Abstract:
A portable body-cooling device, comprises: a mask suitable to be positioned on the face of the patient and to cover its mouth and nose; a connector, suitable to connect said mask to a breathable gas container; and a gas container, containing a breathable gas in compressed state, which, when expanded, undergoes cooling. Also described is a method for reducing the body temperature of the patient in need thereof.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a device and a method for decreasing body temperature. 
       BACKGROUND OF THE INVENTION 
       [0002]    Body core temperature (hereinafter also referred to simply as “body temperature”) is an important parameter that influences physical systems of the body, and can determine the way in which the body will respond under different conditions. 
         [0003]    There is a high correlation between body temperature and metabolic rate. The metabolism is an energy-production process, and its rate is affected, among other factors, by the temperature of the environment. To keep a normal body temperature in a cold environment, the metabolic rate will increase, in order to produce energy that releases heat and warms up the body. 
         [0004]    A higher metabolic rate automatically inflicts a faster activity of different physical systems of the body, and increases body temperature. The correlation between body temperature and metabolic rate works in both directions, so that if the body temperature changes, it also causes the metabolic rate to change accordingly. 
         [0005]    In some cases, an increase of body temperature can be undesirable, since it causes a higher metabolic rate, which can bring to a progression of destructive processes in the body as well. According to medical researches, usually, the greater damage to the body is formed over the first few minutes after an injury. It is especially crucial when experiencing a stroke or a cardiologic episode, since they are very often followed by long-term physical complications. 
         [0006]    After cardiac arrest with no blood flow for more than five minutes, the generation of free radicals, together with other mediators, during reperfusion creates chemical cascades that result in cerebral injury. Until recently, there was no therapy with documented efficacy in preventing brain damage after cardiac arrest. 
         [0007]    Strokes happen when blood flow to the brain stops. Within minutes, brain cells begin to die. There are two kinds of stroke. The more common kind, called ischemic stroke, is caused by a blood clot that blocks or plugs a blood vessel in the brain. The other kind, called hemorrhagic stroke, is caused by a blood vessel that breaks and bleeds into the brain. “Mini-strokes” or transient ischemic attacks occur when the blood supply to the brain is briefly interrupted. In traumatic head injury not only can result in immediate seizures, it often causes chronic seizures which are frequently resistant both to medication and surgical intervention. 
         [0008]    Another example is epilepsy, which is a brain disorder that causes people to have recurring seizures. The seizures happen when clusters of nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle spasms or lose consciousness. Post-traumatic epilepsy is prevalent, often difficult to manage, and currently cannot be prevented. 
         [0009]    In hospitals, doctors use a cooling-cell to decrease the body temperature of patients who suffer from injuries that can cause long-term damages, and induce a mild therapeutic hypothermia. Although the cooling-cells in hospital can minimize the extent of injuries, it is crucial to cool the body as soon as possible, and sometimes it takes too long to get to a hospital, and in any event, the patient is not treated immediately. 
         [0010]    Another disadvantage of cooling-cells is the fact that they do not prevent the involuntary reaction of the human body to a decrease in body temperature, which is a tremor of the muscles that obtains the opposite of the desired effect, e.g., a raise in body temperature. 
         [0011]    Therefore, it is an object of the present invention to provide a device suitable to cause an immediate cooling of the body, which can be operated outdoors, and can be taken to where the patient is located. 
         [0012]    It is another object of the invention to provide a portable device that can be operated and stored essentially everywhere, so as to be available immediately when needed. 
         [0013]    It is a further object of the invention to provide a method for cooling the human body, which is simple to operate by a non-skilled operator, and which can be performed whenever needed, without prior extensive preparations. 
         [0014]    It is yet another object of the present invention to provide a device and method that overcome the drawbacks of the prior art, such as the inability to prevent involuntary tremor of the muscles. 
         [0015]    Other objects and advantages of the invention will become apparent as the description proceeds. 
       SUMMARY OF THE INVENTION 
       [0016]    The device relates to a portable body-cooling device, comprising: a mask suitable to be positioned on the face of the patient and to cover its mouth and nose; a connector, suitable to connect said mask to a breathable gas container; and a gas container, containing a breathable gas in compressed state, which, when expanded, undergoes cooling. 
         [0017]    The connector can be provided with an orifice suitable to allow the expansion of a compressed gas, thus causing the cooling of said compressed gas. The connector can also be provided with a Vortex tube that separates streams of gases into hot and cold streams. A gas expansion chamber can be provided within the connector, or it can be coupled to the gas container or to the mask. 
