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    • 专利摘要:
    THERAPEUTIC SYSTEM FOR BRAIN COOLING AND SPINAL CORD COOLING SYSTEM. The present description refers to a brain cooling system, device or mechanism and a spinal cord cooling system, device or mechanism for use in military helmets, and in a format adapted to non-military helmets. The system consists of an inflatable cushion, or a set of interconnected cushions, attached to the inner surface of the helmet, along with a series of valves that allow cooling gases to be distributed from a high-pressure container. The use of different cooling gases allows the achievement and maintenance of brain cooling for 24 to 96 hours in mild (36 °C) or moderate (33 °C to 35 °C) cerebral hypothermia, which is 1.5 °C at 4.5 °C below core temperature.
    公开号:BR112012033757B1
    申请号:R112012033757-2
    申请日:2011-06-29
    公开日:2021-05-25
    发明作者:Renato Rozental
    申请人:Renato Rozental；
    IPC主号:
    专利说明:

    REFERENCE TO RELATED DEPOSIT REQUESTS
    [001] This application claims benefit to U.S. Provisional Application 61/359,476, filed June 29, 2010. FIELD OF THE INVENTION
    [002] The present description refers to a protective headgear accessory (such as a helmet that can act as a brain cooling system and a spinal cord cooling system), a device or mechanism to be used in conjunction with helmets, in particular, to mitigate the long-term consequences of hypoxic-ischemic or traumatic brain injuries and spinal cord injuries. The drop in temperature needs to be comparatively slow, that is, less than about 0.5°C/h in order to avoid cardiac arrhythmias and maintain blood homeostasis. BACKGROUND
    [003] The skull is hard and inflexible, while the brain is soft with a gelatinous consistency. The brain is confined within the skull. Movement of the skull through space (acceleration) followed by a rapid discontinuation of this action when the skull encounters a stationary object (deceleration) causes the brain to move within the skull. The brain moves at a different rate relative to the skull, and different parts of the brain move at different speeds because of their relative lightness or weight. Differential movement of the skull and brain when the head is struck results in direct brain damage due to diffuse axonal shear, contusion and brain swelling.
    [004] The helmet of the present invention refers to all types of helmets. A helmet top consists of a military helmet, which is a helmet worn by military troops in combat. Military helmets currently in use have Kevlar or projectile resistant armor having a series of non-functionally interconnected pads to hold the helmet in place. The pillows are made from a high energy absorption viscoelastic foam. While providing protection against a diverse range of external head insults, they cannot prevent deceleration (ie, diffuse axonal injury) or other types of projectile injury (eg, a bullet that pierces the helmet).
    [005] Under healthy conditions, the mean brain temperature (about 38°C) exceeds the core body temperature (about 37.5°C) by about 0.2°C to about 0.5°C. "Core temperature" refers to the temperature of the deep tissues of the body. This temperature is maintained with minimal fluctuations through a range of autonomic/endocrinological adjustments, which are effective under normal conditions. Temperature control may fail under pathological conditions, including fever and hyperthermia, which are defined herein as different entities.
    [006] Fever is part of the body's defense mechanism against viruses and bacteria, where the hypothalamus, which behaves like a thermostat and is the primary organ that regulates temperature in the body, loses its ability to properly capture temperature. This allows chills to occur, which generate additional heat, in order to stimulate the effectiveness of the immune system. Raising the temperature in the absence of brain or spinal cord injuries helps the body fight infection-mediated illnesses.
    [007] In contrast, hyperthermia is an elevated body temperature that occurs independently of bodily infection and can become a medical emergency that requires immediate treatment to prevent disability or death. The most common causes are heat stroke, adverse drug reactions, and malignant hyperthermia (following halothane anesthesia). Focal and regional increases, as opposed to systemic increases, in brain temperature are also seen after traumatic brain injuries and strokes.
    [008] The opposite of hyperthermia is hypothermia, which occurs when the core temperature of an organism drops below 36 °C or below the temperature required for normal bodily functions. Hypothermia can be induced systemic or focally by exposure to cooling agents.
    [009] Brain temperature exceeds body core temperature by 0.2 °C to 0.5 °C (the “core temperature” can be extrapolated from bladder or rectal temperature). Maintaining a constant core temperature, or avoiding a rise in temperature after a variety of brain insults, is not enough to antagonize the development of long-term lesions. At present, the neuroprotective properties of mild hypothermia (here defined as reflecting a brain temperature between 33 °C and 36 °C) have been demonstrated without several studies. Mild hypothermia is one of the most effective neuroprotective therapies against cerebral ischemia and trauma currently available. Preliminary clinical studies have shown that mild hypothermia can be a relatively safe treatment. The possibility of using mild hypothermia to treat strokes and patients with spinal cord injuries has been evaluated in several medical studies. Increasing emphasis is being placed on the development of techniques and protocols to ensure rapid cooling of patients. One of the biggest obstacles in moving the application of brain-cooling hypothermia from the hospital to the field (eg, war/civilians) has been the availability of appropriate cooling techniques.
    [0010] Generalized hypothermia was initially achieved by superficial cooling, which sometimes meant submerging the neurosurgical patient in ice water while the patient was on an operating table. This method of cooling was cumbersome and required prolonged anesthesia. More recently, the possibility of active core cooling down to 32°C using an extracorporeal heat exchanger has been realized in patients with severe head injuries. At the present time, the cooling
    [0011] Systemic superficial is a widely used method to induce systemic cerebral hypothermia using water circulation blankets.
    [0012] As cooling devices and methods improve and prove effective, more data regarding the effect of temperature reduction on recovery from injury and illness should be made available.
    [0013] In order to avoid chills after thermal reduction, the patient treated for hypothermia should be sedated. Both clinical experts and basic scientists remain optimistic that over the course of this decade hypothermia will emerge as a major effective therapeutic advance for patients with acute neurological injuries. However, an effective and simple hypothermic device for field use still needs to be developed. For example, U.S. Patent Nos. 6,969,399; 7,056334; 7,077,858; 7,087,075; 7,179,279; 7,303,579; 6,986,783; 7,056,282 and U.S. Patent Publication No. 2010/0211140 describe cooling techniques and systems; however, none of these systems are suitable for use in non-hospital settings. Furthermore, for mild hypothermia to be effective, studies have shown that it must be induced within four hours of injury. See Clifton et al., Lack of the effect of induction of hypothermia after acute brain injury, New England Journal of Medicine, February 22, 2001;344(8):556-63; Clifton, Is keeping cool still hot An update on hypothermia in brain injury, Current Opinion in Critical Care, 10(2): 116-9 (April 2004).
