Device and method for cephalocervical temperature regulation

Abstract

A wearable device for fitting to a cephalocervical region of a subject is provided, the device comprising a first portion for fitting to a forehead of the subject and a second portion for fitting to a back of the head of the subject. The second portion, and optionally the first portion, comprises a temperature regulator. The device does not obscure vision of the subject when fitted. Associated systems and methods are further provided.

Description

TITLEDEVICE AND METHOD FOR CEPHALOCERVICAL TEMPERATURE REGULATION FIELD

[0001] This invention relates to temperature regulation. More particularly, the invention relates to devices and methods for regulating temperature of the head, neck, brain, and / or cranial nerves.BACKGROUND

[0002] Regulating temperature of the cephalocervical region, including the head and brain, is important in various contexts, including for medical neuroprotection and brain injury treatment.

[0003] In some cases, surface packs, pads, or caps are used for conductive temperature regulation (cooling or warming), such as for fever management, neonatal care, or treatment of brain injuries.

[0004] Other approaches for regulation of head and brain temperature include the use of more invasive technique such as application of intranasal cooling devices for delivering cooled air or saline through the nasal cavity, or intravascular cooling catheters for circulating cooled saline or the like, to lower systemic and brain temperature.

[0005] In some circumstances, pharmacological regulation of brain temperature using drugs targeting metabolic activity is used. Additionally, newer methods such as transcranial laser or ultrasound systems are being explored for neuromodulation and neuroprotection, including via temperature regulation.

[0006] Existing approaches for temperature regulation of the head and brain are frequently designed for use in critical care and / or emergency settings. However, temperature regulation of the cephalocervical region might also be desirable in first aid and / or non-emergency health and well-being contexts.

[0007] With the preceding in mind, it would be desirable to develop new approaches for temperature regulation of the cephalocervical region. It could be particularly desirable to develop new approaches having benefits or advantages over existing approaches.

[0008] It may be especially desirable, in at least some instances, to develop new approaches for temperature regulation of the cephalocervical region that are effectivefor use in first aid, non-emergency health and / or well-being contexts, and / or sporting performance contexts.

[0009] The reference to prior art in the background is not and should not be taken as an acknowledgement or suggestion that the referenced prior art forms part of the common general knowledge in Australia or in any other country.SUMMARY

[0010] One form of the present invention broadly provides a wearable device for cephalocervical temperature regulation of a subject.

[0011] Another form of the present invention broadly provides a method of regulating cephalocervical temperature of a subject, including a step of fitting a wearable device to the subject.

[0012] In a first aspect, there is provided a wearable device for fitting to a cephalocervical region of a subject, comprising:a first portion for fitting to a forehead of the subject; anda second portion for fitting to a back of the head and / or neck of the subject, whereinthe second portion, and optionally the first portion, comprises a temperature regulator.

[0013] In embodiments, the second portion of the device is for fitting to the back of the head and the neck of the subject.

[0014] Suitably, when appropriately fitted, the device of the first aspect does not obscure vision, such as cover eyes, of the subject.

[0015] In some embodiments, when appropriately fitted, the device does not cover a top of the head of the subject.

[0016] The device of the first aspect may be substantially unitary, wherein the first and second portions of the device are substantially continuous portions.

[0017] The device of the first aspect may be segmented, wherein the first and second portions are substantially discrete portions.

[0018] In some embodiments, the first and / or second portions may comprise a plurality of sub-parts or sub-portions.

[0019] The first and / or second portions of the device of the first aspect may be resil iently deformable for fitting of the device to the head and / or neck of the subject.

[0020] In embodiments, the first and / or second portions of the device are resil iently stretchable or elastic, for fitting of the device to the head and / or neck of the subject.

[0021] The first portion and / or second portions of the device of the first aspect may be band-like or strap-like portions. The first and second portions may be in a headband, bandanna, or bandeau-like arrangement.

[0022] In embodiments, a surface area of the second portion of the device is substantially greater than a surface area of the first portion of the device. The surface area of the second portion of the device may be about, or at least about: 1.5; 2; 2.5; 3; 3.5; or 4 times that of the surface area of the first portion of the device.

[0023] In embodiments, the surface area of the second portion of the device may be substantially the same as the surface area of the first portion of the device.

[0024] Suitably, the first portion of the device has a first or upper edge; and a second or lower edge. Suitably, the upper and lower edges extend between respective side edges of the first portion of the device.

[0025] In embodiments, the second or lower edge of the first portion of the device is a substantially concave lower edge.

[0026] In embodiments, a first dimension of the first portion of the device, such as substantially corresponding to a length of the first edge of the first portion, is between about 15 cm and about 25 cm, including about: 16; 17; 18; 19; 20; 21 ; 22; 23; and 24 cm.

[0027] In embodiments, a second dimension of the first portion of the device, such as substantially corresponding to a length of the sides of the first portion, is between about 5 cm and about 20 cm, including about: 6; 7; 8; 9; 10; 11 ; 12; 13; 14; 15; 16; 17; 18; and 19 cm.

[0028] In embodiments, the second dimension of the first portion of the device is between about 5 cm and about 10 cm, including about 6; 7; 8; and 9 cm.

[0029] In embodiments, the second dimension of the first portion of the device is between about 10 cm and about 20 cm, including about 11; 12; 13; 14; 15; 16; 17; 18; and 19 cm.

[0030] In embodiments, a surface area of the first portion of the device, such as substantially corresponding to an inner or outer face of the first portion, is betweenabout 100 and about 350 cm2, including about: 125; 150; 175; 200; 225; 250; 275; 300; and 325 cm2.

[0031] In embodiments, the surface area of the first portion of the device is between about 100 and about 250 cm2, including about 110; 120; 130; 140; 150; 160; 170; 180; 190; 200; 210; 220; 230; and 240 cm2

[0032] In embodiments, the surface area of the first portion of the device is between about 200 and about 350 cm2, including about 210; 220; 230; 240; 250; 260; 270; 280; 290; 300; 310; 320; 330; and 340 cm2.

[0033] Suitably, when appropriately fitted, the first portion of the device overlies or covers at least part of the forehead of the subject.

[0034] In embodiments, the first portion deformably engages with at least a part of the forehead of the subject.

[0035] In embodiments, when appropriately fitted, the first portion covers and / or deformably engages with about, or at least about: 20%; 30%; 40%; 50%; 60%; 70%; 80%; or 90% of the forehead of the subject.

[0036] Suitably, when appropriately fitted, the first portion does not cover the eyes of the subject.

[0037] Suitably, the second portion of the device of the first aspect has a first or upper edge; and a second or lower edge. Suitably, the upper and lower edges extend between respective side edges of the second portion of the device.

[0038] In embodiments, the second or lower edge of the second portion of the device is a substantially convex lower edge.

[0039] In embodiments, a first dimension of the second portion of the device, such as substantially corresponding to a length of the first edge of the second portion, is between about 15 cm and about 25 cm, including about: 16; 17; 18; 19; 20; 21; 22; 23; and 24 cm.

[0040] In embodiments, a second dimension of the second portion of the device, such as substantially corresponding to a length of the sides of the second portion, is between about 5 cm and about 25 cm, including about: 5; 6; 7; 8; 9; 10; 11; 12; 13; 14; 15; 16; 17; 18; and 19 cm.

[0041] In embodiments, the second dimension of the second portion of the device is between about 10 cm and about 20 cm, including about 11; 12; 13; 14; 15; 16; 17; 18; and 19 cm.

[0042] In embodiments, a surface area of the second portion of the device, such as substantially corresponding to an inner or outer face of the second portion, is between about 100 cm2and about 450 cm2, including about: 175; 200; 225; 250; 275; 300; 325; 350; 375; 400; and 425 cm2.

[0043] In embodiments, the surface area of the second portion of the device, such as substantially corresponding, is between about 100 and about 250 cm2, including about: 110; 120; 130; 140; 150; 160; 170; 180; 190; 200; 210; 220; 230; and 240 cm2.

[0044] In embodiments, the surface area of the second portion of the device is between about 250 cm2and about 450 cm2, including about 260; 270; 280; 290; 300; 310; 320; 330; 340; 350; 360; 370; 380; 390; 400; 410; 420; 430; and 440 cm2.

[0045] Suitably, when appropriately fitted, the second portion of the device overlies at least a part of the back of the head of the subject. In embodiments, when appropriately fitted, the second portion of the device overlies at least a part of the neck of the subject.

[0046] In embodiments, the second portion deformably engages with at least a part of the back of the head of the subject. In embodiments, the second portion deformably engages with at least a part of the neck of the subject.

[0047] In embodiments, when appropriately fitted, the second portion of the device overlies at least a part of the back of the head of the subject and at least a part of the neck of the subject.

[0048] In embodiments, the second portion deformably engages with at least a part of the back of the head and at least a part of the neck of the subject.

[0049] In embodiments, when appropriately fitted, the second portion covers and / or deformably engages with about, or at least about: 50%; 60%; 70%; 80%; or 90% of the back of the head of the subject.

[0050] In embodiments, when appropriately fitted, the second portion covers and / or deformably engages with about, or at least about: 10%; 20%; 30%; 40%; or 50% of the neck of the subject.

[0051] In embodiments, when appropriately fitted, the second portion covers and / or deformably engages with about, or at least about: 20%; 30%; 40%; 50%; 60%; 70%; 80%; or 90% of a back of the neck of the subject.

[0052] In embodiments, when appropriately fitted, the second portion covers and / or deformably engages with about, or at least about: 10%; 20%; 30%; 40%; or 50% of a right side of the neck of the subject.

[0053] In embodiments, when appropriately fitted, the second portion covers and / or deformably engages with about, or at least about: 10%; 20%; 30%; 40%; or 50% of a left side of the neck of the subject.

[0054] In embodiments, when appropriately fitted, the respective side edges of the second portion of the device are positioned adjacent to or past respective vagus nerve positions of the subject.

[0055] In embodiments, when appropriately fitted, a left side edge of the second portion of the device is positioned adjacent a left vagus nerve position of the subject.

[0056] In embodiments, when appropriately fitted, a right side edge of the second portion of the device is positioned adjacent a right vagus nerve position of the subject.

[0057] Suitably, the temperature regulator of the device of the first aspect is for regulating temperature of at least a part of the cephalocervical region of the subject. The temperature regulator may be for regulating temperature of the head, neck, brain, and / or cranial nerve(s) of the subject.

[0058] In embodiments, the temperature regulator of the device is for regulating temperature of one, one or more, or each of a prefrontal cortex, temporal lobe, and occipital lobe of the brain of the subject.

[0059] In embodiments, the temperature regulator of the device is for regulating temperature of one, one or more, or each of a sternocleidomastoid (SCM), carotid sheath, and vagus nerve of the neck of the subject.

[0060] In embodiments, the temperature regulator is for regulating temperature of a vagus nerve of the subject. The device may be for regulating temperature of left and right vagus nerves of the subject.

[0061] In embodiments, the temperature regulator is for cooling at least a part of the cephalocervical region of the subject. In embodiments, the temperature regulator is for cooling the head, neck, brain, and / or cranial nerve(s) of the subject.

[0062] In embodiments, the temperature regulator of the device is for cooling one, one or more, or each of the prefrontal cortex, temporal lobe, and occipital lobe of the brain of the subject.

[0063] In embodiments, the temperature regulator of the device is for cooling one, one or more, or each of the sternocleidomastoid (SCM), carotid sheath, and vagus nerve of the neck of the subject.

[0064] In embodiments, the temperature regulator is for cooling the vagus nerve(s) of the subject. The device may be for cooling the left and right vagus nerves of the subject.

[0065] The temperature regulator of the device may comprise a solid, semi-solid, or liquid temperature regulator core or temperature regulator body.

