US20080077201A1 - Cooling devices with flexible sensors - Google Patents

Abstract

A device for exchanging heat with a subject having skin is provided. The device includes a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin. The device further includes a substantially flexible sensing device disposed in the interface between the heat exchanging member and the subject's skin. The sensing device is configured to measure a parameter of the interface without substantially impeding heat transfer between the heat exchanging member and the subject's skin.

Description

TECHNICAL FIELD
• The present application relates to cooling devices, systems, and methods for exchanging heat with subcutaneous lipid-rich cells of a subject.
BACKGROUND
• As statistics have shown, excess body fat increases the likelihood of developing various diseases and can detract from personal appearance and athletic performance. One conventional technique of controlling excess body fat is liposuction that can selectively remove body fat to sculpt a person's body. One drawback of liposuction is that it is a complex surgical procedure that can have serious and occasionally even fatal complications.
• 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.
• Other non-invasive treatment methods include applying heat to a zone of subcutaneous lipid-rich cells. U.S. Pat. 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. Another promising method of reducing subcutaneous fat cells is to cool the target cells as disclosed in U.S. Patent Publication No. 2003/0220674, the entire disclosure of which is incorporated herein. U.S. Patent Publication No. 2003/0220674 also discloses methods for selective removal of lipid-rich cells, and avoidance of damage to other structures including dermal and epidermal cells.
• In any of these non-invasive treatment methods, temperatures at heat transfer interfaces (e.g., between a treatment device and a skin surface) are important for safety reasons. High interface temperatures may cause scorching of the skin surface, and low interface temperatures may cause frostbite. Therefore, effective devices and methods for accurately measuring the interface temperatures would be desirable.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.
• FIG. 1 is an isometric view of a system for exchanging heat with a subject in accordance with an embodiment of the invention.
• FIG. 2 is a partially exploded isometric view of a cooling device with flexible sensors in accordance with an embodiment of the invention.
• FIG. 3 is a partially exploded isometric view of a cooling device with flexible sensors in accordance with another embodiment of the invention.
• FIG. 4 is a front view of a flexible sensing device in accordance with another embodiment of the invention.
• FIG. 5 is a back view of a flexible sensing device in accordance with another embodiment of the invention.
• FIG. 6 is a front view of a flexible sensing device in accordance with a further embodiment of the invention.
• FIG. 7 is a block diagram showing computing system software modules for exchanging heat with a subject in accordance with an embodiment of the invention.
DETAILED DESCRIPTIONA. Overview
• The present disclosure describes devices, systems, and methods for exchanging heat with subcutaneous lipid-rich cells. The term “subcutaneous tissue” means tissue lying underneath the dermis and includes adipocytes (fat cells) and subcutaneous fat. It will be appreciated that several of the details set forth below are provided to describe the following embodiments in a manner sufficient to enable a person skilled in the relevant art to make and use the disclosed embodiments. Several of the details and advantages described below, however, may not be necessary to practice certain embodiments of the invention. Additionally, the invention can include other embodiments that are within the scope of the claims but are not described in detail with respect toFIGS. 1-7.
• Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the occurrences of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
• The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention.
• One aspect is directed toward a cooling device for removing heat from subcutaneous lipid-rich cells of a subject's skin. The cooling device can include a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin to remove heat from the lipid-rich cells such that the lipid-rich cells are affected while non-lipid-rich cells in the epidermis are not affected. The cooling device can further include a substantially flexible sensing device disposed in the interface between the heat exchanging member and the subject's skin, wherein the sensing device is configured to sense a parameter at the interface without substantially impeding heat transfer between the heat exchanging member and the subject's skin.
• Another aspect is directed toward a sensing device for measuring parameters of a heat transfer interface between a subject having skin and a cooling device having a substantially flexible substrate positioned in the heat transfer interface between the subject's skin and the cooling device. The substrate can include a temperature sensor disposed on the surface of the substrate. According to aspects, the temperature sensor is configured to measure a temperature of the heat transfer interface without substantially impeding heat transfer between the cooling device and the subject's skin.