    [0014] Therefore, there is a need to develop a simple and effective hypothermic device for mobile use, such as in a field setting. The helmet can be worn by soldiers at war or by civilians. Wearing a helmet will selectively and uniformly reduce a wearer's brain temperature slowly in a controlled manner in order to avoid the risks associated with rapid induction of hypothermia. It would be highly desirable to provide an effective controlled mechanism that can be triggered by others immediately after brain lions, which has the effect of preventing increased intracranial pressure, swelling, and acute and long-term damage. To effectively achieve these goals, the device would need to be effective without removing the patients' existing clothing, including civilian/war helmets. For example, U.S. Patent Nos. 4,552,149; 4,753,242; 5,261,399; 5,539,934; 5,871,526; 5,913,885; 5,957,964; 6,030.412; 6,126,680; 6,183,501; 6,277,143; 6,312,453; 6,416,532; 6,461,379; 6,682,552; 6,962,600 and 7,846,118 describe hats, coats, blankets, etc. to cool body temperatures; however, all of these systems would require the removal of the patient's current helmet or clothing in the field, which could exacerbate the patient's condition or, in the case of combat use, leave the patient vulnerable to further attacks. In addition, the system would need to be highly mobile and incorporated into the user's current equipment, meaning that the system or device would not obstruct the user, impair the operation of the user's current equipment, or be susceptible to failures resulting from incidental damage prior to activation. as could occur in other systems of this type. See U.S. Patent Nos. 4,691,762; 7,008,445; 7,052,509; 7,507,250; 7,565,705 and 7,621,945. SUMMARY OF THE INVENTION
    [0015] The present invention relates to a hypothermic helmet for protecting the brain of a user. The hypothermic helmet has one or more inflatable pads or covers, which can be interconnected, that are fixed inside the helmet body. The system also has at least one container or canister containing different cooling gases, and at least one temperature-sensitive probe capable of determining the user's brain temperature, which can be displayed through a color-indicating meter with variable colors or a reader digital, for temperature monitoring. One or more pressure-sensitive bidirectional valves are positioned over the helmet to receive the container, which inflates the interconnected pads and cools a user's brain in a controlled manner (at a rate of about 0.1 °C to about 0, 5°C/hour) to between about 33°C and about 36°C. Additionally, an inflatable collar enhances the induction of brain cooling by lowering the temperature of arterial blood passing through the neck. One or more pressure sensitive bi-directional valves are positioned over the collar to receive the container filled with cooling gas. A full face mask, visor and thermal insulating hood can also be attached to the helmet and can be used in conjunction with the collar to create a temperature barrier.
    [0016] Another modality refers to a hypothermic helmet for protection of the brain and/or spinal cord of a user. The hypothermic helmet comprises one or more inflatable pads, which can be interconnected. The hypothermic helmet may comprise one or more inflatable spinal cord straps. At least one container or canister containing different cooling gases and at least one temperature-sensitive probe capable of determining the temperature for temperature monitoring are also included. The helmet is capable of cooling the wearer's brain to an average temperature of about 33°C to about 36°C within about 24 hours and is able to keep the wearer's brain temperature within range for about 24 hours. hours to about 96 hours.
    [0017] In another embodiment, this description refers to a brain cooling system, device or mechanism and a spinal cord cooling system, device or mechanism for use in military helmets, which refers to helmets used in combat. In another modality, this description refers to use in non-military helmets, which are helmets used in non-combat scenarios. The brain cooling system comprises an inflatable cushion, or a set of interconnected cushions, attached to the inner surface of a helmet body, along with a series of valves that allow cooling gases to be delivered from a high-pressure container. The spinal cord cooling system includes one or more, for example, an inflatable strap attached to the bottom of the helmet body, along with a series of valves that allow cooling gases to be delivered from a high pressure vessel. The brain and spinal cord systems can be joined together in a collar located on a wearer's neck. The necklace also enhances the induction of brain cooling, decreasing the temperature of the arterial blood passing through the neck. The use of different cooling gases allows for a controlled reduction (at a rate of about 0.1 °C to about 0.5 °C) of the brain to a temperature of about 33 °C, which is about 2, 5°C to 4.5°C below core temperature (about 37.5°C). The brain and spinal cord cooling systems are thermostatically monitored by the inclusion of a temperature-sensitive probe, allowing temperature adjustment as needed.
    [0018] The maximum pressure within the system (eg helmet and collar) is controlled by one or more, eg three, individual pressure sensitive bidirectional valves. The availability of alternative valves avoids the need to move the injured head to implement the cooling mechanism and/or provides optional gas flow rates by calibrating the individual pressure sensitive bi-directional valves. Additional system features include a visor, face mask and hood that attach to the helmet body, and which, when combined, create a temperature barrier after the cooling system has been implemented.
    [0019] The military helmet comprises: a plurality of interconnected inflatable pads that receive hook-and-loop fastening elements, either hook-type or loop-type; the helmet body having a plurality, including, but not limited to, about 6 to about 10, interconnected inflatable cushions between a wearer's head and the helmet body, where the interconnected inflatable cushions are constituted by from an elastic, breathable material in contact with a user's skin, and will accommodate a balloon filled with expandable gas. Additionally, at least one container and/or canister containing different cooling gases and one or more pressure sensitive bidirectional valves that allow a controlled release of pressure are included. The interconnected inflatable cushions are capable of being inflated with gas released from the container inserted into one of the two-way pressure sensitive valves positioned on the top and sides of the helmet body, which are connected to the plurality of interconnected inflatable cushions. The temperature-sensitive probe is connected to a meter, which can be used to monitor temperature. The brain cooling system may also include an inflatable collar, which enhances the induction of brain cooling by lowering the temperature of arterial blood passing through the neck. One or more pressure sensitive bi-directional valves are positioned over the collar to receive the container filled with cooling gas.
    [0020] Another modality refers to a replacement brain cooling system kit for a military helmet or civilian helmet. The kit has a plurality of interconnected inflatable pads attached to the military helmet by any means known in the art, including, but not limited to, receiving hook-and-loop fasteners whether hook-type or loop-type. The helmet body has one or more inflatable pads interconnected between a wearer's head and the helmet body. The interconnected inflatable cushions are constructed from an elastic material, which can be in contact with a user's skin and will accommodate an expandable balloon, which can be filled with gas. Interconnected pads and additional fasteners can be incorporated into an inflatable collar.
    [0021] Another modality refers to the helmet comprising an inflatable headband connected to one or more valves, with the inflatable headband functioning as an air bag. The helmet can have about 2 to about 8 fixed cushioning pads, which are positioned peripherally to allow inflation of the headband. One or more bidirectional pressure sensitive valves allow a controlled release of pressure from at least one container and/or canister inserted into one or more bidirectional pressure sensitive valves positioned on the top and sides of the helmet body, which are connected to the inflatable headband. Additional headbands, cushion pads and pressure sensitive valves can be incorporated into an inflatable collar.
    [0022] Another modality refers to a brain and spinal cord cooling system comprising an inflatable crown cap and an inflatable strap capable of being inflated with gas released from a source, such as a container inserted into one or more pressure sensitive bi-directional valves positioned on top, middle or bottom of adjacent strip or collar.