[0066] In embodiments, the temperature regulator core is a substantially sealed temperature regulator core or temperature regulator body.

[0067] In embodiments, the first portion of the device comprises a first solid, semi-solid, or liquid temperature regulator core; and the second portion of the device comprises a second solid, semi-solid, or liquid temperature regulator core.

[0068] In embodiments, the first portion of the device comprises a seal for substantially containing a substantially sealed temperature regulator core, such as a solid, semi-solid, or liquid temperature regulator core, of the first portion.

[0069] In embodiments, the second portion of the device comprises a seal for substantially containing a substantially sealed temperature regulator core, such as a solid, semi-solid, or liquid temperature regulator core, of the second portion.

[0070] In embodiments, the first temperature regulator core of the device has a first or upper edge; and a second or lower edge. Suitably, the upper and lower edges extend between respective side edges of the first temperature regulator core.

[0071] The first edge, second edge, and / or sides of the first temperature regulator core may extend at, adjacent to, or near to the first edge, second edge, and / or sides of the first portion of the device.

[0072] In embodiments, the second temperature regulator core of the device has a first or upper edge; and a second or lower edge. Suitably, the upper and lower edges extend between respective side edges of the second temperature regulator core.

[0073] The first edge, second edge, and / or sides of the second temperature regulator core may extend at, adjacent to, or near to the first edge, second edge, and / or sides of the second portion of the device.

[0074] In embodiments, a surface area of the first temperature regulator core, such as substantially corresponding to an inner or outer face of the first temperature regulator core, is similar to or substantially the same as the surface area of the first portion of the device.

[0075] In embodiments, the surface area of the first temperature regulator core is at least about 70% of the surface area of the first portion of the device, including about or at least about 75; 80; 85; 90; and 95% of the surface area of the first portion of the device.

[0076] In embodiments, a surface area of the second temperature regulator core, such as substantially corresponding to an inner or outer face of the second temperature regulator core, is similar to or substantially the same as the surface area of the second portion of the device.

[0077] In embodiments, the surface area of the second temperature regulator core is at least about 70% of the surface area of the second portion of the device, including about or at least about 75; 80; 85; 90; and 95% of the surface area of the second portion of the device.

[0078] In embodiments, an average thickness of the temperature regulator or temperature regulator core of the device, such as an average thickness between inner and outer faces of the temperature regulator core, is between about 0.5 cm and about 5 cm, including about: 1 ; 2; 3; and 4 cm.

[0079] In embodiments, the average thickness of the temperature regulator or temperature regulator core of the device is between about 0.5 cm and about 3.5 cm, including about: 1; 1.5; 2; 2.5; and 3 cm.

[0080] In embodiments, embodiments, the average thickness of the temperature regulator or temperature regulator core is between about 1.5 cm and about 3 cm, including about 2 cm and about 2.5 cm.

[0081] In embodiments, an average thickness of the second temperature regulator core is substantially greater than an average thickness of the first temperature regulator core. The average thickness of the second temperature regulator core portion may be about, or at least about: 1.25; 1.5; 1.75; 2; 2.25; 2.5; 2.75; or 3 times that of the first portion of the device.

[0082] In embodiments, an average thickness of the first temperature regulator core of the first portion of the device is between about 0.25 cm and about 2.25 cm, including about: 0.5; 1; 1.5; and 2 cm.

[0083] In embodiments, an average thickness of the second temperature regulator core of the second portion of the device is between about 0.75 cm and about 3.75 cm, including about: 1 ; 1.5; 2; 2.5; 3; and 3.5 cm.

[0084] Suitably, the temperature regulator of the device is for regulating temperature of the at least part of the cephalocervical region of the subject via conduction.

[0085] Suitably, the temperature regulator is for adjustment to or maintenance at an appropriate temperature prior to use of the device, such as directly prior to use, wherein the device fitted to the cephalocervical region of the subject cools the cephalocervical region of the subject such as via conduction.

[0086] In embodiments, the temperature regulator, such as the first temperature regulator core and / or the second temperature regulator core, is for adjustment to or maintenance at a temperature of between about -90°C to about 20°C, including about -80; -70; -60; -50; -40; -30; -20; -10; 0; 5; 10; and 15°C, prior to, such as directly prior to, use of the device.

[0087] In embodiments, the temperature regulator, such as the first temperature regulator core and / or the second temperature regulator core, is for adjustment to or maintenance at a temperature of between about -5°C and about 20°C, including about: -4; -3; -2; -1; 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; 10; 11; 12; 13; 14; 15; 16; 17; 18; and 19°C, prior to, such as directly prior to, use of the device.

[0088] In embodiments, the temperature regulator, such as the first temperature regulator core and / or the second temperature regulator core, is for adjustment to or maintenance at a temperature of between about -5°C and about 5°C, including about: -4; -3; -2; -1 ; 0; 1 ; 2; 3; and 4°C, prior to, such as directly prior, to use of the device.

[0089] In embodiments, the temperature regulator, such as the first temperature regulator core and / or the second temperature regulator core, is for adjustment to or maintenance at a temperature of between about 5°C and about 15°C, including about: 6; 7; 8; 9; 10; 11; 12; 13; and 14°C, prior to, such as directly prior to use of the device.

[0090] In embodiments, the temperature regulator, such as the first temperature regulator core and / or the second temperature regulator core, is for adjustment to or maintenance at a temperature of between about 10°C and about 20°C, including about 11; 12; 13; 14; 15; 16; 17; 18; and 19°C, prior to, such as directly prior to, use of the device.

[0091] In embodiments, the temperature regulator comprises a refrigeratable temperature regulator body or core. The refrigeratable temperature regulator core may be liquid, semi-solid, or solid at room temperature.

[0092] In embodiments, the temperature regulator comprises a settable or freezable temperature regulator temperature regulator body or core. The settable or freezable temperature regulator core may be a liquid or semi-solid at room temperature.

[0093] In embodiments, the refrigeratable, settable, or freezable temperature regulator comprises water and one or more of polyacrylamide; glycerol; sodium alginate; gelatine; superabsorbent polymer; hydroxyethyl cellulose; sodium polyacrylate; silica gel; and isothiazolinone.

[0094] In embodiments, the refrigeratable, settable, or freezable temperature regulator comprises water, polyacrylamide, glycerol, sodium alginate, gelatine, and isothiazolinone.

[0095] In embodiments, the temperature regulator comprises an activatable temperature regulator body or core. The activatable temperature regulator may be a chemically activatable temperature regulator core. In embodiments, the activatable temperature regulator core is activatable by endothermic reaction.

[0096] In embodiments, the activatable temperature regulator core is activated by dissolution. The device, or the first and / or second portion thereof, may comprise an opening for addition of a solution for dissolution for the activatable temperature regulator body or core.

[0097] In embodiments, the activatable temperature regulator core comprises physically separated substances for combination to activate the temperature regulator core. In embodiments, the physically separated substances are separated by a breakable seal or the like of the device, wherein breakage of the seal combines the separated substances to activate the temperature regulator core.

[0098] In embodiments, the activatable temperature regulator comprises an ammonium salt, such as ammonium nitrate or calcium ammonium nitrate. In embodiments, the activatable temperature regulator comprises urea.

[0099] In embodiments, the activatable temperature regulator core is activatable by dissolution of an ammonium salt or urea in water.

[0100] The device of the first aspect may comprise a cover, wherein the temperature regulator of the device, or part thereof, is substantially within the cover.

[0101] In embodiments, the cover is resi I iently stretchable or elastic.

[0102] In embodiments, the first portion of the device comprises a first cover portion. In embodiments, the first temperature core of the device is substantially within the first cover portion.

[0103] In embodiments, the second portion of the device comprises a second cover portion. In embodiments, the second temperature regulator core of the device is substantially within the second cover portion.

[0104] The cover of the device may be substantially unitary, such as wherein the first and second cover portions are substantially continuous portions.

[0105] The cover of the device may be segmented, such as wherein the first and cover portions are substantially discrete portions.

[0106] The cover of the device of the first aspect may be or comprise a replaceable or exchangeable cover.

[0107] The temperature regulator of the device of the first aspect may be or comprise a replaceable or exchangeable temperature regulator.

[0108] In embodiments, the first and / or second portion of the device comprises a pouch or compartment or the like for holding the temperature regulator or temperature regulator body or core. In embodiments, the pouch or compartment is a closeable and / or fastenable pouch or compartment.

[0109] In embodiments, the first cover portion of the device, or a compartment or pouch thereof, is closeable and / or fastenable for holding the first temperature regulator core.

[0110] In embodiments, the second cover portion of the device, or a compartment or pouch thereof, is closeable and / or fastenable for holding the second temperature regulator core.

[0111] In embodiments, the cover of the device and the temperature regulator of the device are replaceable or exchangeable, wherein the replaceable or exchangeable cover is closeable and / or fastenable for substantially secure holding of the replaceable or exchangeable temperature regulator.

[0112] In embodiments, the first cover portion of the device and the first temperature regulator core of the device are replaceable or exchangeable, wherein the replaceable or exchangeable first cover portion, or compartment or pouch thereof, is closeable and / or fastenable for substantially secure holding of the replaceable or exchangeable first temperature regulator core.

[0113] In embodiments, the second cover portion of the device and the second temperature regulator core of the device are replaceable or exchangeable, wherein the replaceable or exchangeable second cover portion, or compartment or pouch thereof, is closeable and / or fastenable for substantially secure holding of the replaceable or exchangeable second temperature regulator core.

[0114] In embodiments, the temperature regulator of the device comprises a replaceable or exchangeable, refrigeratable temperature regulator body or core. In embodiments, the first temperature regulator core is a replaceable or exchangeable, refrigeratable temperature regulator core. In embodiments, the second temperature regulator core is a replaceable or exchangeable, refrigeratable temperature regulator core.

[0115] In embodiments, the temperature regulator comprises a replaceable or exchangeable, settable or freezable temperature regulator body or core. In embodiments, the first temperature regulator core is a replaceable or exchangeable, settable or freezable temperature regulator core. In embodiments, the second temperature regulator core is a replaceable or exchangeable, settable or freezable temperature regulator core.

[0116] In embodiments, the temperature regulator comprises a replaceable or exchangeable, activatable temperature regulator body or core. In embodiments, the first temperature regulator core is a replaceable or exchangeable, activatable temperature regulator core. In embodiments, the second temperature regulator core is a replaceable or exchangeable, activatable temperature regulator core.

[0117] The device of the first aspect may comprise one or more sensors.

[0118] In embodiments, the device comprises one or more temperature sensors or thermometers.

[0119] In embodiments, the temperature sensor or thermometer is or comprises one or more thermochromic temperature sensors. The thermochromic temperature sensor may be in the form of a colour-change label or logo, or the like.

[0120] The temperature sensor of the device, such as the thermochromic temperature sensor, may be of the first and / or second portion of the device. The temperature sensor of the device, such as the thermochromic temperature sensor, may be of the cover of the device, such as of the first and / or second cover portion of the cover.

[0121] In embodiments, an outer face of the first portion of the device comprises a thermochromic temperature sensor. In embodiments, the thermochromic temperature sensor is of the first cover portion of the cover of the device.

[0122] In embodiments, an outer face of the second portion of the device comprises a thermochromic temperature sensor. In embodiments, the thermochromic temperature sensor is of the second cover portion of the cover of the device.

[0123] The temperature sensor or thermometer of the device, such as the thermochromic temperature sensor, may have any suitable operating range.

[0124] In embodiments, the temperature sensor is operable within a range of about -100°C to about 100°C.

[0125] In embodiments, the temperature sensor is particularly adapted or optimised for operation within a range of about -50°C and about 20°C.

