WO2009011708A1

WO2009011708A1 - System for treating lipid-rich regions

Info

Publication number: WO2009011708A1
Application number: PCT/US2007/075935
Authority: WO
Inventors: Mitchell E. Levinson; Jesse Nicasio Rosen; Corydon A. Hinton
Original assignee: Zeltiq Aesthetics, Inc.
Priority date: 2007-07-13
Filing date: 2007-08-14
Publication date: 2009-01-22
Also published as: EP2182872A1; JP2010533054A

Abstract

A cooling system is described for removing heat from a subject's subcutaneous lipid-rich regions, such as tissues, organs, cells, and so forth. In various embodiments, the cooling system includes a controller, a computing device, a data acquisition device, a chiller, and one or more applicators. The cooling system can employ these components to receive a selection of a treatment profile and apply the selected treatment using an applicator. The treatment profile may be received from a sleeve that connects to an applicator.

Description

SYSTEM FOR TREATING LIPID-RICH REGIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of the priority date of U.S. Patent Application Nos. 11/777,992, filed July 13, 2007, entitled SYSTEM FOR TREATING LIPID-RICH REGIONS; 11/777,995, filed July 13, 2007, entitled LIMITING USE OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES; 11/777,999, filed July 13, 2007, entitled MANAGING SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS; 11/778,001 , filed July 13, 2007, entitled USER INTERFACES FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS; and 11/778,003, filed July 13, 2007, entitled SECURE SYSTEMS FOR REMOVING HEAT FROM LIPID-RICH REGIONS, and which are incorporated herein by reference in their entireties.

BACKGROUND

[0002] Excess body fat, or adipose tissue, can detract from personal appearance and athletic performance. Excess adipose tissue may be present in various locations of the body, including, for example, the thigh, buttocks, abdomen, knees, back, face, arms, and other areas. Moreover, excess adipose tissue is thought to magnify the unattractive appearance of cellulite, which forms when subcutaneous fat protrudes into the dermis and creates dimples where the skin is attached to underlying structural fibrous strands. Cellulite and excessive amounts of adipose tissue are often considered to be unappealing. Moreover, significant health risks may be associated with higher amounts of excess body fat. An effective way of controlling or removing excess body fat therefore is needed.

[0003] Liposuction is a method for selectively removing adipose tissue to "sculpt" a person's body. Liposuction typically is performed by plastic surgeons or dermatologists using specialized surgical equipment that invasively removes subcutaneous adipose tissue via suction. One drawback of liposuction is that it is a surgical procedure, and the recovery may be painful and lengthy. Moreover, the procedure typically requires the injection of tumescent anesthetics, which is often

57968-8028. WO00/LEGAL13464640.2 associated temporary bruising. Liposuction can also have serious and occasionally even fatal complications. In addition, the cost for liposuction is usually substantial. Other emerging techniques for removal of subcutaneous adipose tissue include mesotherapy, laser-assisted liposuction, and high intensity focused ultrasound.

[0004] Conventional non-invasive treatments for removing excess body fat typically include topical agents, weight-loss drugs, regular exercise, dieting, or a combination of these treatments. One drawback of these treatments is that they may not be effective or even possible under certain circumstances. For example, when a person is physically injured or ill, regular exercise may not be an option. Similarly, weight-loss drugs or topical agents are not an option when they cause an allergic or negative reaction. Furthermore, fat loss in selective areas of a person's body cannot be achieved using general or systemic weight-loss methods.

[0005] Other non-invasive treatment methods include applying heat to a zone of subcutaneous lipid-rich cells. U.S. Patent No. 5,948,011 discloses altering subcutaneous body fat and/or collagen by heating the subcutaneous fat layer with radiant energy while cooling the surface of the skin. The applied heat denatures fibrous septae made of collagen tissue and may destroy fat cells below the skin, and the cooling protects the epidermis from thermal damage. This method is less invasive than liposuction, but it still may cause thermal damage to adjacent tissue, and can also be painful and unpredictable.

[0006] Additional methods of reducing subcutaneous adipocytes cool or otherwise selectively remove or target them, as disclosed for example in U.S. Patent Publication Nos. 2003/0220674 and 2005/0251120, the entire disclosures of which are incorporated herein. These publications disclose, among other things, the concept of reducing the temperature of subcutaneous adipocytes to selectively affect them without damaging the cells in the epidermis and other surrounding tissue. Although the methods and devices disclosed in these publications are promising, several improvements for enhancing the implementation of these methods and devices would be desirable..

57968-8028.WO00/LEGAL134646402 -2- BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings.

[0008] Figure 1 is an isometric view of an embodiment of a system for treating subcutaneous lipid-rich regions of a subject.

[0009] Figure 2 is a block diagram illustrating an environment in which the system may operate in some embodiments.

[0010] Figure 3 is a block diagram illustrating subcomponents of components of the system in various embodiments.

[0011] Figure 4 is a block diagram illustrating data structures employed by the system in various embodiments.

[0012] Figure 5 is a flow diagram illustrating a control_applicator method invoked by the system in some embodiments.

[0013] Figure 6 is a flow diagram illustrating an authenticate routine invoked by the system in some embodiments.

[0014] Figure 7 is a flow diagram illustrating a validate_disposable_sleeve routine invoked by the system in some embodiments.

[0015] Figure 8 is a flow diagram illustrating an update routine invoked by the system in some embodiments.

[0016] Figure 9 is a front isometric view of an embodiment of an applicator.

[0017] Figures 10A-10B are user interface diagrams illustrating aspects of user interfaces provided by the system in various embodiments.

57968-8028.WO00/LEGAL13464640.2 -3- DETAILED DESCRIPTION

A. Overview

[0018] A system is described for treating a subject's subcutaneous adipose tissue, such as by cooling it. The term "subcutaneous tissue" means lying beneath the dermis and includes subcutaneous fat, or adipose tissue, which primarily is composed of lipid-rich cells, or adipocytes. In various embodiments, the cooling system includes a controller, a computing device, a data acquisition device, a chiller, and one or more applicators. The cooling system can employ these components in various embodiments to receive a selection of a treatment profile and apply the selected treatment using an applicator.

[0019] An applicator is a component of the cooling system that cools a region of a subject, such as a human or animal subject. Various types of applicators can be applied during treatment, such as a massage or vibrating applicator, a vacuum applicator, a belt applicator, and so forth. Each applicator may be designed to treat identified portions of the subject's body, such as chin, cheeks, arms, pectoral areas, thighs, calves, buttocks, and so forth. As an example, the massage or vibrating applicator can be applied at the pectoral region, the vacuum applicator may be applied at the cheek region, and the belt applicator can be applied around the thigh region. One type of applicator is described by commonly assigned U.S. Patent App. Ser. No. 11/528,189, entitled "Cooling Devices With Flexible Sensors," which was filed on September 26, 2006, and is incorporated herein in its entirety by reference.

[0020] A patient protection device ("sleeve") is an apparatus that prevents the applicator from directly contacting a subject's skin and thereby can reduce the likelihood of cross-infection between subjects and cleaning requirements of the applicator. The patient protection device (e.g., sleeve) can be reused or can enforce single use electrically, mechanically, or electromechanically. The sleeve can include a sterility barrier, various electronics, sensors, memory, and/or security components. The sleeve may also contain various storage and communications devices, such as a radio frequency identification (RFID) component. A sleeve may be specifically designed for use with a limited set of applicators. When the sleeve is applied to an applicator, memory included with the sleeve may be accessible by the controller. The memory can include one or more treatment profiles. Each treatment profile can

57968-8028.WO00/LEGAL13464640.2 -4- include one or more segments and each segment can include a specified duration, a target temperature, and control parameters for features such as vibration, massage, vacuum, and other treatment modes. Upon receiving input to start the treatment, the controller can cause the applicator to cycle through each segment of the treatment profile. In so doing, the applicator applies power to one or more cooling devices, such as a thermoelectric cooler, to begin a cooling cycle and, for example activate features or modes such as vibration, massage, vacuum, etc. Using temperature sensors proximate to the one or more coolers, the patient's skin, or other locations, the controller determines whether a temperature that is sufficiently close to the target temperature has been reached. Although the remainder of this detailed discussion and the appended claims may describe or imply that the cooled region of the body (e.g., adipose tissue) 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 tendency. Thus, although the system may attempt to heat or cool to the target temperature, a sensor may measure a sufficiently close temperature. If the target temperature has not been reached, power may be increased or decreased, as needed, to maintain the target temperature or "set-point." When the indicated duration expires, the controller may apply the temperature and duration indicated in the next treatment profile segment. In some embodiments, temperature can be controlled using a variable other than, or in addition to, power output.

