WO2009122336A1 - Device and method to assist the body thermoregulation - Google Patents

Device and method to assist the body thermoregulation Download PDF

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Publication number
WO2009122336A1
WO2009122336A1 PCT/IB2009/051292 IB2009051292W WO2009122336A1 WO 2009122336 A1 WO2009122336 A1 WO 2009122336A1 IB 2009051292 W IB2009051292 W IB 2009051292W WO 2009122336 A1 WO2009122336 A1 WO 2009122336A1
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WO
WIPO (PCT)
Prior art keywords
wall portion
equal
thermoregulating
extension
insulating
Prior art date
Application number
PCT/IB2009/051292
Other languages
French (fr)
Inventor
Mauro Lazzari
Original Assignee
Astaga Communication Di Mauro Lazzari & C. S.A.S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40296697&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009122336(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astaga Communication Di Mauro Lazzari & C. S.A.S filed Critical Astaga Communication Di Mauro Lazzari & C. S.A.S
Priority to EP09729107A priority Critical patent/EP2268241A1/en
Publication of WO2009122336A1 publication Critical patent/WO2009122336A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • A61F2007/0244Compresses or poultices for effecting heating or cooling with layers
    • A61F2007/0249Compresses or poultices for effecting heating or cooling with layers with a layer having low heat transfer capability
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • A61F2007/0295Compresses or poultices for effecting heating or cooling for heating or cooling or use at more than one temperature

Definitions

  • the present invention relates to a device, a use thereof and a method capable of assisting the body thermoregulation process.
  • Heating or cooling devices to be applied on different areas of the body are known. Such devices are described, for example, in GB2160425A, US6139486A, US4981135A, WO96/06580A, US4592358A, US3900035A, US5692238.
  • Known devices are generally designed for the treatment or the cure of traumas or injuries through the application of hot or cold elements: the purpose is therefore to cool or to warm entire parts of the body having a certain extension, and the desired effect is directed to the entire part of the body involved by the intervention and there it ends up.
  • the duration of the cooling or heating effect is short.
  • the required treatment is usually immediate and of a relatively short duration.
  • the encumbrance of the devices is considerable.
  • the need of involving as much as possible of the part involved by the trauma is preeminent.
  • the devices of the known art have a considerable weight.
  • the traumatized person is normally in a condition of immobility, or reduced mobility, and the traumatized person needs not to move autonomously together with the used device.
  • the possible weight increase, leading as a consequence to an increase of the effect duration is generally considered a necessary and therefore desirable or at least acceptable condition.
  • the technical task at the base of the present invention is to provide an assisting device of the body thermoregulation, a use thereof and a method to assist the body thermoregulation that obviate one or more of the drawbacks of the known art above mentioned.
  • One of the purposes of the present invention in one or more of its different aspects, is to obtain a device and an assisting method of the body thermoregulation capable of having an effective and contemporaneously long-lasting assisting effect of the body thermoregulation.
  • thermoregulation which is lightweight and/or compact and/or easy to handle and/or of a practical use and/or easy to wear and/or to take off and/or has wearability, for example such that it can be worn for long times under normal everyday and social life conditions, and/or during sports and/or working activities.
  • thermoregulating intervention is mainly (exclusively under opti- mal conditions) located within one or at most few areas of the epidermis (typically one or at most two areas per device, up to a maximum of 4 or 6 areas in case of contemporaneous use of multiple devices) each one having a reduced extension.
  • such areas are in correspondence with the subcutaneous arterial plexi.
  • thermoregulating intervention ensures the high effectiveness of the thermoregulating effect and/or its long duration and/or the non- implication of areas of the body in which a cooling action can be useless and/or counterproductive and/or even harmful, such as, for example, the muscle fascia during a sports action, or the joints, which could be subjected to rheumatic-like damages from a prolonged exposition at low temperatures.
  • the Applicant has noted that large arterial plexi surface, in an immediately subcutaneous area, in the following areas of the human body: temples, neck, wrists, groin and ankles.
  • thermoregulation action The most suitable areas for the localization of a thermoregulation action according to the present invention are wrists and ankles, without excluding, however, temples and, in a lower extent, the neck.
  • the assisting device of the body thermoregulation is preferably intended for the application on the wrist or, in couple, on both wrists, since such location allows a comfortable wearability in movement, both from sportsmen in the practice of their own disciplines, and from common users in the normal daily use, as well as elderly persons or people having a fal- tering manual skill: both these subjects would have greater difficulties in wearing the device on the ankles.
  • the single device shows a single area in which the heat exchange is mostly or rather exclusively located.
  • the single device in case of a device designed for the application on temples or neck, shows at most two areas in which the heat exchange is mostly or rather exclusively lo- cated.
  • the Applicant believes that the assisting effect of the body thermoregulation will be perceptible in a very short time (about two minutes from the proper application), after which time the user will be able to benefit of a substantial reduction of his own body perspiration, both in case of a high outer temperature, and in case of an prolonged effort (typically a sports effort but also, for example, a professional effort) or both.
  • the Applicant believes that the user will be able to benefit of a progressive slowdown of the heartbeat, due to the assisting effect of the thermoregulation, with imaginable benefits for elderly and/or cardiopathic per- sons and/or athletes which could improve their competitive performances. For all those who are playing a physical activity, a lower fatigue effect could be perceptible.
  • the device of the present invention can be worn by one or more of the following groups of users: athletes involved in competitive and non-competitive sports activities, elderly and/or cardiopathic persons, workers involved in physically heavy activities, users which, during their own daily life, consider important to limit the sweat, with the comfort advantages ensuing from this.
  • One of the purposes of the present invention in one or more of its different aspects is to provide a device which intervenes under conditions of high outer temperature or high body temperature, due to prolonged efforts; however, the use in case of low environmental temperatures is not excluded, and in this case the assisting effect of the body thermoregulation will be carried on by heat transfer from the device towards the distal (radial, in case of the wrist) arteries.
  • the device according to the present invention includes (or is apt to include) (typically) one or more thermoregulating elements thermally insulated on all sides, except for the localized area intended for the thermoregulating intervention.
  • the thermoinsulating coating possibly consisting of multiple layers, functions for localizing the thermoregulation intervention.
  • the terms insulating and thermoinsulating are used as synonymous.
  • thermoinsulating coating besides spatially modulating the passage of the calories/frigories, can also have the function, thanks to its ability of sensitively inhibiting or reducing the passage of the same where not requested, of increasing the duration of the thermoregulating intervention at the same weight (for example, at the same weight of homogeneous thermoregulating element), therefore it contributes to the obtainment of the desired lightness and/or re- prised encumbrance.
  • the insulating coating is made of a layer of highly insulating material, which completely wraps the thermoregulating element, except for the portion intended for the cooling or heating action of the - A - distal or radial artery.
  • Such portion is preferably included for at least 80% of its extension (preferably 90% of its extension) within one area (in case of application on wrist or ankle) or at most two separate areas (for applications on temples), each of such areas being extended less than about 18 cm 2 (preferably less than about 15 cm 2 ).
  • each of said areas is geometrically connected, namely it does not include separate sub-areas.
  • each of such areas has en elongated form having a longitudinal dimension and a cross dimension, wherein said longitudinal dimension is advantageously lower than or equal to about 60 nm and/or greater than or equal to about 15 mm (preferably 30 mm).
  • the cross dimension is advantageously lower than or equal to 30 mm (preferably 20 mm) and/or greater than or equal to 5 mm.
  • said portion intended for the heat exchange is completely included (namely for 100% of its extension) within one or at most two of such areas, however the Applicant believes that the present invention further includes the case in which a minority percentage of the extension of said exchange portion is outside said two areas, without however that this unacceptably degrade the device performances.
  • One of the purposes of the present invention in one or more of its aspects is to provide an assisting device of the body thermoregulation preferably, but not exclusively, apt to be worn and/or taken off from the wrists with a single hand and in a very comfortable way.
  • One of the purposes of the present invention in one or more of its aspects is to provide the user with a device having maximum wearability features and with a great attention to the containment of weights and encumbrances; at the pursuit of this purpose it mainly contributes, in one aspect of the present invention, the rigorous heat insulation of the thermoregulating elements, through the use of lightweight but highly insulat- ing materials which, by limiting the dispersion of the frigories (or calories) from the thermoregulating elements towards the external environment or towards areas of the body to be excluded by the intervention, contribute in a significant way to the realization of constant and long-lasting performances, without for this reason having to increase the quantity, and in consequence the encumbrance and the weight, of the thermoregulating substances.
  • the dimensions of the device are advantageously lower than or equal to 10 cm.
  • the weight of the device is advantageously lower than or equal to 100 g, preferably lower than or equal to 8O g.
  • One of the purposes of the present invention in one or more of its aspects is to carry out an assisting device of the body thermoregulation which does not hinder and/or limits and/or does not create discomfort and/or however not interfere with the joints of the limbs in the normal daily movements, as well as in the course of both amateur and competitive sports activities.
  • the assisting device of the body thermoregulation could be applied on both the concerned limbs (wrists or ankles) and, due to the specular location, relative to the centre of the limb, of the distal (ra- dial, in case of the wrist) arterial plexi, it can be carried out in two "right” and “left” shapes, to be univocally and not interchangeably used on the right and left limbs, respectively.
  • the device of the present invention could clearly and univocally show the identification "right” and "left” of the two devices, for avoiding a wrong positioning of the devices themselves.
  • the present invention also foresees the case in which more of two devices are contemporaneously worn, for example one for each of the two wrists and one on the temples or on the two wrists and on the two ankles, etc.
  • the present invention relates to a portable device to be applied on a portion of epidermis of a human body, the device comprising a positioning structure apt to house at least one thermoregulating l o element, namely apt to assist the body thermoregulation.
  • thermoregulating element is apt to preferably gradually release to the outside frigories or calories or both (in this latter case the frigories and calories are preferably released in spatially separate areas). In one aspect, the thermoregulating element is apt to accumulate calories or frigories and then release the same. In one aspect, the thermoregulating element generates the calories and/or frigories to be
  • thermoelectric effect released, for example by a thermoelectric effect.
  • the device includes said at least one thermoregulating element, typically housed in the positioning structure.
  • the device includes a wall consisting of a first wall portion and a second wall portion, said first and second wall portions being, during the application of the device, all and the only parts of the de-
  • the first wall portion has an insulating power lower than the insulating power of said second wall portion.
  • insulating power is understood to mean the total specific insulating power of the wall or wall portion in all its thickness.
  • the first wall portion is located for at least 80% of its own extension (preferably at least 90% of its own extension) within a localization area or at most two separate localization areas, each of such localization areas being lower than 18 cm 2 , preferably lower than or equal to 15 cm 2 , more preferably lower than or equal to 12 cm 2 , still more preferably lower than or equal to 10 cm 2 , still more preferably lower than or equal to 8 cm 2 .
  • extension is understood to mean the plan extension of the considered ele-
  • each of said localization areas is geometrically connected, namely it does not include separate sub-areas.
  • the Applicant through the proper spatial distribution of wall portions having a different insulat- ing power, the almost total inhibition, or at least the substantial reduction of the passage of calories or fri- gories where not requested, and the calibration of the passage of calories or trigones only in the limited areas suitable for the purpose are obtained.
  • the first wall portion has an insulating power lower than or equal to 0.15 m 2 K/W. In one aspect, the first wall portion has an insulating power lower than or equal to 0.10 m 2 K/W.
  • the first wall portion can assume two operating configurations having a respective differentiated insulating power.
  • the first wall portion has an insulating power lower than or equal to 0.05 m 2 K/W in one of said operating configurations.
  • the first wall portion has an insulating power greater than 0.05 m 2 K/W in the other operating configuration.
  • the first wall portion consist of, namely coincides with, a portion of said positioning structure.
  • the first wall portion can assume the aforesaid two operating configurations, it consists of, namely coincides with, a portion of said positioning structure in one of said operating configurations having a lower insulating power.
  • the device includes a small plate having an insulating power greater than or equal to 0.03 m 2 K/W and lower than or equal to 0.10 m 2 K/W and movable between a first operating position, in which it is comprised in said first wall portion, and a second operating position, in which it is outside said first wall portion.
  • the second wall portion has an insulating power greater than or equal to 0.15 m 2 K/W, preferably greater than or equal to 0.20 m 2 K/W.
  • the first wall portion is located, for at least 80% (preferably 90%) of its own extension only within one of said localization areas.
  • the first wall portion is substantially completely (namely for at least 98%, preferably 100%) located within said one or at most two localization areas.
  • each of said localization areas has an elongated form having a longitudinal dimension and a cross dimension.
  • each of said localization areas is lower than or equal to about 60 mm, preferably lower than or equal to 50 mm.
  • the longitudinal dimension of each of said localization areas is greater than or equal to about 15 mm, preferably greater than or equal to about 30 mm. In one aspect, the cross dimension of each of said localization areas is lower than or equal to 30 mm, preferably lower than or equal to 20 mm. In one aspect, the cross dimension of each of said localization areas is greater than or equal to 5 mm. In one aspect, said positioning structure is countershaped with one part of the body on which the device is intended to be applied, such that the more ergonomic application among all the possible applications on said part of the body is the one in which, once the device has been applied, said first wall portion is in correspondence with a portion of said epidermis in which a distal arterial vessel surfaces.
  • the device includes a positioning indicator apt to display to the user the proper application of the device on said body, such that, once the device has been applied, said first wall portion is in correspondence with a portion of said epidermis on which a distal arterial vessel surfaces.