[0126] In embodiments wherein the temperature sensor is a thermochromic temperature sensor, the thermochromic temperature sensor may undergo a colour change at any suitable temperature. In embodiments, the thermochromic temperature sensor, or a plurality of thermochromic temperature sensors thereof, undergoes a plurality of colour changes at a plurality of suitable temperatures.

[0127] The thermochromic sensor(s) may be adapted to undergo one or more colour changes at any suitable temperature or temperatures, such as one or more temperatures between about -50 and about 30°C, including about -45; -40; -35; -30; -25; -20; -15; -10;-5; -4; -3; -2; -1; 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; 10; 15; 20; and 25°C.

[0128] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a first colour change, at a temperature of between about 8°Cand about 24°C, including about 9; 10; 11 ; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21 ; 22; and 23°C. In embodiments, the colour change is at a temperature of about 10°C, 16°C, or 22°C.

[0129] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a second colour change, at a temperature of between about 0 and about 10°C, including about 1; 2; 3; 4; 5; 6; 7; 8; and 9°C. In embodiments, the colour change is at a temperature of about 5°C or about 8°C.

[0130] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a third colour change, at a temperature of between about 16 and about 30°C, including about 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; and 29°C. In embodiments, the colour change is at a temperature of about 16°C, about 22°C, or about 26°C.

[0131] In embodiments, the device comprises one or more physiological sensors.

[0132] In embodiments, the device comprises sensor(s) for sensing one or more physiological parameters selected from: cranial nerve activity, such as vagus nerve activity; stress; heart rate; blood pressure; inflammation; and digestive activity.

[0133] In embodiments, the device comprises a transmitter for transmitting data, such as to one or more sensors, a data store, or a computing device or system. The transmitter may be a wired or wireless transmitter.

[0134] In embodiments, the device comprises a receiver for receiving data, such as from one or more sensors, a data store, or a computing device or system or the like. The receiver may be a wired or wireless receiver.

[0135] In embodiments, the device comprises a processor for processing data, such as physiological data sensed by one or more sensors of the device; data received by a receiver of the device; and / or data for transmission by a transmitter of the device.

[0136] A second aspect of the invention provides a container for, suitable for, or when used for the device of the first aspect.

[0137] In embodiments, the container of the second aspect is a removeable cover or sleeve for the device of the first aspect. The removeable cover or sleeve may be a reusable cover or sleeve. The removeable cover may be a disposable cover or sleeve.

[0138] Suitably, the removeable cover of sleeve can substantially fully enclose the device of the first aspect. Suitably, the removeable cover can substantially sealingly enclose the device of the first aspect, such as substantially sealingly enclose the device to ingress of water, dust, and / or dirt or the like.

[0139] In embodiments, the removeable cover or sleeve is sized to substantially fittingly enclose the device of the first aspect.

[0140] In embodiments, the removeable cover or sleeve is a resealable or fastenable cover or sleeve. Suitably, the resealable or fastenable cover or sleeve comprises one or more seals or fasteners.

[0141] In embodiments, the container of the second aspect is a bag or the like. Suitably, the bag is an insulated bag. Suitably, the bag is a reusable bag.

[0142] Suitably, the bag can substantially fully enclose the device of the first aspect. The bag may substantially sealingly enclose the device of the first aspect, such as substantially sealingly enclose the device to ingress of water, dust, and / or dirt.

[0143] In embodiments, the bag is sized to substantially fittingly enclose the device of the first aspect. In embodiments, the bag is sized to enclose the device of the first aspect and one or more accessories. In embodiments, the accessories include a cooling block or cooling pack, or the like.

[0144] Suitably, the bag is a resealable or fastenable bag. Suitably, the resealable or fastenable bag comprises one or more seals or fasteners.

[0145] In embodiments, the container of the second aspect comprises one or more temperature sensors or thermometers.

[0146] In embodiments, the temperature sensor or thermometer is or comprises one or more thermochromic temperature sensors. The thermochromic temperature sensor may be in the form of a colour-change label or logo, or the like.

[0147] The temperature sensor of the container, such as the thermochromic temperature sensor, may be of an inner or outer surface of the container.

[0148] In embodiments, the container is the cover or sleeve, and the temperature sensor is of an inner surface of the cover or sleeve. In embodiments, the container is the cover or sleeve, and the temperature sensor is of an outer surface of the cover or sleeve.

[0149] In embodiments, the container is the insulated bag, and the temperature sensor is of an inner surface of the insulated bag. In embodiments, the container is the insulated bag, and the temperature sensor is of an outer surface of the insulated bag.

[0150] The temperature sensor or thermometer of the container of the second aspect, such as the thermochromic temperature sensor, may have any suitable operating range.

[0151] In embodiments, the temperature sensor is operable within a range of about -100°C to about 100°C.

[0152] In embodiments, the temperature sensor is particularly adapted or optimised for operation within a range of about -50°C and about 20°C.

[0153] In embodiments wherein the temperature sensor is a thermochromic temperature sensor, the thermochromic temperature sensor may undergo a colour change at any suitable temperature. In embodiments, the thermochromic temperature sensor, or a plurality of thermochromic temperature sensors thereof, undergoes a plurality of colour changes at a plurality of suitable temperatures.

[0154] The thermochromic sensor(s) may be adapted to undergo one or more colour changes at any suitable temperature or temperatures, such as one or more temperatures between about -50 and about 30°C, including about -45; -40; -35; -30; -25; -20; -15; -10;-5; -4; -3; -2; -1; 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; 10; 15; 20; and 25°C.

[0155] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a first colour change, at a temperature of between about 8°C and about 24°C, including about 9; 10; 11 ; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21 ; 22; and 23°C. In embodiments, the colour change is at a temperature of about 10°C, 16°C, or 22°C.

[0156] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a second colour change, at a temperature of between about 0 and about 10°C, including about 1; 2; 3; 4; 5; 6; 7; 8; and 9°C. In embodiments, the colour change is at a temperature of about 5°C or about 8°C.

[0157] In embodiments, the thermochromic sensor(s) is adapted to undergo a colour change, such as a third colour change, at a temperature of between about 16 and about 30°C, including about 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; and29°C. In embodiments, the colour change is at a temperature of about 16°C, about 22°C, or about 26°C.

[0158] A third aspect of the invention provides a system or kit comprising the wearable device of the first aspect and the container of the second aspect.

[0159] A fourth aspect of the invention provides a method of protecting, storing, or carrying the wearable device of the first aspect, including a step of substantially enclosing the device of the first aspect with the container of the second aspect.

[0160] The method of the fourth aspect may be a method of substantially sealingly protecting the device of the first aspect from ingress of water, dust, and / or dirt or the like.

[0161] The method of the fourth aspect may include a step of insulating the device to reduce or constrain heating of the device.

[0162] In embodiments, the container of the first aspect is the insulated bag, and the method includes a step of cooling the device with a cooling pack or cooling block or the like in the insulated bag.

[0163] A fifth aspect of the invention provides a system for regulating cephalocervical temperature of a subject, the system comprising the device of the first aspect and one or more of:a computing device;a temperature sensor; anda physiological sensor,wherein the device of the first aspect is connected or connectable to the computing device, the temperature sensor, and / or the physiological sensor.

[0164] The computing device of the system of the second aspect may comprise a mobile computing device. The mobile computing device may be a tablet, smartphone, or smartwatch or the like.

[0165] The physiological sensor of the system of the second aspect may comprise one or more sensors for sensing physiological parameters selected from cranial nerve activity, such as vagus nerve activity; stress; heart rate; blood pressure; inflammation; and digestive activity.

[0166] A sixth aspect of the invention provides a method of regulating cephalocervical temperature in a subject using the wearable device of the first aspect or the system of the fifth aspect, including a step of fitting the wearable device of thefirst aspect to the subject to thereby regulate cephalocervical temperature in the subject.

[0167] The method of the sixth aspect may be a method of regulating temperature of a head, neck, brain, and / or cranial nerve of the subject.

[0168] In embodiments, the method is a method of regulating temperature of one, one or more, or each of a prefrontal cortex, temporal lobe, and occipital lobe of the brain of the subject.

[0169] In embodiments, the method is a method of regulating temperature of one, one or more, or each of a sternocleidomastoid (SCM), carotid sheath, and vagus nerve of the neck of the subject.

[0170] In embodiments, the method is a method of regulating temperature of a vagus nerve of the subject. The method may be a method of regulating temperature of left and right vagus nerves of the subject.

[0171] In embodiments, the method of the sixth aspect is a method of cooling at least a part of the cephalocervical region of the subject. The method may be a method of cooling the head, neck, brain, and / or cranial nerve of the subject.

[0172] In embodiments, the method is a method of cooling one, one or more, or each of the prefrontal cortex, temporal lobe, and occipital lobe of the brain of the subject.

[0173] In embodiments, the method is a method of cooling one, one or more, or each of the sternocleidomastoid (SCM), carotid sheath, and vagus nerve(s) of the neck of the subject.

[0174] In embodiments, the method is a method of cooling the vagus nerve(s) of the subject. The method may be a method of cooling the left and right vagus nerves of the subject.

[0175] In embodiments, the method is a method of cooling the at least a part of the cephalocervical region of the subject by between about 0.5°C and about 5°C, including about: 1; 1.5; 2; 2.5; 3; 3.5; 4; and 4.5°C.

[0176] In embodiments, the method is a method of cooling the at least a part of the cephalocervical region of the subject by between about 1°C and about 2.5°C, including about: 1.25; 1.5; 1.75; 2; and 2.25°C.

[0177] A seventh aspect of the invention provides a method of monitoring or assessing temperature using the wearable device of the first aspect or the system ofthe fifth aspect, including sensing temperature using a temperature sensor of the device or the system, to thereby monitor or assess temperature using the wearable device or system.

[0178] The method of the seventh aspect may include a step of fitting the device of the first aspect to a subject, before or after monitoring or assessing temperature.

[0179] In embodiments, the method of the seventh aspect is a method of monitoring temperature of the wearable device.

[0180] In embodiments, the method of the seventh aspect is a method of monitoring temperature of a cephalocervical region of a subject to which the device of the first aspect has been fitted.

[0181] An eight aspect of the invention provides a method of monitoring or assessing a physiological parameter of a subject using the wearable device of the first aspect or the system of the fourth aspect, including a step of fitting the wearable device of the first aspect to the subject and sensing the physiological parameter of the subject using a sensor of the wearable device or the system, to thereby monitor or assess the physiological parameter of the subject.

[0182] A ninth aspect of the invention provides a method of treating or preventing a condition in a subject using the device of the first aspect or the system of the fourth aspect, including a step of fitting the wearable device of the first aspect to the subject to thereby treat or prevent the condition in the subject.

[0183] In embodiments, the condition of the ninth aspect is an impact condition. The impact condition may be impact to the cephalocervical region of the subject. The impact condition may be concussion and / or cumulative brain damage.

[0184] In embodiments, the condition of the ninth aspect is a sporting condition. The condition may be a condition of sports-induced impact. The sports-induced impact may be induced by participation in a sport selected from football, such a National Football League (NFL) football, National Rugby League (NRL) football, or Australian Football League (AFL) football; hockey, such as National Hockey League (NHL) ice hockey; or a combat sport, such as boxing or mixed martial arts (MMA).

[0185] In embodiments, the method of treating or preventing the condition in the subject is a first aid method.

[0186] In embodiments, the method of treating or preventing the condition is a prophylactic method.

[0187] In embodiments, the condition of the ninth aspect is selected from a mental health condition, a stress condition, and a mood condition.

[0188] In embodiments, the condition of the ninth aspect is a heart condition.

[0189] In embodiments, the condition of the ninth aspect is an inflammation condition.

[0190] In embodiments, the condition of the ninth aspect is a digestive condition.

[0191] A tenth aspect of the invention provides a method of improving or enhancing sporting performance of a subject using the device of the first aspect or the system of the fourth aspect, including a step of fitting the wearable device of the first aspect to the subject to thereby improve or enhance sporting performance in the subject.