    [0023] Furthermore, an embodiment of this invention relates to a method for providing benefits of an immediate but controlled hypothermic assistance in the case of acute injuries to the brain and/or spinal cord. One embodiment provides a method of adapting a helmet body to incorporate a brain cooling system comprising the steps of incorporating a plurality of interconnected inflatable pads in a helmet body, incorporating one or more pressure sensitive bidirectional valves in the helmet body, connect said valves to the interconnected inflatable cushions, connect at least one container containing cooling gases to said valves, inflate said interconnected inflatable cushions with the cooling gases, and monitor at least one temperature-sensitive probe to determine the brain temperature of a user. A full face mask, visor, heat insulating hood and/or collar can also be used to create a temperature barrier. A better prognosis is expected if mild to moderate hypothermia is maintained for an extended period of up to four and/or until a patient is transferred from the scene of the incident to the nearest medical facility.
    [0024] Other objects, features and advantages of the present description will be understood with reference to the drawings and the detailed description below. DESCRIPTION OF DRAWINGS
    [0025] Figures 1A to 1K diagrammatically show a military helmet brain cooling system 10 of the present description.
    [0026] Figures 2A to 2D show in detail the location of the three bidirectional valves along a military helmet head article of the present description.
    [0027] Figures 3A to 3E are perspective views of a military helmet of the present description having a face mask, a visor, and a heat-insulating hood attached to the helmet to create a temperature barrier.
    [0028] Figures 4A to 4E diagrammatically show a non-military helmet brain cooling system of the present description.
    [0029] Figures 5A to 5F depict cross-sectional views of a non-military helmet brain cooling system of the present description.
    [0030] Figures 6A and 6B are perspective views of some of the additional features of a military helmet brain cooling system of the present description, for example, bi-directional valves, a color indicative meter, which shows the temperature as variable colors, a face shield/mask, and a chin strap.
    [0031] Figures 7A to 7H are perspective views of the thermal insulating hood for use in a military helmet brain cooling system of the present description.
    [0032] Figures 8A to 8C are perspective views of a military helmet brain and spinal cord cooling system of the present description. DETAILED DESCRIPTION
    [0033] The present invention relates to a brain cooling system comprising a helmet. In one modality, the helmet can fit for use in military helmets or in non-military helmets. The brain cooling system comprises an inflatable cushion, or a set of interconnected inflatable cushions, attached to the inner surface of the helmet body, along with a series of valves that allow refrigerants, including, but not limited to, liquids or pressurized gases to be dispensed from a high pressure vessel. The use of different refrigerants, or cooling gases, achieves (at a rate of about 0.1 °C to about 0.5 °C/hour) mild (about 36 °C) or moderate (about 36 °C) cerebral hypothermia ( about 33 °C to about 35 °C), which is about 2.5 °C to about 4.5 °C below the normal brain temperature range of about 37.5 °C to about 38.0°C. The brain's cooling system is thermostatically monitored by the inclusion of a temperature-sensitive probe and a temperature gauge. The display can be a color indicator gauge, which shows variable colors that allow adjustment of the cooling temperature when necessary.
    [0034] The present invention may also include a collar that increases the induction of brain cooling by decreasing the temperature of arterial blood passing through the neck. The collar may contain one or more pressure sensitive bi-directional valves that can be positioned to receive a container filled with refrigerant. The collar may also have various structural components such as inflatable cushions or other features found throughout the remainder of the present invention or accessories such as buttons, shoulder pads, collar reinforcements and zippers. Furthermore, the collar can have various structural properties, such as being inflatable or non-inflatable, hollow, or it can include rigid components such as metal, rubber, plastic or other materials. The production of the collar as well as the helmet is within the abilities of an ordinary skill in the technique of device development. The collar can consist of an assortment of materials including, but not limited to, breathable elastic materials or polymers such as nylon, dacron, mylar, spandex, kevlar or nomex.
    [0035] The present invention uses refrigerants, typically in the form of pressurized gas, to cool the brain temperature. It is anticipated that various gases and liquids, or mixtures thereof, will be used with this system which includes, but is not limited to, known refrigerants such as nitrogen, carbon dioxide or inert gases such as helium. Liquid refrigerants can include a perfluorocarbon, which include, but are not limited to, perfluorohexane, perfluoropentane, or 2-methyl-perfluoropentane; refrigerants, which include, but are not limited to, halomethanes, haloalkanes, and anhydrous ammonia; and nanofluids, which include, but are not limited to, alumina, titanium dioxide, carbon nanotubes, silica, or metals in a carrier liquid.
    [0036] The refrigerant is distributed through the system through the use of pressurized valves and tubes. The maximum pressure within the system is controlled by one or more, eg three, individual pressure sensitive bi-directional valves. The availability of alternative valves avoids the need to move the injured head to implement the cooling mechanism. The system of the present invention may contain one or more pressure sensitive bi-directional valves that allow a variable amount of gas flow in the inflatable cushions. Additional features of the brain cooling system can include a visor, face mask and hood, which are attached to the helmet body, and which, when combined with the helmet, create a temperature barrier after the cooling system has been implemented, to allow maintenance of therapeutic brain cooling for up to about 12 hours, about 24 hours, about 48 hours, or about 96 hours. This maintenance of brain cooling is usually achieved in a hospital setting after stabilizing the patient.
    [0037] The gas or fluid distribution system of this invention includes distributing a fixed, or substantially fixed, liquid to gas ratio. The distribution system is highly mobile and can be adjusted to particular gas flow rates through the use of pressure sensitive bi-directional valves. As the gas is delivered to the bonnet, the gas will flow from a reservoir or bottle in the container through the pressurized valve. The pressurized gas or liquid can also flow through a series of gas lines incorporated into the inflatable cushions and/or helmet. Gas lines can also comprise single or branched tubes. As the reservoir becomes depressurized upon connection to the pressurized valve, the contents of the reservoir will flow through the line and onto the inflatable cushions. The flow rate of the refrigerant will directly depend on the pressure of the gas being delivered from the reservoir or container, ie a higher gas pressure will result in a faster flow rate. Therefore, a fixed or preset liquid or gas rate can be distributed to the helmet upon use.
    [0038] Flow restrictions can also be incorporated into the helmet or the helmet gas distribution systems. For example, flow restrictors can allow particular inflatable cushions to be closed relative to adjacent inflatable cushions or sections of an inflatable crown or cap. This is particularly useful if a section has been damaged before use. Flow restrictors can be pressure sensitive based on the ambient pressure of the inflatable cushions prior to use. Also, valves can be connected to gas lines between the inflatable pads to direct flow to restrictors or stop liquid flow altogether. Pressurized filters can also be used, ensuring that any inflatable cushion is not overpressurized resulting in cushion failure. Activation of the overpressure safety device can switch the pressure sensitive valves to stop gas flow and vent the particular gas line(s) or inflatable cushion(s).
    [0039] The fluid control container or reservoir may be evaluated to withstand the pressure of the compressed gas, for example, the fluid control container may be a polyethylene terephthalate (PET) container tested for pressures in excess of 100 psi , 150 psi or 200 psi. In addition, a rupture disc or relief valve, set to a value that exceeds the expected operating pressure, eg 60 to 90 psi, can be added to the container as a safety means to vent gas in the event of an overpressurization . The container can also contain a flow meter that allows a user to observe the flow rate of the gas or liquid as it leaves the container. The operator may be able to adjust the flow rate at the helmet through the use of different pressure sensitive valves, each suitable for a specific amount of pressure, through changes to the container, or through any other means known in the art.
