the arc 412 and the first angle 414, are configured to facilitate a vacuum seal between the sealing element 400 and the flank tissue of the cryolipolysis treatment patient.

[00168] FIG. 4B illustrates an exemplary second curvature profile of a cup-sealing element interface 450, which may be, for example, cup-sealing element interface 309 of FIG. 3A. The second curvature profile of the cup-sealing element interface 450 can be defined by a second ellipse 460. Second ellipse 460 may be configured to have, for example, a major axis of between about 300 millimeters and about 400 millimeters, and to have a minor axis of between about 100 millimeters and about 200 millimeters. The second curvature profile of the cup-sealing element interface 450 is configured such that a segment of the cup-sealing element interface 450 coincides with an arc 462 of second ellipse 460. The arc 462 of second ellipse 460 may be configured to subtend a first angle 464 of a center second ellipse 450. The first angle 464 of second ellipse 450 may be configured to be between about 90 degrees and about 140 degrees. The dimensions of second ellipse 460, as well as of arc 462 and first angle 464 may be configured to facilitate a vacuum seal between the tissue of the flank of the cryolipolysis treatment patient.

[00169] Further shown in FIGs. 5A - 7C are additional perspective and cross-section views of cup 306 and sealing element 308 of FIG. 3. As described above with respect to FIGs. 3A-3J, the perimeter 315 of the cavity 310 of the cup 306, defined at least in part by sidewalls 316a and 316b, may be configured to form the cup-sealing element interface 309 with the sealing element 308. The cup-sealing element interface 309 formed between the cup 306 and the sealing element 309 can have a second curvature profile defined by an ellipse, as described above with respect to FIG. 4B. The second curvature profile can be configured to facilitate a vacuum seal between the skin of a flank or side abdomen of the cryolipolysis patient and the heat exchange surface 312 of cup 306.

[00170] As described above with respect to FIG. 4A, sealing element 308 can have a first curvature profile defined by a first ellipse. The first curvature profile of sealing element 308 can be configured to facilitate a vacuum seal between the skin of a flank or side abdomen of the cryolipolysis patient and the applicator cup 306. The unique geometry of the first and second curvature profiles make the applicators described herein particularly well suited for delivering cryolipolysis therapies to patients of smaller statures, and to those areas of the body having large degrees of curvature, such as the flank or side abdomen of a cryolipolysis treatment patient. Conventional applicators, lacking the geometries described herein, may be insufficient in forming the required seals to deliver cryolipolysis therapies to anatomical sites having large degrees of curvature, such as the flank or side abdomen.

[00171] As can be seen in FIGs. 5B and 6B, sealing element 308 has a proximal end and a distal end, the heights of each of which can be configured so as to facilitate the formation of a vacuum seal between the flank tissue of the patient and the treatment cup 306. In some embodiments, a height D3 of a tallest point 602 of the sealing element 308 relative to a lowest point 604 of a top of the sealing element 308 is between about 34 millimeters and 38 millimeters about (e.g., about 36.3 millimeters). In certain embodiments, a height D4 of a tallest point 606 of cup-sealing element interface 309 relative to a lowest point of cup-sealing element interface 608 is between about 23 millimeters and about 27 millimeters (e.g., 25.2 millimeters). In further embodiments a ratio of the height D3 to the height D4 is between about 1.2 and about 1.65.

[00172] FIG. 7A illustrates a perspective view of a cup 306 and sealing element 308 for use in embodiments of the applicator systems described herein. Cup 306 and sealing element 308 meet at cup-sealing element interface 309. As described herein, cup-sealing element interface 309 defines a second curvature profile. As described above with respect to FIG. 4B, the second curvature profile of cup-sealing element interface 309 may be defined in terms of a second ellipse, such that at least a first segment of cup-sealing element interface 309 coincides with an arc of the second ellipse. The first segment of cup-sealing element interface 309 may coincide with an arc of the second ellipse that subtends an angle of a center of the second ellipse of between about 90 degrees and about 150 degrees. The second curvature profile of cupsealing element interface 309 is configured to facilitate a vacuum seal between tissue of the flank of the cryolipolysis patient and the cup 306.

[00173] FIGs. 7B and 7C illustrate cross-section perspective views of cup 306 of FIG. 7 coupled to sealing element 308 to form cup-sealing element interface 309.

[00174] FIGs. 8A and 8B illustrate exemplary isotherms generated within tissue of the flank of the patients subject to cryolipolysis treatment using the applicator systems described in embodiments herein. FIG. 8A shows isotherms in a plane parallel to section A-A of FIG. 7C. FIG. 8B shows isotherms in a plane perpendicular to the plane of FIG. 8 A, which is parallel to section B-B of FIG. 7B. In both FIGs. 8A and 8B, the applicator systems of the embodiments described herein are configured to cool the tissue of the flank of the cryolipolysis patient to below 4° C at a depth of up to approximately 8 millimeters from the surface of the patient’s skin. Temperatures increase with distance from the applicator, as the core temperature of the subject competes with the cooling mechanism of the applicator. The applicator geometries described herein are particularly suitable for creating a vacuum seal between the applicator and the skin of the tissue of the flank or side abdomen. Because the geometries of the applicator systems described herein are configured to form effective vacuum seals on areas of the body having such large degrees of curvature, the applicator systems described herein can establish the isotherms shown in FIGs. 8 A and 8B, allowing the delivery of effective cryolipolysis treatment to the flanks of cryolipolysis treatment patients.