[0021] When the controller controls the temperature applied by the applicator, it employs a chiller. A chiller is a device that, based on variable power input, can increase or decrease the temperature at a connected thermoelectric cooler that is attached to the applicator. The applicator can have one or more attached cooling devices, such as thermoelectric coolers. The chillers can employ a number of cooling technologies ("cooler") including, for example, thermoelectric coolers, recirculating chilled fluid, vapor compression elements, or phase change cryogenic devices. One skilled in the art will recognize that there are a number of other cooling technologies that could be used such that the chillers need not be limited to those described herein.

[0022] A data acquisition device component of the cooling system can collect data from the controller, chiller, applicator, and other components. As examples, the

57968-8028.WO00/LEGAL13464640.2 -5- data acquisition device can collect information such as how much power is being applied, the temperature at each cooler, the temperature at the subject's skin, the status of the chiller, controller, or applicator, and so forth. The data acquisition device component can provide the collected information to a computing device.

[0023] The computing device can receive the information the data acquisition device component collects, collect other information, such as from the sleeve or from user input, and take various actions, such as by commanding the controller. As an example, the computing device can cause the controller to increase or decrease the temperature at various coolers based on the indicated skin temperature, selected treatment profile, and so forth.

[0024] The computing device or the applicator can provide various user interfaces, such as to begin treatment; display treatment profiles or their segments, current status, or terminate treatment; provide alarms or other notifications relating to abnormal or unexpected conditions; and so forth. These user interfaces can be provided to operators of the cooling system or to subjects. The cooling system will now be described with reference to the Figures.

B. Cooling System Components

[0025] Figure 1 is an isometric view of an embodiment of a cooling system 100 for removing heat from subcutaneous lipid-rich regions of a subject 101. The system 100 can include a cooling device 104 including an applicator 105; the cooling device 104 can be placed at an abdominal area 102 of the subject 101 or at any another suitable area for removing heat from a subcutaneous lipid-rich region of the subject 101. Various shapes and sizes of cooling devices 104 and applicators 105 can be applied to different regions.

[0026] The cooling system 100 can further include a chiller 106 and supply and return fluid lines 108a-b between the cooling device 104 and the chiller 106. The chiller 106 can remove heat from a circulating coolant to a heat sink and provide a chilled coolant to the cooling device 104 via the fluid lines 108a-b. Examples of the circulating coolant include water, glycol, synthetic heat transfer fluid, oil, a refrigerant, and/or any other suitable heat conducting fluid. The fluid lines 108a-b can be hoses or other conduits constructed from polyethylene, polyvinyl chloride, polyurethane, and/or other materials that can accommodate the particular circulating

57968-8028. WO00/LEGAL13464640.2 -6- coolant. The chiller 106 can be a refrigeration unit, a cooling tower, a thermoelectric chiller, or any other device capable of removing heat from a coolant.

[0027] As explained in more detail below, the cooling device 104 includes the applicator 105 and one or more heat exchanging units. The heat exchanging unit can be a Peltier-type thermoelectric element, and the cooling device 104 can have multiple individually controlled heat exchanging units to create a custom spatial cooling profile. The system 100 can further include a power supply 110 and a processing unit 114 operatively coupled to the cooling device 104 and the applicator 105. In one embodiment, the power supply 110 can provide a direct current voltage to the thermoelectric cooling device 104 and/or the applicator 105 to remove heat from the subject 101. The controller 114 can monitor process parameters via sensors (not shown) placed proximate to the cooling device 104 via control line 116 to adjust the heat removal rate based on the process parameters. The controller 114 can further monitor process parameters to adjust applicator 105 based on treatment parameters, such as treatment parameters defined in a treatment profile. The controller 114 can exchange data with the applicator via line 112 or via wireless communication. The controller 114 can include any processor, Programmable Logic Controller, Distributed Control System, and the like.

[0028] In another aspect, the controller 114 can receive data from an input device 118, transmit data to an output device 120, and/or exchange data with a control panel 122. The input device 118 can include a keyboard, a mouse, a stylus, a touch screen, a push button, a switch, a potentiometer, a scanner, or any other device suitable for accepting user input. The output device 120 can include a display screen, a printer, a medium reader, an audio device, or any other device suitable for providing user feedback. The control panel 122 can include indicator lights, numerical displays, and audio devices. In alternative embodiments, the cooling device 104 can include the input device 118, output device 120, and/or control panel 122. In embodiments Figure 1 illustrates, the controller 114, power supply 110, control panel 122, chiller 106, input device 118, and output device 120 can be carried by a rack 124 with wheels 126 for portability. In alternative embodiments, the controller 114 can be contained on the cooling device 104 or on the applicator 105. In other embodiments, the various components can be fixedly installed at a treatment site.

57968-8028. WO00/LEGAL13464640.2 -7- [0029] Although a noninvasive applicator is illustrated and discussed herein, minimally invasive applicators may also be employed. In such a case, the applicator and sleeve may be integrated. An example, a cryoprobe that may be inserted directly into the subcutaneous adipose tissue to cool or freeze the tissue is an example of such a minimally invasive applicator. Cryoprobes manufactured by, e.g., Endocare, Inc., of Irvine, California are suitable for such applications.

[0030] Figure 2 is a block diagram illustrating an environment in which the cooling system may operate in some embodiments. The environment 200 includes a power supply 202 and an isolation transformer 204. The power supply 202 can be any ordinary type of power supply, such as alternating current or direct current. The isolation transformer 204 can be a medical grade transformer that isolates the subject from power fluctuations and problems, such as leakage current, voltage spikes or dips, and so forth. The environment 200 also includes a computing device 206 and a user interface 208. The computing device 206 can be integrated with a controller 210 or can be a separate unit. As an example, the computing device 206 can be a single board computer that is adapted for use within a housing of the controller 210. In some embodiments, the controller 210 can be integrated with the applicator 216.

[0031] The user interface 208 can include various input devices for collecting input from a user, such as an operator of the cooling system, and can also include various output devices, such as for providing information to the operator, subject, and so forth. The computing device can be connected to the controller to receive input from the controller and provide commands to the controller. Various components of the cooling system may connect to other components via wired or wireless connections, such as Ethernet, serial (e.g., RS-232 or universal serial bus) connections, parallel connections, IEEE 802.11 , IEEE 802.15, IEEE 802.16, "WIMAX," IEEE 1394, infrared, Bluetooth, and so forth.

[0032] The computing device can also connect to a data acquisition device 212. The data acquisition device 212 can acquire data from various components, such as the controller 210, chiller 214, and applicator 216, and provide the retrieved data to other components, such as to the computing device 206. In various embodiments, the data acquisition device can be incorporated into the controller or applicator.

57968-8028. WO00/LEGAL13464640.2 -8- [0033] The computing device 206 can employ the data it receives from the data acquisition device 212, such as to command the controller 210 to take various actions. As an example, the computing device 206 may command the controller 210 to change operating parameters at the applicator. As another example, detecting that the skin temperature of the subject is too low, the computing device 206 can cause the applicator 216 to increase the temperature via the controller 210. Other connections between components may also exist in various embodiments, but are not illustrated. As an example, the controller 210 can connect to the chiller 214, such as to command the chiller. Alternatively, the connections can be indirect. As an example, the controller 210 can command the chiller 214 via the applicator 216. The applicator can connect to one or more heat exchanging units 218a and 218b, such as thermoelectric heat exchanging units. The heat exchanging units 218a-b may be housed in a sleeve 224. In some embodiments, the applicator 216 and heat exchanging units 218a-b may together be housed in a sleeve 224.