[0192] In embodiments, the sporting performance of the subject according to the method of the tenth aspect is performance in a sport selected from football, such a National Football League (NFL) football, National Rugby League (NRL) football, or Australian Football League (AFL) football; hockey, such as National Hockey League (NHL) ice hockey; or a combat sport, such as boxing or mixed martial arts (MMA).

[0193] An eleventh aspect of the invention provides a method of improving or enhancing workplace performance and / or safety of a subject using the device of the first aspect or the system of the fourth aspect, including a step of fitting the wearable device of the first aspect to the subject to thereby improve or enhance workplace performance and / or safety of the subject.

[0194] In embodiments, the workplace performance and / or safety of the subject according to the method of the eleventh aspect is performance and / or safety in an industrial workplace, such as a construction workplace or trade workplace or the like. The workplace may be a substantially outdoors workplace. The workplace may be a substantially indoors workplace.

[0195] In embodiments of the method of the sixth, ninth, or tenth aspect, the temperature regulator of the wearable device, or a part thereof, is at a temperature of between about -50°C and about 20°C when the device is fitted to the subject, including about: -45; -40; -35; -30; -25; -20; -15; -10; -9; -8; -7; -6; -5; -4; -3; -2; -1; 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; 10; 11; 12; 13; 14; 15; 16; 17; 18; and 19°C.

[0196] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about -20°C when the device is fitted to the subject.

[0197] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about -15°C when the device is fitted to the subject.

[0198] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about -10°C when the device is fitted to the subject.

[0199] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about -5°C when the device is fitted to the subject.

[0200] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about 0°C when the device is fitted to the subject.

[0201] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about 5°C when the device is fitted to the subject.

[0202] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about 10°C when the device is fitted to the subject.

[0203] In embodiments, the temperature regulator of the wearable device, or a part thereof, is at about 15°C when the device is fitted to the subject.

[0204] In embodiments of the method of the sixth, ninth, or tenth aspect, the step of fitting the wearable device to the subject is a step of fitting the wearable device to the subject during and / or after participation of the subject in sport.

[0205] In embodiments, the step of fitting the wearable device to the subject during and / or after participation in sport includes fitting the wearable device to the subject for between about 5 minutes (min) and about 120 min during and / or after participation in the sport, including for about: 10; 20; 30; 40; 50; 60; 70; 80; 90; 100; 110; and 120 min during and / or after participation in the sport.

[0206] In embodiments, the step of fitting the wearable device to the subject during and / or after participation in the sport is or includes fitting the wearable device to the subject for about 10 min after participation in the sport.

[0207] In embodiments, the step of fitting the wearable device to the subject during and / or after participation in the sport is or includes fitting the wearable device to the subject for about 30 min after participation in the sport.

[0208] In embodiments, the step of fitting the wearable device to the subject during and or after participation in the sport is or includes fitting the wearable device to the subject for about 60 min after participation in the sport.

[0209] In embodiments, the method of the sixth, ninth, or tenth aspect includes a step of directing or instructing the subject to undertake a breathing protocol.

[0210] In embodiments, the breathing protocol includes a rate of breaths per minute, or equivalent.

[0211] In embodiments, the rate of breaths per minute is between about 5 breaths per min and about 15 breaths per min, including about: 6; 8; 10; 12; and 14 breaths per min.

[0212] In embodiments, the rate of breaths per minute is about 10 or about 12 breaths per min.

[0213] In embodiments, the rate of breaths per minute is about 6 breaths per min.

[0214] In embodiments, the method of the sixth, ninth, or tenth aspect includes a step of applying auditory stimulation to the subject.

[0215] In embodiments, the auditory stimulation is or includes auditory stimulation for between about 10 min and about 60 min, including about: 20; 30; 40; and 50 min.

[0216] In embodiments, the auditory stimulation is or includes auditory stimulation for about 30 min.

[0217] In embodiments, the auditory stimulation is or includes auditory stimulation at a frequency of between about 5 hertz (Hz) and about 100 Hz, including about: 10; 20; 30; 40; 50; 60; 70; 80; and 90 Hz.

[0218] In embodiments, the auditory stimulation is or includes auditory stimulation at a frequency of about 40 Hz.

[0219] In embodiments, the method of the sixth, ninth, or tenth aspect includes a step of nutritionally supplementing the subject.

[0220] In embodiments, the method includes nutritionally supplementing the subject with fatty acids. The fatty acids may be or include omega-3 fatty acids.

[0221] In embodiments, the method includes nutritionally supplementing the subject with between about 1 gram (g) and about 5 g of fatty acids per day, including about: 2; 3; and 4 g per day.

[0222] In embodiments, the method includes nutritionally supplementing the subject with about 2 or about 3 g of omega-3 per day.

[0223] In embodiments, the method includes nutritionally supplementing the subject with one or more vitamins. The one or more vitamins may be or include vitamin D.

[0224] In embodiments, the method includes nutritionally supplementing the subject with between about 1000 and about 10000 International Units (IU) of one ormore vitamins per day, including about: 2000; 3000; 4000; 5000; 6000; 7000; 8000; and 9000 III per day.

[0225] In embodiments, the method includes nutritionally supplementing the subject with about 2000, 3000, or 4000 IU of vitamin D per day.

[0226] In embodiments, the method includes nutritionally supplementing the subject with one or more amino acid derivatives. The one or more amino acid derivatives may be or include creatine.

[0227] In embodiments, the method includes nutritionally supplementing the subject with between about 1 and 10 g per day of one or more amino acid derivatives, including about: 2; 3; 4; 5; 6; 7; 8; and 9 g per day.

[0228] In embodiments, the method includes nutritionally supplementing the subject with about 5 g of creatine per day.

[0229] In embodiments, the method includes nutritionally supplementing the subject with one or more essential or conditionally essential amino acids. The one or more essential or conditionally essential amino acids may be or include N-acetylcysteine.

[0230] In embodiments, the method includes nutritionally supplementing the subject with between about 200 and about 2000 milligrams (mg) of one or more essential or conditionally essential amino acids per day, including about: 400; 600; 800; 1000; 1200; 1400; 1600; and 1800 mg per day.

[0231] In embodiments, the method includes nutritionally supplementing the subject with between about 600 mg about 1200 mg of N-acetylcysteine per day.

[0232] In embodiments, the method includes nutritionally supplementing the subject with one or more minerals, such as one or more essential minerals. The one or more minerals may be or include magnesium.

[0233] In embodiments, the method includes nutritionally supplementing the subject with between about 500 and about 3000 mg of one or more minerals per day, including about: 1000; 1500; 2000; and 2500 mg per day.

[0234] In embodiments, the method includes nutritionally supplementing the subject with between about 1000 mg and about 2000 mg of magnesium L-threonate per day.BRIEF DESCRIPTION OF THE DRAWINGS

[0235] The invention will be described hereinafter with reference to typical embodiments illustrated in the drawings and wherein:

[0236] Figure 1 sets forth front (A) and rear (B) views of an embodiment of a device for cephalocervical temperature regulation, device 10, according to an aspect of the invention.

[0237] Figure 2 sets forth a front view of a first portion of device 10.

[0238] Figure 3 sets forth a front view of a second portion of device 10.

[0239] Figure 4 sets forth front views of (A) a first portion of device 10 and (B) a second portion of device 10, wherein temperature regulators of the first and second portions are activatable temperature regulators.

[0240] Figure 5 sets forth front views of (A) a first portion of device 10 and (B) a second portion of device 10, showing optional sensors.

[0241] Figure 6 sets forth a front view of a cephalocervical region of a human subject, subject 1 , with device 10 fitted thereto.

[0242] Figure 7 sets forth an embodiment of a system according to an aspect of the invention, system 5.

[0243] Figure 8 sets forth exemplary dimensions of (A) a first portion of device 10 and (B) a second portion of device 10.

[0244] Figure 9 sets forth a front view of device 10, showing an optional thermochromic temperature sensor logo.

[0245] Figure 10 sets forth front views of embodiments of kits according to an aspect of the invention, kits 1000. (A) Kit 1001 comprising device 10 and sleeve 1010. (B) Kit 1002 comprising device 10 and bag 1020.

[0246] Figure 11 sets forth a perspective view of an embodiment of device 10.

[0247] Figures 12 sets forth front views of an embodiment of kit 1002. (A) An embodiment of device 10 of kit 1002. (B) An embodiment of bag 1020 of kit 1020.

[0248] Figure 13 sets forth front (A) and rear (B) views of another embodiment of a device for cephalocervical temperature regulation, device 9, according to an aspect of the invention.

[0249] Figure 14 sets forth front views of embodiments of kits 1000. (A) Kit 1003 comprising device 9 and sleeve 1030. (B) Kit 1004 comprising device 9 and bag 1040.

[0250] Figure 15 sets forth front views of an embodiment of kit 1004. (A) An embodiment of device 9 of kit 1004. (B) An embodiment of bag 1040 of kit 1004.DETAILED DESCRIPTION

[0251] Figures 1 to 5 illustrate typical embodiments of a device according to an aspect of the invention, device 10. Device 10 is a wearable device for cephalocervical temperature regulation of a subject.

[0252] Device 10 comprises first or front portion 100; second or back portion 200; and temperature regulator 300.

[0253] As can be seen in Figure 2, front portion 100 of device 10 comprises front portion cover 110. Front portion cover 110 is a resiliently stretchable or substantially elastic cover.

[0254] Front portion cover 110 defines front face 101; back face 102; top edge 103; bottom edge 104; and side edges 105 of front portion 100. Bottom edge 104 of front portion 100 is a substantially concave edge.

[0255] Certain typical dimensions of front portion 100 can be seen in Figure 8A, by way of example only.

[0256] Front portion temperature regulator 310 (shown with dashed lines) of temperature regulator 300 is fitted within front portion cover 110. Front portion temperature regulator 310 may be considered a part of front portion 100.

[0257] In some typical embodiments, front portion temperature regulator 310 comprises an average thickness, between front face 101 and back face 102, of about 1 cm. In some typical embodiments, the thickness of front portion temperature regulator 310 is substantially uniform.

[0258] Front portion temperature regulator 310 may be or comprise material that is liquid, solid, or semi-solid (e.g. gel or gel-like) as at Normal Temperature and Pressure (NTP) of 20°C and 1 atm.

[0259] Front portion temperature regulator 310 may be or comprise material that is liquid, solid, or semi-solid (e.g. gel or gel-like) as at Standard Temperature and Pressure (STP) of 0°C and 1 bar.

[0260] In some typical embodiments, front portion temperature regulator 310 is liquid at NTP and semi-solid at STP.

[0261] In some typical embodiments, front portion temperature regulator 310 is semi-solid, such as gel or gel-like, at NTP and STP.

[0262] Front portion temperature regulator 310 may comprise water and one or more of polyacrylamide; glycerol; sodium alginate; gelatine; superabsorbent polymer; hydroxyethyl cellulose; sodium polyacrylate; silica gel; and isothiazolinone.

[0263] In some typical embodiments, front portion temperature regulator 310 comprises water and superabsorbent polymer, such as sodium polyacrylate.

[0264] In some typical embodiments, temperature regulator 310 comprises water, polyacrylamide, glycerol, sodium alginate, gelatine, and isothiazolinone. A formulation of temperature regulator 310 according to one typical embodiment is set forth in Table 1, hereinbelow.

[0265] In some embodiments, front portion temperature regulator 310 comprises a phase-change material (PCM). The PCM may be an organic PCM or an inorganic PCM.

[0266] In some embodiments, front portion temperature regulator 310 comprises a solid-solid PCM. The solid-solid PCM may comprise polyethylene glycol or a metalorganic framework.