F. Studies

[00175] Existing cryolipolysis applicators have geometries that are ill-suited for treating tissue located on the flank of a patient due to the high degree of curvature thereof. A first study described in FIG. 9 evaluated the efficacy of the applicator design according to the embodiments described herein in maintaining a secure fit along the tissue of a flank of a patient relative to the efficacies of conventional applicator designs, including the Elite Cl 20 and Elite Cl 50 applicators by Zeltiq Aesthetics, Inc. The subject demographics are described in Table 1 of FIG. 9, and the breakdown of tested body areas is described in Table 2 of FIG. 9. Subjects were selected for the study if a clinician determined that the most effective available cryolipolysis treatment for the subject would require the use of two conventional applicators, such as the Cl 20 or Cl 50 applicators, to treat a given flank of the patient. Such subjects were particularly well suited for a study the goal of which was to determine the applicator geometry that would be able to provide equivalent treatment using a single applicator on the flank of the patient. As described above, conventional applicator geometries are ill-suited for delivery of cryolipolysis treatment to the flank of a patient, due to the large degree of curvature thereon. Clinicians delivering cryolipolysis treatments to patients using the Elite Cl 20 and Cl 50 applicators reported that two Cl 20 applicators would need to be used to deliver cryolipolysis therapy to a patient’s flank or side abdomen, thus increase patient discomfort, treatment time, and treatment cost. It was also reported that the C150 applicator was unable to sufficiently form a seal on a flank or side abdomen of a cryolipolysis treatment patient. Accordingly, a study was conducted to determine an applicator geometry that could form a seal on the flank or side abdomen of a cryolipolysis treatment patient while minimizing the required number of treatment sessions.

[00176] Various applicator cups were designed as part of the study to determine which geometry could provide the most secure seal against a variety of patient flanks. Patient flanks tested had radii ranging between about 70 mm and about 155 mm. Clinicians assessed the contact made between the cup and the tissue of the patient’s flanks by observing if the tissue in the flank drawn into the applicator cup would bottom-out the cup (e.g., achieve an effective tissue contact to treatment surface), and further if any bubbles were present between the cup surface and the flank tissue (e.g., achieve efficient heat transfer to cool tissue). Clinicians would further assess the seal formed between the applicator and the patient tissue by evaluating if the cup were able to stay on the body area during the tissue draw without popping off, and with little to no support.

[00177] Table 3 of FIG. 10 shows one set of results from the study described herein. Novel applicator geometries (e.g., the Experimental Deep, Deep Tall, and Deep Tall Curve applicators) were evaluated in seal efficacy relative to conventional applicator geometries, the C120 and C 150. Table 3 illustrates that the exemplary applicator geometries described herein corresponding to the Experimental geometries can adhere to the tissue of the flank or side abdomen of a patient without popping off during the tissue draw (described above) as compared to other conventional applicator geometries, including the Cl 20 and Cl 50 applicators. Similarly, Table 4 of FIG. 10 shows that the exemplary Experimental applicator geometries described herein can form stronger seals on the flank or side abdomen of a patient relative to conventional applicator geometries including the C150 and 020 applicators. Table 5 of FIG. 10 shows skin pliability (e.g., skin type, skin flexibility) data for patients in the study. Clinicians subjectively evaluated the pliability of the flank tissue of each patient in attempting to determine the geometry of an applicator cup that would determine the most efficient seal against the flanks of patients with smaller statures. Skin types were graded on a scale from very pliable to very fibrous, with possible gradings including (in order of decreasing pliability) very pliable, somewhat pliable, pliable, fibrous, somewhat fibrous, and very fibrous. Clinicians were provided the freedom to select the optimal applicator cup for each patient amongst a number of options, including the Experimental applicator, variant versions of the Experimental applicator having different geometries and dimensions, and the C100, C120, and C150 cups. As shown in FIG. 5, thicker, more fibrous skin was less readily drawn into the Experimental applicator cup, while more pliable skin was more easily drawn into the Experimental applicator cup, allowing the cup to create a tighter seal and eliminating the frequency of bubbles between the flank tissue of the patient and the treatment surface of the applicator cup. In addition, the data also demonstrated clinicians had selected the Experimental cup at a higher frequency relative to the other applicator cups, thus highlighting the unique benefits of the Experimental cup over the other applicator cups for treating patient flanks. The assessment of skin pliability when used either alone or in combination with a patient’s flanks radial profile, allows the appropriate selection of an applicator geometry, thus improving the efficacy and safety of the cryolipolysis treatment.

[00178] FIG. 12 compares the geometry of the Experimental applicator described in embodiments herein to the Cl 20 and C150 applicator geometries, which are ill-suited for administering cryolipolysis therapies to areas of the body having large degrees of curvature. The lines labeled “Experimental” in the illustrations of the Cl 20 and Cl 50 applicators represent the second curvature profile of the cup-sealing element interface 309 described above with respect to FIGs. 3A-7C. As described above, the second curvature profile of cup-sealing element interface 309 is configured so as to facilitate a vacuum seal between the flank tissue of a patient and the applicator cup 306. As illustrated in FIG. 12, the Cl 20 and Cl 50 geometries are not capable of pulling all of the flank tissue to a sufficient depth in the applicator cup 306 for cooling (as shown by the portions of the lines labeled “Experimental” that rise above the dashed line 1202 in the Cl 20 and Cl 50 illustrations). The Experimental geometry is uniquely suited for administering cryolipolysis to the flank or side abdomen of patients of a small stature, as its curvature profiles as described herein allow for the flank tissue of such patients to be pulled into the applicator cup 306 at a sufficient depth for cooling. [00179] As described herein, the efficacy of the cryolipolysis treatment administered with the exemplary applicator embodiments is determined in part by the formation of a tight vacuum seal between the flank tissue of the patient and the applicator cup, but also the ability to effectively cool the target subcutaneous tissue.

G. Kits and Treatment Methods

[00180] The various components described herein can be provided as a kit for treatment of a subject. A kit can include a plurality of applicators (e.g., two or more of the applicators described with respect to any of FIGs. 1 A-7C). The applicators can have dimensions configured to deliver effective cryolipolysis therapy to treatment sites having large degrees of curvature, including the torso or side abdomen of a cryolipolysis treatment patient. The kit can also include one or more cleaning caps, connectors, gel traps, and/or other accessories (e.g., gel pads, liners, straps, etc.) as described in U.S. Patent Application No. 17/402,354, incorporated by reference above.

[00181] FIG. 11 is a flowchart of a method 1100 for treating a subject in accordance with embodiments of the present technology. Although certain features of the method 1100 are described with respect to the embodiments of FIGs. 1A-1C, it will be appreciated that the method 1100 can be performed using any of the systems and devices discussed with respect to FIGs. 1 A-7C.

[00182] The method 1100 begins at step 1102 with applying an applicator to a flank or side abdomen of a subject, such as the subject of FIG. 1A. Step 1102 can further include engaging the skin with a sealing element of the applicator. For example, as discussed in connection with FIG. IB, the sealing element 152 can be placed against the subject to form a vacuum seal suitable for maintaining a desired vacuum within the tissue-receiving cavity 158.