[0034] The applicator 216 can include thermoelectric heat exchanging units, heat exchanging unit temperature sensors, chemical sensors, electrical sensors, moisture sensors, skin temperature sensors, vacuum devices, and vibration or massage devices. The applicator can receive commands from a controller 210 to control temperature, vacuum, vibration, and so forth. It may also provide temperature or operating information to the controller 210 or computing device 206, such as via the data acquisition device 212.

[0035] In some embodiments, the sleeve 224 can be disposed and replaced, such as after every use, every subject, time period, number of uses, and so forth. Information on the application of a sleeve to a patient or subject can be stored in a memory associated with the sleeve. In various embodiments, various components of the cooling system, such as sleeves, can employ a secure memory, such as "CRYPTOMEMORY." Secure memory devices, such as CRYPTOMEMORY devices produced by ATMEL Corp., of San Jose, California, enable memory access through dynamic symmetric mutual authentication, data encryption, and other software- based or firmware-based security techniques. The contents of this memory cannot be accessed by devices or software that do not conform to the security measures. Moreover, the secure memory may employ tamper detection circuitry to also prevent hardware attacks. These and other security measures may be implemented to

57968-8028. WO00/LEGAL13464640.2 -9- ensure subject safety or privacy concerns, comply with laws or regulations, and to generally ensure safety and integrity of the cooling system. In some embodiments, the secure memory can be connected to flex circuits. A flex circuit is a printed circuit board that is pliable and that may be integrated with some types of applicators or sleeves, such as sleeve 224.

[0036] Some components may also employ secure enclosures in various embodiments. As an example, the controller 210 and/or computing device 206 can be housed in a secure enclosure. The secure enclosure may include features to deter physical access to the components of the system, such as switches to detect intrusion. The controller 210 and/or computing device 206 can include hardware and firmware to respond to detected intrusions, such as by disabling the ability to perform treatments, erasing memory, and so forth.

[0037] The computing device 206 may connect to network resources, such as other computers 222a-c. As examples, the computing device 206 may connect to a server 222a to upload data logs, subject information, use information, and so forth. The computing device 206 may also connect to a server 222b to download updates to software, lists of applicators or sleeves that should be disabled, and so forth. As an example, once a sleeve 224 has passed its expiry date or its lifespan has otherwise been determined to be expired, the computing device 206 may upload an identifier associated with the sleeve to a server for download by other computing devices so that the expired sleeve cannot be used with other cooling systems. The computing device 206 may connect to network resources via a network 220, such as the Internet or an intranet.

[0038] Figure 3 is a block diagram illustrating subcomponents of components of the cooling facility in various embodiments. Components of the cooling facility, such as the computing device 206, controller 210, data acquisition device 212, applicator 216, or sleeve 224, can include a computing environment 300. The computing environment 300 can include input lines 302a, 302b, and 302c. In various embodiments, multiple input lines may be employed. The computing environment 300 can also provide output lines 304a, 304b, and 304c. In various embodiments, multiple output lines may be provided. The computing environment may also include a processor 306, memory 308, input handler 310, output handler 312, and bus 314.

57968-8028. WO00/LEGAL13464640.2 - 10- [0039] In various embodiments, the processor 306 can be a standard central processing unit or a security processor. Security 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 security processors may not have debugging pins that enable an external debugger to monitor the security processor's execution or registers. In other embodiments, the cooling system may employ a secure field programmable gate array.

[0040] The memory 308 can be standard memory, secure memory, or a combination of both memory types. By employing a security processor and secure memory, the cooling system can ensure that data and instructions are both highly secure and sensitive operations such as decryption are shielded from observation.

[0041] The input handler 310 and output handler 312 retrieve input from lines 302a-c and provide output to lines 304a-c, such as via bus 314.

C. Cooling System Data Structures

[0042] In various embodiments, the cooling system can employ data structures that are stored in memory, such as in secure memory. The data structures enable the cooling system to provide treatment choices, ensure system integrity, and protect subject safety and privacy.

[0043] While the table data structures discussed below illustrate data structures with contents and organization that are designed to make them more comprehensible by a human reader, those skilled in the art will appreciate that actual data structures used by the facility to store this information may differ from the illustrated data structures, in that they, for example, may be organized in a different manner; may contain more or less information than shown; may be compressed and/or encrypted; etc.

[0044] Figure 4 is a block diagram illustrating data structures employed by the cooling system in various embodiments. The illustrated data structures 400 can be stored in memory associated with various components of the cooling system, such as secure memory associated with sleeves. Some of the data structures 400 may be indicated for read-only access, write-only access, or read/write access. The type of access can be enforced via a combination of hardware and/or software. As an

57968-8028.WO00/LEGAL13464640.2 -1 1 - example, when a field of the data structure is marked for read-only access, various algorithms associated with the cooling system may not attempt to write to the field. Moreover, the memory device storing the data structure may also prevent the field from being written to. When a field is marked for read-only access, the field may nevertheless be writable before it is deployed, such as by the manufacturer or distributor. As an example, a special encryption key or authentication key may be employed to write to read-only data structure fields.

[0045] The data structures 400 can include an identifier ("ID") block 402, profiles block 420, and use block 450. Each of these blocks will now be described.

[0046] The ID block 402 can include fields for a sleeve type 404, manufacturing date 406, serial number 408, and one or more limit type 410, limit value 412 pairs. These fields are generally indicated for read-only access. The sleeve type field 404 can store the type of sleeve, such as whether or not the sleeve is disposable, the types of applicators the sleeve is compatible with, the manufacturer of the sleeve, and so forth. The manufacturing date field 406 can store the date on which the sleeve was manufactured or distributed. The serial number field 408 can store a unique sleeve identifier.

[0047] The limit type field 410 stores the type of limit that is imposed on the sleeve. Limit types can include use counts, dates, times, and so forth. The cooling system includes flexibility in defining limit types. As an example, one sleeve type may have use-based limits whereas another sleeve type may have time-based limits, and a third sleeve type may include both time- and use-based limits. When the limit is based on use, the limit value field 412 may store the number of times that the corresponding sleeve can be used. As an example, when the value stored by the limit type field 410 indicates that the limit is based on use, the limit value field 412 may indicate that the sleeve expires after one use. When the limit is based on dates or times, the limit value field 412 may store the date or time duration after which the sleeve expires. As an example, when the value stored by the limit type field 410 indicates that the limit is based on date, the limit value field 412 may store a specific date after which the sleeve cannot be used, such as the date at which the shelf life of a sterile sleeve expires. As another example, when the value stored by the limit type field 410 indicates that the limit is based on a time duration, the limit

57968-8028.WO00/LEGAL13464640.2 -12- value field 412 may store a time duration after which the sleeve cannot be used. The time duration may be measured from the time the sleeve is first used.

[0048] The profiles block 420 stores information pertaining to treatment profiles. This includes a number of profiles field 422 for storing the number of profiles that are stored in the profiles block. Each profile indicates a name and has a number of segments, which are identified in the profiles block, such as in fields 424, 426, 436, and 438. Each profile also provides treatment-related information for each segment. As an example, segments 434 provide treatment-related information associated to the first profile identified in the illustrated profiles block. The treatment-related information includes ramp time 428, dwell time 430, and target temperature 432. The ramp time is the amount of time, such as in seconds, that the cooling system is to take to cool (or heat) a heat exchanging unit associated with an applicator so as to arrive at the target temperature 432 at the end of the specified amount of time. Various curves can be used to change the temperature, such as linear, asymptotic, geometric, and so forth. The dwell time 430 indicates the amount of time, such as in seconds, that the heat exchanging unit is to apply the target temperature 432. The number of segments for each profile is stored in the number of segments fields associated with each profile, such as fields 426 and 428. The name fields 424 and 436 can store names associated with each profile. These names can be retrieved and displayed in a user interface that an operator of the cooling system can use to select a profile. Each segment of a profile can identify parameters for one or more heat exchanging units associated with an applicator. As an example, blocks 440- 446 identify parameters that can be used to control heat exchanging units independently. Thus, for example, when an applicator with multiple heat exchanging units is employed, different areas of the subject's body proximate to each heat exchanging unit can receive different cooling treatments. The profiles block may also include additional fields, such as to indicate whether a vacuum device, vibrator device, or massage device should be turned on or off, the vacuum force or vibration frequency, and so forth. The profiles block 420 may also be indicated for read-only access.