  • the device includes a heat-insulating material having an insulating power greater or equal than 0.15 m 2 K/W (more preferably greater or equal to 0.20 m 2 K/W, still more preferably greater or equal than 0.25 m 2 K/W), preferably housed in said positioning structure, configured such that at least a portion thereof forms part of said wall of the device.
  • said heat-insulating material is at least in correspondence with said second wall portion of the device, preferably with an insulating power greater than or equal to 0.15 m 2 K/W, more preferably greater than or equal to 0.20 m 2 K/W, still more preferably greater than or equal to 0.25 m 2 K/W.
  • said insulating material is not in correspondence with said first wall portion of the device.
  • the insulating material which is in correspondence with said first wall portion of the device has a lower insulating power than the insulating material which is in correspondence with said second portion of the device wall.
  • the heat-insulating element is in form of a casing which wraps, or is apt to wrap said thermo- regulating element, when this latter is housed in said device.
  • the device includes a casing housed in said positioning structure and apt to wrap said ther- moregulating element, when this latter is housed in said device, wherein said wall includes a portion of said casing, said casing having an insulating power greater than or equal to 0.15 m 2 K/W (preferably 0.20 m 2 K/W) throughout the same, except that in correspondence with the first wall portion.
  • the heat-insulating element is preferably permanently associated or associable with the thermoregulating element.
  • thermoregulating element is a reservoir, preferably of a fluid-tight type, for a thermoregulating substance, namely apt to assist the body thermoregulation, for example through a release of frigories or calories.
  • the reservoir contains said thermoregulating substance.
  • the thermoregulating substance is a liquid or a gel, at least at room temperature, for example a water and glycols-based mixture or a synthetic ice.
  • the thermoregulating substance is a compressed gas.
  • the reservoir is preferably suitable for hermetically containing the gas up to a pressure of at least 5 bars.
  • the reservoir is in metal, such as aluminium.
  • the reservoir has micro-holes for the predetermined exit of the compressed gas and one opening for the introduction of the gas within the reservoir. 5
  • the thermoregulating element exploits the thermoelectric effect, for example it comprises a Peltier cell, for example with a ceramic or copper technology.
  • the Peltier cell has a first surface apt to release frigories during its operation and a second surface, typically opposite to the first one, apt to release calories during the operation.
  • the Peltier cell is arranged in the device in such a way that it has the first surface, during the application of the device, faced towards said epidermis portion.
  • the thermoregulating element preferably includes a heatsink (for example of the type including a battery of protrusions or pins, typically completely made of aluminium) associated with the second surface of the Peltier cell.
  • a graphite foil is interposed between the second surface of the Peltier cell and the heatsink, contacting with both of them.
  • plan extension of the heatsink is greater than the plan extension of the Peltier cell.
  • a heat-conducting foil is associated with the first surface of the Peltier cell and has a plan extension greater than the first surface of the Peltier cell.
  • At least a part of said first wall portion of the device is in correspondence with the first surface of the Peltier cell.
  • said localization area is in correspondence with the first surface of the Peltier cell and, pref- O erably, it has an extension between 0.8 and 1.2 times the extension of the first surface (or, where present, the extension of said heat-conducting foil).
  • said localization area (and/or said wall portion of the device) has the same extension of the first surface (or, where present, the extension of said heat- conducting foil).
  • the device includes a battery, preferably housed within the device, electrically connected or connectable with the Peltier cell in order to supply the required current for its operation.
  • the device can include a switch and/or an adjustment control of the current (for example a trimmer or a couple of O +/- push-buttons) in order to control the operation of the Peltier cell.
  • the device includes a closing system including a tapered portion of the positioning structure, a closing ring apt to receive said tapered portion, a Velcro system placed in correspondence with said ta- pered portion and a block placed at one free end of said tapered portion and apt to loosely engage said ring.
  • the positioning structure is in form of a closed annular band.
  • the invention relates to a couple of devices, each device being according to any one of the above aspects, wherein the two devices are structurally specular therebetween in order to be worn, respectively, on a pair of limbs of a user.
  • the present invention relates to a use, for example a non-therapeutic use, of the portable device in any one of the above aspects, wherein the device is applied to a part of the human body in such a way that said localization area becomes in correspondence with a portion of the dermis in which a distal arterial vessel surfaces.
  • the device is applied to a part of the human body such that said first wall portion becomes in correspondence with a portion of the dermis in which a distal arterial vessel surfaces.
  • the device is applied to a wrist and/or an ankle and/or the head.
  • a couple of devices is applied to a pair of wrists and/or ankles.
  • the aim of such use is to improve the physical performances of said human body.
  • the aim of such use is to reduce the fatigue perception during or after a physical effort.
  • the user is not cardiopathic.
  • the device before the application, is cooled through the introduction of the device within a cooling apparatus, or heated through the introduction within an oven.
  • the device is applied to a wrist and the thermoregulating element lies on the side of the wrist in which there is the distal arterial vessel.
  • the closing system where present, is on the opposite side of the wrist.
  • the present invention relates to a method, for example a non-therapeutic method, for assisting the body thermoregulation, including the step of releasing calories or frigories exclusively on one or more portions of an epidermis of a human body, each portion being located for 80% of its own extension within a respective, geometrically connected localization area and having an extension lower than 18 cm 2 , preferably lower than or equal to 15 cm 2 , more preferably lower than or equal to 12 cm 2 , still more preferably lower than or equal to 10 cm 2 , still more preferably lower than or equal to 8 cm 2 , said respective localization area including a portion of the epidermis in which a distal arterial vessel surfaces.
  • the respective area belongs to wrists or ankles or temples of the body.
  • said one or more portions of epidermis consist of two portions, belonging to the two wrists or the two ankles, respectively, of said body.
  • the above method is for improving the sports or working performance.
  • the above method in one or more of the above aspects comprises the use of the device according to any one of the above aspects.
  • Figure 1 plan view of the outer side of the device of the present invention in a first embodiment in a completely unfold position
  • Figure 2 plan view of the inner side of the device of figure 1 in a completely unfold position
  • Figure 3 sectional view along the line A-A of figure 2 of the device of figure 1 in a completely unfold position, with some cut-away parts;
  • Figures 4A-C illustrations of some steps of the use of the device of figures 1-3;
  • Figure 5 plan view of the outer side of the device of the present invention in a second embodiment in a completely unfold position;
  • Figure 6 plan view of the inner side of the device of figure 5 in a completely unfold position a with some cut-away parts;
  • Figure 7 sectional view along the line A-A of figure 6 of the device of figure 5 in a completely unfold position, with some parts removed and in a first operating configuration
  • Figure 8 sectional view along the line A-A of figure 6 of the device of figure 5 in a completely unfold position, with some parts removed and in a second operating configuration.
  • Figure 9 schematic sectional view of the device of the present invention in an additional embodiment
  • Figure 10 schematic perspective view of the partly sectioned device of the present invention in still another embodiment
  • Figure 11 schematic sectional view of the device of figure 10;
  • FIG 12 schematic sectional view of the device of the present invention in still another embodiment.
  • the device according to the present invention is generally indicated by 1.
  • the device 1 in the case shown by way of example is a left wristband to assist the body thermoregulation.
  • the device 1 includes, or is apt to include, one (or more) thermoregulating elements 2 (whose position and extension is schematically shown by a dotted line in figures 2 and 6), a casing 3 placed around the thermoregulating element, the whole placed within a positioning structure 5.
  • a closing system 6 associated with the positioning structure 5 helps to ensure the proper positioning of the device on the human body, and preferably its fixing with a single hand.
  • the device shows (figures 3, 7 and 8) a wall 20 intended for being interposed between the thermoregulating element 2 and the dermis of a user, when the device is worn.
  • the wall 20 consists of all and the only parts of the device 1 (also considering the hermetic wall of the thermoregulating element itself) which are all contemporaneously interposed between the thermoregulating element 2 (for example, considering the hermetic wall of the thermoregulating element itself as a part of the wall, the fluid contained therein), or all the thermoregulating elements if more than one, and the dermis of a user, when the device is worn.
  • the outermost layer of such wall 20 consists of a portion of the positioning structure 5, the outer surface of such portion of the positioning structure forming the contact surface of the device 1 with the human epidermis.
  • such wall 20 consists of a first wall portion 4, intended for the heat exchange with the outer environment of the device 1 , and a second wall portion 22 complementary to the first portion and thermally insulated with the outer environment.
  • first wall portion 4 is diagrammatically illustrated, by mere way of example, by a continuous line in figures 2 and 6. It is preferable that an indication which localizes the position and/or the shape and/or the extension of the first wall portion 4 is visible to the user, such as for example a line of the kind shown in the figure being present on the outer surface of the positioning structure 5.
  • every other visual indication apt to allow the control of a proper positioning on the body of the device is foreseen, such as for example the display of an anatomic part of the body on the outer surface of the structure 5.
  • the thermoregulating element (or the elements) 2 can be a fluid- or gel-tight recipient or reservoir, prefera- bly made of a waterproof, thin, strong and flexible material. It can contain a substance 2a apt to accumulate frigories through cooling, which can be obtained by introducing the entire device in an apparatus suitable for this purpose, for example a freezer, and/or accumulate calories through, for example, the introduction in a microwave oven. Examples of suitable substances 2a are known in the field.
  • the suitable substances 2a there can be preferentially but not exclusively used glycols and water mixtures with, if nec- essary, additioned elements apt to render the mixture more capable of accumulating cold or warm, but the use of materials capable of generating frigories or calories by its own nature is not excluded.
  • the substance 2a is the NexcareTM gel, marketed from the 3MTM Company.
  • the substance 2a can be a synthetic ice, such as for example of the type commercially known as Po- larPaTM.
  • the substance 2a typically preserves a liquid or gel state also at temperatures remarkably lower than the room temperature, for example -10 0 C.
  • the substances contained within said reservoir 2 are such to ensure the greater specific ability of accumulating calories/frigories, and the greater ability of gradually releasing the same, for the purpose of obtaining the longest possible duration at the same weight.
  • the overall weight of the reservoir 2 for each device 1 is preferably not higher than 50-70 g, so as to reach an overall weight of the device 1 not higher than 80 g per wrist. Higher weights can result critical for their impact on both sports and daily physical activity of who is wearing the device.
  • thermoregulating element(s) 2 can be anyone and it is preferably shaped according to the anatomy of the area involved by the intervention, so as to allow a precise location, besides a greater use comfort.
  • Their length dimension (along the line A-A of figure 2 or 6) does not advantageously exceed that of the mean width of a wrist (or an ankle), while the height dimension (that in the plane of figure 2 orthogonal to the length) does not preferably exceed 10 cm, in such a way to ensure the best use comfort in the daily or sports use.
  • a dimension of the device advantageously not wider than 10 cm is obtained, both because higher dimensions would be useless, considering the localization of the intervention, and because they would be critic in the wearability and handleability.
  • the casing 3 is placed to completely wrap the thermoregulating element 2 (except for a localized portion 31 (figures 3 and 7) which is in correspondence with and forms part of the first wall portion 4 above mentioned, intended for the thermoregulation intervention).
  • the casing 3 includes one (or more) layer of a heat-insulating material 3a, such that the overall insulating power of the casing 3 outside the first wall portion 4 is greater than or equal to 0.15 m 2 K/W, preferably greater than or equal to 0.20 m 2 K/W, still more preferably greater than or equal to 0.25 m 2 K/W.
  • the layer of a heat-insulating material (or coating) 3a is made of a highly insulating material.
  • the layer of the heat-insulating material 3a can be the ThinsulateTM marketed from the 3MTM Company, in its version C200 having an insulating power (also called "heat insulation degree") equal to about 0.31 m 2 K/W (also known as Ret).
  • the function of the casing 3 is to spatially localizing the thermoregulation intervention, through the spatial distribution of layers with a different insulating power, which will completely inhibit the passage of the calories or frigories where not required and will calibrate such intervention exclusively in the area suitable for the purpose, shown by numeral 4, corresponding with the first wall portion, in figures 2 and 3.
  • the heat- insulating coating 3a could also have the function, thanks to its ability of inhibiting the passage of calories/ frigories where not requested, of increasing the duration of the intervention at the same weight.
  • the insulating material which forms the coating 3a is completely absent in correspondence with the above localized portion 31.
  • the first wall portion 4, as shown in figure 3, can only include the wall of the reservoir 2 and possibly the material constituting the positioning structure 5.
  • the insulating material forming the coating 3a is also present in such a portion 31, even if with reduced insulating abilities (for example through a thinning of the insulating material layer).
  • the portion not or almost not insulated 31 is considered as a part of the casing 3, also when it is free of insulating material.
  • the casing 3 is arranged to completely wrap the thermoregulating element 2" and the successive bracket.
  • the overall in- sulating power of the first wall portion 4 preferably remains below 0.15 m 2 K/W (preferably lower than or equal to 0.10 m 2 K/W).
  • Such first wall portion 4 not or almost not insulated and precisely localized, is extending, under optimal conditions, approximately on a 5 cm x 2 cm rectangle and is intended for the cooling or heating action of the radial artery.
  • an additional casing consisting of a thin film (not shown) of a flexible plastic material, such as PVC or polyethylene, wraps the entire casing 3, including the portion 31 , for the purpose of avoiding the possible damage, for example the friction defoliation, of the layer of the insulating material 3a.
  • the coating layer 3a is preferably combined to each thermoregulating element 2 in a fixed way, in such a way to not introduce possible dispersion sources of the frigories/calories contained therein.
  • Such combination could be obtained by using non-toxic and non-aggressive adhesives for the skin, or by seaming, or high-frequency welding or with another method apt to ensure the proper obtainment of the predetermined result.