[00183] At step 1104, a vacuum is drawn to pull tissue into a tissue-receiving cavity of the applicator. The subject’s skin can be drawn toward a temperature-controlled surface of a treatment cup of the applicator while air-egress features maintain airflow paths for removing air from the cavity. As discussed above, to draw the vacuum, a vacuum system (e.g., vacuum system 218 of FIG. 2C) can operate to remove air from a tissue-receiving cavity of the applicator (e.g., tissue-receiving cavity 158 of FIG. IB) to urge tissue into the applicator. Further, the first curvature profile of sealing element and the second curvature profile cupsealing element interface can be configured with dimensions that facilitate the formation of the vacuum seal between the subject’s skin and the treatment cup. The vacuum level can be selected to partially or completely fill the tissue-receiving cavity with tissue. If the vacuum level is too low, tissue will not be drawn adequately into the cavity. The vacuum level can be increased to reduce or eliminate gaps between the skin surface and a temperature-controlled surface (e.g., temperature-controlled surface 160) of the applicator. If the vacuum level is too high, undesirable discomfort to the patient and/or tissue damage could occur. The vacuum level can be selected to comfortably pull the tissue into contact with the desired area of the applicator, and the skin and underlying tissue can be pulled away from the subject’s body which can assist in cooling underlying tissue by, e.g., lengthening the distance between targeted subcutaneous fat and the muscle tissue. As previously described, the vacuum system can be configured to rapidly achieve a target vacuum level (e.g., no more than 5 seconds, 4 seconds, 3 seconds, 2 seconds, or 1 second) with little or no undershoot or overshoot (e.g., no more than 20%, 15%, 10%, or 5% of the target vacuum level).

[00184] In some treatments, tissue can be drawn into the tissue-receiving cavity such that substantially all of the skin surface within the cavity overlies the temperature-controlled surface. For example, 90%, 95%, 99%, or more of the surface area of the skin located in the cavity can overlie the temperature-controlled surface. Optionally, the number and dimensions of the air-egress features can be increased or decreased to achieve desired thermal contact for a particular vacuum level. After a sufficient amount of tissue fills most or all of the cavity, the pressure level can be controlled to comfortably hold the tissue.

[00185] At step 1106, the applicator can extract heat from the tissue. After the skin is in thermal contact with the temperature-controlled surface of the applicator, heat can be extracted from the subject’s tissue to cool the tissue by an amount sufficient to be biologically effective in selectively damaging and/or reducing the subject’s subcutaneous lipid-rich cells. As discussed above, the applicator can include a treatment cup (e.g., cup 156 of FIG. IB) that is designed for rapid cooling and/or heating to, for example, reduce treatment times and/or produce generally flat temperature profiles over the temperature-controlled surface or a portion thereof. Because the subject’s body heat can be rapidly conducted to the cup, the cooled skin can be kept at a generally flat temperature profile (e.g., ±3°C of a target temperature) even though regions of the skin, or underlying tissue, may experience different amounts of blood flow. Because non-lipid-rich cells usually can withstand colder temperatures better than lipid- rich cells, the subcutaneous lipid-rich cells can be injured selectively while maintaining the non-lipid-rich cells (e.g., non-lipid-rich cells in the dermis and epidermis). Accordingly, subcutaneous lipid-rich cells in a subcutaneous layer can be cooled an amount sufficient to be biologically effective in affecting (e.g., damaging and/or reducing) such lipid-rich cells without affecting non-target cells to the same or greater extent.

[00186] In contrast to invasive procedures in which coolant is injected directly into targeted tissue, the temperature-controlled surface can conductively cool tissue to produce a desired temperature in target tissue without bruising, pain, or other problems caused by injections and perfusion of injected fluid. For example, perfusion of injected fluid can affect the thermal characteristics of the treatment site and result in undesired temperature profiles. As such, the non-invasive conductive cooling provided by the applicator can be more accurate than invasive procedures that rely on injecting fluids. Targeted tissue can be cooled from about -20 °C to about 10 °C, from about 0 °C to about 20 °C, from about -15 °C to about 5 °C, from about -5 °C to about 15 °C, or from about -10 °C to about 0 °C. In one embodiment, a liner can be kept at a temperature less than about 0 °C to extract heat from subcutaneous lipid-rich cells such that those cells are selectively reduced or damaged.

[00187] It may take a few days to a few weeks, or longer, for the adipocytes to break down and be absorbed. A significant decrease in fat thickness may occur gradually over 1-3 months following treatment. Additional treatments can be performed until a desired result is achieved. For example, one or more treatments can be performed to substantially reduce (e.g., visibly reduce) or eliminate targeted tissue. In such embodiments, the method 1100 can be repeated multiple times to achieve the desired treatment result.

[00188] Optionally, the method 1100 can include additional steps or processes not illustrated in FIG. 11. For example, the method 1100 can include positioning other elements, materials, components (e.g., gel pads, absorbents, etc.) between the skin and the applicator. U.S. Patent Publication No. 2007/0255362 and U.S. Patent Publication No. 2008/0077201 and U.S. App. No. 14/610,807 disclose components, materials (e.g., coupling gels, cryoprotectants, compositions, etc.), and elements (e.g., coupling devices, liners/protective sleeves, absorbents, etc.) that can be placed between the skin and the applicator. Liners can be used and can include films, sheets, sleeves, or other components suitable for defining an interface surface to prevent direct contact between surfaces of the applicator and the subject’s skin to reduce the likelihood of cross-contamination between patients, minimize cleaning requirements, etc. Exemplary protective liners can be sheets, sleeves, or other components constructed from latex, rubber, nylon, Kevlar®, or other substantially impermeable or semi-permeable material. For example, the liner can be a latex sheet coated with a pressure-sensitive adhesive. Further details regarding a patient protection device may be found in U.S. Patent Publication No. 2008/0077201. In some procedures, a liner or protective sleeve may be positioned between an absorbent and the applicator to shield the applicator and to provide a sanitary barrier that is, in some embodiments, inexpensive and thus disposable. After installing the liner assembly, gel traps, filters, valves, and other components can be installed to keep applied substances (e.g., coupling gels, cryoprotectants, etc.) from being sucked into and/or through the applicator. In some embodiments, the liner is configured to allow air to pass when drawing a vacuum and to restrict passage of a gel.