[0049] The use block 450 stores information relating to use of a component, such as use of the sleeve associated with the memory storing the use block 450. The use block 450 can include a use counter field 452, a use identifier field 456, a

57968-8028.WO00/LEGAL13464640.2 - 13- use start time field 458, a use stop time field 460, an identifier field 462, and a log field 464. The use counter field 452 stores a count of the number of times the sleeve has been used during application of a treatment. A record can be stored in the use block for each use. The use identifier field 456 identifies the record. The use start field 458 stores the time at which treatment started and the use stop field 460 stores the time at which treatment stopped. The identifier ("ID") field 462 stores an identifier, such as an identifier of the applicator and/or controller component that was used during treatment, a patient identifier, and so forth. The log field 464 stores a log of operational characteristics, such as errors, profiles applied, and information from various sensors, such as temperature sensors. In various embodiments, the cooling system may transmit information contained in the use block, such as to a distributor or manufacturer for tracking or troubleshooting purposes. Fields in the use block can be indicated for read/write access.

[0050] In various embodiments, additional data structures can be added, such as to store calibration data, diagnostic data, test data, security data (e.g., to store security keys), executable code, and so forth.

D. Cooling System Routines

[0051] The cooling system invokes a number of routines. While some of the routines are described herein, one skilled in the art is capable of identifying other routines the cooling system could perform. Moreover, the routines described herein can be altered in various ways. As examples, the order of illustrated logic may be rearranged; substeps may be performed in parallel, illustrated logic may be omitted, other logic may be included, etc.

[0052] Figure 5 is a flow diagram illustrating a control_applicator routine invoked by the cooling system in some embodiments. The routine can be invoked by a computing device, such as a single board computer associated with a controller, to control an applicator. As an example, the computing device may invoke the control applicator routine 500 after an operator selects a treatment profile from a list of treatment profiles. The routine 500 begins at block 502.

[0053] At block 504, the routine receives duration information, such as ramp time and dwell time. This information can be retrieved from a selected treatment profile. At block 506, the routine receives a target temperature indication. The

57968-8028.WO00/LEGAL13464640.2 -14- target temperature is the temperature identified in the first segment of the selected treatment profile.

[0054] Within the loop delimited by blocks 508 and 518, the routine causes the applicator to cycle through each segment of the selected treatment profile. At block 508, the routine determines ramp characteristics. Ramp characteristics determine the slope of the increase or decrease in temperature as a function of time. Ramp characteristics can be implemented using various control schemes, such as open loop, bang-bang overshoot, proportional, proportional integral, proportional integral derivative, and others. In the open loop ramp control scheme, the cooling system sends a constant amount of power and does not adjust power based on temperature feedback from sensors. In the bang-bang overshoot control scheme, the cooling system applies power and when it senses via a temperature sensor that it has passed the target temperature, it applies more or less cooling, as appropriate. As an example, when thermoelectric coolers are used, greater power can lead to lower temperatures and so the heat exchanging unit may increase power to cause additional cooling. In the proportional control scheme, the cooling system compares the target temperature with the actual temperature (e.g., at the applicator) and applies a transfer function (e.g., to the power) to correct the temperature. The transfer function can be proportional to the amount of difference between the target and actual temperatures. In the proportional integral control scheme, prior differences between the target and actual temperatures are additionally incorporated when attempting to achieve the target temperature. In proportional integral derivative control scheme, the first derivative of the prior differences is used to reduce the possibility of overshooting the target temperature and react to system perturbations in a more stable manner.

[0055] At block 510, the routine communicates parameters, such as ramp time, dwell time, target temperature, and ramp characteristics, to the controller so that the controller can effectuate the segment of the treatment profile that is presently being applied. At block 512, the routine reads temperature, power, and other data from the controller and/or the data acquisition device ("DAQ"). At block 514, the routine records the read data in a log, such as in a log that is stored in memory or a database. The data that is stored in the log can be transmitted, such as to a server or other computing device via a network or other connection.

57968-8028. WO00/LEGAL13464640.2 - 15- [0056] At decision block 516, the routine determines whether there is a significant difference between the temperatures of the subject's skin and one or more heat exchanging units associated with the controlled applicator. In various embodiments, the significance of the temperature difference can be specified by an operator, by a treatment profile, and so forth. The temperature difference can also be tuned, such as based on the sensitivity of the subject. If the temperature difference is significant, the routine continues at block 520. Otherwise, the routine continues at decision block 518. At block 520, the routine takes corrective actions. As an example, the routine may cause the applicator to raise the temperature of the heat exchanging units having a significant temperature difference, alert the operator to the condition, terminate the treatment, and so forth. The routine may then continue at block 522, where it returns.

[0057] At decision block 518, the routine determines whether the duration, e.g., the dwell time, has expired. If the duration has expired, the routine continues at block 522, where it returns. Otherwise, the routine continues at block 510. In various embodiments, the routine may be invoked for each segment of a treatment profile.

[0058] The cooling system can update various data structures when a treatment is applied. The updates can occur before treatment begins or after it ends. These updates can include use counts, treatment profiles applied, and times treatment started or stopped. The updates can also include records of treatment attributes, such as temperatures, error conditions, and so forth. The updates can be made in secure memory, such as secure memory associated with sleeves, controllers, computing devices, or other components.

[0059] Figure 6 is a flow diagram illustrating an authenticate routine invoked by the cooling system in some embodiments. The cooling system can invoke the authenticate routine 600 when it powers on or when it detects that a component has connected to the cooling system. As an example, the cooling system may invoke the authenticate routine 600 when a sleeve is connected to the cooling system. The routine 600 authenticates each component that is connected to the cooling system. The routine 600 begins at block 602.

57968-8028.WO00/LEGAL13464640.2 -16- [0060] At block 604, the routine detects a power on condition or connection of a component. The cooling system may invoke the routine 600 when an applicator, sleeve, or other component is connected to the cooling system.

[0061] At block 606, the routine identifies each component that is connected to the cooling system, spanning the entire chain from the sleeve to the computing device that executes the routine. In various embodiments, the routine may identify all components in the chain even though the component that invokes the routine may be within the chain or not even in the chain.

[0062] At block 608, the routine authenticates all components in the chain of components. In various embodiments, the routine may authenticate all components in the chain of components when the routine detects a power on condition, and may authenticate only the newly connected component when the routine detects the connection of a component. As an example, the routine may authenticate all components when the cooling system is first powered on and then may authenticate only newly connected sleeves when sleeves are replaced between treatments. Thus, the logic of blocks 606 may be skipped when the routine detects connection of a newly added component.

[0063] The routine may employ various mechanisms for authenticating components. Although some mechanisms are identified herein, one skilled in the art would recognize that various mechanisms exist for authenticating components. As an example, one such mechanism is a concept known as trusted computing. When using the trusted computing concept, transactions between every component are secured, such as by using encryption, digital signatures, digital certificates, or other security techniques. When a component connects to the cooling system, the component may be queried (e.g., challenged) for its authentication credentials, such as a digital certificate. The component could then provide its authentication credentials in response to the query. Another component that sent the query can then verify the authentication credentials, such as by verifying a one-way hash value, private or public key, or other data that can be used to authenticate the component. The authentication credentials or authentication function can be stored in a secure memory that is associated with the component that is to be authenticated. In some embodiments, a querying component can provide a key to a queried component and the queried component can respond by employing an authentication function, such

57968-8028.WO00/LEGAL13464640.2 -17- as a one-way hash function, to produce a responsive key, such as a one-way hash value. The queried component can then respond to the query by providing the produced responsive key to the querying component. The two components can thus authenticate each other to establish a secure communications channel. Further communications between the authenticated components can transpire over the secure communications channel by using encrypted or unencrypted data. Various known encryption techniques can be employed.