    [0040] The Brain Cooling System helmet is designed to cool the brain at a controlled rate over a specific period of time to a specific mean temperature. According to the usage in question, the term “controlled” can mean constant, that is, it does not vary over time where a period of time can be controlled as being as short or long as necessary. In general, different controlled rates can be used by the same patient. The cooling rate can be linear or non-linear. Treating a patient wearing the helmet will also require rewarming the brain at a controlled rate of about 0.1 °C to about 0.3 °C/hour from periods ranging from about 24 to about 72 hours, or until an average brain temperature equals about 37.5 °C. The heating rate can be linear or non-linear. The helmet is capable of providing a brain cooling rate ranging from about 0.1 °C to about 0.5 °C/hour, from about 0.1 °C to about 0.4 °C/ hour, from about 0.1°C to about 0.3°C/hour, from about 0.1°C to about 0.2°C/hour, from about 0.2°C to about from 0.4°C/hour, from about 0.2°C to about 0.3°C/hour, or from about 0.3°C to about 0.5°C/hour.
    [0041] The time required to reach an average brain temperature of about 33°C can range from about 12 hours to about 18 hours. The average temperature can be achieved using the helmet, or alternatively, wearing the helmet in conjunction with advanced medical facilities such as a hospital. Other higher mean brain temperatures can be reached in shorter time periods ranging from immediately after the brain insult to about 2 hours depending on the rate of cooling. An intravenous saline solution that is maintained at temperatures ranging from about 4 °C to about 5 °C in amounts such as 0.5, 1.0 and 1.5 liters can be provided to a patient to aid in cooling of the brain.
    [0042] The mean brain temperature after induction of hypothermia will usually be lower than the core body temperature. The average brain temperature after hypothermia induction can range from about 33°C to about 36°C, from about 34°C to about 37°C, from about 33.5°C to about 36.5°C from about 34°C to about 36°C, from about 35°C to about 36°C, from about 32°C to about 35°C, or from about 32°C to about 33 °C.
    [0043] Average brain temperature can be maintained for an extended period, such as from about 24 hours to about 96 hours, from about 36 hours to about 72 hours, from about 48 hours to about 56 hours , or about 48 hours. Temperature can be maintained using the helmet or, alternatively, the helmet in conjunction with advanced medical facilities.
    [0044] The sensitivity, that is, the resulting temperature change, and/or the resulting rate of temperature change, experienced by the patient, will depend on the patient's physical condition, for example, the patient's size and age. Additionally, calculations can be performed to determine how cold the head can become if all cooling is focused only on the head. The amount of head cooling can be calculated using the following assumptions: (1) brain mass, for example, 1.4 kg, (2) specific heat from water, and (3) body heat transfer (heat from the cerebral blood flow) is negligible. Thermal load calculation is an important part of the sizing and design of a radiant heating/cooling system. There are two types of heat loss to consider: conduction and convection.
    [0045] Calculations - calculate ΔT. For example, ΔT is a difference between the core temperature of the brain (38 °C) and the surface temperature of the brain (37.5 °C). ΔT = 0.5 °C. Brain weight: 1.4 kg (75% water), Blood flow: 1.25 liter/min, brain volume 1400 cc (cm3).
    [0046] A typical brain thermal load calculation consists of a calculation of surface heat loss through convection and heat loss due to blood flow (ie, conduction). The helmet modulates the extent of heat loss primarily by conduction. ΔT is calculated using Fourier's law:
    taking into account the physical “barriers” that reduce or resist heat transfer from the brain (eg, empty spaces between the head and helmet). Brain Heat Loss Vs. rewarming by systemic blood flow (37°C): The mass of blood circulating within the brain per minute is similar to the mass of the brain. The amount of heat to be removed from the brain in order to reduce brain temperature by 1 °C:
    c= 1 kcal /kg/C (considering the specific heat of water)
    [0047] Therefore, it will cost 1400 calories for every 1°C drop. Energy provided by brain blood flow: Assuming 1.25 liter/min, ΔT of 1 °C and 30 min of perfusion (ie within 30 min ~ 37 liters or 37 kg) - there is a need for 37,500 calories for each 1 °C drop - or a continuous removal of 75 kcal/h to reduce blood temperature by 1 °C.
    [0048] The brain can then be heated at a rate ranging from about 0.1 °C to about 0.3 °C/hour, from about 0.1 °C to about 0.2 ° C/hour or from about 0.2°C to about 0.3°C/hour. The time required to rewarm the brain can range from about 24 hours to about 96 hours, from about 36 hours to about 72 hours, from about 48 hours to about 56 hours, or about 48 hours. Typically, brain rewarming is handled clinically.
    [0049] The rate of cooling provided by the refrigerant can be determined by any means known in the art. The following calculations estimate the maximum cooling that can be achieved using a liquid refrigerant; however, it should be understood that similar calculations can be used to determine the cooling rate for other refrigerants.
    [0050] The cooling effect is related to two aspects of thermodynamics: (1) thermal capacity of the liquid, as it is heated from its temperature in the application to that of the body, and (2) heat of vaporization to the as it changes from a liquid to a gaseous state. See U.S. Patent Publication No. 2010/0211140. The relevant properties of a particular liquid are: p (Density), c (Specific Heat) and h (Latent Heat).
    [0051] The calculation for heat transfer due to liquid heating is: Q=c*m*(T2-T1) or Q=cmΔT (where m = mass of the administered liquid, T1 is the temperature of the liquid being administered, and T2 is the temperature to which the liquid is heated).
    [0052] The calculation for heat transfer due to liquid evaporation is: Q=h*m.
    [0053] Brain temperature can be monitored in a variety of ways, both invasively and non-invasively. As the usage in question, the term "average brain temperature" refers to an average temperature of the brain (calculated mathematically by any standard means), because the temperature across the brain from the surface to the core can vary by more than 0.5 °C under normal conditions. Accurate temperature measurements depend on the type of thermometer and where the thermometer is placed. Currently, there are several types of thermometers used. For example, liquid crystal display (LCD) mercury thermocouples and thermistors, which are probes in electrical thermometers that convert the electrical temperature signal into analog and digital displays and are commonly used measurement devices. In addition, zero heat flux thermometers, which combine the use of a thermistor, a heat flux sensor, and a heater, radiotelemetry thermometers, which measure radio frequency changes based on temperature-dependent inductance, and Infrared thermometers, which measure the infrared energy emitted by core temperature tissues, can also be used to measure temperature.
    [0054] The anterior preoptic region in the hypothalamus is the primary thermoregulatory center in mammals. In humans, the hypothalamus maintains body temperature between 36.5 °C and 37.5 °C. Initially, brain temperature was continuously monitored by placing a thermocouple in an intraventricular catheter to monitor intracranial pressure. Mellegard et al., A method for monitoring intracerebral temperature in neurosurgical patients, Neurosurgery, 27, 654-57 (1990). Thermometers or thermistors can be combined with probes to measure intracranial pressure, pO2, pCO2 and other metabolites so that brain temperature can be continuously measured in the lateral ventricles or parenchyma. The use of these techniques revealed regional differences in brain temperature, with deeper zones being warmer than superficial structures. Hirashima et al., Intracerebral temperature in patients with hydrocephalus of varying ethiology, J Neurol Neurosurg Psychiatry, 64, 792-94 (1998).