  • the positioning structure 5 can be assimilated to an additional casing apt to contain or however support the thermoregulating device 2 and the casing 3.
  • the positioning structure 5 entirely covers the thermoregulating device 2 and the insulating material 3 also in corre- spondence with the first wall portion 4 (and the area 31 not or almost not insulated) intended for the thermoregulation intervention; this has the purpose of avoiding a too aggressive impact of the dermis with the cold or hot area 31, and modulating at best the transfer of frigories or calories towards the skin area con- cerned by the passage of arteries, such that to also help to the greater duration of the effect due to the lower dispersion.
  • the structure 5 has a through opening in correspon- dence with the first wall portion 4, in which the material of the structure 5 is absent. Therefore, in this case, when the insulating material of the coating 3a is not present in correspondence with the portion 31 , the first wall portion 4 is only represented by the wall of the reservoir 2 (together with the above thin film of plastic material, if any) which is considered as forming part both of the thermoregulating element 2 and the first wall portion 4.
  • the wall of the reservoir 2 would be considered as not forming part of the first wall portion 4, then this latter would be represented by a through opening free of any substance (or only by the above thin film of a plastic material, if any) which is interposed between the thermoregulating element 2 and the epidermis, when in use.
  • Such through opening is a through opening of the above wall 20 and, even if it is free of any substance, for the purposes of the present invention and claims it has to be considered as the second wall portion 4 to all practical purposes.
  • the positioning structure 5 is made of a soft, flexible, lightweight and washable, natural or synthetic, preferably inelastic material, for example cotton, so as to avoid incorrect positions of the thermoregulating area 4.
  • the insulating power of the material which forms the positioning structure 5 is advantageously lower than or equal to 0.05 m 2 K/W, more advantageously lower than or equal to 0.03 m 2 K/W.
  • FIGS 5-8 a second embodiment of the present invention is shown, for which the elements already above described will not be further described. Such elements are shown by the same reference numbers previously introduced.
  • the device 1 is advantageously equipped with a tab or small plate 60 movable at least between a first position (active position, shown in figures 6 and 7), wherein it is extending on the area 31 not or almost not insulated (thus making part of the aforesaid first wall portion 4) and a second position (passive position, shown in figure 8) wherein it is pulled back so as to not overlap the above portion 31 not or almost not insulated (thus not making part of the aforesaid first wall portion 4).
  • the tab 60 can be advantageously stiffened, while remaining flexible, such that not to deform itself during the repeated actions of activation-removal.
  • each elastic band 61 has one end sewed or fixed on the tab 60 and the opposite end fixed on the positioning structure 5, advantageously on the surface opposite to the outer surface contacting with the epidermis.
  • the elastic bands 61 are thin, strong and not subjected to yield (elongation and/or loss of elasticity) with the time and the use.
  • two or three (sub- stantially inelastic) ties 62 are fixed on a second side of the tab 60 opposite to the first side, to connect this latter with a (substantially inelastic) fabric band 63.
  • the opposite free end of the band 63 exits through an opening hole 65 on the structure 5, from the part of the thermoregulating element 2 opposite to that in which there is the tab 60.
  • Such free end has an insert 64 in a Velcro-hook for the fixing on the Velcro-loop 1OA or on the structure 5 itself.
  • the tab 60, the elastics 61, the ties 62 and a portion of the band 63 are interposed between the thermoregulating element 2 and the positioning structure 5, from the part contacting with the epidermis of the human body.
  • a prominent portion of the band 63 is developed along the outer surface of the casing 3 for about half of the perimeter of its longitudinal section (figure 7 and 8).
  • the semi-insulating tab 61 can be moved in the second position (fig. 8), for the purpose of restoring a proper heat exchange, by acting on the fabric strip exiting on the outer side of the device 1 and which, being equipped with a Velcro end 64, could be fixed on the part of the wristband 10a intended for the closure.
  • the proper repositioning of the semi-insulating small plate 60 in the first position is obtained thanks to the elastic bands 61. It will be sufficient to release the Velcro of the fabric strip from the device and the small plate will automatically return in position.
  • the assisting device of the body thermoregulation 1 is preferably countershaped at the side of the body to which is intended, for example for reducing at the minimum the interference of the same with the movements of the wrist and for not affecting, with an irritating rubbing during the use, the benefits due to the use of the device itself.
  • the positioning structure 5 includes a part 11 containing the thermoregulating element 2 and preferably shaped so as to space the element 2 itself from the joint, and a part 9, opposite to the part 11 , intended for the closing of the device and preferably thinned.
  • thermoregulating elements 2 are preferably fixed in a fixed and immovable way to the device 1 (and in particular to the position- ing structure 5) and in such a way not to allow a mutual movement between the two component, as this ensures a proper and constant alignment of the area 31 not or almost insulated with the first portion of the thermoregulating wall 4.
  • thermoregulating elements 2 preferably to- gether with the insulating casing 3 can be removed from the device, for allowing their replacement for example with other elements ready to use and/or for allowing their cooling/heating without involving also the remaining parts of the device (such as the structure 5 or the closing system 6).
  • the positioning structure 5 and the insulating material 3 are a one-piece unit.
  • the closing system 6 includes the above thinned part 9 of the structure 5 and closing means including, among others, a locking ring 7 fixed to the structure 5 through an elastic support 8, so as to contribute to a proper regulation of the closing.
  • the locking ring 7 is arranged for the passage of the tapered part 9, which is successively blocked by a Velcro system (Velcro loop 1OA and Velcro hook 1OB or vice versa), which makes possible to adjust at best the diameter of the closed device.
  • Velcro Velcro loop 1OA and Velcro hook 1OB or vice versa
  • the part 9 of the closing system is previously introduced in the ring 7, so as to allow to introduce the device on the wrist with a single movement.
  • the closing system 6 advantageously includes a rubber insert 12 acting for slightly holding the part 9 against the ring 7, in such a way not to allow the complete opening of the device, except with a small effort.
  • the closing system 6 is such that it allows to wear and close or open and take off the device 1 with one hand alone, both for who carries out the operation during a movement (typically who does sport), and for who has a faltering manual skill due to the age or a disease.
  • Such closing system 6 is advantageously thin and far from the area of the wrist joint, for avoiding a discomfort to the wrist joint, both during normal daily activities and in the course of competitive or amateur activities.
  • the device 1 above described and shown in figures 1-8 is a "left" device and preferably is combinable with a similar device 1 of a "right” type, whose structure is specular to that of the "left” device.
  • the use of the assisting device of the body thermoregulation 1 of the present invention preferably occurs as below described.
  • the device 1 described with reference to figures 1-8 will be introduced, before the use, in a cooling system (freezer), typically for a minimum of 8 hours, or a heating system (microwave oven), typically for a maximum of 3 minutes.
  • thermo- regulating elements 2 preferably together with the insulating coating 3a
  • the user can immediately use the device, because the positioning structure 5 of the example shown in figures 1-3 shows per se a little insulating power in correspondence with the area 31 not or almost not insulated of the casing 3, so as to avoid any heat shock in the skin area of the intervention.
  • FIG. 5-8 we refer to what above.
  • the device will be worn by the user according to what shown in figures 4A-C, considering the proper orientation of the intervention area 4, namely the proper location of the "right” and “left” devices on the corresponding limbs, because of the precise localization of the thermoregulating intervention.
  • the area 4 intended for the thermoregu- lating intervention will be, in the two right and left devices, in a different position, and precisely specular one to the other (or relative to a median axis of the wrist, once worn).
  • thermoregulating element 2 is located in the internal part of the wrist (the one in which there is the radial artery), while the closing end 9 and all the closing system 6 are on the opposite side of the wrist.
  • Figure 9 diagrammatically shows sectional view of an additional embodiment of the device 1 of the present invention, for which the elements already above described will not be further described. Such elements are shown with the same reference numbers previously used.
  • the positioning structure 5 is closed and, for example, is in form of a closed annular band.
  • a closed band can have a size regulation system (not shown) of the device 1 itself, for example in form of a Velcro string arranged on its outer surface, which can be tighten or released, as required, for ensuring the best wearability.
  • the material with which the positioning structure 5 is made could be, at least in the outer part, of a spongy type.
  • such solution in form of a closed band, with or without the optional solutions above described, can be advantageously adopted also in the embodiments previously described with reference to figures 1-8, instead of the open positioning structure 5 with the Velcro closing.
  • the outer coating in a spongy material could be, at least in the outer part, of a spongy type.
  • thermoregulating element 2 of the device 1 shown in figure 9 is a reservoir apt to contain a gas 2b therein, such as pressurized air, typically up to at least 5 bars.
  • the thermoregulating fluid is the compressed air itself.
  • the reservoir is of a metallic material, such as for example aluminum, which advantageously combines, besides the lightness features, the desired thermal conductivity.
  • the typical plan dimensions of the reservoir are of about 6 cm x 8 cm, with a thickness not exceeding about 2 cm (for example between about 1 and 2 cm).
  • the reservoir has at least a through micro-hole 91 , typically a plurality of micro-holes (for example, from two to six), suitable for allowing the exit of the air contained in the reservoir.
  • the air went out slowly and however in such a way to cool (namely, to subtract calories to) the reservoir containing the same, by exploiting the compressed air property of cooling, due to its exit, the reservoir containing it, according to the principle of the gas expansion.
  • the first wall portion 4 which is not or almost not insulated and precisely localized is approximately extending on a 5 cm x 1,5 cm rectangle. In use, it will be able to act on the wrist area in which the radial artery surfaces, which is typically extending on a 5 cm x 1 cm area.
  • the reservoir 2 preferably has a valve 92 of the type existing, for example, on normal refillable lighters, for charging the compressed gas.
  • a valve 92 of the type existing, for example, on normal refillable lighters, for charging the compressed gas.
  • the execution of proper canisters (not shown) for the refill could be foreseen as an accessory.
  • the duration of the assisting cooling effect of the body thermoregulation can be foreseen around one hour or one hour and half.
  • each micro-hole 91 is associated with a micro-valve which can be, for example, manually actuated and selected among two configurations, closed and open.
  • the reservoir could be placed in the area of the device 1 intended for being located, in use, in correspondence of the radial artery.
  • the reservoir has a branch, for example in form of a curved thin foil, which is extending (typically within the structure 5) from the reservoir up to the area of the device 1 intended for being located, in use, in correspondence of the radial artery (the first wall portion 4).
  • Advanta- geously in this way the exiting compressed air, while cooling the reservoir, also cools such branch.
  • the reservoir branch is entirely insulated, except for the portion which is in correspondence of the first wall portion 4, which can show an insulating coating layer only on the surface opposite to the surface faced, in use, towards the epidermis (whose surface, on the contrary, will typically be not insulated).
  • Figures 10-12 show two additional embodiments of the device 1 of the present invention, for which the elements already above described will not be further described. Such elements are shown by the same numerals previously used.
  • the device has a wall 20 consisting of all and only those parts of the device 1 which are simultaneously interposed between the thermoregulating element 2 and the dermis of a user, when the device is worn.
  • the outermost layer of such wall 20 consists of a portion of the positioning structure 5, the outer surface of such portion of the positioning structure constituting the contact surface of the device 1 with the human epidermis.
  • the wall 20 comprises a first wall portion 4, intended for the heat exchange with the outer environment of the device 1 , and a second wall portion 22 complementary to the first portion (in forming the wall 20) and thermally insulated from the outer environment.
  • the first wall portion 4 only consists of a portion of the positioning structure 5.
  • such portion of the structure 5 can further be lightened in correspondence with the first wall portion 4, for example through a perforated or net-like structure.
  • the positioning structure 5 can have a through opening, free of any substance, in correspondence with the first wall portion 4.
  • the first wall portion 4, corresponding with such through opening (which can be intended as a through opening of the wall 20), is free of any substance and has an insulating power equal to that of the air layer corresponding with such opening.
  • such through opening even if it is free of substance, is to be intended as the second wall portion 4 for all the practical purposes.
  • the thermoregulating element 2 includes a Peltier cell 30, typically having a first surface 31 apt to release frigories during its operation and a second surface 32, typically opposite to the first one, apt to release calories during its operation.
  • the cell 30 is apt, with the application of a (typically direct) current between the two poles (e.g. positive and negative) of the same cell, to cool a first surface 31 and heat a second surface 32, while maintaining between the two surfaces a predetermined temperature difference.
  • the Peltier cell in the device 1 is arranged in such a way to show the first surface 31 faced towards the first wall portion 4 (for example, during the application of the device, towards the portion of epidermis to be subjected to a thermoregulating effect).
  • the Peltier cells available so far are apt to maintain a temperature difference between the two surfaces up to a maximum of 70°, when supplied with a predetermined electric power
  • the device 1 of the present invention is configured in such a way that the aforesaid temperature difference is between about 20 0 C (preferably 25°C) and about 50 0 C (preferably 40°C).
  • Such result could be obtained by supplying the cell 30 with a voltage between about 3V and about 4V and/or a current lower than or equal to about 3A (for example by controlling it with a potentiometer, see below).
  • a voltage between about 3V and about 4V and/or a current lower than or equal to about 3A for example by controlling it with a potentiometer, see below.
  • such electric values can allow a reduced energy consumption, permitting a greater duration of the feed batteries, which are discussed he- reinbelow.
  • the cold side (first surface 31) remains at a temperature between about 0 0 C and about 1O 0 C, with a consequent absence of a heat shock and the discomforts resulting from a too cold surface which contacts the body.
  • the hot side (second surface 32) remains at a temperature not higher than about 50 0 C, preferably 45°C (with the possibility of dissipating the heat through non cumbersome dissipation elements, and/or having a non-aggressive temperature in case of a contact with the body).
