A system and a method for cooling the scalp of a user

Abstract

A system for cooling a head of a user to mitigate or prevent drug-induced hair¬ loss, including a hat, which includes an exterior layer, an interior layer, with an inflatable chamber therebetween, the inflatable chamber being functionally associated with an inflation pump. The hat includes a cooling assembly, reversibly attachable to the interior layer and including a housing defining pockets having cooling pads therein. Each cooling pad comprising a phase-changing-material adapted to obtain a temperature lower than -20°C and to retain that temperature. A sensor is adapted to sense an environmental condition within the hat. A controller is adapted to receive input from the sensor, and to provide a notification when the sensed environmental condition is outside of a specific range. When the hat is donned by the user, the inflatable chamber is inflated sufficiently to ensure that the cooling assembly engages the scalp of the user.

Description

[0001] A SYSTEM AND A METHOD FOR COOLING THE SCALP OF A USER

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to systems and methods for cooling a scalp of a user, and specifically to systems and methods which cool the scalp of the user sufficiently to reduce or prevent drug-induced hair-loss during medical treatments such as chemotherapy.

[0004] BACKGROUND OF THE INVENTION

[0005] Various medical treatments, such as chemotherapy and other treatments which include cytotoxic drugs, induce hair-loss. It is medically known that cooling of a region, such as a user’s scalp during chemotherapy reduces or prevents hair-loss. For example, cooling of the scalp constricts the blood supply to hair follicles in the scalp, thereby diminishing or preventing the hair follicles receiving high cytotoxic drug concentrations during the initial phases of chemotherapy. Furthermore, the coldness itself reduces the metabolism of cells of the hair follicles and thus reduces the ability of the cytotoxic drugs to act on the hair follicles. The combined effect of constricting the blood supply to the hair follicles and reducing the metabolism of the cells of the hair follicles prevents or reduces the hair loss.

[0006] The prior art includes various types of head-cooling devices for cooling the head during chemotherapy treatments.

[0007] For example, some devices include gel- or ice-based cooling pads, which are placed within a helmet or other head wrapper, and placed on the user’s head. However, such devices require frequent changing of the cooling pads (e.g. every half hour to 1 hour), and placing the now-heated pads in dry ice to re-cool. Consequently, the process is highly cumbersome. Additionally, devices using cooled gel packs or ice packs often do not reach, or do not sufficiently maintain, the desired degree of cooling of the user’s scalp in order to reduce or prevent hair-loss.

[0008] As another example, some devices include a hat or helmet including channels for flow of a cooled fluid therethrough. The hat or helmet is fluidly connected to a cooling device, a fluid reservoir, and a pump, and the fluid flowing through the channels is constantly or periodically replaced and re-cooled, in order to maintain the desired temperature. This type of devices, while maintaining an appropriate cooling temperature, are typically large and cumbersome, and are prone to problems and malfunctions because of the many different parts that must interact with each other throughout the process.

[0009] This and more, for best treatment rests, the user’s head must be cooled at the time of initiating the treatment and must continue to be cooled for several hours following completion of the treatment. Typically, the cooling process should begin approximately two hours prior to initiation of the chemotherapeutic treatment, and should terminate approximately two hours following completion of the treatment. As such, the user typically has to travel to the hospital or clinic where the treatment will be provided, and back home following the treatment, while their head is being cooled. The prior art systems requiring fluid flow through the hat or helmet are prohibitive in this regard, because they require an electrical connection for operation of the pump and cooling mechanism during the entire time the user’s head is being cooled, and thus cannot conveniently be used in a vehicle during travel time. Similarly, devices which require frequent changing of cooling pads are inconvenient for use during travel, due to the need to repeatedly stop in order to replace the cooling pads.

[0010] There is thus a need in the art for a system and method for cooling a user’s head before, during, and after chemotherapeutic treatments, in order to reduce or prevent hair-loss, which system and method are suitable for use in a variety of situations, such as during travel.

[0011] SUMMARY OF THE INVENTION

[0012] The present invention relates to systems and methods for cooling a scalp of a user in order to reduce or prevent drug-induced hair-loss during medical treatments such as chemotherapy.

[0013] In accordance with an embodiment of the present invention, there is provided a system for cooling a head of a user during medical treatments so as to mitigate or prevent drug -induced hair-loss. The system includes a hat, including a hat body, and at least one inflatable chamber fixed to the hat body, the at least one inflatable chamber being functionally associated with an inflation interface, connected to or adapted for connection to an inflation pump. The system further includes a cooling assembly, reversibly attachable to the at least one inflatable chamber, the cooling assembly including a plurality of chambers each accommodating a phase-changing-material (PCM) adapted to obtain a predetermined temperature in the range of lower than -20°C to -40°C and to retain the predetermined temperature for a predetermined duration for at least two hours. The system further includes at least one sensor adapted to sense an environmental condition within the hat, a communication interface disposed within the hat body, and a controller disposed within the hat body, the controller being adapted to receive input from the at least one sensor, and to provide a notification to another device, via the first communication interface, when the sensed environmental condition is outside of a specific range.

[0014] In some embodiments, when the hat is donned by the user, the inflatable chamber is inflated sufficiently to ensure that the cooling assembly engages the scalp of the user.

[0015] In some embodiments, the cooling assembly fluidly isolated from any other components.

[0016] In some embodiments, the hat body includes an exterior hat-layer and an interior hatlayer, such that the at least one inflatable chamber is formed between the exterior hat-layer and the interior hat-layer of the hat body.

[0017] In some embodiments, the at least inflatable chamber forms part of an inflatable assembly, the inflatable assembly includes an exterior chamber-layer and an interior chamber-layer, the exterior chamber-layer and the interior chamber-layer being connected to each other to define the at least one inflatable chamber, and the inflatable assembly is attached to an interior of the hat body.

[0018] In some embodiments, the hat body includes a hat-exterior layer and a stabilizing hatinterior layer, the stabilizing hat-interior layer being formed of a stiffer material than the hatexterior layer.

[0019] In some embodiments, the hat body includes an insulating layer, disposed between the hat-exterior layer and the stabilizing hat-interior layer.