[0064] At decision block 610, the routine determines whether a component cannot be authenticated. As an example, the routine may detect whether any component in the chain of components could not be authenticated. If at least one of the components in the chain of components cannot be authenticated, the routine continues at block 612. Otherwise, the routine continues at block 616.

[0065] At block 612, the routine stores an indication in a log that the component(s) could not be authenticated and can report an error to the operator of the cooling system. At block 614, the routine disables treatments so that the unauthenticated component cannot be used with the cooling system. When the unauthenticated component is removed and another component is added that can be authenticated (e.g., starting at block 608), the cooling system can continue treatments. The routine then continues at block 618, where it returns.

[0066] At block 616, the routine enables treatments so that when a treatment is started, appropriate action can be taken by the cooling device, such as based on selected treatment profiles. The routine then returns at block 618.

[0067] In some embodiments, the cooling systems supports an authentication override feature. In these embodiments, an operator may request a manufacturer or distributor of the cooling system for an authentication override key. Upon receiving this authentication override key, the operator can provide it to the cooling system. The cooling system may then operate with unauthenticated components for a defined period of time, such as 30 days. After expiry of this period of time, the cooling system may need to receive code updates or other maintenance to again be able to enable the authentication override feature. In some embodiments, the operator may be able to override authentication a defined number of times with different authentication override keys before the cooling system is updated or

57968-8028.WO00/LEGAL13464640.2 -18- maintained to re-enable the authentication override feature. When the authentication override feature is enabled, the cooling system can ignore authentication failures of some or all components of the cooling system. As an example, an operator may need to use recently expired sleeves because new sleeves are not available. In such a case, the operator may override authentication until the new sleeves arrive.

[0068] Figure 7 is a flow diagram illustrating a validate_disposable_sleeve routine invoked by the cooling system in some embodiments. The cooling system can invoke the validate_disposable_sleeve routine 700 to validate a newly connected sleeve, such as when authenticating connected components (e.g., at block 608 of Figure 6). The validate_disposable_sleeve routine 700 begins at block 702.

[0069] At block 704, the routine detects the connection of a sleeve. As an example, the routine may receive an indication that a sleeve has been connected, such as from an applicator or a controller. The applicator may detect the connection of the sleeve electronically or mechanically. The applicator may then provide an indication that a sleeve has been connected, such as to a controller.

[0070] At block 706, the routine authenticates the remainder of the cooling system with the newly connected sleeve. Authentication of components was described above in relation to Figure 6. The routine may employ the same authentication mechanisms or a different authentication mechanism to authenticate with the sleeve.

[0071] At block 708, the routine retrieves an identification ("ID") block and a use block that are stored in a memory, such as a secure memory, that is associated with the newly connected sleeve. The ID and use blocks are described above in relation to Figure 4.

[0072] In various embodiments, the ID and/or use blocks may be encrypted. When the ID block is encrypted, the routine decrypts the ID block at block 710. The routine can also decrypt use blocks that are encrypted. Various encryption and decryption techniques are known in the art, such as encryption techniques that use public or private keys that can be symmetric or asymmetric. These encryption and decryption techniques can be applied via hardware and/or software.

57968-8028.WO00/LEGAL13464640.2 -19- [0073] At block 710, the routine verifies the validity of the newly connected sleeve. The routine may employ various techniques to verify the validity of the newly connected sleeve. The routine may ensure that the data stored in the fields of the retrieved ID block are valid, such as by verifying the stored sleeve type and serial number. The routine may also compare an identifier (e.g., serial number) of the sleeve to a list of sleeves that are known to be invalid or expired. The list of invalid sleeves may be provided by the operator of the cooling system, manufacturer of the cooling system, distributor of the cooling system, or others. In some embodiments, the cooling system may update the list of invalid sleeves from time to time automatically, such as by downloading the list via a network connection. The list can be stored in a memory or storage device, such as in a circular buffer or a table. The routine can also compare the use limit data from the ID block to the use data recorded in the use block to determine if the sleeve is expired.

[0074] The routine then returns at block 714.

[0075] Figure 8 is a flow diagram illustrating an update routine invoked by the cooling system in some embodiments. The cooling system may invoke the update routine when it receives code for updating updatable code of the cooling system. As an example, the cooling system may receive the code via a network connection or a sleeve. Upon authenticating the source of the code, the cooling system can apply the update. The update routine 800 begins at block 802.

[0076] At block 804, the routine receives a code update from a sleeve. In some embodiments, the routine may receive an indication to update the code from the sleeve and may then retrieves the code via a network connection, such as from a server. In some embodiments, the routine may also receive the indication to update the code from a server, an operator of the cooling system, or from other sources. The routine may then retrieves the code via a network connection or from another source, such as from a storage device that the cooling system connects to. The routine may authenticate the source of the code update before retrieving the code.

[0077] At block 806, the routine applies the code update. As examples, the routine can apply the code update to a computing device, a controller, an applicator, or other component of the cooling system that stores code. The component

57968-8028.WO00/LEGAL13464640.2 -20- receiving the updated code may then need to be restarted, in which case the routine may cause that component to restart. At block 808, the routine returns.

E. User Interfaces

[0078] Figure 9 is a front isometric view of an embodiment of an applicator. In the illustrated embodiment, the applicator 900 includes an application portion 902 and a user interface portion 904. The applicator portion can include heat exchanging units, vibrators or massagers, vacuums, and connections to a controller, chiller, and other components of the cooling system. These units and lines of connection are hidden in the illustrated front isometric view. The user interface portion 904 can include a display panel 906, such as a touchscreen or other output device, and one or more input features, such as buttons or dials 908. In various embodiments, applicators have different sizes and shapes than the illustrated applicator 900. As examples, applicators can take the form of belts, handheld devices, and other devices of various sizes and shapes. In various embodiments, the user interface associated with an applicator can include various input and output devices, such as buttons, knobs, styluses, trackballs, microphones, touchscreens, liquid crystal displays, light emitting diode displays, lights, speakers, earphones, headsets, and the like.

[0079] Figures 10A-10B are user interface diagrams illustrating aspects of user interfaces provided by the cooling system in various embodiments. According to the user interface diagram 1000 illustrated in Figure 10A, the cooling system can display a list of treatment profiles 1004, test routines, or debugging/troubleshooting routines in a display 1002. The display 1002 can be displayed in a display panel 906 associated with an applicator (illustrated in Figure 9) or on some other output device, such as an output device 120 (illustrated in Figure 1). The list of treatment profiles 1004 can be retrieved from memory associated with a sleeve. The operator of the cooling device can select one of the profiles to apply during treatment. As an example, the operator can select one treatment profile for one region of the subject's body and another treatment profile for another segment of the subject's body. The cooling system can connect to multiple applicators in some embodiments and each applicator can be applied in parallel.

57968-8028.WO00/LEGAL13464640.2 -21 - [0080] In various embodiments, the operator can select other attributes that can cause the selected profile to be varied, such as the subject's characteristics (e.g., sex, weight, height, etc.) or subject's goals (e.g., amount of fat removal expressed in millimeters or percentages). The operator can also indicate other attributes, such as the subject's pain sensitivity, total number of treatments desired, and so forth. As an example, if the subject is available for many treatments, each treatment may need less time to administer.

[0081] According to the user interface diagram 1050 illustrated in Figure 10B, the cooling system can display various information during a treatment in a display 1010. The display 1010 can be displayed in a display panel 906 associated with an applicator (illustrated in Figure 9) or on some other output device, such as output device 120 illustrated in Figure 1. The display 1010 can include a count-up timer 1012, a count-down timer 1014, target temperature 1016, actual temperature 1018, and a chart 1020. The count-up timer 1012 can count the elapsed time, such as the elapsed time of the treatment or the current treatment profile segment. The countdown timer 1014 can count the time remaining, such as the time remaining for the treatment or the current treatment profile segment. The target temperature 1016 can show the target temperature, such as for a selected heat exchanging unit or other portion of the applicator. The actual temperature 1018 can show the actual temperature at the region corresponding to the target temperature 1016 or at some other region. The chart 1020 can depict various information in a graphical form, such as a temperature vs. time chart. A marker 1022 can indicate the present time in relation to the chart so that an operator or subject can quickly see what actions the treatment profile will take or has taken. As an example, according to the illustration, the treatment profile will soon reduce the temperature for some time period and will subsequently increase the temperature.