• Another aspect is directed toward a method of applying a cooling device configured for removing heat from a subject having skin, the method including disposing a sensing device proximate to the cooling device, the sensing device being substantially flexible and at least partially conforming to the cooling device. The method can further include positioning the cooling device and the sensing device proximate to the subject's skin, wherein the cooling device and the subject's skin form a heat transfer interface, in which the sensing device is positioned. The method can further include measuring a parameter of the heat transfer interface using the sensing device and removing heat from a region of the subject's skin under the epidermis such that lipid-rich cells are affected while non-lipid-rich cells in the epidermis are not affected.
B. System for Selectively Reducing Lipid-Rich Cells
• FIG. 1 is an isometric view of asystem100 for exchanging heat from subcutaneous lipid-rich cells of asubject101 in accordance with an embodiment of the invention. Thesystem100 can include acooling device104 placed at anabdominal area102 of thesubject101 or another suitable area for exchanging heat from the subcutaneous lipid-rich cells of thesubject101. Thecooling device104 can be fastened to thesubject101 using, for example, a mechanical fastener (e.g., a belt105), an adhesive (e.g., an epoxy), suction (e.g., a vacuum or reduced pressure) or any other mechanisms. Thecooling device104 can be configured to heat and/or cool thesubject101. Various embodiments of thecooling device104 are described in more detail below with reference toFIGS. 2-7.
• In one embodiment, thecooling device104 is configured to cool subcutaneous lipid-rich cells of thesubject101. In such cases, thesystem100 can further include acooling unit106 and fluid lines108a-bconnecting thecooling device104 to thecooling unit106. Thecooling unit106 can remove heat from a coolant to a heat sink and provide the chilled coolant to thecooling device104 via the fluid lines108a-b.Examples of the circulating coolant include water, glycol, synthetic heat transfer fluid, oil, a refrigerant, and any other suitable heat conducting fluids. The fluid lines108a-bcan be hoses or other conduits constructed from polyethylene, polyvinyl chloride, polyurethane, and other materials that can accommodate the particular circulating coolant. Thecooling unit106 can be a refrigeration unit, a cooling tower, a thermoelectric chiller, or any other device capable of removing heat from a coolant or municipal water supply.
• Thecooling device104 can also include one or more thermoelectric elements, such as Peltier-type thermoelectric elements. In such cases, thesystem100 can further include apower supply110 and aprocessing unit114 operatively coupled to thecooling device104 viaelectrical cables112,116. In one embodiment, thepower supply110 can provide a direct current voltage to thecooling device104 to effectuate a heat removal rate from thesubject101. Theprocessing unit114 can monitor process parameters via sensors (not shown inFIG. 1) placed proximate to thecooling device104 and adjust the heat removal rate based on the process parameters. Theprocessing unit114 can include any processor, Programmable Logic Controller, Distributed Control System, and the like.
• Theprocessing unit114 can be in electrical communication with aninput device118, anoutput device120, and/or acontrol panel122. Theinput device118 can include a keyboard, a mouse, a touch screen, a push button, a switch, a potentiometer, and any other device suitable for accepting user input. Theoutput device120 can include a display screen, a printer, a medium reader, an audio device, and any other device suitable for providing user feedback. Thecontrol panel122 can include indicator lights, numerical displays, and audio devices. In the embodiment shown inFIG. 1, theprocessing unit114,power supply110,control panel122, coolingunit106,input device118, andoutput device120 are carried by arack124 withwheels126 for portability. In another embodiment, the various components can be fixedly installed at a treatment site.
• One expected advantage of thesystem100 is that thecooling device104 can be applied to the subject101 irrespective of the current physical condition of the subject101. For example, thesystem100 can be applied even when the subject101 is not ambulatory or is ill. Another expected advantage is that thesystem100 can remove or affect fat non-invasively without piercing the skin of the subject101. Yet another expected advantage is that thesystem100 is compact and can be used in an outpatient facility or a doctor's office. A further expected advantage is that thesystem100 can quickly cool lipid-rich cells in a subcutaneous layer without requiring high-voltage power supplies.
C. Cooling Devices With Flexible Sensors
• FIG. 2 is a partially exploded isometric view of acooling device104 in accordance with one embodiment of the invention and suitable for use in thesystem100. In this example, thecooling device104 includes aheat exchanging member130 and asensing device132 affixed to theheat exchanging member130. Thecooling device104 is generally configured for manual positioning, and/or it can be strapped or otherwise configured to be releasably attached to the subject101. Thesensing device132 is configured to measure a parameter at an interface of thecooling device104 and the skin of the subject101.