    [0055] The placement of temperature probes may vary. For example, there are several placement areas for temperature monitoring, including, sublingual, axillary, rectal, tympanic, esophageal, nasopharyngeal, bladder, and central venous. Brain temperature can also be monitored and is at minimal risk to the patient. Mellegard et al., Epidural temperature and possible intracerebral temperature gradients in man, Br J Neurosurg, 4, 31-8 (1990).
    [0056] Deep brain temperature is slightly higher than core temperature during steady-state conditions. The average difference between brain temperature and esophageal temperature is 1.5 +/- 0.75 °C in 10 cm, 0.6 +/- 0.63 °C in 17 cm, and 0.25 +/- 0.2 °C in 24 cm. This temperature gradient may be a result of the countercurrent exchange phenomenon within the brain. See Hayward et al., A Comparative Study of the Role of Arterial Cerebral Blood in the Regulation of Brain Temperature in Five Mammals, Brain Res, 16, 417-40 (1969). Differences in blood temperature between normal arterial and jugular venous, when calculated based on O2 consumption, blood flow, and heat production in healthy patients should be approximately 0.4 °C. Brengelmann, Body temperature regulation, Textbook of Physiology, 1584-96 (1989). Due to the extensive capillary network within brain tissue, the brain is likely to act as a countercurrent heat exchanger. As arterial blood moves deeper into brain tissues, heat is gained, and as blood moves to cooler, more peripheral tissues in the brain, heat is lost. Therefore, there is a core temperature more of a physiological concept than a temperature of a precise or rigidly defined anatomical location.
    [0057] Ideal sites for temperature measurements should be protected from heat loss, be painless to patients, and be convenient for measurement. Core temperature is best measured from the pulmonary artery, distal esophagus, tympanic membrane, or nasopharynx. Oral, axillary, rectal, and bladder temperatures approach core temperature in many clinical circumstances, except during changes in brain temperature, which can follow traumatic brain injuries or hypoxic-ischemic brain insults.
    [0058] Brain temperature is determined by a number of factors, which include cerebral metabolic rate, cerebral blood flow, and arterial blood temperature. Brain temperature is also influenced by the surrounding environment. Whitby et al, Cerebral, esophageal and nasopharyngeal temperatures, Br J Anaesth, 43, 673-76 (5 1976). Brain metabolic activity generates heat and results in a small temperature gradient (< 1 °C) between the deep brain temperature and that of the superficial parenchyma through which the proximal cerebral arteries extend. Baker et al, Thermal relationship between tympanic membrane and hypothalamus in conscious cat and monkey, J Apply Physiol, 32, 739-42 (1972). Cerebral blood flow and cerebral blood temperature gradient determine the magnitude and direction of heat exchange in the brain. Id.; Hayward et al, Role of arterial blood in the regulation of brain temperature in the monkey, Am J Physiol, 215, 389-403 (1968). Cerebral blood flow and brain temperature are related in two ways. First, blood flow to the brain provides the nutrients that are needed to generate heat through brain metabolism. If cerebral blood flow is reduced to limit metabolism in the brain, then brain temperature also decreases. Minamisawa et al, Preservation of brain temperature during ischemia in rats, Stroke, 21, 87-91 (1990). Second, cerebral blood flow is closely related to cerebral metabolic rate. In healthy patients, brain metabolism and therefore cerebral blood flow are altered by induced changes in brain temperature. Patients with a brain temperature exceeding 36 °C have higher cerebral blood flow values than patients with a brain temperature below 36 °C.
    [0059] Recently, it has been shown that brain temperature can also be monitored through the use of an MMS Radiometric Capture Transducer as suggested by Wouter Stomp, Non-Invasively Measuring Brain Temperature, MedGadget.com (May 31, 2011) available at http://medgadget.com/2011/05/noninvasively_ measuring_brain_temperature-2.html (last visited June 20, 2011), which passively detects microwave emissions produced by the brain tissue below the skull.
    [0060] Alternatively, brain temperature can be monitored through the use of MRS thermometry, which uses the MR frequency of water protons or the resonance of N-acetyl-aspartate methyl groups to determine internal brain temperature as described in M. Zhu et al., Improved Calibration Technique for in Vivo Proton MRS Thermometry for Brain Temperature Measurement, Magn. Reson. Med. 60(3): 536-541 (Sept. 2008) and Bartosz Karaszewski, Early brain temperature elevation and anaerobic metabolism in human acute ischemic stroke, Brain, 132; 955-964 (2009). In MRS thermometry, temperature-dependent changes in hydrogen bonding cause a chemical shift of water to vary linearly with temperature by 0.01ppm/°C, while the chemical shift of N-acetyl aspartate is independent of temperature. Both chemical shifts are essentially independent of pH, making MRS Thermometry a method
    [0061] reliable for temperature determination comparing and contrasting the relative chemical shifts of water and N-acetyl-5-methyl aspartate groups.
    [0062] Additionally, the use of a Magnetic Resonance User Interface (“MRUI”) for spectral quantification is advantageous because the frequency resolution of MRUI is very high as the quantification is performed in the time domain, looking for effectively by small phase changes in the signals over the entire duration of the free induction decay. Therefore, the frequency resolution is determined by the Cramer-Rao bonds and not the apparent digital resolution of the spectra, providing a better determination of any chemical shifts.
    [0063] An embodiment of the invention relates to a brain cooling system consisting of a spinal cord cooling system for cases of spinal cord injury. The spinal cord cooling system includes the anterior components of the brain cooling system and additionally one or more, for example, an inflatable strap fixed to the bottom of the helmet body. The brain cooling system and spinal cord cooling system may also comprise an assortment of inflatable pillows located throughout the system to provide uniform cooling of the brain and spinal cords, including the frontal, parietal and occipital bone, occipital bone and vertebrae.
    [0064] Another modality of the invention relates to a military helmet that has a plurality of interconnected inflatable pads that receive the hook and loop fastening elements, whether hook-type or loop-type. The system comprises a helmet body with preferably about 6 to 10 hollow cushion pads between the head and helmet body. The hollow cushions are constructed from an elastic material that is breathable in contact with a user's fur, and will accommodate a balloon filled with expandable gas. The system can incorporate any type of fastener, which includes, but is not limited to, glue, buttons or other fasteners known in the art. The interconnected inflatable pillows can be inflated with gas released from one or more containers inserted into the valves positioned on the top and sides of the helmet body, which are connected to the pillow systems and avoid the need to move the injured head to implement the cooling mechanism. The valves are bi-directional, allowing for a controlled release of pressure. Additional features of the military helmet include a visor, face mask and hood. These components can be attached to the military helmet after cooling is implemented and positioned to insulate the head, and prevent loss of cooling and a concomitant rise in brain temperature.