[0020] In some embodiments, the cooling assembly includes a plurality of pockets, each pocket adapted to accommodate a corresponding cooling pad of a plurality of cooling pads, the corresponding cooling pad being removable from the pocket, wherein the PCM is disposed within each of the plurality of cooling pads.

[0021] In some embodiments, the cooling assembly includes a plurality of pockets, each pocket being filled with the PCM.

[0022] In some embodiments, the cooling assembly includes a crown cooling subassembly adapted to be disposed within the crown of the hat body, and a circumferential cooling subassembly, separate from the crown cooling subassembly.

[0023] In some embodiments, the PCM is adapted to obtain a predetermined temperature lower than -28°C.

[0024] In some embodiments, the PCM is adapted to retain the predetermined temperature of a duration of at least three hours.

[0025] In some embodiments, the at least one sensor includes at least one temperature sensor adapted to provide to the controller input regarding a temperature within the hat body or regarding a temperature of the cooling assembly. In some embodiments, the at least one sensor includes at least one pressure sensor adapted to provide to the controller input regarding a pressure applied by the hat to the scalp of the user.

[0026] In some embodiments, the hat body further includes a sizing assembly adapted to adjust at least one dimension of the hat so as to maintain the hat fixed on the user’s head.

[0027] In some embodiments, the cooling assembly is devoid of electronic components.

[0028] In some embodiments, the system further including a pumping unit, including a pump adapted to be in fluid communication with the inflation interface for inflation of the inflatable chamber, a second communication interface adapted to be in communication with the communication interface, a user interface, adapted to receive input from a user and to provide output to the user, and a second controller, functionally associated with the pump, the second communication interface, and the user interface, for controlling operation thereof.

[0029] In some embodiments, upon the second controller receiving a signal from the controller indicating that a temperature within the hat or a temperature of the cooling assembly is above a predetermined temperature threshold, the second controller is adapted to provide to the user a notification, via the user interface, to replace the cooling assembly or a component thereof.

[0030] In some embodiments, upon the second controller receiving a signal from the controller indicating that a pressure within the hat is below a predetermined pressure threshold, the second controller is adapted to automatically activate the pump to inflate the at least one inflatable chamber of the hat.

[0031] In some embodiments, the system further includes the inflation pump, the inflation pump being disposed within the hat body.

[0032] In some embodiments, upon the controller an input from the sensor indicating that a pressure within the hat is below a predetermined pressure threshold, the controller is adapted to automatically activate the pump to inflate the at least one inflatable chamber of the hat.

[0033] In some embodiments, the system further including a control unit, remote from the hat, the control unit including a second communication interface adapted to be in communication with the communication interface, a user interface, adapted to receive input from a user and to provide output to the user, and a second controller, functionally associated with the second communication interface and the user interface.

[0034] In some embodiments, upon the second controller receiving a signal from the controller indicating that a temperature within the hat or a temperature of the cooling assembly is above a predetermined temperature threshold, the second controller is adapted to provide to the user a notification, via the user interface, to replace the cooling assembly or a component thereof.

[0035] In accordance with an embodiment of the present invention, there is provided a system for cooling a head of a user during medical treatments so as to mitigate or prevent drug-induced hair-loss. The system includes a hat, which includes an exterior layer, an interior layer, and an inflatable chamber disposed between the exterior layer and the interior layer. The inflatable chamber is functionally associated with an inflation interface adapted for connection to an inflation pump. The hat further includes a cooling assembly, reversibly attachable to an interior surface of the interior layer. The cooling assembly includes a housing defining a plurality of pockets and a plurality of cooling pads, each comprising a phasechanging-material (PCM) adapted to obtain a predetermined temperature lower than -20°C and to retain the predetermined temperature for a predetermined duration. The hat further includes at least one sensor adapted to sense an environmental condition within the hat. The hat additionally includes a first communication interface and a first controller, adapted to receive input from the at least one sensor, and to provide a notification to another device, via the first communication interface, when the sensed environmental condition is outside of a specific range. When the hat is donned by the user, the inflatable chamber is inflated sufficiently to ensure that the cooling assembly engages the scalp of the user.

[0036] In some embodiments, each cooling pad is adapted to obtain a predetermined temperature lower than -28°C.

[0037] In some embodiments, each cooling pad is adapted to retain the predetermined temperature of a duration of at least three hours.

[0038] In some embodiments, the at least one sensor comprises at least one temperature sensor adapted to provide to the first controller input regarding a temperature within the hat.

[0039] In some embodiments, the at least one sensor comprises at least one pressure sensor adapted to provide to the first controller input regarding a pressure applied by the hat to the scalp of the user.

[0040] In some embodiments, the hat further comprises a sizing assembly adapted to adjust at least one dimension of the hat so as to maintain the hat fixed on the user’s head.

[0041] In some embodiments, the cooling assembly is devoid of fluid communication with other elements of the hat or outside the hat.

[0042] In some embodiments, the cooling assembly is devoid of electronic components.

[0043] In some embodiments, the system further includes a pumping unit, including a pump adapted to be in fluid communication with the inflation interface of the hat for inflation of the inflatable chamber, and a second communication interface adapted to be in communication with the first communication interface. The pumping unit may further include a user interface, adapted to receive input from a user and to provide output to the user, and a second controller, functionally associated with the pump, the second communication interface, and the user interface, for controlling operation thereof.

[0044] In some embodiments, upon the second controller receiving a signal from the first controller indicating that a temperature within the hat is above a predetermined temperature threshold, the second controller is adapted to provide to the user a notification, via the user interface, to replace the cooling pads in the cooling assembly.

[0045] In some embodiments, upon the second controller receiving a signal from the first controller indicating that a pressure temperature within the hat is below a predetermined pressure threshold, the second controller is adapted to automatically activate the pump to inflate the inflatable chamber of the hat.