• Theheat exchanging member130 can include ahousing134 and fluid ports136a-bcoupled to the fluid lines108a-b.In one example, thehousing134 is generally rectangular, but in other examples, thehousing134 can be cubic, spherical, semi-spherical, or any other desired shape. Thehousing134 can include features for attaching thesensing device132. In the illustrated example, thehousing134 includes a plurality of indentations142 (identified individually as142a-d). In other examples, thehousing134 can include threaded apertures, channels, slots, pegs, or any other suitable attachment mechanism. Thehousing134 can be constructed from polymeric materials, metals, ceramics, woods, and/or other suitable materials.
• Theheat exchanging member130 can further include aninterface member138 at least partially in thehousing134. Theinterface member138 has aheat exchanging surface140 for transferring heat to/from the subject101. In one example, theheat exchanging surface140 is generally planar, but in other examples, theheat exchanging surface140 can be non-planar (e.g., curved, faceted, etc.) Theinterface member138 can be constructed from any suitable material with a thermal conductivity greater than 0.05 Watts/Meter Kelvin, and in many examples, the thermal conductivity is more than 0.1 Watts/Meter Kelvin. Examples of suitable materials include aluminum, copper, other metals, metal alloys, graphite, ceramics, some polymeric materials, composites, or fluids contained in a flexible membrane. In other embodiments, portions of theheat exchanging surface140 can be constructed from an insulating material with a thermal conductivity less than 0.05 Watts/Meter Kelvin.
• Thesensing device132 can include asubstrate144 having afirst surface146a and asecond surface146b. Thesubstrate144 can have a profile generally corresponding to the profile of theinterface member138. For example, in the illustrated example, thesubstrate144 is a flat and generally rectangular film that generally matches the profile of the illustratedheat exchanging surface140 of theinterface member138. In other examples, the substrate can have curved, faceted, or other desired profiles to correspond to theinterface member138. In further examples, thesubstrate144 can have a profile that corresponds to only a portion of theinterface member138.
• Thesubstrate144 can be substantially flexible to conform to theinterface member138 and have sufficient heat conductivity. As a result, thesensing device132 does not substantially impede heat transfer between the coolingdevice104 and the subject101. In one example, thesubstrate144 can be a thin film constructed from polyimide, polyamide, polycarbonate, or any other suitable material with sufficient heat conductivity. In another example, thesubstrate144 can be a thick film attached to a backing material (not shown, e.g., paper, plastic, etc.) with an adhesive. According to aspects of the invention, thesubstrate144 can be peeled off the backing material and adhered to theinterface member138 during assembly.
• Thesubstrate144 can also include attachment features for affixing thesensing device132 to thehousing134. In the illustrated example, thesubstrate144 includes clips152 (identified individually as152a-d) that correspond to the indentations142 of thehousing134. Individual clips152 include protrusions154 (identified individually as154a-d) that can fit inside the indentations142. During assembly, thesubstrate144 is snapped onto thehousing134 with thefirst surface146a facing theinterface member138. The clips152 fasten thesubstrate144 onto thehousing134 when the protrusions154 of the clips152 engage the indentations142. In other examples, thesubstrate144 can be attached to thehousing134 using screws, pins, hinges, or any other suitable attachment mechanism.
• Thesensing device132 can also include at least one sensor disposed on the first and/or second surfaces146a-bof thesubstrate144 to measure a parameter of the interface. In the illustrated example, thesensing device132 includes afirst temperature sensor148 disposed on thefirst surface146aand asecond temperature sensor150 disposed on thesecond surface146b.Thefirst temperature sensor148 contacts theinterface member138 after assembly to directly measure temperatures of theheat exchanging surface140. Thesecond temperature sensor150 contacts the subject's skin to directly measure skin temperatures during use. In other examples, thesensing device132 can include other types of sensors or a greater or smaller number of sensors disposed on thesubstrate144. For example, thesubstrate144 can include only one temperature sensor disposed on thesecond surface146bfor measuring the skin temperatures or multiple temperature sensors on thesecond surface146bfor redundancy. Alternatively, or in conjunction with multiple sensors, the substrate can include pressure sensors, transmissivity sensors, bioresistance sensors, ultrasound sensors, optical sensors, infrared sensors, heat flux, any other desired sensors, or any combination thereof.