[0082] In some embodiments, the cooling system can take input from other devices. As an example, the cooling system can receive an image, such as from an ultrasound device, and enable the operator or subject to indicate on the image how much fat should be removed. The controller can then determine the applicable treatment profile, such as based on the fat thickness and other attributes.

57968-8028.WO00/LEGAL13464640.2 -22- F. Conclusion

[0083] Various embodiments of the technology are described above. It will be appreciated that details set forth above are provided to describe the embodiments in a manner sufficient to enable a person skilled in the relevant art to make and use the disclosed embodiments. Several of the details and advantages, however, may not be necessary to practice some embodiments. Additionally, some well-known structures or functions may not be shown or described in detail, so as to avoid unnecessarily obscuring the relevant description of the various embodiments. Although some embodiments may be within the scope of the claims, they may not be described in detail with respect to the Figures. Furthermore, features, structures, or characteristics of various embodiments may be combined in any suitable manner. Moreover, one skilled in the art will recognize that there are a number of other technologies that could be used to perform functions similar to those described above and so the claims should not be limited to the devices or routines described herein. While processes or blocks are presented in a given order, alternative embodiments may perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and/or modified. Each of these processes or blocks may be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks may instead be performed in parallel, or may be performed at different times. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claims.

[0084] The terminology used in the description is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of identified embodiments.

[0085] Unless the context clearly requires otherwise, throughout the description and the claims, 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. When the claims use the word "or" in reference to a list of two or more items, that word covers all of

57968-8028.WO00/LEGAL13464640.2 -23- 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.

[0086] Aspects of the technology may be stored or distributed on computer- readable media, including magnetically or optically readable computer discs, hardwired or preprogrammed chips (e.g., EEPROM semiconductor chips), nanotechnology memory, biological memory, or other data storage media. Indeed, computer implemented instructions, data structures, screen displays, and other data under aspects of the technology may be distributed over the Internet or over other networks (including wireless networks), on a propagated signal on a propagation medium (e.g., an electromagnetic wave(s), a sound wave, etc.) over a period of time, or they may be provided on any analog or digital network (packet switched, circuit switched, or other scheme). Those skilled in the relevant art will recognize that portions of the technology reside on various computing devices, such as a server computer, a client computer, and so forth. Thus, while certain hardware platforms are described herein, aspects of the technology are equally applicable to nodes on a network or other types of computing devices.

[0087] 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.

[0088] 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. In general, the terms used in the following claims should not be construed to limit the claims to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such

57968-8028.WO00/LEGAL13464640.2 -24- terms. Accordingly, the actual scope of the claims encompasses not only the disclosed embodiments, but also all equivalents.

57968-8028.WO00/LEGAL13464640.2 -25-

Claims

CLAIMSWe claim:

1. A system for changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface configured to reduce a temperature of a lipid-rich region; a patient protection device having a memory; and a controller that detects when the patient protection device connects to the applicator and authenticates the patient protection device before enabling the patient protection device to be employed with the applicator to change the temperature of the lipid-rich region.

2. The system of claim 1 further comprising a chiller that enables the heat exchanging surface to change the temperature of the lipid-rich region.

3. The system of claim 1 further comprising a computing device that commands the controller to apply a treatment based on a treatment profile wherein the memory stores a treatment profile, the treatment profile indicating a temperature to which the region is to be cooled and a duration during which the region is to maintain the indicated temperature.

4. The system of claim 3 further comprising a data acquisition device that collects data from the applicator and provides the collected data to the computing device.

5. The system of claim 3 wherein the computing device provides a user interface to enable an operator to select a treatment profile from multiple treatment profiles, the multiple treatment profiles identified in the memory of the patient protection device.

57968-8028. WO00/LEGAL13464640.2 -26-

6. The system of claim 3 wherein the computing device connects to a data communications network to retrieve a list of invalidated patient protection devices.

7. The system of claim 3 wherein the computing device connects to a data communications network to provide a list of patient protection devices that have expired.

8. The system of claim 1 wherein the applicator provides a user interface to enable an operator to select a treatment profile from multiple treatment profiles, the multiple treatment profiles identified in the memory of the patient protection device.

9. The system of claim 1 wherein the controller and the patient protection device are configured to authenticate each other.

10. The system of claim 1 wherein the memory is a secure memory.

11. The system of claim 1 wherein the memory is a portion of a secure processor.

12. The system of claim 1 wherein the patient protection device is a sleeve.

13. The system of claim 1 wherein the patient protection device is a plate.

14. The system of claim 1 wherein the patient protection device is a sheet.

57968-8028.WO00/LEGAL13464640.2 -27-

15. A system for changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface is configured to reduce a temperature of a lipid-rich region; and a controller that detects when a sleeve connects to the applicator and authenticates the patient protection device before enabling the patient protection device to be employed with the applicator to change the temperature of the lipid-rich region.

16. The system of claim 15 wherein the patient protection device is a sleeve.

17. The system of claim 15 wherein the patient protection device includes a memory.

18. A method performed by a system for cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device for use with an applicator to cool the subcutaneous lipid-rich region; authenticating the connected patient protection device; receiving from the patient protection device parameters relating to a treatment profile, the parameters including at least a temperature and a duration; and providing the temperature to the applicator so that the applicator cools the subcutaneous lipid-rich region to a temperature that is approximately equal to the temperature indicated by the parameters.

19. The method of claim 18 further comprising decrypting the received parameters when the parameters are encrypted.

57968-8028.WO00/LEGAL13464640.2 -28-

20. The method of claim 18 further comprising receiving an indication from a sensor associated with the applicator and commanding a controller to control the applicator in reaction to the sensed indication.

21. The method of claim 20 wherein the sensed indication is a temperature and power to the applicator is controlled to adjust the temperature.

22. The method of claim 21 further comprising receiving from the patient protection device a set of treatment profiles, displaying the set of treatment profiles in a display, receiving a selection of one of the displayed set of treatment profiles, and applying a treatment specified by the selected treatment profile.

23. The method of claim 22 wherein when the selected treatment profile includes multiple segments, cycling through each segment of the treatment profile, the cycling including varying the temperature provided to the applicator.

24. The method of claim 18 further comprising providing an alarm when a difference between a sensed actual temperature and the provided temperature is determined to be more than a specified amount.

25. The method of claim 24 further comprising taking a corrective action, wherein the corrective action is to change the actual temperature.

26. A computer-readable medium storing computer-executable instructions that, when executed, cause a computing system to perform a method for cooling a subcutaneous lipid-rich region of a subject having a skin, the method comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device for use with an applicator to cool the subcutaneous lipid-rich region; receiving from the patient protection device an indication of a treatment profile, the treatment profile specifying a temperature and a duration; and

57968-8028.WO00/LEGAL13464640.2 -29- commanding a controller to cause the applicator to cool the subcutaneous lipid-rich region to the specified temperature and for the specified duration, thereby causing the controller to control the chiller to begin cooling.

27. The computer-readable medium of claim 26 wherein the method further comprises employing a control function to control the chiller so that a temperature applied by the applicator does not drop below the specified temperature.

28. The computer-readable medium of claim 26 wherein the method further comprises storing in a data storage device information relating to the treatment.

29. A system for changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface is configured to reduce a temperature of a lipid-rich region; and a patient protection device having a memory configured for use with the applicator.

30. A system for cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface that cools a surface it contacts; and a patient protection device for use with the applicator, the patient protection device having a memory, the memory storing a use block and a treatment profile, the use block storing information relating to a use of the patient protection device, the treatment profile indicating a temperature to which the region is to be cooled by the applicator and a duration during which the applicator is to maintain the indicated temperature at the region.