[0046] In accordance with another embodiment of the present invention, there is provided a device for control of a hat for cooling a head of a user, the hat having: (i) an inflatable chamber; (ii) a cooling assembly; (iii) a pressure sensor; (iv) a temperature sensor; and (v) a communication interface. The device includes a pump adapted to be in fluid communication with the inflatable chamber of the hat, a user interface adapted to provide output to the user, and a controller. The controller is configured to receive temperature input from the temperature sensor, and upon identification of the temperature input being indicative of a temperature in the hat being above a predetermined temperature threshold, provide a notification to the user, via the user interface, to replace cooling units of the cooling assembly within the hat.

[0047] In some embodiments, the controller is further configured to receive pressure input from the pressure sensor in the hat, and upon identification of the pressure sensor being indicative of the pressure in the hat being below a predetermined pressure threshold, automatically activate the pump to re-inflate the inflatable chamber of the hat, thereby increasing the pressure therein.

[0048] In accordance with an embodiment of the present invention, there is provided a method of cooling the scalp of a user during a medical treatment so as to reduce or prevent drug-induced hair-loss, using the system described herein. The method includes at a first predetermined duration prior to initiation of the medical treatment, with the cooling assembly having cooling pads therein and being connected to the interior layer, donning the hat on the head of the user, and inflating the inflatable chamber. The method further includes retaining the hat on the head until receipt of a notification indicating that a temperature of the cooling assembly is above a temperature threshold. The method further includes, following receipt of the notification, replacing the cooling pads within the cooling assembly and re-donning the hat on the head of the user, and repeating the retaining, replacing, and re-donning steps until the passage of a second predetermined duration following completion of the medical treatment.

[0049] In some embodiments, the first predetermined duration is at least one hour.

[0050] In some embodiments, the second predetermined duration is at least four hours.

[0051] In some embodiments, the temperature threshold is -20°C.

[0052] In some embodiments, the temperature threshold is -25°C.

[0053] In some embodiments, the temperature threshold is -28°C.

[0054] BRIEF DESCRIPTION OF THE FIGURES

[0055] The foregoing discussion will be understood more readily from the following detailed description of the invention, when taken in conjunction with the accompanying Figures (1-9), in which:

[0056] Figure 1 is a block diagram of a system for cooling the head or scalp of a user according to embodiments of the disclosed technology;

[0057] Figures 2A and 2B are, respectively, a perspective view illustration and a sectional illustration of a hat forming part of the system of Figure 1, according to an embodiment of the disclosed technology;

[0058] Figure 3 is a perspective view illustration of a pumping unit forming part of the system of Figure 1, according to an embodiment of the disclosed technology;

[0059] Figure 4 is a block diagram of another system for cooling the head or scalp of a user according to embodiments of the disclosed technology;

[0060] Figure 5 is a perspective view illustration of a hat forming part of the system of Figure 4, according to an embodiment of the disclosed technology;

[0061] Figures 6A, 6B, and 6C are, respectively, a perspective view illustration, a side view illustration, and a top view illustration of an inflatable assembly and inflation interface forming part of the system of Figure 4, according to an embodiment of the disclosed technology;

[0062] Figure 7 is an illustration of a cooling assembly forming part of the system of Figure 4, according to an embodiment of the disclosed technology;

[0063] Figure 8 is a flow chart of a method of user operation of the system of Figure 1 or Figure 4, according to an embodiment of the disclosed technology; and

[0064] Figure 9 is a flow chart of a method of operation of control components of the system of Figure 1 or Figure 4, according to an embodiment of the disclosed technology.

[0065] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] The principles of the inventive systems and methods for cooling a scalp of a user may be better understood with reference to the drawings and the accompanying description.

[0067] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0068] For the purposes of the present disclosure, the term “substantially” is defined as “within 10% deviation of’.

[0069] Reference is now made to Figure 1, which is a block diagram of a system 10 for cooling the head, or scalp, of a user according to embodiments of the disclosed technology.

[0070] System 10 includes a hat or helmet 12, a pumping unit 14, and a cooler 16.

[0071] Hat 12 is described herein also with reference to Figures 2A and 2B, which are, respectively, a perspective view illustration and a sectional illustration of the hat.

[0072] Hat 12 includes an exterior layer 20, which may be formed of an elastic material or a non-woven material. Typically, exterior layer 20 has some degree of elasticity. Hat 12 further includes an interior layer 22, such that an inflatable chamber 24 is formed between interior layer 22 and exterior layer 20. Inflatable chamber 24 is functionally associated with an inflation interface 26, adapted to be in fluid communication with pumping unit 14 for inflation of the inflatable chamber and / or deflation thereof. In some embodiments, interior layer 22 may include or may be formed of silicone.

[0073] As explained in further detail hereinbelow, inflatable chamber 24 may be inflated with a fluid, such as air, to increase the pressure within hat 12 and to ensure proper engagement between cooling elements of the hat and the scalp of the user. Typically, a single inflatable chamber 24 is used, to ensure even distribution of the pressure through the entire area of the hat.

[0074] Hat 12 further includes a cooling assembly 30, adapted to attach to an interior surface of interior layer 24, such that when hat 12 is worn on the head of a user, cooling assembly 30 engages the scalp. Cooling assembly 30 is formed of a plurality of pockets or chambers 31, each of which receives a cooling pad 32, or is pre-fdled with a cooling material, as explained herein. Cooling assembly 30 is typically formed of silicone, and is adapted to assist in retaining the coldness of cooling pads 32 or of the cooling material for an extended duration.

[0075] Cooling pads 32 typically contain, or are formed of, a cooling material. The cooling material (whether contained directly within pockets or chamber 31 or disposed within cooling pads 32) is typically a phase changing material (PCM) configured to reach and retain a temperature in the range of -40°C to -20°C, or -35°C to -28°C for a duration of at least two hours, at least three hours, or at least four hours. Typically, the PCM of cooling pads 32 is cooled using cooler 16, as explained in further detail hereinbelow.

[0076] It is to be appreciated that the PCM is specifically selected to reach a very low temperature, even if there is a risk that such a temperature would cause frostbite when applied to the head of a user for a sufficient duration.

