System and method for mitigating side effects of chemotherapy

Abstract

To provide an improved portable system for reducing side effects of cancer chemotherapy.SOLUTION: A therapeutic cooling and / or compression system, configured to cool a body portion, comprises a conformal covering 6 for covering the body portion configured to extract heat energy from the body portion, a sensor device 3 within the conformal covering 6 for sensing a parameter of the body portion, an actuator 5 configured for changing an amount of heat energy extracted from the body portion, and a control unit 4 configured for regulating the actuator 5 responsive to control input from the sensor device 3. The system may be portable, enabling a patient to walk while undergoing treatment.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 62 / 966,912, entitled "Method and Device for Scalp Cooling," filed on January 28, 2020, to Spangler Vaughn, which is incorporated by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE Embodiments of the present invention relate to the field of medical devices. More specifically, embodiments of the present invention relate to systems and methods for reducing the side effects of chemotherapy. [Background technology]

[0003] Chemotherapy describes or refers to drug treatments that use powerful chemicals to kill rapidly growing cells. Because cancer cells generally grow and multiply much faster than most cells in the body, chemotherapy is often used to treat a variety of cancers. For medical patients undergoing chemotherapy, the toxicity of chemotherapy drugs can cause several problems (side effects) that make the treatment less tolerable. Some common side effects are, for example, loss of hair from the head, peripheral neuropathy, oral mucositis (inflammation and ulceration of the mucous membrane), and onycholysis (detachment of the nail from the nail bed).

[0004] Several studies have reported that scalp hair loss is one of the most distressing side effects. One study reported that up to 8% of women refuse chemotherapy because of hair loss (Tierney AJ, Taylor J, Closs SJ, Knowledge, expectations and experiences of patients receiving chemotherapy for breast cancer, Scand J Caring Sci 1992:6:75-80). Some patients may discontinue chemotherapy due to the perceived severity of such side effects. Some patients may request and / or request changes and / or reductions in chemotherapy in light of expected or experienced side effects, detrimentally reducing the effectiveness of treatment. Summary of the Invention

[0005] Therefore, there is a need for a system and method for reducing chemotherapy side effects.What is also needed is a system and method for reducing chemotherapy side effects that is portable and allows the patient to walk and / or be carried, for example, in a car or bus during treatment.What is also needed is a system and method for reducing chemotherapy side effects that provides temperature and / or pressure control to the patient and / or caregiver.What is also needed is a system and method for reducing chemotherapy side effects that is compatible and complementary with existing systems and methods for administering chemotherapy.

[0006] According to an embodiment of the present invention, a therapeutic cooling system configured to cool and / or compress a body part, which may also include the ability to control compression, comprises a conformal cover for covering the body part configured to extract thermal energy from the body part, a sensor device in the conformal cover for sensing a parameter of the body part, an actuator configured to vary the amount of thermal energy extracted from the body part, and a control unit configured to adjust the actuator in response to a control input from the sensor device. The system may be portable, allowing a patient to ambulate or be transported while undergoing treatment. The actuator may be configured to vary the amount of compression applied to the body part. [Brief description of the drawings]

[0007] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the invention. Unless otherwise noted, the drawings may not be drawn to scale.

[0008] [Figure 1] FIG. 1 shows a block diagram of an exemplary closed loop controller for use with a heating / cooling / compression device, in accordance with an embodiment of the present invention.

[0009] [Diagram 2] FIG. 1 shows a block diagram of an exemplary gas-based heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0010] [Diagram 3] FIG. 1 shows a block diagram of an exemplary gas-based heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0011] [Figure 4] FIG. 1 shows a block diagram of an exemplary thermoelectric cooler-based heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0012] [Diagram 5] FIG. 1 shows a block diagram of an exemplary thermoelectric cooler-based heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0013] [Figure 6] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0014] [Figure 7] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0015] [Figure 8] FIG. 1 illustrates a block diagram of an exemplary multi-zone thermal management system, in accordance with an embodiment of the present invention.

[0016] [Figure 9] FIG. 1 illustrates a block diagram of an exemplary multi-zone thermal management system, in accordance with an embodiment of the present invention.

[0017] [Figure 10] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0018] [Figure 11] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0019] [Figure 12] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0020] [Figure 13] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0021] [Figure 14] FIG. 1 shows a block diagram of an exemplary heating / cooling / compression system, in accordance with an embodiment of the present invention.

[0022] [Figure 15] 1 illustrates a block diagram of an exemplary thermal safety system, in accordance with an embodiment of the present invention.

[0023] [Figure 16] FIG. 1 illustrates a block diagram of an exemplary thermal control system, in accordance with an embodiment of the present invention.

[0024] [Figure 17] 1 illustrates a block diagram of an exemplary thermal management system in accordance with an embodiment of the present invention.

[0025] [Figure 18] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0026] [Figure 19] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0027] [Figure 20] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0028] [Figure 21] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0029] [Figure 22] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0030] [Diagram 23] FIG. 1 illustrates a block diagram of an exemplary hair management system, in accordance with an embodiment of the present invention.

[0031] [Figure 24] FIG. 1 shows a block diagram of an exemplary closed loop controller for use with a heating / cooling / compression device, in accordance with an embodiment of the present invention.

[0032] [Figure 25A] 1 illustrates an exemplary system for heating, cooling, and / or compressing a hand, a finger, and an arm, respectively, in accordance with an embodiment of the present invention. [Figure 25B] 1 illustrates an exemplary system for heating, cooling, and / or compressing a hand, a finger, and an arm, respectively, in accordance with an embodiment of the present invention. [Figure 25C] 1 illustrates an exemplary system for heating, cooling, and / or compressing a hand, a finger, and an arm, respectively, in accordance with an embodiment of the present invention.

[0033] [Figure 26A] 1 illustrates an exemplary system for heating, cooling, and / or compressing the leg and / or foot, according to an embodiment of the present invention. [Figure 26B] 1 illustrates an exemplary system for heating, cooling, and / or compressing the leg and / or foot, according to an embodiment of the present invention.

[0034] [Figure 27] 1A-1D show diagrams illustrating an exemplary heating / cooling / compression device liner, in accordance with an embodiment of the present invention.

[0035] [Figure 28A] 1 illustrates an exemplary liner according to an embodiment of the present invention. [Figure 28B] 1 illustrates an exemplary liner according to an embodiment of the present invention.

[0036] [Figure 29] 1 illustrates an exemplary heating / cooling / compression device, in accordance with an embodiment of the present invention.

[0037] [Diagram 30] 1 illustrates an exemplary heating / cooling / compression device, in accordance with an embodiment of the present invention.

[0038] [Diagram 31]FIG. 1 shows a block diagram of an exemplary electronic system that can be used as a platform and / or control system for implementing embodiments of the present invention.

[0039] [Diagram 32] 1 illustrates an exemplary method for reducing the side effects of chemotherapy, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] Reference will now be made in detail to various embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with these embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives, modifications, and equivalents that may be included within the spirit or scope of the invention as defined by the appended claims. Furthermore, in the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the invention.

[0041] Some portions of the detailed description which follows (e.g., method 3200) are presented in terms of procedures, steps, logic blocks, processing, and other symbolic representations of operations on data bits that can be performed on a computer memory. These descriptions and representations are the means commonly used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. A procedure, computer-executed step, logic block, process, etc., is herein generally conceived to be a self-consistent sequence of steps or instructions leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals that can be stored, transferred, combined, compared, and otherwise manipulated in a computer system. It has proven convenient at times, primarily for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, data, or the like.