57968-8C28.WO00/LEGAL13464640.2 -30-

31. The system of claim 30 wherein the memory further stores an identifier block that identifies a limit type and a limit value that specify a limit on the use of the patient protection device.

32. The system of claim 31 wherein the patient protection device is configured for limited use and when the use block indicates that the limit value has been reached, the applicator will not reduce temperatures when used with the patient protection device.

33. The system of claim 30 further comprising a controller associated with a computing device that authenticates the patient protection device, reads information stored in the memory of the patient protection device, and commands the applicator via the controller based on whether the use block indicates that the patient protection device can be used.

34. The system of claim 33 wherein the computing device establishes an encrypted communications channel with the patient protection device.

35. The system of claim 34 wherein the encrypted communications channel employs a key.

36. The system of claim 35 wherein the key is a one-way hash.

37. The system of claim 30 wherein the memory is associated with a secure processor.

38. The system of claim 30 wherein components of the system are components of a trusted computing model.

39. The system of claim 30 wherein the patient protection device additionally has a mechanical device that enforces single use by breaking a connector and thereby limits use.

57968-8C28.WO00/LEGAL13464640.2 -31 -

40. The system of claim 30 wherein the patient protection device additionally has an electrical fuse that opens and thereby limits use.

41. A method performed by a system for cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device configured for use with an applicator to cool the subcutaneous lipid-rich region; retrieving from the patient protection device an indication of a limit type, a limit value, and a use indicator; determining, based on the use indicator and limit value, whether the patient protection device has expired; and when the patient protection device has expired, preventing the applicator from cooling the subcutaneous lipid-rich region.

42. The method of claim 41 wherein the indication that the patient protection device has connected to the system is received mechanically.

43. The method of claim 41 wherein when the limit type indicates a count, the determining is based on a use counter that indicates a number of times that the patient protection device has been used and the patient protection device has expired when a value stored in the use counter is equal to a value stored in the limit value.

44. The method of claim 41 wherein when the limit type indicates a time, the patient protection device has expired when the present time is after a time stored in the limit value.

45. The method of claim 41 wherein when the limit type indicates a time duration, the patient protection device has expired when a difference between the present time and a start time stored in a start field of the patient protection device exceeds the time duration stored in the limit value.

57968-8028 WO00/LEGAL13464640.2 -32-

46. The method of claim 41 wherein when the limit type indicates a time duration, the patient protection device has expired when a difference between the present time and a stop time stored in a stop field of the patient protection device exceeds the time duration stored in the limit value.

47. The method of claim 41 wherein the preventing includes ignoring commands to apply a treatment.

48. A computer-readable medium storing computer-executable instructions that, when executed, cause a computing system to perform a method for cooling a subcutaneous lipid-rich region of a subject having a skin, the method comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device for use with an applicator to cool the subcutaneous lipid-rich region; retrieving from the patient protection device an indication of a limit type, a limit value, and a use indicator; determining, based on the use indicator and limit value, whether the patient protection device has expired; when the patient protection device has not expired, commanding a controller to cause the applicator to cool the subcutaneous lipid- rich region to a specified temperature and for a specified duration; and when the patient protection device has expired, preventing the controller from causing the applicator to cool the subcutaneous lipid-rich region.

49. The computer-readable medium of claim 48 wherein the method further comprises detecting that a mechanical connector has broken and preventing the controller from causing the applicator to cool the subcutaneous lipid-rich region.

57968-8028. WO00/LEGAL13464640.2 -33-

50. The computer-readable medium of claim 48 wherein the method further comprises detecting that an electrical fuse has opened and preventing the controller from causing the applicator to cool the subcutaneous lipid-rich region.

51. The computer-readable medium of claim 48 wherein the retrieving includes decrypting the retrieved limit type, limit value, and use indicator.

52. The computer-readable medium of claim 48 wherein the patient protection device has expired after a single use.

53. The computer-readable medium of claim 48 wherein the patient protection device has expired after multiple uses.

54. The computer-readable medium of claim 48 wherein the patient protection device has expired after a specified date.

55. The computer-readable medium of claim 48 wherein the patient protection device has expired after a specified time duration between a first treatment and a last treatment.

56. The computer-readable medium of claim 48 wherein the patient protection device expires when its use is attempted on a second subject other than a first subject on whom the patient protection device was previously used.

57. The computer-readable medium of claim 56 wherein the method further comprises determining that use of the is attempted on the second subject using biometric sensing.

58. The computer-readable medium of claim 48 wherein the patient protection device contains a memory storing information relating to an applied treatment.

57968-8028.WOQ0/LEGAL13464640.2 -34-

59. The computer-readable medium of claim 58 wherein the information includes treatment profile parameters.

60. A system for managing temperature of lipid-rich regions, comprising: an applicator having a heat exchanging surface that manages a temperature of a lipid-rich region; and a patient protection device configured for use with the applicator having a memory that stores a treatment profile, the treatment profile including at least a dwell time and a target temperature, the target temperature indicating a target temperature for the lipid-rich region and the dwell time indicating the time during which the region should be kept at or near the target temperature.

61. The system of claim 60 further comprising a chiller that enables the heat exchanging surface to cool the region, a controller that controls the applicator, and a computing device that reads the treatment profile from the memory of the patient protection device.

62. The system of claim 60 wherein the treatment profile includes several segments, each segment indicating a dwell time and a target temperature.

63. The system of claim 62 wherein each segment further includes a ramp time that indicates a time during which temperature is reduced or increased so that the target temperature indicated in the segment is reached when the ramp time ends.

64. The system of claim 63 wherein the temperature is reduced or increased according to a transfer function.

65. The system of claim 64 wherein the transfer function is proportional integral derivative.

57968-8028.WO00/LEGAL13464640.2 -35-

66. The system of claim 62 wherein the applicator is caused to cycle through a temperature indicated by each segment.

67. The system of claim 62 wherein one of the segments specifies a target temperature for each of two heat exchanging units of the applicator and each heat exchanging unit is cooled to the corresponding specified target temperature.

68. The system of claim 62 wherein one of the segments specifies a target temperature for each of two heat exchanging units of the applicator and each heat exchanging unit is heated to the corresponding specified target temperature.

69. The system of claim 60 wherein the memory specifies a target temperature for each of two heat exchanging units of the applicator and each heat exchanging unit is cooled to the corresponding specified target temperature.

70. The system of claim 60 further comprising a computing device that provides a user interface to enable an operator to select a treatment profile from multiple treatment profiles, the multiple treatment profiles identified in the memory of the patient protection device.

71. The system of claim 70 wherein the computing device retrieves information stored in the memory of the patient protection device using a secure communications channel.

72. The system of claim 71 wherein the memory of the patient protection device contained in a secure processor.

73. The system of claim 71 wherein the secure communications includes encrypted data.

57968-8028.WO00/LEGAL13464640.2 -36-

74. A method for managing system temperature to remove heat performed by a system for cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device configured for use with an applicator to cool the subcutaneous lipid-rich region; retrieving via secure communications from the patient protection device a treatment profile, the treatment profile received in an encrypted manner and specifying a temperature; decrypting the received treatment profile; identifying a specified temperature in the decrypted treatment profile; and providing the specified temperature to the applicator so that the applicator cools the subcutaneous lipid-rich region to a temperature that is approximately equal to the temperature indicated by the parameters.

75. The method of claim 74 further comprising receiving an indication from a sensor associated with the applicator and commanding a controller to control the applicator in reaction to the sensed indication.

76. The method of claim 75 wherein the sensed indication is a temperature and power to the applicator is controlled to adjust the temperature.

77. The method of claim 74 further comprising receiving from the patient protection device a set of names of treatment profiles, displaying the set of names of treatment profiles in a display, and receiving a selection of one of the displayed set of names of treatment profiles wherein the treatment profile corresponding to the selected name is retrieved via secure communications.

78. The method of claim 74 wherein when the retrieved treatment profile includes multiple segments, cycling through each segment of the treatment profile, the cycling including varying the temperature provided to the applicator.