[0077] In some embodiments, cooling assembly 30 and interior layer 24 include corresponding attachment interfaces 34 for rapid and convenient attachment of the cooling assembly to the interior surface of interior layer 24. For example, the attachment interfaces may include Velcro® hooks and loops materials, hooks and eyes, zippers, buttons, snaps, and the like.

[0078] It is a particular feature of the present invention that cooling assembly 30 is a standalone assembly, which is mechanically detachable from hat 12. While connected to hat 12, and in some embodiments at all times, cooling assembly 30 is devoid of fluid communication with pumping unit 14 or with any other pumping or cooling unit. In some embodiments, cooling assembly 30 is devoid of any form of fluid communication, and is fluidly isolated from all other components of system 10. Cooling assembly 30 is further devoid of any electrical or electronic components, and is devoid of connection or communication to any electrical or electronic components.

[0079] Exterior layer 22 and / or interior layer 24 of hat 12 is functionally associated with a sizing assembly 40, adapted to enable adjustment of the size of hat 12 to the head of a specific user. For example, sizing assembly 40 may include a rigid, or semi-rigid, cuff 42, adapted to wrap around the user’s neck and to be adjusted to the size of the user’s neck, so as to ensure that hat 12 does not move relative to the user’s head during cooling of the head. A tightening button 44 allows for mild adjustments of the tightness of cuff 42, and a release button 46 enables immediate release of cuff 42 to facilitate donning and doffing of hat 12, as well as rapid removal of the hat in case of stress or discomfort. Hat 12 further has mounted therein, or thereon, one or more temperature sensors 50 adapted to sense a temperature within the hat, and may include one or more pressure sensors 52 adapted to sense pressure applied to the scalp of the user by the hat, or the pressure within inflatable chamber 24. Sensors 50 and 52 are functionally associated with a controller 54, which in turn is functionally associated with a communication interface 56, both being mounted in or on hat 12. Controller 54 is adapted to receive inputs from sensors 50 and 52, and to provide instructions or communication messages to pumping unit 14 or to a remote computing unit, as explained in further detail hereinbelow. A power source 58, which typically includes a battery such as a rechargeable battery, is disposed within hat 12 and powers electronic components thereof, such as sensors 50 and 52, controller 54, and communication interface 56.

[0080] The term “controller” as used herein means a computing device configured for monitoring, controlling, regulating and / or actuating one or more components, assemblies, stations, systems, or subsystems. A controller should be understood to include any or all of (and not exhaustively): one or more processors, one or more computer-readable media, e.g., transient and / or non-transient storage media, communications arrangements, a power source and / or a connection to a power source, and firmware and / or software. Controllers can be programmed in advance, e.g., by having program instructions stored in the computer-readable media for execution by one of more processors of the controller. Thus, a controller ‘configured’ to perform a function is equivalent herein to the controller being programmed, i.e., having access to stored program instructions for execution, to perform the function.

[0081] In some embodiments, hat 12 may have a pre-formed shape, such as a helmet. The shape and sizing of the hat may be adjustable using sizing assembly 40 and a degree of inflation of inflatable chamber 24.

[0082] In some embodiments, hat 12 may have a flat configuration, in which the exterior layer of the hat forms a plane or flat surface, and a donned configuration as shown in Figure 2A. In such embodiments, hat 12 may further includes reversible connectors for transitioning of the hat between the two configurations.

[0083] Pumping unit 14 is described herein also with reference to Figure 3, which is a perspective view illustration of the pumping unit according to an embodiment of the disclosed technology

[0084] Pumping unit 14 includes a pump 60, functionally associated with a fluid interface 62. Fluid interface 62 is adapted to be in fluid communication with inflation interface 26 of hat 12, so that fluid (e.g. air) pumped by pump 60 can be used to inflate inflatable chamber 24. Fluid interface 62 and inflation interface 26 are reversibly connectable to each other, for example using a suitable pipe or tube.

[0085] Pumping unit 14 further includes a controller 74, functionally associated with pump 60, with a communication interface 76 and with a user interface 78.

[0086] User interface 78 is adapted to receive user instructions for operation of system 10, such as instructions to inflate inflatable chamber 24. User interface 78 is further adapted to provide output to the user, for example via a display 80 forming part of the user interface or via an audio speaker 82. User interface 78 typically further includes an activation switch for activation and deactivation of operation of hat 12 and / or of system 10.

[0087] Communication interface 76 is adapted to communicate with communication interface 56 of hat 12, to enable communication between the hat and the pumping unit. Communication interface 76 may further be adapted to communicate with other remote devices, such as a computing device or smart phone of the user (not explicitly shown) running a dedicated software application. Communication interfaces 56 and 76 may communicate with each other using any suitable protocol known in the art, such as via Bluetooth communication, Radio Frequency communication, Wi-Fi communication, and the like.

[0088] In some embodiments, pumping unit 14 further includes a pressure sensor or a pressure switch 81, adapted to assess the fluid pressure, or air pressure, in the fluid flow system of the pump 60 and inflatable chamber 24. Pressure switch 81 is functionally associated with controller 74, such that, when pressure switch 81 reports to the controller that there is a pressure drop in the fluid flow system, controller 74 activates pump 60 to increase the pressure back to a desired pressure.

[0089] One or more batteries, or another power source, 83, powers the electronic components of pumping unit 14.

[0090] In some embodiments, pumping unit 14 may further include one or more connection ports 84 for connection to external devices. For example, connection port(s) 84 may include a USB connection port for direct connection to controller 54 of hat 12, to a connection interface thereof, or to another computing device such as a smart phone of the user. As another example, connection port(s) 84 may include a connection port for connection to cooler 16, for example for extraction of data relating to the interior of the cooler, as explained in further detail hereinbelow.

[0091] Cooler 16 is adapted to have disposed in a hollow thereof additional cooling pads 32a, typically identical to cooling pads 32 and adapted to fit into cooling assembly 30, or an additional cooling assembly. The additional cooling pads 32a (or the additional cooling assembly) are stored in cooler 16 together with, or within, a cooling element 90, and are brought to and maintained at a desired temperature, ready for a time at which the cooling pads within cooling assembly 30, or the entire cooling assembly, need to be switched.