[0042] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless otherwise indicated, and as will be apparent from the following description, the terms "test" or "heat" or "maintain temperature" or "carry" or "capture" or "store" or "read" or "analyze" or "generate" or "solve" or "accept" or "select" or "determine" or "display" or "present" or "calculate" or "send" or "receive" or "reduce" or "detect" or "set" or "access" or "locate" or "test" or "form" or "attach" or "remove" or "ceasing" or "stopping" or "coat" or "process" or "perform ... It should be understood that discussion utilizing terms such as "calculating," "generating," "regulating," "creating," "executing," "continuing," "indexing," "translating," "calculating," "measuring," "collecting," or "running" refers to operations and processes of, or under the control of, a computer system or similar electronic computing device that manipulates and converts data represented as physical (electronic) quantities in the registers and memory of the computer system into other data that is similarly represented as physical quantities in the memory or registers of the computer system or other such information storage, transmission, or display devices.

[0043] The meaning of "non-transitory computer-readable medium" should be construed to exclude only those kinds of transitory computer-readable media that have been found to be outside the scope of patentable subject matter under 35 U.S.C. § 101 In re Nuijten, 500 F.3d 1346, 1356-57 (Fed.Cir.2007). Use of this term should be understood to exclude only propagating transitory signals, per se, from the claims, and does not waive rights to all standard computer-readable media other than propagating transitory signals, per se.

[0044] In the following description, various elements and / or features of embodiments in accordance with the present invention are presented in isolation to better explain such features and not unnecessarily obscure aspects of the present invention. However, it should be understood that such features as disclosed with respect to, for example, a first drawing, can be combined in various combinations with other features disclosed in other drawings. All such embodiments are contemplated and contemplated and may represent embodiments in accordance with the present invention.

[0045] 1 illustrates a block diagram of an exemplary closed-loop controller 2 for use with a heating / cooling / compression device, such as a cooling cap 6, in accordance with an embodiment of the present invention. The heating / cooling / compression device is configured to fit a particular body part, such as a human head. As described further below, embodiments in accordance with the present invention are not limited to cooling, heating, and / or compression of the head. Rather, embodiments in accordance with the present invention are applicable for application to any suitable body part, including, for example, arms, legs, torso, lower back, hands, fingers, fingertips, ears, feet, toes, face, lips, eyebrows, and / or tongue.

[0046] The controller 2 comprises a measurement device 3, a control unit 4, and an actuator 5. The measurement device 3 may include a thermistor, a fiber optic thermometer, a non-contact thermometer, e.g. an infrared thermometer, or other temperature measuring device. The measurement device 3 may measure the temperature of the skin, the temperature of a medium such as air or a fluid or gel adjacent to the skin, the temperature of hair, the temperature of a cover or clothing adjacent to the skin, or any combination of these.

[0047] The control unit 4 may be an electronic controller such as a thermostat, a PID (Proportional-Integral-Derivative) controller, a computer control unit, or any other control device. The actuator 5 may be any device for controlling the degree of heating / cooling / compression applied to the skin or the space immediately adjacent to the skin. The controller may be programmed by receiving input from a caregiver or patient regarding the medication being administered, and additional information regarding the treatment protocol or patient demographic information. Such programming may allow the heating / cooling / compression protocol to be adapted to the patient, medication, or treatment protocol to optimize the results of the heating, cooling, and / or compression. The control unit 4 may provide for varying the temperature and / or compression of the skin at a finite and / or customized rate, e.g., providing a gradient, to prevent shock to the skin. Such control may be provided independently for either cooling or warming or compression of the skin. The controller may provide safety systems and methods to ensure the safety of the skin tissue and the tissue underneath by varying the amount of cooling, compression, and / or heating.

[0048] According to embodiments of the invention, the measurement device 3 may sense a property of the tissue being cooled, for example, rather than or in addition to directly sensing temperature. Such sensors may sense blood flow, pulse and / or pulse rate, the presence or absence of a substance, cellular metabolism, for example via an NADH (nicotinamide adenine dinucleotide and hydrogen) fluorescent sensor, pressure and / or compression, or any other suitable sensed property. The sensed substance may include chemotherapeutic agents and / or their metabolites, or other substances indicative of tissue status or tissue metabolism. The output from any such sensor may be incorporated into the control such that a change in the sensed property causes a corresponding change in the control of the cooling, heating, and / or compression. Such incorporation of the output of any such sensor into the control may enable the control to modify the cooling, heating, and / or compression to avoid dangerous conditions in which such tissue is cooled. In some embodiments, the sensor may sense a property of tissue of the head or extremities, such as the arms, legs, hands, feet, fingers, face, eyebrows, toes, lips and / or mouth, or any combination thereof.

[0049] FIG. 2 shows a block diagram of an exemplary gas-based heating / cooling / compression system 20, according to an embodiment of the present invention. The heating / cooling / compression system 20 comprises a heating / cooling / compression device 26, e.g., a cooling cap, for application on the head or scalp. The heating / cooling / compression device 26 is configured to fit a particular body part, e.g., a human head. The device 26 can be characterized as having an inner surface 21 that is in close proximity to the skin to be cooled. The inner surface 21 can be perforated by an array of small orifices 24 (regular or irregular) designed to allow compressed gas to be released into the narrow space between the inner surface and the scalp. Gas, such as nitrogen, argon, carbon dioxide, or other gas, can be supplied from a gas source 23, such as a gas bottle (pressure tank) or a chemical gas generator. The gas source can be coupled to the orifices, e.g., by tubes or pipes, and / or by either manifolds and / or plenums.

[0050] The pressurized gas, when released by the orifice, is cooled by the Joule-Thompson effect. The released cooled gas passes close to the skin as it escapes the narrow space, thus heating, cooling, and / or compressing the skin. In some embodiments, the control of temperature can utilize the heating and / or cooling of the gas in its source 23. The control of temperature can be achieved by varying the flow rate of the gas. Such variation can be achieved by an actuator 22, such as a valve, a variable pump, or by adjusting the rate at which a chemical gas generator generates gas. In some embodiments, the gas source 23 can be portable, allowing the patient to move from place to place. It is understood that the embodiment of FIG. 2 is applicable to the control of temperature according to the embodiment of FIG. 1.

[0051] 3 illustrates a block diagram of an exemplary gas-based heating / cooling / compression system 30, in accordance with an embodiment of the present invention. The heating / cooling / compression system 30 includes a heating / cooling / compression device 36, such as a cooling cap. The heating / cooling / compression device 36 is configured to fit a particular body part, such as a human head. The heating / cooling / compression device 36 includes an inner surface 31 and an array of holes 33. A pre-cooling gas 32 can be coupled to the array of holes 33 to allow the gas 32 to flow over the skin.

[0052] The inner surface may be perforated by a plurality or an array of holes 33 (regular or irregular) designed to allow gas to be released into the narrow space between the inner surface and the skin. Some embodiments may further comprise a gas supply 32 that supplies pre-cooling gas to the holes in the cap. The pre-cooling gas source 32 may be connected to the holes 33 in the cap by a tube, plenum, or other connection. The released pre-cooling (or heating) gas passes close to the skin as it escapes the narrow space, thus cooling (heating) the skin. Control of the temperature may be achieved by varying the flow rate of the gas 32 or the temperature of the pre-cooling gas 32. Such variation may be achieved by actuators such as valves, variable pumps, or other control systems. In some embodiments, the pre-cooling gas may be further cooled by the Joule-Thompson effect. In some embodiments, the pre-cooling gas source 32 may be portable, allowing the patient to move from place to place. It is understood that the embodiment of FIG. 3 is applicable to the control of temperature according to the embodiment of FIG. 1.