[0267] In some embodiments, front portion temperature regulator 310 comprises activatable material. The activatable material may comprise water and one or more of ammonium nitrate; calcium ammonium nitrate; and urea.

[0268] A typical embodiment of device 10 wherein front portion temperature regulator 310 comprises activatable material can be seen in Figure 4A.

[0269] As can be seen in Figure 4A, activatable front portion temperature regulator 310 comprises inner section 311 ; outer section 313; and barrier 312.

[0270] Inner section 311 of activatable front portion temperature regulator 310 comprises water.

[0271] Outer section 313 of front portion temperature regulator 310 comprises one or more of ammonium nitrate; calcium ammonium nitrate; and urea.

[0272] Barrier 312 of activatable front portion temperature regulator 310 is a breakable barrier.

[0273] Front portion temperature regulator 310 may be replaceable and / or exchangeable. In typical embodiments wherein front portion temperature regulator 310 is replaceable and / or exchangeable, front portion cover 110 comprises a closable and / or fastenable (e.g. zippable / unzippable) compartment or pouch (not shown) for secure holding of temperature regulator 310.

[0274] As can be seen in Figure 3, back portion 200 of device 10 comprises back portion cover 210. Back portion cover 210 is a resiliently stretchable or substantially elastic cover. In some embodiments, back portion cover 210 is substantially continuous with front portion cover 110, device 10 comprising a single continuous cover forming front portion cover 110 and back portion cover 210.

[0275] Back portion cover 210 defines front face 201; back face 202; top edge 203; bottom edge 204; and side edges 205 of back portion 200. Bottom edge 204 of back portion 200 is a substantially convex edge.

[0276] Certain typical dimensions of back portion 200 can be seen in Figure 8B, by way of example only.

[0277] Back portion temperature regulator 320 (shown with dashed lines) of temperature regulator 300 is fitted within back portion cover 210. Back portion temperature regulator 320 may be considered a part of back portion 200.

[0278] In some typical embodiments, back portion temperature regulator 320 comprises an average thickness, between front face 201 and back face 202, of about 2 cm. In some typical embodiments, the thickness of back portion temperature regulator 320 is substantially uniform.

[0279] Back portion temperature regulator 320 may be or comprise material that is liquid, solid, or semi-solid (e.g. gel or gel-like) as at Normal Temperature and Pressure (NTP) of 20°C and 1 atm.

[0280] Back portion temperature regulator 320 may be or comprise material that is liquid, solid, or semi-solid (e.g. gel or gel-like) as at Standard Temperature and Pressure (STP) of 0°C and 1 bar.

[0281] In some typical embodiments, back portion temperature regulator 320 is liquid at NTP and semi-solid at STP.

[0282] In some typical embodiments, back portion temperature regulator 320 is semi-solid, such as gel or gel-like, at NTP and STP.

[0283] Back portion temperature regulator 320 may comprise water and one or more of polyacrylamide; glycerol; sodium alginate; gelatine; superabsorbent polymer; hydroxyethyl cellulose; sodium polyacrylate; silica gel; and isothiazolinone.

[0284] In some typical embodiments, back portion temperature regulator 320 comprises water and superabsorbent polymer, such as sodium polyacrylate.

[0285] In some typical embodiments, temperature regulator 320 comprises water, polyacrylamide, glycerol, sodium alginate, gelatine, and isothiazolinone. A formulation of temperature regulator 320 according to one typical embodiment is set forth in Table 1, hereinbelow.

[0286] In some embodiments, back portion temperature regulator 320 comprises a phase-change material (PCM). The PCM may be an organic PCM or an inorganic PCM.

[0287] In some embodiments, back portion temperature regulator 320 comprises a solid-solid PCM. The solid-solid PCM may comprise polyethylene glycol or a metalorganic framework.

[0288] In some embodiments, back portion temperature regulator 320 is or comprises activatable material. The activatable material may comprise water and one or more of ammonium nitrate; calcium ammonium nitrate; and urea.

[0289] A typical embodiment of device 10 wherein back portion temperature regulator 320 comprises activatable material can be seen in Figure 4B.

[0290] As can be seen in Figure 4B, activatable back portion temperature regulator 320 comprises inner section 321 ; outer section 323; and barrier 322.

[0291] Inner section 321 of activatable front portion temperature regulator 320 comprises water.

[0292] Outer section 323 of front portion temperature regulator 310 comprises one or more of ammonium nitrate; calcium ammonium nitrate; and urea.

[0293] Barrier 322 of activatable front portion temperature regulator 320 is a breakable barrier.

[0294] Back portion temperature regulator 320 may be replaceable and / or exchangeable. In typical embodiments wherein back portion temperature regulator 320 is replaceable and / or exchangeable, back portion cover 210 comprises a closable and / or fastenable (e.g. zippable / unzippable) compartment or pouch (not shown) for secure holding of temperature regulator 320.

[0295] Some typical embodiments of device 10 comprise one or more sensors 400. In embodiments wherein device 10 comprises one or more sensors 400, front portion 100 and / or back portion 200 of device 100 may comprise one or more sensors 400.

[0296] Some typical embodiments of device 10 comprise one or more processors 500. In embodiments wherein device 10 comprises one or more processors 500, front portion 100 and / or back portion 200 of device 100 may comprise one or more processors 500.

[0297] Some typical embodiments of device 10 comprise one or more data transmitters and / or data receivers 600. In embodiments wherein device 10 comprises one or more data transmitters and / or data receivers 600, front portion 100 and / or back portion 200 of device 100 may comprise one or more data transmitters and / or data receivers 600.

[0298] Exemplary embodiments of device 10 comprising sensors 400; processors 500; and data transmitters / data receivers 600 are shown in Figure 5.

[0299] In Figure 5A, front portion 100 of device 10 is shown comprising electronic sensor unit 410. Sensor unit 410 may comprise a temperature sensor; a heart rate sensor; and / or a nerve activity sensor.

[0300] In Figure 5A, front portion 100 of device 10 is shown comprising processor unit 510; and transmitter / receiver unit 610. Processor unit 510 may be a microprocessor. Transmitter / receiver unit 610 may be a Wi-Fi unit or a Bluetooth unit.

[0301] In Figure 5B, back portion 200 of device 10 is shown comprising electronic sensor units 410. Sensor units 410 may comprise a temperature sensor; a heart rate sensor; and / or a nerve activity sensor. In some typical embodiments, sensor units 410 may comprise respective sensors for sensing activity of left and right vagus nerves, respectively.

[0302] In Figure 5B, back portion 200 of device 10 is shown comprising processor unit 510; and transmitter / receiver unit 610. Processor unit 510 may be a microprocessor. Transmitter / receiver unit 610 may be a Wi-Fi unit or a Bluetooth unit.

[0303] An exemplary embodiment of device 10 comprising sensor 400 is shown in Figure 9.

[0304] As seen in Figure 9, front portion 100 of device 100 comprises sensor 400 in the form of thermochromic temperature sensor 420. Thermochromic sensor 420 is typically arranged using letters and / or pictures to form a desired logo, although without limitation thereto.

[0305] In some typical embodiments, thermochromic sensor 420 is adapted to undergo a colour change at one or more temperatures of about -20°C, about -10°C,about -5°C, about 0°C, about 5°C, about 8°C, about 10°C, about 16°C, and about 22°C.

[0306] In some typical embodiments, thermochromic sensor 420 is adapted to undergo a colour change to white, such as from blue to white, from green to white, or from red to white.

[0307] In some typical embodiments, thermochromic sensor 420 is adapted to undergo a first colour suitable colour change, such as at about 8°C; and a second suitable colour change, such as at about 22°C.

[0308] In some typical embodiments, thermochromic sensor 420 is adapted to undergo a first suitable colour change such as at about 5°C; a second suitable colour change such as at about 10°C; and a third suitable colour change such as at about 16°C.

[0309] In some embodiments, a first part of thermochromic sensor 420, such as comprising one or more letters and / or pictures, is adapted to undergo a first suitable colour change, such as at about 5°C or about 8°C.

[0310] In some embodiments, a second part of thermochromic sensor 420, such as comprising one or more letters and / or pictures, is adapted to undergo a second suitable colour change, such as at about 10°C, about 16°C, or about 22°C.

[0311] In some typical embodiments, a third part of thermochromic sensor 420, such as comprising one or more letters and / or pictures, is adapted to undergo a third suitable colour change, such as at about 16°C or about 22°C.

[0312] In some typical embodiments, device 100 comprise multiple thermochromic sensors.

[0313] In some embodiments, device 100 comprises a first thermochromic sensor 420, such as comprising one or more letters and / or pictures, adapted to undergo a first suitable colour change, such as at about 5°C or about 8°C.

[0314] In some embodiments, device 100 comprises a second thermochromic sensor 420, such as comprising one or more letters and / or pictures, adapted to undergo a second suitable colour change, such as at about 10°C, about 16°C, or about 22°C.

[0315] In some typical embodiments, device 100 comprises a third thermochromic sensor 420, such as comprising one or more letters and / or pictures,adapted to undergo a third suitable colour change, such as at about 16°C or about 22°C.

[0316] Figure 11 further illustrates device 10. More particularly, Figure 11 illustrates one exemplary commercial implementation of device 10 comprising thermochromic sensor 420, wherein thermochromic sensor 420 is in the form of a COOLHED logo.

[0317] Temperature regulator 300 of the Figure 11 embodiment of device 10 is typically fixed within device 10 and typically comprises a semi-solid gel with composition as set out in Table 1 , adapted for refrigeration and / or freezing.

[0318] Front portion temperature regulator 310 of the Figure 11 embodiment of device 10 is typically fittingly covered by front portion cover 110. Back portion temperature regulator 320 of the Figure 11 embodiment of device 10 is typically fittingly covered by back portion cover 210.

[0319] Front portion temperature regulator 310 of the Figure 11 embodiment of device 10 typically comprises a substantially even, average thickness of about 1 cm. Back portion temperature regulator 320 of the Figure 11 embodiment of device 10 typically comprises a substantially even, average thickness of about 2 cm.

[0320] Thermochromic sensor 420 in the form of the COOLHED logo is typically adapted to change colour from blue, green, or red to white. Typically, the COOLHED logo is white at a temperature of between about 5°C and about 15°C, and blue, green, or red outside this temperature range.

[0321] Figure 6 illustrates device 10 fitted to a human subject, subject 1. More particularly, device 10 is fitted to the cephalocervical region, i.e. head and neck, of subject 1.

[0322] Figure 7 illustrates embodiments of a system according to an aspect of the invention, system 5. System 5 comprises device 10 and one or more of smartphone 20; smartwatch 30; and sensor 40.

[0323] Figure 10 illustrates embodiments of container systems or kits according to an aspect of the invention, systems / kits 1000. It will be understood that systems / kits 1000 may be considered systems or kits but will henceforth be referred to as kits.

[0324] Figure 10A illustrates an embodiment of kit 1000, kit 1001. Kit 1001 comprises device 10; and sleeve 1010.

[0325] Sleeve 1010 of kit 1001 comprises front and back portions 1110. Front and back portions 1110 of sleeve 21 are substantially similar in shape to back portion 200 of device 10, as hereinabove described. In some typical embodiments, front and back portions 1110 of sleeve 1010 are substantially continuous such that sleeve 1010 comprises a single continuous sleeve.

[0326] Sleeve 1010 of kit 1001 fittingly encloses device 10, sealing device 10 against ingress of water, dust, and dirt and the like.

[0327] Sleeve 1010 may be a disposable sleeve or a reusable sleeve.

[0328] In embodiments wherein sleeve 1010 is a disposable sleeve, sleeve 1010 is adapted to seal device 10 contained therein prior to opening, such as opening by cutting or tearing. Disposable embodiments of sleeve 1010 may comprise one or more seams or the like (not shown) for cutting or tearing to open sleeve 1010.