[00189] As another example, the method 1100 can include applying a cryoprotectant between the applicator and the skin. The cryoprotectant can be a freezing point temperature depressant that may additionally include a thickening agent, a pH buffer, a humectant, a surfactant, and/or other additives. The temperature depressant may include, for example, polypropylene glycol (PPG), polyethylene glycol (PEG), dimethyl sulfoxide (DMSO), or other suitable alcohol compounds. In a particular embodiment, a cryoprotectant may include about 30% polypropylene glycol, about 30% glycerin (a humectant), and about 40% ethanol. In another embodiment, a cryoprotectant may include about 40% propylene glycol, about 0.8% hydroxyethylcellulose (a thickening agent), and about 59.2% water. In a further embodiment, a cryoprotectant may include about 50% polypropylene glycol, about 40% glycerin, and about 10% ethanol. Other cryoprotectants or agents can also be used and can be carried by a cotton pad or other element. U.S. App. No. 14/610,807 is incorporated by reference in its entirety and discloses various compositions that can be used as cryoprotectants.

[00190] In some embodiments, the method 1100 can include monitoring a temperature of the patient’s tissue. It will be appreciated that while a region of the body has been cooled or heated to the target temperature, in actuality that region of the body may be close but not equal to the target temperature, e.g., because of the body's natural heating and cooling variations. Thus, although the applicator may attempt to heat or cool the target tissue to the target temperature or to provide a target heat flux, sensors may be used to measure a sufficiently close temperature or heat flux. If the target temperature or heat flux has not been reached, operation of the cooling unit can be adjusted to change the heat flux to maintain the target temperature or “set-point” selectively to affect targeted tissue. When the prescribed segment duration expires, the next treatment profile segment can be performed.

[00191] The sensors can be temperature sensors, such as thermistors, positioned to detect temperature changes associated with warm tissue being drawn into and/or located in the cup. A control unit (e.g., control unit 106 of FIG. 1 A, control unit 206 of FIG. 2A) can interpret the detected temperature increase associated with skin contact and can monitor, for example, the depth of tissue draw, tissue, freezing, thawing, or the like. In some embodiments, sensors can be adjacent to the air-egress features and can measure heat flux and/or pressure (e.g., contact pressure) with the skin of the patient. In yet further embodiments, the sensors can be tissue impedance sensors, contact sensors, or other sensors used to determine the presence of tissue and/or whether tissue has been adequately drawn into the applicator so as to completely fill the cavity to achieve a suitable level of thermal contact, limit or reduce voids or gaps, and/or hold tissue while limiting or reducing, for example, pooling of blood, discomfort, and so forth.

[00192] Sensor feedback can be collected in real-time and used in concert with treatment administration to efficaciously target specific tissue. The sensor measurements can also indicate other changes or anomalies that can occur during treatment administration. For example, an increase in temperature detected by the sensors can indicate either a freezing event at the skin or movement of the applicator. An operator can inspect the subject’s skin and/or applicator in response to a detected increase in temperature. Methods and systems for collection of feedback data and monitoring of temperature measurements are described in commonly assigned U.S. Patent No. 8,285,390.

H. Connector

[00193] FIGs. 13A and 13B illustrate a connector 2100 configured in accordance with embodiments of the present technology. The connector 2100 is shown together with the applicator 300 of FIGs. 3A-3J. The connector 2100 includes a distal end section 2102, a proximal end section 2104, and a cable or umbilical 2106 extending between the distal and proximal end sections 2102, 2104. The distal end section 2102 can be permanently coupled to the applicator 300. The applicator 300 and/or connector 2100 can have one or more features described in U.S. Patent Application No. 14/662,181 (U.S. Patent No. 10,675,176) and U.S. Patent No. 10,568,759, which are incorporated by reference in their entireties. For example, the applicator 300 can include one more cooling units, fluid lines, vacuum lines, or connections disclosed in U.S. Patent No. 10,568,759. In some embodiments, the connector 2100 includes supply and return fluid lines 2120a, 2120b and electrical line 2124. The supply and return fluid lines 2120a, 2120b can be coupled to a supply and return fluid line fittings of the proximal end section 2104 and/or internal fittings of the applicator 300 (FIGs. 3A-3J). The connector 2100 can include one or more vacuum lines 2148 coupled to a vacuum fitting and an internal vacuum fitting of the applicator 300. [00194] The connection between the applicator 300 and connector 2100 can be waterproof according to at least IPX1 , IPX3, IPX4, IPX7, or other ingress Protection (IP) rating or standard for substance (e.g., water ingress) defined, for example, by ANSI/IEC 60529, IP test, or similar standard. For example, the connection can be IPX1, IPX3, IPX4, or IPX7 compliant to allow users to wash the applicator 300 using, for example, running water. An internal distal end 2160 of a connector or hose 2106 can be adhered to applicator 300 to provide a watertight connection. One or more sealing members 2164 (e.g., O-rings, gaskets, etc.) can provide sealing between components at the connection. In some embodiments, a protective sleeve 2170 covers interfaces, joints, sealing members, etc. to further inhibit fluid ingress/egress. A proximal end 2180 of the hose 2106 can be adhered to a connector 2181 to provide a watertight connection. One or more sealing members 2184 (e.g., O-rings, gaskets, etc.) can provide sealing between components at the connection. In some embodiments, a protective sleeve 2190 covers interfaces, joints, sealing members, etc. to further inhibit fluid ingress/egress at interfaces. In some embodiments, the connections can be waterproof when submerged in water at a depth of 2-9 feet for at least 1 minute, 2 minutes, 5 minutes, or 10 minutes. This allows the applicator 300 and distal section of the connector 2106 to be submerged for cleaning.