[0053] 4 illustrates a block diagram of an exemplary thermoelectric cooler (TEC) based heating / cooling / compression system 40, in accordance with an embodiment of the present invention. The heating / cooling / compression system 40 comprises a heating / cooling / compression device 43, e.g., a cooling cap, and a control unit 44. The heating / cooling / compression device 43 is configured to fit a particular body part, e.g., a human head. The heating / cooling / compression device 43 comprises an inner surface 41, a convection component 42, e.g., a radiator, and a number of thermoelectric coolers 45. In some embodiments, the thermoelectric coolers may comprise Peltier elements.

[0054] The heating / cooling / compression device 43 fits onto the body, such as the head, hand, fingers, feet, and / or toes, with the inner surface 41 adjacent to the skin. The heating / cooling / compression device 43 comprises a plurality of thermoelectric coolers 45 that remove heat from the surface adjacent to the skin, thus cooling the skin. In some embodiments, the thermoelectric coolers 45 can add heat to the surface adjacent to the skin, thus heating the skin. The cap can further comprise a radiative or convective component 42 that receives the heat removed from the plurality of thermoelectric coolers 45, and a dump that heats into the environment surrounding the patient, such as room air. In some embodiments, the control unit 44 can be portable, allowing the patient to move from place to place. It is understood that the embodiment of FIG. 4 is applicable to control the temperature according to the embodiment of FIG. 1.

[0055] FIG. 5 shows a block diagram of an exemplary thermoelectric cooler (TEC)-based heating / cooling / compression system 50 according to an embodiment of the present invention. The heating / cooling / compression system 50 comprises a heating / cooling / compression device 51, such as a cooling cap, and a remote radiator 53. The heating / cooling / compression device 51 is configured to fit a particular body part, for example the human head. In contrast to the embodiment according to FIG. 4, the radiant element 53 is not part of the cooling device 51, but rather is separate from the cooling device 51. In this embodiment, a thermal conductor 52 may be provided that conducts heat from the cooling device 51 to the remote radiator 53. Such conductors may include metallic media that provide high thermal conductivity, such as copper, silver, mercury, or other metals, heat pipes, pulsating or looped heat pipes, pumped liquids, such as solutions containing water, alcohol, polyethylene glycol, or other liquids, pumped gases, such as nitrogen, argon, carbon dioxide, or other gases, or other systems and methods of conducting heat. Once conducted to the radiator, the removed heat may be released by the radiator to the environment. In some embodiments, the remote radiator 53 may be portable allowing the patient to move from location to location. It will be appreciated that the embodiment of Figure 5 is applicable to controlling temperature according to the embodiment of Figure 1.

[0056] FIG. 6 illustrates a block diagram of an exemplary heating / cooling / compression system 60, according to an embodiment of the present invention. The heating / cooling / compression system 60 includes a heating / cooling / compression device 63, such as a cooling cap. The heating / cooling / compression device 63 is configured to fit a particular body part, such as a human head. A thermally conductive material 61 may be disposed between an inner surface 61 of the cooling device 63 and the skin. The inner surface 61 may be cooled by a cooled gas, a cooled liquid, a thermoelectric cooler, a phase change cooler, or any other cooling device 62. The cap 63 may further include a radiant or convective component 65 that receives heat removed from the skin area and releases the heat to the patient's surrounding environment, such as room air. In some embodiments, the radiant element 65 may include a vent.

[0057] The inner surface 64 provides a low temperature boundary condition in the narrow space between the inner surface 64 and the skin. The material 61 interposed between the inner surface and the skin transfers heat from the skin to the inner surface, cooling the skin. The transfer of heat may be due to inherent properties of the material 61, such as thermal conductance, or the material's tendency to form convection currents, or other properties. The material may be reusable or disposable and may cause pressure and / or compression on the skin. It is understood that the embodiment of FIG. 6 is applicable to control of temperature according to the embodiment of FIG. 1.

[0058] FIG. 7 illustrates a block diagram of an exemplary heating / cooling / compression system 70 according to an embodiment of the present invention. The heating / cooling / compression system 70 includes a heating / cooling / compression device 71, such as a cooling cap. The heating / cooling / compression device 71 is configured to fit a particular body part, such as the human head. Cooling can be provided by a gas, a liquid, a substance between the heating / cooling / compression device 71 and the skin, such as substance 61 in FIG. 6, or by a refrigerator such as a closed-loop heat pump 72, such as a Stirling cycle refrigerator, a thermoacoustic refrigerator, a thermoelectric cooler, or other method of forcing the transport of heat, either to the skin, or to the gas, liquid, a substance between the heating / cooling / compression device 71 and the skin, such as substance 61 in FIG. 6, or to the skin. In some embodiments, the closed-loop heat pump 72 can be portable, allowing the patient to move from place to place. It is understood that the embodiment of FIG. 7 is applicable to the control of temperature according to the embodiment of FIG. 1.

[0059] FIG. 8 illustrates a block diagram of an exemplary multi-zone thermal management system 80, according to an embodiment of the present invention. The system 80 includes a heating / cooling / compression device 71, e.g., a cooling cap, and a warming device 82, e.g., a garment. The heating / cooling / compression devices 71, 82 are configured to fit a particular body part, e.g., the human head and / or torso. According to an embodiment of the present invention, heat removed by cooling one or more body parts, e.g., the scalp, can be supplied to other areas of the patient's body for the purpose of keeping the patient warm. For example, a fluid can transport the heat extracted from the scalp to other body areas. Heat can be supplied by warm air blown on the patient and / or by a liquid to a warming device 82, such as a vest, leg warmer, socks, booties, slippers, gloves or mittens, sleeves, cuffs, and / or masks adjacent to the skin of the body, or by other systems to keep the patient warm. It is understood that the embodiment of FIG. 8 is applicable to control of temperature for both heating and cooling according to the embodiment of FIG. 1.

[0060] 9 illustrates a block diagram of an exemplary multi-zone thermal management system 90, according to an embodiment of the present invention. The system 90 includes a heating / cooling / compression device 91, such as a cooling cap, a cold gas 92, a container of compressed gas 93, a vortex tube 94, a hot gas 95, and a warming device 96, such as a garment. The heating / cooling / compression devices 91, 96 are configured to fit a particular body part, for example, a human head and / or torso. The cooling device 91 and / or the warming device 96 may, in some embodiments, include a cap or hat, a vest, a leg warmer, a sock, a bootie, a slipper, a glove or mitten, a sleeve, a cuff, and / or a mask.

[0061] According to an embodiment of the present invention, one or more parts of the body, e.g., the head, can be cooled while other parts of the body, e.g., the torso, can be warmed. A cold gas 92 can be provided to cool a part of the body, and a hot gas 95 can be provided to warm a part of the body. The cold gas 92 and the hot gas 95 are generated by a vortex tube 94, e.g., a Hilsch vortex tube. The vortex tube can be driven by a compressed gas source 93, such as a gas bottle or tank, or a gas compressor, or other compressed gas source. The cold gas can be provided to the body part to be cooled by a cap or other system. The hot gas can be provided to the body part to be warmed via clothing, e.g., a vest, leg warmers, socks, booties, slippers, gloves or mittens, sleeves, cuffs, and / or a mask. It is understood that the embodiment of FIG. 9 is applicable to the control of temperature for both heating and cooling according to the embodiment of FIG. 1.