[0329] In embodiments wherein sleeve 1010 is a reusable sleeve, sleeve 1010 is adapted to resealably contain device 10. Reusable embodiments of sleeve 1010 typically comprise one or more seals or fasteners (not shown) for opening sleeve 1010.

[0330] Figure 10B illustrates another embodiment of kit 1000, kit 1002. Kit 1002 comprises device 10; and bag 1020.

[0331] Bag 1020 of kit 1002 comprises front and back portions 1120. Front and back portions 1120 of bag 22 are substantially similar in shape to back portion 200 of device 10, as hereinabove described.

[0332] Bag 1020 of kit 102 further comprises side portions 1130; top portion 1140; and bottom portion 1150. Side portions 1130, top portion 1140, and bottom portion 1150 extend between front and back portions 1120, such that cavity 1160 is defined within bag 1002.

[0333] Cavity 1160 of bag 1002 is sized to fit device 10, optionally together with one or more accessories such as a cooling pack or cooling brick (not shown).

[0334] Front and back portions 1120, and typically also side portions 1130, top portion 1140, and bottom portion 1150 of bag 1002 are temperature insulated, such as comprising insulating foam or the like.

[0335] Bag 1002 further comprises fastener 1170, typically comprising a zip arrangement.

[0336] Sleeve 1010 and bag 1020 of systems 1001 and 1002, respectively, typically further comprise thermochromic temperature sensors. Typically, thermochromic temperature sensors of sleeve 1010 and bag 1020 are substantially as described hereinabove in relation to thermochromic sensor 420 of device 10.

[0337] As can be seen in Figure 10A, sleeve 1010 comprises thermochromic sensor 221. Thermochromic sensor 221 may be of an outer face of front portion 1110 and / or back portion 1110 of sleeve 1010. Additionally or alternatively, thermochromic sensor 221 may be of an inner face of front portion 1110 and / or back portion 1110 of sleeve 1010.

[0338] As can be seen in Figure 10B, bag 1020 comprises thermochromic sensor 222. Thermochromic sensor 222 may be of an outer face of front portion 1120 and / or back portion 1120 of bag 1020. Additionally or alternatively, thermochromic sensor 222 may be of an inner face of front portion 1020 and / or back portion 1020 of bag 1020.

[0339] Figure 12 further illustrates kit 1002. More particularly, Figure 12 illustrates one commercial implementation of kit 1002, wherein device 10 comprises thermochromic sensor 420 in the form of a COOLHED logo and bag 1020 comprises thermochromic sensor 222 in the form of a COOLHED logo.

[0340] Figure 13 illustrates another embodiment of a wearable device for cephalocervical temperature regulation of a subject according to an aspect of the invention, device 9.

[0341] Similarly to device 10 hereinabove described, device 9 comprises first or front portion 90; second or back portion 190; and temperature regulator 290.

[0342] Front portion 90 of device 9 comprises front portion cover 91. Front portion cover 91 is a resi liently stretchable or substantially elastic cover.

[0343] Front portion cover 91 defines front face 911; back face 912; top edge 913; bottom edge 914; and side edges 915 of front portion 90.

[0344] Front portion 90, and front portion temperature regulator 291 thereof, is similar as described hereinabove for front portion 100 and front portion temperature regular 310 of device 10. Notably, however, bottom edge 914 of front portion 90 of device 9 is a substantially straight edge, differing from substantially concave edge 104 of front portion 100 of device 10.

[0345] Back portion 190 of device 9 comprises back portion cover 191. Back portion cover 191 is a resiliently stretchable or substantially elastic cover. In some embodiments, back portion cover 191 is substantially continuous with front portion cover 91, device 9 comprising a single continuous cover forming front portion cover 91 and back portion cover 191.

[0346] Back portion cover 191 defines front face 921; back face 922; top edge 923; bottom edge 924; and side edges 925 of back portion 190.

[0347] Back portion 190, and back portion temperature regulator 292 thereof, is substantially the same as described hereinabove for front portion 90. Notably, bottom edge 924 of back portion 190 of device 9 is a substantially straight edge, differing from substantially concave edge 204 of back portion 200 of device 10.

[0348] To avoid doubt, temperature regulator 290, and front portion temperature regulator 291 and back portion temperature regulator 292 thereof, may be substantially as described hereinabove in detail in relation to device 10.

[0349] It will be further understood that device 9 may comprise sensors 400; processors 500; and data transmitters / data receivers 600 substantially as described hereinabove in relation to device 10.

[0350] As seen in Figure 13, front portion 90 of device 9 comprises sensor 400 in the form of thermochromic temperature sensor 421. Thermochromic sensor 421 is substantially as described hereinabove for device 10.

[0351] Figure 14 illustrates further embodiments of systems / kits 1000.

[0352] Figure 14A illustrates a further embodiment of kit 1000, kit 1003. Kit 1003 comprises device 9; and sleeve 1030.

[0353] Sleeve 1030 comprises front and back portions 1113; and thermochromic sensor 223. It will be understood that sleeve 1030 is substantially as hereinabove described for sleeve 1010, with the exception that sleeve 1030 is adapted for containing device 9.

[0354] Figure 14B illustrates a further embodiment of kit 1000, kit 1004. Kit 1004 comprises device 9 and bag 1040.

[0355] Bag 1040 comprises front and back portions 1114; side portions 1134; top portion 1144; bottom portion 1154; cavity 1164; and thermochromic sensor 224. It will be understood that bag 1040 is substantially as hereinabove described for bag 1020, with the exception that bag 1040 is adapted for containing device 9.

[0356] Figure 15 further illustrates kit 1004. More particularly, Figure 15 illustrates one exemplary commercial implementation of kit 1004, wherein device 9 comprises thermochromic sensor 421 in the form of a COOLHED logo and bag 1020 comprises thermochromic sensor 224 in the form of a COOLHED logo.

[0357] Exemplary use of device 10 will now be described.

[0358] In some typical embodiments, front portion temperature regulator 310 and / or back portion temperature regulator 320 are refrigeratable.

[0359] In some typical embodiments, front portion temperature regulator 310 and / or back portion temperature regulator 320 are freezable.

[0360] In some typical embodiments, front portion temperature regulator 310 and / or temperature regulator 320 are activatable.

[0361] In embodiments of device 10 wherein front portion temperature regulator 310 and / or back portion temperature regulator 320 are refrigeratable, front portion temperature regulator 310 and / or back portion temperature regulator 320 may be substantially fixed within device 10, or front portion temperature regulator 310 and / or back portion temperature regulator 320 may be removable and / or exchangeable.

[0362] In embodiments of device 10 wherein front portion temperature regulator 310 and back portion temperature regulator 320 are refrigeratable and substantially fixed within device 10, suitably, device 10 is placed in a refrigerator awaiting use, then removed directly prior to use.

[0363] In embodiments of device 10 wherein front portion temperature regulator 310 and back portion temperature regulator 320 are freezable and substantially fixed within device 10, suitably, device 10 is placed in a freezer awaiting use, then removed directly prior to use.

[0364] In embodiments of device 10 wherein front portion temperature regulator 310 and back portion temperature regulator 320 are refrigeratable and removable, suitably, front portion temperature regulator 310 and back portion temperature regulator 320 are removed from device 10 and placed in a refrigerator awaiting use, then removed and installed in device 10 directly prior to use.

[0365] In embodiments of device 10 wherein front portion temperature regulator 310 and back portion temperature regulator 320 are freezable and removable, suitably, front portion temperature regulator 310 and back portion temperatureregulator 320 are removed from device 10 and placed in a freezer awaiting use, then removed and installed in device 10 directly prior to use.

[0366] In embodiments of device 10 wherein front portion temperature regulator 310 and / or back portion temperature regulator 320 are activatable, typically (although without limitation) activatable front portion temperature regulator 310 and / or activatable back portion temperature regulator 320 are removable and / or exchangeable.

[0367] In embodiments of device 10 wherein front portion temperature regulator 310 and / or back portion temperature regulator 320 are activatable, suitably, front portion temperature regulator 310 and / or back portion temperature regulator 320 are activated directly prior to use.

[0368] In embodiments of device 10 wherein front portion temperature regulator 310 and / or back portion temperature regulator 320 are activatable and removable, suitably, activated front portion temperature regulator 310 and / or back portion temperature regulator 320 are removed from device 10 after use.

[0369] Activation of front portion temperature regulator 310 and / or back portion temperature regulator 320 may be by squeezing or folding or the like to break a breakable barrier, such as breakable barrier 312 / 322 as shown in Figure 4.

[0370] It will be appreciated that breaking of a breakable barrier, such as breakable barrier 312 / 322, can be used to combine substances, such as water and one or more of ammonium nitrate; calcium ammonium nitrate; and urea of front portion temperature regulator 310 and / or back portion temperature regulator 320, wherein the substances undergo endothermic reaction resulting in cooling of front portion temperature regulator 310 and / or back portion temperature regulator 320.

[0371] In use, with temperature regulator 300 prepared as applicable, device 10 is fitted to the cephalocervical region of a subject, such as subject 1 as illustrated in Figure 6.

[0372] As shown in Figure 6, front portion 100 of device 10, including front portion temperature regulator 310 surrounded by substantially elastic front portion cover 110, is fitted to forehead 11 of subject 1, wherein front portion 100 deformably engages with forehead 11.

[0373] As shown in Figure 6, when suitably fitted to subject 1, front portion 100 does not cover eyes 16 of subject 1.

[0374] As shown in Figure 6, back portion 200 of device 10, including back portion temperature regulator 320 surrounded by substantially elastic back portion cover 210, is fitted to back of head 12 and neck 13 of subject 1 , wherein back portion 200 deformably engages with back of head 12 and neck 13.

[0375] As shown in Figure 6, when suitably fitted to subject 1, respective edges 205 of back portion 200 are adjacent left and right vagus nerves 15 of neck 13 of subject 1.

[0376] In use, when fitted to subject 1, device 10 cools the head, neck, brain, and / or cranial nerves of subject 1. More particularly, device 10 can cool the prefrontal cortex, temporal lobe, and occipital lobe of the brain of the subject; and the sternocleidomastoid (SCM), carotid sheath, and vagus nerve(s) of the neck of the subject.

[0377] Typically, device 10 substantially cools one or more cranial nerves of subject 1. Typically, device 10 substantially cools a vagus nerve of subject 1 , such as left and right vagus nerves 15.

[0378] In use, device 10 may provide therapeutic relief or prophylactic protection to subject 1 via cooling of the head, neck, brain, and / or cranial nerves of subject 1.

[0379] In some typical embodiments, device 10 is used for first aid and / or preventive treatment in the context of contact sports, such as football or hockey. In some typical embodiments, device 10 is used for first aid and / or preventive treatment in the context of combat sports, such as boxing or mixed martial arts.

[0380] In some typical embodiments, device 10 is used substantially immediately after sporting impact to the head or neck. Use of device 10 may precede further critical or emergency treatment, such as for concussion.

[0381] In some typical embodiments, device 10 is used prophylactically for sporting competition, such as directly prior to, directly after, or during (e.g. at ends of rounds or periods such as half or quarter time) competition.

[0382] As noted hereinabove, device 10 may provide therapeutic relief to subject 1 via cooling of the vagus nerves of subject 1.

[0383] In use, device 10 may assist with stress reduction in subject 1. The vagus nerve is a major component of the parasympathetic nervous system. Cooling the vagus nerve using device 10 can stimulate the nerve and may improve vagal tone,and can potentially improve stress response, reduce anxiety, and / or improve overall mood.

[0384] In use, device 10 may assist with heart rate and / or blood pressure regulation in subject 1. Cooling the vagus nerve using device 10 can stimulate the nerve and may influence heart rate variability (HRV), helping to lower heart rate and blood pressure, which could be beneficial for hypertension or heart rhythm issues.