  • the Peltier cell preferably has a thickness between about 4 mm and about 6 mm.
  • the Peltier cell (and, with the same, the first and/or second surfaces 31, 32) preferably has a width (namely the dimension along the section line of figure 11) between about 5 and about 20 mm. It preferably has a length (orthogonal to the width) between about 10 and about 60 mm.
  • the thermo- regulating element 2 can include a thin heat-insulating foil (not shown), for example of aluminium, placed into contact with the above first surface 31 and intended for being interposed between this latter and the epidermis to which the thermoregulation treatment has to be applied.
  • Such foil is particularly advantageous if the plan extension and/or one or both the plan dimensions of the first surface 31 (and/or the Peltier cell) are lower than the corresponding optimal extension and/or dimension of the localization area of the ther- moregulating treatment.
  • the optimal dimensions of the localization area of the thermoregulating intervention are from about 1 cm to about 2 cm of the base and from about 4 cm to about 6 cm of the height (typically optimal dimensions of 2 cm x 5 cm). Further preferred dimensions of the localization area are reported in the general part of the present description.
  • the Peltier cell in the perspective of a miniaturization of the device 1 and/or a consumption reduction of the cell itself in order to extend the duration of the thermoregulating effect and/or increase its effectiveness and/or lighten the feed battery (see below), has reduced dimensions (for example 10 mm x 10 mm, or 5 mm x 60 mm, or 15 mm x 15 mm or 15 mm x 30 mm), the surface contacting the wrist could be extended by applying to the cold side 31 of the Peltier cell the aforesaid foil, which will preferably have the above optimal dimensions of the area of epidermis.
  • the Applicant believes that a Peltier cell with dimensions comparable to the above optimal values for the thermoregulating intervention can require a disadvantageously high electric power.
  • the Peltier cell (or its first surface 31) preferably has an extension lower than 1.000 mm 2 , more preferably lower than or equal to 800 mm 2 , more preferably lower than or equal to 600 mm 2 , still more preferably lower than or equal to 500 mm 2 .
  • the Peltier cell preferably has a width lower than or equal to about 15 mm. It preferably has a length lower than or equal to about 30 mm.
  • the Peltier cell 30 could be produced with a ceramic technology or, more suitably, with a copper film technology.
  • the theimoregulating element 2 preferably includes a heatsink 35 associated with the second surface 32.
  • the heatsink 35 can include, for example, a plurality of protrusions or pins 36, typically arranged on the opposite side to the Peltier cell, such as for example in case of a Pinbloc ® -like heatsink.
  • the heatsink 35 is completely made of aluminum.
  • a graphite foil or film 37 (typically having a plan extension comparable with or equal to that of the cell 30) is interposed between the second surface 32 of the Peltier cell and the heatsink 35, contacting both of them, in order to promote an excellent heat transmission between the two surfaces, with a consequent more effective heat dissipation.
  • the adhesion between the heatsink and the Peltier cell, possibly through interposition of the graphite 37, can be obtained through an appropriate heat glue arranged between the adjacent elements.
  • the Peltier cell 30 is made with the copper film technology, it could be produced already built-in in the heatsink 35.
  • the heatsink 35 preferably has a total thickness between about 6 mm and about 10 mm, possibly including the pins 36. As for the plan dimensions, the heatsink 35 preferably has a plan surface between about 4 cm 2 and about 16 cm 2 (for example from about 2 x 2 cm to about 4 x 4 cm). Typically, the plan extension of the heatsink is greater than the plan extension of the Peltier cell. This can promote the heat dissipation on the hot side of the cell and the proper operation of the same. Preferably, at least a part (preferably all) of the above second wall portion 22 of the device is in correspondence with the entire portion of the heatsink exceeding the plan extension of the Peltier cell.
  • the device 1 includes (fig. 11) a layer of insulating material 3a, whose composition can be of the type above described, arranged at least in correspondence with the entire portion of the heatsink 35 exceeding the plan extension of the cell 30.
  • the layer 3a forms part of the second wall portion 22.
  • the layer of insulating material 3a can avoid the heat of the hot side of the Peltier cell from affecting, due to the reduced thickness of this latter, the wrist epidermis, by contrasting the cooling effect and/or causing undesired sensations of warm.
  • the layer of the insulating coating 3a can avoid the heat of the hot side of the Peltier cell from affecting the cold side of the same cell, by preventing the proper functioning thereof.
  • the thickness of the layer 3a is comparable with or equal to that of the Peltier cell.
  • At least a part of (preferably all) the aforesaid first wall portion 4 of the device 1 is in correspon- dence with the first surface 31 of the Peltier cell.
  • the above localization area is in correspondence with the first surface 31 of the Peltier cell and preferably has an extension between 0.8 and 1.2 times the extension of the first surface 31 (including, where present, the above aluminum foil).
  • the above localization area has the same extension of the first surface 31 (including, where present, the above aluminum foil).
  • the insulating layer 3a is not in correspondence with the first surface 31 of the cell 30. It can also extend in correspondence with substantially all the portion of the device 1 which, in use, is in correspondence with the skin of the body.
  • the device 1 can include, on the outer side of the same, a layer of a soft and/or spongy material 40, pref- erably with a good heat dissipation ability (for example perforated, for allowing the aeration of the heat- sink), for avoiding the direct contact of the heatsink itself 35 with the body of the user or, however, accidental contacts with other persons.
  • the thickness of the soft material layer 40 is greater than the total one of the heatsink.
  • the layer 40 can substantially extend in correspondence with the insulating layer 3a.
  • the device 1 includes a battery 50, preferably housed within the device, electrically connected or connectable (for example through opportune electric wires 53, diagrammatically shown in figures 10-12) with the Peltier cell 30 for supplying the required current for its functioning.
  • the battery 50 is a lithium ions polymers (LiPo) battery, for exploiting the features of duration and memory absence in the recharge condition.
  • LiPo lithium ions polymers
  • Such batteries typically have voltages of 3.6 V and current values between 400 and 1 ,300 mA.
  • the maximum dimensions of the battery 50 will be of about 6 cm length, about 4 cm width and about 1 cm thickness, with typical dimensions around the following values: 55 x 35 x 5 mm.
  • the battery 50 could include a plurality of batteries connected in parallel.
  • the battery 50 could preferably have a mini-jack 51 for the connection to a battery charger, which could be provided, for example, as an equipment for the purpose of recharging the device.
  • the device 1 can include a switch 52 (for example a pressure micro-switch) suitable for switch- ing-on and/or switching-off the device.
  • the device 1 can include an adjustment control of the current 54 (for example a trimmer, namely a mini-potentiometer, as shown in the figures or, not shown, a couple of +/- push-buttons) in order to control the current entering the Peltier cell, for the purpose of modulating the cooling effect, depending on the requirement, in a continuous or almost-continuous or discrete way, namely with prefixed steps (typically three-five steps).
  • an adjustment control of the current 54 for example a trimmer, namely a mini-potentiometer, as shown in the figures or, not shown, a couple of +/- push-buttons
  • the switch 52 and/or the adjustment control/s of the current 54 could be located in the part of the device which, in use, lies within the wrist (figures 10 and 11), for a greater protection of the switch-on and adjustment elements, or on the part which lies outside the wrist (figure 12), for a greater handleability and accessibility of such elements.
  • the wires themselves could be suita- bly protected by thermo-contracting sheaths, or the like.
  • the device 1 could include one or more micro-fans 56 (diagrammatically shown in figure 12, but they can be applied to any practical embodiment of the device 1 including the Peltier cells according to this invention), typically with a diameter between 4 and about 10 mm, preferably fed by the same battery 50 used for the feed of the Peltier cell, as the power required by the fans is extremely limited.
  • the fan 56 can be useful in case of an intense use, or for uses in extreme conditions of effort or outer temperature, and therefore where it is necessary a significant heat dispersion on the hot side of the Peltier cell.
  • the action of the fans could be activated by a temperature sensor 57 which, by detecting an excessive temperature in the system, will be able to activate the micro-fans 56 until the correct distribution of temperatures between the two surfaces of the Peltier cell is restored.
  • the fans could be placed laterally relative to the heatsink 35, and oriented such that to direct the air flow outwardly the device 1 , as shown in figure 12 by way of example.
  • the working temperature on the cold side is typically reached in about two minutes, and the duration of the cooling action, as a function of the outer conditions and/or the intensity of the effort to which the subject is subjected, could vary between two hours and four hours. Thanks to the adjustment control of the current it is possible to adjust the current entering the Peltier cell, for modulating the cooling effect thereof depending on the physiology of the user, rather than the effort or outer temperature conditions.

Abstract

A portable device (1) for application on a human body, the device including a positioning structure (5) which houses a thermoregulating element (2) and a wall (20) consisting of a first wall portion (4) and a second wall portion (22), the first and second wall portions being, during the application of the device, all and the only parts of the device (1) which are contemporaneously interposed between the epidermis and the thermoregulating element, wherein the first wall portion (4) has an insulating power lower than the insu lating power of the second wall portion (22), and wherein the first wall portion (4) is localized for at least 80% of its own extension within one or at most two separate areas, each of such areas being lower than or equal to 18 cm2.

Description

"DEVICE AND METHOD TO ASSIST THE BODY THERMOREGULATION"
DESCRIPTION
The present invention relates to a device, a use thereof and a method capable of assisting the body thermoregulation process. Heating or cooling devices to be applied on different areas of the body are known. Such devices are described, for example, in GB2160425A, US6139486A, US4981135A, WO96/06580A, US4592358A, US3900035A, US5692238.
Known devices are generally designed for the treatment or the cure of traumas or injuries through the application of hot or cold elements: the purpose is therefore to cool or to warm entire parts of the body having a certain extension, and the desired effect is directed to the entire part of the body involved by the intervention and there it ends up.
In MI2006A000896 a cooling or heating wristband for ensuring an appropriate regulation of the body temperature is described. The Applicant has realized that the devices of the known art show several drawbacks. In the known art the cooling or heating effect is usually uniformly or almost uniformly distributed on a considerable area of the body part involved by the intervention, which can also have substantial dimensions, for example in case of traumas concerning muscles, joints or tendons.
Moreover, in the known art the duration of the cooling or heating effect is short. For example, in case of a trauma, the required treatment is usually immediate and of a relatively short duration. Furthermore, in the known art the encumbrance of the devices is considerable. For example, in case of a trauma, the need of involving as much as possible of the part involved by the trauma is preeminent. Furthermore, the devices of the known art have a considerable weight. For example, in case of a trauma, the traumatized person is normally in a condition of immobility, or reduced mobility, and the traumatized person needs not to move autonomously together with the used device. On the contrary, the possible weight increase, leading as a consequence to an increase of the effect duration, is generally considered a necessary and therefore desirable or at least acceptable condition. In this context, the technical task at the base of the present invention is to provide an assisting device of the body thermoregulation, a use thereof and a method to assist the body thermoregulation that obviate one or more of the drawbacks of the known art above mentioned. One of the purposes of the present invention, in one or more of its different aspects, is to obtain a device and an assisting method of the body thermoregulation capable of having an effective and contemporaneously long-lasting assisting effect of the body thermoregulation. One of the purposes of the present invention, in one or more of its different aspects, is to provide an assisting device of the thermoregulation which is lightweight and/or compact and/or easy to handle and/or of a practical use and/or easy to wear and/or to take off and/or has wearability, for example such that it can be worn for long times under normal everyday and social life conditions, and/or during sports and/or working activities.
One or more of the technical tasks and/or purpose specified are substantially attained by a device, a use thereof and a method to assist the body thermoregulation, including the technical features stated below in the different aspects and/or claimed. In one aspect of the present invention, the thermoregulating intervention is mainly (exclusively under opti- mal conditions) located within one or at most few areas of the epidermis (typically one or at most two areas per device, up to a maximum of 4 or 6 areas in case of contemporaneous use of multiple devices) each one having a reduced extension. Advantageously, such areas are in correspondence with the subcutaneous arterial plexi. The Applicant believes that such localization of the thermoregulating intervention ensures the high effectiveness of the thermoregulating effect and/or its long duration and/or the non- implication of areas of the body in which a cooling action can be useless and/or counterproductive and/or even harmful, such as, for example, the muscle fascia during a sports action, or the joints, which could be subjected to rheumatic-like damages from a prolonged exposition at low temperatures. The Applicant has noted that large arterial plexi surface, in an immediately subcutaneous area, in the following areas of the human body: temples, neck, wrists, groin and ankles. The most suitable areas for the localization of a thermoregulation action according to the present invention are wrists and ankles, without excluding, however, temples and, in a lower extent, the neck. The assisting device of the body thermoregulation is preferably intended for the application on the wrist or, in couple, on both wrists, since such location allows a comfortable wearability in movement, both from sportsmen in the practice of their own disciplines, and from common users in the normal daily use, as well as elderly persons or people having a fal- tering manual skill: both these subjects would have greater difficulties in wearing the device on the ankles. In one aspect, in case of a device designed for the application on wrist or ankle, the single device shows a single area in which the heat exchange is mostly or rather exclusively located. In one aspect, in case of a device designed for the application on temples or neck, the single device, in form of a band, shows at most two areas in which the heat exchange is mostly or rather exclusively lo- cated.