[0062] FIG. 10 shows a block diagram of an exemplary heating / cooling / compression system 100, according to an embodiment of the present invention. The system 100 comprises a heating / cooling / compression device 106, such as a cooling cap, and an energy storage device 109. The heating / cooling / compression device 106 is configured to fit a particular body part, such as the human head. The energy required to drive the refrigerator, thermoelectric generator, compressor, or pump can be provided by a battery or other energy storage device 109 that can be portable with respect to the patient, thus allowing the patient to travel over long distances. In some embodiments, the energy storage device 109 can be housed in a backpack, chest pack, waist pack, pocket, and / or other wearable container. In some embodiments, the energy storage device 109 can be attached to the patient, for example, via a strap and / or sleeve. In some embodiments, the energy can be provided by a combination of the storage device and external power such that the battery lasts for a period of time suitable for moving the patient. Such a suitable period of time can be 5, 15, 30, or 60 minutes, or 2, 3, 4, 5, 6, 8, 10, or 12 hours. In some embodiments, the duration of energy delivery may correspond to a duration appropriate for treatment. In some embodiments, the duration of energy delivery may correspond to a duration required for the chemotherapy drug to be cleared from the body or reduced to a level not associated with adverse side effects. In some embodiments, the external power may be provided by AC mains power, by inductively coupled power, by an automobile power outlet (AC or DC), or by other external power sources.

[0063] In some embodiments, the energy storage device 199 may power a warming device, such as the warming device 82 of FIG. 8, in addition to or instead of the cooling device 106. In some embodiments, a thermal fluid may be circulated between the cooling device 106 and the warming device 82. It will be understood that the embodiment of FIG. 10 is applicable to controlling temperature for both heating and / or cooling according to the embodiment of FIG. 1.

[0064] FIG. 11 illustrates a block diagram of an exemplary heating / cooling / compression system 110, according to an embodiment of the present invention. The system 110 includes a heating / cooling / compression device 111, such as a cooling cap. The heating / cooling / compression device 111 is configured to fit a particular body part, such as a human head. An inner surface of the heating / cooling / compression device 111 may be cooled by an endothermic chemical reaction 112. The endothermic chemical reaction may be performed adjacent to the inner surface or removed from the inner surface such that a heat transfer medium transfers heat from the inner surface to the endothermic chemical reaction. In some embodiments, the exothermic chemical reaction 112 may be utilized to provide complementary heating of a portion of the body. It is understood that the embodiment of FIG. 11 is applicable to controlling temperature for both heating and cooling according to the embodiment of FIG. 1. For example, the flow rate of the chemical reactants may be controlled to control the amount of heat generated and / or absorbed by the chemical reaction 112.

[0065] 12 illustrates a block diagram of an exemplary heating / cooling / compression system 120, according to an embodiment of the present invention. The system 120 includes a heating / cooling / compression device 121, such as a cooling cap. The heating / cooling / compression device 121 is configured to fit a particular body part, such as a human head. The endothermic chemical reaction involves dissolution of a solid 122, such as ammonium chloride, by a solvent 125, such as water. In some embodiments, the solid 122 may be contained in the heating / cooling / compression device 121, and the solvent may be supplied to the heating / cooling / compression device 121 by a pump, pressurized tank, or other supply system 123.

[0066] In some embodiments, the rate of supply of solvent 125 may be controlled by control unit 124 to achieve the desired amount of heating / cooling / compression. Such a control unit may be part of a closed loop controller, such as closed loop controller 2 as described above with respect to FIG. 1. In some embodiments, heating / cooling / compression device 121 including solid 122 may be a disposable device such that if solid 122 can be partially or completely dissolved, heating / cooling / compression device 121 may be discarded or reprocessed. In some embodiments, solvent source 123 and control unit 124 are portable, allowing the patient to move from place to place.

[0067] In some embodiments, the amount of solid reactant 122 may be sized and / or provided to last for an appropriate period of time, for example, to allow patient mobility. Such an appropriate period of time may be 5, 15, 30, or 60 minutes, or 2, 3, 4, 5, 6, 8, 10, or 12 hours. In some embodiments, the amount of solid reactant 122 may correspond to an appropriate treatment period. In some embodiments, the amount of solid reactant 122 may correspond to the duration required for the chemotherapy drug to be cleared from the body or reduced to a level not associated with adverse side effects. In some embodiments, the solvent source 123 may be supplied by coupling to a utility-scale water supply.

[0068] FIG. 13 illustrates a block diagram of an exemplary heating / cooling / compression system 130, according to an embodiment of the present invention. The system 130 includes a heating / cooling / compression device 131, such as a cooling cap. The heating / cooling / compression device 131 is configured to conform to a particular body part, such as the human head. The heating / cooling / compression device 131 may be cooled by any suitable mechanism. According to an embodiment of the present invention, the cap 131 may be held against the head by straps 132, such as straps that buckle under the chin, straps joined by hook and loop material, or by elastic forces, such as rubber or other elastomeric material that conforms to the head and holds the cap against the head by friction. In some embodiments, the cap applies pressure to the scalp, causing compression of the scalp or skin tissue and underlying tissue.

[0069] FIG. 14 illustrates a block diagram of an exemplary heating / cooling / compression system 140, according to an embodiment of the present invention. The system 140 includes a heating / cooling / compression device 141, such as a cooling cap. The heating / cooling / compression device 141 is configured to fit a particular body part, such as a human head. The heating / cooling / compression device 141 may be cooled by any suitable mechanism. According to an embodiment of the present invention, the heating / cooling / compression device 141 includes an insulating material 142 that prevents heat from the surrounding environment from interfering with the application of cooling to the scalp. The insulating material 142 may include a layer that may be disposed on the exterior of the inner surface opposite the side adjacent to the hair or scalp. In some embodiments, other forms of the cooling device 141, including, for example, a vest, leg warmers, socks, booties, slippers, gloves or mittens, sleeves, cuffs, and / or masks, may include insulating materials comparable in form and function to the insulating material 142.

[0070] FIG. 15 illustrates a block diagram of an exemplary thermal safety system 150, according to an embodiment of the present invention. The thermal safety system 150 includes a heat and / or compression safety device 151. The thermal safety device 151 provides a safe operation such that the temperature of the skin does not exceed a range of temperatures that are safe for the skin of a particular body part, e.g., the head. Such a safe temperature range may be, for example, between −37 degrees Celsius (−35 degrees Fahrenheit) and 48 degrees Celsius (120 degrees Fahrenheit). In some embodiments, the thermal safety system 150 may stop the heating, cooling, and / or compression process. In some embodiments, the thermal safety device 150 may regulate the heating, cooling, and / or compression process. In some embodiments, the thermal safety device 151 may operate within or be part of a closed loop controller, e.g., closed loop controller 2, as described with respect to FIG. 2. In some embodiments, the thermal safety device 151 may operate in an open loop manner, e.g., as a fuse, to prevent heating, cooling, and / or compression beyond a safe limit. In some embodiments, the thermal safety device 151 can stop such a reaction, for example, by closing a valve and / or injecting a reactant to stop a chemical reaction.

[0071] FIG. 16 illustrates a block diagram of an exemplary thermal control system 160, according to an embodiment of the present invention. Thermal control system 160 includes a cooling (or heating) device 161 and a computer interface device 162. Computer interface device 162 may be a handheld computer, such as a smartphone, in some embodiments. Computer interface device 162 may be linked 163 to cooling device 161. Link 163 may be only one-way in some embodiments, e.g., computer interface device 162 sends commands to cooling device 161. In some embodiments, link 163 may be bidirectional. For example, cooling device 161 sends information, such as measured skin temperature and / or coolant temperature, to computer interface device 162 in addition to computer interface device 162 sending commands to cooling device 161.