    [0065] The brain cooling system of the present invention may also include an inflatable collar, which enhances the induction of brain cooling by lowering the temperature of arterial blood passing through the neck. One or more pressure sensitive bi-directional valves can be positioned on the collar to receive the container filled with cooling gas.
    [0066] Another modality of the invention relates to a replacement military helmet. The kit comprises a plurality of interconnected inflatable cushions that receive hook-and-loop fastening elements, either hook-type or loop-type, to be attached to the helmet body with about 6 to 10 hollow cushioning pads between the head and the body of the helmet. helmet. The hollow cushions are constructed from an elastic, breathable material to contact a user's skin and accommodate an expandable gas-filled balloon. Additional features of the military helmet replacement kit include a visor, face mask, and hood. These components are spun into the military helmet after cooling is implemented and positioned to insulate the head and prevent loss of cooling and a concomitant rise in brain temperature. Hollow pillows and additional fasteners can also be incorporated into an inflatable collar.
    [0067] Other embodiments of the invention relate to a military helmet brain cooling system having a single inflatable headband connected to multiple, for example three, valves that can perform or function as an air bag. The valves are positioned in the upper middle and on each side of the helmet body. In this formulation, the helmet body has approximately 2 to 8 cushion pads, which are positioned peripherally to allow inflation of the headband, delimiting the expansion area of the fully inflated gas-cooled pad. The valves are bi-directional, allowing for a controlled release of pressure. The multiple, eg three, valves are aligned along the head bag which avoids the need to move the injured head in order to implement the cooling mechanism. Additional features of the military helmet include a visor, face mask and hood. These components are attached to the military helmet after cooling is implemented and positioned to insulate the head, and prevent loss of cooling and a concomitant rise in brain temperature. Headbands, pillows or additional values can be incorporated into an inflatable collar attached to the system.
    [0068] Another embodiment of the invention relates to a replacement military helmet air bag kit. The kit comprises a single inflatable headband connected to multiple, eg three, valves, which function as an air bag. The valves are positioned in the upper middle and on each side of the helmet body.
    [0069] Another embodiment of the invention comprises a non-military helmet brain cooling system having a single inflatable crown cap attached to a helmet body and connected to up to three valves. The valves are positioned in the upper middle part and on each side of the helmet body, avoiding the need to move the injured head in order to implement the cooling mechanism. The valves are bi-directional, allowing for a controlled release of pressure. Additional features of the non-military helmet brain cooling system include a visor, face mask, and hood. These components are attached to the non-military helmet after cooling is implemented and positioned to insulate the head and prevent loss of cooling and a concomitant rise in brain temperature. The brain cooling system may also include an inflatable collar, which enhances the induction of brain cooling by lowering the temperature of arterial blood passing through the neck. One or more pressure sensitive bi-directional valves can be positioned over the collar to receive the container filled with the cooling gas.
    [0070] Another embodiment of the invention relates to a replacement non-military helmet brain cooling system head cover kit. The kit comprises a single inflatable crown cap connected to multiple, eg three, valves. The valves are positioned in the upper middle and on each side of the helmet body. Additional features of the replacement non-military helmet brain cooling system crown cover kit include a visor, a face mask, a hood and a collar.
    [0071] An embodiment of the invention relates to a non-military helmet brain cooling system having a single inflatable headband connected to multiple, for example three, valves, which function as an air bag. The valves are positioned in the upper middle and on each side of the helmet body. In this formulation, the helmet body has about 2 to 8 fixed cushioning pads, which are peripherally positioned to allow inflation of the headband, delimiting the expansion area of the fully inflated gas-cooled pad. The valves are bi-directional, allowing for a controlled release of pressure. The multiple, eg three, valves are aligned along the headband avoiding the need to move the injured head to implement the cooling mechanism. The optional visor attached to the non-military helmet after cooling is implemented helping to prevent loss of cooling and a concomitant rise in brain temperature.
    [0072] In addition, this modality may include a replacement brain cooling system air bag kit. The kit comprises an inflatable headband connected to multiple, eg three, valves, which function as an air bag. The valves are positioned in the upper middle and on each side of the helmet body. In addition, the kit may include headband replacements adapted for use in an adjacent collar or spinal cord cooling system.
    [0073] When a neck injury is associated with a spinal cord contusion, this description refers to a spinal cord cooling system with at least one inflatable strap. The spinal cord cooling system comprises a strap, which can be attached to the back of a military helmet or to the body of a non-military helmet, and which accommodates a single expandable gas-filled shock absorber. The strap can be incorporated into an inflatable collar. The inflatable strap can be inflated with gas released from containers inserted into one of the bidirectional valves positioned on the upper, intermediate or lower sides of the strap body, avoiding the need to move the injured neck or spinal cord in order to implement the mechanism of cooling. The valves are bi-directional, allowing for a controlled release of pressure. Additional features of the spinal cord cooling system include a set of parachute straps, which attach to the patient's body to properly position and stabilize the hypothermic system.
    [0074] One embodiment of the invention relates to a military helmet brain or spinal cord cooling system having a plurality of interconnected inflatable pads that receive hook-and-loop fasteners whether hook-type or loop-type. The military helmet and spinal cord cooling system comprise a helmet body with preferably about 6 to 10 hollow cushion pads between the head and helmet body. The hollow cushions are constructed from an elastic material that is breathable in contact with a user's skin, and will accommodate a balloon filled with expandable gas. The interconnected inflatable cushions can be inflated with gas released from one or more containers inserted into valves positioned on the top and sides of the helmet body, which are connected to the cushion system. The military helmet and spinal cord cooling system may include an inflatable strap attached to the back of the helmet body for contact with a wearer's skin along the spinal cord. The inflatable strip is capable of being inflated with gas released from at least one container and/or canister inserted into one or more pressure sensitive bi-directional valves positioned at the top, middle or bottom of the strip. This avoids the need to move the injured head to implement the cooling mechanism. The valves are bi-directional, allowing for a controlled release of pressure.
    [0075] One embodiment of the invention relates to a replacement military helmet kit and spinal cord cooling system. The kit comprises a plurality of interconnected inflatable cushions that receive hook-and-loop fastening elements, either hook-type or loop-type, to be attached to the helmet body with about 6 to 10 hollow cushioning pads between the head and the body of the helmet. helmet. The hollow cushions are constructed from an elastic, breathable material to contact a user's skin and accommodate an expandable gas-filled balloon. The Military Helmet and Spinal Cord Cooling System kit includes an inflatable strap for attachment to the back of the helmet body. The inflatable strap contacts a user's skin along the spinal cord.