• In the illustrated example, the first andsecond temperature sensors148,150 are configured as thermocouples as described in more detail below with reference toFIGS. 4 and 5. In other examples, thetemperature sensors148,150 can be configured as Resistive Temperature Detectors (RTD), thermistors, thermopiles, or other types of temperature sensors as described in more detail below with reference toFIG. 6. A thermopile is essentially a series of thermocouples and can be wired to measure temperature difference between two surfaces. In one embodiment, the thermocouples are laminated onto a Kapton backing and measure the temperature across the Kapton backing very accurately, which can then be converted to heat flux. In a further example, thesensing device132 can include pressure sensors, transmissivity sensors, bioresistance sensors, ultrasound sensors, optical sensors, infrared sensors, heat flux, or any other desired sensors.
• A coupling agent may be applied to the subject's skin or to theinterface member138 to provide improved thermal conductivity. The coupling agent may include polypropylene glycol, polyethylene glycol, propylene glycol, and/or glycol. Glycols, glycerols, and other deicing chemicals are efficient freezing-point depressants and act as a solute to lower the freezing point of the coupling agent. Propylene glycol (CH3CHOHCH2OH) is one exemplary component of deicer or non-freezing coupling agents. Other components include polypropylene glycol (PPG), polyethylene glycol (PEG), polyglycols, glycols, ethylene glycol, dimethyl sulfoxide, polyvinyl pyridine, calcium magnesium acetate, sodium acetate, and/or sodium formate. The coupling agent preferably has a freezing point in the range of −40° C. to 0° C., more preferably below −10° C. as further described in U.S. Provisional Application 60/795,799, entitled Coupling Agent For Use With a Cooling Device For Improved Removal of Heat From Subcutaneous Lipid-Rich Cells, filed on Apr. 28, 2006, herein incorporated in its entirety by reference.
• In operation, an operator can place thecooling device104 proximate to the subject's skin to form a heat exchanging interface. In one embodiment, the operator can press thecooling device104 against the subject's skin. In another embodiment, the operator can clamp a portion of the subject's skin between the coolingdevice104 and another device, such as a device similar in function and structure to thecooling device104. The operator can then exchange heat with the subject's skin using thecooling device104. In one embodiment, the operator can cool the subject's subcutaneous tissues by circulating a coolant through theheat exchanging member130 via the fluid lines108a-b. Heat can then be removed from the subject's skin, past thesensing device132, to theheat exchanging member130. By cooling the subcutaneous tissues to a temperature lower than 37° C., preferably between about −20° C. to about 20° C., more preferably between about −20° C. to about 10° C., more preferably between about −15° C. to about 5° C., more preferably between about −10° C. to about 0° C., subcutaneous lipid-rich cells can be selectively affected. The affected cells are resorbed into the subject through natural processes. In any of these embodiments, the operator can monitor and control the heat exchanging process by measuring skin and interface temperatures using thesensing device132. In one example, the operator can prevent excessively cooling the subject's skin by maintaining the skin and/or interface temperatures at a safe level. In other examples, the skin and/or the interface temperatures can be used as process variables to automatically control the heat exchanging process.
• One expected advantage of using thecooling device104 is the reduced risk of overcooling the subject's skin because the heat transfer interface temperature can be directly measured. As is known, heat conduction through an object creates a temperature gradient along a heat transfer path. For example, the temperature of the subject's dermis can be higher than that of the subject's epidermis during heat conduction. As a result, if the dermis temperature or a temperature internal to the cooling device, is used to control a cooling process, the epidermis temperature may be too high or too low. Consequently, using directly measured interface temperatures (e.g., at the epidermis) can reduce the risk of overheating or overcooling the subject's skin.
• Thecooling device104 can have many additional embodiments with different and/or additional features without detracting from the operation of thecooling device104. For example, thecooling device104 can be configured to be a handheld device as described in U.S. patent application Ser. No. 11/359,092 entitled Cooling Device For Removing Heat From Subcutaneous Lipid-Rich Cells, the entire disclosure of which is herein incorporated by reference. Theheat exchanging member130 can include thermoelectric heat exchanging members (e.g., Peltier-type elements), cryogenic elements (e.g., liquid Nitrogen evaporator), or other types of suitable heat exchanging elements. For example, thecooling device104 can be configured as a plurality of thermoelectric heat exchanging members contained on a hinged frame to allow rotation about at least one axis as described in U.S. patent application entitled Cooling Device Having a Plurality of Controllable Thermoelectric Cooling Elements to Provide a Predetermined Cooling Profile filed concurrently herewith, application number not yet assigned, the entire disclosure of which is herein incorporated by reference. Thesensing device132 can also be incorporated into a sleeve that can isolate the subject101 from theheat exchanging member130 as described below in more detail with reference toFIG. 3.