[0072] The computer interface device 162 executes software that provides a line of control for the cooling equipment 161. Such a computer interface device may be a personal computer, tablet, smartphone, smart TV, or other such interface device. An embodiment of the computer interface device 162 is further described below with respect to FIG. 31 below. A particular cooling (or heating) protocol may be automatically selected based on the patient entering the particular drug being infused, with longer cooling times for drugs with longer blood clearance times. In some embodiments, the computer interface device 162 (or a coupled computer system, not shown) may record the actual temperature during the treatment session, for example at intervals. In some embodiments, the computer interface device 162 may display real-time skin temperature, time elapsed, time remaining, and / or other measured parameters during the treatment session. In some embodiments, the computer interface device 162 may be part of a closed-loop temperature control system, for example, as described with respect to FIG. 1. For example, the computer interface device 162 may function as the control unit 4 or may augment the functionality of the control unit 4.

[0073] FIG. 17 illustrates a block diagram of an exemplary thermal management system 170, according to an embodiment of the present invention. The thermal management system 170 can include heating and / or cooling elements for the hand and / or fingers, e.g., mitt 171, and / or heating and / or cooling elements for the foot and / or toes, e.g., bootie 172. The heating / cooling / compression devices 171, 172 are configured to fit a particular body part, e.g., a human hand and / or foot. For example, the thermal management provided to the hand can be configured to allow the patient to continue using the hand in a normal manner. In some embodiments, the cooling provided to the hand may be preferentially provided to the tips of the fingers, thus allowing for the preservation of the nerves that go to and from the tips of the fingers. In some embodiments, the mitt 171 and / or bootie 172 can provide compression of tissue in other areas of the body. In some embodiments, both thermal management and compression are provided.

[0074] FIG. 18 shows a block diagram of an exemplary hair management system 180, according to an embodiment of the present invention. The hair management system 180 comprises a compression device 181 having an aperture or hair port 183.18. To monitor hair retention, embodiments include collecting hair in a bundle 182, e.g., a ponytail, and measuring an aspect of the hair volume of the bundle. In some embodiments, the bundle can be compressed 181 to a predetermined compression, and the area occupied by the hair as it passes through the hair port 183 of the compression device 181 can be measured. In some embodiments, a linear dimension of the area is measured. Such a linear dimension can be the diameter of a circular or approximately circular area, the major and / or minor axis of an elliptical or approximately elliptical area, or the width and height of a linear or approximately linear area, or any such linear characteristic of the area occupied by the hair. In some embodiments, the volume of hair can be estimated from measurements of scattering of electromagnetic radiation by the bundle. Such radiation can be visible light, infrared radiation, terahertz radiation, millimeter wave radiation, microwave radiation, or any other suitable electromagnetic radiation. In some cases, the length of the hair may not be sufficient to gather all of the hair into a single bundle. In some embodiments, separate bundles may be created, and each of those separate bundles may be measured by a system and method similar to those described above. In some embodiments, hair retention may be estimated by measuring hair collected from a portion of the scalp and measuring aspects of the bundle of the portion of hair, as described above. It is understood that the embodiment according to FIG. 18 is applicable to other areas of hair in addition to the scalp, including, for example, facial hair, e.g., beard, and / or body hair.

[0075] FIG. 19 shows a block diagram of an exemplary hair management system 190, according to an embodiment of the present invention. According to an embodiment of the present invention, hair volume can be estimated by measuring an alternative aspect 191 of hair volume. In some embodiments, the aspect can be the weight of the hair. In this case, the weight must be measured so that the weight of the rest of the patient's body, such as the weight of the head, does not perturb the measurement of the hair weight. In some embodiments, the aspect can be the weight or volume of water taken up by the hair when it starts from a dry state and may become wet. In some embodiments, the aspect of hair volume can be the ease with which a puff or flow of air or other gas or other fluid moves or otherwise perturbs the hair.

[0076] FIG. 20 shows a block diagram of an exemplary hair management system 200, according to an embodiment of the present invention. According to an embodiment of the present invention, an aspect may be attenuation or other modification of acoustic energy propagating through the hair. In some embodiments, acoustic energy may be directed from an acoustic source 201 to the head, and the amount of acoustic energy reflected by the head may be measured by an acoustic detector 202. The hair attenuates the acoustic waves as they first propagate toward the head and then move away from the head. The degree of attenuation is related to the amount of hair and the structural properties of the hair. From a change in the degree of attenuation of such reflected acoustic waves, a change in hair retention may be inferred. In some embodiments, the acoustic detector and acoustic source comprise the same instrument, and the two functions are facilitated by first generating acoustic energy, for example as a pulse, and then detecting the return pulse. In some embodiments, the acoustic energy may be aimed to pass through the hair but not reflect back to the head. This may be accomplished, for example, by allowing the hair to hang freely from the head. Hair retention may be inferred from the amount of acoustic energy transmitted through the hair, measured by an acoustic detector positioned on the opposite side of the acoustic source to the hair.

[0077] FIG. 21 shows a block diagram of an exemplary hair management system 210, according to an embodiment of the present invention. According to an embodiment of the present invention, the visual density of hair can be measured. A camera 211 can be used to capture one or more images of the hair. Analysis software can assess how much hair may be present in the captured images, for example by counting hair strands. This can be done close to the hair or from a significant distance.

[0078] FIG. 22 shows a block diagram of an exemplary hair management system 220, according to an embodiment of the present invention. According to an embodiment of the present invention, hair retention can be monitored by measuring mechanical aspects of the hair. In one such embodiment, the curvature of the hair can be measured by allowing the hair to lie across a substantially horizontal surface that includes a raised feature 221. The raised feature 221 can be a thin plate that protrudes substantially vertically from the surface, similar to a fence rising from a field. The hair can be draped across the plate, and the shape that the hair takes can be analyzed to provide a tendency for the hair to remain straight even when bent. The strength of the hair, and therefore the retention of the hair, can be inferred from such an analysis of the curvature.

[0079] 23 shows a block diagram of an exemplary hair management system 230, according to an embodiment of the present invention. According to an embodiment of the present invention, hair retention can be monitored by measuring the interaction of the hair with the tines of a comb 231 or comb-like device. The interaction can be the resistance, expressed as, for example, a force, of the hair as the comb can be pulled through the hair. In some embodiments, the tines can be equipped with optical or acoustic sensors that measure the density of the hair between them.

[0080] 24 shows a block diagram of an exemplary closed loop controller 2 for use with a heating / cooling / compression device, such as a cooling sleeve 241, according to an embodiment of the present invention. The controller 2 includes a measurement device 3 embedded in the cooling sleeve 241. The measurement device 3 may include a thermistor, a fiber optic thermometer, a non-contact thermometer, such as an infrared thermometer, or other temperature measurement device. The measurement device may measure the temperature of the skin, the temperature of a medium such as air or a fluid or gel adjacent to the skin, the temperature of hair, the temperature of a cover or clothing adjacent to the skin, or any combination thereof.