[0092] In some embodiments, cooling element 90 may comprise a suitable chemical cooler, such as dry ice (solid carbon dioxide), or liquid nitrogen. Typically, cooling element 90 is devoid of electronic components, and is not electrically maintained at its cold temperature. Typically, cooling element 90 is maintained at, or is configured to maintain within cooler 16, a temperature in the range of -50°C to -30°C.

[0093] Cooler 16 may further include a temperature sensor 92, adapted to sense the temperature within the cooler. The temperature sensor may be associated with a communication interface (not explicitly shown) for communication of temperature readings to communication interface 76 of pumping unit 14. Alternately, the temperature sensor may be associated with a connection interface adapted for direct connection to connection port(s) 84 for extraction of data from the temperature sensor by controller 74 of the pumping unit.

[0094] Reference is now made to Figure 4, which is a block diagram of another system 110 for cooling the head or scalp of a user according to embodiments of the disclosed technology. System 110 is substantially similar to system 10 of Figures 1-3 described hereinabove, with like numbers representing like elements.

[0095] System 110 includes a hat or helmet 112, and a cooler 116. In some embodiments, system 110 may further include a control unit 118, remote from hat 112.

[0096] Hat 112 is described herein also with reference to Figure 5 which is a perspective view illustration of the hat.

[0097] Hat 112 includes a hat body having three layers. An exterior layer 120 may be formed of an elastic material or a non-woven material. Typically, exterior layer 120 has some degree of elasticity. In some embodiments, exterior layer 120 may be a decorative layer, designed to have an appeasing appearance to the user. In some embodiments, the user may specifically select the fabric, or the design, or exterior layer 120.

[0098] Disposed inwardly of exterior layer 120 is an insulating layer 121. In some embodiments, insulating layer 121 may be formed of an insulating foil fabric, similar to that used in a foil blanket or space blanket.

[0099] The body of hat 112 further includes a stabilizing layer 122, disposed inwardly of insulating layer 121, such that the insulating layer is disposed between the exterior layer and the stabilizing layer. Typically, the stabilizing layer is formed of a relatively rigid, or stiff, material, such as denim, canvas, and the like. In some embodiments, stabilizing layer is significantly stiffer, or significantly more rigid, than exterior layer 120. In some embodiments, stabilizing layer 122 is adapted to control, or retain, the shape of hat 112.

[0100] In some embodiments, hat 112 includes a crown portion 200 (Figure 5), and a circumferential portion 202 (Figure 5). In some embodiments, crown portion 200 and circumferential portion 202 are each formed of the three layers of hat 112, namely exterior layer 120, insulating layer 121, and stabilizing layer 122. When hat 112 is donned by a user, crown portion 200 is adapted to be disposed at the crown of the user’s head, and circumferential portion 202 is adapted to be disposed about the perimeter of the user’s head, but not to extend over the face of the user. As such, circumferential portion 202 includes a forward-facing cavity 204 (Figure 5), adapted to accommodate the face of the user.

[0101] A slit or bore 206 (Figure 5) is disposed at the crown of the body of hat 112, and extends through all three layers of hat 112. Slit 206 is adapted for connection of the three layers of the hat to an inflatable assembly 124 and to a cooling assembly 130, as described hereinbelow.

[0102] It is to be appreciated that while the structure of inflatable assembly 124 and of cooling assembly 130, as illustrated in Figures 5-7, is similar than the structure of the corresponding elements described hereinabove with respect to Figures 1-3, the functionality of these assemblies is substantially as described hereinabove.

[0103] A channel 208 (Figure 5) is disposed at a lower end of circumferential portion 202, distal to the crown of the hat. Channel 208 is adapted to accommodate electronic components of hat 112, such as controller 154, power source 158, and communication interface 156, all of which are similar to those described hereinabove with respect to Figures 1-3. Channel 208 may also include, or accommodate, sizing assembly 140, similar to the sizing assembly described hereinabove with respect to Figures 1-3.

[0104] System 110 of Figures 4-7 is distinct from system 10 of Figures 1-3 in that in system 110, pump 160 forms part of hat 112, and specifically is accommodated within channel 208. As such, the pump can connect directly to inflation interface 126 for direct inflation of inflatable assembly 124, and additional fluid interfaces (e.g. 62 in Figure 3) may be obviated. Additionally, in some such embodiments, pressure sensors are only required within the hat, and as such external pressure switches (e.g. pressure switch 81 of Figure 3) may be obviated.

[0105] In embodiments in which pump 160 forms part of hat 112, operation of the pump is controlled by controller 154 of the hat, for example in response to receipt of pressure inputs from pressure sensor(s) 150 of the hat. As such, in the embodiment of Figures 4-7, no communication or fluid communication out of hat 112 is required in order to ensure proper inflation of inflatable assembly 124.

[0106] As seen in Figure 4, in system 110, user interface 178, external controller 174, external power source 183, and communication interface 176 all form part of control unit 118. In some embodiments, control unit 118 may be a device already carried or used by the user, such as a smart mobile phone, for example running suitable software associated with system 110.

[0107] In some such embodiments, all communication with the user, for example with respect to the need to replace the cooling assembly, is accomplished via control unit 118, and specifically via communication between hat 112 and the control unit.

[0108] For example, when temperature sensor(s) 150 provides temperature inputs to controller 154 indicating that the temperature within the hat has exceeded a threshold, controller 154 may transmit a message to controller 174, via communication interfaces 156 and 176, indicating that the user should be notified to replace the cooling assembly. The notification may then be provided to the user by controller 174, for example via user interface 178. Similarly, the user may cause operation of pump 160 by providing a suitable instruction using user interface 178, which is conveyed to the pump via controller 174, communication interfaces 176 and 156, and controller 154.

[0109] Cooler 116 of Figure 4 is substantially as described hereinabove with respect to Figures 1-3, and includes temperature sensor 192 and cooling element 190. The main distinction between cooler 116 and cooler 16 is that cooler 116 accommodates one or more additional cooling assemblies 130a, rather than accommodating cooling pads.

[0110] Inflatable assembly 124 is described herein with further reference to Figures 6A to 6C.