I. Control Unit

[00195] FIGs. 14A-14C illustrate a control unit 2200 configured in accordance with embodiments of the present technology. More specifically, FIG. 14A is a perspective view of the control unit 2200, FIGs. 14B is a back view, and FIG. 14C is a side view. The control unit 2200 can include any of the features of the control unit 106 of FIG. 1 A and/or the control unit 206 of FIG. 2A. For example, the control unit 2200 can include a housing 2202 with wheels 2204. The housing 2202 can include one or more interconnect mounts 2205 (FIG. 14B) for coupling to one or more applicators 2206 (e.g., a first applicator 2206a and a second applicator 2206b) via one or more respective connectors 2208 (e.g., a first connector 2208a and a second connector 2208b). In the illustrated embodiment, for example, the interconnect mounts 2205 are located in the back of the control unit 2200. The applicators 2206 can be any of the applicators described herein (e.g., with respect to any of FIGs. IB and 3A-7C), and the connectors 2208 can be any of the connectors described herein. Optionally, the control unit 2200 can include a bucket or receptacle 2210 (e.g., in the upper portion of the control unit 2200 (FIG. 14 A)) for storing the applicators 2206 when not in use. [00196] The control unit 2200 can include various functional components located within the housing 2202. For example, the control unit 2200 can include any of the systems and devices described herein, such as any of the components discussed above with respect to FIGs. 1A-2C (e.g., a cooling system, vacuum system(s), main controller, applicator controllers, computing device, power system, etc.). Some or all of the functional components can be operably coupled to the applicators 2206 via the interconnect mounts 2205 and connectors 2208, as previously described. The functional components can be accessed via a removable panel 2212 (e.g., in the back of the control unit 2200 (FIG. 14B)). The panel 2212 can include vents formed therein to allow heat generated by the functional components to escape.

[00197] For example, the control unit 2200 can house one or more applicator controllers (e.g., applicator controllers 224 of FIG. 2A) for monitoring and controlling the operation of the applicators 2206. As previously discussed, the electronics located onboard the applicators 2206 (e.g., circuit boards 210 of FIG. 2A) can have relatively limited functionality, e.g., to reduce the size, thermal footprint, weight, etc. of the applicators 2206. Instead, the applicator controllers within the control unit 2200 can receive and process data from the applicators 2206 (e.g., voltage data, current data, temperature data, etc.), and can transmit control and power signals to the applicators 2206. This approach can reduce costs by allowing a common set of applicator controllers to be used with different types of applicators 2206.

[00198] In some embodiments, the applicator controllers within the control unit 2200 are configured to power and control the operation of the thermoelectric elements within the applicators 2206. For example, the applicator controllers can be or include one or more TEC drivers configured for use with TECs. The TECs can be direct drive TECs, which may be more efficient than other types of TECs. The TEC drivers can measure the voltage and/or current to the TECs to determine the amount of power being delivered to the TECs, which may correlate to the amount of heat removed from the patient’s tissue by the TECs. The voltage and/or current values can be used as feedback for controlling the amount of power delivered to the TECs, e.g., to improve treatment efficacy and safety.

[00199] Optionally, the TEC drivers can control the driving of each TEC individually, e.g., to independently control the amount of heat removed from the treatment zone corresponding to the TEC. For example, the TEC for each zone can be driven based on factors such as such as the measured temperature (e.g., of the patient’s tissue at the particular zone and/or of the corresponding TEC), the power delivered to the corresponding TEC, the power delivered to other TECs, etc. In some embodiments, the driving algorithm for each zone uses a PID algorithm or loop. Different PID algorithms can be used for different applicators 2206. The inputs to the PID algorithm can include the power delivered to the TEC, the response to the measured temperature, and/or tuning parameters. The PID algorithm can assume that the amount of power commanded by the TEC driver is the same or similar to the actual amount of power delivered to the TEC. If the TEC driver detects that the commanded power is significantly different than the actual power delivered, this can indicate a problem in the system.

[00200] In some embodiments, the TEC drivers are configured to implement an anti-freeze process for reducing or avoiding freezing damage to the patient’s skin surface. The tissue response to freezing can generate heat and cause the temperature of the skin surface to increase (e.g., from a target treatment temperature of -11 °C to a temperature within a range from -8 °C to -9 °C within 2-3 seconds). Accordingly, tissue freezing can be detected using temperature sensors (e.g., thermistors) within the applicator 2206 that are located adjacent or near the patient’s skin (e.g., sensors 326 of FIG. 3 A). If an increase in temperature indicative of tissue freezing is detected, the TEC drivers can initiate the anti-freeze process by switching the TECs from cooling mode to heating mode (e.g., by switching the polarity of the TECs). The antifreeze process can involve heating the tissue to a temperature above freezing (e.g., to 5 °C) within a relatively short time frame (e.g., no more than 30 seconds after detection of skin freezing). In some embodiments, all of the treatment zones of the applicator 2206 are concurrently or sequentially switched from cooling to heating so that the entire treatment surface of the applicator 2206 is used to heat the tissue, e.g., to prevent propagation of freezing through tissue. The use of remote TEC drivers and direct drive TECs can allow for a faster anti-freeze response, thus improving the safety of the treatment procedure.

[00201] In some embodiments, applicator controllers of the control unit 2200 are also configured to receive and process data from other electronic components of applicators 2206, such as temperature data from one or more temperature sensors (e.g., thermistors). As previously described, each applicator 2206 can include thermistors (e.g., sensors 326, 333 of FIGs. 3C and 3F, or other temperature sensors) for monitoring the temperature of the patient’s tissue and/or the temperature of the cold side of the TECs. The thermistors can be monitored to check for inaccuracies, malfunctions, or other issues with the treatment. In some embodiments, the temperature measurements are obtained using measurements of the thermistors by, e.g., applying a controlled voltage (e.g., bipolar measurements by applying bipolar voltage across the thermistors). The controlled voltage can originate in the control unit 2200. Temperature measurements can be obtained at any suitable sampling rate, such as 1 sample/sec. This approach can advantageously avoid or reduce problems associated with application of a constant voltage to the thermistors such as metal migration and tin whiskers.