         [0018]    The mask can be provided with a portion located around its contacts area with the face of the patient, which can be heated to avoid involuntary tremor of the muscles. The portion can be, for example, an inflatable portion suitable to host gases, such as the patient&#39;s exhaled breath, or fluids. Another exemplary portion is a portion that can be heated by electrical means. Alternatively, the mask can be provided with a material capable of absorbing and releasing heat, such as a textile material. 
         [0019]    The device can be further provided with one or more sensors of body functions, such as pressure or flow sensors that will indicate an inhalation or an exhalation of the patient, temperature sensors, and hart rate sensors. 
         [0020]    The device can also comprise a display suitable to display information on the operation of the device and/or the patient&#39;s body parameters, and can comprise wired or wireless connection elements suitable to operably connect a smartphone, a tablet or the like device, such as to read data relating to the functioning of the device and/or the condition of the patient, and, optionally, to transmit said information or part thereof to a remote location. 
         [0021]    The invention also relates to a system, comprising the device of the invention and a processor suitable to activate one or more valves as a result of a sensed parameter relating to patient&#39;s body activity. One or more of the processors can be provided in an external device, which can be portable, like a smartphone. 
         [0022]    The invention also relates to a method for reducing the body temperature of a patient in need thereof, comprising: providing a mask suitable to be positioned on the face of the patient and to cover its mouth and nose; providing a connector, suitable to connect said mask to a breathable gas container; providing a gas container, containing a breathable gas in compressed state, which, when expanded, undergoes cooling; and applying said mask to the face of a patient, connecting the gas container to said mask via said connector, and causing gas to flow through an expansion device such as to be cooled before flowing into the inhalation inlet of said mask. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The invention will be further illustrated with reference to the appended drawings, wherein: 
           [0024]      FIG. 1  is a perspective view of the device, according to one embodiment of the invention, showing a mask; 
           [0025]      FIG. 2  is a side view of a second device, according to another embodiment of the invention, and a patient, illustrating the positioning of the mask on the patient; 
           [0026]      FIG. 3  is a perspective view of a connector that can be coupled to the gas opening of a mask; 
           [0027]      FIG. 4  is a perspective view of the mask of  FIG. 1  and the connector of  FIG. 3 , when the gas opening of the mask and the entry opening of the connector are connected: and 
           [0028]      FIG. 5  is a side view of a container, according to yet another embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0029]    Body warmth has a great influence on the metabolic rate of the body, which controls different processes in the body. As explained in the background of the invention, and as indicated according to medical researches, in some injuries, the aim of caregivers is to decrease the body temperature of the patient in order to minimize the extent of long-term complications. 
         [0030]    Nowadays, most cooling devices used for such purposes, cool the body by cooling the environment around the body by convection, or by cooling the surfaces of the body by conduction. Cooling processes of those kinds require adsorption of heat from a relatively large volume or surface, which takes a relatively long period of time. In addition, the cooling devices according to the prior art are not portable and are usually only available in hospitals. 
         [0031]    The present invention relates to a device and method for cooling the human body by utilizing the cardio-vascular system as a temperature-conduction system. The oxygen that we breathe binds to the red blood cells and travels through the blood stream to reach all the organs. If the air we breathe is at a lower temperature than the temperature of the body, when in contact, the air will adsorb the heat of the body, and as a result, the different organs will lose heat and their temperature will decrease. 
         [0032]      FIG. 1  is a perspective view of a device, according to one embodiment of the invention, showing mask  101 . Mask  101  is suitable to be placed around the breathing openings (the nose and mouth), so it is designed to surround them. Mask  101  comprises gas opening  102 , through which breathable gas is inserted. An example of breathable gas is, for example, oxygen-enriched air. 
         [0033]    Mask  101  also comprises surrounding inflatable portion  103  that is necessary for separating the breathing openings from the environment. Inflatable portion  103  provides a direct flow of air (or other breathable gases) from gas opening  102  into the nose and mouth of the person wearing mask  101 , without letting the air escape from the inner volume of mask  101 , as will be further illustrated in  FIG. 2B . 
         [0034]      FIG. 2  is a side view of an alternative mask  201  about to be placed on a patient&#39;s face and illustrating the positioning thereof around the patient&#39;s breathing openings, according to another embodiment of the invention, with an inflatable portion indicated by numeral  202 . Inflatable portion  202  is in contact with the face of patient  203 , surrounding his nose  204  and mouth  205 . 