    [0076] An embodiment of the invention relates to a military helmet and spinal cord cooling system having a single inflatable headband connected to multiple, for example three, valves, which work like an air bag. The valves are positioned in the upper middle and on each side of the helmet body. In this formulation, the helmet body has about 2 to 8 fixed cushioning pads, which are peripherally positioned to allow inflation of the headband, delimiting the expansion area of the fully inflated gas-cooled pad. The Military Helmet and Spinal Cord Cooling System includes an inflatable strap attached to the back of the helmet body for contact with a wearer's skin along the spinal cord. The inflatable strip is capable of being inflated with gas released from at least one container and/or canister inserted into one or more pressure sensitive bi-directional valves positioned at the top, middle or bottom of the strip. The valves are bi-directional, allowing for a controlled release of pressure. The multiple, eg three, valves are aligned along the head bag avoiding the need to move the injured head for the purpose and implement the cooling mechanism.
    [0077] One embodiment of the invention relates to a replacement military helmet kit and spinal cord air bag cooling system. The kit comprises a single inflatable headband connected to multiple, eg three, valves, which work like an air bag. The valves are positioned in the upper middle and on each side of the helmet body. The Military Helmet and Spinal Cord Cooling System kit includes an inflatable strap for attachment to the back of the helmet body. The inflatable strap contacts a user's skin along the spinal cord.
    [0078] Another modality refers to a non-military helmet and spinal cord cooling system having a single inflatable crown cap attached to a helmet body and connected to up to three sides of the helmet body, avoiding the need to move the helmet. injured head in order to implement the cooling mechanism. The non-military helmet and spinal cord cooling system includes an inflatable strap attached to the back of the helmet body for skin contact with a wearer along the spinal cord. The inflatable strip is capable of being inflated with gas released from at least one container and/or canister inserted into one or more pressure sensitive bi-directional valves positioned at the top, middle or bottom of the strip. The valves are bi-directional, allowing for a controlled release of pressure.
    [0079] The description will be further described with reference to the attached drawings, by way of example and without limitation.
    [0080] Figure 1 diagrammatically shows a form of the apparatus or helmet of the description comprising a military helmet having a plurality of interconnected inflatable pads 106. The military helmet includes a helmet body 201 with 6-10 hollow cushioning pads 106 between the head and body of the helmet 201. The hollow pads 106 accommodate an expandable balloon filled with gas as shown in Figures 1D through 1F. The interconnected inflatable pillows 106 are inflated with gas released from the container 103 inserted into the valve 101 positioned on the top and sides of the helmet body 201, which are connected to the pillow system 106. The valves 101 are bidirectional, allowing for controlled release depression. The brain cooling system is thermostatically monitored by the inclusion of a temperature-sensitive probe connected to a 102 color indicative meter, which shows variable slices. A skilled artisan will understand that the invention is not limited to a specific method of temperature monitoring and that the invention encompasses any known technique, which includes, but is not limited to, non-invasive procedures such as monitoring radiation emitted in the spectrum of microwave.
    [0081] CO2 (or other gases) may be included in the cartridge or container 103 which allows for rapid inflation of interconnected pads 106 as shown in Figures 1C to 1F, or a headband 107 as shown in Figures 1G to 1K. The gas can be released by lateral compression of a 103 aluminum canister as shown in Figure 1 C. The gas produces an endothermic reaction. In order to release the gas, in one mode, the nozzle of the cartridge/container/can 105 is manually threaded clockwise into the valve 101 as shown in the inset of Figure 1B, allowing for rapid inflation and cooling of the interconnected pads 106 or the headband 107. The interconnected pads 106 or headband 107 function as an air pocket as diagrammed in Figure 1 after threading the nozzle 105 of the can 103 into a valve 101 positioned on the helmet body 201.
    [0082] The filling dynamics of the pads 106 or headband 107 is illustrated by arrows placed inside the respective helmets and replacing dark colored areas by light gray as shown in Figures 1D to 1K. Container 103 may have a clockwise orientation, with valves 101 and container mouth 105 threaded for a clockwise rotation like arm supination, which is generally used by a right-handed person to rotate container 103 by holding. the handle 104, threading clockwise, is generally stronger than pronation. Likewise, it is smart to adopt a single standard version for most threaded valves to eliminate confusion under stress in the field.
    [0083] Figures 2A to 2D show in detail the location of the three bidirectional valves 101 along the headpiece 202 of the helmet body 201 in use by the user 203. A bidirectional valve 101 (indicated by bidirectional arrows) is positioned on top and two other bidirectional valves 101 are positioned on the sides.
    [0084] Figure 3 is a perspective view of the military helmet. Additional features of the military helmet include a visor 110, a face mask 306 and a thermal insulating hood 112, which are attached to the military helmet after cooling is implemented and positioned to insulate the head, and prevent loss of cooling and a concomitant increase in brain temperature. The three bidirectional valves 101 are positioned along the brain cooling system, inside the helmet body 201. A color indicative meter 102, which shows temperature-dependent variable colors of the brain cooling system, is also included. Velcro fasteners/straps 303 and 305 are attached to the thermal insulating mask 306 and the helmet body 201, respectively. A clamping assembly 304, which protrudes from the helmet body 201, is designed for quick connection 309 with two rigid side straps 308 and stabilization of the chinstrap 307. A collar 311 of a wearer's combat jacket with attachments 704 ( not shown) attached is surrounded by the heat-insulating hood 112, which additionally encircles the helmet body 201, and can be fastened, from the front, with a bolt 113.
    [0085] Figure 4 diagrammatically shows another form of the apparatus of the description comprising a non-military helmet cooling system. The non-military helmet system has a single inflatable crown pad 404 attached to a non-military helmet body 401 and connected to a plurality of bi-directional valves 101, functioning as a tight cap when inflated, as shown in Figures 4B through 4E by coolant from the can/can 103. The non-military helmet brain cooling system includes a 402 non-military visor on the front, which helps isolate the head and prevent loss of cooling. The filling dynamics of crown pad 404 is illustrated by replacing light five shaded areas with dark shading 407 and a concomitant closure of gaps in crown body 404 as shown in Figures 4C through 4E.
    [0086] Figure 5 depicts a cross-sectional view of portions of a non-military helmet cooling system. The non-military helmet has a single inflatable headband 502, which connects to three valves 101, and expands like an air pocket. The valves 101 are positioned in the upper middle part and on each side of the non-military helmet cup 401. In this mode, the non-military helmet body 401 has a headband 502, which is composed of 2 to 8 cushion pads, which are peripherally positioned to allow inflation of the headband 502, delimiting the expansion area of the fully inflated gas-cooled pad after application of the container 103. The bi-directional valves 101 can allow for controlled release of pressure. The three valves 101 are aligned along the headband 502 avoiding the need to move the injured head to implement the cooling mechanism.
    [0087] Figure 6 shows a perspective and exploded view of additional features of the military helmet. The military helmet has bi-directional valves 101, a color indicative gauge 102, which shows temperature as variable colors, a face shield/mask 306, which is heat-insulated and engages Velcro fasteners/straps 303, 5 and a chin strap 307, which is slidable into two rigid side straps 308. Straps 308 have easily gripable ends 309 that connect to the helmet body 201 in the attachment assembly 304 and can be pulled to fit the jaw but allow the chin strap move with the user's jaw.