The Applicant believes that the assisting effect of the body thermoregulation will be perceptible in a very short time (about two minutes from the proper application), after which time the user will be able to benefit of a substantial reduction of his own body perspiration, both in case of a high outer temperature, and in case of an prolonged effort (typically a sports effort but also, for example, a professional effort) or both. The Applicant believes that the user will be able to benefit of a progressive slowdown of the heartbeat, due to the assisting effect of the thermoregulation, with imaginable benefits for elderly and/or cardiopathic per- sons and/or athletes which could improve their competitive performances. For all those who are playing a physical activity, a lower fatigue effect could be perceptible. Moreover, in case of use of the device of the present invention in one or more of its different aspects, after an prolonged competitive or working effort, the times of the physical recovery could be significantly reduced. Advantageously, the device of the present invention can be worn by one or more of the following groups of users: athletes involved in competitive and non-competitive sports activities, elderly and/or cardiopathic persons, workers involved in physically heavy activities, users which, during their own daily life, consider important to limit the sweat, with the comfort advantages ensuing from this.
One of the purposes of the present invention in one or more of its different aspects is to provide a device which intervenes under conditions of high outer temperature or high body temperature, due to prolonged efforts; however, the use in case of low environmental temperatures is not excluded, and in this case the assisting effect of the body thermoregulation will be carried on by heat transfer from the device towards the distal (radial, in case of the wrist) arteries.
In one aspect, the device according to the present invention includes (or is apt to include) (typically) one or more thermoregulating elements thermally insulated on all sides, except for the localized area intended for the thermoregulating intervention. According to the Applicant, the thermoinsulating coating, possibly consisting of multiple layers, functions for localizing the thermoregulation intervention. In the present specification and claims, the terms insulating and thermoinsulating are used as synonymous. Through the proper spatial distribution of coatings having a different insulating power, the almost total inhibition (or at least the substantial reduction) of the passage of calories or frigories where not requested, and the calibration of such passage only in the area suitable for the purpose are obtained. The thermoinsulating coating, besides spatially modulating the passage of the calories/frigories, can also have the function, thanks to its ability of sensitively inhibiting or reducing the passage of the same where not requested, of increasing the duration of the thermoregulating intervention at the same weight (for example, at the same weight of homogeneous thermoregulating element), therefore it contributes to the obtainment of the desired lightness and/or re- duced encumbrance.
Advantageously, the insulating coating is made of a layer of highly insulating material, which completely wraps the thermoregulating element, except for the portion intended for the cooling or heating action of the - A - distal or radial artery. Such portion is preferably included for at least 80% of its extension (preferably 90% of its extension) within one area (in case of application on wrist or ankle) or at most two separate areas (for applications on temples), each of such areas being extended less than about 18 cm2 (preferably less than about 15 cm2). Advantageously, each of said areas is geometrically connected, namely it does not include separate sub-areas. Typically, each of such areas has en elongated form having a longitudinal dimension and a cross dimension, wherein said longitudinal dimension is advantageously lower than or equal to about 60 nm and/or greater than or equal to about 15 mm (preferably 30 mm). The cross dimension is advantageously lower than or equal to 30 mm (preferably 20 mm) and/or greater than or equal to 5 mm. In a preferred aspect, said portion intended for the heat exchange is completely included (namely for 100% of its extension) within one or at most two of such areas, however the Applicant believes that the present invention further includes the case in which a minority percentage of the extension of said exchange portion is outside said two areas, without however that this unacceptably degrade the device performances. One of the purposes of the present invention in one or more of its aspects is to provide an assisting device of the body thermoregulation preferably, but not exclusively, apt to be worn and/or taken off from the wrists with a single hand and in a very comfortable way.
One of the purposes of the present invention in one or more of its aspects is to provide the user with a device having maximum wearability features and with a great attention to the containment of weights and encumbrances; at the pursuit of this purpose it mainly contributes, in one aspect of the present invention, the rigorous heat insulation of the thermoregulating elements, through the use of lightweight but highly insulat- ing materials which, by limiting the dispersion of the frigories (or calories) from the thermoregulating elements towards the external environment or towards areas of the body to be excluded by the intervention, contribute in a significant way to the realization of constant and long-lasting performances, without for this reason having to increase the quantity, and in consequence the encumbrance and the weight, of the thermoregulating substances. In one aspect, the dimensions of the device are advantageously lower than or equal to 10 cm. The weight of the device is advantageously lower than or equal to 100 g, preferably lower than or equal to 8O g.
One of the purposes of the present invention in one or more of its aspects is to carry out an assisting device of the body thermoregulation which does not hinder and/or limits and/or does not create discomfort and/or however not interfere with the joints of the limbs in the normal daily movements, as well as in the course of both amateur and competitive sports activities.
In one aspect, the assisting device of the body thermoregulation could be applied on both the concerned limbs (wrists or ankles) and, due to the specular location, relative to the centre of the limb, of the distal (ra- dial, in case of the wrist) arterial plexi, it can be carried out in two "right" and "left" shapes, to be univocally and not interchangeably used on the right and left limbs, respectively. For this purpose, the device of the present invention could clearly and univocally show the identification "right" and "left" of the two devices, for avoiding a wrong positioning of the devices themselves.
5 The present invention also foresees the case in which more of two devices are contemporaneously worn, for example one for each of the two wrists and one on the temples or on the two wrists and on the two ankles, etc.
In one aspect, the present invention relates to a portable device to be applied on a portion of epidermis of a human body, the device comprising a positioning structure apt to house at least one thermoregulating l o element, namely apt to assist the body thermoregulation.
In one aspect, the thermoregulating element is apt to preferably gradually release to the outside frigories or calories or both (in this latter case the frigories and calories are preferably released in spatially separate areas). In one aspect, the thermoregulating element is apt to accumulate calories or frigories and then release the same. In one aspect, the thermoregulating element generates the calories and/or frigories to be
15 released, for example by a thermoelectric effect.
In one aspect, the device includes said at least one thermoregulating element, typically housed in the positioning structure.
In one aspect, the device includes a wall consisting of a first wall portion and a second wall portion, said first and second wall portions being, during the application of the device, all and the only parts of the de-
20 vice which are at the same time interposed between said epidermis and said thermoregulating element, when this latter is housed in the device.
In one aspect, the first wall portion has an insulating power lower than the insulating power of said second wall portion. By the term "insulating power" is understood to mean the total specific insulating power of the wall or wall portion in all its thickness.
25 In one aspect, the first wall portion is located for at least 80% of its own extension (preferably at least 90% of its own extension) within a localization area or at most two separate localization areas, each of such localization areas being lower than 18 cm2, preferably lower than or equal to 15 cm2, more preferably lower than or equal to 12 cm2, still more preferably lower than or equal to 10 cm2, still more preferably lower than or equal to 8 cm2. By the term extension, is understood to mean the plan extension of the considered ele-
30 ment, such as a wall or a portion thereof. Advantageously, each of said localization areas is geometrically connected, namely it does not include separate sub-areas. According to the Applicant, through the proper spatial distribution of wall portions having a different insulat- ing power, the almost total inhibition, or at least the substantial reduction of the passage of calories or fri- gories where not requested, and the calibration of the passage of calories or trigones only in the limited areas suitable for the purpose are obtained.
In one aspect, the first wall portion has an insulating power lower than or equal to 0.15 m2 K/W. In one aspect, the first wall portion has an insulating power lower than or equal to 0.10 m2 K/W.
In one aspect, the first wall portion can assume two operating configurations having a respective differentiated insulating power. Preferably, the first wall portion has an insulating power lower than or equal to 0.05 m2 K/W in one of said operating configurations. Preferably, the first wall portion has an insulating power greater than 0.05 m2 K/W in the other operating configuration. In one aspect, the first wall portion consist of, namely coincides with, a portion of said positioning structure. In case the first wall portion can assume the aforesaid two operating configurations, it consists of, namely coincides with, a portion of said positioning structure in one of said operating configurations having a lower insulating power. In one aspect, the device includes a small plate having an insulating power greater than or equal to 0.03 m2 K/W and lower than or equal to 0.10 m2 K/W and movable between a first operating position, in which it is comprised in said first wall portion, and a second operating position, in which it is outside said first wall portion.
In one aspect, the second wall portion has an insulating power greater than or equal to 0.15 m2 K/W, preferably greater than or equal to 0.20 m2 K/W. In one aspect, the first wall portion is located, for at least 80% (preferably 90%) of its own extension only within one of said localization areas.
In one aspect, the first wall portion is substantially completely (namely for at least 98%, preferably 100%) located within said one or at most two localization areas. In one aspect, each of said localization areas has an elongated form having a longitudinal dimension and a cross dimension.
In one aspect, the longitudinal dimension of each of said localization areas is lower than or equal to about 60 mm, preferably lower than or equal to 50 mm.
In one aspect, the longitudinal dimension of each of said localization areas is greater than or equal to about 15 mm, preferably greater than or equal to about 30 mm. In one aspect, the cross dimension of each of said localization areas is lower than or equal to 30 mm, preferably lower than or equal to 20 mm. In one aspect, the cross dimension of each of said localization areas is greater than or equal to 5 mm. In one aspect, said positioning structure is countershaped with one part of the body on which the device is intended to be applied, such that the more ergonomic application among all the possible applications on said part of the body is the one in which, once the device has been applied, said first wall portion is in correspondence with a portion of said epidermis in which a distal arterial vessel surfaces. In one aspect, the device includes a positioning indicator apt to display to the user the proper application of the device on said body, such that, once the device has been applied, said first wall portion is in correspondence with a portion of said epidermis on which a distal arterial vessel surfaces. In one aspect, the device includes a heat-insulating material having an insulating power greater or equal than 0.15 m2 K/W (more preferably greater or equal to 0.20 m2 K/W, still more preferably greater or equal than 0.25 m2 K/W), preferably housed in said positioning structure, configured such that at least a portion thereof forms part of said wall of the device. Preferably, said heat-insulating material is at least in correspondence with said second wall portion of the device, preferably with an insulating power greater than or equal to 0.15 m2 K/W, more preferably greater than or equal to 0.20 m2 K/W, still more preferably greater than or equal to 0.25 m2 K/W. In one aspect, said insulating material is not in correspondence with said first wall portion of the device. In an alternative aspect, the insulating material which is in correspondence with said first wall portion of the device has a lower insulating power than the insulating material which is in correspondence with said second portion of the device wall. In one aspect, the heat-insulating element is in form of a casing which wraps, or is apt to wrap said thermo- regulating element, when this latter is housed in said device.
In one aspect, the device includes a casing housed in said positioning structure and apt to wrap said ther- moregulating element, when this latter is housed in said device, wherein said wall includes a portion of said casing, said casing having an insulating power greater than or equal to 0.15 m2 K/W (preferably 0.20 m2 K/W) throughout the same, except that in correspondence with the first wall portion. In one aspect, the heat-insulating element is preferably permanently associated or associable with the thermoregulating element.
In one aspect, the thermoregulating element is a reservoir, preferably of a fluid-tight type, for a thermoregulating substance, namely apt to assist the body thermoregulation, for example through a release of frigories or calories. In one aspect, the reservoir contains said thermoregulating substance.
In one aspect, the thermoregulating substance is a liquid or a gel, at least at room temperature, for example a water and glycols-based mixture or a synthetic ice. In one aspect, the thermoregulating substance is a compressed gas. In such aspect, the reservoir is preferably suitable for hermetically containing the gas up to a pressure of at least 5 bars. Preferably, the reservoir is in metal, such as aluminium. Preferably, the reservoir has micro-holes for the predetermined exit of the compressed gas and one opening for the introduction of the gas within the reservoir. 5 In one aspect, the thermoregulating element exploits the thermoelectric effect, for example it comprises a Peltier cell, for example with a ceramic or copper technology. Typically, the Peltier cell has a first surface apt to release frigories during its operation and a second surface, typically opposite to the first one, apt to release calories during the operation. Typically, the Peltier cell is arranged in the device in such a way that it has the first surface, during the application of the device, faced towards said epidermis portion. 0 In one aspect, the thermoregulating element preferably includes a heatsink (for example of the type including a battery of protrusions or pins, typically completely made of aluminium) associated with the second surface of the Peltier cell. Preferably, a graphite foil is interposed between the second surface of the Peltier cell and the heatsink, contacting with both of them. Typically, the plan extension of the heatsink is greater than the plan extension of the Peltier cell. 5 In one aspect, a heat-conducting foil is associated with the first surface of the Peltier cell and has a plan extension greater than the first surface of the Peltier cell.
In one aspect, at least a part of said first wall portion of the device is in correspondence with the first surface of the Peltier cell. In one aspect, said localization area is in correspondence with the first surface of the Peltier cell and, pref- O erably, it has an extension between 0.8 and 1.2 times the extension of the first surface (or, where present, the extension of said heat-conducting foil). Preferably, said localization area (and/or said wall portion of the device) has the same extension of the first surface (or, where present, the extension of said heat- conducting foil).
In one aspect, at least a part, typically all said second wall portion of the device, is in correspondence with5 a portion of the heatsink exceeding the plan extension of the Peltier cell, preferably in correspondence with all the portion of the heatsink exceeding the plan extension of the Peltier cell. In one aspect, the device includes a battery, preferably housed within the device, electrically connected or connectable with the Peltier cell in order to supply the required current for its operation. Optionally, the device can include a switch and/or an adjustment control of the current (for example a trimmer or a couple of O +/- push-buttons) in order to control the operation of the Peltier cell.
In one aspect, the device includes a closing system including a tapered portion of the positioning structure, a closing ring apt to receive said tapered portion, a Velcro system placed in correspondence with said ta- pered portion and a block placed at one free end of said tapered portion and apt to loosely engage said ring.
In one aspect, the positioning structure is in form of a closed annular band.
In one aspect, the invention relates to a couple of devices, each device being according to any one of the above aspects, wherein the two devices are structurally specular therebetween in order to be worn, respectively, on a pair of limbs of a user.