[0111] As seen, inflatable assembly 124 includes a crown portion 210 and a circumferential portion 212 defining a forward-facing cavity 214. Crown portion 210, circumferential portion 212, and forward-facing cavity 214 are adapted to align with crown portion 200, circumferential portion 202, and forward-facing cavity 204 of the hat body.

[0112] Crown portion 210 and circumferential portion 212 of inflatable assembly each include an exterior layer 220 and an interior layer 222, such that at least one inflatable chamber is formed therebetween. In some embodiments, and as illustrated, multiple inflatable chambers 224a can be formed in crown portion 210, separated by ridges, or seams 226a, and multiple inflatable chambers 224b can be formed in circumferential portion 212, separated by ridges or seams 226b. In some embodiments, exterior layer 220 is adapted to engage stabilizing layer 122 of the hat body.

[0113] A bore or cavity 228 is disposed at the crown of crown portion 210, and is adapted to be aligned with slit 128 (Figure 5) as explained in further detail hereinbelow.

[0114] Inflation interface 126, here illustrated as a tube, extends into at least one of inflatable chambers 224a at a first point, and into at least one of inflatable chamber 224b at a second point. An open end 229 of inflatable interface 126 extends past a lower end of inflatable assembly 124, for fluid communication with pump 160 disposed in channel 208 of the hat (Figures 4 and 5).

[0115] In some embodiments, the tube of inflation interface 126 extends into a single inflatable chamber 224a’. In such embodiments, inflatable chamber 224a’ is in fluid communication with all other inflatable chambers 224a, such that direct inflation of deflation of inflatable chamber 224a’ by inflation interface 126 effects the inflation or deflation of the other inflatable chambers 224a. Similarly, in some embodiments, the tube of inflation interface 126 extends into a single inflatable chamber 224b’. In such embodiments, inflatable chamber 224b’ is in fluid communication with all other inflatable chambers 224b, such that direct inflation of deflation of inflatable chamber 224b’ by inflation interface 126 effects the inflation or deflation of the other inflatable chambers 224b.

[0116] In some other embodiments, inflation interface 126 may include a branched tube, or multiple tubes, such that the inflation interface is in direct fluid communication with each of inflatable chambers 224a and with each of inflatable chambers 224b.

[0117] As explained hereinabove, inflatable chambers 224 may be inflated with a fluid, such as air, to increase the pressure within hat 112 and to ensure proper engagement between cooling elements of the hat and the scalp of the user.

[0118] In some embodiments, inflatable assembly 124 may be fixed to the stabilizing layer 122 of the main hat body, for example by adhesive or by stitching. In some other embodiments, inflatable assembly 124 may be removable from the remainder of hat 112, and may reversibly attached thereto, for example by suitable fasteners 225 (e.g., Velcro®, hooks and eyes, snaps, and the like).

[0119] In some embodiments, exterior layer 220 and interior layer 222 of inflatable assembly 124 may be formed of the same material. In some embodiments, that material may include rubber of silicone. In some embodiments, exterior layer 220 may be formed of a different material from interior layer 222. For example, interior layer 222 may be formed of a material which lends itself to easy fastening of cooling assembly 130 thereto, such as a fabric formed of the female side of Velcro® fasteners, while exterior layer 220 may be formed of a different material, such as one including rubber or silicone.

[0120] Cooling assembly 130 which forms part of system 110 and hat 112 is described herein with respect to Figure 7.

[0121] As seen, cooling assembly 130 includes a crown cooling subassembly 230 and a circumferential cooling subassembly 232. Each of cooling subassemblies includes an outer layer and an inner layer, which are sewn or adhered together such that pockets or chambers 231 are formed therebetween. For example, in the illustrated embodiment, crown cooling subassembly includes six such chambers.

[0122] Cooling assembly 130 is adapted to engage the interior layer of inflatable assembly 124 when it engages stabilizing layer 122, such that when hat 112 is worn on the head of a user, cooling assembly 130 engages the user’s hair or scalp.

[0123] Each of chambers 231 of cooling assembly 130 is pre-filled with a cooling material. Cooling assembly 130 is typically formed of silicone, and is adapted to assist in retaining the coldness of the cooling material for an extended duration. As discussed hereinabove, the cooling material is typically a phase changing material (PCM) configured to reach and retain a temperature in the range of -40°C to -20°C, or -35°C to -28°C for a duration of at least two hours, at least three hours, or at least four hours.

[0124] It is to be appreciated that the PCM is specifically selected to reach a very low temperature, even if there is a risk that such a temperature would cause frostbite when applied to the head of a user for a sufficient duration.

[0125] In some embodiments, circumferential cooling subassembly 232 includes fasteners 235 corresponding to those disposed on the interior layer of inflatable assembly 124, for rapid and convenient attachment of the cooling assembly to the inflatable assembly. For example, the attachment interfaces may include Velcro® hooks and loops materials, hooks and eyes, zippers, buttons, snaps, and the like.

[0126] Additionally, crown cooling subassembly includes a protrusion 234 extending upwardly therefrom, the protrusion terminating in a holder 236, which in the illustrated embodiment is a loop. For attachment of the crown cooling subassembly to the rest of the hat, protrusion 234 and holder 236 are adapted to be put through bore 228 of inflatable subassembly 124 and through slit 128 of the main body of the hat, and to be retained therein, for example by rotation of the protrusion relative to the slit for relative locking thereof. In this way, holder 236 extends out of the rest of the hat, and is accessible to the user for easy removal of the hat. It is a particular feature of the present invention that cooling assembly 130 is a standalone assembly, which is mechanically detachable from hat 112. While connected to hat 112, and in some embodiments at all times, cooling assembly 130 is devoid of fluid communication with pump 160 or with any other pumping or cooling unit. In some embodiments, cooling assembly 130 is devoid of any form of fluid communication, and is fluidly isolated from all other components of system 110. Cooling assembly 130 is further devoid of any electrical or electronic components, and is devoid of connection or communication to any electrical or electronic components.