[0081] According to embodiments of the invention, the measurement device 3 may sense a property of the tissue being cooled, for example, rather than or in addition to directly sensing temperature. Such sensors may sense blood flow, pulse and / or pulse rate, the presence or absence of a substance, cellular metabolism, for example via an NADH (nicotinamide adenine dinucleotide and hydrogen) fluorescent sensor, pressure and / or compression, or any other suitable sensed property. The sensed substance may include chemotherapeutic agents and / or their metabolites, or other substances indicative of the state of the tissue or metabolism of the tissue. The output from any such sensor may be incorporated into the control such that a change in the sensed property causes a corresponding change in the control of the cooling, heating, and / or compression. Incorporating the output of any such sensor into the control may enable the control to modify the cooling, heating, and / or compression to avoid a dangerous condition for such tissue being cooled. In some embodiments, the sensor may sense a property of tissue of the head or extremities, such as the arms, legs, hands, feet, fingers, face, eyebrows, toes, lips, and / or mouth, or any combination thereof.

[0082] 25A, 25B, and 25C show exemplary systems for heating, cooling, and / or compressing a hand, fingers, and arm, respectively, according to embodiments of the present invention. According to embodiments of the present invention, heating, cooling, and / or compression may be applied collectively to the hand and / or fingers and / or arm, in combination and / or alone. As shown in FIG. 25A, heating, cooling, and / or compression is applied by a glove 251 with closed fingers or any other form with substantially one opening, with each finger independently covered. In some embodiments, the hand and / or wrist may not be heated, cooled, and / or compressed. As shown in FIG. 25B, heating, cooling, and / or compression may be applied to one or more fingers individually, for example, via individual finger devices 252. For example, not all fingers may be cooled. In some embodiments, different fingers may be controlled to different temperatures or other criteria, for example, blood flow or the presence of a chemotherapy drug. As shown in FIG. 25c, heat, cold, and / or compression may be applied to the arm or portion of the arm by a sleeve 253 or cuff or fingerless glove or substantially any other form having multiple openings.

[0083] According to embodiments of the present invention, the heating, cooling and / or compression devices can result in the patient being able to use the fingers or hand or arm for any normal use. Such use can include writing, typing, using a telephone, including a smart phone, operating a navigation device, operating controls of an automobile, handling a book, handling food, assisting with a bodily function, or any other normal use. In some embodiments, the ability to use the fingers or hand can include one or more gloves with removable fingertips, such as individual finger devices 252.

[0084] 26A and 26B illustrate an exemplary system for heating, cooling, and / or compressing a foot and / or leg, according to embodiments of the present invention. According to embodiments of the present invention, heating, cooling, and / or compression can be provided to a foot or leg. In some embodiments, heating, cooling, and / or compression is applied by a closed toe bootie 261 or a shoe or sock, or any other form having substantially one opening. In some embodiments, heating, cooling, and / or compression can be applied only to one or more toes, for example, without applying treatment to other parts of the foot or leg. In some embodiments, heating, cooling, and / or compression can be applied to individual toes. In some embodiments, heating, cooling, and / or compression can be applied individually to one or more toes, for example, via individual toe joints, similar to the finger device 252 of FIG. 25B. For example, not all toes can be cooled. In some embodiments, different toes can be controlled to different temperatures or other criteria, for example, blood flow or the presence of a chemotherapy drug. In some embodiments, the heat, cold and / or compression is applied by leggings 262 or sleeves or cuffs or tallless boots or tallless shoes or tallless socks, or substantially any other form having multiple openings.

[0085] According to embodiments of the present invention, the heating, cooling and / or compression device can provide for the patient to be able to use the foot or leg for any normal use thereof. Such use can include standing, walking, running, pedaling a bicycle, operating the controls of an automobile, or any other normal use. In some embodiments, the ability to use the foot or leg can include one or more boots. Such one or more boots can allow for simultaneous use and heating, cooling and / or compression of the foot or leg.

[0086] FIG. 27 illustrates an exemplary heating / cooling / compression device liner 271, according to an embodiment of the present invention. The liner 271 may be part of any heating / cooling / compression device, including, for example, a cooling cap, e.g., cooling cap 6 (FIG. 1), bootie 261 (FIG. 26A), leggings 262 (FIG. 26B), glove 251 (FIG. 25A), individual finger device 252 (FIG. 25B), sleeve 253 (FIG. 25C), sleeve 241 (FIG. 24), and / or mitt 171 (FIG. 17). According to an embodiment of the present invention, the liner 271 may be positioned substantially directly adjacent to the skin of the body part. The liner 271 may be characterized as having a high thermal conductivity to allow for rapid transfer of heat from the skin. In some embodiments, the liner 271 may be characterized as having a low thermal conductivity to prevent excessive transfer of heat from the skin, thus avoiding an unsafe situation for the skin. The liner 271 can create compression and protect the skin from cold and / or heat damage. In some embodiments, the liner 271 can be replaceable, removable, and / or disposable. In some embodiments, the liner 271 can help prevent previous patient contamination of the heating / cooling / compression equipment.

[0087] 28A and 28B show exemplary liners 285 and 286, respectively, according to embodiments of the present invention. According to embodiments of the present invention, the liners 285, 286 can include a flexible polymer or flexible fabric or any other flexible membrane so as to tend to conform to the shape of the body part. Such a shape can be accentuated by applying pressure 281 to a surface of the liner that is not directly adjacent to the skin. The liner 286 can be substantially impermeable to a fluid 283, such as air, water, gas, liquid, or any other such fluid. Such an impermeable liner can allow pressure to be applied by any such fluid while not allowing such fluid to pass through the liner. The liners 285, 286 can include membranes 282, 283, respectively, for applying a therapeutic compressive force to the body part.

[0088] In some embodiments, the liners 285, 286 can provide a barrier against contamination from the environment that may harm adjacent skin. Such contamination may include chemicals or infectious agents or any other contamination. The liners 285, 286 may be washable, single-use, single-patient use, or disposable to avoid the transfer of contamination from one patient to another.

[0089] FIG. 29 illustrates an exemplary heating / cooling / compression device 290, according to an embodiment of the present invention. The device 290 includes an outer container 291. In some embodiments, the outer container 291 can be, for example, rigid and resistant to changes in shape. The outer container 291, together with a liner, can circumscribe a substantially closed volume. Such a volume can be filled with a fluid, such as air or other gas, or water or other liquid. Such a fluid can be introduced at a temperature lower than the temperature of the adjacent skin to effect cooling. Such a fluid can be introduced at a temperature higher than the temperature of the adjacent skin to effect heating. Such a fluid can also be introduced at a pressure higher than the local atmospheric pressure to effect compression. Any combination of fluid temperature and pressure can be effected. In some embodiments, the device 290 can include a membrane 292 configured to apply a therapeutic compressive force to the body part.

[0090] In some embodiments, the temperature and / or pressure at which the fluid may be delivered may be controlled by the controller 293. In some embodiments, control of the temperature and pressure of the introduced fluid is controlled to achieve a therapeutic combination. Such a therapeutic combination may reduce the level of pain or discomfort perceived by the patient. Alternatively, such a therapeutic combination may provide a higher level of efficacy in terms of reducing harm to the hand or foot from the treatment the patient is receiving. Such a therapeutic combination may provide pain relief and / or discomfort relief as well as a higher level of efficacy.

[0091] According to embodiments of the present invention, heat, cold and / or compression may be applied to any combination of body parts including the scalp, fingers, toes, hands, feet, arms, legs, mouth, lips, tongue, and / or eyebrows.

[0092] FIG. 30 illustrates an exemplary heating / cooling / compression device 300, according to an embodiment of the present invention. Device 300 provides heating, cooling, and / or compression to anatomical components of the mouth in any combination, including, for example, lips, gingiva (gums), buccal mucosa (lining of lips and cheeks), floor of mouth, tongue, hard palate, and / or soft palate, to prevent or mitigate chemotherapy side effects, including chemotherapy-induced mucositis. Device 300 can include any suitable combination of heating, cooling, and / or compression mechanisms, including mechanisms described elsewhere herein. Device 300 can include any suitable combination of sensors or sensing mechanisms, including sensors and sensing mechanisms described elsewhere herein. Device 300 can include any suitable combination of control systems for heating, cooling, and / or compression, including control systems and methods described elsewhere herein.