In a further aspect, the present invention relates to a use, for example a non-therapeutic use, of the portable device in any one of the above aspects, wherein the device is applied to a part of the human body in such a way that said localization area becomes in correspondence with a portion of the dermis in which a distal arterial vessel surfaces.
In one aspect, the device is applied to a part of the human body such that said first wall portion becomes in correspondence with a portion of the dermis in which a distal arterial vessel surfaces. In one aspect, the device is applied to a wrist and/or an ankle and/or the head. In one aspect, a couple of devices is applied to a pair of wrists and/or ankles. In one aspect, the aim of such use is to improve the physical performances of said human body.
In one aspect, the aim of such use is to reduce the fatigue perception during or after a physical effort. In one aspect, the user is not cardiopathic.
In one aspect, before the application, the device is cooled through the introduction of the device within a cooling apparatus, or heated through the introduction within an oven. In one aspect, the device is applied to a wrist and the thermoregulating element lies on the side of the wrist in which there is the distal arterial vessel. Typically, the closing system, where present, is on the opposite side of the wrist.
In still another aspect, the present invention relates to a method, for example a non-therapeutic method, for assisting the body thermoregulation, including the step of releasing calories or frigories exclusively on one or more portions of an epidermis of a human body, each portion being located for 80% of its own extension within a respective, geometrically connected localization area and having an extension lower than 18 cm2, preferably lower than or equal to 15 cm2, more preferably lower than or equal to 12 cm2, still more preferably lower than or equal to 10 cm2, still more preferably lower than or equal to 8 cm2, said respective localization area including a portion of the epidermis in which a distal arterial vessel surfaces. In one aspect, the respective area belongs to wrists or ankles or temples of the body.
In one aspect, said one or more portions of epidermis consist of two portions, belonging to the two wrists or the two ankles, respectively, of said body. In one aspect, the above method is for improving the sports or working performance. In one aspect, the above method in one or more of the above aspects comprises the use of the device according to any one of the above aspects.
Further features and advantages of the present invention will become more apparent from the indicative and therefore not limiting description of some preferred embodiments of an assisting device of the body thermoregulation, a use thereof and the relative method to assist the body thermoregulation, according to the present invention, with the help of the enclosed drawings, in which:
Figure 1: plan view of the outer side of the device of the present invention in a first embodiment in a completely unfold position; Figure 2: plan view of the inner side of the device of figure 1 in a completely unfold position;
Figure 3: sectional view along the line A-A of figure 2 of the device of figure 1 in a completely unfold position, with some cut-away parts;
Figures 4A-C: illustrations of some steps of the use of the device of figures 1-3; Figure 5: plan view of the outer side of the device of the present invention in a second embodiment in a completely unfold position;
Figure 6: plan view of the inner side of the device of figure 5 in a completely unfold position a with some cut-away parts;
Figure 7: sectional view along the line A-A of figure 6 of the device of figure 5 in a completely unfold position, with some parts removed and in a first operating configuration; and Figure 8: sectional view along the line A-A of figure 6 of the device of figure 5 in a completely unfold position, with some parts removed and in a second operating configuration.
Figure 9: schematic sectional view of the device of the present invention in an additional embodiment; Figure 10: schematic perspective view of the partly sectioned device of the present invention in still another embodiment. Figure 11 : schematic sectional view of the device of figure 10;
Figure 12: schematic sectional view of the device of the present invention in still another embodiment. With reference to the above drawings, the device according to the present invention is generally indicated by 1. The device 1 in the case shown by way of example is a left wristband to assist the body thermoregulation. With reference to figures 1-8, the device 1 includes, or is apt to include, one (or more) thermoregulating elements 2 (whose position and extension is schematically shown by a dotted line in figures 2 and 6), a casing 3 placed around the thermoregulating element, the whole placed within a positioning structure 5. Preferably, a closing system 6 associated with the positioning structure 5 helps to ensure the proper positioning of the device on the human body, and preferably its fixing with a single hand. According to the present invention, the device shows (figures 3, 7 and 8) a wall 20 intended for being interposed between the thermoregulating element 2 and the dermis of a user, when the device is worn. It is to be observed that in the present description and claims, the wall 20 consists of all and the only parts of the device 1 (also considering the hermetic wall of the thermoregulating element itself) which are all contemporaneously interposed between the thermoregulating element 2 (for example, considering the hermetic wall of the thermoregulating element itself as a part of the wall, the fluid contained therein), or all the thermoregulating elements if more than one, and the dermis of a user, when the device is worn. In the ex- ample shown, the outermost layer of such wall 20 consists of a portion of the positioning structure 5, the outer surface of such portion of the positioning structure forming the contact surface of the device 1 with the human epidermis.
Furthermore, such wall 20 consists of a first wall portion 4, intended for the heat exchange with the outer environment of the device 1 , and a second wall portion 22 complementary to the first portion and thermally insulated with the outer environment. For the sake of clarity, it is specified that no other wail portions constituting the wall 20 as above defined are present in addition to the first and second wall portions. The contours of the first wall portion 4 are diagrammatically illustrated, by mere way of example, by a continuous line in figures 2 and 6. It is preferable that an indication which localizes the position and/or the shape and/or the extension of the first wall portion 4 is visible to the user, such as for example a line of the kind shown in the figure being present on the outer surface of the positioning structure 5. Additionally or alternatively, every other visual indication apt to allow the control of a proper positioning on the body of the device is foreseen, such as for example the display of an anatomic part of the body on the outer surface of the structure 5.
The thermoregulating element (or the elements) 2 can be a fluid- or gel-tight recipient or reservoir, prefera- bly made of a waterproof, thin, strong and flexible material. It can contain a substance 2a apt to accumulate frigories through cooling, which can be obtained by introducing the entire device in an apparatus suitable for this purpose, for example a freezer, and/or accumulate calories through, for example, the introduction in a microwave oven. Examples of suitable substances 2a are known in the field. Amongst the suitable substances 2a, there can be preferentially but not exclusively used glycols and water mixtures with, if nec- essary, additioned elements apt to render the mixture more capable of accumulating cold or warm, but the use of materials capable of generating frigories or calories by its own nature is not excluded. In a preferred solution, the substance 2a is the Nexcare™ gel, marketed from the 3M™ Company. In an alternative solu- tion, the substance 2a can be a synthetic ice, such as for example of the type commercially known as Po- larPa™. The substance 2a typically preserves a liquid or gel state also at temperatures remarkably lower than the room temperature, for example -100C. The substances contained within said reservoir 2 are such to ensure the greater specific ability of accumulating calories/frigories, and the greater ability of gradually releasing the same, for the purpose of obtaining the longest possible duration at the same weight. The overall weight of the reservoir 2 for each device 1 is preferably not higher than 50-70 g, so as to reach an overall weight of the device 1 not higher than 80 g per wrist. Higher weights can result critical for their impact on both sports and daily physical activity of who is wearing the device. Where the elements 2 are more then one, they will preferably be in communication therebetween, as the task of those not directly contacting with the first wall portion 4 (and therefore, in use, with the involved arterial area) is to act as a "stock" of frigories/calories, to be continuously exchanged with the element 2a contacting such portion, for the purpose of increasing the duration and the effectiveness of the intervention. The form of the thermoregulating element(s) 2 can be anyone and it is preferably shaped according to the anatomy of the area involved by the intervention, so as to allow a precise location, besides a greater use comfort. Their length dimension (along the line A-A of figure 2 or 6) does not advantageously exceed that of the mean width of a wrist (or an ankle), while the height dimension (that in the plane of figure 2 orthogonal to the length) does not preferably exceed 10 cm, in such a way to ensure the best use comfort in the daily or sports use. A dimension of the device advantageously not wider than 10 cm is obtained, both because higher dimensions would be useless, considering the localization of the intervention, and because they would be critic in the wearability and handleability.
The casing 3 is placed to completely wrap the thermoregulating element 2 (except for a localized portion 31 (figures 3 and 7) which is in correspondence with and forms part of the first wall portion 4 above mentioned, intended for the thermoregulation intervention). The casing 3 includes one (or more) layer of a heat-insulating material 3a, such that the overall insulating power of the casing 3 outside the first wall portion 4 is greater than or equal to 0.15 m2 K/W, preferably greater than or equal to 0.20 m2 K/W, still more preferably greater than or equal to 0.25 m2 K/W. The layer of a heat-insulating material (or coating) 3a is made of a highly insulating material. Moreover, such material is as light as possible, in order to not affect on the overall weight of the device. For example, the layer of the heat-insulating material 3a can be the Thinsulate™ marketed from the 3M™ Company, in its version C200 having an insulating power (also called "heat insulation degree") equal to about 0.31 m2 K/W (also known as Ret). The function of the casing 3 is to spatially localizing the thermoregulation intervention, through the spatial distribution of layers with a different insulating power, which will completely inhibit the passage of the calories or frigories where not required and will calibrate such intervention exclusively in the area suitable for the purpose, shown by numeral 4, corresponding with the first wall portion, in figures 2 and 3. The heat- insulating coating 3a could also have the function, thanks to its ability of inhibiting the passage of calories/ frigories where not requested, of increasing the duration of the intervention at the same weight.
In one embodiment (shown by way of example in figures 3 and 7), the insulating material which forms the coating 3a is completely absent in correspondence with the above localized portion 31. In this case, the first wall portion 4, as shown in figure 3, can only include the wall of the reservoir 2 and possibly the material constituting the positioning structure 5. Alternatively (not shown), the insulating material forming the coating 3a is also present in such a portion 31, even if with reduced insulating abilities (for example through a thinning of the insulating material layer). In each case, for the purposes of the present description and claims, the portion not or almost not insulated 31 is considered as a part of the casing 3, also when it is free of insulating material. In this regard, are to be interpreted the above phrase "the casing 3 is arranged to completely wrap the thermoregulating element 2" and the successive bracket. The overall in- sulating power of the first wall portion 4 preferably remains below 0.15 m2 K/W (preferably lower than or equal to 0.10 m2 K/W). Such first wall portion 4 not or almost not insulated and precisely localized, is extending, under optimal conditions, approximately on a 5 cm x 2 cm rectangle and is intended for the cooling or heating action of the radial artery. Advantageously, an additional casing consisting of a thin film (not shown) of a flexible plastic material, such as PVC or polyethylene, wraps the entire casing 3, including the portion 31 , for the purpose of avoiding the possible damage, for example the friction defoliation, of the layer of the insulating material 3a. The coating layer 3a is preferably combined to each thermoregulating element 2 in a fixed way, in such a way to not introduce possible dispersion sources of the frigories/calories contained therein. Such combination could be obtained by using non-toxic and non-aggressive adhesives for the skin, or by seaming, or high-frequency welding or with another method apt to ensure the proper obtainment of the predetermined result.
The positioning structure 5 can be assimilated to an additional casing apt to contain or however support the thermoregulating device 2 and the casing 3. In the examples shown in figures 3, 7 and 8, the positioning structure 5 entirely covers the thermoregulating device 2 and the insulating material 3 also in corre- spondence with the first wall portion 4 (and the area 31 not or almost not insulated) intended for the thermoregulation intervention; this has the purpose of avoiding a too aggressive impact of the dermis with the cold or hot area 31, and modulating at best the transfer of frigories or calories towards the skin area con- cerned by the passage of arteries, such that to also help to the greater duration of the effect due to the lower dispersion. In an alternative embodiment (not shown), particularly advantageous when there is the insulating material of the coating 3a with a reduced overall insulating power, also in correspondence with the portion 31 , or in the example shown in figures 5-8, the structure 5 has a through opening in correspon- dence with the first wall portion 4, in which the material of the structure 5 is absent. Therefore, in this case, when the insulating material of the coating 3a is not present in correspondence with the portion 31 , the first wall portion 4 is only represented by the wall of the reservoir 2 (together with the above thin film of plastic material, if any) which is considered as forming part both of the thermoregulating element 2 and the first wall portion 4. Alternatively, it is to be noted that, if the wall of the reservoir 2 would be considered as not forming part of the first wall portion 4, then this latter would be represented by a through opening free of any substance (or only by the above thin film of a plastic material, if any) which is interposed between the thermoregulating element 2 and the epidermis, when in use. Such through opening is a through opening of the above wall 20 and, even if it is free of any substance, for the purposes of the present invention and claims it has to be considered as the second wall portion 4 to all practical purposes. The positioning structure 5 is made of a soft, flexible, lightweight and washable, natural or synthetic, preferably inelastic material, for example cotton, so as to avoid incorrect positions of the thermoregulating area 4. The insulating power of the material which forms the positioning structure 5 is advantageously lower than or equal to 0.05 m2 K/W, more advantageously lower than or equal to 0.03 m2 K/W. In figures 5-8 a second embodiment of the present invention is shown, for which the elements already above described will not be further described. Such elements are shown by the same reference numbers previously introduced.