[00202] The control unit 2200 can also include an input/output device 2214, such as a touchscreen display or monitor. The input/output device 2214 can be used by a physician or other operator to input data (e.g., commands, patient data, treatment data, etc.). For example, commands input by the physician can be converted into control signals for controlling operation of various functional components of the control unit 2200 (e.g., cooling system, vacuum system, applicator controllers, etc.). The input/output device 2214 can also be used to output information to the physician (e.g., treatment progress, sensor data, instructions, feedback, etc.). In some embodiments, sensor data and/or other data from the various functional components of the control unit 2200 can be converted into graphical, textual, audio, or other output that is shown to the physician via the input/output device 2214 so the physician can monitor treatment progress.

[00203] In some embodiments, the control unit 2200 can include other types of components for receiving input data, such as a reader or scanner 2221 (FIG. 14A). The scanner 2221 can be integrated into the input/output device 2214 (e.g., integrated into the bottom of the touchscreen display), or can be separate from the input/output device 2214. The scanner can be an optical scanner configured to scan barcodes or other optical or image data. For example, the scanner can be used to scan a patient barcode (e.g., from an ID card or a mobile app) to verify the identity of the individual being treated and/or obtain demographic information. As another example, the scanner can be used to scan a physician barcode (e.g., from an ID card or mobile app) to verify the identity of the physician carrying out the treatment. Optionally, the scanner 2221 can be used to scan product barcodes or QR codes (e.g., from a product label) to track the use of gel pads or other consumables. Barcodes can be added to cards carried by personnel associated with the treatment (e.g., patients, physicians, other healthcare professionals) and/or printouts (e.g., treatment instructions, product sheets). In some embodiments, the barcodes are not used to enable treatment, but rather for proofing and verification purposes before the treatment commences.

[00204] Optionally, the control unit 2200 can be operably coupled to a notifier device operated by the patient undergoing treatment. The notifier device can be a handheld device with a push button or other input element that allows the patient to send a notification to the provider (e.g., if the patient would like assistance from the system operator, attendant, physician). The notifier device can be operably coupled to the control unit 2200 via wireless communication (e., via a local area network, Bluetooth, WiFi, mobile network, etc.) or wired communication. When the control unit 2200 receives a notification, it can alert the provider via the input/device 2214 and/or via a mobile device carried by the physician. Optionally, the notifier device can be configured to wirelessly transmit the notification directly to the physician’s mobile device, rather than indirectly via the control unit 2200.

[00205] Optionally, the control unit 2200 can include a reader 2216 (FIG. 14A). The reader 2216 can obtain information from machine readable cards 2218 (e.g., provider cards, patient cards, etc.), labels, barcodes, RFID tags, or other types of labels. The reader 2216 and/or scanner 2221 can include one or more card reader devices, scanners, optical sensors, cameras, light sources, bar code scanners, or other components for obtaining information. In some embodiments, the reader 2216 is a card reader device configured to read or obtain data from a card identifier 2219, such as one or more magnetic strips, microchips, barcodes, or the like.

[00206] The information (e.g., provider information, consumable ID, patient information, etc.) from the reader 2216 and/or scanner 2221 can be sent to a controller (e.g., controller 114 of FIG. 1). The controller can evaluate a processing protocol based on the received information and can determine whether the processing protocol can be performed or modified. By way of example, if the controller determines that gel scanned by the scanner 2221 is not suitable for a planned procedure based on information from the card 2218 (e.g., provider or patient card), the system can notify the operator that another gel should be used. Alternatively, the controller can compensate for characteristics of the gel to enable the planned treatment to be performed. Additionally, the controller, reader 2216, and/or scanner 2221 can communicate with databases, such as an inventory tracking database to track applicators (e.g., to determine if an applicator is available for use), consumable inventory, or the like.

J. Computing Environments

[00207] FIG. 15 is a schematic block diagram illustrating subcomponents of a controller 2400 in accordance with an embodiment of the disclosure. The controller can be part of a control unit (e.g., control unit 106 of FIG. 1A, control unit 206 of FIG. 2A) and/or can be incorporated into the applicators or other components disclosed herein. The controller 2400 can include a computing device 2402 having a processor 2404, a memory 2406, input/output devices 2408, and/or subsystems and other components 2410. The computing device 2402 can perform any of a wide variety of computing processing, storage, sensing, imaging, and/or other functions. Components of the computing device 2402 may be housed in a single unit or distributed over multiple, interconnected units (e.g., though a communications network). The components of the computing device 2402 can accordingly include local and/or remote memory storage devices and any of a wide variety of computer-readable media.

[00208] As illustrated in FIG. 15, the processor 2404 can include a plurality of functional modules 2412, such as software modules, for execution by the processor 2404. The various implementations of source code (i.e., in a conventional programming language) can be stored on a computer-readable storage medium or can be embodied on a transmission medium in a carrier wave. The modules 2412 of the processor can include an input module 2414, a database module 2416, a process module 2418, an output module 2420, and, optionally, a display module 2422.

[00209] In operation, the input module 2414 accepts an operator input 2424 via the one or more input devices, and communicates the accepted information or selections to other components for further processing. The database module 2416 organizes records, including patient records, treatment data sets, treatment profiles and operating records and other operator activities, and facilitates storing and retrieving of these records to and from a data storage device (e.g., internal memory 2406, an external database, etc.). Any type of database organization can be utilized, including a flat file system, hierarchical database, relational database, distributed database, etc.

[00210] In the illustrated example, the process module 2418 can generate control variables based on sensor readings 2426 from sensors and/or other data sources, and the output module 2420 can communicate operator input to external computing devices and control variables to the controller. The display module 2422 can be configured to convert and transmit processing parameters, sensor readings 2426, output signals 2428, input data, treatment profiles and prescribed operational parameters through one or more connected display devices, such as a display screen, touchscreen, printer, speaker system, etc.

[00211] In various embodiments, the processor 2404 can be a standard central processing unit or a secure processor. Secure processors can be special-purpose processors (e.g., reduced instruction set processor) that can withstand sophisticated attacks that attempt to extract data or programming logic. The secure processors may not have debugging pins that enable an external debugger to monitor the secure processor's execution or registers. In other embodiments, the system may employ a secure field programmable gate array, a smartcard, or other secure devices.