D. Cooling Devices With Sleeve Sensors
• FIG. 3 is an alternative example of thecooling device104 in accordance with one example of the invention for use in thesystem100. This alternative example, and those alternative examples and other alternatives described herein, is substantially similar to previously described examples, and common acts and structures are identified by the same reference numbers. Only significant differences in operation and structure are described below. In this example, thecooling device104 includes asleeve162 having afirst sleeve portion164 and asecond sleeve portion166. Thefirst sleeve portion164 can be generally similar in structure and function to thesensing device132 ofFIG. 2. Thesecond sleeve portion166 can be an isolation layer extending from thefirst sleeve portion164. For example, thesecond sleeve portion166 can be constructed from latex, rubber, nylon, Kevlar®, or other substantially impermeable or semipermeable material. Thesecond sleeve portion166 can prevent any contact between the subject's skin and theheat exchanging member130. In one example, thesleeve162 can be reusable. In other examples, thesleeve162 can be disposable. Thesleeve162 may be provided sterile or non-sterile.
• Thesecond sleeve portion166 can also include attachment features to affix thesleeve162 to thehousing134. In the illustrated example, thesecond sleeve portion166 includes four brackets172 (identified individually as172a-d), each located at a corner of thesecond sleeve portion166. Individual brackets172 include an aperture174 (identified individually as174a-d) that corresponds to anattachment point170 of thehousing134. During assembly, the apertures174 of the brackets172 can fit over theattachment point170 such that thesecond sleeve portion166 at least partially encloses theheat exchanging member130. In another example, thesecond sleeve portion166 can include brackets that can engage each other. For example, thebracket172acan include a pin that can engage theaperture174dof thebracket172d.During assembly, thesecond sleeve portion166 can wrap around thehousing134 and be held in place by engaging the brackets172 with each other. In a further example, thesecond sleeve portion166 can include a flexible member (not shown, e.g., an elastic band) at anouter edge176 of thesecond sleeve portion166 that can hold thesleeve162 over thehousing134 during assembly. In a further example, thesecond sleeve portion166 can include a releasable attachment member (not shown, e.g., Velcro® or snaps) at theouter edge176 of thesecond sleeve portion166 that can hold thesleeve162 over thehousing134 during assembly. In yet another example, adhesive can hold thesecond sleeve portion166 to thehousing134.
• In addition to the expected advantages described above, one expected advantage of using thesleeve162 is the improved sanitation of using thecooling device104. Thesleeve162 can prevent cross-contamination between the subject's skin and theheat exchanging member130 because thesleeve162 is substantially impermeable. Also, operating expense of thecooling device104 can be reduced because theheat exchanging member130 does not need to be sanitized after each use.
• Thesleeve162 can have many additional embodiments with different and/or additional features without detracting from its operation. For example, the first andsecond sleeve portions164,166 can be constructed from the same material (e.g., polyimide) or different materials. Thesleeve162 can include an adhesive layer (not shown) that binds thesleeve162 to thehousing134. Alternatively, a coupling gel (not shown) can be applied between thesleeve162 and theinterface member138.
E. Sensing Devices
• FIG. 4 is a front view andFIG. 5 is a back view of thesensing device132 illustrating several features in more detail. Thefirst temperature sensor148 can include afirst metal trace180 and asecond metal trace182 spaced apart from thefirst metal trace180. Thefirst metal trace180 includes a firstterminal portion186a,and thesecond metal trace182 includes a secondterminal portion186b.The first and second metal traces180,182 join at one end to form abi-metal junction184. In the illustrated embodiment, the first and second metal traces180,182 are generally parallel to each other. In other examples, the first and second metal traces180,182 can be at an angle.
• The first and second metal traces180,182 can be disposed onto thesubstrate144 using techniques including, for example, bonding, laminating, sputtering, etching, printing, or other suitable methods. The first and second metal traces180,182 can include iron, constantan, copper, nicrosil, platinum, rhodium, tungsten, or other suitable metals or metal alloys. The first and second metal traces180,182 can form thermocouples of the types J, K, T, E, N, R, S, U, B, and other desired types.
• In the illustrated example, thesecond temperature sensor150 is generally similar in structure and function to thefirst temperature sensor148. For example, thesecond temperature sensor150 can include metal traces190,192 joined at an end to form abi-metal junction194 and terminal portions196a-b.In one embodiment, the first andsecond temperature sensors148,150 can be the same type (e.g., type T). In another embodiment, the first andsecond temperature sensors148,150 can be of different types.