[0093] The device 300 can include a control mechanism such that the patient or the patient's caregiver can manually adjust the heating, cooling, and / or compression. The device 300 can include a control mechanism such that the device automatically sets the treatment time based on the infused drug. For example, the patient can enter and / or select the name of the infused drug via an interface device, e.g., a computer interface device 162 as described with respect to FIG. 16. In response to the drug information, the device 300 can automatically set the treatment time. In some embodiments, the device 300 can assign longer treatment times to drugs with longer blood clearance times. The device 300 can include a control mechanism such that the device automatically adjusts the heating, cooling, and / or compression in response to sensors or sensing incorporated into the device. The device 300 can include any suitable structure 303, e.g., a head strap, for fastening or holding the device in place in the patient's mouth. The device 300 can include features to allow the patient to consume a liquid beverage 302 with the device 300 in place in the patient's mouth.

[0094] FIG. 31 illustrates a block diagram of an exemplary electronic system 3100 that can be used as a platform and / or control system for implementing embodiments of the present invention. The electronic system 3100 can be a "server" computer system in some embodiments. The electronic system 3100 includes an address / data bus 3150 for communicating information and a central processing unit complex 3105 operatively coupled to the bus for processing information and instructions. The bus 3150 can include, for example, a Peripheral Component Interconnect Express (PCIe) computer expansion bus, Industry Standard Architecture (ISA), Extended ISA (EISA), MicroChannel, Multibus, IEEE 796, IEEE 1196, IEEE 1496, PCI, Computer Automatic Measurement and Control (CAMAC), MBus, Runway Bus, Compute Express Link (CXL), and the like.

[0095] The central processing unit complex 3105 may include a single processor or multiple processors, such as a multi-core processor, or multiple separate processors, in some embodiments. The central processing unit complex 3105 may include any combination of various types of well-known processors, including, for example, digital signal processors (DSPs), graphic processors (GPUs), complex instruction set (CISC) processors, reduced instruction set (RISC) processors, and / or very long instruction word set (VLIW) processors. The electronic system 3100 may also include a volatile memory 3115 (e.g., random access memory RAM) coupled to the bus 3150 for storing information and instructions for the central processing unit complex 3105, and a non-volatile memory 3110 (e.g., read only memory ROM) coupled to the bus 3150 for storing static information and instructions for the processor complex 3105. The electronic system 3100 may also optionally include a modifiable non-volatile memory 3120 (e.g., NOR flash) for storing information and instructions for the central processing unit complex 3105 that may be updated after the manufacture of the system 3100. In some embodiments, only one of ROM 3110 or Flash 3120 may be present.

[0096] The electronic system 3100 of Figure 31 also includes optional input devices 3130. The devices 3130 can communicate information and command selections to the central processing unit 3100. The input devices 3130 can be any suitable devices for communicating information and / or commands to the electronic system 3100. For example, the input devices 3130 can take the form of a keyboard, buttons, a joystick, a trackball, an audio transducer such as a microphone, a touch-sensitive digitizer panel, an eye scanner, etc.

[0097] The electronic system 3100 may include a display unit 3125. The display unit 3125 may include a liquid crystal display (LCD) device, a cathode ray tube (CRT), a field emission device (FED, also called a flat panel CRT), a light emitting diode (LED), a plasma display device, an electroluminescent display, electronic paper, electronic ink (e-ink), or other display device suitable for producing user-recognizable graphic images and / or alphanumeric characters. In some embodiments, the display unit 3125 may have an associated illumination device.

[0098] The electronic system 3100 also optionally includes an expansion interface 3135 coupled to the bus 3150. The expansion interface 3135 may implement a number of well-known standard expansion interfaces including, but not limited to, a Secure Digital Card interface, a Universal Serial Bus (USB) interface, Compact Flash, a Personal Computer (PC) Card interface, CardBus, a Peripheral Component Interconnect (PCI) interface, Peripheral Component Interconnect Express (PCI Express), a Mini PCI interface, IEEE 1394, a Small Computer System Interface (SCSI), a Personal Computer Memory Card International Association (PCMCIA) interface, an Industry Standard Architecture (ISA) interface, an RS-232 interface, and the like. In some embodiments of the invention, the expansion interface 3135 may include signals that substantially conform to the signals of the bus 3150.

[0099] A wide variety of well-known devices can be attached to the electronic system 3100 via the bus 3150 and / or the expansion interface 3135. Examples of such devices include, but are not limited to, rotating magnetic memory devices, flash memory devices, digital cameras, wireless communication modules, digital audio players, and global positioning system (GPS) devices.

[0100] The system 3100 also optionally includes a communications port 3140. The communications port 3140 may be implemented as part of the expansion interface 3135. If implemented as a separate interface, the communications port 3140 may typically be used to exchange information with other devices via a communications-oriented data transfer protocol. Examples of communications ports include, but are not limited to, an RS-232 port, a universal asynchronous receiver transmitter (UART), a USB port, an infrared transceiver, an Ethernet port, IEEE 1394, and a synchronous port.

[0101] The system 3100 optionally includes a network interface 3160 that may implement a wired or wireless network interface. The electronic system 3100 may, in some embodiments, include additional software and / or hardware functionality (not shown).

[0102] Various modules of the system 3100 have access to computer-readable media, which term is known or understood to include removable media, such as secure digital ("SD") cards, CD and / or DVD ROM, diskettes, etc., as well as non-removable or internal media, such as hard drives, solid state drives (SSD), RAM, ROM, flash, etc.

[0103] FIG. 32 illustrates an exemplary method 3200 for reducing chemotherapy side effects, according to an embodiment of the present invention. At 3210, a conformal covering, such as a cooling cap 6 (FIG. 1) and / or glove 251 (FIG. 25A), is placed on a body part susceptible to chemotherapy side effects, such as the head. At 3220, a cooling protocol is initiated to cool the body part. In some embodiments, the cooling protocol can include increasing the temperature from the ambient temperature to avoid thermal shock to the body part. In some embodiments, the cooling can be tailored to a particular drug treatment. In some embodiments, the cooling can be based on the detected level of the drug within the body part.

[0104] At 3230, the cooling protocol is maintained for a period of time. The cooling protocol can be controlled, for example, by the control unit 4 (FIG. 1), the computer interface device 162 (FIG. 16), and / or the electronic system 3100 (FIG. 31). In some embodiments, the temperature of the body part may be held constant and / or may vary according to sensed aspects of the body part. In some embodiments, cellular metabolism may be sensed. In some embodiments, blood flow may be sensed. At 3240, the cooling of the body part is stopped at the end of the treatment. The end of the treatment may be determined by the elapsed time of the treatment and / or any sensed aspects of the body part, such as the presence or absence of a treatment drug. The cooling may be ramped up from the treatment temperature to ambient temperature to avoid thermal shock to the body part.

[0105] Embodiments according to the invention provide systems and methods for reducing chemotherapy side effects. Additionally, embodiments according to the invention provide systems and methods for reducing chemotherapy side effects that are portable and allow the patient to be ambulate during treatment. Additionally, embodiments according to the invention provide systems and methods for reducing chemotherapy side effects that provide temperature and / or pressure control to the patient and / or caregiver. Still further, embodiments according to the invention provide systems and methods for reducing chemotherapy side effects that are compatible and complementary to existing systems and methods for administering chemotherapy.