[00212] The memory 2406 can be standard memory, secure memory, or a combination of both memory types. By employing a secure processor and/or secure memory, the system can ensure that data and instructions are both highly secure and sensitive operations such as decryption are shielded from observation. In various embodiments, the memory 2406 can be flash memory, secure serial EEPROM, secure field programmable gate array, or secure application-specific integrated circuit. The memory 2406 can store instructions for causing the applicators to cool/heat tissue, pressurization devices to draw a vacuum, or other acts disclosed herein. Vacuum levels can be selected based on characteristics of the applicator, airflow features, and/or treatment site. In one embodiment, the memory 2406 stores instructions executable by the controller 2400 for the thermal device to sufficiently cool conductive cups disclosed herein such that vacuum applicators non-invasively cool the subcutaneous lipid-rich cells to a desired temperature, such as a temperature less than about 0 °C. In some embodiments, the memory 2406 can contain liner installation or draw instructions for causing the liner to be drawn into the applicator, tissue draw instructions for causing the applicator to draw tissue into the applicator, treatment instructions for heating/cooling tissue, tissue release instructions for releasing tissue, and instructions for monitoring treatment. For example, the liner installation or draw instructions can be executed by the controller 2400 to command a vacuum system to suck the liner against a conductive surface of the conductive cup.

[00213] The input/output device 2408 can include, without limitation, a touchscreen, a keyboard, a mouse, a stylus, a push button, a switch, a potentiometer, a scanner, an audio component such as a microphone, or any other device suitable for accepting user input and can also include one or more video monitors, a medium reader, an audio device such as a speaker, any combination thereof, and any other device or devices suitable for providing user feedback. For example, if an applicator moves an undesirable amount during a treatment session, the input/output device 2408 can alert the subject and/or operator via an audible alarm. The input/output device 2408 can be a touch screen that functions as both an input device and an output device.

[00214] Optionally, the controller 2400 can include a control panel with visual indicator devices or controls (e.g., indicator lights, numerical displays, etc.) and/or audio indicator devices or controls. The control panel may be a component separate from the input/output device 2408, may be integrated with the applicators, may be partially integrated with one or more other devices, may be in another location, and so on. In alternative embodiments, the controller 2400 can be contained in, attached to, or integrated with the applicators. Further details with respect to components and/or operation of applicators, control modules (e.g., treatment units), and other components may be found in commonly-assigned U.S. Patent Publication No. 2008/0287839.

[00215] The controller 2400 can include any processor, Programmable Logic Controller, Distributed Control System, secure processor, and the like. A secure processor can be implemented as an integrated circuit with access-controlled physical interfaces; tamper resistant containment; means of detecting and responding to physical tampering; secure storage; and shielded execution of computer-executable instructions. Some secure processors also provide cryptographic accelerator circuitry. Suitable computing environments and other computing devices and user interfaces are described in commonly assigned U.S. Patent No. 8,275,442, entitled “TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS,” which is incorporated herein in its entirety by reference.

K. Conclusion

[00216] The treatment systems, applicators, and methods of treatment can be used reduce adipose tissue or treat subcutaneous tissue, acne, hyperhidrosis, wrinkles, structures (e.g., structures in the epidermis, dermis, subcutaneous fat, muscle, nerve tissue, etc.), and so on. Systems, components, and techniques for reducing subcutaneous adipose tissue are disclosed in U.S. Patent No. 7,367,341 titled “METHODS AND DEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING” to Anderson et al., U.S. Patent Publication No. US 2005/0251120 titled “METHODS AND DEVICES FOR DETECTION AND CONTROL OF SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING” to Anderson et al., and U.S. Patent Publication No. 2007/0255362 titled “CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICH CELLS,” the disclosures of which are incorporated herein by reference in their entireties. Vacuum applicators can stretch, stress, and/or mechanically alter skin to increase damage and fibrosis in the skin, affect glands, control freeze events (including initiating freeze events), etc. Methods for cooling tissue and related devices and systems in accordance with embodiments of the present invention can at least partially address one or more problems associated with conventional technologies as discussed above and/or other problems whether or not such problems are stated herein. [00217] Unless the context clearly requires otherwise, throughout the description, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in a sense of “including, but not limited to.” Words using the singular or plural number also include the plural or singular number, respectively. Use of the word “or” in reference to a list of two or more items covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, the phrase “at least one of A, B, and C, etc.” is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.).

[00218] Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus a range of 5% to 10%.

[00219] Any patents, applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the described technology can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments. These and other changes can be made in light of the above Detailed Description. While the above description details certain embodiments and describes the best mode contemplated, no matter how detailed, various changes can be made. Implementation details may vary considerably, while still being encompassed by the technology disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the technology should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the technology with which that terminology is associated.

Claims

CLAIMS What is claimed is:

1. An applicator for selectively affecting subcutaneous adipose tissue in a flank of a subject, the applicator comprising: a housing; a treatment cup mounted in the housing, wherein the treatment cup defines a tissuereceiving cavity comprising a cavity perimeter and includes a temperature-controlled surface; at least one thermal device coupled to the treatment cup and configured to cool the temperature-controlled surface; at least one vacuum port coupled to the treatment cup, wherein the treatment cup is configured to draw the subject's tissue into the tissue-receiving cavity to ensure the tissue contacts at least a portion of the temperature-controlled surface to selectively damage and/or reduce the subject’s subcutaneous adipose tissue; and a sealing element coupled to the cup at an interface; wherein: the sealing element comprises a sealing element perimeter defining a first curvature profile, the interface defines a second curvature profile, and the first and second curvature profiles are configured to conform to the flank of the subject to facilitate a vacuum seal between the applicator and the flank of the subject to achieve the selective damage and/or reduction of the subject’s subcutaneous adipose tissue along the flank.

2. The applicator of claim 1 , wherein the first and second curvature profiles are configured to facilitate the drawing of tissue of the flank of the subject against the temperature-controlled surface of the tissue-receiving cavity.

3. The applicator of claim 1, wherein each of the first and second curvature profiles are defined in terms of respective first and second ellipses.

4. The applicator of claim 3, wherein at least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse.

5. The applicator of claim 4, wherein the first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, a minor axis of between about 240 millimeters and about 250 millimeters, and wherein the first arc of the first ellipse is configured to subtend an angle of a center of the first ellipse of between about 90 degrees and about 150 degrees.

6. The applicator of claim 5, wherein at least a second segment of the interface is configured to coincide with an arc of the second ellipse.