• FIG. 6 is an alternative example of thesensing device132 in accordance with one example of the invention for use in thesystem100. In this example, thesensing device132 includes anRTD202 and apressure sensor204 disposed on thefirst surface146aof thesubstrate144. TheRTD202 includes a first RTD terminal206a, asecond RTD terminal206b,and aresistance portion208 between the two RTD terminals206a-b. Theresistance portion208 can be constructed from platinum, gold, silver, copper, nickel or a combination of metals, such as nickel-iron, or any other materials or combinations of materials with sufficient temperature resistance change. A preferred embodiment includes a nickel-iron metal foil. Thepressure sensor204 includes terminals210a-b,apressure sensing portion214, and leads212a-bconnecting the terminals210a-bto thepressure sensing portion214. Thepressure sensor204 can be generally similar to a FlexiForcee load sensor (Model No. A201) manufactured by Tekscan, Inc. of South Boston, Mass.
• In operation, theRTD202 senses the interface temperature between the interface member138 (FIG. 2) and the subject's skin, and thepressure sensor204 senses the pressure applied to the subject's skin from the cooling device104 (FIGS. 2 and 3). An operator can then adjust the pressure applied to the subject's skin and/or the heat exchanging rate based on these measurements.
• One expected advantage of using thesensing device132 is the improved uniformity of heat transfer across the heat exchanging interface. If the contact between theinterface member138 and the subject's skin is poor, air gaps in the interface can substantially impede the heat transfer between the coolingdevice104 and the subject's skin and cause faulty interface temperature measurements. By using thesensing device132, the operator can monitor and correct the amount of pressure applied to the subject's skin to ensure good contact at the heat exchanging interface. Consequently, uniformity of the heat transfer across the interface can be improved.
F. Computing System Software Modules
• FIG. 7 illustrates a functional block diagram showingexemplary software modules440 suitable for use in the processing unit114 (FIG. 1). Each component can be a computer program, procedure, or process written as source code in a conventional programming language, such as the C++ programming language, and can be presented for execution by the CPU of aprocessor442. The various implementations of the source code and object and byte codes can be stored on a computer-readable storage medium or embodied on a transmission medium in a carrier wave. The modules of theprocessor442 can include aninput module444, adatabase module446, aprocess module448, anoutput module450, and optionally, adisplay module451. In another embodiment, thesoftware modules440 can be presented for execution by the CPU of a network server in a distributed computing scheme.
• In operation, theinput module444 accepts an operator input, such as process setpoint and control selections, and communicates the accepted information or selections to other components for further processing. Thedatabase module446 organizes records, including operatingparameter454,operator activity456,alarm458, and facilitates storing and retrieving of these records to and from adatabase452. Any type of database organization can be utilized, including a flat file system, hierarchical database, relational database, or distributed database, such as provided by Oracle Corporation, Redwood Shores, Calif.
• Theprocess module448 generates control variables based onsensor readings460 obtained from the sensing device132 (FIG. 2), and theoutput module450 generates output signals462 based on the control variables. For example, theoutput module450 can convert the generated control variables from theprocess module448 into4-20mA output signals462 suitable for a direct current voltage modulator. Theprocessor442 optionally can include thedisplay module451 for displaying, printing, or downloading thesensor readings460 andoutput signals462 via devices such as the output device120 (not shown). Asuitable display module451 can be a video driver that enables theprocessor442 to display thesensor readings460 on theoutput device120.
• Throughout the description and the claims, the words “comprise,” “comprising,” and the like, unless the context clearly requires otherwise, 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 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.
• The above detailed descriptions of embodiments of the invention are not intended to be exhaustive or limit the invention to the precise form disclosed above. While specific embodiments of, and examples for, the invention are described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein can be combined to provide further embodiments.
• In general, the terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification, unless the above detailed description explicitly defines such terms. While certain aspects of the invention are presented below in certain claim forms, the inventors contemplate the various aspects of the invention in any number of claim forms. Accordingly, the inventors reserve the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the invention.