         [0035]    Using inflatable portions around air-supplying masks is very common because it prevents air from escaping the inner volume of a mask to the environment, and therefore ensures that essentially all of the air that is supplied through the mask will be inhaled by the patient. 
         [0036]    According to medical research, it has been proven that the area of the body that senses cold temperatures and sets the natural and automatic tremor reaction in motion is the area that surrounds the breathing opening. As hereinbefore explained, the purpose of the tremor reaction is to move the muscles and release heat that will warm up the body. When trying to cool the body, it is best to avoid the tremor reaction, and the present invention provides a solution for that problem, as will be further described hereinafter. 
         [0037]    The inflatable portion of the mask, according to the present invention, is also suitable to host warm materials and function as a warming component that warms up surfaces with which it is in contact, like the skin that surrounds the breathing openings that are in contact with the inflatable portion.  FIG. 1  shows inflatable portion inlet  104 , through which materials, such as a warm gas, can flow into inflatable portion  103 . The materials can be of any type of materials that will warm up the area that is in contact with inflatable portion  103 , for example, warm air exhaled by the patient. 
         [0038]    In the embodiment of  FIG. 1  there is no continuous flow of gas into inflatable portion  103 , since no outlet is provided. Hence, portion  103  is inflated and then flow is stopped. However, in another embodiment the device can further comprise an outlet. For instance, in the embodiment of  FIG. 1  the outlet can be located anywhere on the circumference of inflatable portion  103 , similarly to inflatable portion inlet  104 , which allows the output of warming substances from inflatable portion  103 . If, for example, the material that flows into inflatable portion  103  through inflatable portion inlet  104  is warm air, it can be pushed out through said additional outlet, which provides a continuous flow of warm air through the inner space of inflatable portion  103 . 
         [0039]    An alternative component that can replace inflatable portion  103 , according to another embodiment of the invention, is a portion of a material that can keep a warm environment, such as textile fabric that is often used in ski face masks, because it retains outbreath heat and thus warms up the surrounding of the breathing opening. 
         [0040]      FIG. 1  also shows hooks  105  of a conventional type, which may or may not be present. Such hooks are usually used for positioning and securing a mask onto the face of a patient and around his breathing openings. The positioning of mask  101  by hooks  105  can be operated by stretching a flexible string and positioning it between hooks  105  and the back of the ears of the patient. Securing the mask around the breathing openings of a patient provides the freedom for a care-giver to operate and monitor the process with both hands, without the need to assure a proper positioning of the mask on the patient&#39;s face. 
         [0041]    The device of the invention is small enough to be stored inside a medical bag, a glove compartment, etc., and can be taken to the field for immediate medical attention, if needed. Therefore, the present invention provides the possibility to use a body-cooling device outside of a hospital, which is a significant advantage, compared to the prior art, especially when taking under consideration the need for an immediate body-cooling treatment when facing injuries that can cause long-term damages, which can be avoided or at least minimized if the body temperature of the patient is decreased soon enough. 
         [0042]    Gas opening  102  of the mask of  FIG. 1  is suitable to be coupled to a container that contains a gas material that can be inhaled.  FIG. 3  is a perspective view of connector  301 , which is a type of vortex tube (see, e.g., http://en.wikipedia.org/wiki/Vortex_tube) that can be coupled to gas opening  102  by entry opening  302 . Connector  301  comprises gas inlet tube  303  that can be connected to a gas container, and gas outlet tube  304 . When a gas container is connected to gas inlet tube  303 , it allows the gas to flow into connector  301  toward entry opening  302  and gas outlet tube  304 . Of course, many different connectors can be employed, and this is just one illustrative example. 
         [0043]      FIG. 4  is a perspective view of mask  101  of  FIG. 1  and connector  301  of  FIG. 3 , when gas opening  102  and entry opening  302  are connected. When gas flows through entry opening  302  into the inner volume of mask  101  it spreads and the pressure of the gas naturally drops, which causes the temperature of the gas to decrease. As will be apparent to the skilled person, allowing the gas to expand through an orifice, located within the connector, will cause the compressed gas to cool. Connector  301  is also provided with an inner structure, such as the aforementioned Vortex tube, which separates the gas stream into hot and cold streams, the cold stream being directed toward the mask and the hot stream being exhausted and, if desired, partly used to heat the inflatable portion. 
         [0044]    The term “inflatable portion”, as used herein, is not limited to materials that can be inflated and is used, for the sake of brevity, also to indicate a chamber through which gas or other material can flow, even if the flow does not cause inflation of the chamber. 