7. The applicator of claim 6, wherein the second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, a minor axis of between about 100 millimeters and about 200 millimeters, and wherein the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees.

8. The applicator of claim 7, wherein a ratio of the major axis of the first ellipse to the major axis of the second ellipse is between about 0.9 and about 1.25.

9. The applicator of claim 7, wherein a ratio of the minor axis of the first ellipse to the minor axis of the second ellipse is between about 1.25 and about 2.4.

10. The applicator of claim 1, wherein the flank of the subject has a radius of between about 70 millimeters and about 155 millimeters.

11. The applicator of claim 1, wherein the sealing element comprises injection- molded liquid silicone rubber.

12. The applicator of claim 1, wherein the cup comprises aluminum.

13. The applicator of claim 1, wherein a first height of a tallest point of the sealing element relative to a lowest point of a top of the sealing element is between about 34 millimeters and about 38 millimeters.

14. The applicator of claim 13, wherein a second height of a tallest point of the interface relative to a lowest point of the interface is between about 23 millimeters and about 27 millimeters.

15. The applicator of claim 14, wherein the ratio of the first heigh to the second height is between about 1.2 and about 1.65.

16. The applicator of claim 1, wherein the patient’s tissue type is generally characterized as being more pliable and less fibrous compared to an average tissue type.

17. The applicator of claim 10, wherein the patient’s tissue type generally characterized as being more pliable and less fibrous compared to an average tissue type.

18. An applicator for selectively affecting subcutaneous adipose tissue in a flank of a subject, the applicator comprising: a housing; a treatment cup mounted in the housing, wherein the treatment cup defines a tissuereceiving cavity comprising a cavity perimeter and includes a temperature-controlled surface; at least one thermal device coupled to the treatment cup and configured to cool the temperature-controlled surface; at least one vacuum port coupled to the treatment cup, wherein the treatment cup is configured to draw the subject's tissue into the tissue-receiving cavity to ensure the tissue contacts at least a portion of the temperature-controlled surface to selectively damage and/or reduce the subject’s subcutaneous adipose tissue; and a sealing element coupled to the cup at an interface; wherein: the sealing element comprises a sealing element perimeter defining a first curvature profile, the interface defines a second curvature profile, and the first and second curvature profiles are configured to conform to the flank of the subject to facilitate a vacuum seal between the applicator and the flank of the subject to achieve the selective damage and/or reduction of the subject’s subcutaneous adipose tissue along the flank, wherein the first and second curvature profiles are configured to facilitate the drawing of tissue of the flank of the subject against the temperature-controlled surface of the tissue-receiving cavity; wherein each of the first and second curvature profiles are defined in terms of respective first and second ellipses; wherein at least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse; wherein the first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, a minor axis of between about 240 millimeters and about 250 millimeters, and wherein the first arc of the first ellipse is configured to subtend an angle of a center of the first ellipse of between about 90 degrees and about 150 degrees; wherein at least a second segment of the interface is configured to coincide with an arc of the second ellipse; wherein the second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, a minor axis of between about 100 millimeters and about 200 millimeters, and wherein the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees; wherein a ratio of the major axis of the first ellipse to the major axis of the second ellipse is between about 0.9 and about 1.25; wherein a ratio of the minor axis of the first ellipse to the minor axis of the second ellipse is between about 1.25 and about 2.4; wherein a first height of a tallest point of the sealing element relative to a lowest point of a top of the sealing element is between about 34 millimeters and about 38 millimeters; wherein a second height of a tallest point of the interface relative to a lowest point of the interface is between about 23 millimeters and about 27 millimeters; wherein the ratio of the first height to the second height is between about 1.2 and about 1.65; wherein the flank of the subject has a radius of between about 70 millimeters and about 155 millimeters; and wherein the patient’ s tissue type is generally characterized as being more pliable and less fibrous compared to an average patient’s tissue type.

19. A method of administering cryolipolysis treatment to a cryolipolysis treatment patient using an applicator, the method comprising: applying an applicator to a portion of tissue of a flank of the patient; drawing a vacuum with the applicator so that the portion of tissue of the flank of the patient is drawn into the applicator; and extracting heat from the portion of tissue of the flank of the patient.

20. The method of claim 19, wherein the applicator comprises: a housing; a treatment cup mounted in the housing, wherein the treatment cup defines a tissuereceiving cavity comprising a cavity perimeter and includes a temperature-controlled surface; at least one thermal device coupled to the treatment cup and configured to cool the temperature-controlled surface; at least one vacuum port coupled to the treatment cup and configured to draw the subject's tissue into the tissue-receiving cavity and against at least a portion of the temperature-controlled surface; and a sealing element coupled to the cup at an interface; wherein: the sealing element comprises a sealing element perimeter defining a first curvature profile, the interface defines a second curvature profile, and the first and second curvature profiles are configured to conform facilitate cryolipolysis treatment for the flank of the subject.

21. The method of claim 20, wherein the first and second curvature profiles are configured to facilitate the drawing of the flank tissue of the subject against the temperature- controlled surface of the tissue-receiving cavity.

22. The method of claim 20, wherein each of the first and second curvature profiles are defined in terms of respective first and second ellipses.

23. The method of claim 22, wherein at least a segment of the sealing element perimeter is configured to coincide with a first arc of the first ellipse.

24. The method of claim 23, wherein the first ellipse comprises a major axis of between about 365 millimeters and about 375 millimeters, and wherein the first arc of the first ellipse is configured to subtend and angle of a center of the first ellipse of between above 90 degrees and about 150 degrees.

25. The method of claim 22, wherein at least a second segment of the interface is configured to coincide with an arc of the second ellipse.

26. The method of claim 25, wherein the second ellipse comprises a major axis of between about 300 millimeters and about 400 millimeters, and wherein the arc of the second ellipse subtends an angle of a center of the second ellipse of between about 90 degrees and 150 degrees.

27. The method of claim 26, further comprising, before the step of applying, determining a pliability of the portion of the tissue of the flank of the patient.

28. The method of claim 27, wherein the pliability of the portion of the tissue of the flank of the patient is determined to be one of very pliable, somewhat pliable, pliable, fibrous, somewhat fibrous, and very fibrous.