    [0088] Figure 7 is a perspective view of the thermal insulating hood 112 and the collar 311 for use in a military helmet system by a soldier. Figures 7A to 7D show a rear view, the thermal insulating hood 112 is fixed to the couplings 704, located behind the collar 311 of the soldier's combat jacket with a bolt 113 in front allowing to tighten the hood 112 in order to isolate the head from the injured user. Alternatively, when cleats 704 are not present on collar 311 of the jacket, hood 112 may be connected to a separate attachable collar 311 placed around the injured patient's neck. A set of lugs 704 located behind collar 311 is revealed when collar 311 is lifted as shown in Figures 7E and 7F. Collar 311 may function simultaneously as an inflatable cooling collar 311 and a base for securing couplings 704. Collar 311 may contain one or more pressure-sensitive bi-directional valves 101 (not shown) that are positioned to receive a container filled with agent soda. The collar may also have various structural components such as the inflatable pads or other features found throughout the remainder of the present invention or accessories such as buttons, shoulder pads, collar reinforcements and zippers. Additionally, Figure 7 depicts a thermo-insulating mask 306 and bidirectional valves 101.
    [0089] Figure 8 is a perspective view of an embodiment of the spinal cord cooling system. In this embodiment, the spinal cord cooling system has a single inflatable strap 801. The strap 801 is attached to the rear of the helmet body 201, which can accommodate a single expandable gas-filled bumper 106 (not shown). The inflatable strip 801 is inflated with gas released from the containers/cans 103 inserted into one of the bidirectional valves 101 positioned on the upper, middle or lower sides of the body of the strip 801, avoiding the need to move the injured neck or spinal cord to implement the cooling mechanism. Valves 101 are bi-directional, allowing for a controlled release of pressure. Additional features of the spinal cord cooling system include a set of 803 parachute straps, which are secured to the patient's body using 804 fasteners to properly position and stabilize the hypothermic system.
    [0090] Although the invention has been particularly shown and described with reference to particular embodiments, it will be appreciated that variations of the features and functions described above and others, or alternatives thereof, may be desirably combined in many other systems or different applications . It will also be appreciated that various presently unexpected and unanticipated alternatives, modifications, variations or improvements may subsequently be made by persons skilled in the art, which are also intended to be covered by the following claims. All references cited in this specification, and references thereto, are incorporated herein by reference in their entirety where appropriate to the teaching of additional or alternative details, resources and/or technical background.
    权利要求:
    Claims (14)
    [0001]
    1. HELMET FOR PROTECTION OF A USER'S BRAIN, characterized by comprising: a. a helmet body (201); B. one or more inflatable pads (106) attached to said helmet body, each one or more of the inflatable pads accommodating a balloon filled with expandable gas; ç. one or more pressure sensitive bidirectional valves (101); d. a temperature-sensitive probe capable of determining the wearer's brain temperature; and is. at least one container (103) containing refrigerant capable of inflating said inflatable pillows and cooling the user's brain; wherein the refrigerant is capable of providing a cooling rate to the brain ranging from 0.1°C to 0.5°C/hour.
    [0002]
    2. HELMET, according to claim 1, characterized in that the helmet is able to reduce the user's brain temperature to an average temperature ranging between 33°C to 36°C.
    [0003]
    3. HELMET, according to claim 2, characterized in that the helmet is capable of maintaining the temperature of the user's brain within the range between 33°C to 36°C for 24 hours to 96 hours, or for 48 hours to 72 hours, or for 48 hours to 56 hours.
    [0004]
    4. HELMET, according to claim 1, characterized in that the helmet is capable of cooling the user's brain to an average temperature between 33°C to 36°C within 24 hours, or within 48 hours.
    [0005]
    5. HELMET, according to claim 1, characterized in that the refrigerant is capable of providing a cooling rate to the user's brain ranging from 0.1°C to 0.4°C/hour, or that ranges from 0.1°C to 0.3°C/hour, or from 0.2°C to 0.3°C/hour.
    [0006]
    6. HELMET, according to claim 1, characterized in that the refrigerant is a cooling gas.
    [0007]
    7. HELMET, according to claim 1, characterized in that the pressure-sensitive bidirectional valves are positioned on the top and sides of the helmet body, in which one or more of the pressure-sensitive bidirectional valves allow a quantity variable gas flow on the inflatable cushions.
    [0008]
    HELMET according to claim 1, characterized in that it further comprises a face mask (306) or a visor (110) or a thermo-insulating hood (112) fixed to the body of the helmet to create a barrier of temperature.
    [0009]
    The HELMET of claim 1, further comprising one or more inflatable straps (803) for spinal cord; or a collar (311) adapted to enhance brain cooling induction by decreasing the temperature of arterial blood passing through the wearer's neck; or a replacement kit.
    [0010]
    10. HELMET, according to claim 1, characterized in that the helmet provides uniform cooling to the surface area of the lobes, frontal, parietal and occipital of the user's brain.
    [0011]
    11. HELMET, according to claim 1, characterized in that the helmet body is a military helmet, or a non-military helmet.
    [0012]
    12. METHOD OF ADAPTING A HELMET BODY (201), as defined in claim 1, to incorporate a brain cooling system, characterized in that it comprises: a. incorporating a plurality of inflatable cushions (106) interconnected in a body of the helmet, each one or more of the inflatable cushions accommodating an expandable gas-filled balloon; B. incorporating one or more pressure sensitive bidirectional valves (101) in the helmet body; ç. connecting said valves to the interconnected inflatable cushions; d. connecting at least one container (103) containing cooling gases to said valves; and. inflating said interconnected inflatable pads with the cooling gases; and f. monitor at least one temperature-sensitive probe to determine a user's brain temperature.
    [0013]
    13. METHOD according to claim 12, characterized in that it further comprises reducing the user's brain temperature to an average temperature ranging from 33°C to 36°C and/or maintaining the user's brain temperature within the range of 33°C to 36°C at a rate of 0.1°C to 0.5°C/hour.
    [0014]
    14. METHOD, according to claim 12, characterized in that it further comprises using a collar to enhance the induction of brain cooling by decreasing the temperature of the arterial blood passing through the user's neck.
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    同族专利:
    公开号 | 公开日
    BR112012033757A2|2018-02-27|
    EP2587951A4|2014-08-13|
    EP2587951A1|2013-05-08|
    WO2012006184A1|2012-01-12|
    CN103037724A|2013-04-10|
    US9770360B2|2017-09-26|
    EP2587951B1|2016-02-10|
    US20130211484A1|2013-08-15|
    EP3162329A1|2017-05-03|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-04-24| B08F| Application fees: application dismissed [chapter 8.6 patent gazette]|Free format text: REFERENTE A 8A ANUIDADE. |
    2019-05-14| B08G| Application fees: restoration [chapter 8.7 patent gazette]|
    2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-06-16| B06G| Technical and formal requirements: other requirements [chapter 6.7 patent gazette]|
    2020-11-03| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-05-04| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-25| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/06/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US35947610P| true| 2010-06-29|2010-06-29|
    US61/359,476|2010-06-29|
    PCT/US2011/042440|WO2012006184A1|2010-06-29|2011-06-29|Therapeutic brain cooling system and spinal cord cooling system|
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