[0385] In use, device 10 may assist with alleviating inflammatory conditions in subject 1. The vagus nerve plays a role in the inflammatory reflex, which helps regulate the immune response. Cooling the vagus nerve using device 10 may help in reducing inflammation such as in conditions like rheumatoid arthritis or inflammatory bowel disease.

[0386] In use, device 10 may assist with digestive health in subject 1. The vagus nerve innervates various digestive organs. Stimulation of the vagus nerve by cooling using device 10 may improve digestion and / or reduce symptoms of conditions such gastroparesis.

[0387] It will be further understood that, in use, device 10 may assist with enhancing or improving sporting performance.

[0388] Without being bound by theory, based on observations and preliminary assessment, the applicant considers that cooling and / or physiological regulation as hereinabove described may assist with sporting performance in at least some subjects and / or for at least certain sporting activities.

[0389] It will be further appreciated understood that, in use, device 10 may assist with enhancing or improving workplace performance and / or workplace safety.

[0390] Without being bound by theory, based on observations and preliminary assessment, the applicant considers that cooling and / or physiological regulation as hereinabove described may assist with workplace performance and / or safety in at least some subjects and / or for at least certain workplace activities.

[0391] As hereinabove described, device 10 may comprise sensors 400.

[0392] As hereinabove described some typical embodiments of device 10 may comprise thermochromic sensor 420. In use, colour change of thermochromic sensor can be observed to determine if temperature regulator 300 is sufficiently cooled and ready for use and / or if temperature regulator 300 has warmed to an extent that recooling and / or replacement of temperature regulator 300 may be required.

[0393] As hereinabove described, device 10 may comprise sensors 400, processor 500, and / or data receivers / data transmitters 600.

[0394] As hereinabove described, device 10, such as comprising electronic sensor units 410, may be used as part of system 5, system 5 further comprising one or more of smartphone 20, smartwatch 30, and sensor(s) 40.

[0395] In use of system 5, device 10 is typically connected with smartphone 20, smartwatch 30, and / or sensor 40 for data exchange. It will be appreciated that sensors and / or microprocessors of device 10, smartphone 20, smartwatch 30, and / or sensor(s) 40 may be in wired or wireless connection for data exchange.

[0396] In one exemplary embodiment of system 5, device 10 comprises sensors for vagus nerve activity and temperature monitoring; smartwatch 30 comprises a sensor for heart rate monitoring; and sensor 40 comprises a sensor for digestive activity monitoring. In use, smartphone 40 receives vagus nerve activity and temperature data from device 10, heart rate data from smartwatch 30, and digestive activity data from sensor 40, and analyses the data using one or more suitable applications or software.

[0397] In use, data from system 5 can be provided to clinicians or researchers, for assessment and / or analysis of health in subject 1 , such as stress levels or mental health, heart health, immune or inflammatory health, and / or digestive health.

[0398] In some typical embodiments, device 10 and / or system 5 is used as part of methods for treatment or prevention of one or more conditions in a subject, the methods including other treatment steps, components, or protocols.

[0399] In some typical embodiments, device 10 and / or system 5 is used as part of a method wherein the subject undertakes a breathing protocol.

[0400] In some typical embodiments, device 10 and / or system 5 is used as part of a method wherein the subject undertakes an auditory stimulation protocol.

[0401] In some typical embodiments, device 10 and / or system 5 is used as part of a method wherein the subject undertakes a nutritional supplementation protocol.

[0402] Some typical embodiments wherein device 10 and / or system 5 are used as part of method additionally including one or more of a breathing protocol, an auditory stimulation protocol, and a nutritional supplementation protocol are particularly adapted for prevention of Chronic Traumatic Encephalopathy (CTE).

[0403] Details of one particular exemplary CTE prevention protocol are provided hereinbelow as Example 1.

[0404] It will be understood that typical use of device 9 is similar as hereinabove described for device 10.

[0405] Notably, device 9 is a substantially headband shaped device, such that when fitted to a suitable subject, front portion 90 of device 9, including front portion temperature regulator 291 surrounded by substantially elastic front portion cover 91, is fitted to a forehead of the subject; and back portion 190 of device 9, including back portion temperature regulator 292 surround by substantially elastic back portion cover 191, is fitted to a back of the head of the subject, wherein device 9 deformably engages around the subjects head in a substantially ring-like manner.

[0406] It will be understood that, as compared to typical embodiments of device 10, typical embodiments of device 9 may be fitted to contact somewhat less of a subject’s forehead, substantially less of the back of a subject’s head, to have no or limited contact a subject’s neck.

[0407] It will be further understood that, particularly in comparatively smaller users such as child users, typical embodiments of device 9 may be fitted to contact a subject’s forehead and the subject’s neck, wherein headband shaped device 9 is fitted such that top edge 923 of back portion 191 of device 9 is at or near a base of the subject’s skull.

[0408] Cephalocervical region contact by properly fitted embodiments of device 10 as hereinabove described may be particularly advantageous for therapeutic and / or prophylactic use as herein described. However, in at least some contexts, cephalocervical region contact by properly fitted embodiments of device 9 may be sufficient or even desirable, such as for users (such as smaller or younger users, although without limitation thereto) experiencing discomfort associated with more extensive contact (including more extensive back of head contact and / or neck contact) associated with use of device 10.

[0409] Exemplary use of systems / kits 1000 will now be described.

[0410] Kit 1001 / 1003 comprising device 10 / 9 and sleeve 1010 / 1030 can improve or enhance hygiene in use of device 10 / 9.

[0411] In use, sleeve 1010 / 1030 is fitted to device 10 / 9 and substantially seals device 10 / 9. When fitted to device 10 / 9, sleeve 101 / 1030 can constrain or preventtransfer of e.g. water, dirt, dust, bodily fluids such as sweet, and microbes or other infectious agents to and from device 10 / 9 and users and / or the environment.

[0412] In use, embodiments of sleeve 1010 / 1030 can protect device 10 / 9 from contamination prior to fitting of device 10 / 9 to a user, with sleeve 1010 / 1030 removed prior to use.

[0413] Alternatively, embodiments of sleeve 1010 / 1030 can be maintained in hygienic conditions and fitted to device 10 / 9 prior to fitting of device 10 / 9 and sleeve 1010 / 1030 to a user, such as to enable hygienic sharing of device 10 / 9 between users.

[0414] Kit 1002 / 1004 comprising device 10 / 9 and insulated bag 1020 / 1040 can improve or enhance hygiene in use of device 10 / 9. Kit 1002 / 1004 comprising device 10 / 9 and insulated bag 1020 / 1040 can assist with maintaining desirable temperature in use of device 10 / 9.

[0415] In use, device 10 / 9 is placed within insulated bag 1020 / 1040 and insulated bag 1020 / 1040 is fastened.

[0416] In use, fastened insulated bag 1020 / 1040 can protect device 10 / 9 from contamination prior to fitting of device 10 / 9 to a user, with device 10 / 9 removed from bag 1020 / 1040 prior to use.

[0417] In use, fastened insulated bag 1020 / 1040 can constrain temperature change of device 10 / 9 prior to use, and assist with maintaining device 10 / 9 at a suitable temperature prior to fitting of device 10 / 9 to a user. In some contexts, it may be desirable or advantageous in use to place a cooling pack or cooling block in insulated bag 1020 / 1040 with device 10 / 9.

[0418] As hereinabove described, typical embodiments of sleeve 1010 / 1030 of kit 1001 / 1003 and insulated bag 1020 / 1040 comprise one or more thermochromic temperature sensors 221 / 222 / 223 / 224. In use, thermochromic temperature sensor 221 / 222 / 223 / 224 can allow monitoring of temperature inside and / or outside of sleeve 1010 / 1030 or insulated bag 1020 / 1040, which can assist with maintaining device 10 / 9 at a suitable temperature prior to and / or during use.

[0419] As discussed herein, at least certain typical aspects and embodiments of the invention can be particularly beneficial or advantageous for cephalocervical temperature regulation, and in particular cephalocervical cooling, in subjects (typically human subjects) in need thereof.

[0420] As discussed herein, cephalocervical cooling in subjects (typically human subjects) in need thereof facilitated with aspects and embodiments of the invention may provide important benefits in relation to treatment and / or prophylaxis of: impact conditions such as chronic traumatic encephalopathy (CTE) and concussion; treatment and / or prophylaxis of health and well being conditions including mental health conditions; enhancing sporting performance; and enhancing workplace safety, without limitation to the preceding conditions.

[0421] To avoid doubt, it will be understood and appreciated that benefits and advantages facilitated by aspects and embodiments of the invention as described herein may arise or be at least in part associated with reduction, mitigation, or prevention of heat stress in subjects (typically human subjects).

[0422] It will be understood generally that the above description of embodiments of the invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. In some instances, well-known components and / or processes have not been described in detail, so as not to obscure the embodiments described herein.

[0423] As described, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. The invention is intended to embrace all alternatives, modifications, and variations that have been discussed herein, and other embodiments that fall within the spirit and scope of the invention.

[0424] In this specification, the use of the terms “suitable" and “suitably”, and similar terms, is not to be read as implying that a feature or step is essential, although such features or steps referred to as “suitable" may well be preferred.

[0425] In this specification, the indefinite articles “a” and “an” are not to be read as singular indefinite articles or as otherwise excluding more than one or more than a single subject to which the indefinite article refers. For example, “a” sensor includes one sensor, one or more sensors, and a plurality of sensors.

[0426] In this specification, the terms “comprises", “comprising", “includes", “including", and similar terms, are intended to denote the presence of a stated integeror integers, but not necessarily the absence of another integer or other integers, depending on context. That is, a device, system, or method, etc., that comprises or includes stated integer(s) need not have those integer(s) solely, and may well have at least some other integers not stated, depending on context.

[0427] In this specification, the terms “consisting essentially of’ and “consists essentially of’ are intended to mean a non-exclusive inclusion only to the extent that, if additional elements are included beyond those elements recited, the additional elements do not materially alter basic and novel characteristics. That is, a device, system, or method that “consists essentially of’ one or more recited elements includes those elements only, or those elements and any additional elements that do not materially alter the basic and novel characteristics of the device, system, or method.

[0428] In this specification, terms such as “above" and “be / ow”; “front’ and “back’-, “top” and “bottom”-, “left’ and “right’-, “horizontaf’ and “verticaf’, and the like, may be used for descriptive purposes. However, it will be understood that embodiments can potentially be arranged in various orientations, and that such relative terms are not limiting and may be interchangeable in appropriate circumstances.

[0429] In this specification, unless the context requires otherwise, the terms “connection" , “connected" , “connecting", and the like, are not to be read as limited to direct connections and may also include indirect connections. For example, unless the context requires otherwise, a stated first component “connected” to a stated second component may be connected via, through, or by, one or more unstated components.EXAMPLESExample 1

[0430] This example describes typical methodology for prevention of Chronic Traumatic Encephalopathy (CTE) in athletes participating in contact sports. This methodology is adapted to reduce or prevent development of CTE in athletes, particularly professional athletes, exposed to repetitive impact affecting the head, neck, and brain over the course of their sporting participation. This methodology may be particularly effective for professional or semi-professional athletes participating in a sport selected from football, such a National Football League (NFL) football, National Rugby League (NRL) football, or Australian Football League (AFL) football;hockey, such as National Hockey League (NHL) ice hockey; or a combat sport, such as boxing or mixed martial arts (MMA).Fitting of device 10.

[0431] A suitable wearable device for cephalocervical temperature regulation, such as device 10 described herein, is fitted to an athlete directly after completion of a sporting match. The device is fitted to contact the forehead, back of the head, and neck of the athlete.