As it can be seen, particularly in figures 6, 7 and 8, the device 1 is advantageously equipped with a tab or small plate 60 movable at least between a first position (active position, shown in figures 6 and 7), wherein it is extending on the area 31 not or almost not insulated (thus making part of the aforesaid first wall portion 4) and a second position (passive position, shown in figure 8) wherein it is pulled back so as to not overlap the above portion 31 not or almost not insulated (thus not making part of the aforesaid first wall portion 4). The tab 60 can be advantageously stiffened, while remaining flexible, such that not to deform itself during the repeated actions of activation-removal. Advantageously, it has an overall insulating power greater than or equal to 0.03 m2 K/W and lower than or equal to 0.10 m2 K/W. From a first side of the tab 60 to the two ends of such side, two elastic bands 61 are located. Each elastic band 61 has one end sewed or fixed on the tab 60 and the opposite end fixed on the positioning structure 5, advantageously on the surface opposite to the outer surface contacting with the epidermis. The elastic bands 61 are thin, strong and not subjected to yield (elongation and/or loss of elasticity) with the time and the use. Moreover, two or three (sub- stantially inelastic) ties 62 are fixed on a second side of the tab 60 opposite to the first side, to connect this latter with a (substantially inelastic) fabric band 63. The opposite free end of the band 63 exits through an opening hole 65 on the structure 5, from the part of the thermoregulating element 2 opposite to that in which there is the tab 60. Such free end has an insert 64 in a Velcro-hook for the fixing on the Velcro-loop 1OA or on the structure 5 itself. As visible in figure 7 and 8, the tab 60, the elastics 61, the ties 62 and a portion of the band 63 are interposed between the thermoregulating element 2 and the positioning structure 5, from the part contacting with the epidermis of the human body. A prominent portion of the band 63 is developed along the outer surface of the casing 3 for about half of the perimeter of its longitudinal section (figure 7 and 8). The solution above described by way of example allows to modulate the cooling/heating effect over time, for example for the purpose of maintaining the same as more as homogeneous and constant possible throughout the duration of the intervention. In more detail, the small plate 60 is maintained in the first position at the beginning of the use of the device 1, for example approximately for 15-20 minutes. Successively, when the substance 2a has lost part of its accumulated frigories or calories, reducing the thermal ef- ficiency, the semi-insulating tab 61 can be moved in the second position (fig. 8), for the purpose of restoring a proper heat exchange, by acting on the fabric strip exiting on the outer side of the device 1 and which, being equipped with a Velcro end 64, could be fixed on the part of the wristband 10a intended for the closure. The proper repositioning of the semi-insulating small plate 60 in the first position, in case of a new reuse, is obtained thanks to the elastic bands 61. It will be sufficient to release the Velcro of the fabric strip from the device and the small plate will automatically return in position.
The assisting device of the body thermoregulation 1 , and in particular the positioning structure 5, is preferably countershaped at the side of the body to which is intended, for example for reducing at the minimum the interference of the same with the movements of the wrist and for not affecting, with an irritating rubbing during the use, the benefits due to the use of the device itself. In the examples shown in figures 1-8, the positioning structure 5 includes a part 11 containing the thermoregulating element 2 and preferably shaped so as to space the element 2 itself from the joint, and a part 9, opposite to the part 11 , intended for the closing of the device and preferably thinned. The thermoregulating elements 2, possibly together with the heat-insulating coating 3a surrounding the same, are preferably fixed in a fixed and immovable way to the device 1 (and in particular to the position- ing structure 5) and in such a way not to allow a mutual movement between the two component, as this ensures a proper and constant alignment of the area 31 not or almost insulated with the first portion of the thermoregulating wall 4. However, in an alternative version the thermoregulating elements 2 (preferably to- gether with the insulating casing 3) can be removed from the device, for allowing their replacement for example with other elements ready to use and/or for allowing their cooling/heating without involving also the remaining parts of the device (such as the structure 5 or the closing system 6). In an embodiment not shown, the positioning structure 5 and the insulating material 3 are a one-piece unit. The closing system 6 includes the above thinned part 9 of the structure 5 and closing means including, among others, a locking ring 7 fixed to the structure 5 through an elastic support 8, so as to contribute to a proper regulation of the closing. The locking ring 7 is arranged for the passage of the tapered part 9, which is successively blocked by a Velcro system (Velcro loop 1OA and Velcro hook 1OB or vice versa), which makes possible to adjust at best the diameter of the closed device. Alternatively to the Velcro, it is possible to use also other systems, such as automatic buttons, zip, buckles or the like. Advantageously, the part 9 of the closing system is previously introduced in the ring 7, so as to allow to introduce the device on the wrist with a single movement. The closing system 6 advantageously includes a rubber insert 12 acting for slightly holding the part 9 against the ring 7, in such a way not to allow the complete opening of the device, except with a small effort. The closing system 6 is such that it allows to wear and close or open and take off the device 1 with one hand alone, both for who carries out the operation during a movement (typically who does sport), and for who has a faltering manual skill due to the age or a disease. Such closing system 6 is advantageously thin and far from the area of the wrist joint, for avoiding a discomfort to the wrist joint, both during normal daily activities and in the course of competitive or amateur activities. The device 1 above described and shown in figures 1-8 is a "left" device and preferably is combinable with a similar device 1 of a "right" type, whose structure is specular to that of the "left" device. The use of the assisting device of the body thermoregulation 1 of the present invention preferably occurs as below described. The device 1 described with reference to figures 1-8 will be introduced, before the use, in a cooling system (freezer), typically for a minimum of 8 hours, or a heating system (microwave oven), typically for a maximum of 3 minutes. The entire device will be introduced in said systems or, alternatively, only the thermo- regulating elements 2 (preferably together with the insulating coating 3a), in the version which allows the removal and the introduction of the thermoregulating elements 2 without prejudicing the proper location of the thermoregulating effect. When the above time is elapsed, the user can immediately use the device, because the positioning structure 5 of the example shown in figures 1-3 shows per se a little insulating power in correspondence with the area 31 not or almost not insulated of the casing 3, so as to avoid any heat shock in the skin area of the intervention. For the example of figures 5-8, we refer to what above. The device will be worn by the user according to what shown in figures 4A-C, considering the proper orientation of the intervention area 4, namely the proper location of the "right" and "left" devices on the corresponding limbs, because of the precise localization of the thermoregulating intervention. In particular, the area 4 intended for the thermoregu- lating intervention will be, in the two right and left devices, in a different position, and precisely specular one to the other (or relative to a median axis of the wrist, once worn).
The thermoregulating element 2 is located in the internal part of the wrist (the one in which there is the radial artery), while the closing end 9 and all the closing system 6 are on the opposite side of the wrist. Figure 9 diagrammatically shows sectional view of an additional embodiment of the device 1 of the present invention, for which the elements already above described will not be further described. Such elements are shown with the same reference numbers previously used.
In the embodiment shown in figure 9 (as well as in those shown in the following figures 10-12), the positioning structure 5 is closed and, for example, is in form of a closed annular band. Advantageously, such solution can ensure an improved wearability, for example in terms of comfort and/or rapidity. It can also ensure a better protection of the elements contained therein, in particular with the embodiments described below with reference to figures 10-12. Optionally, the positioning structure 5 in form of a closed band can have a size regulation system (not shown) of the device 1 itself, for example in form of a Velcro string arranged on its outer surface, which can be tighten or released, as required, for ensuring the best wearability. The material with which the positioning structure 5 is made could be, at least in the outer part, of a spongy type. This has the advantage that the device 1, for example once the thermoregulating ability is ended, could be suitably used as a traditional anti-sweat band for wiping the forehead. It is understood that such solution in form of a closed band, with or without the optional solutions above described, can be advantageously adopted also in the embodiments previously described with reference to figures 1-8, instead of the open positioning structure 5 with the Velcro closing. The same applies for the outer coating in a spongy material.
On the contrary, it is understood that the solution of the open positioning structure 5 with a Velcro closing described with reference to figures 1-8, with or without the optional solutions described therein, can be advantageously adopted also in the embodiments previously described with reference to figures 9-12, instead of the closed band. The thermoregulating element 2 of the device 1 shown in figure 9 is a reservoir apt to contain a gas 2b therein, such as pressurized air, typically up to at least 5 bars. In this case, the thermoregulating fluid is the compressed air itself. Preferably, the reservoir is of a metallic material, such as for example aluminum, which advantageously combines, besides the lightness features, the desired thermal conductivity. The typical plan dimensions of the reservoir are of about 6 cm x 8 cm, with a thickness not exceeding about 2 cm (for example between about 1 and 2 cm).
Advantageously, the reservoir has at least a through micro-hole 91 , typically a plurality of micro-holes (for example, from two to six), suitable for allowing the exit of the air contained in the reservoir. Preferably, the air went out slowly and however in such a way to cool (namely, to subtract calories to) the reservoir containing the same, by exploiting the compressed air property of cooling, due to its exit, the reservoir containing it, according to the principle of the gas expansion. By way of example, the first wall portion 4 which is not or almost not insulated and precisely localized is approximately extending on a 5 cm x 1,5 cm rectangle. In use, it will be able to act on the wrist area in which the radial artery surfaces, which is typically extending on a 5 cm x 1 cm area. The reservoir 2 preferably has a valve 92 of the type existing, for example, on normal refillable lighters, for charging the compressed gas. To that end, the execution of proper canisters (not shown) for the refill, for example having such a capacity to ensure three or four refill cycles, could be foreseen as an accessory. The duration of the assisting cooling effect of the body thermoregulation can be foreseen around one hour or one hour and half. In an alternative embodiment, not shown, each micro-hole 91 is associated with a micro-valve which can be, for example, manually actuated and selected among two configurations, closed and open. As shown in the figure, the reservoir could be placed in the area of the device 1 intended for being located, in use, in correspondence of the radial artery. In an alternative (not shown), it could be placed in the area of the device 1 intended for being located, in use, on the side of the wrist opposite to the one in which the radial artery surfaces. In this case, the reservoir has a branch, for example in form of a curved thin foil, which is extending (typically within the structure 5) from the reservoir up to the area of the device 1 intended for being located, in use, in correspondence of the radial artery (the first wall portion 4). Advanta- geously, in this way the exiting compressed air, while cooling the reservoir, also cools such branch. Typically, also the reservoir branch is entirely insulated, except for the portion which is in correspondence of the first wall portion 4, which can show an insulating coating layer only on the surface opposite to the surface faced, in use, towards the epidermis (whose surface, on the contrary, will typically be not insulated). Figures 10-12 show two additional embodiments of the device 1 of the present invention, for which the elements already above described will not be further described. Such elements are shown by the same numerals previously used. According to the present invention, the device has a wall 20 consisting of all and only those parts of the device 1 which are simultaneously interposed between the thermoregulating element 2 and the dermis of a user, when the device is worn. In the examples shown, the outermost layer of such wall 20 consists of a portion of the positioning structure 5, the outer surface of such portion of the positioning structure constituting the contact surface of the device 1 with the human epidermis. The wall 20 comprises a first wall portion 4, intended for the heat exchange with the outer environment of the device 1 , and a second wall portion 22 complementary to the first portion (in forming the wall 20) and thermally insulated from the outer environment. In the examples shown, the first wall portion 4 only consists of a portion of the positioning structure 5. Optionally, such portion of the structure 5 can further be lightened in correspondence with the first wall portion 4, for example through a perforated or net-like structure. In an alternative example, not shown, the positioning structure 5 can have a through opening, free of any substance, in correspondence with the first wall portion 4. In this case, the first wall portion 4, corresponding with such through opening (which can be intended as a through opening of the wall 20), is free of any substance and has an insulating power equal to that of the air layer corresponding with such opening. For the purposes of the present description and claims, such through opening, even if it is free of substance, is to be intended as the second wall portion 4 for all the practical purposes.
In the device of figures 10-12, the thermoregulating element 2 includes a Peltier cell 30, typically having a first surface 31 apt to release frigories during its operation and a second surface 32, typically opposite to the first one, apt to release calories during its operation. Advantageously, the cell 30 is apt, with the application of a (typically direct) current between the two poles (e.g. positive and negative) of the same cell, to cool a first surface 31 and heat a second surface 32, while maintaining between the two surfaces a predetermined temperature difference. As shown in the figures, the Peltier cell in the device 1 is arranged in such a way to show the first surface 31 faced towards the first wall portion 4 (for example, during the application of the device, towards the portion of epidermis to be subjected to a thermoregulating effect). Although the Peltier cells available so far are apt to maintain a temperature difference between the two surfaces up to a maximum of 70°, when supplied with a predetermined electric power, the device 1 of the present invention is configured in such a way that the aforesaid temperature difference is between about 200C (preferably 25°C) and about 500C (preferably 40°C). Such result could be obtained by supplying the cell 30 with a voltage between about 3V and about 4V and/or a current lower than or equal to about 3A (for example by controlling it with a potentiometer, see below). Advantageously, such electric values can allow a reduced energy consumption, permitting a greater duration of the feed batteries, which are discussed he- reinbelow. Advantageously, in use, the cold side (first surface 31) remains at a temperature between about 00C and about 1O0C, with a consequent absence of a heat shock and the discomforts resulting from a too cold surface which contacts the body. Advantageously, in use, the hot side (second surface 32) remains at a temperature not higher than about 500C, preferably 45°C (with the possibility of dissipating the heat through non cumbersome dissipation elements, and/or having a non-aggressive temperature in case of a contact with the body).