Claims (30)

1. A device for removing heat from subcutaneous lipid-rich cells of a subject having skin, comprising:

a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin to remove heat from the lipid-rich cells such that the lipid-rich cells are substantially affected while non-lipid-rich cells in the epidermis are not substantially affected; and

a substantially flexible sensing device disposed in the interface between the heat exchanging member and the subject's skin, wherein the sensing device is configured to sense a parameter at the interface.

2. The device ofclaim 1 wherein the sensing device is further configured to sense a parameter at the interface without substantially impeding heat transfer between the heat exchanging member and the subject's skin.

3. The device ofclaim 1, further comprising a thermally conductive sleeve configured to be releasably retained on the heat exchanging member, wherein the sensing element is incorporated into the sleeve.

4. The device ofclaim 1, wherein the sensing device is a temperature sensor.

5. The device ofclaim 1, wherein the sensing device includes a substrate and a temperature sensor disposed on the substrate.

6. The device ofclaim 5, wherein the temperature sensor includes first and second metal traces deposited on the substrate, the first and second metal traces at least partially contacting each other to form a bi-metal junction.

7. The device ofclaim 1, wherein the sensing device includes a first surface corresponding to the heat transfer surface and a second surface opposite the first surface and corresponding to the subject's skin, and wherein a first sensor is disposed on the first surface and a second sensor is disposed on the second surface.

8. The device ofclaim 1, wherein the sensing device includes a pressure sensor and a temperature sensor.

9. The device ofclaim 1, further comprising a measuring circuit in electrical communication with the sensing device and configured to convert electrical temperature signals from the sensing device to temperatures in degrees Celsius or Fahrenheit.

10. The device ofclaim 9, further comprising a logic controller in electrical communication with the measuring circuit and configured to control a temperature of the subject's skin and/or the heat exchanging member based on the interface temperature measured by the sensing device.

11. The device ofclaim 1, further comprising a plurality of sensing devices configured to provide temperature information about the interface at regions on the heat exchanging member.