[0106] Although the present invention has been shown and described with respect to one or more specific exemplary embodiments, equivalent changes and modifications will occur to those skilled in the art upon reading and understanding this specification and the accompanying drawings. In particular, with respect to the various functions performed by the above-mentioned components (assemblies, devices, etc.), the terms used to describe such components (including references to "means") are intended to correspond to any component that performs the specific function of the described component (e.g., which is functionally equivalent), even if it is not structurally equivalent to the disclosed structure that performs the function in the exemplary embodiment of the present invention shown herein, unless otherwise indicated. Furthermore, although a particular feature of the present invention may be disclosed with respect to only one of several embodiments, such feature can be combined with one or more features of other embodiments as may be desired and advantageous for any given or specific application.

[0107] Various embodiments of the present invention have thus been described. While the present invention has been described in specific embodiments, it should be understood that the invention should not be construed as limited by such embodiments, but rather should be construed according to the following claims.

Claims

1. 1. A therapeutic cooling system configured to cool a body part, comprising: a conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) for covering the body part, the conformal cover being configured to extract thermal energy from the body part; a sensor device (3, 151) within said conformal cover for sensing a parameter of said body part; an actuator (5, 22) configured to vary the amount of thermal energy extracted from said body part; A cooling system comprising a control unit (4, 44, 124, 162, 3100) configured to adjust the actuator (5, 22) in response to a control input from the sensor device (3, 151).

2. The therapeutic cooling system of claim 1 , wherein the sensor device (3, 151) measures temperature in proximity to the body part.

3. The therapeutic cooling system of claim 1 , wherein the sensor device (3, 151) measures a metabolic state of the body of the body part.

4. The therapeutic cooling system of claim 1 , wherein the sensor device (3, 151) measures the presence of a therapeutic agent in the body part.

5. 5. The therapeutic cooling system of claim 4, wherein the control unit (4, 44, 124, 162, 3100) is further configured to adjust an amount of heat extracted from the body part based on the presence of a therapeutic agent in the body part.

6. 10. The therapeutic cooling system of claim 1, wherein the control unit (4, 44, 124, 162, 3100) is further configured to adjust an amount of heat extracted from the body part based on manual input.

7. 2. The therapeutic cooling system of claim 1, wherein the control unit (4, 44, 124, 162, 3100) is further configured to adjust an amount of heat extracted from the body part based on an amount of hair between a surface of the skin and the conformal covering (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301).

8. 10. The therapeutic cooling system of claim 1, wherein the control unit (4, 44, 124, 162, 3100) is further configured to regulate an amount of heat extracted from the body part to maintain a safe temperature of the body part.

9. 10. The therapeutic cooling system of claim 1, further comprising a safety device (151) configured to regulate cooling of the body part to maintain a safe temperature of the body part.

10. 10. The therapeutic cooling system of claim 1, wherein the actuator (5, 22), the control unit (4, 44, 124, 162, 3100), and the cooling source are fixed to the patient so that the patient is ambulatory during treatment.

11. 2. The therapeutic cooling system of claim 1, wherein the body part includes a hand, and the conformal covering (241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) is configured to enable use of the hand.

12. 2. The therapeutic cooling system of claim 1, wherein the conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) is further configured to apply compression to the body part.

13. 2. The therapeutic cooling system of claim 1, further comprising a second conformal covering (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) for covering a second body portion configured to extract thermal energy from the second body portion, the second conformal covering configured to operate independently of the first conformal covering.

14. 2. The therapeutic cooling system of claim 1, wherein the conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) is configured to isolate and cool one or more fingers from other body parts.

15. 2. The therapeutic cooling system of claim 1, wherein the conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) is configured to isolate and cool one or more toes from other body parts.

16. 1. A therapeutic thermal management system configured to cool a first body part and warm a second body part, comprising: a first conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) for covering the first body part, the first conformal cover being configured to extract thermal energy from the first body part; a second conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) for covering the second body part configured to apply thermal energy from the second body part; first and second sensor devices (3, 151) within the first and second conformal covers for sensing parameters of the first and second body parts; an actuator (5, 22) configured to vary the amount of thermal energy extracted from the first body part and applied to the second body part; A system comprising a control unit (4, 44, 124, 162, 3100) configured to adjust the actuator (5, 22) in response to control inputs from the first and second sensor devices (3, 151).

17. The therapeutic thermal management system of claim 16 , wherein heat extracted from the first body part is applied to the second body part.

18. The therapeutic thermal management system of claim 16, wherein at least one of the first and second sensor devices (3, 151) is configured to measure a metabolism of a cell.

19. The therapeutic thermal management system of claim 16, further comprising a replaceable liner (271, 285, 286).

20. 20. The therapeutic thermal management system of claim 18, wherein the control unit (4, 44, 124, 162, 3100) is further configured to raise at least one of the first and second conformal covers from an ambient temperature to a therapeutic temperature to prevent impact to a patient's skin.

21. 17. The therapeutic thermal management system of claim 16, wherein the control unit (4, 44, 124, 162, 3100) is further configured to control at least one of the first and second conformal covers from zero pressure to a therapeutic pressure to prevent impact to a patient's skin.

22. 17. The therapeutic thermal management system of claim 16, wherein the control unit (4, 44, 124, 162, 3100) is further configured to receive manual control input from a portable computing device (162, 3100) to control a desired temperature of the first and / or second conformal coverings.

23. 23. The therapeutic thermal management system of claim 22, wherein the portable computing device (162, 3100) is further configured to display elapsed and remaining treatment time.

24. 23. The therapeutic thermal management system of claim 22, wherein the portable computing device (162, 3100) is further configured to receive user input of a particular drug therapy and, in response to said input, automatically initiate an appropriate cooling protocol for said particular drug therapy.

25. 1. A therapeutic cooling system configured to cool a body part, the cooling device comprising: a conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301) for covering the body part, the conformal cover being configured to extract thermal energy from the body part; a cooling device (23, 32, 45, 53, 62, 72, 94, 121) configured to cool the conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301); a sensor device (3, 151) within said conformal cover for sensing a parameter of said body part; an actuator (5, 22) configured to vary the amount of thermal energy extracted from said body part; A cooling system comprising a control unit (4, 44, 124, 162, 3100) configured to adjust the actuator (5, 22) in response to a control input from the sensor device (3, 151).

26. 26. The therapeutic cooling system of claim 25, wherein the cooling device includes a gas source at ambient temperature and cooling is achieved by expansion of the gas (23).

27. 26. The therapeutic cooling system of claim 25, wherein the cooling device comprises a pre-cooled gas (32).

28. 26. The therapeutic cooling system of claim 25, wherein the cooling device comprises a thermoelectric cooler (45).

29. 26. The therapeutic cooling system of claim 25, wherein the cooling device comprises a remote radiator (53).

30. 26. The therapeutic cooling system of claim 25, wherein the cooling device comprises a closed loop heat pump (72).

31. 26. The therapeutic cooling system of claim 25, wherein the cooling device comprises a vortex tube (94).

32. 26. The therapeutic cooling system of claim 25, wherein the cooling device (23, 32, 45, 53, 62, 72, 94, 121) is part of the conformal cover (6, 26, 36, 43, 51, 63, 71, 81, 82, 91, 96, 106, 111, 121, 131, 141, 161, 171, 172, 241, 251, 252, 253, 261, 262, 271, 282, 284, 292, 301).

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