         [0045]    In one embodiment of the invention, when no Vortex tube is used and heating of the mouth area is obtained by retaining the heat of the exhaled breath, a suitable textile material is provided in the area surrounding the lips and nose of the patient, or in part of it. 
         [0046]    In order to cause the gas to flow into the inner volume of mask  101  only when the patient is inhaling, the device can be further provided with a sensor that detects the timing of inhalation and signals a processor to allow gas to flow from the gas container and into the inner volume of mask  101 , e.g., by actuating a valve that regulates the flow of the gas, and the processor can be a processor that is located within the device, or it can be an external processor that communicates with the device, such as a smartphone. Employing an external processor allows to simplify the device and to reduce its size. Moreover, it allows to upgrade the performance of the device as new and improved smartphones become available, with stronger processors. 
         [0047]    Suitable software can be provided on the external processor, to operate the device, and in the case of a smartphone an application can be used, which can be readily available from the relevant app store to a smartphone user or to a user of another suitable device, such as a tablet. 
         [0048]    Gas outlet tube  304  can be further attached to another tube that can be connected to inflatable portion inlet  104 . The gas that flows through gas outlet tube  304  does not expand and therefore keeps a temperature that is higher than the temperature of the gas that flows into the inner volume of mask  101 , so it can be used to warm the surface that comes in contact with inflatable portion  103 . 
         [0049]    Connector  301  can be replaced with any other type of connector that provides the flow of breathable gas through gas opening  102 , and it does not necessarily need to be provided with an outlet tube such as gas outlet tube  304 . The connector can comprise a valve that will help determined the flow rate and amount of gas released into gas opening  102 . 
         [0050]    When a patient that wears the mask of the device exhales, the exhaled air needs to escape the inner volume of the mask. The release of exhaled air can be obtained by one-way-valve(s) that is connected to the mask (not shown). An example of such one-way-valve is a valve that opens when pressure increases, for example, as a result of exhaling air into the inner volume of the mask. 
         [0051]    The breathable gas can comprise cooling materials, such as mint that is known to be harmless and has a cooling effect on the body. The device can further comprise an adapter that allows the connection of two containers simultaneously, as well as additional sensors, such as a thermometer and a heart-rate measuring component. 
         [0052]      FIG. 5  schematically illustrates a cooling reservoir  501  according to another embodiment of the invention, consisting of the housing  502  that contains a heat exchanger  503 , connected to a compressed gas bottle  504 . 
         [0053]    Alternatively, a low-temperature, liquefied material, such as liquid nitrogen, can be used, instead of a compressed gas. When the patient inhales air flows through openings  505  and around heat exchanger  503 , as indicated by arrows  506 , flowing on the surface of heat exchanger  503 , and thereby being cooled. Bottle  504  is fitted with a valve  507  (the tubing connecting them not being shown, for the sake of simplicity), which can be manually or electronically activated by the user. When valve  507  is actuated gas expands and flows into heat exchanger  503 . A suitable connector can be provided, either attached to reservoir  501  or to mask  101 , which is not shown for the sake of brevity. 
         [0054]    An optional cooling material reservoir  508 , containing, for instance, a fragrance such as mint, which is known to provide a cooling effect to the body, can be also coupled to reservoir  501 . Further optionally, it may be provided with a valve  509 , which can be used to regulate the release of said material into the stream of in breath that has been cooled by heat exchanger  503 . 
         [0055]    As said, in order to monitor the body temperature throughout the process, the device can be further provided with a temperature-measuring component and an indicator that will remind the care-giver to measure the body temperature of a patient. Measuring body temperature throughout the process is important in order to determine the necessary flow rate and duration of the process, since an overcooling of the body can also cause damages, such as hypothermia. 
         [0056]    The temperature-measuring component can be a conventional thermometer that measures the temperature of the surface with which it comes in contact, like thermometers that can be attached to the forehead of a patient, or it can be a component that measures the exhaled air of the patient, e.g., a thermocouple. The temperature of the exhaled air can be set as a reference point and can be used to calculate the body temperature of the patient, when taking under consideration physical indicators, such as the weight and age of the patient. 
         [0057]    The device can also be provided with a screen that shows data, such as the current body temperature, the duration of the process, hart rate, etc., or it can be connected to a smart phone instead, since smartphone devices are nowadays provided with powerful CPUs and with a variety of sensors that can be used for such purposes. The gathered data can be important while providing the treatment, can be sent on to the medical team that will treat the patient, and can also be used further on at a hospital. 
         [0058]    All the above description has been provided for the purpose of illustration and is not meant to limit the invention in any way.