12. A sensing device for measuring parameters of a heat transfer interface between a subject having skin and a cooling device, comprising:

a substantially flexible substrate positioned in the heat transfer interface between the subject's skin and the cooling device, the substrate having a surface facing the cooling device; and

a sensor disposed on the surface of the substrate, the sensor configured to measure a temperature of the heat transfer interface without substantially impeding heat transfer between the cooling device and the subject's skin.

13. The sensing device ofclaim 12 wherein with heat transfer interface is configured to remove heat from the lipid-rich cells of the subject's skin such that the lipid-rich cells are substantially affected while non-lipid-rich cells in the epidermis are not substantially affected.

14. The sensing device ofclaim 12 wherein the sensor is a temperature sensor.

15. The sensing device ofclaim 14, wherein the temperature sensor includes a thermocouple type selected from the group consisting of the types J, K, T, E, N, R, S, U, and B.

16. The sensing device ofclaim 15, wherein the temperature sensor includes a first metal portion and a second metal portion spaced apart from the first metal portion, the first and second metal portions forming a bi-metal junction.

17. The sensing device ofclaim 15, wherein the temperature sensor includes two metal films sputtered, etched, or printed onto the substrate.

18. The sensing device ofclaim 14, wherein the temperature sensor is a first temperature sensor and the surface is a first surface, and wherein the substrate further includes a second surface opposite the first surface, and the device further includes a second temperature sensor disposed on the second surface.

19. The sensing device ofclaim 14, further comprising a pressure sensor disposed on the surface.

20. The sensing device ofclaim 14, wherein the temperature sensor includes one of a thermistor, a Resistive Temperature Detector or a thermopile deposited onto the substrate.

21. The sensing device ofclaim 20, wherein the temperature sensor is a metal foil type Resistive Temperature Detector.

22. The sensing device ofclaim 14, further comprising a measuring circuit in electrical communication with the temperature sensor and configured to convert electrical signals from the temperature sensor to temperatures in degrees Celsius or Fahrenheit.

23. A method of applying a cooling device configured for removing heat from a subject having skin, comprising:

disposing a sensing device proximate to the cooling device, the sensing device being substantially flexible and at least partially conforming to the cooling device;

positioning the cooling device and the sensing device proximate to the subject's skin, wherein the cooling device and the subject's skin form a heat transfer interface, in which the sensing device is positioned;

measuring a parameter of the heat transfer interface using the sensing device; and

removing heat from a region of the subject's skin under the epidermis such that lipid-rich cells are substantially affected while non-lipid-rich cells in the epidermis are not substantially affected.

24. The method ofclaim 23, wherein the lipid-rich cells are adipocytes.

25. The method ofclaim 23, further comprising controlling a rate of heat removal from the subject's skin to the cooling device based on a measured parameter of the heat transfer interface.

26. The method ofclaim 23, further comprising maintaining a temperature of the heat transfer interface based on a measured temperature of the heat transfer interface.

27. The method ofclaim 23, further comprising, indicating a temperature alarm if a measured temperature of the heat transfer interface is outside a specified target range.

28. The method ofclaim 23, wherein the sensing device includes a substrate having a first surface facing the cooling device and a second surface opposite the first surface, and wherein the sensing device further includes a first temperature sensor disposed on the first surface and a second temperature sensor disposed on the second surface, the method further comprising:

measuring a temperature of the cooling device using the first temperature sensor; and

measuring a temperature of the subject's skin using the second temperature sensor.

29. The method ofclaim 23, wherein the sensing device further includes a pressure sensor, the method further comprising:

pressing the cooling device and the sensing device against the subject's skin;

measuring a pressure between the cooling device and the subject's skin using the pressure sensor; and

if the measured pressure is not less than a pressure threshold, indicating sufficient contact between the cooling device and the subject's skin; and

if the measured pressure is less than the pressure threshold, indicating insufficient contact between the cooling device and the subject's skin.

30. The method ofclaim 23, wherein the sensing device is incorporated into a sleeve, the method further comprising isolating the cooling device from the subject's skin using the sleeve.

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