[0432] Temperature regulators of the device, such as temperature regulators 310 and 320 of device 10, are typically adjusted to 5 to 15°C when device 10 is fitted to the athlete, such that the forehead, back of the head, and neck of the athlete are cooled using the temperature regulars. The device is typically worn by the athlete for about 30 minutes.

[0433] In certain cases, such as where the athlete is at particular risk of CTE and / or has experienced severe acute or repetitive head injury (although without limitation thereto), temperature regulators may be adjusted to about 0°C or even lower temperatures such as -5°C or -10°C, and / or duration of fitting may be extended. In certain cases, duration of fitting of the device is extended by use of a second device, such as a second device 10, with swapping of the devices occurring at about 30 minutes.Breathing protocol

[0434] After fitting of device 10, the athlete typically performs slow-paced breathing for about 10 to about 30 minutes. A typical recommended breathing pattern is 4 seconds per inhalation, 6 seconds per exhalation, and 10-12 breaths per minute. The breathing protocol is designed to stimulate the vagus nerve, increase heart rate variability (HRV), and reduce sympathetic overdrive as part of the overall methodology.Auditory stimulation

[0435] After fitting of device 10, the athlete typically listens to recorded auditory output for about 10 to about 30 minutes, typically concurrently with performing the breathing protocol. Typical auditory output is binaural beats or auditory tones at about 40 hertz. Typically, the auditory output is delivered through wireless headphones, such as noise-cancelling wireless headphones. The auditory stimulation is designed to reduce neuroinflammation (such as associated with Interleukin 6 and / or C-reactiveprotein markers), enhance microglial clearance, and boost vagal tone as part of the overall methodology.Nutritional supplementation

[0436] The athlete is typically under nutritional supplementation as part of the methodology. The typical nutritional supplementation regime includes:• 2-3 g per day of omega-3 including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and optionally a further 1 g omega-3 post-match • 2000-4000 III per day of vitamin D, and optionally a further 2000 IU vitamin D post-match• 5 g per day creatine monohydrate, and optionally a further 3 g creatine monohydrate post-match• 600-1200 mg per day N-acetylcysteine, and optionally a further 600 mg N- acetylcysteine post-match• 1000-2000 mg per day of magnesium L-threonate, and optionally a further 500 mg magnesium L-threonate post-match.Table 1. A typical composition of a temperature regulator of device 10 as described hereinabove. PAM = polyacrylamide.

Claims

CLAIMS1. A wearable device for fitting to a cephalocervical region of a subject, comprising:a first portion for fitting to a forehead of the subject; anda second portion for fitting to a back of the head and / or neck of the subject, whereinthe second portion, and optionally the first portion, comprises a temperature regulator, and whereinthe device does not obscure vision of the subject when fitted.

2. The wearable device of claim 1 , wherein the device does not cover a top of the head of the subject when fitted.

3. The device of claim 1 or claim 2, wherein the second portion of the device is for fitting to the back of the head and the neck of the subject.

4. The device of any preceding claim wherein the first and / or second portions are resiliently deformable.

5. The device of any preceding claim, wherein the first and / or second portions are resiliently stretchable or elastic.

6. The device of any preceding claim, wherein a surface area of the second portion of the device is substantially greater than a surface area of the first portion of the device, such as at least about 1.5; 2; 2.5; 3; 3.5; or 4 times that of the surface area of the first portion of the device.

7. The device of any preceding claim, wherein the first portion of the device comprises a substantially concave lower edge.

8. The device of any preceding claim, wherein when properly fitted to the subject the first portion of the device covers about, or at least about: 20%; 30%; 40%; 50%; 60%; 70%; 80%; or 90% of the forehead of the subject9. The device of any preceding claim, wherein the second portion of the device comprises a substantially convex lower edge.

10. The device of any preceding claim, wherein when properly fitted to the subject the second portion of the device cover about, or at least about: 50%; 60%; 70%; 80%; or 90% of the back of the head of the subject.

11. The device of any preceding claim, wherein when properly fitted to the subject the second portion covers about, or at least about: 10%; 20%; 30%; 40%; or 50% of the neck of the subject.

12. The device of any preceding claim, wherein when properly fitted to the subject respective side edges of the second portion of the device are positioned adjacent to or past respective vagus nerve positions of the subject.

13. The device of any preceding claim, wherein the temperature regulator comprises a solid, semi-solid, or liquid temperature regulator core or temperature regulator body.

14. The device of any preceding claim, wherein the first portion of the device comprises a first solid, semi-solid, or liquid temperature regulator core; and / or the second portion of the device comprises a second solid, semi-solid, or liquid temperature regulator core.

15. The device of claim 14, wherein a surface area of the first temperature regulator core is substantially the same as or at least about 70% of a surface area of the first portion of the device.

16. The device of claim 14 or claim 15, wherein a surface area of the second temperature regular core is substantially the same as or at least about 70% of a surface area of the second portion of the device.

17. The device of any one of claims 13 to 16, wherein an average thickness of the temperature regulator core of the device, such as an average thickness between inner and outer faces of the temperature regulator core, is between about 0.5 cm and about 3.5 cm, including about: 1 ; 1.5; 2; 2.5; and 3 cm.

18. The device of any of claims 14 to 17, wherein an average thickness of the second temperature regulator core is about, or at least about: 1.25; 1.5; 1.75; 2; 2.25; 2.5; 2.75; or 3 times that of the second temperature regulator core.

19. The device of any preceding claim, wherein the temperature regulator is for adjustment to a temperature of between about -5°C and about 20°C prior to use of the device.

20. The device of any preceding claim, wherein the temperature regulator is for adjustment to a temperature of between about 5°C and about 15°C prior to use of the device.

21. The device of any preceding claim, wherein the temperature regulator comprises a refrigeratable temperature regulator body or core.

22. The device of any preceding claim, wherein the temperature regulator comprises a settable or freezable temperature regulator temperature regulator body or core.

23. The device of claim 21 or claim 22, wherein the temperature regulator comprises water and one or more of polyacrylamide; glycerol; sodium alginate; gelatine; superabsorbent polymer; hydroxyethyl cellulose; sodium polyacrylate; silica gel; and isothiazolinone.

24. The device of any preceding claim, wherein the temperature regulator comprises an activatable temperature regulator body or core.

25. The device of claim 24, wherein the activatable temperature regulator is activatable by endothermic reaction.

26. The device of any preceding claim, comprising one or more sensors.

27. The device of claim 26, wherein the sensors comprise one or more temperature sensors or thermometers.

28. The device of claim 27, wherein the temperature sensors comprise one or more thermochromic temperature sensors, such as colour-change labels or logos.

29. The device of claim 27, wherein an outer face of the first portion of the device comprises a thermochromic temperature sensor.

30. The device of claim 28 or claim 29, wherein the thermochromic sensor is adapted to undergo one or more colour change at one or more temperatures of between about 0°C and about 30°C.

31. The device of any one of claims 26 to 30, comprising one or more physiological sensors.

32. The device of claim 31, wherein the physiological sensors are for sensing one or more physiological parameters selected from: cranial nerve activity, such as vagus nerve activity; stress; heart rate; blood pressure; inflammation; and digestive activity.

33. The device of any preceding claim, comprising a data transmitter.

34. The device of any preceding claim, comprising a data receiver.

35. The device of any preceding claim, comprising a data processor.

36. A container for, suitable for, or when used for containing the device of any one of claims 1 to 35.

37. The container of claim 36, wherein the container is a removable sleeve.

38. The container of claim 36, wherein the container is an insulated bag.

39. The container of any one of claims 36 to 38, comprising one or more thermochromic temperature sensors, such as colour-change labels or logos.

40. The container of claim 39, wherein thermochromic sensor is adapted to undergo one or more colour changes at one or more temperatures of between about 0°C and about 30°C.

41. A system comprising the device of any one of claims 1 to 35; and the container of any one of claims 36 to 40.

42. A kit comprising the device of any one of claims 1 to 35; and the container of any one of claims 36 to 40.

43. A method of protecting, storing, carrying, or insulating the device of any one of claims 1 to 35, including a step of substantially enclosing the device with the container of any one of claims 36 to 40.

44. A system for regulating cephalocervical temperature of a subject, the system comprising the device of any one of claims 1 to 35, and one or more of:a computing device;a temperature sensor; anda physiological sensor,wherein the device is connected or connectable to the computing device, the temperature sensor, and / or the physiological sensor.

45. The system of claim 44, wherein the computing device is a mobile computing device, such as a tablet, smartphone, or smartwatch.

46. A method of regulating cephalocervical temperature in a subject using the wearable device of any one of claims 1 to 35 or the system of claim 44 or claim 45, including a step of fitting the wearable device to the subject to thereby regulate cephalocervical temperature in the subject.

47. The method of claim 46, wherein the method is a method of regulating temperature of a head, neck, brain, and / or cranial nerve of the subject.

48. The method of claim 47, wherein the method is a method of regulating temperature of a vagus nerve of the subject, such as regulating temperature of left and right vagus nerves of the subject.

49. The method of any one of claims 46 to 48, wherein the method is a method of cooling at least a part of the cephalocervical region of the subject by between about 0.5°C and about 5°C.

50. A method of monitoring or assessing temperature using the device of any one of claims 1 to 35 or the system of claim 44 or claim 45, including sensing temperature using a temperature sensor of the device or the system, to thereby monitor or assess temperature using the wearable device or system.

51. A method of monitoring or assessing a physiological parameter of a subject using the device of any one or claims 1 to 35 or the system of claim 44 or claim 45, including a step of fitting the device to the subject and sensing the physiological parameter of the subject using a sensor of the device, to thereby monitor or assess the physiological parameter of the subject.

52. A method of treating or preventing a condition in a subject using the device of the any one of claims 1 to 35 or the system of claim 44 or claim 45, including a stepof fitting the device to the subject to thereby treat or prevent the condition in the subject.

53. The method of claim 52, wherein the condition of the ninth aspect is an impact condition, such as concussion and / or cumulative brain damage.

54. The method of claim 52 or claim 53, wherein the condition is a sporting condition, such as a condition of sports-induced impact.

55. The method of any one of claims 52 to 54, wherein the method is a first aid method.

56. The method of any one of claims 52 to 54, wherein the method is a prophylactic method.

57. The method of claim 52, wherein the condition is selected from a mental health condition, a stress condition, and a mood condition.

58. The method of claim 52, wherein the condition is selected from a heart condition, an inflammation condition, and a digestive condition.

59. A method of enhancing or improving sporting performance of a subject using the device of the any one of claims 1 to 35 or the system of claim 44 or claim 45, including a step of fitting the wearable device to the subject to thereby enhance or improve sporting performance of the subject.

60. A method of improving or enhancing workplace performance and / or safety of a subject using the device any one of claims 1 to 35 or the system of claim 44 or claim 45, including a step of fitting the wearable device to the subject to thereby improve or enhance workplace performance and / or safety of the subject.

61. The method of any one of claims 52 to 60, wherein the temperature regulator of the device, or a part thereof, is at a temperature of between about -5°C and about 20°C when the device is fitted to the subject.

62. The method of claim 52 or claim 59, wherein the step of fitting the device to the subject is a step of fitting the device to the subject during and / or after participation of the subject in sport.

63. The method of claim 62, wherein the step of fitting the wearable device to the subject during and / or after participation in sport includes fitting the wearable device to the subject for between about 5 minutes (min) and about 120 min during and / or after participation in the sport, including for about: 10; 20; 30; 40; 50; 60; 70; 80; 90; 100; 110; and 120 min during and / or after participation in the sport.

64. The method of any one of claims 52 to 63, including a step of directing or instructing the subject to undertake a breathing protocol.

65. The method of any one of claims 52 to 64, including a step of applying auditory stimulation to the subject.

66. The method of any one of claims 52 to 65, including a step of nutritionally supplementing the subject.

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