The Peltier cell preferably has a thickness between about 4 mm and about 6 mm. As for the plan dimensions, the Peltier cell (and, with the same, the first and/or second surfaces 31, 32) preferably has a width (namely the dimension along the section line of figure 11) between about 5 and about 20 mm. It preferably has a length (orthogonal to the width) between about 10 and about 60 mm. Advantageously, the thermo- regulating element 2 can include a thin heat-insulating foil (not shown), for example of aluminium, placed into contact with the above first surface 31 and intended for being interposed between this latter and the epidermis to which the thermoregulation treatment has to be applied. Such foil is particularly advantageous if the plan extension and/or one or both the plan dimensions of the first surface 31 (and/or the Peltier cell) are lower than the corresponding optimal extension and/or dimension of the localization area of the ther- moregulating treatment. Considering the extension of the area in which the distal artery surfaces, about 1 cm x 5 cm, it can be assumed that the optimal dimensions of the localization area of the thermoregulating intervention (by supposing a rectangular area), namely the extension of the first wall portion 4 in the examples shown, are from about 1 cm to about 2 cm of the base and from about 4 cm to about 6 cm of the height (typically optimal dimensions of 2 cm x 5 cm). Further preferred dimensions of the localization area are reported in the general part of the present description. Therefore, if the Peltier cell, in the perspective of a miniaturization of the device 1 and/or a consumption reduction of the cell itself in order to extend the duration of the thermoregulating effect and/or increase its effectiveness and/or lighten the feed battery (see below), has reduced dimensions (for example 10 mm x 10 mm, or 5 mm x 60 mm, or 15 mm x 15 mm or 15 mm x 30 mm), the surface contacting the wrist could be extended by applying to the cold side 31 of the Peltier cell the aforesaid foil, which will preferably have the above optimal dimensions of the area of epidermis. The Applicant believes that a Peltier cell with dimensions comparable to the above optimal values for the thermoregulating intervention can require a disadvantageously high electric power. Due to one or more of the above reasons, the Peltier cell (or its first surface 31) preferably has an extension lower than 1.000 mm2, more preferably lower than or equal to 800 mm2, more preferably lower than or equal to 600 mm2, still more preferably lower than or equal to 500 mm2. As for the plan dimensions, the Peltier cell preferably has a width lower than or equal to about 15 mm. It preferably has a length lower than or equal to about 30 mm. The Peltier cell 30 could be produced with a ceramic technology or, more suitably, with a copper film technology. This latter technology can allow to carry out, with the same efficiency, thinner cells 30 and/or having any shape, also a rounded shape (differently from the ceramic technology cells, which can be currently carried out only in a rectangular or squared shape). The theimoregulating element 2 preferably includes a heatsink 35 associated with the second surface 32. Advantageously, it can promote the heat dissipation from the hot side (second surface 32) of the cell 30. The heatsink 35 can include, for example, a plurality of protrusions or pins 36, typically arranged on the opposite side to the Peltier cell, such as for example in case of a Pinbloc®-like heatsink. Typically, the heatsink 35 is completely made of aluminum. Preferably, a graphite foil or film 37 (typically having a plan extension comparable with or equal to that of the cell 30) is interposed between the second surface 32 of the Peltier cell and the heatsink 35, contacting both of them, in order to promote an excellent heat transmission between the two surfaces, with a consequent more effective heat dissipation. The adhesion between the heatsink and the Peltier cell, possibly through interposition of the graphite 37, can be obtained through an appropriate heat glue arranged between the adjacent elements. When the Peltier cell 30 is made with the copper film technology, it could be produced already built-in in the heatsink 35.
The heatsink 35 preferably has a total thickness between about 6 mm and about 10 mm, possibly including the pins 36. As for the plan dimensions, the heatsink 35 preferably has a plan surface between about 4 cm2 and about 16 cm2 (for example from about 2 x 2 cm to about 4 x 4 cm). Typically, the plan extension of the heatsink is greater than the plan extension of the Peltier cell. This can promote the heat dissipation on the hot side of the cell and the proper operation of the same. Preferably, at least a part (preferably all) of the above second wall portion 22 of the device is in correspondence with the entire portion of the heatsink exceeding the plan extension of the Peltier cell.
Preferably, the device 1 includes (fig. 11) a layer of insulating material 3a, whose composition can be of the type above described, arranged at least in correspondence with the entire portion of the heatsink 35 exceeding the plan extension of the cell 30. Advantageously, the layer 3a forms part of the second wall portion 22.
The layer of insulating material 3a can avoid the heat of the hot side of the Peltier cell from affecting, due to the reduced thickness of this latter, the wrist epidermis, by contrasting the cooling effect and/or causing undesired sensations of warm. The layer of the insulating coating 3a can avoid the heat of the hot side of the Peltier cell from affecting the cold side of the same cell, by preventing the proper functioning thereof.
Preferably, the thickness of the layer 3a is comparable with or equal to that of the Peltier cell.
Preferably, at least a part of (preferably all) the aforesaid first wall portion 4 of the device 1 is in correspon- dence with the first surface 31 of the Peltier cell.
Preferably, the above localization area is in correspondence with the first surface 31 of the Peltier cell and preferably has an extension between 0.8 and 1.2 times the extension of the first surface 31 (including, where present, the above aluminum foil). Preferably, the above localization area has the same extension of the first surface 31 (including, where present, the above aluminum foil).
Advantageously, the insulating layer 3a is not in correspondence with the first surface 31 of the cell 30. It can also extend in correspondence with substantially all the portion of the device 1 which, in use, is in correspondence with the skin of the body. The device 1 can include, on the outer side of the same, a layer of a soft and/or spongy material 40, pref- erably with a good heat dissipation ability (for example perforated, for allowing the aeration of the heat- sink), for avoiding the direct contact of the heatsink itself 35 with the body of the user or, however, accidental contacts with other persons. Preferably, the thickness of the soft material layer 40 is greater than the total one of the heatsink. Advantageously, the layer 40 can substantially extend in correspondence with the insulating layer 3a. Preferably, the device 1 includes a battery 50, preferably housed within the device, electrically connected or connectable (for example through opportune electric wires 53, diagrammatically shown in figures 10-12) with the Peltier cell 30 for supplying the required current for its functioning. Preferably, the battery 50 is a lithium ions polymers (LiPo) battery, for exploiting the features of duration and memory absence in the recharge condition. Such batteries typically have voltages of 3.6 V and current values between 400 and 1 ,300 mA. Advantageously, the maximum dimensions of the battery 50 will be of about 6 cm length, about 4 cm width and about 1 cm thickness, with typical dimensions around the following values: 55 x 35 x 5 mm. The battery 50 could include a plurality of batteries connected in parallel. The battery 50 could preferably have a mini-jack 51 for the connection to a battery charger, which could be provided, for example, as an equipment for the purpose of recharging the device. Optionally, the device 1 can include a switch 52 (for example a pressure micro-switch) suitable for switch- ing-on and/or switching-off the device.
Optionally, the device 1 can include an adjustment control of the current 54 (for example a trimmer, namely a mini-potentiometer, as shown in the figures or, not shown, a couple of +/- push-buttons) in order to control the current entering the Peltier cell, for the purpose of modulating the cooling effect, depending on the requirement, in a continuous or almost-continuous or discrete way, namely with prefixed steps (typically three-five steps). The switch 52 and/or the adjustment control/s of the current 54, if any, could be located in the part of the device which, in use, lies within the wrist (figures 10 and 11), for a greater protection of the switch-on and adjustment elements, or on the part which lies outside the wrist (figure 12), for a greater handleability and accessibility of such elements. In this latter case, for protecting and reinforcing the electric connection wires 55 among the above controls 52 and/or 54 and the battery 50, the wires themselves could be suita- bly protected by thermo-contracting sheaths, or the like.
Suitably, the device 1 could include one or more micro-fans 56 (diagrammatically shown in figure 12, but they can be applied to any practical embodiment of the device 1 including the Peltier cells according to this invention), typically with a diameter between 4 and about 10 mm, preferably fed by the same battery 50 used for the feed of the Peltier cell, as the power required by the fans is extremely limited. The fan 56 can be useful in case of an intense use, or for uses in extreme conditions of effort or outer temperature, and therefore where it is necessary a significant heat dispersion on the hot side of the Peltier cell. The action of the fans could be activated by a temperature sensor 57 which, by detecting an excessive temperature in the system, will be able to activate the micro-fans 56 until the correct distribution of temperatures between the two surfaces of the Peltier cell is restored. The fans could be placed laterally relative to the heatsink 35, and oriented such that to direct the air flow outwardly the device 1 , as shown in figure 12 by way of example.
In use, once the device 1 has been switched-on and worn, the working temperature on the cold side is typically reached in about two minutes, and the duration of the cooling action, as a function of the outer conditions and/or the intensity of the effort to which the subject is subjected, could vary between two hours and four hours. Thanks to the adjustment control of the current it is possible to adjust the current entering the Peltier cell, for modulating the cooling effect thereof depending on the physiology of the user, rather than the effort or outer temperature conditions.
Despite the description has been particularly exhaustive with regard to some embodiments of the assisting device of the body thermoregulation of the present invention, given by exemplifying and not limiting exam- pie, this patent does not exclude all modifications and variants which fall within the spirit and the protective ambit of the following claims.

Claims

1. A portable device (1) for application on an epidermis portion (40) of a human body, the device including a thermoregulating element (2), a positioning structure (5) apt to house said thermoregulating element (2), and a wall (20) consisting of a first wall portion (4) and a second wall portion (22), said first and second wall portions being, during said application of the device, all and the only parts of the device (1) which are contemporaneously interposed between said epidermis and said thermoregulating element (2), wherein said first wall portion (4) has an insulating power lower than the insulating power of said second wall portion (22), and wherein said first wall portion (4) is localized for at least 80% of its own extension within a localization area, or at most two separate localization areas, each of said localization areas being geometrically connected and extended for less than 18 cm2, preferably less than or equal to 15 cm2.
2. The device according to claim 1 , wherein said first wall portion (4) has an insulating power lower than or equal to 0.15 m2 K/W, preferably lower than or equal to 0.10 m2 K/W.
3. The device according to claim 2 or 3, wherein said second wall portion (22) has an insulating power greater than or equal to 0.15 m2 K/W, preferably greater than or equal to 0.20 m2 K/W.
4. The device according to any one of the preceding claims, wherein said thermoregulating element (2) comprises a Peltier cell (30).
5. The device according to the preceding claim, wherein the Peltier cell (30) is apt, when powered by a current, to cool a first surface (31) and heat a second surface (32), the Peltier cell being arranged in the device (1) in such a way that the first surface (31) faces the said first wall portion (4).
6. The device according to claim 5, wherein the thermoregulating element (2) includes a heatsink (35) associated with the second surface (32).
7. The device according to claim 5 or 6, wherein the plan extension of the heatsink (35) is greater than the plan extension of the Peltier cell (30) and at least a part of the said second wall portion (22) of the device is in correspondence with a portion of the heatsink (35) which exceeds the plan extension of the Peltier cell (30).
8. The device according to any one of the claims 4 to 7, wherein the Peltier cell has a plan extension lower than 800 mm2, preferably lower than or equal to 600 mm2.
9. The device according to any one of the preceding claims, wherein said first wall portion (4) is localized for at least 80% of its own extension within only one of said localization areas.
10. The device according to any one of the preceding claims, wherein said first wall portion (4) is substantially completely localized within said one or at most two localization areas.
11. The device according to any one of the preceding claims, including a heat-insulating element (3a) hav- ing an insulating power greater than or equal to 0.15 m2 K/W, configured in such a way that at least a portion thereof forms part of said second wall portion (22).
12. The device according to the preceding claim, wherein said heat-insulating element (3a) is made of an insulating material, which is not in correspondence with the first wall portion (4).
13. The device according to claims 11 or 12, including a casing (3) which wraps said thermoregulating element (2), wherein said wall (20) includes a portion of said casing (3), said casing (3) having an insulating power greater than or equal to 0.15 m2 K/W at every point, except in correspondence with the first wall portion (4).
14. The device according to claims 7 and 11, wherein said heat-insulating element (3a) is in correspon- dence with at least said portion of the heatsink (35) which exceeds the plan extension of the cell (30).
15. The device according to any one of the preceding claims, wherein said thermoregulating element (2) is a fluid-tight reservoir for a thermoregulating substance.
16. The device according to any one of the preceding claims, wherein said first wall portion (4) can assume two operating configurations having a respective differentiated insulating power.
17. The device according to the preceding claim, wherein said first wall portion (4) has an insulating power lower than or equal to 0.05 m2 K/W in one of said operating configurations, and greater than or equal to 0.05 m2 K/W in the other operating configuration.
18. The device according to any one of the preceding claims, including a small plate (60) having an insulating power greater than or equal to 0.03 m2 K/W and lower than or equal to 0.10 m2 K/W, and being movable between a first operating position, in which it is comprised in said first wall portion (4), and a second operating position, in which it is outside said first wall portion (4).
19. A couple of devices, each device (1) being according to any one of the preceding claims, wherein the two devices are mutually structurally specular for being wearable on a pair of limbs, respectively, of a user.
20. A non-therapeutic method to assist the body thermoregulation, including the step of releasing calories or frigories exclusively on one or more portions of a epidermis of a human body, each portion being localized for 80% of its own extension within a respective geometrically connected localization area, and having an extension lower than 18 cm2, preferably lower than or equal to 15 cm2, said respective localization area comprising a portion of the epidermis in which a respective distal arterial vessel (30) surfaces.
21. A method according to the preceding claim, wherein the device (1) according to any one of the claims 1 to 19 is applied to a part of said human body in such a way that said first wall portion (4) is in correspondence with said epidermis portion in which a respective distal arterial vessel (30) surfaces.
22. A method according to claim 20 or 21, wherein the device (1) is applied to a wrist or an ankle, and the thermoregulating element (2) is on the side of the wrist or the ankle wherein there is the respective distal arterial vessel (30).
23. A method according to any one of the claims 20 to 22, wherein said respective localization area belongs to the wrists or the ankles or the temples or the neck of said body.
24. A method for improving the sports or working performance, including the method according to any one of the claims 20 to 23.
PCT/IB2009/051292 2008-04-04 2009-03-27 Device and method to assist the body thermoregulation WO2009122336A1 (en)

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ITBS20080068 ITBS20080068A1 (en) 2008-04-04 2008-04-04 DEVICE AND METHOD TO SUPPORT BODY THERMOREGULATION

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