[0127] Reference is now made to Figure 8, which is a flow chart of a method of user operation of systems 10 and / or 110, according to an embodiment of the disclosed technology.

[0128] At step S300, the user removes cooled cooling pads from the cooler, and inserts them into the suitable pockets in the cooling assembly. The user then attaches the cooling assembly to an interior surface of the inflatable assembly (which in the embodiment of Figures 1-3 is also the interior surface of the hat) at step S302. The user then dons the hat at step S304. In some embodiments, in which the cooling assembly 30 is pre-formed, such as the embodiment of Figures 4-7 step S300 may be obviated.

[0129] In some embodiments, following donning of the hat, the user may adjust the hat size using sizing assembly 40, at step S306. In accordance with some embodiments of the disclosed technology, donning of the hat and initiating the cooling process takes place a predetermined duration prior to initiation of therapeutic treatment, such as half an hour to 2 hours prior to the beginning of the therapeutic treatment.

[0130] At step S308, the user activates the pump (whether in the pumping unit or within the hat) to pump fluid to inflate the inflatable chamber(s). Control of the inflation process is automatic, as explained hereinbelow with respect to Figure 9, so that it is sufficient for the user to give a single inflate command (e.g., at the pumping unit or at the control unit) for the system to work as required.

[0131] The user then keeps the hat on their head, and periodically checks, at step S310 whether a notification is received via the user interface that the cooling pads or cooling assembly must be replaced. This may occur, for example, when the system identifies that the temperature within the hat is above a desired temperature, as explained hereinbelow with respect to Figure 9.

[0132] If such a notification is received, at step S312 the user doffs the hat, and, in some embodiments, also deflates the inflatable chambers) at step S314. The user then replaces the now-heated cooling pads or cooling assembly with cooling pads or with a cooling assembly, taken from cooler 16 and having a desired cooled temperature, at step S316.

[0133] For example, replacement of the cooling pads may include detaching the cooling assembly from the hat, removing the now-heated cooling pads from within the cooling assembly and placing them in the cooler to cool, inserting cold cooling pads from the cooler into the cooling assembly, and re-attaching the cooling assembly to the hat.

[0134] In embodiments in which the cooling assembly is pre-formed, replacement of the cooling assembly may include detaching the cooling assembly from the hat and placing it in the cooler to cool, and re-attaching a cold cooling assembly, taken from the cooler, to the hat.

[0135] In the embodiment of Figures 4 to 7, the replacement of the cooling assembly typically includes replacement of both the crown cooling subassembly and the circumferential cooling subassembly. However, in some embodiments, replacement of each of these cooling subassemblies may occur at a separate time, and in response to a separate notification received via the user interface. In some such embodiments, separate temperature sensors may provide information relating to the temperature of each such cooling subassembly.

[0136] The flow then returns to step S304, where the user once again dons the hat with the cold cooling assembly. In some embodiments, in which the size of the hat was not changed when it was doffed by the user, there is no need to re-adjust the size of the hat at step S306. Similarly, in embodiments in which the inflatable chamber(s) was not deflated when it was doffed by the user, there is no need to re-inflate the inflatable chamber(s) at step S308.

[0137] Alternately, if no notification to replace the pads is received, the user may replace the pads following the passage of a predetermined duration, such as 3 hours. Additionally, the user occasionally checks whether the cooling duration is complete, at step S320. For example, the cooling duration may be complete approximately 4 to 5 hours after completion of the chemotherapeutic treatment.

[0138] If the cooling treatment is complete, the user deflates the inflatable assembly at step S322, and doffs it at step S324. Otherwise, the flow returns to step S310.

[0139] Reference is now made to Figure 9, which is a flow chart of a method of operation of control components of system 10 or 110, and specifically of the pump thereof, according to an embodiment of the disclosed technology.

[0140] At step S350, which occurs following activation of the pump, the controller controlling the pump drives the pump to inflate the inflatable chamber(s) of the hat. In the embodiment of Figures 1-3, in which the pump forms part of an external pumping unit, this is accomplished by controller 74. In the embodiment of Figures 4-7, in which the pump is disposed within the hat, this is accomplished by controller 154.

[0141] At some later time, at step S352, the controller (i.e., controller 74 in system 10 or controller 154 in system 110) receives a pressure reading from the pressure sensor(s) within the hat, or from the pressure switch, which reading is indicative of a pressure within the hat or within the pumping system. Such a reading may be received periodically (e.g. every 1 second, every 15 seconds, every 30 seconds, every minute, every 2 minutes, every 5 minutes, etc.) or intermittently. For example, in the embodiment of Figures 1-3, the pressure reading may be received from pressure sensor(s) 52 via communication interfaces 56 and 76.

[0142] The controller (i.e., controller 74 in system 10 or controller 154 in system 110) then evaluates whether the hat pressure is within range, at step S354. If the pressure within the hat is outside of the desired range, the flow returns to step S350, for re-inflation of the hat.

[0143] Otherwise, if the pressure in the system is within the desired range, the flow continues to step S356, where, at some time, the controller (i.e., controller 74 in system 10 or controller 154 in system 110) receives a temperature reading from the temperature sensor(s) in the hat. Such a reading may be received periodically (e.g. every 1 second, every 15 seconds, every 30 seconds, every minute, every 2 minutes, every 5 minutes, etc.) or intermittently. For example, in the embodiment of Figures 1-3, the temperature reading may be received from temperature sensor(s) 50 via communication interfaces 56 and 76.

[0144] The controller then evaluates whether the temperature is within range, at step S358. For example, the temperature is considered within range if it is the range of -40°C to -20°C, or -35°C to -28°C. If the temperature is out of range, and specifically higher than the desired range, at step S360 the controller notifies the user that the cooling pads or cooling assembly must be replaced.

[0145] For example, in system 10, controller 74 may utilize user interface 78 to notify the user of the required cooling pad replacement, for example using screen 80 of the pumping unit.

[0146] As another example, in system 110, controller 154 may send a message to controller 174, e.g., via communication interfaces 156 and 176, and controller 174 may provide the notification to the user on user interface 178 of control unit 118, for example on a screen of the user’s phone.