57968-8028.WO00/LEGAL13464640.2 -37-

79. The method of claim 74 wherein when the retrieved treatment profile specifies multiple heat exchanging units, applying a specified temperature to each corresponding heat exchanging unit.

80. The method of claim 74 further comprising taking a corrective action when an error condition is detected, wherein the corrective action is to change the temperature.

81. The method of claim 74 further comprising taking a corrective action when an error condition is detected, wherein the corrective action is to terminate treatment.

82. A computer-readable medium storing computer-executable instructions that, when executed, cause a computing system to perform a method for managing system temperature to remove heat performed by a system for cooling a subcutaneous lipid-rich region of a subject having a skin, the method comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device for use with an applicator to cool the subcutaneous lipid-rich region; receiving from the patient protection device an indication of a treatment profile, the treatment profile specifying a temperature and a duration; and controlling the applicator to cool the subcutaneous lipid-rich region to the specified temperature and for the specified duration.

83. The computer-readable medium of claim 82 wherein the controlling includes applying a control function to control temperature changes.

84. The computer-readable medium of claim 83 wherein the control function is a proportional integral derivative control function.

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85. A system for providing a user interface relating to changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface; a patient protection device operably configured to function with the applicator and having a memory; and a computing device operably configured to retrieve data stored in the memory of the patient protection device to display the data on a display and cause the heat exchanging surface to change the temperature of a region of the subject to which the heat exchanging surface is contacted.

86. The system of claim 85 wherein the display is connected to the computing device.

87. The system of claim 85 wherein the display is connected to the applicator.

88. The system of claim 85 wherein the data include a treatment profile name.

89. The system of claim 85 wherein the data include a temperature.

90. The system of claim 85 wherein the display shows a count-up clock.

91. The system of claim 85 wherein the display shows a count-down clock.

92. The system of claim 85 wherein the display shows a time- temperature graph.

93. The system of claim 85 wherein the display shows a heat flux.

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94. The system of claim 85 wherein the display shows a number of joules.

95. The system of claim 85 wherein the display shows an amount of fat reduced.

96. The system of claim 85 wherein the display shows a chart of temperature without showing a magnitude for the chart.

97. The system of claim 85 further comprising a user input device.

98. The system of claim 97 wherein the user input device is a touch screen.

99. The system of claim 97 wherein the user input device is a button.

100. A method performed by a system for providing a user interface relating to cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: displaying a list of treatment profile names, the treatment profile names retrieved from a patient protection device manufactured to function with an applicator; receiving a selection of a treatment profile; and displaying a time and a target temperature associated with the treatment profile retrieved from the patient protection device.

101. The method of claim 100 further comprising retrieving the list of treatment profile names from a memory associated with the patient protection device and decrypting the list of treatment profile names before displaying the list.

102. The method of claim 100 further comprising retrieving the time and target temperature from a memory associated with the patient protection device and decrypting the time and target temperature.

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103. The method of claim 100 further comprising displaying the time and the target temperature at a display connected to the applicator.

104. The method of claim 100 further comprising raising an alarm when an actual temperature differs from the target temperature by more than a specified amount.

105. A computer-readable medium storing computer-executable instructions that, when executed, cause a computing system to perform a method for providing a user interface relating to cooling a subcutaneous lipid-rich region of a subject having a skin, the method comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device for use with an applicator to cool the subcutaneous lipid-rich region; determining whether the patient protection device is valid; and when the patient protection device is valid, retrieving data contained in a memory of the patient protection device; displaying a selectable portion of the retrieved data; receiving a selection from the displayed data; and beginning a treatment based on the selection, the selection indicating a treatment profile.

106. The computer-readable medium of claim 105 wherein the method further comprises displaying a target temperature indicated by the selected treatment profile.

107. The computer-readable medium of claim 105 wherein the method further comprises displaying an actual temperature.

108. The computer-readable medium of claim 105 wherein the method further comprises displaying a timer that counts down from a time indicated by the selected treatment profile.

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109. The computer-readable medium of claim 105 wherein the method further comprises displaying a timer that counts up to a time indicated by the selected treatment profile.

110. The computer-readable medium of claim 105 wherein the method further comprises displaying a time-temperature chart relating to temperatures that are specified in the treatment profile over a period of time.

111. The computer-readable medium of claim 105 wherein the method further comprises displaying an indication of a feature control parameter indicated by the selected treatment profile.

112. A secure system for cooling a subcutaneous lipid-rich region of a subject having a skin, comprising: an applicator having a heat exchanging surface that reduces temperatures of surfaces it contacts; and a controller having communicably coupled therewith a computing device that detects when a patient protection device connects to the applicator and authenticates the patient protection device before enabling the patient protection device to be employed with the applicator to reduce the temperature of the lipid-rich region, the authentication employing the encryption key.

113. The secure system of claim 112 further comprising the patient protection device having a secure processor, the secure processor having a secure processor memory, the secure processor memory storing an encryption key.

114. The secure system of claim 113 wherein when the secure processor is physically tampered with, it becomes unusable and its digital contents cannot be accessed.

115. The secure system of claim 113 wherein the secure processor stores a digital signature.

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116. The secure system of claim 113 wherein the secure processor memory further stores a treatment profile indicating a temperature to which the region is to be cooled and a duration during which the region is to maintain the indicated temperature.

117. The secure system of claim 113 wherein information that the computing device retrieves from the patient protection device is encrypted.

118. The secure system of claim 112 wherein the computing device employs a secure field programmable gate array.

119. The secure system of claim 112 wherein the computing device employs a secure application specific integrated circuit.

120. The secure system of claim 112 wherein the controller is housed in a secure housing.

121. The secure system of claim 112 wherein the computing device employs a processor that provides tamper resistance, detects intrusion, and takes corrective actions taken in response to a detected intrusion.

122. The secure system of claim 112 wherein the computing device authenticates the controller.

123. The secure system of claim 112 wherein the applicator is authenticated.

124. The secure system of claim 112 wherein the patient protection device is authenticated.

125. The secure system of claim 112 wherein the computing device includes an authentication mechanism.

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126. A method performed by a secure system for changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, comprising: receiving an indication that a patient protection device has connected to the system, the patient protection device configured for use with an applicator to cool the subcutaneous lipid-rich region; receiving from the patient protection device one or more temperatures, the one or more temperatures provided as encrypted data; decrypting the encrypted data to identify the one or more temperatures; and providing the one or more identified temperatures to the applicator so that the applicator cools the subcutaneous lipid rich region to one or more temperatures that are approximately equal to the one or more temperatures indicated by the parameters.

127. The method of claim 126 wherein a secure processor associated with the patient protection device encrypts the data.

128. The method of claim 126 further comprising authenticating the patient protection device.

129. The method of claim 126 wherein the authentication employs a public key exchange mechanism.

130. The method of claim 126 wherein the authentication employs a digital certificate.

131. The method of claim 126 wherein the authentication employs a shared key.

132. A computer-readable medium storing computer-executable instructions that, when executed, cause a computing system to perform a method for

57968-8028.WO00/LEGAL13464640.2 -44- changing a temperature of a subcutaneous lipid-rich region of a subject having a skin, the method comprising: receiving an indication that a patient protection device has connected, the patient protection device configured for use with an applicator to change the temperature of the subcutaneous lipid-rich region; authenticating the patient protection device; receiving from the patient protection device via secure communications a target temperature; and providing the target temperature to the applicator so that the applicator changes the temperature of the subcutaneous lipid-rich region.

133. The computer-readable medium of claim 132 wherein the method further comprises decrypting the received temperature before providing it to the applicator.

134. The computer-readable medium of claim 132 wherein the method further comprises receiving a duration.

135. The computer-readable medium of claim 134 wherein the method further comprises decrypting the received duration and providing the decrypted duration to the applicator.

136. The computer-readable medium of claim 135 wherein the method further comprises receiving a feature control parameter.

137. The computer-readable medium of claim 135 wherein the method further comprises decrypting the received feature control parameter and providing the decrypted feature control parameter to the applicator.

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