[0147] In some embodiments, the controller may optionally receive a signal from the user following replacement of the cooling pads or cooling assembly, at step S362. For example, such a signal may be provided via a suitable switch or button in the user interface, and may be delivered from there to the controller. If at step S358 the temperature is within the desired range, the flow continues to step S364, where the controller evaluates whether the cooling duration is complete. For example, the cooling duration may be pre-programmed into controller 74 or controller 154, or may be provided by the user via the user interface, prior to or at the time of initiating the cooling process. If the cooling duration is complete, the controller deflates the inflatable chamber(s) at step S366. Otherwise, the flow returns to step S352.

[0148] It will be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. Similarly, the content of a claim depending from one or more particular claims may generally depend from the other, unspecified claims, or be combined with the content thereof, absent any specific, manifest incompatibility therebetween.

[0149] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A system for cooling a head of a user during medical treatments so as to mitigate or prevent drug-induced hair-loss, the system comprising a hat including: a hat body; at least one inflatable chamber fixed to the hat body, the at least one inflatable chamber being functionally associated with an inflation interface, connected to or adapted for connection to an inflation pump; a cooling assembly, reversibly attachable to the at least one inflatable chamber, the cooling assembly including a plurality of chambers each accommodating a phasechanging-material (PCM) adapted to obtain a predetermined temperature in the range of lower than -20°C to -40°C and to retain the predetermined temperature for a predetermined duration for at least two hours; at least one sensor adapted to sense an environmental condition within the hat; a communication interface disposed within the hat body; and a controller disposed within the hat body, the controller being adapted to receive input from the at least one sensor, and to provide a notification to another device, via the first communication interface, when the sensed environmental condition is outside of a specific range, wherein when the hat is donned by the user, the inflatable chamber is inflated sufficiently to ensure that the cooling assembly engages the scalp of the user, and wherein the cooling assembly fluidly isolated from any other components.

2. The system of claim 1, wherein the hat body includes an exterior hat-layer and an interior hat-layer, such that the at least one inflatable chamber is formed between the exterior hat-layer and the interior hat-layer of the hat body.

3. The system of claim 1, wherein the at least inflatable chamber forms part of an inflatable assembly, the inflatable assembly comprises an exterior chamber-layer and an interior chamber-layer, the exterior chamber-layer and the interior chamber-layer being connected to each other to define the at least one inflatable chamber, and wherein the inflatable assembly is attached to an interior of the hat body.

4. The system of claim 3, wherein the hat body comprises a hat-exterior layer and a stabilizing hat-interior layer, the stabilizing hat-interior layer being formed of a stiffer material than the hat-exterior layer.

5. The system of claim 4, wherein the hat body comprises an insulating layer, disposed between the hat-exterior layer and the stabilizing hat-interior layer.

6. The system of any one of claims 1 to 5, wherein the cooling assembly comprises a plurality of pockets, each pocket adapted to accommodate a corresponding cooling pad of a plurality of cooling pads, the corresponding cooling pad being removable from the pocket, wherein the PCM is disposed within each of the plurality of cooling pads.

7. The system of any one of claims 1 to 5, wherein the cooling assembly comprises a plurality of pockets, each pocket being filled with the PCM.

8. The system of any one of claims 1 to 7, wherein the cooling assembly comprises a crown cooling subassembly adapted to be disposed within the crown of the hat body, and a circumferential cooling subassembly, separate from the crown cooling subassembly.

9. The system of any one of claims 1 to 8, wherein the PCM is adapted to obtain a predetermined temperature lower than -28°C.

10. The system of any one of claims 1 to 9, wherein the PCM is adapted to retain the predetermined temperature of a duration of at least three hours.

11. The system of any one of claims 1 to 10, wherein the at least one sensor comprises at least one temperature sensor adapted to provide to the controller input regarding a temperature within the hat body or regarding a temperature of the cooling assembly.

12. The system of any one of claims 1 to 11, wherein the at least one sensor comprises at least one pressure sensor adapted to provide to the controller inputregarding a pressure applied by the hat to the scalp of the user.

13. The system of any one of claims 1 to 12, wherein the hat body further comprises a sizing assembly adapted to adjust at least one dimension of the hat so as to maintain the hat fixed on the user’s head.

14. The system of any one of claims 1 to 13, wherein the cooling assembly is devoid of electronic components.

15. The system of any one of claims 1 to 14, further comprising a pumping unit, including: a pump adapted to be in fluid communication with the inflation interface for inflation of the inflatable chamber; a second communication interface adapted to be in communication with the communication interface; a user interface, adapted to receive input from a user and to provide output to the user; and a second controller, functionally associated with the pump, the second communication interface, and the user interface, for controlling operation thereof.

16. The system of claim 15, wherein, upon the second controller receiving a signal from the controller indicating that a temperature within the hat or a temperature of the cooling assembly is above a predetermined temperature threshold, the second controller is adapted to provide to the user a notification, via the user interface, to replace the cooling assembly or a component thereof.

17. The system of claim 15 or claim 16, wherein, upon the second controller receiving a signal from the controller indicating that a pressure within the hat is below a predetermined pressure threshold, the second controller is adapted to automatically activate the pump to inflate the at least one inflatable chamber of the hat.

18. The system of any one of claims 1 to 14, further comprising the inflation pump, the inflation pump being disposed within the hat body.

19. The system of 18, wherein, upon the controller an input from the sensor indicating that a pressure within the hat is below a predetermined pressure threshold, the controller is adapted to automatically activate the pump to inflate the at least one inflatable chamber of the hat.

20. The system of any one of claims 1 to 14, further comprising a control unit, remote from the hat, the control unit including: a second communication interface adapted to be in communication with the communication interface; a user interface, adapted to receive input from a user and to provide output to the user; and a second controller, functionally associated with the second communication interface and the user interface.

21. The system of claim 20, wherein, upon the second controller receiving a signal from the controller indicating that a temperature within the hat or a temperature of the cooling assembly is above a predetermined temperature threshold, the second controller is adapted to provide to the user a notification, via the user interface, to replace the cooling assembly or a component thereof.

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